This content is current only at the time of printing. This document was printed on 23 June 2021. A current copy is located at http://www.plural-consulting.com/node/62216
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As a world class regulator, the APVMA participates in a number of international committees and working groups.
- Joint FAO/WHO Expert Committee on Food Additives
- Joint FAO/WHO Meeting on Pesticide Residues
- Organization for Economic Co-operation and Development
- VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products)
The APVMA actively participates in the Joint FAO/WHO Expert Committee on Food Additives, which is an international expert scientific committee administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).
The committee has been meeting since 1956, initially to evaluate the safety of food. Its work now includes the evaluation of contaminants, naturally occurring toxicants and residues of veterinary drugs in food. To the end of 2012, the committee has evaluated the residues of approximately 95 veterinary drugs.
The committee has developed principles for the safety assessment of chemicals in foods that are consistent with current thinking on risk assessment and take account of developments in toxicology and other relevant sciences. We use the committee’s methodology to evaluate residues of veterinary drugs in food to establish maximum residue limits.
The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) provides independent, expert scientific advice to the Codex Alimentarius Commission and its specialist committee on pesticide residues, the Codex Committee on Pesticide Residues (CCPR). The Codex Alimentarius Commission develops international food standards and guidelines, with the aim of protecting consumer health, ensuring fair trade practices and promoting coordination of all food standards work undertaken by government and non-government organisations.
The JMPR comprises the World Health Organisation (WHO) Core Assessment Group and the Food and Agricultural Organization of the United Nations (FAO) Panel of Experts on Pesticide Residues in Food and the Environment. The WHO Core Assessment Group undertakes toxicological reviews of pesticides and establishes health-based guidance values, such as acceptable daily intakes and acute reference doses, which in turn are important for establishing maximum residue limits (MRLs) used in international trade. The FAO Panel reviews pesticide residue data, undertakes dietary risk assessments and recommends to CCPR to be considered for adoption by the Codex Alimentarius Commission as Codex MRLs. APVMA scientists participate in both the WHO Core Assessment Group and FAO Panel of Experts on Pesticides Residues.
In addition to its role in international standing-setting for pesticides, the JMPR also develops scientific guidelines on the interpretation of toxicological studies and advances pesticide risk assessment methodologies.
The toxicological and residues monographs published by the JMPR are an important source of information used by the APVMA.
The APVMA participates in various activities of the Organization for Economic Co-operation and Development (OECD) including:
The Working Group on Pesticides is a committee that directs and oversees the work of the OECD Agricultural Pesticide Programme that encompasses agricultural pesticides. It is composed of government officials from OECD member countries, representatives from the European Commission and other international organisations, observers from the pesticide industry, and public interest non-governmental organisations.
The Pesticide Programme has three main objectives:
- to help OECD governments share the work of pesticide registration and re-registration—the licensing of new products and re-licensing of old ones. This collaboration involves finding ways for governments to work together in assessing pesticide risks to humans and the environment. Work sharing is possible because the same pesticides are often used in many countries
- to harmonise the data and methods used to test and assess pesticide risks. Harmonisation not only helps governments work together but also ensures the quality of the data and the rigour of the assessments
- to help OECD governments reduce the risks associated with pesticide use. The programme identifies how governments can supplement pesticide registration and further reduce the risks that may result even when registered pesticides are used properly.
The Task Force on Biocides manages the work of the Biocide Programme including non-agricultural pesticides, and reports directly to the Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology.
The task force is composed of government officials from OECD member countries, representatives from the European Commission and other international organisations, observers from the pesticide industry, and public interest non-governmental organisations.
The OECD Working Party on Manufactured Nanomaterials concentrates on human health and the implications for the safety of the environment posed by manufactured nanomaterials (limited mainly to the chemicals sector). The working party also aims to ensure that the approach to the assessment of hazard, exposure and risk is of a high, scientifically-based, and internationally harmonised standard.
VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) is a trilateral (European Union–Japan–United States) program that was established under the auspices of the World Organisation for Animal Health to harmonise technical requirements for veterinary product registration. Australia, Canada, New Zealand and South Africa have observer status on VICH.
The objectives of the VICH are:
- to establish and implement harmonised regulatory requirements for veterinary medicinal products in the VICH regions, which meet high quality, safety and efficacy standards and minimise the use of test animals and costs of product development
- to provide a basis for wider international harmonisation of registration requirements
- to monitor and maintain existing VICH guidelines, taking particular note of the International Conference on Harmonisation work program and, where necessary, update these VICH guidelines
- to ensure efficient processes for maintaining and monitoring the consistent interpretation of data requirements following the implementation of VICH guidelines
- by means of a constructive dialogue between regulatory authorities and industry, to provide technical guidance for responses to significant emerging global issues and science that affect regulatory requirements within VICH regions.
The APVMA supports the international harmonisation of requirements for data. The APVMA participates in the working process of the VICH Steering Committee, joins in Committee discussions and provides experts where appropriate to the VICH Expert Working Groups. However, Australia’s observer status does not confer voting rights in the VICH process.
To date, the APVMA has adopted VICH guidelines on data requirements for chemistry, human safety (toxicology), environmental safety, anthelmintics and good clinical practices.
Before adopting a VICH guideline, we ensure its suitability to Australian conditions. This practice reflects a principle in the APVMA Standard on Good Regulatory Science Practice—namely, that we will follow international, harmonised guidelines where it is possible or appropriate to do so.
When we adopt VICH guidelines that describe the global harmonisation of registration requirements, we minimise the use of test animals and the cost of product development, and increase the availability of veterinary medicinal products in Australia.