Many laboratorians are not sufficiently aware that there are a number of possible complications associated with shipping infectious biological substances and patient specimens. These complications are often due to misunderstanding the transport regulations or possible cost concerns, and this confusion can lead to package rejections or even fines. One method currently employed by some shippers to alleviate these complications is to neutralize the infectious agent in the sample so the biological substance is no longer considered an infectious substance and therefore not regulated by transport regulations.
As practical as this solution may seem to be, it has a significant flaw: the neutralizing agent that is used could itself be considered a dangerous good. If it were, the shipment would be considered to be improperly prepared and packaged, and this could still result in package rejection or fines.
In 2010, for example, the U.S. Department of Transportation issued fines ranging from $800 to $7,100 to a number of laboratories for improperly prepared shipments of dangerous goods. Common culprits are solutions of formaldehyde or formalin, which may qualify as dangerous goods. The transport regulations concerning formaldehyde and formalin solutions may be confusing, so here are some key points to help properly classify them and avoid potential transport complications. (This article is not a comprehensive overview of the transport requirements, as additional training and certification are required to ship formaldehyde solutions.)
The reason for the classification of dangerous goods in transport is that they might pose risks to people, property or the environment if an incident occurred during transport and the substance was exposed outside of its packaging. Consequently, the substances that pose a greater risk require increased measures of protection, and the risks of transporting them may not be the same as those commonly found in the laboratory. In the laboratory, for example, long-term exposure to formaldehyde may be carcinogenic. In the transport setting, this risk, although significant, is not a concern. When formaldehyde is shipped, it should be placed in protective packaging so transport workers are not in direct contact with the substance. If an incident occurred in which the contents of the package leaked, the leaked material would need to be cleaned up quickly and properly, to ensure there would be no long-term risks associated with exposure.
The transport regulations recognize the risks of formaldehyde solutions as a corrosive material and place these under the classification “Dangerous Goods, Class 8.” Formaldehyde solutions are generally assigned to UN 2209 (UN numbers, assigned as part of the Recommendations on the Transport of Dangerous Goods, refer to hazardous substance in the context of international transport) and given the proper shipping name Formaldehyde solution. As transport regulations recognize that formaldehyde becomes less dangerous when diluted, the only solutions required to be shipped according to the requirements of UN 2209 are those which contain more than 25% formaldehyde. If the solution is commercially prepared, the best place to find the concentration is in the Safety Data Sheet (SDS) or the Materials Safety Data Sheet (MSDS), where this information should be listed in the ingredients section. If this information is not available, it is in the best interest of safety to consider the solution to contain more than 25% formaldehyde, and prepare the shipment according to the requirements of UN 2209.
If the concentration of formaldehyde in the solution is 25% or less, there are a few different options available. As the percentage of the formaldehyde in the solution becomes more diluted, the risks during transport are also reduced. For solutions where the concentration of formaldehyde is between 10% and 25%, the main concern is the irritable nature of the formaldehyde vapors. With the decreased risk, the solution is no longer classified as a Class 8 Corrosive material, but rather as a Class 9 Miscellaneous Dangerous Good, and assigned to UN 3334, with the proper shipping name Aviation regulated liquid n.o.s. (not otherwise specified). Aviation regulated liquids are those liquids that have noxious or irritating properties where, if the solutions were to leak during air transport, they could cause discomfort or annoyance to crew members and might inhibit them from properly performing their duties. The requirements for these shipments are reduced from those of UN 2209 Formaldehyde solution.
When the percentage of formaldehyde in the solution is below 10%, there are two classification options. The difference between these options depends on the presence of alcohol in the solution. This will be indicated on the Safety Data Sheet (SDS) in the ingredients section. If there is no alcohol in the less than 10% formaldehyde solution, it is not considered dangerous and therefore is not subject to the transport regulations. However, many solutions with less than 10% formaldehyde use an alcohol to stabilize the mixture. Some common alcohols used in these solutions are methyl alcohol or methanol. Any quantity of alcohol changes the classification of the solution.
Since the formaldehyde in the solution is less than 10%, it is not considered a dangerous good; however, the alcohol in the solution is a dangerous good, and therefore the solution is classified as a Class 3 Flammable Liquid. In addition, the formaldehyde in the solution is recognized as a secondary or subsidiary risk. Finally, the classification of a solution with less than 10% formaldehyde and with any quantity of an alcohol is a Class 3 Flammable Liquid with a Class 8 Corrosive subsidiary risk, and is assigned to UN 1198 with the proper shipping name Formaldehyde solution, flammable.
In summary, to avoid potential fines it is important to remember that there are four different classification options for formaldehyde solutions. If more than 25% of the solution is formaldehyde, it is assigned to UN 2209 Formaldehyde solution. If there is 10% to 25% formaldehyde in the solution, it is assigned to UN 3334 Aviation regulated liquid, n.o.s. If there is less than 10% formaldehyde in the solution and the solution also contains an alcohol, it is assigned to UN 1198 Formaldehyde solution, flammable. If there is less than 10% formaldehyde in the solution and there is no alcohol in the solution, the transport regulations do not consider it a dangerous good and therefore it is not subject to the regulations. However, for formaldehyde solution options that are considered dangerous goods, all shippers must be trained and certified before they are authorized to offer their shipments for transport.
David Creighton is Regulatory and Training Manager for Maryland-based Saf-T-Pak. As the company's regulatory expert, David speaks to groups ranging from government agencies and pharmaceutical companies to clinical trial sites. He also serves as Saf-T-Pak's Training Product Manager and oversees the development of Saf-T-Pak's training products.
