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CONSUMER PRODUCTS Kinesiology Tape / Wristbands Rusty Lundberg Utah Division of Radiation Control OAS Annual Meeting August 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 INSPECTION February 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-232 Endevr™ Wrist Band Samples Gamma Spectroscopy Analytical Service Provider LowHigh Utah0.020%0.090% Colorado0.037%0.176% Virginia0.090%0.170% NRC – ORAU0.080%0.200%
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ANALYTICAL RESULTS Percent by Weight of Thorium-232 in Negative Ion Powder* by Inductively Coupled Plasma-Atomic Emission Spectrometry Analytical Service Provider LowHigh 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
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Contact Information: Rusty Lundberg Utah Division of Radiation Control rlundberg@utah.gov 801-536-4257 QUESTIONS?
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