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Guidance on submitting environmental data in support of non-agricultural pesticides under COPR

ANNEX i - Consolidated environmental data requirements for non-agricultural pesticides September 2000

1. General principles for data requirements

The data requirements outlined in this document are not intended to form a rigid step-sequence testing scheme. A core data package is required in support of each application. Additional data requirements are dependent on a number of factors including user category, area of use and the results of the core data package. If it is not technically possible to provide data, the reasons must be stated.

All data should be generated on representative batches of the active substance or formulation. The tests should be conducted wherever possible according to internationally acceptable guide-lines (e.g. OECD, EEC Annex V). The tests should also be conducted, where appropriate, in accordance with the provisions laid down in Directives 86/609/EEC and 87/18/EEC on the protection of animals used for experimental purposes and Good Laboratory Practice, respectively.

2. Core data requirements

All data should be presented in a summary document set out as below. References should be given against each summary. Copies of the data used, together with permission for their use by the Registration Authority if they originate from organisations other than the applicant, should be provided.

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3. Environmental toxicology on the active substance

3.1 FATE AND BEHAVIOUR

(i) Data on the loss and rate of loss of the active substance from surface(s) treated with the formulation (suitable tests to be discussed with the Registration Authority).

(ii) Adsorption and desorption properties of the active substance in soil or sediment as appropriate (a suitable test is OECD method 106).

3.2 DEGRADATION STUDIES

(i) Abiotic degradation: Hydrolysis as a function of pH.

3.3 ECOTOXICITY STUDIES

(i) Inhibition of respiration in activated sewage sludge.

(ii) Growth inhibition test on one freshwater species of algae.

(iii) Acute toxicity (48 h EC50) to a suitable pelagic non-target invertebrate species (e.g. Daphnia magna).

(iv) Acute toxicity to a suitable juvenile fish species (96 h flow through).

3.4 ECOTOXICITY STUDIES ON THE FORMULATION

Studies on the most sensitive species in section 3.3 above are required unless the data on the active substance can be extrapolated to each formulation.

3.5 ENVIRONMENTAL EXPOSURE

A reasoned case demonstrating that the active substance can be used without adverse effects to the environment.

4. Additional data requirements on the active substance

The Registration Authority will require the following additional studies where use of the pesticide product may result in significant operator, consumer and/or environmental exposure to the active substance. Additionally, some or all of these studies may be required if the results from the core package indicate they are necessary for a full risk assessment.

4.1 FATE AND BEHAVIOUR

If it is likely that the active substance will leach into soil then the following data are required:-

(i) The mobility and persistence (T1/2), in soil, of the active substance and important degradation products. This should normally be assessed in laboratory tests. Mobility should be studied in at least 3 soil types and presented in terms of Koc.

4.2 DEGRADATION STUDIES

If the active substance does not readily hydrolyse then the following study is required:-

(i) A ready biodegradation test

If the active substance does not readily hydrolyse and/or biodegrade and is mobile and persistent in soil then the following study is required:-

(i) A static sediment/water degradation test including photodegradation (UV light) in natural waters (e.g. marine or freshwater as appropriate). Results should be expressed as T1/2 and include details of significant degradation products.

4.3 BIOACCUMULATION STUDIES

If the log Pow is greater than 3.0 and/or the active substance does not hydrolyse, biograde or degrade in sediment/natural water, then bioaccumulation tests are required:-

(i) In a suitable fish species (e.g. sheepshead minnow).

(ii) Where the active substance has the potential to reach the marine environment, a test is also required in a suitable bivalve mollusc (e.g. oyster or mussel).

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4.4 ECOTOXICITY STUDIES

If it is likely that the active substance will leach into freshwater bodies then the following studies are required:-

(i) Growth inhibition test on one freshwater species of diatom and/or algae (e.g. selenastrum capricornutum, scenedesmus subspicatus or chlorella vulgaris) and one higher plant species (e.g. Lemna sp.).

(ii) Acute toxicity (48 h EC50) to a suitable demersal non-target invertebrate species (e.g. Gammarid sp.).

(iii) Acute toxicity to the appropriate adult fish species (96 h flow-through). See section 4.3 (i).

If it is likely that the active substance will leach into marine/estuarine water bodies then the following studies are required:-

(i) Growth inhibition test on a species of common marine unicellular algae (e.g. Skeletonema costatum, Gymodium splendens) and a higher plant species (e.g. Zostera).

(ii) Acute toxicity (48 h EC50) to a suitable marine/estuarine planktonic or larval crustacean (e.g. copepod, mysid or lobster larvae) and oyster embryo.

(iii) Acute toxicity to the appropriate adult fish species (96 h flow-through). See section 4.3 (i).

If bioaccumulation studies show accumulation factors which are greater than 100, or a substance is expected to persist in the water column (e.g. more than 1 or 2 weeks) then the following studies are required:-

(i) Developmental toxicity to a suitable fish species. This test should be run from freshly fertilised embryos through to independently feeding fry (and should last at least 14 days).

(ii) Acute and sub-acute toxicity studies on a suitable avian species. Information on any effects on avian species (e.g. impaired fertility, residues in tissues of birds and their eggs) may also be required.

(iii) Developmental toxicity to larval crustacean and oyster embryo. This study is only required if the active substance is likely to enter marine/estuarine water bodies.

If the active substance is used during the cultivation of fish and/or shellfish then tissue residue data on the active substance and/or metabolites should be provided.

If sediment is a likely compartment of exposure then further studies on a suitable sediment dwelling organism may be required.

NOTE: For some use patterns further studies may also be required if the use of the active/product indicates a potential for exposure of non-target terrestrial species, e.g. birds, soil fauna and non-target arthropods.

4.5 ENVIRONMENTAL EXPOSURE

If an assessment of the ecotoxicology data indicates a concern for the environment then further information which could include environmental monitoring may be required.

In addition, further guidance is available on the exposure/risk assessment for bats.

September 2000

Annex ii - Good laboratory practice

1. General principles

GLP is concerned with the organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. It ensures that the way the work undertaken is adequately standardised and of a sufficient quality to produce reliable and verifiable results which can be compared with confidence with those of others carrying out the same work and applying the same general principles.

EC Directive 87/18/EEC (as applied to data generated on certain classes of chemical including pesticides) requires Member States to take all measures necessary to ensure that data submitted, for the purpose of assessing safety, to registration authorities in support of the notification or registration, are generated in accordance with GLP.

The studies required to be undertaken in compliance with the principles of GLP are:

  1. Toxicity studies started after 30 June 1988;
  2. Physico-chemical studies started after 1 January 1993;
  3. Ecotoxicity studies started after 1 January 1993;
  4. All other safety studies started after 1 January 1993.

For the purpose of pesticide registration in the UK, GLP applies only to safety studies (which includes both those undertaken in a laboratory and experimental field study).

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2. Exemptions

In general, regulations do not provide any flexibility for the acceptance of studies that have not been performed to GLP if they were started after 30 June 1988. Where a study was started before 30 June 1988, or a study did not require GLP certification before 13 May 2000 repeat testing will not normally be necessary provided the study is scientifically valid. The acceptance of other studies that have not been performed to GLP but were started after 30 June 1988 must always be decided on a case-by-case basis. However needless repetition of testing on animals should be avoided.

3. Certificates of GLP in a study report

Final study reports should include all necessary indications that the study was performed in accordance with GLP. The report should be signed and dated by the study director to indicate the acceptance of responsibility for the validity of the data and to confirm compliance with principles of GLP. Any deviations from full GLP compliance should be stated. A certificate/statement by a Quality Assurance Unit (QAU) must be attached to a study report and a certificate from a GLP monitoring authority may also be attached, if available. The certificate/statement from the QAU must be signed by a member of the QAU staff stating that the study has been monitored by the QAU (the dates of inspection should be given where appropriate) and that the final report is a fair representation of the results obtained in the study. The study report should also include:

Updated 2013-07-29