Issue link: http://palletcentral.uberflip.com/i/507696
palletcentral.com PalletCentral • March-April 2015 15 Background: Starting in 2009 the pharmaceutical industry began receiving complaints from customers (patients) about "musty/moldy odor products." In the pharmaceutical industry, complaints are categorized into the three distinct categories (1) quality assurance complaints (e.g. tablet is cracked) (2) medical complaints/adverse events (AE) (e.g. I developed a rash at my injection site) and (3) service complaint (e.g. wholesaler might state that they received shipment 1 day late). These initial complaints came in on a branded OTC product in the U.S. (packaged in U.S. and in Puerto Rico), but soon spread to greater than a dozen products both OTC and prescription drugs, and to Canada and western EU. Since some of the complaints resulted in patients vomiting and a few going to the hospital, these were initially classified as medical complaints AE. During the development of this issue, many MoH (Ministry of Health) officials started to get involved, initially the U.S. FDA then other countries' MoHs. So What Caused the Odor ? The complaint samples were returned to the manufacturers and tested for mold contamination (a logical response due to the product's odor), but no mold was found, which led to the investigation of the packaging process where the "taint" (odor) was found. Basically lumber received for pallet manufacturing was pre-treated with a fungicide called 2,4,6 Tribromophenol (2,4,6 TBP), or 2,4,6, Trichlorophenol (2,4,6, TCP) both of which are used commonly in hot humid regions like Brazil and southeast Asia to impede the growth of mold on the newly cut wood and new wood pallets. Neither TBP nor TCP are registered in the U.S. by the EPA or USDA. Since this "taint" issue spread to many companies and multiple products, a multi-pharma group under the PDA (Parenteral Drug Association) was formed to collectively work with U.S. FDA guidance on the RCA (root cause analysis) of this issue. With this initial investigation pointing to wood pallets, many pharma companies investigated switching their whole supply chain from wood to plastic or possibly even stainless steel pallets, and quickly realized this was not a near term feasible option. Then controls for wood pallet manufacturers (article #2) and the pharma supply chain (article #3) were investigated. But the fundamental questions to be asked were 1) what is 2,4,6 TBP/TCP and 2) is this a new issue? What are "Taints"? By far, the best educational document available is authored by the Australia Food and Grocery Association (AFGA). In this booklet, the AFGA chronicles five decades of taints due to 2,4,6, TCA and 2,4,6, TBA in the food and beverage supply chain. The musty odor caused by TBA and TCA have resulted in complaints and recalls on food and beverages (see table #1) for decades despite their ubiquitous nature (e.g. they naturally occur in potable water system). TBA and TCA (substances called anisoles) are converted via a process called biomethylation from 2,4,6, TBP and 2,4,6 TCP (parent phenol compound), respectively. TBP and TCP are phenol-based compounds commonly used as a fungicide in some countries (see Figure #1) The Australian Food and Grocery Council published "Organohalogen Taints in Foods", which documented taints detected in food, beverages (e.g. canned beer), water, etc. from the 1960 to 2010 (see table #1). There were a number of sources found to be the root cause of taints including fiberboard and wood floors of shipping containers. The very low odor threshold of various organohalogens like TBA and TCA was also included in the report. This authoritative document confirmed that the taint problem is not a pallet issue, but more of a pallet management and supply chain issue. 2,4,6, Tribromophenol and 2,4,6 Trichlorophenol are common fungicides used in hot, humid climates to control mold growth on freshly cut wood and new pallets. Through biomethlylation (a naturally occurring process and ubiquitous in nature) the phenol is converted to an anisole resulting in 2,4,6, Tricholoranisole and 2,4,6, Tribromoanisole. The anisoles have a low odor threshold, which means that we can smell them at very low concentration and have a musty moldy smell. FIGURE 1