technical guidance documents - Institute for Health and Consumer ...
technical guidance documents - Institute for Health and Consumer ...
technical guidance documents - Institute for Health and Consumer ...
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MARINE RISK ASSESSMENT<br />
Derivation of the PNECoral values<br />
In the derivation of the PNECoral values only toxicity studies reporting on dietary <strong>and</strong> oral<br />
exposure are relevant as the pathway <strong>for</strong> secondary poisoning refers exclusively to the uptake of<br />
chemicals through the food chain. However, reliable toxicity data <strong>for</strong> predatory marine birds<br />
(such as gulls <strong>and</strong> penguins) <strong>and</strong> mammals (such as seals, dolphins, whales <strong>and</strong> polar bears) are<br />
extremely limited (Nendza et al., 1997). Furthermore, testing of such species would be ethically<br />
unsound <strong>and</strong> contrary to animal welfare concerns. There<strong>for</strong>e, it is necessary to extrapolate<br />
threshold levels <strong>for</strong> marine species from terrestrial species assuming there are interspecies<br />
correlations between laboratory bird species <strong>and</strong> marine predatory bird species, <strong>and</strong> between<br />
laboratory mammals (e.g. rats) <strong>and</strong> the considerably larger marine predatory mammals. This<br />
procedure is identical to that applicable <strong>for</strong> other media (see Section 3.8.3.5).<br />
4.3.3.3 Testing strategy<br />
If the PEC/PNEC ratio based on use of default BMF values indicates potential problems at any<br />
trophic level it should first be considered whether a refinement of the PEC-assessment is<br />
possible, i.e. the release <strong>and</strong> exposure assessment, including the fate related parameters such as<br />
determination of log Kow or BCF. In special cases it may even be considered to start with<br />
bioaccumulation studies in fish to determine the assimilation coefficient <strong>and</strong> the biological halflife<br />
of the substance (i.e. to determine BMF1) prior to estimating or determining the<br />
bioconcentration factor (BCF). Also a refinement of the PNECoral could be considered, i.e. to<br />
require a long-term feeding study with laboratory mammals or birds to derive a more realistic<br />
NOECoral value. In conducting such a study according to current test methods, it may in special<br />
cases be considered whether to extend such studies to include satellite groups <strong>for</strong> determination<br />
of the concentration of the substance in the animals during exposure (i.e. to measure<br />
BMF2 values). Alternatively or supplementary to actual testing can be monitoring of biota <strong>for</strong><br />
which it is clear that they have lived in the environment that is covered in the assessment. Of<br />
course no active sampling of (top)predators should be per<strong>for</strong>med, but <strong>for</strong> instance animals that<br />
are found dead can be used to get an indication about possible biomagnification factors in<br />
wildlife. Useful in<strong>for</strong>mation might also be obtained from eggs or from biopsies of skin or<br />
blubber of marine birds or mammals.<br />
4.4 PBT ASSESSMENT<br />
4.4.1 Introduction<br />
The PBT assessment is considered to be different from the local <strong>and</strong> regional assessment<br />
approaches, as it seeks to protect ecosystems where the risks are more difficult to estimate.<br />
These additional concerns <strong>for</strong> the marine environment, which may not be adequately addressed<br />
by the traditional risk assessment methodologies, can be summarised as:<br />
a. the concern that hazardous substances may accumulate in parts of the marine environment<br />
<strong>and</strong> that:<br />
162<br />
(i) the effects of such accumulation are unpredictable in the long-term;<br />
(ii) that such accumulation would be practically difficult to reverse;