U.S. Nuclear Regulatory Commission.
Final Branch Technical Position.
In 2010, the U.S. Nuclear Regulatory Commission (NRC) staff published a final rule amending its regulations concerning export and import of nuclear equipment and material. Among other things, it added the phrase “of U.S. origin” to the first exclusion to the definition of “radioactive waste” to confirm that the return of U.S. origin radioactive sources is not classified as the import of radioactive waste. The NRC staff drafted the Branch Technical Position (BTP) on the Import of Non-U.S. Origin Sources to provide additional guidance on the application of this exclusion in the regulations.
In developing this BTP, the NRC staff has engaged with States, Low-Level Waste Compacts, industry, and the public by providing two opportunities for public comment via
The BTP is effective on September 27, 2013.
You can access publicly available documents related to this document using the following methods:
Jennifer C. Tobin, Office of International Programs, U.S. Nuclear Regulatory Commission, MS–O4E21, Washington, DC 20555–0001; telephone: (301) 415–2328; email:
The NRC published “Notice of Public Meeting and Request for Comment on the BTP on the Import of Non-U.S. Origin Radioactive Sources,” 77 FR 2924 (January 20, 2012), and received five comment letters as a result of that publication. The NRC staff made no substantive changes to the draft BTP based on these comment letters. However, minor editorial changes were made to the draft BTP to provide greater clarity.
The NRC published “Request for Comment on the BTP on the Import of Non-U.S. Origin Radioactive Sources,”
The NRC's regulations in 10 CFR part 110 (Part 110), “Export and Import of Nuclear Equipment and Material,” establish the general and specific export and import licensing requirements for special nuclear, source, and byproduct material including radioactive waste. “Radioactive waste” is defined in 10 CFR 110.2 as:
There are six exclusions in 10 CFR 110.2 to the definition of “radioactive waste.” The sealed source exclusion (exclusion one) is defined as radioactive material that is “[o]f U.S. origin and contained in a sealed source, or device containing a sealed source, that is being returned to a manufacturer, distributor or other entity which is authorized to receive and possess the sealed source or the device containing a sealed source.”
The NRC staff has developed this BTP to provide guidance to source manufacturers, distributors, or other entities on the NRC's application of the sealed source exclusion to imports into the United States of non-U.S. origin disused sources.
On July 28, 2010, the NRC published a final rule in the
In September 1990, the IAEA General Conference adopted the Code of Practice on the International Transboundary Movement of Radioactive Waste (Code of Practice) which provides that “[t]he sending State should take the appropriate steps necessary to permit readmission into its territory of any radioactive waste previously transferred from its territory if such transfer is not or cannot be completed in conformity with this Code . . ., unless an alternate safe arrangement can be made.” This Code of Practice served as a basis for the sealed source exclusion in the 1992 proposed rule (57 FR 17859) that described a United States policy of encouraging the return of disused sources to the country of origin for the purposes of helping to ensure that the sources will be handled responsibly at the end of their life cycle. The regulatory history of this rule, finalized in 1995 (60 FR 375567), was in principal and intent identical to the sealed source exclusion embraced by the proposed rule. In the Statements of Consideration, the NRC described industry practice as limited to return of disused sources to the original supplier or country of origin.
Shortly thereafter, the adoption of the Code of Practice resulted in the international development of the Joint Convention on the Safety of Spent Fuel Management and the Safety of Radioactive Waste Management (Joint Convention) that opened for signature in September 1997 and entered into force in 2001. In terms of this BTP, a key point in the legally-binding Joint Convention to which the United States is a party, is found in Article 28, “Disused Sealed Sources,” which states:
“A Contracting Party shall allow for reentry into its territory of disused sealed sources if, in the framework of its national law, it has accepted that they be returned to a manufacturer qualified to receive and possess the disused sealed sources.”
Nearly identical language was included in the non-legally binding Code of Conduct on the Safety and Security of Radioactive Sources (Code of Conduct), along with the supplementary Guidance on Import and Export, that was internationally approved in 2003 and to which the United States made a political commitment in 2004. In accordance with the Code of Practice, the Joint Convention, and the Code of Conduct (including the supplemental Guidance on Import and Export), the NRC believed that encouraging return of disused sources to the country of origin would help prevent sources from becoming “orphaned” by facilitating responsible handling of sources at the end of their life cycle. See
The NRC's willingness to embrace this policy was in large part informed by U.S. industry comments that there is a:
After the addition of “U.S. origin” to the sealed source exclusion in the 2010 rule, it came to the NRC staff's attention that, while it remains a widespread industry practice to exchange new and disused sources on a “one-for-one” basis, the current global supply market does not always allow a supplier to definitively ascertain the origin of a particular disused source that is exchanged for a new one before import and receipt of the disused source. With established customers, the disused sources will generally be of U.S. origin; however, for new customers, some of the sources initially being returned may not be of U.S. origin. The result is still a “one-for-one” exchange, resulting in the number imported not being greater than new sources exported.
Once a source is imported and received, the manufacturer, distributor, or other entity technically has the ability to determine the source's origin. However, the only way for the supplier to accomplish this is by exposing its personnel to additional radiation doses. Specifically, the supplier must use a glove-box to take the source out of its casing to read the serial numbers and correlate those numbers to different manufacturer's coding patterns.
The NRC staff has construed the “U.S. origin” provision in the context of the industry's recent clarification of international source exchange practices. The NRC staff recognizes that in some circumstances it may not be feasible for the importer to determine the country of origin for disused sources it seeks to exchange prior to import. If, after a good faith effort and without exposing personnel to additional doses, the U.S. manufacturer, distributor, or other entity cannot determine whether an imported disused source that has been exchanged for a new source is of U.S. origin, the source in question shall be deemed to be of U.S. origin for the purposes of the sealed source exclusion to the definition of “radioactive waste” in 10 CFR 110.2.
The NRC staff believes that this application of the sealed source exclusion reasonably balances the interests of public health and safety and international policy interests in responsible handling of sources at the end of their useful life. The approach preserves the fundamental policy rationale underlying the original exclusion—to prevent sources from being dispersed in unregulated locations around the world by facilitating a “one-for-one” exchange of U.S.-supplied new and disused sources—while achieving occupational doses to workers that are as low as reasonably achievable, as specified in 10 CFR 20.1101(b).
The NRC staff expects U.S. manufacturers, distributors, and suppliers to make a good faith effort to determine source origin before an import occurs. A good faith effort by the importer includes, but is not limited to, communication of U.S. import requirements with its foreign customers, examination of a photograph of the source the customer seeks to exchange, and obtaining other relevant information related to the disused sources' origin. It is recommended that U.S. importers retain copies of their communications with their foreign customers regarding U.S. import requirements. At all times, the U.S. importer must comply with the specific license requirement for disused sources known to be of non-U.S. origin prior to import into the United States. The specific license requirements include meeting the provisions/conditions of the material possession license which may limit the quantity/activity held in storage on site. Licensees should consider the potential ramifications and costs of extended storage due to lack of disposal options. Licensees should recognize that the low-level radioactive waste compacts have legal jurisdiction for the availability and access to disposal options.
Consistent with 10 CFR 110.53, the NRC staff may inspect the licensee's records, premises, and activities pertaining to its exports and imports to ensure compliance with the sealed source exclusion to the definition of “radioactive waste.”
This position was distributed to all Agreement States and material licensees as a proposed document for comment and is publicly available for use by all potentially affected parties. Additionally, the NRC staff has coordinated this position with the Department of Energy/National Nuclear Safety Administration's (DOE/NNSA) Global Threat Reduction Initiative (GTRI) and confirmed that NRC does not have jurisdiction over the GTRI program.
This technical position reflects the current NRC staff position on acceptable use of the general license for import of disused radioactive sources. Therefore, except in those cases in which the source manufacturer or distributor proposes an acceptable alternative method for complying with the definition of “radioactive waste” in Section 110.2, the guidance described herein will be used in the evaluation of the use of the general import license for disused sources.
The NRC received responses from eight organizations including States, licensees, and others on the proposed BTP on the Import of Non-U.S. Origin Radioactive Sources, 77 FR 64435 (October 22, 2012) that was published for a 60-day public comment period. The commenters were: the Northwest Interstate Compact on Low-Level Radioactive Waste Management (Northwest Compact), the State of Utah's Department of Environmental Quality (UDEQ), the State of Virginia's Department of Health–Division of Radiological Health (State of Virginia), the Organization of Agreement States (OAS), the Nuclear Energy Institute (NEI), the International Source Suppliers and Producers Association (ISSPA), QSA Global Inc. (QSA), the Low-Level Radioactive Waste Forum Inc.–Disused Sources Working Group (LLW Forum), and International Isotopes Inc. (International Isotopes).
Most of the comments did not disagree with the underlying rationale for the regulation in Part 110 and justification for the BTP's interpretation (i.e., to construe non-U.S. origin disused
To address this concern, International Isotopes suggested that a footnote be added to the BTP such as the following:
“Non-U.S. origin radioactive sources containing byproduct material, as defined in paragraphs (3) and (4) of the definition of “byproduct material” set forth in 20.1003, does not require a specific import license if it [the material] is intended for disposal at a disposal facility authorized to dispose of such material in accordance with any Federal or State solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005.”
“We understood that the draft BTP was going to further clarify, that if a non-U.S. origin source is contained in a U.S. device, and that U.S. device needs to be returned to the U.S. for use, then that can be considered a legitimate import regardless of the source origin. We suggest the BTP add further clarification on this point for sources returned in a device under footnote 1. This change will continue to support international commerce, and will not impose unfair competitive restrictions on U.S. manufacturers since many other countries do not have this restriction.”
QSA explained that disused sources (both U.S. and foreign origin) are loaded into U.S. shipping containers, presumably when customers order replacement sources and if they have limited or no storage capacity for spent sources. QSA's interpretation of “U.S. origin” devices include U.S. shipping containers. Specifically, QSA uses the terms “device” and “shipping container” interchangeably in the 10 CFR 110.2 definition of “radioactive material.”
The NRC staff believes that the guidance for “U.S. origin” in Footnote 1 is clearly addressing medical, industrial, or other types of sources that are included in devices. For those radiographic exposure devices, as defined in 10 CFR 34.3, which meet the performance requirement of 10 CFR 34.20(b)(2) and qualify as Type B transport containers in accordance with the applicable requirements of 10 CFR part 71, the radiographic exposure device houses the source and is integral to the use of the material for its intended purpose. The sealed source exclusion is applicable as is the “one-for-one” discussion. These are not the same as shipping containers that are used solely for transferring new or used sources. NRC does not consider a Type B shipping container that is not integral to the use of the material for its intended purpose to be a device, as the term is commonly used and understood in NRC's domestic regulatory program. A device typically only contains one source whereas a shipping container can include a number of sources with different origins. All of the sources in the shipping container need to be taken into account in the one-to-one exchange and determining origin.
In addition to the LLW Forum's comment, the NRC also received several questions from industry regarding the applicability of the sixth exclusion to long-lived isotopes sealed in radioactive sources. Specifically, the NRC has been asked for clarification on the applicability of exclusion six in cases where sources were imported for recovery and reuse of the radioactive material but, upon import, due to the condition of the source or device, it was determined that the material could not be recovered or reused as intended. The NRC staff recognizes that in some circumstances sources imported with the intent to recycle may be discovered to be not recyclable. The NRC staff construes the sixth exclusion in 10 CFR 110.2 to authorize import for recycle
At all times, the U.S. importer 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 using exclusion six, but with the intent of disposing of that material 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 NRC staff should 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. This guidance is also posted as an FAQ on the import/export Web site at
“A depleted sealed source means that the useful life of the returned radioactive sealed sources is exhausted or used up which means the Compacts would view such sources as radioactive waste. Following purchase from a U.S. manufacturer, the source spent its entire useful life employed for its specific purpose in the foreign country. So although the BTP would allow such sources to be returned to the manufacturer as material, in reality the radioactive sealed source actually became waste following its use within a foreign country, prior to its return to the U.S. manufacturer.”
Furthermore, The Northwest Compact stated that:
“It is difficult to envision the return of a “depleted” radioactive sealed source as anything other than the return of waste that was generated within a foreign country. Without such a policy, there is little incentive for out-of-region states or foreign countries to develop the capacity to properly handle radioactive sealed sources following their useful life.”
The Northwest Compact recommended that the NRC add a statement such as the following to the BTP:
“Returned sources may have limited disposal access as the interstate compacts in which three of the four operating Part 61 commercial disposal facilities in the U.S. are located may view the returned radioactive sealed sources as foreign low-level waste and would not provide access for disposal.”
The return of disused sources to the country of origin is a well-established industry practice not only in the United States but in many other countries. Global implementation of the Code of Practice, Joint Convention, and Code of Conduct (including the supplementary Guidance on Import and Export) provides responsible end-of-life management for all international parties (see Background section of BTP for additional details). The practice of allowing return to the U.S. under general license of U.S.-manufactured disused sources has been in use in the United States at least since the mid-1990's.
The NRC staff recognizes that differences in interpretation of the meaning of “foreign” radioactive waste may limit disposal options for licensees. The Northwest Compact's current “Resolution Clarifying the Third Amended Resolution and Order” would appear not to allow sources used in foreign jurisdictions (to the end of useful life) to be disposed of at a Compact facility even if a source originated in a Northwest Compact member state and is considered to be “U.S. origin” and excluded from the definition of radioactive waste by the NRC for purposes of import. The Northwest Compact thus purports to have the authority to prevent return to the U.S. of disused sources originating in the U.S. but used in a foreign country.
The NRC staff believes that the Northwest Compact's interpretation of country of origin and what is “foreign” waste is inconsistent with the commonly understood and accepted interpretation of country of origin for disused sources (i.e., the country where the disused sources were manufactured rather than used) under the international agreements to which the U.S. is a signatory, including the Code of Practice, the Joint Convention, and the Code of Conduct, all of which expect that signatory countries be responsible for the disposition of disused sources originating within their own country.
To the extent that the Northwest Compact is suggesting that its Compact authority may be exercised in a manner that is contrary to federal law, including NRC regulations, and underlying U.S. policy objectives to promote responsible handling of disused sources on an international scale, the NRC staff disagrees. Section 4(b)(4) of the Low Level Radioactive Waste Policy Act of 1985, as amended, provides that, “[e]xcept as expressly provided in this Act, nothing contained in this Act or any compact may be construed to limit the applicability of any Federal law or to diminish or otherwise impair the jurisdiction of any Federal agency. . . .” The NRC staff questions whether application of the Northwest Compact's “Resolution” in a manner that would interfere with the federal scheme for responsible disposition of U.S. origin disused sources used overseas, including disused sources originating within a Northwest Compact member state, would be a permissible exercise of Compact authority consented to by Congress under the Northwest Interstate Compact on Low-Level Radioactive Waste Management. The NRC staff recognizes, however, that legal and policy issues regarding the interface between federal authority and state compact authority have yet to be tested in this particular context and, in any event, are beyond the scope of the BTP. We reiterate that the BTP itself is
By addressing this aspect of the Northwest Compact's comment in this comment resolution document (published at the same time as the BTP), the NRC is reiterating to licensees the potential limits both to disposal options for disused sources and long-term storage capacity at the licensees' respective sites.
UDEQ also suggested adding more explanatory text regarding potential storage and disposal considerations and requirements directly into the BTP as a clarifying footnote. The Northwest Compact and LLW Forum raised similar concerns about potential impacts on capacity for domestic long-term storage and ultimate disposal by NRC and Agreement State licensees. Specifically, the LLW Forum observed that
Agreement State and NRC possession license holders historically have not differentiated use or storage of radioactive sources based on origin. In terms of their possession limits and storage capacity, licensees handle the sources identically regardless of origin in order to protect public health and safety. With the “one-for-one” exchange required under the BTP, there should be no increase in the volume of disused sources for management or disposal as a result of the BTP. The application of this BTP is limited to those radioactive sources that have been exchanged on a “one-for-one” basis and after a good faith effort has been made by the importer to determine the origin. Accordingly, it is the NRC's expectation that the number of disused sources imported by the manufacturer or distributor into the United States must not be greater than the number of new or refurbished sources exported by that manufacturer or distributor.
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