3.102.  The main development in the area of sanitary and phytosanitary measures in Australia in the period under review was the entry into force of the Biosecurity Act, 2015, replacing the Quarantine Act, 1908, on 16 June 2016.[168] The new biosecurity legislation is co-administered by the ministers responsible for agriculture and health, and includes a variety of regulations, determinations and legal instruments that, for example, lay down specific conditions for the importation and exportation of various commodities.[169] According to the authorities, the Act provides a modern regulatory framework, reduces duplication, and enables more efficient and effective risk assessment to prevent pests and diseases from crossing Australia's border. The Act is flexible by design to respond to changes in technology, biosecurity challenges, and the need for more adaptability to increasing passenger traffic and trade. As at November 2019, 117 legal instruments related to biosecurity had been issued, in addition to the Act itself and the two basic regulations (the Biosecurity Regulations, 2016 and the Biosecurity (Human Health) Regulations, 2016). Most of these legal instruments were determinations of first point of entry, i.e. goods that may, or may not, enter a specific location in Australia

3.103.  The Biosecurity Act, 2015 was amended in 2018, as the Biosecurity Legislation Amendment (Miscellaneous Measures) Bill, 2018 received Royal Assent on 31 August 2018. In addition to various technical revisions, the main purposes of the amendments were to introduce new arrangements regarding the collection of information on the monitoring of, control of, and response to, biosecurity risks within Australia; to clarify the terms "commercial-in-confidence information" and "human remains"; and to clarify that Australia's National Focal Point may disclose protected information to other member States of the World Health Organization under the International Health Regulations, 2005. The amended Act also repealed the Quarantine (Validation of Fees) Act, 1985.[170]

3.104.  Australia's states and territories maintain their own legislation, and take measures to minimize the spread of pests and diseases that threaten livestock or crop production. The requirements may affect interstate trade as well as the intrastate/territory movement of animals and animal products, plants and plant products, and materials of quarantine concern. For example, based on its Plant Biosecurity Act, 2010, Victoria established zones to prevent the spread or entry of certain pests and diseases, affecting the movement of fruit (Queensland fruit fly); grapes, grapevine material, agricultural equipment and soil (Grape Phylloxera); potatoes, potato plant material, agricultural equipment and soil (Potato cyst nematode); and chestnut blight host materials. Governed by its Livestock Disease Control Act, 1994, Victoria applies entry requirements to cattle, sheep, goats, pigs, deer, poultry and bees from other states and territories in Australia.[171] Diseased livestock may, with few exceptions, only enter Victoria if a licence has been issued by the Chief Veterinary Officer, and all transportation of livestock must meet Australian animal welfare standards. Farms in Victoria running certain livestock species are required to have a Property Identification Code.[172] Importation orders, i.e. restrictions on entry from other parts of Australia to prevent the spread of disease or pest, have been issued in relation to cucumber green mottle mosaic virus, pyriform scale, and tomato potato psyllid

3.105.  The Imported Food Control Act, 1992 and the Imported Food Control Regulations, 1993 govern food entering Australia.[173] The Act was amended in 2018, through the Imported Food Control Amendment Act, 2018, to strengthen the safety system for imported food. It affects the operation of the risk-based Imported Food Inspection Scheme, as it increases the importers' accountability for food safety and the sourcing of safe food. It also strengthens the monitoring and management of new and emerging food safety risks, and incident response. For certain imported food, the Department of Agriculture requires evidence of through-chain controls, to demonstrate that food safety hazards were effectively managed during production. The Department has a whole system agreement (Food Safety Recognition Agreement) in place with the United States since April 2017, and it has a number of government-to-government certification arrangements with other countries for certain imported food. In all, 16 certification arrangements are in place with national competent authorities, covering a range of high-risk foods such as seafood, beef and raw milk cheese

3.106.  The Biosecurity Act, 2015 and the Biosecurity Regulation, 2016 mandate the Department of Agriculture to review existing trade and to undertake risk analysis in response to requests to import goods that have never been imported into Australia, or have not previously been imported from a particular country or region. The risk analysis may be conducted through a regulated process provided for in the legislation (Biosecurity Import Risk Analysis BIRA) or through a non-regulated procedure (e.g. a scientific review of existing policy and import conditions, a pest-specific assessment, a weed risk assessment, or a biological control agent assessment). If the identified biosecurity risks exceed the appropriate level of protection (ALOP) for Australia, goods may not be imported unless the proposed risk management measures reduce the risks to an acceptable level. Australia's risk assessment method has been used since 2001, and includes a risk estimation matrix that follows international principles consistent with World Organisation for Animal Health (OIE) and International Plant Protection Convention risk management standards. Australia's ALOP is only considered achieved when the estimated risk is at or below "very low"

3.107.  A BIRA for a good or class of goods may be initiated by the Director of Biosecurity if s/he believes that the criteria for the BIRA have been met, or upon instruction from the Minister of Agriculture. The Director of Biosecurity may choose to commence a BIRA, for example, upon the request of the government of an exporting country or of institutions and traders proposing to import plants, animals or other goods in circumstances where import conditions have not been established previously. The Director of Biosecurity must (i) outline opportunities for consultation, and prepare and publish an issues paper on the Department of Agriculture website when announcing the commencement of the BIRA; (ii) prepare and publish a draft BIRA report on the website, and allow for a public submission period of a minimum of 60 calendar days; (iii) prepare and publish on the website the provisional BIRA report, which must include any information or submissions received, inputs from the scientific advisory group (where provided), and findings, including economic consequences, associated with the entry, establishment or spread of pest and diseases included in the class of goods under review; and (iv) progress the provisional BIRA report as it becomes the final BIRA report, unless the Inspector General of Biosecurity is requested to review the process used to conduct the BIRA within 30 days of publication of the provisional report. Unless specific circumstances apply, the BIRA report must be finalized within 30 months from the date of publication of the notice that the BIRA is commencing

3.108.  When importing into Australia, importers of plant, animal, mineral and biological products are responsible for compliance with conditions set by the Department of Agriculture. They may use the Biosecurity Import Conditions (BICON) system to determine whether: a commodity is permitted to be imported; importation is subject to specific conditions; supporting documentation is required; the commodity must undergo treatment; or an import permit is needed. Most import permits are issued within 20 working days of receipt, provided the application has been completed correctly and the required fees have been paid in full.[174] Australia's biosecurity system is based on the Biosecurity Act, 2015, and information on biosecurity conditions may also be obtained through BICON. Fresh beef can now be imported from Japan (in addition to New Zealand and Vanuatu), subject to import permit conditions

3.109.  The Department of Agriculture is seeking to optimise voluntary compliance with biosecurity requirements, where possible. The regulatory tools available under the Biosecurity Act to manage compliance include infringement notices (as an alternative to court resolution) for low-level contraventions and offences, enforceable undertakings, injunctions, and civil penalties. Infringement notices may be issued under Part 5 of the Regulatory Powers (Standard Provisions) Act, 2014, to persons contravening the strict liability offence (4) and civil penalty (48) provisions of the Biosecurity Act.[175] In 2018, the Department of Agriculture announced its intention to utilize infringement notices more broadly, including in relation to international cargo and mail and, in August 2019, that it was adopting a less tolerant attitude towards non-compliance.[176]

3.110.  Food standards applicable in Australia (and New Zealand) are developed by Food Standards Australia New Zealand (FSANZ), an Australian agency established under the Food Standards Australia New Zealand Act, 1991. The results of the work of the FSANZ are embodied in the Australia New Zealand Food Standards Code. In addition, it collaborates with industry to develop codes of conduct. In Australia, it develops standards for food safety, labelling, composition and contaminants; establishes maximum residue limits; and performs a range of other functions, such as the coordination of recall systems and the provision of risk assessment advice.[177] Compliance with the Code is monitored by the authorities of the states and territories, while the Department of Agriculture is responsible for the inspection and sampling of imported food

3.111.  The Australia New Zealand Food Standards Code may be amended, inter alia, at the request of stakeholders. Applications to amend the Code are forwarded to the FSANZ, which must make an administrative assessment of the application within 15 business days. The assessment determines whether the application meets the requirements of the Application Handbook (Part 3) and the procedure (i.e. general, high-level health claim, minor, major, or urgent) under which it should be considered. Accepted applications are incorporated into the FSANZ Work Plan, and the agency has fixed time-lines to finalize its formal proposals, depending on the procedure chosen (3 to 12 months). Fees apply if the applicant derives "an exclusive capturable commercial benefit" from the amendment, or if s/he would like to expedite the process. Non-payment prompts the automatic rejection of the application. A revised version of the Australia New Zealand Food Standards Code was introduced on 1 March 2016. The principal purpose was to clarify the requirements applicable to the labelling of food

3.112.  Australia introduced a new country of origin labelling system on 1 July 2016 that became mandatory for "priority food" from 1 July 2018.[178] The new system is enforced by the Australian Competition and Consumer Commission. The labelling requirements include a country of origin statement and a prescribed logo/mark and bar chart. Food with all ingredients grown, produced or made in Australia carry a prescribed kangaroo logo. For imported food or food ingredients, the marking should include a text and bar chart indicating the proportion of Australian ingredients by ingoing weight

3.113.  In Australia, activities with genetically modified (GM) crops are regulated in accordance with the Commonwealth Gene Technology Act, 2000, the Gene Technology Regulations, 2001, and corresponding state and territory legislation. In addition, the Commonwealth, states and territories governments signed an intergovernmental Gene Technology Agreement to ensure a consistent national scheme in 2001. Key elements of the Act are the establishment of the Gene Technology Regulator and committees providing expert advice to the Regulator, a process to assess risks associated with genetically modified organisms (GMOs), and the creation of a database of all GMOs approved in Australia. GMOs may be authorized for release for a limited time under specified conditions or without a time-limit (commercial release). All releases are assigned a licence number. As at September 2019, the database maintained by the Office of the Gene Technology Regulator comprised 17 current authorizations for the commercial release of GM crop plants.[179]

3.114.  Regarding compliance with transparency obligations under the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), Australia's SPS contact point is located within the Department of Agriculture; it serves as the national enquiry point and the national notification authority. Between January 2015 and 19 November 2019, Australia provided 218 notifications (including addenda and corrigenda) to the WTO related to the SPS Agreement. On average, Australia receives approximately 12 queries per year from other WTO Members, ranging from requests for further information on notifications to comments regarding specific trade concerns for these. These queries are processed by providing an acknowledgement and a confirmation of receipt to the WTO Member, before coordinating a response through the appropriate channels to address the concern or question. Two new specific trade concerns (STCs) were raised in the WTO Committee on Sanitary and Phytosanitary Measures, regarding measures maintained by Australia during the period under review.[180] One STC, raised by Australia regarding a measure maintained by Turkey, was last on the agenda of the SPS Committee in March 2015.[181]

3.100.  Notices of technical regulations are generally published in the Australia Government Gazette, and on websites of agencies such as the Food Standards Australia New Zealand.[165] In addition, standards and conformity assessment procedures are notified widely by e‑mail alerts, in-house journals and other relevant Commonwealth, state, and territory government publications. Notices on some standards are also published in Standards Australia's monthly e-publication.[166] Furthermore, information on conformity assessment procedures is published on the NATA website and in NATA News.[167]

3.101.  Between January 2015 and November 2019, Australia made 12 notifications under the WTO TBT Agreement. The majority of the notifications were under Articles 2.9.2 (proposed technical regulations), 2.10.1 (technical regulation urgency), 5.6.2 (proposed conformity assessment procedure) and 5.7.1 (urgent measure). In most cases, the submission allowed for a comment period of 60 days or more. During the review period, one specific trade concern was raised in the TBT Committee involving Australia's plain packaging measure

3.89.  The Mutual Recognition Agreement (MRA) Act, 1992 allows goods sold in one state or territory to be sold in another without needing to meet further requirements. Several government agencies are responsible for monitoring and regulating the safety of different types of products. Product safety regulation for general consumer products is a shared responsibility between the Australian Competition and Consumer Commission (ACCC)[157] and the states and territories agencies, such as Australian Capital Territory Fair Trading (Department of Justice and Community Safety, Office of Regulatory Services); Consumer Affairs Victoria (Department of Justice); New South Wales Fair Trading; Queensland Fair Trading; South Australia Consumer and Business Services; Tasmania Consumer Affairs and Fair Trading (Department of Justice); and Western Australia Consumer Protection (Department of Commerce)

3.90.  Australia's peak standards and conformance organizations are the National Measurement Institute, responsible for biological, chemical, legal, physical and trade measurement; Standards Australia, an independent, not-for-profit national standards development body; the National Association of Testing Authorities Australia (NATA), an independent, not-for-profit national accreditor of conformity assessment bodies involved in testing and calibration and other areas; and the Joint Accreditation System of Australia and New Zealand (JAS-ANZ), a bi-national government accreditor of certification bodies, inspection bodies and validation and verification bodies

3.91.  The current five‑year memoranda of understanding (MoUs) between the Commonwealth Government (the lead agency for which is the Department of Industry, Innovation and Science (DIIS)) and Standards Australia and the NATA were signed in November 2018 and August 2018, respectively. The MoUs frame the Government's policy relationship with the organizations. The MOU with Standards Australia requires the development of new or amended standards, and the setting of priorities to be transparent, ensuring the primary decision criterion is of net benefit to the community.[158] The MoU stipulates that Standards Australia has a policy of adopting international standards wherever possible, which is in line with the Code of Good Practice for the Preparation, Adoption and Application of Standards of the WTO Technical Barriers to Trade (TBT) Agreement (Annex 3). In addition, the MoU with the NATA indicates that the NATA will prepare, publish and, where appropriate, review its procedures, accreditation criteria and key performance indicators to ensure that these conform with Australia's obligations in the WTO TBT Agreement.[159]

3.92.  As at November 2019, Standards Australia had published approximately 5,400 Australian Standards. In addition, approximately one third of Standards Australia's catalogue is referenced in Commonwealth, state and territory regulations. Mandatory product safety requirements, often based on these standards (including some on labelling), affected 42 consumer items.[160] These requirements apply to the Commonwealth territory upon imposition, decided by the relevant Australian government minister. When considering whether to introduce a technical regulation, the Commonwealth Government conducts research and consults with industry and consumer representatives to develop a regulation impact statement (RIS). The RIS weighs up evidence of current market forces influencing the product and market; causes of potential dangers; options for reducing the risk for consumers; and the potential economic and social impact of regulatory and non‑regulatory measures.[161]

3.93.  The ACCC annually conducts safety audits on products where there are indications of non-compliance with specific regulations. The audits include a national series of surveys to determine the level of compliance in the market (including online suppliers). Audits are also conducted on unsafe goods that are not subject to any specific mandatory requirement. Between July 2019 and June 2020, 20 products were prioritized to undergo surveillance and testing.[162] The ACCC carries out the audits and, if a non-compliant product is identified, suppliers are required to remove these products from sale, and conduct a voluntary recall. In serious instances, the ACCC may take immediate enforcement action by issuing Infringement Notices or court action with penalties of up to AUD 1.1 million. Each supplier in the supply chain is responsible for compliance and ensuring products are safe and fit for purpose, regardless of where they may be in the supply chain, or whether they are domestic or overseas manufacturers, suppliers or distributors. According to the authorities, between 2015 and 2019, the ACCC, together with state and territory counterparts, removed millions of products from sale across 198 product types for breaches of, or suspected non-compliance with, mandatory standards and bans

3.94.  The Government adopted the principle that, if a system, service or product has been approved under a trusted international standard or risk assessment, Australian regulators should not impose any additional requirements unless it can be demonstrated that there is a good reason to do so. The principle has been acknowledged in the Regulatory Reform Agenda and the National Innovation and Science Agenda. The principle is also consistent with Australia's obligations under the WTO TBT Agreement. To abide by this, policy officers who use standards or risk assessments in support of policies or programmes should select an appropriate international version where possible. The Best Practice Guide to Using Standards and Risk Assessments in Policy and Regulation assists policy officers assess which standards or risk assessments to use to support their policy and programmes.[163] According to the authorities, aligning with international standards improves Australian access to overseas markets; reduces costs and delays for businesses; and increases the supply of reliable products into the Australian market

3.95.  In the absence of a suitable international standard, national standards are developed, with transparency and consensus being two key requirements. As at November 2019, approximately 40% of Australian Standards were identical to, or slightly modified adoptions of, international standards

3.96.  NATA and JAS-ANZ accreditation helps to ensure that laboratories, facilities and conformity assessment bodies (e.g. certifiers and inspectors) have the technical capacity to perform their duties, which includes their ability to meet relevant international standards, and suitable levels of impartiality and competence. This provides domestic and international confidence in the safety and reliability of Australian goods, services and systems. The NATA is also Australia's compliance monitoring authority for the OECD Principles of Good Laboratory Practice. In June 2019, there were 3,337 NATA-accredited laboratories and facilities. There were also over 130 JAS-ANZ-accredited conformity assessment bodies, 145 accredited schemes, and more than 140,000 active certificates carrying JAS-ANZ accreditation

3.97.  The NATA and the JAS-ANZ are guided by international standards, including: ISO/IEC 17011:2017 (Conformity assessment Requirements for accreditation bodies); ISO 9001 (Quality Management Systems); ISO 14001 (Environmental Management); AS/NZS 4801 (Safety Management Systems) and ISO 22000 (Food Safety Management); ISO/IEC 17025 (Testing and Calibration); ISO/IEC 17020 (Inspection); ISO/IEC 17034 (Reference Materials Producers); ISO 17043 (Proficiency Testing Providers); and ISO 15189 (Medical Testing)

3.98.  The Government has MRAs with the Australian states and territories (Mutual Recognition Act, 1992), New Zealand (Trans-Tasman Mutual Recognition Act, 1997), the European Union (1999, amended 2013), the European Free Trade Association (EFTA) (2000, currently being updated), and Singapore (2001). It also signed an MRA with the United Kingdom, which will enter into force once it departs the European Union.[164]

3.99.  Australia is a party to the MRAs within the Asia-Pacific Economic Cooperation for Conformity Assessment of Telecommunications Equipment (1999); Conformity Assessment of Electrical and Electronic Equipment (1999); and Conformity Assessment of Foods and Food Products (1997). The NATA and the JAS-ANZ have developed a network of multilateral recognition arrangements (MLAs) and MRAs through international and regional fora. The NATA is an inaugural signatory to the International Laboratory Accreditation Cooperation MRA; and JAS-ANZ is a signatory to the International Accreditation Forum MLA. Both the NATA and the JAS-ANZ are signatories to the Asia Pacific Accreditation Cooperation (APAC) MRA. The APAC was formed on 1 January 2019 from the amalgamation of the Asia Pacific Accreditation Cooperation (APLAC) and the Pacific Accreditation Cooperation (PAC). The NATA and the JAS-ANZ had previously been signatories to the APLAC and the PAC, respectively