Fully-Assessed Trials Permits

If you need more than 10 hectares for your research and development work, you must apply for a Fully-Assessed Trials Permit (FATP) and submit a justification to support this area.

You will also need to submit data so that we can carry out a consumer exposure, operator exposure and wildlife and environmental impact risk assessment.

If the submitted data are acceptable we will not specify that treated crop material has to be destroyed. Additional restrictions may be required.

Microbial pest control agents (MPCAs)

For MPCAs, taking account of the proposed conditions of use and the biological characteristics of the MPCA, you will need to consider:

whether or not the MPCA would result in the generation of secondary metabolites and/or toxins, and if so, whether these metabolites would impact on the area of consumer risk assessment
whether the MPCA could be pathogenic to humans and animals and whether the proposed use of the MPCA could result in residues in the edible portion of the treated crop
taking into account persistence in the soil, whether there is the potential for residues in rotational crops.

If the residue levels in crops which have been subject to experimentation are within the appropriate current MRL, and there is no risk to consumers (human or animal), then treated crops can be placed into the supply chain for human and/or animal consumption.

However, if there is no current MRL, or (for a microbial pest control agent active substance) the substance is not included on Annex IV of Regulation No 396/2005, or the current MRL for the proposed use is exceeded, then the permit will carry a restriction for treated crop material to be destroyed and this restriction will apply until a suitable MRL is in place and no unacceptable risk to consumer health has been demonstrated.

For the protection of the environment

The same restrictions as detailed for administrative trials permits will be specified unless the impact of any of these restrictions is to be the subject of your trials work or is unavoidable as in outdoor mesocosm studies. You must submit a reasoned case if you wish to remove any of the restrictions from your permit.
If the active substance is a MPCA that is not approved and it is not indigenous to the UK, then you will need to submit information that addresses the competitiveness of the MPCA relative to other micro-organisms in any environmental compartment (soil, water or sediment) that may be exposed, and information on the potential for the agent to disperse from the treated area (potential to produce mobile resting stages, spores etc). This is to allow us to carry out an assessment of environmental persistence.

For the protection of operators

The same restrictions will apply as specified for Administrative Trials Permits (ATPs).

What to consider for a Fully-Assessed Trials Permit (FATP)

The maximum area to be treated

You will need to specify the area which you require for your trials work and provide a full justification for the proposed area. If your application is successful then your permit will specify a maximum area to be treated as a condition of the permit.

For the protection of consumers

You will need to address the same data requirements as detailed above.

For the protection of the environment

You will need to submit the appropriate data in the following situations:

for pellets, granules and seed treatments; data on the acute and dietary avian toxicity of the active substance(s) in one species
for rodenticides; for outdoor use, data on the acute and dietary avian toxicity of the active substance(s) and the residue of the active substance(s) in treated rodents from laboratory studies; for indoor use, a reasoned scientific case regarding the risk from primary and secondary consumption
for the use of a sprayed product which may be applied to a crop which is likely to be grazed by birds at the time of application; data on the acute and dietary avian toxicity of the active substance(s) in one bird species
for the use of a sprayed product which may be applied to a crop or situation in which bees are actively foraging; an acute oral and contact toxicity of the active substance(s) to the honeybee
for an application that may lead to the contamination of water:

an aquatic toxicity data set to include acute toxicity of the active substance(s) to one species of fish, Daphnia magna and one algal species
a reasoned scientific case to address the fate and behaviour of the active substance(s) in water so that we can make a preliminary assessment of the risk to aquatic life. The information required will depend on the properties of the active substance(s) involved and advice should be sought from our Environmental Fate and Behaviour Branch via an enquiry (go to our contact details page for further information)
if there is containment and appropriate disposal of any effluent or contaminated water or an 18-metre buffer zone is left between treated areas or surface waters or ditches, then no data are required. However, you will not be able to contaminate surface waters or ditches with chemical or used container, and you must not carry out your trials work on soils obviously vulnerable to leaching or above groundwater reserves

For all other situations, no specific data are required. However, if you wish to use a plant protection product or active substance outside of the restrictions stated as in (a), (b) and (c) in the appropriate guidance for ATPs, advice should be sought from our Ecotoxicology Branch via an enquiry (go to the contact details page). You must submit a reasoned case if you wish to remove any of the restrictions from your permit. If the active substance is a biological control agent (MPCA) that is not approved and it is not indigenous to the UK, then you will need to submit information that addresses the competitiveness of the MPCA relative to other micro-organisms in any environmental compartment (soil, water or sediment) that may be exposed and information on the potential for the agent to disperse from the treated area (potential to produce mobile resting stages, spores etc). This is to allow us to carry out an assessment of environmental persistence.

For the protection of operators

You will need to submit the following data so that we can set a health-based temporary Operator Exposure Limit (OEL):

a full technical specification for the active substances
safety Data Sheets for all the co-formulants
a thirteen-week feeding study on the active substances in one species along with additional information (such as the results from dose ranging experiments or preliminary studies) on a second species to indicate the potential for inter‑species variability
a mutagenicity package in accordance with the Committee on Mutagenicity guidelines (2 in vitro studies may suffice where the results are satisfactory and where it can be argued that exposure will be minimal)
a complete teratogenicity study in one species along with relevant information from a second species (like the results from dose ranging experiments or preliminary studies) to indicate the potential for inter-species variability
skin sensitisation data on the active substances and the formulation, and acute oral and acute dermal toxicity, skin and eye irritancy data on the formulation

You should also be aware of the following:

the same restrictions will apply as specified for Administrative Trials Permits (ATPs)
where a FATP has been recommended for more than 10 hectares per year but where insufficient data and/or information have been submitted to perform a full operator exposure risk assessment, we may restrict the area allowed for your trials work to 10 hectares per year for any one operator

How to apply for a Fully-Assessed Trials Permit

For this type of application you will need to submit:

covering letter explaining your application
completed application form CRD1
relevant correspondence, including any previous advice from CRD and if relevant/available, a copy of any product authorisations
mammalian toxicology and residues data to allow a consumer exposure risk assessment to be carried out
operator exposure data/modelling to allow an operator exposure risk assessment to be carried out
if appropriate, environmental data or risk assessment to allow an environmental exposure risk assessment to be carried out;
reasoned scientific case justifying the maximum area on which you wish to carry out your experimental work