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Chapter 2 - Regulation and management of food risks

Strategic imperative

To maintain a transparent and evidence-based approach to regulation and the management of food risks.

Highlights 2012–13

  • Led the Australian delegation to four committees of the Codex Alimentarius Commission and actively participated in their working groups.
  • Carried out dietary exposure assessments for a range of food standards projects and for other purposes, including an assessment for the irradiation of capsicums and tomatoes.
  • Continued to co-chair (with China) the APEC Food Safety Cooperation Forum on behalf of Australia, with the annual meeting involving approximately 90 delegates from 16 member economies, as well as participants from a range of government, industry, academic and other organisations.
  • Acted as a World Health Organization (WHO) Collaborating Centre for Food Contamination Monitoring.
  • Maintained oversight of the surveillance and monitoring activities of the Implementation Sub-Committee for Food Regulation (ISFR).
  • Commenced work on the 25th Australian Total Diet Study, which focuses on metal contaminants, agricultural and veterinary chemicals, and radionuclides.
  • Conducted surveys of cyanogenic glycosides in plant-based foods and arsenic in seaweed.
  • Received 2,631 food-related mandatory reports from the Australian Competition and Consumer Commission (ACCC), representing 46 per cent of all mandatory reports (food and non-food) received by the ACCC at 30 June 2013.
  • Coordinated 44 Australia-wide food recalls.

Introduction

Once a food hazard has been identified and characterised (i.e. the likelihood and potential severity to human health assessed), how does FSANZ decide what control measures to recommend?

For example, can education programs or product information adequately protect consumers from potential harm from low-risk foods, and should high-risk foods or food ingredients be removed from sale completely? In between these extremes lies a range of management options aimed at reducing the risk to consumers to acceptable levels. The amount of regulation imposed by FSANZ, through food standards and other measures, depends on the 'risk appetite' of the agency and our regulatory partners.

We define risk appetite as the amount and type of risk that we are willing to pursue or retain. This definition is based on the AS/NZS ISO 31000:2009 Risk Management—Principles and Guidelines. As an agency, our risk appetite is the level of risk that we are prepared to accept in fulfilling our statutory objectives, without taking action to reduce that risk. The level of risk that remains after risk management action is taken to reduce that risk is known as the residual risk.

A low risk appetite, therefore, generally results in a greater stringency of risk mitigation measures, and vice versa.

Organisations can benefit from having a clear and concise statement relating to the extent of their willingness to take risk in pursuit of their business objectives. The statement can also provide a basis on which to evaluate and monitor the amount of risk being faced, to determine whether the risk has risen above an acceptable range. Articulating risk appetite is a complex endeavour.

FSANZ maintains its lowest risk appetite in setting standards when addressing our primary objective of protecting public health and safety through a safe food supply. In meeting this objective, we adopt a conservative approach. This is particularly the case where there is a level of uncertainty in the risk assessment due to a lack of data or when dealing with susceptible population subgroups. In such cases, we operate with a zero to negligible tolerance for residual risk.

We have a slightly higher risk appetite in relation to our other statutory objectives—providing adequate information and preventing misleading or deceptive conduct. In discharging our duties here, we adopt a more managed approach, balancing risks, benefits and costs with a moderate tolerance for residual risk.

Strengthening our evidence base

Internal expertise

Dietary exposure assessments

Dietary exposure assessments provide an estimate of the magnitude, frequency and duration of exposure to the nutrient or food chemical of interest.

In 2012–13, we carried out dietary exposure assessments for a range of food standards projects and other purposes, including an assessment for the irradiation of capsicums and tomatoes. We also provided dietary exposure assessment data for surveillance activities (24th Australian Total Diet Study and the ISFR [then the Implementation Sub-Committee] coordinated survey for cyanogenic glycosides in plant-based foods) and food incidents (e.g. contamination of the Northern Territory's Edith River following a train derailment).

In addition, we have an ongoing role in approving dietary exposure assessments conducted by the Australian Pesticides and Veterinary Medicines Authority (APVMA) when assessing the safety of residues in food for new or amended uses of agricultural and veterinary chemicals, including assessments for chemicals under review by the APVMA.

During the year, we also responded to international requests for dietary data from the Food and Agriculture Organization of the United Nations (FAO) and WHO, and provided assistance to other government agencies on exposure assessment matters, on an ad hoc basis. For example, we contributed exposure estimates to the 77th meeting of the Joint FAO/WHO Expert Committee on Food Additives and provided input into Codex working groups for contaminants.

External expertise

FSANZ Fellows

The Fellows program creates a network of respected experts to provide advice on applications, proposals and other risk assessment activities in their relevant areas of expertise, to peer-review FSANZ work and to provide training to FSANZ staff.

In 2012–13, the FSANZ Board approved the appointment of one new Fellow, Dr Jason Riis. Dr Riis is Assistant Professor of Business Administration in the Marketing Unit at Harvard Business School. Dr Riis has extensive research experience in the area of behavioural economics and the use of behavioural economics techniques, which will contribute to FSANZ's regulatory design.

Membership of the FSANZ Fellows program appears in Table 8.

Table 8: FSANZ Fellows 2012–13

FSANZ Fellow
Background or expertise
Affiliated institution
Professor Ken Buckle
Food science, processing and microbiology
University of New South Wales
Professor John Cary
Social science
Victoria University
Professor Lynne Cobiac
Nutrition and dietetics
Flinders University
Dr Laurence Eyres
Food technology
ECG Ltd
Professor David Fraser
Vitamin D
University of Sydney
Professor Nigel French
Molecular epidemiology and risk research
Massey University
Professor Graham Giles
Cancer epidemiology
Cancer Council; University of Melbourne
Professor Stephen Goodall
Health economist
University of Technology
Dr Heather Greenfield
Food composition
University of New South Wales
Professor Peter Langridge
Genomics
University of Adelaide
Associate Professor Winsome Parnell
Surveys and infant nutrition
University of Otago
Professor Brian Priestly
Health risk assessment
Monash University
Dr Jason Riis
Behavioural economics
Harvard Business School
Professor Seppo Salminen
Intestinal microbiota and health, probiotics and prebiotics, health claims
University of Turku
Professor Richard Shepherd
Consumer behaviour
United Kingdom
Professor Murray Skeaff
Nutrition
University of Otago
Professor Anthony Smith
Complementary medicines
Newcastle Mater Hospital/ University of Newcastle
Professor Mark Tamplin
Microbiology and food safety
University of Tasmania
Associate Professor Peter Williams
Nutrition
University of Wollongong

Regulatory Science Network

FSANZ is a member of the Regulatory Science Network, a network of Australian Government agencies5 responsible for regulating chemicals (including radio-isotopes) and/or biological agents. The aim of the network is to forge closer linkages and promote common approaches to regulatory science between the agencies.

During the year, the network presented a symposium on 'Assessing emerging chemical and biological risks' at the Society for Risk Analysis World Congress on Risk 2012, convened two risk analysis workshops for regulatory agencies and developed a formal charter for the network itself. The network sits under the Regulators' Forum, which is a high-level group of representatives from regulatory agencies in the Australian Government Health and Ageing and Agriculture, Fisheries and Forestry portfolios.

International networks

Codex Alimentarius Commission

The Codex Alimentarius Commission (Codex) is the international food standards–setting body established by the FAO and WHO. Codex develops international food standards, guidelines and codes of practice for an international food code that contributes to the safety, quality and fairness of food trade.

The Food Standards Australia New Zealand Act 1991 requires FSANZ to have regard to the international harmonisation of food standards and to use the best available scientific evidence in our regulatory decision-making. Our international networks provide opportunities for achieving both these objectives. FSANZ plays a significant role in developing international food standards produced by Codex.

During the year, FSANZ led the Australian delegation at a number of meetings. Table 9 summarises our participation in the work of Codex.

Table 9: FSANZ participation in the work of the Codex Alimentarius Commission 2012–13

Codex committee
FSANZ participation
34th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses
Led Australian delegation and is leading an electronic working group on Proposed and Draft Additional or Revised Nutrient Reference Values—Requirement for Labelling Purposes in the Codex Guidelines on Nutrition Labelling
34th Session of the Codex Committee on Food Hygiene
Led Australian delegation and is leading an electronic working group to prepare a discussion paper on the occurrence and control of parasites in food
45th Session of the Codex Committee on Food Additives
Led Australian delegation and chaired an electronic working group on Harmonisation of the Food Additive Provisions of the Commodity Standards with the General Standard for Food Additives, chaired and facilitated discussions on Note 161, and chaired an in-session working group on Endorsement of Food Additive Provisions at Step 8
7th Session of the Codex Committee on Contaminants in Food
Led Australian delegation and led electronic working group on Proposed Draft Maximum Levels for Hydrocyanic Acid in Cassava and Cassava Products, and co-chaired the development of a Code of Practice to Reduce the Presence of Hydrocyanic Acid in Cassava and Cassava Products

Case study: food safety

At the 44th session of the Codex Committee on Food Hygiene in 2012, Australia was asked to lead an electronic working group to prepare a discussion paper on the occurrence and control of parasites in food. This followed work undertaken by the Food and Agriculture Organization of the United Nations and the World Health Organization on control measures for the top-ranked parasites (the parasites of greatest concern in public health), the primary commodities of concern and their relevance in international trade.

FSANZ has developed a discussion paper for international consideration of issues, such as the form of guidance, whether guidance on criteria for prioritisation of parasites should be developed, and the scope and approach of potential work. These issues will be considered by the committee at its annual meeting in November 2013.

International Food Chemical Safety Liaison Group

In November 2012, FSANZ hosted and chaired a teleconference of the International Food Chemical Safety Liaison Group. The liaison group, formed in 2006, provides a platform for regulators in different countries to exchange information on chemical risk analysis, emerging issues and food surveillance.

The group also met via teleconference in May 2013. Food chemical safety issues discussed by the group over the last year include acrylamide, contaminants such as inorganic arsenic, safety assessment of radionuclides, natural toxins and food contact packaging chemicals. Frameworks and approaches for considering potential emerging food chemical safety issues have also been discussed and shared.

International Microbial Food Safety Liaison Group

The International Microbial Food Safety Liaison Group remains an active source of information sharing among food regulation agencies. FSANZ accepted the role of meeting chair in December 2012, for a period of 12 months. Specific topics of discussion have included the management of enteric viruses such as norovirus and hepatitis A virus in the food supply, and the application of microbiological criteria for Listeria monocytogenes in ready-to-eat foods.

Relationships in the Asia-Pacific region

The Asia-Pacific Economic Cooperation (APEC) Food Safety Cooperation Forum (FSCF) continues to restate its commitment for member economies to work together to strengthen food safety systems, progress towards a safer food supply and promote harmonisation of food standards with international standards.

Image of members of the fourth APEC Food Safety Cooperation Forum (FSCF).

Members of the fourth APEC Food Safety Cooperation Forum (FSCF).

FSANZ (on behalf of Australia) and the People's Republic of China share responsibility for co-chairing the APEC FSCF. In 2012–13, the fourth APEC FSCF and the Partnership Training Institute Network (PTIN) suite of events were held in Surabaya, Indonesia. Events included a workshop educating small and medium enterprises on food safety standards (led by Indonesia), an FSCF PTIN steering group meeting, and a Food Safety Incident Network (FSIN) workshop (led by FSANZ).

Image of FSANZ Chief Scientist Dr Paul Brent and Dr Barbara Butow (FSANZ) at the APEC Food Safety Cooperation Forum in Surabaya, Indonesia.

FSANZ Chief Scientist Dr Paul Brent and Dr Barbara Butow (FSANZ) at the APEC Food Safety Cooperation Forum in Surabaya, Indonesia.

The FSIN workshop was organised and implemented by Australia (FSANZ) and involved approximately 90 delegates from 16 member economies, as well as participants from a range of government, industry, academic and other organisations. Key recommendations included agreement to develop an FSIN portal in the International Food Safety Authorities Network (INFOSAN) website and improved cooperation with the INFOSAN secretariat.

The fourth meeting of the FSCF involved about 80 delegates from 16 APEC member economies, as well as representatives from WHO/INFOSAN, the World Bank, GS1 and the Association of Southeast Asian Nations.

An action plan was endorsed to implement the APEC Regulatory Cooperation Plan, which was recommended by APEC ministers in 2012. This action plan sets out the steps by which the FSCF will promote alignment to relevant international standards, and consistency with WTO obligations.

World Health Organization Collaborating Centre for Food Contamination Monitoring

FSANZ is a WHO Collaborating Centre for Food Contamination Monitoring, and carries out activities to support WHO programs. In 2013, we were re-designated as a collaborating centre for a further five-year term, demonstrating the value of the data we contribute and highlighting that our expertise is highly sought after.

During the year, we submitted data on the chemical residues in domestic and imported aquacultured fish and ethyl carbamate in Australian foods. We also provided data for lead and cadmium from the 20th and 23rd Australian Total Diet Surveys to assist the work of expert working groups.

Monitoring food hazards

Monitoring

Implementation Sub-Committee for Food Regulation Coordinated Food Survey Plan6

FSANZ oversees the surveillance and monitoring activities of the Implementation Sub-Committee for Food Regulation (ISFR). A three-year survey plan is the major planning tool for food surveillance and monitoring activities. It outlines national and bi-national food survey activities for Australia and New Zealand. In 2013, two activities were completed under the plan:

  • a research report on pine nuts and pine mouth, led by the New South Wales Food Authority
  • reference data for Listeria monocytogenes in ready-to-eat foods, led by the New Zealand Ministry for Primary Industries.

In addition, the ISFR Surveillance Register was completed. This is a large compilation of surveillance activities conducted in Australia and New Zealand that were done as coordinated surveys or separately by agencies. The surveillance activity is mapped against each standard in the Code. It is to be used as a tool for identifying potential areas to focus future food surveillance activities.

Food Surveillance Network

The Food Surveillance Network (FSN) continues to be an effective forum for food regulatory agencies in Australia and New Zealand to discuss, plan and implement food surveillance activities. The FSN supports the work of the ISFR, particularly with respect to its three-year forward-looking Coordinated Food Survey Plan and implementation of those survey activities.

Surveys

Australian Total Diet Study

The Australian Total Diet Study (ATDS) is Australia's most comprehensive assessment of consumers' dietary exposure (intake) to pesticide residues, contaminants and other substances. It enables FSANZ to monitor the food supply to ensure that existing food regulatory measures provide adequate protection of consumer health and safety.

The 24th ATDS involved an analysis of 94 Australian foods and beverages. Because of the broad range of scope of the survey, we are releasing the results in two phases, with the first phase of the report now complete. The first phase of the report covers the analysis of acrylamide, aluminium and perchlorates.

We have started preparing the second report for the 24th ATDS. This report will cover bisphenol A, epoxidised soy bean oil, phthalates, perfluorinated compounds and printing inks. We intend to publish the report in early 2014.

Work on the 25th ATDS has started, with samples being collected during May 2013. The 25th ATDS focuses on metal contaminants, agricultural and veterinary chemicals, and radionuclides.

Survey of cyanogenic glycosides in plant-based foods

Since 2010, FSANZ has undertaken three analytical surveys of cyanogenic glycosides in a range of plant-based foods. Cyanogenic glycosides are a group of natural toxicants that occur in a number of plants used as foods. Potential toxicity arises when these substances are degraded to hydrogen cyanide (which is measured as total hydrocyanic acid), resulting in acute cyanide poisoning.

Information from the surveys will help us determine whether there are any potential public health and safety issues associated with the consumption of any of the sampled foods. The risk assessment is due to be completed later in 2013.

Inorganic arsenic in seaweed

We conducted a small survey, in 2010, investigating levels of inorganic arsenic in seaweed and seaweed-containing products. The levels found were all below the maximum permitted level for seaweed of 1 mg/kg (as described in the Code), with the exception of one composite sample of hijiki seaweed. The relevant jurisdiction was notified of the result for the hijiki seaweed for further investigation and relevant follow-up action. We published the results on our website in January 2013.

Food incidents

National Food Incident Response Protocol

The National Food Incident Response Protocol provides whole-of-government guidance on responding to national food incidents. Under the protocol, FSANZ has responsibility for coordination, information gathering, risk assessment and communication. The protocol has not been activated by food regulators since June 2012.

In 2012–13, the protocol was amended to facilitate initial information sharing between agencies to determine whether response action is required at the national level. In addition, we have refined our internal operating procedures, developed online tools and continue to progress training materials to ensure efficient coordination of national food incidents.

Food recalls

Mandatory reporting

All participants in the food supply chain must report food-related incidents—where death or serious injury or illness has resulted, requiring medical or surgical treatment—to the Australian Competition and Consumer Commission (ACCC).

The ACCC now refers food-related mandatory reports directly to the relevant state or territory food enforcement agency (where consent from the supplier has been received), for possible action. FSANZ simultaneously receives copies of these mandatory reports for national monitoring and reporting purposes.

Since mandatory reporting commenced in January 2011, FSANZ has received 2,631 food-related mandatory reports from the ACCC. This figure represents 46 per cent of all mandatory reports (food and non-food) received by the ACCC as at 30 June 2013. Some 82 per cent of food businesses gave the ACCC permission to refer their reports to FSANZ in 2011, increasing to 92 per cent in 2012–13.

Most of the mandatory reports come from businesses in the food manufacturing and retail sectors, followed by the catering sector. They mainly concern alleged food poisoning.

Food recalls

During the year, FSANZ met with state and territory food recall officers to review recall policies and procedures. We also briefed the Retailers and Manufacturers Liaison Committee on our recall processes so that businesses at this end of the supply chain fully understand the current recall arrangements.

We finalised a new edition of the Food Industry Recall Protocol, to provide the food industry with detailed guidance on how to undertake a recall. The revised edition provides more information on the importance of communicating recalls to the public and a new section on the importance of traceability. The most up-to-date advice on food recalls can be found on our website.7

FSANZ coordinated 44 food recalls in 2012–13, mainly involving microbial contamination (mainly Listeria and Salmonella) and the presence of undeclared allergens (e.g. dairy, peanuts and sulphites) (Figure 2).

Figure 2: Food recalls by recall category

Figure 2: Food recalls by category. Microbial contamination: 22, undeclared allergen: 12, foreign matter: 7, other: 2, biotoxin: 1.

Three-quarters of recalled food products originated in Australia. The 44 food recalls coordinated by FSANZ in 2012–13 were the fewest in the past decade (Figure 3).

Figure 3: Food recalls in Australia in 2003–13

Figure 3: Food recalls in Australia in 2003-13. 2003-04: 77, 2004-05: 66, 2005-06: 66, 2006-07: 58, 2007-08: 52, 2008-09: 54, 2009-10: 51, 2010-11: 70, 2011-12: 63, 2012-13: 44.


5 Current membership of the Regulatory Science Network is the Australian Pesticides and Veterinary Medicines Authority; the Australian Radiation Protection and Nuclear Safety Agency; the Australian Government Department of Agriculture, Fisheries and Forestry; FSANZ; the National Industrial Chemicals Notification and Assessment Scheme; the Office of the Gene Technology Regulator; the Therapeutic Goods Administration; and the Office of Chemical Safety, Australian Government Department of Health and Ageing.

6 Formerly the Implementation Sub-Committee Coordinated Food Survey Plan.

7 www.foodstandards.gov.au/industry/foodrecalls

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