Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2018 (No. 1)

Administered by Department of Agriculture

Legislation au F2018L00041 Not in force Legislative Instrument

Legislation content

 

EXPLANATORY STATEMENT

 

Issued by the authority of the Chief Executive Officer, Australian Pesticides and Veterinary Medicines Authority

 

Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012

 

Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2018 (No. 1)

 

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is an independent statutory authority of the Commonwealth.  Amongst other things, the APVMA is responsible for ensuring agricultural and veterinary (agvet) chemicals used in Australia are not harmful to public health as a result of residues. 

Subsection 6(1) of the Agricultural and Veterinary Chemicals Code (Agvet Code), which is a Schedule to the Agricultural and Veterinary Chemicals Code Act 1994, expressly authorises the APVMA to give an approval where the Agvet Code merely refers to an approval given by the APVMA.  Subparagraph 5A(3)(b)(iii) of the Agvet Code refers to limits that the APVMA has approved or approves for residues of agvet chemical products. Residues are defined in the relevant part in s 3(1) of the Agvet Code as remains persisting in or on a protected commodity. Section 7A of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Administration Act) requires the APVMA to publish in each calendar year approved standards for residues of chemical products in protected commodities. These limits are referred to by the APVMA and known as maximum residue limits (MRLs).

The Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012 (MRL Standard) is made under the Agvet Code for the purposes of subsection 6(1) and the reference in subparagraph 5A(b)(iii) of the Agvet Code, and published as a legislative instrument having regard to s 7A of the Administration Act. Subsection 32(1) of the Administration Act provides that the Chief Executive Officer is to manage the affairs of the APVMA and in doing so, may exercise any of the powers and perform any of the functions of the APVMA.

On 1 July 2014, the Agricultural and Veterinary Chemicals Legislation Act 2013 (the Amending Act) commenced, and made substantial amendments to the Agvet Code.  Despite those amendments, the function of the MRL Standard remains substantially the same.  Previously, it was made for the purposes of paragraph 14(5)(f) of the Agvet Code.  Now it is taken to be made for the purposes of subparagraph 5A(3)(b)(iii) of the Agvet Code.  Under each provision, the role of the MRL Standard is to provide the reference point against which the residues of a product, as determined by trials or laboratory experiments, are assessed for safety purposes.  The MRL Standard continues in force despite the amendments to the Agvet Code, pursuant to subitem 49(2) of Schedule 6 to the Amending Act.

Purpose

The purpose of the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2018 (No. 1) (the Amendment Instrument) is to amend the Tables in the Schedule to set new and varied MRLs and make other changes to the Tables.

Assessment and Determination of MRLs

MRLs are regulatory standards which assist in monitoring whether agvet chemical products are used in accordance with the approved instructions.  If an MRL is exceeded, it usually indicates a misuse of the chemical but does not normally indicate a public health or safety concern.

In evaluating the safety and performance of agvet chemicals, the APVMA’s assessment also includes a determination of an MRL for the chemical in relation to relevant crops and animals.  The APVMA uses data from a series of residue trials and calculates whether the application of the minimum amount of chemical that is required to achieve effective pest or disease control will leave any residue in the plant or animal commodity.  In order to legitimise the presence of these residues, MRLs are established by the APVMA by entry into the APVMA’s MRL Standard, which is regularly updated when new assessments indicate the need to establish new or varied MRLs.

If there are small amounts of chemical residue in produce, the APVMA uses the toxicological evaluation and the dietary exposure assessment to examine the potential occurrence of adverse effects on human health when the produce is consumed. 

Dietary exposure assessments undertaken by the APVMA as part of the registration of the relevant agvet chemical products indicate that the MRLs approved by the APVMA and included in the MRL Standard do not present any public health and safety concerns.

Regulatory Impact Assessment

On 22 November 2012, the Office of Best Practice Regulation provided an exemption from the need to assess if a Regulatory Impact Statement is required for the approvals of MRLs by the APVMA. The MRLs are an essential consequence of the decision by the APVMA to register agvet chemical products (or to extend their approved label instructions) or to issue a permit in relation to an agvet chemical product.  The setting of an MRL and its inclusion in the MRL Standard is a science-based outcome arising from these decisions and for which there is only very limited discretion on the part of the APVMA decision maker. 

The setting of MRLs by the APVMA and their inclusion in the MRL Standard is unlikely to have any impact on the States, other regulatory agencies, business including primary producers, individuals, or the economy.  Primary producers understand the need to use only registered agvet chemical products and to use those products strictly in accordance with approved instructions.  In doing so, produce grown will be within the MRLs set by the APVMA and included in the APVMA’s MRL Standard. 

Consultation

The APVMA seeks the wider community’s involvement through public consultation as part of its evaluation process for the registration of new agvet chemicals or a major extension of the use of existing products to new crops and target animals.  During this consultation phase any person may comment or raise concerns about any relevant aspect of the intended registration, sale and use of the chemical product, including proposed MRLs and the dietary exposure assessment.  The APVMA addresses any concerns that are raised as part of the registration and approval process. 

Disallowance and Sunsetting and the Updating of the MRL Standard

Although the MRL Standard is a legislative instrument for the purposes of the
Legislation Act 2003, pursuant to subsections 44(1) and 54(1) it is neither subject to disallowance nor sunsetting.  The Agvet Code is part of a co-operative scheme involving the Commonwealth and all States and Territories; and the MRL Standard is authorised by the Agvet Code.  The APVMA proposes to amend the MRL Standard on a monthly basis to incorporate new and varied MRLs. 

 

Details of the Amendment Instrument are set out below:

Section 1

This section provides that the Amendment Instrument is named the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2018 (No. 1).

Section 2

This section provides that the Amendment Instrument commences on the day after it is registered.

Section 3

This section provides that Schedule 1 of the Amendment Instrument amends the MRL Standard.

SCHEDULE 1 Amendments

Item 1

Item 1 amends Table 1 of the Schedule to vary the MRLs of agricultural and veterinary chemicals and associated substances in food commodities. These variations are made consequent upon the results of recent assessments by the APVMA of the safety and performance of agvet chemicals. 

Item 2

Item 2 amends Table 3 of the Schedule to vary the residue definitions for certain compounds.  These variations are made consequent upon the results of recent assessments by the APVMA of the safety and performance of agvet chemicals. 

Item 3

Item 3 amends Table 4 of the Schedule to vary the MRLs for pesticides in animal feed commodities. These variations are made consequent upon the results of recent assessments by the APVMA of the safety and performance of agvet chemicals. 

Item 4

Item 4 amends Table 5 of the Schedule to vary the uses to which certain substances may be put for which MRLs are not necessary. These variations are made consequent upon the results of recent assessments by the APVMA of the safety and performance of agvet chemicals. 


STATEMENT OF COMPATIBILITY FOR A LEGISLATIVE INSTRUMENT
THAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2018 (No. 1) was enacted to address the need for updated maximum residue limits (MRLs) for agricultural and veterinary chemicals in Australia. This legislative instrument was created by the Australian Pesticides and Veterinary Medicines Authority (APVMA), an independent statutory authority of the Commonwealth, under the authority of the Agricultural and Veterinary Chemicals Code (Agvet Code) and the Agricultural and Veterinary Chemicals (Administration) Act 1992. The purpose of the Amendment Instrument is to amend the MRL Standard to set new and varied MRLs for agricultural and veterinary chemicals, thereby ensuring that the chemical residues in food and feed commodities do not pose a risk to public health. The APVMA evaluates the safety and performance of these chemicals and establishes MRLs through the MRL Standard, which is updated regularly to reflect the latest assessments. The legislative instrument aims to maintain public confidence in the safety of agricultural and veterinary chemicals by ensuring that MRLs are scientifically based and do not present any public health or safety concerns. The Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2018 (No. 1) was introduced to amend the MRL Standard to incorporate new and varied MRLs, reflecting the latest assessments of the safety and performance of agricultural and veterinary chemicals. The APVMA, under the Agvet Code and the Agricultural and Veterinary Chemicals (Administration) Act 1992, is responsible for ensuring that MRLs are set appropriately and that they do not pose any risks to public health. The Amendment Instrument makes changes to various tables in the MRL Standard, including variations to MRLs for chemicals in food and animal feed commodities, residue definitions for certain compounds, and the uses for which MRLs are not necessary. These amendments are based on recent evaluations by the APVMA and are designed to maintain the safety and integrity of agricultural and veterinary chemicals used in Australia.

Scope and Application

The Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2018 (No. 1) is a legislative instrument issued by the Australian Pesticides and Veterinary Medicines Authority (APVMA), an independent statutory authority of the Commonwealth, under the authority of the Agricultural and Veterinary Chemicals Code (Agvet Code). The purpose of this instrument is to amend the maximum residue limits (MRLs) for agricultural and veterinary chemical products used in Australia, as part of the ongoing process to ensure that these products do not pose a risk to public health due to chemical residues. The MRL Standard sets the reference point for assessing the safety of residues in protected commodities, such as crops and animal products, following the application of these chemicals. The MRL Standard applies to all agricultural and veterinary chemical products used in Australia and is updated regularly by the APVMA to reflect new scientific assessments. The instrument is not subject to disallowance or sunsetting, but the APVMA plans to update the MRL Standard on a monthly basis to incorporate new and varied MRLs as required. The changes made by this instrument are based on recent assessments by the APVMA of the safety and performance of agvet chemicals, and the MRLs included in the updated MRL Standard do not present any public health and safety concerns.

Key Provisions

The Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2018 (No. 1) introduces amendments to the MRL Standard, setting new and varied maximum residue limits (MRLs) for agricultural and veterinary chemicals. These MRLs are crucial in ensuring that residues of chemicals in protected commodities, such as food and animal feed, do not pose a risk to public health. The MRLs are established based on scientific assessments and residue trials conducted by the Australian Pesticides and Veterinary Medicines Authority (APVMA) (section 32(1)). The primary objective of these amendments is to reflect the latest safety evaluations and performance assessments of agricultural and veterinary chemicals, ensuring they align with contemporary standards and best practices (section 5A(3)(b)(iii)). Entities governed by the MRL Standard, including chemical manufacturers, importers, and users, must ensure that the chemicals they produce, import, or use comply with the established MRLs. This involves adhering to the approved instructions for the use of these chemicals and ensuring that residues in commodities do not exceed the specified limits. The APVMA conducts rigorous evaluations, including toxicological assessments and dietary exposure assessments, to determine safe MRLs. Failure to comply with these MRLs can lead to regulatory action, as the MRLs are integral to the approval process for chemical products (section 6(1)). It is the responsibility of these entities to regularly update their practices and ensure compliance with the current MRLs as outlined in the APVMA’s MRL Standard. Breaches of the MRLs set forth in the MRL Standard can result in significant consequences. For manufacturers and importers, exceeding the MRLs can lead to the suspension or revocation of product approvals, which can severely impact their ability to operate within the market. Users who fail to comply with the MRLs may face penalties, including fines and potential legal action. Additionally, any adverse effects on public health identified due to non-compliance can result in broader regulatory scrutiny and potential criminal charges for those found responsible. The MRLs are designed to safeguard public health, and violations can lead to both civil and criminal penalties, with the specific consequences determined by the nature and extent of the breach.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.