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
GB/T 34033.3-2023 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 document 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 document does not specify a specific test method for evaluation of hazard and toxicity or recommend usage restrictions of certain substances.
Note 1: This document 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 Normative references
There are no normative references in this document.
3 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.
3.1
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: This definition is given in reference WHO/IPCS, 1994.
3.2
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)
3.3
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: Systems of control utilizing only physical means are not included.
3.4
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
3.5
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
3.6
chemical substance
chemical element or its compound in the natural state or obtained by any manufacturing process
3.7
core data
information
study
basic data, information or study which should, in principle, be provided for all biocidally active substances
3.8
expert
person with great knowledge or skill in hazard assessment of chemicals certified by academic society, organization or authority
Note: 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).
3.9
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
3.10
exposure scenario
set of conditions estimating or clarifying the exposure pathways of a chemical substance to the operator
Note: 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.
3.11
hazard assessment
process to identify and characterize the adverse effects of a biocidally active substance to which individuals could be exposed
Note: Effects should be assessed adverse only if they affect the viability and normal function of the organism under test.
3.12
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
3.13
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: This definition is given in reference IUPAC Compendium of Chemical Terminology Second Edition; 1997.
3.14
margin of exposure; MOE
ratio of the no observed adverse effect level (NOAEL) to the estimated exposure dose
Note: MOE is also defined as the following formula:
MOE=NOAEL/EXPOSURE
3.15
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: Some effects may be produced at this level, but they are not considered as adverse or as precursors to adverse effects.
3.16
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: This definition is given in reference IUPAC Compendium of Chemical Terminology Second Edition; 1997.
3.17
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
3.18
operator
person applying and/or removing the anti-fouling paint
3.19
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
