The Department of Homeland Security (DHS) has established Chemical Facility Anti-Terrorism Standards (CFATS) covering sites handling over 300 Chemicals of Interest. http://www.dhs.gov/xlibrary/assets/chemsec_appendixa-chemicalofinterestlist.pdf The listed chemicals were identified in the Federal Register on November 20, 2007. This table lists Minimum Concentrations and Screening Thresholds for addressing Release, Theft and Sabotage concerns for these chemicals. Seven different Security Issues are contained within the list. Triethanolamine (TEA) is listed as a chemical weapons precursor when at a minimum concentration of 80% and a screening threshold quantity of 220 lb.

Triethanolamine is commonly sold in two grades of purity, 99% and 85% (the remainder of the 85% grade is diethanolamine. Both grades are offered in LFG or Low Freeze Grade versions. The LFG versions contain 15% added water to prevent them from solidifying at common storage temperature.

If you buy only TEA 85 LFG, the concentration is 85% of 85 or 72.25% thus it fails to make the 80% minimum concentration that would trigger the CFATS rules. The three remaining grades are all above the minimum concentration threshold.

500lb is the common weight for TEA in drums. All grades of TEA in drums exceed the 200# screening threshold quantity. None of the grades meet this quantity in 40# pails. Doing a little math reveals that you could have the following number of pails:

• TEA 85                         5 pails
• TEA 85 LFG               Any Quantity of pails or drums
• TEA 99                         4 pails
• TEA 99 LFG                5 Pails

If you find that you need to comply with CFATS because you store or use TEA (or any of the additional 300 or so chemicals of Interest on the list), your first step in is to arrange to have the U.S. Department of Homeland Security’s Office of Infrastructure Protection appoint you or one of your employees as an Authorized User of Chemical-terrorism Vulnerability Information. They will then need to prepare a Top-Screen profile using the DHS Chemical Security Assessment Tool (CSAT). Once this has been done and submitted to DHS a Chemical Security Identification Number will be assigned to your facility. In our experience it appears unlikely that your facility would be classified as High-Risk if the sole reason for registering was a drum or two of TEA. It could be more of a problem if the DHS identified you as a consignee of TEA while inspecting the shipping records of a vendor.

The Federal Food and Drug Administration (FDA) has announced it is reviewing the safety of triclosan, the active ingredient in many antibacterial soaps and body washes.  This follows the December 10th release of the Fourth National Report on Human Exposure to Environmental Chemicals by the Centers for Disease Control and Prevention.  The report provided an extensive look at 75 chemicals that had not been previously measured in the US population.  Triclosan, characterized in the report as an “endocrine disruptor” was among the materials present in blood or urine samples from the 2400 study participants.  While industry trade groups point out that the mere presence of environmental chemicals in blood or urine is not necessarily cause for health concerns, it is eerily similar to the situation that caused the demise of the material triclosan replaced, hexachlorophene.

Some will remember the trade name pHisoHex, a highly effective over-the-counter (OTC) antibacterial skin cleanser available in the 1960’s.  In 1969, hexachlorophene was suspected as being a carcinogen.  pHisoHex and several OTC antibacterials for treating acne and other uses including surgical scrubs were withdrawn from the market.  Later studies cast doubt on the original classification of hexachlorophene as a carcinogen but the damage was done.  Once FDA approval for an active ingredient has been withdrawn, it is all but impossible to undo the damage.  Caution is advised if triclosan plays an important role in your product mix.

Last December, the producer of  Tylenol reported a recall due to what was described as an unusual odor.  Since then, the recall has been extended to include additional products most of which were produced at a factory in Puerto Rico.  The recall now covers more than 50 million consumer packages.  Some illnesses are alleged.

Tylenol’s manufacturer issued a statement on December 18 stating: “The uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The source of the 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.”

The pallets in question are believed to have originated in the Dominican Republic however; it is proving to be difficult to trace their exact origin.  To complicate matters, the Dominican Republic shares the island of Hispaniola with Haiti and has suffered significant infrastructure disruption as a result of the recent earthquake.

What might this mean to you?  Keep in mind that wooden pallets are used and re-used throughout the industry.  The problem was identified following a spike in consumer complaints.  The pallets bearing early shipments of off-odor products have had plenty of time to work their way to your dock!  Once in your warehouse, they may cause issues with product stored on or adjacent to affected pallets.

If your product line includes FDA Regulated Food, Drug, Cosmetic or Medical Device items you should be especially concerned.  The FDA’s position is bluntly stated in an official warning letter to the Tylenol Manufacturer that you can examine at:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm197811.htm .

The National Wooden Pallet and Container Association has issued a fact sheet regarding the Tylenol recall which can be viewed at:

http://www.nwpca.com/_INTLRegulations/Tylenol.pdf

The FDA Warning Letter cites Tylenol’s producer for failure to submit Field Action Reports (FARs) to the FDA within three days.  Had the product been a food, the allowed time would have been 24 hours effective when the Reportable Food Registry (RFR) regulations went into effect on September 8, 2009.  The RFR uses FDA’s new electronic portal.

Be sure your drivers, warehousemen and dock workers are alert to this problem and equipped to take prompt decisive action.