APPENDIX C
STANDARD CITATIONS
This Appendix includes standard citations to be used in preparing enforcement actions. These standard
citations are available as a computer file and can be electronically transmitted either from the Office of
Enforcement or from the Regional Enforcement Coordinators.
Requirement sections are identified by bold type and are followed by one or more examples of violation
("contrary to") sections.
The following is a key to the notation used in the standard citations:
Symbol
Meaning
(____) or _____
Fill in the blank with the appropriate information
(
)
Text within parentheses indicates the optional use of an alternative word or an
optional choice or the plural form of the word preceding the parentheses.
[
]
Text within brackets indicates narrative guidance that should be followed in
terms of addressing specific elements that should be included in the particular
document.
"
"
Text within quotes indicates a suggested sentence or language.
NUREG/BR-0195, Rev. 2
C-i
Standard Citations - Index
Appendix C
- INDEX 10 CFR Part 19 NOTICES, INSTRUCTIONS, AND
REPORTS TO WORKERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
19.11 Posting of Notices to Workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
19.12 Instructions to Workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
10 CFR Part 20 STANDARDS FOR PROTECTION
AGAINST RADIATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20.1201
20.1301
20.1501
20.1502
20.1601
20.1801
20.1902
20.1904
20.1906
20.2001
20.2103
20.2106
20.2108
20.2206
Occupational Dose Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dose Limits for the Public . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Surveys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Personnel Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Control of Access to High Radiation Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Security of Stored Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Posting Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labeling Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Procedures for Receiving and Opening Packages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Waste Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records of Surveys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records of Individual Monitoring Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records of Waste Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reports of Individual Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10 CFR Part 30 DOMESTIC LICENSING OF
BYPRODUCT MATERIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . .
30.3
30.9
30.34
30.35
30.36
License Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Completeness and Accuracy of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Terms and Conditions of Licenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Financial Assurance and Recordkeeping for Decommissioning . . . . . . . . . . . . . . . . . . . . . . .
Expiration and Termination of Licenses and Decommissioning
of Sites and Separate Buildings or Outdoor Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
30.41 Transfer of Byproduct Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
30.51 Records of Receipt, Transfer, and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10 CFR Part 31 GENERAL DOMESTIC LICENSES
FOR BYPRODUCT MATERIAL . . . . . . . . . . . . . . . . . . . . .
3
3
3
4
5
5
6
6
7
7
8
8
8
9
9
11
11
11
13
13
13
16
16
17
31.5 Certain Measuring, Gauging, or Controlling Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
31.11 Certain in vitro Clinical or Laboratory Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
C-ii
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Index
10 CFR Part 34 RADIOGRAPHY
34.11
34.22
34.24
34.25
34.26
34.27
34.28
34.29
34.31
34.33
34.41
34.42
34.43
34.44
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Inspection Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Locking of Radiographic Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Radiation Survey Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Leak Testing, Tagging, Repair and Modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Quarterly Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Utilization Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Permanent Installations: Access Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Training Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Personnel Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Site Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Posting Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Radiation Surveys Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supervision of Radiographer's Assistants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21
21
21
22
22
22
22
23
23
25
25
26
26
27
10 CFR Part 35 MEDICAL USE OF BYPRODUCT
MATERIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
29
35.13
35.14
35.21
35.22
35.25
35.27
35.29
35.31
35.32
35.33
35.49
35.50
35.51
35.53
35.59
35.60
35.61
35.70
35.75
License Amendments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Radiation Safety Officer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Radiation Safety Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Visiting Authorized User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mobile Nuclear Medicine Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Radiation Safety Program Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Quality Management Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records/Reports of Misadministration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Suppliers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dose Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Calibration/Check Survey Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Measurement of Radiopharmaceutical Doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sealed and Brachytherapy Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Syringe Shields and Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vial Shields and Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Surveys for Contamination/Exposure Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Release of Patents Containing Radiopharmaceuticals or
Permanent Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35.80 Technical Regulations Mobile Nuclear Medical Services . . . . . . . . . . . . . . . . . . . . . . . . . .
35.90 Storage Volatiles and Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35.92 Decay in Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35.204 Permissible Mo-99 Concentration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35.205 Control of Aerosols and Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35.220 Possession of Survey Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35.315 Safety Precautions (Radiopharmaceuticals) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35.404 Release of Patients/Temporary Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35.406 Brachytherapy Sources Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
NUREG/BR-0195, Rev. 2
C-iii
29
30
30
31
33
34
35
36
36
39
39
39
43
45
46
48
59
59
51
52
53
54
54
55
56
56
58
58
Standard Citations - Index
35.410
35.415
35.605
35.615
35.632
35.634
Appendix C
Safety Instructions (Brachytherapy) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety Precautions (Brachytherapy) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maintenance and Repair Teletherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety Precautions (Teletherapy) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Full Calibration Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Periodic Spot-checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
59
59
60
60
61
62
10 CFR Part 71 PACKAGING AND TRANSPORTATION
OF RADIOACTIVE MATERIAL . . . . . . . . . . . . . . . . . . . . .
63
71.3 Requirement for License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
71.5 Transportation of Licensed Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
71.12 General License: NRC Approved Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
49 CFR Part 172
172.200
172.201
172.202
172.203
172.310
172.312
172.403
172.502
172.504
172.600
172.602
172.604
172.702
172.704
HAZARDOUS MATERIALS
. . . . . . . . . . . . . . . . . . . 65
Applicability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General Entries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Description of Hazardous Material on Shipping Papers . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional Description Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Radioactive Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Liquid Hazardous Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Radioactive Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prohibited Placarding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General Placarding Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Applicability and General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Emergency Response Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Emergency Response Telephone Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Responsibility for Training and Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Training Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
49 CFR Part 173
SHIPPERS: REQUIREMENTS
FOR SHIPMENTS AND
PACKAGINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
173.25 Authorized Packages and Overpacks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
173.411 Industrial Packagings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
173.415 Authorized Type A Packages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
173.421 Additional Requirements for Limited Radioactive Materials . . . . . . . . . . . . . . . . . . . . . . . .
173.422 Additional Requirements for Excepted Packages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
173.424 Exceptions for Instruments and Articles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
173.425 Transport Requirements for LSA Radioactive Materials . . . . . . . . . . . . . . . . . . . . . . . . . .
173.427 Low Specific Activity and Surface Contamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
173.448 General Transportation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
173.466 Additional Tests for Type A Packagings for
Liquids and Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
173.475 Quality Control Requirements Prior to Shipment of
Radioactive Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
C-iv
65
65
66
66
67
67
67
69
69
70
70
71
72
72
73
73
73
74
75
75
76
76
77
79
79
78
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Index
173.476 Approval of Special Form Radioactive Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
49 CFR Part 177
CARRIAGE BY PUBLIC HIGHWAY . . . . . . . . . .
81
177.817 Shipping Papers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
177.834 General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
177.842 Radioactive Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
10 CFR Part 150
EXEMPTIONS AND CONTINUED REGULATORY
REGULATORY AUTHORITY IN
AGREEMENT STATES AND IN
OFFSHORE WATERS
UNDER SECTION 274 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
30.3 Reciprocity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
NUREG/BR-0195, Rev. 2
C-v
Appendix C
Standard Citations - Part 19
10 CFR PART 19
NOTICES, INSTRUCTIONS, AND
REPORTS TO WORKERS
_______________________________
19-10
10 CFR 19.11(a) and (b) require, in part, that the licensee post current copies of Part 19,
Part 20, the license, license conditions, documents incorporated into the license, license
amendments and operating procedures; or that the licensee post a notice describing these
documents and where they may be examined. 10 CFR 19.11(c) requires that a licensee post
Form NRC-3, "Notice to Employees."
Contrary to the above, on (date) , the licensee did not post any of the required documents (or
specify which document were not posted) or notices.
This is a Severity Level
violation (Supplement VI).
NOTE:
10 CFR 19.12 pertains specifically to training to protect personnel working in or frequenting a
restricted area from exposure to radiation. There must be a relationship between the lack of
training and the potential exposure of personnel to radiation before this citation can be used.
19-20
10 CFR 19.12 requires, in part, that all individuals working in a restricted area be instructed
in the precautions and procedures to minimize exposure to radioactive materials, in the
purpose and functions of protective devices employed, and in the applicable provisions of the
Commission's regulations and licenses.
Contrary to the above, as of (date) , individuals who were working in ________________, a
restricted area, had not been instructed in the applicable provisions of the regulations and the
conditions of the license. Specifically, __________.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-1
THIS PAGE INTENTIONALLY LEFT BLANK
Appendix C
Standard Citations - Part 20
10 CFR PART 20
STANDARDS FOR PROTECTION
AGAINST RADIATION
PERMISSIBLE DOSES, LEVELS
AND CONCENTRATIONS
_____________________________
20-10
10 CFR 20.1201(a)(1)(i) requires, with exceptions not applicable here, that the licensee control
the occupational dose to individual adults to an annual dose limit of 5 rems total effective dose
equivalent.
Contrary to the above, the licensee did not limit the annual occupational dose to an adult (identify
the worker, e.g., "technologist") to 5 rems, total effective dose equivalent. Specifically, the
individual received rems, total effective dose equivalent, for the period (date) to (date) .
This is a Severity Level
20-11
violation (Supplement IV).
10 CFR 20.1201(a)(1)(ii) requires, with exceptions not applicable here, that the licensee control
the occupational dose to individual adults such that the sum of the deep-dose equivalent and
committed dose equivalent to any individual organ or tissue other than the lens of the eye does
not exceed an annual dose limit of 50 rems.
Contrary to the above, the licensee did not limit the annual dose to the (identify the organ or tissue)
of an adult (identify the worker, e.g., "technologist") to 50 rems. Specifically, for the period
(date) to (date) , the individual received rems deep-dose equivalent and rems committed dose
equivalent to the (identify the organ or tissue) for a sum of rems.
This is a Severity Level
20-15
violation (Supplement IV).
10 CFR 20.1201(a)(2)(ii) requires, with exceptions not applicable here, that the licensee control
the occupational dose to the skin or to any extremity of individual adults to an annual dose limit
of 50 rems shallow-dose equivalent.
Contrary to the above, the licensee did not limit the annual dose to the (skin) / (extremity) of an
adult (identify the worker, e.g., "technologist") to 50 rems shallow-dose equivalent. Specifically,
the individual received rems shallow-dose equivalent to the (identify the site, e.g., "skin", "left
hand", etc.) for the period (date) to (date) .
This is a Severity Level
20-25
violation (Supplement IV).
10 CFR 20.1301(a)(2) requires that the licensee conduct operations so that the dose in any
unrestricted area from external sources does not exceed 2 millirem in any one hour.
Contrary to the above, on (date) , licensee operations resulted in a dose of millirem in one hour
in (identify the area, e.g., "an employee lunch room") , an unrestricted area.
NUREG/BR-0195, Rev. 2
C-3
Standard Citations - Part 20
This is a Severity Level
Appendix C
violation (Supplement IV).
CITATIONS FOR FAILURE TO MAKE SURVEYS
NOTE:
20-30
Citations against 10 CFR 20.1501 should include, in the first paragraph, the definition of
survey in 10 CFR 20.1003. Use the paragraph below. Then list the specific citations as
subheadings, without repeating the initial paragraph. (Note: All survey citations issued
under §20.1501 are contingent on referencing some other section of the Part 20 regulations.
This does not mean that noncompliance with that other section is necessary.)
10 CFR 20.1501 requires that each licensee make or cause to be made surveys that may be
necessary for the licensee to comply with the regulations in Part 20 and that are reasonable
under the circumstances to evaluate the extent of radiation levels, concentrations or quantities
of radioactive materials, and the potential radiological hazards that could be present.
Pursuant to 10 CFR 20.1003, survey means an evaluation of the radiological conditions and
potential hazards incident to the production, use, transfer, release, disposal, or presence of
radioactive material or other sources of radiation.
20-30a
Contrary to the above, as of (date) , the licensee did not make surveys to assure compliance with
10 CFR 20. , which limits radiation exposure to (specify) . Specifically, (briefly describe the
specific circumstances1) .
This is a Severity Level
20-30b
Contrary to the above, as of (date) , the licensee did not make surveys to assure compliance with
10 CFR 20. , which limits radiation levels in (specify) . Specifically, (briefly describe the
specific circumstances1) .
This is a Severity Level
20-30c
violation (Supplement IV).
violation (Supplement IV).
Contrary to the above, the licensee did not make surveys to assure compliance with 10 CFR
20.2001(a), which describes authorized means of disposing of licensed material. Specifically, on
(date) , the licensee did not perform a survey before disposing of (specify) , which contained
(nuclide(s)) as normal, non-radioactive waste.
This is a Severity Level
violation (Supplement IV).
1
If specific dates are known or can be determined, they should be included in the description of the
circumstances.
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NUREG/BR-0195, Rev. 2
Appendix C
20-30d
Standard Citations - Part 20
Contrary to the above, as of (date) , the licensee did not make surveys to assure compliance with
10 CFR 20.2003(a), which limits the disposal of licensed material by release into a sanitary
sewerage system. Specifically, (briefly describe the specific circumstances2) .
This is a Severity Level
violation (Supplement IV).
20-40
10 CFR 20.1502(a)(3) requires, in part, that each licensee supply and require the use of
individual monitoring devices by individuals entering a high or very high radiation area.
20-40a
Contrary to the above, on (date) , the licensee did not (supply) / (require the use of) an individual
monitoring device by a (identify the worker, e.g., "technologist") who entered the (identify the
area) , a high radiation area with a radiation dose rate of approximately rem in one hour at 30
centimeters from the (radiation source) / (surface that the radiation penetrated) .
This is a Severity Level
20-40b
Contrary to the above, on (date) , the licensee did not (supply) / (require the use of) an
individual monitoring device by a (identify the worker, e.g., "technologist") who entered the
(identify the area) , a very high radiation area with a radiation dose rate of approximately rads
in one hour at one meter from the (radiation source) / (surface that the radiation penetrated) .
This is a Severity Level
20-45
violation (Supplement IV).
violation (Supplement IV).
10 CFR 20.1601(a) requires, with exceptions not applicable here, that the licensee ensure that
each entrance to a high radiation area has one or more of the following features: (1) a control
device that, upon entry into the area, causes the level of radiation to be reduced below that
level at which an individual might receive a deep-dose equivalent of 0.1 rem in one hour at 30
centimeters from the radiation source or from any surface that the radiation penetrates; (2) a
control device that energizes a conspicuous visible or audible alarm signal so that the individual
entering the high radiation area and the supervisor of the activity are made aware of the entry;
or (3) entryways that are locked, except during periods when access to the areas is required,
with positive control over each individual entry.
10 CFR 20.1601(b) provides that, in place of the controls required by 10 CFR 20.1601(a) for
a high radiation area, a licensee may substitute continuous direct or electronic surveillance that
is capable of preventing unauthorized entry.
Contrary to the above, as of (date) , the entrance to the (identify the area, e.g., by room number,
location, etc.) , a high radiation area with a radiation dose rate of approximately millirem in one
hour at 30 centimeters from the (radiation source) / (surface that the radiation penetrated) , was
not controlled by any of the methods described in 10 CFR 20.1601(a) or (b).
This is a Severity Level
violation (Supplement IV).
2
If specific dates are known or can be determined, they should be included in the description of the
circumstances.
NUREG/BR-0195, Rev. 2
C-5
Standard Citations - Part 20
Appendix C
SECURITY
20-60
10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed
materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 requires that the
licensee control and maintain constant surveillance of licensed material that is in a controlled
or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area
means an area, outside of a restricted area but inside the site boundary, access to which can
be limited by the licensee for any reason; and unrestricted area means an area, access to which
is neither limited nor controlled by the licensee.
Contrary to the above, on (date) , the licensee did not secure from unauthorized removal or limit
access to (specify the type and amount of licensed material) located in (identify the area) , which
is (a controlled area) / (an unrestricted area), nor did the licensee control and maintain constant
surveillance of this licensed material.
This is a Severity Level
20-65
violation (Supplement IV).
10 CFR 20.1902(a) requires that the licensee post each radiation area with a conspicuous sign
or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."
Contrary to the above, as of (date) , the (identify the area) , a radiation area with a radiation dose
rate of approximately
millirem in one hour at 30 centimeters from the (radiation source) /
(surface that the radiation penetrated) was not posted with a sign bearing the radiation symbol and
the words "CAUTION, RADIATION AREA."
This is a Severity Level
20-70
violation (Supplement IV).
10 CFR 20.1902(e) requires that the licensee post each area or room in which certain amounts
of licensed material, specified in §20.1902(e), are used or stored, with a conspicuous sign or
signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE
MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."
Contrary to the above, on (date) , the (identify the room) , an area or room in which (specify
radionuclide and approximate quantity) was (used) / (stored) , was not posted with a conspicuous
sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE
MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."
This is a Severity Level
violation (Supplement IV).
C-6
NUREG/BR-0195, Rev. 2
Appendix C
20-75
Standard Citations - Part 20
10 CFR 20.1904(a) requires the licensee to ensure that each container of licensed material bears
a durable, clearly visible label bearing the words "CAUTION, RADIOACTIVE
MATERIAL," or "DANGER, RADIOACTIVE MATERIAL." The label must also provide
sufficient information (such as the radionuclide(s) present, an estimate of the quantity of
radioactivity, the date for which the activity is estimated, etc.) to permit individuals handling
or using the containers, or working in the vicinity of the containers, to take precautions to
avoid or minimize exposures.
Contrary to the above, on (date) , a container of (specify the licensed material) did not bear a
label that identified the radionuclide(s) or the quantity of radioactivity, nor did it otherwise bear
sufficient information to permit individuals handling or using the container, or working in the vicinity
of the container, to take precautions to avoid or minimize exposure.
This is a Severity Level
20-76
violation (Supplement IV).
10 CFR 20.1904(b) requires that, prior to removal or disposal of empty uncontaminated
containers to unrestricted areas, each licensee remove or deface the radioactive material label
or otherwise clearly indicate that the container no longer contains radioactive materials.
Contrary to the above, on (date) , the licensee transferred empty uncontaminated containers labeled
as containing (specify the licensed material) to the non-radioactive trash without first removing
or defacing the radioactive material label or otherwise indicating that the containers no longer
contained radioactive material.
This is a Severity Level
violation (Supplement IV).
20-80
10 CFR 20.1906(b) and (c) require that each licensee monitor the external surfaces of a
package labeled with a Radioactive White 1, Yellow II, or Yellow III label for: (1) radioactive
contamination, unless the package contains only radioactive material in the form of a gas or in
special form as defined in 10 CFR 71.4; and (2) radiation levels, unless the package contains
quantities of radioactive material that are less than or equal to the Type A quantity, as defined
in 10 CFR 71.4 and Appendix A to Part 71. This monitoring shall be performed as soon as
practicable, but not later than 3 hours after receipt of the package during the licensee's normal
working hours, or not later than 3 hours from the beginning of the next working day if it is
received after working hours.
20-80a
Contrary to the above, on (date) , the licensee received a package labeled with a Radioactive
(White I) / (Yellow II) / (Yellow III) label (during working hours) / (after working hours) , the
package was not exempt from the monitoring requirement for (radioactive contamination) /
(radiation levels) , and the licensee did not perform the required monitoring. Specifically, the
package received by the licensee contained (specify the radionuclide and approximate quantity)
in (specify) form.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement IV).
C-7
Standard Citations - Part 20
20-80b
Appendix C
Contrary to the above, on (date, time) , the licensee received a package labeled with a Radioactive
(White I) / (Yellow II) / (Yellow III) label (during working hours) / (after working hours) , the
package was not exempt from the monitoring requirement for (radioactive contamination) /
(radiation levels) , and the licensee did not perform the required monitoring within 3 hours (after
receipt) / (from the beginning of the next working day) . Specifically, the package received by the
licensee contained (specify the radionuclide and approximate quantity) in (specify) form, and
the licensee did not monitor the package until (date, time) .
This is a Severity Level
violation (Supplement IV).
WASTE DISPOSAL
20-90
10 CFR 20.2001(a) requires that the licensee dispose of licensed material only by certain
specified procedures.
Contrary to the above, on (date) , the licensee disposed of (specify the type and amount of licensed
material) by release to the non-radioactive trash, a method not authorized by §20.2001.
This is a Severity Level violation (Supplement IV).
RECORDS, REPORTS, AND NOTIFICATIONS
20-100
10 CFR 20.2103(a) requires that each licensee maintain records of the results of surveys and
calibrations required by § § 20.1501 and 20.1906(b). The licensee shall retain these records
for three years after the record is made.
Contrary to the above, as of (date) , the licensee did not maintain records of the results of
(surveys) / (calibrations) performed on (date(s)) and these (surveys) / (calibrations) were
required by (§20.1501) / (§20.1906(b)) .
This is a Severity Level
20-105
violation (Supplement IV).
10 CFR 20.2106(a) requires, in part, that each licensee maintain records of doses received by
all individuals for whom monitoring was required pursuant to §20.1502, and records of doses
received during planned special exposures, accidents, and emergency conditions.
20-105a Contrary to the above, as of (date) , the licensee did not maintain records of doses received by a
(identify the individual, e.g., "technologist"), an individual for whom monitoring was required
pursuant to §20.1502.
This is a Severity Level
violation (Supplement IV).
20-105b Contrary to the above, as of (date) , the licensee did not maintain records of doses received by a
(identify the individual, e.g., "health physics technician") , an individual for whom monitoring was
required (during a planned special exposure) / (during an accident) / (during emergency conditions)
that occurred on (date) .
This is a Severity Level
violation (Supplement IV).
C-8
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Appendix C
20-110
Standard Citations - Part 20
10 CFR 20.2106(a) requires, in part, that each licensee maintain records of doses received by
all individuals for whom monitoring was required pursuant to §20.1502, and records of doses
received during planned special exposures, accidents, and emergency conditions.
10 CFR 20.2106(c) requires that such records be maintained on NRC Form 5, in accordance
with the instructions for NRC Form 5, or in clear and legible records containing all of the
information required by NRC Form 5.
Contrary to the above, as of (date) , the licensee did not maintain records of doses received by
individuals for whom monitoring was required pursuant to §20.1502 that contained all of the
information required by NRC Form 5. Specifically, the licensee did not maintain (identify the
missing information) , which is information required by NRC Form 5.
This is a Severity Level
20-115
violation (Supplement IV).
10 CFR 20.2108 requires that each licensee maintain records of the disposal of licensed
materials made under § § 20.2002, 20.2003, 20.2004, 20.2005, Part 61, and disposal by burial
in soil, including burials authorized before January 28, 1981.
Contrary to the above, on (date(s)) , the licensee disposed of (specify the type and amount of
licensed material) by (method of disposal3) , and the licensee did not maintain a record of these
disposal(s).
This is a Severity Level
20-130
violation (Supplement IV).
10 CFR 20.2206 requires that certain licensees submit an annual report of the results of
individual monitoring carried out by the licensee for each individual for whom monitoring was
required by 10 CFR 20.1502 during that year.
Contrary to the above, although the licensee is subject to the reporting requirement in
10 CFR 20.2206, as of (date) , the licensee did not submit the required report for calendar year(s)
.
This is a Severity Level
violation (Supplement IV).
3
For location-specific disposals such as burial, if the disposal location is known or can be determined, it should
be specified in the violation.
NUREG/BR-0195, Rev. 2
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NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 30
10 CFR PART 30
DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
__________________________
CITATIONS FOR ACTIVITIES OR LOCATIONS NOT
AUTHORIZED BY A LICENSE
NOTE: If a non-licensee conducts activities for which a license is required, use 30-10. If an activity has
been conducted by a licensee which is not authorized by the license, use 30-30a. If an activity has
been conducted by a licensee at a place not authorized by the license, use 30-30b. If an Agreement
State licensee conducts an activity in NRC jurisdiction without filing NRC Form-241, use 150-10.
30-10
10 CFR 30.3 requires, in part, that except for persons exempted, no person shall possess or use
byproduct material except as authorized by a specific or general license issued pursuant to Title
10, Chapter 1, Code of Federal Regulations.
Contrary to the above, on (date) , (name of person or corporate entity) (possessed) / (used)
(nuclide) without a valid NRC license, and was not exempt from the requirements for a license.
This is a Severity Level
30-20
violation (Supplement VI).
10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee
be complete and accurate in all material respects.
Contrary to the above, the licensee did not provide to the Commission information that was complete
and accurate in all material respects. Specifically, on (date) , ___________________________.
This information was material because _______________.
This is a Severity Level
30-22
violation (Supplement VII).
10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee,
or information required by the Commission's regulations to be maintained by the licensee, shall
be complete and accurate in all material respects.
Contrary to the above, on (date) , information provided by licensee's (title of employee) to an
NRC inspector was inaccurate in that (employee) , in response to the inspector's questions
regarding _______________, stated that _______________. This statement was not accurate in
that ________________. This statement was material because _______________.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VII).
C-11
Standard Citations - Part 30
30-30
Appendix C
10 CFR 30.34(c) requires, in part, that each licensee confine his possession and use of
byproduct materials to the locations and purposes authorized by the license.
of License No. ___________ requires that licensed material be used only at
Condition
________________.
Contrary to the above, on (date) , the licensee possessed (specify amount and type of licensed
material) at ______________, a location not authorized by the license.
This is a Severity Level
30-30a
violation (Supplement VI).
10 CFR 30.34(c) requires, in part, that each licensee confine his possession and use of
byproduct materials to the locations and purposes authorized by the license.
Condition
use(s)) .
of License No. ___________ limits the use of licensed materials to (specify the
Contrary to the above, on (date) , the licensee used (byproduct material) for (specify the use) ,
a use not authorized by the license.
This is a Severity Level
30-30b
violation (Supplement VI).
10 CFR 30.34(c) requires, in part, that each licensee confine his possession and use of
byproduct material to the locations and purposes authorized by the license.
Contrary to the above, on (date) , the licensee did not confine its (possession) / (use) of
byproduct material to the location(s) authorized by the license. Specifically, the licensee
(possessed) / (used) (byproduct material) at (specify the location) , a location not authorized
by the license.
This is a Severity Level
violation (Supplement VI).
DECOMMISSIONING
NOTE: For a violation of 30.35(c)(4), first determine whether the licensee is subject to 10 CFR 30.35(a)
or (b). Use either 30-32 or 30-33, as appropriate, followed by 30-34.
30-32
10 CFR 30.35(a) requires each applicant for a specific license authorizing possession and use
of unsealed byproduct material of half-life greater than 120 days and in quantities exceeding
105 times the applicable quantities set forth in 10 CFR Part 30 Appendix B to submit a
decommissioning funding plan as described in 10 CFR 30.35(e). The decommissioning funding
plan must also be submitted when a combination of isotopes is involved if R divided by 105 is
greater than 1 (unity rule), where R is defined as the sum of the ratios of the quantity of each
isotope to the applicable value in 10 CFR Part 30 Appendix B.
C-12
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 30
30-33
10 CFR 30.35(b) requires, in part, that each applicant for a specific license authorizing
possession and use of byproduct material of half-life greater than 120 days and in quantities
specified in 10 CFR 30.35(d) must either--(1) Submit a decommissioning funding plan as
described in 10 CFR 30.35(e); or (2) Submit a certification that financial assurance for
decommissioning has been provided in the amount prescribed by 10 CFR 30.35(d) using one
of the methods described in 10 CFR 30.35(f).
30-34
10 CFR 30.35(c)(4) requires any licensee who has submitted an application for license renewal
before July 27, 1990, to provide financial assurance for decommissioning in accordance with
10 CFR 30.35(a) and (b). This assurance was required to be submitted by November 24, 1995.
Contrary to the above, the licensee applied for renewal of Byproduct Material License (number)
on (date) , and the license authorizes possession and use of (quantity) of (nuclide) and is
therefore subject to 10 CFR (specify "30.35(a)" or "30.35(b)" ; however, as of (date) , the
licensee did not submit a decommissioning funding plan or otherwise satisfy the requirements for
providing financial assurance for decommissioning.
This is a Severity Level ___ violation (Supplement VI).
NOTE: Citations for violations of the Timeliness Rule must be modified to conform to differences in
wording among the requirements in 10 CFR 30.36, 40.42, 70.38, and 72.54. Standard Citations for
10 CFR 30.36 are provided below. These citations may be used as a template to formulate citations
for violations of 10 CFR 40.42, 70.38, or 72.54. For failure to begin decommissioning when
required, use 30-36b and follow with either 30-36d or 30-36e. For failure to submit a
decommissioning plan, use 30-36b and then follow with 30-36f and 30-36g.
30-36a
10 CFR 30.36(d) requires, in part, that licensees provide notification to the NRC in writing within
60 days of any of the following occurrences:
(1) The license has expired,
(2) The licensee has decided to permanently cease principal activities at the entire site or in any
separate building or outdoor area that contains residual radioactivity such that the building or
outdoor area is unsuitable for release in accordance with NRC requirements,
(3) No principal activities under the license have been conducted for a period of 24 months, or
(4) No principal activities have been conducted for a period of 24 months in any separate building
or outdoor area that contains residual radioactivity such that the building or outdoor area is
unsuitable for release in accordance with NRC requirements.
Contrary to the above, as of (date) , (specify the occurrence from (1) through (4) above, e.g., "the
licensee permanently ceased principal activities conducted under Byproduct Material License No.
(number)" , and the licensee failed to notify the NRC in writing within 60 days of this occurrence.
(Add, if appropriate: Specifically, the licensee did not notify the NRC of this occurrence until
(date) .
This is a Severity Level ___ violation (Supplement VI).
NUREG/BR-0195, Rev. 2
C-13
Standard Citations - Part 30
30-36b
Appendix C
10 CFR 30.36(d) requires in part that, unless an extension of time has been granted by the
Commission pursuant to §30.36(f), in addition to notifying the NRC of any of the following
occurrences:
(1) The license has expired, or
(2) The licensee has decided to permanently cease principal activities at the entire site or in any
separate building or outdoor area that contains residual radioactivity such that the building or
outdoor area is unsuitable for release in accordance with NRC requirements, or
(3) No principal activities under the license have been conducted for a period of 24 months, or
(4) No principal activities have been conducted for a period of 24 months in any separate building
or outdoor area that contains residual radioactivity such that the building or outdoor area is
unsuitable for release in accordance with NRC requirements,
a licensee shall either: (1) begin decommissioning its site, or any separate building or outdoor area
so that the building or outdoor area is suitable for release in accordance with NRC requirements;
or (2) if required by §30.36(g)(1), submit, within 12 months of the notification, a decommissioning
plan and begin decommissioning upon approval of that plan.
30-36c
10 CFR 30.36(e)(1) requires that any license who has not provided financial assurance to cover
the detailed cost estimate submitted with the decommissioning plan shall do so by November
24, 1995.
Contrary to the above, the licensee submitted its detailed cost estimate for decommissioning on
(date) ; however, as of (date) , the licensee has not provided financial assurance to cover the
detailed cost estimate.
This is a Severity Level
30-36d
violation (Supplement VI).
Contrary to the above, the licensee had not been granted an extension of time under §30.36(f) and
was not required to submit a decommissioning plan pursuant to §30.36(g)(1), and, as of (date) ,
the licensee notified NRC that (specify the occurrence from (1) through (4) of Standard Citation
30-36b above, e.g., "the licensee permanently ceased principal activities conducted under Byproduct
Material License No. (number)" ; however, the licensee failed to begin decommissioning its (site)/
(building) / (area) containing residual activity, including (specify nuclide(s) and approximate
activity) . Specifically, the licensee (did not begin) / (had not begun) decommissioning (until)
/ (as of) (date) .
This is a Severity Level ___ violation (Supplement VI).
30-36e
Contrary to the above, the NRC approved the licensee's decommissioning plan on (date) ; however,
the licensee (did not begin) / (had not begun) decommissioning (until) / (as of) (date) .
This is a Severity Level ___ violation (Supplement VI).
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NUREG/BR-0195, Rev. 2
Appendix C
30-36f
10 CFR 30.36(g)(1) requires that a decommissioning plan must be submitted if required by
license condition or if the procedures and activities necessary to carry out the decommissioning
have not been previously approved by the Commission and these procedures could increase
potential health and safety impacts to workers or to the public, such as in any of the following
cases:
(i)
(ii)
30-36g
Standard Citations - Part 30
Procedures would involve techniques not applied routinely during cleanup or
maintenance operations;
Workers would be entering areas not normally occupied where surface contamination
and radiation levels are significantly higher than routinely encountered during
operation;
(iii)
Procedures could result in significantly greater airborne concentrations of radioactive
materials than are present during operation; or
(iv)
Procedures could result in significantly greater releases of radioactive material to the
environment than those associated with operation.
Contrary to the above, as of (date) , the licensee, who was not granted an extension of time
pursuant to §30.36(f), notified NRC that (specify the occurrence from (1) through (4) of
Standard Citation 30-36b above, e.g., "the licensee permanently ceased principal activities
conducted under Byproduct Material License No. (number)" , and the licensee was required
by §30.36(g)(1) to submit a decommission plan within 12 months of that date because (specify
the reason(s), i.e., either required by license condition or choose from i - iv of Standard Citation
30-36e above) ; however, the licensee
(did not submit) / (has not submitted)
a
decommissioning plan (until) / (as of) (date) .
This is a Severity Level ___ violation (Supplement VI).
30-36h
10 CFR 30.36(h) requires, in part, that a licensee complete decommissioning of its site or
separate building or outdoor area as soon as practicable but no later than 24 months following
the initiation of decommissioning, unless the NRC has approved an alternative
decommissioning schedule.
Contrary to the above, the licensee initiated decommissioning of its (identify the site, building, or
outdoor area) on (date) ; however, the licensee (did not complete) / (had not completed) the
decommissioning (until) / (as of)
(date) , and the NRC has not approved an alternate
decommissioning schedule.
This is a Severity Level ___ violation (Supplement VI).
NUREG/BR-0195, Rev. 2
C-15
Standard Citations - Part 30
Appendix C
TRANSFER OF MATERIAL
30-40
10 CFR 30.41(a) and (b)(5) require, in part, that no licensee transfer byproduct material except
to a person authorized to receive such byproduct material under the terms of a specific or
general license issued by the Commission or Agreement State.
Contrary to the above, on (date) , the licensee transferred a source containing ____ curies of
(nuclide) to (person) , a person who was not authorized to receive such byproduct material under
the terms of a specific or general license issued by the Commission or Agreement State.
This is a Severity Level
30-41
violation (Supplement VI).
10 CFR 30.41(c) requires that, prior to transferring byproduct material, the licensee verify that
the transferee's license authorizes the receipt of the type, form, and quantity of byproduct
material to be transferred. 10 CFR 30.41(d) specifies acceptable methods for this verification.
Contrary to the above, on (date) , the licensee transferred millicuries of (byproduct material)
to (transferee) and, prior to the transfer, the licensee did not verify by an acceptable method that
the transferee's license authorized receipt of this material.
This is a Severity Level
30-50
violation (Supplement VI).
10 CFR 30.51(a) requires that each licensee keep records showing the receipt, transfer, and
disposal of byproduct material.
Contrary to the above, as of (date) , the licensee did not keep records of the (receipt) / (transfer)
/ (disposal) of (byproduct material) .
This is a Severity Level
violation (Supplement VI).
C-16
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 31
10 CFR PART 31
GENERAL DOMESTIC LICENSES
FOR BYPRODUCT MATERIAL
_______________________________
31-20
10 CFR 31.5(c)(1) requires that any person who acquires, receives, possesses, uses or transfers
byproduct material in a device pursuant to a general license shall assure that all labels affixed
to the device at the time of receipt and bearing a statement that removal of the label is
prohibited are maintained thereon and shall comply with all instructions and precautions
provided by such labels.
31-20a
Contrary to the above, as of (date) , the licensee did not assure that a label affixed to a
(manufacturer, model, name of device) containing (byproduct material) was maintained on the
device, and the label was affixed to the device at the time of receipt and bore a statement that
removal of the label is prohibited.
This is a Severity Level
31-20b
Contrary to the above, as of (date) , the licensee did not comply with all instructions and
precautions provided by the label affixed to a (manufacturer, model, name of device) containing
(nuclide). Specifically, although the label was affixed to the device at the time of receipt and bore
statements that removal of the label is prohibited and that (specify the instruction or precaution) ,
the licensee did not ________________ ___.
This is a Severity Level
31-21
violation (Supplement VI).
violation (Supplement VI).
10 CFR 31.5(c)(2) requires, with certain exceptions, that any person who acquires, receives,
possesses, uses or transfers byproduct material in a device pursuant to a general license shall
assure that the device is tested for leakage of radioactive material and proper operation of the
on-off mechanism and indicator, if any, at no longer than six month intervals or at such other
intervals as are specified in the label.
Contrary to the above, the licensee's (manufacturer, model, name of device containing (nominal
activity) (nuclide) was not tested for (leakage) / (proper operation of the on-off mechanism) /
(proper operation of the on-off indicator) between (date) and (date) , an interval greater than
the required (time) interval specified (in the regulation) / (on the label) , and the device was not
subject to the specified exemptions.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-17
Standard Citations - Part 31
31-22
Appendix C
10 CFR 31.5(c)(3) requires that any person who acquires, receives, possesses, uses or transfers
byproduct material in a device pursuant to a general license shall assure that tests for leakage
of radioactive material and proper operation of the on-off mechanism and indicator, if any, and
other testing, installation, servicing, and removal from installation involving the radioactive
material, its shielding or containment, are performed: (1) in accordance with the instructions
provided by the labels; or (2) by a person holding a specific license pursuant to 10 CFR Parts
30 and 32 or from an Agreement State to perform such activities.
Contrary to the above, on (date) , (specify the testing, installation, servicing, or removal activity)
of the licensee's (manufacturer, model, name of device) containing (nuclide) was not performed
in accordance with the instructions provided by the labels or by a person holding a specific license
pursuant to 10 CFR Parts 30 and 32 or from an Agreement State to perform such activities.
Specifically, _____.
This is a Severity Level
31-23
violation (Supplement VI).
10 CFR 31.5(c)(4) requires, in part, that any person who acquires, receives, possesses, uses or
transfers byproduct material in a device pursuant to a general license shall maintain records
showing the results of tests for leakage and proper operation of the on-off mechanism and
indicator, and of other testing, installation, servicing, and removal from installation involving
the radioactive material, its shielding or containment. The records must show the dates of
performance of, and the names of the persons performing the recorded event, and be retained
for three years or until the sealed source is transferred or disposed of.
Contrary to the above, as of (date) , the licensee did not maintain records of (specify the testing,
installation, servicing, or removal activity) performed on (date) on the licensee's (manufacturer,
model, name of device) containing (byproduct material) .
This is a Severity Level
31-25
violation (Supplement VI).
10 CFR 31.5(c)(6) requires that any person who acquires, receives, possesses, uses or transfers
byproduct material in a device pursuant to a general license shall not abandon the device
containing byproduct material.
Contrary to the above, as of (date) , the licensee abandoned a (manufacturer, model, name of
device) containing (nuclide) that the licensee possessed pursuant to a general license.
Specifically, the device was (indicate how abandoned) .
This is a Severity Level
violation (Supplement VI).
C-18
NUREG/BR-0195, Rev. 2
Appendix C
31-27
Standard Citations - Part 31
10 CFR 31.5(c)(8) requires, in part, that any person who acquires, receives, possesses, uses or
transfers byproduct material in a device pursuant to a general license shall, except as provided
in 10 CFR 31.5(c)(9), transfer or dispose of the device containing byproduct material only by
transfer to persons holding a specific license pursuant to 10 CFR Parts 30 and 32 or from an
Agreement State to receive the device.
Contrary to the above, on (date) , the licensee (transferred) / (disposed of) a (manufacturer,
model, name of device) containing (nuclide) , and this (transfer) / (disposal) was not made to
a person holding a specific license pursuant to 10 CFR Parts 30 and 32 or from an Agreement State
to receive the device, and the exceptions in 10 CFR 31.5(c)(9) did not apply. Specifically, the device
was (transferred to) / (disposed of in) an unlicensed (individual/company) .
This is a Severity Level
31-85
violation (Supplement VI).
10 CFR 31.11(c)(1) requires, in part, that the general licensee shall not possess at any one time,
pursuant to the general license in 10 CFR 31.11(a), at any one location of storage or use, a total
amount of iodine-125, iodine-131, selenium-75, and/or iron-59 in excess of 200 microcuries.
Contrary to the above, on (date) , at (location) , the licensee possessed (activity) of (nuclide)
under the general license, an amount in excess of 200 microcuries.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-19
THIS PAGE INTENTIONALLY LEFT BLANK
C-20
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 34
10 CFR PART 34
RADIOGRAPHY
__________________
34-10
10 CFR 34.11(d)(1) requires, in part, that an applicant have an inspection program that
requires the observation of the performance of each radiographer and radiographer's assistant
during an actual radiographic operation at intervals not to exceed three months.
License Condition ___ incorporates the inspection program containing the requirements stated
in 10 CFR 34.11(d)(1) as submitted in licensee's application dated ___________, into License
No. _______________.
Contrary to the above, as of (date) , the licensee had not observed the performance of a
(radiographer) / (radiographer's assistant) involved in radiographic operations since (date) , an
interval in excess of three months.
This is a Severity Level
34-20
violation (Supplement VI).
10 CFR 34.22(a) requires, in part, that, during radiographic operations, the sealed source
assembly be secured in the shielded position each time the source is returned to that position.
Contrary to the above, on (date) , a licensee radiographer did not secure the sealed source
assembly in the shielded position after returning the source to the shielded position at the termination
of a radiographic exposure.
This is a Severity Level
34-30
violation (Supplement VI).
10 CFR 34.24 requires, in part, that each survey instrument used to conduct physical radiation
surveys be calibrated at intervals not to exceed three months and after each instrument
servicing.
Contrary to the above, on (date) , a licensee radiographer conducted physical radiation surveys
with a (model name and number) survey instrument which was last calibrated on (date) , an
interval greater than three months.
This is a Severity Level
34-30a
violation (Supplement VI).
10 CFR 34.24 requires, in part, that the licensee maintain sufficient calibrated and operable
radiation survey instruments to make physical radiation surveys as required by 10 CFR Parts
20 and 34.
Contrary to the above, on (date) , the licensee did not maintain sufficient calibrated and operable
radiation survey meters to make the physical radiation surveys as required by 10 CFR Parts 20 and
34 during radiographic operations at (location) in that no operable radiation survey instruments
were available at the site.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-21
Standard Citations - Part 34
34-40
Appendix C
10 CFR 34.25(b) requires that each sealed source be tested for leakage at intervals not to
exceed six months.
Contrary to the above, from (date) to (date) , an interval greater than six months, the licensee
did not leak test its _____ Curie (nuclide) sealed source.
This is a Severity Level
34-50
violation (Supplement VI).
10 CFR 34.26 requires, in part, that the licensee conduct a quarterly inventory to account for
all sealed sources.
Contrary to the above, from (date) to (date) , an interval encompassing
licensee did not perform an inventory of its sealed sources.
This is a Severity Level
34-60
quarterly periods, the
violation (Supplement VI).
10 CFR 34.27 requires, in part, that each licensee maintain current utilization logs, which shall
be kept available for three years from the date of the recorded events, for inspection by the
Commission, at the address specified in the license, showing for each sealed source: the make
and model number of the radiographic exposure device or storage container in which the sealed
source is located; the identity of the radiographer to whom assigned; and the plant or site
where used and dates of use.
Contrary to the above, on (date) , the licensee did not maintain utilization logs at its facility located
in ____________, for radiographic operations conducted between (date) and (date) , at
(location(s)) .
This is a Severity Level
34-61
violation (Supplement VI).
10 CFR 34.27 requires, in part, that each licensee maintain current utilization logs, which shall
be kept available for three years from the date of the recorded events, for inspection by the
Commission, at the address specified in the license, showing for each sealed source: the make
and model number of the radiographic exposure device or storage container in which the sealed
source is located; the identity of the radiographer to whom assigned; and the plant or site
where used and dates of use.
Contrary to the above, as of (date) , the licensee's utilization logs were inadequate in that the logs
did not show for each sealed source: (indicate the deficiencies) .
This is a Severity Level
34-70
violation (Supplement VI).
10 CFR 34.28(a) requires that the licensee check radiographic exposure devices, storage
containers, and source changers for obvious defects prior to use each day the equipment is
used.
Contrary to the above, on (date) , the licensee did not check a
(exposure device, etc.) for defects prior to use that day.
C-22
(model name and number)
NUREG/BR-0195, Rev. 2
Appendix C
34-80
Standard Citations - Part 34
This is a Severity Level violation (Supplement VI).
10 CFR 34.29(b) requires that each entrance used for personnel access to the high radiation
area in a permanent radiographic installation have both visible and audible signals to warn of
the presence of radiation. The visible signal must be actuated by radiation whenever the source
is exposed and the audible signal must be actuated when an attempt is made to enter the
installation while the source is exposed.
Contrary to the above, on (date) , each entrance used for personnel access to the high radiation
area of the licensee's permanent radiographic installation located at __________ did not have either
visible or audible signals (or specify which one was lacking) as required.
This is a Severity Level
34-90
violation (Supplement VI).
10 CFR 34.31(a) requires that the licensee not permit any individual to act as a radiographer
until such individual: has been instructed in the subjects outlined in Appendix A of
10 CFR Part 34; has received copies of and instruction in NRC regulations contained in
10 CFR Part 34 and in the applicable sections of 10 CFR Parts 19 and 20, NRC license(s)
under which the radiographer will perform radiography, and the licensee's operating and
emergency procedures; has demonstrated competence to use the licensee's radiographic
exposure devices, sealed sources, related handling tools, and survey instruments; and has
demonstrated understanding of the instructions in this paragraph by successful completion of
a written test and field examination on the subjects covered.
Contrary to the above, between (date) and (date) , the licensee permitted (an) individual(s) to
act as (a) radiographer(s) on _____ occasions without any of the above requirements being fulfilled.
This is a Severity Level
34-91
violation (Supplement VI).
10 CFR 34.31(a)(2) requires that the licensee not permit any individual to act as a radiographer
until such individual has received copies of and instruction in NRC regulations contained in 10
CFR Part 34 and in the applicable sections of 10 CFR Parts 19 and 20, NRC license(s) under
which the radiographer will perform radiography, and the licensee's operating and emergency
procedures.
Contrary to the above, the licensee permitted (an) individual(s) to act as (a) radiographer(s) on
(date) at (location) without having received (copies of and instruction in the applicable sections
of 10 CFR Parts 19 and 20) / (the NRC license(s) under which the radiographer performed
radiography) / (the licensee's operating and emergency procedures) .
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-23
Standard Citations - Part 34
34-92
Appendix C
10 CFR 34.31(a)(4) requires that the licensee not permit any individual to act as a radiographer
until such individual has demonstrated understanding of the instructions in the subjects
outlined in Appendix A of 10 CFR Part 34 and NRC regulations contained in 10 CFR Part 34
and in the applicable sections of 10 CFR Parts 19 and 20, NRC license(s) under which the
radiographer will perform radiography, and the licensee's operating and emergency
procedures by successful completion of a written test and field examination on the subjects
covered.
Contrary to the above, between (date) and (date) , the licensee permitted (an) individual(s) to
act as (a) radiographer(s) on ___ occasions before (the) / (these) individual(s) had demonstrated
understanding of the instructions specified above by the successful completion of a written test and
field examination on the subjects covered.
This is a Severity Level
34-100
violation (Supplement VI).
10 CFR 34.31(b)(1) and (3) requires that the licensee not permit any individual to act as a
radiographer's assistant until that individual has received copies of and instruction in the
licensee's operating and emergency procedures and has demonstrated an understanding of
them.
Contrary to the above, on (date) , the licensee permitted an individual in its employment to act as
a radiographer's assistant prior to receiving copies of the operating and emergency procedures and
demonstrating an understanding of them.
This is a Severity Level
34-102
violation (Supplement VI).
10 CFR 34.31(b) requires that the licensee not permit any individual to act as a radiographer's
assistant until such individual: has received copies of and instruction in the licensee's operating
and emergency procedures; has demonstrated competence to use, under the personal
supervision of the radiographer, the radiographic exposure devices, sealed sources, related
handling tools, and radiation survey instruments that the assistant will use; and has
demonstrated understanding of the instructions in this paragraph by successfully completing
a written or oral test and field examination on the subjects covered.
Contrary to the above, on (date) , the licensee permitted an individual to act as radiographer's
assistant without the above requirements being fulfilled, in that (specify the deficiencies) .
This is a Severity Level
violation (Supplement VI).
C-24
NUREG/BR-0195, Rev. 2
Appendix C
34-104
Standard Citations - Part 34
10 CFR 34.31(c) requires that records of training of radiographers and radiographer's
assistants, including copies of written tests and dates of oral tests and field examinations, be
maintained for three years.
Contrary to the above, no records of training, including copies of written tests and dates of oral tests
and field examinations, were maintained for individuals who had worked as (radiographers,
radiographer's assistants) between (date) and (date) , at (locations) .
This is a Severity Level
34-110
violation (Supplement VI).
10 CFR 34.33(a) requires that the licensee not permit any individual to act as a radiographer
or a radiographer's assistant unless, at all times during radiographic operations, the individual
wears a direct-reading pocket dosimeter, an alarming ratemeter, and either a film badge or a
thermoluminescent dosimeter.
Contrary to the above, on (date) , a licensee (radiographer, radiographer's assistant) did not wear
a pocket dosimeter while conducting radiographic operations.
This is a Severity Level
34-120
violation (Supplement VI).
10 CFR 34.33(b) requires that pocket dosimeters be read and exposures recorded daily and
that the licensee retain each record of these exposures for three years after the record is made.
Contrary to the above, from (date) to (date) , licensee radiographers did not record their pocket
dosimeter readings.
This is a Severity Level
34-130
violation (Supplement VI).
10 CFR 34.33(c) requires that pocket dosimeters be checked at intervals not to exceed one year
for correct response to radiation.
Contrary to the above, from (date) to (date) , an interval exceeding one year, pocket dosimeters
were not checked for correct response to radiation.
This is a Severity Level
34-140
violation (Supplement VI).
10 CFR 34.33(d) requires that if an individual's pocket dosimeter is discharged beyond its
range, his film badge or TLD be immediately sent for processing.
Contrary to the above, on (date) during radiography performed at ________ a (radiographer's)
/ (radiographer assistant's) pocket dosimeter discharged beyond its range and the (film badge)
/ (TLD) worn by the individual (was) / (were) not immediately sent for processing.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-25
Standard Citations - Part 34
34-150
Appendix C
10 CFR 34.41 requires that during each radiographic operation, the radiographer or
radiographer's assistant maintain direct surveillance of the operation to protect against
unauthorized entry into a high radiation area, as defined in 10 CFR Part 20, except where the
high radiation area is equipped with a control device or alarm system, or locked.
Contrary to the above, on (date) , at a field site in ________, neither the licensee's radiographer
nor the radiographer's assistant maintained direct surveillance over the radiographic operation to
protect against entry into the high radiation area, and the high radiation area was not equipped with
a control device or alarm system or locked. Specifically, _____.
This is a Severity Level
34-160
violation (Supplement VI).
10 CFR 34.42 requires, notwithstanding any provisions in 10 CFR 20.1903, that areas in which
radiography is being performed be conspicuously posted as required by 10 CFR 20.1902(a)
and (b).
10 CFR 20.1902(a) requires that each radiation area shall be conspicuously posted with a sign
or signs bearing the radiation caution symbol and the words "CAUTION, RADIATION
AREA."
10 CFR 20.1902(b) requires that each high radiation area shall be conspicuously posted with
a sign or signs bearing the radiation caution symbol and the words "CAUTION, HIGH
RADIATION AREA" or "DANGER, HIGH RADIATION AREA."
Contrary to the above, on (date) , during radiography performed at (location) , the licensee did
not post the radiation area and the high radiation area in which industrial radiography was being
performed.
This is a Severity Level
34-170
violation (Supplement VI).
10 CFR 34.43(b) requires, in part, the licensee to ensure that a survey with a calibrated and
operable radiation survey instrument is made after each radiographic exposure to determine
that the sealed source has been returned to its shielded position.
Contrary to the above, on (date) , a licensee radiographer did not perform a survey after a
radiographic exposure to determine that the sealed source had been returned to its shielded position.
This is a Severity Level
violation (Supplement VI).
C-26
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 34
34-107a 10 CFR 34.43(b) requires, in part, the licensee to ensure that a survey with a calibrated and
operable radiation survey instrument is made after each radiographic exposure to determine
that the sealed source has been returned to its shielded position. The survey must include the
entire circumference of the radiographic exposure device and any source guide tube.
Contrary to the above, on (date) , at (location) , a licensee radiographer did not perform an
adequate survey after each radiographic exposure to determine that the sealed source had been
returned to its shielded position, in that the survey did not include the entire circumference of the
radiographic exposure device and the source guide tube.
This is a Severity Level
violation (Supplement VI).
34-170b 10 CFR 34.43(b) requires, in part, the licensee to ensure that a survey with a calibrated and
operable radiation survey instrument is made after each radiographic exposure to determine
that the sealed source has been returned to its shielded position. The survey must include the
entire circumference of the radiographic exposure device and any source guide tube.
Contrary to the above, on (date) , a licensee radiographer did not perform a survey after each
radiographic exposure to determine that the sealed source had been returned to its shielded position,
in that the radiation survey meter was neither in calibration nor operable.
This is a Severity Level
34-180
violation (Supplement VI).
10 CFR 34.43(d) requires the licensee to ensure that a record of the storage survey required
by 10 CFR 34.43(c) is retained for three years when that storage survey is the last one
performed in the work day.
Contrary to the above, as of (date) , the licensee did not retain records of the last storage survey
of the radiographic exposure device performed in the work day.
This is a Severity Level
34-190
violation (Supplement VI).
10 CFR 34.44 requires that whenever a radiographer's assistant uses radiographic exposure
devices, uses sealed sources or related source handling tools, or conducts radiation surveys
required by 10 CFR 34.43(b) to determine that the sealed source has returned to the shielded
position after an exposure, he shall be under the personal supervision of a radiographer. The
personal supervision shall include: (a) the radiographer's personal presence at the site where
sealed sources are being used; (b) the ability of the radiographer to give immediate assistance
if required; and (c) the radiographer watching the assistant's performance of the above
referred to operations.
Contrary to the above, on (date) , a licensee radiographer's assistant operated radiographic
exposure devices and conducted radiation surveys without the personal supervision of a radiographer
at (location) , in that (specify the deficiency of supervision).
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-27
Standard Citations - Part 34
Appendix C
34-190a 10 CFR 34.44 requires that whenever a radiographer's assistant uses radiographic exposure
devices, uses sealed sources or related source handling tools, or conducts radiation surveys
required by 10 CFR 34.43(b) to determine that the sealed source has returned to the shielded
position after an exposure, he shall be under the personal supervision of a radiographer. The
personal supervision shall include: (a) the radiographer's personal presence at the site where
the sealed sources are being used; (b) the ability of the radiographer to give immediate
assistance if required; and (c) the radiographer watching the assistant's performance of the
operations referred to in this section.
Contrary to the above, on (date) , an individual acted as a radiographer's assistant, used a
radiographic exposure device and was not adequately supervised by a radiographer, in that the
radiographer was not watching the performance of operations including exposure of the source.
This is a Severity Level violation (Supplement IV).
C-28
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 35
10 CFR PART 35
MEDICAL USE
______________________
35-10
10 CFR 35.13(a) requires that a licensee apply for and must receive a license amendment
before it receives or uses byproduct material for a clinical procedure permitted under 10 CFR
Part 35 but not permitted by the license issued pursuant to 10 CFR Part 35.
Contrary to the above, as of (date) , the licensee received and used byproduct material for a
(name of clinical procedure) , a clinical procedure permitted under 10 CFR Part 35 but not
permitted by the licensee's license issued pursuant to 10 CFR Part 35; and, as of that date, the
licensee had not (applied for) / (received) a license amendment authorizing the performance of this
procedure.
This is a Severity Level
35-11
violation (Supplement VI).
10 CFR 35.13(b) requires that a licensee apply for and must receive a license amendment
before it permits anyone, except a visiting authorized user described in 10 CFR 35.27, to work
as an authorized user under the license.
Contrary to the above, as of (date) , the licensee permitted a physician to work as an authorized
user under the license; however, that individual was not a visiting authorized user as described in
10 CFR 35.27, and, as of that date, the licensee had not (applied for) / (received) a license
amendment naming that individual as an authorized user.
This is a Severity Level
35-12
violation (Supplement VI).
10 CFR 35.13(c) requires that a licensee apply for and must receive a license amendment before
it changes Radiation Safety Officers or Teletherapy Physicists.
Contrary to the above, on (date) , the licensee changed its named (Radiation Safety Officer) /
(Teletherapy Physicist) , and, as of that date, the licensee had not (applied for) / (received) a
license amendment authorizing the change.
This is a Severity Level
35-13
violation (Supplement VI).
10 CFR 35.13(d) requires that a licensee apply for and must receive a license amendment
before it orders byproduct material in excess of the amount, or radionuclide or form different
than authorized on the license.
Contrary to the above, on (date) , the licensee ordered ___ curies of (nuclide) , an amount in
excess of the amount authorized on the license, and, as of that date, the licensee had not (applied
for) / (received) a license amendment authorizing the increased amount.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-29
Standard Citations - Part 35
35-14
Appendix C
10 CFR 35.13(e) requires that a licensee apply for and must receive a license amendment before
it adds to or changes the areas of use or address or addresses of use identified in the application
or on the license.
Contrary to the above, as of (date) , the licensee changed the area where byproduct material is used
for (describe the use) from (identify the old area) to (identify the new area) , and, as of that
date, the licensee had not (applied for)/(received) a license amendment authorizing the change.
This is a Severity Level
35-20
violation (Supplement VI).
10 CFR 35.14 requires that a licensee notify the NRC by letter within thirty days when an
authorized user, Radiation Safety Officer (RSO), or Teletherapy Physicist permanently
discontinues performance of duties under the license or has a name change, or when the
licensee's mailing address changes.
Contrary to the above, on (date) , the licensee's (RSO) / (Teletherapy Physicist) permanently
discontinued performance of duties under the license and the licensee did not notify NRC (until
(date) , a period in excess of 30 days).
This is a Severity Level
NOTE:
35-40
violation (Supplement VI).
For licenses issued against the new Part 35 (i.e., after April 1, 1987), the citation below
replaces the old citations that were written against the tie-down condition on the license:
10 CFR 35.21(a) requires that the licensee, through the Radiation Safety Officer, ensure that
radiation safety activities are being performed in accordance with approved procedures. The
licensee's procedures for (identify the procedure) are described in the (application) / (letter)
dated (date) , and were approved by License Condition No. ___.
The (application) / (letter) dated (date) states in Item No. ___ that
procedure from licensee's application or letter) .
(insert applicable
Contrary to the above, on (date) , the licensee, through its Radiation Safety Officer, failed to
ensure that radiation safety activities were being performed in accordance with the above procedures.
Specifically, (describe how the licensee violated the procedure) .
This is a Severity Level
35-44
violation (Supplement VI).
10 CFR 35.21(b)(4) requires that the Radiation Safety Officer establish personnel exposure
investigational levels that, when exceeded, will initiate an investigation by the Radiation Safety
Officer of the cause of the exposure.
Contrary to the above, as of (date) , the licensee's Radiation Safety Officer had not established the
required investigational levels.
This is a Severity Level
violation (Supplement VI).
C-30
NUREG/BR-0195, Rev. 2
Appendix C
35-45
Standard Citations - Part 35
10 CFR 35.21(b)(5) requires that the Radiation Safety Officer establish personnel exposure
investigational levels that, when exceeded, will initiate a prompt investigation by the Radiation
Safety Officer of the cause of the exposure and a consideration of actions that might be taken
to reduce the probability of recurrence.
Contrary to the above, the licensee's established personnel exposure investigational level of (rems)
to the (whole body) / (extremities) was exceeded as evidenced by a report of an exposure of ___
rem exposure on (date) , and, as of (date) , the licensee's Radiation Safety Officer had not
(investigated the cause of the exposure) / (considered actions to reduce the possibility of recurrence)
.
This is a Severity Level
35-50
violation (Supplement VI).
10 CFR 35.22 requires that a licensee establish a Radiation Safety Committee to oversee the
use of byproduct material.
Contrary to the above, as of (date) , the licensee had not established a Radiation Safety Committee.
This is a Severity Level
35-51
violation (Supplement VI).
10 CFR 35.22(a)(1) requires that the membership of the Radiation Safety Committee consist
of at least three individuals and include an authorized user of each type of use permitted by the
license, the Radiation Safety Officer, a representative of the nursing service, and a
representative of management who is neither an authorized user nor the Radiation Safety
Officer.
Contrary to the above, as of (date) , the membership of the licensee's Radiation Safety Committee
did not include ____________.
This is a Severity Level
35-52
10 CFR 35.22(a)(2) requires that the Radiation Safety Committee meet at least quarterly.
Contrary to the above, the licensee's Radiation Safety Committee did not meet between (date) and
(date) , a period in excess of ___ calendar (quarter) / (quarters) .
This is a Severity Level
35-53
violation (Supplement VI).
violation (Supplement VI).
10 CFR 35.22(a)(3) requires that to establish a quorum and conduct business, at least one half
of the Radiation Safety Committee's membership must be present, including the Radiation
Safety Officer and the management's representative.
Contrary to the above, on (date) , the licensee's Radiation Safety Committee met and conducted
business and (the Radiation Safety Officer) / (the management representative) / (a quorum) was
not present.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-31
Standard Citations - Part 35
35-54
Appendix C
10 CFR 35.22(a)(4) requires that the minutes of each Radiation Safety Committee meeting
include: (i) The date of the meeting (ii) Members present; (iii) Members absent; (iv) Summary
of deliberations and discussions; (v) Recommended actions and the numerical results of all
ballots; and (vi) ALARA program reviews described in Section 35.20(c).
Contrary to the above, the minutes for the meeting of the Radiation Safety Committee held on
(date) did not include (insert description from items i through vi above) .
This is a Severity Level
35-55
violation (Supplement VI).
10 CFR 35.22(b)(2) requires that, to oversee the use of licensed material, the Radiation Safety
Committee must review, on the basis of safety and with regard to the training and experience
standards in Subpart J of 10 CFR Part 35, and approve or disapprove any individual who is
to be listed as an authorized user, the Radiation Safety Officer, or a Teletherapy Physicist
before submitting a license application or request for amendment or renewal.
Contrary to the above, on (date) , the licensee submitted a request for a license (amendment) /
(renewal) and, as of that date, the licensee's Radiation Safety Committee had not reviewed and
approved, on the basis of safety and with regard to the training and experience standards in Subpart
J of 10 CFR Part 35, an individual who was named in the request as the licensee's (Radiation Safety
Officer) / (Teletherapy Physicist) / (authorized user) .
This is a Severity Level
35-56
violation (Supplement VI).
10 CFR 35.22(b)(3) requires that, to oversee the use of licensed material, the Radiation Safety
Committee must review on the basis of safety, and approve with the advice and consent of the
Radiation Safety Officer and the management representative, or disapprove, minor changes
in radiation safety procedures that are not potentially important to safety and are permitted
under 10 CFR 35.31.
Contrary to the above, as of (date) , the licensee changed its procedure for (identify the
procedure) by (describe how the procedure changed) , which is a change permitted under 10 CFR
35.31, and, as of that date, the licensee's Radiation Safety Committee had not reviewed this change
on the basis of safety, and approved it with the advice and consent of the Radiation Safety Officer
and the management representative.
This is a Severity Level
violation (Supplement VI).
C-32
NUREG/BR-0195, Rev. 2
Appendix C
35-57
Standard Citations - Part 35
10 CFR 35.22(b)(4) requires that, to oversee the use of licensed material, the Radiation Safety
Committee must review quarterly, with the assistance of the Radiation Safety Officer, a
summary of the occupational radiation dose records of all personnel working with byproduct
material.
Contrary to the above, as of (date) , the Radiation Safety Committee did not review, with the
assistance of the Radiation Safety Officer, a summary of the occupational radiation dose records of
all personnel working with byproduct material during the _____ quarter(s) of 19__.
This is a Severity Level
35-58
violation (Supplement VI).
10 CFR 35.22(b)(5) requires that, to oversee the use of licensed material, the Radiation Safety
Committee must review quarterly, with the assistance of the Radiation Safety Officer, all
incidents involving byproduct material with respect to cause and subsequent actions taken.
Contrary to the above, as of (date) , the licensee's Radiation Safety Committee did not review, with
the assistance of the Radiation Safety Officer, the cause and subsequent actions taken for an incident
involving (briefly describe the incident) , which occurred during the _____ quarter of 19__.
This is a Severity Level
35-59
violation (Supplement VI).
10 CFR 35.22(b)(6) requires that, to oversee the use of licensed material, the Radiation Safety
Committee must review annually, with the assistance of the Radiation Safety Officer, the
radiation safety program.
Contrary to the above, from (date) until (date) , the licensee's Radiation Safety Committee did
not review, with the assistance of the Radiation Safety Officer, the licensee's radiation safety
program.
This is a Severity Level
35-60
violation (Supplement VI).
10 CFR 35.25(a)(1) requires, in part, that a licensee that permits the use of byproduct material
under the supervision of an authorized user shall instruct the supervised individual in the
licensee's written quality management program.
Contrary to the above, as of (date) , the licensee did not instruct (identify the supervised
individual, e.g., "a nuclear medicine technologist") in the licensee's written quality management
program.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-33
Standard Citations - Part 35
35-61
Appendix C
10 CFR 35.25(a)(2) requires, in part, that a licensee that permits the use of byproduct material
by an individual under the supervision of an authorized user shall require the supervised
individual to follow the instructions of the supervising authorized user.
The instructions of the supervising authorized user, entitled "_______________", dated
__________, require, in part, that (describe the required instruction) .
Contrary to the above, on (date) , a (e.g., technologist) , an individual under the supervision of
the licensee's authorized user, (describe how the individual failed to follow the instruction while
using byproduct material--specify the byproduct material) .
This is a Severity Level
35-62
violation (Supplement VI).
10 CFR 35.25(a)(2) requires, in part, that a licensee that permits the use of byproduct material
by an individual under the supervision of an authorized user shall require the supervised
individual to follow the written quality management procedures established by the licensee.
The licensee's quality management procedure, dated (date) , (identify subsection, e.g., by
title, paragraph, or page) , requires that (briefly state the requirement) .
Contrary to the above, on (date) , the licensee's (identify the supervised individual, e.g.,
"technologist") , an individual under the supervision of the licensee's authorized user, did not follow
the written quality management procedures established by the licensee in that (briefly state how the
requirement was violated) .
This is a Severity Level
35-70
violation (Supplement VI).
10 CFR 35.27(a) provides that a licensee may permit any visiting authorized user to use
licensed material for medical use under the terms and conditions of the licensee's license for
sixty days each year if certain requirements are met.
Contrary to the above, the licensee permitted a visiting authorized user to use licensed material for
medical use under the terms and conditions of the licensee's license from (date) until (date) , a
period in excess of sixty days.
This is a Severity Level
violation (Supplement VI).
C-34
NUREG/BR-0195, Rev. 2
Appendix C
35-72
Standard Citations - Part 35
10 CFR 35.27(a)(2) provides, in part, that a licensee may permit any visiting authorized user
to use licensed material for medical use under the terms and conditions of the licensee's license
for sixty days each year if the licensee has a copy of a license issued by the Commission or an
Agreement State or a permit issued by a Commission or Agreement State broad licensee that
identifies the visiting authorized user by name as an authorized user for medical use.
Contrary to the above, from (date) until (date) , the licensee permitted a visiting authorized user
to use licensed material for medical use under the terms and conditions of the licensee's license, and
the licensee did not have a copy of a license issued by the Commission or an Agreement State or a
permit issued by a Commission or Agreement State broad licensee that identified the visiting user
by name as an authorized user for medical use.
This is a Severity Level
35-75
violation (Supplement VI).
10 CFR 35.27(c) requires, in part, that a licensee retain records showing that permission was
given to a visiting authorized user to use licensed material for medical use under the terms and
conditions of the licensee's license. Unless the visiting authorized user has been listed as an
authorized user on the licensee's license, the records shall be retained for three years after the
visiting authorized user's last use of licensed material.
Contrary to the above, as of (date) , the licensee did not maintain records showing that permission
was given for a visiting authorized user's use of licensed material for medical use under the terms
and conditions of the licensee's license from (date) to (date) , and the visiting authorized user
was not listed as an authorized user on the licensee's license.
This is a Severity Level
35-83
violation (Supplement VI).
10 CFR 35.29(d) requires that a mobile nuclear medicine service not order byproduct material
to be delivered directly from the manufacturer or distributor to the client's address of use.
Contrary to the above, on (date) , the licensee, a mobile nuclear medicine service, ordered
(byproduct material) to be delivered directly from the (manufacturer) / (distributor) to its client's
address of use.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-35
Standard Citations - Part 35
35-92
Appendix C
10 CFR 35.31(b) requires that a licensee that makes minor changes in radiation safety
procedures, as permitted under 10 CFR 35.31(a), retain a record of each change until the
license has been renewed or terminated. The record shall include the effective date of the
change, a copy of the old and new radiation safety procedures, the reason for the change, a
summary of radiation safety matters that were considered before making the change, the
signature of the Radiation Safety Officer, and the signatures of the affected authorized users,
and of management or, in a medical institution, the Radiation Safety Committee's chairman and
the management representative.
Contrary to the above, on (date) , the licensee made a ministerial change in its radiation safety
procedures, as permitted under 10 CFR 35.31(a), to (describe the change) , and (no record of
the change was kept) / (the licensee's record of the change did not include ( ) ).
This is a Severity Level
violation (Supplement VI).
QUALITY MANAGEMENT PROGRAM
NOTE:
35-93
If there is no quality management (QM) program, use 35-95a and 35-95b. If there is a QM
program, but the program does not meet a required QM objective, first use 35-95a, then select
the applicable paragraph from 35-95c through 35-95f, and finish with 35-95f. If an individual
working under the supervision of an authorized user has not followed some requirement in the
licensee's written QM program, use 35-62. For other cases in which a requirement in the written
QM program was not followed, use 35-95a followed by 35-95h.
10 CFR 35.32(a)(1) requires, in part, that the licensee establish and maintain a quality
management program which must include written policies and procedures to meet the objective
that, prior to administration, a written directive is prepared for (specify the modality from
10 CFR 35.32(a)(1)(i) - (v), e.g., "any teletherapy radiation dose") .
10 CFR 35.2 defines a written directive as an order in writing for a specific patient, dated and
signed by an authorized user prior to the administration of a radiopharmaceutical or radiation
and containing certain information including for (specify the modality, e.g., "teletherapy")
, the (specify the information required for the modality--see definition of written directive in
10 CFR 35.2, e.g., "total dose, dose per fraction, treatment site, and overall treatment
period").
35-93a
Contrary to the above, as of (date) , the licensee's quality management program did not include a
written procedure to meet the objective that a written directive be prepared prior to administering
(specify the modality from 10 CFR 35.32(a)(1)(1) - (v), e.g., "any teletherapy radiation dose").
This is a Severity Level violation (Supplement VI).
35-93b
Contrary to the above, as of (date) , written directives prepared for (specify the modality, e.g.,
"teletherapy") did not include (specify the missing information required for the modality--see
definition of written directive in 10 CFR 35.2, e.g., "the treatment site") .
This is a Severity Level
violation (Supplement IV)
C-36
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 35
35-95a
10 CFR 35.32(a) requires, in part, that the licensee establish and maintain a written quality
management program to provide high confidence that byproduct material or radiation from
byproduct material will be administered as directed by the authorized user.
35-95b
Contrary to the above, as of (date) , the licensee used (specify the byproduct material) for
(indicate the use(s) that required a QM program) , and the licensee had not established a written
quality management program.
This is a Severity Level
violation (Supplement VI).
35-95c
Pursuant to 10 CFR 35.32(a)(2), the quality management program must include written policies
and procedures to meet the specific objective that, prior to each administration, the patient's
identity is verified by more than one method.
35-95d
Pursuant to 10 CFR 35.32(a)(3), the quality management program must include written policies
and procedures to meet the specific objective that final plans of treatment and related
calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in
accordance with a written directive, which is defined in 10 CFR 35.2.
35-95e
Pursuant to 10 CFR 35.32(a)(4), the quality management program must include written policies
and procedures to meet the specific objective that each administration is in accordance with
a written directive, which is defined in 10 CFR 35.2.
35-95f
Pursuant to 10 CFR 35.32(a)(5), the quality management program must include written policies
and procedures to meet the specific objective that any unintended deviation from the written
directive is identified and evaluated, and appropriate action is taken.
35-95g
Contrary to the above, as of (date) , the licensee's quality management program did not include a
written procedure to meet the objective that (restate the applicable objective--select from the
objectives stated in 35-95c through 35-95f above) .
This is a Severity Level
35-95h
violation (Supplement VI).
The licensee's written quality management program dated (date) , (identify applicable section
of QM program, e.g., by title, paragraph, or page) , requires that (briefly state the
requirement, e.g., "the authorized user utilize a radiograph to verify the position of temporary
brachytherapy implant sources") .
Contrary to the above, on (date) , (briefly state how the requirement was violated, e.g., "an
authorized user performed a temporary brachytherapy implant procedure with an iridium 192 source
and did not utilize a radiograph to verify the position of the source. Specifically, a radiograph was
taken, but it was not read until after the therapy treatment was concluded") .
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-37
Standard Citations - Part 35
Appendix C
35-96
10 CFR 35.32(b) requires, in part, that the licensee develop procedures for and conduct a
review to verify compliance with all aspects of the quality management program at intervals
no greater than 12 months.
35-96a
Contrary to the above, between (date) and (date) , the licensee did not develop procedures to
verify compliance with the licensee's quality management program.
This is a Severity Level
35-96b
Contrary to the above, the licensee did not conduct a review to verify compliance with the quality
management program between (date) and (date) , an interval greater than 12 months.
This is a Severity Level
35-97
violation (Supplement VI).
violation (Supplement VI).
10 CFR 35.32(c) requires, in part, that the licensee evaluate and respond to each recordable
event within 30 days after the discovery of the recordable event, retaining a record for three
years of the relevant facts and what corrective action, if any, was taken.
Recordable events as defined in 10 CFR 35.2 include the administration of (select the
appropriate event from the definition of recordable event in 10 CFR 35.2, e.g., "a
radiopharmaceutical or radiation without a written directive where a written directive is
required") .
Contrary to the above, a recordable event involving the administration of (repeat the recordable
event from above) occurred on (date) , and as (date) , the licensee did not evaluate the event
and retain a record of the relevant facts.
This is a Severity Level
35-98
violation (Supplement VI).
10 CFR 35.32(d) requires, for each administration of a radiopharmaceutical or radiation for
which a written directive is required under 10 CFR 35.32(a)(1), that the licensee retain, for
three years after the date of the administration, the written directive and a record of the
radiation dose or radiopharmaceutical dosage administered.
10 CFR 35.2 defines a written directive as an order in writing for a specific patient, dated and
signed by an authorized user prior to the administration of a radiopharmaceutical or radiation
and containing certain specified information.
10 CFR 35.32(a)(1) requires that a written directive be prepared for (indicate the use that
required a written directive, e.g., "any teletherapy radiation dose") .
Contrary to the above, the licensee used (specify the byproduct material(s) for (indicate the
use(s) that required a written directive) on (date(s) and, as of (date) , the licensee did not
maintain (the written directive for the administration) / (a record of the radiation dose administered)
/ (a record of the radiopharmaceutical dosage administered) .
This is a Severity Level
violation (Supplement VI).
C-38
NUREG/BR-0195, Rev. 2
Appendix C
35-99
Standard Citations - Part 35
10 CFR 35.32(f)(2) requires that the licensee submit to the NRC Region
Office, by
January 27, 1992, a written certification that the licensee's quality management program has
been implemented along with a copy of the program.
Contrary to the above, the licensee used (specify the byproduct material(s) for (indicate the
use(s) that required a quality management program from 10 CFR 32(a)(1)(i) - (v), e.g.,
"teletherapy") on (date(s) and, as of (date) , the licensee had not submitted to the NRC a copy
of the licensee's quality management program and a written certification that the program had been
implemented.
This is a Severity Level
35-100
violation (Supplement VI).
10 CFR 35.33(a) requires, in part, that, for a misadministration, the licensee notify by
telephone the NRC Operations Center not later than the next calendar day after discovery of
the misadministration. 10 CFR 35.2 defines, in part, "misadministration," to mean (fill in
applicable definition) .
Contrary to the above, on (date) , the licensee became aware that a misadministration occurred and
the licensee did not notify the NRC until __________, which was later than the next calendar day.
Specifically, the misadministration involved (give a brief description of the misadministration to
show that it meets the applicable definition used above) .
This is a Severity Level
35-110
violation (Supplement VI).
10 CFR 35.49(a) requires, in part, that a licensee use for medical use only byproduct material
manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant
to the regulations in 10 CFR Part 30 and Sections 32.72, 32.73, or 32.74, or the equivalent
regulations of an Agreement State.
Contrary to the above, on (date) , the licensee administered to a patient (byproduct material)
which was not manufactured, labeled, packaged, and distributed in accordance with a license issued
pursuant to the regulations in 10 CFR Part 30 and Sections 32.72, 32.73, or 32.74, or the equivalent
regulations of an Agreement State.
This is a Severity Level
35-120
violation (Supplement VI).
10 CFR 35.50(a) requires that a medical use licensee authorized to administer
radiopharmaceuticals have in its possession a dose calibrator and use it to measure the amount
of activity administered to each patient.
Contrary to the above, from (date) to (date) , the licensee did not possess a dose calibrator to
measure the activity of radiopharmaceuticals that were administered to patients.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-39
Standard Citations - Part 35
35-121
Appendix C
10 CFR 35.50(b)(1) requires, in part, that a licensee check each dose calibrator for constancy
with a dedicated check source at the beginning of each day of use and that the check be done
on a frequently used setting.
Contrary to the above, on (date) , the licensee did not check the dose calibrator for constancy with
a dedicated check source at the beginning of each day of use, and the dose calibrator was used to
measure patient doses of radiopharmaceuticals on that day.
This is a Severity Level
35-122
violation (Supplement VI).
10 CFR 35.50(b)(2) requires, in part, that a licensee test the dose calibrator for accuracy at
least annually.
Contrary to the above, the licensee did not test its dose calibrator for accuracy from (date) until
(date) .
This is a Severity Level
35-123
violation (Supplement VI).
10 CFR 35.50(b)(3) requires, in part, that a licensee test each dose calibrator for linearity over
the range of its use between the highest dosage that will be administered to a patient and 10
microcuries.
Contrary to the above, the licensee's dose calibrator linearity test performed on (date(s)) covered
only the range between _____ millicuries and _____ (millicuries) / (microcuries) (and the highest
dosage that the licensee administers to a patient is _____ millicuries).
This is a Severity Level
35-124
violation (Supplement VI).
10 CFR 35.50(b)(3) requires, in part, that a licensee test each dose calibrator for linearity at
least quarterly.
Contrary to the above, the licensee did not test its dose calibrator for linearity from (date) until
(date) , a period in excess of a calendar quarter.
This is a Severity Level
35-125
violation (Supplement VI).
10 CFR 35.50(b)(4) requires, in part, that a licensee test each dose calibrator for geometry
dependence upon installation over the range of volumes and volume configurations for which
it will be used.
Contrary to the above, the licensee did not test its dose calibrator for geometry dependence at the
time of installation, which occurred on (date) .
This is a Severity Level
violation (Supplement VI).
C-40
NUREG/BR-0195, Rev. 2
Appendix C
35-126
Standard Citations - Part 35
10 CFR 35.50(c) requires a licensee to perform appropriate checks for constancy and tests for
accuracy, linearity, and geometry dependence required by 10 CFR 35.50(b) following
adjustments or repair of the dose calibrator.
Contrary to the above, following the (adjustment) / (repair) of the dose calibrator on (date) , the
licensee did not perform a (check) / (test) for (constancy) / (accuracy) / (linearity) / (geometry
dependence) , and such (check) / (test) was appropriate due to the nature of the (adjustment) /
(repair) .
This is a Severity Level
35-127
violation (Supplement VI).
10 CFR 35.50(d) requires, in part, that a licensee mathematically correct dosage readings for
any geometry or linearity error that exceeds 10 percent if the dosage is greater than 10
microcuries.
Contrary to the above, on (date) , the licensee did not mathematically correct patient dosage
readings for a dose calibrator (geometry) / (linearity) error of ___ percent, and the patient dosages
were greater than 10 microcuries.
This is a Severity Level
violation (Supplement VI).
35-128a 10 CFR 35.50(e) requires, in part, that a licensee retain records of constancy checks of the dose
calibrator for three years unless directed otherwise.
Contrary to the above, as of (date) , the licensee did not retain a record of the daily constancy
checks of its dose calibrator performed between (date) and (date) , which constitutes a retention
period of less than three years; and no other retention period had been directed.
This is a Severity Level
violation (Supplement VI).
35-128b 10 CFR 35.50(e) requires, in part, that a licensee retain records of (accuracy) / (linearity) /
(geometry dependence) tests of the dose calibrator for three years unless directed otherwise.
Contrary to the above, as of (date) , the licensee did not retain a record of the (accuracy) /
(linearity) / (geometry dependence) test of its dose calibrator performed on (date) , which
constitutes a retention period of less than three years; and no other retention period had been
directed.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-41
Standard Citations - Part 35
35-129
Appendix C
10 CFR 35.50(e) and 35.50(e)(1) require, in part, that a licensee retain records of daily
constancy checks of the dose calibrator for three years unless directed otherwise, and that the
records include the model and serial number of the dose calibrator, the identity of the
radionuclide contained in the check source, the date of the check, the activity measured, and
the initials of the individual who performed the check.
Contrary to the above, as of (date) , the licensee's records of daily constancy checks of its dose
calibrator performed between (date) and (date) did not include (specify the missing item(s))
This is a Severity Level
35-130
violation (Supplement VI).
10 CFR 35.50(e) and 35.50(e)(2) require, in part, that a licensee retain records of annual
accuracy tests of the dose calibrator for three years unless directed otherwise, and that the
records include the model and serial number of the dose calibrator, the model and serial
number of each source used, the identity of the radionuclide contained in the source and its
activity, the date of the test, the results of the test, and the identity of the individual performing
the test.
Contrary to the above, as of (date) , the licensee's record of the annual accuracy test of its dose
calibrator performed on (date) did not include (specify the missing item(s)) .
This is a Severity Level
35-131
violation (Supplement VI).
10 CFR 35.50(e) and 35.50(e)(3) require, in part, that a licensee retain records of quarterly
dose calibrator linearity tests for three years unless directed otherwise, and that the records
include the model and serial number of the dose calibrator, the calculated activities, the
measured activities, the date of the test, and the identity of the individual performing the test.
Contrary to the above, as of (date) , the licensee's record of the quarterly linearity test of its dose
calibrator performed on (date) did not include (specify the missing item(s)) .
This is a Severity Level
35-132
violation (Supplement VI).
10 CFR 35.50(e) and 35.50(e)(4) require that a licensee retain records of tests for dose
calibrator geometrical dependence for three years unless directed otherwise and that the
records include the model and serial number of the dose calibrator, the configuration of the
source measured, the activity measured for each volume measured, the date of the test, and the
identity of the individual performing the test.
Contrary to the above, as of (date) , the licensee's record of the geometrical dependence test of its
dose calibrator performed on (date) did not include (specify the missing item(s)) .
This is a Severity Level
violation (Supplement VI).
C-42
NUREG/BR-0195, Rev. 2
Appendix C
35-140
Standard Citations - Part 35
10 CFR 35.51(a) requires that a licensee calibrate the survey instruments used to show
compliance with 10 CFR Part 35 before first use, annually, and following repair.
35-140a Contrary to the above, as of (date) , the licensee was using a (manufacturer name), (model
number) survey instrument to show compliance with 10 CFR Part 35, and this survey instrument
had not been calibrated from (date) through (date) .
This is a Severity Level
violation (Supplement VI).
35-140b Contrary to the above, the licensee was using a (manufacturer name), (model number) survey
instrument to show compliance with 10 CFR Part 35, and this survey instrument had not been
calibrated (before its first use) / (following a repair) , which occurred on (date) .
This is a Severity Level
35-142
violation (Supplement VI).
10 CFR 35.51(a) requires, in part, that for survey instruments used to show compliance with
10 CFR Part 35, a licensee calibrate two separated readings with a radiation source on all
scales with readings up to 1000 millirem per hour.
Contrary to the above, the calibration of the licensee's (manufacturer name), (model number)
survey instrument performed on (date) was not performed at two separated readings on the (state
which) scale(s), and the licensee uses this survey instrument to show compliance with 10 CFR
Part 35.
This is a Severity Level
35-143
violation (Supplement VI).
10 CFR 35.51(a)(3) requires that a licensee conspicuously note the apparent exposure rate from
a dedicated check source, as determined at the time of calibration, and the date of calibration
on any survey instrument used to show compliance with 10 CFR Part 35.
Contrary to the above, as of (date) , the licensee did not have (the apparent exposure rate from
a dedicated check source as determined at the time of calibration) / (the date of calibration) noted
on its (manufacturer name), (model number) survey instrument, and the licensee was using this
survey instrument to show compliance with 10 CFR Part 35.
This is a Severity Level
violation (Supplement VI).35-144
10 CFR 35.51(a) requires, in part, that a licensee calibrate the survey instruments used to show
compliance with 10 CFR Part 35.
NUREG/BR-0195, Rev. 2
C-43
Standard Citations - Part 35
Appendix C
10 CFR 35.51(b) states in part that, when calibrating a survey instrument, a licensee shall
consider a point as calibrated if the indicated exposure rate differs from the calculated
exposure rate by not more than 20 percent.
Contrary, to the above, as of (date) , the licensee was using a (manufacturer name), (model
number) survey instrument to show compliance with 10 CFR Part 35 and, when the instrument was
last calibrated, the indicated exposure rate differed from the calculated exposure rate by more than
20 percent at various points on the scales of this instrument.
This is a Severity Level
35-145
violation (Supplement VI).
10 CFR 35.51(c) requires, in part, that a licensee check each survey instrument for proper
operation with the dedicated check source each day of use.
Contrary to the above, as of (date) , the licensee routinely failed to check its survey meter with a
dedicated check source on days when the instrument was used.
This is a Severity Level
35-146
violation (Supplement VI).
10 CFR 35.51(d) requires, in part, that a licensee retain a record of each survey instrument
calibration for three years.
Contrary to the above, as of (date) , the licensee did not retain a record of the survey instrument
calibration performed on its (manufacturer name) / (model number) survey instrument on (date)
. This constitutes a retention period of less than three years.
This is a Severity Level
35-147
violation (Supplement VI).
10 CFR 35.51(d) requires that a licensee retain a record of each survey instrument calibration
for three years and that the record include a description of the calibration procedure; and the
date of the calibration, a description of the source used and the certified exposure rates from
the source, and the rates indicated by the instrument being calibrated, the correction factors
deduced from the calibration data, and the signature of the individual who performed the
calibration.
Contrary to the above, the licensee's record of calibration of the (manufacturer name), (model
number) survey instrument performed on (date) did not include (specify the missing item) .
This is a Severity Level violation (Supplement VI).
C-44
NUREG/BR-0195, Rev. 2
Appendix C
35-150
Standard Citations - Part 35
10 CFR 35.53(a) requires that a licensee measure the activity of each radiopharmaceutical
dosage that contains more than 10 microcuries of a photon-emitting radionuclide before
medical use.
Contrary to the above, on (date) , the licensee did not measure a radiopharmaceutical containing
(microcuries) / (millicuries) of (byproduct material) , a photon-emitting radionuclide, before it
was administered to a patient for medical use.
This is a Severity Level
35-151
violation (Supplement VI).
10 CFR 35.53(b) requires that a licensee measure the activity of each radiopharmaceutical
dosage with a desired activity of 10 microcuries or less of a photon-emitting radionuclide
before medical use to verify that the dosage does not exceed 10 microcuries.
Contrary to the above, on (date) , the licensee did not measure a radiopharmaceutical with a
desired activity of ___ microcuries of (byproduct material) to verify that the dosage did not
exceed 10 microcuries before it was administered to a patient.
This is a Severity Level
35-152
violation (Supplement VI).
10 CFR 35.53(c) requires that a licensee retain records of the measurement of
radiopharmaceutical dosages for three years, and that the record contain the:
(1) Generic name, trade name, or abbreviation of the radiopharmaceutical, its lot number, and
expiration dates and the radionuclide;
(2) Patient's name, and identification number if one has been assigned;
(3) Prescribed dosage and activity of the dosage at the time of measurement, or a notation that
the total activity is less than 10 microcuries;
(4) Date and time of the measurement; and
(5) Initials of the individual who made the record.
Contrary to the above, as of
(date) , the licensee's records of the measurement of
radiopharmaceutical dosages did not contain the (specify the missing item(s)) from above) .
This is a Severity Level
35-153
violation (Supplement VI).
10 CFR 35.53(c) requires that a licensee retain records of the measurement of
radiopharmaceutical dosages for three years.
Contrary to the above, as of (date) , the licensee did not retain records of the measurements of
radiopharmaceutical dosages that were performed between (date) and (date) . This constitutes
a retention period of less that three years.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-45
Standard Citations - Part 35
35-155
Appendix C
10 CFR 35.59(b)(l) requires that a licensee in possession of a sealed source test the source for
leakage before its first use unless the licensee has a certificate from the supplier indicating that
the source was tested within six months before transfer to the licensee.
Contrary to the above, on (date) , the licensee placed into use a sealed source containing (nominal
activity) of (nuclide) without performing a test for leakage, and the licensee did not have a
certificate from the supplier indicating that the source was leak tested within six months before
transfer to the licensee.
This is a Severity Level
35-156
violation (Supplement VI).
10 CFR 35.59(b)(2) requires, in part, that a licensee in possession of a sealed source test the
source for leakage at intervals not to exceed six months or at other intervals approved by the
Commission or an Agreement State.
Contrary to the above, the licensee did not test a sealed source containing (nominal activity) of
(nuclide) for leakage between (date) and (date) , an interval in excess of six months, and no
other interval was approved by the Commission or an Agreement State.
This is a Severity Level
35-160
violation (Supplement VI).
10 CFR 35.59(d) requires that a licensee retain records of leakage test results for five years;
and that the records contain the model number, and serial number if assigned, of each source
tested; the identity of each source radionuclide and its estimated activity; the measured activity
of each test sample expressed in microcuries; a description of the method used to measure each
test sample; the date of the test; and the signature of the Radiation Safety Officer.
Contrary to the above, as of (date) , the licensee's records of leakage test results did not contain
(specify the missing item(s)) from above) .
This is a Severity Level
violation (Supplement VI).
35-160a 10 CFR 35.59(d) requires, in part, that a licensee in possession of a sealed source retain leakage
test records for five years.
Contrary to the above, as of (date) , the licensee did not retain a record of a leakage test performed
on the licensee's (nominal activity), (nuclide) sealed source on (date) . This constitutes a
retention period of less than five years.
This is a Severity Level
violation (Supplement VI).
C-46
NUREG/BR-0195, Rev. 2
Appendix C
35-167
Standard Citations - Part 35
10 CFR 35.59(g) requires, in part, that a licensee in possession of a sealed source or
brachytherapy source conduct a quarterly physical inventory of all such sources in its
possession.
Contrary to the above, the licensee did not conduct a physical inventory of its (sealed sources) /
(brachytherapy sources) from (date) to (date) , a period in excess of a calendar quarter.
This is a Severity Level
violation (Supplement VI).
35-167a 10 CFR 35.59(g) requires, in part, that a licensee retain for five years records of quarterly
physical inventories of sealed sources and brachytherapy sources in its possession, and that the
records contain the model number of each source, and serial number if one has been assigned,
the identity of each source radionuclide and its nominal activity, the location of each source,
and the signature of the Radiation Safety Officer.
Contrary to the above, as of (date) , the licensee's records of physical inventories of its (sealed
sources) / (brachytherapy sources did not contain (specify the missing item(s)) from above) .
This is a Severity Level violation (Supplement VI).
35-167b 10 CFR 35.59(g) requires, in part, that a licensee retain for five years records of quarterly
physical inventories of sealed sources and brachytherapy sources in its possession.
Contrary to the above, as of (date) , the licensee did not retain records of quarterly physical
inventories of its (sealed sources) / (brachytherapy sources) performed on (date) . This
constitutes a retention period of less than five years.
This is a Severity Level
35-168
violation (Supplement VI).
10 CFR 35.59(h) requires, in part, that a licensee in possession of a sealed source or
brachytherapy source measure the ambient dose rates quarterly in all areas where such sources
are stored.
Contrary to the above, from (date) until (date) , a period in excess of a calendar quarter, the
licensee did not measure the ambient dose rates in the (specify area) , an area where (sealed
sources) / (brachytherapy sources) were stored.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-47
Standard Citations - Part 35
35-169
Appendix C
10 CFR 35.59(i) requires, in part, that a licensee in possession of a sealed source or
brachytherapy source retain for three years a record of each quarterly ambient dose rate
survey conducted in all areas where such sources are stored.
Contrary to the above, as of (date) , the licensee did not retain records of the ambient dose rate
surveys conducted on (date) in the area4 where the licensee's (sealed sources) / (brachytherapy
sources) were stored. This constitutes a retention period of less than three years.
This is a Severity Level
35-171
violation (Supplement VI).
10 CFR 35.60(b) requires that, to identify its contents, a licensee conspicuously label each
syringe, or syringe radiation shield that contains a syringe with a radiopharmaceutical, and
that the label show the radiopharmaceutical name or its abbreviation, or the clinical procedure
to be performed, or the patient's name.
Contrary to the above, on (date) , the licensee did not label a syringe containing
(pharmaceutical form) (to show the specify the missing item(s) ).
This is a Severity Level
(nuclide),
violation (Supplement VI).
35-172a 10 CFR 35.60(c) requires, in part, that a licensee require each individual who prepares a
radiopharmaceutical kit to use a syringe radiation shield when preparing the kit.
Contrary to the above, on __________, while preparing a radio-pharmaceutical kit, the licensee's
(e.g., nuclear medicine technologist) did not use a syringe radiation shield for a syringe containing
(nuclide) .
This is a Severity Level
violation (Supplement VI).
35-172b 10 CFR 35.60(c) requires, in part, that a licensee require each individual to use a syringe
radiation shield when administering a radiopharmaceutical by injection, unless the use of the
shield is contraindicated for that patient.
Contrary to the above, on __________, when administering a radiopharmaceutical by injection, the
licensee's (e.g., nuclear medicine technologist) did not use a syringe radiation shield for a syringe
that contained (nuclide) , and the use of the shield was not contraindicated for that patient.
This is a Severity Level
violation (Supplement VI).
4
If information, such as a room number, is readily available to further identify the area(s), it should be included
in the citation.
C-48
NUREG/BR-0195, Rev. 2
Appendix C
35-175
Standard Citations - Part 35
10 CFR 35.61(a) states that a licensee shall require each individual preparing or handling a vial
that contains a radiopharmaceutical to keep the vial in a vial radiation shield.
Contrary to the above, on __________, the licensee's (e.g., nuclear medicine technologist) was
(preparing) / (handling) a vial that contained (nuclide) in the form of a radiopharmaceutical, and
the individual did not keep the vial in a vial radiation shield.
This is a Severity Level
35-176
violation (Supplement VI).
10 CFR 35.61(b) requires that, to identify its contents, a licensee conspicuously label each vial
radiation shield that contains a vial of a radiopharmaceutical. The label must show the
radiopharmaceutical name or its abbreviation.
Contrary to the above, on __________, the licensee did not label a vial radiation shield to show the
radiopharmaceutical name or its abbreviation, and the shield contained a vial of (nuclide) in the
form of a radiopharmaceutical.
This is a Severity Level
35-180
violation (Supplement VI).
10 CFR 35.70(a) requires that a licensee survey with a radiation detection survey instrument
at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for
use or administered.
Contrary to the above, on numerous occasions from __________ until __________, the licensee did
not survey with a radiation detection instrument at the end of the day areas5 where
radiopharmaceuticals were routinely (prepared for use) / (administered) . For example, no such
survey was performed on (date(s)) .
This is a Severity Level
35-181
violation (Supplement VI).
10 CFR 35.70(b) requires that a licensee survey with a radiation detection survey instrument
at least once each week all areas where radiopharmaceuticals or radiopharmaceutical waste
is stored.
Contrary to the above, during the week(s) of (date) to (date) , the licensee did not survey with a
radiation detection survey instrument the
(identify the area) , an area where
(radiopharmaceuticals were) / (radiopharmaceutical waste was) stored.
This is a Severity Level
violation (Supplement VI).
5
If information, such as a room number, is readily available to further identify the area(s), it should be included
in the citation.
NUREG/BR-0195, Rev. 2
C-49
Standard Citations - Part 35
35-182
Appendix C
10 CFR 35.70(c) requires that a licensee conduct the daily and weekly surveys of areas where
radiopharmaceuticals are routinely prepared for use or administered and areas where
radiopharmaceuticals or radiopharmaceutical waste is stored, in such a manner so as to be able
to detect dose rates as low as 0.1 millirem per hour (mr/hr).
Contrary to the above, as of ___________, the licensee did not conduct surveys so as to be able to
detect dose rates as low as 0.1 mr/hr in areas5 where radiopharmaceuticals were routinely prepared,
administered, stored, or held as waste. Specifically, the lowest range of the survey instrument used
to conduct such surveys was _____ to _____ mr/hr.
This is a Severity Level
violation (Supplement VI).
35-183a 10 CFR 35.70(d) requires, in part, that a licensee establish radiation dose trigger levels for
daily and weekly surveys of areas where radiopharmaceuticals are routinely prepared for use
or administered and areas where radiopharmaceuticals or radiopharmaceutical waste is stored.
Contrary to the above, as of __________, the licensee did not establish radiation dose trigger levels
for its (daily) / (weekly) surveys of area6 where radiopharmaceuticals were prepared, administered,
stored, or held as waste.
This is a Severity Level
violation (Supplement VI).
35-183b 10 CFR 35.70(d) requires that a licensee establish radiation dose trigger levels for the daily and
weekly surveys conducted in areas where radiopharmaceuticals are routinely prepared for use
or administered and areas where radiopharmaceuticals or radiophar-maceutical waste is
stored, and that the individual performing the survey immediately notify the Radiation Safety
Officer if a dose rate exceeds a trigger level.
Contrary to the above, on __________, while performing a survey of the areas6 where (specify
from the choices above) , the licensee's (e.g., nuclear medicine technologist) obtained a survey
result of _____ Mr/hr, which exceeded the licensee's established trigger rate level of _____ Mr/hr,
and the Radiation Safety Officer was not notified.
This is a Severity Level
violation (Supplement VI).
6
If information, such as a room number, is readily available to further identify the area(s), it should be included
in the citation.
C-50
NUREG/BR-0195, Rev. 2
Appendix C
35-184
Standard Citations - Part 35
10 CFR 35.70(e) requires that a licensee survey for removable contamination once each week
all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored.
Contrary to the above, during the week(s) of (date) to (date) , the licensee did not survey for
removable contamination in the (identify the area) , an area where radiopharmaceuticals were
routinely (prepared) / (administered) / (stored) .
This is a Severity Level
35-185
violation (Supplement VI).
10 CFR 35.70(f) requires that a licensee conduct the weekly surveys for removable
contamination of all areas where radiopharmaceuticals are routinely prepared for use,
administered, or stored, as required by 10 CFR 35.70(e), so as to be able to detect
contamination on each wipe sample of 2,000 disintegrations per minute.
Contrary to the above, as of __________, the licensee did not conduct weekly surveys for
contamination in areas where radiopharmaceuticals were routinely prepared for use, administered,
or stored in such a manner so as to be able to detect contamination on each wipe sample of 2,000
disintegrations per minute. Specifically, the equipment used to analyze the wipe samples (briefly
state why equipment could not detect 2,000 dpm) .
This is a Severity Level
35-186
violation (Supplement VI).
10 CFR 35.70(g) requires, in part, that a licensee establish removable contamination trigger
levels for weekly surveys of all areas where radiopharmaceuticals are routinely prepared for
use, administered, or stored.
Contrary to the above, as of __________, the licensee did not establish removable contamination
trigger levels for its weekly surveys of areas7 where radiopharmaceuticals are prepared,
administered, and stored.
This is a Severity Level
violation (Supplement VI).
7
If information, such as a room number, is readily available to further identify the area(s), it should be included
in the citation.
NUREG/BR-0195, Rev. 2
C-51
Standard Citations - Part 35
Appendix C
35-186a 10 CFR 35.70(g) requires that a licensee establish removable contamination trigger levels for
weekly surveys of areas where radiopharmaceuticals are routinely prepared for use,
administered, or stored, and that the individual performing the survey immediately notify the
Radiation Safety Officer if contamination exceeds a trigger level.
Contrary to the above, on __________, while performing a survey for removable contamination in
the areas7 where (specify from the choices above) , the licensee's (e.g., nuclear medicine
technologist) obtained a survey result of _____ dpm, which exceeded the licensee's established
trigger rate level of _____ dpm, and the Radiation Safety Officer was not notified.
This is a Severity Level
35-190
violation (Supplement VI).
10 CFR 35.75(a) requires that a licensee not authorize release from confinement for medical
care any patient administered a radiopharmaceutical until either the measured dose rate from
the patient is less than 5 millirems per hour (mr/hr) at a distance of one meter or the activity
in the patient is less than 30 millicuries.
Contrary to the above, on (date) , the licensee released a patient who had received (activity) of
(nuclide) on (date) , and, at the time of release, the (measured) / (calculated) dose rate from the
patient was _____ mr/hr at a distance of one meter and the (measured) / (calculated) activity in
the patient was _____ millicuries.
This is a Severity Level
35-191
violation (Supplement VI).
10 CFR 35.75(b) requires that a licensee not authorize release from confinement for medical
care of any patient administered a permanent implant until the measured dose rate from the
patient is less than 5 millirems per hour (mr/hr) at a distance of one meter.
Contrary to the above, on __________, the licensee released a patient who had received a permanent
implant of (activity), (nuclide) on (date) , and, at the time of release, the (measured) /
(calculated) dose rate from the patient was _____ mr/hr at a distance of one meter.
This is a Severity Level violation (Supplement VI).
35-195
10 CFR 35.80(a) requires, in part, that a licensee providing mobile nuclear medicine service
transport to each address of use only syringes or vials containing prepared
radiopharmaceuticals or radiopharmaceuticals that are intended for reconstitution of
radiopharmaceutical kits.
Contrary to the above, on __________, the licensee, a mobile nuclear medicine service, transported
a molybdenum-99/technetium-99m generator to (location) , and used it at that address.
This is a Severity Level
35-196
violation (Supplement VI).
10 CFR 35.80(b) requires, in part, that a licensee providing mobile nuclear medicine service
bring to each address of use all byproduct material to be used at that address.
Contrary to the above, on __________, the licensee, a mobile nuclear medicine service, arranged
for (nuclide) to be delivered to (location) for the licensee's use at that address.
C-52
NUREG/BR-0195, Rev. 2
Appendix C
This is a Severity Level
Standard Citations - Part 35
violation (Supplement VI).
35-196a 10 CFR 35.80(b) requires, in part, that a licensee providing mobile nuclear medicine service
remove all unused byproduct material and all associated waste from each address of use before
leaving.
Contrary to the above, on __________, before leaving (location) , an address of use, the licensee,
a mobile nuclear medicine service, (did not remove unused nuclide(s)) / (did not remove radioactive
waste associated with the use of nuclide(s) ).
This is a Severity Level
35-198
violation (Supplement VI).
10 CFR 35.80(e) requires, in part, that a licensee providing mobile nuclear medicine service
survey all radiopharmaceutical areas of use with a radiation detection survey meter to ensure
that all radiopharmaceuticals and all associated waste are removed before leaving a client
address of use.
Contrary to the above, on __________, the licensee did not conduct a survey8 to determine that all
radiopharmaceuticals and all associated waste were removed before leaving (location) , a client
address of use.
This is a Severity Level
35-200
violation (Supplement VI).
10 CFR 35.90 requires that a licensee store volatile radiopharmaceuticals and radioactive gases
in the shipper's radiation shield and container, and that a licensee store a multi-dose container
of such materials in a fume hood after drawing the first dosage from it.
35-200a Contrary to the above, on __________, the licensee stored
(nuclide) , a (volatile
radiopharmaceutical) / (radioactive gas) in a (radiation shield) / (container) not supplied by the
shipper.
This is a Severity Level
violation (Supplement VI).
35-200b Contrary to the above, on __________, the licensee did not store a multi-dose container of
(nuclide) in the form of a (volatile radiopharmaceutical) / (radioactive gas) in a fume hood after
drawing the first dosage from the vial.
This is a Severity Level
violation (Supplement VI).
8
If information, such as a room number, is readily available to further identify the area(s) where the survey
should have been conducted, it should be included in the citation.
NUREG/BR-0195, Rev. 2
C-53
Standard Citations - Part 35
35-210
Appendix C
10 CFR 35.92(a) permits a licensee to dispose of byproduct material with a physical half-life
of less than 65 days in ordinary trash, provided, in part, that the licensee first holds such
byproduct material for decay a minimum of ten half-lives.
Contrary to the above, (on) / (as of) (date) , the licensee (routinely) disposed of (nuclide(s))
in ordinary trash without first holding this material for decay a minimum of ten half-lives.
This is a Severity Level
35-211
violation (Supplement VI).
10 CFR 35.92(a) permits a licensee to dispose of byproduct material with a physical half-life
of less than 65 days in ordinary trash provided, in part, that the licensee first monitors such
byproduct material at the container surface and determines that its radioactivity cannot be
distinguished from the background radiation level with a radiation detection survey meter set
on its most sensitive scale and with no interposed shielding.
Contrary to the above, (on) / (as of) (date) , the licensee (routinely) disposed of (nuclides) in
ordinary trash without first monitoring this material to determine that its radioactivity could not be
distinguished from the background radiation level.
This is a Severity Level
35-212
violation (Supplement VI).
10 CFR 35.92(b) requires that a licensee retain for three years a record of each disposal of
byproduct material permitted under 10 CFR 35.92(a), and that the record include the date of
the disposal, the date on which the byproduct material was placed in storage, the radionuclides
disposed, the survey instrument used, the background dose rate, the dose rate measured at the
surface of each waste container, and the name of the individual who performed the disposal.
Contrary to the above, as of ________, the licensee's records of disposal of byproduct
material permitted under 10 CFR 35.92(a) did not include (specify the missing item(s)).
This is a Severity Level
35-230
violation (Supplement VI).
10 CFR 35.204(a) requires that a licensee not administer to humans a radiopharmaceutical
containing more than 0.15 microcuries of molybdenum-99 per millicurie of technetium-99m.
Contrary to the above, on _____ occasions from (date) to (date) , the licensee administered to
humans radiopharmaceuticals containing more than 0.15 microcuries of molybdenum-99 per
millicurie of technetium-99m.
This is a Severity Level
violation (Supplement VI).
C-54
NUREG/BR-0195, Rev. 2
Appendix C
35-231
Standard Citations - Part 35
10 CFR 35.204(b) requires that a licensee that uses molybdenum-99/ technetium-99m
generators for preparing a technetium-99m radiopharmaceutical measure the molybdenum-99
concentration in each eluate or extract.
Contrary to the above, on __________, the licensee used a molybdenum-99/technetium-99m
generator to prepare a technetium-99m radiopharmaceutical and the licensee did not measure the
molybdenum-99 concentration in the generator eluate.
This is a Severity Level
35-232
violation (Supplement VI).
10 CFR 35.204(b) states that a licensee that uses molybdenum-99/ technetium-99m generators
for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99
concentration in each eluate or extract.
10 CFR 35.204(c) requires, in part, that a licensee that must measure molybdenum
concentration retain records that include, for each elution or extraction of technetium-99m, the
ratio of microcuries of molybdenum per millicurie of technetium, and the initials of the
individual who made the measurement.
Contrary to the above, from __________ to __________, the licensee used molybdenum99/technetium-99m generators for preparing technetium-99m radiopharmaceuticals, and the
licensee's records of elutions of technetium-99m did not include the (ratio of microcuries of
molybdenum per millicurie of technetium) / (initials of the individual who made the measurement)
This is a Severity Level
35-241
violation (Supplement VI).
10 CFR 35.205(b) requires that a licensee administer radioactive gases only in rooms that are
at negative pressure compared to surrounding rooms.
Contrary to the above, from __________ to __________, the licensee administered radioactive
xenon-133 gas in (identify the location) , which was not at negative pressure compared to
surrounding rooms.
This is a Severity Level
35-242
violation (Supplement VI).
10 CFR 35.205(c) requires, in part, that before receiving, using, or storing a radioactive gas,
the licensee calculate the amount of time needed after a spill to reduce the concentration in the
room to the occupational limit listed in 10 CFR Part 20, Appendix B.
Contrary to the above, from __________ to __________, the licensee (used) / (stored) radioactive
xenon-133 gas in (identify the location(s)) and the licensee did not calculate the amount of time
needed after a spill to reduce the concentration therein to the occupational limit listed in 10 CFR Part
20, Appendix B.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-55
Standard Citations - Part 35
35-243
Appendix C
10 CFR 35.205(d) requires, in part, that a licensee post the safety measures to be instituted in
case of a spill of a radioactive gas at the area of use and the calculated time needed after a spill
to reduce the concentration to the occupational limit listed in 10 CFR Part 20, Appendix B.
Contrary to the above, from __________ to __________, the licensee used radioactive xenon-133
gas in (identify the location(s)) and the licensee did not post (the safety measures to be instituted
in case of a spill of xenon-133 gas) / (the calculated time needed after a spill to reduce the
concentration to the occupational limit listed in 10 CFR Part 20, Appendix B)
This is a Severity Level
violation (Supplement VI).
35-245a 10 CFR 35.205(e) requires, in part, that a licensee check each month the operation of reusable
collection systems for radioactive gases.
Contrary to the above, the licensee used a reusable collection system for radioactive xenon-133 gas
and did not check the operation of the collection system from __________ to __________.
This is a Severity Level
violation (Supplement VI).
35-245b 10 CFR 35.205(e) requires, in part, that a licensee measure each six months the ventilation
rates available in areas of use of radioactive gas.
Contrary to the above, the licensee used radioactive xenon-133 gas in (identify the location(s))
and did not measure the ventilation rates therein from __________ to __________.
This is a Severity Level
35-250
violation (Supplement VI).
10 CFR 35.220 requires that a licensee authorized to use byproduct material for imaging and
localization possess a portable radiation detection survey instrument capable of detecting dose
rates over the range of 0.1 millirem per hour to 100 millirem per hour, and a portable radiation
measurement survey instrument capable of measuring dose rates over the range 1 millirem per
hour to 1000 millirem per hour.
Contrary to the above, as of __________, the licensee did not possess a portable radiation
(detection) / (measurement) survey instrument capable of measuring the above listed dose rates.
This is a Severity Level
violation (Supplement VI).
35-272a 10 CFR 35.315(a)(2) requires in part that, for each patient receiving radiopharmaceutical
therapy and hospitalized for compliance with 10 CFR 35.75, a licensee post the patient's door
with a "Radioactive Materials" sign.
Contrary to the above, on __________, the licensee did not post the door to the room9 of a patient
with a "Radioactive Materials" sign, and the patient was receiving radiopharmaceutical therapy and
hospitalized for compliance with 10 CFR 35.75.
This is a Severity Level
violation (Supplement VI).
C-56
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 35
35-272b 10 CFR 35.315(a)(2) requires in part that, for each patient receiving radiopharmaceutical
therapy and hospitalized for compliance with 10 CFR 35.75, a licensee note on the patient's
door or in the patient's chart where and how long visitors may stay in the patient's room.
Contrary to the above, on __________, the licensee did not note on a patient's door9 or in the
patient's chart where and how long visitors could stay in the patient's room, and the patient was
receiving radiopharmaceutical therapy and hospitalized for compliance with 10 35.75.
This is a Severity Level
35-274
violation (Supplement VI).
10 CFR 35.315(a)(4) requires in part that, for each patient receiving radiopharmaceutical
therapy and hospitalized for compliance with 10 CFR 35.75, a licensee promptly after
administration of the dosage, measure the dose rates in contiguous restricted and unrestricted
areas with a radiation measurement survey instrument to demonstrate compliance with the
requirements of 10 CFR Part 20.
Contrary to the above, on __________, the licensee administered to a patient _____ millicuries of
iodine-131 for radiopharmaceutical therapy, a dosage which requires hospitalization for compliance
with 10 CFR 35.75, and the licensee did not measure the dose rates in contiguous restricted and
unrestricted areas.
This is a Severity Level
35-277
violation (Supplement VI).
10 CFR 35.315(a)(7) requires that, for each patient receiving radio-pharmaceutical therapy and
hospitalized for compliance with 10 CFR 35.75, a licensee survey the patient's room and
private sanitary facility for removable contamination with a radiation detection survey
instrument before assigning another patient to the room. The room must not be reassigned
until removable contamination is less than 200 disintegrations per minute per 100 square
centimeters.
Contrary to the above, on __________, the licensee did not conduct a survey for removable
contamination before assigning another patient to room _____, the room of a patient who had
received radiopharmaceutical therapy and had been hospitalized for compliance with 10 CFR 35.75.
This is a Severity Level
9
violation (Supplement VI).
If the room number is readily available, it should be included in the citation in reference to the patient's
door.
NUREG/BR-0195, Rev. 2
C-57
Standard Citations - Part 35
Appendix C
35-278a 10 CFR 35.315(a)(8) requires, in part, that a licensee measure the thyroid burden of each
individual who helped prepare or administer dosages of iodine-131 in amounts that required
the patient to be hospitalized for compliance with 10 CFR 35.75, and that the measurements
be performed within three days after the administration of the dosage.
Contrary to the above, on __________, the licensee administered to a patient _____ millicuries of
iodine-131, a dosage which requires hospitalization for compliance with 10 CFR 35.75, and the
licensee did not measure the thyroid burden of the (e.g., nuclear medicine technologist) who
helped (prepare) / (administer) this dosage (until date , a period in excess of three days).
This is a Severity Level
violation (Supplement VI).
35-278b 10 CFR 35.315(a)(8) requires, in part, that a licensee retain records of thyroid burden
measurements performed on individuals who help prepare or administer dosages of iodine-131
in amounts that require the patient to be hospitalized for compliance with 10 CFR 35.75, and
that the records include the date of the measurement, the name of the individual whose thyroid
burden was measured, and the initials of the individual who made the measurements.
Contrary to the above, as of __________, the licensee's records of thyroid burden measurements
performed on individuals who had helped prepare or administer dosages of iodine-131 in amounts
that required the patient to be hospitalized for compliance with 10 CFR 35.75, did not include
(select missing items from above) .
This is a Severity Level
35-300
violation (Supplement VI).
10 CFR 35.404(a) requires that, immediately after removing the last temporary implant source
from a patient, the licensee make a radiation survey of the patient with a radiation detection
survey instrument to confirm that all sources have been removed, and that the licensee not
release from confinement for medical care a patient treated by temporary implant until all
sources have been removed.
Contrary to the above, on __________, the licensee released a patient treated with a temporary
implant of (nuclide) , and the licensee did not perform a radiation survey of the patient to confirm
that all sources had been removed.
This is a Severity Level
35-310
violation (Supplement VI).
10 CFR 35.406(a) requires that promptly after removing them from a patient, a licensee return
brachytherapy sources to the storage area and count the number returned to ensure that all
sources taken from the storage area have been returned.
35-310a Contrary to the above, after removing (nuclide) brachytherapy sources from a patient at (time),
(date) , the license did not return the sources to the storage area until (time), (date) .
This is a Severity Level
violation (Supplement VI).
C-58
NUREG/BR-0195, Rev. 2
Appendix C
35-310
Standard Citations - Part 35
10 CFR 35.406(a) requires that promptly after removing them from a patient, a licensee return
brachytherapy sources to the storage area and count the number returned to ensure that all
sources taken from the storage area have been returned.
35-310b Contrary to the above, on __________, after removing (nuclide) brachytherapy sources from a
patient and returning them to the storage area, the licensee did not count the number returned to
assure that all sources taken from the storage area had been returned.
This is a Severity Level
35-311
violation (Supplement VI).
10 CFR 35.406(b) requires that a licensee make a record of brachytherapy source use,
including: (1) The names of the individuals permitted to handle the sources, (2) The number
and activity of sources removed from storage, the patient's name and room number, the time
and date they were removed from storage, the number and activity of the sources in storage
after the removal, and the initials of the individual who removed the sources from storage;
(3) The number and activity of sources returned to storage, the patient's name and room
number, the time and date they were returned to storage, the number and activity of sources
in storage after the return, and the initials of the individual who returned the sources to
storage.
Contrary to the above, as of __________, the licensee's record of brachytherapy source usage for
(date) did not include (select missing items from above) .
This is a Severity Level
35-320
violation (Supplement VI).
10 CFR 35.410 requires that a licensee provide radiation safety instruction to all personnel
caring for a patient undergoing implant therapy. This instruction must describe: (1) Size and
appearance of the brachytherapy sources; (2) Safe handling and shielding instructions in case
of a dislodged source; (3) Procedures for patient control; (4) Procedures for visitor control;
and (5) Procedures for notification of the Radiation Safety Officer if the patient dies or has a
medical emergency.
Contrary to the above, on (date(s)) , licensee (e.g., nursing) personnel cared for patients
undergoing implant therapy and the licensee had not provided the required radiation safety
instruction to those individuals (concerning select missing items from above ).
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-59
Standard Citations - Part 35
Appendix C
35-334a 10 CFR 35.415(a)(4) requires, in part, that a licensee, promptly after implanting brachytherapy
sources, survey the dose rates in contiguous restricted and unrestricted areas with a radiation
measurement survey instrument to demonstrate compliance with the requirements of 10 CFR
Part 20.
Contrary to the above, on __________, the licensee implanted (nuclide) brachytherapy sources
and did not survey the dose rates in restricted and unrestricted areas contiguous to the room of the
implanted patient to demonstrate compliance with the requirements of 10 CFR Part 20.
This is a Severity Level
violation (Supplement VI).
35-334b 10 CFR 35.415(a)(4) requires that the licensee retain for three years a record of each survey
of dose rates in restricted and unrestricted areas contiguous to rooms of patients implanted
with brachytherapy sources. The record shall include the time and date of the survey, a plan
of the area or list of points surveyed, the measured dose rate at several points expressed in
millirem per hour, the instrument used to make the survey, and the initials of the individual
who made the survey.
Contrary to the above, as of __________, the licensee's survey records of dose rates in restricted and
unrestricted areas contiguous to rooms of patients implanted with brachytherapy sources did not
include (select missing item(s) from above) .
This is a Severity Level
35-380
violation (Supplement VI).
10 CFR 35.605 requires that only a person specifically licensed by the Commission or an
Agreement State to perform teletherapy unit maintenance and repair shall install, relocate, or
remove a teletherapy sealed source or a teletherapy unit that contains a sealed source, or
maintain, adjust, or repair the source drawer, the shutter or other mechanism of a teletherapy
unit that could expose the source, reduce the shielding around the source, or result in increased
radiation levels.
Contrary to the above, on __________, the licensee permitted a (e.g., licensee contractor) , a
person not specifically licensed by the Commission or an Agreement State to perform teletherapy
unit maintenance and repair, to perform such work on the licensee's teletherapy equipment.
Specifically, this individual (describe the work performed from the choices above).
This is a Severity Level
35-415
violation (Supplement VI).
10 CFR 35.615(c) requires that a licensee equip each entrance to the teletherapy room with a
beam condition indicator light.
Contrary to the above, from __________ to __________, the entrance to the licensee's teletherapy
room was not equipped with a functional beam condition indicator light.
This is a Severity Level
violation (Supplement VI).
C-60
NUREG/BR-0195, Rev. 2
Appendix C
35-420
Standard Citations - Part 35
10 CFR 35.615(d)(3) requires that the permanent radiation monitor installed in each
teletherapy room be checked with a dedicated check source for proper operation each day
before the teletherapy unit is used for treatment of patients.
Contrary to the above, on (date(s)) , days that the licensee used its teletherapy unit for treatment
of patients, the permanent radiation monitor in the teletherapy room was not checked with a
dedicated check source for proper operation before the teletherapy unit was used for treatment.
This is a Severity Level
35-422
violation (Supplement VI).
10 CFR 35.615(d)(5) requires that if a radiation monitor is inoperable, the licensee shall
require any individual entering the teletherapy room to use a survey instrument or audible
alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism
that may result in an exposed or partially exposed source.
Contrary to the above, from __________ to __________, the radiation monitor for the licensee's
teletherapy room was inoperable and the licensee did not require individuals entering the teletherapy
room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction
of the source exposure mechanism that may have resulted in an exposed or partially exposed source.
This is a Severity Level
35-443
violation (Supplement VI).
10 CFR 35.632(a)(2)(i) requires that a licensee perform full calibration measurements on each
teletherapy unit whenever the spot-check measurements indicate that the output differs by
more than 5 percent from the output obtained at the last full calibration, corrected
mathematically for radioactive decay.
Contrary to the above, on __________, the licensee did not perform full calibration measurements
on its teletherapy unit when spot check measurements performed by the licensee indicated that the
teletherapy unit output differed by more than 5 percent from the output obtained at the last full
calibration (corrected mathematically for radioactive decay).
This is a Severity Level
35-444
violation (Supplement VI).
10 CFR 35.632(a)(3) and (f) require that full calibration measurements on each teletherapy unit
be conducted at intervals not to exceed one year and that these measurements must be
performed by the licensee's teletherapy physicist.
35-444a Contrary to the above, on __________, individuals other than the licensee's designated teletherapy
physicist performed the annual full calibration measurements of the licensee's teletherapy unit.
This is a Severity Level
violation (Supplement VI).
35-444b Contrary to the above, the licensee did not perform a full calibration of its teletherapy unit from
__________ to __________, an interval greater than one year.
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-61
Standard Citations - Part 35
35-448
Appendix C
10 CFR 35.632(b)(3) requires that full calibration measurements performed on each
teletherapy unit include determination of the uniformity of the radiation field and its
dependence on the orientation of the useful beam.
Contrary to the above, the annual full calibration measurements performed on the licensee's
teletherapy unit on (date(s)) did not include a determination of the uniformity of the radiation field
and its dependence on the orientation of useful beam.
This is a Severity Level
35-449
violation (Supplement VI).
10 CFR 35.632(b)(4) requires that full calibration measurements performed on each
teletherapy unit include determination of timer constancy and linearity over the range of use.
Contrary to the above, the annual full calibration measurements performed on the licensee's
teletherapy unit on date(s) did not include a determination of timer constancy and linearity (over
the licensee's full range of use, _____ to _____ minutes).
This is a Severity Level
35-461
violation (Supplement VI).
10 CFR 35.634(a)(1) requires that a licensee authorized to use teletherapy units for medical use
perform monthly output spot-checks on each teletherapy unit that include determination of
timer constancy and timer linearity over the range of use.
Contrary to the above, from __________ to __________, the licensee's monthly output spot-checks
on its teletherapy unit did not include a determination of timer constancy and timer linearity (over
the licensee's full range of use, _____ to _____ minutes and
to
mCi).
This is a Severity Level
35-462
violation (Supplement VI).
10 CFR 35.634(a) requires, in part, that a licensee authorized to use teletherapy units for
medical use perform output spot-checks on each teletherapy unit once in each calendar month.
10 CFR 35.634(c) requires, in part, that the licensee have the teletherapy physicist review the
results of each spot-check within 15 days, and promptly notify the licensee in writing of the
results of each spot-check.
Contrary to the above, from __________ to __________, the licensee routinely did not assure that
its teletherapy physicist reviewed the results of the monthly spot-checks of the licensee's teletherapy
unit within 15 days and promptly notified the licensee in writing of the results of each spot-check.
For example, for the spot-checks performed on (date) and (date) , the licensee did not receive
written notification of the results from its teletherapy physicist until (date) and (date) ,
respectively.
This is a Severity Level
violation (Supplement VI).
C-62
NUREG/BR-0195, Rev. 2
Appendix C
35-469
Standard Citations - Part 35
10 CFR 35.634(f) requires that a licensee retain a record of each monthly spot-check required
by 10 CFR 35.634(a) and (d) for three years. The record must include, among other things,
(specify the applicable item(s) from the regulation).
Contrary to the above, as of __________, the licensee's records of monthly spot-checks required by
10 CFR 35.634(a) and (d) did not include (specify the item(s) as above) .
This is a Severity Level
NUREG/BR-0195, Rev. 2
violation (Supplement VI).
C-63
Standard Citations - Part 71
Appendix C
10 CFR PART 71
PACKAGING AND
TRANSPORTATION OF
RADIOACTIVE MATERIAL
_______________________________
71-10
10 CFR 71.3 states that, except as authorized in a general license or a specific license issued by
the Commission, or as exempted by other paragraphs in 10 CFR Part 71, no licensee may: (1)
deliver licensed material to a carrier for transport, or (2) transport licensed material.
10 CFR 71.10(b) states, in part, that a licensee is exempt from all requirements of 10 CFR Part
71, other than 10 CFR 71.5 and 10 CFR 71.88, with respect to shipment or carriage of a
package containing no more than a Type A quantity of radioactive material, provided the
package contains no fissile material or if the fissile material exemption standards of
10 CFR 71.53 are satisfied.
71-12
Contrary to the above, on (date) , the licensee (transported) / (delivered to a carrier for transport)
(amount) of (nuclide) , which is greater than a Type A quantity of radioactive material; and the
licensee was not otherwise exempted pursuant to 10 CFR Part 71, nor did the licensee meet the
criteria for a general license, nor was this transport authorized in a specific license issued by the
Commission.
This is a Severity Level ___ violation (Supplement V).
71-14
Contrary to the above, on (date) , the licensee (transported) / (delivered to a carrier for transport)
(amount) grams of fissile material consisting of (nuclide(s)) , which does not meet the exemption
standards set forth in 10 CFR 71.53; and the licensee was not otherwise exempted pursuant to 10
CFR Part 71, nor did the licensee meet the criteria for a general license, nor was this transport
authorized in a specific license issued by the Commission.
This a Severity Level ___ violation (Supplement V).
C-64
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 71
CITATIONS FOR FAILURE TO FOLLOW DOT REGULATIONS
NOTE: Citations for failure to follow specific DOT regulations should include, in the first paragraph, the
authority under 10 CFR 71.5(a). Use the paragraph below. Then list the specific citations as
subheadings, without repeating the initial paragraph.
71-20
10 CFR 71.5(a) requires that a licensee who transports licensed material outside of the site of
usage, as specified in the NRC license, or where transport is on public highways, or who
delivers licensed material to a carrier for transport, comply with the applicable requirements
of the regulations appropriate to the mode of transport of the Department of Transportation
(DOT) in 49 CFR Parts 170 through 189.
71-30
10 CFR 71.12 states, in part, that a general license to transport licensed material, or to deliver
licensed material to a carrier for transport, applies only to a licensee who has a quality
assurance program approved by the Commission as satisfying the provisions of subpart H of
10 CFR Part 71; has a copy of the certificate of compliance, or other approval of the package;
and submits in writing to NRC, prior to the first use of the transport package, the licensee's
name, license number, and package identification number.
Contrary to the above, as of (date) , the licensee routinely (transported licensed material) /
(delivered licensed material to a carrier for transport) under the general license pursuant to 10 CFR
71.12, and the licensee (did not have a quality assurance program approved by the Commission)
/ (did not have a copy of the certificate of compliance, or other approval of the package) / (had
not submitted in writing to NRC prior to the first use of the transport package the licensee's name,
license number, and package identification number) .
This is a Severity Level ___ violation (Supplement V).
NUREG/BR-0195, Rev. 2
C-65
Standard Citations - Part 71
Appendix C
49 CFR PART 172
HAZARDOUS MATERIALS
_______________________________
SHIPPING PAPERS
NOTE: If there is no shipping paper, choose one of the two citations below, depending on whether the
licensee transported the material or offered it for transport. If the shipping paper is incomplete or
inaccurate, begin with either 71-50 or 71-55 as appropriate, and then follow with the specific
citation, choosing from among 71-60 through 71-90.
71-50
49 CFR 172.200(a) requires, with exceptions not applicable here, that each person who offers
a hazardous material for transportation describe the hazardous material on the shipping paper
in the manner required by subpart C of 49 CFR Part 172. Pursuant to 49 CFR 172.101,
radioactive material is classified as hazardous material.
Contrary to the above, on (date) , the licensee offered (licensed material) to a carrier for
transport and did not include with the shipment a shipping paper describing the material.
This is a Severity Level
71-55
violation (Supplement V).
49 CFR 177.817(a) requires that a carrier not transport a hazardous material unless it is
accompanied by a shipping paper prepared in accordance with 49 CFR 172.200-203. Pursuant
to 49 CFR 172.101, radioactive material is classified as hazardous material.
Contrary to the above, on (date) , the licensee transported (licensed material) outside the confines
of its plant without a shipping paper.
This is a Severity Level
violation (Supplement V).
EMERGENCY RESPONSE TELEPHONE NUMBER
NOTE: If the emergency response telephone number is on the shipping paper but does not meet the
requirements of 49 CFR 172.602, use 71-220.
71-60
49 CFR 172.201(d) requires that a shipping paper contain an emergency response telephone
number, as prescribed in subpart G of 49 CFR Part 172.
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) , and the shipping paper that accompanied
the shipment did not contain an emergency response telephone number.
This is a Severity Level ___ violation (Supplement V).
C-66
NUREG/BR-0195, Rev. 2
Appendix C
71-70
Standard Citations - Part 71
49 CFR 172.202(a) and (b) require in part, with exceptions not applicable here, that the
shipping description of a hazardous material on the shipping paper include, in the following
sequence: (1) the proper shipping name prescribed for the material in 172.101 (2) the hazard
class prescribed for the material as shown in Column 3 of the 172.101 Table, and (3) the
identification number prescribed for the material as shown in Column 4 of the 172.101 Table.
Pursuant to 49 CFR 172.101, radioactive material is classified as hazardous material.
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport)
(licensed material) , and the shipping description on the
shipping paper that accompanied the shipment did not include (select the missing item(s) from the
paragraph above) .
This is a Severity Level ___ violation (Supplement V).
71-80
49 CFR 172.203(c)(2) requires that the letters "RQ" be entered on the shipping paper either
before or after the basic description required for each hazardous substance. Pursuant to
49 CFR 172.101, radioactive material is classified as hazardous material.
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) , and the letters "RQ" were not entered
either before or after the description on the shipping paper that accompanied the shipment.
This is a Severity Level ___ violation (Supplement V).
71-90
49 CFR 172.203(d) requires, in part, that the description for a shipment of radioactive material
include: (1) the name or abbreviation (e.g., 99Mo) of each radionuclide that is in the radioactive
material and is listed in 49 CFR 173.435, or for mixtures of radionuclides, those nuclides
determined in accordance with the provisions of 49 CFR 173.433(f); (2) the physical and
chemical form of the material (if not special form); (3) the activity contained in each package
of the shipment in terms of the appropriate SI units (e.g., Becquerel, Terabecquerel etc...), or
in terms of appropriate SI units followed by customary units (e.g., curies, millicuries, or
microcuries) [Note that for domestic transportation, use of customary units only is authorized
until April 1, 1997]; (4) the category of label applied to each package (e.g., RADIOACTIVE
WHITE-I), and 5) the transport index assigned to each package in the shipment bearing
RADIOACTIVE YELLOW-II OR YELLOW-III labels.
71-92
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport)
(licensed material) , and the description on the shipping
paper that accompanied the shipment did not include select missing item(s) from above) .
This is a Severity Level ___ violation (Supplement V).
71-94
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport)
(licensed material) , and the description on the shipping
paper that accompanied the shipment did not include the correct (select item(s) from above) .
Specifically, (state how each item was incorrect) .
This is a Severity Level ___ violation (Supplement V).
NUREG/BR-0195, Rev. 2
C-67
Standard Citations - Part 71
71-100
Appendix C
49 CFR 172.310 requires, in part, that for each package containing radioactive materials, the
packaging must be marked on the outside of the package, in letters at least 13 mm (0.5 inch)
high, with the words “TYPE A” or “TYPE B” as appropriate, and requires that packagings
which do not conform to Type A or Type B requirements may not be so marked.
Contrary to the above, as of (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) in a (Type A) / (Type B) package which
was not marked "(Type A)" / "(Type B)".
This is a Severity Level ___ violation (Supplement V).
71-110
49 CFR 172.312 requires in part, with exceptions not applicable here, that each package having
an inside packaging containing liquid hazardous materials be (1) packed with closures upward,
and (2) legibly marked, with package orientation markings that conform pictorially to ISO
Standard 780-1985, on two opposite vertical sides of the package with the arrows pointing in
the correct upright direction. Pursuant to 49 CFR 172.101, radioactive material is classified
as hazardous material.
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) in liquid form, and the outer package was
not marked on two opposite vertical sides with package orientation arrows pointing in the correct
upright direction.
This is a Severity Level
violation (Supplement V).
71-120
49 CFR 172.403 requires, in part, with exceptions not applicable here, that each package of
radioactive material be labeled, as appropriate, with two RADIOACTIVE WHITE-I,
RADIOACTIVE YELLOW-II, or RADIOACTIVE YELLOW-III labels on opposite sides
of the package. The contents, activity, and transport index must be entered in the blank spaces
on the label using a legible and durable, weather resistant means. The contents entered on the
label must include the name or abbreviation (e.g., 99Mo) of the radionuclides as taken from the
listing in 49 CFR 173.435, or for mixtures of radionuclides, those nuclides determined in
accordance with the provisions of 49 CFR 173.433(f), with consideration of space available on
the label. The activity must be expressed in terms of the appropriate SI units (e.g., Becquerel,
Terabecquerel etc...), or in terms of appropriate SI units followed by customary units (e.g.,
curies, millicuries, or microcuries) [Note that for domestic transportation, use of customary
units only is authorized until April 1, 1997].
71-122
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) without the required (RADIOACTIVE
WHITE-I) / (RADIOACTIVE YELLOW-II) / (RADIOACTIVE YELLOW-III) labels.
This is a Severity Level
71-124
violation (Supplement V).
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) , and the RADIOACTIVE label affixed
to the package did not identify the (contents) / (activity) / (transport index) .
This is a Severity Level ___ violation (Supplement V).
C-68
NUREG/BR-0195, Rev. 2
Appendix C
71-126
Standard Citations - Part 71
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) , and the RADIOACTIVE label affixed
to the package incorrectly identified the (contents) / (activity) / (transport index) . Specifically,
(state how each item was incorrect) .
This is a Severity Level ___ violation (Supplement V).
71-128
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport)
(licensed material) , and the package had only one
RADIOACTIVE label affixed to it.
This is a Severity Level ___ violation (Supplement V).
71-140
49 CFR 172.403(b) requires that the label to be affixed to a package is based on the radiation
level at the surface of the package and the transport index. The label to be applied must be the
highest category required for either of the two determining conditions of the package. 49 CFR
172.403(c) defines the categories of labels to be applied to radioactive materials packages and
requires, in part, that: (1) packages with surface radiation levels of less than or equal to 0.005
millisievert per hour (0.5 millirem per hour) be labeled "White-I," (2) packages with surface
radiation levels greater than 0.005 millisievert per hour (0.5 millirem per hour) but less than
or equal to 0.5 millisievert per hour (50 millirem per hour) be labeled "Yellow-II," and (3)
packages with surface radiation levels greater than 0.5 millisievert per hour (50 millirem per
hour) be labeled "Yellow-III."
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) in a package that was improperly labeled.
Specifically, the package had surface radiation levels of (specify) millirem per hour and was
labeled ________, instead of __________.
This is a Severity Level ___ violation (Supplement V).
71-150
49 CFR 172.403(b) requires that the label to be affixed to a package is based on the radiation
level at the surface of the package and the transport index (T.I.). The label to be applied must
be the highest category required for either of the two determining conditions of the package.
49 CFR 172.403(c) defines the categories of labels to be applied to radioactive materials
packages and requires, in part, that: (1) packages with a T.I. of zero (i.e., a measured T.I. of
not greater than 0.05) be labeled “White-I”, (2) packages with aT.I. of more than zero but less
than or equal to 1.0 be labeled "Yellow-II," and (2) packages with a T.I. greater than 1.0 be
labeled "Yellow-III."
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) in a package that was improperly labeled.
Specifically, the package had a T.I. of (specify) and was labeled __________, instead of
__________.
This is a Severity Level ___ violation (Supplement V).
NUREG/BR-0195, Rev. 2
C-69
Standard Citations - Part 71
Appendix C
PROHIBITED PLACARDING
NOTE: DOT regulations prohibit the use of the "RADIOACTIVE" placard ONLY when the vehicle
contains NO radioactive material. The violation below normally should be considered to be a minor
violation and not the subject of formal enforcement action in accordance with the Enforcement
Policy.
71-170
49 CFR 172.502(a) requires, in part, with exceptions not applicable here, that no person affix
or display on a transport vehicle any placard unless the placard represents a hazard of the
material being transported.
Contrary to the above, on (date) , the licensee operated a transport vehicle, outside the site of
usage, as specified on the NRC license, or on a public highway, with a "RADIOACTIVE" placard
displayed on it and no packages containing radioactive material were present in the vehicle at the
time.
This is a Severity Level ___ violation (Supplement V).
71-180
49 CFR 172.504 prescribes requirements for placarding vehicles used to transport hazardous
materials. Specifically, Table 1 requires that the transport vehicle be placarded on each side
and each end with a "RADIOACTIVE" placard when transporting: a) packages bearing a
"RADIOACTIVE YELLOW-III" label, and b) exclusive-use shipments of low specific activity
(LSA) radioactive materials and surface contaminated objects (SCO) transported in
accordance with 49 CFR 173.427(b)(3) or (c) (see footnote in Table 1, 49 CFR 173.504(e)).
71-182
Contrary to the above, on (date) , the licensee transported (licensed material) , outside the site of
usage, as specified on the NRC license, or on a public highway, in a package with YELLOW-III
labels, and the transport vehicle was not placarded with "RADIOACTIVE" placards.
This is a Severity Level
71-184
violation (Supplement V).
Contrary to the above, on (date) , the licensee transported (LSA material/ SCO) consisting
of (specify) as an exclusive use shipment in accordance with 49 CFR 173.427(b)(3) or (c),
outside the site of usage, as specified on the NRC license, or on a public highway, , and the transport
vehicle was not placarded with "RADIOACTIVE" placards.
This is a Severity Level
violation (Supplement V).
C-70
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 71
EMERGENCY RESPONSE TELEPHONE NUMBER
NOTE: If the emergency response telephone number is not entered on the shipping paper, use 71-60.
71-190
49 CFR 172.600 requires, with exceptions not applicable here, that no person may offer for
transportation, accept for transportation, transfer, store, or otherwise handle during
transportation, a hazardous material unless emergency response information conforming to
Subpart G of 49 CFR Part 172 is immediately available for use at all times the hazardous
material is present. 49 CFR 172.602 requires, in part, that the emergency response
information must be presented: (1) on a shipping paper; (2) in a document, other than a
shipping paper (e.g., a material safety data sheet); or (3) in a separate document (e.g., an
emergency response guidance document), in a manner that cross-references the description of
the hazardous material on the shipping paper with the emergency response information on the
document. Pursuant to 49 CFR 172.101, radioactive material is classified as a hazardous
material.
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) , without the required emergency response
information.
This is a Severity Level ___ violation (Supplement V).
71-200
49 CFR 172.602 requires, in part, that as a minimum, the emergency response information
required by Subpart G of 49 CFR Part 172 must contain: (1) the basic description and
technical name of the hazardous material, (2) immediate hazards to health, (3) risks of fire or
explosion, (4) immediate precautions to be taken in the event of an accident of incident, (5)
immediate methods for handling fires, (6) initial methods for handling spills or leaks in the
absence of fire, and (7) preliminary first aid measures. Pursuant to 49 CFR 172.101,
radioactive material is classified as a hazardous material.
71-202
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) , and the emergency response information
that accompanied the shipment did not include select missing item(s) from above) .
This is a Severity Level ___ violation (Supplement V).
71-204
Contrary to the above, on (date) , the licensee (transported outside the confines of its plant) /
(delivered to a carrier for transport) (licensed material) , and the emergency response information
that accompanied the shipment did not include the (correct/complete) (select item(s) from above)
. Specifically, (state how each item was incorrect/incomplete) .
This is a Severity Level ___ violation (Supplement V).
NUREG/BR-0195, Rev. 2
C-71
Standard Citations - Part 71
71-210
Appendix C
49 CFR 172.602(c) requires, with exceptions not applicable here, that the emergency response
information specified in 49 CFR 172.602(a) must be maintained by each carrier who transports
hazardous material in the same manner as prescribed for shipping papers. 49 CFR 177.817(e)
requires, in part, that the driver of a motor vehicle containing hazardous material ensure that
the shipping paper is readily available to, and recognizable by, authorities in the event of
accident or inspection. Specifically, (i) when the driver is at the vehicle's controls, the shipping
paper shall be: (a) within his immediate reach while he is restrained by the lap belt; and (b)
either readily visible to a person entering the driver's compartment or in a holder which is
mounted to the inside of the door on the driver's side of the vehicle; (ii) when the driver is not
at the vehicle's controls, the shipping paper shall be: (a) in a holder which is mounted to the
side of the door on the driver's side of the vehicle; or (b) on the driver's seat in the vehicle.
Pursuant to 49 CFR 172.101, radioactive material is classified as a hazardous material.
Contrary to the above, on (date) , the licensee transported (licensed material) , outside the site of
usage, as specified on the NRC license, or on a public highway, and the driver of the vehicle did not
ensure that the emergency response information was readily available in the driver's compartment,
as required. Specifically, (state where the emergency response information was and why it was not
accessible) .
This is a Severity Level ___ violation (Supplement V).
NOTE: If the emergency response telephone number is not entered on the shipping paper, use 71-60.
71-220
49 CFR 172.604 requires, in part, that a person who offers a hazardous material for
transportation provide a 24 hour emergency response telephone number for use in the event
of an emergency involving the hazardous material. The telephone number must be:
(1) monitored at all times the hazardous material is in transportation, including storage
incidental to transportation, (2) the number of a person who is either knowledgeable of the
hazardous material being shipped and has comprehensive emergency response and incident
mitigation information for that material, or has immediate access to a person who possesses
such knowledge, and (3) entered on the shipping paper.
Contrary to the above, on (date) , the licensee delivered to a carrier for transport (licensed material) and the emergency response telephone number on the shipping paper that the licensee used to
accompany the shipment was inadequate in that it was not (select from item (1) or (2) above) .
This is a Severity Level ___ violation (Supplement V).
C-72
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 71
HAZMAT TRAINING REQUIREMENTS
NOTE: Always include the first paragraph below. If there is no hazmat training provided, cite against that
paragraph. If the training is incomplete, also include the second citation. Or, if the training records
are not adequate, also include the third citation.
71-230
49 CFR 172.702 requires that each hazmat employer shall ensure that each hazmat employee
is trained and tested, and that no hazmat employee performs any function subject to the
requirements of 49 CFR Parts 171-177 unless trained, in accordance with Subpart H of
49 CFR Part 172. The terms Hazmat Employer and Hazmat Employee are defined in 49 CFR
171.8.
Contrary to the above, during the period between
(date and date) , the licensee did not provide
training for its hazmat employees as required by Subpart H to 49 CFR Part 172, and the licensee
otherwise meets the definition of hazmat employer in 49 CFR 171.8.
This is a Severity Level ___ violation (Supplement V).
71-240
49 CFR 172.704(a) specifies the elements of hazmat employee training as: (1) general
awareness/familiarization training, (2) function-specific training, and (3) safety training.
49 CFR 172.204(c) requires, in part, that a hazmat employee receive initial training, and
recurrent training at least once every two years.
Contrary to the above, the licensee’s did not provide training for its hazmat employees which
satisfied the requirements in Subpart H to 49 CFR Part 172, in that
(Specify the deficiencies
in the training program) , and the licensee otherwise meets the definition of hazmat employer in
49 CFR 171.8.
This is a Severity Level ___ violation (Supplement V).
71-250
49 CFR 172.704(d) requires that a record of current training, inclusive of the preceding two
years, in accordance with Subpart H of 49 CFR Part 172, shall be created and retained by each
hazmat employer for each hazmat employee for as long as that employee is employed by that
employer as a hazmat employee and for 90 days thereafter. The record must include: (1) the
hazmat employee’s name, (2) the most recent training completion date of the hazmat
employee’s training, (3) a description, copy, or location of the training materials, (4) the name
and address of the person providing the training, and (5) certification that the hazmat employee
has been trained and tested in accordance with Subpart H of 49 CFR Part 172.
Contrary to the above, the licensee’s records of hazmat employee training were inadequate in that
they did not include
(Specify the missing/incomplete items from the above list) , and the
licensee otherwise meets the definition of hazmat employer in 49 CFR 171.8.
This is a Severity Level ___ violation (Supplement V).
NUREG/BR-0195, Rev. 2
C-73
Standard Citations - Part 71
Appendix C
49 CFR PART 173
SHIPPERS: REQUIREMENTS FOR
SHIPMENTS AND PACKAGINGS
_______________________________
71-260
49 CFR 173.25 requires, in part, for packages containing hazardous materials and offered for
transportation in an overpack, that: 1) the overpack be marked with the proper shipping name
and identification number, and labeled as required by 49 CFR Parts 171-177 for each
hazardous material contained therein unless markings and labels representative of each
hazardous material in the overpack are visible; and 2) the overpack be marked with a
statement indicating that the inside (inner) packages comply with prescribed specifications
when specification packagings are required, unless specification markings on the inside
packages are visible. Pursuant to 49 CFR 172.101, radioactive material is classified as
hazardous material.
Contrary to the above, as of (date) , the licensee offered for transportation in an overpack
(licensed material) that was not marked with the proper shipping name and identification number,
nor with any statement indicating that the inner package complied with the prescribed specifications;
and the markings on the inside package were not visible.
This is a Severity Level ___ violation (Supplement V).
71-270
49 CFR 173.411(c) requires that, except for Industrial Packaging Type 1 (IP-1) packagings,
each offeror of an industrial package must maintain on file for at least one year after the latest
shipment, a complete documentation of tests and an engineering evaluation or comparative data
showing that the construction methods, packaging design, and materials of construction comply
with that specification.
71-272
Contrary to the above, as of (date) , the licensee shipped (licensed material) in an (IP-2/IP-3)
package, and did not maintain for a period of at least one year following that shipment
documentation of tests and an engineering evaluation or comparative data showing that the package
complied with the applicable specification.
This is a Severity Level ___ violation (Supplement V).
71-274
Contrary to the above, as of (date) , the licensee shipped (licensed material) in an (IP-2/IP-3)
package, and did not maintain for a period of at least one year following that shipment complete
documentation of tests and an engineering evaluation or comparative data showing that the package
complied with the applicable specification. Specifically, the documentation was incomplete in that
__________________________. [state how/why the documentation was not adequate, e.g., it did
not show that the (construction methods) / (packaging design) / (materials of construction)
comply with (the applicable specification)].
This is a Severity Level ___ violation (Supplement V).
C-74
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 71
71-280
49 CFR 173.415(a) requires that each shipper of a DOT Specification 7A Type A package must
maintain on file for at least one year after the latest shipment a complete documentation of tests
and an engineering evaluation or comparative data showing that the construction methods,
packaging design, and materials of construction comply with the specification as described in
49 CFR 178.350.
71-282
Contrary to the above, as of (date) , the licensee shipped (licensed material) in a package marked
DOT Specification 7A Type A and did not maintain for a period of at least one year following that
shipment documentation of tests and an engineering evaluation or comparative data showing that the
package complied with the applicable DOT specification.
This is a Severity Level ___ violation (Supplement V).
71-284
Contrary to the above, as of (date) , the licensee shipped (licensed material) in a package marked
DOT Specification 7A Type A and did not maintain for a period of at least one year following that
shipment complete documentation of tests and an engineering evaluation or comparative data
showing that the package complied with the applicable DOT specification. Specifically, the
documentation was incomplete in that __________________________. [state how/why the
documentation was not adequate, e.g., it did not show that the (construction methods) / (packaging
design) / (materials of construction) comply with (the applicable DOT specification)].
This is a Severity Level ___ violation (Supplement V).
NUREG/BR-0195, Rev. 2
C-75
Standard Citations - Part 71
Appendix C
71-290
49 CFR 173.421 excepts limited quantities of radioactive material, specified as radioactive
material whose activity per package does not exceed the limits in 49 CFR 173.425, from the
specification packaging, marking, and labeling requirements, and if not a hazardous substance
or hazardous waste, the shipping paper and certification requirements of 49 CFR Parts 171177, and the requirements of Subpart I of 49 CFR Part 173, provided, among other things, that
.
(Insert here the applicable item(s) from the below list)
(1)
(2)
each package meets the general design requirements in 49 CFR 173.410.
the radiation level at any point on any external surface of the package does not exceed 0.005
millisievert per hour (0.5 millirem per hour)
the nonfixed (removable) radioactive surface contamination on the external surface of the
package does not exceed the limits specified in 49 CFR 173.443(a)
the outside of the inner packaging, or if there is no inner packaging, the outside of the
packaging itself bears the marking “Radioactive.”
with exceptions not applicable here, the package does not contain more than 15 grams of
uranium-235.
the material is otherwise prepared for shipment in accordance with 49 CFR 173.422. 49 CFR
173.422 requires, in part, that a limited quantity of radioactive material, prepared for shipment
in accordance with 49 CFR 173.421, must, be certified as being acceptable for transportation
by having a notice enclosed in or on the package, included with the packing list, or otherwise
forwarded with the package. This notice must include the name of the consignor or consignee
and the statement: "This package conforms to the conditions and limitations specified in 49
CFR 173.421 for radioactive material, excepted package-limited quantity of material,
UN2910."
(3)
(4)
(5)
(6)
Contrary to the above, on (date) , the licensee (transported/delivered to a carrier for transport)
(amount) of (licensed material) , as an excepted package-limited quantity of material, but the
package was not prepared for shipment, as required, in accordance with 49 CFR 173.421.
Specifically,
(Identify the specific deficiencies which were noted) .
This is a Severity Level ___ violation (Supplement V).
C-76
NUREG/BR-0195, Rev. 2
Appendix C
Standard Citations - Part 71
71-300
49 CFR 173.424 permits the shipment of certain devices containing radioactive materials as
"instruments and articles", excepted from the specification packaging, shipping paper and
certification, marking and labeling requirements, provided, among other things, that (Insert
here the applicable item(s) from the below list) .
(1)
(2)
each package meets the general design requirements in 49 CFR 173.410.
the activity of the instrument or article does not exceed the relevant limit listed in Table 7 of
49 CFR 173.425. 49 CFR 173.425 lists the activity limit for each instrument and article
containing (Special form solid/ normal form solid/...) radioactive material as (10-2 A1/102
A2/...) .
the total activity per package does not exceed the relevant limit listed in Table 7 of
49 CFR 173.425. 49 CFR 173.425 lists the total activity limit per package for instrument and
articles containing (Special form solid/ normal form solid/...) radioactive material as ( A1/
A2/...) .
the radiation level at 10 centimeters (4 inches) from any point on the external surface of any
unpackaged instrument or article does not exceed 0.1 millisievert per hour (10 millirem per
hour).
the radiation level at any point on any external surface of the package does not exceed
0.005 millisievert per hour (0.5 millirem per hour), or for exclusive use domestic shipments,
0.02 millisievert per hour (2 millirem per hour).
the nonfixed (removable) radioactive surface contamination on the external surface of the
package does not exceed the limits specified in 49 CFR 173.443(a).
with exceptions not applicable here, the package does not contain more than 15 grams of
uranium-235.
the package is otherwise prepared for shipment in accordance with 49 CFR 173.422.
49 CFR 173.422 requires, in part, that an excepted package of radioactive material, prepared
for shipment in accordance with 49 CFR 173.424, must, be certified as being acceptable for
transportation by having a notice enclosed in or on the package, included with the packing list,
or otherwise forwarded with the package. This notice must include the name of the consignor
or consignee and the statement: "This package conforms to the conditions and limitations
specified in 49 CFR 173.424 for radioactive material, excepted package-instruments or articles,
UN2910."
(3)
(4)
(5)
(6)
(7)
(8)
Contrary to the above, on (date) , the licensee (transported/delivered to a carrier for transport)
(amount) of (licensed material) , as an excepted package-instruments or articles, but the
package was not prepared for shipment, as required, in accordance with 49 CFR 173.424.
Specifically,
(Identify the specific deficiencies which were noted) .
This is a Severity Level ___ violation (Supplement V).
NUREG/BR-0195, Rev. 2
C-77
Standard Citations - Part 71
71-310
Appendix C
49 CFR 173.475 requires, in part, that before each shipment of any Class 7 (radioactive)
materials package, the offeror must insure by examination or appropriate tests, that the
packaging is proper for the contents to be shipped. 49 CFR 173.427(a) requires that, unless
excepted by §173.427(d), low specific activity (LSA) materials and surface contaminated
objects (SCO), must be packaged in accordance with 49 CFR 173.427(b) or (c).
Contrary to the above, on (date) , the licensee transported (LSA materials/SCO) in a package
which was not authorized for that material pursuant to 49 CFR 173.427. . Specifically, the
materials were packaged in (describe the package and state why it did not meet the applicable
condition(s) in §173.427, for example, why a strong-tight container did not: (1) meet the general
design requirements of 49 CFR 173.410; (2) contained greater than an A2 quantity, ....) .
This is a Severity Level ___ violation (Supplement V).
71-320
49 CFR 173.427(a)(6) requires, in part, that packages offered for domestic transportation
containing low-specific activity (LSA) material or surface contaminated objects (SCO), which
are required by 49 CFR 173.427 to be consigned as exclusive use, are excepted from marking
and labeling requirements of 49 CFR Parts 171-177, provided that the exterior of each nonbulk
package is stenciled or otherwise marked “Radioactive-LSA” or “Radioactive-SCO” as
appropriate, and nonbulk packages that contain a hazardous substance are stenciled or
otherwise marked “RQ” in association with the above description.
71-322
Contrary to the above, on (date) , the licensee transported, in a domestic shipment, (LSA
materials/SCO) in a nonbulk package required by 49 CFR 173.427 to be consigned exclusive use
, and the exterior of the packages was not marked or stenciled ("Radioactive - LSA"/”RadioactiveSCO”) .
This is a Severity Level ___ violation (Supplement V).
71-324
Contrary to the above, on (date) , the licensee transported, in a domestic shipment,
(LSA
materials/SCO)
containing
(specify) terabecquerels ( (specify) curies) of
(specify
the nuclide(s))
, which is a reportable quantity of a hazardous substance pursuant to
49 CFR 171.8 and Table 2 of Appendix A to 49 CFR 172.101, in a nonbulk package required by
49 CFR 173.427 to be consigned exclusive use, and the exterior of the packages was not stenciled
or otherwise marked “RQ.”
This is a Severity Level ___ violation (Supplement V).
C-78
NUREG/BR-0195, Rev. 2
Appendix C
71-330
Standard Citations - Part 71
49 CFR 173.475 requires, in part, that before each shipment of any Class 7 (radioactive)
materials package, the offeror must insure by examination or appropriate tests, that the
external radiation and contamination levels are within the allowable limits in
49 CFR Parts 171-178. 49 CFR 173.441(a) requires in part, with exceptions not applicable
here, that each package of radioactive materials offered for transportation be designed and
prepared for shipment so that under conditions normally incident to transportation the
radiation level does not exceed 2 millisievert per hour (200 millirem per hour) at any point on
the external surface of the package.
Contrary to the above, on (date) , the licensee (transported outside the site of usage, as specified
on the NRC license, or on a public highway) / (delivered to a carrier for transport)
(licensed
material)
in a package that arrived at its destination with a measured radiation level of
approximately (specify) millisievert per hour (_____ millirem per hour).
This is a Severity Level ___ violation (Supplement V).
71-340
49 CFR 173.475 requires, in part, that before each shipment of any Class 7 (radioactive)
materials package, the offeror must insure by examination or appropriate tests, that the
external radiation and contamination levels are within the allowable limits in
49 CFR Parts 171-178. 49 CFR 173.443(a) requires, in part, with exceptions not applicable
here, that for beta and gamma emitting contaminants, the level of non-fixed (removable)
radioactive contamination on the external surfaces of each package offered for transport, at the
beginning of transport,, not exceed 0.4 Becquerel per square centimeter (22 disintegrations per
minute per square centimeter) on any single wiping material, determined by wiping an area of
300 square centimeters of the surface concerned with an absorbent material, using moderate
pressure, and averaging over the surface wiped. Sufficient measurements must be taken in the
most appropriate locations to yield a representative assessment of the non-fixed contamination
levels.
71-342
Contrary to the above, on (date) , the licensee delivered to a carrier for transport a package which
contained (licensed material) , and the licensee did not determine the non-fixed contamination level
prior to offering the package for transport .
This is a Severity Level ___ violation (Supplement V).
71-344
Contrary to the above, on (date) , the licensee delivered to a carrier for transport a package which
was determined to have non-fixed contamination caused by (nuclide) , a (beta/gamma) emitting
radionuclide, of approximately (specify) disintegrations per minute per square centimeter averaged
over the surface wiped.
This is a Severity Level ___ violation (Supplement V).
NUREG/BR-0195, Rev. 2
C-79
Standard Citations - Part 71
71-350
Appendix C
49 CFR 173.448(a) requires that each shipment of radioactive materials be secured in order
to prevent shifting during normal transportation conditions.
Contrary to the above, on (date) , the licensee (transported outside the site of usage, as specified
on the NRC license, or on a public highway) / (delivered to a carrier for transport) a package
containing (licensed material) which was not properly secured to prevent shifting during transport.
Specifically, (state how/why the package was not properly secured, what happened, etc.) .
This is a Severity Level ___ violation (Supplement V).
71-360
49 CFR 173.466 requires, in part, that Type A packagings designed for liquids shall be capable
of withstanding the tests described in section 173.466(a)(1) and (2).
49 CFR 173.461 requires, in part, that compliance with the test requirements in section 173.466
shall be shown by any of the methods prescribed in section 173.461(a)(1)-(4), or by a
combination of these methods appropriate for the particular feature being evaluated.
Contrary to the above, on (date) , the licensee (transported outside the site of usage, as specified
on the NRC license, or on a public highway) / (delivered to a carrier for transport) (amount) of
(licensed material) in liquid form, a quantity that requires Type A packaging, in a (specify the
container, e.g., cardboard box) that had not been tested or evaluated for compliance with the test
requirements in section 173.466.
This is a Severity Level ___ violation (Supplement V).
71-380
49 CFR 173.475 requires, in part, that before each shipment of any Class 7 (radioactive)
materials package, the offeror must insure by examination or appropriate tests, that: (1) the
packaging is proper for the contents to be shipped; (2) the packaging is in unimpaired physical
condition, except for superficial marks; (3) each special instruction for filling, closing, and
preparation of the packaging for shipment has been followed. 49 CFR 173.415 lists the
packages that are authorized for shipment to contain quantities of Class 7 (Radioactive)
material not exceeding the A1 or A2 value, as appropriate.
Contrary to the above, on (date) , the licensee (transported outside the site of usage, as specified
on the NRC license, or on a public highway) , (amount) of (licensed material) , a quantity not
exceeding the
(A1 / A2 )
value, in a packaging which was not authorized pursuant to
49 CFR 173.415. Specifically, (state how/why the package was not an authorized Type A package
(e.g., a damaged/leaking drum was offered, a gauge device was shipped without retracting the
source, etc...)) .
This is a Severity Level ___ violation (Supplement V).
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49 CFR 173.475 requires, in part, that before each shipment of any radioactive materials
package, the shipper ensure by examination or appropriate tests that each closure, valve, or
other opening of the containment system through which the radioactive content might escape
is properly closed and sealed.
Contrary to the above, on (date) , the licensee failed to examine or test the (specify valves, seals,
etc.) of a package containing (licensed material) before delivering the package to a carrier for
transport. [If appropriate, add a sentence to describe the result: "This resulted in (briefly describe
what leaked, etc.) "]
This is a Severity Level ___ violation (Supplement V).
71-400
49 CFR 173.476(a) requires, in part, that each shipper of special form radioactive materials
maintain on file, for at least one year after the latest shipment, a complete safety analysis
including documentation of any tests, demonstrating that the special form material meets the
requirements of 49 CFR 173.469. 49 CFR 173.469(b) specifies the tests to be conducted for
the safety analysis.
71-402
Contrary to the above, as of (date) , the licensee shipped packages containing (licensed material)
in special form, and did not maintain for a period of at least one year following each shipment
documentation that the special form material meets the requirements of 49 CFR 173.469.
This is a Severity Level ___ violation (Supplement V).
71-404
Contrary to the above, as of (date) , the licensee shipped packages containing (licensed material)
in special form, and the special form radioactive material had not undergone the required safety
analysis to determine that it met the requirements of 49 CFR 173.469.
This is a Severity Level ___ violation (Supplement V).
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Standard Citations - Part 71
Appendix C
49 CFR Part 177
CARRIAGE BY PUBLIC HIGHWAY
_______________________________
1-410
49 CFR 177.817(e) requires, in part, that the driver of a motor vehicle containing hazardous
material ensure that the shipping paper is readily available to, and recognizable by, authorities
in the event of accident or inspection. Specifically, (i) when the driver is at the vehicle's
controls, the shipping paper shall be: (a) within his immediate reach while he is restrained by
the lap belt; and (b) either readily visible to a person entering the driver's compartment or in
a holder which is mounted to the inside of the door on the driver's side of the vehicle; (ii) when
the driver is not at the vehicle's controls, the shipping paper shall be: (a) in a holder which is
mounted to the side of the door on the driver's side of the vehicle; or (b) on the driver's seat
in the vehicle.
Pursuant to 49 CFR 172.101, radioactive material is classified as a hazardous material.
Contrary to the above, on (date) , the licensee transported (licensed material) , outside the site of
usage, as specified on the NRC license, or on a public highway, and the driver of the vehicle did not
ensure that the shipping paper was readily available in the driver's compartment, as required.
Specifically, (state where the shipping paper was and why it was not accessible) .
This is a Severity Level ___ violation (Supplement V).
71-420
49 CFR 177.834(a) requires, in part, that packaging not permanently attached to the motor
vehicle and containing radioactive material must be secured against movement within the
vehicle on which it is being transported, under conditions normally incident to transportation.
Contrary to the above, on (date) , the licensee transported (licensed material) , outside the site of
usage, as specified on the NRC license, or on a public highway, and the package was not secured
against movement within the vehicle. Specifically, (state how/why the package was not considered
to be secured ) .
This is a Severity Level ___ violation (Supplement V).
71-430
49 CFR 177.842 requires, in part, that packages of radioactive materials be so blocked and
braced that they cannot change position during conditions normally incident to transportation.
Contrary to the above, on (date) , the licensee transported a package containing (licensed
material) , outside the site of usage, as specified on the NRC license, or on a public highway, and
the package was not blocked and braced such that it could not change position during conditions
normally incident to transportation. Specifically, (describe how/why the package was not
sufficiently blocked and braced and what happened as a result) .
This is a Severity Level ___ violation (Supplement V).
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Appendix C
Standard Citations - Part 150
10 CFR PART 150
EXEMPTIONS AND CONTINUED REGULATORY
AUTHORITY IN AGREEMENT STATES AND
IN OFFSHORE WATERS UNDER SECTION 274
_______________________________________________
RECIPROCITY
150-10
10 CFR 150.20(a) provides in part that any person who holds a specific license from an
Agreement State is granted an NRC general license to conduct the same activity in (nonAgreement States) (areas of exclusive Federal jurisdiction within Agreement States) (offshore
waters), provided that the provisions of 10 CFR 150.20(b) have been met.
10 CFR 150.20(b)(1) requires, in part, that any person engaging in activities in (non-Agreement
States) (areas of exclusive Federal jurisdiction within Agreement States) (offshore waters),
shall, at least 3 days before engaging in each such activity, file 4 copies of NRC Form-241,
"Report of Proposed Activities in Non-Agreement States", with the Regional Administrator
of the appropriate NRC regional office.
Contrary to the above, on (date) , (name of Agreement State Licensee) , a licensee of
(Agreement State) , used (nuclide) in (specify location, including State) , a (non-Agreement
State) (area of exclusive Federal jurisdiction within Agreement State) (offshore waters), without
filing Form-241 with the NRC.
This is a Severity Level ___ violation (Supplement VI).
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