COVID-related constraints and concerns have led to significant changes to how cargo is carried and what cargo is carried, with particular dangerous goods implications. While it may be some time before operations can be considered "normal", guidance provided in this section offers a means for adapting cargo management in the "new normal" of COVID conditions.
Worldwide demand for COVID-19 vaccines results in a significant increase in the volume of vaccines offered for air transport. The purpose of this guidance is to identify the specific areas related to the air transport of vaccines that may require action by the operator and regulator to facilitate their safe transport.
Operators will be able to safely accept, handle and transport vaccines by complying with the requirements of Annexes 6, 18, 19 and the Technical Instructions for the Safe Transport of Dangerous Goods by Air (Doc 9284, Technical Instructions).
Chapter 15 of Annex 6, Part I (applicable Nov 2020) requires operators of aeroplanes transporting items in the cargo compartment to conduct a risk-based assessment. Additionally, the guidance provided is relevant to transport of vaccines on-board any aircraft and may be used as part of an operator risk assessment for this purpose.
Where operators are intending to transport vaccines in the passenger compartment of an aircraft, additional guidance is provided here [link to https://www.icao.int/safety/COVID-19OPS/Pages/Airworthiness.aspx].
The Technical Instructions add prescriptive requirements for operators transporting dangerous goods as cargo.
Guidance to support the operator's risk assessment process in accordance with Annex 6, Part I
The elements of the safety risk assessment set out in Chapter 15 of Annex 6, Part I, have been used as the basis for reviewing the changes proposed to the existing requirements to determine what additional risk mitigations operators may need to implement.
This section aims to facilitate a common understanding for both the air operator and the regulator of the ICAO requirements related to the carriage of vaccines. It is structured around each element the operator is required to consider as part of its specific safety risk assessment and based on Guidance for Safe Operations Involving Aeroplane Cargo Compartments (Doc 10102). However, the carriage of vaccines should not be construed as limited to aeroplane cargo compartments only. When transportation of vaccines in the passenger cabin or use of smaller aircraft without cargo compartments is envisaged, operators and regulators can still use this material as guidance to develop the associated risk assessments for these types of operations. Operators or regulators may need to develop different mitigation strategies depending upon the type of aircraft and operation being considered.
Packages of vaccines may contain multiple elements such as:
For each identified element in the package, the risk management process should address associated hazards, as doing so is important for maintaining safe operations. The information in the table below is not an exhaustive or limiting list. Each operator should tailor their risk assessment as necessary for the individual case and context.
Specific guidance to conduct risk assessments with respect to operations that involve the transport of items in the cargo compartments of an aeroplane can be found in Doc. 10102. Further guidance on safety risk management can be found in Chapter 2.5 of the Safety Management Manual (4th edition).
Data loggers and/or cargo tracking devices (batteries & quantities)section of the Guidance to support the operators risk assessment process website page.
Data loggers and/or cargo tracking devices may be necessary for monitoring the temperature and location of COVID-19 pharmaceuticals during transport. Most such devices are powered by lithium batteries and the packages may need to be identified as such (see also Complying with the provisions of the Technical Instructions section).
Note: For the purposes of special provision A220, pharmaceuticals may include but are not limited to: vaccines, drug substances used in the development of vaccines, and medications used for the treatment of COVID-19 symptoms. Data loggers and cargo tracking devices (batteries & quantities)
Data loggers and cargo tracking devices (batteries & quantities)
| a) hazards associated with the properties of the items to be transported; | |
| Hazard Description | Information to support hazard assessment |
| Increased quantities of data loggers and cargo tracking devices containing lithium batteries. |
Examples of prior arrangements with the operator include:
Example 1
Example 2
Specific considerations:
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| b) capabilities of the operator | |
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| c) operational considerations; | |
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| d) capabilities of the aircraft and its systems; | |
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| e) containment characteristics of unit load devices; | |
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| f) packing and packaging; | |
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| g) safety of the supply chain for items to be transported; | |
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| h) quantity and distribution of dangerous goods items to be transported | |
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2. Data loggers and/or cargo tracking devices (EMI)
Inclusion of transmitting/receiving devices in packages for the purposes of tracking and data logging (e.g. recording temperature) has the potential for electromagnetic interference with aircraft systems. The potential risk to the operations should be assessed.
Data loggers and cargo tracking devices (EMI)
| a) hazards associated with the properties of the items to be transported; | |
| Hazard Description | Information to support hazard assessment |
| Data loggers and cargo tracking devices used in monitoring the transport of the vaccine |
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| b) capabilities of the operator | |
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| c) operational considerations; | |
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| d) capabilities of the aircraft and its systems; | |
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| e) containment characteristics of unit load devices; | |
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| f) packing and packaging; | |
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| g) safety of the supply chain for items to be transported; | |
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| h) quantity and distribution of dangerous goods items to be transported | |
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3. Requirement for carriage of quantities of dry ice in excess of that previously specified by the operator for the aircraft type
At present, many of the vaccines need to be transported in temperature controlled conditions. These conditions are specific to the type of vaccine. For example, some vaccines need to be kept at very cold temperatures that require dry ice (carbon dioxide, solid) for cooling purposes. In certain cases, the amount of vaccine to be transported may require a quantity of dry ice that exceeds the maximum allowable quantity of dry ice that is currently specified for the aircraft type in the operator's manuals. A review of the risk assessment based on the considerations provided may be needed.
Requirement for carriage of quantities of dry ice in excess of that previously specified by operator for the aircraft type
| a) hazards associated with the properties of the items to be transported; | |
| Hazard Description | Information to support hazard assessment |
| Carriage of large quantities of dry ice (CO2, solid) |
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| b) capabilities of the operator | |
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| c) operational considerations; | |
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| d) capabilities of the aircraft and its systems; | |
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| e) containment characteristics of unit load devices; | |
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| f) packing and packaging; | |
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| g) safety of the supply chain for items to be transported; | |
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| h) quantity and distribution of dangerous goods items to be transported | |
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Complying with provisions of the Technical Instructions
Information relevant to the carriage of COVID-19 vaccines including the classification and requirements for markings of the elements in the vaccine package.
The transport of vaccines must comply with the detailed provisions of the Technical Instructions if the vaccines are classified as dangerous goods, when the vaccines are shipped with dry ice as a refrigerant, or when data loggers and/or cargo tracking devices are included in packages or attached to packages or overpacks.
The UN Sub-Committee of Experts of the Transport of Dangerous Goods (57th session) confirmed that genetically modified micro-organisms based vaccines (including those used in clinical trials) are not subject to the UN Model Regulations for transport. As a result, the Technical Instructions were amended to reflect that COVID-19 vaccines containing GMOs or GMMOs, including those in clinical trials, are not subject to the Technical Instructions (see Addendum No. 1 to the 2021-2022 Edition of the Technical Instructions).
To facilitate the transport of COVID-19 vaccines, a change was made to the Technical Instructions in January 2021. A special provision was added to reflect that packages containing COVID-19 vaccines accompanied by data loggers and/or cargo tracking devices containing lithium batteries are not subject to the marking and associated documentation requirements of Section II of Packing Instruction 967 or 970, as applicable (see Addendum No. 1 to the 2021-2022 Edition of the Technical Instructions).
Security of vaccine transport
Guidance intended to help States and Industry apply aviation security measures while facilitating a smooth flow of vaccines throughout the supply chain and to the final destination.
Additional resources
FAA
EASA
https://www.icao.int/operational-safety/contingency-Airworthiness
https://www.icao.int/operational-safety/contingency-Airworthiness
Annex 18, Chapter 10 requires that "initial and recurrent dangerous goods training programmes shall be established and maintained in accordance with the Technical Instructions". The Technical Instructions require that recurrent training and assessment must be provided within 24 months of previous training and assessment to ensure that competency has been maintained.
Difficulties in obtaining or providing recurrent training and assessment at the beginning of the COVID-19 pandemic led many States to issue temporary extensions to the period of validity for dangerous goods training. A quick reference guide on alleviations related to recurrent dangerous goods training was published to assist States that needed to grant them. Alleviations were established as interim measures to support continued operations during the initial stages of the pandemic, but they cannot sustain safe operations indefinitely. Accordingly, the Council Aviation Recovery Taskforce (CART) formulated the following recommendation:
Recommendation 12:
States should put in place the necessary measures to mitigate risks associated with prolonged regulatory alleviations and should not extend alleviations (both core and extended COVID-19 Contingency Related Differences (CCRDs)) beyond 31 March 2021, unless circumstances dictate otherwise. In addition, States are encouraged to facilitate access to medical and training facilities, including flight simulation training devices used for flight crew (national and foreign) to maintain their certifications, recency of experience and proficiency.
Many States have found ways to address difficulties in obtaining or providing dangerous goods training and assessment during the pandemic and have already removed alleviations. As States return to compliance with the SARPs, the objective of dangerous goods training and assessment should be kept in mind, which is to ensure personnel are competent to perform any function for which they are responsible prior to performing any of these functions. The type of training provided to achieve this objective is not prescribed in Annex 18 or the Technical Instructions. While physical distancing practices or closure of workspaces may make classroom training difficult, other means of training and assessment or combination of training and assessment methods can be used to achieve the training objective. Examples include online courses, webinars, virtual classrooms, and on-the-job training.
ICAO has been made aware that some States are restricting certain people on board cargo-only aircraft transporting dangerous goods not permitted on passenger-carrying aircraft. These restrictions have been based on their interpretation of definitions for passenger and cargo aircraft contained in Annex 18 and the Technical Instructions. There are concerns that the restrictions will further impede the ability of operators to position crew.
Annex 18 should not be interpreted to prohibit or limit positioning of crew on an operator's cargo aircraft carrying dangerous goods not permitted on passenger aircraft. This includes personnel that may not be assigned operational duties on the specific flight, such as repositioning flight and cabin crew, loadmasters and maintenance personnel.
The definitions for passenger and cargo aircraft are included in Annex 18 and the Technical Instructions for the purpose of distinguishing between the types and quantities of dangerous goods permitted on a cargo versus a passenger-carrying aircraft. The carriage of passengers on an aircraft is governed by the Standards in Annex 6.