consumer products kinesiology tape / wristbands
DESCRIPTION
CONSUMER PRODUCTS Kinesiology Tape / Wristbands. Rusty Lundberg Utah Division of Radiation Control OAS Annual Meeting August 26, 2014. Utah Department of Environmental Quality. EVENT. Initial embargo of Kinesiology Tape (K-tape) at the Port of Los Angeles containing Th-232 - PowerPoint PPT PresentationTRANSCRIPT
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CONSUMER PRODUCTS
Kinesiology Tape / Wristbands
Rusty LundbergUtah Division of Radiation Control
OAS Annual MeetingAugust 26, 2014
Utah Department of Environmental Quality
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EVENT
Initial embargo of Kinesiology Tape (K-tape) at the Port of Los Angeles containing Th-232
Identification of U.S. importer Endevr™ – located in St. George, Utah
Formerly DBA LifeStrength, LLC Distributor, wholesale and retail sales
(including online) Also sells silicone wrist bands using
negative ion technology Eventual inclusion of wrist bands
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SEQUENCE OF EVENTS
FDA Inspection of Endevr™ Endevr™ follow-up actions / contacts made Utah DRC (UDRC) notification
NRC Region 4 (email February 2014) UDRC
Contacts made with: NRC, FDA, OAS, Endevr™, CA
UDRC Site visit of Endevr™ Conference calls
FDA, NRC, OAS, CRCPD
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Endevr™ – St. George, Utah
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SITE INSPECTIONFebruary 19, 2014
Date Findings
photos
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SITE INSPECTION
Findings No manufacturing of products at site Exposure rate measurements taken
Warehouse – Background ~ 10 µR/hr Warehouse – surface box containing about
2,000 wrist bands ~ 60 µR/hr (net) No removable contamination detected Collected sample K-tape and wrist
bands Wrist bands analyzed by UDRC & ORAU
Sent report to NRC
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K-TAPE / WRIST BANDS
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ANALYTICAL WORK
K-tape FDA – WEAC FDA – Health Risk Assessment
Wristbands OAS
VA & CO (UT DRC) NRC – Oak Ridge
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ANALYTICAL RESULTS
Percent by Weight of Thorium-232Endevr™ Wrist Band Samples
Gamma Spectroscopy
Analytical Service Provider
Low High
Utah 0.020% 0.090%
Colorado 0.037% 0.176%
Virginia 0.090% 0.170%
NRC – ORISE 0.080% 0.200%
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ANALYTICAL RESULTS
Percent by Weight of Thorium-232in Negative Ion Powder*
by Inductively Coupled Plasma-Atomic Emission Spectrometry
Analytical Service Provider
Low High
CITEK** <0.001% <0.01%
*Wrist bands Endevr™ purchases use negative ion powder at a concentration of 3% of the silicone matrix.
** Shenzhen Citek Technology Co., TLD (Zhejiang Province, China)
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COMMUNICATIONS
NRC to OAS/UDRC
OAS/CRCPD/NRC Monthly calls
FDA to UDRC
FDA analytical results
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UTAH ACTIONS
New web page
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UTAH ACTIONS
Coordination with Endevr™ Final disposition of unsold wristbands
likely subject to licensing and remaining as stored inventory
Periodic evaluation of products now being sold/distributed with lower source concentration in ion powder