Primary Produce (Food Safety Schemes) (Seafood) Regulations 2017

Several key concepts define the regulatory architecture.

Licensee - defined as the holder of an aquaculture licence (under the Aquaculture Act 2001) or a fishery licence (under the Fisheries Management Act 2007). Every licensee is subject to the basic duty under regulation 5 to comply with Division 2 of Standard 4.2.1. This concept covers a wide range of seafood operations, not just bivalve mollusc producers.

Bivalve mollusc producer - a sub‑category of licensee. The definition is “the holder of an aquaculture or fishery licence authorising the farming or taking of bivalve molluscs”. The term “bivalve molluscs” is defined by example: cockles, clams, mussels, oysters, pipis and scallops. The definition is functional, not taxonomic - it captures any licence that authorises the farming or taking of these species.

Bivalve mollusc production activities - defined as “activities constituted of the production of primary produce involving bivalve molluscs intended for sale or supply for human consumption”. This deliberately tracks the scope of the seafood food safety scheme. It does not include activities where the molluscs are not intended for human consumption (e.g., bait, pearl production).

Accredited producer - a bivalve mollusc producer who holds an accreditation under these regulations. Accreditation is mandatory for bivalve mollusc production activities (subject to the spat and scallop‑adductor exemptions). The Minister is the accreditation body (regulation 4(2)).

Standard 4.2.1 - the Primary Production & Processing Standard for Seafood under the Food Standards Code, as adopted by the Food Act 2001 (SA). It includes documents called up by that Standard (e.g., relevant Australian Standards for food safety management). Regulation 5 compels licensees to comply with Division 2 of that Standard.

Food safety arrangement - a documented food safety management system that must be approved by the Minister for each accredited producer’s bivalve mollusc production activities. It must comply with Division 3 of Standard 4.2.1, be designed to ensure compliance with regulation 9, and ensure the producer meets obligations under the Food Act 2001 regarding the safety and suitability of food. A limited exemption exists for producers who farm bivalve molluscs under an aquaculture licence if all molluscs are moved to another accredited producer’s licence area for further development before harvest (regulation 8(3)).

Approved area and restricted area - classifications made by the Minister by notice in the Gazette or by written notice to affected producers (regulation 9(3)). An approved area may be open or closed for particular species or periods. Restricted areas have similar classifications. Harvest for human consumption must be from an approved area that is open for the species (regulation 9(1)(a)). Relaying (moving molluscs from closed or restricted areas into approved areas) requires a written relaying authorisation from the Minister.

Relaying authorisation - a written authorisation from the Minister permitting a producer to bring bivalve molluscs from a closed part of an approved area, or from an open part of a restricted area, into an approved area. The authorisation must specify that the molluscs be kept in a clearly marked relaying area, adequately separated from other molluscs to avoid cross‑contamination, and subjected to a process for reduction of pathogenic organisms or contaminants.

Wet storage - defined as “the storage of live bivalve molluscs in containers (not located in the sea) of natural or synthetic seawater”. This is a tightly regulated activity: it requires a wet storage authorisation; the water must be tested as required by the authorisation and found suitable before the molluscs can be sold (regulation 9(1)(d) and (e)).

Spat - a mollusc that would pass through a screen with a mesh size of 10 mm x 10 mm. Spat are exempt from the accreditation requirement (regulation 6(2)(a)) and from the harvest‑area restriction (regulation 9(1)(a) applies to molluscs “other than spat”). However, the exemption applies only if the producer’s only bivalve molluscs taken or farmed are spat.

Scallop adductor muscle exemption - if the only bivalve molluscs farmed or taken are scallops and only the adductor muscle is sold or supplied for human consumption, the producer need not hold accreditation (regulation 6(2)(b)), and the harvest‑area restriction does not apply (regulation 9(2)).

Fee - the annual fee prescribed by fee notice under the Legislation (Fees) Act 2019. The fee is payable annually by the prescribed date, which depends on the licence expiry or annual return date, subject to the Minister’s specification (regulation 10). Penalty for default is as prescribed.

The regulations directly affect every person who holds an aquaculture licence under the Aquaculture Act 2001 (SA) or a fishery licence under the Fisheries Management Act 2007 (SA). This includes oyster farmers, mussel farmers, scallop fishers, and any other commercial operator farming or taking fish for human consumption in South Australia. Because the definition of “licensee” in regulation 3 is broad, and regulation 5 applies to all licensees, even a licence holder who does not deal with bivalve molluscs must still comply with Division 2 of Standard 4.2.1. That standard covers matters such as water quality, handling, temperature control, and traceability for all seafood.

However, the most intensive regulatory impact falls on bivalve mollusc producers - those with a licence authorising the farming or taking of bivalve molluscs. They must obtain accreditation, maintain an approved food safety arrangement, observe area classifications, obtain relaying and wet storage authorisations, implement testing regimes, and comply with labelling and notification duties. This group includes small‑scale oyster growers, larger mussel producers, and scallop fishers who sell whole scallops or roe‑on product (as opposed to those who sell only the adductor muscle, who are exempt from accreditation).

Indirectly, the regulations affect downstream businesses such as wholesalers, processors, and retailers who purchase from accredited producers. The labelling requirements (regulation 9(1)(g)) create traceability obligations that flow through the supply chain. The notification duty (regulation 9(1)(i)) may also affect those handling bivalve molluscs if they become aware of safety concerns.

The Minister (or the government agency acting on the Minister’s behalf) is the accreditation body and bears the cost of administering area classifications, processing applications, conducting testing (the regulations require producers to facilitate testing but do not specify who pays for it), and enforcement. The Minister has broad discretion to classify areas, open or close them, and grant or refuse authorisations, which affects producers’ ability to harvest and market product.

Consumers are the ultimate intended beneficiaries of the food safety outcomes, but they bear the cost through higher prices as producers pass on compliance costs. Taxpayers also bear the cost of government administration and enforcement.

Small and independent producers stand to be disproportionately affected. The fixed cost of developing an approved food safety arrangement (which must be a documented management system complying with Division 3 of Standard 4.2.1), the annual fee, and the ongoing cost of water testing and compliance record‑keeping create barriers to entry and maintenance. The exemptions for spat and scallop adductor muscle reduce the burden for very narrow segments but do not assist producers raising adult oysters or whole scallops.

Producers who rely on relaying or wet storage are especially exposed. They must obtain and comply with ministerial authorisations, which may be time‑limited or subject to conditions. The requirement to have water tested as specified by the wet storage authorisation adds variable cost and operational risk if testing results are unfavourable.

Finally, producers whose operations cross classified areas (e.g., moving spat from a restricted area to an approved area for grow‑out) must manage the relaying authorisation process carefully. The scheme effectively gives the Minister control over the timing and location of harvest, which can constrain commercial flexibility.

Duties on all licensees. Regulation 5 imposes a duty on every licensee to ensure compliance with Division 2 of Standard 4.2.1 in respect of activities to which the seafood food safety scheme applies. This is a continuing duty that requires the licensee to maintain practices consistent with the Standard’s requirements for harvesting, handling, processing, and transport of seafood. The duty is triggered by the existence of the licence and the conduct of covered activities.

Duty to be accredited. Regulation 6(1) prohibits a bivalve mollusc producer from engaging in bivalve mollusc production activities without an accreditation. This is a mandatory licensing‑style requirement. The prohibition is subject to the narrow exemptions for spat‑only operations and scallop‑adductor‑only operations (regulation 6(2)). The duty to obtain accreditation is ongoing; ceasing production may end the duty, but any production activity requires prior accreditation.

Duty to have an approved food safety arrangement. Regulation 8(1) requires every accredited producer to have a food safety arrangement approved by the Minister for their bivalve mollusc production activities. This is a proactive duty: the producer must apply for and maintain approval. The arrangement must meet three criteria: compliance with Division 3 of Standard 4.2.1, design to ensure compliance with regulation 9, and design to ensure obligations under the Food Act 2001 regarding safety and suitability are met (regulation 8(2)). An exemption applies to producers who farm bivalve molluscs under an aquaculture licence if all molluscs farmed are moved to another accredited producer’s licence area for further development before harvest (regulation 8(3)). In that case, the first producer does not need an approved food safety arrangement, but the receiving producer presumably must have one.

Duty to comply with specific operational requirements. Regulation 9 sets out nine detailed duties applicable to every accredited producer’s bivalve mollusc production activities. These include:

• Only harvest for human consumption from an approved area that is open for the species (9(1)(a)).
• Not bring bivalve molluscs into an approved area unless taken from another approved area or an open part of a restricted area (9(1)(b)).
• If bringing molluscs from a closed approved area or open restricted area into an approved area, do so only under a relaying authorisation, with mandatory separation, marking, and depuration (9(1)(c)).
• Not keep molluscs in wet storage without a wet storage authorisation (9(1)(d)).
• Not sell wet‑stored molluscs unless the storage water has been tested as required by the authorisation and found suitable (9(1)(e)).
• Supply bivalve molluscs and water samples for testing as requested by the Minister, and facilitate on‑site sampling (9(1)(f)).
• Store and handle harvested molluscs so that they are traceable by harvest date and area, and label containers with specific information before supply (9(1)(g)).
• If exempt from the food safety arrangement requirement, ensure molluscs are moved to another accredited producer’s licence area for further development before sale (9(1)(h)).
• Immediately notify the Minister if there is reason to believe molluscs are unsafe or unsuitable as food under the Food Act 2001 (9(1)(i)).

Duty to pay fees and lodge annual returns. Regulation 10 requires each accredited producer to pay the annual fee prescribed by fee notice and lodge an annual return by the prescribed date. Failure attracts a penalty as prescribed.

Rights of producers. Accredited producers have the right to apply for and receive accreditation (regulation 7 sets the criteria), and to have their food safety arrangement approved (regulation 8). They may seek relaying authorisations and wet storage authorisations from the Minister (regulation 9(1)(c) and (d)). They may challenge area classifications or closures, though the regulations do not specify appeal mechanisms (they likely exist under the Act or judicial review). They may request fee waivers, deferrals, or reductions from the Minister (regulation 10(4)). Producers also have the right to rely on the spat and scallop‑adductor exemptions without accreditation, which is a significant relief from the full scheme.

Minister’s powers and duties. The Minister classifies areas, opens/closes them, specifies species and periods (regulation 9(3)), varies or revokes notices (9(4)), grants/refuses accreditation (regulation 7), approves food safety arrangements (regulation 8), grants relaying and wet storage authorisations (regulation 9), requests samples (9(1)(f)), waives fees (10(4)), and recovers unpaid fees as a debt (10(5)). The Minister also has the power to specify the prescribed date for fee payment where the licence is not annual (regulation 10(2)(c)).

The regulations do not themselves create specific penalty provisions for breach of the duties they impose. Instead, enforcement is through the Primary Produce (Food Safety Schemes) Act 2004 (the Act). Regulation 6(1) prohibits engaging in bivalve mollusc production activities without accreditation “for the purposes of section 12 of the Act”. Section 12 of the Act would make it an offence to contravene that prohibition. The penalties under the Act are not reproduced in these regulations, but practitioners should consult the Act for maximum fines and possible imprisonment terms.

The most significant enforcement risk for licensees arises from non‑compliance with regulation 5 (failure to comply with Standard 4.2.1). That regulation is a direct obligation; a breach could lead to prosecution under the Act or enforcement action by the relevant food safety authority. Similarly, failure to have an approved food safety arrangement (regulation 8) or to comply with any of the specific requirements in regulation 9 (e.g., harvesting from a closed area, failing to test wet storage water, failing to label containers, failing to notify) would be a breach of the regulations and thus an offence under the Act.

The regulations also provide a specific penalty for default in paying the annual fee or lodging the annual return: the penalty is “as prescribed by fee notice” (regulation 10(3)). This means that the Legislation (Fees) Act 2019 fee notice sets a penalty amount (likely a late payment fee or additional charge). Additionally, the Minister may recover unpaid fees as a debt (regulation 10(5)), which is a civil remedy rather than a criminal penalty, but it can be enforced through court proceedings.

The Minister’s broad powers to classify areas, close them, and grant or refuse authorisations can function as a de facto enforcement tool. A producer who breaches harvesting conditions may find their area closed or their relaying authorisation revoked. The scheme thus combines criminal sanctions with administrative controls that can stop a producer from operating effectively.

Enforcement may also involve the Food Act 2001. Regulation 9(1)(i) imposes a duty to notify the Minister if there is reason to believe bivalve molluscs are unsafe or unsuitable. Failure to notify could be dealt with under the Food Act 2001 as well. The Food Act 2001 gives enforcement officers powers to inspect, seize, and issue improvement notices or prohibition orders.

For small operators, the compliance burden itself can be a practical enforcement risk: if they cannot afford the testing, documentation, and food safety arrangement, they face suspension or revocation of accreditation. The Minister’s discretion to waive fees (regulation 10(4)) is some relief but is entirely discretionary.

There is no private right of action under these regulations; enforcement is entirely by the state. However, producers should be aware that failure to comply with the regulations could also expose them to civil liability under common law or other statutes (e.g., for selling contaminated food), independent of regulatory penalties.

The regulations sit within a web of interconnected South Australian and national food safety legislation.

Primary Produce (Food Safety Schemes) Act 2004 - the parent Act. The regulations are made under this Act. Section 12 of the Act deals with offences for acting without accreditation. Section 15 deals with grant of accreditation. Section 17 deals with fees. The regulations give effect to these provisions. The Act provides the overarching enforcement and administrative framework.

Food Act 2001 (SA) - Standard 4.2.1 is defined by reference to the Food Standards Code as it applies under the Food Act 2001. The regulations repeatedly cross‑reference obligations under the Food Act 2001, notably in regulation 8(2)(c) (food safety arrangement must ensure obligations under the Food Act 2001 about safe and suitable food) and regulation 9(1)(i) (notification duty using the same unsafe/unsuitable standard). The Food Act 2001 also empowers authorised officers to take enforcement action in relation to food safety matters generally, which may overlap with regulatory actions under the Primary Produce (Food Safety Schemes) Act.

Food Standards Code - Standard 4.2.1 - Division 2 of this Standard is made mandatory by regulation 5. Division 3 (documented food safety management system) is incorporated into the requirement for a food safety arrangement (regulation 8(2)(a)). The Standard itself is legislative instrument made by Food Standards Australia New Zealand and adopted into South Australian law via the Food Act 2001. Practitioners must consult the current version of Standard 4.2.1.

Aquaculture Act 2001 (SA) - the definition of “aquaculture licence” is imported. A person must hold an aquaculture licence to farm fish in South Australia. The regulations add a further layer of accreditation on top of that licence for bivalve mollusc producers. This means a producer needs both the licence and the accreditation. The expiry date of the aquaculture licence may determine the prescribed date for payment of the annual fee under these regulations (regulation 10(2)(a)).

Fisheries Management Act 2007 (SA) - similarly, the definition of “fishery licence” is imported. Wild‑capture fishers who take bivalve molluscs under a fishery licence must also obtain accreditation under these regulations (unless exempt). The interaction with management plans under the Fisheries Management Act 2007 (e.g., quotas, size limits, seasonal closures) adds another layer of regulation.

Legislation (Fees) Act 2019 (SA) - the term “fee notice” in regulation 10(6) is defined by reference to this Act. Fees are set by notice under that Act, not by these regulations. This means fees can be varied without amending the regulations, which gives flexibility but also makes the cost uncertain for producers until the fee notice is published.

Environment Protection Act 1993 (SA) - though not referenced in the regulations, water quality standards for farming areas may be influenced by environmental laws. The Minister’s classification of approved areas under regulation 9(3) may take into account water quality data from environmental monitoring.

Food Act 2001 - Australia New Zealand Food Standards Code - the full Food Standards Code includes many other standards that may apply to seafood processing, labelling, and composition. These regulations only directly incorporate Standard 4.2.1, but producers must still comply with other applicable standards under the Food Act 2001 (e.g., labelling standard 1.2.1, food safety standards for processing).

Common law - compliance with these regulations does not automatically discharge a duty of care in negligence or liability under the Australian Consumer Law for unsafe food. The regulations set minimum public law standards; private law claims may impose higher standards or additional liability.

These regulations commenced on 19 January 2018, replacing the Primary Produce (Food Safety Schemes) (Seafood) Regulations 2006 (which were revoked). The legislative history shows multiple amendments since commencement.

2018 amendments (two instruments): Variation No 99 of 2018, commencing 1 July 2018, omitted regulation 2 (which was likely the commencement provision, now unnecessary) under the Legislation Revision and Publication Act 2002 and substituted Schedule 1. Variation No 169 of 2018, also commencing 1 July 2018 (immediately after No 99), further varied Schedule 1. These changes presumably updated the fee schedule and other prescribed matters.

2019 amendment: Variation No 124 of 2019, commencing 1 July 2019, substituted Schedule 1 again. This continued the pattern of periodic fee updates.

2020 amendment: Variation No 186 of 2020, commencing 1 July 2020, made substantive changes to the fee provisions. It varied regulation 10(1) and (3), inserted new subregulations (4) to (6) into regulation 10, and deleted regulation 12 and Schedule 1. The inserted subregulations gave the Minister power to waive, defer, or reduce fees (new s 10(4)), to recover unpaid fees as a debt (new s 10(5)), and defined “fee notice” and “fee” by reference to the Legislation (Fees) Act 2019 (new s 10(6)). This moved fee‑setting out of the regulations and into a separate fee notice, which is more flexible for government but less transparent for producers.

The deletion of regulation 12 (which previously dealt with expiry of accreditation? Not clear from text) and Schedule 1 (the fee schedule) completed the shift to external fee setting.

Transitional provisions: Schedule 2 Part 2 (transitional) ensures continuity from the 2006 regulations. Approved food safety arrangements in force under the old regulations continue as if approved under new regulation 8. Notices to accredited producers made under old regulation 8(2) (area classifications, etc.) continue as if made under new regulation 9(3). This means producers did not have to re‑apply when the 2017 regulations commenced, and area classifications remained unchanged.

The legislative history also notes that Part 1 of Schedule 2 was omitted under the Legislation Revision and Publication Act 2002 on 1 July 2018, which is a routine clean‑up of spent transitional provisions.

Practitioners should always verify they are using the current version of the regulations, as fees and minor administrative details may change annually via fee notice without amending the regulations themselves.

The source text contains no references to any reported cases, court decisions, or tribunal rulings concerning these regulations. The regulations are administrative in nature and have been in force since 2018 (with predecessors since 2006). Given their prescriptive nature, it is possible that enforcement actions have been taken under the parent Act, but no specific litigation is recorded in the regulations themselves.

Potential areas of dispute that could generate litigation include: challenges to area classifications or closures by the Minister (regulation 9(3)) on grounds of unreasonableness or procedural fairness; disputes over the refusal or revocation of accreditation or food safety arrangement approval; and prosecutions for harvesting from closed areas or failing to test wet storage water. However, none of these have resulted in published decisions in the text.

Practitioners should note that the regulations confer very broad discretionary powers on the Minister - to classify areas (9(3)), to grant or refuse authorisations (9(1)(c), (d)), to approve or reject food safety arrangements (8(1)), and to waive fees (10(4)). Such discretion is often subject to judicial review, but the administrative law threshold is high. The regulations do not specify merits review or appeal mechanisms, so any challenge would likely be through the South Australian Civil and Administrative Tribunal or the Supreme Court under judicial review, depending on the Act’s provisions.

Given the absence of litigated cases in the source, it is reasonable to infer that either compliance levels are sufficient to avoid litigation, or that enforcement actions are resolved without published decisions. Neither inference is guaranteed. Producers should not assume that the regulations are lightly enforced; the prescriptive nature of the duties suggests the government takes food safety seriously.

The spat exemption is narrower than it appears. Regulation 6(2)(a) exempts a bivalve mollusc producer from needing accreditation if “the only bivalve molluscs farmed or taken by the producer comprise spat”. If the producer also farms or takes adult bivalve molluscs of any species - even if the main product is spat - the exemption is lost and accreditation is required for all bivalve mollusc production activities. Similarly, the scallop adductor muscle exemption only applies if the producer’s only bivalve molluscs are scallops and only the adductor muscle is sold. Any other sale (e.g., whole scallops, roe‑on) triggers full accreditation requirements.

Wet storage requires prior written authorisation - not just compliance with a standard. Regulation 9(1)(d) prohibits keeping bivalve molluscs in wet storage unless a written wet storage authorisation has been granted. This is not a tick‑a‑box requirement; the authorisation is discretionary and may set specific conditions, including water testing requirements. Operating wet storage without authorisation is a breach, even if the water quality is excellent.

Relaying authorisations require a written document and active process. A producer who moves bivalve molluscs from a closed area or restricted area into an approved area must have a relaying authorisation. The three sub‑conditions (marked relaying area, adequate separation from other molluscs, reduction of pathogenic organisms/contaminants) are mandatory per the authorisation. The authorisation is per‑operation, not a blanket permission; the Minister may prescribe specific processes.

Testing requirements are not self‑executing. Regulation 9(1)(e) requires that the water in wet storage be “tested as required by the wet storage authorisation and found to be suitable as specified by the authorisation”. The authorisation dictates the testing regime - frequency, parameters, laboratory - so a producer cannot simply test at their own discretion and declare suitability. Failure to follow the authorisation’s testing requirements voids the right to sell.

Labelling must contain specific details, including the accreditation number. Regulation 9(1)(g) requires containers to be labelled with the producer’s name, accreditation number, licence number(s), harvest date, and details of the approved area. The accreditation number is a unique identifier; a mistake in the number could break traceability and potentially lead to enforcement or product recall difficulties.

The notification duty is triggered by a low threshold. Regulation 9(1)(i) requires immediate notification to the Minister if “there is reason to believe” bivalve molluscs are unsafe or unsuitable. This is an objective test based on reasonable belief, not certainty. A producer who suspects a problem (e.g., based on unusual mortality, off‑flavours, or a test result) must notify promptly. Delay could be a separate breach.

Fee deadlines depend on the underlying licence. The prescribed date for paying the annual fee and lodging the annual return varies: for annual licences, it is the expiry day and month; for multi‑year licences with an annual return requirement, it is the return due date; for others, it is the date the Minister specifies in writing (regulation 10(2)). A producer who misreads this may miss the deadline and incur penalty.

The Minister may change area classifications without notice beyond the Gazette. Regulation 9(3) allows classification by notice in the Gazette or by written notice to affected producers. If the Minister uses written notice, a producer who fails to check their correspondence may miss a closure or change.

The food safety arrangement exemption for moving molluscs to another producer does not remove all duties. Regulation 8(3) exempts a producer from needing an approved food safety arrangement if all farmed bivalve molluscs are moved to another accredited producer for further development. However, the producer still must have accreditation (unless exempt under regulation 6(2)) and must comply with all other duties in regulation 9 that are relevant, including labelling the containers before supply (9(1)(h) cross‑references 9(1)(g)). The exemption is narrow.

Transitional provisions do not save expired approvals. Schedule 2 clause 3 continues food safety arrangements “in force immediately before the commencement”. If a food safety arrangement had lapsed or been revoked, it does not revive. Similarly for notices under clause 4.

Fees are now set externally. With the 2020 amendments, fees are prescribed by fee notice under the Legislation (Fees) Act 2019, not in Schedule 1. Producers cannot see the fee in the regulations themselves and must check the current fee notice. The fee can change annually without amending the regulations.

A licensee (holder of an aquaculture or fishery licence in South Australia) must first determine whether their activities fall under the seafood food safety scheme. The scheme applies to production of primary produce involving fish intended for human consumption (regulation 4(1)). If yes, step one is to ensure compliance with Division 2 of Standard 4.2.1 (regulation 5). This requires a detailed understanding of that Standard, which covers harvesting, handling, processing, transport, and traceability requirements. Documenting procedures and training staff is prudent, though not explicitly mandated by the regulation.

If the licensee is a bivalve mollusc producer (licence authorises farming or taking of bivalve molluscs), further steps are required unless the narrow exemptions apply.

Step 1 - Determine exemption. Check if the only bivalve molluscs farmed or taken are spat (mesh size under 10 mm) OR if only scallops are involved and only the adductor muscle is sold. If either exemption applies, the producer does not need accreditation but must still comply with regulation 5 and any other applicable law. Note that mixing spat and adult molluscs removes the exemption.

Step 2 - Apply for accreditation. If not exempt, the producer must apply to the Minister for accreditation under regulation 7. The applicant must satisfy the Minister of capacity to meet the Act and regulations. Practical advice: prepare a detailed application showing knowledge of obligations, including a draft food safety arrangement, to demonstrate capacity. Pay the pro‑rata fee (regulation 11) before accreditation is granted.

Step 3 - Obtain and maintain an approved food safety arrangement. Regulation 8 requires an approved arrangement. It must comply with Division 3 of Standard 4.2.1 (documented food safety management system), be designed to ensure compliance with regulation 9, and ensure obligations under the Food Act 2001. Develop the system in writing (e.g., HACCP‑based plan). Submit it to the Minister for approval. Once approved, keep it current. If the producer farms bivalve molluscs under an aquaculture licence and moves all molluscs to another accredited producer’s licence area for further development before harvest, the food safety arrangement is not needed (regulation 8(3)), but accreditation is still required.

Step 4 - Comply with specific requirements of regulation 9.

• Know the classification of the area: obtain from the Minister the list of approved areas, restricted areas, and their open/closed status (Gazette notices or written notices).
• Harvest only from approved areas that are open for the species harvested. Check closures daily.
• When moving molluscs into an approved area, ensure they come from another approved area or an open part of a restricted area. If from a closed area or restricted area, apply for a relaying authorisation; comply with its conditions (marked relaying area, separation, depuration).
• For any wet storage, apply for a wet storage authorisation before storing. Test the water as the authorisation specifies. Do not sell until results show suitability.
• Be prepared to supply bivalve mollusc and water samples for testing on ministerial request. Keep records of any testing performed.
• Implement a lot‑traceability system. On the same harvest date and from the same approved area, bivalve molluscs must be stored and handled so they can be distinguished from other lots. Before selling or supplying, label each container with: producer name, accreditation number, licence number(s) for aquaculture and/or fishery licence, harvest date, and details of the approved area. Use durable labels.
• If exempt from the food safety arrangement requirement, ensure all molluscs are moved to another accredited producer’s licence area before sale (regulation 9(1)(h)).
• Establish a procedure for immediate notification to the Minister if there is reason to believe molluscs are unsafe or unsuitable as food under the Food Act 2001. Ensure staff know to report immediately internally.

Step 5 - Pay annual fees and lodge annual return. Determine the prescribed date from regulation 10(2) (based on licence expiry or annual return date). Pay the fee prescribed by the current fee notice (check the Legislation (Fees) Act 2019 fee notices). Lodge an annual return in the form required by the Minister. If financial difficulty arises, consider requesting a waiver, deferral, or reduction of fee under regulation 10(4).

Step 6 - Stay informed. Monitor the Gazette for area classification notices and variations. Check written notices from the Minister. Keep records of all authorisations, test results, and consignments. Review the current fee notice annually.

Step 7 - Consider the indirect effects. Even if not a bivalve mollusc producer, regulation 5 compliance with Standard 4.2.1 is mandatory. For those moving bivalve molluscs into or out of South Australia, consider interactions with Commonwealth food safety requirements and the Food Act 2001.

Compliance is a regulatory burden with ongoing costs: documentation, testing, labelling, fees, and administrative time. Producers should factor these into their business planning. Non‑compliance risks prosecution, debt recovery for unpaid fees, and potential loss of accreditation - effectively a shutdown of operations. Engage legal and technical advisors familiar with the food safety scheme and Standard 4.2.1.