ISO 13073-2:2013

INTERNATIONAL ISO
STANDARD 13073-2
First edition
2013-06-01
Ships and marine technology — Risk
assessment on anti-fouling systems on
ships —
Part 2:
Marine environmental risk
assessment method for anti-fouling
systems on ships using biocidally
active substances
Navires et technologie maritime — Évaluation des risques pour les
systèmes antisalissure sur les navires —
Partie 2: Méthode d’évaluation des risques environnementaux
maritimes pour les systèmes antisalissure sur les navires utilisant des
substances actives biocides
Reference number
©
ISO 2013
© ISO 2013
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ii © ISO 2013 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Application . 2
4.1 General . 2
4.2 Application considerations. 2
4.3 Structure and procedure of environmental risk assessment . 3
5 Review of the risk of a biocidally active substance when used in the anti-fouling system .3
5.1 General . 3
5.2 Assessment when a biocidally active substance is tentatively deemed to have “relatively
low risk” . 4
5.3 Assessment when a certain type of marine environment is considered to be a recipient of
biocidally active substances . 4
6 Exposure assessment . 4
6.1 Preparing the emission scenario . 4
6.2 Determination of the PEC . 6
7 Selection of the appropriate PNEC . 7
8 Risk characterization . 7
9 Risk assessment of similar anti-fouling systems . 7
10 Substances of concern . 7
11 Risk assessment report . 7
Annex A (normative) Minimum information required for a risk assessment report .8
Bibliography .10
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
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. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
The committee responsible for this document is ISO/TC 8, Ships and marine technology, SC 2, Marine
environment protection.
ISO 13073 consists of the following parts, under the general title Marine environment protection — 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 2013 – 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 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 for anti-fouling systems substituting organotin-based anti-fouling systems. This part
of 13073 allows 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 allow such
countries to improve protection of the aquatic environment.
INTERNATIONAL STANDARD ISO 13073-2:2013(E)
Ships and marine technology — Risk assessment on anti-
fouling systems on ships —
Part 2:
Marine environmental risk assessment method for anti-
fouling systems on ships using biocidally active substances
1 Scope
This part of ISO 13073 specifies a risk assessment method that protects the marine environment from
the potential negative impacts of anti-fouling systems intentionally using biocidally active substances
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 specific test methods for evaluating the hazards nor recommends
usage restrictions for certain anti-fouling systems. It also does not provide an efficacy-evaluation
method of the anti-fouling system using a specific substance.
The following uses of anti-fouling systems are also not covered by this part of ISO 13073:
— use at the application and removal stages, during new building, vessel maintenance and repair or
ship recycling;
— use of 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;
— use of 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.); and
— test patches of anti-fouling systems on ships and small panels for the purposes of research and
development of anti-fouling systems.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 13073-1:2012, 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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 13073-1 and the following apply.
3.1
substance of concern
an intentionally added non-biocidal substance which is classified as acute or long-term hazard category
1 or 2 for “hazardous to aquatic environment” under the Globally Harmonized System of Classification
and Labelling of Chemicals (GHS) (United Nations, 2009) and is released to the marine environment
based on emission scenario(s)
4 Application
4.1 General
Risk assessment, as defined in this part of ISO 13073 and ISO 13073-1, is conducted for the protection of the
marine environment. In order to confirm the risk of a biocidally active substance in an anti-fouling system,
a risk assessment according to this part of ISO 13073 shall be conducted. In this part, the risk assessment
is conducted for anti-fouling systems using biocidally active substances which have undergone the risk
assessment given in ISO 13073-1. This assessment will identify the risk categorization of the anti-fouling
system to allow decisions to be made on the use of this anti-fouling system in a certain environment.
This part of ISO 13073 provides a minimum guideline for the following uses:
— regulation of anti-fouling systems by government organizations;
— self-regulation or approval systems carried out for industry by industrial organizations or other
third parties; and
— evaluations conducted for product development by the industry.
This part of ISO 13073 will enable the quantitative characterization of the environmental risk posed by
an anti-fouling system on the marine environment and determine whether the environmental risk of the
system is acceptable.
This part of ISO 13073 could be modified for assessing risk to freshwater environments such as rivers and
lakes. Special attention should be given to defining the emission scenarios required for freshwater areas,
and particular care should be taken to consider the effects on the species found in those environments.
4.2 Application considerations
This part of ISO 13073 provides a method for quantifying the marine (and freshwater, where necessary)
environmental risk posed by an anti-fouling system, but does not directly regulate or approve the use
or commercialization of the anti-fouling system. As a result of risk characterization of an anti-fouling
system designated in Clause 8, a categorization into “possible high risk to the marine environment” does
not necessarily mean a prohibition of its use. It may be accepted for use under certain conditions which
demonstrates a reduction in the environmental exposure such as by use of additional mitigation measures,
by refinement of the exposure assessment or by continuous monitoring of the relevant environment.
The risk assessment of the biocidally active substances that are in an anti-fouling system shall be
conducted in accordance with ISO 13073-1 prior to making the assessment using this part of ISO 13073.
Substances categorized as “low risk” or “relatively low risk” to the marine environment through the
ISO 13073-1 risk assessment should generally be used in this risk assessment. In exceptional cases,
special care shall be taken with the description designated in 5.1 when substances categorized as “risk
of high concern” to the marine environment through the ISO 13073-1 risk assessment are used.
All data submitted by an applicant are, and shall remain, the property of the applicant under this part
of ISO 13073. These data shall not be made available to other applicants without prior written approval
from the owner of the data.
2 © ISO 2013 – All rights reserved

4.3 Structure and procedure of environmental risk assessment
The environmental risk assessment procedure consists of four components: review of the risk of
biocidally active substance under ISO 13073-1, exposure assessment, representation of result of the
hazard assessment, and risk characterization. The ratio of the predicted environment concentration
(PEC) to the predicted no-effect concentration (PNEC) (PEC/PNEC) is used as a quantitative index for the
risk assessment. The procedure is summarized in Figure 1.
Figure 1 — Composition and schematic procedure of environmental risk assessment for anti-
fouling systems on ships using biocidally active substances
5 Rev
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