PART 2 – TEST AND PERFORMANCE SPECIFICATIONS FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS

.1 a Quality Management Plan (QMP), which addresses the quality control management structure and policies of the testing body (including subcontractors and outside laboratories);

.2 a Quality Assurance Project Plan (QAPP), which defines the methods, procedures, and quality assurance and quality control (QA/QC) protocols used by the test facility for testing BWMS in general. It identifies the test team members, and it includes all relevant standard operating procedures (SOPs), typically as appendices; and

.3 a Test/Quality Assurance Plan (TQAP), that provides specific details for conducting a test of a given BWMS at a given site and time. The TQAP includes detailed plans for commissioning the BWMS, the experimental plan, decommissioning, and reporting the results. The TQAP identifies all organizations involved in the test and includes the BWMS vendor's documentation and performance claims. The TQAP also identifies the data to be recorded, operational and challenge parameters that define a valid test cycle, data analyses to be presented in the verification report, and a schedule for testing. Appropriate statistical distributions should be considered and used to analyse data.

.1 the uptake of ballast water of the ship;

.2 treatment of the ballast water in accordance with paragraph 2.3.3.4 by the BWMS;

.3 the storage of ballast water on the ship during a voyage; and

.4 the discharge of ballast water from the ship.

.1 test plan to be provided prior to testing;

.2 documentation that an inline BWMS is of a capacity to reflect the flow rate of the ballast water pump for the full rated capacity range of the BWMS;

.3 documentation that an in-tank BWMS is of a capacity to reflect the ballast water volume that it is intended to treat within a specified period of time;

.4 the amount of ballast water tested in the test cycle on board should be consistent with the normal ballast operations of the ship and the BWMS should be operated at the treatment rated capacity for which it is intended to be approved;

.5 documentation showing that the discharge of each valid test cycle was in compliance with regulation D-2;

.6 for a test to be valid, the uptake water for the ballast water to be treated should contain a density of viable organisms exceeding 10 times the maximum permitted values in regulation D-2.1;

.7 sampling regime and volumes for analysis:

• .1 for the enumeration of viable organisms greater than or equal to 50 micrometres or more in minimum dimension:

  • .1 influent water should be collected over the duration of uptake as one, time-integrated sample. The sample should be collected as a single, continuous sample or a composite of sequential samples, e.g. collected at intervals during the beginning, middle and end of the operation. The total sample volume should be at least one cubic metre. If smaller volume is validated to ensure representative sampling of organisms, it may be used;

  • .2 treated discharged water should be collected as one time-integrated sample over the duration of discharge from the tank(s). The sample may be collected as a single, continuous sample or a composite of sequential samples, e.g. collected throughout the beginning, middle and end the operation. The total sample volume should be at least three cubic metres;

  • .3 if samples are concentrated for enumeration, the organisms should be concentrated using a mesh with holes no greater than 50 micrometres in the diagonal dimension. Only organisms greater than 50 micrometres in minimum dimension should be enumerated; and

  • .4 the full volume of the sample should be analysed unless the total number of organisms is high, e.g. 100. In this case, the average density may be extrapolated based on a well-mixed subsample using a validated method.

• .2 for the enumeration of viable organisms greater than or equal to 10 micrometres and less than 50 micrometres in minimum dimension:

  • .1 influent water should be collected over the duration of uptake as one, time-integrated sample. The sample should be collected as a single, continuous sample or a composite of sequential samples, e.g. collected at intervals during the beginning, middle and end of the operation. A sample of at least 10 litres should be collected, and a fraction may be subsampled for transport to the laboratory, provided it is representative of the sample and is a minimum of 1 litre. A minimum of three, 1-millilitre sub-samples should be analysed in full to enumerate organisms;

  • .2 treated discharged water should be collected as one time-integrated sample over the duration of discharge from the tank(s). The sample may be collected as a single, continuous sample or a composite of sequential samples, e.g. collected throughout the beginning, middle and end the operation. A sample of at least 10 litres should be collected, and a fraction may be subsampled for transport to the laboratory, provided it is representative of the sample and is a minimum of 1 litre. A minimum of six, 1-millilitre sub-samples should be analysed in full to enumerate organisms;

  • .3 the sample may not be concentrated for analysis unless the procedure is validated. Only organisms greater than 10 micrometres and less than 50 micrometres in minimum dimension should be enumerated; and

  • .4 the full volume of the sample should be analysed unless the total number of organisms is high, e.g. 100. In this case, the average density may be extrapolated based on a well-mixed subsample using a validated method.

• .3 for the evaluation of bacteria:

  • .1 for the influent and discharge samples, the minimum 10-litre sample referred to in paragraph 2.3.3.7.2.2, or another sample at least 10 litres in volume and collected in a similar manner, a sub-sample of minimum 1 litre may be transferred to a sterile container for analysis;

  • .2 a minimum of three, subsamples of appropriate volume taken from the 1 litre subsample described above should be analysed for colony forming units of bacteria listed in regulation D-2; and

  • .3 the toxicogenic test requirements should be conducted in an appropriately approved laboratory. If no approved laboratory is available, the analysis method may be validated to the satisfaction of the Administration.

.8 the test cycles including invalid test cycles are to span a period of not less than six months;

.9 the applicant is requested to perform three consecutive test cycles in compliance with regulation D-2. Any invalid test cycle does not affect the consecutive sequence;

.10 the six-month shipboard test period starts and ends with the completion of a successful test cycle or invalid test cycle that meets the D-2 standard. The three consecutive and valid test cycles that are required in paragraph 2.3.3.9 must be suitably separated across the six-month period;

.11 the source water for test cycles shall be characterized by measurement of salinity, temperature, particulate organic carbon, total suspended solids and dissolved organic carbon;

.12 for system operation throughout the test period, the following information should also be provided:

• .1 documentation of all ballast water operations including volumes and locations of uptake and discharge, and if heavy weather was encountered and where;

• .2 documentation that the BWMS was operated continuously throughout the test period for all ballasting and deballasting of the ship;

• .3 documentation detailing water quality parameters identified by the testing organisation, should be measured as appropriate and practicable;

• .4 the possible reasons for an unsuccessful test cycle, or a test cycle discharge failing the D-2 standard should be investigated and reported to the Administration;

• .5 documentation of scheduled maintenance performed on the system during the test period;

• .6 documentation of unscheduled maintenance and repair performed on the system during the test period;

• .7 documentation of engineering parameters monitored as appropriate to the specific system; and

• .8 a report detailing the functioning of the control and monitoring equipment.

.1 the complete BWMS to be tested;

.2 piping and pumping arrangements; and

.3 the storage tank that simulates a ballast tank, constructed such that the water in the tank should be completely shielded from light.

.1 a minimum capacity of 200 m³;

.2 normal internal structures, including lightening and drainage holes;

.3 standard industry practices for design and construction for ships; surface coatings should be in accordance with Performance standard for protective coatings of dedicated seawater ballast tanks on all new ships and of double-sided skin spaces of bulk carriers (PSPC); and

.4 the minimum modifications required for structural integrity on land.

.1 BWMS with at least one model with a TRC larger than 200 m³/h but smaller than 1,000 m³/h may be downscaled to a maximum of 1:5 scale, but may not be smaller than 200 m³/h; and

.2 BWMS with at least one model with a TRC equal to, or larger than, 1,000 m³/h may be downscaled to a maximum of 1:100 scale, but may not be smaller than 200 m³/h.

.1 the use of standard test organisms (STO) is permissible if the challenge levels in naturally occurring water at the test facility require supplementation. The use of STO should not be considered standard practice and the Administration should in every case review that the selection, number and use of supplementary STOs ensures that the challenge posed to the BWMS provides an adequately robust test. The use of STOs should not bias a test for or against any specific treatment process. They should be locally isolated to ensure that the risk to the local environment is minimised; non indigenous organisms which have the potential to cause harm to the environment should not be used;

.2 procedures, processes and guidance for the use of STO should be based on the most relevant and up to date available scientific data. Such procedures, processes and guidance should form a part of the testing facilities quality assurance regimes; and

.3 the use of STO, including concentrations and species, should be recorded within the test report. The test report should include information pertaining to the evaluation and justification for the use of STO, an assessment of the impact of their use on other test parameters and potential impacts on the test being undertaken. The information contained within the report should reflect both the positive and negative impacts of the use of STO.

.1 test organisms of greater than or equal to 50 micrometres or more in minimum dimension should be present in a total density of preferably 10⁶ but not less than 10⁵ individuals per cubic metre, and should consist of at least 5 species from at least 3 different phyla/divisions;

.2 test organisms greater than or equal to 10 micrometres and less than 50 micrometres in minimum dimension should be present in a total density of preferably 10⁴ but not less than 10³ individuals per millilitre, and should consist of at least 5 species from at least 3 different phyla/divisions;

.3 heterotrophic bacteria should be present in a density of at least 10⁴ living bacteria per millilitre; and

.4 the variety of organisms in the test water should be documented according to the size classes mentioned above regardless if natural organism assemblages or cultured organisms were used to meet the density and organism variety requirements.

.1 coliform;

.2 Enterococcus group;

.3 Vibrio cholerae; and

.4 heterotrophic bacteria.

1 the name and address of the laboratory performing or supervising the inspections, tests or evaluations, and its national accreditation or quality management certification, if appropriate;

.2 the name of the manufacturer;

.3 the trade name, product designation (such as model numbers), and a detailed description of the equipment or material inspected, tested or evaluated;

.4 the time, date, and place of each approval inspection, test or evaluation;

.5 the name and title of each person performing, supervising, and witnessing the tests and evaluations;

.6 executive summary;

.7 introduction and background;

.8 for each test cycle, inspection or evaluation conducted, summary descriptions of:

• .1 experimental design;

• .2 methods and procedures;

• .3 results and discussion, including a description of any invalid test cycle (in the case of a report referred to in Part 2 of this annex) and a comparison to the expected performance; and

• .4 in the case of land-based testing, test conditions including details on challenge water preparation in line with paragraph 2.4.21;

.9 a description or photographs of the procedures and apparatus used in the inspections, tests or evaluation, or a reference to another document that contains an appropriate description or photographs;

.10 at least one photograph that shows an overall view of the equipment or material tested, inspected or evaluated and other photographs that show:

• .1 design details; and

• .2 each occurrence of damage or deformation to the equipment or material that occurred during the approval tests or evaluations;

.11 the operational safety requirements of the BWMS and all safety related findings that have been made during the inspections, tests or evaluations

.12 an attestation that the inspections, tests or evaluations were conducted as required and that the report contains no known errors, omissions, or false statements. The attestation must be signed by:

• .1 the manufacturer or manufacturer's representative, if the inspection, tests or evaluations are conducted by the manufacturer; or

• .2 the chief officer of the laboratory, or the chief officer's representative, if the Inspection or tests were conducted by an independent laboratory;

.13 appendices, including:

• .1 the complete test plan and the data generated during tests and evaluations reported under subparagraph 2.7.2.8 above, including at least:

  • .1 for land-based tests, whether ambient, cultured or a mixture of test organisms have been used (including a species-level identification for cultured organisms, and an identification to the lowest possible taxonomic level for ambient organisms);

  • .2 for shipboard tests, the operating parameters of the system during successful treatment operations (e.g. dosage rates, ultraviolet intensity and the energy consumption of the BWMS under normal or tested Treatment Rated Capacity, if available);

  • .3 for System Design Limitations, details of all procedures, methods, data, models, results, explanations and remarks, leading to validation; and

  • .4 invalid test information;

• .2 the QMP, the QAPP and Quality Assurance and Quality Control records;

• .3 maintenance logs including a record of any consumable components that were replaced; and

• .4 relevant records and tests results maintained or created during testing.