NPUF License Renewal Proposed Rule revised supporting statement

DRAFT SUPPORTING STATEMENT

FOR 10 CFR PART 50

NON-POWER PRODUCTION OR UTILIZATION FACILITY LICENSE RENEWAL

PROPOSED RULE

3150-0011

Description of the Information Collection

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations that govern the license renewal process for non-power reactors, testing facilities, and other
non-power production or utilization facilities, licensed under the authority of Section 103, Section 104a, or Section 104c of the Atomic Energy Act of 1954, as amended (AEA), that are not nuclear power reactors. In this proposed rule, the NRC collectively refers to these facilities as non-power production or utilization facilities (NPUFs). The NRC is proposing a rule with the following regulatory objectives that would result in incremental changes in recordkeeping and reporting burden relative to existing rules:

1. Eliminate license terms for class 104a or c NPUFs,¹ other than testing facilities, and define the license renewal process for class 103 NPUFs and testing facilities;² and

2. Require the submittal of periodic updates to the final safety analysis report (FSAR).

The paperwork burden associated with the proposed rule largely results from revising procedures, updating FSARs, and submitting the updated FSARs to the NRC.

In addition to the proposed revisions and amendments to part 50 of title 10 of the Code of Federal Regulations (10 CFR) that would result in incremental changes in recordkeeping and reporting burden, the proposed rule also would include provisions for which there would be no change in the incremental burden. These proposed requirements include:

Section 50.33 would eliminate the requirement that applicants submit in their license renewal application financial information equivalent to what is included at the time of initial licensing. This provision would result in a reduction to the paperwork burden during the license renewal process, but the reduction would not come during the 3-year period covered by this Supporting Statement because no license renewals are anticipated during this period.

Section 50.34(a)(1)(i)(D)(2) would establish an accident dose criterion for NPUFs, other than testing facilities. The accident dose criteria in § 50.34(a)(1)(i)(D)(1) would not change for testing facilities or power reactors. The proposed rule would add the accident dose criterion for NPUFs, other than testing facilities, but would not impose any additional recordkeeping or reporting requirements beyond what is currently required of licensees in § 50.34. The existing paperwork burden is currently accounted for under OMB Clearance 3150-0011.³

Section 50.51(c) would specify that NPUFs, other than testing facilities, licensed after the effective date of the final rule, would be issued with no fixed license term. These licensees would not be required to submit license renewal applications. This provision would result in a reduction to paperwork burden, but the reduction would not come during the 3-year period covered by this Supporting Statement because no license renewals are anticipated during this period. As detailed in the regulatory analysis for this rulemaking, the NRC anticipates that each licensee granted a non-expiring license would eventually save 2,000 to 3,000 hours of burden at the time of license renewal. (Note: the burden reduction varies across NPUFs according to licensed power level. See the discussion under Affected Entities.)

Section 50.59(b) would extend the applicability of § 50.59 to NPUFs that have permanently ceased operations and that no longer have fuel (e.g., they have returned all of their fuel to the U.S. Department of Energy ) . These licensees currently must request a license amendment to add a license condition similar to § 50.59. As a result, the proposed rule would not impose any additional recordkeeping or reporting requirements beyond what is currently required of licensees. The existing paperwork burden is accounted for under OMB Clearance 3150-0011.⁴

Section 50.135 would define a license renewal process specific to testing facilities licensed under § 50.21(c) and NPUFs licensed under § 50.22, consolidating existing requirements for current and future licensees in one section. The proposed rule would not change the current license renewal process for testing facilities and class 103 NPUFs. Therefore, the proposed requirements would not impose any additional recordkeeping or reporting burden beyond what is currently required of licensees. The existing paperwork burden is accounted for under OMB Clearance 3150-0011.⁵

Section 51.56 would clarify the existing requirements for each applicant for an NPUF license or license renewal to submit an environmental report. Applicants are currently required to submit this information under § 51.41(a). The proposed requirements would not impose any additional recordkeeping or reporting burden beyond what is currently required of licensees. The existing paperwork burden is accounted for under OMB Clearance 3150-0021.⁶

The following section would result in incremental burden during the 3-year analysis period:

Section 50.71(e) would require all NPUF licensees to submit FSAR updates to the NRC every five years. Updates should reflect the changes and effects of changes to the facility’s design basis and licensing basis, including any information provided in annual reports and other submittals to the NRC since the previous FSAR update submittal. Each update would reflect all changes made to the FSAR up to a maximum of 6 months prior to the date of filing the update.

Affected Entities

The proposed rule requirements would impact 31 NPUFs that are licensed to operate. However, the incremental burdens affecting individual NPUFs differ depending on whether the NPUF would submit an updated FSAR during the 3-year period covered by this Supporting Statement as well as the NPUF’s power level.

Specifically, the NRC expects that all but four NPUFs would submit an updated FSAR during the 3-year period covered by this Supporting Statement (2019–2021). Following implementation of the rule, four NPUFs would be required to undergo the license renewal process prior to the NRC granting a non-expiring license. As a result, these NPUF licensees would not submit an updated FSAR until completing the license renewal process (expected after 2022). Therefore, only 27 of the 31 affected NPUFs would incur a burden related to updating and submitting FSARs during the period covered by this Supporting Statement.

Burdens also vary depending on the NPUF’s power level. Of the 27 NPUFs that will submit updated FSARs, five have a power level less than 100 kilowatts (kW), nine have a power level greater than or equal to 100 kW but less than 1,000 kW, and 13 have a power level greater than or equal to 1,000 kW. The NRC assumes that the burden associated with updating and submitting FSARs would be greater for NPUFs with higher power levels relative to NPUFs with lower power levels.

A. JUSTIFICATION

1. Need for and Practical Utility of the Information

The NRC anticipates that, overall, the proposed rule would result in reduced burden on licensees and NRC staff, and would create a more responsive and efficient licensing process that would continue to protect public health, safety, and the environment.

Currently, NPUF licensees are not required to submit to the NRC updated FSARs except as part of a license renewal application. Under the current license renewal process, the NRC found that licensees were not always able to provide documentation describing the details of their licensing basis, including their design basis calculations, in license renewal applications. The lack of ongoing FSAR updates added burden to the license renewal process for NPUF licensees and the NRC because many facilities’ licensing bases had to be re-established. The submittal of periodic updates to FSARs would create a mechanism for incorporating design and operational changes into the licensing basis as they occur. As a result, NPUFs would routinely update their licensing bases and NRC staff would be made aware of changes to the licensing bases more frequently.

The NRC has determined that the proposed information collection requirements are necessary for the following reasons:

• Information collection related to updating procedures. This information collection is necessary to ensure that licensee procedures are up-to-date and are consistent with the NRC’s requirements.

• Information collection related to preparing updated FSARs. Under the current license renewal process, the NRC found that licensees were not always able to provide documentation describing the details of their licensing basis, including their design basis calculations, in license renewal applications. Some licensees had difficulty documenting the necessary updates to licensing bases when they were called upon to do so between initial licensing and license renewal. From a safety perspective, an updated FSAR is important for the NRC’s inspection program and for effective licensee operator training and examination. Therefore, this information collection is necessary to maintain the continuity of knowledge both for the licensee and the NRC staff and the understanding of changes and effects of changes on the facility.

The specific recordkeeping and reporting requirements associated with the proposed revisions and amendments to 10 CFR part 50 are identified below.

Section 50.71(e) would require all NPUF licensees to submit FSAR updates to the NRC every five years. Updates should reflect the changes and effects of changes to the facility’s design basis and licensing basis, including any information provided in annual reports and other submittals to the NRC since the previous FSAR update submittal. Each update would reflect all changes made to the FSAR up to a maximum of 6 months prior to the date of filing the update.

NPUF licensees would incur a one-time recordkeeping burden associated with updating procedures to comply with new regulations (e.g., procedures for tracking, updating, and submitting FSAR updates). The incremental one-time recordkeeping burden associated with this requirement is included in Table 1.

NPUF licensees would incur an annual recordkeeping burden to document the updated FSARs and an annual reporting burden to submit the updated FSARs to the NRC.⁷ The incremental annual recordkeeping and reporting burdens associated with this requirement are included in Table 2 and Table 3, respectively. Burden hours vary by power level and are therefore presented for three separate categories of affected NPUFs.

2. Agency Use of the Information

The updated FSARs would indicate changes made in the facility or the procedures for its operation and any analyses affected by these changes. The NRC staff would review the updated FSARs to ensure that licensing bases remain up-to-date.

3. Reduction of Burden Through Information Technology

There are no legal obstacles to reducing the burden associated with this information collection. The NRC encourages respondents to use information technology when it would be beneficial to them. The NRC issued a regulation on October 10, 2003 (68 FR 58791), consistent with the Government Paperwork Elimination Act, which allows its licensees, vendors, applicants, and members of the public the option to make submissions electronically via CD-ROM, e-mail, special Web-based interface, or other means. The NRC estimates that 75 percent of responses will be submitted electronically.

4. Effort to Identify Duplication and Use Similar Information

There is no duplication of requirements. The NRC has in place an ongoing program to examine all information collections with the goal of eliminating all duplicate and/or unnecessary information collections.

5. Effort to Reduce Small Business Burden

The NRC has determined that the affected entities are not small entities or businesses as those terms are used in the Regulatory Flexibility Act.

6. Consequences to Federal Program or Policy Activities if the Collection Is Not Conducted or Is Conducted Less Frequently

If the information were not collected, or collected less frequently, the NRC would be unaware for extended periods of time whether NPUF licensees have updated FSARs over the operating period. Under the current license renewal process, NPUF licensees are not required to submit updated FSARs during the license term. As a result, the NRC found that licensees were not always able to provide documentation describing the details of their licensing basis, including their design basis calculations, in license renewal applications. Consequently, the license renewal process was burdensome on both the licensees and the NRC.

7. Circumstances which Justify Variations from OMB Guidelines

This section identifies incremental recordkeeping and reporting burdens as a result of the proposed rule that vary from OMB guidelines established in 5 CFR 1320.5(d)(2).

Each NPUF licensee would be required to comply with the information collections until the NPUF ceases to operate. These requirements vary from the OMB guidelines in 5 CFR 1320.5(d)(2)(iv) because they require licensees to retain records for more than 3 years.

These variations from the OMB guidelines are justified because maintenance of the licensing basis over the NPUF’s entire license term helps maintain the continuity of knowledge both for the licensee and the NRC staff and the understanding of changes and effects of changes on the facility

8. Consultations Outside the NRC

During the development of the regulatory basis for the rulemaking, the NRC staff provided the public an opportunity to comment on the draft regulatory basis (published June 29, 2012; ADAMS Accession No. ML12167A383). The NRC staff also held three public meetings that supported the development of the draft regulatory basis document and the rulemaking. These meetings were held on September 13, 2011, December 19, 2011, and June 20, 2012.

During the development of the proposed rule language, the NRC staff provided the public an opportunity to comment on the proposed rule. Specifically, the NRC staff held two additional public meetings on August 7, 2014 and October 7, 2015

In addition, the NRC published the information collection requirements contained in the proposed rule in the Federal Register to provide the public with the opportunity to comment. The NRC will respond to the public comments 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

There are no sensitive questions included in these information collections.

12. Estimate of Industry Burden and Cost

The burden associated with the information collections is given in Table 1 for one-time recordkeeping burden, Table 2 for annual recordkeeping burden, and Table 3 for annual reporting burden. All one-time burden hours are annualized in this analysis by dividing by the number of years covered by the information collection request (three years). The NRC estimates that the incremental burden on NPUF licensees to update procedures and FSARs is estimated to total 1,551 hours (93 hours one-time recordkeeping from Table 1, plus 1,409 hours annual recordkeeping from Table 2, and 49 hours annual reporting from Table 3) with an annual cost to NPUF licensees of $415,668 (1,551 hours x $268 per hour).

Of this total, approximately 6 percent (93 hours or $24,924) of the burden is attributed to

one-time activities due to the implementation of the rule requirements. Therefore, the information collection burden will decrease by 6 percent once the one-time requirements have been completed.

Table	Description	Annualized Burden Hours	Cost at $268/hr
1	One-Time Recordkeeping	93	$24,924
2	Annual Recordkeeping	1,409	$377,612
3	Annual Reporting	49	$13,132
TOTAL		1,551	$415,668

13. Estimate of Other Additional Costs

The quantity of records to be maintained is roughly proportional to the recordkeeping burden and therefore can be used to calculate approximate records storage costs. Based on the number of pages maintained for a typical clearance, the records storage cost has been determined to be equal to 0.0004 x the recordkeeping burden cost. Therefore, the annual records storage cost in Tables 1 and 2 is estimated to be $161 (0.0004 x 1,502 hours x $268/hour).

The current approved costs in ROCIS for the Part 50 information collection is $269,617. The proposed rule would increase the total additional costs to $269,778 ($269,617 + $161).

14. Estimated Annualized Cost to the Federal Government

Table 4 describes the estimated annual cost to the NRC for administration of the recordkeeping requirements related to documenting the receipt of an updated FSAR. The total estimated annual cost to the government is estimated at $7,236 (27 hours x $268/hour).

15. Reasons for Changes in Burden or Cost

The regulations in Part 50 are promulgated by the Nuclear Regulatory Commission pursuant to the Atomic Energy Act of 1954, as amended (68 Stat. 919), and Title II of the Energy Reorganization Act of 1974 (88 Stat. 1242), to provide for the licensing of production and utilization facilities. The current burden for the Part 50 information collection is 3,708,530 hours. The proposed rule would increase the burden for the Part 50 information collection by 1,551 hours, for a total burden of 3,710,081 hours (3,708,530 + 1,551). The estimate of 1,551 hours is composed of one-time and annual requirements of the proposed rule. This would result in a increased burden hour cost of $415,668 (1,551 hours x $268/hr).

The proposed rule would require licensees to update procedures as well as to update and submit FSARs every 5 years to maintain the continuity of knowledge both for the licensee and the NRC staff and the understanding of changes and effects of changes on the facility.

In addition, the proposed rule would eliminate fixed license terms for class 104a or c NPUFs, other than testing facilities. This rule change would result in future reductions in burden because affected NPUFs would no longer incur recordkeeping or reporting burdens related to the license renewal application process. However, these burden reductions are not included in burden totals as they will not occur during the clearance period (next three years).

16. Publication for Statistical Use

This information will not be published for statistical use.

17. Reason for Not Displaying the Expiration Date

The recordkeeping and reporting requirements for this information collection are associated with regulations and are not submitted on instruments such as forms or surveys.  For this reason, there are no data instruments on which to display an OMB expiration date.  Further, amending the regulatory text of the CFR 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.

2. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

Statistical methods are not used in this collection of information.

Table 1 Estimated One-Time Recordkeeping Burden
Section	Number of Recordkeepers	Burden Hours per Recordkeeper (Annualized)	Total Burden Hours (Annualized)	Total Cost at $268/hr (Annualized)
50.71(e): Updating procedures	31	3	93	$24,924
Table 1 Total	31	3	93	$24,924

Note: The burden hours per recordkeeper are based on the estimates used in the regulatory analysis for the proposed rule. The NRC burden hours in this supporting statement reflect the hours required for recordkeeping activities only, while the regulatory analysis includes hours for additional activities.

Table 2 Estimated Annual Recordkeeping Burden
Section	Number of Recordkeepers	Burden Hours per Recordkeeper	Total Annual Burden Hours	Total Annual Cost at $268/hr
50.71(e): Preparing updated FSAR (< 100 kW)	5	27	135	$36,180
50.71(e): Preparing updated FSAR (≥ 100 kW but < 1,000 kW)	9	39	351	$94,068
50.71(e): Preparing updated FSAR (≥ 1,000 kW)	13	71	923	$247,364
Table 2 Total	27*	Varies	1,409	$393,111

Note: The burden hours per recordkeeper are based on the estimates used in the regulatory analysis for the proposed rule. The NRC burden hours in this supporting statement reflect the hours required for recordkeeping activities only, while the regulatory analysis includes hours for additional activities.

* Only 27 of the 31 affected NPUFs would incur a burden related to updating and submitting FSARs during the period covered by this Supporting Statement. See the discussion in the Affected Entities section above.

Table 3 Estimated Annual Reporting Burden
Section	Number of Respondents	Responses per Respondent	Total Responses	Burden Hours per Response	Total Burden Hours	Total Cost at $268/hr
50.51(c): Burden reduction from no longer required license renewal applications	0	0	0	2,000 – 3,000	0	$0
50.71(e): Submitting updated FSAR (< 100 kW)	5	1	5	1	5	$1,340
50.71(e): Submitting updated FSAR (≥ 100 kW but < 1,000 kW)	9	1	9	2	18	$4,824
50.71(e): Submitting updated FSAR (≥ 1,000 kW)	13	1	13	2	26	$6,968
Table 3 Total	27*	1	27	Varies	49	$13,132

Note: The burden hours per response are based on the estimates used in the regulatory analysis for the proposed rule. The NRC burden hours in this supporting statement reflect the hours required for reporting activities only, while the regulatory analysis includes hours for additional activities.

* Only 27 of the 31 affected NPUFs would incur a burden related to updating and submitting FSARs during the period covered by this Supporting Statement. See the discussion in the Affected Entities section above.

TOTAL BURDEN: 1,551 hours (93 hours one-time recordkeeping (annualized) + 1,409 hours annual recordkeeping + 49 hours annual reporting) for a total cost of $415,668 (1,551 hours x $268/hr)

TOTAL RESPONSES: 58 (27 annual responses + 31 recordkeepers)

NUMBER OF RECORDKEEPERS: 31

THIRD-PARTY DISCLOSURE BURDEN: 0

Table 4 Annualized NRC Burden
NRC Action	Rule Text Provision	No. Actions/Year	Burden Hours/Action	Total Hours	Total Costs
Documenting the receipt of an updated FSAR	50.71(e)	27	1	27	$7,236
Table 4 Total			Varies	27	$7,236

1 Class 104a and c NPUFs are used for medical therapy and research and development activities. Per 10 CFR 50.51(a), NPUF license terms may be issued for up to 40 years. If the license is initially issued for a shorter period, then it may be renewed by amendment for a maximum aggregate period not to exceed 40 years. An NPUF license is usually renewed for a term of 20 years.

2 A class 103 NPUF is used for commercial or industrial purposes.

3 See the Final OMB Supporting Statement for 10 CFR part 50, “Domestic Licensing of Production and Utilization Facilities.” (3150-0011). October 2014, ICR Reference #201410-3150-005, available at: http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201410-3150-005.

4 See the Final OMB Supporting Statement for 10 CFR part 50, “Domestic Licensing of Production and Utilization Facilities.” (3150-0011). October 2014, ICR Reference #201410-3150-005, available at: http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201410-3150-005.

5 See the Final OMB Supporting Statement for 10 CFR part 50, “Domestic Licensing of Production and Utilization Facilities.” (3150-0011). October 2014, ICR Reference #201410-3150-005, available at: http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201410-3150-005.

6 See the Final OMB Supporting Statement for 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.” (3150-0021). August 2012, ICR Reference # 201208-3150-001, available at: http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201208-3150-001.

7 Non-power production or utilization facilities would be required to submit an updated FSAR to the NRC once every five years. The burden related to these submissions have been annualized in Table 2 and 3.