9/15/2020 - STOP SALE, USE, OR REMOVAL ORDER ISSUED.
ON OR AROUND JUNE 26, 2020, MALLORY ALEXANDER INTERNATIONAL LOGISTICS (HEREIN MALLORY), THE LICENSED CUSTOMS BROKER FOR SD INTERNATIONAL, INCORRECTLY FILED AN ENTRY IN THE CBP ACE SYSTEM ON BEHALF OF SD INTERNATIONAL FOR THE IMPORTATION OF 690 OZONE GENERATORS INDICATING THAT THE GENERATORS WERE NOT PESTICIDES OR PESTICIDE DEVICES. THE SHIPMENT OF PRODUCTS ARRIVED AT THE PORT OF ATLANTA, GEORGIA ON OR AROUND JUNE 23, 2020.
UPON FURTHER REVIEW OF THE COPIES OF THE LABELS AND OWNER?S MANUALS 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 A REPRESENTATIVE OF SD INTERNATIONAL, IT WAS FOUND THAT STUDIES HAVE NOT BEEN CONDUCTED TO SUPPORT THE PESTICIDE CLAIMS, THEREFORE, THE CLAIMS ON THE LABEL APPEAR TO BE FALSE OR MISLEADING.
BETWEEN AUGUST 12, 2020 AND SEPTEMBER 3, 2020, SD INTERNATIONAL REQUESTED PERMISSION TO RELABEL THE OZONE GENERATORS, EPA ADVISED SD INTERNATIONAL THAT AN APPROPRIATE NEW ENTRY WAS REQUIRED IN THE CBP ACE SYSTEM WHICH INDICATES THAT THE PRODUCTS BEING IMPORTED ARE PESTICIDE DEVICES BEFORE THE EPA COULD ALLOW THE PRODUCTS TO BE RELABELED; THE APPROPRIATE LABELS WERE AFFIXED TO THE PRODUCTS; AND THE EPA NOTIFIED SD INTERNATIONAL THAT THE OZONE GENERATORS COULD BE RELABELED TO REMOVE THE PESTICIDAL CLAIMS AND TO AFFIX THE EPA ESTABLISHMENT NUMBER OF THAT FACILITY ON THE LABELS AT AN EPA-RE