7 RISK ASSESSMENT

 7.1 Risk to safety of ship

This section describes the risk to safety of ship specified in section 6.3 and chapter 7 of Procedure (G9).

7.1.1 The potential risk to the safety of the ship raised by the operation of the BWMS should be assessed, taking into account the identified risk mitigation measures to be applied and any relevant legislative requirements such as provided in SOLAS and MARPOL. Potential risks to the ship may include, inter alia:

• .1 increased corrosion;.

• .2 fire and explosion; and

• .3 storage and handling of the substances.

7.1.2 The operations manual provided for the BWMS should include suitable and sufficient information regarding the safe operation of the system under normal use. If there are operational errors then the control system should give appropriate alarms alerting the crew to instigate corrective actions or shutdown procedures. Potential hazards arising from operational misuse of the BWMS are not evaluated.

7.1.3 Increased corrosion

7.1.3.1 The introduction of Active Substances into ship operating equipment and ballast tanks may give rise to detrimental corrosion effects. In paragraphs 7.1.3.2 to 7.1.3.7 the criteria are stated for instigating a prescribed corrosion assessment along with the standard test procedure to be adopted and the resultant minimum acceptable values.

7.1.3.2 The BWMS that make use of an Active Substance (such as hypochlorite electrolysis, chlorine dioxide, sodium hypochlorite, peroxyacetic acid or ozone) may have a direct effect on organic material like epoxy tank coatings. Depending on the dose and degradation rate of Active Substance there could be an impact on the coating system. For a BWMS with a TRO dose ≥ 10 mg/L, expressed as Cl₂ mg/L, the compatibility with coating systems is to be validated by the testing described in paragraphs 7.1.3.3 and 7.1.3.4.

7.1.3.3 Testing should be conducted in accordance with the NACE TM0112-2012 Standard Test Method with two series of test panels and the coating should be applied in accordance with Table 1 of the Performance standard for protective coatings for dedicated seawater ballast tanks in all types of ships and double-side skin spaces of bulk carriers (PSPC) (resolution MSC.215(82)). One set of panels should be exposed to treated ballast water. Other test conditions are described in the table below.

7.1.3.4 Testing of corrosion should take place in the laboratory, but it is recommended to make use of the full-scale BWMS which is to be used for efficacy testing in accordance with the 2016 Guidelines (G8), for the preparation of treated ballast water for this purpose. However, if it is impractical to maintain the renewal frequency described in the table, ballast water may be prepared by a separate treatment using an identical BWMS.

7.1.3.5 After the exposure duration, several corrosion relevant measurements as listed in paragraph 7.1.3.7 should be scored against the PSPC criteria and reported.

Acceptance criteria

7.1.3.6 In order to determine whether the BWMS has influenced the coating's properties as evaluated according to ISO standards, the principles and acceptance criteria mentioned in paragraph 7.1.3.7 should be employed. Paint coatings evaluation should be carried out on treated ballast water. Paint coatings for BWMS compliance testing will already be required to have PSPC approval and this additional evaluation is to employ the NACE TM0112-2012 Standard Test Method to assess any potential detrimental effects on a coating system resulting from the use of a particular BWMS.

7.1.3.7 For the BWMS to be found suitable for Final Approval, it should not fail in any test evaluation of epoxy based coating systems as specified below:

• .1 ISO 4624: Adhesion: "Fail" if the adhesive or cohesive values at the treated panel are below those required in the table in resolution MSC.215(82), annex 1, appendix 1, paragraph 3.1;

• .2 ISO 4628-2: Blistering: "Fail" if any blisters occur;

• .3 ISO 4628-3: Rusting: "Fail" if any rusting occurs;

• .4 ISO 4628-4: Cracking: "Fail" if any cracking occurs;

• .5 ISO 4628-8: Delamination and corrosion around a scribe: "Fail" if the delamination at the treated panel is greater than that specified in the table in resolution MSC.215(82), annex 1, appendix 1, paragraph 3.1; and

• .6 ISO 15711: Cathodic protection – disbondment from artificial holiday (NACE TM0112-2012 Method B – Sacrificial Anode): "Fail" if the values at the treated panel are greater than those required in the table in resolution MSC.215(82), annex 1, appendix 1, paragraph 3.1.

7.1.3.8 The criteria expressed in 7.1.3.7, subparagraphs .1, .5 and .6 may be revised in the future based on new scientific insights based on test experiences gained, including information on degradation of TRO during the tests.

7.1.4 Fire and explosion

Where ship safety may be affected by potential fire or explosion arising from the use of a BWMS, the outline procedures to prevent such occurrence and consequent mitigating emergency actions to be taken should be included in the dossier as expressed in paragraphs 4.1.7.3 and 4.1.7.4 of this Methodology.

7.1.5 Storage and handling

Where a BWMS has operational features requiring the loading, storage and handling of ancillary substances, the potential hazards arising from the improper handling or storage on board a ship of such substances should be addressed as required in section 4.1.7.2 of this Methodology. The hazards associated with the possible creation of atmospheric dusts should also be included.

7.2 Risks to human health

This section describes the risk to human health specified in section 6.3 and chapter 7 of Procedure (G9).

7.2.1 General

The human health risk assessment should follow generally accepted guidelines including acute/short-term and long-term exposure situations. The risk assessment should entail hazard identification and, as appropriate, dose (concentration) – response (effect) assessment, exposure assessment and risk characterization as indicated in section 5.2 of this Methodology. The population groups deemed to be at risk and so to be examined should include crew, port State control officers and general public. The evaluation of the risks to human health should include risk reduction (risk management) by specific measures proposed by the manufacturer and of the ballast water management system.

7.2.2 Health effects in humans

The effect assessment of the Active Substances, Preparations and Relevant Chemicals should include a screening on carcinogenic, mutagenic and reproductive toxic properties. If the screening results give rise to concerns, this should give rise to a further effect assessment (G9: 5.3.12) (see also section 6.1.4 of this Methodology).

7.2.3 Human Exposure Scenario

7.2.3.1 A Human Exposure Scenario (HES) should be provided by the applicant as part of the risk assessment procedure for ballast water management systems (G9: 6.3.3).

7.2.3.2 The risk assessment should include a description of the ballast water treatment process associated with the system as a set of unit operations, i.e. in doing so, identifying clearly which individual system components of a BWMS are likely to lead to human exposure to Active Substances, Relevant Substances and by-products. For each system five scenarios have been defined as follows:

• .1 delivery, loading, mixing or adding chemicals to the BWMS;

• .2 ballast water sampling;

• .3 periodic cleaning of ballast tanks;

• .4 ballast tank inspections; and

• .5 normal work on deck.

The way the risk assessment is performed is elaborated in appendix 4 of this Methodology.

7.2.3.3 For the general public two scenarios have been defined:

• .1 swimming in seawater contaminated with treated ballast water where exposure may be via ingestion (accidental swallowing), inhalation and dermal contact; and

• .2 consumption of seafood which has been exposed to Relevant Chemicals in the treated ballast water.

The risk assessment approach is also given in appendix 4.

7.2.3.4 In cases where RCR is above 1, then, to demonstrate that there is no unacceptable risk, the applicant should provide scientific justification, which may include potential risk mitigation measures.

7.3 Risks to the aquatic environment

This section describes the risk to safety of ship specified in section 6.4 and chapter 7 of Procedure (G9).

7.3.1 The potential risks to the aquatic environment should be assessed for both Basic and Final Approval.

7.3.2 When no aquatic toxicity of the treated ballast water at discharge is found either through direct testing of the treated ballast water or if the estimated ratios between predicted concentrations of the Active Substance, components of Preparations or Relevant Chemicals, described in paragraph 6.3.3 and the respective PEC/PNEC ratios are less than 1, no further assessment of direct toxic effects to the aquatic environment is necessary.

7.3.3 In cases where a PEC/PNEC ratio is above 1, then, to demonstrate that there is no unacceptable risk, the applicant should provide scientific justification, which may include potential risk mitigation measures.

7.4 Hierarchy of the Environmental Risk Assessment

7.4.1 During the Basic Approval evaluation priority is given to the PEC/PNEC ratios above the laboratory effluent toxicity testing (STW 5) whilst at the Final Approval evaluation priority is given at the results of the WET testing above the PEC/PNEC ratios.

7.4.2 In Table 7 an overview is given of the different data that are available at Basic Approval and Final Approval in relation to the risk assessment possibilities.

Table 7: Overview of data availability and risk assessment possibilities

7.4.3 As indicated in table 7, there are only differences between Basic Approval and Final Approval with respect to the results of the effluent testing and the conclusion. The laboratory ecotoxicity tests at Basic Approval are considered indicative for potential effects but are not yet final and decisive. The WET tests at Final Approval are intended to be final and to give decisive information on the hazards of the discharge. If the discharge shows no effects in the WET tests, the discharge should be considered safe. Therefore, the preferred method of risk assessment changes between Basic Approval and Final Approval. The risk assessment based only on the PNEC determined and literature data is not considered sufficient for a final decision, at least not for Final Approval. For Basic Approval such assessment result gives an indication where to search for improvements in the system leading to a lower PEC/PNEC ratio.