Overseas trade (Part 5B)

Introduction

The APVMA must be satisfied that a chemical product meets the trade criteria—that use of the chemical product according to the use pattern on the approved label would not unduly prejudice trade or commerce between Australia and places outside Australia. We therefore assess potential trade risks as part of our assessment of veterinary chemical products.

To enable an assessment of the use of veterinary chemicals in food commodities, and the related potential risks to overseas trade, we recommend a range of information that should be submitted with an application. For further assistance, refer to the guideline: Veterinary drug residues in food commodities and overseas trade. This information and data are part of the overall residues evaluation and assessment of the veterinary chemical product.

Trade can be adversely affected if the presence of residues of veterinary chemicals in export commodities is higher than the standards set for those commodities by an importing country. Australia has experienced a number of episodes of interrupted trade in commodities derived from livestock, following the detection of residues at levels above those allowed in the importing country.

Most of Australia’s trading partners have established maximum residue limits (MRLs). These are also known as ‘tolerances’ in some countries, if the chemicals have approved uses for residues of chemicals in food commodities in those countries. MRLs can vary from country to country due to different use patterns and other factors. Consequently, the legitimate use of a chemical 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.

The purpose of providing information in the Part 5B (Overseas trade) submission is to enable us:

  • to identify any potential risks to Australia’s export trade associated with the use of a veterinary chemical product
  • to assess proposed strategies that may be used to mitigate any identified export trade risks
  • to consult with relevant stakeholder groups (such as peak industry bodies and 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
  • to conduct a public consultation through either a notice in the APVMA Gazette or a Trade Advice Notice (TAN).

Types of data

Applicants should submit information to demonstrate that when the veterinary product is used as proposed and relevant residue-management strategies are followed, residues in food commodities will comply with the residue standards in relevant export markets.

If the proposed use of the veterinary product is expected to result in quantifiable residues in more than one food commodity and the information to be submitted is different for each affected commodity, applicants should provide separate trade information for each commodity, for example cattle meat and cattle milk.

We will consider a range of factors when assessing whether a product will cause undue prejudice to trade, including:

  • whether a potential trade risk exists (for example, due to inconsistencies between Australian MRLs and the import tolerances of the trading partner)
  • the applicant’s proposed strategies to minimise and manage an identified trade risk
  • the capacity of affected industries to implement strategies to minimise and manage the risk to trade
  • communication of trade advice to product users.

Strategies to manage identified trade risks 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.

The ESI is the minimum period of time that should elapse between the last treatment of an animal with a veterinary chemical product and the slaughter of that animal. The ESI is included on the product label under the heading ‘Trade advice’. For further information on label statements refer to the Veterinary Labelling Code.

The trade advice statements are intended to alert the user of possible trade risks associated with their use of the product, and to provide sources of further information to identify and manage the trade risks. ESIs assist producers and exporters to comply with MRLs or import residue tolerances of trading partners when the MRLs or import tolerances are more stringent than the respective Australian MRLs.

ESIs are therefore important tools in the management of potential risks to trade arising from the use of a registered product. They are advisory periods which the applicant proposes, and are agreed to or amended by the APVMA in consultation with the affected producer industries. However, ESIs are non-statutory in that the Agvet Code does not specifically require that they be set.

The submission of overseas trade information may demonstrate that when the chemical product is used as proposed and relevant residue management strategies are followed, chemical residues in food commodities will comply with residue standards that currently apply in relevant export markets.

To assist in the assessment of trade risks, we consult with state and territory governments, stakeholder organisations, other interested parties and the general public. We conduct public consultation primarily by one or both of two processes:

Data submission and application layout

A checklist of data submitted for Part 5B (Trade) of an application for veterinary chemical products, and the way in which they should be set out, appears in Table 1. Each area should be addressed. If information is not provided, the subject heading should be retained with an explanation of why the information has not been provided (for example, ‘not relevant’ or ‘no information available’). 

Table 1: Data submission for Part 5B (Overseas trade)
Submission Comments

Table of contents

List the sections included in the trade submission and their page numbers

Summary

  • Provide an overview of the application
  • Identify relevant food commodities and the countries to which Australia exports the commodities
  • State whether any potential trade problem exists with these countries. Identify any potential trade problems
  • You should briefly summarise all data and information supporting your proposal
  • Please provide general information that will assist the APVMA, and other authorities and stakeholders, to evaluate particular features of the product that might affect trade

Export markets

Identify the most important export markets for the relevant species/commodities

The APVMA has defined the major markets that are to be considered when establishing ESIs for cattle, pig and sheep tissues. Details can be found under the heading ‘Markets for consideration in export slaughter interval determination for cattle, pigs and sheep’ below. For all other species/commodities, you should identify the most important export markets by listing the top six to 10 importing countries ranked by Australian dollar value and volume.

    Proposed Australian use pattern and label

    Provide details of the proposed Australian use pattern for the veterinary product, including:

    • route(s) of administration
    • maximum dose rate
    • minimum re treatment interval
    • withholding periods (WHPs) etc.

    You should include a copy of the draft label which shows trade statements

    Overseas registration status

    List overseas registrations, impending registrations and cancelled registrations

    • While this information may appear elsewhere in the application, you should repeat it in this section
    • Where possible, you should provide copies of the approved overseas label(s)

    Use patterns in overseas market countries

    • Indicate registered or approved use patterns in overseas market countries.
    • List the directions for use including, as applicable:
      • disease or pest treated
      • target animal and situation
      • dose and concentration of active constituent(s) in the product
      • frequency of treatments
      • number of repeat treatments
      • withholding periods
      • critical comments
    • You should use attachments if necessary
    • Where possible, please provide copies of the approved overseas label(s)

    MRLs in overseas market countries

    Specify the current relevant MRLs, or import tolerances and residue definitions/marker residues that apply in the market countries

    • Where the product is registered, you should provide a copy of the notice of MRL from the competent authority
    • Where the product is not registered, but import tolerances have been established, you should provide a statement from the competent authority specifying the acceptable limits
    • You should indicate any action taken, or planned to be taken, to obtain or amend MRLs (including ‘import tolerances’) in overseas market countries

    Codex MRLs (CXLs)

    • Indicate current relevant CXLs and residue definitions
    • You should include recommendations from the Codex Committee on Pesticide Residues (CCPR) or Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) that are currently under consideration

    Proposed Australian MRLs

    List the proposed Australian MRL(s)

    You should provide a list of the proposed Australian MRLs.

    Potential prejudice to trade

    Identify any potential prejudice to trade for the target commodity

    • If relevant, you should describe how any import tolerances affect other exporting countries and how those countries have dealt with such issues
    • You should consider any potential prejudice to trade for non-target commodities, ie the potential for collateral damage to Australia’s export trade in other animal commodities

    Export slaughter interval (ESI) proposal

    The ESI proposal should identify the most sensitive export market in terms of its residue requirements

    Proposed strategies to minimise trade risk

    You should provide details of any proposed trade risk-management strategies and associated communication strategies

    Other relevant trade information

    Indicate results of any relevant trade-risk consultations with authorities and/or producer organisations

    Any other relevant information should be included in this section

    Markets for consideration in export slaughter interval determination for cattle, pigs and sheep

    The Codex MRL standard and the standards of the markets In Table 3 for meat (fat), kidney and liver will be considered in trade assessments and in establishing export slaughter intervals for cattle, pigs and sheep.

    Table 3: Significant markets for trade considerations for cattle, pigs and sheep. Significant markets for each livestock type are marked with 'yes'.

    Standard

    Cattle

    Pig

    Sheep

    Codex

    Yes

    Yes

    Yes

    China

       

    Yes

    European Union

    Yes

     

    Yes

    Japan

    Yes

    Yes

    Yes

    Republic of Korea

    Yes

       

    Russia

    Yes

     

    Yes

    Saudi Arabia

       

    Yes

    Singapore

     

    Yes

     

    Taiwan

    Yes

       

    United Arab Emirates

       

    Yes

    United States

    Yes

     

    Yes

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