The Advisory Committee on Pesticides (ACP) agreed a framework for the consideration of applications for ‘emergency authorisation’ in 2002. This framework included the criteria laid down by the Directive 91/414/EEC. It required that:
- the emergency situation must be unforeseen [with the implementation of Regulation (EC) 1107/2009 this first requirement has been removed];
- that there must be no effective and economic alternative chemical or non-chemical treatment available (emerging resistance thus being an acceptable reason to allow treatment);
- there must be adequate evidence of human and environmental safety available;
- the proposed use of the compound must be limited in scale;
- the proposed use must be controlled allowing perhaps for additional conditions of approval to be required; and
- the long-term economic and environmental benefits from granting a temporary emergency authorisation must outweigh any potential adverse effects resulting from the authorisation.
Members agreed that as the emergency authorisations are to deal with emergency situations and will be temporary, limited in scale and controlled, it should be possible to allow some flexibility in the safety assessment, with each case considered on its merits. Members also noted that an assessment will need to rely on existing information that is both relevant to the proposed emergency use and of adequate quality. As emergency applications need to be considered within a short period, the ACP also agreed that consultation via email to seek advice would be appropriate. However, if the use is a situation that can be foreseen and it is known in advance when the use is required and the product that needs to be authorised then applicants should time their submissions so that they are submitted in sufficient time to allow CRD to assess the application, prepare a paper for consideration by the ACP at the meeting closest to when the use is required. This enables all the members of the ACP to consider and discuss the use at a meeting. For details of ACP meeting dates see link .
It would not be expected that there will be requests for emergency authorisations that have been previously granted to be renewed.
In all cases of a potential application for emergency authorisation, applicants are encouraged to contact CRD at the earliest possible stage to seek advice. CRD will try to work with applicants in identifying and drawing together the information that will be required to consider these applications.
Experience to date both here and elsewhere in the EC indicates that applications for emergency approvals come from potential users (usually farmer’s organisations) and not from companies. They are driven by an immediate need and in many cases the applicant is unlikely to be able to provide data to support the ‘safety case’. In addition there is usually no time to generate data. A decision, therefore, has to be made on the information that is available.
Outline for an application for emergency use
Information on the emergency situation:
This is essential to enable confirmation of emergency status.
- What is the danger threatening plant production? What other means of containing the problem have been considered and why have they been found to be unsuitable? (Note: Chemical, cultural and biological control methods should all be considered)
- What will be the consequence if authorisation is not given (e.g. crop losses, costs)
Information to help assess the likely scale of the problem and hence the likely scale of use of the emergency authorisation:
- If known, is this a general problem likely to affect this crop, or is it present in one area only and unlikely to spread if appropriately controlled?
- Any additional information on severity, likely duration and extent of the emergency
A map of the emergency area showing the locations of any protected areas (e.g. nature reserves, SSSIs) is very helpful.
Information about the product proposed for emergency authorisation:
- What is the product proposed for emergency use?
- What is the active substance?
- Is it authorised in another EU member state? Y/N
If Yes, provide details of approval including any conditions of authorisation that apply in the other Member State.
If No, is it authorised in another OECD member state e.g. USA, Canada, Australia or has it been considered by JMPR? If so provide any relevant information about the authorisation.
- Why is this product expected to contain the problem?
(E.g. is there experimental data demonstrating effectiveness, is it used elsewhere in the world to contain the problem, etc.)
- What are the reasons for considering the risks to humans will be acceptable?
(Groups of people that will need to be considered are those using the product and any others who might be exposed by working in the crop after treatment, bystanders who might be in the locality, consumers of treated produce).
This might include evidence of authorisations elsewhere, information on the protective equipment required for use elsewhere, information that the treatment is for an enclosed area with limited access, information on MRLs proposed elsewhere or, if available, data to enable a risk assessment taking into account the limited nature of the use.
- What are the reasons for considering the risks to the environment will be acceptable?
(This will include a consideration of the likely environmental fate and behaviour and the risks to groups of organisms likely to be exposed. It will also consider the likelihood of contamination of water – including groundwater).
This might include evidence of authorisations elsewhere, including any restrictions on that use to protect the environment such as buffer zones next to water, information that the treatment is for an enclosed area with limited exposure to the environment, for treatment of a limited area with limited environmental impact or if available, data to enable a risk assessment taking into account the limited nature of the use.
Authorisation considerations
It seems likely that with virtually all applications the ‘evidence base’ on human and environmental safety will be weaker than would be required for a normal commercial authorisation.
On the other hand the one-off nature of an emergency authorisation does allow special conditions (which might be inappropriate for a standard authorisation) to be applied. For instance limiting treatment to a particular site or site(s) (such as might be the case under a Plant Health Order) might allow environmental impacts or uncertainties which would not normally be permitted to be tolerated.
It might be that the emergency use can comply with some or all of the general conditions applied to permits for trials purposes where data are still being gathered about the safety of the product. Where this is the case, the applicant for an emergency authorisation could use these controls as a reason for considering the risks acceptable. The controls that apply to permits for trials purposes are set out in the Applicant Guide.
