8/7/2020 - STOP SALE, USE, OR REMOVAL ORDER ISSUED.
ON OR AROUND APRIL 21, 22, AND 28, 2020, UPS SUPPLY CHAIN SOLUTIONS, INC. (HEREIN UPS), THE LICENSED CUSTOMS BROKER FOR CPAP, INCORRECTLY FILED THREE SEPARATE ENTRIES, IN THE CBP ACE SYSTEM ON BEHALF OF CPAP FOR THE IMPORTATION OF 360 OZONE GENERATORS PER SHIPMENT INDICATING THAT THE GENERATORS WERE NOT PESTICIDES OR PESTICIDE DEVICES. THE PRODUCTS ARRIVED AT THE PORT OF LOUISVILLE, KENTUCKY UPS ON OR AROUND APRIL 20, 2020.
THE OZONE GENERATORS IMPORTED BY CPAP ARE ?PESTICIDE DEVICES? AS THAT TERM IS DEFINED BY SECTION 2(H) OF FIFRA, 7 U.S.C. 136H, IN THAT THEY ARE INSTRUMENTS INTENDED FOR DESTROYING PESTS. SPECIFICALLY, THE LABEL CLAIMS THAT THE OZONE GENERATOR IS A ?CPAP SANITIZER SYSTEM? AND ?DUAL SANITIZER.?
UPON FURTHER REVIEW OF THE COPIES OF THE LABELS FOR THE OZONE GENERATORS, THE EPA DETERMINED THAT THE GENERATORS WERE MISBRANDED DUE TO THE ABSENCE OF AN EPA ESTABLISHMENT NUMBER. FURTHER, AFTER DISCUSSIONS WITH REPRESENTATIVES OF CPAP, IT WAS FOUND THAT STUDIES HAVE NOT BEEN CONDUCTED TO BACK UP THE ?SANITIZING? CLAIMS, THEREFORE, THE CLAIMS ON THE LABEL APPEAR TO BE FALSE OR MISLEADING.
THE 1,080 OZONE GENERATORS PESTICIDE DEVICES THAT WERE IMPORTED INTO THE UNITED STATES BY CPAP, AS SET FORTH IN THIS SSURO, ARE MISBRANDED AS SET FORTH IN PARAGRAPH 15 ABOVE AND FURTHER SALE OR DISTRIBUTION OF THESE PESTICIDE DEVICES IN THE UNITED STATES, INCLUDING MOVING THE PRODUCT TO ANY OTHER FACILITY FOR RELABELING,