ISO 13073-3:2016
(Main)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
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
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 — 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
General Information
Standards Content (Sample)
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 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 .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
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 PROOF/ÉPREUVE © 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 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.
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 PROOF/ÉPREUVE © ISO 2016 – All rights reserved
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
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
4 PROOF/ÉPREUVE © ISO 2016 – All rights reserved
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
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 dockyard, the following personnel may be exposed:
— sprayers;
6 PROOF/ÉPREUVE © ISO 2016 – All rights reserved
— other persons in close contact with the sprayer such as boom operators;
— pot-men (operators using spray pumps to supply the sprayers);
— by-standers, etc.
Similar considerations should be given to all other use scenarios such as boatyards.
4.2.3 Determination of a representative exposure
Once the persons who will be exposed have been identified, the task should be defined, i.e. the
parameters governing the amount of exposure that the person will receive. The following considerations
shall be taken into account:
a) the application/removal method(s):
1) airless spray;
2) brush and roller;
3) blast cleaning;
4) all other application and removing processes (e.g. sand papering, ultra high pressure water
jetting);
b) the actual exposure period for each activity of the person in a given day;
NOTE For example, a person spraying paints may only do so for 3 h during a normal working day
because time will be required for preparing equipment for use/meal breaks/waiting, etc.
c) frequency and duration of exposure (days per month or year);
d) level of personal protective equipment (PPE).
NOTE It is important to determine how much protection is offered by the equipment.
Defining the parameters mentioned above for the exposure will provide the baseline data to establish
how much paint the worker is exposed to, that is how much paint comes into contact with skin (dermal
exposure) or is inhaled.
NOTE Inhalation exposure should take account of the respirable fraction of any particles.
4.3 Determination of dose
Once the exposure scenario parameters have been determined, the potential dose can be calculated. In
order to determine the total potential exposure to the paint, define the rate of exposure when applied
using the application/removal method of interest. In simple terms, the amount of paint that is deposited
on the worker’s overalls and the concentration of paint in the working atmosphere shall be determined.
There are two principal ways to define the potential exposure rate:
— measured data from worker’s exposure studies;
— extrapolation of existing exposure data for comparable methods.
Once the potential exposure rate is known, the actual exposure to the paint shall be determined by
taking into account the protection afforded to the operator by the PPE and the length of time taken to
complete that task.
To determine the actual dose from the exposure to the paint, the following data are needed:
— the content of the biocidally active substance in the paint which is typically expressed in %
weight/weight wet paint (%w/w wet paint) terms;
— the absorption of the biocidally active substance from the paint across the skin;
— the absorption of the biocidally active substance from the paint across the lungs.
The concentration of the biocidally active substance in the paint can be obtained from the label on the
paint can, the safety data sheet (SDS) or from the paint manufacturer.
Absorption of biocidally active substances through the skin should preferably be determined from a
dermal absorption study with a representative paint containing the biocidally active substance at an
appropriate concentration. A combination of the results of the OECD guidelines 427 (in vivo, rats) and
428 (in vitro) provide good methods for dermal absorption evaluation. In vitro studies with human skin
according to OECD guidelines 428 as stand-alone test are also accepted. Where no test data is available,
an appropriate default value may be selected.
For exposure by inhalation, it shall be determined whether the adverse effect is local or systemic.
For local effects (irritation/corrosion, sensitization), inhalation and dermal exposure shall be assessed
separately. For systemic effects, inhalation and dermal exposure shall be assessed together when the
critical endpoint is common but may be assessed separately where the critical endpoints are different.
By using the exposure data and the dermal/lung absorption data, the amount of biocidally active
substance which passes across relevant biological membranes can be determined and the systemic
dose calculated by taking into account the typical weight of the operator exposed. Generally, this is
expressed in terms of exposure per unit body weight (bw) of operator per day (i.e. mg biocidally active
substance/kg bw/day).
An example of existing human exposure scenarios for preparing emission scenarios can be found in the
Technical Notes for Guidance (TNsG) for Human Risk Assessment developed for the Biocidal Products
Directive (98/8/EC). Further details regarding determining exposure are given in Annex C.
5 Hazard assessment
5.1 Data and information
5.1.1 Collection and acquisition of data and information
In order to conduct the assessment appropriately, studies to identify the physico-chemical or hazardous
properties of the biocidally active substance (and, where necessary, its metabolites) should be
conducted in accordance with International Standards. Examples of studies are provided in Annex E.
Data and information to identify the physico-chemical or hazardous properties of the biocidally active
substance (and, where necessary, its metabolites) should be collected. Studies and data in accordance
with internationally recognized test methods should be collected with priority in order to conduct the
assessment appropriately.
5.1.2 Information acquisition through testing
5.1.2.1 Test implementation
Tests shall be conducted according to internationally recognized test methods, or test methods
equivalent to such methods, by an organization or a laboratory meeting the Good Laboratory Practice
(GLP) requirements or with the equivalent qualification. Examples of testing methods are provided in
Annex E.
Due consideration should be given to minimizing the use of animals and, where appropriate, validated
in vitro studies should be used in preference to in vivo studies.
8 PROOF/ÉPREUVE © ISO 2016 – All rights reserved
5.1.2.2 Selection of test species
Unless otherwise stated in a particular test method, animals used for toxicity testing should be
chosen on the basis of their suitability for the test and that their physiological response is considered
analogous to that of humans or that the physiology of the organism is sufficiently well understood to
allow extrapolation to human responses.
5.1.2.3 Test omission (data waiving)
Where a substantiated scientific basis has been developed, some necessary tests may be omitted
and/or replaced with other test results or test methods. In each case, existing test results on structurally
similar substances or other reasoning such as lack of foreseen exposure may be applicable. For example,
a quantitative structural analysis-relationship (QSAR) approach may be possible. An overview of QSAR
analysis can be found in the European Union Technical Guidance Document on Risk Assessment, Part III.
Mode of action studies on the substance may be particularly helpful for waiving in vivo studies.
5.1.3 Reliability assessment of the collected data
All studies and data used in the risk assessment shall be assessed for their quality. Unreliable data
should not be used in the risk assessment process. Examples of guidance on data quality evaluation
methods are shown in Annex F.
All data to be submitted as part of the risk assessment shall be evaluated for quality according to
the reliability assessment. The applicant may submit data evaluated as “not reliable” or “of very low
reliability”. These data may be used in a “weight of evidence” approach.
Irrespective of reliability of the data, potentially severe health effects shall be reported and accounted for.
5.1.4 Consideration of animal welfare
When planning the test program, consideration should be given to animal welfare, i.e. using the
minimum number of test animals necessary. Tests should only be conducted when it is clear that the
risk assessment will be improved by the tests. For example, irritation tests may be omitted regardless
of the requirement in A.2.1.1 when a sequential testing strategy for irritation or corrosion studies in
OECD 404 and 405 can be applied.
5.2 Defining the NOAEL
Once a hazard assessment has been conducted and the critical endpoint(s) is identified, the risk assessor
shall identify the highest dose at which no critical adverse effect(s) was demonstrated. The dose
(expressed as NOAEL) shall be selected from the studies judged to be most relevant to the exposure
scenario being evaluated.
In order to define the no observed adverse effect level (NOAEL), the available toxicological data for the
active substance shall be reviewed and considered for use according to the process given in Annex A.
6 Risk characterization
6.1 General
Risk characterization is conducted with the tiered process described in Annex A. Note that the NOAEL
is calculated using toxicity data required in each tier of the process and the risk level is determined
by comparing the ratio of the exposure level to the NOAEL for the most relevant exposure model
(NOAEL/exposure level ratio). This ratio [margin of exposure(MOE)] is used to determine whether the
risk can be considered acceptable or not.
6.2 Tiered system
The risk characterization process starts at Tier 1 and proceeds stepwise to end in Tier 3. By using a
tiered approach, limited approvals can be granted at each tier enabling companies to develop further
data to improve and refine the risk assessment. The tiered approach, therefore, enables placement
of a product on the market with a basic data set in order that product development can continue and
revenue be generated to justify further investment in studies to refine the risk assessment. Once the
data criteria in Tier 3 are met, the risk assessment of the biocidally active substance can be regarded as
complete.
If a biocidally active substance does not meet the criteria described in Tier 1, it implies that the
substance may have an adverse effect on the exposed person. The biocidally active substance shall
therefore not be considered acceptable for use unless more data is supplied to comply with the higher
Tiers (Tiers 2 and 3).
Where data for a particular toxicological effect are required at multiple tiers, longer term studies may
be used in lieu of short-term studies. For example, a 90-day oral exposure study can be used in place of
a 28-day oral exposure study.
6.3 Consideration of uncertainty factor
The process of choosing an uncertainty factor (UF), which may sometimes be referred to as assessment
factor (AF), shall account for each of the applicable areas of uncertainty. The primary reason for using
UFs is to account for scientific uncertainty in the results from toxicity studies and their relevance to
humans. A typical UF in common use is 100 which accounts for a 10-fold factor when extrapolating
results from long-term animal studies to humans and a 10-fold factor to account for variation in
sensitivity among humans. As variation in sensitivity among professionals is lower than for the general
population, a lower uncertainty factor could be justified. Additional factors may be applied when
deriving the reference dose (Rfd) from the lowest observed adverse effect level (LOAEL) instead of the
NOAEL or utilizing subchronic data in place of chronic data, etc.
Some examples of setting the UF are described in Annex D; a combination of these methods/perspectives
may be appropriate.
6.4 Characterization of risk
Following the process described in Annex A, the risk associated with a biocidally active substance used
in an anti-fouling paint is determined based on the results of the test data obtained at each tier.
7 Assessment results
7.1 Decision at each tier
7.1.1 Tier 1 decision: Preliminary acceptability
Successful evaluation results in “Preliminary acceptability” at Tier 1 which is granted on the basis that
data according to Tier 2 requirements will be provided in order to allow a more robust assessment to
be made. A suitable time should be defined after which the data should be submitted.
Supply to the market at this stage is also restricted to professional use only.
7.1.2 Tier 2 decision: Continuing acceptability
Successful evaluation results in “Continuing acceptability” at Tier 2 which is granted on the basis that
data according to Tier 3 requirements will be provided in order to allow a more robust assessment to
be made. A suitable time should be defined after which the data should be submitted.
10 PROOF/ÉPREUVE © ISO 2016 – All rights reserved
For professional use, continued supply to the market at this Tier will only be granted for products with
an acceptable MOE.
Non-professional use can be allowed as long as an acceptable MOE can be demonstrated.
7.1.3 Tier 3 decision: Full acceptability
Successful evaluation results in “Full acceptability” at Tier 3. Full acceptability is allowed only for those
use scenarios that have been fully evaluated. For example, biocidally active substances which have only
been risk assessed for professional use shall not be made available for use by non-professional users.
It is advisable that a time limit should be placed on the acceptability after which the biocidally active
substance should be re-reviewed taking into account advances in risk assessment and applying best
practice. Typical acceptability periods are generally within 10 years from the date of the original
evaluation.
7.2 Expert judgement
When uncertainties exist, or toxicity data in one or more areas are inadequate, the uncertainty factor
(UF) should be increased. It should also be recognized that expert judgement is often necessary to
define a particular endpoint. It should be ensured that data are evaluated by a competent person.
7.3 Additional information obtained after last risk assessment
Whenever additional information regarding a substance’s toxicological properties becomes known,
the risk assessment should be refined. This may change the earlier decision and thus the earlier
conditions on use.
8 Risk assessment report
Regarding the risk assessment conducted according to this part of ISO 13073, a risk assessment report
shall be prepared. The minimum required information to be cited in the risk assessment report is
described in Annex G.
...
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
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
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Tel. +41 22 749 01 11
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copyright@iso.org
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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
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
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 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.
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
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
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
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
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 dockyard, the following personnel may be exposed:
— sprayers;
6 © ISO 2016 – All rights reserved
— other persons in close contact with the sprayer such as boom operators;
— pot-men (operators using spray pumps to supply the sprayers);
— by-standers, etc.
Similar considerations should be given to all other use scenarios such as boatyards.
4.2.3 Determination of a representative exposure
Once the persons who will be exposed have been identified, the task should be defined, i.e. the
parameters governing the amount of exposure that the person will receive. The following considerations
shall be taken into account:
a) the application/removal method(s):
1) airless spray;
2) brush and roller;
3) blast cleaning;
4) all other application and removing processes (e.g. sand papering, ultra high pressure water
jetting);
b) the actual exposure period for each activity of the person in a given day;
NOTE For example, a person spraying paints may only do so for 3 h during a normal working day
because time will be required for preparing equipment for use/meal breaks/waiting, etc.
c) frequency and duration of exposure (days per month or year);
d) level of personal protective equipment (PPE).
NOTE It is important to determine how much protection is offered by the equipment.
Defining the parameters mentioned above for the exposure will provide the baseline data to establish
how much paint the worker is exposed to, that is how much paint comes into contact with skin (dermal
exposure) or is inhaled.
NOTE Inhalation exposure should take account of the respirable fraction of any particles.
4.3 Determination of dose
Once the exposure scenario parameters have been determined, the potential dose can be calculated. In
order to determine the total potential exposure to the paint, define the rate of exposure when applied
using the application/removal method of interest. In simple terms, the amount of paint that is deposited
on the worker’s overalls and the concentration of paint in the working atmosphere shall be determined.
There are two principal ways to define the potential exposure rate:
— measured data from worker’s exposure studies;
— extrapolation of existing exposure data for comparable methods.
Once the potential exposure rate is known, the actual exposure to the paint shall be determined by
taking into account the protection afforded to the operator by the PPE and the length of time taken to
complete that task.
To determine the actual dose from the exposure to the paint, the following data are needed:
— the content of the biocidally active substance in the paint which is typically expressed in %
weight/weight wet paint (%w/w wet paint) terms;
— the absorption of the biocidally active substance from the paint across the skin;
— the absorption of the biocidally active substance from the paint across the lungs.
The concentration of the biocidally active substance in the paint can be obtained from the label on the
paint can, the safety data sheet (SDS) or from the paint manufacturer.
Absorption of biocidally active substances through the skin should preferably be determined from a
dermal absorption study with a representative paint containing the biocidally active substance at an
appropriate concentration. A combination of the results of the OECD guidelines 427 (in vivo, rats) and
428 (in vitro) provide good methods for dermal absorption evaluation. In vitro studies with human skin
according to OECD guidelines 428 as stand-alone test are also accepted. Where no test data is available,
an appropriate default value may be selected.
For exposure by inhalation, it shall be determined whether the adverse effect is local or systemic.
For local effects (irritation/corrosion, sensitization), inhalation and dermal exposure shall be assessed
separately. For systemic effects, inhalation and dermal exposure shall be assessed together when the
critical endpoint is common but may be assessed separately where the critical endpoints are different.
By using the exposure data and the dermal/lung absorption data, the amount of biocidally active
substance which passes across relevant biological membranes can be determined and the systemic
dose calculated by taking into account the typical weight of the operator exposed. Generally, this is
expressed in terms of exposure per unit body weight (bw) of operator per day (i.e. mg biocidally active
substance/kg bw/day).
An example of existing human exposure scenarios for preparing emission scenarios can be found in the
Technical Notes for Guidance (TNsG) for Human Risk Assessment developed for the Biocidal Products
Directive (98/8/EC). Further details regarding determining exposure are given in Annex C.
5 Hazard assessment
5.1 Data and information
5.1.1 Collection and acquisition of data and information
In order to conduct the assessment appropriately, studies to identify the physico-chemical or hazardous
properties of the biocidally active substance (and, where necessary, its metabolites) should be
conducted in accordance with International Standards. Examples of studies are provided in Annex E.
Data and information to identify the physico-chemical or hazardous properties of the biocidally active
substance (and, where necessary, its metabolites) should be collected. Studies and data in accordance
with internationally recognized test methods should be collected with priority in order to conduct the
assessment appropriately.
5.1.2 Information acquisition through testing
5.1.2.1 Test implementation
Tests shall be conducted according to internationally recognized test methods, or test methods
equivalent to such methods, by an organization or a laboratory meeting the Good Laboratory Practice
(GLP) requirements or with the equivalent qualification. Examples of testing methods are provided in
Annex E.
Due consideration should be given to minimizing the use of animals and, where appropriate, validated
in vitro studies should be used in preference to in vivo studies.
8 © ISO 2016 – All rights reserved
5.1.2.2 Selection of test species
Unless otherwise stated in a particular test method, animals used for toxicity testing should be
chosen on the basis of their suitability for the test and that their physiological response is considered
analogous to that of humans or that the physiology of the organism is sufficiently well understood to
allow extrapolation to human responses.
5.1.2.3 Test omission (data waiving)
Where a substantiated scientific basis has been developed, some necessary tests may be omitted
and/or replaced with other test results or test methods. In each case, existing test results on structurally
similar substances or other reasoning such as lack of foreseen exposure may be applicable. For example,
a quantitative structural analysis-relationship (QSAR) approach may be possible. An overview of QSAR
analysis can be found in the European Union Technical Guidance Document on Risk Assessment, Part III.
Mode of action studies on the substance may be particularly helpful for waiving in vivo studies.
5.1.3 Reliability assessment of the collected data
All studies and data used in the risk assessment shall be assessed for their quality. Unreliable data
should not be used in the risk assessment process. Examples of guidance on data quality evaluation
methods are shown in Annex F.
All data to be submitted as part of the risk assessment shall be evaluated for quality according to
the reliability assessment. The applicant may submit data evaluated as “not reliable” or “of very low
reliability”. These data may be used in a “weight of evidence” approach.
Irrespective of reliability of the data, potentially severe health effects shall be reported and accounted for.
5.1.4 Consideration of animal welfare
When planning the test program, consideration should be given to animal welfare, i.e. using the
minimum number of test animals necessary. Tests should only be conducted when it is clear that the
risk assessment will be improved by the tests. For example, irritation tests may be omitted regardless
of the requirement in A.2.1.1 when a sequential testing strategy for irritation or corrosion studies in
OECD 404 and 405 can be applied.
5.2 Defining the NOAEL
Once a hazard assessment has been conducted and the critical endpoint(s) is identified, the risk assessor
shall identify the highest dose at which no critical adverse effect(s) was demonstrated. The dose
(expressed as NOAEL) shall be selected from the studies judged to be most relevant to the exposure
scenario being evaluated.
In order to define the no observed adverse effect level (NOAEL), the available toxicological data for the
active substance shall be reviewed and considered for use according to the process given in Annex A.
6 Risk characterization
6.1 General
Risk characterization is conducted with the tiered process described in Annex A. Note that the NOAEL
is calculated using toxicity data required in each tier of the process and the risk level is determined
by comparing the ratio of the exposure level to the NOAEL for the most relevant exposure model
(NOAEL/exposure level ratio). This ratio [margin of exposure (MOE)] is used to determine whether the
risk can be considered acceptable or not.
6.2 Tiered system
The risk characterization process starts at Tier 1 and proceeds stepwise to end in Tier 3. By using a
tiered approach, limited approvals can be granted at each tier enabling companies to develop further
data to improve and refine the risk assessment. The tiered approach, therefore, enables placement
of a product on the market with a basic data set in order that product development can continue and
revenue be generated to justify further investment in studies to refine the risk assessment. Once the
data criteria in Tier 3 are met, the risk assessment of the biocidally active substance can be regarded as
complete.
If a biocidally active substance does not meet the criteria described in Tier 1, it implies that the
substance may have an adverse effect on the exposed person. The biocidally active substance shall
therefore not be considered acceptable for use unless more data is supplied to comply with the higher
Tiers (Tiers 2 and 3).
Where data for a particular toxicological effect are required at multiple tiers, longer term studies may
be used in lieu of short-term studies. For example, a 90-day oral exposure study can be used in place of
a 28-day oral exposure study.
6.3 Consideration of uncertainty factor
The process of choosing an uncertainty factor (UF), which may sometimes be referred to as assessment
factor (AF), shall account for each of the applicable areas of uncertainty. The primary reason for using
UFs is to account for scientific uncertainty in the results from toxicity studies and their relevance to
humans. A typical UF in common use is 100 which accounts for a 10-fold factor when extrapolating
results from long-term animal studies to humans and a 10-fold factor to account for variation in
sensitivity among humans. As variation in sensitivity among professionals is lower than for the general
population, a lower uncertainty factor could be justified. Additional factors may be applied when
deriving the reference dose (Rfd) from the lowest observed adverse effect level (LOAEL) instead of the
NOAEL or utilizing subchronic data in place of chronic data, etc.
Some examples of setting the UF are described in Annex D; a combination of these methods/perspectives
may be appropriate.
6.4 Characterization of risk
Following the process described in Annex A, the risk associated with a biocidally active substance used
in an anti-fouling paint is determined based on the results of the test data obtained at each tier.
7 Assessment results
7.1 Decision at each tier
7.1.1 Tier 1 decision: Preliminary acceptability
Successful evaluation results in “Preliminary acceptability” at Tier 1 which is granted on the basis that
data according to Tier 2 requirements will be provided in order to allow a more robust assessment to
be made. A suitable time should be defined after which the data should be submitted.
Supply to the market at this stage is also restricted to professional use only.
7.1.2 Tier 2 decision: Continuing acceptability
Successful evaluation results in “Continuing acceptability” at Tier 2 which is granted on the basis that
data according to Tier 3 requirements will be provided in order to allow a more robust assessment to
be made. A suitable time should be defined after which the data should be submitted.
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For professional use, continued supply to the market at this Tier will only be granted for products with
an acceptable MOE.
Non-professional use can be allowed as long as an acceptable MOE can be demonstrated.
7.1.3 Tier 3 decision: Full acceptability
Successful evaluation results in “Full acceptability” at Tier 3. Full acceptability is allowed only for those
use scenarios that have been fully evaluated. For example, biocidally active substances which have only
been risk assessed for professional use shall not be made available for use by non-professional users.
It is advisable that a time limit should be placed on the acceptability after which the biocidally active
substance should be re-reviewed taking into account advances in risk assessment and applying best
practice. Typical acceptability periods are generally within 10 years from the date of the original
evaluation.
7.2 Expert judgement
When uncertainties exist, or toxicity data in one or more areas are inadequate, the uncertainty factor
(UF) should be increased. It should also be recognized that expert judgement is often necessary to
define a particular endpoint. It should be ensured that data are evaluated by a competent person.
7.3 Additional information obtained after last risk assessment
Whenever additional information regarding a substance’s toxicological properties becomes known,
the risk assessment should be refined. This may change the earlier decision and thus the earlier
conditions on use.
8 Risk assessment report
Regarding the risk assessment conducted according to this part of ISO 13073, a risk assessment report
shall be prepared. The minimum required information to be cited in the risk assessment report is
described in Annex G.
Annex A
(normative)
Risk characterization process fo
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