“ International context and response to draft D5b – a conservation agencies view”

1. “International context and response to draft D5b – a conservation agencies view” PROTECT Workshop, Aix en Provence.14 May 2008

2. Natural England • Natural England is a new organisation which has been established under the Natural Environment and Rural Communities Act 2006 in England. We are a non-departmental public body. • Natural England has been charged with the responsibility to ensure that England’s unique natural environment including its flora and fauna, land and seascapes, geology and soils are protected and improved. • Natural England’s purpose as outlined in the Act is to ensure that the natural environment is conserved, enhanced, and managed for the benefit of present and future generations, thereby contributing to sustainable development.

3. Tiered approach • We agree with the use of a tiered approach • We are happy with the first tier being conservative and acting as a screen below which we are confident that there will be no unacceptable adverse effects. • We are also happy in principle with the use of a higher tier assessment allowing for refinement. • We are happy that the EU TGD for ESR and Biocides has been used, but there are alternatives for example for plant protection products guidance 91/414/EC and EFSAs opinions on the use of supplemental test data in risk assessment. This is probably more tried and tested then the ESR TGD. • As this is a probabilistic approach for PPPs, there has been work in Europe under EUFRAM and in the UK WEBFRAM. These groups have been evaluating and producing models and guidance for probabilistic assessments for use in 91/414 assessments. It may have been of interest to compare the outputs from the two methodologies.

4. Protection Goals • What are the regulatory/policy environmental drivers e.g. Natura 2000; Sites of Special Scientific Interest; Wildlife and Countryside Act protected species; Biodiversity Action Plan species; subject to other international agreements • What is required scale of protection – individual; site; species; habitat; community; ecosystem (incl. function). • What is the required level of protection e.g. sustainable population; no deterioration; population growth (incl. targets); ecosystem function; in-combination (all challenges) assessments; no adverse effect on integrity of the site. • Mainly protection goals are generic, such as “To ensure the site’s ability to support …(insert details)…. identified as SAC/SPA interest features the agreed radioactivity dosage threshold(s) should not breached.” But, occasionally very specific in the case of Government targets for population recovery or for reintroduced species.

5. Species Sensitivity Distributions • We agree that the use of SSDs has a place in risk assessment for chemicals and ionising radiation. However, they do have limitations as outlined in the circulated document • The use of SSDs poses mathematical, ecological and communication challenges. They have also to date had limited use in regulatory risk assessment and decision-making. • One of the key issues for us is the use of multi-trophic level, multi-class SSDs for regulatory decision-making. For screening, these may be appropriate, however we would have difficulty in accepting the use of these for generating regulatory limits. We would prefer that SSDs were generated for each class of organisms. Although this poses challenges for small data sets – similar issues have arisen in PPPs and statistical methods for extrapolation have been proposed (see WEBFRAM). • Validation of models also pose challenges.

6. Assessment Factors • The use of assessment factors exists within deterministic and probabilistic risk assessment. They also differ with SSDs has been looked by a number of regulatory organisations and committees. EFSA have produced an opinion on which provides guidance on the AF when supplemental test data is available to use in the case of plant protection products. • In the UK the Advisory Committee on Pesticides and it’s Environmental panel have also discussed this issue. • Due to the uncertainties in species coverage and the limitations within the testing methodologies, even in data rich assessments Natural England are unable to support the use of an AF less than 2.

7. Species coverage • In the UK we have a large number of sites designated for their bird assemblages. We note that in annex 2 there are no bird species included. • Our SPA sites, also have protection goals for the birds food source (e.g. plant, algae, invertebrates) which could be covered by the assessment framework. • Therefore an understanding of the food webs and the effects of the “contaminant or activity” on the food supply species is important but also habitat usage. For if the assessment is species based then assessments for migratory species can problematic. • Marine mammals are also a challenge

8. Added risk / background dose approach • The debate on the use of added risk or the inclusion of background within the assessment of chemicals in particular inorganics such as metals is a long running and somewhat unresolved debate. • We are happy to support the use of an added risk approach, but care must be taken on how this is taken into account in a probabilistic assessment especially if there is a wide range of actual background “doses”. • For chemicals we believe that refinement to take naturally occurring background concentrations into account is best undertaken at a site specific level. For example for conservation we have the challenge of dealing with adapted and non-adapted sub-populations.

9. Acceptability • As was mentioned in the document, acceptability of effects is a difficult area and is not wholly a scientific decision. The setting of these thresholds must involve stakeholders. • This will also draw on the previous discussions regarding protection goals.