Part 110 Update: "Export and Import of Nuclear Equipment and Material: Updates and Clarifications" (RIN 3150-AI16) Effective August 27, 2010
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Overview
On July 28, 2010, the NRC published a final rule in the Federal Register (75 FR 44072) that updates, clarifies, and corrects several provisions in Part 110 to improve NRC's regulatory framework for the export and import of nuclear equipment, material, and radioactive waste. The final rule also clarifies and corrects the regulations addressing the general license for the export of byproduct material (10 CFR §110.23). In addition, the final rule amended the regulations governing the export and import of Category 1 and 2 quantities of materials listed in Appendix P to Part 110 and the definition of "radioactive waste" in Part 110. This rule is effective on August 27, 2010. A summary of the most significant changes follows:
Category 1 and 2 Quantities of Radioactive Material Listed in Appendix P to Part 110
On July 1, 2005, the NRC published a final rule that amended 10 CFR Part 110 to take into account provisions of the International Atomic Energy Agency (IAEA) Code of Conduct on the Safety and Security of Radioactive Sources (Code of Conduct), and the supplemental IAEA Guidance on the Import and Export of Radioactive Sources. These requirements became effective on December 28, 2005. Since these new requirements have been implemented, the NRC has reevaluated the need for a specific license for the import of IAEA Category 1 and 2 quantities of radioactive material to a U.S.-licensed recipient or user in light of enhancements made to the NRC's domestic regulatory framework. As a result, the NRC is amending 10 CFR Part 110 to allow imports of Category 1 and 2 quantities of materials listed in Appendix P under a general license.
Specifically, this final rule revised § 110.27(f) by removing the specific license requirement for imports of radioactive material listed in Table 1 of Appendix P to 10 CFR Part 110. Conforming changes are made to §§ 110.32, 110.43, and 110.50. Imports of radioactive material into the United States continue to be contingent on the consignee being authorized to receive and possess the material under a general or specific NRC or Agreement State license. See § 110.27(a). Moreover, importers of Category 1 and 2 materials under a general license are still subject to the notification requirements prior to shipment as required by § 110.50. Section 110.50 (c) is revised to require advance notifications of imports to be submitted seven days in advance of shipment. This change permits NRC staff adequate time to verify the information provided in the advance notification. Previously, the pre-shipment notification was at least seven days in advance of each shipment, to the extent practical, but in no case less than 24 hours in advance of each shipment. Additionally, the advance notification requirements for imports of Category 1 and 2 quantities of material in § 110.50 (c) now requires the exporting facility name, location, address, contact name and telephone number as part of the pre-shipment notification.
Under the 2005 rule, at the time of the license application, for both Category 1 and Category 2 exports, the applicant for the export license is required to provide the NRC with pertinent documentation demonstrating that the recipient of the radioactive material has the necessary authorization under the laws and regulations of the importing country to receive and possess the material. For Category 2 exports, the NRC waived this requirement for a number of licensees to allow the exporter to provide this authorization at the time of notification of shipment instead of at the time of the application. This waiver is consistent with the Code of Conduct and supplemental Guidance, under which the authorization from the importing country can be verified by the exporter of Category 2 material if permitted by the licensing agency. This final rule amends § 110.32 to allow the export licensee (for Category 2 material only) to verify the authorization from the importing country at the time of shipping instead of at the time of the license application. The regulations continue to require licensees to send copies of the authorizations to the NRC.
Export and Import of Radioactive Waste
This final rule revises the definition of radioactive waste and incorporates aspects of the removed definition of incidental radioactive material (IRM). The revised definition of "radioactive waste" improves consistency with and eliminates differences between the licensing requirements for export and import and the domestic licensing requirements for possession. The revised definition links the specific license requirement for the export and import of radioactive waste to those materials (in the form of waste) that require a specific license in accordance with NRC's domestic regulations. This eliminates the need for a specific license to export or import materials that, under NRC's regulations in 10 CFR Chapter 1, do not require a specific license to possess them.
This final rule requires a specific export or import license for any material that requires a specific NRC license to possess domestically, in accordance with the requirements in 10 CFR Chapter 1, that is exported or imported for the purposes of (1) disposal in a land disposal facility as defined in Part 61, a disposal area as defined in Appendix A to Part 40, or an equivalent facility; or (2) recycling, waste treatment or other waste management process that generates radioactive material for disposal in a land disposal facility as defined in Part 61, a disposal area as defined in Appendix A to Part 40, or an equivalent facility. This change simplifies the regulatory framework by clearly stating that exporting or importing material for recycling, waste treatment, or other waste management process that generates radioactive material for disposal in a Part 40 or Part 61 facility (or the equivalent) would require a specific export or import license.
This rule also deletes the definition of "incidental radioactive material" (IRM) from 10 CFR Part 110. This change clarifies the scope of "radioactive waste" and addresses confusion created by the definition of IRM. While the definition of IRM is deleted, the rule does incorporate aspects of IRM into the revised definition of radioactive waste and the exclusions from that definition. For example, the scope of the exclusion related to contamination on service equipment (including service tools) used in nuclear facilities (if the service equipment is being shipped for use in another nuclear facility and not for waste management purposes or disposal) is expanded and broadened to include some of the material that fell under the definition of IRM such as launderable protective clothing.
Under the final rule, the three exclusions to the previous definition of "radioactive waste" are retained, with some modifications, and three new exclusions are added. The six are set forth below:
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Radioactive material in sealed sources or devices containing sealed sources that are of U.S. origin and being returned to any manufacturer, distributor or other entity which is authorized to receive and possess them. This change allows the return of U.S. origin sources or devices to distributors and other appropriately authorized entities. A specific import license is required for the importation of sources (devices containing sealed sources) originating outside of the United States for disposal in the United States. Licensing and notification requirements for Category 1 and Category 2 quantities of material listed in Table 1 of Appendix P are applicable.
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A contaminant on any non-radioactive material (including service tools and protective clothing) used in a nuclear facility (an NRC- or Agreement State-licensed facility (or equivalent facility) or activity authorized to possess or use radioactive material), if the item is being shipped solely for recovery and beneficial reuse of the non-radioactive component in a nuclear facility and not for waste management purposes or disposal. The scope of the exclusion is expanded and broadened to include some of the material that previously fell under the definition of IRM such as launderable protective clothing. Other examples of materials meeting this exclusion include:
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Importing contaminated metal for the purpose of recovery of the non-radioactive metal for beneficial reuse as shield blocks or other industrial/construction purposes in licensed facilities domestically and abroad is an import not "solely" for waste management or disposal purposes. This example is within the scope of exclusion two even though the recycling process will produce some waste that may require disposal at a Part 61 disposal site. This is similar to the laundering of protective clothing, which also may have a waste stream to a Part 61 facility.
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Decontamination and repair of contaminated equipment such as pumps, valves, and motors that after recovery would be beneficially reused in a licensed facility.
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Decontaminating shipping containers used to import radioactive material for the purpose of reusing the shipping containers.
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Importing contaminated magnesium metal and using the recovered magnesium as a neutralizing agent for disposing of mixed waste in a licensed disposal facility.
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Materials exempted from regulation by the NRC or equivalent Agreement State regulations. This exclusion is consistent with the previously mentioned revision that links the requirement for a specific import or export license for radioactive waste to the specific licensing requirements in 10 CFR Chapter 1 (e.g., Parts 30, 40, and 70). This change eliminates some of the differences between NRC's export and import regulations and domestic regulation of the same material or equipment.
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Materials generated or used in a U.S. Government waste research and development testing program under international arrangements.
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Materials being returned by or for the U.S. Government or military to a facility that is authorized to possess the material. This exclusion recognizes that the U.S. Government or military will, in certain circumstances, seek to return material to the United States. Material returned must be to a facility that is authorized to possess the material.
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Materials imported solely for the purposes of recycling and not for waste management or disposal where there is a market for the recycled material and evidence of a contract or business agreement can be produced upon request by the NRC. This exclusion was added to address concerns regarding the legitimate recycling of radioactive material that might otherwise be seen as waste. For example, under certain circumstances, this exclusion would permit the import under general license of depleted uranium for use in shielding applications or catalyst manufacturing.
General License for the Export of Byproduct Material
Our experience implementing the requirements in § 110.23, General license for the export of byproduct material, has demonstrated the need to revise this section in order to clarify the requirements and to address inconsistencies inadvertently resulting from prior changes made to the section in 1994 (September 26, 1994; 59 FR 48994) and 2000 (November 22, 2000; 65 FR 70287). A complete discussion of the regulatory history of this section can be found in Statements of Consideration for the proposed rule.
Prior to 1994, a general license was issued to any person to export any byproduct material, except for tritium, polonium-210, neptunium-237, and americium-241, to any country not listed in § 110.28 (embargoed destinations). In 1994, the NRC revoked the general license for Nuclear Supplier Group (NSG)-controlled alpha-emitters and International Atomic Energy List of the Coordinating Committee on Multilateral Export Controls (COCOM)-controlled transuranic isotopes. The NRC established a new general license authorizing the export of the specified alpha-emitting radionuclides to countries which are members of the NSG and authorizing the export of the specified alpha-emitting radionuclides to most other countries when in a device, or in a source for use in a device, containing less than 3.7 x 10-3 terabequerels (TBq) (100 millicuries (mCi)) of alpha activity per device or source. (10 CFR Part 71, Appendix A, provides specific activities in terabequerels per gram and in curies per gram.) The alpha-emitting radionuclides added to § 110.23 (a)(2) in 1994 were:
Actinium-225
Actinium-227
Californium-248
Californium-250
Californium-252
Curium-240
Curium-241
Curium-242
Curium-243
Curium-244
Einsteinium-252
Einsteinium-253
Einsteinium-254
Einsteinium-255
Fermium-257
Gadolinium-148
Mendelevium-258
Polonium-208
Polonium-209
Polonium-210
Radium-223
The NRC also revoked the general license and began requiring specific licenses for exports of americium-242m, californium-249, californium-251, curium-245, and curium-247 (transuranic isotopes) to conform NRC's regulations with the COCOM control list.
At the final rule stage, curium-246 was added to § 110.23(a)(1) (1994) which had the effect of restricting the general license for curium-246 to a specified activity level. It appears that this restriction was in error. Curium-246 is not on the NSG-control list or the COCOM-control list. Further, there is no discussion in the final rule (or the proposed rule) in 1994 of restricting the general license for curium-246 at a specified activity level. Therefore, this rule removes the limitation on the use of a general license for export of curium-246. Curium-246, at any activity level, can be exported under a general license to any country not listed in § 110.28 (embargoed destination).
As a result of the 2000 amendments, the NSG-controlled and COCOM-controlled radionuclides were merged into § 110.23(a)(2) (2000). Americium-241 and neptunium-237 were included in this section even though they were not NSG- or COCOM-controlled. As a result of the 2000 amendments, all of the radioisotopes listed in that section could be exported under a general license up to 3.7 x 10-3 TBq (100 millicuries).
In this rule, new § 110.23(a)(2) contains the requirements for COCOM-controlled radionuclides and new § 110.23(a)(4) contains the general license for the NSG-controlled alpha-emitting radionuclides.
The general license authorizing exports of americium-241 is also revised. In 2000, when § 110.23 was clarified for ease of reading, americium-241 (and neptunium-237) were included in the "merged" list of NSG- and COCOM-controlled radionuclides even though they were not NSG- or COCOM-controlled (see § 110.23(a)(2) (2000)). The effect of the 2000 amendments was to restrict the general license for exports of americium-241 to 3.7 x 10-3 TBq (100 mCi). Prior to the changes in 2000, there were no activity restrictions on exports to countries not listed in §§ 110.29 (restricted destinations) and 110.28 (embargoed destinations). Americium-241 exports under a general license could not exceed 3.7 x 10-2 TBq (one curie) per shipment or 3.7 TBq (100 curies) per year to any one country listed in § 110.29. For exports to § 110.29 (restricted) countries that exceeded the limit above, the americium-241 must be contained in petroleum exploration or industrial process control equipment in quantities not exceeding 0.74 TBq (20 curies) per device or 7.4 TBq (200 curies) per year to any one restricted country.
In 2005, the Commission published a final rule that conformed NRC's export and import regulations to the provisions of the IAEA Code of Conduct and supplemental Guidance (July 5, 2005; 70 FR 37985). The specific radioactive material and quantities added by this rule are listed in Table 1 of Appendix P to 10 CFR Part 110. Americium-241 is one of the materials listed in this table. As a result of the 2005 rule, an NRC specific license was required to export (and import) these radioactive materials at IAEA Code of Conduct Category 2 and above quantities. For americium-241, the Category 2 threshold limit was set at 0.6 TBq (16 Ci). As part of the 2005 rulemaking, changes were made to the general license for americium-241 in an effort to conform it to the threshold for americium-241 in Table 1 of Appendix P.
This final rule removes americium-241 from § 110.23 (a)(2) and rewrites the general license authorizing exports of americium-241 in § 110.23(a)(5) to address the inconsistencies inadvertently resulting from prior changes to the section. A specific license is required for exports that exceed the Appendix P thresholds for americium-241.
Likewise, the general license for the export of neptunium-237 is revised to address inconsistencies resulting from prior rule changes. Under this rule the general license for the export of neptunium-237 authorizes shipments that do not exceed one gram for individual shipment and do not exceed a cumulative total of 10 grams per year to any one country. The general license is found in § 110.23(a)(6).
As part of this rulemaking, the NRC also reexamined the general license authorizing exports tritium. Several editorial changes were made to the general license in an effort to make it more readable. Over the years, the various restrictions prohibiting use of general license for exports of tritium had been merged into a single subparagraph – § 110.23 (a)(6). In this final rule, the general license authorizing exports of tritium has been divided into four sections, § 110.23(a)(8)(i) through (a)(8)(iv), for clarity.
Supporting Documents
Section-by-Section Analysis
110.1 • 110.2 • 110.6 • 110.7 • 110.7a • 110.10 • 110.11 • 110.19 • 110.20 • 110.21 • 110.22 • 110.23 • 110.24 • 110.26 • 110.27 • 110.30 • 110.31 • 110.32 • 110.40 • 110.41 • 110.43 • 110.44 • 110.45 • 110.50 • 110.51 • 110.53 • 110.54 • 110.60 • 110.70 • 110.80 • 110.81 • 110.82 • 110.112 • Appendix L
Section 110.1, Purpose and scope. This final rule removes paragraph (b)(1) and the remainder of paragraph (b) is renumbered accordingly. Paragraph (b) is clarified regarding the regulation of U.S. Munitions List nuclear items.
Section 110.2, Definitions. This final rule revises the definitions for Agreement for Cooperation, Atomic Energy Act, Classified Information, Conversion facility, Depleted uranium, Effective kilograms of special nuclear material, Embargoed, Executive Branch, General license, Heels, Medical isotope, Natural uranium, Non-Nuclear Weapons State, NRC Public Document Room, Obligations, Person, Physical security, Production facility, Radioactive waste, Radiopharmaceutical, Recipient Country, Restricted destinations, and Specific license. The revision to the definition of radioactive waste is discussed in detail in Section I.B of this document. The definitions for Bulk material, Low-level waste compact, and Nuclear Suppliers Group are added for clarification purposes. In addition, this final rule removes the definition of Incidental radioactive material.
Section 110.6, Retransfers. This final rule adds language clarifying the scope of the provisions to be consistent with the requirements of the Atomic Energy Act. Paragraph (b) is amended to update the address for the Department of Energy.
Section 110.7, Information collection requirements: OMB approval. This final rule restructures the section for clarification and makes a minor editorial change.
Section 110.7a, Completeness and accuracy information. This final rule makes an editorial change to paragraph (b).
Section 110.10, General. This final rule amends paragraph (c) to clarify that an exemption does not relieve any person from complying with the regulations of other U.S. Federal and/or State government agencies.
Section 110.11, Export of IAEA safeguards samples. This final rule makes editorial changes.
Section 110.19, Types of licenses. This final rule removes paragraph (b) which relates to exports of incidental radioactive material. This final rule also amends paragraph (a) by removing the last sentence regarding compliance with other applicable regulations, and the paragraphs designation. The requirement that general and specific licensees are subject to other applicable laws or regulations is addressed in §110.50(a).
Section 110.20, General license information. This final rule removes references to "incidental radioactive material" and corrects citations in paragraph (a). Paragraph (d) is amended to preclude use of generally licensed material in any illegal or inappropriate activity such as use in a radiological dispersion device, diversion of material or equipment, and other malicious acts.
Section 110.21, General license for the export of special nuclear material. This final rule removes the general license provision related to the export of incidental radioactive material in paragraph (e) and makes editorial changes to paragraphs (a), (b), and (c).
Section 110.22, General license for the export of source material. This final rule deletes paragraph (c), makes editorial changes, corrects internal reference errors in the section, and adds a reference to paragraph (d) to the text of paragraph (e). Paragraph (c) is removed because it repeats rule text found in §110.21(b)(3). The final rule also removes the general license provision related to the export of incidental radioactive material in paragraph (g).
Section 110.23, General license for the export of byproduct material. This final rule makes editorial and organizational changes to clarify what materials are authorized for export under a general license. The reporting requirements in paragraph (b) for exports of americium and neptunium are moved to §110.54, Reporting requirements.
Section 110.24, General license for the export of deuterium. This final rule makes editorial changes to clarify the text in order to improve readability.
Section 110.26, General license for the export of nuclear reactor components. This final rule restructures paragraph (a) to clarify that the general license authorizes exports of components of U.S. origin. In response to a comment received on the proposed rule, a clarifying note is added at the end of §110.26 regarding "U.S. origin". The text of paragraph (a)(1) is incorporated into the introductory text of paragraph (a). Paragraphs (a)(2) and (a)(3) are redesignated as (a)(1) and (a)(2), respectively. New paragraph (a)(2) is revised to allow a component to be returned to the United States after final fabrication or repair or to be used in a nuclear power or research reactor in one of the destinations listed in the section. This allows, for example, a component that was sent to Japan for final fabrication or repair to be sent to Spain for use in a nuclear power or research reactor in that country. The list of destinations previously contained in paragraph (a) are now in the new paragraph (b) of this final rule. Subsequent paragraphs are renumbered accordingly.
New paragraph (b) is revised to include additional destinations to which exports may be sent under a general license. These destinations are Cyprus, Estonia, Hungary, Malta, Poland, Slovak Republic, and Slovenia. The United States has received broad generic assurances from EURATOM which also apply to these new EURATOM member countries for purposes of section 109b. of the Atomic Energy Act.
The reporting requirements contained in paragraph (d) for exports of reactor components are moved to § 110.54, Reporting requirements, in this final rule.
Section 110.27, General license for imports. This final rule removes paragraphs (a)(1) and (a)(2). NRC's import regulations do not apply to DOE imports of source, special nuclear, or byproduct material including imports conducted on DOE's behalf by DOE contractors. Paragraph (a)(2) is removed because a general license is not required for the import of byproduct, source, or special nuclear material when that same material is exempt from NRC domestic licensing requirements. This change clarifies that material that is exempt or else not subject to domestic licensing requirements (e.g., § 31.18 and § 40.13) does not require a general or specific import license unless otherwise mandated in Part 110.
Paragraph (b) is revised to clarify that the 100 kilograms per shipment limit only applies to the material and does not include the weight of the container. As revised, this paragraph states that the general license in paragraph (a) does not authorize the import of more than 100 kilograms per shipment of source and/or special nuclear material in the form of irradiated fuel.
This final rule revises paragraph (f) by removing the specific license requirement for imports of radioactive material listed in Table 1 of Appendix P to Part 110 and referencing the advance notification requirement in §110.50.
Section 110.30, Members of the Nuclear Suppliers Group. This final rule updates the list of Nuclear Suppliers Group members by adding China, Croatia, Estonia, Iceland, Kazakhstan, Lithuania, and Malta.
Section 110.31, Application for a specific license. The final rule amends this section to require requests for an exemption from a licensing requirement to be filed on NRC Form 7. This is consistent with NRC regulations that require all licensing requests (e.g., exports, imports, amendment, and renewal applications) to be made using NRC Form 7. See 71 FR 19102; April 13, 2006.
This final rule also requires a request for an exemption from a licensing requirement to be accompanied by the appropriate fee in accordance with the fee schedules in §§170.21 and 170.31. This change is consistent with the Fiscal Year 2007 NRC Fee Rule which established a flat fee for requests for exemptions from the NRC's export and import licensing requirements. See 72 FR 31402; June 6, 2007. This change updates Part 110 to reflect recent changes to the fee schedule in 10 CFR Part 170.
Additionally, this final rule adds a signature requirement to §110.31 that each application submitted on NRC Form 7 must be signed by the applicant or licensee or a person duly authorized to act for and on behalf of the applicant or licensee. This change is consistent with requirements related to applications for specific licenses in other parts of the NRC's regulations. It also clarifies that a signature is required to certify the veracity of information submitted to the agency on the NRC Form 7.
Finally, the order of paragraphs (b) and (c) is reversed so that §110.31 flows in a more logical manner where the requirement for an application for a specific license to export or import or a request for an exemption from a licensing requirement precedes the requirement that such an application or request be accompanied by the appropriate license fee. In paragraph (b), as revised, "combined export/import" is removed to be consistent with the proposal to allow imports of Category 1 and 2 materials listed in Table 1 of Appendix P of Part 110 under general license.
Section 110.32, Information required on an application for a specific license/NRC Form 7. This final rule change to paragraph (b) to clarify that the name and address of any other party, including the supplier of the equipment or material, if different from the applicant, must be provided on the application. Paragraphs (f)(1) and (f)(2) are amended for consistency purposes. Specifically, for the export of nuclear equipment to a foreign reactor, a license application will include the name of the facility so the NRC will know whether Executive Branch review is required, per §110.41(a)(7).
This section is also amended to clarify that applicants for the import of radioactive waste must provide the classification of that waste as defined in 10 CFR 61.55 when the waste is being imported for direct disposal. If the waste is being imported for treatment or management at an NRC- or Agreement State-licensed waste processor, classification, as defined in 10 CFR 61.55, is not required. Rather, a detailed characterization (physical and chemical characteristics) of the waste being imported for treatment or management must be provided in the application.
Paragraph (g) is deleted to conform to the change that allows Category 1 and Category 2 quantities of radioactive materials to be imported under a general license. This change is discussed in more detail in the section-by-section analysis for §110.27.
Paragraph (h) is redesignated as new paragraph (g) and allows the exporter of Category 2 quantities of material listed in Table 1 of Appendix P to provide the pertinent documentation that the recipient of the material has the necessary authorization under the laws and regulations of the importing country to receive and possess the material to the NRC at least 24 hours prior to the shipment. The requirement that the applicant for a Category 1 export license provide the NRC, at the time the application is submitted, with pertinent documentation demonstrating that the recipient of the radioactive material has the necessary authorization (usually in the form of a license) under the laws and regulations of the importing country to receive and possess the material remain unchanged.
Section 110.40, Commission review. This final rule amends this section to reduce the number of export license applications that require Commission review, and instead focuses Commission review on the export license applications that raise significant policy issues. For example, mandatory Commission review of export applications for nuclear grade graphite for nuclear end use and 1,000 kilograms or more of deuterium oxide are no longer required unless the export raises an important policy issue. This change also increases the proposed export of one effective kilogram of high-enriched uranium, plutonium or uranium-233 to five effective kilograms for mandatory Commission review. The change mandates Commission review of import license applications that raise significant policy issues. Significant policy issues include, but are not limited to, the proposed initial decision on whether to issue a license with special limitations to a country, or the proposed decision on issuance of a license covering a facility where major safety or security issues have been recently raised. If the staff is uncertain whether a license application raises a significant policy issue, the license application should receive Commission review. However, any export that is subject to special limitations as determined by the staff or the Executive Branch will considered one that raises a significant policy issue and will continue to require Commission review. By focusing on policy issues, this change increases efficiency and reduces fees on routine NRC export applications. This final rule also adds a requirement for Commission review of export applications of material listed in Table 1 of Appendix P to Part 110 involving exceptional circumstances, as defined in §110.42, or Category 1 quantities of material to any country listed in §110.28.
Section 110.41, Executive Branch review. The final rule makes a minor editorial change and requires Executive Branch review of exports raising significant policy issues, including exports of radioactive material listed in Table 1 of Appendix P to Part 110 involving exceptional circumstances, as defined in §110.42. Also, the export of radioactive material listed in Table 1 of Appendix P to any country listed in §§ 110.28 or 110.29 requires the review of the Executive Branch in accordance with § 110.41(a)(9).
Section 110.43, Import licensing criteria. This final rule clarifies that, with respect to the import of radioactive waste, the NRC consults with, as applicable, the Agreement State in which the facility is located and the low-level waste compact commission(s) to confirm that an appropriate facility has agreed to accept and is authorized to possess the waste for management or disposal. This change addresses commenters questions that the NRC received on the scope of the Agreement State and low-level waste compact commission's role (if applicable) regarding the NRC's review of import applications for radioactive waste.
Additionally, this final rule removes the import licensing criteria related to the imports of radioactive material listed in Appendix P. This change conforms §110.43 with the change to allow Category 1 and Category 2 quantities of radioactive materials to be imported under a general license. This change is discussed in more detail in the section-by-section analysis for §110.27.
Section 110.44, Physical security standards. This final rule corrects the Website address for the National Archives and Records Administration. Changes to § 110.44(b)(1) clarify that the Commission determinations on the adequacy of physical security measures are based on receipt by the appropriate U.S. Executive Branch agency of written assurances from the relevant recipient country governments that physical security measures for providing protection are at least comparable to the recommendations set forth in INFCIRC/225/Rev. 4 (corrected), June 1999.
Section 110.45, Issuance or denial of license. This final rule removes the parenthetical text in paragraph (a) that states "If an Executive Order provides an exemption pursuant to section 126a of the Atomic Energy Act, proposed exports to EURATOM countries are not required to meet the criteria in §110.42(a)(4) and (5)". This is no longer needed because the Agreement for Cooperation in the Peaceful Uses of Nuclear Energy between the European Atomic Energy Community (EURATOM) and the United States of America that went into effect in 1995 obviates the need for a presidential exemption.
This final rule makes conforming changes to paragraph (b)(4) which are consistent with the changes to §110.43(d), regarding the issuance of an import license for radioactive waste. Paragraph (b)(5) is removed to eliminate the criteria related to the imports of radioactive material listed in Appendix P to Part 110. This change conforms §110.45 with the change to allow Category 1 and Category 2 quantities of radioactive materials to be imported under a general license. This change is discussed in more detail in the section-by-section analysis for §110.27. Additionally, paragraph (d) is amended to clarify that the provisions in this paragraph do not apply to Commission decisions regarding license applications for specific licenses to export radioactive material listed in Table 1 of Appendix P.
Section 110.50, Terms. This final rule makes several editorial, clarifying, and conforming changes to this section. In paragraph (a)(1), changes clarify that each license is subject to all applicable provisions of the Atomic Energy Act or other applicable law. Paragraph (a)(4) is rewritten and renumbered as paragraph (a)(5) to make clear that each license issued by the NRC for the export or import of nuclear material authorizes only the export or import of that nuclear material and accompanying packaging, fuel element, hardware, or other associated devices or products. Paragraph (b)(5) is revised to remove reference to 10 CFR Parts 40, 70, 71, and 73 and renumbered as paragraph (a)(3). This license term applies to both general and specific licenses and is moved to paragraph (a).
In paragraph (b)(2), changes clarify that a licensee may export or import only for the purpose(s) and/or end-use(s) stated in the specific export or import license issued by the NRC. Paragraph (b)(3) is amended by adding a new paragraph (b)(3)(i) and renumbering current paragraphs (b)(3)(i) and (b)(3)(ii) as (b)(3)(ii) and (b)(3)(iii), respectively. New paragraph (b)(3)(i) clarifies that prior to shipment of certain nuclear material or equipment that has associated with it export controls imposed by other countries (foreign-obligated material or equipment), a license amendment may be required to authorize the shipment. Alternatively, the licensee is to give the NRC 40-days advance notice of the intended shipment.
Paragraph (b)(4) is redesignated as new paragraph (c) and includes the requirements for advanced notifications related to the export or import of radioactive material listed in Table 1 of Appendix P to Part 110. Changes to the advance notification requirements conforms this section to the change to allow Category 1 and Category 2 quantities of radioactive materials to be imported under a general license. This change is discussed in more detail in the section-by-section analysis for §110.27. Additionally, editorial changes update the Web site information for the Office of International Programs and provide specific details on where to send the information required for export and import notifications.
Section 110.51, Amendment and renewal of licenses. This final rule separates the requirements for license amendments and renewals into separate paragraphs. This change clarifies the differences in requirements between amendment and renewal requests and improves readability of the section. No substantive changes are made to the requirements of the paragraphs.
Section 110.53, United States address, records, and inspections. This final rule clarifies that both general and specific licensees are required to have an office in the United States where papers may be served and where records required by the Commission will be maintained. Also, similar clarifying language is added to paragraph (b) of this section that license applicants and both general and specific licensees shall maintain records concerning its exports and imports. Clarifying language is added that byproduct material records must be retained for three years after the date of each export or import shipment.
Section 110.54, Reporting requirements. The reporting requirements in §110.23 for exports of americium and neptunium, and in §110.26 for exports of reactor components have been moved to §110.54. This change consolidates the reporting requirements in Part 110 into one section.
Sections 110.60, Violations, 110.66, Enforcement hearing, and 110.67, Criminal penalties. This final rule makes non-substantive changes for the purposes of consistency and clarification.
Section 110.70, Public notice of receipt of an application. This final rule clarifies that the Commission will publish in the Federal Register a notice of receipt for applications for amendment or renewal for the export of the nuclear equipment and material listed in § 110.70(b)(1) through (b)(5) and for applications for amendment or renewal for the import of radioactive waste. Once a notice has been published, the Commission would not publish in the Federal Register proposed minor amendments to the application or license. Proposed amendments would be posted on the NRC's Web site.
Section 110.80, Basis for hearings. This final rule corrects the omission of the word "import" from the section. This change clarifies that the procedures in Part 110 constitute the exclusive basis for hearings on export and import license applications.
Section 110.81, Written comments. This final rule clarifies that 30 days after public notice of receipt of the application means 30 days after the application is posted on the NRC Web site or in the Federal Register for those applications required to be published in the Federal Register.
Section 110.82, Hearing request or intervention petition. This final rule adds language stating that hearing requests and intervention petitions are considered timely when filed no later than 30 days after publication of notice on the NRC Web site. This change is consistent with § 110.70, which states that the Commission will notice the receipt of each specific license application for an export or import by making a copy available at the NRC Web site. Paragraphs (c)(2) and (c)(3) are renumbered accordingly.
Section 110.112, Reporter and transcript for an oral hearing. This final rule clarifies the scope of information that will be made available at the NRC Website or Public Document Room. Any portions of the transcript for an oral hearing containing classified information, Restricted Data, Safeguards information, proprietary information, or other sensitive unclassified information will not be made available to the public.
Appendix L to 10 CFR Part 110 – Illustrative list of byproduct material under NRC export/import licensing authority. This final rule revises the list of byproduct material in Appendix L to include several radionuclides that are now classified as byproduct material as a result of the Energy Policy Act of 2005, which expanded the definition of byproduct material in Section 11e. of the Atomic Energy Act.
Questions & Answers
What are the most significant changes to 10 CFR Part 110 as a result of this rulemaking?
Appendix P to Part 110 – This final rule allows imports of Category 1 and Category 2 quantities of materials listed in Table 1 of Appendix P to be imported under a general license. Imports of Category 1 and 2 quantities of materials under the new general license are still subject to the notification requirements prior to shipment as required by § 110.50. The notification must be submitted 7 days in advance of shipment.
Definition of Radioactive Waste – This final rule reviews the definition of radioactive waste in Part 110 to improve consistency with and eliminated differences between licensing requirements for export and import and the domestic licensing requirements for possession. In addition, this change simplifies the regulatory framework by clearly stating that exporting or importing material for recycling, waste treatment, or other waste management process that generates radioactive material for disposal in a Part 40 or Part 61 facility (or the equivalent) would require a specific export or import license.
General License for the Export of Byproduct Material – Section 110.23 was revised to clarify the requirements and address inconsistencies resulting from prior changes made to the section.
Were there significant changes to the rule text in response to comments about the proposed rule?
There are no significant changes in the rule text in response to comments about the proposed rule. Clarifying rule text changes were made in response to several comments and are discussed at length in the final rule.
Why did the NRC change from specific to general licensing for imports?
The NRC reevaluated the need for a specific license for the import of Category 1 and 2 quantities of radioactive material to a U.S.-licensed recipient or user in light of enhancements made to the NRC's domestic regulatory framework. A more detailed discussion can be found in the proposed rule and the final rule .
What changes were made to the Part 110 reporting requirements?
No substantive changes were made to the reporting requirements in 10 CFR Part 110 as a result of this rule. However, the reporting requirements in §110.23 for exports of americium and neptunium, and in §110.26 for exports of reactor components have been moved to §110.54. This change consolidates the reporting requirements in Part 110 into a single section.
Reporting requirements in § 110.54 should not be confused with the pre-shipment notification requirements in § 110.50.
What changes were made to the definition of radioactive waste?
The revised definition of "radioactive waste" improves consistency with and eliminates some of the differences between the licensing requirements for export and import and the domestic licensing requirements for possession. The revised definition links the specific license requirement for the export and import of radioactive waste to those materials (in the form of waste) that require a specific license in accordance with NRC's domestic regulations. This eliminates the need for a specific license to export or import materials that, under NRC's regulations in 10 CFR Chapter 1, do not require a specific license to possess them. It also clearly states that exporting or importing material for recycling, waste treatment, or other waste management process that generates material for disposal in a 10 CFR Part 40 or Part 61 facility (or equivalent) requires a specific export or import license.
Why has the definition of "Incidental Radioactive Material" been removed?
This rule deletes the definition of "incidental radioactive material" (IRM) from 10 CFR Part 110 to clarify the scope of "radioactive waste" and address confusion created by the current definition of IRM. While the definition of IRM is deleted, the rule does incorporate aspects of IRM into the revised definition of radioactive waste and the exclusions from that definition
What does "U.S. origin" mean as used in the first exclusion to the definition of "radioactive waste" in §110.2?
U.S. origin was added in the first exclusion to the definition of radioactive waste to clarify that the exclusion only applies to sources of U.S. origin. U.S. origin sources may include sources with U.S. origin material and sources or devices manufactured, assembled or distributed by a U.S. company from a licensed domestic facility. Disused sources that originated in a country other than the United States would require a specific license if being exported or imported for disposal.
The NRC published a Branch Technical Position (BTP) on the Import of Non-U.S. Origin Radioactive Sources on August 28, 2013 (78 FR 53020). This BTP provides additional guidance on the application of the first exclusion to the definition of "radioactive waste" in 10 CFR Part 110.
As mentioned in Exclusion 6 in the 10 CFR Part 110.2 definition of "radioactive waste", when and how is the recyclability of radioactive material determined?
As stated in the final rule, the NRC added a sixth exclusion to the definition of "radioactive waste" to clarify that the definition does not include material imported solely for the purposes of recycling and not for waste management or disposal where there is a market for the recycled material and evidence of a contract or business agreement can be produced upon request by the NRC. Since publication of the final rule, the NRC received several questions from industry regarding the applicability of this exclusion to long-lived isotopes sealed in radioactive sources. Specifically, importers have asked about applicability of this exclusion in cases where sources were imported under exclusion six for recovery and reuse of the radioactive material; however, upon import, due to the condition of the source or device, it was determined that the material cannot be recovered or reused as intended. The NRC recognizes that in some circumstances sources imported with the intent to recycle may be discovered to be not recyclable upon import. The NRC staff construes the general license to apply in a situation where, based on the best available information and after a good faith effort to determine recyclability of the source(s) prior to the import taking place, a U.S. company imports a source with the intent of recovering the radioactive material for reuse in another application but upon import discovers that a source is not recyclable. A good faith effort by the importer may include communication of U.S. import requirements with its foreign customers, examination of a photograph of the source(s) the customer seeks to exchange, and other relevant information related to the source's recyclability such as current activity level.
The U.S. importer at all times must comply with the specific license requirement for "radioactive waste" as defined in 10 CFR 110.2. Any person who imports materials under a general license for recycling, but with the purpose of disposing of them in the United States would be subject to NRC enforcement action. In addition, there may be instances in which some small value may be obtained from the materials that are imported, but the primary intention is for disposal. In such cases, to avoid possible enforcement action, the staff recommends that the Commission be consulted before any such imports are made. It is recommended that U.S. importers retain copies of their communications with their foreign customers regarding U.S. import requirements and records of efforts taken to determine recyclability of the source(s) prior to import.
How is NARM treated for purposes of import and export?
Under the Energy Policy Act of 2005, NRC was given authority to regulate certain NARM. In 2006, the definition of "byproduct material" in 10 CFR Part 110.2 was revised to include discrete sources of radium-226, accelerator-produced radioactive material, and discrete sources of naturally occurring radioactive material, other than source material. Except as provided in paragraphs (b) and (c) of 10 CFR 110.27, a general license is issued to any person to import byproduct, source, or special nuclear material (including NARM) if the U.S. consignee is authorized to receive and possess the material under the relevant NRC or Agreement State regulations. With regard to the import or export of NARM for the purpose of disposal, the import or export must be made in accordance with the definition "radioactive waste" in 10 CFR 110.2.
Will my current license to import Category 1 and 2 materials identified in Appendix P to Part 110 remain active under the changes to the regulation?
The changes to 10 CFR Part 110 eliminate the requirement to apply for a specific license to import Category 1 and Category 2 quantities of materials listed in Table 1 of Appendix P. Specific licenses (both import and combined) issued under the previous regulation remain valid until the date specified on the license, or until a licensee decides to terminate the specific license and import using general license provisions. Specific licensees (both import and combined) who wish to terminate their specific license in advance of the date specified on the license, in order to apply the general license import provisions of the new rule, should submit a license termination request to the NRC.
Are there operational impacts to licensees associated with using a general license to import Category 1 and 2 quantities of material identified in Appendix P?
Section 110.50(c) has been revised to require advance notifications of imports, no later than seven days in advance of shipment. Additionally, notifications must include the exporting facility name, location, address, contact name and telephone number.
What are the considerations for a licensee who needs to amend an active specific license for import or export/import of Category 1 and 2 quantities of materials listed in Appendix P?
If a licensee needs to amend a specific combined export/import license they may either (1) submit an application for amendment of the existing license, in which case the amendment will change the existing combined license to an export license (the licensee will then import using a general license), or (2) submit an application for a new specific license, accounting for the amended provisions (the new license may exist in parallel with the existing license until its expiration). Amendments to existing specific import licenses will only be considered under extenuating circumstances.