6 RISK CHARACTERIZATION – ENVIRONMENT

 The environmental risk assessment approach is set up according to the following principles:

• .1 Hazard identification – what are the substances of concern and what are their effects?

• .2 Dose (concentration) – response (effect) relation – what is the relationship between the dose and the severity or the frequency of the effect?

• .3 Exposure assessment – what is the intensity, and the duration or frequency of exposure to an agent?

• .4 Risk characterization – how to quantify the risk from the above data?

6.1 Screening for persistence, bioaccumulation and toxicity

This section describes the screening for persistence, bioaccumulation and toxicity specified in paragraphs 5.3.12, 5.3.13 and section 6.3 of Procedure (G9).

6.1.1 Persistence

6.1.1.1 Persistence is preferably assessed in simulation test systems to 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.

6.1.1.2 For persistence and degradation data, see sections 3.5.2 and 3.5.4 of this Methodology.

6.1.2 Bioaccumulation

6.1.2.1 The assessment of the bioaccumulation potential should use measured bioconcentration factors in marine (or freshwater organisms). Where test results are not available, the assessment of the bioaccumulation potential of an organic substance may be based on the log P_ow.

6.1.2.2 For bioaccumulation data, see sections 3.3.6 and 3.5.3 of this Methodology.

6.1.3 Toxicity tests

6.1.3.1 Acute and/or chronic ecotoxicity data, ideally covering the sensitive life stages, should be used for the assessment of the toxicity criterion.

6.1.3.2 For ecotoxicity data, see section 3.3 of this Methodology.

6.1.3.3 It is necessary to consider, whether an effect assessment based on tests in freshwater species offers sufficient certainty that sensitive marine species will be covered by any risk assessment.

6.1.4 Does the Active Substance and/or Relevant Chemicals meet all three criteria for PBT?

Table 2: Criteria for identification of PBT Substances

6.1.4.1 Active Substances, Relevant Chemicals or Preparations identified as PBT substances will not be recommended for approval in accordance with paragraph 6.4.1 of Procedure (G9).

6.1.4.2 The CMR assessment is based on new regulations in several jurisdictions as part of the PBT assessment. This is a new development in the risk assessment methods as applied by jurisdictions to register pesticides, biocides and industrial chemicals. Therefore, it is considered appropriate that including CMR into the methodology of the evaluation of BWMS is necessary to be in line with these jurisdictions.

6.1.4.3 Based on the appropriate toxicological studies on carcinogenicity, mutagenicity and reproductive toxicity, the Relevant Chemicals should be scored on these three items, using 1 (one) if the substance showed the hazard under consideration and 0 (zero) if the substance did not show the hazard under consideration.

6.1.4.4 For any Relevant Chemical showing at least one of the hazards, carcinogenicity, mutagenicity or reproductive toxicity, exposure should be avoided or relevant risk mitigation measures should be proposed to minimize exposure to an acceptable level using appropriate extrapolation methods.

6.2 Evaluation of the discharged ballast water

This section describes the evaluation of the discharged ballast water specified in paragraphs 5.2 and 8.2.2 of Procedure (G9).

6.2.1 General

6.2.1.1 The advantage of toxicity testing on the ballast water discharge is that it integrates and addresses the potential aquatic toxicity of the Active Substance, Preparation including any of its components and Relevant Chemicals formed during and after application of the BWMS.

6.2.1.2 For ecotoxicity data, see sections 3.3.2 and 3.3.3 of this Methodology.

6.2.1.3 The validity criteria should be clearly established during planning and the results of the validation should be stated in the report.

6.2.1.4 For the growth inhibition test using algae, the following three criteria should be taken into account:

• .1 The biomass should increase exponentially by a factor of at least 16 within the 72-hour test period. This corresponds to a specific growth rate of 0.92 d^-1.

• .2 The mean coefficient of variation (mCV) for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72-hour tests) must not exceed 35% in accordance with OECD 201, even if ISO 10253 is used.

• .3 The coefficient of variation of average specific growth rates in the replicates during the whole test period must not exceed 7% for ISO10253 or 10% for OECD 201.

6.2.2 Basic Approval

6.2.2.1 Testing should be performed in the laboratory using a sample prepared by simulation of the BWMS (G9: 5.2.1).

6.2.2.2 It is required that the residual toxicity of treated ballast water is assessed in marine, brackish and fresh water to provide certainty as to acceptability when the treated water is discharged because discharge of ballast water may occur in all three salinities and, therefore, risk assessment in three salinities is needed. Any limitations as to environmental acceptability should be clearly indicated in the submission.

6.2.2.3 The sampled water for Relevant Chemical identification, described in paragraph 3.2.3, should be used for the ecotoxicity testing at Basic Approval. The applicant does not need to make use of the test water that has been sampled prior to neutralization.

6.2.2.4 It is recommended to use water from the 5-day storage tank for the WET tests.

Table 3: Test waters needed for laboratory ecotoxicity testing in conjunction with the 2016 Guidelines (G8) for Basic Approval

Note: The numbers in brackets show the minimum number of sets of samples for each parameter.

6.2.3 Final Approval

6.2.3.1 Toxicity tests (Whole Effluent Toxicity test) with samples of ballast water treated with the BWMS from the land-based test set-up should be conducted (G9: 5.2.1.2, 5.2.2 and 5.2.3).

6.2.3.2 The full-scale BWMS from the land-based test set-up should be used to prepare test water for WET testing. The recommendations described in paragraphs 6.2.2.3 to 6.2.2.4 should apply.

6.2.3.3 From a pragmatic standpoint, the submission of WET tests on growth inhibition using algae (plants), and acute toxicity for invertebrates and fish, would provide adequate safeguards for the environment.

6.2.4 Comparison of effect assessment with discharge toxicity

The results of the effect assessment of the substances that are likely to be present in the treated ballast water at discharge are compared to the results of the toxicity testing of the treated ballast water. Any unpredicted results (e.g. lack of toxicity or unexpected toxicity in the treated ballast water at discharge) should give rise to a further elaboration on the effect assessment (G9: 5.3.14).

6.2.5 Determination of retention time^footnote

6.2.5.1 The test data should be used to determine the no adverse-effect concentration upon discharge, i.e. the necessary dilution of the treated ballast water. The dosage rates and transformation half-life, system parameters and toxicity should be used to determine the retention time needed to hold the treated ballast water before discharge (G9: 5.2.7). An indication of the uncertainty of the retention time to protect environmental acceptability should be given, taking into account different variables (e.g. temperature, salinity, DOC/POC/TSS concentration and any SDL of the BWMS).

6.2.5.2 In general, for BWMS with a neutralization process where the MADC of Active Substance at any discharge can be ensured, no minimum retention time is required. For other BWMSs, the GESAMP-BWWG should determine a minimum retention time to ensure the environmental acceptability. It should be noted that if the retention time determined in this paragraph is longer than the minimum holding time at determined according to paragraph 2.4.5 in part 2 of the annex to the 2016 Guidelines (G8) for attaining biological efficacy, the BWMS should not discharge any treated ballast water before the end of the retention time in accordance with this paragraph (a clarification regarding the definition of the term "retention time" is given in the table below).

Table 4: Clarification of the terms "tank holding time", "storage period" and "retention time"

6.3 Risk characterization and analysis

This section describes the risk characterization and analysis specified in paragraphs 5.3.1 to 5.3.14 and paragraphs 6.4.2 to 6.4.4 of Procedure (G9).

6.3.1 Prediction of discharge and environmental concentrations

6.3.1.1 Based on measured data of the Active Substances, Preparations including any of its components, and Relevant Chemicals, the worst-case concentration at discharge should be established.

6.3.1.2 Environmental concentrations after discharge of treated ballast water under controlled conditions during development and type approval tests should be estimated and provided in the application dossier for Basic Approval.

6.3.1.3 Environmental concentrations, under suitable emission scenarios developed describing typical full-scale use and discharge situations, should also be estimated for treated ballast water, Active Substances, Relevant Chemicals and other components of Preparations, as appropriate.

6.3.1.4 MAMPEC-BW, latest available version, should be used to calculate PEC values with its standard settings. All information about MAMPEC-BW can be found through the information given in appendix 5.

6.3.1.5 The MAMPEC-BW, latest available version, will calculate the stationary concentration in the harbour after discharge of ballast water. To account for local effects, near the ship at discharge, the local concentration at near ship is estimated using the formulae suggested in Zipperle et al., 2011 (Zipperle, A., Gils J. van, Heise S., Hattum B. van, Guidance for a harmonized Emission Scenario Document (ESD) on Ballast Water discharge, 2011):

• C_max = the maximum concentration due to near ship exposure (μg/L)
• C_BW = the concentration found in the discharged ballast water (μg/L)
• S = dilution factor based on sensitivity analysis with a higher Tier model, default value = 5
• C_mean = the mean concentration as output from MAMPEC-BW

6.3.1.6 The concentration calculated with this formula will be compared to acute toxicity data for the Active Substances and Relevant Chemicals to evaluate the short-term effects on aquatic organisms.

6.3.1.7 It is further recommended that the effect of cold and/or fresh water to the natural degradation process of the Active Substances and Relevant Chemicals is considered.

6.3.1.8 It is not necessary to undertake further assessment of temperature effects on the degradation rate of Active Substances and Relevant Chemicals if the PEC/PNEC ratio is found to be acceptable assuming no degradation.

6.3.1.9 If the PEC/PNEC ratio is not found to be acceptable assuming no degradation, further analysis is required. In the literature, the degradation rate of the Active Substance and Relevant Chemicals is typically determined at mid-range temperatures of 10°C to 20°C. Because the degradation rate is slower in cold environments, the risk should be assessed at a temperature of 0°C (2°C for fresh water).

6.3.1.10 Extrapolation of the temperature effect for a difference less than or equal to 10°C is generally scientifically accepted when assessed by application the Q10 approach according to the Arrhenius equation. Extrapolation of the temperature effect for a difference greater than 10°C should also be undertaken as a best estimate using the Arrhenius equation.

6.3.2 Effects assessment

6.3.2.1 The effect assessment of the Active Substances, Preparations including any of their components, and Relevant Chemicals is initially based on a data-set of acute and/or chronic ecotoxicity data for aquatic organisms, being primary producers (e.g. algae), consumers (e.g. crustacean), and predators (e.g. fish) (G9: 5.3.9).

6.3.2.2 An effect assessment could also be prepared on secondary poisoning to mammalian and avian top-predators where relevant. Only toxicity studies reporting on dietary and oral exposure are relevant, as the pathway for secondary poisoning refers exclusively to the uptake of chemicals through the food chain. It might be necessary to extrapolate threshold levels for marine species from terrestrial species assuming there are interspecies correlations between laboratory bird species and marine predatory bird species and between laboratory mammals (e.g. rats) and the considerably larger marine predatory mammals. 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 5% fat) (G9: 5.3.10).

6.3.2.3 An assessment of effects to sediment species should be conducted unless the potential of the substance of concern to partition into the sediment is low (e.g. K_oc < 500 L/kg) (G9: 5.3.11).

6.3.2.4 The effect assessment of the Active Substances, Preparations and Relevant Chemicals, taking the indicated information into account, should be based on internationally recognized guidance (G9: 5.3.13).

6.3.3 Effects on aquatic organisms

6.3.3.1 For assessment of effects to the aquatic environment, appropriate Predicted No-Effect Concentrations (PNEC) should be derived. A PNEC is typically derived at a level that, when not exceeded, protects the aquatic ecosystem against toxic effects of long-term exposures. However, for situations where only short-term exposures are expected, an additional PNEC for short-term (or near ship) exposure may be useful. PNEC values are normally derived from acute and/or chronic aquatic toxicity results for relevant aquatic species by dividing the lowest available effect concentration with an appropriate assessment factor. For the aquatic effect assessment, the assessment factors, given in Table 5, should provide guidance although these may be altered on a case-by-case basis based on expert judgment. In cases where a comprehensive data-set is available, the PNEC may be derived with a mathematical model of the sensitivity distribution among species.

Table 5: Assignment of Assessment Factors (AF) used for deriving PNEC values

Notes: *.1 If the lowest value is not used, based on expert judgement, a scientific rationale should be submitted.

• .2 AF assigned to chronic data may be lowered if sufficient (for instance three different trophic levels) acute values are available.

  .3 See section 3.3.3 of this Methodology for information on suitable chronic testing.

  .4 For the determination of the assessment factor for the NOEC values in Table 5 micro-algae have been excluded because of the short duration of the chronic test for algae (4 days) and, therefore, it is not considered by some jurisdictions as a real chronic test.

  .5 The rule numbers are used in the GESAMP-BWWG Database containing the 41 substances as indicated in appendix 6 to this Methodology to determine the PNEC taking into account the indicated Assessment Factor (see paragraph 6.3.3.7).

6.3.3.2 In some cases, the PNEC_{near ship} may be substantially lower than the PNEC_harbour due to insufficient availability of acute ecotoxicity data. In such cases, the PNEC_{near ship} should be set equal to the PNEC_harbour. This would still be considered a worst-case PNEC.

6.3.3.3 PNEC values should be derived for any substances that may be found in treated ballast water in concentrations that may be of concern for the aquatic environment. The relevance of deriving PNEC values for Active Substances, any other components of Preparations and/or Relevant Chemicals should thus be considered.

6.3.3.4 Currently there is no compelling physiological or empirical proof that marine organisms are more sensitive than freshwater organisms or vice versa and, therefore, an additional assessment factor is not applied. Should this, however, be demonstrated for the substance under consideration, an additional assessment factor should be taken into account.

6.3.3.5 Where data are available for additional marine taxa, for example, rotifers, echinoderms or molluscs, the uncertainties in the extrapolation are reduced and the magnitude of the assessment factor applied to a data-set can be lowered.

6.3.3.6 Because sediment constitutes an important compartment of ecosystems, it may be important to perform an effects assessment for the sediment compartment for those substances that are likely to transfer substantially into the sediment.

6.3.3.7 Forty-one chemicals most commonly associated with treated ballast water (see appendix 6) have been already assessed by the GESAMP-BWWG. The PNEC values can be found in the online GESAMP-BWWG Database of chemicals most commonly associated with treated ballast water (https://gisis.imo.org/).

6.3.4 Comparison of effect assessment with discharge toxicity

The results of the effect assessment of the substances that are likely to be present in the treated ballast water at discharge are compared to the results of the toxicity testing of the treated ballast water. Any unpredicted results (e.g. lack of toxicity or unexpected toxicity in the treated ballast water at discharge) should give rise to a further elaboration on the effect assessment (G9: 5.3.14).