New procedures for amending the Code
On 1 July 2007, the Australian Parliament passed a package of amendments to the Food Standards Australia New Zealand Act 1991 (FSANZ Act). New procedures for amending the Code will into effect in 2007-08.
These measures introduced new assessment and consultation procedures intended to speed up the standards development process. Unnecessary duplication and red tape have been eliminated to remove obstacles to industry innovation. New, stricter timeframes for dealing with Applications are an integral part of the latest reforms. Applicants will be required to provide supporting information at the start of the process to facilitate more efficient and expeditious handling of their Applications.
New requirements for applicants will apply to those Applications received by FSANZ on or after 1 October 2007
In the past, the Act provided little guidance about Application requirements. Often, Applications that we received did not contain sufficient information to enable them to be properly assessed. This frequently led to delays in assessments while we awaited further information from an applicant.
In 2006-07, we prepared an Application Handbook after extensive discussions with our jurisdictional partners and industry. The Handbook provides guidelines to assist potential applicants. We will be able to refuse to accept an application on the basis that it has not met any information requirements set out in the Application Handbook.
The Application Handbook incorporates information on cost-recovery, confidentiality, application templates and minimum data requirements to complete an assessment. It will be available on our website in a format that will allow applicants to complete relevant details and submit their Application electronically via the web.
As depicted in Figure 3, Applications will be assigned one of three procedures, depending on the complexity of the project:
General procedure (default) (9 months to complete assessment)
The default process for variations to a food regulatory measure, involving one round of public consultation. Most Applications and Proposals will be assessed under this procedure.
Minor procedure (3 months to complete assessment)
Applies to minor variations to food regulatory measures including, but not limited to, correction of a typographical error or minor editorial changes. It involves one round of limited consultation with government agencies only and, if relevant, affected parties.
Major procedure (12 months to complete assessment)
Applies to the development of a new food standard or a major variation to a food regulatory measure involving considerable scientific or technical complexity. This procedure involves two rounds of public consultation
Under the amended FSANZ Act, the terms Initial, Draft and Final Assessment will be removed, being replaced by the following:
Administrative Assessment– to determine whether an Application includes certain minimum requirements (including in any Application ‘guidelines’ issued by FSANZ) and the procedure by which it should be assessed. Fees will be payable after FSANZ has determined whether or not to accept the Application and the assessment procedure. FSANZ has 15 working days to complete this process. An ‘early bird’ public notification then occurs, advising of the acceptance of the Application or Proposal and its placement on the Work Plan.
Assessment– a decision to proceed to develop a food regulatory measure or reject (in whole or part) having regard to the (current) Section 10 objectives in the Act and other relevant matters, including consideration of the benefits vs. costs or alternatives.
Development of food regulatory measure or variation to food regulatory measure– development of food regulatory measure.
Approval– FSANZ approves or rejects an Application or approves or abandons a proposal, having regard to the requirements of the FSANZ Act, submissions and other relevant matters. A report is prepared containing the decision, reasons, submissions list, analysis of submissions, Regulatory Impact Statement and draft food regulatory measure or variation.
FSANZ will have the discretion to ‘stop the clock’ for up to 18 months for Applications if the Ministerial Council has notified FSANZ that it is developing policy guidelines on a specific, clearly defined issue or subject matter. Applicants with paid Applications must consent to this suspension.
Food standards development
Detailed information on Applications and Proposals processed in 2006-07 is contained in Appendices 1 and 2. We describe our process for assessing Applications and Proposals in Appendix 3.
Ministerial Policy Guidelines notified to FSANZ in 2006-07
The Australian Government, States, Territories and the New Zealand Government are represented by their Health, Food or Agriculture Ministers (as Lead Ministers) on the Australia and New Zealand Food Regulation Ministerial Council. Other Ministers from relevant portfolios such as agriculture, industry, or consumer affairs, also participate on the Ministerial Council to ensure a whole-of-Government approach to food regulation.
The Ministerial Council is responsible for the development of food regulatory policy for domestic and imported foods and the development of policy guidelines for setting food standards for domestic and imported foods. In developing or reviewing food regulatory measures and variations to food regulatory measures, FSANZ must have regard to any written policy guidelines formulated by the Ministerial Council and notified to FSANZ for these purposes.
Policy Guideline on the Regulation of Residues of Agricultural and Veterinary Chemicals in Food(notified to FSANZ on 31 October 2006)
The purpose of this Guideline is to form a framework within which FSANZ is to consider alternative approaches to address the issues surrounding the current zero tolerance approach to the regulation of residues of agricultural and veterinary chemicals in food.
Food standards development
Detailed information on Applications and Proposals processed in 2006-07 is contained in Appendices 1 and 2. We describe our process for assessing Applications and Proposals in Appendix 3.
Ministerial Policy Guidelines notified to FSANZ in 2006-07
The Australian Government, States, Territories and the New Zealand Government are represented by their Health, Food or Agriculture Ministers (as Lead Ministers) on the Australia and New Zealand Food Regulation Ministerial Council. Other Ministers from relevant portfolios such as agriculture, industry, or consumer affairs, also participate on the Ministerial Council to ensure a whole-of-Government approach to food regulation.
The Ministerial Council is responsible for the development of food regulatory policy for domestic and imported foods and the development of policy guidelines for setting food standards for domestic and imported foods. In developing or reviewing food regulatory measures and variations to food regulatory measures, FSANZ must have regard to any written policy guidelines formulated by the Ministerial Council and notified to FSANZ for these purposes.
Policy Guideline on the Regulation of Residues of Agricultural and Veterinary Chemicals in Food (notified to FSANZ on 31 October 2006)
The purpose of this Guideline is to form a framework within which FSANZ is to consider alternative approaches to address the issues surrounding the current zero tolerance approach to the regulation of residues of agricultural and veterinary chemicals in food.
Standards Development Work Plan
While the number of Applications and Proposals made to or prepared by FSANZ respectively, decreased compared to last year, our workload continues to be characterised by increased demands and complexities. Table 1 shows the number of Applications, Proposals and potential Proposals on the Work Plan from 30 June 2004 in all Work Plan Groups.
Our capacity to manage cost-recovered applications (Group 3) also impacts on our ability to manage our workloads as it is difficult to forecast the number and complexity of cost-recovered applications we are likely to receive.
Tables 2 and 3 show the number of Applications and Proposals received and prepared, and finalised, respectively. The increasingly complex nature of projects in recent times makes it difficult to directly compare the magnitude of work carried out between 2003-04 and 2006-07.
For example, the standard requiring mandatory fortification with folic acid took more than three years to finalise this year; permissions for the voluntary addition of vitamins and minerals to water-based non-alcoholic beverages took five years to resolve.
Further information on the above can be obtained from Appendix 2.
Ministerial Council Reviews
As shown in Table 4, the Australia New Zealand Food Regulation Ministerial Council requested 3 (17%) 1st reviews of FSANZ decisions during the year, a decrease on the previous year. A similar pattern over the same period is reflected in the number of 2nd requests for review.
Under the 2002 Inter-Governmental Agreement, Ministers can only request reviews of FSANZ decisions based on one or more of the following criteria:
(i) it is not consistent with existing policy guidelines set by the Ministerial Council; or
(ii) it is not consistent with the objectives of the legislation which establishes FSANZ; or
(iii) it does not protect public health and safety; or
(iv) it does not promote consistency between domestic and international food standards where these are at variance; or
(v) it does not provide adequate information to enable informed choice; or
(vi) it is difficult to enforce or comply with in both practical or resource terms; or
(vii) it places an unreasonable cost burden on industry or consumers.
Three requests for a 1st Review were on a genetically modified corn, definition of meat pies and the mandatory fortification of foods with folic acid. The request on the decision relating to fortification was based on criteria (i), (iii), (v), (vi) and (vii); that for the review of the decision on meat pies on criteria (ii), (iii) and (vi); and that for the review of the genetically modified corn on criteria (iii) and (iv).
Work requested by the Ministerial Council
The Ministerial Council notified FSANZ of the following matters on 21 May 2007:
1. FSANZ to consider an amendment to the Novel Food Standard that would limit the period of exclusive approval as a novel food for a particular brand for up to 15 months and ensure that any exclusive approval reverts to a generic permission at the expiration of the approved period of exclusivity.
2. FSANZ undertake a review of the advantages, disadvantages and impact of the novel foods recommendation within 3-5 years of implementation, pursuant to section 33(1A) of the FSANZ Act.
3. With regard to the Application to FSANZ to consider the voluntary addition of fluoride to bottled water (A588), FSANZ should seek the Applicant’s cooperation to change the Application from an unpaid Application to a paid Application. If this approach is not successful, FSANZ is to work to its original timetable of commencing work on the Application before the end of 2007.
Note that Application A581 on this same matter was previously lodged with FSANZ as a paid Application. However, the Applicant decided to not proceed with the Application as a paid Application, withdrew it and re-submitted it as a new unpaid Application (A588). This procedure was necessary as there is no provision in the FSANZ Act allowing a paid application to revert to being unpaid.