Regulated Fish Proposal - Additional Information

​​​​​​National Primary Production and Processing Standards

Primary Production and Processing (PPP) Standards impose mandatory obligations on producers to control food safety hazards occurring in the primary production phase of the food supply chain – before the produce enters the food retail and service sector. 

PPP Standards are set by Food Standards Australia New Zealand (FSANZ) and incorporated into Chapter 4 of the Australia New Zealand Food Standards Code (Food Standards Code). There currently exist PPP Standards for meat, dairy, seed sprouts, eggs, poultry and seafood.  The PPP Standards are available for download from the FSANZ website​.

All Australian states and territories are required under a Council of Australian Governments (COAG) agreement to enforce PPP Standards through state legislation. 

​Standard 4.2.1 - Primary Production and Processing Standard for Seafood aims to reduce the incidence of illness associated with seafood by ensuring that producers and processors of seafood control food safety hazards in accordance with a Government-approved food safety program that is audited regularly. 

Regulatory Impact Assessment

FSANZ carried out a national regulatory impact assessment in relation to Standard 4.2.1. FSANZ determined that mandatory implementation of the Standard by all Australian states and territories would yield an estimated (nationwide) benefit of between $30 million and $75 million per year.  The final report of the regulatory impact assessment for Standard 4.2.1 is available for download from the FSANZ website.

Proposal to Determine Class of Regulated Fish

The Primary Produce Safety Act 2011 (the Act) applies Standard 4.2.1 to the Tasmanian seafood industry; at the industry level via the Primary Produce Safety (Seafood) Regulations 2014 (Seafood Food Safety Scheme) and, at the business enterprise level, via mandatory accreditation for high-risk seafood production. 

Copies of Tasmanian legislation are available for download from the Tasmanian Legislation website:

Accreditation is the internationally recognised mechanism for verifying business compliance with PPP standards such as Standard 4.2.1. 

The fish currently regulated under the Seafood Food Safety Scheme are bivalve molluscs (cockles, clams, mussels, oysters, pipis, and scallops) and abalone.  The Chief Inspector has also proposed that “smoked and preserved fish” are to be made a regulated class of fish under the Seafood Food Safety Scheme.

The Scheme will require producers of smoked or preserved fish to:

  • comply with Standard 4.2.1;
  • hold an accreditation in order to carry on a business involving the production or processing of seafood; and
  • prepare and implement an approved (usually HACCP based) food safety program which is audited at least once a year (NB: The Act allows audits to be performed by approved private third party auditors).

For the purposes of the proposed determination, “smoked or preserved fish” means any fish that is smoked, cured, brined or otherwise processed in order to be made suitable for human consumption without further heating or cooking, such as:

(a) hot or cold smoked fish; or
(b) canned fish; or
(c) pickled fish; or
(d) fish pate; or
(e) other similar ready-to-eat fish.


A national investigation of four cases of human illness (listeriosis) during the period February to July 2019 linked to Tasmanian smoked salmon was concluded by health officials on 31 October 2019.  There was no evidence of salmon product in the market place that was not compliant with the Food Standards Code nor evidence of an ongoing unmanaged public health risk.

However, an independent expert review commissioned by Tasmania’s Chief Inspector of Primary Produce Safety provided risk-based recommendations to improve the current regulatory system for smoked salmon.  Hence, the proposed determination for smoked or preserved fish and improvements to Listeria management practices through the application of guidelines are being made to ensure we have best practice in our regulatory system.

Biosecurity Tasmania, in consultation with seafood producers, developed the guidelines to provide businesses and auditors with risk-based tools for Listeria management that have clear, scientific underpinning.  The implementation of these tools will be supported via provisions for accreditation and approved food safety programs in the Act and the Seafood Food Safety Scheme. 

​Download a copy of the Guidelines:

To achieve this, the proposed determination will require all existing and new producers of smoked or preserved fish to be accredited in accordance with the Act and the Scheme and implement an approved food safety program that is consistent with the guidelines.

​Whilst Listeria is common in the environment and is found in a range of produce including chilled ready-to-eat (RTE) meats and seafood, rockmelon, pate, soft cheeses, dip, soft-serve ice cream, and unpasteurised dairy products, the existing public health advice for people at higher risk of Listeria infection to avoid such foods remains relevant.


The determination referred to in paragraph 1 of the Notice will not be made until a period of 21 days after the publication of the Notice in the Tasmanian Government Gazette has elapsed.

Any person may, within the period referred to in paragraph 3 of the Notice, make a submission or comment in respect of the proposed determination by emailing the submission/comment to​ ​


Program Manager (Primary Produce Safety)

Karen Loone
13 St Johns Avenue,
New Town, TAS, 7008.