Research under COPR
This guidance is to help researchers in the biocide and non-agricultural pesticide industries comply with the requirements of the Control of Pesticides Regulations (COPR). It:
- has no legal standing;
- does not absolve industry of any additional responsibilities they may have under other legislation (e.g. COSHH).
It is worth considering HSE’s previously commissioned research before embarking upon any independent research. Search the website to find research commissioned by HSE to assist in their role as the UK Competent Authority under the Biocidal Products Regulations 2001 (BPR).
Under COPR an Experimental Permit can be granted to allow the use of a non-agricultural pesticidal substance, preparation or organism for the purpose of research/development or in experimental trials.
Two types of Experimental Permit are granted for work involving non-agricultural pesticides:
An Automatic experimental permit (AEP) is issued, free of charge, for small-scale development work in specific locations. These permits are issued for a set period of time, normally 12 months, and may be renewed.
To apply, complete an AEP application form and return it to HSE.
The issuing of an AEP is subject to a number of conditions (as outlined below). Any contraventions of these conditions may give rise to an offence under Section 16(12)(a)(ii) of FEPA:
- The testing of any substance, preparation or organism for use as a non-agricultural pesticide anywhere (other than in the laboratory) where the use in question is not covered by provisional or full approval from Ministers under The Control of Pesticides Regulations 1986, must be notified to HSE.
- The applicant must wait for written acknowledgement before experimental work can commence. The permit is valid for one year from the date of issue (i.e. the date of the letter of acknowledgement).
- The substance, preparation or organism must be stored on the premises of the permit holder or an agent of the holder. (In these conditions, ‘Agent’ means any other person, organisation or company engaged by or acting on behalf of the permit holder).
- The research and development work carried out must be on the premises of the permit holder or their agent.
- The permit holder must advise their agent in writing of all the conditions which relate to the use of the substance. The substance must be accompanied with adequate information to ensure that it can be disposed of safely.
- Whoever carries out the work (the permit holder or agent) must be adequately trained to do the job and possess equipment suitable for the safe application of the substance. The issue of an AEP does not detract in any way from the permit holder or their agent’s duties under other legislation, e.g. COSHH.
- Full records must be kept by the permit holder, of all treatments carried out, including details of the specific sites treated, application rates and amount of substance used.
- Wood or any other treated material must not be sold on for use.
- Only unoccupied domestic premises may be used for trials. (In these conditions ‘unoccupied’ means that the property does not have anyone in the residence).
- All reasonable precautions must be taken to avoid post-treatment exposure of humans, the environment, animals, food or feeding stuffs to test material or treated items.
- A product, which has been revoked or suspended, must not be used under an AEP except for the purposes of comparison during the testing of alternatives.
Please note, an AEP cannot be issued for antifouling products, the use of Genetically Modified Organisms (GMOs) and for products used on sewage treatment systems.
If the conditions for an AEP cannot be complied with, anyone wishing to carry out any experimental work must apply in writing for a specific experimental permit.
An experimental permit is usually required to:
- generate active ingredient/product data in support of an application;
- generate active ingredient/product data in support of an extension of use;
- carry out research and development work on active ingredient/product involving substantial human or environmental exposure.
A specific experimental permit is required for all trials involving antifouling products, the use of Genetically Modified Organisms (GMOs) and products for use on sewage treatment systems.
An application for an experimental permit is normally considered as a "Departmental" application. However, depending upon the substances involved and the use profiles, it may be possible to deal with it as a "Secretariat" application. This will be decided at the fee-banding stage once the RA1 form has been received.
Before submitting an application, it is advisable to contact HSE to discuss the specifics of the application so that we can advise a course of action.
Research involving GMOs
Researchers may apply for permission to carry out research on Genetically Modified Organisms (GMOs). Researchers must comply with the provisions of the legislation controlling activities with such organisms. The issuing of an experimental permit under the legislation does not free the holder from other duties concerning work with GMOs.
There are two sets of legislation, one covering contained use (e.g. work in laboratories and similar buildings) and other covering deliberate release into the environment. Experimental work, which consists of or contain GMOs could fall under either set of legislation. For contained use all premises must be notified to HSE from where further advice about the legislation can be obtained. In certain cases notification to HSE and formal consent may be required before work can proceed.
Research commissioned by HSE
HSE has commissioned studies to help implement COPR. This enables HSE to:
- understand how pesticide products are used, e.g. where they are used, how many people use them, what happens to them after use;
- understand how chemicals interact with humans and the environment, e.g. how long it takes for a liquid to be absorbed by the skin, how long an aerosol spray remains in the air;
- develop exposure scenarios for risk assessment, i.e. estimate how much of a product humans and the environment come into contact with, and therefore assess the potential for ill health and other adverse effects.
Any research that has been commissioned by HSE for COPR has been done so using the practices and principles of HSE's Research Ethics Committee.
Some examples of the areas of research that HSE has been involved in previously have included;
- assessing the risks to sheep dippers of suffering short-term ill-health effects from using organophosphates;
- developing and applying instrumental techniques to assess risks from harmful substances in the workplace;
- measuring the effectiveness of labelling pesticides;
- establishing the extent of usage of antifouling products in freshwater in order to find out whether an additional risk assessment and/or monitoring would be necessary.