Veterinary Manual of Requirements and Guidelines - Vet MORAG

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Part 5B - Overseas Trade Aspects of Residues in Food Commodities

1.   Introduction

Section 14(3)(e)(iv) of the Agvet Code provides that before granting an application for registration of a veterinary chemical product, the APVMA must be satisfied 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. Therefore, the APVMA assesses potential trade risks as part of the assessment of applications for registration of veterinary chemical products.

This chapter sets out the APVMA’s requirements for information and data relating to the assessment of the use of veterinary chemicals in food commodities, and the related potential risks to overseas trade. This information and data are part of the overall residues evaluation and assessment of the product (see Part 5A: Residues).

The presence of residues of veterinary chemicals in export commodities above the standards set for those commodities by an importing country, can adversely affect trade. Australia has experienced a number of episodes of interrupted trade in commodities derived from livestock, following the detection of residues above the levels allowed in the importing country.

Most of Australia’s trading partners have established maximum residue limits (MRLs, also known as ‘tolerances’ in some countries) for residues of chemicals in food commodities, if the chemicals have approved uses 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 the information provided in the Part 5B (Trade) submission is to enable the APVMA to:

  • identify any potential risks to Australia’s export trade associated with the use of a veterinary chemical product
  • assess 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
  • prepare the public consultation documents - either the Public Release Summary (PRS) or the Trade Advice Notice (TAN).

2.   OVERSEAS TRADE INFORMATION

To enable the APVMA to assess the risks of residues in trade, applicants must submit overseas trade information (data Part 5B) with applications for registration of veterinary chemicals that are used in or on any of the food-producing animals listed in Table 1.

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 and the potential impact that the presence of residues in a food commodity would have on Australia’s total export trade.

Table 1: Animals from which major export food commodities are derived

Cattle Sheep
Pigs Goats
Poultry Aquatic species
Bees  

2.1.  Overseas trade information is required if Australian MRLs must be set or amended

Applicants must submit overseas trade information (data Part 5B) with any application that involves the establishment or amendment of Australian MRLs for veterinary chemicals.

Examples of applications where a data Part 5B submission is required include:

  • a veterinary product containing a new active constituent is submitted for registration for the first time1.
  • a veterinary product containing an APVMA approved active constituent that is submitted for registration for the first time in or on a food producing animal species in Table 1
  • a veterinary product containing an APVMA approved active constituent that is submitted for registration for the first time in or on a new food producing animal species in Table 1
  • a veterinary product containing an APVMA approved active constituent is submitted for registration in or on a food producing animal species in Table 1 via a new route of administration, or using an amended dosing regimen.

3.  OVERSEAS TRADE INFORMATION REQUIREMENTS

Applicants must submit information to demonstrate that when the chemical product is used as proposed and relevant residue management strategies are followed, chemical residues in food commodity will comply with residue standards that currently apply in relevant export markets.

Each information element specified in this section must be addressed. If information is not provided, the subject heading should be retained with an explanation of why the information has not been provided (eg ‘not relevant’ or ‘no information available’). Justification should be given for all such statements.

Applicants may encounter difficulty in obtaining information such as overseas MRLs. The APVMA will take these difficulties into account in considering applications.

If the proposed use of the veterinary chemical 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 must provide separate trade information for each commodity.

The Part 5B submission must include the following information elements:

3.1.  Table of contents

List the sections included in the Part 5B submission and their page numbers.

3.2.  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 problem eg contravention of an importing country’s MRLs, or a ban on the chemical in specific countries.

Briefly summarise all data and information supporting the proposal. Also provide general information that will assist the APVMA, and other authorities and stakeholders, to evaluate particular features of the product that might affect trade.

3.3.  Export markets

Identify the most important export markets for the relevant commodities.

List the top six to 10 importing countries ranked by dollar value and volume.

3.4.  Proposed Australian use pattern and label

Provide details of the proposed Australian use pattern for the veterinary chemical product, including route of administration, maximum dose rate, minimum re treatment interval, withholding periods (WHPs) etc.

Include a copy of the label (printed or e-label), which shows trade statements.

3.5.  Overseas registration status

List overseas registrations, impending registrations and cancelled registrations. While this information may appear elsewhere in the application, repeat it in this section.

3.6.  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
  • rate, dose
  • frequency of treatments
  • number of repeat treatments
  • withholding periods
  • critical comments.

Use attachments if necessary. Copies of overseas registered labels may be attached if they in English.

3.7.  MRLs in overseas market countries

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

Indicate any action taken, or planned to be taken, to obtain or amend MRLs (including ‘import tolerances’) in overseas market countries.

Information on how to find some overseas MRLs is given in Appendix A.

3.8.  Codex MRLs (CXLs)

Indicate current relevant CXLs and residue definitions.

Indicate any action taken, or planned to be taken, to obtain or amend CXLs.

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.

Indicate when the applicant would be prepared to submit an application to Codex for the establishment of CXLs.

3.9.  Proposed Australian MRLs

List the proposed Australian MRLs.

3.10. Potential prejudice to trade

Identify any potential prejudice to trade. If relevant, describe how any import tolerances affect other exporting countries and how those countries have dealt with such issues.

3.11. Export interval (EI) proposal

An export interval (EI) proposal is required when this is appropriate for the use pattern of the veterinary chemical. The EI proposal should identify the most sensitive export market in terms of its residue requirements.

Refer to section 5 for detailed information on the EI proposal.

3.12. Proposed strategies to minimise trade risk

Provide details of any proposed trade risk management strategies and associated communication strategies.

3.13. Other relevant trade information

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

Include any other relevant information.

4. THE TRADE ASSESSMENT

The potential risks to Australia’s export trade in commodities from animals treated with the product are assessed as part of the residues evaluation report. As indicated in section 1, the purpose of the trade assessment is to:

  • identify any potential risks to Australia’s export trade associated with the use of a veterinary chemical product
  • assess 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 is dependent on whether or not applicants have authorised the APVMA to release trade information at a relatively early stage of the assessment process.

If the applicant authorises early release of trade information, the APVMA is able to consult with relevant user groups, peak industry bodies, AQIS, state departments of agriculture and other relevant stakeholders prior to completion of 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. The APVMA is still required to conduct a public consultation phase post assessment, but the extent of feedback is reduced due to early engagement of stakeholders. For these reasons, early release of trade information facilitates the resolution of any identified trade risks.

If the applicant does not authorise early release of trade information, the APVMA can only undertake consultation with stakeholders after completion of the residues evaluation report and release of the public consultation documents (the Public Release Summary (PRS) or the Trade Advice Notice (TAN)). After the consultation period has elapsed, the APVMA considers submissions it has received as a result of public consultation, and prepares a supplementary residues evaluation report, with a revised trade assessment that takes into account the comments of stakeholders.

4.1.  Early release of trade information

The APVMA can release trade information for consideration by authorities and stakeholders during the assessment of the application (ie before public release gazettal) to facilitate the public consultation process. However, the applicant must give consent for the APVMA to do this. Applicants should clearly state whether they give permission for early release of trade information.

5.   EXPORT INTERVALS AND COMMUNICATION OF TRADE ADVICE TO USERS OF THE PRODUCT

5.1.  Export intervals (EIs)

EIs are important tools in the management of potential risks to trade arising from the use of a registered product. EIs are advisory periods which the applicant proposes, and are agreed to or amended by the APVMA in consultation with the affected producer industries.

EIs are an important component of the APVMA being satisfied that use of the product would not result in undue prejudice to trade, however EIs are non statutory in that the Agvet Code does not specifically require that they be set.

EIs assist producers, processors 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.

EIs are set to ensure that exported food commodities meet the lower of either the CXL or the most sensitive MRL or import tolerance set by a major trading partner. Applicants must conduct residue depletion trials for determining an EI for veterinary chemicals, using the product formulation that is to be marketed in Australia, and animals must be treated in accordance with the critical use pattern specified on the label of the product.

The critical use pattern refers to the maximum dose rate to which animals may be exposed. Some major trading partners have not set an MRL for a particular veterinary chemical. In this case, EIs will be based on the time required for residues to deplete to the limit of quantification (LOQ; see NRA Gazette February 2002, p39).

Adequate residues data are required for the establishment of an EI. The data must show depletion of the chemical down to the lowest MRL or import tolerance of the major trading partners for the relevant food commodity. The APVMA does not accept the use of extrapolation of residues data beyond the sampling points when determining an EI.

Applicants are advised to consult with users and affected industries to determine EIs that are practical and manageable for all relevant parties. The APVMA will independently seek advice from user groups and peak industry bodies on whether the proposed EIs are practicable.

5.2   The EI is not the same as the Australian withholding period (WHP)

The EI should not be confused with the Australian withholding period (WHP), which relates only to Australian MRLs.

The WHP is a statutory statement, because section 14(3)g(v) of the Agvet Code specifies that a WHP must be placed on approved labels as part of the Australian use pattern for veterinary chemical products.

The EI may be the same number of days, or a greater number of days than the relevant Australian WHP.

5.3   Export slaughter interval (ESI)

For food commodities derived from livestock that are slaughtered, the EI is known as an export slaughter interval (ESI). 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.

5.4   Communication of trade advice to users

Applicants must address the communication of trade advice to all stakeholders in all relevant food commodity production chains. Communication of trade advice can include EIs or generic export statements on labels, supported by any or all of the following:

  • an entry on the ESI database on the APVMA website
  • information in a brochure supplied by the registrant
  • through the registrant company’s information phone line or website.

Inclusion of a trade advice statement on the product label is essential if the product is intended for use in or on any of the livestock species listed in Table 1.

5.4.1  Trade advice on product labels

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.

The APVMA and commodity industries support information on EIs being freely available. All methods of promoting and communicating EIs 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.

Applicants must ensure that strategies for the communication of EIs achieve the following:

  • integration with strategies which minimise trade risk measures already implemented by users
  • integration with strategies which minimise trade risk measures already implemented by commodity industries
  • facilitation of an effective whole-of-chain communication of trade information.

In consultation with industry stakeholders, the APVMA has developed a number of EI statements for inclusion on veterinary product labels. Selection of the appropriate label statement depends on whether or not an ESI has been established, and whether or not the company is prepared to include the ESI (number of days) on the product label.

Label statement 1

Where an ESI has been determined and is listed on the APVMA website, and the chemical company is prepared to put it on the product label, a statement such as the following must be included on the product label:

TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): DO NOT USE less than ## days before slaughter for export. The ESI on this label was correct at the time of label approval. Before using this product, confirm the current ESI from the manufacturer on <insert telephone contact number> or the APVMA website (www.apvma.gov.au/use/residues/esi_whp/vet_meds.php).

Label statement 2

Where an ESI has been determined and is listed on the APVMA website, but the chemical company is not prepared to include the ESI on the product label, a statement such as the following must be included on the product label:

TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): An ESI has been determined for this product. Before using this product, confirm the current ESI from the manufacturer on <insert telephone contact number> or the APVMA website (www.apvma.gov.au/use/residues/esi_whp/vet_meds.php). DO NOT USE this product less than this number of days before slaughter for export.

Label statement 3

Where it is recognised that an ESI is not required, for example vaccines, direct-fed microbials, and vitamins and minerals, a statement such as the following must be included on the product label:

TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): ESI NOT REQUIRED.

Label statement 4

Where an ESI has not been established, a statement such as the following must be included on the product label:

TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI established. For advice on the ESI, contact the manufacturer on <insert telephone contact number> before using this product.

5.5.  Strategies to minimise trade risk

The Agvet Code provides that before granting registration to a veterinary chemical product, the APVMA must be satisfied that registration of the product will not result in undue prejudice to trade.

In being satisfied, the APVMA considers a range of factors, including:

  • whether a potential trade risk exists (eg due to inconsistencies between Australian MRLs and the import tolerances of the trading partner)
  • the applicant’s 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 EIs
  • the establishment of import tolerances
  • making a submission to Codex for the establishment of an appropriate CXL
  • industry specific management strategies.

The applicant should consult with the user industry and any other affected industries when developing their proposed strategy for communicating trade advice.

Many commodity industries have, or are developing, mechanisms to facilitate effective ‘whole of chain’ communication of trade advice. Trade risk management mechanisms, such as vendor declarations, are widely used in production of livestock commodities.

The APVMA will take particular note of how the applicant’s proposed communication strategy integrates with industry measures to manage trade risks when determining whether it is satisfied that a product’s registration will not cause undue prejudice to trade. 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.

6.  PUBLIC CONSULTATION

To assist in the assessment of trade risks, the APVMA consults with state and territory governments, stakeholder organisations, other interested parties and the general public. The APVMA conducts public consultation primarily by one or more of three processes:

  1. Publishing a notice in the APVMA Gazette;
  2. Publishing a Public Release Summary;
  3. Publishing a Trade Advice Notice.

6.1.  Gazette notice

Section 13 of the Agvet Code provides that the APVMA must publish a notice when considering an application to register a new veterinary chemical product containing a new active constituent. The APVMA publishes a notice in the Gazette after it has completed its assessment of the application and proposes to be satisfied that the product has met the Agvet Code’s criteria for safety and efficacy.

6.2.  Public release summary

If the application is for registration a product which:

  • contains an active constituent which will be used in a registered product for the first time and
  • is intended for use in or on a food-producing animal species included in Table 1;
  • the APVMA publishes a document called a public release summary (PRS). The PRS is announced in the Gazette notice described in paragraph 6.1.

The PRS contains a summary of the APVMA’s evaluation of the product with regard to the Agvet Code’s criteria of safety, efficacy, and trade.

6.3. Trade advice notice

The APVMA publishes a trade advice notice (TAN) in the following circumstances:

  • an application is made to register a new veterinary chemical product containing an APVMA-approved active constituent, where the product is intended for use in or on a new food-producing animal species included in Table 1

    or
  • an application is made for extension of use of an existing registered product for the first time to a food producing species in Table 1

    or
  • Australian MRLs must be set or amended for an active constituent contained in a product.

The TAN addresses trade issues such as:

  • the volume and value of trade in relevant food commodities
  • the results of residues trials presented to the APVMA
  • overseas MRLs
  • an analysis of the potential risks to trade
  • strategies for mitigating any potential risks to trade.

Note that a PRS contains all of the information normally contained in a TAN, so if the APVMA publishes a PRS, a separate TAN is not required.

Table 2 is a summary of the of the circumstances under which the APVMA publishes a Gazette notice and a PRS, or a Gazette Notice and a TAN.

Table 2: Publication and notification for veterinary products used in food producing species

Situation Gazette
Notice
PRS TAN Form of consultation
before granting
registration
A veterinary product containing a new active constituent is submitted for registration for the first time, or an APVMA-approved active constituent is submitted for use in or on a food-producing animal species for the first time a a  
  • Actively seek public comment
  • Refer to AQIS and States
  • Refer to peak body of relevant user groups and affected non-user groups
A veterinary product containing an APVMA-approved active constituent is submitted for registration for use in or on a new food-producing animal species (extension of use) a   a
  • Refer to peak body of relevant user groups and affected non-user groups
  • Refer to AQIS and states
A veterinary product containing an APVMA-approved active constituent is submitted for registration for use in or on a food-producing animal species via a new route of admin istration, or using an amended dosing regimen a   a
  • Refer to peak body of relevant user groups and affected non-user groups

7.  TEMPLATE FOR SUBMISSION OF PART 5B INFORMATION ON OVERSEAS TRADE ASPECTS OF RESIDUES IN FOOD COMMODITIES

TABLE OF CONTENTS

SUMMARY

EXPORT MARKETS

PROPOSED AUSTRALIAN USE PATTERN AND LABEL

OVERSEAS REGISTRATION STATUS

USE PATTERNS IN OVERSEAS MARKET COUNTRIES

MRLs IN OVERSEAS MARKET COUNTRIES

CODEX MRLs (CXLs)

PROPOSED AUSTRALIAN MRLs

POTENTIAL PREJUDICE TO TRADE

EXPORT INTERVAL (EI) PROPOSAL

PROPOSED STRATEGIES TO MINIMISE TRADE RISK

OTHER RELEVANT TRADE INFORMATION

8.  REFERENCES

All APVMA guidelines for registration requirements and labelling are available from the APVMA website Guidelines page.

The MRL Standard is available from the APVMA website Maximum Residue Limits page.

The following might also be useful in preparing trade information:

APPENDIX A: MRLs in overseas countries

Assistance in ascertaining the MRLs that apply in overseas countries or Codex can be obtained from the following websites:

Canadian MRLs http://www.hc-sc.gc.ca/dhp-mps/vet/mrl-lmr/
mrl-lmr_versus_new-nouveau_e.html
EU Veterinary http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/
docs/doc2005/10_05/an1to4237790.pdf
Japanese Veterinary http://www.m5.ws001.squarestart.ne.jp/foundation/agrlist.php
New Zealand http://www.nzfsa.govt.nz/policy-law/legislation/food-standards/
nz-mrl-fs-2007-consolidation.pdf
US Code of Federal Regulations http://www.fsis.usda.gov/OPHS/red_book_2001/2001_Residue _Limits_Veterinary_Drugs_App4.pdf#search=%22USDA%20 veterinary%20residue%20tolerances%22
Codex http://www.codexalimentarius.net/mrls/vetdrugs/jsp/vetd_q-e.jsp
DAFF: Australian and international MRLs http://www.affa.gov.au/content/output.cfm?ObjectID=
D2C48F86-BA1A-11A1-A2200060B0A05743

FOOTNOTES

  1. An application is considered to be submitted ‘for the first time’ when the APVMA has not previously approved the use-pattern.

REVISION HISTORY

1 October 2005

Second edition

  • changed formatting
  • corrected hyperlink to Canadian MRLs.
1 April 2006

Third edition

  • updated hyperlink to Japanese agricultural chemical MRLs.
1 July 2007

Fourth edition

  • extensive revision of all text.