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 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering an application for the development or variation of food regulatory measures.
The Authority accepted Application A1147 which seeks approval for food derived from cotton line GHB811, genetically modified to provide resistance to isoxaflutole and glyphosate. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft variation of a standard.
Following consideration by the Australia and New Zealand Ministerial Forum on Food Regulation, 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 Legislation Act 2003.
2. Purpose
The purpose of this instrument is to amend the table to subsection S26—3(4) of Schedule 26 of the Code (permitted food produced using gene technology and conditions) to permit the use or sale of food derived from herbicide tolerant cotton line GHB811.
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 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1147 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 9 November 2017 for a six-week consultation period.
The Office of Best Practice Regulation (OBPR), in a letter to FSANZ dated 24 November 2010, granted a standing exemption from the need for the OBPR to assess if a Regulatory Impact Statement is required for the approval of genetically modified foods (ref 12065). Therefore, a Regulation Impact Statement was not required in this case because the proposed variation to Schedule 26 is likely to have a minor impact on business and individuals.
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 paragraph (o) into item 3 in the table to subsection S26—3(4) in Schedule 26. The new paragraph refers to ‘herbicide-tolerant cotton line GHB811’. The effect of the variation is to permit the use or sale of food derived from that cotton line in accordance with Standard 1.5.2.
Overview
The Food Standards Australia New Zealand Act 1991, as amended by the legislative instrument F2018L00652, addresses the need for updating food standards to accommodate new genetically modified food products. Enacted by the Parliament of Australia, this legislation empowers Food Standards Australia New Zealand to develop and approve variations to food standards, ensuring they remain current with scientific advancements and consumer expectations. The specific problem this instrument tackles is the incorporation of food derived from herbicide-tolerant cotton line GHB811 into the Australia New Zealand Food Standards Code, thereby allowing its use and sale under specified conditions. The policy objective is to facilitate the safe introduction of genetically modified foods into the marketplace while ensuring consumer protection and maintaining high food safety standards. Public consultation was undertaken to gather input on the proposed variation, ensuring transparency and stakeholder engagement in the regulatory process.
Scope and Application
The legislation, F2018L00652, applies to Food Standards Australia New Zealand (FSANZ) in its capacity to develop and vary food regulatory measures, including standards, in accordance with the Food Standards Australia New Zealand Act 1991 (FSANZ Act). This particular legislative instrument amends the Australia New Zealand Food Standards Code to permit the use or sale of food derived from herbicide-tolerant cotton line GHB811. The geographic and jurisdictional reach of this Act is national, affecting both Australia and New Zealand, as the FSANZ Act governs food standards across both countries. There are no specific exclusions mentioned within the text, but the application of this amendment is limited to the use or sale of food derived from the specified genetically modified cotton line. The FSANZ Act allows for the extension or restriction of the application through subordinate instruments, although such mechanisms are not elaborated upon in this specific legislative instrument. Public consultation was conducted as part of the approval process, and a Regulatory Impact Statement was deemed unnecessary due to the minor impact on business and individuals.
Key Provisions
The main sections of the legislation revolve around the approval process for genetically modified food products and the subsequent variations of standards under the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Specifically, section 13 of the FSANZ Act grants the Authority the power to develop and vary standards, including those related to genetically modified foods. The Authority’s acceptance of Application A1147, which pertains to food derived from the herbicide-tolerant cotton line GHB811, was conducted in line with Division 1 of Part 3 of the FSANZ Act, which outlines the procedure for considering such applications. Once an application is approved, section 92 of the FSANZ Act mandates the Authority to publish a notice regarding the draft variation of a standard. This draft variation, once finalised, becomes a legislative instrument as per section 94, although it is exempt from parliamentary disallowance or sunsetting under the Legislation Act 2003.
The legislation imposes several obligations on the parties involved. Primarily, the Authority is required to follow a formal process, including public consultation, when considering applications for the development or variation of food regulatory measures. The Authority must also ensure that any draft variations are assessed and reported on appropriately. Furthermore, the Authority must publish a notice about the standard or draft variation in accordance with section 92 of the FSANZ Act. Additionally, the Office of Best Practice Regulation (OBPR) has determined that certain variations, like the one proposed for GHB811 cotton, may be exempt from requiring a Regulatory Impact Statement due to their expected minor impact on business and individuals.
The legislation does not explicitly outline specific offences, penalties, or civil/criminal consequences for breach. However, non-compliance with the FSANZ Act or failure to follow the mandated procedures could lead to legal repercussions. The FSANZ Act provides for the imposition of penalties for breaches of its provisions, although the specifics of these penalties are not detailed in this particular legislative instrument. It is also worth noting that the instrument itself is not subject to parliamentary disallowance or sunsetting, meaning that its provisions remain in effect unless otherwise varied or revoked by subsequent legislation.
The variation specified in Item [1] of the legislation inserts a new paragraph (o) into item 3 in the table to subsection S26—3(4) in Schedule 26. This insertion permits the use or sale of food derived from herbicide-tolerant cotton line GHB811 in compliance with Standard 1.5.2. This amendment is intended to incorporate the new food product into the existing regulatory framework, thereby allowing its use and sale under specified conditions. The legislative instrument ensures that any food derived from GHB811 cotton can be marketed and consumed in accordance with the standards set forth in the Australia New Zealand Food Standards Code.