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 A1198 which seeks approval for food derived from a new food produced using gene technology: corn line DP202216, genetically modified for enhanced yield and tolerance to glufosinate. The Authority considered the application in accordance with Division 1 of Part 3 and has approved a draft variation.
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 Authority has approved the draft variation to permit the sale and use of food derived from corn line DP202216, genetically modified for enhanced yield and herbicide-tolerance to glufosinate. The sale and use of food derived from corn line DP202216 would be in accordance with the Code.
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 A1198 included one round of public consultation following an assessment and the preparation of a draft variation and associated report.
The Office of Best Practice Regulation (OBPR) granted FSANZ a standing exemption from the requirement to develop a Regulatory Impact Statement for permitting new GM foods (OBPR correspondence dated 24 November 2010, reference 12065). This standing exemption was provided because varying Schedule 26 is a consequential change of maintaining a permitted schedule of GM foods. Additionally, permitting new GM foods is deregulatory as using the GM technology will be voluntary if the application is approved. The standing exemption relates to the introduction of a food to the food supply that is voluntary and has been determined to be safe.
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] amends Schedule 26 by inserting, in alphabetical order, new paragraph ‘(zc)’ into item 2 in the table to subsection S26—3(4) in Schedule 26. Item 2 relates to the commodity ‘Corn’.
The new paragraph refers to ‘enhanced yield and herbicide-tolerant corn line DP202216’. Corn line DP202216 is a corn line genetically modified for enhanced yield and herbicide-tolerance to glufosinate.
The effect of the variation is to permit the sale and use of food derived from that corn line in accordance with the Code.
Overview
The Food Standards Australia New Zealand Amendment (Genetically Modified Corn Line DP202216) Legislative Instrument 2021 (F2021L00144) was enacted to address the need for updating food regulatory measures to include genetically modified foods. This legislation, introduced by the Australian Government, aims to streamline the process for approving and incorporating new genetically modified food products into the Australia New Zealand Food Standards Code. The policy objective is to ensure that the Authority can efficiently manage the safety and regulation of genetically modified foods, thereby supporting innovation in agricultural practices while maintaining public health safeguards. Public consultation was conducted as part of the legislative process, and the instrument is exempt from certain regulatory requirements, reflecting its deregulatory nature and the voluntary use of the genetically modified technology.
Scope and Application
The legislation F2021L00144, which pertains to the Food Standards Australia New Zealand Act 1991, specifically addresses the approval of food derived from genetically modified corn line DP202216, which has been engineered for enhanced yield and tolerance to glufosinate. This Act applies to Food Standards Australia New Zealand, which is responsible for developing and varying standards within the Australia New Zealand Food Standards Code. The legislation outlines the procedure for considering applications for new food regulatory measures, including those involving genetically modified foods. Once approved, the Authority must publish a notice regarding the standard or draft variation, and this notice constitutes a legislative instrument, albeit one that is not subject to parliamentary disallowance or sunsetting. The purpose of this legislation is to permit the sale and use of food derived from the specified genetically modified corn line, ensuring compliance with the Code. It does not incorporate any documents by reference and was developed following a round of public consultation as mandated by the FSANZ Act. Furthermore, the Office of Best Practice Regulation has granted a standing exemption from the requirement to develop a Regulatory Impact Statement for permitting new genetically modified foods, deeming such changes as voluntary and safe for the food supply. The legislation also exempts itself from the requirements for a statement of compatibility with human rights due to its status as a non-disallowable instrument under the FSANZ Act.
Key Provisions
The legislation F2021L00144 outlines the key provisions of a draft variation approved by Food Standards Australia New Zealand (FSANZ) concerning the sale and use of food derived from a genetically modified corn line, DP202216, which is engineered for enhanced yield and tolerance to the herbicide glufosinate. This draft variation was approved in accordance with the provisions of the Food Standards Australia New Zealand Act 1991 (FSANZ Act). Section 13 of the FSANZ Act mandates that FSANZ is responsible for developing 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 the procedure for considering applications for the development or variation of food regulatory measures, including standards. Section 92 of the FSANZ Act requires that FSANZ publish a notice about the standard or draft variation of a standard, while section 94 states that such a standard or variation is a legislative instrument, but it is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003.
This draft variation imposes specific obligations on FSANZ and potentially on food businesses. FSANZ is obligated to assess applications for the development or variation of food regulatory measures, including standards, following the procedure outlined in Division 1 of Part 3 of the FSANZ Act. This process includes a mandatory round of public consultation. The approved draft variation aims to permit the sale and use of food derived from corn line DP202216, ensuring compliance with the Code. Businesses intending to sell or use food derived from this genetically modified corn line must ensure that their practices align with the updated standards and variations as stipulated in the Code.
Failure to comply with the provisions of the FSANZ Act or the variations approved by FSANZ can result in various consequences. Although the legislation does not explicitly state penalties for non-compliance, breaches of food standards and variations can lead to enforcement actions by FSANZ, which may include fines, public warnings, product recalls, or legal proceedings. The severity of the penalty depends on the nature and extent of the breach, with potential for significant fines under state and territory food legislation. It is essential for businesses to adhere to the approved variations to avoid these consequences and ensure the safety and quality of food products entering the market.