ISO 13073-1:2012
(Main)Ships and marine technology - Risk assessment on anti-fouling systems on ships — Part 1: Marine environmental risk assessment method of biocidally active substances used for anti-fouling systems on ships
Ships and marine technology - Risk assessment on anti-fouling systems on ships — Part 1: Marine environmental risk assessment method of biocidally active substances used for anti-fouling systems on ships
ISO 13073-1.2012 specifies a risk assessment method that protects the marine environment from the potential negative impacts of biocidally active substances that are intentionally used in the anti-fouling system applied to a ship during its service life. This method can also be modified for use in freshwater environments. ISO 13073-1.2012 does not provide a specific test method for evaluating the hazard and toxicity or usage restrictions of certain substances. This also does not provide an efficacy-evaluation method for an anti-fouling system using a specific substance. The following are not covered by ISO 13073-1.2012: the risk assessment of biocidally active substances in anti-fouling systems during their application and removal during vessel maintenance and repair, new building or ship recycling; the use of anti-fouling systems intended to control harmful aquatic organisms and pathogens in ships' ballast water and sediments according to the International Convention for The Control and Management of Ships' Ballast Water and Sediments, 2004; anti-fouling systems applied to fishing gear, buoys and floats used for the purpose of fishing, and to equipment used in fisheries and aquaculture (nets/cages etc); test patches of anti-fouling systems on ships for the purpose of research and development of anti-fouling products; and the assessment of risk of biocidally active substances in cases of accidental releases, such as spillage during ocean transport or releases into the sea from rivers and/or coastal facilities.
Navires et technologie maritime — Évaluation des risques pour les systèmes antisalissure sur les navires — Partie 1: Méthode d'évaluation des risques environnementaux maritimes des substances actives biocides utilisées pour les systèmes antisalissure sur les navires
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 13073-1
First edition
2012-08-01
Ships and marine technology — Risk
assessment on anti-fouling systems on
ships —
Part 1:
Marine environmental risk assessment
method of biocidally active substances
used for anti-fouling systems on ships
Navires et technologie maritime — Évaluation des risques pour les
systèmes antisalissure sur les navires —
Partie 1: Méthode d’évaluation des risques environnementaux
maritimes des substances actives biocides utilisées pour les systèmes
antisalissure sur les navires
Reference number
©
ISO 2012
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ii © ISO 2012 – All rights reserved
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Terms and definitions . 1
3 Application . 4
3.1 General . 4
3.2 Application considerations . 4
4 Structure and procedure of environmental risk assessment . 5
5 Exposure assessment . 5
5.1 Selection of representative product . 5
5.2 Quantification of release rate . 6
5.3 Preparing the emission scenario . 6
5.4 Determination of PEC . 8
6 Hazard assessment . 8
6.1 Setting of PNEC . 8
6.2 Consideration of assessment factors .10
6.3 Determination of PNEC used for risk characterization .10
7 Risk characterization . 11
7.1 General . 11
7.2 Data and information . 11
7.3 Assessment results .12
7.4 Additional information obtained after last risk characterization .13
8 Risk assessment report .13
Annex A (informative) Systems for estimation of release rates of biocidally active substances from anti-
fouling paints .14
Annex B (normative) Details of risk characterization process of an environmental risk assessment for
organic biocidally active substances used in anti-fouling systems on ships .17
Annex C (normative) Issues to be considered for risk characterization for inorganic biocidally active
substances used in anti-fouling systems on ships .24
Annex D (informative) Examples of guidance for determining data quality .28
Annex E (informative) Examples of testing methods.29
Annex F (informative) Setting of assessment factors (AF) .34
Annex G (normative) Minimum information required for the risk assessment report .40
Annex H (informative) Previously validated models for predicting environmental concentrations .44
Bibliography .46
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 13073-1 was prepared by Technical Committee ISO/TC 8, Ships and marine technology, Subcommittee
SC 2, Marine environment protection
ISO 13073 consists of the following parts, under the general title Ships and marine technology — Risk
assessment on anti-fouling systems on ships:
— Part 1: Marine environmental risk assessment method of biocidally active substances used for anti-fouling
systems on ships
— Part 2: Marine environmental risk assessment method for anti-fouling systems on ships using biocidally
active substances
— Part 3: Human health risk assessment for the application and removal of anti-fouling systems (under development)
iv © ISO 2012 – All rights reserved
Introduction
The attachment of fouling organisms, such as barnacles and algae, on the submerged parts of a ship’s hull
increases the propulsive resistance of the hull against water, leading to increased fuel consumption and
accidental introduction of non-indigenous species to a foreign marine environment, which may possibly cause
significant and harmful changes. As a means of preventing such circumstances, an anti-fouling system that
relies on biocidally active substances (e.g. anti-fouling paint) to prevent attachment of fouling organisms can
be applied onto the hull of the ship. The harmful effects of organotin compounds used as biocides (historically
used in anti-fouling paint) on marine organisms and human health have been of global concern. To prevent
the continued use of these compounds, a legally-binding international framework regulating the use of anti-
fouling systems containing harmful substances was enacted by the International Maritime Organization (IMO).
Consequently, the International Convention on the Control of Harmful Anti-fouling Systems on Ships (the AFS
Convention) was adopted at the IMO diplomatic conference held in London in October 2001, and entered into
force in September 2008.
The Convention envisages handling various harmful anti-fouling systems within its framework and lays out a
process by which anti-fouling systems can be risk assessed. Annexes 2 and 3 of the Convention include the
list of information needed to determine whether an anti-fouling system is harmful to the environment and should
be restricted from use on ships, but a marine environmental risk assessment method for making this decision
is not provided. Furthermore, Resolution 3, adopted by IMO along with the AFS Convention, recommends that
contracting Parties continue to work in appropriate international fora for harmonization of test methods and
assessment methodologies, and performance standards for anti-fouling systems containing biocidally active
substance(s).
Based on this, there is a global need for an international method for conducting scientific environmental risk
assessments of biocidally active substances for use in anti-fouling systems. This part of ISO 13073 provides a
pragmatic approach to introducing systems (i.e., self-regulation or approval systems) in countries where either
no system exists, or a less developed system is in place and would help such countries improve protection of
the aquatic environment.
This part of ISO 13073 is intended to be used for the positive evaluation of biocidally active substances for
use in anti-fouling systems. For an evaluation of a biocidally active substance’s entry onto Annex 1 of the AFS
Convention, which is a negative listing, the methodology can be used but the evaluation should include an
extensive assessment supported by the full data requirements established in the AFS Convention.
INTERNATIONAL STANDARD ISO 13073-1:2012(E)
Ships and marine technology — Risk assessment on anti-
fouling systems on ships —
Part 1:
Marine environmental risk assessment method of biocidally
active substances used for anti-fouling systems on ships
1 Scope
This part of ISO 13073 specifies a risk assessment method that protects the marine environment from the
potential negative impacts of biocidally active substances that are intentionally used in the anti-fouling system
applied to a ship during its service life. This method can also be modified for use in freshwater environments.
This part of ISO 13073 does not provide a specific test method for evaluating the hazard and toxicity or usage
restrictions of certain substances. This also does not provide an efficacy-evaluation method for an anti-fouling
system using a specific substance.
The following are not covered by this part of ISO 13073:
— the risk assessment of biocidally active substances in anti-fouling systems during their application and
removal during vessel maintenance and repair, new building or ship recycling;
— use of anti-fouling systems intended to control harmful aquatic organisms and pathogens in ships’ ballast
water and sediments according to the International Convention for The Control and Management of Ships’
Ballast Water and Sediments, 2004;
— anti-fouling systems applied to fishing gear, buoys and floats used for the purpose of fishing, and to
equipment used in fisheries and aquaculture (nets/cages etc);
— test patches of anti-fouling systems on ships for the purpose of research and development of anti-
fouling products;
— the assessment of risk of biocidally active substances in cases of accidental releases, such as spillage
during ocean transport or releases into the sea from rivers and/or coastal facilities.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
acute test
exposure test on an aquatic species conducted for a short period (mostly for several dozen hours, although it
varies among species), in order to obtain an LC or EC for fish fatality, abnormal behaviour of invertebrates,
50 50
or inhibition of algal growth as the end point
2.2
anti-fouling system(s)
coating, paint, surface treatment, surface, or device that is used on a ship to control or prevent attachment of
unwanted organisms
2.3
assessment factor(s)
numerical factor that accounts for the uncertainty of extrapolating an effect concentration based upon
experimentally derived hazard end points (for example, dose-dependent measures such as NOEC) to Predicted
No-Effect Concentrations for use in environmental risk assessment
NOTE The hazard end point derived using a particular data point is divided by the assessment factor to define the
PNEC for that particular biocidally active substance. It is equivalent to the “uncertainty factor” used in risk assessment for
human health effects.
2.4
biocidally active substance(s)
substance having general or specific action such as mortality, growth inhibition, or repellence, on unwanted
fouling organisms, used in anti-fouling systems, for the prevent
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