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Chemical Taint, Mold and Pallet Sanitation Update
Update on the latest developments on the concerns raised about mold and pallet sanitation.

By Matt Foley, Chaille Brindley
Date Posted: 8/1/2011

            On the heels of another recall by McNeil Healthcare involving an unusual moldy, musty, or mildew-like odor in some products, a group of pallet industry leaders has recently engaged in discussions with a pharmaceutical industry task force. This is a collaborative effort to provide information, answer concerns and better understand potential links between the chemical taint and treated lumber making its way into the US from various off-shore destinations.

            In late 2010, the Parenteral Drug Association (www.PDA.org) created a Task Force “to evaluate the available information and data in scientific literature regarding contamination of drug products with 2,4,6-tribromoanisole (TBA) through contact with wooden pallets treated with TBP (2,4,6-tribromophenol)”. The group is comprised of representatives from Johnson and Johnson, Genentech, Pfizer, GlaxoSmithKline, Merck, West Pharma, Rexam Pharma, Patheon, Depomed, Perrigo, SP Corp, The Consumer Healthcare Products Association and others.

            After having telephone conversations with Matt Foley of X-Mold and NWPCA Chairman John Swenby, the Chairperson of the PDA Task Force agreed to give an audience to the group of ad hoc pallet industry representatives. On Monday July 18th, a conference call was convened with the objectives of a) development of a better understanding on the PDA group’s part regarding the multitude of overall issues contributing to taint by TBP (issues well beyond wooden pallets!) and, b) outlining a simple set of pallet and lumber industry best practices to prevent pallet-related mold, taint and sanitation problems. The PDA Task Force then presented its findings to Food and Drug Administration (FDA) officials, having received input from pallet industry.

            The pallet industry leaders who worked together as a team on this issue include: the National Wooden Pallet & Container Association (NWPCA), researchers from the Virginia Tech Center For Unit Load Design, the Director of Technical Microbiology Services from Troy Corporation (a manufacturer of mold/mildew chemicals), the Pallet Enterprise staff, and other industry voices. Led by John Swenby and Virginia Tech’s Ralph Rupert as Co-Chairpersons, they educated the small PDA Task Force group by telephone, and notified the PDA group of NWPCA’s current focus on announcing its own Best Handling Practices involving pallet storage & handling, and to provide voluntary guidelines to add value in the supply chain.

            TBP/TBA and taint on exterior packaging connected to drug recalls has received much media scrutiny, especially over the last year or so. From the chaos which ensued, there are several key points the pallet industry leaders focused on in their discussion with the PDA group.

            1.) TBP – The root of almost all of the pharmaceutical industry issues and recalls is now believed to be pervasive gases Tribromoanisole (TBA) and Trichlorolanisole (TCA). Both gases are derivatives of Tribromophenol (TBP) or Trichlorolphenol (TCP), fungicides used extensively outside the US, but banned from use by the US lumber industry by the Environmental Protection Agency (EPA). Under certain conditions, this “phenol” class of fungicide (TBP/TCP) undergoes an adverse chemical reaction and results in the release of the tainting gases (TBA or TCA). There is very little likelihood that any TBA and TCA entered the pharmaceutical supply chain on a new U.S. manufactured pallet. The key is to eliminate the problem at the source, where offshore lumber production is still heavily reliant on treating wood with TBP which is then fashioned into a pallet in Puerto Rico or elsewhere. TBA and TCA also occur naturally in water systems with plastic pipes and are widely present in many other materials and locations throughout the supply chain. Because of this, the elimination of TBA and TCA from the supply chain is a steep challenge.

            2.) Mold – Mold is essentially everywhere.  All you can do is reduce the potential for wooden pallets to develop mold. The primary means for accomplishing this are to dry lumber to a low moisture content, to properly store and handle pallets and to use mold and mildew resistant wood coatings to reduce the threat.

            3.) Heat-Treating – Heat treating has very little to do with mold treatment unless it is accompanied by significant drying of the wood. International heat treating requirements are in place to deal with forest quarantine pests. In many instances heat treating can and will make wood more prone to mold. Most woods, even kiln-dried pines, can eventually mold when the right set of conditions exist.

            4.) Chemistry & Fungicides – Offshore, the TBP or TCP based fungicide class of wood treatment should be avoided due to its known issues, and lumber from destinations where its use is still prevalent needs to be more closely scrutinized. In North America and elsewhere, there are active ingredients that can be helpful to reduce the risk of mold without jeopardizing product safety. Numerous active ingredients, registered by the EPA and intended for use as wood coatings, are available. Examples include chlorothalonil, copper 8 quinolinate, IPBC & propiconizole and quaternary ammonium, to name a few. Many end users of pallets still have concerns about the use of chemical treatments on mold, because they fear someday having to face the same costly “TBP-like” issues that have beset the pharmaceutical industry. While mitigating risk always makes sense, this particular fear is unfounded. As long as EPA registered active ingredients are being used properly, the likelihood of further adverse chemical reactions is remote. All of that said, North American end users of pallets should become increasingly more comfortable about the use of chemical wood coatings as a mold preventative measure and value added offering from their pallet suppliers.

            5.) Best Practices – The NWPCA is finalizing a Best Handling Practices to be used by pallet manufacturers, recyclers and end users. After the draft guidelines are vetted by the industry, NWPCA will present its best handling practices to the FDA in the hope that the agency recognizes the effort of the industry to resolve pallet handling issues throughout the supply chain. Bruce Scholnick, president of the NWPCA, recently wrote, “With the introduction last year of the Food Modernization Act, which will be implemented by FDA, pallets and containers will be under new scrutiny and likely subjected to more regulations.”

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