Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2017 (No. 7)

Administered by Department of Agriculture

Legislation au F2017L00892 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 2017 (No. 7)

 

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 2017 (No. 7) (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 2017 (No. 7).

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. 


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 2017 (No. 7) was introduced to address the need for updated maximum residue limits (MRLs) for agricultural and veterinary chemicals used in Australia. This amendment instrument was enacted by the Australian Pesticides and Veterinary Medicines Authority (APVMA), an independent statutory authority responsible for ensuring that these chemicals do not pose a risk to public health through chemical residues. The APVMA’s role in approving MRLs is integral to this process, as it conducts assessments to determine safe residue levels in produce and animal commodities, thereby safeguarding human health. The purpose of this amendment is to incorporate new and varied MRLs into the MRL Standard, reflecting the latest scientific evaluations of the safety and performance of these chemicals. This legislative instrument ensures that the MRLs set by the APVMA remain current and reflective of the latest safety standards, thus continuing to protect the health of consumers and the integrity of the agricultural sector.

Scope and Application

The Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2017 (No. 7) applies to the Australian Pesticides and Veterinary Medicines Authority (APVMA), which is responsible for ensuring that agricultural and veterinary chemicals used in Australia are not harmful to public health due to residues. The MRL Standard, which is amended by this instrument, sets the maximum residue limits (MRLs) for residues of agricultural and veterinary chemical products in food and animal feed commodities. The MRLs are based on assessments of the safety and performance of these chemicals and are designed to ensure that their use does not pose a risk to human health. The MRL Standard applies to all persons and entities involved in the production, distribution, and use of agricultural and veterinary chemicals in Australia, including primary producers, manufacturers, importers, and retailers. The MRL Standard is a legislative instrument made under the Agricultural and Veterinary Chemicals Code, which is a Schedule to the Agricultural and Veterinary Chemicals Code Act 1994. The MRL Standard is not subject to disallowance or sunsetting, and the APVMA proposes to update it on a monthly basis to incorporate new and varied MRLs. The Amendment Instrument amends the MRL Standard to vary the MRLs of agricultural and veterinary chemicals and associated substances in food commodities and animal feed commodities based on recent assessments of the safety and performance of these chemicals. The Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2017 (No. 7) applies nationally across Australia and is relevant to all persons and entities involved in the production, distribution, and use of agricultural and veterinary chemicals. There are no stated exclusions or exemptions from the application of the MRL Standard, and the MRLs apply to all food and animal feed commodities produced or sold in Australia. The MRL Standard may be extended or restricted through subordinate instruments, such as regulations or guidelines, issued by the APVMA. However, the primary purpose of the MRL Standard is to provide a reference point against which the residues of agricultural and veterinary chemical products are assessed for safety purposes, and the MRLs are set based on scientific assessments conducted by the APVMA.

Key Provisions

The Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2017 (No. 7) provides a framework for the Australian Pesticides and Veterinary Medicines Authority (APVMA) to set and revise maximum residue limits (MRLs) for agricultural and veterinary (agvet) chemical products in food and animal feed commodities. These MRLs are essential in ensuring that residues from these chemicals do not pose a risk to public health (Schedule 1). The MRL Standard, which is regularly updated, serves as the reference point against which the safety of residues in crops and animals is assessed. It is designed to monitor compliance with approved instructions for the use of these chemicals and to maintain public health and safety by ensuring that residues do not exceed safe levels (Subparagraph 5A(3)(b)(iii) of the Agvet Code). The APVMA is tasked with the responsibility of determining MRLs for agvet chemicals through rigorous assessments that include toxicological evaluations and dietary exposure assessments. This process involves the use of data from residue trials to determine the safe levels of chemical residues in food and animal feed commodities. The MRLs are established by the APVMA and included in the MRL Standard, which is updated as new assessments indicate the need for changes. The APVMA also engages in public consultation during the evaluation process for new agvet chemicals or significant extensions of existing products to ensure transparency and address community concerns. The MRL Standard imposes obligations on the APVMA to conduct thorough assessments of agvet chemicals to determine safe MRLs, ensuring that residues in food and animal feed do not present public health concerns. The APVMA must also regularly update the MRL Standard to incorporate new MRLs based on the latest assessments. Additionally, the APVMA is required to publish approved MRLs in each calendar year, ensuring that these standards are accessible and applied consistently across the agricultural sector. There are no explicit offences, penalties, or civil/criminal consequences outlined for breaches of the MRL Standard itself, as the primary focus is on ensuring public health and safety through the establishment and maintenance of safe MRLs. However, non-compliance with the MRLs set by the APVMA could lead to regulatory actions under other provisions of the Agricultural and Veterinary Chemicals Code Act 1994 and the Agricultural and Veterinary Chemicals (Administration) Act 1992. These actions could include fines, recalls of non-compliant products, and other regulatory measures to ensure adherence to approved MRLs and maintain public health standards.

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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.