Zika virus – the name itself sounds exotic and dangerous. It is believed to be a serious risk for pregnant women. And it’s due to arrive in North America. Just how great a danger is this virus, and how should research and medical facilities prepare for the regulatory burden?
First of all, Zika is not a new virus. It has been known since the 1950s in equatorial Africa and Asia, but only recently has it appeared to migrate to new territories, including South and Central America, the Caribbean and Mexico. It is primarily a mosquito-borne illness, transmitted by the Aedes genus of mosquitos. Possibly climate change has increased the populations of these mosquitos in the areas where Zika is spreading. Aedes mosquitos are found in some parts of the U.S., and although they are not currently believed to be in Canada, they may spread as the climate warms. Person-to-person transmission by body fluids is possible, but this would be relatively rare compared to the mosquito vector.
Zika is classed in the Flaviviridae family of viruses, along with dengue fever, West Nile virus and the notoriously dangerous yellow fever. However, compared to these, Zika is usually a mild affliction. According to the Centers for Disease Control (CDC), only one in five persons infected with the virus shows any symptoms at all. For those who do fall ill, the symptoms are described as flu-like: fever, joint and muscle pain, inflammation of the eyes (conjunctivitis) and a rash. Although there is no cure, and the virus does not respond to antibiotics, the infection normally resolves without treatment within a week. Fatalities are extremely rare. In other words, Zika is, for most people, a mildly unpleasant illness that they recover from quickly. Even better, exposure to Zika usually results in lasting immunity.
So, why has Zika become such a big issue in public health? While most people only become mildly ill when infected with Zika, the infection appears to be correlated to increases in two much more serious conditions: the neurological condition called Guillain-Barré syndrome (which can be triggered by a number of infections), and most tragically, the birth defect called microcephaly.
Microcephaly is a condition where a baby’s head is smaller than normal, and often includes abnormal brain development. The CDC indicates “problems can range from mild to severe and are often lifelong. In some cases, these problems can be life-threatening.“
It should be noted that we don’t yet have a conclusive linking of Zika to microcephaly, but some relatively strong evidence has been gathered. There appears to be a statistical increase in microcephaly in the children of mothers infected by Zika, as well as evidence that the virus can pass the placental barrier. The virus has been found in the brains of affected infants. So, it seems at least plausible that there is connection between the condition and exposure to the virus during fetal development. We don’t yet know just how likely the condition will be if the mother is infected with the virus, and we don’t know if it can occur at any stage in fetal development, or if there is only a short window of time for the defect to arise.
It would appear, therefore, that the main public health issue is the risk to developing fetuses. This is not a new problem; pathogens such as those responsible for rubella (German measles) and toxoplasmosis are also known to cause serious birth defects. But Zika has gathered headlines due to its fast spread, its previously unknown status to the public, and the difficulty in avoiding exposure to mosquitos if you live in an area where the disease is prevalent.
Based on mosquito distribution, it’s likely that Zika will obtain at least a foothold into the United States. Canada may be at less risk due to its colder climate, but there is a possibility of spread as global temperatures warm. The CDC and Health Canada have put out advisories to help people protect themselves from exposure to the virus. But medical facilities and laboratories must also take steps to prepare for Zika’s arrival, from preparing the infrastructure to send samples for analysis and diagnosis, to disposing of contaminated linens.
The first step in transporting infectious substances is to classify it according to either the U.S. “Hazardous Materials Regulations” of 49 CFR, or Canada’s “Transportation of Dangerous Goods Regulations”. Although many disease organisms have accepted classifications established for them (such as those found in the IATA Dangerous Goods Regulations), Zika virus is so new to North America that there has not yet been an official classification assigned.
Pathogens fall under two categories. Category A is used for organisms that are “transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals.” Pathogens that do not meet that criteria will be classed as Category B, less hazardous.
Although it is not immediately dangerous to the person affected, Zika is capable of causing permanent disability (birth defects) or life-threatening conditions (Guillain-Barré syndrome). However, it is not likely to cause these effects simply from a spill in transportation – it appears that direct blood contact is necessary to contract the disease. Unless the Department of Transportation or Transport Canada make an official determination of the appropriate category, as they did in the SARS outbreak, the decision will be the shipper’s, and should be guided by medical or scientific personnel. It may be noted that many other viruses in the Flaviviridae family have a split classification; they are placed in Category A when transported as a culture (artificially propagated to increase the virus concentration), but Category B when transported in samples in their natural state, such as blood or other body fluids.
Once the classification has been determined, packaging must be selected for Category A or B as appropriate. Obviously, the highly dangerous Category A organisms will require a much more secure packaging, one which must be approved to a standard created by the United Nations. Category B packages do not have to meet UN specification, but they must follow the regulations for construction and use. Note that ICC Compliance Center can provide packagings for various needs, from shipping small samples to disposing of contaminated linens as hazardous waste.
Once assembled, you must identify the package as containing Category A or B substances with the appropriate safety marks and labels. Note that Category B substances do not have to show the Class 6.2 label, but must show a diamond with the applicable UN number, UN3373, in the center. Category A pathogens will require full dangerous goods shipping papers. Most regulations exempt Category B from some or all of the shipping paper requirements. While placards are not required for Class 6.2 materials under the “Hazardous Materials Regulations” in the U.S., Canada does require placards if the shipment exceeds 500 kilograms or is subject to an Emergency Response Assistance Plan (ERAP). And, of course, personnel performing dangerous goods functions must be trained and certified in the appropriate regulations.
If you intend to ship pathogens outside your own country (for example, for international research efforts), remember that exporting and importing of infectious substances will involve additional regulations, such as the CDC’s Import Permit Program.
Do you have questions about how to transport infectious substances? Need labels, packaging or other supplies for such shipments? Contact ICC Compliance Center here at 888-442-9628 (U.S.) or 888-977-4834 (Canada), and ask for one of our regulatory specialists.