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 A1138 which seeks permission for the sale and use of food derived from a genetically modified rice line, GR2E, which produces provitamin A in the grain. The Authority considered the Application in accordance with Division 1 of Part 3 and has prepared 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 draft variation.
Section 94 of the FSANZ Act specifies that 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 Schedule 26 of the Code to permit the sale, or use in food, of food derived from provitamin A rice line GR2E and make a consequential amendment to Standard 1.5.2.
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 A1138 included one round of public consultation following an assessment and the preparation of a draft variation and associated report. Submissions were called for on 3 August 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 amendments to Standard 1.5.2 and Schedule 26 are 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] amends Standard 1.5.2 by replacing the reference to ‘subsections S26—3(2) and (3)’ in subparagraph 1.5.2—4(1)(a)(ii) with a reference to ‘section S26—3.’ This is a consequential amendment required as a result of the variation proposed by item [2.1] below.
Item [2] amends Schedule 26.
Subitem [2.1] inserts new subsection S26—3(2A) into Schedule 26. The new subsection requires food products containing beta-carotene derived from provitamin A rice line GR2E to comply with the labelling requirement imposed by section 1.5.2—4 of the Code.
Subitem [2.2] inserts new paragraph (b) into item 6 in the table to subsection S26—3(4). Paragraph (b) refers to ‘provitamin A rice line GR2E’. This amendment will permit the sale, or use in food, of food derived from provitamin A rice line GR2E.
Overview
The Food Standards Australia New Zealand Amendment Instrument 2018 (F2018L00131) was enacted to address the regulatory gap in allowing the sale and use of food derived from a genetically modified rice line, GR2E, which produces provitamin A in the grain. The instrument was developed under the authority granted by section 13 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) and follows the procedure specified in Division 1 of Part 3 of the same Act for considering applications for the development or variation of food regulatory measures. The primary objective of this amendment is to permit the sale and use of food derived from the genetically modified rice line GR2E, ensuring that it complies with the relevant labelling requirements outlined in the Australia New Zealand Food Standards Code. The legislative instrument was prepared after a round of public consultation and was exempt from the need for a Regulatory Impact Statement due to its anticipated minor impact on business and individuals.
Scope and Application
The F2018L00131 instrument amends the Australia New Zealand Food Standards Code to allow the sale and use of food derived from a genetically modified rice line, GR2E, which produces provitamin A in the grain. This variation applies to persons or entities that produce, manufacture, process, store, import, export, or supply food products containing beta-carotene derived from this rice line. The geographic reach of this Act extends to both Australia and New Zealand as it pertains to the binational Food Standards Australia New Zealand Authority. The amendment involves a consequential change to Standard 1.5.2 and a specific addition to Schedule 26, ensuring compliance with labelling requirements. Notably, the instrument does not require a Regulatory Impact Statement as it falls under a standing exemption granted by the Office of Best Practice Regulation, considering the minor impact on business and individuals. Furthermore, this legislative instrument, being a non-disallowable instrument under section 94 of the FSANZ Act, is exempt from the need for a statement of compatibility with human rights.
Key Provisions
The primary operative sections of this legislation concern the variation of food regulatory measures in the Australia New Zealand Food Standards Code (Code) to permit the sale and use of food derived from a genetically modified rice line, GR2E, which produces provitamin A in the grain (Item [2.2]). This variation also includes a consequential amendment to Standard 1.5.2 to reflect the new requirements (Item [1]). The new subsection S26—3(2A) introduced by Item [2.1] ensures that any food products containing beta-carotene derived from provitamin A rice line GR2E must comply with specific labelling requirements as outlined in section 1.5.2—4 of the Code. This process was undertaken following a formal application and a round of public consultation, as specified by the Food Standards Australia New Zealand Act 1991 (FSANZ Act).
The obligations imposed by this Act on the relevant parties include the requirement for Food Standards Australia New Zealand (the Authority) to consider applications for the development or variation of food regulatory measures and to follow the procedure outlined in Division 1 of Part 3 of the FSANZ Act. This includes conducting a public consultation as part of the process. The Authority must also ensure that any variations proposed are consistent with the existing standards and that appropriate labelling requirements are established for any new food products derived from genetically modified organisms. Furthermore, the Authority is mandated to publish a notice about any draft variations in accordance with section 92 of the FSANZ Act.
There are no explicit offences or penalties outlined in the explanatory statement for breaches of this variation. However, non-compliance with the new requirements could potentially lead to enforcement actions under the FSANZ Act or other relevant legislation. For instance, failure to adhere to the labelling requirements could result in regulatory sanctions or legal actions aimed at ensuring compliance with food safety and labelling standards. The legislative instrument itself is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003, as stipulated by section 94 of the FSANZ Act.