Information Notice 1997-50, Contaminated Lead Products
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UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555
July 10, 1997
NRC INFORMATION NOTICE 97-50: CONTAMINATED LEAD PRODUCTS
Addressees
All U.S. Nuclear Regulatory Commission licensees.
Purpose
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to alert
addressees to the potential for some shielding products containing lead to be contaminated
with small amounts of naturally occurring radioactive material. It is expected that recipients
will review the information for applicability to their facilities and consider actions, as
appropriate, to avoid unnecessary exposure to radioactive material. However, suggestions
contained in this information notice are not NRC requirements; therefore, no specific action
nor written response is required.
Description of Circumstances
NRC recently was notified of the distribution of contaminated lead and lead products, including medical shielding devices. The contaminants are lead-210 and its daughter
nuclides bismuth-210 and polonium-210. Based on current information, it appears that the
contaminated products were manufactured from lead processed by one supplier between
November 1996 and May 1997.
The contaminated lead was used to manufacture a variety of products consisting of lead-vinyl
or lead-plastic products used to make radiation shielding materials for x-ray machine drapes, aprons, gonad shields, and sheet shielding. The contaminated lead may also have been
incorporated into other commercially distributed products, such as brushes for electric
motors, bullets, lead shot, lead roof flashing, and galvanizing compounds. Radiation from
these products does not appear to represent a public health and safety hazard and there is
little possibility of persons being exposed to radiation from any of these products except the
radiation shielding products (vinyl-lead and plastic-lead).
Although NRC does not regulate the radioactive contaminants and the products do not
appear to represent a threat to public health and safety, we are issuing this notice because of
the use of many of the contaminated lead products as medical devices and temporary
shielding and that users may not be aware of the contamination.
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July 10, 1997 Discussion
This information has been coordinated with the Food and Drug Administration (FDA), the
U.S. Environmental Protection Agency (EPA), and the Conference of Radiation Control
Program Directors (CRCPD). The FDA has distributed a Public Health Notice to health care
professionals advising them of this issue and requesting a report if any contaminated lead
products are identified (see attachment). Some medical device firms and distributors have
initiated a voluntary recall. The EPA and CRCPD have provided relevant information, respectively, to regional offices and all members.
If you discover that you possess a product that contains this contaminated lead, please
contact the appropriate EPA regional office and State radiation regulatory agency.
This information notice requires no specific action or written, response. If you have any
questions about the information in this notice, please contact the technical contact listed
below or the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical contact: Brian W. Smith, NMSS
301-415-5723 E-mail: bwsl@nrc.gov
Attachments:
1. FDA Public Health Notice
2. List of Recently Issued NMSS Information Notices
3. List of Recently Issued NRC Information Notices
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_Attachment 1 IN 97-50
July 10, 1997 HMDEPARTMENT
O EALT HU
MAN
SERVICES
Public Heathf Service
Food and Drug Administation
9200 Corporate Boulevard
Rockville MD 20850
June 13, 1997
FDA PUBLIC HEALTH NOTICE
Radioactivity in Radiation Protection Devices
TO:
Health Care Professionals
FDA is notifying you that some shielding products used for radiation protection contain
lead contaminated with small amounts of naturally occurring radionuclides. The
contaminants are lead-210 (Pb-210) and its daughter nuclides bismuth-210 (Bi-210) and
polonium-210 (Po-210). Initial FDA and state evaluations indicate that there is only a
very small exposure to radioactivity from the affected products, and the contaminants are
not transferable to patients, personnel or equipment by ordinary use. The products
identified to date include medical devices used for radiation protection such as lead
aprons, gonad shields, and thyroid shields manufactured after October 1, 1996.
Standard radiation safety practice is to avoid unnecessary exposure to radiation.
Therefore the use of contaminated products should be discontinued. However, in cases
where no alternative shielding is available, continued use of the contaminated products will
be likely to provide greater protection during therapeutic and diagnostic procedures than
using no shielding. Facilities which have no alternative protective devices available should
consider continued use of the contaminated items until replacements are obtained.
Investigations are underway to identify all firms that received contaminated lead. FDA
and state radiation control program officials have determined that a shipment of
contaminated tin-lead alloy was imported from Brazil and then processed by MIDCO
Industries of St. Louis, MO. MIDCO sold contaminated lead to Taracorp Industries of
Granite City, IL. Taracorp then manufactured contaminated lead powder which was sold
to 19 firms. Some of these 19 firms manufactured or distributed contaminated lead or
lead products to a number of companies, including medical device manufacturers.
Recalls are being initiated by medical device firms and distributors. To date, E-Z-EM of
Portchester, NY, and Picker Corporation of Cleveland, OK, are voluntarily recalling
contaminated products. Other manufacturer recalls are likely to follow. If you have
purchased affected products, you should receive notice from your supplier. The notice
should provide instructions for disposition or return of the devices, and may include
replacement information. As affected product lists are available, they will be provided to
the Conference of Radliation Program Control Directors and posted on the FDA's internet
site (http:Itw/ w.fda.gov/cdrh/safety.html).
FDA recommends radiation protection medical devices containing lead purchased after
October 1, 1996 be surveyed for radionuclide contamination. This should be done by
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V
Attachment 1
July 10, 1997 i
2 qualified personnel with a suitable survey meter, such as a thin window Geiger Mueller
(G-M) instrument in contact with the product. The 1.16 MeV beta from the Bi-210 is
easily detected with this type of instrument.
If the survey results indicate contamination, contact your supplier for further
instructions.
- If you don't have the capability to survey, contact the supplier of your devices
purchased after October 1, 1996, to determine if their products are affected by this
problem.
- If you receive a notice or a customer letter from a manufacturer or supplier
concerning this matter, follow the instructions which should include information on
disposition of affected products.
FDA is working with state radiation control program officials to identify all contaminated
lead products that have been introduced into commercial distribution and to facilitate
effective recalls of all contaminated devices. As additional information becomes
available, FDA will issue updated notices.
FDA requests users who discover shielding products with contaminated lead to report this
information directly to MedWatch, the FDA's voluntary reporting program. Submit these
reports to MedWatch by telephone at 1-800-FDA-1088, by FAX at 1-800-FDA-0178, or
by mail to:
MedWatch
Food and Drug Administration, HF-2
5600 Fishers Lane
Rockville, MD 20857
Contact Sherry Purvis-Wynn of FDA's Center for Devices and Radiological Health by
E-mail slpecdrh.fdagov or by fax 301-594-2968 if you have any questions about this
notice.
Sincerely yours, D. Bruce Burlington, M.D.
Director
Center for Devices and
Radiological Health
Attachment 2
July 10, 1997 LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
Information
Date of
Notice No.
Subject
Issuance
Issued to
97-47
97-42
97-39
96-53, Supp. 1
97-35
97-30
Inadequate Puncture
Tests for Type B
Packages Under 10 CFR
71.73(c)(3)
Management Weaknesses
Resulting in Failure to
Comply with Shipping
Requirements for Special
Nuclear Material
Inadequate 10 CFR 72.48
Safety Evaluations of
Independent Spent Fuel
Storage Installations
Retrofit to Amersham 660
Posilock Radiography
Camera to Correct
Inconsistency in 10 CFR
Part 34 Compatibility
Retrofit to Industrial
Nuclear Company (INC)
IR100 Radiography Camera
to Correct Inconsistency
Compatibility
Control of Licensed
Material During Reorgani- zations, Employee- Management Disagreements, and Financial Crises
06/27/97
06/27/97
06/26/97
06123/97
06/18/97
06/03/97 All "users and fabricators"
of type B transportation
packages [as defined in
10 CFR 171.16(10(B)]
All fuel cycle conversion, enrichment, and fabrication
facilities
All holders of OLs or CPs
for nuclear power reactors.
All holders of licenses for
independent spent fuel
storage installations
All industrial radiography
licensees
All industrial radiography
licensees
All material and fuel
cycle licensees
Attachment 3
July 10, 1997 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
Information
Date of
Notice No.
Subject
Issuance
Issued to
97-49
97-48
97-47 B&W Once-Through Steam
Generator Tube Inspection
Findings
Inadequate or Inappro- priate Interim Fire
Protection Compensatory
Measures
Inadequate Puncture
Tests for Type B
Packages Under 10 CFR
71.73(c)(3)
Unisolable Crack in
High-Pressure
Injection Piping
Failure of Reactor
Trip Breaker from
Cracking of Phenolic
Material in Secondary
Contact Assembly
07/10/97
07/09/97
06/27/97
07/09/97
07/02/97
All holders of OLs or CPs
for nuclear power reactors
Ail holders of OLs or CPs
for nuclear power reactors
All "users and fabricators"
of type B transportation
packages [as defined in
All holders of OLs or CPs
for nuclear power reactors
All holders of OL permits
for nuclear power reactors
97-46
96-44, Supp. 1
97-45
Environmental
Qualification
Deficiency for
Cables and Contain- ment Penetration
Pigtails
07/02/97
All holders of OLs or CPs
for nuclear power reactors
97-44
Failures of Gamma
Metrics Wide-Range
Linear Neutron Flux
Channels
07/01/97
All holders of OLs or CPs
for test and research
reactors
OL = Operating License
CP = Construction Permit
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IN 97-XX
June 2X, 1997 Discussion
This information has been coordinated with the Food and Drug Administration (FDA), the U.S.
Environmental Protection Agency (EPA), and the Conference of Radiation Control Program
Directors (CRCPD). The FDA has distributed a Public Health Notice to health care
professionals advising them of this issue and requesting a report if any contaminated lead
products are identified (see attachment). Some medical device firms and distributors have
initiated a voluntary recall. The EPA and CRCPD have provided relevant information, respectively, to regional offices and all members.
If you discover that you possess a product that contains this contaminated lead, please contact
the appropriate EPA regional office and State radiation regulatory agency.
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 below
or the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical contact: Brian W. Smith, NMSS
301-415-5723 E-mail: bwsl@nrc.gov
COORDINATED WITH EPA C. CONKLIN 6/13/97 Attachments:
1. FDA Public Health Notice
2. List of Recently Issued NMSS Information Notices
3. List of Recently Issued NRC Information Notices
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OFFICIAL RECORD COPY