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Part 5A – Residues

1.  INTRODUCTION

These guidelines describe the general requirements for submitting residue data for the registration of agricultural chemicals, including establishment of maximum residue limits (MRLs) and withholding periods.

The data submitted is evaluated by the Chemistry and Residue Evaluation Section of the National Registration Authority (APVMA). Where relevant, other information, including recommendations made by other governments and internationally recognised organisations, are taken into consideration. Evaluations are subject to peer review. Public comment is sought when a product containing a new active constituent is considered for registration for the first time or when a product containing an APVMA approved active constituent is first considered for registration for use in food producing crops or animals. Final recommendations for MRLs and other pertinent recommendations are published in the Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette (APVMA Gazette).

The APVMA's MRL recommendations are considered by the Australia New Zealand Food Authority (ANZFA) for inclusion in Standard A14 of the Food Standards Code, and subsequent incorporation into State and Territory food legislation. Applicants should note that MRLs may be subject to reconsideration, which could be prompted by a change in use of a chemical or by availability of new data.

MRLs of agricultural and veterinary chemicals and associated substances in foods and primary feed commodities are also set out in the MRL Standard: Maximum Residue Limits in Food and Animal Feedstuffs of Agricultural and Veterinary Chemicals and Associated Substances. The MRL Standard includes tables listing the MRLs of agricultural and veterinary chemicals, tables listing the portion of the commodity to which the MRL applies, residue definitions and uses of substances where MRLs are not necessary. The APVMA from time to time publishes changes to the MRL Standard in the APVMA Gazette.

1.1  Reference materials

The details of documents referred to in these instructions (including codes and standards) are given in the References section. Bibliographic details and, where appropriate, ISBN and purchase information are given. Applicants should be aware that many of these documents are updated regularly (hence dates are not supplied in the text). It is therefore important to ensure that the latest editions of reference materials are obtained.

2.  GENERAL INSTRUCTIONS

2.1  Residue data (updated 28 Nov 2002)

Both field and laboratory phases of residue studies conducted in Australia, and used to support the establishment of MRLs in food and feed commodities, must be generated in accordance with the OECD Principles of GLP.

Applicants conducting GLP-compliant residue trials in Australia should refer to the OECD Principles of Good Laboratory Practice (No. 1) that is available at the OECD's website http://www.oecd.org/ehs/.

For a study conducted in Australia to be GLP-compliant it must be undertaken by facilities that are accredited and within the Australian GLP compliance monitoring program. The National Association of Testing Authorities (NATA) is the sole Australian organisation responsible for monitoring compliance with the OECD Principles of GLP. Additional information is available regarding GLP accreditation in Australia from the NATA website http://www.nata.asn.au. Overseas studies must be conducted by facilities covered by that country's GLP compliance monitoring program.

Applicants should note that certain residue trials will be exempt from GLP requirements as set out below:

1. Transitional requirement: A submission to the APVMA after 1 January 2003 may contain non-GLP compliant studies but only where those studies are commenced in Australia prior to 1 January 2003; or for overseas studies, only where the studies are commenced prior to 1 January 2003 and conducted in accordance with the standards in place in that overseas country at the time the studies are initiated;
2. Characterisation of test items (active ingredients or formulation) for use in GLP studies need not be conducted according to the OECD Principles of GLP but it is recommended that a laboratory accredited to ISO/IEC 17025 by NATA or a NATA mutual recognition partner be used.
   
   (Note: Some Member States of the EU may require that characterisation of test items be in accordance with GLP. Applicants intending to submit residues data to both the APVMA and these Member States may wish to comply with the standards applied by the Member States to the characterisation of test items);
3. The GLP requirement does not apply to clinical bioequivalence or pharmacokinetic studies or to studies on residues in fibre; and
4. The GLP requirement is not mandatory for studies in support of Permits and Minor Use approvals, however it is strongly recommended.

2.2  Residue Guidelines

The APVMA, in cooperation with peak industry bodies, has prepared a series of residue guidelines addressing specific residue requirements. The guidelines are published in the APVMA Gazette.

Some of these guidelines are referred to in the respective explanatory sections of these instructions. These and other guidelines which deal with specific residue issues. They should be consulted and followed where relevant.

Note: Guidelines No.s 3, 9, 16,18, 22, 23 and 25 refer specifically to veterinary chemical products. New guidelines will continue to be published in the APVMA Gazette. All guidelines are available from the Chemistry and Residues Evaluation Section of the APVMA on request.

3. OUTLINE OF DATA REQUIREMENTS AND APPLICATION LAYOUT

A check list of data requirements for Part 5A (Residues) of an application for agricultural chemical products is given in Table 1 and the way in which they should be set out follows. Note the format used supersedes that shown in Appendix E of Ag Manual: The Requirements Manual for Agricultural Chemicals.

4. RESIDUE STUDIES

4.1 Data requirements

Data should show whether, and to what level, residues occur in edible crops, fodder, animal tissues, milk and eggs.

The formulation to be sold in Australia should be subjected to trials that address the maximum use rate. The applicant may also include a rate one-and-a-half to two times the maximum recommended application rate run concurrently with the maximum use rate at one of the trial locations.

Experiments should show the rate of disappearance of residues and/or the interval that elapses before the residues substantially disappear.

Trials should be planned with care so that the results will enable the necessary MRLs and withholding periods to be recommended with confidence. The authorities responsible for these recommendations should not be called upon to extrapolate or otherwise place undue dependence on inadequate data. Residue trials should therefore be extensive enough to provide opportunity for all probable sources of variation to express themselves.

In the case of products intended for application in the home garden to food crops, and where no MRL and withholding period has been established for the same use-pattern in broad-scale agriculture, the applicant is expected to produce residue data from home garden applications and/or argument to justify the safety of the proposed use.

Table 1: Data requirements for Part 5A (Residues)

Part 5A Residues

Table of contents

Summary of residue studies

Residue database form

Crop residues

-  crops for human consumption

-  crops used as livestock feed

Livestock, poultry, egg and milk residues

-  from direct application (not relevant for ag chemicals) -  from feeding of treated crops (animal transfer data) -  wool residues (if applicable)

Analytical methods

Fate of residues during storage, processing and cooking

Maximum residue limits

-  Australia

-  other countries

-  Codex

-  applicant's proposed MRL

Applicant's proposed withholding periods

4.2  Reporting of residue trials

Full details of trial procedures must be provided, including data on variables that might influence the decline of residues. Each study reported must include an abstract summarising the methodology and the results.

Each application should contain a summary of the residue application. Normally this summary will not extend beyond a few pages, and tables are favoured as a means of condensing information. Applicants are also required to submit a residue database overview (see Table 2) and trial summaries (Table 3).

Further information is provided in Residue Guideline No. 11, Reporting of residue trials.

4.3  Crop residue data

Draft guidelines for the conduct of residue studies in plants have been published in the United Nations Food and Agriculture Organization (FAO) Guidelines on Producing Pesticide Residue Data from Supervised Trials.¹

4.4  Livestock residue data

Residue data are required where pesticides are to be applied to livestock premises, regardless of whether livestock are likely to be present at the time of application. Data should be presented to show the levels of residues in commodities from livestock and poultry normally held in such premises. These commodities include meat, fat of meat, edible offal, eggs and milk, as applicable.

Further information is provided in Residue Guideline No.13, Animal housing.

Table 2: Residue database form - overview of trial submitted

Date:  ..........................

Crop or animal:
End-use product name:
Active constituent:
Formulation type and level of active constituent:
Recommended dose rate:
MRL proposed:
Withholding period proposed:

Trial reference, volume and page number	Year	Location	Dose rate	No. of applications & intervals

Notes on summary of all trials

1. This summary sheet should include all residue trials (Australian and overseas) submitted.
2. Notes 2, 3, 4, 5, 6, 7 and 8 in the explanatory notes to the trial summary form are also applicable (see Figure 5A-3).

Table 3:   Residue database - trial summary

Date:...........................

End-use product name:
Active constituent:
Formulation type and level of active constituent:
Trial reference and page no. in submission:
Location of trial:
Recommended dose rate:
Dose rate used:
Method of application:
Number of applications/intervals:
Crop and area treated, or No. and species of animals treated:
Product(s) and portion(s) analysed:

Date of application	Date of sampling	Interval (days)	Residues found (mg/kg)

Analytical method No./ref:
Limits of detection:
Method recoveries:
Metabolites included in analyses:
Organisation performing field trial (incl. officers' names):
Laboratory performing analyses(incl. officers' names):
Date of analyses:

Notes: Trial summary

1. Complete a separate sheet for each Australian residue trial or for overseas trials if no Australian trials are submitted.
2. The format may be modified to suit individual company practice, but all of the information must be provided.
3. Use tabular format where possible.
4. Location:   Insert district and State.
5. Recommended dose rate:   Insert label recommendation.
6. Actual dose rate:   Insert rate used in trial.
7. Method of application:   Include equipment and spray volume used in trial, as applicable.
8. No. of applications:   Insert number of treatments in the trial and the intervals between (days).

4.5 Animal transfer data

Residue data are required where pesticides are applied to crops which may subsequently be fed to livestock and/or poultry (e.g. pasture, forage crops, silage, hay and grain), or by grazing livestock on failed crops or crop stubble. Such data are necessary to enable the establishment of MRLs in livestock and livestock products.

The data should indicate the levels of residue in the crop concerned, and in commodities from livestock and poultry which would normally eat such plant material. These commodities include meat, fat of meat, edible offal, eggs and milk as applicable.

Guidance on the conduct of animal transfer studies is provided in the APVMA's Residue Guideline No. 1, Animal Transfer Studies and in the FAO guidelines on pesticide residue trials.

Several important points to consider in designing these studies are:

• use of animals in store condition - avoid animals that are rapidly gaining weight, if possible;
• feed animals on a maintenance diet;
• trials should confirm that residue levels in animals have reached plateau; and
• where appropriate, perform depletion studies.

4.6 Metabolism studies

The Chemistry and Residue Evaluation Section also evaluates metabolism and kinetics data. See Part 4 (Metabolism and Kinetics) of this requirements series.

4.7 Overseas residue data

Relevant data from residue trials carried out overseas may be submitted in support of an application. However, in most cases applicants will be expected to conduct, as a minimum, confirmatory tests under typical conditions of use in Australia to indicate the levels of residues under local conditions, and to validate any extrapolation from the overseas data. Australian residue data are required for agricultural chemicals whose use-patterns or conditions of use are different from those overseas.

4.8 Extrapolation from one species to another

Data on residue levels in one species of plant, or animal, do not necessarily represent the residue levels that might reasonably be expected to occur in distinctly different species. In the case of plants, consideration will be given to the use of satisfactory data from several crops in a crop group to reflect the position on another member of that group, or even to a very similar crop in another group, provided use-patterns are comparable. In relation to extrapolation from one species of animal to another, each case will be examined on its merits and will include consideration of the similarities in the metabolic pathways for these chemicals.

The Codex Classification of Foods and Animal Feeds has been developed by the Codex Committee on Pesticide Residues for international use. It provides lists of crops and raw agricultural commodities considered essentially similar for the purposes of recommending MRLs. Applicants should refer to the latest edition.

Overseas residue data may assist in the extrapolation of Australian data from one crop when MRLs are sought for an allied crop. If overseas data show that residues are substantially similar for a number of related crops, this could provide a good case for extrapolating Australian data on one or two crops to other similar crops in a crop group.

4.9 Residue analytical method

The applicant must provide complete details of the analytical methods used for the determination of residues in the trials conducted. The method should:

• possess a suitable degree of specificity for the agricultural chemical in question;
• have a limit of analytical quantitation at a level considerably lower than any MRL proposed for finite residues (see Residue Guideline No.4); and
• be substantiated by adequate evidence in the form of blanks, recovery and extraction data, to show that the method is effective for  determining residues in the substrates analysed, and at the levels under consideration. Where the analytical method involves an instrumental determination such as spectrophotometry, HPLC, or gas-liquid chromatography, specimen output charts showing blank determination and recovery determinations should be provided to assist in evaluating the method.

It is important to relate the residue analytical procedures applied in the particular trial to those provided in the supporting documentation. It is essential that the detailed method of analysis be clearly identified with a distinctive reference number. The same reference number must then be specified in the section providing the relevant trial data, with an indication that this was the analytical method used to determine the residues.

Because methods can be modified over time, problems arise when, in a subsequent application, reference is simply made to previously submitted methodology. The complete method must again be described in the new application.

A method of analysis suitable for routine monitoring and for regulatory control should be submitted. In some cases, this method may be that used for determination of the residues in the trials conducted for the purposes of requesting an MRL. In other cases a separate method may be required for regulatory purposes.

Further information is given in Residue Guideline No. 19, Residue Analytical Method.

4.10 Post-harvest applications

Where post-harvest application is proposed, good agricultural practice will dictate that withholding periods will not be practical, and hence will not be approved in other than exceptional circumstances.

The information required will include multiple replications to show variability of the residue. Replication within one trial will not be sufficient. Rather, multiple trials under different conditions, including different operators and equipment, should be conducted. Any indication of residue breakdown with time, with manufacturing processes, or with domestic use is of significance and should be reported.

Further information is given in Residue Guideline No. 14, Crops -  post harvest applications except fumigants and grain protectants.

4.11 Fate of residues during processing and cooking

Applicants should provide any available information regarding the effect of processing and cooking on the level of residues at harvest, slaughter, etc  so that the likely pesticide intake in diets can be estimated. Details should be inclusive of all components of the residue definition.

In some circumstances, it will be essential that applicants provide information on the level of residues in the food, as consumed, for example, the residue levels in banana pulp as compared to the whole commodity. This could be required for a first application, or at a future time if the use-pattern is expanded to include further crops or in situations where the acceptable daily intake is a low number in relation to the residues of intake of the whole commodity.

Further information is given in Residue Guideline No. 7, Processing Studies.

4.12 Fate of residues during storage

Storage stability data representative of the proposed uses of the product are required for treated food commodities in order to ensure that MRLs are based upon accurate knowledge of the residue level in a commodity.

Generally, stability of the residues in food commodities should be demonstrated when samples are stored for 6 months or more. However, for intrinsically less stable molecules, the time-frame is shorter.

Further information is given in Residue Guideline No. 8, Stability of residues during storage.

4.13 Nomination of maximum residue limits and withholding periods

It is essential for applicants to nominate a proposed complete use-pattern, including withholding periods and proposed MRLs. The pertinent withholding period and residue restraints to be included on proposed labels should be selected from those specified in the respective Ag Labelling Code: Code of Practice for Labelling Agricultural Chemicals.

When conducting trials where a finite residue occurs, and/or where a withholding period will be necessary, it is essential for the sampling regime to be spread across the time range within which the withholding period is expected to occur. It is also essential to sample at the recommended withholding period, otherwise the withholding period will be set at the next longest sampling time.

Further information is given in Residue Guideline No. 10, Withholding periods and No. 4, Maximum residue limit proposals 'at or about the limit of analytical quantitation'.

4.14 Establishment of MRLs

The use-pattern of an end-use product influences the level and nature of residues that will occur in food. It is therefore essential that applications include the complete, detailed use-pattern proposed for the product, including rate of application, timing (including interval between treatments) and number of applications, and withholding periods. The applicant is also required to nominate MRLs for the active constituents contained in the product. The MRLs nominated must be compatible with the proposed use-pattern of the product and based on the Codex nomenclature for commodities. Regardless of the apparent lack of toxicity of residues, human intake of agricultural chemicals should be kept to a minimum consistent with effective use. Where the residue level immediately after application is unacceptably high, the use pattern will have to be re-examined or rejected. Further information is given in Residue Guideline No. 6, Definition of residue for the purpose of setting an MRL.

(a) MRLs 'at or about the limit of analytical quantitation'

If use of the end-use product according to the proposed use-pattern (which includes the withholding period) is shown not to give rise to detectable residues in food, an MRL will normally be recommended 'at or about the limit of analytical quantitation'. Such use-patterns (including the withholding period) must be compatible with good agricultural practice (GAP).

Where the end-use product is to be used on this basis, the residue trials must show the rate of decline and ultimate reduction of residue levels to the point at which they are in fact 'at or about the limit of analytical quantitation'.

Reliable and extensive data from overseas experiments, which demonstrate the absence of residues of the parent compound or its toxicologically significant metabolites following application as proposed, may be acceptable evidence. However, data from locally conducted trials may still be necessary.

For further advice, see Residue Guideline No. 4, Maximum residue limit proposals 'at or about the limit of analytical quantitation'.

(b) 'Finite' MRLs

If use of the end-use product according to the proposed use-pattern (which includes the withholding period) is shown to give rise to detectable residues in food, then it will be necessary to establish a 'finite' MRL.

This will always be the case where residues are present in the crop at harvest, or animal at slaughter.

4.15  Compounds for which MRLs are not necessary

Wherever possible, the applicant must propose an entry for inclusion in Table 1 (Maximum residue limits of agricultural and veterinary chemicals and associated substances in food commodities) of the MRL Standard.

A proposal for a Table 5 (Uses of substances where maximum residue limits are not necessary) entry in the MRL Standard will only be considered where the applicant can clearly demonstrate that a Table 1 entry is not practical for some stated, and supported, reason. Applicants should note that merely requesting a 'Table 5 entry' or 'exemption from an MRL' will not be considered as adequate. The proposed wording for entry in Table 5 should also be provided.

In order to substantiate the proposal, applicants must:

• submit appropriate detailed residue data; or
• present sound scientific argument as to why such data are not necessary.

4.16  Special requirements for seed dressings

Seed dressings for use on cereal seeds are subject to special requirements laid down by the former Standing Committee on Agriculture. Evidence of their fate when fed to livestock, including poultry, must be presented. Detailed guidelines on these requirements are to be found in Appendix 1.

5.  OTHER RELATES STUDIES

Where data is required to show that the use of agricultural chemicals is not likely to affect the taste of produce (organoleptic tests), or have any effect on subsequent processing (e.g. brewing, wine fermentation, cheese manufacture), that data should be included in Part 8 (Efficacy and Crop Safety) of the application.

APPENDIX 1

ANIMAL FEEDING STUDIES FOR SEED DRESSINGS

When the decision was made to discontinue the use of organo-mercury compounds and hexachlorobenzene as seed treatment chemicals on cereal and coarse grain seeds, the Australian Agricultural Council, in August 1971 recommended:

that fungicides which, when applied to human foodstuffs or feed for animals, are known to give rise to residues of public health significance, should not be permitted registration as dressings on cereal and coarse grain seeds.

To ensure that this recommendation is met, it may be necessary to conduct feeding studies with poultry, cattle, sheep and pigs, to determine whether residues of chemicals used to treat cereals and other coarse grain seeds are likely to occur in the edible products derived from livestock receiving small quantities of such chemicals in their rations.

Livestock feeding studies should, when required, be conducted to provide the following residue data:

• poultry - residues in meat, fat, eggs and edible offal;
• cattle, goats or sheep - residues in meat, fat, edible offal, milk and fat of milk;
• pigs - residues in meat, fat and edible offal;

on the understanding that the protocol is likely to require modification in accordance with the results obtained from previously conducted livestock metabolic studies.

When required, the test species should be fed a diet containing the chemical in amounts that would normally be expected on cereal and coarse grain seeds treated in accordance with the directions for use, or at an elevated level. In preference, feeding should be carried out with treated seed.

This diet, comprising the treated grain in the same proportion as would normally be used for the particular species of livestock, should be fed for a period of seven days at which time half the test group should be sacrificed and residue determinations carried out on the appropriate tissues. The remaining portion of the test group should be maintained for a further seven days on a non-adulterated diet and sacrificed for residue determinations at the end of this second seven-day period. A test group (control) which has had no access to the adulterated feed over the whole 14-day period should be included for comparative purposes.

The test groups do not need to be large and the following figures are the minimum which would be accepted for each of the species concerned:

• poultry  6 birds
• cattle  2 animals
• sheep  2 animals
• pigs  2 animals

Control animals would be additional to these figures.

Milk and eggs should be collected throughout the period of the test and retained under suitable conditions, for analysis at a convenient time along with the other test tissues. The analytical techniques used must be appropriate for both the chemical residue and the particular tissues being examined and should be capable of detecting residues at a level of 0.1 mg/kg or lower.

GLOSSARY

Acceptable daily intake (ADI)  The daily intake of a chemical which, during an entire lifetime, appears to be without appreciable risk to the health of the consumer on the basis of all the known facts at the time. It is expressed in milligrams of the chemical per kilogram of body weight per day (mg/kg/day). It is derived from the no observable effect level observed in the most sensitive animal species, utilising an appropriate safety factor.

Adverse product experiences Any unexpected effect on plants, animals, human beings or the environment, which is thought to be associated with a formulated product when used in accordance with registered conditions.

Agricultural chemical product A substance or mixture of substances that fits the legal definition in the Agricultural and Veterinary Chemicals Code Act 1994. This definition appears in the Ag Manual, Module A.

Codex Short title for Codex Classification of Foods and Animal Feeds published by the Codex Alimentarius Commission, the international body which, in collaboration with the World Health Organization and other international bodies, sets standards for foodstuffs in international commerce.

Food-producing animal  Any animal used to produce food for human consumption, or which is used as food for human beings, and includes:

1. any buffalo, cattle, deer, fish (other than ornamental fish), goat, kangaroo, pig, poultry, rabbit, sheep, bee, crustacean or mollusc; or
2. any animal declared by the regulations to be a food-producing species.

Food Standards Code  A set of legal national standards for the composition and labelling of food for human consumption. The standards are developed and maintained by the Australia New Zealand Food Authority (ANZFA) and are enforced under individual States and Territory food acts. The Food Standards Code is regularly updated and amendments are published in the Commonwealth of Australia Gazette.<

Gazette  The Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette, published monthly (with additional special gazettes published from time to time) and available from the Australian Government Publishing Service.

Good agricultural practice (GAP) in the use of agricultural and veterinary chemical products  The nationally recommended, authorised or registered use-pattern of chemicals that is necessary for effective and reliable pest control under actual conditions at any stage of production, storage, transport, distribution and processing of food commodities and animal feed.

Health agency  The general term used for the chemicals unit formerly known as the Chemicals Safety Unit, the Environmental Health and Safety Unit or the Chemicals Policy and Assessment Unit of the Commonwealth Department of Health and Family Services. The unit was transferred to the Therapeutic Goods Administration in 1996 and renamed as the Chemicals and Non-Prescription Drug Branch in August 1996.

Impurity Any constituent other than an active constituent or an intentionally added non-active constituent. Impurities include intermediates, reaction products, degradation products, contaminants or chemicals added for purposes of extraction or purification.

Limit of quantitation (LOQ)  The level below which an analytical method is unable to accurately quantify the substance being measured.

Maximum residue limit (MRL) The maximum concentration of a chemical residue that is legally permitted in or on a food or food commodity when that chemical is applied according to GAP or GPVD. The concentration is expressed in milligrams of the residue per kilogram of the food (mg/kg).

No observable effect level (NOEL) The highest concentration or amount of a substance, found by study or observation, to cause no detectable (usually adverse) alteration of morphology, functional capacity, growth, development or life span of the most sensitive test organism.

APVMA Gazette see Gazette

Product  A formulation containing one or more active constituent(s), and possibly non-active constituents(s), which is intended for application, with or without dilution before use, and which is labelled with directions for use.

Relevant scientific argument Arguments based on:

accepted scientific principles;
data published in peer reviewed journals;
relevant texts;
relevant case studies; and/orrelevant clinical studies,

where: relevant means:

related to the active constituent and/or product; and/or
related to the claims and use patterns

Residue  The remains of the active constituent(s) in a chemical product persisting in or on food, agricultural commodities or plants, soil, water or other environmental components, together with all derivatives, metabolites, and degradation products of the active constituent(s) arising from their use.

Stockfeed  Includes hay, straw, chaff, grain, manufactured stockfeed and by-products, and other substances intended for feeding to animals, but does not include a stock medicine,  a stock food additive, a stock food non-active constituent, or a medicated stock food.

Use-pattern  The combination of all factors involved in the use of a formulated product, including the concentration of active constituent in the preparation being applied, rate of application, method of application, frequency and duration of treatments, additives recommended and other directions which determine total quantity applied, timing of treatment and withholding period.

Veterinary chemical product A substance or mixture of substances that fits the legal definition in the Agricultural and Veterinary Chemicals Code Act 1994. This definition appears in the Vet Manual, Module A.

Withholding period  The minimum recommended interval that should elapse between the last application of a formulated product to any crop or pasture, and the harvesting or cutting thereof. It is part of the directions for use within the concepts of GAP in the use of agricultural chemical products.

REFERENCES

Note: Details are provided for the current edition at the time of publication in each case. Applicants should always ensure that they obtain the most up to date version of any publication that they require. Books with an asterisk can be obtained from the Australian Government Publishing Service (AGPS) or Government Info Shops in capital cities.

Australia New Zealand Food Authority 1997. Food Standards Code, ANZFA Canberra. (Available from ANZFA and AGPS. Amendments appear in the Commonwealth of Australia Gazette).²

Codex Alimentarius Commission 1989. Codex Classification of Foods and Animal Feeds (second edition). Food and Agriculture Organization of the United Nations and World Health Organization, Rome.

Food and Agriculture Organization (FAO)of the United Nations  1990: Guidelines on producing pesticide residus data from supervised trials, Rome.

National Registration Authority for Agricultural and Veterinary Chemicals 1997. Ag Labelling Code: Code of Practice for Labelling Agricultural Chemical Products, APVMA, Canberra. ISBN 0 642 26474 0.²

National Registration Authority for Agricultural and Veterinary Chemicals 1996. Ag Manual: The Requirements Manual for Agricultural Chemicals, APVMA, Canberra. ISBN 0 642 25922 4.²

National Registration Authority for Agricultural and Veterinary Chemicals. Maximum Residue Limits in Food and Animal Feedstuffs of Agricultural and Veterinary Chemicals and Associated Substances (MRL Standard). APVMA, Canberra, http://www.APVMA.gov.au/APVMA/mr11.html.

National Registration Authority for Agricultural and Veterinary Chemicals 1997. Vet Labelling Code: Code of Practice for Labelling Veterinary Chemical Products, APVMA, Canberra. ISBN 0 642 26471 6.²

National Registration Authority for Agricultural and Veterinary Chemicals 1996. Vet Manual:The Requirements Manual for Veterinary Chemicals, APVMA, Canberra. ISBN 0 642 25882 1.

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