RISK-BASED REGULATIONPOLICING THE STANDARDS SET BY THE REGULATOR

28 July 2015

Greg Vakaci

Manager, Compliance Investigations

OUTLINE

• About the NSW Food Authority and how we work

• Food regulatory framework in Australia

• National co-ordination and implementation of food standards

• Risk-based prioritisation, compliance & enforcement

• Case Study: New Health Claims Standard

NSW FOOD AUTHORITY

• Department of Primary Industries: NSW Food Authority

• Protect: 7.2 million NSW consumers – largest consumer base

• Support: 55,000 NSW food businesses (including 14,500 licensed)

• Develop: $25 billion NSW food processing industry

• 101 FTE (NSW Food Authority)

• Partner with 152 NSW Local Councils (retail food service)

• 162 Environmental Health Officers involved in NSW food work

NSW GOVERNMENT FOOD SAFETY STRATEGY• Strategy articulates the NSW Government’s commitment to

ensuring food safety and productivity.

• Our priorities - 2015 to 2021 include:

• Reduce food poisoning incidents in NSW by 30%

• Cut red tape by $4.5 million, with $6 million already achieved in streamlined regulatory processing

• Improving service delivery to businesses by introducing 24/7 online licensing

REGULATORY FRAMEWORK

National framework

Food Regulation Agreement

Model Food Provisions

Australia NZ

Food Standards Code

Cwth Export Control Act

State framework

Food Act 2003

Food Regulation 2010

Regulatory partnersFood Authority Local Government Cwth Dept

Agriculture

Food labelling and making claims about food

Offences & penalties apply for:

• False description of food resulting in physical harm to consumer- Serious offences (eg. sell food containing allergen to allergic consumer)

• Engaging in misleading or deceptive conduct and false description of food

• Food not complying with purchaser’s demand

• Not complying with Food Standards Code

• Failing to display kJ content on menu boards

FOOD ACT 2003 (NSW)

• State and Territory food regulations require that all food sold complies with requirements within the Australia New Zealand Food Standards Code

• The Code is constantly revised; in-line with safety requirements, consumer expectations and emerging evidence and trends.

• Applications and proposals open for public comment:

http://www.foodstandards.gov.au/code/changes/Pages/Documents-for-public-comment.aspx

NATIONAL FOOD STANDARDS

NATIONAL CO-ORDINATION

Forum

• Legislative & Governance Forum on Food Regulation• Develop regulatory policy and guidelines• Adopt, amend, reject or request review of food standards

FRSC

• Food Regulation Standing Committee• Co-ordinates policy advice to FoFR and ensures national

consistency to implementation & enforcement of standards

ISFR

• Implementation Subcommittee for Food Regulation• Implementation, monitoring and enforcement strategies to

achieve consistency

Stakeholder engagement & consultation

RISK-BASED APPROACH• To target and apply resources where they are most needed a

regulator must prioritise effort according to risk.

• On average 25,000 complaints and enquiries each year :

• Not all complaints made equal! What would happen if we prioritised our work based on the order it was received?

NIP not in prescribed format

Country of origin labelling not displayed on unpackaged fish

Outbreak of salmonella in nursing home

Food safety supervisor certificate expired

Allergen declaration missing on toddler snack

RISK-BASED APPROACH

• Risk-based approach applies to compliance and enforcement activities – graduated and proportionate

• To do this the regulator examines trends and data to inform action

• Regulators also take into account compliance history and impact on industry where breaches are low risk but ongoing

• Eg. Country of origin of food (repeat offender) – escalate action : Warning to Penalty Notice. Penalty Notice to Prosecution

• Labelling hierarchy from Labelling Logic considers risk

Labelling Logic (2011) p45

Tier of Conceptual Framework

Example of labelling Examples of dominant mode(s) of intervention

Food safety Ingredient list Mandatory on labels of packaged foodMandatory declaration of certain substances in food, such as allergens

Mandatory declaration:1. On the label on the package, or2. On or in connection with the display of

unpackaged food or 3. To the purchaser upon request regarding

unpackaged food

Preventative health Nutrition information panels Mandatory on labels of packaged food 

Point of sale kilojoule labelling Mandatory and voluntaryNutrition, health and related claims Claims are voluntary, but mandatory rules

apply in the event that claims are made on labels and in advertisements including the internet (i.e. the intervention is voluntary/mandatory)

Health Star Rating Voluntary on labels of packaged food

Consumer values issues

Country of origin Mandatory on labels of packaged food and mandatory display in connection with the display of some specified unpackaged food

Organic Voluntary statements on packaged and unpackaged food and in advertisements

Free-range, halal Voluntary statements on packaged and unpackaged food and in advertisements

COMPLIANCEC

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Activities for Generating compliance

Proactive/Reactive

Education

Information and Advice

Use of the Integrated Model in Standards Development

Mediation

Public disclosure e.g. register of prosecutions

Activities for monitoring and assessing compliance

Proactive/Reactive

Audits and Inspections

Sampling and Surveys

Trend analysis of data

Actions for Responding to non-compliance

Reactive

Warning

Notice / Order

Conditions on / Cancellations of Registration

Seizure or Mandated Recalls

Enforceable Undertakings

Expiation

Prosecution

COMPLIANCE & ENFORCEMENT POLICY

• NSW Food Authority reflects best practice

• Australia and New Zealand Enforcement Guideline

• NSW Government’s Quality Regulatory Services Initiative

• Published on the Food Authority’s website www.foodauthority.nsw.gov.au

ENFORCEMENTNational enforcement guidelines for food regulators has been adopted by NSW. The purpose of the enforcement guideline is to ensure action by the food regulator is consistent with the following principles:

• Apply a graduated and proportionate approach

• Actions must be authorised by law

• Apply impartiality and procedural fairness

• Actions should be accountable and transparent

• Promote consistency of enforcement activity between food regulators

• Actions should be in the public interest

• Apply multiple enforcement tools under appropriate circumstances

These principles reflect the Australian National Audit Office Best Practice GuideAdministering Regulation - Best Practice Guide, Australian National Audit Office, June 2014

ENFORCEMENTFactors that the Food Authority will consider in making decisions about the choice of enforcement action include:

• impact on the consumer and competitors

• circumstances of the offence, business and associated individuals

• compliance history of the business

• cooperation demonstrated by the alleged offender

• remedial action

• degree of care and due diligence exercised

• timeframe over which the offence was committed, and

• need to provide the Food Authority staff with a safe working environment

ENFORCEMENT

QUALITY REGULATORY SERVICES INITIATIVE

• NSW Government has in place an initiative to ensure better regulatory outcomes are achieved.

• Whole-of-government initiative for all NSW Government regulators.

• One component of this initiative is requiring all regulators in NSW to apply a risk-based approach to regulation.

NEW Standard for Nutrition Content & Health Claims

• Voluntary to make claims – if made then must comply with Standards

• Transition period (18 January 2013 – 18 January 2016)

• Standard 1.1A.2 – Transitional Standard - Health Claims

• Standard 1.2.7 – Nutrition Content, Health & Related Claims

• Standard 1.2.7 commenced in Australia on 18 January 2013

• Between this time and 18 January 2016, businesses can choose to comply with either

Standard 1.1A.2 or Standard 1.2.7 (not both)

• Using a combination of permissions within both Standards on a product label or

advertising is not permitted!

• 18 January 2016: Standard 1.1A.2 will sunset with no stock in trade provisions;

business must then comply with only Standard 1.2.7

CASE STUDY

ISFR Health Claims Working Group

• Purpose: to develop industry guidance material and to co-ordinate a national approach to the implementation of the Standard 1.2.7, including compliance monitoring and enforcement

• Consultation with industry stakeholders was key

• Industry were interested in consistency of enforcement

CASE STUDY

Industry Reference Group

• Role: assist ISFR Working Group in preparing materials for the implementation and compliance of Standard 1.2.7

• Associations in key interest areas for Standard 1.2.7

• Working Group has requested input from Industry Reference Group on all public documents produced

CASE STUDY

CASE STUDY

Industry Assistance

• “Getting Your Claims Right” - guidance for industry on compliance with Standard 1.2.7

• NSW Food Authority Helpline 1300 552 406

o Food Authority - Senior Labelling Officer

http://www.health.gov.au/internet/publications/publishing.nsf/Content/frs-getting-your-claims-right-toc

• “Health claims and enforcement – how regulators will enforce the nutrition and health claims standard”

• Available from Food Regulation Secretariat website:

http://www.health.gov.au/internet/main/publishing.nsf/Content/foodsecretariat-isc-publications.htm

• Compliance tools reflect those checklists available to industry.

• Bi-national compliance survey planned for 2016

CASE STUDY

Food Authority applies a risk-based approach - informed by best practice policy

Risk management principles apply to:

• Prioritisation of complaints & enquiries

• Compliance, monitoring & enforcement activities

Achieve compliance through a range of mechanisms including

• Information and education

• Industry and stakeholder consultation

• Co-ordination between regulators to achieve consistency

REVIEW

RESOURCESNSW Government Food Safety Strategy 2015 – 2021http://www.foodauthority.nsw.gov.au/_Documents/corporate_pdf/Food_Safety_Strategy.pdf

NSW Food Authority’s Compliance & Enforcement Policyhttp://www.foodauthority.nsw.gov.au/_Documents/industry_pdf/compliance_enforcement_policy.pdf

Australia and New Zealand Enforcement Guideline http://www.health.gov.au/internet/main/publishing.nsf/Content/36E7BF5C3B397261CA257BF0001C960C/$File/Australia-and-New-Zealand-Enforcement-Guideline.pdf

NSW Government’s Quality Regulatory Services Initiativehttp://www.dpc.nsw.gov.au/programs_and_services/better_regulation/quality_regulatory_services_initiative

Guidance for regulators to implement an outcomes and risk based approach to regulationhttp://www.dpc.nsw.gov.au/__data/assets/pdf_file/0010/164782/QRS_Outcomes_and_Risk_Based_Regulation_Guidelines_-_July_2014_-_Web.pdf

Australian National Audit Office : Administering Regulationhttp://www.anao.gov.au/Publications/Better-Practice-Guides/2013-2014/Administering-Regulation

THANK YOURisk-based regulation: Policing the standards set by the regulator28 July 2015

Greg Vakaci – Manager, Compliance Investigationscontact@foodauthority.nsw.gov.au

QUESTIONS?

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