The Applicant Guide: General Information on Trials Permits and Information on Administrative Trials Permits

When will I need a Trials Permit?

You must apply for a Permit for Trials Purposes ('Trials Permit', previously known as an Experimental Approval) if you wish to carry out research and development work involving the release into the environment of an approved or unapproved active substance and/or plant protection product that is not authorised for the proposed use. Permits for trials uses are issued under Article 54 ("Research and Development) of Regulation No (EC) 1107.

What type of research and development work will require a Trials Permit?

If you are carrying out research and development work with an active substance or plant protection product, you must do this under a Trials Permit unless it falls under one of the following exemptions:

• None of the research material (including the experimental active substance or plant protection product) is released into the environment eg where trials are conducted exclusively in laboratories and where all treated materials are destroyed in an appropriate manner.
• The experimental trials will be performed within the conditions of use of a currently authorised plant protection product.
• The experimental trials to be performed within the conditions of use of a currently authorised plant protection product.
• Taint testing where a COSHH assessment is required.

Farmer demonstration trials may be performed under a Trials Permit. However, the results of such trials work must not be advertised as permits for trials purposes are not issued for the purposes of advertisement.

What type of Trials Permit can I apply for?

Trials Permits are generally issued for a period of three years and there are four different types which you can apply for:

Administrative Trials Permits

You can apply for an Administrative Trials Permit (ATP) if you do not need more than 5 hectares per year per active substance to carry out your research and development work, and can comply with the restrictions.

Further information is provided on the general conditions for Trials Permits and specific guidance for ATPs.

Extrapolated Trials Permits (ETPs)

You can apply for an Extrapolated Trials Permit (ETP) if the active substance to be used in your experimental work has been considered in a formulation that has been authorised in the UK or another Competent Authority (where possible and appropriate). The extrapolations to support the proposed formulation(s) and use(s) must be fully justified. Restrictions may be specified on any ETP.

Further information is provided on the general conditions for Trials Permits and specific guidance for ETPs.

Consumer-Assessed Trials Permits

You can apply for a Consumer-Assessed Trials Permit (CATP) if you do not need more than 10 hectares per year to carry out your work. You will need to submit data so that we can carry out a consumer exposure risk assessment. If the submitted data are acceptable we will not specify a restriction for the treated crop material to be destroyed on your permit.

Further information is provided on the general conditions for Trials Permits and specific guidance for CATPs.

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.

Further information is provided on the general conditions for Trials Permits and specific guidance for FATPs.

What should I do if I want to carry out research and development work on more than one formulation?

You may apply for a Trials Permit to carry out research and development work on a range of similar formulations under one application. The formulations must have the same active substance and be of the same basic type, with only minor changes in the amounts of constituents. You may use different co-formulants if they perform the same function (eg surfactants) but you must submit all the appropriate Safety Data Sheets and full details of the formulation ranges (or individual formulation details where these can be specified).

If you submit any data in support of your application it must be based on all the formulations for which you wish to receive a Trials Permit unless you submit reasoned scientific cases to extrapolate the submitted data across all of the formulations.

What research and development work will require the submission of additional data and/or information?

If you wish to carry out research and development work on the following types of active substances then you should contact us for advice in the first instance:

• Genetically modified organisms.
• Microbial pest control agents (including viruses, bacteria, fungi, protozoa and mycoplasmas). Some information is included in the appropriate sections below.
• Vertebrate control agents (excluding repellents).
• Active substances that have previously been evaluated and for which approval has been refused.
• Banned or severely restricted pesticides.
• Products for aerial application (note that the aerial use of experimental substances is not permitted under Administrative Trials Permits unless a previous, relevant risk assessment has been performed).
• Products for use in or near water (where the statutory restrictions to protect aquatic life cannot be adhered to).
• Products for use on land openly accessible to the public and accessible to companion or grazing animals (eg public parks, common land, moor and heathland).

In addition, you must consult us before making an application for a Trials Permit for the use of an active substance or plant protection product on crops genetically-modified for tolerance to that active substance, as these will require an additional risk assessment.

How do I renew my Trials Permit?

ATPs: You must apply for a new permit.

ETP, CATP or FATP: You may apply for renewal of your permit by submitting an Admin Stream application except where data requirements were set as a condition of renewal, or changes to the Trials Permit are required which cannot be considered via this stream see the guidance document on application streams.

What are the general conditions that apply to all Trials Permits?

There are a number of general conditions that apply to all Trials Permits:

1. You must ensure that the pesticide is stored, handled, applied and disposed of in accordance with the Code of Practice for Using Plant Protection Products.
2. The material to be used in the experimental work, and for which you have received your permit, must only be stored, supplied or used by you (the permit holder) or your agent. You (the permit holder) must advise your agent(s) in writing of all the conditions which relate to the use of the active substance/plant protection product under the permit. The number of agents used must be kept to a minimum.
3. You must ensure that the person who carries out the trials work possesses a recognised certificate of competence (unless the person carrying out the work or the product itself is exempt from this requirement). You must ensure that the appropriate application equipment is used.
4. You must keep full records of all applications carried out under the permit and keep these for at least ten years following treatment. These records must include details of the specific sites that are treated and their Ordnance Survey grid references. We may ask you to submit this information after you have carried out your trials work.
5. You must ensure that the material to be used in the trials work is accompanied by adequate information to ensure it can be used and disposed of safely. This information must be presented in line with 'The Labelling Handbook Volume 4 (Requirements for Labels of Products used under Permits for Trials Purposes)' and comply with the requirements of Regulation No (EC) 1107. You must avoid direct or indirect post-treatment exposure of humans or animals wherever possible.
6. Trials Permits are generally granted for a period of three years and you may carry out your experimental work at any time in that period.
7. You must immediately submit any new information on the potentially dangerous effects of the active substance or plant protection product for which you have received your permit. These effects relate to human or animal health and any effects on ground water or the environment. There is also an obligation on you to inform us of any wildlife casualties that occur following treatment.
8. You cannot use your permit for performing research and development work on genetically-modified crops without consulting us beforehand.
9. All Trials Permits will specify a restriction to protect groundwater. The restriction will prohibit you carrying out experimental work on soils with high leaching potential and (in England and Wales) to areas within a 'Zone 1' Groundwater Source Protection (GSP) Zone or within 50 metres of other sources of groundwater used to supply drinking water.

Details of the leaching potential of soils in England and Wales are given on Groundwater Vulnerability Maps available from the Stationery Office (for major and minor aquifers) and from the Environment Agency (for non-aquifer areas). In Scotland a limited number of groundwater vulnerability maps are available from the Scottish Environment Protection Agency (SEPA). Details of GSP Zones in England and Wales are available from the Environment Agency (there are currently no GSP Zones in Scotland).

If the statutory conditions cannot be complied with then you may gain agreement from the Environment Agency or SEPA on using a particular site to carry out your trials work. For further advice on avoiding leaching then you may wish to contact your local Environment Agency or SEPA office.

Administrative Trials Permits

What restrictions will be specified on an Administrative Trials Permit?

The exact wording of these restrictions on your permit may vary. Further restrictions will be specified if your application is for a microbial pest control agent.

The maximum area to be treated

The total area on which you can carry out the trials work is 5 hectares per year for each active substance specified on the ATP. However, you must carry out the work on the minimum area required to obtain the required data.

For the protection of consumers

1. You should ensure that the total area on which the trials work is carried out is less than 2% of the treated area to be planted with any following crop at the site in which the trials work is undertaken, unless the trial site is not to be used to grow edible crops in the year of treatment or the year following treatment.
2. The land on which you have carried out your trials work under your ATP can be subsequently used for growing crops that can be placed into the supply chain for human or animal consumption. However, treated perennial or semi-perennial crops cannot be placed into the supply chain until five years after harvest.
3. If you have treated crop material that needs to be destroyed, it must be disposed of in an appropriate manner. Burning, burying or disposal at a licensed facility are typical destruction methods but are not always appropriate (contact us for advice if required).. You may desiccate the treated crop, but only before the development of the harvestable portion of the crop.
4. You will not be able to place any treated annual crops into the supply chain for human or animal consumption. In addition you will not be able to dispose of any treated perennial crops (eg apples) or semi-perennial crops (eg strawberries) into the supply chain for human or animal consumption for five years between treatment and harvest. This restriction will not apply if:
   1. You can show that the potential exposure from consuming the annual crop, or subsequent crop from treated perennial/semi-perennial plants, is at or below 1 µg/kg bw/day (ie from a residues evaluation performed by HSE, for either a previous or ongoing application, of the same formulation OR a similar formulation type, which is to be applied at or within the same GAP as proposed for the trials work. This can include standard extrapolation between crop types and formulation types as described in the extrapolations guidance or
   2. You receive a subsequent authorisation for the use of the plant protection product on the crop, or on a crop from which an extrapolation is allowed, at the same or greater rates and timings specified on your Trials Permit. The crop extrapolations as detailed in the extrapolations guidance would be acceptable provided the Good Agricultural Practice for both crops is comparable in terms of application type (eg foliar spray) and application conditions (eg outdoor).

Treating perennial or semi-perennial crops that are due to be destroyed may help you minimise any problems you have complying with this restriction for such crops.

Please note that restrictions 2-4 above do not apply if you are treating non-edible crops or land not intended to bear vegetation.

For the protection of the environment

The following restrictions apply unless the impact of any of these restrictions is to be the subject of your trials work or is unavoidable (eg outdoor mesocosm studies). If this is the case, you must indicate in your application whether any of the restrictions will cause you difficulties in performing your experimental work:

1. For the protection of bees, you must ensure that spray applications are not made immediately preceding or during the flowering stage of the crops or weeds. You must also ensure that spray applications are not made where bees are actively foraging.
2. For the protection of game, wild birds and animals, you must take precautions to protect them from harm eg only making applications when mammals and birds are unlikely to forage in the area being treated and recovering or burying spillages of chemical or treated seed.
3. For the protection of non-target plants, insects or other arthropods, applications must not be made within 6 metres of a field boundary.
4. You must ensure that run-off from the treatment of land not intended to bear vegetation must be prevented from entering surface waters and disposed of safely.
5. For the protection of aquatic life:
   • You must not contaminate surface waters or ditches with chemical or used container.
   • You must ensure that direct spray from ground crop sprayers does not fall within 5 metres of the top of the bank of any static or flowing waterbody or within 1 metre from the top of any ditch which is dry at the time of application. You must ensure that spray from hand-held sprayers does not fall within 1 metre of the top of the bank of any static or flowing waterbody. In all cases you must ensure that spray is directed away from water. Your experimental product will not be eligible for a reduction in the buffer zone under the LERAP (Local Environment Risk Assessment for Pesticides) scheme.
   • You must ensure that direct spray from broadcast air assisted sprayers does not fall within 18 metres of surface waters or ditches.
   • The buffer zones detailed above must be measured in accordance with the guidance set out in our booklets 'Local Environmental Risk Assessments for Pesticides'– ' Horizontal Boom Sprayers' (PB5621) and 'Broadcast Air-Assited Sprayers' (PB6533), both of which, along with further information, are available from this website: Local Environment Risk Assessment for Pesticides (LERAPs)

For the protection of operators

If you are using an authorised product in an unauthorised situation and you can meet the following criteria, then the Personal Protective Equipment (PPE) required for the use of your Trials Permit will be the same as recommended on the authorised product label if:

• The proposed dose for the experimental work is the same or within that on the authorised label for the product;
• The in-use concentration (ie the dilution) of the product for the experimental work is the same or within that on the authorised label for the product;
• The proposed method of application would be considered acceptable for uses on the authorised label for the product.

In all other situations full PPE must be used unless a COSHH assessment indicates otherwise. For further information see the Code of Practice for Using Plant Protection Products.

How do I apply for an Administrative Trials Permit?

To apply for an ATP then you will need to submit:

1. A suitable covering letter;
2. A completed CRD 7 application form. Please ensure that the application form is dated. There are no restrictions on the number of active substances that can be included on an individual application form. However, separate application forms will be required for microbial ('biological') pest control agents that are to be used as plant protection products. A separate fee will be required for each application form (see the guidance document on application fees);
3. If any of the restrictions detailed above will provide difficulties in carrying out the trials work, this should be indicated in the covering letter so that we can consider this aspect when we process your application. In this situation you will need a separate application form for each active substance.

How do I apply for an Administrative Trials Permit for use on Genetically-Modified Herbicide-Tolerant crops?

If you wish to apply for an ATP for the use of a pesticide on a genetically-modified herbicide-tolerant crop then you will need to submit the following:

• A completed CRD7 application form. Please ensure that the application form is dated. Separate application forms are required for each active substance;
• Full details of the active substance(s) and the product(s), the proposed rates and timings and the total area required to carry out the experimental work;
• A summary of the authorisation status of the product(s) to be used in the trials work;
• A brief summary of the crop and the associated mechanism of herbicide tolerance;
• Information on the sites where the trials work will be performed;
• Full copies of the consents issued by the Advisory Committee on the Releases to the Environment (including a clear reference to the date of issue and the appropriate reference number) and the associated correspondence which permits the planting of the crops for the areas, manner and purpose proposed. If these are not yet issued, details of the current status of the consent application must be provided. If the release consents have already been submitted to us, please provide a suitable reference for the application under which they were submitted;
• Details of the purpose of the trials work and a full justification for the area required to carry out the trial.

Further Information

• The contents page for Trials Permits
• Information on Extrapolated Trials Permits
• Information on Consumer-Assessed Trials Permits
• Information on Fully-Assessed Trials Permits

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