CONSUMER PRODUCTS Kinesiology Tape / Wristbands Rusty Lundberg Utah Division of Radiation Control OAS Annual Meeting August 26, 2014 Utah Department of.

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Presentation transcript:

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  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

SEQUENCE OF EVENTS  FDA Inspection of Endevr™  Endevr™ follow-up actions / contacts made  Utah DRC (UDRC) notification NRC Region 4 ( February 2014)  UDRC Contacts made with: NRC, FDA, OAS, Endevr™, CA UDRC Site visit of Endevr™  Conference calls FDA, NRC, OAS, CRCPD

Endevr™ – St. George, Utah

SITE INSPECTION February 19, 2014  Date  Findings photos

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

K-TAPE / WRIST BANDS

ANALYTICAL WORK  K-tape FDA – WEAC FDA – Health Risk Assessment  Wristbands OAS  VA & CO (UT DRC) NRC – Oak Ridge

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%

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)

COMMUNICATIONS  NRC to OAS/UDRC  OAS/CRCPD/NRC Monthly calls  FDA to UDRC  FDA analytical results

UTAH ACTIONS New web page

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

Contact Information: Rusty Lundberg Utah Division of Radiation Control QUESTIONS?

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