Final SS 10 CFR Part 110

FINAL SUPPORTING STATEMENT

FOR

10 CFR PART 110

EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL

(3150-0036)

EXTENSION

DESCRIPTION OF THE INFORMATION COLLECTION

All persons who wish to export or import nuclear equipment and material as specified in 10 CFR §§ 110.8, 110.9, and 110.9a must provide certain information collection elements to enable the U.S. Nuclear Regulatory Commission (NRC) and the Executive Branch to make required export and import licensing determinations to ensure compliance with NRC regulations and to satisfy statutory requirements of the AEA.

The information collected is pre-shipment notification data including:

• license number (as appropriate) being used,

• shipper name and contact information,

• the radionuclide(s) being shipped,

• the destination address,

• the end use,

• the proposed date of shipment, and

• the documentation that demonstrates authority to receive/possess the material being shipped.

To assist the respondent in generating and submitting the advanced notification, NRC developed optional NRC Forms 830 and 830A, “Report of Import and Continuation Sheet,” and NRC Forms 831 and 831A, “Report of Export and Continuation Sheet.” Use of the NRC forms is optional, as many respondents have developed their own forms. However submitting timely and accurate notifications is not optional.

In instances where data is missing or incorrect, staff will attempt to contact respondents to obtain the data. In some instances, enforcement action is taken to bring the respondent into compliance with the notification requirement.

A. JUSTIFICATION

1. Need for and Practical Utility of the Collection of Information

The NRC, under the Atomic Energy Act of 1954, as amended (AEA), and Title II of the Energy Reorganization Act of 1974, as amended, has authority for exercising export and import controls over nuclear equipment and material as specified in Title 10 of the Code of Federal Regulations (10 CFR), §§ 110.8, 110.9, and 110.9a. Any person who wishes to export or import nuclear equipment and material under the provisions in 10 CFR Part 110 must provide certain information collection elements to enable the NRC and the Executive Branch to make required export and import licensing determinations.

Information collections in 10 CFR Part 110 are as follows:

Section 110.7a(a) states information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commission’s regulations, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects.

Section 110.7a(b) requires that each applicant or licensee notify the Administrator of the appropriate NRC Regional Office within two working days of identifying any information that has a significant implication for public health and safety or common defense and security on a regulated activity.

Section 110.23(a)(5)(iii) states that all exports of americium are subject to the reporting requirements listed in 110.54(b).

Section 110.23(a)(6) states that all exports of neptunium are subject to the reporting requirements listed in 110.54(b).

Section 110.26(a)-(e) states that a general license is issued to any person to export certain nuclear reactor components of U.S. origin to countries listed in this part. This authorization is subject to the reporting requirements listed in 110.54(c).

Section 110.27(d) states that persons using the general license for imports of formula quantities of strategic special nuclear material (as defined in 73.2 of this chapter) under this general license shall provide the notifications required in § 73.27 and § 73.72 of this chapter.

Section 110.50(a)(8) states that a licensee shall not proceed to export or import and shall notify the Commission promptly if he knows or has reason to believe that the packaging requirements of 10 CFR Part 71 have not been met.

Section 110.50(b)(3) states that unless a license specifically authorizes the export of certain foreign-obligated nuclear material or equipment, a licensee may not ship such material or equipment until the licensee has requested and the Commission has issued an amendment to the license authorizing such shipment; or the licensee has given at least 40 days advance notice of the intended shipment in writing to the Deputy Director, Office of International Programs (OIP); and the Deputy Director, OIP has obtained confirmation, through either the Department of Energy or State, that the foreign government in question has given its consent to the intended shipment pursuant to its agreement for cooperation with the United States; and communicated this in writing to the licensee.

Section 110.50(c) states that a licensee authorized to export or import the radioactive material listed in Appendix P to 10 CFR Part 110 is responsible for notifying NRC and, in cases of exports, the government of the importing country in advance of each shipment. A list of points of contact in importing countries is available at NRC’s OIP Web site, accessible on the NRC Public Web site at http://www.nrc.gov.

NRC Form 830 “Report of Import” (and continuation sheet 830A) is a voluntary form that licensees may use to comply with the requirements of § 110.50(c) and report the import of radioactive material. NRC Form 831 “Report of Export” (and continuation sheet 831A) is a voluntary form that licensees may use to report the export of radioactive material. These forms are designed to assist licensees in complying with the reporting requirement.

Section 110.52(b) states that the Commission may require further information from a licensee to determine whether a license should be revoked, suspended, or modified.

Section 110.53(b)(1) states that each license applicant or licensee (general or specific) shall maintain records concerning its exports or imports. The licensee shall retain these records for five years after each export or import except that byproduct material records must be retained for three years after the date of each export or import shipment.

Section 110.53(b)(2) states that records which must be maintained pursuant to this part may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

Section 110.54(a) states that reports of exports of nuclear facilities and equipment, nuclear grade graphite for nuclear end use, and deuterium shipped during the previous quarter must be submitted by licensees making exports under the general license or specific license of this part by January 15, April 15, July 15, and October 15 of each year on Forms AP–M, “Exports of specified equipment and non-nuclear material” or AP–13, “Exports of specified equipment and non-nuclear material”, and associated forms, submitted to OMB by U.S. Department of Commerce, Bureau of Industry and Security, and cleared under #0694-0135. The reports must contain information on all nuclear facilities, equipment, and non-nuclear materials (nuclear grade graphite for nuclear end use and deuterium) listed in Annex II of the Additional Protocol.

Section 110.54(b) states that persons making exports under the general license established by § 110.23(a) or under a specific license shall submit by February 1 of each year one copy of a report of all americium and neptunium shipments during the previous calendar year. This report shall be submitted to the Deputy Director, Office of International Programs, at the address provided in § 110.4. The report must include a description of the material, including quantity in terabecquerels and grams, approximate shipment dates and a list of recipient countries, end users, and intended use keyed to the items shipped.

Section 110.54(c) states that persons making exports under the general license established by § 110.26(a) shall submit by February 1 of each year one copy of a report of all components shipped during the previous calendar year. This report shall be submitted to the Deputy Director, Office of International Programs, at the address provided in § 110.4. This report must include a description of the components keyed to the categories listed in Appendix A to 10 CFR Part 110, approximate shipment dates, and a list of recipient countries and end users keyed to the items shipped.

2. Agency Use of Information

The information submitted pursuant to 10 CFR Part 110 is necessary to ensure that nuclear equipment and material are being exported/imported to licensed entities, and only to the entities listed on the license. The NRC ensures the information is complete, accurate and timely.  If not, staff often contact the licensee and asks that they correct the information. A failure of any of these criteria can lead to Enforcement action.  Each record is reviewed for accuracy and filed by the licensee.  In addition, all import records subject to this requirement are reviewed and logged into an electronic spreadsheet.

The requirement of § 110.7a (a), that information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commission’s regulations, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects is essential to ensure that licensees not withhold or misrepresent material facts which could impact a license determination.

The notification requirement in § 110.7a (b) enhances the capability of the Commission to respond rapidly and effectively if such a threat were to materialize on a regulated activity.

The requirement in § 110.50(b)(3) states that unless a license specifically authorizes the export of certain foreign-obligated nuclear material or equipment, a licensee may not ship such material or equipment until the licensee has requested and the Commission has issued an amendment to the license authorizing such shipment; or the licensee has given at least 40 days advance notice of the intended shipment in writing to the Deputy Director, Office of International Programs (OIP); and the Deputy Director, OIP has obtained confirmation, through either the Department of Energy or State, that the foreign government in question has given its consent to the intended shipment pursuant to its agreement for cooperation with the United States; and communicated this in writing to the licensee.

Prior notification of shipments of radioactive materials listed in Appendix P required by § 110.50(c) is used to track this material within the U.S. and to detect any diversions of the material.

The additional information that the Commission may require from licensees as specified in § 110.52(b) is used by the NRC to make necessary statutory, regulatory, and policy determinations in connection with prospective actions to revoke, suspend or modify an export or import license.

Shipment records required by § 110.53(b) are used for NRC inspection to ensure compliance with regulations and are necessary in connection with prospective enforcement actions against possible violators of 10 CFR Part 110.

The requirement in § 110.54(b) to submit annual reports of americium and

neptunium exported under general license provide the NRC with data which the U.S. Government must report to the IAEA.

The requirement in Section 110.54(c) to submit annual reports of components exported under general license provide NRC with additional assurance against the improper accumulation of sensitive components in the country of import.

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. NRC issued a regulation on October 10, 2003 (68 FR 58791), consistent with the Government Paperwork Elimination Act, which allows 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 mandatory prior notifications under § 110.50(c) can be submitted electronically, and optional reporting forms for import and export notifications are now available from the NRC web site. All of these notifications are now being transmitted to the NRC either by telefax or e-mail. It is estimated that more than 90 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. NRC has in place an ongoing program to examine all information collections with the goal of eliminating all duplication and/or unnecessary information collections.

The Department of Energy’s (DOE) reporting requirements under 10 CFR Part 810 and the NRC’s reporting requirements under 10 CFR Part 110 are for entirely separate purposes and there is no overlap in the information that must be reported to DOE or NRC. The DOE regulations at 10 CFR Part 810, “Assistance to Foreign Atomic Energy Activities” pertain to the export of unclassified nuclear technology and assistance (provision of information or technical services) to foreign destinations. The NRC’s 10 CFR Part 110 regulates the export of actual nuclear materials, radioactive sources and/or nuclear facilities/equipment (physical commodities) to foreign destinations. NRC reporting records come from private companies that use radioactive materials. DOE’s records are derived from government-funded and licensed entities.

5. Effort to Reduce Small Business Burden

The requirements specified in 10 CFR Part 110 are the same for large and small businesses, because the proliferation and policy concerns are the same; thus, all businesses must provide the same data. The NRC staff estimates that less than 10% of all businesses subject to the information collections in this Part are small businesses.

6. Consequences to Federal Program or Policy Activities if the Collection is not

Conducted or is Conducted Less Frequently

Failure to provide complete and accurate information on all applications as specified in

§ 110.7a could result in an unreliable applicant obtaining an import or export authorization.

Failure to fully comply with § 110.7a(b) could result in a licensee not providing information that has significant implications for public health and safety or common defense and security.

Failure to fully comply with §§ 110.8, 110.9, and 110.9(a) could result in unauthorized and unregulated import or export of material and equipment subject to NRC licensing jurisdiction.

If the collection in § 110.50(a)(8) is less frequent, the licensee could possibly ship improperly packaged nuclear materials which may endanger the health and safety of the public.

If the collection in § 110.50(b)(3) is less frequent, the U.S. Government might violate the provisions of U.S. bilateral agreements with other Governments. The report is not frequently required because the origin of the material is normally identified before the export license is issued, and, accordingly, is authorized for export on the face of the license.

The records maintained in § 110.53 are largely common business records and do not contain any special requirements; therefore, the regulatory impact is minimal. If the information is provided less frequently, the NRC would be unable to verify compliance with requirements in a timely manner.

The reporting requirements in § 110.54 provide trade statistics for strategic exports and support international obligations to report certain exports under general license

authorizations. The information requested in § 110.54(b) must be collected on a yearly

basis to comply with a U.S. Government reporting commitment to the IAEA. The reporting requirement in § 110.54(c) is reasonable and less burdensome on exporters than submitting specific license applications.

7. Circumstances Which Justify Variation from OMB Guidelines

The reason for retaining records for five years for each export or import except for byproduct material, where records shall be retained for three years, is that these exports or imports are relatively more important with respect to nuclear nonproliferation.

Requiring the applicant or licensee to notify the Commission within two days of identifying information having a significant implication for public health and safety or common defense and security on a regulated activity enables the Commission to respond rapidly and effectively to a threat to the public health and safety or the common defense and security. This collection requirement is contained in other parts of NRC's regulations. No notifications are expected.

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 July 1, 2015 (80 FR 37669). In addition, five active NRC licensees (ATI Wah Chang d/b/a Speciality Alloys, Halliburton Energy Services, QSA Global, Inc., International Isotopes, Inc., and Industrial Nuclear Company) also received copies of this Supporting Statement as part of the public consultation process via email. No comments were received.

9. Payment or Gift to Respondents

Not applicable.

10. Confidentiality of the 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

Not applicable.

12. Estimated Burden and Burden Hour Cost

There are approximately 136 record keepers for exporters/importers of nuclear material and equipment. The following table illustrates how many burden hours are used for reporting and recordkeeping:

Activity	Reg Section	No. of Respondents	Responses	Hrs per response	Total Hrs
Notification that Package requirements have not been met	110.50(a)(8)	1	1	0.5	0.5
Submitting an amendment authorizing a shipment; submitting an advanced notice and filing the written confirmation	110.50(b)(3)	1	15	1	15
Submitting an Advanced Shipment notification using no form	110.50(c)	39	195	.3	59
Submitting an Advanced Shipment notification using Custom form	110.50(c)	15	88	.2	264
Submitting an Advanced Shipment notification using NRC Form 830, 830i, 831, or 831i	110.50(c)	12	1200	0.2	240
Time spent conferring with licensing staff and possibly responding to an Enforcement action	110.50(c)	10	20	5	100
Additional information from licensee to determine if license should be suspended or revoked	110.52(b)	1	1	0.5	0.5
Annual report of Americium and Neptunium shipments	110.54(b)	28	28	2	56
Annual report of nuclear component shipments	110.54(c)	29	29	2	58
TOTAL		136			793

The estimated annual burden for this collection is 929 hours (793 hours reporting and 136 hours recordkeeping). The total cost for the collection is $259,191 (929 hours x $279.00/hr). See tables 1 – 3 for a detailed breakdown of licensee burden for each requirement under Part 110.

13. Estimate of Other Additional Costs

For licensees subject to 10 CFR Part 110, it is most likely that any purchases of equipment and services were made before October 1, 1995, in order to achieve regulatory compliance with requirements not associated with this information collection, for reasons other than to provide information or keep records for the government, or as part of customary and usual business or private practices.

NRC estimates that the storage and equipment costs for licensees subject to this information collection are approximately $22.50 per license, based on a rate of $45.00 per square foot of filing space. The recordkeeping burden is roughly proportional to the quantity of records to be maintained. Based on the number of active licenses issued annually, the total annual records storage cost is estimated to be equal to the per license rate of ($22.50) x (136 record keepers) x (an average of 1.16 licenses issued per year per record keeper) x (5 years of required record retention) or $17,748.00.

14. Estimated Annualized Cost to the Federal Government

The collection of information under 10 CFR Part 110 requires approximately 101.5 NRC professional staff hours per year to investigate, review and take action on the reported information associated with the collections referred to above. The annual labor cost to the Federal Government at an average of $279.00 per staff hour for reactor and materials licensees is $28,319.00 (101.5 hours x $279.00). The costs for OMB 3150-0036 are recovered fully through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and 171. Table 4 summarizes costs to the NRC for processing information under this collection.

15. Reasons for Changes in Burden or Cost

The estimated annual public burden increased by 149 hours from 780 hours up to 929 hours, while annual responses increased by 347 responses, from 2,598 responses to 2,945 responses. There have been no changes to the requirements under 10 CFR Part 110 that would affect public burden. Furthermore, no change was made to the estimated hours per response, whether or not an NRC form or a custom form was used for submitting notices. NRC increased the estimated number of annual responses in the table to reflect an increase in annual activity subject to the notification requirement. The table of data was also expanded to identify the burden associated with the use of custom reporting forms for notices, the typical practice used by most Ir-192 licensees. These respondents account for the greatest number of annual responses, and essentially expend the same per-response public burden as the respondents who submit notices on the NRC forms. Notices on non-standard forms are typically submitted by licensees with fewer transactions. These notices are not custom-designed, and usually contain other unrelated data. Most respondents use non-standard forms, but they report much less frequently than those that use either custom forms or NRC forms. The number of individual respondents increased from 108 to 136 from the last clearance cycle.

The primary reason for the increase in responses is due to an adjustment in the number of export and import transactions subject to the notification requirement. Use of the NRC notification forms is also increasing. As a result, the number of respondents using neither the NRC form nor a custom form is decreasing. Most of these respondents export and import radioisotopes with longer half-lives such as Am-241 (432.7 years) and Cs-137 (30 years) and therefore, require fewer notifications. As a result, there is less incentive for these respondents to develop a custom form for their notification requirements. On the other hand, respondents that export and import radioisotopes with shorter half-lives such as Ir-192 (74 days) and Se-75 (120 days) make many more shipments and benefit from development of custom forms and automated notification capabilities. The NRC notification forms only became available years after the notification requirement was implemented. As a result, respondents are reluctant to adopt use of the form as it would be of no benefit. However, new respondents prefer to use NRC forms, as they serve as a template for the required data elements and therefore, reduce errors.

Lastly, the NRC has increased the follow-up time from 15 minutes to 5 hours for each of 20 annual responses to account for time spent resolving or clarifying omitted information submitted on the advanced notification of shipments.  The NRC may require licensees to obtain additional or corrected information and re-submit the corrected information to the Headquarters Operations Office or the Office of International Programs.  The corrections might require licensees to search for or request documentation from foreign regulators to prove authorization to export radioactive materials.  In some cases, NRC takes enforcement action with a licensee, requiring the licensee to respond to a Notice of violation. This may require the licensee to develop and document corrective actions taken or to be taken to prevent recurrence in the future, re-train personnel, or submit a written response to the Office of Enforcement. In some cases, licensees may hire consultants and attorneys to assist them in properly addressing our concerns.

The cost increase also reflects an increase in the annual labor cost for reactor and materials licensees from $274.00 to $279.00 per hour.

There has been no regulatory changes made that would result in a change in the information being collected. Furthermore, there are no plans to make any changes to the NRC forms used to obtain the information.

16. Publication for Statistical Use

NRC does not perform statistical analysis of the submissions. The records are reviewed for accuracy and compliance with the regulation. The records are not published or made public.

17. Reason for Not Displaying the Expiration Date

The NRC displays the expiration date of the collection of information on the forms used for submitting notifications of exports and imports subject to this requirement. The annual reporting requirement has no forms, and 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.

TABLE 1.

ANNUAL REPORTING BURDEN

Section	Description	Number of Respondents	Responses per Respondent	Responses	Burden Per Response	Burden Hours	Cost at $279/hr
110.7a(a)&(b)	Accuracy of data and requirement to notify NRC of substantive changes affecting public health and safety	0	0	0	0.25	0	$0
110.23(a)(5)(iii)	Respondents exporting americium must also comply with annual reporting requirements in 10 CFR 110.54(b)	Included in 110.54(b)
110.23(a)(6)	1- Establishes per shipment, per country and per year limitations on shipments of neptunium, and; 2- respondents exporting neptunium must also comply with annual reporting requirements in 10 CFR 110.54(b)	Included in 110.54(b)
110.26(a)-(e)	Describes scope of the general license for exports of nuclear reactor components and the annual reporting requirement	Included in 110.54(c)
110.50(a)(8)	Requirement to notify the Commission if they believe packaging requirements of part 71 have not been met	1	1	1	0.5	0.5	$ 140
110.50(b)(3)	Procedures for exports with foreign obligations attached to the material	1	1	15	1	15	$ 4,185
110.50(c) - no form	Identifies the data elements and timing of submitting advanced notifications of shipments	39	5	195	0.3	59	$16,461
110.50(c) - Custom form		15	88	1320	0.2	264	$73,656
110.50(c) - with NRC forms1		12	100	1200	0.2	240	$66,960
110.50(c) - add'l follow-up	Identifies addition time needed to correct incomplete notifications or to take enforcement action	10	2	20	5	100	$27,900
110.52(b)	For instances when respondents must provide additional information in order to determine if a license should be suspended or revoked.	1	1	1	0.5	0.5	$ 140
110.54(b)	Describes data elements required and due date of the annual reporting requirement for shipments of americium and neptunium	28	1	28	2	56	$15,624
110.54(c)	Describes data elements required and due date of the annual reporting requirement for shipments of nuclear components and equipment	29	1	29	2	58	$16,182
TOTAL		136		2,809		793	$221,247

TABLE 2.

ANNUAL RECORDKEEPING BURDEN

Section	Description	Number of Record keepers	Hours per Record keeper	Burden Hours	Cost at $279/hr
110.53(b)(1)&(2)	(1)- Describes record retention periods, and (2)-describes record storage methods and reproduction capabilities	136	1	136	$ 37,944

TABLE 3

ANNUAL LICENSEE BURDEN TOTALS

	Responses	Hours	Cost at $279/hr
Reporting	2,809	793	$ 221,247
Recordkeeping	136	136	$ 37,944
TOTAL	2,945	929	$ 259,191

TABLE 4.

COSTS TO THE FEDERAL GOVERNMENT

Section	Description	Number of Respondents	Responses per Respondent	Responses	Time Per Response	Hours	Cost at $279/hr
110.7a(a)&(b)	(a)- Time required to evaluate completeness of an application; (b)- Time required to evaluate information provided by a respondent as having a significant implication for public health and safety or common defense and security.	0	0	0	0.25	0	$ -
110.50(a)(8)	Time required to investigate licensee’s claim that packaging requirements of Part 71 have not been met.	1	1	1	0.5	0.5	$ 140
110.50(b)(3)(i)	Time required to obtain interagency confirmation that the foreign government of import has given its consent to the intended shipment pursuant to its agreement for cooperation with the U.S. and communicate this in writing to thhe licensee	1	1	1	1	1	$ 279
110.50(c)- no form	Time required to evaluate advanced notification of shipment submitted by a licensee who provides the information without using a form or in an otherwise easy to read format	39	5	195	0.025	5	$ 1,395
110.50(c)- Custom form	Time required to evaluate advanced notification of shipment submitted by a licensee who provides the information on a form of their own design	15	88	1,320	0.02	27	$ 7,533
110.50(c)- with NRC forms	Time required to evaluate advanced notification of shipment submitted by a licensee who provides the information using an NRC notification Form 830 or 831	12	100	1,200	0.02	24	$ 6,696
110.50(c)- add'l follow-up	Time required to evaluate advanced notification of shipment submitted by a licensee who provides incomplete or conflicting information. Some of these result in enforcement action.	10	10	100	0.2	20	$ 5,580
110.52(b)	Time required to request and evaluate additional information to determine whether a license should be revoked, suspended or modified	1	1	1	1	1	$ 279
110.54(b)	Time required to review an annual report of exports of americium and neptunium made under the general license in 10 CFR 110.23 compliance with this requirement.	28	1	28	0.2	6	$ 1,674
110.54(c)	Time required to review an annual report of exports of nuclear reactor components made under the general license in 10 CFR 110.26 for compliance with this requirement.	29	1	29	0.1	3	$ 837
TOTAL		136		2,875		87.5	$24,413

1 110.50(c) requires licensees exporting radioactive material listed in Appendix P to notify both the NRC and the government of the importing country in advance of each shipment. The licensee fulfills this responsibility by emailing the NRC and copying the importing country on the message. Because this is a single notification sent to two entities, no additional third party burden has been included in this collection. All burden for these notifications is captured as reporting burden under 110.50(c).

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