Information Notice 1997-50, Contaminated Lead Products

Contaminated Lead Products

ML031050338
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:	07/10/1997
From:	Cool D NRC/NMSS/IMNS
To:
References
IN-97-050, NUDOCS 9707030268
Download: ML031050338 (7)

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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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IN 97-50

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

-> -- < _Attachment 1 IN 97-50

July 10, 1997 SERVICES

O EALTHU

HMDEPARTMENT

MAN 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

V) Attachment 1 IN 97-50

July 10, 1997 i 2 window Geiger Mueller

qualified personnel with a suitable survey meter, such as a thin

beta from the Bi-210 is

(G-M) instrument in contact with the product. The 1.16 MeV

easily detected with this type of instrument.

for further

If the survey results indicate contamination, contact your supplier

instructions.

of your devices

• If you don't have the capability to survey, contact the supplier

are affected by this

purchased after October 1, 1996, to determine if their products

problem.

or supplier

• If you receive a notice or a customer letter from a manufacturer

which should include information on

concerning this matter, follow the instructions

disposition of affected products.

to identify all contaminated

FDA is working with state radiation control program officials

and to facilitate

lead products that have been introduced into commercial distribution

information becomes

effective recalls of all contaminated devices. As additional

available, FDA will issue updated notices.

lead to report this

FDA requests users who discover shielding products with contaminated

program. Submit these

information directly to MedWatch, the FDA's voluntary reporting

at 1-800-FDA-0178, or

reports to MedWatch by telephone at 1-800-FDA-1088, by FAX

by mail to:

MedWatch

Food and Drug Administration, HF-2

5600 Fishers Lane

Rockville, MD 20857 Radiological Health by

Contact Sherry Purvis-Wynn of FDA's Center for Devices and

any questions about this

E-mail slpecdrh.fdagov or by fax 301-594-2968 if you have

notice.

Sincerely yours, D. Bruce Burlington, M.D.

Director

Center for Devices and

Radiological Health

Attachment 2 IN 97-50

July 10, 1997 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

97-47 Inadequate Puncture 06/27/97 All "users and fabricators"

Tests for Type B of type B transportation

Packages Under 10 CFR packages [as defined in

71.73(c)(3) 10 CFR 171.16(10(B)]

97-42 Management Weaknesses 06/27/97 All fuel cycle conversion, Resulting in Failure to enrichment, and fabrication

Comply with Shipping facilities

Requirements for Special

Nuclear Material

97-39 Inadequate 10 CFR 72.48 06/26/97 All holders of OLs or CPs

Safety Evaluations of for nuclear power reactors.

Independent Spent Fuel All holders of licenses for

Storage Installations independent spent fuel

storage installations

96-53, Retrofit to Amersham 660 06123/97 All industrial radiography

Supp. 1 Posilock Radiography licensees

Camera to Correct

Inconsistency in 10 CFR

Part 34 Compatibility

97-35 Retrofit to Industrial 06/18/97 All industrial radiography

Nuclear Company (INC) licensees

IR100 Radiography Camera

to Correct Inconsistency

in 10 CFR Part 34 Compatibility

97-30 Control of Licensed 06/03/97 All material and fuel

Material During Reorgani- cycle licensees

zations, Employee- Management Disagreements, and Financial Crises

Attachment 3 IN 97-50

July 10, 1997 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

97-49 B&W Once-Through Steam 07/10/97 All holders of OLs or CPs

Generator Tube Inspection for nuclear power reactors

Findings

97-48 Inadequate or Inappro- 07/09/97 Ail holders of OLs or CPs

priate Interim Fire for nuclear power reactors

Protection Compensatory

Measures

97-47 Inadequate Puncture 06/27/97 All "users and fabricators"

Tests for Type B of type B transportation

Packages Under 10 CFR packages [as defined in

71.73(c)(3) 10 CFR 171.16(10)(B)l

97-46 Unisolable Crack in 07/09/97 All holders of OLs or CPs

High-Pressure for nuclear power reactors

Injection Piping

96-44, Failure of Reactor 07/02/97 All holders of OL permits

Supp. 1 Trip Breaker from for nuclear power reactors

Cracking of Phenolic

Material in Secondary

Contact Assembly

97-45 Environmental 07/02/97 All holders of OLs or CPs

Qualification for nuclear power reactors

Deficiency for

Cables and Contain- ment Penetration

Pigtails

97-44 Failures of Gamma 07/01/97 All holders of OLs or CPs

Metrics Wide-Range for test and research

Linear Neutron Flux reactors

Channels

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: CRCPD

1. FDA Public Health Notice

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices

DOCUMENT NAME: CONTLEAD.IN

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IMOB Tech Editor I IMOL I OSP I FCSS I Z

NAME BSmit-}EKraus LBangart LETenEYCK

DATE 6/13 /97 1 6/1 -/97 6/3/97 6/ /97 j 6/ /97 OFC NRR lEI III ZI IZK

NAME AChaffee 7i

DATE 6/ /97 3/97 _ _

OFFICIAL RECORD COPY