Ships and marine technology -- Risk assessment on anti-fouling systems on ships

ISO 13073-3:2016 specifies a method of human health risk assessment that enables the evaluation of anti-fouling paint application and removal in order to determine if the product can be used safely where users are at risk of being exposed to biocidally active substances contained within anti-fouling paints. This can be used for a risk assessment to determine the impact(s), if any, on professional or non-professional operators. ISO 13073-3:2016 does not specify a specific test method for evaluation of hazard and toxicity or recommend usage restrictions of certain substances. NOTE 1 ISO 13073-3:2016 is a "minimum" method, i.e. additional regulations or assessments based on national needs can be warranted. NOTE 2 While the approach prescribed is a tiered system, studies required in higher tiers can be undertaken in lieu of equivalent lower tier studies.

Navires et technologie maritime -- Évaluation des risques pour les systèmes antisalissure sur les navires

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Status
Published
Publication Date
01-Jun-2016
Current Stage
9020 - International Standard under periodical review
Start Date
15-Apr-2021
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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 13073-3:2016(E)
ISO 2016
---------------------- Page: 1 ----------------------
ISO 13073-3:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 13073-3:2016(E)
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

© ISO 2016 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 13073-3:2016(E)
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 (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
---------------------- Page: 4 ----------------------
ISO 13073-3:2016(E)
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.
© ISO 2016 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 13073-3:2016(E)
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
1 Scope

This part of ISO 13073 specifies a method of human health risk assessment that enables the evaluation

of anti-fouling paint application and removal in order to determine if the product can be used safely

where users are at risk of being exposed to biocidally active substances contained within anti-fouling

paints. This can be used for a risk assessment to determine the impact(s), if any, on professional or non-

professional operators.

This part of ISO 13073 does not specify a specific test method for evaluation of hazard and toxicity or

recommend usage restrictions of certain substances.

NOTE 1 This part of ISO 13073 is a “minimum” method, i.e. additional regulations or assessments based on

national needs can be warranted.

NOTE 2 While the approach prescribed is a tiered system, studies required in higher tiers can be undertaken

in lieu of equivalent lower tier studies.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

NOTE Some of the definitions for environmental risk assessment provided in ISO 13073-1 and ISO 13073-2

may be different from those of this part of ISO 13073.
2.1
adverse effect

change in morphology, physiology, growth, development or lifespan of an organism which results in

impairment of its functional capacity or impairment of its capacity to compensate for additional stress

or increased susceptibility to the harmful effects of other environmental influences

[63]
Note 1 to entry: This definition is given in reference WHO/IPCS, 1994 .
2.2
anti-fouling paint

type of anti-fouling system supplied as a form of paint typically consisting of a matrix polymer,

pigment(s) and solvent(s)
2.3
anti-fouling system

coating, paint, surface treatment, surface, or device that is used on a ship to control or prevent

attachment of unwanted organisms

Note 1 to entry: Systems of control utilizing only physical means are not included within this International

Standard.
© ISO 2016 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO 13073-3:2016(E)
2.4
biocidally active substance

substance having general or specific action such as mortality, growth inhibition, or repellence, on

unwanted fouling organisms, used in anti-fouling systems, for the prevention of attachment of sessile

organisms
2.5
by-stander

person who is not a direct user of the product or application/removal equipment but who nevertheless

may be exposed to the product during its use
2.6
chemical substance

chemical element or its compound in the natural state or obtained by any manufacturing process

2.7
core data
information
study

basic data, information or study which should, in principle, be provided for all biocidally active

substances
2.8
expert

person with great knowledge or skill in hazard assessment of chemicals certified by academic society,

organization or authority

Note 1 to entry: Those experts include Diplomat of American Board of Toxicology (USA), Fellow of the American

Toxicological Society (USA), Diplomat of Japanese Society of Toxicology (Japan), European Registered Toxicologist

(EU), Diploma, Korean Board of Toxicology (Korea), Expert in Toxicology, DGPT: sponsored by the German

Society of Experimental and Clinical Pharmacology and Toxicology (Germany), UK Register of Toxicologists:

sponsored by the Society of Biology and the British Toxicology Society (UK) and Diplomat of the Chinese Society

of Toxicology (China).
2.9
exposure assessment

estimation of the range of possible doses (of a biocidally active substance, its degradants and/or

metabolites) to individuals (operators) exposed to the biocidally active substance, taking into account

the magnitude, frequency, duration, route, and extent (number of people) of exposure

2.10
exposure scenario

set of conditions estimating or clarifying the exposure pathways of a chemical substance to the operator

Note 1 to entry: The exposure scenario should describe the conditions of use, including, but not limited to, routes

of exposure, application method, protective equipment used, job duration, etc.
2.11
hazard assessment

process to identify and characterize the adverse effects of a biocidally active substance to which

individuals could be exposed

Note 1 to entry: Effects should be assessed adverse only if they affect the viability and normal function of the

organism under test.
2.12
lowest observed adverse effect level
LOAEL

lowest tested dose or exposure level at which there are statistically significant increases in frequency

or severity of adverse effects between the exposed population and an appropriate control group

2 © ISO 2016 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 13073-3:2016(E)
2.13
lowest observed effect level
LOEL

lowest concentration or amount of a substance, found by experiment or observation, that causes any

alteration in morphology, functional capacity, growth, development, or life span of target organisms

distinguishable from normal (control) organisms of the same species and strain under the same defined

conditions of exposure

Note 1 to entry: This definition is given in reference IUPAC Compendium of Chemical Terminology Second

Edition; 1997.
2.14
margin of exposure
MOE

ratio of the no observed adverse effect level (NOAEL) to the estimated exposure dose

Note 1 to entry: MOE is also defined as the following formula:
NOAEL
MOE=
EXPOSURE

Note 2 to entry: MOE is used for toxic effects other than non-threshold oncogenic effects. For non-threshold

oncogenic effects, then a lifetime exposure analysis with a unit risk should be developed.

Note 3 to entry: This definition is given in reference USEPA.
2.15
no observed adverse effect level
NOAEL

highest tested dose or exposure level at which there are no statistically or biologically significant

increases in the frequency or severity of adverse effects between the exposed population and its

appropriate control

Note 1 to entry: Some effects may be produced at this level, but they are not considered as adverse or as

precursors to adverse effects.
2.16
no observed effect level
NOEL

greatest concentration or amount of a substance, found by experiment or observation, which causes no

detectable alteration of morphology, functional capacity, growth, development or life span of the target

organism under defined conditions of exposure

Note 1 to entry: This definition is given in reference IUPAC Compendium of Chemical Terminology Second

Edition; 1997.
2.17
non-professional operator

user of the anti-fouling paint, who is considered not to have received specific training relevant to the

application or removal of anti-fouling paints and is also known as a consumer, Do It Yourself (DIY) or

“amateur” user
2.18
operator
person applying and/or removing the anti-fouling paint
2.19
potential exposure rate

total amount of a defined substance found on the outer layers of clothing or overalls, plus the amount

of substance found on subsequent layers inside the outer layer plus the amount of substance found on

the skin
© ISO 2016 – All rights reserved 3
---------------------- Page: 8 ----------------------
ISO 13073-3:2016(E)
2.20
professional operator

user of the anti-fouling paint who has been formally trained in the use of both application or removal

equipment and in the use of protective clothing necessary for the task
2.21
risk

combination of the probability and the severity of an adverse effect caused by exposure to a chemical

substance under defined conditions
2.22
risk assessment

process intended to quantitatively or qualitatively estimate the risk posed by exposure to a substance

Note 1 to entry: A risk assessment may be qualitatively performed in case data on dose-response is insufficient

to define a NOAEL (threshold dose).
2.23
risk characterization

estimation of the incidence and severity of the adverse effects likely to occur in a human population due

to actual or predicted exposure to a substance

Note 1 to entry: Risk characterization may include “risk estimation”, i.e. the quantification of that likelihood.

2.24
ships

vessels of any type whatsoever operating in the marine environment including hydrofoil boats, air-

cushion vehicles, submersibles, floating craft, fixed or floating platforms, floating storage units (FSUs)

and floating production storage and off-loading units (FPSOs)
2.25
systemic dose

amount of biocidally active substance absorbed by the exposed individual (operator)

2.26
uncertainty factor(s)
UF(s)

factor(s) used to derive a safe dose for humans with (most often) an experimental NOAEL as a

starting point

Note 1 to entry: For animal data, a 100-fold uncertainty factor is usually applied to the NOAEL, which includes a

10-fold factor to allow for differences between animals and an average human, and 10-fold to allow for differences

[61]

between average humans and sensitive sub-groups (WHO/IPCS, 1987 ). Where data exists on the level of

effects shown in humans versus animals, for example, in physiologically based kinetic effects, then a lower factor

may be employed on a case-by-case basis.
2.27
worst case scenario

realistic scenario in which operators are expected to be most exposed to the biocidally active substance

2.28
50 % lethal concentration
LC50
concentration at which 50 % of the test organisms would die in an experiment
4 © ISO 2016 – All rights reserved
---------------------- Page: 9 ----------------------
ISO 13073-3:2016(E)
3 General principles
3.1 Application

This part of ISO 13073 can be used for the risk assessment of users exposed to anti-fouling paints

(i.e. painters) and other individuals exposed during the application of paint (such as co-workers or

painting assistants) for the purpose of protecting persons from unacceptable exposure to biocidally

active substances used in anti-fouling paints. Both professional and non-professional operators can

be assessed; special attention should be paid to ensuring that the exposure scenarios which most

accurately reflect the activities involved are chosen.
This part of ISO 13073 provides minimum guidelines for the following uses:
— regulation of anti-fouling paints by government organizations;

— self-regulation or approval systems carried out for industries or industrial organizations or other

third parties;
— evaluations conducted for product development by industries.

Risk assessment shall be conducted for biocidally active substances including their impurities if they

meet the requirements for classification as health hazards according to the Globally Harmonized

System of Classification and Labelling of Chemicals (GHS).

This part of ISO 13073 will enable quantification of the risk posed to operators handling an anti-fouling

paint containing a biocidally active substance.
3.2 Application consideration
This part of ISO 13073 shall be used with considerations described below.

— This part of ISO 13073 provides a method for evaluating the risk of a biocidally active substance

(and its relevant metabolites) when applying or removing anti-fouling paints. It does not directly

regulate or approve the use or commercialization of the substance.

— This part of ISO 13073 does not include a method for general risk assessment of industrial chemical

substances based on the assumption that it can be carried out adequately by other methods.

— When using this part of ISO 13073 in systems of regulation, approval or use of a biocidally active

substance which is demonstrated as not having an acceptable risk assessment at Tier 1 and Tier 2

shall be restricted and the substance shall be evaluated according to the process of Tier 3. These

restrictions shall be established by considering the potential severity of the substance on the

persons potentially exposed.

All data submitted by an applicant are considered 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.
3.3 Structure and procedure of human health risk assessment

Human health risk assessment consists of three procedures: exposure assessment, hazard assessment

and risk characterization (see Figure 1). Exposure assessment is a procedure to estimate the dose

that the persons receive, while the hazard assessment aims at defining the dose at which a potential

health effect would be expected. If a threshold dose (i.e. a safe dose) cannot be found, qualitative hazard

assessment should be applied.

Risk characterization is the final phase of the human health risk assessment process. It integrates

hazard assessment and exposure assessment. This phase determines the probability of an adverse

effect to human health at the estimated exposure levels. The quantitative risk characterization is shown

© ISO 2016 – All rights reserved 5
---------------------- Page: 10 ----------------------
ISO 13073-3:2016(E)

as a “margin of exposure (MOE)” using the data derived from the exposure and hazard assessments.

The MOE is a quantitative index for the risk assessment.
Detailed procedures of the risk assessment are given in Annex A.
Figure 1 — Composition and schematic procedure of human health risk assessment
4 Exposure assessment
4.1 Selection of a representative product

A representative product for exposure assessment shall be selected to ensure that the anti-fouling paint

contains the biocidally active substance to be assessed. In order to assume the worst case, the product

chosen shall contain the highest concentration of the biocidally active substance as proposed for use in

the marketplace. If no product exists in the marketplace, an experimental product can be used where

the level of biocidally active substance has been found to return acceptable anti-fouling performance.

4.2 Defining the exposure scenario
4.2.1 General

An exposure scenario defines the route of exposure and potential level of exposure for the exposed

individuals carrying out the activity under consideration. The scenario defined shall consider all

elements of the task involved in order to model the exposure as accurately as possible for determining

the dose received by the person using the product.
Examples of existing human exposure scenarios can be found in Annex B.
4.2.2 Types of exposure to consider

The risk assessment shall take into account all people who are likely to be exposed to the paint during

application or removal. This will depend upon the intended use scenario and could include the use by

either professional or non-professional operators [Consumers or Do It Yourself, (DIY)].

It is important to define activities of persons that will be exposed to the product during use. For

example, in a do
...

INTERNATIONAL ISO
STANDARD 13073-3
First edition
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
PROOF/ÉPREUVE
Reference number
ISO 13073-3:2016(E)
ISO 2016
---------------------- Page: 1 ----------------------
ISO 13073-3:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 13073-3:2016(E)
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 ........................................................................................................................32

Annex F (informative) Examples of guidance for determining data quality ............................................................34

Annex G (normative) Minimum required information for a risk assessment report ....................................35

Bibliography .............................................................................................................................................................................................................................37

© ISO 2016 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO 13073-3:2016(E)
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 (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
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ISO 13073-3:2016(E)
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.
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INTERNATIONAL STANDARD ISO 13073-3:2016(E)
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
1 Scope

This part of ISO 13073 specifies a method of human health risk assessment that enables the evaluation

of anti-fouling paint application and removal in order to determine if the product can be used safely

where users are at risk of being exposed to biocidally active substances contained within anti-fouling

paints. This can be used for a risk assessment to determine the impact(s), if any, on professional or non-

professional operators.

This part of ISO 13073 does not specify a specific test method for evaluation of hazard and toxicity or

recommend usage restrictions of certain substances.

NOTE 1 This part of ISO 13073 is a “minimum” method, i.e. additional regulations or assessments based on

national needs can be warranted.

NOTE 2 While the approach prescribed is a tiered system, studies required in higher tiers can be undertaken

in lieu of equivalent lower tier studies.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

NOTE Some of the definitions for environmental risk assessment provided in ISO 13073-1 and ISO 13073-2

may be different from those of this part of ISO 13073.
2.1
adverse effect

change in morphology, physiology, growth, development or lifespan of an organism which results in

impairment of its functional capacity or impairment of its capacity to compensate for additional stress

or increased susceptibility to the harmful effects of other environmental influences

Note 1 to entry: This definition is given in reference WHO/IPCS, 1994.
2.2
anti-fouling paint

type of anti-fouling system supplied as a form of paint typically consisting of a matrix polymer,

pigment(s) and solvent(s)
2.3
anti-fouling system

coating, paint, surface treatment, surface, or device that is used on a ship to control or prevent

attachment of unwanted organisms

Note 1 to entry: Systems of control utilizing only physical means are not included within this International

Standard.
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ISO 13073-3:2016(E)
2.4
biocidally active substance

substance having general or specific action such as mortality, growth inhibition, or repellence, on

unwanted fouling organisms, used in anti-fouling systems, for the prevention of attachment of sessile

organisms
2.5
by-stander

person who is not a direct user of the product or application/removal equipment but who nevertheless

may be exposed to the product during its use
2.6
chemical substance

chemical element or its compound in the natural state or obtained by any manufacturing process

2.7
core data
information
study

basic data, information or study which should, in principle, be provided for all biocidally active

substances
2.8
expert

person with great knowledge or skill in hazard assessment of chemicals certified by academic society,

organization or authority

Note 1 to entry: Those experts include Diplomat of American Board of Toxicology (USA), Fellow of the American

Toxicological Society (USA), Diplomat of Japanese Society of Toxicology (Japan), European Registered Toxicologist

(EU), Diploma, Korean Board of Toxicology (Korea), Expert in Toxicology, DGPT: sponsored by the German

Society of Experimental and Clinical Pharmacology and Toxicology (Germany), UK Register of Toxicologists:

sponsored by the Society of Biology and the British Toxicology Society (UK) and Diplomat of the Chinese Society

of Toxicology (China).
2.9
exposure assessment

estimation of the range of possible doses (of a biocidally active substance, its degradants and/or

metabolites) to individuals (operators) exposed to the biocidally active substance, taking into account

the magnitude, frequency, duration, route, and extent (number of people) of exposure

2.10
exposure scenario

set of conditions estimating or clarifying the exposure pathways of a chemical substance to the operator

Note 1 to entry: The exposure scenario should describe the conditions of use, including, but not limited to, routes

of exposure, application method, protective equipment used, job duration, etc.
2.11
hazard assessment

process to identify and characterize the adverse effects of a biocidally active substance to which

individuals could be exposed

Note 1 to entry: Effects should be assessed adverse only if they affect the viability and normal function of the

organism under test.
2.12
lowest observed adverse effect level
LOAEL

lowest tested dose or exposure level at which there are statistically significant increases in frequency

or severity of adverse effects between the exposed population and an appropriate control group

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ISO 13073-3:2016(E)
2.13
lowest observed effect level
LOEL

lowest concentration or amount of a substance, found by experiment or observation, that causes any

alteration in morphology, functional capacity, growth, development, or life span of target organisms

distinguishable from normal (control) organisms of the same species and strain under the same defined

conditions of exposure

Note 1 to entry: This definition is given in reference IUPAC Compendium of Chemical Terminology Second

Edition; 1997.
2.14
margin of exposure
MOE

ratio of the no observed adverse effect level (NOAEL) to the estimated exposure dose

Note 1 to entry: MOE is also defined as the following formula:
NOAEL
MOE=
EXPOSURE

Note 2 to entry: MOE is used for toxic effects other than non-threshold oncogenic effects. For non-threshold

oncogenic effects, then a lifetime exposure analysis with a unit risk should be developed.

Note 3 to entry: This definition is given in reference USEPA.
2.15
no observed adverse effect level
NOAEL

highest tested dose or exposure level at which there are no statistically or biologically significant

increases in the frequency or severity of adverse effects between the exposed population and its

appropriate control

Note 1 to entry: Some effects may be produced at this level, but they are not considered as adverse or as

precursors to adverse effects.
2.16
no observed effect level
NOEL

greatest concentration or amount of a substance, found by experiment or observation, which causes no

detectable alteration of morphology, functional capacity, growth, development or life span of the target

organism under defined conditions of exposure

Note 1 to entry: This definition is given in reference IUPAC Compendium of Chemical Terminology Second

Edition; 1997.
2.17
non-professional operator

user of the anti-fouling paint, who is considered not to have received specific training relevant to the

application or removal of anti-fouling paints and is also known as a consumer, Do It Yourself (DIY) or

“amateur” user
2.18
operator
person applying and/or removing the anti-fouling paint
2.19
potential exposure rate

total amount of a defined substance found on the outer layers of clothing or overalls, plus the amount

of substance found on subsequent layers inside the outer layer plus the amount of substance found on

the skin
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ISO 13073-3:2016(E)
2.20
professional operator

user of the anti-fouling paint who has been formally trained in the use of both application or removal

equipment and in the use of protective clothing necessary for the task
2.21
risk

combination of the probability and the severity of an adverse effect caused by exposure to a chemical

substance under defined conditions
2.22
risk assessment

process intended to quantitatively or qualitatively estimate the risk posed by exposure to a substance

Note 1 to entry: A risk assessment may be qualitatively performed in case data on dose-response is insufficient

to define a NOAEL (threshold dose).
2.23
risk characterization

estimation of the incidence and severity of the adverse effects likely to occur in a human population due

to actual or predicted exposure to a substance

Note 1 to entry: Risk characterization may include “risk estimation”, i.e. the quantification of that likelihood.

2.24
ships

vessels of any type whatsoever operating in the marine environment including hydrofoil boats, air-

cushion vehicles, submersibles, floating craft, fixed or floating platforms, floating storage units (FSUs)

and floating production storage and off-loading units (FPSOs)
2.25
systemic dose

amount of biocidally active substance absorbed by the exposed individual (operator)

2.26
uncertainty factor(s)
UF(s)

factor(s) used to derive a safe dose for humans with (most often) an experimental NOAEL as a

starting point

Note 1 to entry: For animal data, a 100-fold uncertainty factor is usually applied to the NOAEL, which includes a

10-fold factor to allow for differences between animals and an average human, and 10-fold to allow for differences

between average humans and sensitive sub-groups (WHO/IPCS, 1987). Where data exists on the level of effects

shown in humans versus animals, for example, in physiologically based kinetic effects, then a lower factor may be

employed on a case-by-case basis.
2.27
worst case scenario

realistic scenario in which operators are expected to be most exposed to the biocidally active substance

2.28
50 % lethal concentration
LC50
concentration at which 50 % of the test organisms would die in an experiment
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ISO 13073-3:2016(E)
3 General principles
3.1 Application

This part of ISO 13073 can be used for the risk assessment of users exposed to anti-fouling paints

(i.e. painters) and other individuals exposed during the application of paint (such as co-workers or

painting assistants) for the purpose of protecting persons from unacceptable exposure to biocidally

active substances used in anti-fouling paints. Both professional and non-professional operators can

be assessed; special attention should be paid to ensuring that the exposure scenarios which most

accurately reflect the activities involved are chosen.
This part of ISO 13073 provides minimum guidelines for the following uses:
— regulation of anti-fouling paints by government organizations;

— self-regulation or approval systems carried out for industries or industrial organizations or other

third parties;
— evaluations conducted for product development by industries.

Risk assessment shall be conducted for biocidally active substances including their impurities if they

meet the requirements for classification as health hazards according to the Globally Harmonized

System of Classification and Labelling of Chemicals (GHS).

This part of ISO 13073 will enable quantification of the risk posed to operators handling an anti-fouling

paint containing a biocidally active substance.
3.2 Application consideration
This part of ISO 13073 shall be used with considerations described below.

— This part of ISO 13073 provides a method for evaluating the risk of a biocidally active substance

(and its relevant metabolites) when applying or removing anti-fouling paints. It does not directly

regulate or approve the use or commercialization of the substance.

— This part of ISO 13073 does not include a method for general risk assessment of industrial chemical

substances based on the assumption that it can be carried out adequately by other methods.

— When using this part of ISO 13073 in systems of regulation, approval or use of a biocidally active

substance which is demonstrated as not having an acceptable risk assessment at Tier 1 and Tier 2

shall be restricted and the substance shall be evaluated according to the process of Tier 3. These

restrictions shall be established by considering the potential severity of the substance on the

persons potentially exposed.

All data submitted by an applicant are considered 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.
3.3 Structure and procedure of human health risk assessment

Human health risk assessment consists of three procedures: exposure assessment, hazard assessment

and risk characterization (see Figure 1). Exposure assessment is a procedure to estimate the dose

that the persons receive, while the hazard assessment aims at defining the dose at which a potential

health effect would be expected. If a threshold dose (i.e. a safe dose) cannot be found, qualitative hazard

assessment should be applied.

Risk characterization is the final phase of the human health risk assessment process. It integrates

hazard assessment and exposure assessment. This phase determines the probability of an adverse

effect to human health at the estimated exposure levels. The quantitative risk characterization is shown

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ISO 13073-3:2016(E)

as a “margin of exposure (MOE)” using the data derived from the exposure and hazard assessments.

The MOE is a quantitative index for the risk assessment.
Detailed procedures of the risk assessment are given in Annex A.
Figure 1 — Composition and schematic procedure of human health risk assessment
4 Exposure assessment
4.1 Selection of a representative product

A representative product for exposure assessment shall be selected to ensure that the anti-fouling paint

contains the biocidally active substance to be assessed. In order to assume the worst case, the product

chosen shall contain the highest concentration of the biocidally active substance as proposed for use in

the marketplace. If no product exists in the marketplace, an experimental product can be used where

the level of biocidally active substance has been found to return acceptable anti-fouling performance.

4.2 Defining the exposure scenario
4.2.1 General

An exposure scenario defines the route of exposure and potential level of exposure for the exposed

individuals carrying out the activity under consideration. The scenario defined shall consider all

elements of the task involved in order to model the exposure as accurately as possible for determining

the dose received by the person using the product.
Examples of existing human exposure scenarios can be found in Annex B.
4.2.2 Types of exposure to consider

The risk assessment shall take into account all people who are likely to be exposed to the paint during

application or removal. This will depend upon the intended use scenario and could include the use by

either professional or non-professional operators [Consumers or Do It Yourself, (DIY)].

It is important to defi
...

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