NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555
August 24, 1999
|NRC INFORMATION NOTICE 99-26:||SAFETY AND ECONOMIC CONSEQUENCES OF MISLEADING MARKETING INFORMATION|
All Distributors and/or Manufacturers of Generally Licensed Products.
The U.S. Nuclear Regulatory Commission (NRC) is issuing this Information Notice to alert addressees to a possible threat to public safety caused by misleading marketing information and lack of end-user understanding of the regulatory requirements. It is anticipated that recipients of this notice will review this information for applicability to their marketing, sales literature, and management practices. Distributors and/or manufacturers of generally licensed products should provide information to the customers so that they are fully aware before acquisition of products, of regulatory responsibilities associated with use, transfer and disposal of radioactive products. Suggestions, contained in this information notice, are not new NRC requirements, therefore, no specific action nor written response is required.
Radioisotopes may be used for measuring industrial-process parameters, physical properties of materials, or diagnostic or beneficial therapeutic medical applications. Thousands of industrial and consumer products contain radioactive materials. Some products have small quantities of authorized radioactive materials incorporated into them for functional purposes. Examples of such products are self-luminous exit signs, precision balances, thickness and density gauges. Other products may incorporate radioactive gas (such as in watch dials, hands or faces), which allow watches, clocks, and other products to be read or to be manipulated reliably in the dark, twilight, or on failure of normal lighting.
Radioactive products to be distributed under a general license are required to be inherently safe so that they can be used by untrained people. However, licensed devices containing radioactive materials have not always been disposed of, nor handled properly, particularly those authorized by general licenses. This has, on some occasions, resulted in radiation exposure to the public and subsequent costly decontamination of property. NRC's routine inspections of licensees indicate that some distributors and manufacturers appear not to completely understand these regulations and their responsibilities. For example:
On routine inspection vendors have been found to be marketing and distributing products to specific and general licensees not in accordance with their commitments made in support of the application for safety evaluation and registration of the product.
Some manufacturers are unclear as to what changes should be identified or what differences between the registration certificate and current design should be brought to the attention of licensees through marketing literature updates and mass distributions or other forms of communications.
Some manufacturers have failed to notify users that deviations from the stated marketing literature, approved design, and processes may cause the product to fail prematurely or be unable to survive its intended conditions of use, or harsh environment or may cause the radiation safety features of the product to be ineffective.
Many times the manufacturers and distributors of these types of radioactive products portray them to prospective customers as non-maintenance items that can be readily bought off the shelf, installed without any consideration given to special circumstances or safe location, and forgotten about. Product-related literature may provide misleading information, or information that can easily be misconstrued by omission or commission. An example of such literature, (italics added for emphasis) that has been brought to NRC's attention is:
" ...the easiest to install, zero-maintenance building exit signs in existence. They can literally be screwed into place and forgotten for up to 20 years. The low installed cost is the last cost for the guaranteed life of the sign."
This type of language in an advertisement may suggest to the end-user that its responsibilities are over after the installation of the device. However, the user as a General Licensee is responsible for the device until it is safely returned or disposed off according to regulatory requirements.
During 1997, within a 6-month period, two separate incidents occurred in New Jersey, where damaged exit signs caused significant contamination. The incidents involved a private residence and a housing cottage at a school for emotionally impaired children. In one incident, a young boy found three exit signs powered by radioactive material at a building demolition site near his home. The boy brought home and broke one of the exit signs to examine it and thereby contaminated some portions of his home and the contents. In another accident a mentally impaired boy shattered an exit sign at an adolescence psychiatric hospital run by the State of New Jersey. Each of these accidents resulted in temporary relocation of the residents while the facilities were being decontaminated at a cost in excess of $ 200,000 per incident to resolve. Exit signs, powered with radioactive material, that are forgotten and/or unattended for a long time, often are direct results of misleading information and contribute to increased risk of accidents which may result in substantial decontamination costs.
It is not the intent of this information notice to encourage or discourage the use of radioactive products. However, manufacturers and distributors are reminded of the problems that may arise when radioactive products sold through misleading or inexact marketing lead to improper control, transfer, damage, disposal, or discarding. Section 20.2001 of 10 CFR Part 20 specifies general requirements for disposal of licensed material. Because of the nature of the licensed material contained in a device, currently one of the options for disposal of licensed material is to transfer products containing radioactive material to an authorized recipient, as specified in 10 CFR 20.2001(a).
As a manufacturer/distributor of products licensed to 10 CFR Part 32 or by an Agreement State, you should inform the end-user that disposal of radioactive products will be by transfer to an authorized licensee. Authorized recipients of the used products for disposal are the original suppliers of the device, or a commercial firm, licensed by NRC or an Agreement State, to accept radioactive waste from another person.
Clear understanding of regulations and availability of accurate and complete information is the key to ensuring the safety and security of the public. The general licensees that possess these types of products have responsibilities, but many times do not clearly understand them until an accident forces them to do so. Often the chemical form of the source is mentioned by name, but the advertising text fails to mention that the source is radioactive and that owners of these types of devices are licensed to possess them. Accidents resulting from lapses in responsibilities and accountability may cause substantial and avoidable burdens on the agencies having jurisdiction over radioactive materials or members of the public and result in avoidable financial costs involved in dealing with such accidents.
A need for corrective action has been perceived for a long time. In a recent proposed rule (July 26, 1999; Volume 64 of Federal Register , page 40295), the Commission would require licensees that distribute products containing radioactive material to provide information to their customers prior to purchase and/or transfer of such products. The proposed rule would include a list of services that must be offered to users, information on disposal options including a cost estimate, and if transferred to an Agreement State, the name, address and the phone number for the appropriate Agreement State contact. The intent of this proposed requirement is to ensure that distributors of generally licensed products provide adequate radioactive product related information to their customers prior to purchase and/or transfer. All manufacturers and distributors are encouraged to examine the proposed rule and provide their comments. For more information on the rulemaking, please contact Catherine R. Mattsen, at (301)415-6264.
This Information Notice requires no specific action nor written response. If you have any questions about the information in this notice, please contact the technical contact listed or the appropriate regional office.
Donald A. Cool, Director
|Attachments:||1. List of recently issued NMSS Information Notices|
2. List of Recently Issued NRC Information Notices
|Technical Contact:||Ujagar S. Bhachu, NMSS|
(NUDOCS Accession Number 9908180183)