APVMA risk assessment manual, residues and trade

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Residues and trade risk assessment

Residues that remain in food commodities after treatment of a crop or animal species with an agvet chemical have the potential to adversely affect the health of the consumers of treated food and unduly prejudice Australia’s international trade in the treated commodity. A residues and trade assessment is undertaken to determine that the Australian Pesticides and Veterinary Medicines Authority (APVMA) can be satisfied that the proposed use of an agvet chemical meets the statutory safety criteria, related to consumer safety, and trade criteria.

For uses of agvet chemicals in non-food situations such as ornamental plants or companion animals, a residues and trade assessment is not required.

Residues assessment

The APVMA must be satisfied that consumer safety is not be adversely affected by residues of agvet chemicals and that these residue safety risks are determined by considering:

  • the occurrence of residues in food produce and animal feed following treatment in accordance with proposed label or permit instructions, which is the basis for the setting of Maximum Residue Limits (MRLs);
  • appropriate withholding periods for the proposed use pattern; and
  • a dietary exposure assessment considering the expected residue exposure, Health Based Guidance Values for the active constituent and Australian consumption figures for the relevant food commodities.

The residues assessment will consider if new or amended MRLs are required should the application be supported by the APVMA.

The maximum residue limit (MRL) is defined as the maximum concentration of a residue resulting from the APVMA approved use of an agricultural or veterinary chemical which is legally permitted or recognised as acceptable to be present in or on a food, agricultural commodity or animal feed.

MRL amendments may be required in the two Australian MRL standards:

  • The Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012 contains MRLs for food and animal feed commodities for APVMA approved use patterns, as well as a list of situations where MRLs are not necessary
  • Schedule 20 of the Food Standards Code is jointly administered by the APVMA and Food Standards Australia and New Zealand (FSANZ) and contains MRLs for Australian uses as well as MRLs set for use patterns approved in countries other than Australia where treated commodities may be imported. MRL establishment for import purposes is the responsibility of FSANZ.

Trade assessment

The APVMA must be satisfied that the proposed use of agvet chemicals does not unduly prejudice trade or commerce between Australia and places outside Australia.

Countries set MRLs in food and other commodities (such as livestock feed) to control and minimise exposure of people and animals to residues of agvet chemicals. If a country does not have an MRL set for a chemical, its laws may not allow any quantifiable residue in a commodity.

This situation can arise when the importing country’s regulations do not yet recognise a new chemical, or when Australia needs to use a particular chemical (because of its unique pests or weeds) which is not used in the same manner elsewhere.

This means that Australian MRLs for agvet chemicals in food and other commodities may differ from those of our trading partners. This can result in potential risk, or prejudice, to trade.

The APVMA undertakes formal trade risk assessments in relation to agvet major chemical use on commodities where overseas trade is of significance to the Australian economy, such as for cereal grains and meat. Where there is little or no export trade in produce treated with agvet chemicals then no trade assessment is required. The APVMA uses an evidence-based approach to assess the risks that residues may pose to our overseas trade at the time of assessment.

A typical APVMA trade assessment involves comparing the level of residues that may occur in treated produce with the known residue standards in major export markets for that commodity, and with the international standards for residues set by the Codex Alimentarius Commission (Codex). Codex is a body established by the (World Health Organisation) WHO and the (Food and Agriculture Organisation) FAO for the protection of health of consumers, and to ensure fair practices in international food trade. Many countries apply Codex MRLs to food that they import.

Once a comparison with established national and international standards has been made, the potential for the proposed Australian MRL to pose a significant trade risk is communicated to stakeholders and their comments and suggestions for minimising the risk are requested. After consideration of this information, the APVMA determines whether the risk can be managed with appropriate conditions and systems of use. When this is possible the product can be registered for use as this will not unduly prejudice Australia’s overseas trade.

The statutory tests for trade risk does not require the use to result in zero, or nil risk. Rather, the APVMA seeks to determine a level of risk that is manageable and acceptable to all the stakeholders involved, in order to allow producers, their crops and animals to benefit from the use of the agvet chemical, and to allow the Australian and international community to benefit from trade in safe produce.

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