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Preface
This document sets out the acceptable daily intakes (ADI) for agricultural and veterinary (agvet) chemicals used on food producing crops or animals. It includes entries which were recommended by the former Pesticides and Agricultural Chemicals Standing Committee (PACSC) of the National Health and Medical Research Council (NHMRC) until November 1992. The responsibility for establishing ADIs transferred to the Australian Department of Health on 12 March 1993. On 1 July 2016, the task of establishing ADIs was transferred to the Australian Pesticides and Veterinary Medicines Authority (APVMA).
ADIs which had been established by all previous Australian authorities are included in this document provided the agvet chemical is currently approved for use in food producing animals or crops. Agvet chemicals which are no longer approved for use by the APVMA have been removed. However, where persistent residues of agvet chemicals which are no longer approved may sporadically be detected in some crops, a tolerable daily intake (TDI – with the same numerical value as the original ADI) is included in the table as a reference. An ADI is usually only established for agvet chemicals which are intentionally used in food producing crops, animals or crops used for stock feed. In this table the term TDI is reserved for agvet chemicals which are not intentionally used in food producing animals or crops.
Introduction
Over the past several decades, pesticides and other agricultural chemicals and veterinary drugs have become an important factor in food production. The availability of these chemicals has enabled significant increases in agricultural productivity to be achieved.
While the consumption of agvet chemicals is not desirable in itself, ingestion of these substances in the form of residues in agricultural produce may occur as a consequence of their intended use. Residues resulting from proper agricultural use are either very low or not detected as has been consistently demonstrated in several Australian Total Diet Studies. Australian Total Diet Studies, previously known as Australian Market Basket Surveys, are a comprehensive assessment of consumers’ dietary exposure (intake) to pesticide residues, contaminants and other substances.
Australian Total Diet Studies are undertaken by Food Standards Australia New Zealand (FSANZ) approximately every two years and involve purchasing food from local stores in each state of Australia and preparing them to a ‘table ready’ state before they are analysed. As a consequence, both raw and cooked foods (for example, potatoes) are examined. Results of completed Australian Total Diet Studies are available on the FSANZ website.
Prior to the registration of an agricultural or veterinary chemical product applicants are required to provide the APVMA with relevant information, such as toxicological studies, to support the safe use of a product. Toxicological studies required for agricultural and veterinary chemicals range from those measuring single dose effects to those which examine the effects of lifetime exposure. Toxicity studies are generally performed in laboratory animals, such as rats and rabbits, and are designed to identify potential toxic effects which may be important for humans. The studies usually involve the feeding/administration of various levels of the compound under investigation to animals, followed by observation and monitoring of clinical parameters and pathology which are indicative of toxicity in the test species. The range of toxicological studies usually undertaken is described under ‘Data guidelines’ which are available on the APVMA website.
The hazard from a chemical is determined by identifying the acute toxicity by the most likely routes of exposure, together with tests for skin and eye irritation and skin sensitisation. The potential for toxicity over longer periods, including possible tumour induction, is determined by studying the effects of repeated dosing, in some cases for the entire lifespan of the species. Multi-generation and developmental studies predict reproductive toxicity and the potential to cause birth defects, and studies are performed to assess the potential to cause effects on genetic material. Other specific investigations also may be required to clarify the mechanism of toxicity of a particular chemical.
Designs for the conduct of toxicological studies have become standardised to a large extent and international guidelines have been developed to achieve consistency in experimental techniques. In general, groups of the test species/organism are exposed to a number of dose levels (usually three) of the substance and a further group is left unexposed (control group). The treatment levels are selected so that the highest dose will cause some obvious toxic effects, while the lowest dose at least, should not result in a toxic effect. These toxicological studies are assessed with a view to determining the potential hazards associated with exposure to the chemical. Assessment of individual toxicity studies includes the determination of a no-observed-adverse-effect level (NOAEL), which is the highest administered dose which does not cause any detectable (usually adverse) effect in the study. The overall NOAEL for a chemical, determined in the most sensitive species, is then used to estimate the acceptable daily intake.
The ADI for humans is considered to be a level of intake of a chemical that can be ingested daily over an entire lifetime without any appreciable risk to health. It is calculated by dividing the overall NOAEL from the animal studies by an uncertainty (safety) factor. The magnitude of the uncertainty factor is intended to account for uncertainties in extrapolating animal data to humans, variation between humans and completeness of the toxicological database.
The most common uncertainty (or safety) factor is 100 which takes into account that humans may be 10 times more sensitive to the chemical than laboratory animals and that a proportion of the population may be 10 times more sensitive than the average person. Where there is satisfactory information in humans, there is no necessity to extrapolate from animal data and an uncertainty factor of 10 is considered adequate to account for inter-individual variation. On the other hand when uncertainty is increased because the toxicity data base is incomplete, an additional uncertainty factor of 10 to 20 may be incorporated. In these situations, the overall NOAEL is divided by an uncertainty factor of 1,000 to 2,000 in determining the ADI.
It is important to note that the toxicological studies on which the overall NOAEL is based are invariably carried out by oral dosing of laboratory animals and usually by incorporation of the chemical in the diet. The subsequent establishment of an ADI is thus directed to human exposure by the oral route.
Due to likely differences in absorption and other kinetic and metabolic parameters, the comparison of exposure by non-oral routes with the ADI should be interpreted with caution.
Notes
- Use of the terms JMPR or JECFA in the no-observed-adverse-effect-level (NOAEL) column indicates that the Australian ADI has been adopted from the figure established by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) or the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
- (H) indicates that the NOAEL was determined on the basis of experimental data in humans.
- (LOAEL) indicates that no NOAEL has been identified in a pivotal study.
- The words 'not specified' in the ADI column indicates that there is a large margin of safety for consumption of residues in food when the chemical is used according to good agricultural/veterinary practice. Due to low levels of residues and the lack of oral activity of these chemicals, a numerical ADI is not considered necessary.
- (M) indicates that the ADI is derived from microbiological data.
- TDI means tolerable daily intake. ADIs are not maintained for those agricultural and veterinary chemicals that are no longer permitted for use in agricultural practice. However, residues of certain environmentally persistent pesticides may occur as residues in agricultural commodities as a consequence of past use. In these cases, health intake values are maintained as tolerable daily intake values, to serve as a guideline with which potential dietary intakes of these environmentally persistent chemicals can be compared.
Contact
If you have any questions about the ADI list, or require this content in another format, please contact:
Assistant Director, Communications
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001 Australia
Telephone: +61 2 6700 2300
Email: communications@apvma.gov.au.