Australian & New Zealand Food Regulation Enforcement Guideline Version 9 10 November 2009 Prepared by the Implementation Sub-Committee Enforcement Guideline Working Group Version History Version Date 8 10 November 2009 9 October 2015 Amendment Initial Preparation Update to Appendix 1 to expand enforcement actions. Prepared by The Implementation Sub-Committee Enforcement Guideline Working Group The Joint Food Regulation Standing Committee (FRSC)/ Implementation Sub-Committee for Food Regulation (ISFR) Working Group on Food Labelling Monitoring and Enforcement TABLE OF CONTENTS Acknowledgements Definitions iii iv Context Executive Summary Objectives Compliance & Enforcement Strategies Food Legislation Enforcement Guideline Principles 5.1 A graduated and proportionate response to legislative non-compliance 5.1.1 Proportionate response 5.2 Authorised by law 5.3 Impartiality and Procedural fairness 5.4 Accountable and Transparent 5.5 Promote consistency of Enforcement activity between food regulators 5.6 The Public Interest 5.7 Application of multiple enforcement tools Cross Jurisidictional Issues Conclusion 1 3 4 5 6 6 6 8 9 10 10 10 11 11 12 Appendix 1 Enforcement Actions for Food Regulators to Address Non-Compliance Introduction i. Verbal Warnings ii. Correction Action Requests iii. Written Warnings iv. Improvement Notices v. Prohibition Orders vi. Seizure Powers vii. Penalty Notices viii. Enforceable Undertakings ix. Prosecution x. Corrective Advertising xi. Injunctions or Injunctive Relief xii. Publication of the Names of Offenders xiii. Action against Registration xiv. Mandated Recall xv. Emergency Orders xvi. Privilege Statements 13 13 14 14 14 15 16 17 18 19 19 21 22 22 22 23 23 23 1. 2. 3. 4. 5. 6. 7. Figures Figure 1 Figure 2. Figure 3. Risk & Compliance Matrix Enforcement Response Graduated use of Enforcement tools. 5 8 24 ii Acknowledgements The Implementation Sub-Committee Enforcement Guideline Working Group prepared the Australia and New Zealand Food Regulation Enforcement Guideline with assistance from affiliated staff. Members of the working group included: ACT Department of Health Australian Quarantine and Inspection Service Dairy Food Safety Victoria Department of Human Services, Victoria Department of Health, Western Australia Food Safety Management Solutions Environmental Health Australia Local Government Association New Zealand Food Safety Authority NSW Food Authority Primary Industry and Resources, South Australia Queensland Health Safe Food Production Queensland South Australian Department of Health iii DEFINITIONS Act means the: o Model Food Provisions as adopted within the jurisdictions; o AQIS legislation (including the Imported Food Control Act); or o New Zealand Food Act 1981 as amended. Compliance refers to a state when persons, food businesses or primary producers are operating within the regulatory requirements that apply to that person, food and associated inputs, food business or primary producer. Corrective Action an action taken by a food business/primary food producer to rectify a non-conformance or systems deviation to ensure ongoing compliance with its legislated food safety program and relevant regulatory scheme. Enforcement refers to use of regulatory tools to achieve compliance. Food Standards Code means the Australia New Zealand Food Standards Code as defined in the Food Standards Australia New Zealand Act, 1991 of the Commonwealth of Australia. Section 17 of the Model Food Provisions 2002 provides for enforcement of the Food Standards Code, which has requirements relating to: labelling and advertising; substances added to foods (food additives, vitamins and minerals, processing aids, identity & purity); contaminants and residues (metals & toxicants, environmental residues, packing materials, moisture absorbers, mould inhibitors, promotional materials, graphics, prohibited & restricted plants, fungi); foods requiring pre-market clearance (novel foods, food produced using gene technology, food irradiation); microbiological and processing requirements; food product standards; food safety standards (food safety programs, food safety practices and food premises and equipment); and primary production standards. Food regulator state, territory or Commonwealth bodies responsible for food safety legislation; these organisations may be part of government departments or be semi-independent of government and, while many are enforcement agencies, some may delegate enforcement responsibility to other bodies such as local governments. iv Improvement Notice improvement notices are provided for in Section 30 of the Model Food Provisions 2002, and means a statutory notice served by an authorised officer, which may require: - compliance by a food business with the Food Standards Code; or - cleaning, repair or replacement of equipment, premises or food transport vehicles. Non-Compliance refers to a state when persons, food businesses or primary producers are operating outside the regulatory requirements, including its legislated food safety program or relevant regulatory scheme that applies to that person, food and associated inputs, food business or primary producer. Penalty Notice penalty notices and infringement notices are provided for by Sections 93 and 116 of the Model Food Provisions 2002 and mean the same as a penalty infringement notice (PIN), expiation fee or on the spot fine. Prohibition order prohibition orders are provided for by Section 33 of the Model Food Provisions 2002, and means an order served upon a food business by an enforcement agency prohibiting: - handling of food on specified premises, parts of premises, vehicles, or use of specified equipment where the proprietor of a food business has not complied with an improvement notice; or - the order is necessary to prevent or mitigate a serious danger to public health. Prosecution refers to the application of legal court procedures to seek a conviction of an offence. Registration has the same meaning as licensing or accreditation as applied within food legislation in various jurisdictions. Sanctions refers to a range of regulatory responses to a given noncompliance that involves the application of legal powers in response to a given non-compliance or to the consequences of a non-compliance. Note: Audit terms are defined in the National Food Safety Audit Policy, which can be found at: http://www.health.gov.au/internet/wcms/publishing.nsf/Content/foodsecretariat-policydocs.html v AUSTRALIAN AND NEW ZEALAND FOOD LEGISLATION ENFORCEMENT GUIDELINE 1. CONTEXT On 3 November 2000, the Council of Australian Governments (COAG) signed an Inter-governmental Food Regulation Agreement (FRA)1, (amended on 3 July 2008) agreeing to a new food regulatory system. The Commonwealth of Australia and all the Australian States and Territories are signatories to the Agreement. The FRA requests all States and Territories to use their best endeavours to ensure their respective Parliaments retain in force, legislation which gives effect to the provisions of the Model Food Act. The purpose of this food legislation is to provide for the effective and consistent administration and enforcement of the Food Standards Code (including the Food Safety Standards). The core provisions of the Model Food Act are contained in Annexure A, and under the FRA, are required to be adopted into state/territory legislation in the same terms, or in terms consistent with those used in Annexure A. The Annexure B provisions are administrative in nature and, because of the differing administrative and enforcement arrangements of particular jurisdictions may be adopted in a manner consistent with the relevant provisions. The FRA also established the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) and a Food Regulation Standing Committee (FRSC). FRSC is responsible for co-ordinating policy advice to the Ministerial Council and ensuring a nationally consistent approach to the implementation and enforcement of food standards. It also advises the Ministerial Council on the initiation, review and development of Standing Committee activities. The Implementation Sub Committee (ISC) is a sub committee of FRSC and its role is to develop and oversee a consistent approach across jurisdictions to the implementation and enforcement of food regulations and standards, regardless of whether food is sourced from domestic producers, export-registered establishments or from imports. ISC will develop, or assist in the development of guidelines on consistent enforcement of food regulations, which will also be aimed at minimising cost to industry and meeting the objective of minimum effective regulation. 1 www.health.gov.au/internet/main/publishing.nsf/Content/foodsecretariat-system1 1 ISC has developed a strategy for consistent implementation and enforcement of food regulation in Australia, the Strategy for Consistent Implementation of Food Regulation in Australia (the Strategy)2 which was endorsed by FRSC and the Ministerial Council in 2005. The Australia New Zealand Food Regulation Enforcement Guideline has been developed by ISC under the Strategy as a framework to assist in providing national consistency in the application of enforcement provisions by food regulators to identified non-compliance issues or breaches by food businesses. It is noted that this Guideline offers advice to Australian and New Zealand food regulators. 2 www.health.gov.au/internet/main/publishing.nsf/Content/foodsecretariat-isc-strategy 2 2 EXECUTIVE SUMMARY This Guideline provides a framework for food regulators to utilise to provide interjurisdictional consistency in enforcement and is not intended to provide a step by step guide to enforcement activities or instructions on how to conduct enforcement activity. Given the variation in administrative and legislative arrangements (as provided for in Annexure B of the Model Food Act) for the management of food safety in the various Australian jurisdictions, it is not possible to develop a detailed policy document that will address the specific circumstances of all food regulators, nor the specific circumstances relevant to food safety compliance issues. Consequently, it is agreed that the principles in this Guideline will not be modified, however, tools that may be used by food regulators to enact these principles may be removed or inserted to reflect the individual circumstances of food regulators. Australian food law provides food regulators with a range of regulatory tools of varying severity and efficiency that may be applied in the event of legislative noncompliance. This Guideline advocates the graduated application of enforcement measures against food businesses, commencing with milder measures, such as verbal warnings, but then progressing to more severe measures (e.g. prosecution) should the milder measures not address the issue of concern. While advocating a graduated approach to the application of enforcement provisions, it is important to note that advice offered in this Guideline does not prevent food regulators applying more severe provisions in the first instance (e.g. prohibition order), should serious legislative breaches be encountered (e.g. serious hygiene breach with the potential to be an imminent threat to food safety). As a result, this Guideline should be interpreted as advising regulators to operate within a framework provided by a graduated but proportionate response to legislative non-compliance. The remit of advice provided in this Guideline is the full extent of food legislation of Australian and New Zealand food regulators, and so includes food safety issues and issues concerning the appropriate labelling, advertising, composition and sale of food. It is expected that adoption of principles contained in this Guideline by food regulators will provide greater consistency in the application of enforcement provisions to food businesses, and help to provide a level playing field across Australia for businesses that will assist in protecting them from unfair competition or gain in commercial advantage due to their location within Australia or New Zealand. 3 3 OBJECTIVES The objectives of this Guideline are to promote the following: Compliance with the legislative provisions of Australian and New Zealand food regulation. Under the FRA, the legislation of Australian food regulators will be consistent with the following objectives outlined in the Model Food Provisions: (a) to ensure food for sale is both safe and suitable for human consumption, (b) (c) to prevent misleading conduct in connection with the sale of food, to provide for the application of the Food Standards Code in all jurisdictions A consistent approach to the application of enforcement provisions by food regulators; A risk based approach to compliance and enforcement activities through adoption of a graduated and proportionate response to legislative noncompliance; Transparency in the decision making processes used by food regulators to determine enforcement responses to legislative non-compliances; Use compliance and enforcement strategies in such a way as to best achieve legislative compliance; A cooperative and collaborative approach with businesses or between jurisdictions to legislative compliance, and one that does not place unnecessary impost on food businesses in Australia; Protection for consumers from inappropriate and/or misleading trade practices. 4 4 COMPLIANCE & ENFORCEMENT STRATEGIES In meeting the objectives stated above, food regulators are advised to adopt a strategic approach to the application of enforcement provisions. In adopting a strategic approach to enforcement, it is important for food regulators to implement a successful compliance strategy. This strategy should address a number of elements: identification of food industry sectors with a history of adopting noncompliant practices; identification of inappropriate or misleading trade practices with the potential to intentionally mislead consumers; development of compliance level indicators for food businesses; prioritisation of enforcement tasks based on a risk and compliance matrix; identification of behavioural issues; and the use of compliance data to evaluate/review the compliance strategy. Figure 1 (below) provides further guidance. Figure 1. Risk & Compliance Matrix RISK LEVEL REGULAR AUDITS & INSPECTIONS PRIORITY ACTIVITY COMPLAINT INVESTIGATION ONLY REGULAR AUDITS & INSPECTIONS NON - COMPLIANCE LEVEL 5 5 FOOD LEGISLATION ENFORCEMENT GUIDELINE PRINCIPLES This Guideline advises food regulators to apply enforcement provisions consistent with the following principles: A graduated and proportionate approach; Authorised by law; Impartial and procedurally fair; Accountable and transparent; Promote consistency of enforcement response between food regulators; In the public interest; and Allow for application of multiple enforcement tools under appropriate circumstances. 5.1 A graduated and proportionate response to legislative non-compliance Food regulators are advised to adopt a graduated and proportionate approach to the application of enforcement tools upon food businesses. This approach envisages the application of mild enforcement tools to businesses in the first instance; to be followed by more severe tools should the business continue the non-compliant activity. Examples of mild enforcement tools that may be employed include improvement notices or warning letters. Examples of more severe tools include prohibition orders, penalty notices, registration suspension/ cancellation or prosecution. The tool box appended to this Guideline provides further detail. Food regulators may also wish to consider using mediation and conciliation as preliminary steps in enforcement processes. Mediation and conciliation provide the proprietor of the business with the opportunity to explain mitigating circumstances of the legislative non-compliance to the regulator. Following this explanation, the regulator may make a determination on an appropriate course of action. Through employment of a graduated approach, it is considered that offences may be appropriately managed and allow regulators to use their resources to the greatest effect. 5.1.1 Proportionate response Notwithstanding the above advice, it is important that food regulators select an enforcement response that is proportionate to the identified non-compliance and capable of providing sufficient incentive to the business to amend the non-compliant 6 behaviour. For example, identification of a critical non-conformance in a businesses food safety management program, or of a matter where a business is intentionally providing inappropriate or misleading information to the consumer in order to capture market share, may lead to more severe enforcement tools such as product seizure, issue of a prohibition order or prosecution being used by a regulator in the first instance. Furthermore, should the circumstances surrounding an offence be considered sufficiently serious (e.g. an imminent risk to public health and safety), the regulator may elect to employ multiple enforcement tools at the same time. This Guideline should not be interpreted as preventing regulators from exercising such powers. As a result, this Guideline should be interpreted as advising food regulators to operate within the context of a graduated but proportionate response to legislative noncompliance. Factors that regulators may wish to consider in making decisions concerning the choice of enforcement tool to respond to a particular incident include: Evaluating the impact of the alleged offence; on the consumer, to competitors of the offending business, and to any profits earned by the business resulting from the offence; The particular circumstances of the alleged offence and the individual circumstances of the business and persons associated with the business that is subject to enforcement action; The compliance history of the business that is subject to enforcement action, both in general and with respect to the incident that is the subject of enforcement action; The co-operation demonstrated by the alleged offender; both in relation to investigations conducted on the offender’s premises relating to the offence and in respect to the co-operation demonstrated by the alleged offender following commencement of enforcement action; Any remedial action implemented by the alleged offender to address the noncompliance that is the subject of enforcement action; The degree of care and due diligence exercised by the food business to avoid non-compliance (e.g. implementation of Australian Standard AS3806-1998 Compliance programs); The timeframe over which the offence was committed; and The need to provide the enforcement agency staff with a safe working environment within the requirements of occupational health and safety laws, particularly in relation to matters involving assaults and intimidation. 7 The following diagram illustrates the graduated nature of enforcement responses in concert with the seriousness of the non-compliance. Figure 2 – Enforcement Response Possible Response registration cancellation ENFORCEMENT RESPONSE prosecution registration suspension i ec Sp d ete arg t y ll fica product seizure penalty notice Improvement notice Warning letter d ete arg t dly oa Br Increasing level of financial gain and/or risk to consumers 5.2 Authorised by law Authorised officers should only act within their legal remit of statutory power when undertaking enforcement activity against food businesses. Businesses should not be required either directly or by inference, to observe requirements that are not authorised by law. The following advice is offered concerning the collection of evidence: Evidence obtained by authorised officers relating to actual or alleged offences should be obtained within the requirements of food legislation, and also within the requirements of criminal law. Evidence should be admissible under the appropriate rules of evidence, (regardless of severity of action taken), and sufficient to establish that an offence has been committed (this will assist in ensuring that enforcement action is only taken under appropriate circumstances). Evidence should also be sufficient to support a case against appeal (e.g. a penalty notice referred to a court for a defended hearing, or matter appealable to an Administrative Decisions Tribunal). Evidence need not be assembled into a full prosecution brief for minor enforcement action, however evidence collected should be sufficient to substantiate the offence if questioned. 8 It is suggested that formal enforcement action should not proceed unless sufficient evidence has been obtained to provide a reasonable prospect of conviction, should the matter be heard before a Court. 5.3 Impartiality and Procedural fairness Food regulators should undertake enforcement activity against food businesses in a manner that is procedurally fair and impartial to the interests of any particular food business. This will assist in minimising opportunities for arbitrary or inexplicable differences between the handling of individual cases, or classes of cases, to occur. Discrimination, (e.g. with regard to ethnicity, religion, age or gender), by food regulators when undertaking enforcement action is unacceptable practice. Decision making concerning application of enforcement provisions should not be influenced by: political advantage or disadvantage to a government or any political party or group; the consequences of a decision to undertake enforcement action on the personal or professional circumstances of staff of the food regulator; or the personal feelings of the decision makers towards the offenders. Commencement of enforcement action should be timely to ensure food businesses associate action with non-compliance. Delayed action runs the risk of businesses not associating an enforcement action with a legislative breach. Food business proprietors should receive written advice of available statutory rights of appeal when decisions are made by food regulators to apply enforcement provisions. This advice will preferably be provided, at the time that enforcement measures are first applied to businesses. It may also be worth commenting that regulators should appropriately document their reasons for a decision (e.g. to suspend or revoke a licence) in case it is necessary to provide a statement of reasons as part of any administrative review of the decision. Many juveniles (10 -18 year olds) work in (or operate) food businesses and may therefore be subject to enforcement action under some circumstances. Under these circumstances, young offenders’ legislation for dealing with children (between the ages of 10 and 18) should be applied to those who commit offences. 9 5.4 Accountable and Transparent Food regulators should be accountable and transparent in their actions concerning the application of enforcement measures on food businesses. Food regulators are recommended to consider including the following issues in their enforcement procedures to promote transparency and accountability: Ensure that legislation, enforcement policies, complaints procedures and relevant information are readily accessible to food businesses and the public; Use plain language to communicate with the public and the food industry; Ensure that policies and procedures that will be followed in addressing stakeholder issues associated with enforcement action are readily available; Advise of available complaint or appeal processes associated with enforcement action, inclusive of timeframes applicable to these processes; and Provide advice of fees and charges that may be applied in discharging enforcement obligations or providing services under the relevant legislation. It is noted that food regulators will observe the constraints of any privacy legislation and confidentiality provisions when initiating enforcement action against food businesses (unless a statutory requirement exists to disclose the information). 5.5 Promote consistency of Enforcement activity between food regulators Consistency with respect to the application of enforcement provisions by food regulators is important to ensure that food businesses in different Australian jurisdictions do not receive differential treatment with respect to measuring compliance with legislative obligations. Food regulators should adequately train and monitor the performance of enforcement staff to ensure that food businesses are treated in a consistent manner. Examples of practices that may be implemented to promote consistency are staff rotation, peer review and secondment. 5.6 The Public Interest The overriding consideration in taking enforcement action should always be the protection of public health and safety. 10 5.7 Application of multiple enforcement tools While a graduated approach to the application of individual enforcement tools is advocated by this Guideline, under appropriate circumstances, the simultaneous application of multiple enforcement tools by regulators is not considered outside of the scope of advice provided to food regulators by this Guideline (e.g. a serious hygiene breach where the concurrent issue of a penalty notice and prohibition order is considered appropriate). Additionally there may be circumstances where there are multiple non-compliances detected, each of varying significance. In such circumstances, the use of differing enforcement tools may be warranted. Equally the existence of multiple breaches may indicate system failure which may result in the use of more significant enforcement tools. 6. CROSS JURISIDICTIONAL ISSUES ISC has created the Home Jurisdictional Rule to aid in resolving cross jurisdictional issues involving food. The Home Jurisdiction Rule is an administrative process for liaison and coordination between food regulators where goods produced and used by food businesses are traded across borders and where the head office of a business is located in a different state or territory. The Home Jurisdiction Rule aims to: Provide a framework for food regulators to manage issues of legislative noncompliance or complaints outside the scope of the National Food Incident Response Protocol (NFIRP)3 for foods processed in one state or territory and sold, transported or traded to another; Facilitate and support efficient communication between food regulators on cross jurisdictional matters; Reduce duplication of enforcement action in more than one jurisdiction; Promote the provision of information to another jurisdiction of any compliance or enforcement activities involving a business that is based in the other state/territory. Further detail on the operation of the Home Jurisdiction Rule may be obtained by contacting a food regulator. 3 Note that the NFIRP will generally override the Home Jurisdiction Rule (HJR), however there may be incidences where the NFIRP may operate in conjunction with the HJR. The NFIRP may be downloaded from the Food Regulation Secretariat website: www.foodsecretariat.health.gov.au 11 7. CONCLUSION This Guideline has been drafted as advisory material for food regulators in order to promote a consistent approach to the application of enforcement provisions upon food businesses. Food regulators are advised by this Guideline to adopt a graduated and proportionate approach to the application of enforcement provisions to food businesses. 12 ENFORCEMENT ACTIONS FOR FOOD REGULATORS TO ADDRESS NON-COMPLIANCE APPENDIX 1 Note: It is anticipated that food regulators will delete or add reference to any enforcement tool discussed in this toolbox that is not available within the law administered by that regulator. Note that AQIS administer legislation for imported food and exports of meat, fish, dairy and other commodities, and consequently have specialised enforcement tools. It is further noted that some differences may exist in terminology used to describe enforcement tools in the legislative framework of some food regulators compared to the Model Food Provisions. Introduction While the majority of food businesses comply with legislation voluntarily, a level of non-compliance with food legislation has been observed to occur. There are many enforcement tools available to food regulators that may be employed in the event of an observed legislative non-compliance. The following list of tools is not ranked in order of graduating severity, offers advice to regulators that can further assist in enhancing national consistency in the application of enforcement provisions against food businesses4. It should be noted that not all of the tools below are available to all jurisdictions. Warning letters; A statutory improvement notice which may consider issues such as cleaning of premises, equipment or transport, or repair or replacement of equipment or transport, or request revision of a food safety management system; A prohibition order which controls certain activities, the use of certain appliances or prevents operation of the food business entirely. May be used in situations where there is failure to comply with an improvement notice or to prevent or mitigate a serious danger to public health; Downgrading the status of food or restricting its use e.g. for reprocessing or sale as animal food; The seizure of food, vehicles, equipment, and labelling or advertising material that does not comply with the legislation or as evidence of an offence; A penalty notice; Prosecution in the Local Court; Publication of the names of offenders after conviction; 4 Note that regulators may choose to hold informal mediation and conciliation sessions with alleged offenders prior to initiating enforcement action against food businesses. Further advice is offered in Section 5.1 of this document. 13 Request of court orders for corrective advertising by a person found guilty of an offence; Requiring a registered food business to show cause why registration conditions should not be altered or why a registration should not be suspended or cancelled; Alteration of registration conditions; The institution of proceedings in the Supreme Court; Suspension of a registration; Cancellation of a registration; and Enforceable undertakings, mandated recalls, emergency orders and privilege statements. Further detail on some of the more commonly used enforcement tools is provided in this Appendix. The success of strategies adopted by food regulators to address non-compliance may be influenced by identification of the behavioural causes of non-compliance, and the implementation of suitable measures to promote compliant behaviour. i. Verbal Warnings Authorised officers are recommended to routinely provide food safety advice to food businesses. Advice should be presented in a way that businesses may readily determine the difference between general advice and directed compliance advice (i.e. a legal requirement). Such advice should not extend beyond the level of expertise of the authorised officer. Verbal warnings, as they are not accompanied by formal notification are prone to improper documentation by the regulator and the business, or misinterpretation or being completely forgotten. Due to the informal nature of verbal warnings, it is suggested that they are only used for issues of a minor technical nature. ii. Correction Action Requests While predominately associated with compliance and auditing, Corrective Action Requests (CARs) are useful as preliminary steps in the enforcement process. A corrective action request (CAR) is a request for a business to implement action to eliminate the cause of a detected non compliance during an audit. iii. Written Warnings Food regulators are recommended to exercise discretion with regard to the issuing of 14 warning letters as opposed to improvement notices. Generally speaking, warning letters should only be used for breaches, where the issuing of an improvement notice is not appropriate or warranted in the first instance. When issued, it is suggested that warnings letters detail the following: the nature of the offence; the relevant legislation and clauses breached; the required remedial action; the timeframe for implementation of the proposed remedial action; and specify the maximum penalty for the offence and the intention of the agency to enforce the legislation should the business fail to address the detected breach. Food regulators are encouraged to allow no more than 3 months following the expiry of a timeframe in a warning letter before following up to ensure the required actions have been undertaken. It is likely that failure to comply with a warning letter may, in most cases, result in the implementation of more serious enforcement action, e.g. A penalty notice. iv. Improvement Notices Improvement notices are statutory notices issued by authorised officers upon food businesses that address prescribed issues and have prescribed content. An authorised officer may issue an improvement notice to a food business5 if it is believed that the business is acting in contravention to the appropriate legislation, or to particular instruments associated with the legislation (e.g. not operating in accordance with a food safety management system). Improvement notices should only be issued when it is considered to be an appropriate tool, i.e. capable of providing sufficient incentive to the business to address the matter. Improvement notices may be issued to businesses for cleaning and sanitation issues, maintenance issues (including repair and replace) for premises, food transport vehicles or processing equipment within premises. Improvement notices may also be issued in relation to a businesses food safety management system, compliance with the Food Safety Standards of the Food Standards Code (i.e. Standards 3.2.2 and 3.2.3), or concerning a businesses’ particular practice for handling a food. 5 It is suggested that Improvement notices only be issued to the proprietor of a food business. 15 Improvement notices should contain certain information. Authorised officers are encouraged to include the following in improvement notices issued: The provision(s) of the appropriate legislation that the authorised officer reasonably believes is being, or has been, contravened; A brief description of how the relevant legislative provision(s) have been or are being breached; The particular action that the business should undertake in order to rectify the observed legislative non-compliance; The timeframe in which the legislative contravention should be resolved by the business; for more serious issues this period is likely to be 24 hours, and for less serious issues, a period considered appropriate by the authorised officer, but normally longer than 24 hours; Advise the business that it is an offence not to comply with a notice without reasonable cause. Food regulators are encouraged to conduct follow-up inspections at the timeframe nominated in the notice. Extensions to the date of compliance provided in an improvement notice may be granted at the discretion of an authorised officer, however it is recommended that extensions are only provided in instances where the business requests an extension before the expiry date of the notice. It is further suggested that extensions only be considered for more minor matters such as repairs to equipment or replacement of equipment parts, or for minor revision of a businesses food safety management system. Exceptions may be granted by authorised officers at their discretion subject to the business satisfying the officer that exceptional circumstances prevail. Businesses are advised that failure to comply with an improvement notice will generally result in implementation of more serious enforcement action such as a prohibition order, penalty notice, or both. v. Prohibition Orders A prohibition order forbids the handling of food on a specified premises, vehicle or equipment, or requires that food may not be handled in a specified way or for a specified purpose. Prohibition orders may be issued where it is necessary to prevent or mitigate a serious danger to public health or where an improvement notice has not provided sufficient 16 incentive to a business to address an issue of legislative non-compliance. A penalty notice may also be issued to businesses that have not addressed matters listed in an Improvement notice within the prescribed timeframe. Prohibition orders may be very specifically directed, such as to apply to a specific piece of equipment or part of the premises, or be more broadly directed and applied to an entire premises. It should be noted that a food regulator’s legislation will most likely define food handling very broadly, and include activities such as collection, transporting, storing or displaying food. Regulators are further advised to only serve prohibition orders to the proprietor of a food business. A brief of evidence sufficient to prove all elements of a prosecution is the recommended practice prior to the issue of a prohibition order. Breach of a prohibition order is a serious matter that will likely result in prosecution. It should be noted that the legislation of food regulators will likely contain compensation provisions to be paid to food businesses if it is proven that a prohibition order has been issued on insufficient grounds. A prohibition order will remain in place until a certificate of clearance is issued following a request for inspection from the business. The legislation of a food regulator may require it to inspect a business under a prohibition order within 48 hours of receiving a written request for inspection from the proprietor of a food business. Should the regulator not undertake an inspection within this timeframe, it is likely that the regulator’s legislation will require it to automatically issue a certificate of clearance to a business under a prohibition order. vi. Seizure Powers Authorised officers generally have legislative seizure powers to seize food, vehicles, equipment, and labelling or advertising materials which the authorised officer reasonably believes do not comply with a provision of the relevant legislation or may form part of evidence that an offence has been committed. 17 Seized goods that are forfeited to the Crown should be destroyed or disposed of in a manner that ensures there can be no allegation of improper conduct. Records should be kept of how, when and where seized goods are disposed. It is further advisable to have disposals of seized goods witnessed. While seizures are undertaken to collect evidence or prevent further offences being committed they effectively impose a penalty upon the person from whom the food, vehicle, equipment and labelling or advertising material has been seized. Persons from whom items are seized should be provided with at the time of seizure, a statement that describes the items seized, the reasons for seizing those items, the address where those items will be held, and informed of rights of appeal. Should subsequent investigation reveal that the business has not contravened the legislation, all seized materials should be returned to the business at the earliest possible convenience. It should be noted that the food regulator’s legislation will likely provide for compensation to be paid to food businesses from whom materials (i.e. food, equipment etc) have been seized should the grounds for the making of a seizure be proven to be inadequate. vii. Penalty Notices A penalty notice is issued to a person that has committed a specific offence against a food regulator’s legislation. If the person does not wish to have the matter dealt with before a Court they will need to pay a specified amount for the offence within a specific timeframe. Alternatively, the person may elect to have the matter heard before the Court. Penalty notices provide food regulators with an efficient method of dealing with breaches of food legislation, that may otherwise require presentation to a local Court. As penalty notices may be referred to a Court for hearing, authorised officers are advised to collect sufficient evidence to prove the elements of the alleged offence before issuing penalty notices. It is suggested that this evidence be appropriately logged and secured as for a prosecution. 18 Food regulators are advised to not use penalty notices where the penalty imposed is significantly out of proportion to the profit gained by the business through the noncompliance. Food regulators are further advised to not use penalty notices where the penalty is not likely to have an impact on the proprietor of a very large food business. In this instance, another enforcement tool may be more appropriate, e.g. prosecution or the imposition of specific registration conditions upon a business. viii. Enforceable Undertakings An Enforceable Undertaking involves an agreement between a business and a regulator whereby a business undertakes to take a specified action within an agreed timeframe to remedy an alleged breach. The terms of an Enforceable Undertaking are negotiated between the parties, so that the Enforceable Undertaking is offered by the noncompliant business back to the regulator. Key differences between an Enforceable Undertaking and other options are that it is negotiated between the parties; includes an admission by the business that it has contravened the law (admission of ‘guilt’ is not necessarily required but rather an acknowledgement that the regulator believes the business has contravened legislation and this is accepted by the business); and failure to comply generally results in court proceedings. An Enforceable Undertaking can be designed to simply achieve compliance rather than apply a penalty or designed to also deliver other outcomes, such as remedying the harm caused by conduct. ix. Prosecution Prosecution will generally be utilised for more serious legislative breaches or for matters where less severe enforcement action has not been sufficient to convince the business to address the observed non-compliance. It should be noted that matters heard in the Local Courts may not attract the full penalties provided by the regulator’s legislation. Where offences are knowingly committed with intent, or where defendants have previously been convicted in a Local Court of offences of a similar nature within a reasonable timeframe, consideration should be given to having matters heard before the Supreme Court. 19 Submissions to Court on penalties should include details about the risk to public health, including the severity of the possible harm that may result (where appropriate) and take full account of the economic benefit gained by the food business in not complying with the legislation. If referred to a Court or appeal tribunal, it is recommended that all supportive evidence concerning an enforcement action taken by a regulator be made available. Evidence supporting enforcement action should be objective and as comprehensive as possible. Briefs of evidence for the commencement of proceedings may include the following: Physical evidence (seized material); Photographs or video recordings of evidence; and Video or sound recordings of conversations and interviews with alleged offenders; and Records of interviews signed by all parties. Full documentation of the chain of evidence and secure storage of all exhibits submitted as evidence should further form part of the brief of evidence. To enable an unprejudiced defence, the alleged offender will generally have access to the brief of evidence once investigations have been completed and proceedings have commenced. It is recommended that advice be sought from Crown lawyers on this issue. In all cases, an opportunity should be provided to alleged offenders to place their version of events on record and to outline any mitigating circumstances to be considered by those making decisions prior to the commencement of proceedings. Prior to commencing a prosecution, authorised officers are advised to collect sufficient evidence to prove each element of the alleged offence beyond reasonable doubt. The prosecution case should be structured in an organised fashion that allows for expedient processing by the Courts. It is likely to be a legislative requirement for food regulators to commence proceedings within 6 months for matters relating to food samples and 12 months for all other matters. All matters should be prepared for hearing as quickly as possible6. A food regulator’s legislation may extend liability to a wide range of persons who 6 Section 92 Model Food Provisions, http://www.foodstandards.gov.au/aboutfsanz/modelfoodbilloctober779.cfm 20 could be in some way involved with legislative contraventions, including employees, proprietors, managers and individual company directors. Where a food regulator has elected to commence prosecution, it is at the regulator’s discretion as to whom the prosecution is directed toward. Action against the directors and managers of food businesses should only be considered where evidence exists that a director or a manager knowingly allowed non-compliance to occur. The charge/s laid should appropriately reflect the nature and extent of the legislative breach disclosed by the gathered evidence and provides sufficient material for the Courts to consider in imposing an appropriate penalty upon the offending business. Care should be taken to ensure that the laying of multiple charges does not infringe the prohibition against double jeopardy. Furthermore, food legislation may provide several different provisions that may be applied to the same offence, which may be activated by a single incident. Regulators are advised to apply discretion in selecting the most appropriate charge/s to apply, bearing in mind that sufficient evidence should be obtained to substantiate any charges applied. Upon commencing proceedings, the defence may wish to pursue charge bargaining. Generally speaking, this process involves negotiations between the defence and the prosecution that may result in the prosecution withdrawing one or more charges in return for the defendant pleading guilty to some or all of the remaining charges. Charge bargaining arrangements may sometimes include agreements on submissions to be placed before the Court. Charge bargaining should not be initiated by the prosecution. Where charge bargaining occurs the prosecution should ensure that the remaining charges adequately reflect the elements of the offence to assist the Court in making an appropriate judgement. The prosecution should not accept charge bargaining proposals should the defendant wish to maintain their innocence with respect to a charge/s to which they have previously offered to plead guilty as part of the charge bargaining arrangement. Any agreements that the prosecution will not oppose defence submissions on penalty, or the scale of the offence should only be made where the penalty nominated is considered to allow a proper exercise of the sentencing discretion. x. Corrective Advertising Requests may be made for Court orders for corrective advertising should a person be 21 found guilty of an offence where there is potential ongoing risk to public health, or where it has been proven that a food has been promoted through advertising, in an inappropriate or intentionally misleading way (e.g. deliberately incorrect Country of Origin Labelling). xi. Injunctions or Injunctive Relief It is also possible for food regulators to seek an injunction or injunctive relief to prevent continuing illegal activity. Consideration should however be given to the potential for compensation following failure of any subsequent related prosecution. xii. Publication of the Names of Offenders Food regulators may wish to publicise details of successful prosecutions. Legislative constraints should be considered prior to a decision to publicise. xiii. Action against Registration Many food regulators require food businesses to be registered as a legislative requirement. Where registration is a legislative requirement, operation of nominated food businesses without registration will be an offence. Actions against a businesses registration are likely to have defined legislative procedures and be subject to administrative review. Nominated food businesses that fail to comply with registration conditions imposed by legislation will be subject to enforcement action. This may involve the imposition of additional conditions upon a businesses registration to limit or otherwise control their activities or the suspension or cancellation of a business’s registration. Registration cancellation is a very serious level of enforcement action as the removal of registration, if imposed by legislation as an operating condition for the business, effectively closes the business. This is likely to impact not only on the proprietors of the food business, but also employees, suppliers, and customers. Evidence of the development, implementation and commitment to maintain a compliance program in accordance with Australian Standard 3806-1998 Compliance Programs is an example of the type of submission that a business may supply as part of an adequate response to a show cause letter from a food regulator concerning a businesses registration. Failure to respond, or to respond in an adequate manner to a request from a food regulator concerning a food businesses registration may result in changes to the 22 businesses registration conditions, or suspension of the businesses registration for a set period, or the immediate cancellation of the businesses registration. Persons who operate a food business required by legislation to be registered, while that registration is under suspension or cancellation will usually be subject to prosecution. Applications to food regulators for registration may be refused where the applicant does not satisfy the food regulator that they have the necessary capacity, experience or qualifications to ensure the production of safe food, or the applicant is a person who was previously the proprietor or director of a company that has had its registration cancelled. In circumstances where a food regulator rejects a businesses application for registration, the regulator must inform the applicant in writing of the reason for refusal, citing the appropriate grounds of its legislation that support its decision to refuse the application. Appeals to the food regulator concerning changes to registration conditions, registration suspensions or registration cancellations will undergo formal review by senior officers independent of those who actioned the change of registration status. Legislation may also provide for an external appeal mechanism. xiv. Mandated Recall All food businesses engaged in the wholesale supply, manufacture or importation of food in Australia are required to have a food recall plan under Standard 3.2.2, allowing food product that poses a health and/or safety risk to the public to be removed from all areas of the supply chain. While typically undertaken voluntarily by the business, recalls can be mandated by the regulator. Some jurisdictions are also able to mandate recalls for food that is not safe or suitable or if there is doubt about the safety and suitability; and food that is mislabeled or incorrectly identified. xv. Emergency Orders Relevant authorities have emergency powers to make an order if it is necessary to do so to prevent or reduce the possibility of a serious danger to public health or mitigate the adverse consequences of a serious danger to public health. xvi. Privilege Statements In New Zealand the Chief Executive of the Ministry for Primary Industries has power to make privileged statements for the purpose of protecting human life or public health or informing the public. The statements are protected by qualified privilege. 23 Figure 3. Graduated use of Enforcement tools. Notes: 1 The severity of seizure as an enforcement measure can vary considerably, dependant upon not only the value of the food, equipment or materials seized but the subsequent impact of the loss of the food, equipment or materials on the conduct of the business. 2 Internal and informal mediation can be implemented at any stage in an enforcement process. 24