Frequently Asked Questions About the New Requirements for Distributors of Generally Licensed (10 CFR 31.5) Devices
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What is the effective date of the new requirements?
The rule was effective February 16, 2001, except that the revised labels must be on devices distributed after February 19, 2002.
When must all new information be included in the quarterly material transfer reports?
The revisions to the material transfer reporting requirements were effective February 16, 2001; however, the new information need not be included in the first report submitted after this date, rather the new information must be in the report for the calendar quarter ending on June 30 (i.e., the first report for a full reporting period occurring after February 16, 2001).
Must we use the new NRC Form 653 when making material transfer reports?
No, the use of the form is optional. Material transfer reports must be clear and legible and include all of the required information. The form may be useful in providing some additional clarification of the requirements and a possible format for new and existing vendors preparing or revising procedures for their quarterly material transfer reports.
Is it okay to use abbreviations for customers' company names in material transfer reports?
The full name should be written out. However, consistent with common standards of writing a name used repeatedly may be abbreviated if it is once shown in full along with its abbreviation; standard abbreviations such as Inc., Ltd., Co., etc. may be used; and a company that has a well-known acronym as their trademark or official name can be identified in that manner (e.g., IBM, 3M, USAA).
We do almost all of our repairs by having the customer return the unit to the factory and the unit soon returned to the general licensee. Do we need to report this activity as a receipt from and retransfer to the general licensee?
Generally, no. The reporting of transfers (and receipts) of generally licensed devices is for tracking what specific devices general licensees possess. Taking temporary physical custody for the purpose of repairing a device is not considered a transfer (or receipt) for this purpose. However, if the repair involves a change to the source such that the label information changes, it must be reported under 10 CFR 32.52(a)(4) or (b)(4). Care should be taken to ensure that any device sent in for repair, but not ultimately returned to the same general licensee, is reported. It may be reported for the quarter in which it was determined that the device would not be returned to the same general licensee, if not previously reported for the quarter in which the device was received.
If a device is received from a general licensee (e.g., for repair) and then returned to the same company, but is installed in a use location that is different from the original use location, must this be reported as a receipt and retransfer?
The return of a device to the same corporate entity but at a different use location may constitute an "initial transfer" and require reporting of both the receipt and retransfer. The requirement to report depends on how the use locations differ. Transfer reports must include the mailing address for the location of use, except when there is no mailing address for the location of use, in which case, an alternate address for the general licensee must be submitted along with information on the actual location of use. If the information required in the transfer reports has not changed, it is not a new "initial transfer." However, an organization that uses generally licensed devices at different locations is considered a separate general licensee at each location, except in the case of portable devices, where there is a separate general licensee for each primary storage location. Use and storage locations within the same complex or campus are considered the same location. Therefore, reporting is not be required if the new use or storage location is within the same complex or campus.
Concerning the requirement to include information about changes on labels to required information in material transfer reports, what is meant by "the required information"?
The Commission is interested in changes to the information specifically required to be included on the label by 10 CFR 32.51(a)(3) and (4) that is also required in the material transfer reports (i.e., information necessary for the tracking of devices). Changes to the device model number, device serial number, isotope, and activity during device repair or maintenance require a corresponding change to the device labeling and require reporting for the quarter in which the labeling change occurred. For activity, this means a new initial activity, not accounting for decay. (NRC Form 653B has spaces for changes to device serial numbers, isotopes, activity, and units.) The report must identify the general licensee, the device, and the applicable changes to the information on the device label. Changes to source serial numbers do not need to be reported unless the same number is also used as the device serial number. [Note: The manufacturer/initial transferor name is that used at the time of the manufacture/initial transfer. This name will not change simply because of subsequent company name changes. However, labels on devices that are "redistributed" must contain manufacturer or initial transferor information that is current when the device is distributed. In this case, a separate receipt and transfer would take place, which would be reported as such and not under 10 CFR 32.52(a)(4) or (b)(4).]
How is the labeling requirement different?
For devices subject to registration, there is a higher standard for durability for the label "permanent." The NRC will consider a label "permanent" if, for example, it were embossed, etched, stamped, or engraved in metal. This does not, however, mean that it is not removable, but it is unlikely to be defaced under conditions of use. Labels should be securely affixed to the device, tamper resistant, but able to be removed, defaced, or otherwise marked to indicate no radioactive material to meet requirements in 10 CFR 20.1904(b) (and similar requirements of the Agreement States). The other change is that any separable source housing must also be labeled.
Must we submit new labels for NRC approval?
New distributors will have labels approved as part of obtaining a license; all distributors, including existing licensees, must meet the new labeling requirements as a condition of license (under 10 CFR 32.51a(d)) for devices distributed after February 19, 2002. Approval of the new labels by NRC for existing distributors is not required. However, distributors may voluntarily submit information for NRC review on how they plan to comply with the new labeling requirements. In any case, labeling is subject to inspection. The new labeling requirements supercede anything contradictory in individual license conditions. The individual license conditions will be updated to include specifics related to the new requirements during the first license renewal or amendment after February 19, 2002.
Has the final version of the guidance concerning licenses for distribution to general licenses been published?
Yes. NUREG-1556, Vol. 16, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees," was revised and published in July 2018.
Is the guidance in Appendices F and G of NUREG-1556, Vol. 16, Revision 1, the information I must provide to my customers?
No. The information to be provided to customers (including both intermediate persons and ultimate users) are (1) copies of 10 CFR 31.2, 31.5, 30.51, 20.2201, and 20.2202 (paragraphs (c)(2) through (4) or (c)(13) may be omitted if they do not apply to the particular device); (2) a listing of the services that can only be performed by a specific licensee; (3) information on acceptable disposal options including estimated costs of disposal; (4) a statement indicating that NRC's policy is to issue high civil penalties for improper disposal. This last item is applicable only for transfers to NRC general licensees. For transfers to general licensees in Agreement States, the distributor may furnish either the applicable NRC regulations or the comparable ones of the Agreement State. In addition, the distributor must furnish the name or title, address, and phone number of the contact at the Agreement State regulatory agency from which additional information may be obtained.
The distributor may propose for Commission approval some alternative to that prescribed for adequately disclosing information to their customers. Distributors would have to obtain Commission approval before using a substitute to the prescribed information. One might, for example, provide a more simply stated summary of regulatory requirements in sales information and provide actual copies of regulations at transfer. The questions and answers guidance provided in the appendices to the NUREG-1556, Vol. 16 are not intended to replace this information. It is intended only as an aid for the general licensee in understanding applicable requirements. It may be provided voluntarily by distributors if they find it useful.
When should required information be provided to customers?
The rule requires that the information be provided before a device may be transferred. While the Commission does not want to get involved with details of licensees' business practices, it is the Commission's intent that "before transfer" will be before a final decision to purchase so that the information can be considered in making that decision. The general licensee should be aware of the specific requirements before purchasing a generally licensed device, not afterward.
What do I do differently when I sell a device to a specific licensee?
A specific licensee may possess some devices under either their specific license or under the general license. There are tradeoffs for the licensee in deciding how to obtain such a device. If a customer is considering buying a device generally licensed under 10 CFR 31.5 (or comparable Agreement State general license), you must provide the information required by 10 CFR 32.51a. The requirements for transfers for use under a specific license have not changed. If a customer wants to purchase a device under his specific license, you must (1) verify that the purchaser's license authorizes receipt of the type of device, (2) label the device appropriately (under 10 CFR 20.1904 or comparable Agreement State requirements) and not with the standard statements for generally licensed devices, and (3) not include information on the device in the material transfer reports required under 10 CFR 32.52.