Comments on this guidance note should be sent before 17 November 2000 to The Secretary, ACRE Wider Biodiversity Issues Sub-group, Floor 3/H11, Ashdown House, London, SW1E 6DE.
Aim
To assess risk to farmland biodiversity arising directly or indirectly from the management associated with the growing of genetically modified (GM) crops.
Principles
- This risk assessment applies to all GM crops at time of application for general cultivation consent and is intended to clarify and be applied in addition to the standard requirements set out in Directive 90/220/EEC.
- Risks will be assessed relative to the range of current management practices for equivalent non-GM crops, and/or the crops most likely to be replaced by the new GM crop, and relative to relevant Biodiversity Action Plans (BAP).
- Risks will be assessed for each particular crop and its associated management on the basis of experimental work, prediction from existing literature and post-release monitoring.
- Whether the application is submitted to the UK competent authority, or through another member-state, the assessment should be sufficient to consider thoroughly the risks in the UK and include details adequate for other member states.
- The risk assessment should consider that risks may vary across the range over which a crop will be grown, either as a result of differences in the wildlife present, or because of differences in the management of the crop.
Risk Assessment
1. Likely management regime
(a) Applicants will need to describe the appropriate commercial management regime for the new crop. This should be detailed and supported by evidence from experimental work where appropriate. Important factors will include information such as pesticide application rate and timing, which should be based on sound agronomic advice to ensure cost-effective pest control when applied commercially.
(b) Applicants should consider also possible risk associated with management practice outside that advised for appropriate commercial application, as it is likely that advised practice will not always be followed. Applicants will need to comment on how variation from advised practice could affect the environment and how advised practice could be ensured where necessary.
2. Risk to the environment
(a) Applicants will have to assess the direct and indirect risks to farmland wildlife arising from the likely management regime of the GM crop.
(b) The risk assessment should consider the management of the GM crop in comparison to the equivalent non-GM crop. This assessment should consider the range of conventional management practices for the equivalent crop in order to quantify the impact of the GM crop in relation to an alternative crop. This assessment should include both high and low intensity regimes and other systems, such as integrated crop management. The assessment should consider the likely impact of the new crop across the whole of its potential geographic range within the UK and more widely.
(c) In some cases, the new GM crop is likely to replace the growing of an existing crop that is not directly equivalent. For example, a GM frost tolerant potato may not replace the equivalent non-GM potato, and so would allow that crop to be grown where it was not previously possible. The impact of this type of situation should be assessed.
(d) Every risk assessment will need to consider if the new GM crop will replace a different crop or crops. Where the GM crop is likely to replace a different crop, the risk assessment should, in addition to comparing the management to the non-GM equivalent (as described above), compare the management to the range of conventional management practices for the crop that will be replaced. As before, this assessment should include both high and low intensity regimes and other systems, such as integrated crop management.
(e) Applicants should assess the direct and indirect effects of the management on farmland habitat types, Biodiversity Action Plan (BAP) animal and plant species within these habitats, and key plant and invertebrate components of farmland food chains.
(f) For simplicity, the farmland habitat types (e.g. field margins, hedgerows etc., see Appendix A) are grouped broadly within the farmland ecosystem of which they are a component. The risk assessment process should consider each of these habitat types in turn and then check to ensure that BAP species likely to be present in these habitats have been covered.
(g) In the case of crops modified to possess insecticidal or fungicidal properties (etc.) the impact on farmland habitats should be considered as the net impact of the crop and the likely management regime.
(h) The risk assessment may well need to be supported by experimental work demonstrating the effects of the management on farmland habitat types in comparison with the range of management practices for the equivalent non-GM crops and with respect to BAP targets. The scale of this experimental work will be determined by the level of risk associated with the particular crop and its associated management, and on the quality of available literature relevant to the risk assessment. No fixed approach will be defined, as the aim will simply be to demonstrate whether the proposed release presents unacceptable risks or not. For example, an oil-seed rape crop modified for oil quality may not result in any change in management relative to conventional oil-seed rape. Little or no experimental work would be needed to demonstrate associated risk, as it would be similar to that for the non-GM equivalent. Another crop such as a herbicide tolerant cereal may be of far more concern. Any application would need to be supported by a sufficient amount of experimental data demonstrating the effect of growing the crop on the abundance and diversity of farmland wildlife.
(i) Where a large body of literature exists for a similar crop, it may be sufficient to perform only as much experimental work as necessary to demonstrate that the literature is applicable to the new crop. For example, the current farm-scale evaluations of glufosinate tolerant oil-seed rape may be to a greater or lesser extent relevant to glyphosate tolerant oil-seed rape. On the other hand, some additional experimental work may be required to compare the weed control efficiency of glufosinate and glyphosate.
3. Post-release monitoring
(a) Post-release monitoring could be used in a range of ways to contribute to the risk assessment. If a particular crop is of concern and requires field trials to investigate the effect of its management on the environment, trials could be conducted under experimental consent prior to the application for marketing consent. Alternatively the work could be conducted as part of a post-release monitoring programme. In the latter case, the post-release monitoring plan could include restrictions on the commercial growing of the crops outside the monitoring sites, and the marketing consent limited in area and time until the necessary data are collected. In this way, it would not always be necessary to conduct all investigative work prior to the granting of marketing consent. However, the applicants would have to satisfy the authorities that risks associated with proposed management during the experimental period are acceptable.
(b) If the risks associated with a proposed release are acceptably low, then a post-release monitoring scheme may not be necessary or need only be minimal. If the impacts of the management of the crop on wildlife cannot reliably be predicted, but are sufficiently low or reversible to allow field testing, applicants may propose to investigate the environmental impact under a marketing consent, rather than experimental consent. Such a case may require intensive post-release monitoring coupled with a phased commercial introduction or complete restriction on use outside trial sites. Marketing consent could be limited to reflect the field-testing period.
4. Risk management
(a) If risk assessment identifies that a proposed GM crop management regime presented unacceptable risks to the environment, then applicants should submit risk management measures sufficient to negate these risks. Such measures could potentially include reduced pesticide application rates, restrictions on pesticide timing or requirements to implement wildlife sympathetic management measures, such as creation of selectively sprayed headlands etc.
(b) The responsibility will be with the applicants to demonstrate that these measures will give net benefits to practical wildlife conservation. Full details would need to be provided on how the measures would be assured in commercial situations.
Appendix A
Key Farmland Habitat Types
The risk assessment should primarily consider the likely impact of the new management practice on the Biodiversity Action Plan species within the broadly defined agricultural ecosystem components listed below.Crop - those species reliant on the crop itself
Within-crop flora and fauna - plants and animals living within the fields
Headland flora and fauna - plants and animals living within the field headland, where proposed headland management differs from that in the rest of the field
Soil beneath the crop - plants and animals in the soil
Field margin - plants and animals in the field margin
Hedgerow - plants and animals in hedgerows
Advisory Committee on Releases to the Environment: Sub-group on Wider Biodiversity Issues, September 2000.
Document Reference: ACRE/BIO/00/G1.
Published 15 March 2000
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