Guidance on submitting environmental data in support of non-agricultural
pesticides under COPR
This document provides guidance to applicants/approval holders on the standards required for submitting any fate and behaviour and/or ecotoxicological data requested by Biocides and Pesticides Unit for the support of new products to be approved by the Departmental route. This document supplements information contained in HSE's 'Consolidated Data requirements document' in Annex i. This additional guidance aims to promote consistency, transparency and high scientific standards. This also gives the advantage of avoiding additional costs to industry.
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The type and quality of data required
- The core data requirements are the minimum set required for all product types. However depending upon the characteristics of the active substances and the nature of the product, in some circumstances not all the data may be required. Therefore, some active ingredients are not fully supported by core data, which may be deemed necessary for a new product application. Reasons for this will be given in such cases.
- Additional data requirements are triggered by the characteristics of the active substance, the product type or the potential for environmental exposure. The applicant will be informed as to what additional studies are required at the Fee Banding stage of their application for a new product. However, it is for the applicant to employ expert judgment in the decision to commission further studies and how these should be performed, for example, test conditions and most suitable test organisms. The expert judgment must however be transparent and scientifically justified and should consider both the proposed and possible worst-case use pattern. The applicant may discuss proposed testing requirements with HSE, taking into account the benefit of the test data to the risk assessment and the feasibility of carrying out the test.
- When undertaking new studies current test methods should be used. New test methods are continuously being developed and the applicant should be aware of any developments pertinent to their application. This is particularly important for substances suspected to be endocrine disrupters as several international programmes are currently developing test methods.
- All data contained in an application must be supported by study reports, other data or a letter of access. The data must be sufficient to allow an adequate risk assessment, and allow decisions on whether the active substance is likely to show adverse effects on the environment. If in doubt, the applicant should consult HSE on which data should be submitted.
- The data should suit individual circumstances and should assess risks under differing conditions. The characteristics of the application technique, by the users (e.g. professional or non-professional users) and the environment in which the product is intended to be used or into which the product may be released should be set out.
- The supporting data provided for a new product can include older, scientifically robust , studies even if they do not comply to modern audit controls such as G.L.P. (see Section 5 vii). Study reports should be provided but where they are not available all other conditions outlined in (iv) above must still be followed (see Section 5 also).
- Animal testing, especially on vertebrates, should be minimised. All unnecessary testing of substances and preparations must be avoided and data should be shared between applicants where possible.
- Any available extra data, above and beyond that which have been requested but the applicant considers to be relevant to the risk assessment, must also be submitted. This requirement corresponds to the obligation to submit any additional adverse data after an approval has been granted.
Applicants/approval holders should consult HSE if they have further questions regarding the data requirements, or wish to discuss any issues pertinent to their application. HSE should also be informed of any changes to the product and its use pattern.
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How the data should be presented
4.1 key elements for reporting of data requirements
A description of the key elements expected in any company data reports is as follows:
(i) Hazard Data and Summaries
There should be a clear and concise discussion and conclusion of all results at the end of each test report setting out the author's conclusion on what the results show. If this agrees with HSE's interpretation of the data, it will be used in any submission to advisory panels and subsequent disclosure documents.
(ii) Risk (Exposure) Assessment
In some cases Biocides and Pesticides Unit may request that applicants/approval holders to provide an overview of the risks associated with the use of a new product. This approach is most likely for a new product with novel use(s) that contains a very old active ingredient, for which the majority of available data is in the public domain i.e. copper. This is because Biocides and Pesticides Unit could not carry out a risk assessment within the normal charging scales. A risk assessment depends on a comparison between two things;
- the toxicity of a compound, expressed as a concentration (EC 50, LC 50 or NOEC),
- the anticipated exposure of an organism to the same chemical, expressed in the same units as in point 1 above (a concentration in water, food or soil to which the organism is exposed).
This should be quantified where possible. For new products a realistic exposure scenario should be presented reflecting the probable market potential of the product. The possible effects on the environment of a mixture of active and non active ingredients in a single formulation should be presented. Where a major metabolite (e.g. greater than 10% of the active) is more toxic and/or more persistent than the parent compound the risk assessment should address this. It may be more appropriate then to treat the metabolite as the active component of the product, and assess the possible consequences for the environment. On a case-by-case basis, the regulatory authority may require a full core data package on significant metabolites.
Exposure can occur at a number of stages post application so exposure assessments should cover all relevant compartments of the environment; air, soil, water, sediment and biota. The exposure assessment should show the likely concentration of each relevant active substance present in the product (and the product itself, if relevant) in different compartments of the environment.
Calculations are then required to calculate a risk quotient (RQ) using the PEC:PNEC ratio. The PEC is the predicted environmental concentration. This is based on known rates of release and dilution factors in the environment. The PNEC is the predicted no effect concentration. This can be calculated by dividing the EC 50 or LC 50 for the most sensitive species by an arbitrary safety factor (often 1000). This is to allow for the great uncertainty in extrapolating from laboratory toxicity data for one species to expected field toxicity to another species. It is proposed that the following assessment factors are used when reviewing data from laboratory testing;
A. 1000 applied to the lowest L (E)C 50 from base-set toxicity data (fish, Daphnia and algae),
B. 50 applied to the lower NOEC from long-term toxicity data from two species in two taxonomic
C. 10 applied to the lowest NOEC from long-term toxicity data from fish, Daphnia and algae,
D. if field data exist, they will need to be reviewed case-by-case.
The PEC is then divided by the PNEC to give an RQ value. If the value for RQ is < 1 then the risk is low. If it is >1 then there is a possible risk. Where it is not possible to establish a PEC a qualitative assessment of whether exposure can occur is required.
PEC values are derived for local as well as regional situations, each based on specific emission characteristics with respect to time and scale. To ensure PECs are realistic, they should be based on the information in the submitted technical dossier and on any other available and relevant information. Data on loss of the product from treated materials (leaching profile) is usually essential but this is largely product dependent. For instance, this would be essential for treated wood or for antifouling products, but less so for insecticidal sprays.
Particular account should be taken of:
- adequately measured exposure data;
- the form in which the product is marketed;
- the type of product;
- the application method and application rate;
- the physico-chemical properties of the product;
- breakdown/transformation products;
- likely pathways to environmental compartments and potential for adsorption and degradation;
- the frequency and duration of exposure;
- the likely routes of exposure to the compartment or population of concern;
- the potential for absorption of the substance under consideration by organisms and
- the type and size of specific exposed populations where such information is available.
A general rule for predicting the environmental concentration is that the best and most realistic information available should be used. However, it is often useful to conduct an initial exposure assessment based on worst case assumptions, using default values when model calculations are applied. This approach can also be used in the absence of sufficiently detailed data. If the outcome of the risk characterisation based on worst case assumptions for the exposure is that the product is not of concern, the risk assessment for that end point can stop with regard to the compartment considered. If the product is of concern, the assessment must be refined using more realistic exposure predictions.
In some cases, confirmatory environmental monitoring may be set as a condition of approval, for example, where modelled exposure data have raised some concern (e.g. if a model suggests the exposure exceeds the PNEC by a small margin).
iii) Overall Summary
The report should contain a concise succinct overview of the main results and conclusions of the studies. This will include all the relevant end points. The results from the active substances, together with the results of any substances of concern, should be combined in order to produce an overall assessment of the effect of a product's use on the environment.
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- All reports should show that experiments have been carried out systematically using sound scientific procedures. Adequate use of controls must be evident and all experimental parameters must be explained and fully recorded. There should be sufficient details from preliminary/range finding tests to confirm the validity of the chosen test parameters.
- The approval holder should submit all available data, which may be relevant for decision making including original reports. Data from published literature or other sources will only be considered where a clear description of the method and detailed presentation of results are provided. Unsupported declarations of toxicological end points will not be accepted. Tests conducted in accordance with internationally recognised guidelines (e.g. OECD, EPA, ASTM, Annex 5, ISO) are accepted and recognised by HSE.
- Whenever possible appropriate statistical analysis should be applied to the results and where applicable, dose response curves should be plotted.
- Sufficient raw data should be presented to back up any derived end points. All results should be recorded including, where appropriate, details of mortalities throughout the test.
- All stages in experimental procedures from the raw data to the derived endpoints should be clear from the test report. Not all calculations need to be included but sufficient worked examples should be supplied to allow a third party to either repeat the test or manipulate the raw data to derive the same end results.
- For fate and behaviour studies recoveries/mass balances are required, e.g. in an absorption/desportion study this may indicate if the active ingredient is absorbing to the glassware and not to the soil.
- All studies should show evidence of appropriate quality assurance. For pre clinical /safety data, this should be GLP (Good Laboratory Practice)*. Where there is no full description of quality assurance procedures, in depth descriptions of scientific methodology are required.
*Annex ii of this document gives details of GLP requirement under COPR.
- Applicants/approval holders should state whether tests have been carried out according to agreed international standards (e.g. OECD). Information is normally given on reporting standards in official guidelines. The OECD guidelines for testing chemicals are available from:-
Organisation for Economic Co-operation and Development (OECD) Publications
Service/Commercial Operations Section
2 rue André Pascal
75775 Paris CEDEX, 16 FRANCE
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