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 Englands unique
  natural environment including its flora and
  fauna, land and seascapes, geology and soils are
  protected and improved.
• Natural Englands 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 sites 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 its 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.