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pdfFINAL OMB SUPPORTING STATEMENT
FOR
10 CFR PART 20
"STANDARDS FOR PROTECTION AGAINST RADIATION”
(3150-0014)
Extension
Description of the Information Collection
The general requirements for radiation protection, that are applicable to all NRC licensees, are
contained in 10 CFR Part 20, “Standards for Protection Against Radiation.” The provisions of 10
CFR Part 20 apply to individuals licensed by the NRC to possess byproduct, source, or special
nuclear material. 10 CFR Part 20 also contains criteria for decommissioning of facilities and
termination of the facility license. 10 CFR Part 20 is intended to ensure that occupationally
exposed individuals and members of the public are adequately protected from the potential
hazards of exposure to radiation and/or radioactive materials (for example, by requiring
licensees to report theft or loss of licensed radioactive materials and specific incidents causing
substantial exposures to or release of radioactive material).
The recordkeeping and reporting requirements for possession of material are in Subpart L -Records (20.2102 - 2110) and Subpart M – Reports (20.2201-2207). Recordkeeping and
reporting requirements for license termination are contained in Subpart E.
Two record retention periods appear in Part 20: 3 year retention for most survey records, and
retention for the lifetime of an active NRC license for those records of doses (or records that
provide a basis for dose estimates) received by individual workers or members of the public.
A.
JUSTIFICATION
The statutory authority of the NRC derives from the Atomic Energy Act of 1954 (AEA), as
amended; the Energy Reorganization Act of 1974, as amended, the Uranium Mill
Tailings Radiation Control Act of 1978, as amended; the Low-Level Radioactive Waste
Policy Act of 1980; the Nuclear Waste Policy Act of 1982; and the National
Environmental Policy Act of 1969. The basic authorities from the AEA include licensing
and regulation of production, use, ownership, and distribution of special nuclear
materials, source material, and byproduct materials, and licensing and control over the
manufacture, production, possession, use, importation, or exportation of production and
utilization facilities.
Section 161b of the AEA provides that the Commission may establish such standards as
the Commission deems necessary to protect public health and safety. Section 161o
gives the Commission authority to require by rule, regulation, or order, such reports, and
the keeping of such records as may be necessary to carry out the purposes of the AEA.
1.
Need for and Practical Utility of the Collection of Information
The information collected is used to evaluate the effectiveness of NRC regulations
and to discern any trends, problems, or special situations requiring additional
controls. The NRC uses information on worker exposures and effluents from
facilities such as nuclear power plants to analyze trends and compare licensee
performance. This information is also published in annual reports for use by industry
and other interested organizations. The NRC also uses the information to assess
applications for decommissioning and license termination. The Description of
Information Collections are listed in Appendix A.
2.
Agency Use of Information
The NRC uses the required information collection and reports to ensure that doses
to workers and members of the public do not exceed limits, are as low as is
reasonably achievable, that radioactive materials are stored and handled, and that
facilities are decommissioned in a way that will adequately protect the health and
safety of workers and the public.
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 (EIE) process,
which is available from the NRC's “Electronic Submittals” Web site, by Optical
Storage Media (OSM) (e.g. CD-ROM, DVD), by facsimile or by e-mail. It is
estimated that approximately 75 percent of the 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
Some of the licensees who use byproduct, source, and special nuclear materials are
small businesses. However, since the health and safety consequences of improper
handling or use of these materials are the same for large and small entities, it is not
possible to reduce the burden on small businesses by less frequent or less complete
reporting, recordkeeping, or accounting and control procedures.
6.
Consequences to Federal Program or Policy Activities if the Collection is Not
Conducted or is Conducted Less Frequently
Required reports are collected and evaluated on a continuing basis as events occur.
Applications for new licenses and amendments are submitted only once. Information
submitted in previous applications may be referenced without being resubmitted.
The schedule for collecting the information is the minimum frequency necessary to
assure that licensees will continue to conduct programs in a manner that will
adequately protect the health and safety of the public. If the information were not
2
collected, it would not be possible for NRC to intervene if safety were to decline at a
licensed facility in order to ensure the continued health and safety of the public and
workers.
7.
Circumstances that Justify Variation from OMB Guidelines
10 CFR 20.1906, 20.2201, and 20.2202 require licensees to report information in
less than 30 days. These immediate and 24-hour reporting requirements are
necessary for NRC to provide rapid response to incidents and to ensure public
health and safety.
Appendix G, Section III, Paragraph (E) requires licensees to report information in
less than 30 days. This notification time period is needed so that state and local
authorities can be mobilized to assist in locating lost radioactive materials as quickly
as possible to minimize the potential hazard to members of the public.
Records pertaining to the radiation doses and radionuclide intakes by individual
workers, to effluents released to air and water, and to the resultant radiation exposure
of members of the public must be retained for the life of the license and transferred to
the NRC upon termination of the license. This retention is required so that the past
exposure history of any worker can be reconstructed to allow the worker to move from
licensed facility to licensed facility and to permit the identification of trends, so that
declining licensee performance can be detected and corrected.
8.
Consultations Outside the NRC
Opportunity for public comment on the information collection requirements for this
clearance package was published in the Federal Register on April 10, 2018 (83 FR
15411). NRC received two comments on the information collection requirements.
Comment 1: The commenter stated their objections to wind turbines.
Response: NRC considers this comment to be out-of-scope and is not related to the
questions asked in our request for comments posted in the Federal Register on April
10, 2018 (83 FR 15411).
Comment 2: The commenter expressed concern that radiation dose information
available does not fully represent how the body reacts to radiation exposure. The
commenter stated that the NRC will not be able to predict the outcome of radiation
exposure or how the public can be protected unless information about the biological
impact of radiation exposure and the role of hydrogen peroxide in inflammation and
immunity is collected.
Response: NRC considers this comment to be out-of-scope and is not related to the
questions asked in our request for comments posted in the Federal Register on April
10, 2018 (83 FR 15411).
NRC also contacted three licensees by email with no responses received. No
additional comments were received.
3
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).
No sensitive information is requested under these regulations.
11.
Justification for Sensitive Questions
No sensitive information is requested under these regulations.
12.
Estimated Burden and Burden Hour Cost
The $263 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 this rate, see
the Revision Of Fee Schedules; Fee Recovery For Fiscal Year 2017 (82 FR 30682;
June 30, 2017).
NRC Licensees
The burden for NRC licensees to respond to the collection is shown in Tables 1, 3,
and 5. The total burden for NRC licensees is 91,545 hours (5,479 hours for
reporting + 342 hours for third-party disclosure + 85,724 hours for recordkeeping) at
a cost of $24,076,335 (91,545 hours x $263/hour).
An estimated 3000 NRC licensees respond to the 10 CFR Part 20 information
collections. These are licensees who are directly regulated by the NRC and includes
materials and reactor licensees.
Agreement State Licensees
Section 274 of the AEA provides a statutory basis under which NRC relinquishes to
the States portions of its regulatory authority to license and regulate byproduct
materials (radioisotopes); source materials (uranium and thorium); and certain
quantities of special nuclear materials. The mechanism for the transfer of NRC’s
authority to a State is an agreement signed by the Governor of the State and the
Chairman of the Commission, in accordance with section 274b of the AEA.
Licensees operating in these “Agreement States” are referred to in this supporting
statement as “Agreement State Licensees.”
The NRC has established compatibility requirements for Agreement States to
implement their own regulations in a manner consistent with NRC regulations. The
number of NRC licensees is known, whereas the total number of Agreement State
licensees is an estimate based on NRC’s best information available from the
Agreement States. NRC uses the ratio of the total of NRC licensees (subject to 10
CFR Part 20) to the total number Agreement State licensees to estimate the number
of Agreement State respondents for each section. NRC uses this ratio approach as
the total number of Agreement State licensees subject to various 10 CFR Part 20
Sections. The current ratio, based on the number and size of NRC regulated states
4
to Agreement States, is approximately 1:6 (NRC licensees: Agreement State
licensees).
The burden for Agreement State licensees to respond to the collection is shown in
Tables 2, 4, and 6. The total burden for Agreement State licensees is 549,231 hours
(32,874 hours reporting + 2,052 hours third-party disclosure + 514,305 hours
recordkeeping) at a cost of $144,447,753 (549,231 x $263/hour).
Total
The total burden for the collection is 640,776 hours (91,545 hours for NRC licensee
respondents and 549,231 hours for Agreement State licensee respondents), at a
total cost of $168,524,088 (640,776 hours x $263/hour). See Tables 7 and 8.
13.
Estimate of Other Additional Costs
The NRC has determined that the records storage cost is roughly proportional to the
recordkeeping burden cost. Based on a typical clearance, the records storage cost
has been determined to be equal to 0.0004 percent of the recordkeeping burden
cost. Therefore, the records storage cost is estimated to be $63,123 (85,724 NRC
recordkeeping hours + 514,305 Agreement State recordkeeping hours x 0.0004 x
$263/hour).
14.
Estimated Annualized Cost to the Federal Government
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.
The estimated annualized cost to the Federal Government is $2,091,639 (see Table
9). This cost is calculated using 7,953 total annual hours at a labor rate of
$263/hour to review reports submitted by NRC licensees. Note that costs do not
include costs to review Agreement State licensee actions, as this is a responsibility
that has been relinquished to the Agreement States.
The NRC costs associated with this collection are recovered through license fees
assessed to NRC licensees pursuant to 10 CFR Parts 170 and/or 171.
15.
Reasons for Change in Burden or Cost
The estimate of the total number of burden hours has remained the same at 640,776
hours. There have been no changes to the numbers of respondents or the burden
per respondent.
In addition, the hourly fee rate decreased from $279 to $263.
16.
Publication for Statistical Use
This information will not be published for statistical use.
17.
Reason for Not Displaying the Expiration Date
5
The requirement is contained in a regulation. Amending the Code of Federal
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
There are no exceptions.
B.
COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
Statistical methods are not used in this collection of information.
6
TABLE 1
REPORTING BURDEN FOR NRC LICENSEES
SECTION
20.1101(d)
20.1202
20.1203
20.1204
20.1206
20.1208
20.1301(d)
20.1302(c)
20.1403(a),(c),(d),(e)(1)
20.1403(e)(2)
20.1404
20.1406
20.1601(c)
20.1703(b)
20.1705(a)&(b)
20.1906(d)
20.2002
20.2004
20.2006
NO. OF
RESPONDENTS
RESPONSES
PER
RESPONDENT
TOTAL
RESPONSES
ANNUAL
BURDEN PER
RESPONDENT
0
0
see § 20.2203
see § 20.2206
see § 20.2206
see § 20.2206
see § 20.2204
see § 20.2206
0
2
3
1
0
10
10
15
15
14
20
1
1
1
0
1
1
1
1
1
1
2
3
1
0
10
10
15
15
14
20
TOTAL
ANNUAL
BURDEN
4
0
10
23
10
20
20
8
40
40
3
20
20
69
10
0
200
80
600
600
42
400
NOTES
None
expected
Burden included under 10 CFR 50 (OMB clearance no. 3150-0011)
20.2201(a)
20.2201(b)
20.2201(d)
20.2202(a)
20.2202(b)
20.2203(a)&(b)
20.2204
Burden included under NRC Forms 540-542 (OMB clearance nos. 3150-0164, 3150-0166,
3150-0165)
30.3
1
30.3
3
90.9
30.3
1
30.3
3
90.9
5.3
1
5.3
3
15.9
10
1
10
1
10
38
1
38
40
1,520
20
1
20
6
120
5
1
5
5
25
20.2205
Burden included in 20.2203(a) except for doses to individuals (see Table 3)
20.2206
Burden included under NRC Form 5 (OMB clearance 3150-0006)
20.2207(a), (b), (c), (d),
(e), (f)
20.2207 (g)
20.2207(h)
20.2301
App G
TOTAL
Burden included in OMB clearance for NRC Form 748 (OMB clearance 3150-0202)
1,425
One time report completed
20
3
1,425
1
1
1
7
1,425
20
3
1,677
1
1,425
5
20
100
60
5,479
TABLE 2
REPORTING BURDEN FOR AGREEMENT STATE LICENSEES
SECTION
NO. OF
RESPONDENTS
RESPONSES
PER
RESPONDENT
20.1101(d)
20.1202
20.1203
20.1204
20.1206
20.1208
TOTAL
RESPONSES
ANNUAL
BURDEN PER
RESPONDENT
TOTAL
ANNUAL
BURDEN
see § 20.2203
see § 20.2206
see § 20.2206
see § 20.2206
see § 20.2204
see § 20.2206
20.1301(d)
0
0
0
4
0
20.1302(c)
12
1
12
10
120
20.1403(a),(c),(d),(e)(1)
18
1
18
23
414
20.1403(e)(2)
20.1404
20.1406
20.1601(c)
20.1703(b)
20.1705(a)&(b)
20.1906(d)
20.2002
20.2004
20.2006
NOTES
6
1
6
10
0
0
0
20
60
1
60
20
60
1
60
8
90
1
90
40
90
1
90
40
84
1
84
3
120
1
120
20
Burden included under 10 CFR 50 (OMB clearance no. 3150-0011)
None
expected
60
0
1,200
480
3,600
3,600
252
2,400
20.2201(a)
20.2201(b)
20.2201(d)
20.2202(a)
20.2202(b)
20.2203(a)&(b)
20.2204
Burden included under NRC Forms 540-542 (OMB clearance nos. 3150-0164, 31500166, 3150-0165)
182
1
182
3
546
182
1
182
3
546
32
1
32
3
96
60
1
60
1
60
228
1
228
40
9,120
120
1
120
6
720
30
1
30
5
150
20.2205
Burden included in 20.2203(a) except for doses to individuals (see Table 4)
20.2206
Burden included under NRC Forms 4 and 5 (OMB clearance 3150-0005 & 3150-0006)
20.2207(a), (b), (c), (d),
(e), (f)
20.2207 (g)
20.2207(h)
20.2301
App G
TOTAL
Burden included in OMB clearance for NRC Form 748 (OMB clearance 3150-0202)
8,550
1
8,550
One time report completed
120
18
8,556
1
1
8
120
18
10,062
1
8,550
5
20
600
360
32,874
TABLE 3
THIRD PARTY DISCLOSURE BURDEN FOR NRC LICENSEES
SECTION
20.1901(b)&(c)
20.1904
20.1906(d)
20.2006(b)
20.2205
Appendix G,
Section III,
Paragraphs (A)(D)
TOTAL
NO. OF
RESPONDENTS
RESPONSES
PER
RESPONDENT
TOTAL
RESPONSES
ANNUAL
BURDEN PER
RESPONDENT
TOTAL
ANNUAL
BURDEN
750
750
14
1
1
1
750
750
14
0.1
0.1
3
75
75
42
NOTES
Burden included under NRC Forms 540-542 (OMB clearance nos. 3150-0164, 3150-0166,
3150-0165)
25
1
25
6
150
Burden for Sections I and II included under NRC Forms 540-542 (OMB clearance nos. 31500164, 3150-0166, 3150-0165)
750
1,539
9
342
TABLE 4
THIRD PARTY DISCLOSURE BURDEN FOR AGREEMENT STATE LICENSEES
SECTION
20.1901(b)&(c)
20.1904
20.1906(d)
20.2006(b)
20.2205
Appendix G,
Section III,
Paragraphs (A)(D)
TOTAL
NO. OF
RESPONDENTS
RESPONSES
PER
RESPONDENT
TOTAL
RESPONSES
ANNUAL
BURDEN PER
RESPONDENT
TOTAL
ANNUAL
BURDEN
4,500
4,500
84
1
1
1
4,500
4,500
84
0.1
0.1
3
450
450
252
NOTES
Burden included under NRC Forms 540-542 (OMB clearance nos. 3150-0164, 3150-0166,
3150-0165)
150
1
150
6
900
Burden for Sections I and II included under NRC Forms 540-542 (OMB clearance nos. 31500164, 3150-0166, 3150-0165)
4,500
9,234
10
2,052
TABLE 5
RECORDKEEPING BURDEN FOR NRC LICENSEES
SECTION
NO. OF
RECORDKEEPERS
BURDEN
PER
RECORDKEEPER
20.1101(a)
20.1202
20.1203
20.1204
20.1206
20.1208
20.1403(d)
20.1501
20.1703(c)(2)
20.1703(c)(4)
3
20
100
80
20.1901
20.1905(e)
750
600
0.1
0.2
20.1906(e)
20.2005(c)
20.2006
1,803
1
3,003
4
TOTAL
ANNUAL
BURDEN
20.2104
20.2105
20.2106 (records of
dose)
20.2106 (declaration of
pregnancy)
20.2107(a)
20.2108(a)&(b)
RULT1
60
see § 20.2103
see § 20.2103
8,000
RULT
75
120
1
2
RULT
LOC2
1,803
RULT
see § 20.2108
Burden included under Forms 540-542 (OMB clearance nos. 3150-0164,
3150-0166, 3150-0165)
12,012
(a)(1)=RULT,
(a)(2)=3 yrs
(a)=3 yrs,
24,024
(b)=RULT
see § 20.2106
0
3
0
RULT
none expected
Burden included under NRC Forms 4 & 5 (OMB clearance nos. 3150-0005 &
3150-0006)
150
1
150
RULT
3,003
8
3,000
3,000
5
8
20.2110
20.2207(a), (b), (c), (d),
(e)
NOTES
see § 20.2102
see § 20.2106
see § 20.2106
see § 20.2106
see § 20.2105
see § 20.2106
20.2102(a)&(b)
20.2103(a)&(b)
RECORD
RETENTION
15,000
24,000
RULT
RULT
No additional burden (included in 20.2102 through 20.2108)
Burden included in OMB clearance for NRC Form 748 (3150-0202)
App. G
3
TOTAL
3,003
160
480
85,724
RULT = Retained until license termination
LOC = Life of container
11
RULT
Burden for Sections I
and II included under
NRC Forms 540-542
(OMB clearance nos.
3150-0164, 31500166, 3150-0165)
TABLE 6
RECORDKEEPING BURDEN FOR AGREEMENT STATE LICENSEES
SECTION
20.1101(a)
20.1202
20.1203
20.1204
20.1206
20.1208
20.1403(d)
20.1501
20.1703(c)(2)
20.1703(c)(4)
NO. OF
RECORDKEEPERS
BURDEN
PER
RECORDKEEPER
18
20
600
80
20.1901
20.1905(e)
4,500
3,600
0.1
0.2
20.1906(e)
20.2005(c)
20.2006
10,815
1
18,015
4
TOTAL
ANNUAL
BURDEN
20.2104
20.2105
20.2106
(records of dose)
20.2106 (declaration of
pregnancy)
20.2107(a)
20.2108(a)&(b)
20.2110
20.2207(a), (b), (c), (d),
(e)
3
4
NOTES
see § 20.2102
see § 20.2106
see § 20.2106
see § 20.2106
see § 20.2105
see § 20.2106
360
RULT3
see § 20.2103
see § 20.2103
48,000
RULT
450
720
RULT
LOC4
10,815
RULT
see § 20.2108
Burden included under Forms 540-542 (OMB clearance nos. 3150-0164,
3150-0166, 3150-0165)
20.2102(a)&(b)
20.2103(a)&(b)
RECORD
RETENTION
72,060
(a)(1)=RULT,
(a)(2)=3 yrs
(a)=3 yrs,
144,120
(b)=RULT
see § 20.2106
0
3
0
RULT
none expected
Burden included under NRC Forms 4 & 5 (OMB clearance nos. 3150-0005 &
3150-0006)
18,015
8
900
1
900
RULT
18,000
5
90,000
RULT
18,000
8
144,000
RULT
No additional burden (included in 20.2102 through 20.2108)
Burden included in OMB clearance for NRC Form 748 (3150-0202)
App. G
18
TOTAL
18,015
160
2,880
514,305
RULT = Retained until license termination
LOC = Life of container
12
Burden for Sections I
and II included under
NRC Forms 540-542
(OMB clearance nos.
3150-0164, 31500166, 3150-0165)
TABLE 7
BURDEN SUMMARY
Hours
5,479
342
Responses
1,677
1,539
NRC Licensee Recordkeeping
85,724
3,003
Agreement State Reporting
Agreement State 3rd Party Disclosure
32,874
2,052
10,062
9,234
Agreement State Recordkeeping
514,305
18,015
TOTAL
640,776
43,530
NRC Licensee Reporting
NRC Licensee 3rd Party Disclosure
TABLE 8
TOTALS FOR NRC LICENSEES AND AGREEMENT STATE LICENSEES
NRC Licensees Total
Agreement State Licensees Total
TOTAL
Hours
91,545
549,231
Responses
6,219
37,311
640,776
43,530
Total Number of recordkeepers:
21,018 (3,003 NRC licensee recordkeepers +
18,015 Agreement State licensee recordkeepers)
Number of respondents:
21,018 (3,003 NRC licensees +
18,015 Agreement State licensees)
13
TABLE 9
ANNUALIZED COST TO THE FEDERAL GOVERNMENT
(NRC Staff Burdens Associated with 10 CFR Part 20)
SECTION
TOTAL HOURS
NOTES
20.1101
0
see § 20.2102
20.1202
0
see § 20.2106
20.1203
0
see § 20.2106
20.1204
0
see § 20.2106
20.1206
0
see § 20.2106
20.1208
0
see § 20.2106
20.1301(d)
0
none expected
20.1302(c)
4
20.1403(a-e)
60
20.1404
0
20.1406
200
20.1501
0
20.1601(c)
8
20.1703(b)
300
20.1703(c)(2)
0
20.1703(c)(4)
200
20.1705(a)&(b)
300
20.1904
50
20.1905(e)
9
20.1906(d)
6
20.1906(e)
9
20.2002
150
20.2004
0
Burden included in OMB Clearance for Part 50
(OMB clearance no. 3150-0011)
20.2005(c)
0
see § 20.2108
20.2006
0
Burden included in OMB clearance for NRC
Forms 540-542 (OMB clearance nos. 3150-0164,
3150-0166, 3150-0166)
see § 20.2103
see § 20.2103
14
SECTION
TOTAL HOURS
20.2102(a)
2250
20.2103(a)
3000
20.2103(b)
0
see §20.2103(a)
20.2104
0
see § 20.2106
20.2105
0
none expected
0
Burden included in OMB Clearance for NRC Forms
4 and 5 (OMB clearance nos. 3150-0005, 31500006)
0
none expected
20.2106
(records of dose)
20.2106
(declaration of pregnancy)
NOTES
20.2107(a)
7
20.2107(b)
0
20.2108(a)
510
20.2108(b)
0
see §20.2108(a)
20.2110
0
format requirement only
20.2201(a)
91
20.2201(b)
91
20.2201(d)
5
20.2202(a)
60
20.2202(b)
117
20.2203(a)
320
20.2203(b)
0
20.2204
100
20.2206(b)&c)
0
Burden included in OMB Clearance for NRC Forms
4 and 5 (OMB clearance nos. 3150-0005, 31500006)
20.2207(a), (b), (c), (d), (e), (g)
0
Burden included in OMB clearance for NRC Form
748
20.2207(h)
0
One time report completed
20.2301
100
App G
6
TOTAL
7,953
15
see §20.2107(a)
see § 20.2203(a)
For Sections I and II, Burden included in OMB
Clearance for NRC Forms 540-542 (OMB
clearance nos. 3150-0164, 3150-0166, 3150-0165)
Appendix A: Description of Information Collections for 10 CFR Part 20
10 CFR 20.1003 defines a declared pregnant woman as a woman who has
voluntarily informed the licensee in writing that she is pregnant. Licensees are
required to maintain records of doses to the embryo/fetus and the declared
pregnant woman in 10 CFR 20.2106. Licensees are also required by
10 CFR 20.2106(e) to keep the declaration on file, although it may be
maintained separately from the dose records.
10 CFR 20.1101 requires licensees to develop, document and implement
radiation protection programs; establish radiation protection procedures; and
perform program reviews periodically. This is necessary to ensure the health
and safety of the workers and the general public. The burden for recordkeeping
requirements is contained in 10 CFR 20.2102.
10 CFR 20.1201 and 20.1202 set limits for occupational exposures. The
recordkeeping requirements for this section are contained in 10 CFR 20.2106.
Dose limits are necessary to ensure the health and safety of the workers. The
reporting requirements for this section are contained in 10 CFR 20.2206. Both
requirements are covered under the OMB clearance for NRC Forms 4 and 5
(3150-0005 and 3150-0006, respectively).
10 CFR 20.1203 requires licensees to determine dose from airborne radioactive
material. This is necessary to ensure compliance with dose limits. The
recordkeeping and reporting requirements for this section are contained in
10 CFR 20.2106 and 20.2206 respectively and are covered under a separate
OMB clearance for NRC Forms 4 and 5 (OMB 3150-0005 and 3150-0006).
10 CFR 20.1204 requires licensees to make measurements as needed to assess
internal exposures of occupationally exposed individuals. The recordkeeping and
reporting requirements for this section are contained in 10 CFR 20.2106 and
20.2206 respectively and are covered under a separate OMB clearance for NRC
Forms 4 and 5 (OMB 3150-0005 and 3150-0006).
10 CFR 20.1206 sets limits for planned special exposures. This is necessary to
ensure the health and safety of workers. The recordkeeping and reporting
requirements for this section are contained in 10 CFR 20.2105 and 20.2204
respectively.
16
10 CFR 20.1208 sets limits for doses to an embryo/fetus of a declared
pregnant worker. This is necessary to protect the health and safety of the
embryo/fetus.
10 CFR 20.1301(d) allows licensees to apply to the Commission to increase the
dose limit for the general public from 0.1 rem/year to up to 0.5 rem/year. This is
needed to ensure that a temporary deviation from the established dose limits
adequately protects the health and safety of workers and the public.
10 CFR 20.1302(c) allows licensees to apply to the Commission for permission
to use alternate effluent release concentration limits based on actual physical
and chemical characteristics of the effluent released. This is needed to ensure
that if alternate values are used by licensees, then the values are adequate to
protect the health and safety of the public.
10 CFR 20.1403(a)-(c) and (e)(1) require that, if restrictions on future use of the
site are proposed, the information that the licensee must provide is as follows:
(1) further reductions in residual radioactivity necessary to release the site for
unrestricted use would result in net public or environmental harm or were not
being made because the residual levels associated with restricted conditions are
as low as is reasonably achievable (ALARA); (2) adequate provisions for legally
enforceable institutional controls that provide reasonable assurance that the
total effective dose equivalent (TEDE) from residual radioactivity distinguishable
from background to the average member of the critical group will not exceed 25
mrem per year; (3) provisions have been made for sufficient financial assurance
to enable an independent third party to assume and carry out responsibilities for
any necessary control and maintenance of the site; and (4) residual radioactivity
at the site has been reduced so that if the institutional controls were no longer in
effect, there is reasonable assurance that the TEDE from residual radioactivity
distinguishable from background to the average member of the critical group is
as low as reasonably achievable and would not exceed 100 mrem per year.
10 CFR 20.1403(d) requires that a decommissioning plan or License Termination
Plan (LTP) be submitted to the Commission by the licensee indicating the
licensee’s intent to decommission in accordance with 10 CFR Parts 30.36(d),
40.42(d), 50.82(a) and (b), 70.38(d), or 72.54, and specifying that the licensee
intends to decommission by restricting use of the site, and that the
decommissioning plan or LTP document how the advice of individuals or
institutions in the community who may be affected by the decommissioning has
been sought and incorporated, as appropriate, following analysis of that advice. In
seeking advice on issues associated with restricted use, licensees are required
to provide for participation by a broad cross section of community interests
who may be affected by the decommissioning, provide an opportunity for
comprehensive, collective discussion on the issues by the participants
represented, and prepare a publicly available summary of the results of all such
discussions, including a description of the individual viewpoints of the participants
on the issues and the extent of agreement and disagreement among the
participants on the issues.
17
10 CFR 20.1403(e)(2) requires that, as an option to the 100 mrem per year level,
a level of 500 mrem/year may be allowed if the licensee demonstrates that further
reductions in residual radioactivity necessary to comply with the 100 mrem/year
value are not technically achievable, would be prohibitively expensive,
or would result in net public or environmental harm, that provisions exist
for durable institutional controls, and that there is sufficient financial assurance
to enable a responsible government entity, or independent third party, both
to carry out periodic rechecks of the site no less frequently than every 5 years
and to assume and carry out responsibilities for any necessary control and
maintenance of those controls.
10 CFR 20.1404 requires that, if the licensee proposes to use alternate criteria,
the information the license must provide is as follows: (1) an analysis of possible
sources of exposure that provides assurance that public health and safety would
continue to be protected, and that it is unlikely that the dose from all
man-made sources combined, other than medical, would be more than the
1 mSv/year (100 mrem/year) limit of Subpart D of 10 CFR Part 20; (2) an
indication that restrictions on site use according to the provisions of
10 CFR 20.1403 have been employed to the extent practical to minimize
exposures at the site; (3) doses have been reduced to ALARA levels; and (4) a
decommissioning plan or LTP has been submitted indicating the licensee's intent
to decommission in accordance with 10 CFR Parts 30.36(d), 40.42(d), 50.82(a)
and (b), 70.38(d), or 72.54, and specifying that the licensee proposes to
decommission by use of alternate criteria, and documenting in the
decommissioning plan or LTP how the advice of individuals and institutions in the
community who may be affected by the decommissioning has been sought and
incorporated, as appropriate, following analysis of that advice.
10 CFR 20.1406 requires applicants for licenses to describe in the application
how facility design and procedures for operation will minimize contamination of
the facility and the environment, facilitate eventual decommissioning, and
minimize the generation of radioactive waste.
10 CFR 20.1501 requires licensees to conduct surveys and to monitor
radiological conditions. These are necessary to ensure that the licensee is
aware of all the radiological conditions that could contribute to dose in order to
comply with dose limits. The recordkeeping requirements for this section are
contained in 10 CFR 20.2103.
10 CFR 20.1601(c) allows licensees to apply to the Commission for approval of
alternate methods for controlling access to high radiation areas. This is needed
to ensure that any proposed deviation from established mechanisms adequately
protects the health and safety of workers and the public.
10 CFR 20.1703(b) allows licensees to submit an application to the Commission
for permission to use respiratory protection equipment that has not been tested
or certified for use by the National Institute for Occupational Safety and Health.
Records of this application and its approval are required to ensure that licensee
practices are in compliance with regulations.
18
10 CFR 20.1703(c)(2) requires licensees to perform surveys and bioassay as
needed to evaluate actual intakes. The recordkeeping requirement for this
paragraph is contained in 10 CFR 20.2103. These records are needed so that
NRC can ensure, through inspection, that the licensee is adequately protecting
the health and safety of workers.
10 CFR 20.1703(c)(4) requires licensees to have written procedures regarding
the proper issue and use of respiratory protection equipment. This is needed to
ensure, through inspection, that these devices are used consistent with the goal
to maintain occupational doses ALARA and in a safe manner.
10 CFR 20.1705(a) and (b) required licensees to submit an application to the
Commission before using assigned protection factors higher than those in
Appendix A to 10 CFR Part 20 for the purpose of calculating exposures. Records
of this application and its approval are required to ensure that respiratory
protective equipment is being used in a manner that will protect the health and
safety of workers.
10 CFR 20.1901(b) and (c) allows licensees to label sources, source holders, or
device components containing sources of licensed materials and to provide
additional information, as appropriate, to make individuals aware of potential
radiation exposures and to minimize exposures.
10 CFR 20.1904 requires that labels used to identify radioactive material
containers use specified formats and wording. This is needed to minimize
potential doses or releases of radioactive material due to worker confusion.
10 CFR 20.1905(e) requires that licensees maintain records of radioactive
material containers that cannot be labeled in accordance with this Part due to
special circumstances for the life of the container. This is necessary to ensure
that radioactive material is properly monitored at all times.
10 CFR 20.1906(d) requires licensees to notify the carrier and the NRC
Operations Center upon receipt of a radioactive material package which is
damaged, contaminated, or where radiation levels exceed limits. This is needed
so that NRC can, through inspection, ensure that shipment procedures and
practices are adequate to protect the health and safety of workers and the public.
10 CFR 20.1906(e) requires licensees to develop, maintain and retain written
procedures regarding radioactive material shipment. This is needed to ensure
that the packages containing radioactive material will be opened in a manner
consistent with the protection of the health and safety of the public and workers.
10 CFR 20.2002 allows licensees to apply to the Commission for approval of
procedures not otherwise allowed in this Part regarding the disposal of licensed
material. The application must include: (a) a description of the waste, (b) an
environmental analysis, (c) the nature and location(s) of other potentially affected
facilities, and (d) analyses and procedures to ensure that doses are ALARA.
This is needed to ensure that licensed material is handled in a manner that will
adequately protect the health and safety of the public and workers.
19
10 CFR 20.2004 requires Part 50 licensees who incinerate waste oils onsite to
report any changes or additions to the information supplied under 10 CFR 50.34
and 50.34a, and to follow the procedures of 10 CFR 50.59 with respect to such
changes. This is needed so that NRC can ensure that radioactive effluents
associated with incineration of waste oils conform to the requirements of
Appendix I to 10 CFR Part 50.
10 CFR 20.2005(c) requires licensees to maintain records of waste disposal. The
recordkeeping requirement for this section is contained in 10 CFR 20.2108. This
is needed to allow NRC to ensure, through inspection, that waste disposal is in
accordance with NRC regulations.
10 CFR 20.2006(a) requires that licensees establish a manifest tracking system
to control transfers of low-level radioactive waste intended for disposal at a land
disposal facility so that NRC can inspect to ensure that adequate control of this
material exists as specified in Appendix G to 10 CFR Part 20.
10 CFR 20.2006(b) requires that licensees use NRC's Uniform Low-level
Radioactive Waste Manifest and transfer this information to the intended
consignee, as specified in Section I of Appendix G to 10 CFR Part 20.
10 CFR 20.2006(c) requires a certification by the waste generator, processor, or
collector as specified in Section II of Appendix G to 10 CFR Part 20.
The information in 10 CFR 20.2006 (a)-(c) is needed to control shipments and
disposal of Low Level Waste (LLW) to ensure public health and safety and to
protect the environment. The specific requirements are discussed in more detail
in Appendix G to 10 CFR Part 20.
These reporting requirements are covered under the clearances for NRC Forms
540, 541, and 542 (OMB Clearance numbers 3150-0164, 3150-0166, and
3150-0165).
10 CFR 20.2102(a) requires licensees to maintain records of the radiation
protection program, including ALARA provisions and program reviews. This is
needed so that NRC can ensure, through inspection, that the health and safety of
workers and the public is adequately protected.
10 CFR 20.2102(b) requires licensees to retain records of radiation protection
programs until the Commission terminates the license. This is needed so that
workers will have ready access to radiation protection programs and procedures
as long as the facility is in operation. This paragraph further requires that
licensees retain records of radiation protection program reviews for 3 years. This
is needed so that adequate records will exist at the time of inspection to
determine if the radiation protection program adequately protects the health and
safety of workers and the public.
10 CFR 20.2103(a) requires licensees to maintain records showing the results of
surveys and calibrations required by this Part. These records will be maintained
for 3 years after the records are created. This is needed to ensure, through
inspection, that surveys required for adequate radiation protection have been
made.
20
10 CFR 20.2103(b) requires licensees to maintain records that form the basis of
dose estimates, results of air sampling surveys, and bioassays required under
the Radiation Protection Standard and results of measurements and calculations
used to evaluate radioactive effluents released to the environment be maintained
for as long as the facility is licensed by NRC. This is needed to ensure that
adequate records exist at the time of routine inspection to support an assertion
that adequate radiation surveys have been performed and to ensure that
adequate records exist to reconstruct a worker’s dose estimate at any time during
the period in which the facility is licensed by NRC.
10 CFR 20.2104 requires licensees to attempt to obtain records of prior
occupational exposures prior to authorizing entry into restricted or controlled
areas by individuals for whom personnel radiation monitoring is required. This
recordkeeping requirement is covered in a separate OMB clearance for NRC
Form 4 (OMB clearance number 3150-0005).
10 CFR 20.2105 requires licensees to maintain records of planned special
exposures until the Commission terminates the license since they form the basis
for assessing dose to an individual.
10 CFR 20.2106 requires licensees to record and maintain the results of
individual monitoring until the Commission terminates the license. This
recordkeeping requirement is covered in a separate OMB clearance for NRC
Form 5 (OMB clearance number 3150-0006).
10 CFR 20.2107(a) requires licensees to maintain records of compliance with
does limit for individuals of the public. This is needed to permit assessment of
the dose to the public that might result from these radionuclide releases in order
to confirm compliance with dose limits.
10 CFR 20.2107(b) requires that the records required in 10 CFR 20.2107(a) be
maintained until the license is terminated by the Commission as they form the
basis for estimating dose.
10 CFR 20.2108(a) requires licensee to maintain records of waste disposal to
permit (1) routine inspection for compliance with the provisions of the sections in
10 CFR Part 20 related to waste disposal, (2) inspection against constraints on
the kinds and quantities of licensed material in the possession of the licensee at
any given time, and (3) assessment of the kinds and quantities of radioactive
material disposed of by various methods and the potential dose to the public.
10 CFR 20.2108(b) requires that the waste disposal records be retained until the
termination of the license by the Commission.
10 CFR 20.2110 establishes the quality, format and retention of records required
by this Part. There are no additional recordkeeping or reporting requirements
associated with this section. This establishes a common format to minimize
confusion for workers moving from licensee to licensee in the course of their
employment and to facilitate inspection.
21
10 CFR 20.2201(a) requires licensees to report any theft or loss of licensed
material by telephone immediately or in writing within 30 days, dependent upon
the potential risk to the health and safety of the public associated with the missing
radioactive material. This is needed so that prompt corrective action can be
taken.
10 CFR 20.2201(b) requires licensees to follow up telephone reports with written
reports of the incident within 30 days of the telephone report. This is needed to
ensure that the proper follow-up actions were taken by the licensee.
10 CFR 20.2201(d) requires the licensees to report any additional information
relevant to the loss of radioactive material, discovered subsequent to the written
report, be submitted within 30 days of discovery. This is needed to ensure that
the actions were taken to protect the health and safety of workers and the public
are based on complete information regarding the event.
10 CFR 20.2202(a) require that the licensee immediately notify the NRC upon
becoming aware of specific incidents causing substantial exposures to or release
of licensed material. This is needed so that the NRC can identify possible
generic problems and notify other licensees.
10 CFR 20.2202(b) requires that the licensee notify the NRC within 24 hours
upon becoming aware of specific incidents involving licensed material. This is
needed to allow early evaluation of the incident by NRC to ensure that
appropriate action can be taken to protect against further hazard to life or
property.
10 CFR 20.2203(a) establishes that, in addition to the notification required by
10 CFR 20.2202, each licensee is required to submit a written report within 30
days after learning of specific incidents involving doses or concentrations of
radioactive materials in excess of limits. This is needed to ensure that there are
appropriate follow-up actions to avoid a recurrence.
10 CFR 20.2203(b) contains the requirements for the content of reports required
by 10 CFR 20.2203(a).
10 CFR 20.2204 requires licensees to submit a written report to the NRC within
30 days after a planned special exposure. This is needed to ensure that the use
of planned special exposures is in accordance with requirements.
10 CFR 20.2205 establishes that when a licensee is required, pursuant to
10 CFR 20.2203 or 20.2204 to report to the Commission any exposure of an
identified occupational exposed individual, the licensee must also provide a copy
of the report submitted to the Commission to the individual at the same time.
10 CFR 20.2206(b) and (c) require licensees to report the results of individual
monitoring annually to NRC on NRC Form 5 or equivalent electronic media.
These requirements are covered under a separate OMB clearance for NRC Form
5 (OMB clearance number 3150-0006).
22
10 CFR 20.2207 requires licensees who manufacture, transfer, receive,
disassemble, or dispose of a nationally tracked source complete and submit a
National Source Tracking Transition Report as specified in paragraphs (a)
through (e) of this section. Paragraph (f) of this section specifies the timing
requirements for the report, and the methods of submitting the report. These
requirements are included in the clearance package for NRC Form 748 (OMB
clearance number 3150-0202).
10 CFR 20.2207(g) requires licensees to correct errors in previously filed reports
or file any missed transaction reports within 5 business days of the discovery.
The section also requires licenses to reconcile and verify the inventory of
nationally tracked sources possessed by the licensee against the licensee’s data
in the National Source Tracking System (NSTS) on an annual basis. This
verification is necessary to maintain the accuracy and reliability of the system
over time. The burden to correct errors and file missed transaction reports is
included in the clearance package for NRC Form 748 (OMB clearance number
3150-0202). The burden to conduct an annual reconciliation with the NSTS
database is included in this clearance package for 10 CFR Part 20.
10 CFR 20.2207(h) required licensees to report their initial inventory of Category
1 and Category 2 nationally tracked sources to the NSTS by January 31, 2009.
The initial inventory report included the source information such as make,
model, serial number, radionuclides, source strength, and date for which the
source strength is reported. The report also included the licensee name,
address, and license number along with the name of the individual that prepares
the report. This information is needed to ensure accountability of nationally
tracked sources. This is a one-time collection that has been completed.
10 CFR 20.2301 allows licensees to apply to the Commission for exemption from
this rule.
Appendix G, Section I requires that waste generators, collectors, and processors
of LLW intended for ultimate disposal at a licensed low-level radioactive waste
facility to prepare a manifest on NRC Forms 540, 541, and 542, as appropriate.
The justification for the information collection requirements in these forms are
covered in separate OMB clearances for NRC Forms 540, 541, and 542 (OMB
clearance numbers 3150-0164, 3150-0166, and 3150-0165).
This section specifies the specific data to meet NRC manifest requirements
(i.e., shipper, date, total radioactivity, container identification and description,
physical and chemical description of the waste, chelating agents, classification of
the waste, radiation levels, etc). This information is electronically submitted to
the NRC (discussed in 10 CFR 61.80(l)), to enhance the ability of the NRC and
State regulatory agencies to control and safely regulate disposal of LLW.
Without this information the ability for the licensee and the regulatory agencies to
assess the site's performance would be severely impacted and thus the
regulatory agency responsibility to protect public health and safety and the
environment could not be adequately accomplished.
23
Appendix G, Section II requires that all generators, processors, and collectors certify by signing
and dating the shipment manifest, that the shipment is properly classified, described, packaged,
marked and labeled to meet Department of Transportation, NRC, and State requirements. This
is necessary to ensure that the proper company official verifies that appropriate requirements
have been met prior to shipment.
Appendix G, Section III, Paragraphs (A)-(D) provides the specific manifesting procedures for
generators, processors, collectors, and the land disposal facility operators during shipment and
receipt of the LLW. This includes classification of and labeling of the LLW, conducting a quality
assurance program to assure compliance with §§ 61.55 and 61.56, requirement to use the NRC
Uniform Low- Level Radioactive Waste Manifest, requirements to provide the intended consignee
the manifest information and acknowledgment of its receipt and procedures in the event
acknowledgment is not received, and storage of manifest data. These procedures are necessary
to ensure that LLW is tracked from generator shipment to ultimate disposal and that no LLW is
unaccounted for. A quality assurance program is necessary to ensure companies are properly
following the procedures. The receipt acknowledgment is necessary to ensure investigations are
undertaken when LLW is not where it is supposed to be. The storage of the manifest information
is necessary to conduct audits and in the event that any discrepancies or other problems needed
to be investigated.
Sections A.5 (generators), B.3 (collectors), and C.6 (processors) authorize that the manifest data
may be transmitted electronically instead of by hard copy. This is a voluntary option designed to
allow the manifest system to work more effectively and efficiently.
Appendix G, Section III, Paragraph (E) requires investigations and reporting to NRC when LLW
has not been accounted for. This information is needed to identify and locate missing LLW and
to identify improper procedures.
24
| File Type | application/pdf |
| File Modified | 2018-08-06 |
| File Created | 2018-08-06 |