5 RISK CHARACTERIZATION
5.1 Screening for persistency, bioaccumulation and toxicity
5.1.1 An assessment on the intrinsic properties of the Active Substance and/or Preparation such as persistency, bioaccumulation and toxicity should be conducted (see Table 1 in section 6).
.1 Persistence tests;
Persistence should preferably be assessed in simulation test systems that determine the half-life under relevant conditions. Biodegradation screening tests may be used to show that the substances are readily biodegradable. The determination of the half-life should include assessment of relevant chemicals.
.2 Bioaccumulation tests;
The assessment of the (potential for) bioaccumulation should use measured bioconcentration factors in marine (or freshwater) organisms. Where these tests are not applicable, or if logPow <3, Bio Concentration Factor (BCF) values may be estimated using (Quantitative) Structure-Activity Relationship ((Q)SAR) models.
.3 Toxicity tests:
Acute and/or chronic ecotoxicity data, ideally covering the sensitive life stages, should in principle be used for the assessment of the toxicity criterion.
5.2 Toxicity testing of the treated Ballast Water
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 tested6.
6 Currently there is no compelling physiological or empirical proof that marine organisms are more sensitive than freshwater organisms or vice versa. Should this however be demonstrated for the substance under consideration, this should be taken into account.
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.
5.3 Risk characterization and analysis
5.3.1 For the basic approval process, fate and effect testing should be performed in the laboratory with Active Substances and Preparations. This section lists information that could be useful for a preliminary risk characterization.
5.3.2 Both the Active Substance or Preparation as well as the treated Ballast Water Discharge should be subject to toxicity testing in order to protect the receiving environment from toxic effects due to discharges.
5.3.3 The reaction with organic matter of Active Substances and Preparations that produce free radicals, should be addressed qualitatively so as to identify products of concern to the environment.
5.3.4 The rate of abiotic and biotic degradation of the Active Substances and Preparations under aerobic and anaerobic conditions should be assessed, resulting in the identification of relevant metabolites in the relevant media (ballast water, marine and fresh waters).
5.3.5 The rate of abiotic and biotic degradation of the Active Substances and Preparations under aerobic and anaerobic conditions should be assessed, resulting in the characterization of the persistence of the Active Substances, Preparations and Relevant Chemicals in terms of degradation rates under specified conditions (e.g. pH. redox, temperature).
5.3.6 The partition coefficients (solids-water partition coefficient (Kd) and/or organic carbon normalized distribution coefficient (Koc)) of the Active Substances, Preparations and Relevant Chemicals should be determined.
5.3.7 For Active Substances and Preparations, the potential for bioaccumulation should be assessed in marine or freshwater organisms (fish or bivalves) if the logarithm octanol/water partition coefficient (logPow) is >3.
5.3.8 Based on the information on fate and behavior of Active Substances and Preparations, the discharge concentrations at selected time intervals should be predicted.
5.3.9 The effect assessment of the Active Substances, Preparations and Relevant Chemicals is initially based on a dataset of acute and/or chronic ecotoxicity data for aquatic organisms, being primary producers (algae or sea grasses), consumers (crustaceans), predators (fish), and should include secondary poisoning to mammalian and avian top-predators, as well as data for sediment species.
5.3.10 An assessment of secondary poisoning is redundant if the substance of concern demonstrates a lack of bioaccumulation potential (e.g., BCF <500 L/kg wet weight for the whole organism at 6% fat).
5.3.11 An assessment of sediment species is redundant if the potential of the substance of concern to partition into the sediment is low (e.g., Koc <500 L/kg).
5.3.12 The effect assessment of the Active Substances, Preparations and Relevant Chemicals should include a screening on carcinogenic, mutagenic and endocrine disruptive properties. If the screening results give rise to concerns, this should give rise to a further effect assessment.
5.3.13 The effect assessment of the Active Substances, Preparations and Relevant Chemicals, taking the indicated information into account, should be based on internationally recognized guidance7.
7 Such as relevant OECD guidelines or equivalent.
5.3.14 The results of the effect assessment are compared to the results of the discharge toxicity testing. Any unpredicted results (e.g., lack of toxicity or unexpected toxicity in the discharge assessment) should give rise to a further elaboration on the effect assessment.
5.3.15 An analytical method suitable for monitoring Active Substances and Preparations in ballast water discharges should be available.
The Organization should evaluate the application for approval based on the criteria in this section.
6.1 The information that has been provided should be complete, of sufficient quality and in accordance with this procedure.
6.2 That this information does not indicate possible unacceptable adverse effects to environment, human health, property or resources.
6.3 Ship and personnel safety
6.3.1 In order to protect the ship and personnel safety the technical group should evaluate the physical and chemical hazards (see paragraph 22.214.171.124) to ensure that potential hazardous properties of the Active Substances, Preparations or Relevant Chemicals formed in the treated ballast water should not create any unreasonable risk to the ship and personnel. Proposed procedures for the use and technical equipment introduced needs to be taken into account.
6.3.2 For the protection of personnel involved in the handling and storage of the Active Substances and Preparations. the proposal should include relevant ((M)SDS). The Organization should evaluate (M)SDS, mammalian toxicity data and chemical properties hazards (see paragraphs 126.96.36.199 and 188.8.131.52) and ensure that potential hazardous properties of the Active Substances, Preparations or Relevant Chemicals should not create any unreasonable risk to the ship or personnel. This evaluation should take into account the different circumstances that a ship or personnel may face in its trade (e.g., ice, tropical, humidity, etc.).
6.4 Environmental protection
6.4.1 In order to approve the application, the Organization should determine that the Active Substances, Preparations or Relevant Chemicals are not Persistent, Bioaccumulative and Toxic (PBT). Preparations that exceed all these criteria (Persistence, Bioaccumulation and Toxicity) in the table below are considered PBT.
Table 1 Criteria for identification of PBT substances
> 60 days in marine water, or
> 40 days in freshwater*, or
> 180 days in marine sediment, or
> 120 days in freshwater sediment*
||BCF > 2,000 or
||Chronic NOEC < 0.01 mg/l
* For the purpuse of marine environmental risk assessment half-life data in freshwater and freshwater sediment can be overruled by data obtained under marine conditions.
6.4.2 The Organization should determine the overall acceptability of the risk the Preparation may pose in its use for Ballast Water Management. It should do so by comparing the information provided and the undertaken assessment of PBT and the discharge with scientific knowledge of the Active Substances, Preparations and Relevant Chemicals concerned. The risk evaluation should qualitatively take into account cumulative effects that may occur due to the nature of shipping and port operations.
6.4.3 The risk evaluation should consider the uncertainties involved in the application for approval, and as appropriate, provide advice on how these uncertainties can be dealt with.
7 REGULATION OF THE USE OF ACTIVE SUBSTANCES AND PREPARATIONS
7.1 Handling of Active Substances and Preparations
7.1.1 The proposal for approval of Active Substances and Preparations should include information on their intended use and application. The quantity of Active Substances and Preparations to be added to the ballast water and the maximum allowable concentration of the Active Substances therein should be described in the instructions provided by the manufacturer. The system should ensure that the maximum dosage and maximum allowable discharge concentration are not exceeded at any time.
7.2 Hazard documentation and labelling
7.2.1 The proposal should include ((M)SDS) as required. The (M)SDS should describe appropriate storage and handling together with the effects of degradation and chemical reactivity during storage and should be included in the instructions provided by the manufacturer.
7.2.2 Documentation of hazards or the (M)SDS should conform to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and the relevant IMO regulations (e.g. the IMDG Code) and guidelines (e.g. the GESAMP Hazard Evaluation Procedure). Where these regimes are not applicable, relevant national or regional regimes should be followed.
7.3.1 Detailed procedures and information for safe application of Active Substances and Preparations on board should be supplied and comply with the approval conditions such as maximum allowable concentration and maximum discharge concentration, if any.