This content is current only at the time of printing. This document was printed on 24 April 2019. A current copy is located at https://apvma.gov.au/node/669
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Veterinary drug residues in food commodities and overseas trade
The Agvet Code provides that before granting an application for a veterinary chemical product, the APVMA must be satisfied that the chemical product meets the trade criteria. This means that if a product is used in accordance with the use pattern on the approved label, it would not unduly prejudice trade or commerce between Australia and places outside Australia.
The legislative requirement to consider the overseas trade aspects of veterinary residues in food commodities is unique to Australia.
- 1. Scope
- 2. Identification of potential risks to Australia’s export trade
- 3. Commodities considered in the trade assessment
- 4. Overseas trade information data package
- 5. The trade assessment
- 6. Strategies to mitigate identified trade risks
- 7. Export intervals and export slaughter intervals
- 8. Communication of trade advice to users
- 9. Maximum residue limits in overseas countries
This guidance document is intended to provide recommendations on the type of information that should be provided to enable the APVMA to:
- identify any potential risks to Australia’s export trade associated with the use of a veterinary product
- assess proposed strategies that may be used to mitigate any identified export trade risks
- consult with relevant stakeholder groups (such as peak industry bodies, state departments of agriculture), prior to the public consultation phase of registration, to explore any potential trade risks and the feasibility of any proposed risk mitigation strategies
- conduct a public consultation through either a notice in the APVMA Gazette or a Trade Advice Notice (TAN).
2. Identification of potential risks to Australia’s export trade
Most of Australia’s trading partners have established maximum residue limits (MRLs). These are also known as ‘tolerances’ in some countries if the drugs have approved uses for veterinary drug residues in food commodities in those countries. MRLs can vary from country to country due to different use patterns and other factors. In some countries, particular veterinary medicines may not be registered and MRLs may not have been established; these countries may have a zero tolerance for residues of these chemicals. Consequently, the legitimate use of a drug in Australia according to the use pattern on the APVMA-approved label can result in residues in food that exceed the MRLs or tolerances of importing countries, even though the residues are below the Australian MRL.
3. Commodities considered in the trade assessment
The food-producing animals listed in Table 1 are animals from which major export food commodities are derived. They have been selected on the basis of both the dollar value of trade (more than A$100 million per annum) and the potential impact that the presence of residues in a food commodity could have on Australia’s total export trade. Where an application is made for a veterinary product to be used in or on any of the food-producing animals listed in Table 1, and an MRL is required to be established or amended, a trade assessment will be performed.
|Aquatic species||Crustaceans: crabs, prawns, lobsters etc. Fin fish Molluscs: clams, mussels, oysters, squid, scallops, abalone|
|Cattle||Meat, milk, processed dairy commodities|
4. Overseas trade information data package
Residues in food commodities should comply with residue standards that currently apply in relevant export markets.
Each area in this guideline should be addressed. If information is not provided, an explanation of why it has not been provided should be included (for example, ‘not relevant’ or ‘no information available’).
Where more than one food commodity is onvolved, each commodity should be address separately; for example, cattle meat and cattle milk.
5. The trade assessment
The potential risks to Australia’s export trade in commodities from animals treated with the veterinary drugs are assessed as part of the residues assessment.
The purpose of the trade assessment is to:
- consider any potential risks to Australia’s export trade associated with the use of a veterinary chemical product
- assess proposed strategies that may be used to mitigate any identified export trade risks
- consult with relevant stakeholder groups (such as peak industry bodies, state departments of agriculture) prior to the public consultation phase of registration, to explore any potential trade risks and the feasibility of any proposed risk mitigation strategies.
The timeline for the trade assessment depends on whether you have authorised us to release trade information at a relatively early stage of the assessment process. If you authorise early release of trade information, we are able to consult with relevant stakeholders before completing the residues evaluation report.
In this case, the trade component of the evaluation report is more advanced than when consultation is restricted to the post-assessment period. We still conduct a public consultation phase post assessment, but the extent of feedback is more informed, due to early engagement of stakeholders. For these reasons, early release of trade information facilitates the resolution of any identified trade risks.
If you do not authorise early release of trade information, we can only undertake consultation with stakeholders after completion of the residues assessment. After the consultation period, we consider submissions we have received as a result of public consultation, and prepare a supplementary assessment taking into account the comments of stakeholders.
5.1. Early release of trade information
We can release trade information for consideration by authorities and stakeholders during the assessment of the application (ie before public release) to facilitate the public consultation process. However, you must give your consent for us to do this. You should clearly state whether you give permission for early release of trade information.
6. Strategies to mitigate identified trade risks
There is a range of strategies you may propose to mitigate the potential trade risks identified. In considering proposals to minimise and manage identified trade risk you should take into account:
- inconsistencies between Australian MRLs and the import tolerances of overseas trading partners
- the capacity of affected industries to implement strategies to minimise and manage the risk to trade
- methods for communicating trade advice to product users.
Strategies to manage these matters can include:
- the establishment and effective communication of export slaughter intervals (ESIs)
- the establishment of import tolerances
- making a maximum residue limit submission to Codex for the establishment of an appropriate Codex MRL
- industry-specific management strategies.
When developing proposed strategies for communicating trade advice, you should consult with the user industry and any other affected industries. We will take particular note of how the applicant’s proposed communication strategy integrates with industry measures to manage trade risks. A statement on the veterinary chemical product’s label may be the only means of alerting the user to the possibility of trade risks arising from use of the product.
7. Export intervals and export slaughter intervals
The ESI is the primary tool used to mitigate trade risks for food commodities derived from livestock that are slaughtered. The ESI is the minimum period of time that should elapse between the last treatment of an animal with a veterinary product and the slaughter of that animal for export.
7.1. The export slaughter interval is not the same as the Australian withholding period
The Australian withholding period (WHP) is the minimum period that needs to elapse between the last administration of a veterinary product to an animal, and the slaughtering of the animal or the collection of milk, eggs or honey from the animal for human consumption. The withholding period ensures that edible commodities from treated animals contain residue levels below the MRL. WHPs are intrinsically linked to food safety.
In contrast, ESIs are an important component of the APVMA being satisfied that use of the product would not result in undue prejudice to trade. The ESI is the minimum period that must elapse between last administration of the veterinary product to an animal (including medicated feed), and slaughter for export. ESIs are used to manage trade risks, ensuring that exported food commodities meet the most sensitive MRL, import tolerance or other requirement set by a major trading partner. For any one product, the ESI may be the same as, or longer than, the product WHP.
7.2. Establishing export slaughter intervals
ESIs for veterinary drugs are established on the basis of residue-depletion data. Studies should be conducted with the formulation that is to be marketed in Australia, and animals should be treated in accordance with the critical use pattern specified on the product‘s label.
Residues data should support the establishment of an ESI. The data should show depletion of the veterinary drug down to the lowest MRL, import tolerance or other requirement of the major trading partners for the relevant food commodity. Where it is identified that some of the major trading partners have not set an MRL for a particular veterinary drug, the ESI will be based on the time required for residues to deplete to the limit of quantification of an appropriately validated analytical method. We do not accept the use of extrapolation of residues data beyond the sampling points when determining an ESI.
8. Communication of trade advice to users
A trade submission should show how communication of trade advice will be provided for all stakeholders in all relevant food commodity production chains. The communication of trade advice can include ESIs or generic export statements on labels, supported by any or all of the following:
- an entry in the APVMA’s ESI website databases for:
- cattle and/or
- ESI information records associated with:
- information in a brochure supplied by the registration holder
- information obtained through the registration holder company’s information phone line or website.
8.1. Trade advice on product labels
Trade-advice statements are intended to alert the user to possible trade risks associated with their use of the product, and to provide sources of further information to identify and manage the trade risks.
The APVMA and commodity industries support the free availability of information on ESIs. All methods of promoting and communicating ESIs are encouraged, including:
- information on the product’s label
- education campaigns
- website listings
- publication of lists
- point-of-sale material
- quality assurance programs
- vendor declarations.
Strategies for the communication of ESIs should achieve the following:
- integration with strategies already implemented by users which minimise trade risk measures
- integration with strategies already implemented by commodity industries which minimise trade risk measures
- facilitation of an effective whole-of-chain communication of trade information.
Trade-advice statements are established for all products used in or on cattle, sheep and pigs. Products for use in or on other food-producing (meat) species (such as aquatic species, goats etc.) may also have trade advice and ESIs assigned to them.
In consultation with industry stakeholders, we have developed a number of ESI statements for inclusion on veterinary product labels. For further information on the label statements, refer to the Veterinary Labelling Code.
9. Maximum residue limits in overseas countries
For assistance in ascertaining the MRLs that apply in overseas countries or the Codex MRLs, you should visit the following websites: