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pdfFINAL OMB SUPPORTING STATEMENT
FOR
10 CFR PART 36
"LICENSES AND RADIATION SAFETY REQUIREMENTS
FOR IRRADIATORS"
(3150-0158)
--EXTENSION
Description of the Information Collection
The Nuclear Regulatory Commission's (NRC) regulations in Title 10 of the Code of Federal
Regulations (10 CFR) Part 36, contain requirements for the issuance of a license authorizing
the use of sealed sources containing radioactive materials in irradiators used to irradiate objects
or materials for a variety of purposes in research, industry, and other fields. This part also
contains the radiation safety requirements for operating irradiators. These regulations were
issued pursuant to the Atomic Energy Act of 1954, as amended, and the Energy Reorganization
Act of 1974, as amended.
The regulations in 10 CFR Part 36 (as described in Subpart A) apply to panoramic, dry or wet
storage irradiators, and underwater irradiators in which both the source and the products being
irradiated are under water. They do not cover self-contained dry-source-storage irradiators,
medical uses of sealed sources (such as teletherapy), or nondestructive testing (such as
industrial radiography). The irradiators covered by this part have dose rates that exceed 5
grays (500 rads) per hour at 1 meter from the radioactive sealed sources in air or in water, as
applicable for the irradiator type.
Subpart B of this part covers specific licensing requirements for obtaining a license or a license
exemption. Subpart C lists the design and performance criteria for irradiators, including special
requirements for sealed sources installed, licenses issued, and irradiator construction begun
after July 1, 1993. The requirements for operating irradiators are covered in Subpart D. These
include operator training, written operating and emergency procedures, personnel monitoring,
radiation surveys, inspection, and maintenance. The records and reports required to ensure
that the irradiator is being safely operated so that it poses no danger to the health and safety of
the general public and the irradiator employees are listed in Subpart E.
A.
Justification
1.
Need for and Practical Utility of the Information Collection
The records that 10 CFR Part 36 requires the licensees to maintain will be used
by the NRC or Agreement State inspectors to evaluate compliance with NRC
regulations to ensure that public health and safety are protected. The reports
required by 10 CFR Part 36 will be used to alert the NRC to any special problems
that may be a threat to health and safety so that adequate protective actions can
be taken.
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The need for practical utility of the specific information collection requirements
of 10 CFR Part 36 are identified in Appendix A-10 CFR Part 36, Information
Collection Requirements.
2.
Agency Use of Information
Reports of operational data surrounding several significant safety occurrences at
irradiators have been utilized by the NRC to develop the presently used safety
criteria and license conditions. These requirements have precluded a repetition
of these events at facilities and have resulted in safe operation of licensed
facilities. The NRC's Office of Nuclear Material Safety and Safeguards (NMSS)
monitors the operation of the irradiators in conjunction with regional staff
assigned to inspect and monitor these facilities. The reports containing timely
operational data are essential in order to ensure safe operation. If the reports
indicate the possibility of a continuing hazard at the irradiator, the NRC will take
action. In many situations an emergency inspection may be carried out. The
records that 10 CFR Part 36 requires the licensees to maintain are reviewed
during inspections, license renewals, and license amendment reviews to
evaluate compliance with NRC radiation safety requirements for irradiators.
3.
Reduction of Burden Through Information Technology
The NRC has issued Guidance for Electronic Submissions to the NRC which
provides direction for the electronic transmission and submittal of documents to
the NRC. Electronic transmission and submittal of documents can be
accomplished via the following avenues: the Electronic Information Exchange
process, which is available from the NRC's “Electronic Submittals” Web page, by
Optical Storage Media (e.g. CD-ROM, DVD), by facsimile or by e-mail. It is
estimated that approximately 5 percent of the potential responses are filed
electronically.
4.
Effort to Identify Duplication and Use Similar Information
No sources of similar information are available. There is no duplication of
requirements.
5.
Effort to Reduce Small Business Burden
While a number of the licensees are considered small businesses under the
NRC's current definitions, all licensees have the same responsibility for safe
operation of their irradiators. Therefore, there is no way to reduce the burden on
small businesses by less frequent or less complete records or reports while
maintaining the required level of safety.
6.
Consequences to Federal Program or Policy Activities if the Collection Is Not
Collected or is Conducted Less Frequently
If the information is not collected, the NRC will not have a way to assess whether
this category of licensee is operating within the radiation safety requirements
applicable to the use of licensed material in irradiators. If the information is
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collected less frequently, then the NRC will have access to the most recent
information less frequently.
7.
Circumstances Which Justify Variation From OMB Guidelines
NRC Section 36.83(b) requires licensees to submit significant safety events in a
manner which varies from OMB guidelines.
Section 36.83(b) requires the licensee to report significant safety events by
telephone within 24 hours and in writing within 30 days: (1) in case emergency
actions are necessary to reduce the hazard; (2) in case an emergency NRC
inspection is necessary to ensure the problem is being handled properly; and
(3) in case the problem is important enough that other licensees should be
promptly informed.
Records that must be retained longer than 3 years are contained in Sections
36.81(a), 36.81(b), 36.81(d), 36.81(e), 36.81(k), 36.81(l), and 36.81(m). The
justifications are as follows:
Section 36.81(a) requires that the licensee keep a copy of the current license,
including the license conditions, documents incorporated by reference, and
amendments, until license termination. It would be difficult to comply with the
conditions of a license if there were no written record of the commitments the
licensee has made.
Section 36.81(b) requires that the licensee keep records of each individual’s
training, tests, and safety reviews provided to meet the requirements of Sections
36.51 (except Section 36.51(e)) until 3 years after the individual terminates work.
The record retention is necessary for assuring that individuals who are currently
working or who have recently worked in the facility are properly trained and the
training records can be reviewed in accordance with the requirements.
Section 36.81(d) requires that the licensee keep a copy of the current written
operating and emergency procedures until license termination. Written
procedures are considered necessary to operate the irradiator safely and to
protect the health and safety of the public and irradiator employees in the event
of an emergency.
Section 36.81(e) restates, as a reminder, an existing 10 CFR Part 20
requirement that personnel dosimeters results be kept until license termination.
This requirement is necessary to verify that the irradiator operators and other
individuals for whom monitoring is required have not exceeded the dose limits in
10 CFR Part 20.
Section 36.81(k) restates, as a reminder, the requirements of Sections 30.51 and
30.41 for records of receipt, transfer, and disposal of all licensed sealed sources.
These records are required for tracking the location of all byproduct material
licensed under the Atomic Energy Act of 1954, as amended, and under Title II of
the Energy Reorganization Act of 1974.
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Section 36.81(l) requires that the licensee retain the design checks required by
Section 36.39 and the construction control checks required by Section 36.41 until
the license for the facility is terminated. As long as the facility is in operation,
records of the design and construction of its principal safety features are
important in maintaining and demonstrating the safety of the facility. In addition,
they would be useful for correcting problems in the case where a vendor
discovered a design flaw.
Section 36.81(m) restates, as a reminder, the existing requirements in Section
30.35(g) that the licensee keep records of information important to the safe and
effective decommissioning of the facility until the site is released for unrestricted
use. The information in these records is necessary for the safe and effective
decommissioning of the facility.
8.
Consultations Outside the NRC
Clearance package was published in the Federal Register on December 10,
2020 (85 FR 79531). NRC did not receive any comments.
NRC also contacted four licensees by e-mail and no comments were received.
9.
Payment or Gift to Respondents
Not applicable.
10.
Confidentiality of Information
Confidential and proprietary information is protected in accordance with NRC
regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b).
11.
Justification for Sensitive Questions
No sensitive information is requested under these regulations.
12.
Estimated Burden and Burden Hour Cost
The estimates are based on submittals to and reviews by NRC in past years.
The cost to licensees and applicants is calculated at a rate of $279/hour for the
professional staff that prepares the technical reports and records in response to
the 10 CFR Part 36 information collection requirements.
The regulations in 10 CFR Part 36 establish licensing and radiation safety
requirements for irradiator licensees, which include training requirements. As
such, a number of the requirements under this Part represent third-party
disclosure notifications, in which the licensees are providing training information
to workers. In this renewal, third-party disclosure notifications have been
captured as such in the burden tables.
The $279 hourly rate used in the burden estimates is based on the Nuclear
Regulatory Commission’s fee for hourly rates as noted in 10 CFR 170.20
“Average cost per professional staff-hour.” For more information on the basis of
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this rate, see the Revision of Fee Schedules; Fee Recovery for Fiscal Year 2020
(85 FR 37250, June 19, 2020).
Estimated Annual Cost to Respondents
NRC Licensees: The burden for NRC licensees to respond to the collection is
shown in Tables 1, 2, and 3. The total burden for NRC licensees is 5,688 hours
(93 hours reporting + 4,185 hours annual recordkeeping + 1,410 hours third-party
disclosures) at a cost of $1,586,952 (5,688 hours x $279/hour).
Agreement State Licensees: The recordkeeping and reporting burden on the
Agreement State licensees is based on several assumptions, including:
(1) The Agreement States implement 10 CFR Part 36 in exactly the same
manner as the NRC.
(2) The Agreement States license 6 times the number of irradiators that are
covered by 10 CFR Part 36 than the NRC.
(3) The frequency of incidents requiring reports from Agreement State licensees
is the same for the NRC licensees.
The burden for Agreement State licensees to respond to the collection is shown
in Tables 4, 5 and 6. The total burden for Agreement State licensees is 34,148
hours (578hours reporting + 25,110 hours annual recordkeeping + 8,460 hours
third-party disclosures) at a cost of $9,520,596 (34,124 hours x $279/hour).
Total Estimated Burden: 39,836 hours (671 reporting hours + 29,295
recordkeeping hours + 9,870 third-party disclosure hours).
NRC Licensees
Reporting (hours)
Recordkeeping (hours)
Third-Party Disclosures (hours)
Total (hours)
93
4,185
1,410
5,688
Agreement State Licensees
578
25,110
8,460
34,148
Total number of respondents: 70 (10 NRC licensees and 60 Agreement State
licensees).
Total number of responses: 2,396.3 (16.3 for reporting [2.3 NRC licensees and
14 Agreement State licensees], 70 for recordkeepers [10 NRC licensees and 60
Agreement State Licensees], and 2,310 for third-party disclosures [330 NRC
licensees and 1,980 Agreement State licensees]).
13.
Estimate of Other Additional Costs
The quantity of records to be maintained is roughly proportional to the
recordkeeping burden. Based on the number of pages maintained for a typical
clearance, the records storage cost has been determined for 2021 to be equal to
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0.0004 times the recordkeeping burden cost. Therefore, the storage cost for this
clearance is $3,269.32 (29,295 recordkeeping hours x 0.0004 x $279).
14.
Estimated Annualized Cost to the Federal Government
The estimated burden on the NRC to review the records and reports is based on
the frequency the NRC inspects the 10 CFR Part 36 licensees.
Category
Number of
Licensees
Inspection Cycle
Irradiators - Other, less than
10,000 Curies
3
Every 5 Years
Irradiators - Other, greater than
10,000 Curies
7
Every 2 Years
The annual burden on the NRC to review records is estimated to be 8 hours per
licensee per year, or 32.8 hours for the 4.1 NRC licensees inspected per year (7
licensees every 2 years + 3 licensees every 5 years = 4.1 per year). The annual
burden to review reports submitted by these licensees is estimated to be an
additional 76 hours per year. The total is 108.8 hours per year. At a cost of $279
per hour, the total annual cost to the NRC is $30,355 per year. The annualized
cost is based on staff's best estimate.
The staff has developed estimates of annualized costs to the Federal
Government related to the conduct of this collection of information. These
estimates are based on staff experience and subject matter expertise and include
the burden needed to review, analyze, and process the collected information and
any relevant operational expenses.
15.
Reasons for Changes in Burden or Cost
The overall burden has decreased by 2,776 hours from 42,612 to 39,836 hours
because the recordkeeping burden associated with 10 CFR 36.81(d) was
accidentally accounted for twice. Removing the additional burden caused the
recordkeeping burden to decrease by 2,776 hours. Other than this correction, all
other factors impacting burden for reporting, recordkeeping, and third-party
disclosures remained the same. The cost estimates have changed since the last
clearance, as a result of a decrease in the fee rate per hour from $263 to
$279/hour.
16.
Publication for Statistical Use
None.
17.
Reason for Not Displaying the Expiration Date
The requirement is contained in a regulation. Amending the Code of Federal
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Regulations to display information that, in an annual publication, could become
obsolete would be unduly burdensome and too difficult to keep current.
18.
Exceptions to the Certification Statement
None.
B.
COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
Statistical methods are not used in this collection of information.
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Table 1: NRC Licensee Recordkeeping Requirements for Part 36
Total Annual
Burden
Hours
Number of
Recordkeepers
Hours Per
Recordkeeper
36.21(a)(1)
10
0.5
5
$1,395
36.81(a)
10
2
20
$5,580
36.81(b)
10
20
200
$55,800
36.81(c)
10
2
20
$5,580
36.81(d)
10
60
600
$167,400
36.81(e)
10
36.81(f)
10
20
200
$55,800
36.81(g)
10
4
40
$11,160
36.81(h)
10
10
100
$27,900
36.81(i)
10
200
2,000
$558,000
36.81(j)
10
20
200
$55,800
36.81(k)
10
36.81(l)
10
36.81(m)
10
Section
TOTALS
10
Cost at
$279/hr
Addressed under OMB # 3150-0014
Addressed under OMB #3150-0017
80
800
$223,200
Addressed under OMB #3150-0017
418.5
4,185
$1,167,615
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Table 2: NRC Licensee Reporting Requirements for Part 36
Total
Annual
Burden
(Hrs)
Number
of
Licensees
Estimated
Annual
Responses
Burden
Hrs Per
Response
Application for
Specific
License
10
0
0
0
0
Requirements
for Specific
License
10
0
0
0
0
36.17(a), (b)
Application for
exemption
10
1
8
8
2,232
36.19 (a) and
(b)
Request for
written
statements
10
0.5
10
5
1,395
36.69(a), (b)
Irradiation of
explosives or
flammable
materials
10
0
0
0
0
36.83(a), (b)
Reports
10
0.8
100
80
22,320
10
2.3
93
$25,947
Section
36.11 - See
OMB
clearance No.
3150-0120
36.13(b), (c),
(d), (e), (f),
(g), and (h) See OMB
clearance
3150-0120
TOTALS
Description
Cost at
$279/hr
Note: Burden calculates only those events that would not be reported under 30.50(b).
10
Table 3: NRC Licensee Third-Party Disclosures for Part 36
Burden
Hrs per
Response
Total
Annual
Burden
(hrs)
Respondents
Responses
per
Respondent
10
1
10
24
240
$66,960
10
1
10
2
20
$5,580
10
1
10
40
400
$111,600
10
5
50
8
400
$111,600
36.51(e)
Irradiator operator
safety performance
evaluation and
discussion (for
current operators)
10
5
50
4
200
$55,800
36.51(f)
Training and testing
for unescorted
access only
10
10
100
1
100
$27,900
36.51(g)
Training and testing
for workers prepared
for alarm response
only
10
10
100
1
50
$13,950
1,410
$393,390
Section
36.51(a)
36.51(b)
36.51(c)
36.51(d)
Total
Description
Irradiator operator
instruction (in
preparation for
operation without
supervision)
Irradiator operator
testing (in
preparation for
operation without
supervision)
Irradiator operator
on-the-job or
simulator training (in
preparation for
operation without
supervision)
Irradiator operator
safety review
training and testing
(for current
operators)
10
Total
Responses
330
Cost at
$279/hr
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Table 4: Agreement State Licensee Recordkeeping Requirements for Part 36
Total
Annual
Burden
Hours
Number of
Recordkeepers
Hours Per
Recordkeeper
36.21(a)(1)
60
0.5
30
$8,370
36.81(a)
60
2
120
$33,480
36.81(b)
60
20
1200
$334,800
36.81(c)
60
2
120
$33,480
36.81(d)
60
60
3600
$1,004,400
36.81(e)
60
36.81(f)
60
20
1200
$334,800
36.81(g)
60
4
240
$66,960
36.81(h)
60
10
600
$167,400
36.81(i)
60
200
12,000
$3,348,000
36.81(j)
60
20
1200
$334,800
36.81(k)
60
36.81(l)
60
36.81(m)
60
Section
TOTALS
60
Cost at
$279/hr
Addressed under OMB # 3150-0014
Addressed under OMB #3150-0017
80
4800
$1,339,200
Addressed under OMB #3150-0017
418.5
25,110
$7,005,690
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Table 5: Agreement State Licensee Reporting Requirements for Part 36
Number
of
Licensees
Estimated
Annual
Responses
Burden
Hrs Per
Response
Total
Annual
Burden
(Hrs)
Cost at
$279/hr
Section
Description
36.11 - See
OMB
clearance No.
3150-0120
Application
for Specific
License
60
0
0
0
$0
36.13(b), (c),
(d), (e), (f),
(g), and (h) See OMB
clearance
3150-0120
Requirements
for Specific
License
60
0
0
0
$0
36.17(a), (b)
Application
for exemption
60
6
8
24
$6,696
36.19 (a) and
(b)
Request for
written
statements
60
3
10
30
$8,370
36.69(a), (b)
Irradiation of
explosives or
flammable
materials
60
0
0
0
$0
36.83(a), (b)
Reports
60
5
100
500
$139,500
60
14
578
$161,262
TOTALS
Note: Burden calculates only those events that would not be reported under 30.50(b).
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Table 6: Agreement State Licensee Third-Party Disclosures for Part 36
Respondents
Responses
per
Respondent
Total
Responses
Burden
Hrs per
Response
Total
Annual
Burden
(hrs)
Cost at
$279/hr
Section
Description
36.51(a)
Irradiator operator
instruction (in
preparation for
operation without
supervision)
60
1
60
24
1,440
$401,760
36.51(b)
Irradiator operator
testing (in
preparation for
operation without
supervision)
60
1
60
2
120
$33,480
36.51(c)
Irradiator operator
on-the-job or
simulator training (in
preparation for
operation without
supervision)
60
1
60
40
2,400
$669,600
36.51(d)
Irradiator operator
safety review
training and testing
(for current
operators)
60
5
300
8
2,400
$669,600
60
5
300
4
1,200
$334,800
60
10
600
1
600
$167,400
60
10
600
1
300
$83,700
8,460
$2,360,340
36.51(e)
36.51(f)
36.51(g)
Total
Irradiator operator
safety performance
evaluation and
discussion (for
current operators)
Training and testing
for unescorted
access only
Training and testing
for workers
prepared for alarm
response only
60
1,980
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Appendix A- 10 CFR Part 36, Information Collection Requirements
Section 36.11 states how a person may file an application for a specific license
authorizing the use of a sealed source in an irradiator on NRC Form 313,
"Application for Material License," and where the application must be mailed.
The information on NRC Form 313 is used by the NRC to determine whether the
applicant's equipment, procedures, and personnel are adequate to protect public
health and safety. NRC Form 313 has previously been cleared under OMB
Clearance No. 3150-0120, which should be referred to for additional supporting
information, burden and cost data.
Section 36.13 describes the information that must be included in an application
for a specific license for an irradiator if it is to be approved. This information is
reviewed by the NRC staff to determine if the applicant's training program,
operating and emergency procedures, organizational structure, radiation safety
program, personnel qualifications, and inspection and maintenance procedures
will provide adequate protection of the public health and safety.
Section 36.17(a) allows an applicant to apply for an exemption from the
requirements in 10 CFR Part 36. This information is used by the Commission to
grant exemptions from the requirements in this part as long as they are
authorized by law and will not endanger life or property or the common defense
and security.
Section 36.17(b) allows applicants for a license or for amendment of a license
authorizing use of teletherapy-type units for irradiation of materials or objects to
include proposed alternatives to the requirements in this part in their application.
The Commission reviews this information to determine if the applicant provides
adequate rationale for the proposed alternatives and demonstrates that they are
likely to provide an adequate level of safety for workers and the public. The
requests in Section 36.17 are part of the application process under Section
36.13 and, thus, the burden is covered under that section.
Section 36.19(a) and (b) allows the Commission to request additional
information. Paragraph (a) of this section allows the Commission to request any
additional information that NRC may need to determine whether or not the
application should be granted or denied. Paragraph (b) allows the Commission
to request written statements to determine whether a license should be modified,
suspended, or revoked. This section codifies a requirement (found in Section
182 of the Atomic Energy Act) that licensees must supply any additional
information required by NRC to assure that health and safety will be protected.
Additional information is sometimes needed to clarify information submitted in the
application, or to rectify deficiencies in proposed or existing programs for
protection of the public health and safety, the common defense and security, or
the environment. The additional information submitted is reviewed by various
NRC organizational units to assess the adequacy of the applicant's physical
15
plant, procedures, and plans for protection of the public health and safety. The
NRC review and the findings therefrom form the basis for NRC decisions
concerning the issuance, modification, or revocation of licenses authorizing the
use of sealed sources containing radioactive materials in irradiators.
Section 36.21(a)(1) requires that sealed sources installed after July 1, 1993,
must have a certificate of registration issued under 10 CFR 32.210. The
certificate of registration demonstrates that the source design has been reviewed
and approved by either the NRC or an Agreement State.
Section 36.51(a), (b), and (c) list requirements that individuals must fulfill before
they are permitted to operate an irradiator without a supervisor present.
Paragraph (a) of this section requires that before an individual is permitted to
operate an irradiator without a supervisor present, the individual must be
instructed in:
(1)
(2)
(3)
(4)
(5)
The fundamentals of radiation protection applied to irradiators;
The requirements of parts 19 and 36 of NRC regulations that are relevant
to the irradiator;
The operation of the irradiator;
Those operating and emergency procedures listed in 36.53 that the
individual is responsible for performing;
Case histories of accidents or problems involving irradiators.
Paragraph (b) requires that before an individual is permitted to operate an
irradiator without a supervisor present, the individual shall pass a written test on
the instruction received consisting primarily of questions based on the licensee’s
operating and emergency procedures that the individual is responsible for
performing and other operations necessary to safely operate the irradiator
without supervision.
Paragraph (c) requires that before an individual is permitted to operate an
irradiator without a supervisor present, the individual must have received
on-the-job training or simulator training in the use of the irradiator as described in
the license application and shall demonstrate the ability to perform those portions
of the operating and emergency procedures that he or she is to perform.
These training requirements listed in 36.51(a), (b), and (c) ensure that individuals
permitted to operate the irradiator without supervision have been adequately
prepared for their responsibilities.
Section 36.51(d) and (e) list requirements that must be completed at least
annually for irradiator operators. Paragraph (d) of this section requires that the
licensee shall conduct safety reviews for irradiator operators at least annually.
The licensee shall give each operator a brief written test on the information.
Each safety review must include, to the extent appropriate: (1) any changes in
operating and emergency procedures since the last review; (2) any changes in
regulations and license conditions since the last review; (3) reports on recent
16
accidents, mistakes, or problems that have occurred at irradiators, if any; (4)
relevant results of inspections of operator safety performance; (5) relevant results
of the facility’s inspection and maintenance checks; and (6) a drill to practice an
emergency or abnormal event procedure.
Paragraph (e) of this section requires that the licensee shall evaluate the safety
performance of each irradiator operator at least annually to ensure that
regulations, license conditions, and operating and emergency procedures are
followed. The licensee shall discuss the results of the evaluation with the
operator on how to correct any mistakes or deficiencies observed.
These training requirements listed in 36.51(d) and (e) ensure that licensees
provide updated training to their irradiator operators with updated safety
information and changes to regulations, as well as evaluate their safety
performance at least annually. The purpose is to ensure continued safe
operation of the irradiator.
Section 36.51(f) requires that individuals who will be permitted unescorted
access to the radiation room of the irradiator or the area around the pool of an
underwater irradiator, but who have not received the training required for
operators and the radiation safety officer, shall be instructed and tested in any
precautions they should take to avoid radiation exposure, any procedures or
parts of procedures listed in 36.53 that they are expected to perform or comply
with, and their proper response to alarms required in this part. The purpose of
these requirements is to ensure that unescorted individuals (without operator or
radiation safety officer training) are prepared to safely perform their
responsibilities and access potentially high-radiation areas.
Section 36.51(g) requires that individuals who must be prepared to respond to
alarms required by 36.23(b), 36.23(i), 36.27(a), 36.29(a), 36.29(b), and 36.59(b)
shall be trained and tested on how to respond. Each individual shall be retested
at least once a year. The purpose of this requirement is to ensure that
individuals who must be prepared to respond to alarms are adequately trained to
safely perform their responsibilities.
Section 36.53(a) requires licensees to have and follow written operating
procedures. Paragraph (a) lists the operating, monitoring, surveying, testing, and
inspection procedures that must be addressed in the licensee's written operating
procedures. The procedures ensure there is a standard way of safely operating
the irradiator that can be followed by all personnel and reviewed by NRC
inspectors.
Section 36.53(b) requires licensees to have and follow emergency or abnormal
event procedures, appropriate for the irradiator type. Paragraph (b) lists the
types of emergency or abnormal events that must be addressed in the licensee's
written emergency procedures. The purpose is to have preplanned, approved
procedures for responding to emergencies.
17
Section 36.69(a) prohibits the irradiation of explosive material, unless the
licensee has applied for and received prior written approval. The purpose of this
section is to assure that the licensee can demonstrate that detonation of the
explosive would not rupture the sealed sources, injure personnel, damage safety
systems, or cause radiation overexposures of personnel.
Section 36.69(b) prohibits the irradiation of more than small quantities of
flammable material (flash point below 140 degrees F) in panoramic irradiators
unless the licensee has received prior written authorization from the Commission.
The application must demonstrate that the licensee can control a fire in the
radiation room without damage to the sealed sources or safety systems and
without radiation overexposures of personnel.
Section 36.81 states the records that a licensee must maintain and the retention
periods for these records. These are as follows:
a) A copy of the license, license conditions, documents incorporated into a
license by reference, and amendments thereto until superseded or until the
NRC terminates the license. These documents must be maintained so that
the licensee has a record of the commitments that it has made and must
comply with.
b) Records of each individual's training, tests, and safety evaluations provided to
meet the requirements of Section 36.51 (except Section 36.51(e)) until 3 years
after the individual terminates work. The records allow NRC inspectors to
verify that the irradiator operators have received the required training.
c) Records of the annual evaluations of the safety performance of irradiator
operators required by Section 36.51(e) for 3 years after the evaluation. The
records allow NRC inspectors to verify that the licensee has been evaluating
the performance of its operators.
d) A copy of the current operating and emergency procedures required by
Section 36.53, until superseded or the NRC terminates the license. Records
of the radiation safety officer's review and approval of changes in the
procedures must be retained for 3 years from the date of the change. The
records allow the operators to have access to an up-to-date set of written
operating procedures, so that they can operate the irradiator properly and
safely. The procedures may be discarded immediately after a new or revised
procedure is approved.
e) Personnel dosimeters results required by Section 36.55, until the license is
terminated by the Commission. The records allow NRC inspectors to verify
that the licensee is complying with the NRC's radiation dose limits. This
requirement in 10 CFR Part 36 is a reminder to licensees of the requirement
in Section 20.2106, which is covered under OMB Clearance No. 3150-0014.
18
f)
Records of radiation surveys required by Section 36.57 for 3 years from the
date of the survey. The records allow NRC inspectors to verify that the
required radiation surveys have been done and radiation dose limits are
being complied with.
g) Records of radiation survey meter calibrations required by Section 36.57 and
pool water conductivity meter calibrations required by Section 36.63(b) for 3
years from the date of each calibration. The records allow the NRC
inspectors to verify that required calibrations have been performed.
h) Records of the results of leak tests required by Section 36.59(a) and the
results of contamination checks required by Section 36.59(b) for 3 years
from the date of each test. The records allow NRC inspectors to verify that
the required tests to detect radioactive contamination have been done.
i)
Records of inspection and maintenance checks required by Section 36.61 for
3 years. The records allow NRC inspectors to verify that the licensee is
making necessary checks to maintain the irradiator in safe working condition.
j)
Records of major malfunctions, significant defects, operating difficulties or
irregularities, and major operating problems that involve required radiation
safety equipment for 3 years after the repairs are completed. These records
allow NRC inspectors to verify that the irradiator is being properly maintained
and repaired. The records also allow NRC to identify generic problems that
may decrease safety.
k) Records of the receipt, transfer, and disposal of licensed sealed sources, as
required by Sections 30.51 and 30.41. This is a reminder that the
requirements of Sections 30.51 and 30.41 must be met. (Agreement States
must have requirements compatible with those of Sections 30.51 and 30.41.)
For Section 30.51 recordkeeping requirements for byproduct materials, the
licensee shall retain each record of receipt as long as the material is
possessed and 3 years following transfer or disposal of the material. The
licensee who transfers the material shall retain each record of transfer for 3
years after each transfer unless a specific part in this chapter dictates
otherwise. The licensee who disposes of the material shall retain each
record of disposal until the license is terminated. These records allow NRC
to track the possession, use, and location of byproduct material. The
collection of this information has been previously cleared under
OMB Clearance No. 3150-0017.
l)
Records of the design checks required by Section 36.39 and the construction
control checks required by Section 36.41 until the license is terminated. The
records must be signed and dated. The title or qualification of the person
signing must be included. These records allow NRC inspectors to assure
that the irradiator was properly and carefully designed and constructed.
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m) Records related to decommissioning of the irradiator as required by Section
30.35(g) until the site is released for unrestricted use. This reference is
added for completeness to remind the licensee that 10 CFR Part 30 requires
certain records that are related to decommissioning. The information in these
records is necessary for the safe and effective decommissioning of the
facility.
Section 36.83(a) requires that, in addition to any other NRC reporting
requirements, the licensee shall report the following events if not reported under
other parts of NRC regulations:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
Source stuck in unshielded position.
Any fire or explosion in radiation room.
Damage to the source racks.
Failure of the cable or drive mechanism used to move the source racks.
Inoperability of the access control system.
Detection of a radiation source by the product exit monitor.
Detection of radioactive contamination attributable to licensed
radioactive material.
Structural damage to the pool liner or walls.
Abnormal water loss or leakage from the source storage pool.
Pool water conductivity exceeding 100 microsiemens per centimeter.
Section 36.83(b) requires that the events listed in Section 36.83(a) must be
reported by telephone within 24 hours as described in Section 30.50(c)(1), and in
writing within 30 days as described in Section 30.50(c)(2). The purposes of
these reports are to ensure that the licensee has properly corrected a potentially
hazardous situation and to determine if any class of irradiators might have
generic safety problems that should be corrected.
| File Type | application/pdf |
| File Modified | 2021-04-12 |
| File Created | 2021-03-31 |