Food Standards (Application A1216 – Food derived from herbicide-tolerant canola line MON94100) Variation

Overview

The Food Standards Australia New Zealand Act 1991, enacted by the Australian Parliament, establishes the framework for the development of food standards by Food Standards Australia New Zealand (FSANZ). This legislation was introduced to address the need for consistent and science-based food safety and quality standards across Australia and New Zealand. The Act enables FSANZ to create and vary standards that are incorporated into the Australia New Zealand Food Standards Code. One of the significant gaps it addresses is the regulation of genetically modified (GM) foods, ensuring they meet safety standards before being permitted for sale and use. In 2021, FSANZ accepted an application to permit the sale and use of food derived from a genetically modified canola line, MON94100, which has been modified for tolerance to the herbicide dicamba. This application was processed according to the procedures outlined in the Act, involving public consultation and a review by the Food Ministers’ Meeting. The policy objective of this draft variation is to allow the introduction of this new GM food into the food supply, contingent on its safety being determined.

Scope and Application

The draft variation, stemming from Application A1216 accepted by Food Standards Australia New Zealand (FSANZ) under the Food Standards Australia New Zealand Act 1991, aims to facilitate the sale and use of food derived from canola line MON94100, a genetically modified organism (GMO) engineered for dicamba herbicide tolerance. The FSANZ Act mandates that the Authority must publish a notice concerning any standard or draft variation of a standard, and this draft variation is considered a legislative instrument exempt from parliamentary disallowance or sunsetting under the Legislation Act 2003. The variation specifically seeks to amend Schedule 26 by incorporating a new paragraph, thereby permitting the addition of canola line MON94100 to the list of GM foods in the Australia New Zealand Food Standards Code. This legislative action applies to all entities involved in the production, sale, and use of food derived from this GM canola within the jurisdiction governed by the FSANZ Act. The application of this Act spans across the Commonwealth, ensuring a cohesive regulatory framework for GMOs across Australia and New Zealand. The Office of Best Practice Regulation has granted a standing exemption for this specific regulatory change, deeming it a consequential adjustment to an existing permitted schedule and a deregulatory measure since the use of this GM food remains voluntary. This draft variation does not incorporate any documents by reference and is exempt from the need for a Regulatory Impact Statement or a statement of compatibility with human rights.

Key Provisions

The key sections of this legislation revolve around the Food Standards Australia New Zealand Act 1991 (FSANZ Act), specifically focusing on the Authority’s functions and the procedure for developing or varying food regulatory measures. Section 13 of the FSANZ Act empowers the Authority to develop and vary food standards and other food regulatory measures, which includes accepting applications for new food substances, such as genetically modified foods (sections 13 and 92). Here, the Authority has accepted an application (A1216) to permit the sale and use of canola line MON94100, a genetically modified canola developed for herbicide tolerance, as a new GM food (section 92). The procedure for considering such applications is detailed in Division 1 of Part 3 of the FSANZ Act. Following this process, the Authority must publish a notice regarding the draft variation of a standard, which becomes a legislative instrument under section 94 of the FSANZ Act, though it is not subject to parliamentary disallowance or sunsetting (section 94). The Act imposes several obligations on the parties and entities it governs. The Authority is required to follow a structured procedure for assessing applications to develop or vary food regulatory measures, including conducting public consultation as stipulated in Division 1 of Part 3 of the FSANZ Act. Additionally, the Authority must ensure that any new GM food introduced into the food supply is safe for consumption. This safety assessment is integral to the process and is reflected in the Authority's thorough evaluation of Application A1216. The Office of Best Practice Regulation (OBPR) has granted a standing exemption from assessing whether a Regulatory Impact Statement is required for this particular application, as varying Schedule 26 is a consequential change and the introduction of a new GM food is considered deregulatory. Under the FSANZ Act, there are potential civil and criminal consequences for breaches of food regulatory measures, though specific offences and penalties are not detailed in the explanatory statement. The Act’s focus is on ensuring that new food substances, particularly GM foods, are safe for the public to consume. Non-compliance with these standards could lead to enforcement actions, potentially including fines or other penalties as prescribed under the FSANZ Act or other relevant legislation. The legislative instruments created by the Authority, such as the draft variation permitting the sale and use of canola line MON94100, are designed to maintain these safety standards and ensure that the food supply remains safe and reliable. The process of approving new GM foods is stringent, reflecting the importance of public health and safety in the regulation of food standards.