5.2.1 Toxicity testing is necessary for the Active
Substance, or Preparations (see sections 4.2.1 and 5.3) and the treated
ballast water discharge as covered in this section. The advantage
of conducting toxicity testing on the ballast water discharge is that
it integrates and addresses the potential for interactions of the
Active Substances and Preparations with the possible by-products:
-
.1 For the Basic Approval process, the discharge
testing should be performed in a laboratory using techniques and equipment
to simulate ballast water discharge following treatment by the Preparation.
-
.2 For Final Approval, the discharge testing should
be performed as part of the land-based type approval process using
the treated ballast water discharge.
5.2.2 The applicant should provide both acute
and chronic toxicity test data using standardized test procedures
to determine the toxicity of the Preparation and Relevant Chemicals
as used in conjunction with the ballast water management system. This
testing approach should be performed on the treated ballast water
discharge, as the ballast water management system could either mitigate
or enhance the adverse effects of the Preparation or Relevant Chemicals.
5.2.3 The discharge toxicity tests should be conducted
on samples drawn from the land-based test set-up, which would be representative
of the discharge from the ballast water management system.
5.2.4 These toxicity tests should include chronic
test methods with multiple test species (a fish, an invertebrate and
a plant) that address the sensitive life-stage. The preference is
to include both a sub-lethal endpoint (growth) and a survival endpoint.
Either freshwater or marine test methods should be testedfootnote.
5.2.5 The test results to be provided include:
acute 24-hour, 48-hour, 72-hour, and 96-hour Lethal Concentration
at which x % of the test organisms die (LCx), No Observed Adverse
Effect Concentrations (NOAECs), chronic No Observed Effect Concentration
(NOEC) and/or Effect Concentration at which x % of test organisms
show effect (ECx), as appropriate based on the experimental design.
5.2.6 A dilution series including a 100% ballast
water discharge would be tested to determine the no adverse effect
level using the statistical endpoints (NOEC or ECx). An initial analysis
could use a conservative approach where the dilution capacity would
not be taken into consideration (no modelling or plumes analysis would
be used). The rationale for taking a conservative approach is that
there could be multiple discharges into one location (even though
this is not necessarily the case).
5.2.7 The acute and chronic toxicity test data
in conjunction with the information in section 4.2.1 should be used
to determine the holding time necessary to achieve the no adverse
effect concentration upon discharge. Knowing the half-life (days),
decay rate, dosage rate, volume of system and toxicity tests with
time series, then a computational model can be used to determine the
amount of time needed to hold the treated ballast water before discharge.
5.2.8 Information on Total Residual Oxidants (TRO)
and Total Residual Chlorine (TRC) should be provided as part of the
application for evaluation, for both the ballast water treatment process
and the ballast water discharge.