Draft 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 A1206 which seeks to permit the use of subtilisin (EC 3.4.21.62) from a genetically modified strain of Bacillus licheniformis (B. licheniformis) containing the subtilisin gene from Pyrococcus furiosus, as a processing aid in the production of potable alcohol. The Authority considered the Application in accordance with Division 1 of Part 3 and has approved a draft variation.
Following consideration by the Food Ministers’ Meeting,[1] 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 a draft variation amending the table to subsection S18––9(3) of the Code to permit the use of the enzyme subtilisin (EC 3.4.21.62) sourced from B. licheniformis containing the gene for subtilisin from Pyrococcus furiosus, as a processing aid in the production of potable alcohol.
3. Documents incorporated by reference
The variation in this instrument does 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 A1206 included one round of public consultation following an assessment and the preparation of a draft variation and associated assessment summary. Submissions were called for on 3 December 2020 for an eight-week consultation period.
The Office of Best Practice Regulation (OBPR) granted FSANZ a standing exemption from the requirement to develop a Regulatory Impact Statement (RIS) for permitting genetically modified foods and the voluntary addition of processing aids to foods (OBPR correspondence dated 24 November 2010, reference 12065). This standing exemption was provided as permitting new GM foods and new enzyme processing aids is deregulatory as their use will be voluntary if the application is approved. This standing exemption relates to the introduction of a food to the food supply that 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] inserts a new entry, in alphabetical order, into the table to subsection S18—9(3) of the Code.
The new entry consists of the enzyme subtilisin (EC 3.4.21.62) sourced from Bacillus licheniformis containing the gene for subtilisin from Pyrococcus furiosus, as a processing aid in food for a specific technological purpose.
The technological purpose is for use in the production of potable alcohol.
The permission is subject to the condition that the maximum permitted level or amount of this enzyme that may be present in the food must be consistent with good manufacturing practice.
1 Formerly referred to as the Australia and New Zealand Ministerial Forum on Food Regulation.
Overview
The Food Standards Australia New Zealand Act 1991 (FSANZ Act) was enacted to provide for the establishment of Food Standards Australia New Zealand (FSANZ) and to set out its functions and powers, including the development of food standards. In 2021, a draft legislative instrument was issued under the FSANZ Act to amend the Australia New Zealand Food Standards Code to permit the use of the enzyme subtilisin from a genetically modified strain of Bacillus licheniformis as a processing aid in the production of potable alcohol. This legislative instrument follows the acceptance and consideration of an application under the FSANZ Act and includes a period of public consultation. The instrument's purpose is to allow the voluntary use of this enzyme, provided it adheres to good manufacturing practices, and is subject to the FSANZ Act's provisions regarding the publication of draft variations and the non-disallowable nature of such instruments.
Scope and Application
The F2021L00984 legislation, a legislative instrument under the Food Standards Australia New Zealand Act 1991, pertains to the regulation of food standards within Australia and New Zealand. This Act applies to Food Standards Australia New Zealand, the regulatory body tasked with developing and varying food standards as outlined in the Australia New Zealand Food Standards Code. The Authority's approval of Application A1206, which seeks to permit the use of subtilisin from a genetically modified strain of Bacillus licheniformis as a processing aid in the production of potable alcohol, is the subject of this legislation. The approved draft variation allows for the enzyme subtilisin, sourced from B. licheniformis containing the gene from Pyrococcus furiosus, to be used in food production, specifically for the technological purpose of producing potable alcohol, subject to certain conditions such as adhering to good manufacturing practice levels. This legislation does not incorporate any documents by reference and has a jurisdictional reach that includes both Australia and New Zealand. Public consultation was undertaken as part of the process, and the instrument is exempt from certain regulatory requirements, including the need for a statement of compatibility with human rights, as it is a non-disallowable instrument under the FSANZ Act.
Key Provisions
The key provisions of the explanatory statement revolve around the development and variation of food standards by Food Standards Australia New Zealand (FSANZ). Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) (1) empowers the Authority to create and amend food standards, including the acceptance of applications for new food regulatory measures, as outlined in Division 1 of Part 3 (2). This process was followed for Application A1206, which sought to permit the use of subtilisin, derived from a genetically modified strain of Bacillus licheniformis containing the subtilisin gene from Pyrococcus furiosus, as a processing aid in the production of potable alcohol (3). The Authority approved the draft variation following the necessary considerations and consultations, and this decision was subsequently reviewed by the Food Ministers’ Meeting (4).
The primary obligation under this legislation is the requirement for FSANZ to publish a notice about the draft variation, as stipulated by section 92 of the FSANZ Act (5). This notice is a crucial step in the legislative process, ensuring transparency and allowing for public scrutiny before the standard or variation becomes official. Additionally, section 94 of the FSANZ Act (6) clarifies that the draft variation, once published, is considered a legislative instrument but is not subject to parliamentary disallowance or sunsetting under the Legislation Act 2003. This means that the variation will come into effect unless specifically objected to by Parliament, and it does not automatically expire after a certain period.
The explanatory statement also outlines the specific variation to be implemented. Item [1] of the statement introduces a new entry into the table of subsection S18–9(3) of the Australia New Zealand Food Standards Code, permitting the use of the enzyme subtilisin, derived from Bacillus licheniformis with the subtilisin gene from Pyrococcus furiosus, as a processing aid in the production of potable alcohol (7). This permission is conditional on the maximum permitted level of the enzyme being consistent with good manufacturing practices. This provision aims to ensure that the use of this enzyme is safe and controlled within the food production process.
In terms of compliance and enforcement, the FSANZ Act does not specify particular offences or penalties for breaches related to the draft variation. However, as a legislative instrument, any non-compliance with the final standard could lead to enforcement actions under relevant food safety and quality regulations. The specifics of such actions would depend on the broader regulatory context and the particulars of any non-compliance identified.
Consultation was a critical component of this process. FSANZ conducted one round of public consultation as per the procedure in Division 1 of Part 3 of the FSANZ Act (8). Public submissions were invited on 3 December 2020, allowing for an eight-week period to gather feedback. The Office of Best Practice Regulation granted FSANZ a standing exemption from the requirement to develop a Regulatory Impact Statement for this specific application, considering it deregulatory and safe (9). This exemption facilitated a streamlined process for introducing the new enzyme processing aid, aligning with regulatory best practices.