Wood Pallet and Pharmaceutical Industries Working Together – Part 1
By David Ulrich (Abbott Industries), Jorgelina González (Paleteras Unidas & Caribe Recycling) and
Edgar Deomano, Ph.D. (NWPCA), June 2012
In
2010, Abbott Laboratory invited the National Wooden Pallet and Container
Association (NWPCA) on site for a workshop to understand, from
the NWPCA perspective, the issue of 2,4,6 tribromoanisole (TBA)
and 2,4,6 trichloroanisole (TCA) taints. Our question was
whether the numerous pharmaceutical and over-the-counter (OTC) products
that were being recalled was truly a wood pallet issue (i.e. inherent
to wood pallets) or was it more of a supply chain pallet management
issue (i.e. would appropriate controls mitigate this issue). The
goal of these initial discussions was to determine the root cause
of the taints.
- This first installment will give background on the recalls and what TBA or
tca are, where they come from and why wood pallets were initially accused
of being the culprit of the taints and therefore the recalls.
It will also give a non-pharmaceutical history of these taints related
to the food and beverage industry, based off of the Australia
Food and Grocery Council report “Organohalogen Taints in Foods”.
- The second article will focus heavily on controls needed at the mill and
the pallet manufacturing site to eliminate the risk of taints in their products.
It will also focus on cleaning and how pallet manufacturers can be proactive in
mitigating the risk of these taints in their supply chain and manufacturing
process, and how the pallet industry can partner with the pharmaceutical industry
to educate them on wood pallets.
- The third article will focus on controls needed by the pharmaceutical manufacturers
and recommendations that the “pallet management controls” (which will be
discussed in this installment) be integrated into their Good Distribution Practices
(GDP) and part of their Supply Chain Integrity (SCI) plan.
- The fourth, and final, article will give an overview of a computer based training
(CBT) program that will be published by the NWPCA for use by both pallet manufacturers
and pharmaceutical manufacturers that will educate on the issue of taints and controls
needed by both pallet manufacturer and pharmaceutical supply chain personnel.
Background
Starting in 2009 and continuing into 2011, the
pharmaceutical industry began receiving complaints from customers
about “musty/moldy odor products.” In the pharmaceutical industry,
complaints are categorized into the three distinct categories:
1) Quality Assurance (QA) complaints,
e.g. a tablet is cracked); 2) medical complaints / adverse events
(AE), e.g. consumer developed a rash at the injection site; and
3)
service complaint, e.g. wholesaler states they received shipment
day late.
Initial complaints came
in on a branded OTC product in the United States and Puerto Rico, but
soon included more than a dozen products, both OTC and prescription
(Rx), and spread to Canada and western Europe. Initially these were
classified as medical complaints because some of the complaints resulted
in patients vomiting and a few going to the hospital. During the development
of this issue, Ministry of Health (MoH)
departments started to get involved, initially the U.S. Food and
Drug Administration (FDA), then other country’s MoH.
So,
what caused the odor?
The complaint samples were returned to the manufacturers
and tested for mold contamination, which makes sense due to the product’s
odor, but no mold was found. This then lead the investigation to
the packaging process where the “taint” (odor) was found.
Basically, wood used for pallets was treated with a fungicide called
2,4,6 tribromophenol(TBP), or 2,4,6 trichlorophenol(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.
Neither TBP nor TCP are registered in the
United States by the Environmental Protection Agency (EPA) or the
U.S. Department of Agriculture (USDA). Since this “taint” issue
spread throughout many companies and multiple products, a multi-pharmaceutical
group under the Parenteral Drug Association (PDA) was formed to collectively
work on the root cause analysis (RCA) of this issue.
With this initial investigation pointing
to wood pallets, many pharmaceutical companies looked into switching
their entire supply chain from wood to plastic, or possibly even
stainless steel, pallets. They quickly realized this was not a near-term
feasible option. Controls were then investigated with wood pallet manufacturers
(to be discussed in the next article of this series) and the pharmaceutical
supply chain (article #3). But the first questions to be asked were:
what is TBP/TCP and is this a new issue?
By far the best educational document available on this issue was published by the Australia Food
and Grocery Council. The report chronicles five decades of taints due
to TCA and TBA in the food and beverage supply chain. Their musty odor has caused
complaints and recalls on food and beverages (see Table 1) for decades.
They are ubiquitous in nature (e.g. naturally occurring in potable
water system). TBA and TCA(the anisoles) are converted via biomethylation of TBP and
TCP (parent phenol compound), respectively. TBP and TCP are phenol-based compounds commonly used as fungicide in some countries (see Figure 1).
The Australia Food and Grocery Council published “Organohalogen Taints
in Foods” which documented taints detected in food, beverages
(e.g. canned beer), water, etc. from the 1960s to 2010 (see Table 1). A number of sources were found to be the root cause of taints including fiberboard and wood floors of shipping
containers. The very low odor threshold of various organohalogens was
also included in the report. After digesting this informative report,
it confirmed that the taint problem is not a pallet issue but more
of a pallet management and supply chain issue.
ISPM-15, which prescribes treating pallets
to control quarantine pests from freely moving around the
world via wood pallets, prescribes two methods for treating
wood: 1) methyl bromide (MB) fumigation, which is very effective
but no longer allowed in many countries; and 2) heat treatment,
which is also very effective and economical but can increase
surface moisture, hence possibly encouraging mold to grow (moisture
control and mold control will be addressed in articles #2 and
#3).
Initially, the pharmaceutical
industry thought heat treatment was an answer to control taints.
However, as our industry learned more about heat treating vs.
kiln drying, the industry eventually realized it is not intended
for mold control but for control of invasive species. We have
also learned that heat treatment can actually induce mold growth
if not done properly. But this standard was developed for control
of quarantine pests – not mold control – so logically
a country (e.g. Brazil) that wants to control mold would actively
use a fungicide, hence the use of the phenol based TBP and TCP.
Here is the problem: these very effective
fungicides are used on wood for pallets and if the pallets
are not properly stored (i.e. pallet management program) by
either the pallet manufacturer or the supply chain that uses
them, the phenol can convert to the anisole which once again
smells like mold as it has an extremely low odor threshold.
Obviously, understanding the pallet manufacturing process and
not allowing TCP or TBP to be used on wood for pallets is a
first step towards controlling these taints in the pharmaceutical
supply chain. However, that is not the only corrective action
/ preventive action (CAPA). Proper storage of pallets, away
from weather elements with adequate ventilation, is just as
important (more in articles #2 & #3).
Let’s say you have a shipping container used to transport pineapples or bananas or any “organic” product,
and naturally some juice is leaked onto the container floor. If the transport container has wood runners and the container
is washed out with bleach (an acceptable procedure) BUT the bleach is allowed to sit and soak into the wood, this can naturally
produce anisole (note bleach is hypochloric acid [HOCl]). These containers that are washed with bleach (but not rinsed), are
the cause of a great many of the taints found in food products.
- Pharmaceutical manufacturers need to know their pallet supplier and make them part of their supplier program and an approved vendor (with agreed upon specifications).
- Make pallet management part of an audit program for third party manufacturers
(TPMs) including packaging supplier and commodity, e.g. plastic bottles.
- Specification of handling instructions, e.g. – “Don’t apply any halogenated fungicides on wood pallets.”
- ISPM 15 compliance is necessary but does not mitigate taints and the pharmaceutical company needs to know what method the pallet manufacturer uses.
- Pallets should be inspected for “household cleanliness”.
- Pallets should be stored high and dry.
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