Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2016 (No. 16)

Administered by Department of Agriculture

Legislation au F2016L01816 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 2016 (No. 16)

 

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 2016 (No. 16) (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 2016 (No. 16).

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 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 3

 Item 3 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 2016 (No. 16) was enacted to amend the maximum residue limits (MRLs) for agricultural and veterinary chemicals in food and animal feed commodities. This legislative instrument is an amendment to the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012, made under the Agricultural and Veterinary Chemicals Code (Agvet Code), a Schedule to the Agricultural and Veterinary Chemicals Code Act 1994. The Australian Pesticides and Veterinary Medicines Authority (APVMA), an independent statutory authority of the Commonwealth, is responsible for ensuring that the use of agvet chemicals in Australia does not harm public health due to chemical residues. The primary purpose of this Amendment Instrument is to update the MRLs in response to the APVMA's latest safety assessments of agvet chemicals. These assessments ensure that the residues of agvet chemicals in food and feed do not pose a risk to public health. The APVMA undertakes toxicological evaluations and dietary exposure assessments to determine safe MRLs, which are then incorporated into the MRL Standard. The MRLs are set based on scientific data from residue trials and experiments, and their inclusion in the MRL Standard ensures that agvet chemicals are used safely and effectively. The APVMA consults with the community during the evaluation process, addressing any concerns about proposed MRLs and dietary exposure assessments. The MRL Standard is updated monthly to reflect new or varied MRLs, and although it is a legislative instrument, it is not subject to disallowance or sunsetting provisions.

Scope and Application

The Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2016 (No. 16) is a legislative instrument made under the authority of the Australian Pesticides and Veterinary Medicines Authority (APVMA), an independent statutory authority of the Commonwealth. This Amendment Instrument applies to the establishment and variation of maximum residue limits (MRLs) for agricultural and veterinary chemical products in food and feed commodities. The MRLs are set to ensure that residues of these chemicals in food and feed commodities do not pose a risk to public health. The instrument is applicable to the agricultural and veterinary chemical industries, including chemical manufacturers, importers, and users, as well as to food and feed producers. The MRL Standard is updated regularly to reflect the latest scientific assessments, and these updates are made through the Amendment Instrument. The MRL Standard is part of a cooperative scheme involving the Commonwealth, all States and Territories, and the MRL Standard is not subject to disallowance or sunsetting. It is important to note that the MRLs set by the APVMA are science-based and are not intended to restrict the use of agricultural and veterinary chemicals in accordance with approved instructions. The Amendment Instrument amends the MRL Standard by varying the MRLs for agricultural and veterinary chemicals and associated substances in food and feed commodities, based on the results of recent assessments by the APVMA of the safety and performance of these chemicals. The variations in MRLs are made to ensure that the use of these chemicals does not result in residues that are harmful to public health. The MRL Standard is amended to incorporate these new and varied MRLs, and the Amendment Instrument is registered on the day after it is made. The MRL Standard is a reference point against which the residues of a product, as determined by trials or laboratory experiments, are assessed for safety purposes. The MRLs approved by the APVMA and included in the MRL Standard do not present any public health and safety concerns, as confirmed by dietary exposure assessments undertaken by the APVMA as part of the registration of the relevant agricultural and veterinary chemical products.

Key Provisions

The main operative sections of the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2016 (No. 16) (Amendment Instrument) pertain to the amendment of maximum residue limits (MRLs) for agricultural and veterinary chemicals. This Amendment Instrument revises the MRLs for agricultural and veterinary chemicals and substances in various food and animal feed commodities, as outlined in the Schedule. Specifically, it amends Table 1 to adjust MRLs for chemicals in food commodities, Table 4 to adjust MRLs for pesticides in animal feed commodities, and Table 5 to adjust the uses of certain substances for which MRLs are not necessary. These amendments are based on recent safety and performance assessments conducted by the Australian Pesticides and Veterinary Medicines Authority (APVMA). The APVMA, acting under the Agricultural and Veterinary Chemicals Code (Agvet Code) and the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Administration Act), has specific obligations to ensure the safety of agricultural and veterinary chemicals used in Australia. These obligations include establishing and maintaining MRLs, which are regulatory standards that monitor the safe use of these chemicals. The APVMA must ensure that residues of these chemicals in produce do not exceed the approved MRLs, as determined through residue trials and laboratory experiments. Additionally, the APVMA must conduct toxicological evaluations and dietary exposure assessments to ensure that the MRLs do not pose public health or safety risks. The Amendment Instrument imposes penalties and consequences for breaches of MRLs. While the specific penalties are not detailed in the explanatory statement, it is implied that exceeding the MRLs could lead to regulatory action against the manufacturers or users of the agricultural and veterinary chemicals. Such actions could include fines, recalls of non-compliant products, or other enforcement measures to ensure compliance with the MRLs. The MRLs established and updated by the APVMA are crucial for maintaining public health safety and ensuring that agricultural produce meets safety standards for consumption. The MRL Standard, as amended by this Amendment Instrument, is designed to provide a consistent and science-based framework for setting MRLs. This framework is critical for the APVMA's role in approving the use of agricultural and veterinary chemicals, ensuring that these chemicals are used in a manner that does not pose risks to human health or the environment. The regular updating of the MRL Standard reflects the ongoing evaluation process and the need to adapt to new scientific information and changes in the use of agricultural and veterinary chemicals. The APVMA's approach to setting MRLs involves extensive consultation with the wider community, including primary producers, to address any concerns and ensure that the MRLs are appropriate and enforceable.

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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.