Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991
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Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 November 2020 Dietitians Australia is the national association of the dietetic profession with over 7500 members, and branches in each state and territory. Dietitians Australia is the leading voice in nutrition and dietetics and advocates for food and nutrition for healthier people and healthier communities. Dietitians Australia appreciates the opportunity to provide feedback to FSANZ regarding the Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 (Cth). Contact Person: Elizabeth World Position: Policy Officer Organisation: Dietitians Australia Address: 1/8 Phipps Close, Deakin ACT 2600 Telephone: 02 6189 1200 Email: policy@dietitiansaustralia.org.au A 1/8 Phipps Close, Deakin ACT 2600 | T 02 6189 1200 E info@dietitiansaustralia.org.au W dietitiansaustralia.org.au | ABN 34 008 521 480 Dietitians Australia and the associated logo is a trademark of the Dietitians Association of Australia.
Dietitians Australia interest in this consultation As the leading organisation of nutrition and dietetic professionals in Australia, Dietitians Australia (DA) supports reforms to the food regulation system via the Food Standards Australia New Zealand Act 1991 (Cth) (the Act). The Accredited Practising Dietitian (APD) program provides an assurance of safety and quality and is the foundation of self-regulation of the dietetic profession in Australia. Accredited Practising Dietitians have an important role in the food system to support consumers in making healthy food choices and companies with product formulation, marketing, consumer education and compliance. This submission was prepared by the Dietitians Australia Food Regulatory and Policy Committee following the Conflict of Interest Management Policy and process approved by the Board of Dietitians Australia. This policy can be viewed on the Dietitians Australia website. The committee’s membership is comprised of Dietitians Australia members with wide ranging expertise in areas including public health, food systems, food industry and academia. Recommendations 1. Add additional considerations to which the Authority must have regard to: a. The environmental sustainability and minimising the environmental impact of the food supply. b. Support to protect and improve the healthiness of the food supply. 2. Incorporate activities regarding coordination of critical food safety incident investigations as a core statutory function in the Act. 3. Maintaining current function of providing assistance to industry intending to make applications to create or vary food regulatory measures, to support long-term nutrition and health, and to enable an agile ‘future-proofed’ food regulatory system. 4. FSANZ should not take on the responsibility of pursuing and/or coordinating food crime investigations as this function suitably sits currently with expert bodies such as the Australian Competition and Consumer Commission (ACCC) and relevant Government agencies. 5. The Act be amended to specifically provide for scheduled and orderly review of the standards to ensure they are still relevant and fit for purpose. 6. The criteria for decisions on timeframes for applications must be clear, and outcomes transparently communicated. 7. When making decisions on applications, their impact, including public health significance, should be a key criterion. 8. FSANZ should play a central role in evaluating food-health claims prior to businesses being permitted to use the claim in market 9. The FSANZ Board have a quota for members with expertise in different subject areas. 10. The FSANZ Board adopts an appointment cycle whereby half the Board change at a set time point, preserving balance between corporate knowledge and fresh perspectives. Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 2
Discussion Objectives 1a. Is there still a case for food regulation? Yes. Food regulation is essential to ensure the production, supply and sale of safe and healthy food. Food regulation must extend beyond food safety and ensure the food supply promotes long-term health of Australians. This includes: • Consistent, accurate accessible evidence-based information to enhance consumer capacity and confidence to make informed choices to support positive health outcomes • Consumer assurance that potentially injurious products will be restricted • Incentive for industry to develop, produce and market healthy products Well-designed regulation builds and supports the integrity, efficiency and innovation in Australian and New Zealand food industries, which in turn supports global competitiveness. As the prevalence and social and economic burden of non-communicable food related illnesses continue to increase there are long-term global opportunities in ensuring our food is safe and supports good health. 1b. What market failure(s) should governments seek to address through regulation of food? Regulation of food should not seek to only address market failures but protect public health through and reducing diet-related chronic disease and promoting healthy eating behaviours. Without effective regulation, market failures are inevitable because of the inevitable variation between consumer and industry goals and knowledge. Without the requirements to ensure safe food production and provide independent, evidence-based product information, consumers cannot be confident that their food is safe. Regulation is also required to ensure consumers can access adequate accurate information on ingredients and nutritional composition of their food to enable informed food choice. Key market failures the government should seek to address through food regulation include existing and market incentives for manufacturers to introduce new unhealthy products, and limited or misleading information that constrains consumer capacity to make informed choices. Examples include lack of added sugar labelling and lack of energy labelling on alcohol. 2. Are there other significant focus areas that should be considered as part of the Review? The Review should have a significant focus on ensuring that food regulation is as much about long- term public health and wellbeing as it is about food safety. Dietitians Australia considers it is a false and unhelpful dichotomy to position the debate as consumers versus industry. The position is analogous to effective share market regulation to build market integrity and investment. If Australian and New Zealand food regulation supports the integrity and reputation of our food industry for safety and health, this will enhance the global market for our products, especially as the health and economic global burden of non-communicable food-related illness increases. 3. To what degree are the current legislated objectives an issue for the system? What are the types of problems that different stakeholder groups face as a consequence? FSANZ has achieved the Object of the Food Standards Australia New Zealand Act 1991 (Cth) (the Act) as it was written 30 years ago. Now is a good opportunity to review the Objectives to ensure the purpose of the Act fits with the changing health and food environments in Australia and New Zealand. The following points must be considered. Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 3
Chronic disease prevention – Chronic disease risk is a significant health problem in Australia1 that can be moderated by reorienting the food supply to facilitate increased consumption of healthy foods and reduced intake of unhealthy foods, and providing consumers with sufficient, accurate, accessible information to make an informed choice. Although the current objective of the Act makes general reference to public health protection, the four associated goals do not explicitly refer to reduction of diet-related chronic disease or facilitating national dietary intakes consistent with other key government recommendations such as the Dietary Guidelines. As such the current objectives do not provide a clear mandate to prioritise nutritional considerations in risk assessments and standard setting. Food supply in remote communities – Australians living in rural and remote areas experience different food supply issues to Australians living in metropolitan areas. Often, Australians living in rural and remote areas have a greater reliance on canned and dried products for their fruit and vegetable intake.2, 3 These products are high in sugar and salt to ensure food safety but are not conducive to good long-term health. It is important that FSANZ is cognisant of remote communities’ reliance on processed foods when making food regulation decisions, and ensures that this vulnerable section of Australians have access to as healthy foods as possible. Environmental and social costs of food production and food choice - Focus on sustainable production of a secure and safe food supply to meet the challenges of a changing climate. 4a. What would be the impact of implementing "Reform idea 1 – Define ‘public health’ and ‘safety’ in legislation to affirm the inclusion of long-term health and nutrition as a core objective", and how could the outcome best be achieved? Reform idea 1 would have a net positive impact. Dietitians Australia recommends both suggested changes ‘protecting public health and safety’ and (Option 1) and aligning wording (Option 2) should be adopted. Short and long-term health impacts can compete, for example increased sugar and salt content may increase food safety but is worse for chronic disease risk. Short and long-term health risks therefore need to be considered in tandem.4 The level of evidence of short- and long-term health impacts can also be substantially different. It is generally easier to isolate short-term impacts such as food safety or nutrient intakes using randomised controlled trials, and much more difficult to measure long-term health outcome of dietary patterns. Evidence assessment must therefore take a risk-based approach and include other sources of high-quality evidence to estimate long-term public health impact.5 4b. What would be the impact of implementing "Reform idea 2 - Recognise trade as a core goal and reframe consumer choice as a factor to which FSANZ ‘must have regard’ ", and how could the outcome best be achieved? Reform idea 2 would have a net negative impact. Dietitians Australia strongly supports the maintenance of the protection of public health and safety as the primary objective of the FSANZ. In recognition of the occasional conflicts between public health and trade, it is important that FSANZ has a clearly articulated mandate to promote health over trade. In aid of this, we support the maintenance of "The promotion of fair trading in food” and “Support an efficient and internationally competitive food industry” as elements that FSANZ “must have regard to”. Clarifying the order of priorities will enable decision-making where public health and safety and commerce conflict. This section could read: Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 4
The objectives (in descending priority order) of the Authority in developing or reviewing food regulatory measures and variations of food regulatory measures are: a. The protection of public health and safety b. The provision of accurate and accessible information relating to food to enable consumers to make informed choices In developing or reviewing food regulatory measures and variations of food regulatory measures, the Authority must also have regard to the following: a. The need for standards to be based on risk analysis using the best available scientific evidence b. The promotion of consistency between domestic and international food standards c. The information required relating to food to enable consumers to make informed choice d. the environmental sustainability and minimising the environmental impact of the food supply e. The need to prevent misleading or deceptive conduct f. The promotion of fair trading in food g. Support to protect and improve the healthiness of the food supply h. Support an efficient and internationally competitive food industry. We also request a clear definition of what “have regard to” means and how this should influence decision-making. 4c. What would be the impact of implementing of implementing "Reform idea 3 – Establish criteria in the Act that the Forum must meet to request a review of a draft regulatory measure", and how could the outcome best be achieved? Reform idea 3 would have a net positive impact. The Forum provides an important mechanism for timely resolution and advancement of food regulation decisions. Dietitians Australia supports the development of criteria to trigger a review of a draft regulatory measure. Developed criteria should be consistent with the FSANZ objectives and criteria FSANZ is required to give regard to, the Food Regulation Policy Framework6 and reference to relevant policy guidelines.7 Clearer criteria may reduce potential effect of industry and/or public health lobbying to ministers on final decision-making. It is crucial that FSANZ and Forum are both clearer throughout process about appropriate grounds for review so FSANZ can anticipate any concerns in preparing draft, and ministers know what is appropriate grounds to request draft. This will also increase efficiency of use of Forum and FSANZ time and resources. Inadequate transparency in the Forum’s decision-making process is evident from the recent requests for review with very limited explanation (for example, pregnancy warning labels on alcohol). Establishing criteria in the Act will assist in transparency and accountability of the Forum’s decision. Dietitians Australia also supports consideration of more straightforward regulatory measures to be signed off by FRSC, rather than through full review by the Forum. Decisions about which measures require Forum consideration and which can be approved by FRSC could be underpinned by a more risk-based approach. The option for abridged approvals will improve the agility of the Food Regulatory System. Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 5
5. Are there other potential issues or solutions relating to legislated objectives? Dietitians Australia recommends inclusion of two additional factors which FSANZ “must have regard” to: 1. The environmental sustainability and minimising the environmental of the food supply. 2. Support to protect and improve the healthiness of the food supply. Recommendation 1 is an acknowledgement of the growing scientific consensus on the interrelationship between planetary health and human health.8 This acknowledgement will ensure FSANZ’s ability to continue to serve the needs of the Australian and New Zealand public and adapt to changing food supply and climate over the coming decades. Recommendation 2 directs that FSANZ standards and processes should encourage the food industry to improve nutrient profile of products by removing negative nutrients and increasing healthy ingredients including wholegrains, fruits, vegetables, nuts and legumes. Functions 6. To what degree are FSANZ’s functions (as currently stated in the Act) an issue for the system? What are the types of problems that different stakeholder groups face as a consequence? Dietitians Australia recognises the complexity of the Australian and New Zealand food system, particularly with regard to food regulation and policy. It also acknowledges that the current system generally functions well; nonetheless, there are opportunities to improve and optimise the system. Critical to the prescription of FSANZ’s statutory functions, clear alignment between agreed objectives and functions is required to eliminate ambiguity, improve clarity, and ensure stakeholder (including community) understanding and trust of FSANZ roles and activities in the system. The existing 20 statutory functions outlined in the Food Standards Australia New Zealand Act 1991 (Cth) (the Act) are generally broad and ambiguous. Other key issues identified with the current functions and how they are an issue for the system include: • Lack of clarity in how the functions serve to meet the overarching objectives of the Act to ensure a high standard of public health protection. • The current functions do not specifically address modern day food system issues (for example, food sustainability and food crime). • The majority of existing functions are passive in their approach to coordination and monitoring (~17/20 of the current functions) and therefore provide less value to the system. A shift to more proactive functions could enhance value – as per frameworks identified in overseas regulatory bodies (highlighted in Figure 3 of the FSANZ Act review scoping paper). Many of the existing statutory functions could be consolidated and/or amended to better reflect FSANZ’s scope of practice, reduce ambiguity and improve stakeholder/community understanding of FSANZ activities/functions. This would provide opportunities to amend statutory functions in the Act to ensure they more accurately reflect the broader roles already delivered by FSANZ (that are not currently identified in the functions) and the addition of new functions that will facilitate delivery of greater value, a ‘future-proofed’ system and enhance consumer/stakeholder trust. There is also an opportunity for the functions to be made more specific and purposeful to support targeted outputs that are clearly defined and can complement other subsystem functions. Various stakeholder groups are likely to experience different barriers/challenges under the current system. The Australian food governance system appears to be less streamlined than systems employed in other countries. From a consumer perspective, poor consumer understanding and Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 6
interaction with relevant bodies and stakeholders has previously been identified.9 Now more than ever, there is heightened public interest in science-based issues and a desire for public participation in decision making. However, existing barriers to participation in the policy-making process means that consumers are increasingly removed, sceptical, and confused by the food regulatory system. Maintaining consumer/stakeholder trust is fundamental to the effective operation of the food system10-12 and in the authoritative presence of FSANZ as a regulatory agent in this system. As such, FSANZ must have clear functions outlined to remove any ambiguity in stakeholder/consumer interpretation and promote greater transparency through industry and consumer involvement in food governance.13 For industry stakeholders specifically, factors such as lack of guidance for Code implementation, the timeliness and cost associated with preparation/review of proposals/applications and concern regarding FSANZ prioritisation of submissions may present issues. The current functions outlined for FSANZ may also present problems for other stakeholder groups acting within the food regulatory system, including governmental organisations such as the ACCC, Therapeutic Goods Administration, and Department of Agriculture, Water and Environment; particularly where responsibilities are shared and a lack of congruence exists. While the opportunities for FSANZ functions are endless, agreed functions need to be supported by adequate resourcing to achieve anticipated outcomes. Furthermore, if the objectives of the Act are amended, then stated functions must shift to reflect appropriate focus areas that support intended outcomes. 7a. What would be the impact of implementing "Reform idea 4 - Amend the Act to better reflect the functions FSANZ currently delivers, particularly as they relate to supporting long-term health and nutrition" and how could the outcome best be achieved? Reform idea 4 would have a net positive impact. The ambit of FSANZ functions must be clear and publicly transparent, with statutory responsibilities clearly defined for the work FSANZ actually delivers. Reform idea 4 will provide an opportunity to develop a clear legislative basis for work that currently FSANZ undertakes and will improve transparency of FSANZ’s agreed roles/activities that will likely improve how stakeholders/consumers perceive FSANZ and its role in the food regulatory system. Several activities currently undertaken by FSANZ that are not explicitly captured by existing functions are noted in the scoping paper for public consultation, including: CONDUCTING RESEARCH THAT CONTRIBUTES TO THE EVIDENCE BASE RELATING TO LONG TERM HEALTH AND NUTRITION (COVERING ACTIVITIES UNDERTAKEN BY FSANZ SUCH AS CONTRIBUTIONS TO THE AUSTRALIAN HEALTH SURVEY, DEVELOPMENT OF A BRANDED FOOD DATABASE AND THE AUSTRALIA TOTAL DIET SURVEY). FSANZ performs an essential role in monitoring nutrients in the food supply to enable the compilation of food composition databases. This data plays a pivotal role in ascertaining and monitoring population nutritional status (e.g. AHS - Australia’s largest, most comprehensible health survey), plus feeds into FSANZ's risk assessment process and informs food-based dietary guidelines and standards. FSANZ’s food composition program is peer-reviewed, to ensure best practice scientific outputs. This FSANZ function is an essential element to support long-term nutrition and health at a population level and will continue to be relied on for upcoming public health nutrition decisions - such as the Australian Dietary Guidelines review. As such, this workstream should be explicitly stated among the Act functions if the objective to ‘Protect public health’, is to be maintained.14 Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 7
UNDERTAKING AND COORDINATING CRITICAL FOOD SAFETY INCIDENT INVESTIGATIONS. It is outlined on the FSANZ website that its role is to “coordinate activities [including food recalls], collate and share information and, in many cases, develop public statements” to respond according to food law, response plans and protocols to achieve consistent responses to critical food safety incidents.15 This is done in consultation with the Department of Health (OzFoodNet), the Department of Agriculture and the food enforcement agencies of all Australian states and territories and New Zealand. When a critical food safety incident occurs, a swift, coordinated and collective national response is required to uphold public health and safety. FSANZ has played a significant role coordinating a number of trade recalls in the past and also more recently (for example, Salmonella and rockmelons (2016); Hepatitis A in frozen berries (2015) amongst others),15 this is well positioned to deliver on this activity. As such, Dietitians Australia recommends incorporating activities regarding coordination of critical food safety incident investigations as a core statutory function in the Act. PROVIDING ASSISTANCE TO INDUSTRY INTENDING TO MAKE APPLICATIONS TO CREATE OR VARY FOOD REGULATORY MEASURES. To ensure public health and safety is upheld within a fast evolving food system, it is in FSANZ’s best interest as the Food Standards Code owner, to continue working with industry to support safe and justified change to current regulatory measures. The FSANZ work plan shows 20 non-FSANZ generated applications received in 2019-2020 (inclusive).16 Food regulation is heavily influenced by global economic liberalisation such as international free trade and food safety treaties, which have diminished the extent of control of national governments over internal food safety standards.9 Globalisation, foreign trade and rapid innovation will see our food system continually evolve; thus, anticipation of further industry-based applications for regulatory changes are warranted. Whilst FSANZ provides a handbook guide of how to make an application and offers some pre- lodgement consultations, pain points in the system include turnaround time and accessibility (discussed in further detail later in this submission). Dietitians Australia recommends maintaining this current function to support long-term nutrition and health, and to enable an agile ‘future-proofed’ food regulatory system. However, the function to specifically provide assistance to ‘industry’ should be more explicitly stated in the revised Act Functions - beyond the existing ambiguous (a) - (c) functions currently stated. 7b. What would be the impact of implementing "Reform idea 5 – Amend s 13 of the Act to reflect a broader range of functions that FSANZ could deliver now and in the future" and how could the outcome best be achieved? Reform idea 5 would have a net positive impact. FSANZ could add a number of statutory functions beyond those currently identified in the Act, and those currently delivered in practice, which reflect important and emerging food regulation issues and priorities. However, Dietitians Australia also acknowledges stakeholder concerns that if FSANZ broadens its scope too wide it risks diluting its current functions and compromising public credibility and trust in its role. As such, should FSANZ expand functions beyond its current core activities and expertise, these decisions must be carefully considered on the basis of any amendments to FSANZ objectives. Furthermore, FSANZ must be appropriately resourced (including staffing, expertise, financial resources) to ensure it has capacity to deliver on the additional functions. Several potential activities that could be undertaken by FSANZ and indicated as statutory functions are noted in the scoping paper for public consultation, based on research of comparable international standard-setting bodies and stakeholder feedback (outlined below). While it may be appropriate for some of these functions to be undertaken by FSANZ and incorporated into the Act, others may be beyond the scope of FSANZ, particularly given other actors in the system who are Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 8
likely to be better suited, have the expertise and be more appropriately resourced to oversee these roles. EXPANDING THE STATUTORY FUNCTIONS TO INCLUDE PROVIDING ADVICE, GUIDANCE, ASSISTANCE AND SUPPORT AT THE REQUEST OF LAW ENFORCEMENT AGENCIES TO SUPPORT FOOD FRAUD AND FOOD CRIME INVESTIGATIONS Dietitians Australia acknowledges that food ‘fraud’ and ‘crime’ is a significant issue facing food regulators, the food industry and consumers globally;17 and is a risk to the safety and trust in Australia’s food supply.18, 19 As such, there is a need for a holistic, all-encompassing approach to focus on a prevention strategy for food fraud and food crime. Efficient and effective food fraud prevention requires an interdisciplinary and public-private partnership approach.20 To protect public health and safety, FSANZ should continue to be involved in this interdisciplinary approach. Dietitians Australia does not recommend FSANZ take on the responsibility of pursuing and/or coordinating food crime investigations as this function suitably sits currently with expert bodies such as the Australian Competition and Consumer Commission (ACCC) and relevant Government agencies; however, it would be appropriate for FSANZ to assist and contribute to such investigations where it protects public health and safety, and directly aligns to established functions. COORDINATING A CENTRALISED REPOSITORY OF INFORMATION ON FOOD SAFETY (BEING ‘THE FACE OF FOOD SAFETY’) Digital platforms have become the key source of information and news for Australians, yet misinformation is a significant issue, with many Australians concerned about discerning between fake and real news online.21 In the case of food safety and health, misinformation has the potential for wide-spread detrimental outcomes. Thus, it is logical to create a centralised online repository or hub of information housing reputable, scientific-based food safety information. As noted in the scoping paper, currently there are duplicated efforts regarding food safety materials and education initiatives, with key players including the Food Safety Information Council, who can act on its own initiative, and FSANZ, who is dependent on State and Territory cooperation. Given FSANZ’s existing responsibility to food safety, plus its role in the broader food system and established communication channels, the body is well positioned to be the ‘Face of Food Safety’ and for the FSANZ website to house this online hub. However, to avoid dilution of FSANZ core functions, a strengths-based approach would be to shift FSANZ’s function to focus on raising awareness and to partner with reputable organisations (for example, Food Safety Information Council) who would be responsible for developing food safety education materials and initiatives. Information and initiatives targeting consumers would be developed by experts in consumer communication and pushed through appropriate FSANZ mediums, leveraging the FSANZ’s existing consumer reach with is considerably larger than other food safety organisations (for example, 43,000 Facebook followers versus Food Safety Information Council’s 4200 followers). Employing such an approach would also support unification to food safety across Australia, create efficiencies and eliminate challenges associated with the need to achieve State and Territory cooperation. COORDINATING FOOD SAFETY RESEARCH Challenges associated with ensuring food safety in Australia cannot be adequately addressed without participation from the research community. Ideally, research should inform practice and research priorities should be informed by the needs identified by jurisdictions and industry to build collective knowledge and drive innovation. To take advantage of opportunities offered by new technologies, innovations and processes, it is critical for these activities to be evidenced-based and underpinned by rigorous scientific endeavours. However, under the current system with research engagement from a Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 9
significant number of bodies, often acting in silos, there are likely to be high levels of unnecessary research duplication, inefficiencies and associated investment costs. As such, Dietitians Australia supports the premise of taking a more coordinated and collaborative approach to food safety research, for which FSANZ could facilitate as a core element of its statutory function. This would provide an opportunity for FSANZ to establish a focused research agenda and ensure efficient allocation and use of resources to support research priorities. Coordinating stronger research linkages across industry, universities, government agencies and private organisations will also facilitate knowledge sharing and maximise the value of research findings. UNDERTAKING EDUCATION CAMPAIGNS IN ALIGNMENT WITH OTHER FOOD REGULATION SYSTEM PRIORITIES There is continued need for public education campaigns that support food regulation system priorities, including those related to reducing foodborne illnesses and chronic diseases. However, much of this work is conducted using a siloed approach by a variety of different bodies; and employment of a coordinated approach is clearly lacking. To uphold FSANZ’s trusted status and credibility as a risk- and science-based standard-setting body, Dietitians Australia encourages FSANZ to maintain its core functions pertaining to the body’s expertise and avoid expanding its remit to include this type of work. This would allow FSANZ to commit to purposeful, targeted functions that elicit desired outputs and avoid diluting and compromising functionality. To strengthen this focus area, a similar model could be developed as outlined for food safety education, whereby FSANZ works more closely with bodies currently pursuing such work (e.g. Dietitians Australia, Department of Health) who would be responsible for content creation and FSANZ to play a role in disseminating key messages, campaigns and information, through established FSANZ channels. Such an approach would have the benefit of unification across Australia, creating efficiencies by removing duplicated efforts and eliminating challenges associated with the need to achieve State and Territory co-operation. 8. Are there other potential solutions relating to FSANZ’s statutory functions? No comment. Legislative processes and decision-making arrangements 9. To what degree are the current processes for strategically reviewing standards an issue for the system? What are the types of problems that different stakeholder groups face as a consequence? The current processes for reviewing standards are largely reactive. As noted in the scoping paper, applications are generally industry initiated and proposals are prepared by FSANZ. The current system has the following consequences: • Industry-led applications set the agenda on standard variations. Although there is opportunity for public comment on applications, this tends to be reactive and focused only on the application sought. Dietitians Australia considers it is essential for industry to be able to seek variations. However, it is equally important that public health organisations have the same balance for input into standard development. If better public health is to be a FSANZ objective, public health agencies and organisations need earlier and more strategic input into the development and variation of standards. • Variations to standards tend to be made in a piecemeal manner. Standards fail to have holistic reviews as to whether the policy objectives underlying the standards are relevant and whether the standards are appropriate for meeting those objectives. This is evident in relation to Chapter 2 standards covering specific ranges of products such as infant formula and formulated supplementary sports foods. It also applies to Chapter 1 standards. For Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 10
example, whether the current Food Standards Code labelling requirements are adequate to protect consumers given media reports that online grocery sales have doubled to make up 8% of all food sales for one retailer.22 • Reviews sitting dormant on workplan. While FSANZ does proactively conduct some strategic reviews of its standards, some never seem to come to fruition or can stay dormant on the workplan for years. For example, P1028 Infant Formula which commenced in 2013, P1024 Revision of the Regulation of Nutritive Substances & Novel Foods which commenced in late 2012 and P1034 Chemical Migration from Packaging into Food which commenced in November 2014 and was abandoned in October 2017. 10a. What would be the impact of implementing "Reform idea 6 – Remove exemption of food standards from sunsetting arrangements" and how could the outcome best be achieved? Reform idea 6 would have a net negative impact. Dietitians Australia supports greater investment in the review of the food standards to support the integrity of food regulation in Australia and New Zealand and to ensure the objectives of food regulation are met by the standards. However, Dietitians Australia does not support removing food standards from sunsetting arrangement for the following reasons: • To support confidence and certainty in the ongoing integrity of our food regulation system. • Sunsetting may be difficult to implement in the current cooperative framework. • Without ongoing resourcing commitment, standards may be simply rolled over without adequate review. • The resource costs of sunsetting will not only impact FSANZ but all stakeholders within the process. 10b. What would be the impact of implementing "Reform idea 7 – Resource FSANZ to undertake regular, more holistic reviews of food standards" and how could the outcome best be achieved? Reform idea 7 would have a net positive impact. Dietitians Australia supports regular, holistic reviews of the food standards. This is more likely to ensure the objectives of the Food Standards Australia New Zealand Act 1991 (Cth) (the Act) are relevant and that the standards achieve those objectives. This is important for offering consumers the widest possible range of foods that are safe, to continue to ensure consumers can make informed choices and that industry is able to meet demand for products safely consumed in other comparable jurisdictions. Recognising the resource constraints FSANZ faces, Dietitians Australia is concerned these reviews could become a low priority or only reactive in nature if they are not specifically required in the Act. Therefore, Dietitians Australia recommends the Act be amended to specifically provide for scheduled review. Provisions requiring the review of the operation of legislation are a common way of ensuring legislative objectives are still relevant and the legislation is appropriate to meet those objectives. Examples of review provisions include Section 552A of the Environment Protection and Biodiversity Conservation Act 1999 (Cth) and Section 251 of the Anti-Money Laundering and Counter-Terrorism Financing Act 2006 (Cth). 11. Are there other potential solutions relating to the timing of reviews of food standards? Dietitians Australia recommends that there should be an orderly review of the standards to ensure they are still relevant and fit for purpose. This review should be conducted every 5 to 10 years. Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 11
12. To what degree are the current statutory application and proposal processes an issue for the system? What are the types of problems that different stakeholder groups face as a consequence? The current processes are inefficient for low-risk applications, such as applications to use new processing aids or additives already approved in other jurisdictions with a rigorous scientific risk analysis approach and high integrity. This reduces the resources available to consider more comprehensive and strategic reviews of the standards. As a consequence, FSANZ resources are directed to low-risk applications driven by industry, there is less focus on strategic and comprehensive reviews and public health issues may not be expedited in the same way. If the regulation of low-risk amendments is processed in a more efficient and effective way, it is critical that any cost savings be redirected for comprehensive standard reviews. 13a. What would be the impact of implementing "Reform idea 8 – Reframe legislation to support more agile, risk-based processes" and how could the outcome best be achieved? Reform idea 8 would have a net positive impact. If co-ordination issues in amending FSANZ regulations can be resolved, the use of the subordinate legislation to address the procedural content of the current Act is likely to enable faster changes of decision-making procedures. The disadvantage of this approach is the reduced parliamentary oversight of any changes to the procedures. To maintain public confidence in FSANZ’s integrity it is critical that the risk-based framework be publicly available and reasons for risk categorisations of all applications and proposals be documented and transparent. 13b. What would be the impact of implementing "Reform idea 9 – Redefine the decision-making arrangements to support timelier and more efficient sign-off of regulatory measures" and how could the outcome best be achieved? Reform idea 9 would have a net positive impact. Dietitians Australia supports the Forum delegating decision-making to FSANZ for low-risk technical amendments, such as processing aids applications. The proposal to provide the Forum and FSANZ Board with the power to delegate decision making for draft standards and/or for the Forum to delegate decision making following Board approval appears unduly complex and Dietitians Australia does not support it in its current form. 14. Are there other potential solutions relating to streamlining current legislative process to develop or vary regulatory measures? No comment. 15. To what degree is the current approach to using only applications and proposals to develop or vary food standards an issue for the system? What are the types of problems that different stakeholder groups face as a consequence? The current approach is overly reactive and in practice favours larger food businesses that are better resourced to make applications. Greater harmonisation with credible and well-regulated jurisdictions such as the European Union (informed by the EFSA) would reduce costs to businesses and FSANZ and allow for wider range of products in the Australian and New Zealand markets. The current system directs significant resources to assessing low-risk applications such as processing aids, reducing the resources and opportunities for comprehensive and strategic reviews of the standards. Under the current system, industry applications tend to set the agenda for standard amendments through the application process, reducing the opportunity for public health and nutrition Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 12
stakeholders to achieve reforms that would improve public health and reduce the risk of chronic disease. 16a. What would be the impact of implementing "Reform idea 10 – Provide for FSANZ to adopt or accept risk assessments from overseas jurisdictions" and how could the outcome best be achieved? To some extent, FSANZ already adopts this approach for the use of permitted flavourings. Standard 1.1.2 permits flavours if they are listed in specific publications. Greater harmonisation for low-risk change is appropriate. It is important that the system be transparent, credible and risk-based. Therefore, if harmonisation is increased it is essential that the scientific and policy bases for FSANZ’s decision are publicly available. For certainty for consumers and businesses, the sources of international food safety decisions must be clearly identified and limited to credible and scientifically rigorous agencies such as the EFSA. 16b. What would be the impact of implementing "Reform idea 11 – Enable FSANZ to adopt international standards" and how could the outcome best be achieved? For certainty for consumers and businesses, and to protect the integrity of Australian and New Zealand food regulation this will require considerable planning for specific types of foods and consultation with business, consumers and public health and nutrition. For instance, the Std 2.9.3 requirements for formulated supplementary foods for young children vary greatly from Codex Standard for Follow-Up Formula - Codex Stan 156-1987. Dietitians Australia is not opposed in principle to adopting international standards but it will still require comprehensive analysis to ensure consistent and strategic food regulation suitable to the markets in Australia and New Zealand. 16c. What would be the impact of implementing "Reform idea 12 – Create industry-led pathways to expedite applications and bring new products to market" and how could the outcome best be achieved? Reform idea 12 would have a net negative impact. Industry-led pathways for expedited applications for new foods are challenging. The TGA model for regulating medical devices is not suitable for FSANZ. Unlike the TGA, FSANZ cannot conduct post- market monitoring enforcement and regulation. If unforeseen health and safety consequences for consumers ultimately appear there is no rapid and effective way to address them. This regulatory and enforcement gap is not acceptable if public health is a FSANZ priority. Consumers do not have full information to make informed choices about the health and safety of products and rely on FSANZ’s assessments. We recognise there is a balance to be sought between meeting the commercial objectives of industry and protecting consumers the health and safety of consumers. Relying on existing risk assessments from credible and rigorous overseas regulators is an appropriate way of achieving that balance. However, introducing new products with a less than complete health and safety assessment where FSANZ is not able to take enforcement action if health issues emerge post-market entry is not in the best interests of the health and well-being of consumers. 17. Are there other potential solutions relating to additional pathways to develop or vary food regulatory measures? No comment. Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 13
Partnerships 18. To what degree is the current alignment between policy development and standards setting an issue for the system? What are the types of problems that different stakeholder groups face as a consequence? Currently, tensions exist between achieving policy work and review or setting of standards. As a result, work can be slow to progress in both areas causing delays and frustrations for both FSANZ staff and industry. A further impact is that some standards have become increasingly outdated. For example, whilst waiting for review of formulated supplementary sports foods, with FSANZ unable to progress for many years. This impact is felt by both industry, who are trying to interpret and adhere to standards and consumers, who are not supported in decision making by up-to-date standards. 19a. What would be the impact of implementing "Reform idea 13 – Facilitate joint agenda setting between FSANZ and the Forum" and how could the outcome best be achieved? Reform idea 13 would have a net positive impact. Joint agenda setting between FSANZ and the Forum will provide for more dynamic priority setting and resourcing for timely delivery of priority proposals and project work. Communicating the decisions of joint agenda setting will be important to ensure external stakeholders clearly understand the outcomes and impacts of the decision on projects or proposals impacted. 19b. What would be the impact of implementing "Reform idea 14 – Amend statutory timeframes to support more strategic prioritisation of work" and how could the outcome best be achieved? Reform idea 14 would have a net positive impact. ESTABLISHING TIMEFRAMES FOR PROPOSALS ON A CASE-BY-CASE BASIS. Proposals of significant public health importance and those with broader impacts should be prioritised and delivered faster. Establishing timeframes for proposals on a case-by-case basis to ensure that proposals of public health importance and broader impacts are expedited will have the positive impact of ensuring food safety and supporting public health. CREATING MORE FLEXIBILITY AROUND STATUTORY TIMEFRAMES FOR APPLICATIONS. Providing FSANZ the ability to prioritise work with higher impact and of public health importance is a positive outcome. As discussed in Section 6.3 of the scoping paper, the current approach “does not deliver the best value to the Australian and New Zealand community; applications may have a small number of beneficiaries outside the initial applicant, while proposals often have system-wide impacts and stakeholders are highly invested in outcomes.” The criteria for decisions on timeframes for applications must be clear, and outcomes transparently communicated. Dietitians Australia recommends that the impact including public health significance should be a key criterion. The option for applicants to pay for expedited timeframes should remain and paid applications should recover cost and resources needed to expedite these applications and should not impede on work prioritised based on being strategic priority including work with public health importance. Unpaid applications affected by a ‘stop the clock’ are likely to be industry-led and with fewer beneficiaries outside the applicant. The option of applicants being able to pay to expedite an application that has been stopped could be made available where an applicant affected may choose to invest to expedite their application. This would require FSANZ to have the ability to find and add new resources if needed whilst not impacting the prioritised work, which may be a limitation to expedite stopped applications. Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 14
20. Are there other potential solutions relating to agreeing system priorities between FSANZ and the Forum? In some instances, FSANZ may be directed by the Forum to review a particular standard but given the complex nature of the Food Standard Code, this can interact with many other standards or even with other governing bodies (for example, the Therapeutic Goods Administration) and a resolution requires a more holistic review and cooperation across multiple organisations. Having mechanisms in place which facilitate cross-organisation discussion and decision-making may assist in expediting some of these issues. 21. To what degree does inconsistent interpretation of food standards present an issue for the system? What are the types of problems that different stakeholder groups face as a consequence? Industry – When businesses are seeking assistance with interpretation, advice may be sought from the State/Territory enforcement agencies. However, significant differences exist in the capacity and capability of these agencies across the country. This may result in inconsistent interpretation of food standards, with impacts such as companies selling similar products receiving conflicting advice. This variation in assistance is more likely to negatively impact small businesses who are also more likely to be unable to afford specialist legal advice and hence rely on support from local enforcement agencies. Consumers – If businesses are not interpreting food standards consistently and accurately (for example, inconsistent or inaccurate labelling of products such as ingredients information or nutrition and health claims), there are potential flow on effects to the consumers which can at best confuse and potentially mislead consumers, and at worst pose a major safety concern in high risk areas such as allergen labelling. Confusion can also result if different companies get conflicting advice from local enforcement agencies. While instances of this this should be minimised by the Implementation Subcommittee for Food Regulation (ISFR), a subcommittee of the Food Regulation Standing Committee (FRSC) whose role is to ensure food standards are implemented and enforced consistently, anecdotally there are still occurrences of conflicting advice. 22a. What would be the impact of implementing "Reform idea 15 – Enhance FSANZ’s role in providing guidance about food standards within its current statutory remit" and how could the outcome best be achieved? Reform idea 15 would have a net positive impact. Including a statement of intent alongside food standards in the Food Standards Code would have the positive effect of providing stakeholders with more information to base judgments on. For example, conduct for industry and interpretation for enforcement agencies. Resourcing FSANZ to update and maintain industry guidelines would reduce duplication of resources from State/Territory agencies, allowing State/Territory agencies to redirect efforts elsewhere. It would also prevent guidelines from different jurisdictions providing conflicting advice or interpreting the standards differently. For example, most states and territories have developed a webpage or resource explaining food labelling and health claims, that sits alongside documents hosted on the FSANZ website like “getting your claims right". Having one comprehensive and consistent document which all states/territories refer to would reduce this duplication. However, this would require resourcing, adding more to the FSANZ workload, and may be a lower priority activity. Any resources need to be developed with input from those using the resource to ensure they are user friendly and achieve their intended purpose of simplifying the standards and assisting with interpretation. Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 15
An alternative to FSANZ updating and maintaining industry guidelines would be jointly tasking the jurisdictions with developing, maintaining and updating industry guidelines. This should include a process or mechanism for industry to identify areas for consideration in the development or updating of these guidelines or seek clarity on interpretation. In this alternative approach it may be beneficial if FSANZ has an overarching assistance role to the jurisdictions and support them in their interpretation based on the intent of the clauses in the Food Standards Code. 22b. What would be the impact of implementing "Reform idea 16 – Provide for FSANZ to give binding interpretive advice on food standards" and how could the outcome best be achieved? Reform idea 16 would have a net positive impact. INTRODUCING COMPLIANCE CODES OR ADVICE In the scoping document it is unclear in which parts of the Food Standards Code that compliance codes or advice would be added. Examples of existing guidelines include those on health claims from FSANZ23 and a Ministry of Primary Industries guidance document,24 as well as Policy guidelines from the Forum.7 INTRODUCING A POWER FOR FSANZ TO MAKE BINDING INTERPRETATIONS ABOUT FOOD STANDARDS. An approach where FSANZ provides binding interpretations would support jurisdiction enforcement bodies in their interpretation and consistency across jurisdictions on specific issues. An alternative to FSANZ making binding interpretations that may be less resource intensive could be that FSANZ provide an overarching assistance role to the jurisdiction enforcement bodies. The jurisdiction enforcement bodies could continue to manage and guide a process where issues requiring clarification are identified and FSANZ could provide non-binding support that supports jurisdictional interpretation and actions. 22c. What would be the impact of implementing "Reform idea 17 – Enhance FSANZ’s regulatory role by providing limited enforcement powers" and how could the outcome best be achieved? Reform idea 17 would have a net negative impact. The current approach to enforcement of food-health claims is inadequate as evidenced by an independent review of claims which were on FSANZ website in 2017. This review showed the majority of claims could not be substantiated by an independent assessment of the evidence available.25 FSANZ taking on enforcement powers to address the inadequate and inconsistent enforcement of food health claims is not the best approach. Instead, Dietitians Australia recommends that the food- health claims provisions should be overhauled, moving away from a self-substantiation approach for general level health claims. FSANZ should play a central role in evaluating food-health claims prior to businesses being permitted to use the claim in market. This approach could be facilitated in a similar way to the European Union model where the European Food Safety Authority issues Scientific Opinions on health claim applications by industry. In instances where multiple unsuccessful applications for health claims have been made for a similar food/property of food and health effect, an opinion is issued which provides further clarity and guidance to future proponents (industry) as to why these claims have been unsuccessful. This would have the impact of supporting jurisdictions with enforcement, prevent unsubstantiated claims being made and un-evaluated due to jurisdictions either not having the expertise or resource to evaluate dossiers of evidence. Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 16
23. Are there other potential issues or solutions relating to interpretation of food standards? A joint committee with representatives from FSANZ and all enforcement agencies from all the State/Territory jurisdictions could assist in interpretation of the Food Standards Code so that there is consistent interpretation across the jurisdictions. This would empower and support each jurisdiction in decision making, rather than transferring responsibility to FSANZ. 24a. To what degree is the food-medicine interface an issue for the system? What are the types of problems that different stakeholder groups face as a consequence? While the Food-Medicine Interface Guidance Tool seeks to provide clarity about whether products should be regulated as foods or therapeutic goods, it is clear that much confusion remains. A 2017 review of self-substantiated health claims found 56% of food-health relationships investigated (15 in total) were for products that may be considered on the medicine side of the food-medicine interface, as determined by the Food-Medicine Interface Guidance Tool.25 Recent collaborations between FSANZ and TGA on the regulation of sport supplements across the food-medicine interface may form a good basis of regulation across the interface into the future. Consumer – The food-medicine interface creates confusion when like products can be regulated under different regulations (TGA and FSANZ) and as a result hold different health claims. For example, on the market currently there are electrolyte capsules marketed as formulated supplementary sports foods which are not permitted to hold vitamin or minerals claims and similar electrolyte capsules marketed as therapeutic goods which do hold vitamin and mineral claims. This is confusing for consumers trying to make an informed choice about products. Industry – Current management of the food-medicine interface creates uncertainty as to which regulation applies, creating difficulty navigating their responsibilities. Lack of clarity may result in businesses incorrectly classifying their product as a food instead of a medicine or vice versa. This is potentially costly for the business if the product and its production does not meet the correct regulatory requirements, resulting in a post launch regulatory action. Enforcement agencies – Enforcement agencies are often a source of advice for companies, particularly small businesses, regarding issues relating to product compliance and labelling. Lack of clarity may be leading to unnecessary resource being allocated by enforcement agencies in reviewing and making determinations in relation to products that have already been launched or products in development if/where businesses have approached the agency. Clearer and more specific guidance may support enforcement agencies in monitoring the food medicine interface and providing advice. 24b. To what degree is the oversight of health claims an issue for the system? What are the types of problems that different stakeholder groups face as a consequence? The current system of self-substantiated health claims lacks oversight. This is a major issue that must be addressed. Consumers – The system of self-substantiated health creates confusion and undermines trust in the system as a result of potentially misleading health claims. Health claims are viewed with suspicion compared to more standardised label information such as the nutrition information panel.26 In an independent review of claims listed on FSANZ website in 2017, the majority could not be substantiated by an independent assessment of the evidence available.25 Health claims influence consumer purchasing decisions,27 so misleading claims have the potential to result in consumers purchasing products which are not as healthy as they purport to be, and this may be in preference to similar products not bearing claims, or to alternative less processed foods (for example, fresh fruit and vegetables) which do not bear claims due to a lack of packaging. Response to Scoping Paper on the Review of the Food Standards Australia New Zealand Act 1991 17
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