Explanatory Statement
1. Authority
Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) provides that the functions of Food Standards Australia New Zealand (the Authority) include the development of standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code (the Code).
Division 2 of Part 3 of the FSANZ Act specifies that the Authority may prepare a proposal for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering a proposal for the development or variation of food regulatory measures.
The Authority prepared Proposal M1012 to consider introducing certain temporary maximum residue limits (MRLs) for residues of agricultural and veterinary (agvet) chemicals that may occur in food, in order to align standards with the Australian Pesticides and Veterinary Medicines Authority (APVMA) temporary MRLs for coumatetralyl and warfarin in pork commodities. The Authority considered the Proposal in accordance with Division 2 of Part 3 and has approved a draft variation.
Following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation[1], section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the standard or draft variation of a standard.
Section 94 of the FSANZ Act specifies that a standard, or a variation of a standard, in relation to which a notice is published under section 92 is a legislative instrument, but is not subject to parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003.
2. Purpose
The approved draft variation to Standard 1.4.2 includes temporary MRLs for residues in pork commodities of the agvet chemicals coumatetralyl and warfarin.
Standard 1.4.2 lists the limits for agvet chemical residues which may occur in foods. If a limit is not listed for a particular agricultural or veterinary chemical/food combination, there must be no detectable residues of that chemical in that food. This general prohibition means that, in the absence of the relevant limit in the Code, food may not be sold where there are detectable residues.
MRL variations may be required to permit the sale of foods containing legitimate residues. These are technical amendments that align Standard 1.4.2 with the APVMA’s Agricultural and Veterinary Chemicals Code Instrument No.4 (MRL Standard).
A dietary exposure assessment is conducted before MRLs are varied to ensure that proposed limits do not present any public health or safety concerns.
3. Documents incorporated by reference
The variations to food regulatory measures do not incorporate any documents by reference.
4. Consultation
In accordance with the procedure in Division 2 of Part 3 of the FSANZ Act, the Authority’s consideration of Proposal M1012 included one round of public consultation following an assessment and the preparation of a draft Standard and associated report. Submissions were called for on 25 May 2015 for a four-week public consultation period.
A Regulation Impact Statement was not required because the proposed variations to Standard 1.4.2 are minor and do not substantially alter existing arrangements.
Business compliance costs and other impacts on business, individuals, regulatory agencies and the economy are low or nil. The regulatory proposal does not impose impacts on business, individuals, regulatory agencies or the economy that warrant further analysis. The changes to regulation are machinery in nature involving technical variations to the Standard, which will not have appreciable impacts and are consistent with existing policy.
5. Statement of compatibility with human rights
This instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 94 of the FSANZ Act.
6. Variation
Item 1 inserts new entries for the chemicals listed. The entries include the chemical name, residue definition, foods and associated MRLs. This item incorporates the new entries in alphabetical order among the chemicals listed in the Schedule.
[1] convening as the Australia and New Zealand Food Regulation Ministerial Council
Overview
The Food Standards Australia New Zealand Act 1991, as amended by the legislative instrument F2015L01668, addresses the need to align the Australia New Zealand Food Standards Code with temporary maximum residue limits (MRLs) set by the Australian Pesticides and Veterinary Medicines Authority (APVMA) for certain agricultural and veterinary chemicals in pork commodities. This legislative instrument was enacted to introduce temporary MRLs for coumatetralyl and warfarin residues in pork, ensuring that food standards are consistent with APVMA’s MRLs and do not present public health or safety concerns. The Authority, in accordance with the FSANZ Act, conducted a consultation process and approved the draft variation, which was subsequently considered by the Australia and New Zealand Ministerial Forum on Food Regulation. This legislative update ensures that food standards remain current and aligned with other regulatory frameworks, facilitating the legitimate sale of food products that contain allowable residues of specified chemicals.
Scope and Application
The explanatory statement outlines the legislative proposal to amend the Australia New Zealand Food Standards Code through the Food Standards Australia New Zealand Act 1991. The draft variation of Standard 1.4.2, concerning temporary maximum residue limits (MRLs) for agricultural and veterinary chemicals in food, applies to the residues of coumatetralyl and warfarin in pork commodities. The legislative instrument is intended to align with the Australian Pesticides and Veterinary Medicines Authority's temporary MRLs, ensuring food safety and public health are upheld. The Authority's proposal follows the stipulated procedure under the FSANZ Act, involving public consultation and assessment, and has been approved as a draft variation. The changes are minor and do not impose significant impacts on businesses, individuals, regulatory agencies, or the economy, and thus did not require a Regulation Impact Statement. The Act applies to any entities or individuals involved in the production, sale, or handling of pork commodities within Australia and New Zealand, ensuring compliance with the updated standards. The Authority's consideration and approval process ensure that the proposed variations are consistent with existing policy and regulatory frameworks, reflecting a commitment to maintaining high standards of food safety and public health.
Key Provisions
The key operative sections of the legislation focus on the development and variation of food regulatory measures by Food Standards Australia New Zealand (FSANZ) under the FSANZ Act. Specifically, section 13 outlines the Authority’s function to develop standards and variations of standards for the Australia New Zealand Food Standards Code, while Division 2 of Part 3 details the procedure for considering proposals for such variations (FSANZ Act, ss 13, 92, 94). The Authority prepared Proposal M1012 to introduce temporary maximum residue limits (MRLs) for certain agvet chemicals in pork commodities, which was approved as a draft variation following consultation and assessment. The purpose of these variations is to align the standards with the APVMA’s MRLs, ensuring there are no detectable residues in food unless permitted by the updated limits (FSANZ Act, s 92).
The obligations imposed by this Act on the relevant parties include the requirement for FSANZ to consult the public when considering variations to food regulatory measures. In this case, FSANZ conducted one round of public consultation for Proposal M1012, inviting submissions for a four-week period. FSANZ must also ensure that any proposed MRL variations do not present public health or safety concerns, as evidenced by the dietary exposure assessment conducted prior to approving the draft variation. Additionally, FSANZ must publish a notice about the standard or draft variation of a standard, as stipulated by section 92 of the FSANZ Act.
The legislation does not detail specific offences, penalties, or civil/criminal consequences for breach in the context of MRL variations. However, it is important to note that the draft variation, once finalised, becomes a legislative instrument under section 94 of the FSANZ Act, which means it is not subject to parliamentary disallowance or sunsetting under the Legislative Instruments Act 2003. This implies that while the process for developing and varying standards is stringent and includes public consultation, the legal framework does not explicitly outline penalties for non-compliance with these variations beyond the inherent regulatory oversight and potential public health implications if unlisted chemicals are detected in food products.