ISO 13073-3:2016

INTERNATIONAL ISO
STANDARD 13073-3
First edition
2016-06-01
Ships and marine technology — Risk
assessment on anti-fouling systems
on ships —
Part 3:
Human health risk assessment
method of biocidally active substances
used in anti-fouling paints on ships
during the application and removal
processes
Navires et technologie maritime — Évaluation des risques pour les
systèmes antisalissure sur les navires —
Partie 3: Méthode d’évaluation du risque pour la santé humaine des
substances bioacidement actives dans les peintures antisalissure sur
les navires durant les processus d’application et d’élimination
Reference number
©
ISO 2016
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 General principles . 5
3.1 Application . 5
3.2 Application consideration . 5
3.3 Structure and procedure of human health risk assessment . 5
4 Exposure assessment . 6
4.1 Selection of a representative product . 6
4.2 Defining the exposure scenario . 6
4.2.1 General. 6
4.2.2 Types of exposure to consider . 6
4.2.3 Determination of a representative exposure . 7
4.3 Determination of dose . 7
5 Hazard assessment. 8
5.1 Data and information . 8
5.1.1 Collection and acquisition of data and information . 8
5.1.2 Information acquisition through testing . 8
5.1.3 Reliability assessment of the collected data . 9
5.1.4 Consideration of animal welfare . 9
5.2 Defining the NOAEL . 9
6 Risk characterization . 9
6.1 General . 9
6.2 Tiered system .10
6.3 Consideration of uncertainty factor .10
6.4 Characterization of risk .10
7 Assessment results .10
7.1 Decision at each tier .10
7.1.1 Tier 1 decision: Preliminary acceptability.10
7.1.2 Tier 2 decision: Continuing acceptability .10
7.1.3 Tier 3 decision: Full acceptability .11
7.2 Expert judgement .11
7.3 Additional information obtained after last risk assessment .11
8 Risk assessment report .11
Annex A (normative) Risk characterization process for human health risk assessment of
biocidally active substances used in anti-fouling paints on ships .12
Annex B (informative) Examples of operator exposure models .22
Annex C (informative) Predicting operator exposure values .24
Annex D (informative) Examples of setting of uncertainty factor (UF) .27
Annex E (informative) Examples of testing methods .31
Annex F (informative) Examples of guidance for determining data quality .33
Annex G (normative) Minimum required information for a risk assessment report .34
Bibliography .36
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
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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 (see 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 (see 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.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is 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 method of biocidally active substances used in anti-fouling paints
on ships during the application and removal processes
iv © ISO 2016 – 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.
In addition, this may also result in accidental introduction of non-indigenous species to a foreign marine
environment, which may possibly cause significant and harmful impact on the local environment. In
order to prevent such circumstances, an anti-fouling system that employs 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 in the maritime industry as biocides against
marine organisms have been of global concern on human health. To prevent the continued use of these
compounds, the International Convention on the Control of Harmful Anti-fouling Systems on Ships (the
AFS Convention) was adopted at the International Maritime Organization (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; however, a marine environmental risk
assessment method for making this decision is not provided. There is a global need for an international
assessment method for scientific environmental risk assessment for biocidally active ingredients being
substituted for organotin biocides in anti-fouling systems.
ISO 13073-1 and ISO 13073-2 specify the risk assessment methods for biocidally active substances
and anti-fouling systems containing the biocidally active substances, respectively. In addition to these
risk assessments to protect the delicate marine ecosystems, there is also a need for protecting human
health. Anti-fouling paints, which are the most commonly used anti-fouling systems to ships, potentially
result in risk to the workers applying or removing them.
This part of ISO 13073 describes a method which allows a pragmatic approach to introducing human
health risk assessment particularly for the workers engaged in anti-fouling paint application and
removal operations. This method provides comprehensive guidelines for a risk assessment that helps
protect workers in countries without a self-regulation or approval system on anti-fouling paints or
those with a less well-developed system.
INTERNATIONAL STANDARD ISO 13073-3:2016(E)
Ships and marine
...