ECP Guidance On Emergency Authorisations
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The Expert Committee on Pesticides (ECP) agreed a framework for the consideration of applications for Article 53 'emergency authorisation'. This framework includes the criteria laid down by Regulation (EC) 1107/2009. It required that:
- 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 authorisation to be required;
- the long-term economic and environmental benefits from granting a temporary emergency authorisation must outweigh any potential adverse effects resulting from the authorisation.
- there is evidence of a permanent solution to the problem being developed
Emergency authorisations are to deal with emergency situations and will be temporary, limited in scale and controlled. On this basis, it may be possible to allow some flexibility in the safety assessment, with each case considered on its merits. 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 ECP also agreed that consultation via email to seek advice could be appropriate.
When submitting an application requesting the repeat of an emergency authorisation, applicants know when the use is required. To allow sufficient time for HSE to consider the application and consult with the ECP and Ministers, repeat applications must be submitted by the end of January in the year of use to allow consideration at the Spring ECP meeting of that year. Ministerial agreement can then be obtained before the season of use.
It would not generally 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.
Article 53 emergency authorisations are driven by an immediate need and therefore, applications are usually submitted by users (farmer and grower organisations) and not companies. In many cases the applicant is unlikely to be able to generate and/or provide data to support the ‘safety case’. A decision, therefore, has to be made on the information 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 (eg 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 (eg nature reserves, SSSIs) is very helpful.
- If it is a large scale crop details of how you intend to limit and control the use should be provided.
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 (MS)? Y/N
If Yes, provide details of the authorisation including any conditions of authorisation that apply in the other MS.
If No, is it authorised in another Organisation for Economic Co-operation and Development (OECD) MS eg USA, Canada, Australia or has it been considered by Joint Meeting on Pesticide Residues (JMPR)? If yes, provide any relevant information about the authorisation.
- Why is this product expected to contain the problem?
(eg 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 are acceptable to humans ?
(Groups of people 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, and 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 may include evidence of:
- Authorisations elsewhere;
- Information on the protective equipment required for use;
- Information that the treatment is for an enclosed area with limited access;
- Information on the Maximum Residue Levels (MRLs) proposed elsewhere;
- If available, data to enable a risk assessment taking into account the limited nature of the use.
Information about the work being done to develop a permanent solution - this can be any of the following:
- Details of trials work being conducted on a permanent solution and the time lines for submitting an application for a product authorisation.
- Details of the proposed submission of a product authorisation to control the problem with the intended date of submission.
- Details of an application already within the authorisation system at CRD for which the emergency authorisation is needed as an interim measure. Details of the current target date for completion should be provided.
It is highly likely with Article 53 emergency applications that the ‘evidence base’ on human and environmental safety will be weaker than that required for a normal commercial authorisation.
Article 53 emergency authorisations allow in some circumstances for special conditions (which might be inappropriate for a standard authorisation) to be applied. For instance limiting treatment to a particular site(s) (such as might be the case under a Plant Health Order) might allow environmental impacts or uncertainties to be tolerated.
Compliance 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, may apply to the Article 53 emergency authorisation. Where this is the case, the applicant for an Article 53 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.