Appendix 3 - Model Document for the Annex on Non-Confidential Dossier of an Application for Basic Approval and/or Final Approval of a Ballast Water Management System (BWMS)

 1 INTRODUCTION

This section should include:

• .1 a brief history of any previous applications; and

• .2 the results of any previous evaluations with references to any pertinent documents;

2 DESCRIPTION OF THE SYSTEM

2.1 This section should include:

• .1 a list of all the relevant parts of the BWMS, e.g. filtration, treatment (e.g. U.V. or electrolysis or chemicals), neutralization and any feedback controls;

• .2 a schematic representation of the system showing the component parts; and

• .3 a general description of how the BWMS works and how all the component parts are integrated.

2.2 The operation of the BWMS is preferably highly automated. A compact description of the control system should be provided.

3 CHEMICALS ASSOCIATED WITH THE SYSTEM

3.1 Chemical reactions associated with the system

This section should describe the anticipated chemical reactions associated with the particular system involved and residual chemicals expected to be discharged to the sea.

3.2 Identification of chemicals associated with the ballast water management system

3.2.1 This section should include all Active Substances (AS), Relevant Chemicals (RC) and any Other Chemicals (OC) potentially associated with the system either intentionally or as by-products resulting from the treatment.

Table: Composition / Chemicals associated with the BWMS

3.2.2 A summary of all chemicals analysed in the treated ballast water, in all three salinities should be presented in a table, as shown below, including those not actually detected. Where a chemical could not be detected, a less than value (< x μg/L) should be associated with it to indicate the detection limits of the analysis.

3.2.3 For each chemical measured above the detection limits of the system (and above the control levels of untreated ballast water), a separate data sheet (as shown at the end of this appendix) should be included in the application where the chemical has not been evaluated by the GESAMP-BWWG and listed in appendix 6 to this Methodology (see paragraph 5.3). The appropriate detection limits to be used in conjunction with the chemicals listed in appendix 6 are listed in appendix 7.

Table: Chemical analysis of treated ballast water in different salinities as reported by the applicant

3.2.4 If the applicant disagrees with these data chosen by the GESAMP-BWWG, the applicant should provide reasons for disagreeing and support replacement data for consideration based on a scientific paper or test result.

3.2.5 For the further risk assessment for human health and the environment, the Group selects only the substances that have been detected in a concentration above the detection limit from the table listing all of the potential by-products produced in ballast water. These substances should be considered the Relevant Chemicals for the BWMS. If the detection limit for a substance is determined to be unreasonably high, the substance will be included in the further risk assessment with a value corresponding to the detection limit. It may be suitable to use two worst-case concentrations, one for occupational risk assessment (in a ballast water tank) and the other for environmental and general public risk assessment (in the discharged ballast water).

Table: Selected Relevant Chemicals and maximum concentrations for further risk assessment

4 RESPONSE TO THE GESAMP-BWWG REQUESTS (BASIC APPROVAL) OR CONSIDERATION OF CONCERNS EXPRESSED BY THE GROUP DURING ITS PREVIOUS REVIEW (FINAL APPROVAL)

This section should include a copy of each concern raised by the GESAMP-BWWG with an appropriate response from the applicant (valid in case an earlier submission was denied Basic Approval (BA) or Final approval (FA), or in case of a Final Approval submission following a Basic Approval).

5 HAZARD PROFILE DATA AND EXPOSURE OF CHEMICALS ASSOCIATED WITH THE BWMS

5.1 This section should contain a summary of the hazards to mammals and the environment associated with each chemical associated with or generated by the BWMS (the format of the summary is outlined in the section regarding a separate data sheet at the end of this appendix). Where possible, references should be added.

5.2 The hazards identified will be used to perform a risk assessment of the BWMS on the environment, the ships' crews and the general public.

5.3 For the forty-one chemicals most commonly associated with treated ballast water indicated in appendix 6, no additional properties on physico-chemistry, ecotoxicology and toxicology have to be submitted, as these substances have been already assessed by the GESAMP-BWWG. Data for these substances can be found in the online GESAMP-BWWG Database of chemicals most commonly associated with treated ballast water (https://gisis.imo.org/).

5.4 The reason for this approach is to:

• .1 provide a consistent set of data for all applications;

• .2 assist applicants in collating the data associated with their BWMS; and

• .3 streamline the work of the GESAMP-BWWG in assessing applications.

5.5 The following endpoints should be recorded:

• .1 The proposed PNEC based on the available ecotoxicological data, including the final assessment factor to establish the PNEC. This value will be used in the environmental risk assessment.

• .2 The proposed DNEL and/or DMEL based on the available toxicological data, including the final assessment factor to establish the DNEL and / DMEL to be used in the human risk assessment.

5.5.1 Predicted No Effect Concentrations (PNEC)

Table: PNEC values of Chemicals associated with the BWMS and included in the GESAMP-BWWG Database

Table: PNEC values of Chemicals associated with the BWMS, not included in the GESAMP-BWWG Database

5.5.2 Derived No Effect Levels (DNEL) and/or Derived Minimum Effect Level (DMEL)

Based on the appropriate toxicological studies on carcinogenicity, mutagenicity and reproductive toxicity (Procedure (G9), paragraph 5.3.12), each chemical should be scored on these three items, using 'yes' if the substance showed the hazard under consideration and 'no' if the substance did not show the hazard under consideration as shown below:

Table: CMR properties for selected Chemicals

Table: DNELs and DMELs to be used in the risk assessment for humans

5.6 Exposure assessment

5.6.1 In order to perform a risk assessment related to both the environment and those people who may be exposed to any chemicals associated with the BWMS, it is necessary to estimate the concentration of such chemicals in:

• .1 the air space in the ship's ballast water tank;

• .2 the atmosphere surrounding the ship;

• .3 leakages and spills when operating the system; and

• .4 in the harbour water and surrounding area.

5.6.2 It is recognized that there are various computer models which can be used to fulfil this requirement and that such models can produce differing results depending on a range of input parameters which can be used. So, in order to provide some standardization and a mechanism for comparing the various systems, it is recommended that applicants use the model of paragraph 5.6.3 associated with the standard inputs described in appendix 5 resulting in a Predicted Environmental Concentration (PEC) for the Active Substance, all Relevant Chemicals and relevant disinfection by-products.

5.6.3 Predicted Environmental Concentration (PEC)

The Predicted Environmental Concentration (PEC) should be calculated using the MAMPEC-BW 3.1 model or latest available version with the appropriate environment definition and emission input. The results of these calculations should be used to estimate the risk to the general public and the environment. See the guidance in appendix 4 for the risk assessment for humans and appendix 5 for the risk assessment for the aquatic ecosystem.

Table: PEC from MAMPEC modelling results from the GESAMP-BWWG Model Harbour for the harbour and near ship scenario

5.6.4 Concentration of Chemicals associated with the BWMS in the atmosphere

An inventory should be made of the ways humans (crew, port State control and the general public) may be exposed to Relevant Chemicals due to the ballasting and deballasting processes. Guidance to the potential exposure routes is given in appendix 4, together with calculation tools, to estimate the worst-case exposure concentration. These resulting concentrations should be used in the risk assessment for humans and reported here.

Table: Resulting concentrations to be used in the risk assessment for humans

6 LABORATORY TOXICITY TEST WITH TREATED WATER (FOR BASIC APPROVAL) OR WET TESTS (FOR FINAL APPROVAL)

This section should include:

• .1 a description of the tests carried out; and

• .2 a table of the results, e.g. as shown below:

7 RISKS TO SHIP SAFETY

This section covers damage to the structure of the ship which might be caused by various effects including:

• .1 increased corrosion;

• .2 fire and explosion; and

• .3 storage and handling of chemicals.

8 RISKS TO THE CREW

Risks to the crew may be assumed to be associated with:

• .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.

These situations are covered in the guidance in appendix 4.

8.1 Delivery, loading, mixing or adding chemicals to the BWMS

8.1.1 Dilution of concentrated chemical products is often referred to as mixing and loading. On smaller vessels this process may be performed manually. Exposure through inhalation is considered unlikely for non-volatile or water-based chemical formulations. Potential dermal exposure of the hands can be estimated by several available models. It is recommended to use the UK Predictive Operator Exposure Model (POEM) for this estimation. This approach is described in appendix 4.

8.1.2 The result from the calculations may be presented as shown in the table below:

Table: Crew, scenario: loading and filling, scenario 1

8.1.3 In the Tier 2 calculation it is assumed that the exposure can be reduced by the use of gloves.

8.2 Ballast water sampling/Periodic cleaning of ballast tanks/Ballast tank inspections/Normal work on deck

8.2.1 When considering various work operations, it should be assumed that the exposure routes of concern for the crew and/or port State workers will be inhalation and dermal. In this respect, it is assumed that the crew will be exposed by inhalation to the highest concentration of each chemical in the atmosphere above the treated ballast water at equilibrium and by dermal uptake to the highest concentration of each chemical in the treated ballast water. These approaches are described in appendix 4.

Table: Crew/port State control, scenarios 2 to 5, Tier 1 DNEL approach

8.2.2 Taking into account that the DNEL is calculated for chronic exposure, while exposure through these occupational scenarios are assumed to occur only over a limited period of time, Tier 2 calculations may be performed using correction factors which are calculated from the exposure frequencies for the various scenarios multiplied by the exposure duration (20 years) and divided by the averaging time (exposure duration) for non-carcinogenic effects (7,300 days). This approach is described in paragraph 2.1.3.6 in appendix 4.

Table: Crew/Port State control, scenarios 2-5, Tier 2 DNEL approach

8.2.3 Indicative risk levels available from internationally recognized bodies may be used to calculate the indicative RCR regarding potential cancer risk in the DMEL approach. Furthermore, the group RCR approach may be applied to the calculation. The group RCR approach is to be applied for substances with a DMEL value, and is described in paragraph 8.4.3 in appendix 4.

Table: Crew/Port State control, scenarios 2-5: – Tier 1 DMEL approach

8.2.4 Taking into account that the DMEL is calculated for daily exposure over a lifetime (70 years), while exposure through these occupational scenarios are assumed to occur only over a limited period of time, Tier 2 calculations may be performed using correction factors which are calculated from the exposure frequencies for the various scenarios multiplied by the exposure duration (20 years) and divided by the life expectancy (25,550 days).

Table: Crew/Port State control, scenarios 2-5: – Tier 2 DMEL approach

9 RISKS TO THE GENERAL PUBLIC

9.1 Risks to the general public are most likely to occur as a result of:

• .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.

9.2 The risk to the general public from the oral, dermal and inhalatory exposure of chemical by-products may be calculated according to the guidance in appendix 4.

Table: General public scenario: swimming and consumption of seafood

9.3 An indicative risk level may be used to calculate an indicative RCR regarding potential cancer risk. These values can be used to estimate a risk dose based on the probability of increased cancer incidence over a lifetime (10^-6) and may be regarded as a DMEL for the general public.

Table: General public scenario: swimming and consumption of seafood – Tier 1 DMEL approach

9.4 If an elevated risk to the general public is identified in the Tier 1 calculation, a Tier 2 calculation may be performed by taking into consideration the assumption that the general public activities take place in areas more remote to the actual harbour. In this case additional dilution of chemicals is to be expected (see paragraph 2.2.5.2 in appendix 4).

Table: General public scenario: swimming and consumption of seafood – Tier 2 DMEL approach

10 RISKS TO THE ENVIRONMENT

10.1 Assessment of Persistence (P), Bioaccumulation (B) and Toxicity (T)

Based on the half-life, BCF or Log K_ow and the chronic NOEC values for each chemical (Procedure (G9), paragraph 6.4), the PBT properties of each chemical should be reflected in a table with the justification in parentheses as shown below:

10.2 Calculation of PEC/PNEC ratios

10.2.1 The ratio of PEC/PNEC is a measure of the risk that each chemical is deemed to present to the environment.

10.2.2 For each chemical the estimation of the PEC/PNEC ratio should be summarized as shown in the table below:

Table: PEC/PNEC ratios

10.3 Determination of retention time

The retention time of Active Substances should be determined in accordance with the results of chapter 6 and of the assessment above.

11 ADDITIONAL HEADINGS

11.1 As part of the report to be made by the Group during its evaluations, the following parts also appear:

11.1.1 CONCLUSIONS AND RECOMMENDATIONS

11.1.1.1 Risks to ship safety

11.1.1.2 Risks to the crew and the general public

11.1.1.3 Risks to the environment

11.1.1.4 Recommendation

SEPARATE DATA SHEET FOR CHEMICALS NOT LISTED IN APPENDIX 6

DATA ON EACH COMPONENT OF THE PREPARATION AND BY-PRODUCT PRODUCED IN BALLAST WATER

Chemical Name …..………………………………………………………………………………. Where the applicant considers that it is not necessary to complete the data form for a given chemical, a full justification should be given (e.g. the ½-life of the chemical is only a few seconds and so will have disappeared by the time the ballast water is discharged into the sea).

1 EFFECTS ON AQUATIC ORGANISMS

1.1 Acute aquatic toxicity data

• * The duration is given in hours (h) or days (d), e.g. 96h-LC₅₀ or 7d-NOEC.

1.2 Chronic aquatic toxicity data

• * The duration is given in hours (h) or days (d), e.g. 96h-LC₅₀ or 7d-NOEC.

1.3 Information on endocrine disruption

1.4 Sediment toxicity

1.5 Bioavailability/biomagnification/bioconcentration

1.6 Food web/population effects

1.6.1 A description of potential food web and population effects should be provided supported by a full justification.

2 MAMMALIAN TOXICITY

2.1 Acute toxicity

2.2 Corrosion/irritation

2.3 Sensitization

2.4 Repeated-dose toxicity

2.5 Development and reproductive toxicity

2.6 Carcinogenicity

2.7 Mutagenicity

2.8 Carcinogenicity/mutagenicity/reproductive toxicity (CMR)

3 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

3.1 Modes of degradation (biotic and abiotic)

3.2 Partition coefficients

3.3 Persistence and identification of main metabolites

3.4 Reaction with organic matter

3.5 Potential physical effects on wildlife and benthic habitats

3.6 Potential Residues in seafood

3.7 Any known interactive effects

4 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE

* If units are indicated for the property, then these should be considered the preferred unit.

5 OTHER INFORMATION

5.1 Analytical methods for measuring the concentration at environmentally relevant concentrations

5.2 Material Safety Data Sheet provided (Yes/No)

5.3 GHS classification ……………………………………………………………………….

5.4 Risk characterization