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 A1154 which seeks approval for food derived from cotton line MON88702, genetically modified to provide protection from piercing and sucking insects. 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 the insect-protected cotton line MON88702.
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 A1154 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 18 December 2017 for an eight-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).
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 (p) into item 3 in the table to subsection S26—3(4) in Schedule 26. The new paragraph refers to ‘insect-protected cotton line MON88702’. 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 Amendment Instrument 2018 (F2018L01150) was enacted to address the need for updated food regulatory measures to accommodate new genetically modified organisms in the food supply. The Food Standards Australia New Zealand Act 1991 (FSANZ Act) empowers the Authority to develop and vary standards, and following public consultation and Ministerial consideration, this instrument was introduced to permit the use or sale of food derived from the insect-protected cotton line MON88702. The purpose of this legislative instrument is to amend the table in subsection S26-3(4) of Schedule 26 of the Australia New Zealand Food Standards Code, thus allowing food derived from MON88702 to be legally used or sold. This legislative update was considered in accordance with the FSANZ Act, including a public consultation process, and is a legislative instrument not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003.
Scope and Application
The legislation F2018L01150 pertains to the Food Standards Australia New Zealand Act 1991, specifically concerning the approval and regulation of food derived from genetically modified organisms. This legislative instrument focuses on the approval of food derived from cotton line MON88702, which has been genetically modified to offer protection against piercing and sucking insects. The legislation applies to the Authority, specifically Food Standards Australia New Zealand, and encompasses the processes for accepting, considering, and approving applications for variations in food standards. The approval process includes public consultation as mandated by the FSANZ Act, ensuring transparency and stakeholder engagement. The instrument's geographic reach is national, applying to both Australia and New Zealand under the Australia New Zealand Food Standards Code. There are no documents incorporated by reference in this instrument. Notably, this legislative instrument is exempt from the need for a Regulatory Impact Statement and a statement of compatibility with human rights, as it falls under the category of non-disallowable instruments under section 94 of the FSANZ Act.
Key Provisions
The main operative sections of this legislation (F2018L01150) amend the table in subsection S26-3(4) of Schedule 26 of the Australia New Zealand Food Standards Code to permit the use or sale of food derived from cotton line MON88702, which has been genetically modified for protection against insects (Item [1]). This variation was developed following an application process (FSANZ Act s13) and has been approved by Food Standards Australia New Zealand (FSANZ), subsequently reviewed by the Australia and New Zealand Ministerial Forum on Food Regulation (FSANZ Act s92).
The Act imposes several obligations and requirements on parties and entities it governs. Firstly, FSANZ must consider applications for the development or variation of food regulatory measures in accordance with the procedures outlined in Division 1 of Part 3 of the FSANZ Act. This includes conducting a round of public consultation as was done for Application A1154. Secondly, once a draft variation is approved, FSANZ must publish a notice about the standard or draft variation under section 92 of the FSANZ Act. This ensures transparency and provides the public with the opportunity to comment on the proposed changes.
There are no specific offences or penalties mentioned in this legislation; however, the FSANZ Act stipulates that the approved standard, or variation of a standard, is a legislative instrument that is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003 (FSANZ Act s94). Any breaches of the standards or variations once enacted would fall under the purview of the relevant authorities, such as FSANZ, which could take appropriate actions in line with other regulatory frameworks.
The legislative instrument is exempt from the requirements for a statement of compatibility with human rights as it is classified as a non-disallowable instrument under section 94 of the FSANZ Act. This exemption is based on the nature of the instrument and its purpose, which does not directly relate to fundamental human rights considerations. The exemption was granted following an assessment by the Office of Best Practice Regulation, which determined that a Regulatory Impact Statement was not required for the approval of this genetically modified food (ref 12065).