Information Notice 1999-26, Safety and Economic Consequences of Misleading Marketing Information

Safety and Economic Consequences of Misleading Marketing Information

ML031040375
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	08/24/1999
From:	Cool D NRC/NMSS/IMNS
To:
References
IN-99-026, NUDOCS 9908180183
Download: ML031040375 (10)

UNITED STATES

OFFC ONUCLEAR 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

Addressees

All Distributors and/or Manufacturers of Generally Licensed Products.

Purpose

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.

Description of Circumstances

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.

TDIL 1S E -02 091 ,,

ha1 \cB

IN 99-26 August 24, 1999 be identified or what

Some manufacturers are unclear as to what changes should

design should be brought to

differences between the registration certificate and current

and mass distributions or

the attention of licensees through marketing literature updates

other forms of communications.

from the stated marketing

Some manufacturers have failed to notify users that deviations

to fail prematurely or

literature, approved design, and processes may cause the product

environment or may cause

be unable to survive its intended conditions of use, or harsh

the radiation safety features of the product to be ineffective.

of radioactive products portray

Many times the manufacturers and distributors of these types

can be readily bought off the

them to prospective customers as non-maintenance items that or safe location, and

shelf, installed without any consideration given to special circumstances

information, or information

forgotten about. Product-related literature may provide misleading of such literature, An example

that can easily be misconstrued by omission or commission. is:

attention

(italics added for emphasis) that has been brought to NRC's

existence. They can

" ...the easiest to install, zero-maintenance building exit signs in

The low installed cost is

literally be screwed into place and forgotten for up to 20 years.

the last cost for the guaranteed life of the sign.

end-user that its responsibilities

This type of language in an advertisement may suggest to the

as a General Licensee is

are over after the installation of the device. However, the user

off according to regulatory

responsible for the device until it is safely returned or disposed

requirements.

occurred in New Jersey, where

During 1997, within a 6-month period, two separate incidents involved a private residence

damaged exit signs caused significant contamination. The incidents

In one incident, a young boy

and a housing cottage at a school for emotionally impaired children..

building demolition site near his

found three exit signs powered by radioactive material at a

to examine it and thereby

home. The boy brought home and broke one of the exit signs accident a mentally

In another

contaminated some portions of his home and the contents. run by the State of

hospital

impaired boy shattered an exit sign at an adolescence psychiatric

relocation of the residents while the

New Jersey. Each of these accidents resulted in temporary

200,000 per incident to resolve. Exit

facilities were being decontaminated at a cost in excess of $

and/or unattended for a long time, signs, powered with radioactive material, that are forgotten

to increased risk of accidents

often are direct results of misleading information and contribute

which may result in substantial decontamination costs.

DISCUSSION

the use of radioactive

It is not the intent of this information notice to encourage or discourage problems that may arise

of the

products. However, manufacturers and distributors are reminded

or inexact marketing lead to improper

when radioactive products sold through misleading

of 10 CFR Part 20 specifies

control, transfer, damage, disposal, or discarding. Section 20.2001 nature of the licensed

of the

general requirements for disposal of licensed material. Because

disposal of licensed material is to

material contained in a device, currently one of the options for

recipient, as specified in

transfer products containing radioactive material to an authorized

10 CFR 20.2001 (a).

IN 99-26 August24, 1999 Part 32 or by an Agreement State, As a manufacturerldistributor of products licensed to 10 CFR

will be by transfer to an

you should inform the end-user that disposal of radioactive products

for disposal are the original

authorized licensee. Authorized recipients of the used products

or an Agreement State, to accept

suppliers of the device, or a commercial firm, licensed by NRC

radioactive waste from another person.

and complete information is the key

Clear understanding of regulations and availability of accurate

licensees that possess these types

to ensuring the safety and security of the public. The general

understand them until an accident

of products have responsibilities, but many times do not clearly

is mentioned by name, but the

forces them to do so. Often the chemical form of the source

and that owners of these types of

advertising text fails to mention that the source is radioactive

lapses in responsibilities and

devices are licensed to possess them. Accidents resulting from

on the agencies having jurisdiction

accountability may cause substantial and avoidable burdens

in avoidable financial costs involved

over radioactive materials or members of the public and result

in dealing with such accidents.

In a recent proposed rule

A need for corrective action has been perceived for a long time.

the Commission would require

(July 26, 1999; Volume 64 of Federal Register, page 40295),

to provide information to their

licensees that distribute products containing radioactive material

The proposed rule would include a

customers prior to purchase and/or transfer of such products.

disposal options including a cost

list of services that must be offered to users, information on

address and the phone number for

estimate, and if transferred to an Agreement State, the name, proposed requirement is to ensure

the appropriate Agreement State contact. The intent of this

radioactive product related

that distributors of generally licensed products provide adequate

All manufacturers and

information to their customers prior to purchase and/or transfer.

provide their comments. For

distributors are encouraged to examine the proposed rule and

R. Mattsen, at (301)415-6264.

more information on the rulemaking, please contact Catherine

response. If you have any

This Information Notice requires no specific action nor written

the technical contact listed or the

questions about the information in this notice, please contact

appropriate regional office.

/Ronald A. Cool, Director

// Division of Industrial and

V Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Attachments:

1. List of recently issued NMSS Information Notices

2. List of recently issued NRC Information Notices

Ujagar S. Bhachu, NMSS

(301)415-7894 E-mail usbenrc.gov

Attachment 1 IN 99-26 August 24, 1999

.  :

Page 1 of I

LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

99-24 Broad-Scope Licensees' 7/12199 All medical licensees' of broad- Responsibilities for Reviewing and scope and master materals

Approving Unregistered Sealed licensees

Sources and Devices

99-23 Safety Concerns Related To 7/6199 All U.S. NRC medical licensees

Repeated Control Unit Failures authorized to use brachytherapy

of the Nucletron Classic Model sources in Nucletron Classic

High-Dose-Rate Remote Model high-dose-rate (HDR)

Aferloading Brachytherapy remote afterloaders

Devices

99-22 10 CFR 34.43(a)(1): Effective 6/25/99 Industrial Radiography Licensees

Date for Radiographer Certification

and Plans for Enforcement Discretion

99-20 Contingency Planning for the 6/25/99 All material and fuel cycle

Year 2000 Computer Problem licensees and certificate holders

99-18 Update on NRC's Year 2000 6/14/99 All material and fuel cycle

Activities for Materials Licensees licensees and certificate

and Fuel Cycle Licensees and holders

Certificate Holders

99-16- Federal Bureau of Investigation's 5/28 All U.S. Nuclear Regulatory

Nuclear Site Security Program Commission fuel cycle, power

reactor, and non-power reactor

licensees

99-11 Incident Involving the Use of 4/16/99 All medical use licensees

Radioactive Iodine-131

99-09 Problems Encountered When 3/24/99 All medical licensees authorized

Manually Editing treatment Data to conduct high-dose-rate (HDR)

on the Nucletron Microselectron- remote after loading

HDR (New) Model 105-999 brachytherapy treatments

99-06 1998 Enforcement Sanctions as 3/19/99 All U. S. Nuclear Regulatory

a Result of Deliberate Violations Commission licensees

of NRC Employee Protection

Requirements

KJ Attachment 2 IN 99-26 August 25, 1999

.  : LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

99-25 Year 2000 Contingency Planning 8110/99 All holders of operating licenses

Activities for nuclear power plants and fuel

cycle facilities

99-24 Broad-Scope Licensees' 7/12/99 All medical licensees of broad- Responsibilities for Reviewing scope and master materials

and Approving Unregistered licensees

Sealed Sources and Devices

99-23 Safety Concerns Related To 7/6/99 All U.S. NRC medical licensees

Repeated Control Unit Failures authorized to use brachytherapy

of the Nucletron Classic Model sources in Nucletron Classic

High-Dose-Rate Remote Model high-dose-rate (HDR)

Aferloading Brachytherapy remote afterloaders

Devices

99-22 10 CFR 34.43(a)(1); Effective 7/6/99 Industrial Radiography Licensees

Date for Radiographer Certification

and Plans for Enforcement Discretion

99-21 Recent Plant Events Caused 6/25/99 All holders of licenses for nuclear

By Human Performance Errors power, test, and research reactors

99-20 Contingency Planning for the 6/25/99 All material and fuel cycle

Year 200 Computer Problem licensees and certificate holders

99-19 Rupture of the Shell Side of a 6/23/99 All holders of operating licenses

Feedwater Heater at the Point or construction permits for nuclear

Beach Nuclear Plant power reactors

99-18 Update on NRC's Year 2000 6/14/99 All material and fuel cycle

Activities for Materials Licensees licensees and certificate holders

and Fuel Cycle Licensees and

Certificate Holders

OL = Operating License

CP = Construction Permit

IN 99-

<a. August, 1999 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

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Attachments:

1. List of recently issued NMSS Information Notices

2. List of recently issued NRC Information Notices

Ujagar S. Bhachu, NMSS

(301)415-7894 E-mail: usbj nrc-gov *See previous concurrence g:\bhachu~info5.wpd

OFFICE MSIB NMSS* MSIB* MSIB*

NAME UBhachu/Lucy EKraus JTelford LCamper

DATE 1/4/99 3/2/99 3/3/99 3/9199 OFFICE MSZl OGC* lI

NAME, SMoore SLewis for PHolahan Streby(no legal objection _____

DATE 3/10/99 6/11/99 6/18/99 8/(7 /99 OFFICIAL RECORD COPY

IN 99- August, 1999 t' ~2 Page 3of3 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

.?uthocized 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,gut

the advertising text fails to mention that the source is radioactive and that owners of these pes

of devices are licensed to possess them. Accidents resulting from lapses in responsib tes and

accountability may cause substantial and avoidable burdens on the agencies havin risdiction

over radioactive materials or members of the public and result in avoidable financi costs

involved in dealing with such accidents.

A need for corrective action has been perceived for a long time. Ina rece proposed rule

(July 26, 1999; Volume 64 of Federal Register, page 40295), the Commi ion would require

licensees that distribute products containing radioactive material to pro de information to their

customers prior to purchase and/or transfer of such products. The pr posed rule would include a

list of services that must be offered to users, information on dispo options including a cost

estimate, and if transferred to an Agreement State, the na ipe, ad ress and the phone number for

the appropriate Agreement State contact. The intent ofi pr osed requirement is to ensure

that general licensed distributors would provide ade ate a active product related information

to their customers prior to purchase and/or transfer All ufacturers and distributors are

encouraged to examine the proposed rule and pr vide their comments. For more information on

the rulemaking, please contact Catherine R. M sen, at (301)415-6264.

This Information Notice requires no specifi ction nor written response. If you have any

questions about the information in this noice, please contact the technical contact listed or the

appropriate regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Attachments:

1. List of recently issued SS Information Notices

2. List of recently issue NRC Information Notices

Uj gar S. Bhachu, NMSS

(301)415-7894

/E-mail: usb(fnrc.aov

• See previous c currence g:\bhachu\info5.wpd Ag.

I AE,

OFFICE NMSS* MSIB* lIBI

NAME Ahachu/Lucy EKraus JTelford LCamper

DATE 1/4/99 3/2/99 3/3/99 3/9/99 OFFICE MSIB* RGB* OGC* IMNS

NAME SMoore SLewis for PHolahan Streby(no legal objection DCool

DATE 3/10/99 6/11/99 6/18/99 8/ /99 OFFICIAL RECORD COPY

Incidents resulting from lapses in responsibilities, accountability, or control of the devices

may cause substantial and avoidable burdens for members of the public or the agencies

having jurisdiction over the radioactive material. These incidents may also result in

unwarranted and avoidable financial costs for clean-up of contamination.

Distributors and manufacturers should review the requirements of their licenses and

should take any appropriate actions to prevent loss of control of the radioactive material

once it has been transferred to the General Licensee. Specifically, the distributors and

manufacturers should take appropriately conscientious actions to ensure that the

purchasers are encouraged to return the device the them at its end-of-life or when it is

no longer needed by the General Licensee.

Although this Information Notice requires no specific action nor written response, we do

appreciate your help in avoiding these types of incidents. If you have any questions

about the information in this notice, please address them to the technical contact listed

below or the appropriate regional office.

Donald A. Cool, Director

Division 9f Industrial and

.M &dical Nuclear Safety

ffice oi Nuclear Materi afety

and 'afeguards

Attachments:

1. List of recently issued NMSS Inf mation Noties

2. List of recently issued NRC In rmation Noti es

Ujagar S. hachu, NMSS

301-41 894 E-mai sb @nrc.gov I -

On

DOCUMENT NAME: A:infonot.wpd (IMNS-7262) -See previous concurrence _ _ _

OFC MSB* I /NMSS* I MSB*l M OB l,I , lIl OGC,l

NAME UBhachuAl / EKrauslfax JTelford LCamper _5__ 4__ H WIa an r}y

DATE 1/4/99 03/02199 3/3/99 03/9/99 3/l 0 /99 al /' /99 (9/ /99 OFC IMNS /

NAME DCJo1

DATE 31 /99 OFFICIAL RECORD COPY

- ' I,

4 These aforementioned types of problems can be confusing and misleading the end- user. The general licensees that possess these types of products have r onsibilities, but many times do not understand them until accidents forces them to to understand

them. Often a source chemical form is mentioned by name, but the vertising text fails

to mention that source material is radioactive and that owners of t se types of devices

are licensed to possess them.

Accidents resulting from lapses in responsibilities and acco ability may cause

substantial and avoidable burdens on the agencies havinc urisdiction over radioactive

materials or members of the public and result in avoida e financial costs involved in

dealing with such accidents.

This Information Notice requires no specific actio or written response. If you have

any questions about the information in this notin, please contact the technical contact

listed or the appropriate regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Attachments:

1. List of recently issued IMSS Information Notices

2. List of recently issue NRC Information Notices

Technical Contact:

jagar S. Bhachu, NMSS

01-415-7894 E-mail usbenrc.gov

DOCUMENT ME: G:ljnfonotwpd (IMNS-7262) See previous concurrence

OFC Ms_ NMSS* I MSB* I OB RGB

NAME UB chu/Il EKrauslfax JTelford amper SMoore PHolahan STreby

DATE 1 03102099 3/3/99 03A /99 3/ /99 13/ /99 3/ /99 OFC I / IMNS

NAME DCool

DATE 3/ /99

/

4 These aforementioned types of problems can be confusing and misleading tte end- user. The general licensees that possess these types of products have re onsibiliti

but many times do not understand them until accidents forces them to t to undesand

them. Often a source chemical form is mentioned by name, but the a ertisin xt falls

to mention that source material is radioactive and that owners of thye types f devices

are licensed to possess them.

Accidents resulting from lapses in responsibilities and account ility y cause

substantial and avoidable additional burdens on the agencie and rsonnel having

jurisdiction over radioactive materials, as well as cause the arlo stresses and

financial costs involved in dealing with such accidents.

This Information Notice requires no specific action nor ri n response. If you have

any questions about the information in this notice, pie s contact the technical contact

listed or the appropriate regional office.

0 nald A. Cool, Director

ivision of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Attachments:

1. List of recently issued NMSS formation Notices

2. List of recently issued NRC formation Notices

Ujagar 6Bhachu, NMSS

3041 $-7894 DOCUMENT N G:Mnfonot.wpd (IMN5-7262) *See previous concurrence

OFC IISB* /v/ N Jj VI

MSNM ISI I Ll Ri l l

NAME UBha I EKraus/fax JTelrrd LCamper SMoore PHolahan STreby

DATE 99 03/02/99 3133 /99 03/ /99 3/ /99 3/ /99 13/ /99 OFC A /IMNS

NAME / / DCool

DATE // 3/ /99 i/ OFFICIAL RECORD COPY