[b][COLOR=“blue”]Tribromanisole (TBA) contamination has already affected multiple firms. This is acknowledged by USFDA. The issue of tribromoanisole (TBA) is a relatively new one to pharmaceuticals, but the wine and food industry has dealt with this for a while. Organo halogen taints were first reported in Dutch boiler chickens exposed to trichlorophenol treated wood chips used as bedding materials 45 years ago.
Wooden pallets were constructed from this lumber and the pallets where used to transport Packaging components to pharmaceutical plants in Puerto Rico. Fungal growth on the wooden pallets resulted in the biomethylation of TBP to TBA. The moisture content of wood must exceed 13% to support fungal growth so insufficiently dried lumber or pallets exposed to relative humidity exceeding 70% will be susceptible to fungal growth. Poor ventilation of warehouses may have contributed to the fungal growth. TBA, a highly volatile chemical, is detected at part per trillion concentrations as a moldy, musty odor, was absorbed into the walls of high density polyethylene containers and nauseated people when they open containers of consumer healthcare products.
The voluntary standards for pallets used in international trade are specified in the International Standards for Phytosanitary Measures 15 Guidelines for Regulating Wood Packaging Material in International Trade. Pallets used in international commerce are heat treated at 56ºC for at least 30 minutes and fumigated with methyl bromide as specified in the ISPM 15 Guidelines. TBP is not registered as a pesticide by the U.S Environmental Protection Agency. Hence, it is illegal to use it to treat pallets in the United States.
TBA taints is relatively new to the pharmaceutical industry, an organohalogen taint, trichloroanisole, was reported in association with compressed tablets by Upjohn in the early 1990’s.[/color][/b]