Federal Register of Legislation - Australian Government

Primary content

Food Standards as made
This instrument amends food standards in the Australia New Zealand Food Standards Code.
Administered by: Health
General Comments: This instrument varies the Australia New Zealand Food Standards Code by inserting Standard 4.2.1 - Primary Production and Processing Standard for Seafood (Australia Only).
Exempt from sunsetting by the Legislative Instruments Act 2003 s 54(1), Food Standards Australia New Zealand Act 1991 s 82(2)
Registered 26 May 2005
Tabling HistoryDate
Tabled HR31-May-2005
Tabled Senate14-Jun-2005
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014
Table of contents.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EXPLANATORY STATEMENT

 

 

 

PROPOSAL P265

 

 

 

Primary Production & Processing Standard for Seafood

 

 


FOOD STANDARDS AUSTRALIA NEW ZEALAND (FSANZ)

FSANZ’s role is to protect the health and safety of people in Australia and New Zealand through the maintenance of a safe food supply.  FSANZ is a partnership between ten Governments: the Commonwealth; Australian States and Territories; and New Zealand.  It is a statutory authority under Commonwealth law and is an independent, expert body.

FSANZ is responsible for developing, varying and reviewing standards and for developing codes of conduct with industry for food available in Australia and New Zealand covering labelling, composition and contaminants.  In Australia, FSANZ also develops food standards for food safety, maximum residue limits, primary production and processing and a range of other functions including the coordination of national food surveillance and recall systems, conducting research and assessing policies about imported food.

The FSANZ Board approves new standards or variations to food standards in accordance with policy guidelines set by the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) made up of Commonwealth, State and Territory and New Zealand Health Ministers as lead Ministers, with representation from other portfolios.  Approved standards are then notified to the Ministerial Council.  The Ministerial Council may then request that FSANZ review a proposed or existing standard.  If the Ministerial Council does not request that FSANZ review the draft standard, or amends a draft standard, the standard is adopted by reference under the food laws of the Commonwealth, States, Territories and New Zealand.  The Ministerial Council can, independently of a notification from FSANZ, request that FSANZ review a standard.

The process for amending the Australia New Zealand Food Standards Code (the Code) is prescribed in the Food Standards Australia New Zealand Act 1991 (FSANZ Act).  The diagram below represents the different stages in the process including when periods of public consultation occur.  This process varies for matters that are urgent or minor in significance or complexity.

 

 



Final Assessment Stage

 

FSANZ has now completed two stages of the assessment process and held two rounds of public consultation as part of its assessment of this Proposal. This Final Assessment Report and its recommendations have been approved by the FSANZ Board and notified to the Ministerial Council.

 

If the Ministerial Council does not request FSANZ to review the draft amendments to the Code, an amendment to the Code is published in the Commonwealth Gazette and the New Zealand Gazette and adopted by reference and without amendment under Australian State and Territory food law.

 

Note, however, that this particular Standard, will not apply in New Zealand.

 

Further Information

 

Further Information on this Proposal and the assessment process should be addressed to the FSANZ Standards Management Officer at one of the following addresses.

 

Food Standards Australia New Zealand        Food Standards Australia New Zealand
PO Box 7186                                                     PO Box 10559
Canberra BC ACT 2610                                 The Terrace WELLINGTON 6036
AUSTRALIA                                                   NEW ZEALAND
Tel (02) 6271 2222                                             Tel (04) 473 9942
www.foodstandards.gov.au                             www.foodstandards.govt.nz

 

Assessment reports are available for viewing and downloading from the FSANZ website www.foodstandards.gov.au or alternatively paper copies of the reports can be requested from FSANZ’s Information Officer at info@foodstandards.gov.au including other general enquiries and requests for information.


TABLE OF CONTENTS

 

EXECUTIVE SUMMARY.. 4

1.     Introduction.. 4

1.1       Food safety is a public health issue. 4

1.2       Australian food standards. 4

2.     Background.. 4

2.1       The seafood sector. 4

2.2       Development of a primary production and processing standard for seafood. 4

2.3       Labelling of fish names. 4

3.     Current management strategies to address seafood safety.. 4

3.1       Domestic Production - regulatory requirements for food safety. 4

3.1.1        Australia New Zealand Food Standards Code - adopted nationally under State/Territory legislation  4

3.1.2        State and Territory regulations for the primary production of seafood. 4

3.1.3        Australian Shellfish Quality Assurance Program (ASQAP) 4

3.2       Voluntary industry standards and guidelines for domestic production. 4

3.3       Imported seafood - regulatory requirements for food safety. 4

3.3.1        Recognised quality assurance arrangements. 4

3.3.2        Certification provided by overseas governments. 4

3.3.3        Monitoring for food safety by States and Territories. 4

3.3.4        Enforcement of process standards for imported food. 4

3.3.5        Importation of seafood from New Zealand. 4

3.4       Food safety and exported seafood. 4

3.5       Summary of regulation of the Australian seafood sector. 4

4.     Regulatory problem... 4

4.1       Growing global burden of food-borne illness. 4

4.2       Impacts of food-borne illness in Australia. 4

4.3       A new approach to food safety. 4

4.4       Identification of public health and safety risks posed by seafood. 4

4.4.1        Risk ranking method. 4

4.4.2        Future reviews of the risk ranking. 4

4.4.3        Food safety hazards in seafood. 4

4.4.4        Summary of risk rankings. 4

4.5       Examination of existing management systems and their control of identified risks  4

4.5.1        Seafood ranked as high (relative to other seafood) 4

4.5.2        Lower risk seafood. 4

5.     Objective.. 4

6.     Regulatory options. 4

6.1       Scope of the Standard and Definition of Seafood. 4

6.2       Option 1 – The status quo. 4

6.3       Option 2 – A Primary Production and Processing Standard targeting high-risk seafood activities only  4

6.4       Option 3 – A risk-based Primary Production and Processing Standard to improve the overall safety in the seafood supply chain. 4

6.5       Summary of options. 4

7.     Impact analysis for seafood.. 4


7.1       Affected Parties. 4

7.2       Option 1: the status quo. 4

7.2.1        Benefits of Option 1. 4

7.2.2        Costs of Option 1. 4

7.3       Option 2 – A Primary Production and Processing Standard targeting high-risk seafood activities only  4

7.3.1        Benefits of Option 2. 4

7.3.2        Costs of Option 2. 4

7.4       Option 3 – A risk-based Primary Production and Processing Standard to improve the overall safety in the seafood supply chain. 4

7.4.1        Benefits of Option 3. 4

7.4.2        Costs of Option 3. 4

8.     Consultation on the Draft Assessment Report.. 4

8.1       Consultation on the Draft Assessment Report. 4

8.1       World Trade Organization Notification. 4

9.     Conclusions. 4

10.       Recommendation.. 4

11.       Implementation, monitoring and review... 4

Attachment 1 - Draft variations to the Australia New Zealand Food Standards Code   4

Attachment 2 - The Policy and Regulatory Framework for the Development of Food Standards. 4

Attachment 3 - The Seafood Sector.. 4

Attachment 4A - Consultation on Initial Assessment Report.. 4

Attachment 4B - Consultation on Draft Assessment Report.. 4

Attachment 5A - Summary of Submissions at Initial Assessment.. 4

Attachment 5B - Summary of Submissions at Draft Assessment.. 4

Attachment 6A - Summary of Submissions by Issue at Initial Assessment   4

Attachment 6B - Summary of Submissions by Issue at Draft Assessment.. 4

Attachment 7 - Australia New Zealand Food Standards Code requirements for seafood.. 4

Attachment 8 - Available Codes of Practice for the Safe Production of Seafood   4

Attachment 9 - The Imported Food Inspection Scheme and Seafood Testing   4

Attachment 10 - A Risk Ranking of Seafood in Australia (February 2005) 4

Summary.. 4

Risk ranking method. 4

Future reviews of the risk ranking. 4

Food safety hazards in seafood. 4

Summary of risk rankings. 4

1.     Scope and purpose.. 4

2.     Introduction.. 4

Sources of hazards associated with seafood in Australia. 4

Food-borne illness associated with Australian seafood. 4

Approaches taken in this report. 4

Alternative risk ranking methods. 4

Risk ranking model employed. 4

3.     Risk rankings. 4

Food safety risks due to molluscan shellfish. 4

Food safety risks due to cephalopod molluscs. 4

Food safety risks due to crustacea. 4

Food safety risks due to finfish. 4

4.     Discussion of relative risk rankings. 4

High relative risk rankings. 4

Medium relative risk rankings. 4

Low relative risk rankings. 4

5.     Uncertainty and variability.. 4

6.     Conclusions. 4

References. 4

Appendix 1 - Hazards along the seafood production and processing supply chain   4

Molluscan shellfish. 4

Cephalopod molluscs. 4

Crustacea. 4

Finfish. 4

Appendix 2 - Epidemiological data.. 4

Appendix 3 - Seafood consumption in Australia by gender and age.. 4

Limitations of the dietary modelling. 4

Molluscan shellfish. 4

Cephalopod molluscs. 4

Crustacea. 4

Fish and fish products. 4

Appendix 4 - Hazard identification/hazard characterisation.. 4

Bacterial pathogens. 4

Viral pathogens. 4

Parasites. 4

Chemical contaminants. 4

References in Appendix 4. 4

Appendix 5 - Pearl oyster meat and offshore scallops. 4

Background:  Requirements for producers of bivalve molluscs. 4

Scientific issues. 4

Applying the Risk Ranking Methodology. 4

References. 4

 

 


EXECUTIVE SUMMARY

 

This Report proposes, for the first time, that there be a single, national food safety standard for the primary production and processing of seafood.

 

Australia enjoys a high level of food safety protection but, like many other nations, we face the challenge of improving food safety. It is recognised that the risks from seafood are usually well managed and are therefore considered low. There are only a very small number of products that may present higher public health and safety risks.

 

Food-borne illness is a growing public health problem globally because of the increasing global trade in food, changes in the way food is produced and consumers’ changing requirements. These changing patterns are causing new challenges in the way food safety is managed.

 

A recent study conducted by the food-borne illness surveillance network of Australia, OzFoodNet, estimates that there are 5.4 million cases of food-borne illness in Australia each year from a variety of foods. There is a need to ensure that there are appropriate strategies in place to effectively manage food safety across all food sectors in the current environment of global food trading and in light of the estimates of the incidence of food-borne illness.

 

A whole of government approach is now being taken in Australia to the management of food safety. Governments have agreed that food safety should be managed throughout the food supply chain. This approach aims to improve public health and safety and ensure that consumers continue to have the highest confidence in the safety of the food they consume.

 

FSANZ has been given responsibility for the development of food safety standards in the primary production and processing part of the food supply chain – in addition to its existing responsibilities for the manufacturing, retail and food service sectors. Under the FSANZ Act, the objectives for developing all food standards, in descending order of priority, are:

 

·                the protection of public health and safety;

·                the provision of adequate information relating to food to enable consumers to make informed choices; and

·                the prevention of misleading or deceptive conduct.

 

Seafood is one of the first industries to be examined in relation to a national approach to improving the primary production end of the food supply chain. The seafood industry itself has encouraged this early work.

 

Seafood is an important part of the diet for consumers in Australia and New Zealand. The sector is an important part of the Australian food industry - the fourth largest after beef, wheat and milk – with a considerable focus on exports.

 

This Final Assessment Report outlines how industry and government currently achieve seafood safety in Australia – generally with a mixture of industry self-regulation, licensing schemes, and general and specific (albeit differing) State legislation. While providing a measure of assurance, this mix of arrangements, both voluntary and mandatory, creates some gaps in the management of food safety.


FSANZ has consulted widely in the development of this proposed Standard. A Standards Development Committee, consisting of representatives from State and Territory jurisdictions and New Zealand, and industry and consumer representatives, has carefully considered the results of committee discussions, opinion at public fora and written feedback from stakeholders on both the Initial Assessment Report and the Draft Assessment Report for this Proposal.

 

FSANZ, with assistance from the Seafood Standards Development Committee, has examined how to improve further the management of public health and safety issues in the sector in Australia. A number of options have been considered and these are outlined in the table below:

 

 

NATURE OF FOOD SAFETY CONTROL

OPTION

1

Status quo

OPTION

2

Mgt of higher risk only
OPTION
3

Basic Safety Provisions + Mgt of higher risk

Current arrangements:

-General obligation under Food Acts to produce safe food

-Food Std Code provisions (except for primary production)

-State and Territory schemes (NSW, VIC)  

-Voluntary industry codes of practice

 

P

P

P

P

 

P

P

P

P

 

P

P

 

P

General Provisions:

Food safety practices applied to primary production end of seafood sector (similar to current hygiene requirements for the manufacturing, retail and food service sectors but tailored to seafood industry)

 

 

 

 

P

Specific Provisions:

Standard 3.2.1 (Food Safety Programs) or equivalent applied to higher risk activities of the seafood industry

 

 

P

 

P

 

States and Territories will be responsible for compliance with and enforcement of this Standard. Government costs may vary from State to State, but overall arrangements for industry will be more efficient by having a single national standard.

 

A regulatory impact analysis has been undertaken to consider which option provides the maximum public health protection, with least impost on industry. The estimated benefits of introducing Option 2 (before costs) is $26.4 million per year, while benefits of introducing Option 3 are estimated between $30 million to $75 million per year. The preferred option is Option 3.

 

Option 3 is preferred as it provides a single set of national standards to protect public health and safety (the primary objective of the FSANZ standard-setting process under section 10 of the FSANZ Act).  It would do this by requiring an approach that is more rigorous for the higher risk products, which were identified from a review (risk ranking report) of the public health and safety risks associated with the consumption of seafood.  The products include oysters and other bivalve molluscs (with some exceptions).


For seafood businesses producing bivalves[1], compliance with pre-harvest provisions of the Australian Shellfish Quality Assurance Program and the implementation of food safety programs for the post-harvest sector up to the beginning of the retail sector is proposed. Food safety requirements for retail and the food service sector are already covered under Chapter 3 of the Code.

 

For the majority of the seafood industry - that poses lower risk (medium and low risk categories according to the risk ranking report) – a basic set of food safety provisions (called general provisions) are proposed. Such provisions would include requirements to ensure that food is not contaminated during its production or handling, that adequate temperature control of food is maintained and that staff have the skills and knowledge about food safety that is necessary for the work they undertake. Some of the medium risk products may benefit from more specific risk management strategies. However, these may vary according to geographic/climatic and other factors, as well as existing jurisdictional and industry infrastructures.

 

For this reason, the proposed Standard does not prescribe a documented seafood safety management system for the lower risk products as for the high risk products. Nevertheless, the Standard will require a seafood business to systematically examine all its primary production operations to identify potential seafood safety hazards and implement controls that are commensurate with the food safety risk The extent of hazard identification, implementation of control measures and verification required should also be commensurate with the level of food safety risk involved. This is most appropriately determined by State and Territory jurisdictions in consultation with industry, taking account of local environmental factors. Where possible, State and Territory jurisdictions should use national forums such as the Implementation Subcommittee (ISC) if the Food Regulation Standing Committee to develop nationally consistent approaches to verification.

 

The philosophy behind this approach is about taking a preventive approach to managing food safety hazards and for industry, at all parts of the food supply chain, to play their role in minimising such hazards.

 

Option 3 proposes an approach based on risk – where risk is lower, the requirements are basic and where risks are higher, more significant requirements are proposed to manage food safety. The Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) made a decision in December 2003 – that food safety management approaches be based on risk and that food safety programs only be introduced where the benefits outweighed the costs of their implementation.  Ministers also decided, based on the outcomes of the National Risk Validation Project, to require the introduction of food safety programs for oysters and other bivalves, up to the back door of the retail sector.   The proposed Standard will implement the decision of Ministers.

 

Specific recommendations are made in this Draft Assessment about implementation (effectively over a two year period) and a draft of the proposed Standard is included at Attachment 1.

 


The Standard will be supported by an interpretive guideline for enforcement officers, developed by FSANZ, and industry developed guides to assist industry comply with the Standard. The framework for Option 3 is outlined below.

 

Proposed Regulatory framework for food safety management in seafood

Consideration has also been given to fish names labelling requirements.  While a comprehensive regulatory analysis has not been undertaken to support a case for mandating prescribed labelling of all fish species in all circumstances across the catching/production, processing, wholesale and retail sectors of industry, consultations have been undertaken with Standards Australia on the development of a national fish names standard for fish names.

 

To assist industry, FSANZ has facilitated discussions and agreements with various Australian government and industry agencies, to help develop an Australian Standard for fish names that could serve as a reference document for action under trade practices laws. Following implementation of these arrangements, further consideration will be given (through FSANZ’s standards development processes) to whether any further coverage in the Code is required.

 


1.        Introduction

 

1.1         Food safety is a public health issue

 

Food-borne illness is a significant public health issue.  In Australia, a national survey of gastroenteritis during 2001-02[2] estimated that 5.4 million cases are due to contaminated food, resulting in the loss of 6.5 million days of paid work.  This means that about one in four Australians get sick annually from eating unsafe food.

 

On the basis of these findings, together with costing data from a previous study[3], the Australian Government Department of Health and Ageing has estimated that food-borne illness comes at a substantial economic and social cost to the Australian community – estimated at $3.75 billion annually.

 

Food-borne illness impacts on health, consumer confidence in the food supply as well as on local and global trade in food.  It is therefore important for consumers, industry, and governments that effective measures are put in place to ensure the safety of food. 

 

The public is increasingly aware of the potential health risks posed by pathogenic micro-organisms and chemical substances in the food supply.  Such challenges to food safety must be met by a fully effective food safety system that protects public health, builds confidence of consumers in the food supply and has a positive effect on food trade.  Such a system needs to have capacity to meet future challenges. Food safety regulation should also be sensitive to, and supportive of, the needs of the food industry. It should result in the lowest achievable regulatory costs on industry and facilitate industry innovation and growth. In order to achieve these dual aims of consumer protection and industry support, it needs to be based on sound scientific evidence and be commensurate with the risks.

 

Since 1996, international agreements have resulted in the World Trade Organization (WTO) being an interested party in the work of the Codex Alimentarius Commission (Codex), which is responsible for developing international food standards. Those agreements have significantly changed approaches to food safety by all WTO members, including Australia, as they oblige Member States to set health and safety standards on the grounds of protecting public health.  Such standards must be justified by a sound, scientific risk assessment.

 

Australia’s approach to food safety, modelled on international principles, addresses food safety across the entire food chain and manages hazards that pose a significant risk to public health.  Australia takes a preventive approach to managing food safety and national standards are framed to achieve outcomes, rather than prescribe approaches, to provide businesses with flexibility in how they achieve the outcomes.

 

1.2         Australian food standards

 

The Code sets standards for chemical and microbiological safety, composition and labelling of food, approves new foods and foods using new technologies, and establishes food safety standards for the hygienic production and handling of food.


The existing food safety standards apply from processing and manufacturing through to the retail sector of the food chain.  However, these food safety provisions do not apply to primary production.

 

In 2000, the Council of Australian Governments (COAG) agreed to major changes to the food regulatory system. As part of these changes, Food Standards Australia New Zealand (FSANZ) received a mandate to address food safety across the entire food chain where appropriate[4].  This facilitates a preventive approach to significant food safety risks across the food supply chain.

 

FSANZ must adhere to specific legislative requirements and guidelines when developing food standards, and receives policy guidance from the Ministerial Council.

 

Further details about the policy and regulatory framework for the development of food standards is contained at Attachment 2.

 

In December 2003, the Ministerial Council developed Ministerial Policy Guidelines for Food Safety Management in Australia, whereby food safety programs were made mandatory for identified highest risk sectors where the benefit to cost ratio justified their implementation. These Ministerial Guidelines identify specific high-risk business sectors where food safety programs should be made a mandatory regulatory requirement in accordance with Standard 3.2.1 of Chapter 3 of the Code.  These were:

 

·                food service in which potentially hazardous food is served to vulnerable populations (e.g. hospitals and nursing homes);

·                producing, harvesting, processing and distributing raw bivalve molluscs

·                catering operations serving food to the general public; and

·                producing manufactured and fermented meat.

 

The Ministerial Council noted in its Guidelines that in relation to raw bivalve molluscs, FSANZ would address this sector in the Draft Assessment process for the primary production and processing Standard for seafood. 

 

It is within this context that FSANZ is developing the first primary production and processing Standard for the seafood sector in Australia. The principle purpose of FSANZ’s food standards is to protect public health and safety (and may also address consumer information needs) under the objectives for standard-setting under the FSANZ Act. In developing this Standard, FSANZ must follow its statutory standard-setting processes to implement the decision of the Ministerial Council in relation to bivalve molluscs.

 


2.        Background

 

2.1         The seafood sector

 

The seafood industry is the fourth largest sector of the Australian food industry (by value) after beef, wheat and milk. The gross value of production (GVP) during 2000-01 was  $2.44 billion[5]. Since 1992, the GVP has increased, on average, by 10 per cent per annum[6]. Approximately 87 per cent of the value and 34 per cent of the edible volume of Australian seafood production is exported.

 

At 11 million square kilometres, the Australian fishing zone is the third largest in the world. Most wild fish stocks are fished at their optimal sustainable level, with aquaculture making an increasing contribution to the industry. Between 1991-92 and 2001-2, aquaculture was responsible for approximately 24 per cent of the total volume of seafood produced in Australia.

 

During 2001-02, 186,777 tonnes of seafood were produced in Australia, covering approximately 600 marine and freshwater seafood species. Approximately 66 per cent was consumed domestically, with the remainder exported. A further 144,474 tonnes were imported, mainly from Thailand and New Zealand.

 

Further details about the seafood sector, its nature and the value and volume of production, can be found at Attachment 3.

 

2.2         Development of a primary production and processing standard for seafood

 

Proposal P265 – Primary Production and Processing Standard for Seafood, was raised by FSANZ in December 2002 under its mandate to develop domestic standards for the primary production and processing of food.

 

Recently, some State Governments have developed seafood safety schemes to ensure that a ‘boat to plate’ (i.e. paddock to plate) approach to seafood safety was implemented across the seafood supply chain.  However, other Governments are not yet at that point, leaving the primary production end of the domestic seafood chain largely unregulated.

 

The seafood sector is also increasingly aware that food safety issues are vital to the continued growth of the industry, and has developed a national voluntary seafood safety Standard.  The industry has also produced a number of guidance documents on food safety across a range of sectors.  It is therefore considered an opportune time to move these developments forward nationally to further improve food safety outcomes.

 

As required by the Ministerial policy guidelines, a Standards Development Committee (SDC) was appointed in September 2002 by the FSANZ Board to assist in the development of the Standard.  The SDC contributes a broad spectrum of knowledge and expertise covering industry, government, research and consumers.

 


Since December 2002, FSANZ, with the assistance of the SDC, has:

 

·                considered the written submissions  received in response to the public consultation on the Initial Assessment Report and the Draft Assessment Report and;

 

·                 conducted face-to-face consultations with stakeholders (see Attachments 4, 5 and 6);

 

·                undertaken an evaluation of public health risks and identified sectors of the seafood industry that pose a potential high risk to safety;

 

·                considered current strategies to manage those risks and determined what, if any, residual risks need to be managed;

 

·                considered options for the management of these residual risks that aim to ensure the safety of seafood;

 

·                conducted an impact analysis of the options to identify the option that meets the minimum effective regulation requirements that would effectively address public health and safety risks associated with seafood production;

 

·                recommended a preferred option;

 

·                considered the implementation of the preferred option; and

 

·                drafted a proposed Standard consistent with the preferred option.

 

This Report forms the third stage in the process of developing a primary production and processing Standard for seafood. It takes into account the matters raised above and other deliberations of the Seafood SDC. Industry, government, agencies, consumers and other interested parties are invited to comment on these or any other matters relating to the development of a primary production and processing Standard for seafood.

 

2.3         Labelling of fish names

 

Ministers with responsibility for food regulation in Australia and New Zealand have stated that primary production standards should be developed to focus primarily on food safety matters and be complementary to, and not inconsistent with, the other chapters of the Code.  These other sections of the Code contain generic and specific standards for all foods as well as standards for hygienic production of food. A primary reason for this separation of issues is that primary production standards will apply in Australia only and under the Treaty between Australia and New Zealand, the composition and labelling provisions of the Code apply in both Australia and New Zealand.

 

Labelling requirements for foods are determined following analysis against the objectives for standards set out in the FSANZ Act, COAG policy requirements for minimum effective regulation that is not anti-competitive and relevant Ministerial policy guidelines[7].

During the development of the primary production Standard for seafood, some sectors of the fishing industry have advocated the need for mandatory labelling of fish names to prevent or limit consumer deception, a view that has also been supported by a major supermarket. Furthermore, the Australian Seafood industry Council (ASIC), the peak industry body for seafood, has incorporated the Australian Fish Names List in the industry voluntary Standard. Part 1.2 – Labelling and other Information Requirements, could be amended if a need were demonstrated, following a comprehensive analysis of the consumer risks, the regulatory options, and the likely costs and benefits to consumers, industry[8] and governments and public comment on the analysis. This analysis is required in the development of any standard in the Code to ensure that it receives Ministerial agreement and enforcement support by the States and Territories.

 

Discussions have also included reference to the existing protection consumers have against false and misleading claims in the various trade practices laws in Australia and New Zealand and the general principle of not duplicating legislation if this can be avoided.

 

In the meantime, following extensive discussions with industry (through the Seafood SDC), Standards Australia, the Australian Competition and Consumer Commission, the Australian Government Department of the Treasury (the agencies responsible for developing and administering Australia’s consumer protection and business development laws) and with the Office of Regulation and Review, the following steps have been initiated by FSANZ and industry:

 

1.             FSANZ and the seafood industry has entered into discussions with Standards Australia to develop an Australian Standard for fish names, based on the existing list of fish names developed by the fishing industry.

 

2.             Preliminary discussions with the ACCC indicate that such a standard could be used as a reference document to assist in enforcement by the ACCC under the fair trading laws.

 

3.             Once there is a formally recognised Australian Standard for fish names, consideration could be given to an Application to amend the Code to refer to the resulting Australian Standard on fish names. The nature of the reference (mandatory or voluntary; in all circumstances or only where there is a demonstrated health risk) would be determined at that time following FSANZ’s normal assessment procedures.

 

3.        Current management strategies to address seafood safety

 

The safety of Australian seafood is controlled under a variety of schemes from primary production through processing, manufacture, wholesale, retail and food service.  Regulatory and non-regulatory approaches are taken and these are outlined below.


3.1         Domestic Production - regulatory requirements for food safety

 

3.1.1      Australia New Zealand Food Standards Code - adopted nationally under State/Territory legislation

 

Domestic seafood production and imported seafood sold in Australia are subject to the requirements of the Code, as adopted under State and Territory legislation.  State and Territory governments enforce compliance with the Code under their Food Acts.

 

Management of the public health and safety risks and consumer information needs associated with wholesale trade, processing, manufacture, retail and foodservice of seafood products are covered by existing standards.

 

Chapter 1 of the Code specifies permissions for the use of food additives, processing aids and pesticides and also sets maximum limits for chemical and microbiological contaminants in seafood.  There are also requirements for the labelling of seafood. Chapter 2 of the Code contains specific requirements for fish and fish products.

 

Chapter 3 of the Code contains provisions for the hygienic processing and handling of food, and voluntary provisions covering the application of Food Safety Programs to the processing and retail part of the food chain.  The Food Safety Standards in Chapter 3 do not currently apply to the primary production of seafood, except where there is direct sale to the public or the primary producer substantially processes the seafood.

 

It should be noted that the point in the processing part of the food chain at which the Food Safety Standards apply is not the same in all jurisdictions.  Generally, the Standards do not apply on board vessels for activities such as gutting and filleting.

 

Attachment 7 provides a summary of these national standards impacting on seafood.

 

3.1.2      State and Territory regulations for the primary production of seafood

 

Different regulatory arrangements for seafood are in place in each of the States and Territories. These schemes are outlined in the sections below. (See also Table 1.)

 

Table 1:     Seafood activities covered by food safety standards (Chapter 3) and State primary production food safety schemes

 

State/Territory

Seafood industry activities covered by

State/Territory Primary Production food safety schemes

Food Safety Standards (Chapter 3) under the Code and State/Territory Food Acts

New South Wales

§ Capture/harvest to wholesale*

§ Bivalve molluscs

Manufacturing, retail and food service

Queensland**

§ Bivalve molluscs

Manufacturing, retail, food service

Victoria ***

§ Capture/harvest, processing, wholesale, transport and retail fresh fish outlets

§ Bivalve molluscs

Retailers selling cooked seafood

South Australia

§ Bivalve molluscs

Gutting or filleting off-vessel or off-farm, bivalve molluscs from storage onwards (cleaning, grading, packing, shucking), wholesale, manufacture, retail, foodservice

Western Australia

§ Bivalve molluscs

From land based seafood-processing facilities to retail sale.  Shellfish - handled after harvest

Tasmania

§ Bivalve molluscs

Shellfish - bagging, holding tanks, shucking. Finfish - filleting, thermal packaging, smoking and other manufacturing, retail sale and foodservice

Northern Territory

-

Wholesale, manufacture, retail, food service

Australian Capital Territory

-

Wholesale, manufacture, retail, food service

*           State-based scheme under NSW Food Production (Seafood Safety Scheme) Regulation 2001.

**         Initial/preparatory work on a Queensland Seafood Safety Scheme, which covers capture/harvest, gutting and filleting, shucking, boiling, freezing and wholesaling fresh fish.  Note this scheme is not yet in place (pending outcome of the development of a national seafood standard)

***        Victorian scheme under the Seafood Safety Act.

 

3.1.2.1   New South Wales

 

The NSW seafood industry is regulated under the NSW Food Production (Seafood Safety Scheme) Regulation 2001. The original requirement for HACCP-based food safety programs[9] for all seafood businesses has subsequently been modified to match the rigor and complexity of the food safety systems, and the degree to which they are to be audited, with the level of risk to public health and safety.

 

For example, a food safety plan for a low risk business will not fully implement all HACCP principles and will only need to cover activities that impact on hygiene, sanitation and any necessary temperature controls.  Roll-out of the system is being staggered, with the catch/harvest sector (excluding shellfish aquaculture), deemed to be mostly low-medium risk, being the first sector considered.

 

The NSW Food Production Regulation 2001 also incorporates a shellfish quality assurance program.  Principles of the Australian Shellfish Quality Assurance Program (ASQAP) have been incorporated into the mandatory Shellfish Program to ensure safety in the consumption of bivalve molluscs. 

 

3.1.2.2   Victoria

 

In Victoria, legislation for a new seafood safety system came into effect on 1 July 2003, with the exception of the wild catch and aquaculture sectors, which will come under the new legislation on 1 July 2004.  The Seafood Safety Act extends the responsibilities of the Victorian Meat Authority (now called Primesafe) to cover the primary production, processing and retail sectors of the seafood industry.  All seafood businesses must be licensed by Primesafe, and operate to approved food safety programs audited under the authority of Primesafe.

 

Seafood processors, wholesalers and retailers of fresh fish transferred from supervision under the Victorian Food Act to Primesafe on 1 January 2004.  Victoria will adopt the national primary production and processing standard for seafood under this legislation.

 

In addition to the requirements imposed on primary production and processing of seafood under the proposed Seafood Safety Act, supermarkets and businesses engaged in retail sale of cooked seafood, such as fish and chip shops and restaurants, are required to implement a food safety program under provisions of the Food Act 1984.


3.1.2.3   Queensland

 

Queensland commenced consultation and development work on a seafood safety scheme, but is now waiting for the development (by FSANZ) and gazettal of the national primary production and processing Standard for seafood in the Code. 

 

3.1.3      Australian Shellfish Quality Assurance Program (ASQAP)

 

The safe production of bivalve molluscs is effectively managed through a single management system, the ASQAP.  ASQAP is a national program modelled on the United States Food and Drug Administration’s National Shellfish Sanitation Program.  The Program was initially developed to meet AQIS export requirements and adapted to local conditions by the Australian Shellfish Quality Assurance Advisory Committee (ASQAAC), to provide guidelines for the safe production and marketing of bivalve molluscs for domestic production.

 

Bivalve molluscs are filter feeders, extracting phytoplankton, bacteria and suspended organic and inorganic particles (including heavy metals, toxins, enteric pathogens and endogenous marine pathogens) from the surrounding water.  Waters from which bivalves are harvested may be subjected to pollution from discharges of untreated or poorly treated human waste, direct discharges of industrial wastes and runoff from urban and agricultural areas.  Bivalves have been associated with numerous outbreaks of human illness because of their ability to bio-accumulate pathogens and toxins derived from contaminated waters, and because they are often eaten raw or only lightly cooked with their gastrointestinal tract intact.

 

The most commonly used approach for managing these risks involves harvesting shellfish only from waters that are shown to be free from harmful contaminants or pathogenic micro-organisms.

 

Federal, State and (sometimes) local government agencies share administrative responsibilities for the management of bivalves; sanitation controls for growing areas (including sanitary surveys and water classification); harvesting controls; and post-harvest processing and handling of bivalves consumed in Australia.  ASQAP is administered on a co-operative basis by these agencies.  For bivalves destined for export markets, AQIS administers sanitation controls for post-harvesting processing and handling of product.

 

In each State, the State Government regulates and manages the strict water and environmental monitoring provisions in the State program e.g. QSWAMP (Queensland Shellfish Water Assurance Monitoring Program), VSQAP (Victorian Shellfish Quality Assurance Program), TSQAP, SASQAP, NSWSQAP, WASQAP etc.  Under these arrangements, there is a State Shellfish Control Authority (SSCA) that undertakes shoreline sanitation surveys, sanitation reviews, and risk management procedures.

 

Under ASQAP, harvest areas must be classified by the SSCA on the basis of the shoreline sanitary survey and an on-going water-sampling program. Production areas are classified as: Approved; Approved conditional; Restricted; Restricted conditional; and Prohibited.  ASQAP also imposes controls on bivalve harvesting and ensures protection from contamination after harvesting.

 


The success of the program is based on continual and extensive monitoring of all commercial growing areas.  It entails a precautionary approach, resulting in the closure of a harvesting area following a trigger event such as heavy rainfall or toxic algal bloom.  Rainfall can flush microbiological and other pollution into harvesting areas and may also lead to conditions that encourage blooms of toxic phytoplankton.

 

Australian States and Territories also regulate bivalve safety through aquaculture licences, making it a condition of the licence to be part of the State shellfish quality assurance program.  The approach under this system, while not embedded in the food regulation system, is recognised to be effective.

 

3.2         Voluntary industry standards and guidelines for domestic production

 

Many seafood businesses comply with voluntary industry guidelines and codes of practice developed by industry peak bodies to address seafood quality and safety issues. Examples of industry guidelines and codes of practice are listed in Attachment 8.

 

There are no data on the extent to which these guides are implemented by industry, but large operations and those that perceive a market advantage tend to implement and adhere to guidelines, while smaller, resource-constrained businesses are less likely to adopt them. 

 

3.3         Imported seafood - regulatory requirements for food safety

 

Imported foods must meet the same standards as domestic foods.

 

At the border, the safety of imported seafood is regulated under the Imported Food Control Act 1992 administered by AQIS.  FSANZ and AQIS have joint responsibility for regulating the safety of imported food, with their roles defined by a memorandum of understanding.  FSANZ is responsible for conducting risk assessment of imported food, and AQIS provides operational services at the border, including inspections, verifications and tests in line with FSANZ’s advice and to ensure that imported foods comply with the Code.

 

Imported seafood that is currently classified as ‘Risk’ food and therefore subjected to 100 per cent inspection levels, consists of the following:

 

·                crustaceans, cooked and chilled or cooked and frozen.  Includes cooked peeled prawns but excludes canned product that is commercially heat treated;

 

·                fish (whole, filleted, further processed or dried), all shark (including Dogfish), Rexea solandri (Gemfish) and tuna;

 

·                smoked vacuum packed fish and smoke flavoured vacuum packed fish;

 

·                marinara mix - chilled or frozen, whether blanched or not.  Excludes canned product that is commercially heat treated; and

 

·                molluscs ready for consumption, whether chilled or frozen.  Includes all bivalve molluscs such as mussels, clams, cockles and scallops.  Excludes canned product that is commercially heat treated.

 


All other imported seafood products are included in the random surveillance category and inspected at a rate of 5 per cent.  For further details on the current tests applied to imported seafood refer to Attachment 9.

 

FSANZ and AQIS are undertaking a review of the random and active surveillance categories.  This review is considering existing limits in the Code, the risks to public health and safety and imported food data.  The new imported food surveillance system is intended to reward those importers with a good history of compliance, and to allow greater flexibility in relation to inspection frequencies. 

 

The involvement of domestic surveillance agencies in the review of imported food surveillance will result in a more inclusive consideration of issues and allow a greater integration of surveillance functions.  It will also ensure that a broader range of information sources is considered when developing surveillance priorities.

 

The review of the imported foods random and active surveillance categories has been substantially progressed by FSANZ.  In the next few months, proposals on inspection rates for classes of foods will be presented to State and Territories and industry for their comment.  It is expected that implementation of the new, more flexible system will be in a phased approach with different rates of inspection being applied to some food categories by the end of 2004.

 

Importers can avail themselves of two mechanisms to reduce the level of inspection and testing at the border.  These include (a) recognition of quality assurance arrangements and (b) certification provided by overseas governments (see below).

 

3.3.1        Recognised quality assurance arrangements

 

AQIS may enter into quality assurance arrangements with individual overseas manufacturers that are able to demonstrate that they operate to a HACCP based quality management system that ensures their products meet the requirements of the Code and other requirements of the Imported Food Control Act 1992 and are therefore eligible for importation into Australia.  Shipments from that company will be monitored by AQIS at reduced rates.  To be eligible to enter into an agreement a company must be certified by a third party certification body to the ISO 9000 quality management standards and be able to meet requirements of relevant Codex Codes of Practice.  There are currently no such agreements in place.

 

3.3.2        Certification provided by overseas governments

 

Australia has voluntary arrangements to accept assurances from a number of governments on the safety of the food exported to Australia. Food that is accompanied by certificates issued by these governments will generally be released with document inspection only and without routine inspection of the food.  Inspections will only be carried out for verification checks of the certification arrangement or if AQIS has concerns about a particular consignment.  The certification arrangements may apply to risk, active or random surveillance foods from any country and to risk foods from New Zealand under terms of the Trans-Tasman Mutual Recognition Arrangement.

 

Currently certification is provided for a range of foods, including seafood, from at least nine countries.


3.3.3      Monitoring for food safety by States and Territories

 

In addition to border inspection, States and Territories test imported food to ensure it meets requirements of the Code at the point of sale.  States and Territories also undertake specific food surveillance surveys on food sold in Australia. These surveys cover domestically produced and imported foods.  Specific surveys on fish and fish products have been undertaken (see Table 2).

 

Table 2:     State and Territory surveys of fish and fish products sold in Australia (covers domestic and imported products)

 

Survey Title

State

Year

Foods

Listeria Monocytogenes in nil-tolerance products

QLD

1995

Smoked Fish Products

Heavy Metals/Pesticides in Brisbane River seafoods

QLD

1996

Seafood (Fish/Prawns)

Microbial quality of marinara mix

ACT

1997

Marinara mix

Biogenic amines in fish and fish products

ACT

1997

Fish and fish products

How safe are smorgasbord foods?

WA

1998

Cooked Prawns

Sulphur dioxide in cooked prawns

QLD

1999

Prawns

Mobile seafood vendor survey

NSW

2000

Seafood

Metal contamination of major NSW fish species

NSW

2001

Fin fish

Metal contamination of major NSW fish species

NSW

2001

Crustaceans

Metal contamination of major NSW fish species

NSW

2001

Molluscs

Histamines – Storage Conditions in Fish

VIC

2002

Finfish

Fish speciation, Cairns Public Health Unit

QLD

2002

Fish

Fish substitution survey

National

2003

Finfish

Shelf life of Sushi products Nigiri pieces and Nori rolls

VIC

2003

Fish products

 

These surveys may provide information on compliance with the Code at point of sale, hazards in seafood and in some instances insights into hazards that may commonly be associated with particular foods.  In relation to any public health and safety impact arising from food/hazard combinations, this would need to be established through epidemiological investigations.

 

In 2000, the OzFoodNet project was established in Australia as a collaborative project between the Commonwealth and States and Territories to enhance the surveillance of food-borne diseases and to provide a means for facilitating the national investigation of and determine the causes of food-borne illness. It is anticipated that as a result of these activities and over time, Australia will have access to improved information about the sources of food-borne illness.

 

3.3.4      Enforcement of process standards for imported food

 

Consumers need to have confidence that the food they consume is safe, irrespective of its source.  Mandatory national food standards in the Code apply to both domestically produced and imported foods.  However, the mechanisms used to determine that food is safe may differ between domestic and imported foods.

 

For imported foods, the monitoring system aims to achieve the same outcome i.e. that only safe and suitable food is sold on the Australian market. The monitoring of imported foods often examines the end point of production and tests against agreed microbiological or chemical residual limits in the Code. 


For example, instead of being able to check that specified processing requirements were applied during the production and processing of food, product safety is determined by testing, for example, for coagulase-positive staphylococci, salmonella, E. coli or histamine etc.

 

End point testing can have limitations in terms of being able to reliably ensure safe food outcomes.  Therefore, FSANZ and AQIS, in conjunction with the States and Territories, have begun to examine systems that can more reliably monitor the safety of imported foods.  It is expected that the Implementation Sub-Committee of the Food Regulation Standing Committee will consider the outcome of this work in 2005.

 

3.3.5      Importation of seafood from New Zealand

 

Seafood imported from New Zealand operates under the Trans Tasman Mutual Recognition Agreement.  The Imported Food Control Act of 1992 applies the standards in the Code to risk categorised food imported from New Zealand.

 

3.4         Food safety and exported seafood

 

Seafood exports must comply with national legislation for export control administered by AQIS.  This legislation includes the Export Control Act 1982, Export Control Prescribed Goods (General) Orders and more specifically the Export Control (Processed Foods) Orders.  These provide Government-to-Government certification to assist in fulfilling importing country food safety requirements and trade description for seafood exports. 

 

Export processing establishments (including some vessels) must be registered by AQIS and have, as a minimum, procedures to address the risks associated with the processing of different seafood products to assure an appropriate level of food safety.  International market access for Australian fish product exports are facilitated and maintained through this process, and the country’s competitive position as a supplier of safe products is enhanced.

 

AQIS systems for exported seafood are based on the auditing of processing of seafood managed under two approved arrangements.  The two systems currently available are:

 

·                Approved Quality Assurance (AQA) - based on the company having a fully documented quality management system (similar to ISO 9002 but including technical standards) audited by AQIS at least twice a year.

 

·                Food Processing Accreditation (FPA) - a simpler system than AQA, requiring only documentation of a process flow chart and HACCP plan, and Good Manufacturing Practice (GMP), which is managed as part of a premise’s registration.  Registered establishments are audited at a frequency based on the risk rating of their products, past compliance with their documented system and legislative standards.

 

3.5         Summary of regulation of the Australian seafood sector

 

The existing regulatory arrangements for domestically produced, imported and exported seafood are summarised in Table 3.

 


There is no nationally consistent approach to seafood that obliges all of the industry to manage the safety of their product at the primary end of the food chain. The fragmented, and at times voluntary nature of existing management systems, creates gaps and an uneven approach to food safety.

 

Table 3:               Seafood regulation in Australia

 

Sector è

 

Market

    ê

PRIMARY PRODUCTION

Catching Sector and Aquaculture

PROCESSING AND TRANSPORT

RETAIL AND FOOD SERVICE

 

 

 

 

Exports

Export Control (Processed Food) Orders

-   HACCP based-food safety programs required.

Export Control (Processed Food) Orders

-  HACCP based-food safety programs required.

Not applicable

 

 

 

 

Domestic seafood

Variable regulation:

-   NSW and Vic regulate primary production sector of the seafood chain requiring food safety programs.

-   Various industry food safety and quality assurance guidelines, schemes and codes.

-   Shellfish growers required to meet ASQAP requirements

State and Territory legislation (including requirements of Code).  Requirement for good hygiene practices etc.

-  Considerable variation as to what point in the supply chain the Food Safety Standards apply.

-  Various industry food safety and quality assurance guidelines, schemes and codes.

State and Territory legislation (including requirements of Code). Requirement for good hygienic practices etc.

- More consistent application except in Victoria, where food safety programs are mandatory.

- Various industry food safety and quality assurance guidelines, schemes and codes.

 

 

 

 

Imported seafood

In country production requirements.

-   Some AQIS certification requirements in place e.g. fish products imported from Thailand.

 

In country production requirements.

-  Some AQIS certification requirements in place e.g. fish products from Thailand.

 

Imports are evaluated by AQIS against requirements of the Imported Food Inspection Scheme and the Code and inspected and tested for compliance to the Code.

Seafood from New Zealand operates under the Trans Tasman Mutual Recognition Agreement and the Imported Food Control Act of 1992 applies the standards in the Code to risk categorised food imported from New Zealand.

 

4.        Regulatory problem

 

Before Governments act to regulate any sector of business, it is necessary to describe what the regulatory needs are – ‘the regulatory problem’.

 

4.1         Growing global burden of food-borne illness

 

Australia and most other countries in the world, as well as the World Health Organization (WHO)[10], recognise the increasing burden of food-borne illness worldwide. The growing burden of food-borne illness may be attributed largely to a rapidly changing global environment.  The growth in global food trade – where food grown in one country can now be transported and consumed halfway across the world, changing patterns of food production and distribution, and evolving consumer preferences for food are some of the elements of the changing environment and it is likely that these will continue in the future.  These changes create an environment that favours the emergence and re-emergence of new pathogens and contaminants in food, and the resulting food-borne illness in our population.


4.2         Impacts of food-borne illness in Australia

 

Consumers typically respond to outbreaks of food-borne illness in seafood by reducing their demand for seafood products.  For example, following contamination of NSW oysters in 1997, NSW consumers immediately reduced their demand for oysters by 85 per cent.  They also immediately reduced their demand for all seafood products by 30 per cent, indicating that consumers readily generalise a specific seafood risk to the broad category of seafood products[11].

 

However, despite consumers’ immediate reactions to outbreaks of food-borne illness, demand for seafood recovers over time.  Notwithstanding 24 outbreaks associated with raw-ready-to-eat seafood[12] during the 1990s, consumer demand for seafood has increased steadily over the medium term[13].  The implication is that while consumers immediately perceive costs when outbreaks of food-borne illness occur, these short-term costs are not sufficient to outweigh the perceived benefits of seafood to consumers over the medium-term.

 

Each outbreak of food-borne illness imposes an immediate cost on industry, by reducing sales revenues for the implicated product and with follow-on effects to the seafood industry more generally[14].

 

4.3         A new approach to food safety

 

In this environment, the effectiveness of the existing food safety management systems needs to be examined and strategies identified to further improve food safety management.  Traditional food safety systems have tended to focus on testing food at the end of the food chain, often after an outbreak of food-borne illness or an incident has been reported.  While this approach assists prosecution of offending parties, it rarely prevents food-borne illness. 

 

The more recently introduced HACCP approach to food safety offers a preventive approach to food safety, but does not approach the management of food safety from a priority perspective, i.e. it makes little distinction between controlling hazards that translate into significant risks to public health as opposed to hazards that lead to a relatively low risk to public health. The HACCP system is relatively costly to implement, and in an environment of limited resources, may not be cost-effective for all food sectors or activities.

 

The Ministerial Council has recognised the need for Australia to develop a new approach to managing food-borne risks to human health.  This approach includes a nationally consistent, whole-of-chain food safety management system that is preventive in nature, focuses on food safety outcomes rather than prescriptive requirements and identifies management systems that are commensurate with public health risks.

 

A nationally consistent, preventive approach has recently been adopted in Chapter 3 of the Code, specifying baseline food safety provisions for the hygienic production of food in the manufacturing and retail sectors.  Chapter 3 also sets out voluntary provisions for food safety programs. 


As identified earlier, the Ministerial Council recently agreed that food safety programs should become mandatory for certain food sectors identified as posing a higher risk to public health, where food safety programs would be cost-effective.

 

However, the provisions in Chapter 3 do not apply to the primary production end of the food chain.  For many industry sectors and activities, hazards introduced at the primary end of the food chain may not be able to be managed effectively further up the food chain, resulting in public health incidents.  The effective management of hazards of public health significance at the primary end of the food chain makes the task of managing hazards in the later part of the food chain easier and more effective, resulting in safer food and improved public health outcomes.

 

Section 3.5 highlighted the inconsistent approaches being taken at the primary production end of the seafood supply chain in Australia.  These gaps in the coverage of current regulation and industry compliance with voluntary management systems may have implications in terms of public health and safety.  This will need to be considered in light of the inherent public health and safety risks presented by seafood and the current strategies used to minimise these risks.

 

4.4         Identification of public health and safety risks posed by seafood

 

The Risk Ranking Report (Attachment 10) provides the scientific basis for the development of a Primary Production and Processing Standard for seafood.  The report qualitatively ranks the public health and safety risk posed by consumption of seafood in Australia.  Overall the risks from seafood are usually well managed and are therefore considered relatively low.

 

The risk ranking compares the relative risks associated with the wide variety of seafood commodities available in Australia – domestically produced and imported.  It takes into account the chemical and biological food safety hazards potentially present, and assigns each commodity or group of commodities to a broad relative risk category: low, medium or high.  There are only a very small number of products that may present relatively high public health and safety risks.

 

The ranking brings together the available scientific and technical information on food safety hazards in seafood and identifies seafood commodities of higher priority for the development of risk management strategies in the context of the Primary Production and Processing Standard for seafood.

 

4.4.1      Risk ranking method

 

FSANZ estimated relative public health risks by considering the severity of any adverse health effect resulting from the presence of a particular hazard in a seafood commodity, together with the likelihood of that adverse health effect occurring.

 

Estimates of the severity of illness due to the presence of hazards in seafood followed an internationally accepted procedure, which considers the duration of illness, likelihood of death and potential for ongoing adverse health effects.

 

Estimates of the likelihood of adverse health effects were based on:

 


·                the link between the hazard and illness due to consumption of the particular seafood (epidemiological data);

·                the prevalence and concentration or level of the hazard in seafood;

·                patterns of consumption of the specific seafood (i.e. frequency of consumption, amount consumed);

·                the impact of existing regulatory and non-regulatory risk management systems; and

·                data and information on the following factors related to the properties of the hazard and the effect of production, processing and handling, particularly in terms of how they might influence hazard levels at the point of consumption:

 

-        the capacity for microbiological pathogens to survive or grow in the commodity;

-        any other relevant properties of the hazard (e.g. toxigenic or infectious dose);

-        the probable effect of production, processing and handling on the presence and level of the hazard; and

-        the likely effect of consumer handling (including cooking and product shelf life) on hazard levels.

 

Using a ranking matrix, FSANZ combined the severity and likelihood estimates into a broad relative risk estimate for each hazard that might be found in a seafood commodity (e.g. prawns) or group of similar commodities (e.g. oysters and other bivalve molluscs).  An overall relative risk ranking for each commodity (or group of commodities) was then obtained by determining the highest relative risk ranking estimated for the commodity.

 

4.4.2      Future reviews of the risk ranking

 

The risk ranking is based on the best current knowledge and data.  Such rankings are dynamic, with their evolution reflecting increasing knowledge about the hazards and the consumer’s exposure to them. For example, the introduction of new technologies, modified production practices, and changes in management strategies may influence the need to review the rankings.

 

FSANZ will maintain a watching brief of the scientific literature and international activities, e.g. Codex Alimentarius, which may impact on the risk ranking.  Where significant data gaps impacting upon the risk ranking process are filled by the results of ongoing scientific studies and surveys of the prevalence and levels of food safety hazards in seafood in Australia, the robustness of the risk rankings can be better assessed and the rankings may be further refined.

 

4.4.3      Food safety hazards in seafood

 

Seafood can contain food safety hazards derived from several different sources.  Some of these hazards occur naturally in the environment in which seafood lives and grows and are unavoidable contaminants of seafood when it is harvested.  Others are a consequence of the impact of human activities on the environment.

 

In the pre-harvest phase of production, feed components, veterinary drugs and other chemicals employed in aquaculture production may also present a public health risk.

In addition to these, food hazards can be introduced into seafood, or caused to increase to potentially hazardous levels, through direct contamination by food handlers and contaminated utensils and equipment and by inadequate handling (e.g. temperature abuse, cross-contamination, inadequate processing).


The extent to which any food safety hazard is likely to be present in seafood depends on a number of factors.  These factors include the biology of the particular seafood species, its growing environment, and the conditions along its production and processing supply chain.  Therefore, the broad biological classes of seafood species (bivalve and cephalopod molluscs, crustacea and finfish), and the public health risks posed by hazards associated with specific commodity groups within those classes, have been considered separately.

 

4.4.4      Summary of risk rankings

 

The relative risk rankings described in this report demonstrate the generally high level of safety of seafood products.  Under current risk management practices – both voluntary and mandatory – public health risks are relatively low for the majority of seafood.  A small number of commodities present a higher public health risk than other seafood, taking into account the impact of existing regulatory and non-regulatory risk management systems.

 

The Report concludes that the following seafood sectors are ranked in the higher relative risk category:

 

·                oysters and other bivalve molluscs (except when the consumed product is only the adductor muscle, e.g. roe-off scallops) harvested from growing environments likely to be exposed to faecal contamination and/or not under a shellfish safety management scheme; and

·                ready-to-eat cold-smoked finfish (and other ready-to-eat cold-smoked seafood products), when consumed by population sub-groups susceptible to invasive listeriosis.

 

Table 4:     Seafood commodities ranked as higher relative risk

 

Risk Ranking

Commodity

High

Molluscs      - oysters and other bivalve molluscs

Finfish          - cold-smoked (including other cold-smoked seafood)

 

4.4.4.1   Oysters and other bivalve molluscs

 

Oysters and other bivalve molluscs (except when the consumed product is only the adductor muscle, e.g. roe-off scallops) harvested from growing environments vulnerable to faecal contamination and/or not under a shellfish safety management scheme present a relatively high risk to public health, mainly due to the likelihood of illness caused by contamination with hepatitis A virus and algal biotoxins (particularly Neurotoxic Shellfish Poisoning [NSP]; and Amnesic Shellfish Poisoning [ASP]).  These hazards are introduced in the pre-harvest phase of bivalve production.

 

This relatively high risk ranking is consistent with other studies based on recent epidemiological data that reflected a situation where inconsistent risk management systems were in place across Australia.

 

Food-borne illness due to oysters and other bivalve molluscs in Australia have resulted in a number of small outbreaks and sporadic cases due to Vibrio species and a few large outbreaks due to enteric viruses in oysters harvested from polluted and inadequately controlled waters.

 


While adoption of risk management strategies has improved the safety of bivalve shellfish in recent times, some risk remains.  While monitoring of harvest waters for indicators of sewage pollution (e.g. faecal or total coliforms) helps to manage the risks due to enteric pathogens, bacterial and viral, it cannot predict levels of Vibrio species and enteric viruses in oysters.  Oysters harvested from waters without a risk management system in place have a higher risk of contamination by algal toxins.  Therefore, where oysters and bivalves are harvested from waters managed under a comprehensive shellfish safety scheme, such as the Australian Shellfish Quality Assurance Program (ASQAP), the risk is significantly reduced, notably, the likelihood of a food-borne illness is very low.

 

The risk rankings for oysters and other bivalves were the same regardless of whether they were to be cooked or eaten raw, as the hazards leading to the risk rankings are not greatly affected by the light cooking normally applied to these products.

 

4.4.2      Cold-smoked seafood

 

Ready-to-eat cold-smoked finfish (and other ready-to-eat cold-smoked seafood products) present a higher risk to public health relative to other seafoods due to the possibility of contamination with Listeria monocytogenes and the potentially severe illness it causes in at-risk population sub-groups such as pregnant women.  L. monocytogenes is a ubiquitous organism often found in processing environments, and may also be present in fish at the time of harvest.  Cold smoking is not a listericidal[15] process.

 

Recognition of the risks by both regulators and the industry has resulted in a high level of management of L. monocytogenes in Australia and a lower risk of illness to the general population.  FSANZ has previously recognised the inherent risk to the general population due to L. monocytogenes in cold-smoked seafoods by including a microbiological limit standard for the organism in ‘ready-to-eat processed finfish, other than fully retorted finfish’ in the Code.  When the food safety risks are managed such that cold-smoked seafoods meet this regulatory requirement, the relative risk ranking for the general population is low, although the relative risk ranking for susceptible populations (e.g. pregnant women, newborn and young children and the elderly) is high.  FSANZ is currently reviewing its dietary advice to these at-risk sub-groups in order to manage their food safety risks due to L. monocytogenes from all food sources.

 

If the food safety risks are not properly managed, such that cold-smoked seafoods do not meet the microbiological limit standard for L. monocytogenes, the relative risk ranking is high for at-risk sub-groups and medium for the general population.

 

This takes account of the relatively long shelf life of the product and the high standards of hygiene and sanitation in processing and good temperature controls across the food supply chain, up to and including the consumer, that is required to ensure the safety of the product.

 

4.4.3      Other seafood commodities

 

FSANZ ranked other seafood commodities as presenting a low or medium relative public health risk.


The vast majority of whole and filleted finfish was ranked in the low relative risk category.  A few groups of fish species were ranked in the medium relative risk category:

 

·                larger specimens of certain species of tropical and sub-tropical finfish, due to the potential for illness due to the accumulation of ciguatoxins; and

·                large, long living or predatory fish, such as swordfish, shark/flake and some tuna, which tend to accumulate higher levels of methylmercury than other fish species.  The ranking applies to the at-risk sub-population (the foetus) when the mother consumes mainly those species.

 

A medium ranking was also assigned to the following commodity groups (due to the listed hazards):

 

·                univalve molluscs (e.g. abalone) and roe-off scallops (from algal biotoxins causing amnesic shellfish poisoning and paralytic shellfish poisoning);

·                prawns (V. cholerae O1, Salmonella Typhi, arsenic);

·                canned seafood (Clostridium botulinum);

·                hot-smoked fish products (C. botulinum); and

·                some whole and filleted finfish (arsenic).

 

In most cases, hazards linked to these medium risk commodities are already regulated in the Code (e.g. Salmonella in prawns, arsenic in finfish) or through longstanding and effective industry codes of practice (e.g. C. botulinum in low-acid canned foods).

 

Of the seafood commodities ranked in the medium risk category, prawns and some finfish (whole or as fillets) have been linked to several outbreaks of food-borne illness in Australia in recent years.  For prawns, the associated food safety hazards have been primarily microbiological hazards, while for finfish, ciguatoxin, histamine fish poisoning and escolar wax esters account for the great majority of the outbreaks.

 

The majority of seafood commodities presented a lower risk to the general population.  For some of these commodities, the limited consumption of the products was the main factor in leading to the conclusion that the likelihood of adverse health effects from associated hazards was very low.  For others, the probable effects of downstream processing and consumer handling in reducing hazard levels were factors leading to a low likelihood of illness.

 


Table 5:     Summary of selected seafood commodities including current risk management*.

 

Commodity

Hazard/Environment or species

Severity

Likelihood

Relative risk Ranking1

Current risk management

Raw Oysters

V. vulnificus

Serious

Likely

Medium

ASQAP/Ch 32

V. cholerae O1/O139

Severe

Unlikely

Medium

ASQAP/Ch 32

Noroviruses/Uncontrolled3

Moderate

Very likely

Medium

 

Noroviruses/Managed4

Moderate

Unlikely

Low

ASQAP

Hepatitis A virus/Uncontrolled3

Serious

Very likely

High

 

Hepatitis A virus/Managed4

Serious

Unlikely

Low

ASQAP

Algal biotoxins/Uncontrolled3

Severe

Likely

High

Ch 1

Algal biotoxins/Managed4

Severe

Unlikely

Medium

ASQAP/Ch 1

Arsenic, Cadmium, Lead

Severe

Unlikely

Medium

ASQAP/Ch 1

Cooked Oysters

V. cholerae O1

Severe

Unlikely

Medium

ASQAP/Ch 32

Noroviruses/Uncontrolled3

Moderate

Very likely

Medium

Ch 32

Noroviruses Managed4

Moderate

Unlikely

Low

ASQAP/Ch 32

Hepatitis A virus/Uncontrolled3

Serious

Very likely

High

 

Hepatitis A virus/Managed4

Serious

Unlikely

Low

ASQAP

Algal biotoxins//Uncontrolled3

Severe

Likely

High

Ch 1

Algal biotoxins/Managed4

Severe

Unlikely

Medium

ASQAP/Ch 1

Arsenic, Cadmium, Lead

Severe

Unlikely

Medium

ASQAP/Ch 1

Cooked abalone /roe-off scallops

Algal biotoxins

Severe

Unlikely

Medium

Ch 1

Green prawns

V. cholerae O15

Severe

Unlikely

Medium

Ch 32

Salmonella Typhi5

Severe

Unlikely

Medium

Ch 1/Ch 32

Arsenic

Severe

Unlikely

Medium

Ch 1

Cooked prawns

V. cholerae O15

Severe

Unlikely

Medium

Ch 32

Salmonella Typhi5

Severe

Unlikely

Medium

Ch1/Ch 32

Arsenic

Severe

Unlikely

Medium

Ch 1

Chilled/ frozen whole fin fish and fillets

Mercury, Ciguatoxin6

Serious

Unlikely

Low

Ch 1/Advisory Notes

Ciguatoxin/Tropical7

Serious

Likely

Medium

Advisory Notes

Mercury/Predatory species8

Serious

Likely

Medium

Ch 1/Advisory Notes

Arsenic

Severe

Unlikely

Medium

Ch 1

Canned fish products

C. botulinum4,9

Severe

Unlikely

Medium

GMP/GHP

Arsenic

Severe

Unlikely

Medium

Ch 1

Cold-smoked fish products

C. botulinum4,9

Severe

Unlikely

Medium

GMP/GHP

L. monocytogenes

Serious

Unlikely

Low10

Ch 1/Ch 32/Advisory

L. monocytogenes

Severe

Likely

High10, 12

Ch 1/Ch 32/Advisory

L. monocytogenes

Serious

Likely

Medium11

 

L. monocytogenes

Severe

Very likely

High11, 12

 

Hot-smoked fish products

C. botulinum4,9

Severe

Unlikely

Medium

GMP/GHP

Footnotes for Table 5:

*   Relative risk rankings are under constant review to identify emerging significant information.

1.   Risk ranking reflects current practice for that commodity/seafood sector.  The risk ranking is based on the severity of the hazard and an estimate of the likelihood of illness that takes into account various factors, including current risk management practices.

2.   Chapter 3 provisions in the Code apply to the processing sector only.

3.   Uncontrolled describes a growing environment not under a shellfish safety management scheme and/or likely to be exposed to faecal contamination. Includes growing waters adjacent to urban areas and rural habitation. In contrast, a growing environment considered pristine is unlikely to be exposed to faecal contamination.  Pristine environments would typically include growing waters remote from human habitation and even if uncontrolled, present similar risk to managed waters for enteric pathogens.  Algal toxins remain a risk for pristine environments.

4.   Where a food safety hazard is controlled under a management system/program, the likelihood of illness is very low.

5.   For product from intensive farming systems or estuarine harvest areas subject to human faecal contamination.

6.   Majority of finfish present a low risk to consumers (Serious x Unlikely) due to mercury or ciguatoxin.

7.   Ciguatoxin may be found in larger specimens of particular species of tropical and sub-tropical finfish from certain fishing areas.  It is predominantly a problem in the recreational fishing sector (See Appendix 4, Table 19).

8.   Predatory species – mercury is a problem in big, long living or predatory fish, such as swordfish, shark/flake and some tuna.  These fish tend to accumulate higher levels of methylmercury than other species.  The relative risk ranking is medium for the at-risk sub-population (the foetus) when the mother consumes mainly large, predatory or long-lived fish species.

9.   Industry adherence to GMP, GHP and appropriate product formulation (e.g. pH, levels of salt, preservatives) control this hazard.


10. When correctly managed, the risk ranking is low for the general population (Serious x Unlikely), but high for at risk sub populations.

11. When not managed, i.e. processing, product handling and storage not adequately controlled, the risk ranking is medium for the general population and high for at risk populations.

12. L. monocytogenes is a severe hazard for at risk populations.

 

4.5         Examination of existing management systems and their control of identified risks

 

The previous section concludes that there are a small number of seafood commodities that may pose a higher relative risk to public health and safety when compared with other commodities in the seafood sector. It also concludes that the remaining seafood commodities pose a lower individual risk, but that when the risk is aggregated, these contribute significantly to the background incidence of food-borne illness associated with seafood.

 

It is noted that in identifying risks, use was made of the available epidemiological data. However, this data is limited due to significant underreporting (one per cent of cases are estimated to be reported). With this in mind, well over 90 per cent food-borne illness related to seafood is likely to be unreported.  However, the relative risk ranking took into account other information, as detailed previously, to develop a view of the overall risks posed.

The following section of this Report further examines current management systems for higher risk sectors as well as the remaining sectors, to identify where these would benefit from application of additional or different risk management practices or a single integrated national scheme.  Table 5 summarises current regulatory and food safety control measures in place for those seafood commodities ranked as either medium or higher relative risk.

 

4.5.1      Seafood ranked as high (relative to other seafood)

 

4.5.1.1   Oysters and other bivalve molluscs

 

Bivalves[16] were assessed as posing a higher relative risk to public health when harvested from growing environments likely to be exposed to faecal contamination and/or not under a shellfish safety management scheme.

 

The food safety of bivalves is controlled through State-based programs that utilise ASQAP as a guide to safe production and harvesting.  All Australian producers must now comply with the State-based programs as a condition of their aquaculture licence. 

 

State ASQAP programs adopt measures to prevent the growing and harvesting of bivalves from waters made unsuitable by the presence of biological or chemical hazards at levels likely to present a public health risk.  These programs allow for the purification of bivalves from such waters, under certain conditions, through the application of techniques such as relaying and depuration.  However, the vibrios, algal biotoxins and enteric viruses, in particular, tend to be removed ineffectively by these purification techniques, so that the higher inherent risk cannot be completely managed by these practices.  Because of this, ASQAP prescribes the testing of bivalve flesh for biotoxins under certain circumstances, and requires temperature control to limit outgrowth of bacterial pathogens post-harvest.


The State ASQAP programs are essential tools for the management of the safety of bivalve molluscs.  It is clear that bivalve mollusc producers achieve a satisfactory level of safety for this inherently hazardous food through adherence to the requirements stated in ASQAP by the State Shellfish Control Authorities (SSCA).  The use of very similar systems is mandated in many developed countries as the only recognised and effective means of producing safe bivalve molluscs.  The control of waters from which the product is harvested is beyond the capacity of individual growers.  Additionally, the current system ensures that the extensive sampling regime undertaken under the program is affordable for each grower.

 

The recent achievement of a national approach for industry compliance with the requirements set out in ASQAP for the safe production of shellfish has closed some of the gaps in the food safety management system for bivalves.  The industry and the State regulators of the Program, through ASQAAC, have recommended to FSANZ that compliance with the pre-harvest requirements of ASQAP as well as biotoxins management plans be mandated in the Code and that food safety plans be mandated for certain post-harvest activities associated with these products.  This aims to ensure that the current legislative basis for shellfish standards are based on food safety requirements, that States/Territories regulate shellfish safety through a nationally consistent standard and that there is a means to recognise ASQAAC as the body that maintains and updates ASQAP.  Given the proven effectiveness of the ASQAP system, it would be appropriate to mandate compliance with requirements of the program as administered by the SSCA within the Code.

 

This approach would have the benefit of ensuring:

 

·                an appropriate legislative basis by bringing it under the health umbrella;

·                national consistency as all States would pick up the requirement uniformly and fully;

·                once in the Code it would allow health portfolios to verify compliance by industry; and

·                provide a mechanism for maintenance of guidelines that are essential for the safety of this food.

 

The development of mandatory documented risk management standards in the Code is consistent with the recent Ministerial decision and Guidelines on Food Safety Management Options in Australia.

 

In conclusion, the potential public health and safety risks associated with oysters and other bivalve molluscs are considered higher relative to other seafood and, therefore, voluntary or other non-regulated mechanisms to address this level of risk are not considered appropriate or sufficient to address the problem. 

 

4.5.1.2   Cold-smoked finfish

 

Cold-smoked finfish (and other cold-smoked seafood products) were found to present a higher relative risk to public health for at-risk population sub-groups, due mainly to the severity of illness caused by contamination with Listeria monocytogenes. Listeriosis is a serious food-borne illness that affects susceptible populations and can lead to death.  Because of its long incubation period (up to three months), it is often difficult to identify the food vehicle responsible for the illness. 

 

Listeria is a ubiquitous organism in the environment and because the cold-smoking process does not contain a listericidal step, it is difficult to eliminate this pathogen from the product. 


Instead, strict adherence to good hygienic practices and proper maintenance of the processing environment are essential for controlling this organism.  The long storage periods of the products at low temperatures favour the growth of the pathogen.  Typically the shelf-life for vacuum packed cold smoked fish is up to 4 weeks at 5°C.

 

The Code sets a limit for L. monocytogenes in smoked fish and processors use this limit as one criterion for evaluating the safety of their products before release into the marketplace and in setting use-by-dates.  Testing of products in the marketplace also contributes to recall of contaminated product.  However, good hygienic practices and clean premises are essential tools in maintaining low levels of the pathogen in the product.  These practices are already mandated for processing of this product in Chapter 3 of the Code.

 

In addition, FSANZ publishes and distributes information material to alert susceptible populations such as pregnant women to the high risk posed to them by this food.  It must be concluded, however, that these current management strategies for Listeria in cold-smoked finfish leave a residual, albeit small, risk to public health.

 

One approach to manage the residual risks posed to public health by cold-smoked finfish would be to propose implementation of additional risk management systems.  These could consist of a HACCP system or food safety program as described in the voluntary Standard 3.2.1 in the Code.  It is clear that the risks lie mainly in the processing part of the food chain where the pathogen may be introduced, and also in the retail shop where Listeria growth may occur during the long shelf life of the product.

 

The implementation of HACCP or food safety programs would need to be justified by a positive benefit-cost ratio demonstrating that the burden would be clearly outweighed by the public health improvements.  Such a benefit-cost study has not been done and until it is done, the proposal to mandate HACCP-based approach for this food would not meet with stakeholder agreement.

 

As the main sub-populations at risk are pregnant women and the elderly, improved education of these vulnerable populations may be the best approach, in the short-term, to manage the residual risk, combined with improved compliance and enforcement of the existing mandatory Standards in Chapters 1 and 3 of the Code. FSANZ  has recently reviewed the Listeria pamphlet for pregnant women to broaden its audience to the main vulnerable population groups at risk.

 

In summary, at this point in the standard development process, no additional regulatory requirements are proposed for cold smoked finfish.

 

4.5.2      Lower risk seafood

 

The majority of seafood commodities were ranked as presenting a lower public health risk than bivalve molluscs and cold-smoked finfish.  The lower risk seafood products, when grouped together, do contribute to the overall level of food-borne illness and therefore have an impact on public health and safety.  Because of the continuing burden this will have on the community and the consequent costs it imposes, there is an argument for the introduction of basic measures, at low cost, across the seafood industry that would have a broad impact in improving public health and maintaining the high level of consumer confidence in the consumption of seafood.


The existing food safety provisions in the Code recognise that good hygienic practices and pre-requisite programs must apply to all food businesses (other than primary production) to ensure a basic level of food safety for all food. Codex, in its General Principles of Food Hygiene[17], also takes the approach that the primary production and processing of all food must meet basic requirements of food safety. The work of both the WHO and Codex indicates that reducing the hazards introduced at the primary end of the food supply chain will minimise food safety hazards at the later stages of the food chain.[18] The approach in Standards 3.2.2 and 3.2.3 of the Code that mandate minimum requirements for food safety do not apply to businesses in the primary production and processing sector - they apply to manufacturers through to retailers.

 

The various voluntary industry codes of practice and industry guidelines, in some cases, do pick up such requirements, but national consistency of coverage would be improved through the introduction of a single national scheme.

 

Therefore, there is a strong case to extend the basic food safety provisions of the Code throughout the primary production and processing supply chain to ensure there are basic food safety practices underpinning the production of all food, rather than at just one end of the supply chain. Some of the medium risk products may benefit from more specific risk management strategies; however, these may vary according to geographic/climatic and other factors, as well as existing jurisdictional and industry infrastructures. For this reason, the proposed Standard does not prescribe a documented seafood safety management system for the lower risk products as for oysters and other bivalve molluscs. Nevertheless, the Standard requires a seafood business to systematically examine all its primary production operations to identify potential seafood safety hazards and implement controls that are commensurate with the food safety risks. The extent of hazard identification, implementation of control measures and verification required should also be commensurate with the level of food safety risk involved. This is most appropriately determined by jurisdictions in consultation with industry, taking account of local environmental factors. Where possible, jurisdictions should use national forums such as the Implementation Subcommittee (ISC) of the Food Regulation Standing Committee to develop nationally consistent approaches to verification.

One example of a specific risk management strategy that is required is in relation to escolar (or rudderfish), where specific advice may be required at the retail and consumer level to advise people of the risk of consuming wax esters that are found in this fish.

 

5.        Objective

 

The objective of the measures proposed in this draft assessment is to effectively address the public health and safety risks associated with seafood through the development of a single, nationally consistent, set of risk management measures that address food safety issues across the food chain, are preventive, outcomes-based and cost-effective.


6.        Regulatory options

 

6.1         Scope of the Standard and Definition of Seafood

 

Any mandatory regulatory approach for managing public health risks associated with seafood will be defined by the scope of the Standard and the definition of seafood.  After consideration of issues raised by responses to the Initial Assessment Report and advice from the SDC and the Ministerial Council, it was determined that:

 

·                The scope of the Standard should cover all aspects of primary production and processing, from harvest/capture (whether wild-catch or aquaculture) up to the point at which Chapters 1, 2 and 3 of the Code currently apply.

 

·                The Standard should not cover indigenous/traditional fishers or recreational fishers, as the Standard applies only if the seafood is intended for sale.

 

·                The Standard should be outcome-based, developed by utilising a risk-based approach, with the level of regulatory intervention to be commensurate with the level of public health risk.

 

·                The Standard should apply to both imported and domestically produced seafood, and should avoid duplication of existing food safety Standards, such as Standards 3.2.2 and 3.2.3.

 

Options 2 and 3 are considered to be feasible and address the objectives of this proposal. Option 1 is included in the Impact Analysis for comparative purposes.

 

Option 1:    The status quo - continuing the current regulatory arrangements.

Option 2:    A Primary Production and Processing Standard targeting high-risk seafood activities only.

Option 3:    A risk-based Primary Production and Processing Standard to improve the overall safety of the seafood supply chain.

 

6.2         Option 1 – The status quo

 

The status quo option involves continuation of current State and Territory regulatory arrangements, including the obligation to produce safe food under the Food Acts, and application of the current provisions of the Code as administered and enforced by the States and Territories.  This includes provisions applicable to seafood in Chapters 1, 2, and 3 of the Code.  States and Territories and AQIS would continue to test for compliance against the Code and undertake other enforcement measures.

 

State-based standards for the primary production of seafood have been implemented in NSW and Victoria’s scheme will commence for wild catch and aquaculture in 2004.  It is likely that other States will develop their own standards if there is no nationally consistent standard.  These schemes would continue to be enforced by States and Territories.  The regulation of bivalve molluscs through aquaculture licensing arrangements would continue on a State-by-State basis.

 


The status quo would include the voluntary uptake of the Seafood Services Australia industry standard for seafood safety and the ongoing utilisation/implementation of various industry guidelines and codes of practice addressing seafood safety and quality (industry self-regulation). 

 

6.3         Option 2 – A Primary Production and Processing Standard targeting high-risk seafood activities only

 

A Primary Production and Processing Standard addressing only high-risk seafood activities will require identified high-risk seafood sectors (bivalve molluscs) to implement written food safety management systems such as Standard 3.2.1.  It will not contain general provisions for the primary production and processing sector. 

 

In the case of seafood businesses producing bivalve molluscs, it will be mandatory to comply with pre-harvest provisions identified in the Australian Shellfish Quality Assurance Program to ensure that bivalve molluscs are harvested under conditions that assure their safety.  In addition, these businesses will be required to implement food safety programs for the post-harvest sector up to the back door of the retail sector.

 

6.4         Option 3 – A risk-based Primary Production and Processing Standard to improve the overall safety in the seafood supply chain

 

A new Primary Production and Processing Standard to address food safety risks in two ways:

 

·                basic hygiene requirements for all primary production of seafood; and

·                a requirement for specific provisions for higher risk primary production of seafood.

 

This Standard would provide a single, nationally consistent and risk based approach to facilitate the safe production of seafood. Having a consistent approach to the management of food safety during seafood primary production will positively impact on safety across the seafood supply chain.

 

The Standard (Documented as Chapter 4 in the Code) would be divided into two main components as follows:

 

·                General provisions which set out basic food safety requirements for the hygienic primary production and processing of seafood, and

 

·                Specific provisions for higher risk primary production seafood sectors, requiring the implementation of food safety management systems.

 

Figure 1 outlines the relationship between general provisions, specific provisions for higher risk sectors, and guideline documents that will assist regulators to interpret the Standard and industry to comply with the Standard.


Figure 1:    Regulatory framework for food safety management in seafood

The general provisions are designed to minimise food safety hazards, and cover seafood primary production and processing activities that are not currently regulated under the Code.  Such provisions are similar to the provisions in Chapter 3 of the Code (Standards 3.2.2 and 3.2.3), but tailored to the needs and situation of the seafood primary production sector.  These provisions would include requirements to ensure that food was not contaminated during its production or handling, that adequate temperature control of the food is maintained, and that staff have the necessary skills and knowledge about food safety for the work they undertake. This option is intended to include simple on-vessel processing such as the gutting and filleting of finfish.

 

The specific provisions address identified higher risk seafood sectors, and require those seafood businesses to implement written food safety management systems such as Standard 3.2.1.  In the case of seafood businesses producing bivalve molluscs, it will be mandatory to comply with pre-harvest provisions identified in the Australian Shellfish Quality Assurance Program.  This will ensure that bivalve molluscs are only harvested under conditions that assure their safety.  Additionally, these businesses will be required to implement food safety programs for the post-harvest sector up to the back door of the retail sector. This is consistent with the Ministerial decision of December 2003 on food safety management in Australia to only have requirements for food safety programs for sectors that have been identified as higher risk and where it has been demonstrated that the benefits will outweigh the costs. In this regard, Ministers agreed to specifically recommend the introduction of food safety programs for oysters and other bivalves following a benefit-cost analysis undertaken as part of the National Risk Validation Project.

 

Regulators will be assisted with enforcement by the development of an interpretive guide prepared by FSANZ, and industry will be assisted by tools such as guidelines and templates to comply with the Standard.  States will replace any existing Standards with the new Primary Production and Processing Standard for Seafood (in the Code) and thus achieve a single, national, approach to food safety along the seafood supply chain.

 


6.5         Summary of options

 

The three options proposed above may be summarised as follows:

 

 

NATURE OF FOOD SAFETY CONTROL

OPTION

1

Status quo

OPTION

2

Mgt of higher risk only
OPTION
3

Basic Safety Provisions + Mgt of higher risk

Current arrangements:

-General obligation under Food Acts to produce safe food

-Food Std Code provisions (except for primary production)

-State and Territory schemes (NSW, VIC)  

-Voluntary industry codes of practice

 

P

P

P

P

 

P

P

P

P

 

P

P

 

P

General Provisions:

Food safety practices applied to primary production end of seafood sector (similar to current hygiene requirements for the manufacturing, retail and food service sectors but tailored to seafood industry)

 

 

 

 

P

Specific Provisions:

Standard 3.2.1 (Food Safety Programs) or equivalent applied to higher risk activities of the seafood industry

 

 

P

 

P

 

The proposed options are considered further in the next section of the report where an impact (benefits versus cost) analysis of the various options is undertaken.

 

7.        Impact analysis for seafood

 

FSANZ must consider the impact of various regulatory (and non-regulatory) options on all sectors of the community when it considers measures to mitigate public health and safety risks, including the seafood sector, governments, and consumers.  The benefits and costs associated with any proposed amendment to the Code must be analysed using regulatory impact principles with the view to choosing the alternative with the maximum positive impact, whist minimising the regulatory burden on industry.

 

7.1         Affected Parties

 

The main stakeholders in the introduction of a new Standard are:

 

·                Consumers – Australian consumers of seafood and the community.

 

·                Seafood industry – businesses involved in the primary production, processing, distribution and wholesaling of seafood products and those involved in the importation of seafood for the Australian market.

 

·                Government – Government agencies (National, State and Territory, and Local) responsible for the enforcement of food safety regulations and for providing health care.


7.2         Option 1: the status quo

 

7.2.1      Benefits of Option 1

 

7.2.1.1   Consumers and the community

 

Australian households spend about 2.5 per cent of their food budgets on seafood products, which is about the same level as for poultry[19].  A study of consumer attitudes in Sydney and Perth found that the perceptions that fish is healthier than meat and that it adds variety to the diet were major factors influencing consumption.  However uncertainty about safety and contamination, a lack of knowledge about seafood and high prices were major barriers to increased consumption[20].  Public health professionals also advocate seafood in the diet as a means to address obesity and as a good source of omega-3 fatty acids[21].

 

The consumption of seafood is valued by consumers and can confer considerable nutritional benefits. For example, fish is an excellent source of protein, is low in saturated fat, is a good source of some vitamins and is an excellent source of iodine.

 

7.2.1.2   Seafood industry

 

Apart from the current obligation in Food Acts to produce safe food, the regulatory regime of most State and Territory governments, with some exceptions, places few specific food safety requirements on seafood businesses in the primary production sector.  Only NSW and Victoria, the smaller seafood production States, have put in place mandatory safety and hygiene regulations over the entire seafood supply chain. 

 

In the other jurisdictions, hygiene and safety outcomes are mainly influenced by industry guidelines and codes of practice and by the regulation of export establishments (where these establishments also supply the domestic market) based on HACCP programs[22]

 

Industry bodies report that a significant majority of Australian seafood businesses do follow industry guidelines and codes of practice and incorporate good hygiene practices into their normal business operations[23].  The consequence of applying self-regulation is of commercial benefit to these businesses because good food safety practices enhance their capacity to meet market needs and achieve higher returns from their products[24].

 

Seafood businesses that meet food safety needs through a formal food safety program report additional benefits including: reduced wastage, lower maintenance costs, production savings, enhanced understanding of their own business and improved management practices[25].


7.2.1.3   Government

 

The current regulatory regime places few specific safety requirements for the hygienic production and processing of the seafood in most jurisdictions. Hence there is little pressure on Government enforcement resources.

 

7.2.2      Costs of Option 1

 

7.2.2.1   Consumers and the community

 

Current regulatory arrangements mean that some businesses are not required to undertake specific action to effectively manage food safety. The current Food Acts have a general obligation for primary producers to produce safe food – but does not give industry any guidance on these obligations. Where there is unmanaged risk, this gives rise to food-borne illness and imposes costs on consumers.  Costs include personal distress, medical treatment, and time off work (patients and carers), with possible implications for forgone household income.

 

Australians consume over 1.1 billion seafood meals annually[26][27].  Demand for seafood continues to grow, reflecting its role in a balanced, nutritious diet.  As with all food commodities, seafood is responsible for some of the burden of food-borne illness in the community.  FSANZ has estimated the annual burden of food-borne illness that might be attributed to seafood in Australia, drawing on two studies published by the Food and Agriculture Organization (FAO)[28][29] which reported that:

 

(i)            seafood accounted for between 4.4 and 16.1 per cent of food-borne illness outbreaks in Western countries, in cases where the food vehicle for the outbreaks was known; and

 

(ii)          seafood was involved in 10-25 per cent of food-borne disease outbreaks in developed countries.

 

Based on this information, FSANZ estimates that 10 per cent of all food-borne illness in Australia might be attributable to seafood (approximately 500,000 cases annually).  Clearly, only a very small percentage of seafood meals cause food-borne illness.

 


The direct cost of food-borne illness to the Australian community was estimated by the Allen Consulting Group to be $350 per case[30]. Hence, taking account of the 5.4 million cases of food-borne illness annually, discounting an estimated 20 per cent of cases for in-the-home contamination, provides an estimate of $150 million per year as the cost of food-borne illness to the Australian community associated with the consumption of seafood.

 

Raw-ready-to-eat seafood (oysters and other bivalve molluscs) was ranked in the top five high-risk food industry sectors in Australia by the National Risk Validation Project[31], on the basis of this sector’s history of food-borne illness.  The NRVP estimated the average cost of illness from eating raw-ready-to-eat seafood at $4.87 per meal, far higher (by a factor of 10) than the cost of any other high-risk food sector considered in the report[32]

 

Improvements in the risk management of bivalve molluscs since the NRVP collected this data imply that, currently, the costs to consumers should be lower than this estimate[33].

 

Consumers typically respond to outbreaks of food-borne illness in seafood by reducing their demand for seafood products.  For example, following contamination of NSW oysters in 1997, NSW consumers immediately reduced their demand for oysters by 85 per cent.  They also immediately reduced their demand for all seafood products by 30 per cent, indicating that consumers readily generalise a specific seafood risk to the broad category of seafood products[34].

 

However, despite consumers’ immediate reactions to outbreaks of food-borne illness, demand for seafood recovers over time.  Notwithstanding 24 outbreaks associated with raw-ready-to-eat seafood[35] during the 1990s, consumer demand for seafood has increased steadily over the medium term[36].  The implication is that while consumers immediately perceive costs when outbreaks of food-borne illness occur, these short-term costs are not sufficient to outweigh the perceived benefits of seafood to consumers over the medium-term.

 

7.2.2.2   Seafood industry

 

Each outbreak of food-borne illness imposes an immediate cost on industry, by reducing sales revenues for the implicated product and with follow-on effects to the seafood industry more generally[37].  A succession of outbreaks will repeatedly reduce industry sales revenues in the short term.  In addition, small remote communities that derive a very substantial part of their income from fishing would be particularly vulnerable to outbreaks of food-borne illness.  An adverse incident would have very serious implications for the economic base for these communities[38].

 

Apart from the bivalve mollusc sector, under current regulations, only seafood businesses in the primary production sector in NSW and Victoria incur compliance costs for food safety.  These costs are very small.


Under current arrangements, the bivalve mollusc sector must pay the majority of the cost incurred by their SSCA who implement and examine requirements set out by the ASQAP in their jurisdiction.

 

7.7.7.3   Government

 

The current regulatory regime places few specified safety requirements on the primary production end of seafood supply chain in most jurisdictions. Hence there is little pressure on the resources of enforcement agencies.  Only NSW and Victoria currently apply hygiene and safety regulation on the seafood industry from the production end of the chain; and only one seafood sector is regulated (through licensing arrangements and not under health legislation) by all jurisdictions: the sector producing oysters and other bivalve molluscs.

 

The public health system e.g. hospitals, provision of pharmaceuticals, etc contributes to the care of people with food-borne illness and hence any food-borne illness associated with seafood imposes cost on government.

 

7.3         Option 2 – A Primary Production and Processing Standard targeting high-risk seafood activities only

 

7.3.1      Benefits of Option 2

 

7.3.1.1   Consumers and the community

 

Consumers and the community will benefit from the greater assurance of the safety of the high risk seafood products: oysters and other bivalve molluscs.  Outbreaks of food-borne illness have arisen from these high risk products in the past and imposed costs on consumers in the form of personal distress, incidents of death, costs of medical treatment, and time off work (patients and carers) which also implies some forgone household income.   Under Option 2 the risk of future outbreaks will be minimised and hence the costs to consumers will be substantially reduced.

 

The benefits to the community of introducing food safety programs into the high risk bivalve mollusc industry were calculated by the National Risk Validation Project at $26.4 million per year[39].  These benefits mainly accrue from a nationally consistent approach to managing bivalve safety, through a system that doesn’t permit opt-out by any State or Territory, and which enables food safety portfolios in all jurisdictions to audit the system.

 

7.3.1.2   Seafood industry

 

Improvement to the management of the safety for high risk seafood products will benefit industry because the recurring reductions in consumer demand and product sales that have resulted from incidences of food-borne illness, such as those that occurred as a result of the Wallis Lake outbreak, would be minimised under this option.

 

The consequence will be fewer incidents of food-borne illness and fewer highly visible outbreaks that have been a feature of the past and may still occur under the status quo.

 


The National Risk Validation Project showed that reductions in demand occur not only for the high risk product that caused the food-borne illness, but flow through to all seafood products.  Ensuring that the safety of high risk products is appropriately managed on the basis of risk from boat to plate will improve safety overall and protect the sales revenues of the seafood industry.  This is likely to have a positive impact on both the local and international markets.

 

Nationally consistent, mandatory requirements that ensure compliance with ASQAP and with food safety programs will contribute to a consistent record of safety for bivalves, thereby reducing the chance of something going wrong in one State and putting the entire sector at risk.

 

7.3.1.3        Government

 

The government sector may benefit from the material improvement in the safety of seafood products and fewer incidents of food-borne illness through lower utilisation of public health services.  While this is a true benefit to government it may not translate into lower public expenditure.  For example, public hospitals have an obligation to provide health care for the whole community and for a broad range of ailments and medical emergencies, and will respond to lower utilisation of their services from food-borne illness by providing quicker services to patients with other ailments.  In practical terms the benefits to government could be negligible[40].

 

7.3.2      Costs of Option 2

 

7.3.2.1   Consumers and the community

 

This option will not impose costs on consumers or the community, over and above the costs incurred under the status quo.

 

7.3.2.2   Seafood industry

 

The impact of Option 2 limited to the high risk industry sector producing oysters and other bivalve molluscs. Businesses in this industry sector already comply with State based versions of ASQAP and, in some States, are required to have post harvest food safety programs. These requirements are administered by the States and Territories as a condition of obtaining an aquaculture licence. The additional costs on oyster growers and other primary producers in this sector as a result of this option will impact on those not already required to have food safety programs post harvest.

 

The effectiveness of ASQAP requirements in addressing the health and safety risks in the pre-harvest shellfish sector (including biotoxin testing) is recognised by all jurisdictions, although only recently by NSW.  The cost of mandating compliance in the Code with specific pre-harvest requirements (stated in ASQAP) and food safety programs for the post-harvest activities is expected to be small, as compliance is mostly in place.

 


There will also be some additional compliance costs incurred further along the supply chain, for example by distributors and wholesalers, in meeting the requirements of a food safety program for these products.

 

7.3.2.3   Government

This option will not significantly expand the responsibilities of government enforcement agencies for the shellfish sector, as these arrangements already exist (e.g. ASQAP), and hence the impact on their resource requirements should be small.

 

7.4     Option 3 – A risk-based Primary Production and Processing Standard to improve the overall safety in the seafood supply chain

 

7.4.1      Benefits of Option 3

 

7.4.1.1   Consumers and the community

 

Consumers benefit from the greater assurance of safety of the high risk seafood products of oysters and bivalve molluscs, as with the previous option.

 

In addition, Option 3 addresses safety risks comprehensively across the seafood industry so that consumers also benefit from greater assurance of the safety of all the lower risk products.  This option will achieve a through-chain consideration of food safety, and eliminate gaps and inconsistencies in State and Territory approaches to the current management of seafood safety.  It will improve on the status quo where there are inconsistencies in safety practices, particularly at the primary production and processing end of the seafood industry, and at the interfaces between the primary production and the processing sectors.

 

While the seafood industry has benefited from industry codes of practice and guidelines, these codes and guidelines are voluntary and a proportion of seafood businesses are not compliant with them[41].  The proposed Standard would make a clear statement, obliging all seafood businesses involved in primary production and processing to achieve an appropriate level of hygiene and safety.  Basic food safety requirements across these sectors of the industry will improve the safety of seafood products for consumers by reducing food-borne illness.

 

The international literature shows that the burden of food-borne illness attributable to seafood is sourced from a broad range of products, the high risk and the lower risk products.[42]  The consequence of implementing a comprehensive set of management strategies under this option, including for the majority of seafood products that are lower risk, will be to significantly reduce the likelihood and severity of food-borne illness in the Australian population.  The costs to consumers of food-borne illness – personal distress, medical treatment, and time off work (both patients and carers) which implies some foregone household income – will be reduced under this option and the greater assurance of the safety of all seafood products will benefit consumers.

 


Imported seafood products will be required to demonstrate an equivalent level of safety to domestically produced products. This measure will ensure that consumers can feel secure in the knowledge that all seafood, regardless of where it is sourced, meets the same level of food safety.

 

If the current cost of food-borne illness associated with seafood is estimated to be $150 million p.a. and the greater safety of the full range of seafood products under this option can reduce food-borne illness by between 20 and 50 per cent, then the benefit to the community would be in the range of $30 million to $75 million per year.

 

7.4.1.2   Seafood industry

 

Industry will benefit from the reduction of the periodic disruptions to sales that occurred in the past in association with highly visible outbreaks of food-borne illness, because under this option (as with the previous option) these outbreaks will be further minimised.

 

This option also supports the widespread adoption of good hygiene practices, by all seafood businesses in all sectors of the industry.  The minority of seafood businesses that currently do not follow industry codes of practice, and whose hygiene can be improved, will be required to comply with the new Standard.  Hence the level of food-borne illness associated with poor hygiene practices in the industry can be reduced.  For consumers, this means fewer experiences of food-borne illness and a higher regard for the safety of seafood.  Industry will benefit from the greater consumer satisfaction with the safety of seafood, which translates into a lift in demand for its products and higher sales. 

 

7.4.1.3   Government

 

The government sector may benefit from the material improvement in the safety of seafood products under this option, compared with the status quo, because the lower incidence of food-borne illness should result in lower utilisation of public health services.  While this is a true benefit to government, it may not translate into lower public expenditure.  For example, public hospitals have an obligation to provide health care for the whole community and for a broad range of ailments and medical emergencies, and will respond to lower utilisation of their services from food-borne illness by providing quicker/enhanced services to patients with other ailments.  In practical terms the benefits to government could be small[43]. However, government will benefit in terms of greater consumer confidence in the ability to ensure a safe food supply.

 

Mandating specific requirements for bivalve molluscs in the Code will provide government with a more appropriate legislative basis for regulation i.e. the approach is centred on food safety rather than existing aquaculture legislation that focuses on licensing rather than food safety.  It will ensure a single, national approach to the safe production these higher risk products.

 


7.4.2      Costs of Option 3

 

7.4.2.1   Consumers and the community

 

This option will not impose costs on consumers or the community, over and above the costs incurred under the status quo.

 

It is considered that the additional compliance costs incurred by seafood businesses under this option are unlikely to be passed on to consumers.  However, if it did occur, any increase would be minimal, as the wholesale price of seafood is frequently set by auction. Furthermore, industry bodies have advised that the majority of seafood businesses already undertake basic safety practices.

 

Therefore, for these businesses, the proposed provisions would not adversely affect their operating costs and there would be no costs passed on to the consumers.

 

7.4.2.2   Seafood industry

 

The impact on producers of oysters and other bivalve molluscs under this option will be the same as under the previous option, essentially imposing some additional compliance costs where post harvest food safety programs are not yet in place.

 

In addition, the general provisions of this option mandate basic food safety obligations on all seafood businesses.  The mandatory nature of the basic food safety obligations will be new for businesses in the primary production sector.  Fulfilling the basic food safety provisions required by the general provisions under this option is anticipated to have little impact on those seafood businesses which either supply the domestic market to the standards required under export controls, or fully comply with the voluntary industry standards and codes of practice.  Advice from industry bodies such as Seafood Services Australia and the Sydney Fish Market indicates that the majority of seafood businesses already undertake basic safety practices as set out in industry codes of practice and guidelines to at least the level required under this option.  For these businesses, the proposed general provisions will not affect their operating costs.

 

FSANZ undertook a number of interviews with fisheries, enforcement agencies, inspection auditors and commercial fishers from around Australia’s coastline, to obtain detailed information about the effect of mandating good hygiene practices on industry operating costs.  The interviews revealed a consistent picture of hygiene practices across the seafood industry (although the examples differed).  The principal themes are documented below.

 

·                Good hygiene practice is basic and easily achievable by the seafood industry.  Examples include: appropriate temperature control of the catch, typically an ice slurry or refrigerated holding tank; ensuring water for holding tanks is sourced from clean sea water, and changed as required; keeping bait and chemicals separate from the catch; ensuring there is no contamination of the catch; keeping haulage areas clear of weeds; regular cleaning of desks and protective clothing; appropriate vessel maintenance to address cracks and crevices in surface areas or holding tanks, and to ensure there are no oil leaks over the deck; use of gilling and gutting boards (rather than the boat’s gunnels); regular cleaning of prawn cookers; and advice such as ‘don’t take your dog fishing’.


·                The practice of good hygiene does not require additional equipment.  Good temperature control is widespread across the industry and hence the equipment such as iceboxes and refrigerated holding tanks are already widely used (where required).  Good hygiene practice will require some fishers to purchase tools such as gilling and cutting boards. Where this is the case, it is estimated that these boards would cost between $100-$200 and have a life expectancy of five years.

 

·                Good hygiene practice is essentially a matter of the practical adaptation of hygiene and sanitation principles to fishers’ work practices.

 

·                Most fishers already incorporate hygiene into their work practices.  They achieve hygiene outcomes through traditional methods and by following existing industry guidelines and codes of practice. While there are a large number of these guides and codes available, the industry Code of Practice developed in NSW for commercial fishers, could be considered indicative. This code is generally outcomes based and the little prescription that may bring a relatively small cost is the requirement to use a chemical sanitiser.

 

·                The principal reason that some fishers do not comply with good hygiene practice is lack of awareness.  When given clear guidance on the requirements of hygiene standards, advice from auditors in the NSW Food Authority or the Southern Rocklobster Fishery is that the fishers easily and enthusiastically embrace industry best practice.  Some fishers follow traditional methods, which achieve hygiene outcomes in most circumstances, but training (a one-day workshop[44]) that explains why hygiene outcomes are achieved provides the fishers with the knowledge to achieve good hygiene in unusual circumstances too.

 

·                A mandated hygiene standard, even where outcomes-based and allowing for variation in approaches between fishers and fisheries, will be superior to a voluntary industry code of practice in achieving good hygiene outcomes.

 

·                Implementation of good hygiene practices is typically a matter of refining current work practices.  This can be achieved easily.  In NSW the Food Authority ran workshops in each of the fisheries, which cost the fishers $50 and one day’s participation at a workshop.  The cost of foregone earnings to attend the workshops were minimised by scheduling a range of days when training was available and at times when boats were in port. The fishers left with the ability to develop a simple food safety plan for their operation (which is more than is required under the proposed general provisions of Option 3).  Likewise the Southern Rocklobster Fishery provided training and support for its members in a comprehensive integrated program covering all aspects of fishing, at a cost of $275 per operator, and by the end of 2004 the fleet will be performing at a level that will satisfy third party auditors.

·                 

·                The industry acknowledged that good hygiene practice is essential for high quality seafood.  However the industry gave a qualified response as to whether quality would attract a price premium – i.e. whether the commercial incentives in the market supported hygiene practices and quality seafood. 


For example, one fishery acknowledged that market recognition of quality would take time, but in due course a price premium would be possible with effective branding.  Other sectors mentioned that poor quality product would be penalised with a price discount, or not accepted at all by the wholesale markets.  Another fishery achieved premium prices for its quality product at times of strong demand, but not all the time.  However its reputation for quality product meant that it was able to sell its products all year round, hence it could depend on income throughout the year and on this basis plan to undertake investments to maintain the quality of its products.  Continuing market access was a significant benefit from its focus on quality. 

 

This information indicates that the seafood industry can readily achieve good hygiene outcomes through refinements to their work practices, with minimal impact on their costs of operation.  Higher quality of product that is associated with good hygiene is recognised in the market, although what this means for price and sales revenue will depend on the type of product and market conditions.  Overall, attention to good hygiene, with the outcome of higher quality product, appears to be commercially viable for the seafood industry.

There may be costs to industry as a result of States’ recovery costs to implement the proposed Standard. These costs may be comparable to those experienced by NSW in the implementation of their State-based hygiene and safety regulations.

 

In NSW there is a $50 cost for a licence and annual fees have recently been introduced to cover enforcement costs. Annual fees for commercial fishers are $310 and for finfish and crustacea aquaculture fees vary from $250 (for businesses with less than 10 employees) up to $2,000 for businesses with more than 50 employees.

 

Victoria has enacted legislation for a through-chain regulation of all seafood businesses.  The legislation came into force on 1 July 2004 for wildcatch and aquaculture businesses and requires businesses to obtain a licence and demonstrate they are meeting the basic requirements of the Victorian Food Act.  The are required to prepare a food safety plan by the end of the first year. The regulator, Primesafe, requires annual fees to be paid by businesses, dependent on the level of annual throughput. Hence the fees are less costly for the smaller operators (e.g. $200 for lower annual catch) and more expensive for larger operators (up to $800 for high annual throughput). Audit costs will be additional to these costs, however there is no advice on the likely audit costs.

 

The examples above of the flow on costs to industry of States’ recovery costs to implement food safety schemes are indicative.  It should be recognised that the costs to implement food safety schemes may vary across jurisdictions.

 

7.4.2.3   Government

 

The new Standard will expand the responsibilities of government enforcement agencies at the primary production end of the seafood chain.  The agencies have indicated that they are not expecting an increase in resources to address their new responsibilities and will respond to the situation by prioritising their efforts where enforcement will be most effective[45]


A possible management option would differentiate between the lower risk businesses, that could be licensed but not systematically inspected, and the higher risk businesses that would be subject to rigorous enforcement[46].

 

Enforcement agencies will be assisted by the development of a guide developed by FSANZ, to aid in the interpretation of the Standard.

 

Some jurisdictions are likely to be faced with a major effort in implementing the new Standard.  The experience of SafeFood Production NSW, bearing in mind that it is one of the smaller seafood producing jurisdictions, is that implementation can be accomplished within existing resources, where assistance to specific sectors of industry is staged over a period of years.

 

The staged implementation of the regulations in NSW - focusing initially on the wild catch sector and progressing to the smoked fish and aquaculture sectors - means that SafeFood Production NSW could apply the regulations within existing resources.  The cost of running the training workshops for fishers was covered by industry ($50 per fisher) together with a subsidy from the Australian Department of Agriculture, Fisheries and Forestry.  Extending hygiene and safety regulations to the seafood industry in NSW did not, in practice, impose new costs on the NSW Government but will vary across States.  It did incur costs on the Commonwealth government, and would result in additional costs if the program were rolled-out to other jurisdictions.

 

8.                       Consultation on the Draft Assessment Report

 

8.1         Consultation on the Draft Assessment Report.

 

FSANZ conducted face to face consultations in each State and the Northern Territory on the Draft Assessment Report to explain the draft assessment report and its implications to stakeholders and to receive feedback on the proposed Standard.

 

Twenty nine public submissions were received in response to the Draft Assessment Report.

 

The issues raised in the public submissions and at the face-to-face consultations at the Draft Assessment stage are detailed at Attachments 5 (Summary of each Submission) and Attachment 6 (Summary of Submissions by Issue Raised).

 

The SDC met on October 2004 to consider the issues raised during the public consultation process and responses to these issues, including modifications to the drafting of the Standard. FSANZ also undertook further targeted discussions with State and Territory governments and industry on a number of issues following the October SDC meeting.

 

Given the concerns of industry members on the SDC in relation to consistent implementation of the Standard, FSANZ raised these matters at the ISC meeting held in October 2004. ISC agreed to a process to engage with members of the group to address these issues as well as discuss issues related to guidelines to support the Standard.

 


A further meeting of the SDC was held in January 2005 attended by the Chair of ISC, to resolve the remaining issues to enable finalisation of the Standard. The meeting was also to agree on a process for further consideration of implementation issues.

 

The main issues at Draft Assessment included:

 

·                drafting issues, including:

 

-        the divide between Chapter 3 and Chapter 4

-        the scope of the Standard for seafood

-        definitions such as ‘frozen’, ‘chilled’, ‘thermal centre’, ‘thawed’ ‘live seafood’ and the exclusion in the definition for bivalve molluscs

-        the definition of ‘primary production and processing’

 

·                consistent implementation across the jurisdictions

·                audit costs and third party audit arrangements

·                the exclusion of mandatory fish marketing names from the Standard

·                labelling of imported product

·                enforcement of the Standard at the border

·                the risk ranking report

 

In response to the issues raised at the Draft Assessment stage, the drafting of the Standard has been reconsidered. In summary, the Standard has been amended as follows:

 

·                to clarify the issues around the scope and application of the Standard, including the division between Chapters 3 and 4 of the Code. This has been achieved through amendments to the definition of primary production and the processing of seafood, the purpose and commentary section and additional editorial notes;

 

·                a number of definitions within the Standard have been amended or removed to address issues identified through the consultation process;

 

·                other amendments to clauses to simplify the legal drafting, clarify the intent of the Standard or rectify other identified issues.

 

A number of issues relating to implementation of the Standard have been raised by industry. A process has been established with the Implementation Sub-Committee of the Food Regulation Committee and representatives of the SDC to consider implementation issues raised and assist with consistent implementation of the Standard.  This matter is discussed further in the next section of this report.

 

Further details on the issues raised and their consideration are outlined at Attachment 4B of this Report.

 


8.1         World Trade Organization Notification

 

As members of the World Trade Organization (WTO), Australia and New Zealand are obligated to notify WTO member nations where proposed mandatory regulatory measures are inconsistent with any existing or imminent international standards and the proposed measure may have a significant effect on trade.

 

The proposed regulatory measures, the inclusion of a primary production and processing Standard for seafood in Chapter 4 of the Code is likely to have an effect on trade for sanitary or phytosanitary reasons.  Therefore a notification to the WTO under the SPS Agreement has been made by FSANZ. No responses to this notification were received.

 

9.        Conclusions

 

The existing system, as described in Option 1, includes regulation across the food chain for seafood in the two smaller jurisdictions, requirements in the Code, the current general obligation in Food Acts to produce safe food and a strong lead by the seafood industry to develop a voluntary food safety standard. However, it is clear that this approach can be further improved to minimise food safety risks and that arrangements under the status quo do not fully meet the objective of this proposal, to effectively address the public health and safety risks associated with seafood.  Food-borne illness imposes costs on consumers, industry and governments, and while the current arrangements only partially manage the burden of food-borne illness estimated for seafood, they still contribute a net-benefit to the economy.

 

Option 2 will provide more benefits than the status quo by targeting businesses in the high risk bivalve mollusc sector, and requiring these businesses to manage their food safety risks through compliance with certain pre-harvest requirements and documented food safety programs for specified post-harvest activities.  Consumers will benefit, in comparison with the status quo, from a greater assurance of the safety of these products and a reduction in incidents of severe food-borne illness.  Industry also benefits because outbreaks of food-borne illness, which reduce sales of the high risk products and have flow on effects of reducing sales of other seafood products, will be minimised under this option.  Additional industry compliance costs from this option are expected to be small.  The impact of the targeted arrangements will be minimal on the sector because it must already comply with a comprehensive program and will require little change to satisfy the requirements of a food safety management plan program. However, it is expected to have an impact on food safety by ensuring that no opt-out of the current system is possible and that food safety portfolios are empowered to audit the sectors.  In comparison with the status quo, Option 2 will more effectively achieve the objective of this Proposal.

 

Option 3 will provide all the benefits of the previous option but will also deliver additional higher value benefits because it will provide a single, consistent, national regulatory arrangement to manage seafood safety and the impost will be commensurate with the risks posed. The estimated benefits of  introducing Option 2 (before costs) is $26.4 million per year,  while benefits of introducing Option 3 are estimated between $30 million to $75 million per year.

 


For the primary production and primary processing segment of the seafood industry, it will mandate basic food safety provisions and a requirement for businesses to systematically examine their operations to identify potential seafood safety hazards and implement controls that are commensurate with the food safety risks. It will also specifically address identified higher risk activities.  It will deliver a material reduction in public health and safety risks and a greater net benefit by reducing food-borne illness in Australia, because it will require those businesses currently not adequately managing basic food safety to do so.

 

Consumers will benefit from the lower risk of food-borne illness and industry will minimise the periodic losses of sales revenues that have occurred following food-borne illness outbreaks.  For the government sector, data on the new seafood regulations in NSW indicate that the introduction of food safety regulation into the seafood industry may be accomplished with minimal additional resources. However how jurisdictions implement the Standard and the related costs incurred will vary.

 

Option 3 will impose new costs on businesses only where they do not currently manage food safety adequately. Note that it is expected that a significant majority of seafood businesses will meet or exceed these basic requirements and the new Standard will, therefore, not affect their operating costs.

 

Overall, Option 3 will most effectively meet the objective of this proposal.   It is superior to the previous option in that it has the capacity to deliver greater reductions in food-borne illness, as it will address a greater range of public health and safety risks in the seafood sector in comparison to Option 2.  Additional compliance costs for industry appear to be small and, in comparison to the previous two options, Option 3 will provide superior net-benefits to the economy.

 

On a practical issue, one possible risk to achieving the potential benefits of Option 3 (as well as Option 2) is inconsistent implementation.  SDC industry representatives have voiced concerns about the need for consistent implementation of the Standard across States and Territories and the resulting costs and uncertainty for industry of inconsistent implementation. The differing costs between States and Territories for licensing and registration are also of concern.  Industry has also emphasised the need for collaboration between industry and government to provide the necessary guidance to industry to support the Standard.  In response to these issues, ISC has agreed that once the standard-setting process is completed a process will commence with an ISC representative, members of the SDC and ASQAAC representatives to consider implementation issues and to progress issues in relation to the guidelines.

 

The preferred option is Option 3 (a Primary Production and Processing Standard - targeting higher risk activities and requiring minimum food safety requirements for lower risk activities/sectors), which combines general and specific provisions for seafood production and processing based on risk.  This option is preferred because:

 

·                it is consistent with the findings and conclusions of the scientific evaluation of public health and safety risk;

 

·                the risk management strategy is commensurate with the level of public health risk identified in the risk ranking document and is in harmony with the approach agreed to by the Ministerial Council;


·                the need for basic food safety and hygiene requirement is consistent with the requirement for the manufacturing and retail sectors to meet good hygienic practice as defined in Chapter 3 of the Code – Food Safety Standards 3.2.2 and 3.2.3;

 

·                it represents a minimum effective standard with the highest net benefit, and the risk management approaches and their verification are commensurate with the risks posed; and

 

·                it is consistent with Codex in requiring that all food production meet basic requirements of good hygienic practice.

 

In conclusion, Option 3 is preferred because it achieves the objectives of:

 

·                effectively addressing public health and safety risks, and demonstrates the highest net-benefits to the Australian community;

 

·                improving national consistency in the management of seafood safety;

 

·                improving food safety management across the seafood supply chain;

 

·                providing a preventive approach to the management of food safety;

 

·                providing outcomes-based standards to allow maximum flexibility for business; and

 

·                being cost-effective as demonstrated in the regulatory impact assessment.

 

A draft of the proposed Primary Production and Processing Standard for Seafood, consistent with Option 3 is located in Attachment 1.

 

10.      Recommendation

 

It is recommended that Option 3 (Primary Production and Processing Standard for Seafood as described in Attachment 1) be adopted.  This option will manage food safety risks in two ways:

 

·                the requirement to adopt basic food safety provisions for lower risk seafood; and

 

·                more stringent food safety management requirements for higher  risk seafood in the primary production and processing sector. Specifically, for bivalve molluscs there will be mandatory requirements to comply with pre-harvest provisions in the Australian Shellfish Quality Assurance Program so they are only harvested under conditions that assure their safety.  In addition, businesses that deal with bivalve molluscs post-harvest up to (but not including) the retail sector will be required to implement food safety programs.

 

A nationally agreed date for commencement of the Primary Production and Processing Standard for Seafood of one year from the date of gazettal is recommended. 


However, with provisions in the Code that allow for a compliance requirement of 12 months after gazettal of a variation to the Code, this means there is effectively a two year lead in period before businesses are required to comply.

 

This is also consistent with the decision by Ministers at their meeting in December 2003 where it was agreed that the implementation of national food safety management options for high risk businesses would be implemented by all States and Territories, no later than 2 years after gazettal of the Standard.

 

11.      Implementation, monitoring and review

 

Once accepted into the Code, the proposed Primary Production and Processing Standard for Seafood would become mandatory on a national basis.  It would then be adopted into the appropriate legislation of each Australian State and Territory, providing each jurisdiction with the necessary legal basis for enforcement of the Standard.

 

Factors influencing successful implementation of the Standard include:

 

·                implementation timeframe;

·                provision of a suitable compliance timeframe for industry;

·                implementation of appropriate audit management and inspection systems; and

·                appropriate tools to provide assistance and guidance to industry (of which many currently exist – see Attachment 8). 

 

Because of the non-prescriptive nature of the new seafood Primary Production and Processing Standard, interpretive documents are essential for enforcement officials (such as Environmental Health Officers) to assist with consistent implementation and for training organisations helping seafood businesses to meet the requirements of new standards. FSANZ will develop an interpretive guide to the Primary Production and Processing Standard to aid consistent interpretation of the Standard by enforcement agencies. The guide will be developed in conjunction with  an advisory group comprising of SDC representatives and others  and the Implementation Sub-Committee (ISC).

 

A qualitative review of the implementation of the Food Safety Standards (Chapter 3)[47] identified that the States and Territories were at different stages of implementation as a result of:

 

·                dissimilar timing of adoption;

·                diverse approaches to communicating with food businesses;

·                widely different context of implementation; and

·                different choices in aspects of implementation including inconsistencies in interpretation.

 

The Implementation Sub-Committee (ISC) of the Food Regulation Standing Committee is examining these issues.

 


In addition, the issues raised by industry SDC members about the consistent implementation of the seafood Standard will be facilitated through a process between industry SDC representatives and ISC.  ISC is charged with responsibility for overseeing cross-jurisdictional agreement on consistent approaches to implementing and ensuring compliance with food standards.

 

ISC will have a major role in the implementation aspects of the Standard to ensure consistent interpretation of issues related to the implementation and enforcement of the Standard, and to encourage cost-effective approaches to compliance and enforcement. 

 

FSANZ will undertake baseline qualitative research on businesses in the seafood sector to determine awareness, knowledge and behaviour in relation to safe food handling, current regulations, sources of information and staff training. Follow up research will be undertaken at least two years after the Standards are implemented in all States and Territories.

 

States and Territories will undertake routine surveillance of food for sale on the Australian market against the requirements of the Code as well as other specific surveillance activities.  AQIS and FSANZ and the States and Territories will continue to work together to examine systems that can more reliably monitor the safety of imported foods.

 

ATTACHMENTS

 

1.       Draft variations to the Australia New Zealand Food Standards Code

2.       The Policy and Regulatory Framework for the Development of Food Standards

3.       The Seafood Sector

4A.    Consultation on Initial Assessment Report

4B.    Public Consultation on Draft Assessment Report

5A.    Summary of Submissions at Initial Assessment

5B.    Summary of Submission at Draft Assessment

6A.    Summary of Submissions by Issue at Initial Assessment

6B.    Summary of Submission by Issue at Draft Assessment

7.       Australia New Zealand Food Standards Code Requirements for Seafood

8.       Available Codes of Practice for the Safe Production of Seafood

9.       The Imported Food Inspection Scheme and Seafood Testing

10.     A Risk Ranking of Seafood in Australia.


Attachment 1

 

Draft variations to the Australia New Zealand Food Standards Code

 

To commence:  12 months from gazettal

 

Note on commencement:

 

Subclause 1(2) of Standard 1.1.1 applies to these amendments to the Food Standards Code.  The effect of this subclause is that a food is taken to comply with Standard 4.2.1 (below) for a period of 12 months after the commencement of the Standard, provided the food otherwise complied with the Food Standards Code.  This means that seafood producers have 2 years from the gazettal of Standard 4.2.1 before they are required to comply with the new requirements.

 

[1]          Standard 3.2.1 of the Australia New Zealand Food Standards Code is varied by omitting subclause 2(2), substituting -

 

(2)          Unless expressly provided elsewhere in this Code, this Standard applies to all food and primary food production businesses that are determined by the appropriate enforcement agency under the Act to be within a priority classification of food business from the commencement date for that priority classification of food business.

 

[2]          The Australia New Zealand Food Standards Code is varied by inserting after Standard 3.3.1 -

 

Standard 4.2.1

 

PRIMARY PRODUCTION AND PROCESSING STANDARD FOR Seafood

(Australia Only)

 

 

Purpose and commentary

 

This Standard sets out food safety and suitability requirements for seafood generally from pre-harvesting production of the seafood up to, but not including manufacturing operations.   Chapter 3 of this Code applies to seafood manufacturing and retail sale activities.

 

Under this Standard, a seafood business must identify potential seafood safety hazards and implement controls that are commensurate with the risk.

 

Additionally, this Standard requires primary producers and processors of certain bivalve molluscs to implement a food safety management system.  This particular requirement also extends to manufacturing activities relating to bivalve molluscs.

 


For primary producers and processors of bivalve molluscs, the food safety management system incorporates conditions on the areas from which the product may be harvested or harvested for depuration or relaying, along with conditions on the water used for wet storage.

 

Table of Provisions

 

Division 1 – Preliminary

1            Application

2            Interpretation

 

Division 2 – General seafood safety requirements

3            General seafood safety management

4            Contamination and handling

5            Inputs and harvesting areas

6            Seafood storage

7            Seafood transportation

8            Seafood packaging

9            Seafood for disposal

10          Seafood receipt

11          Seafood tracing

12          Skills and knowledge

13          Health and hygiene requirements

14          Seafood premises and equipment

 

Division 3 – Harvesting and other requirements for bivalve molluscs

15          Interpretation

16          Food safety management systems for bivalve molluscs

17          Co-mingling of bivalve molluscs

 

Clauses

 

Division 1 – Preliminary

 

1            Application

 

(1)          This Standard applies to seafood businesses and seafood handlers in Australia but not in New Zealand.

 

(2)          Unless the contrary intention appears in this Standard, Chapter 3 of this Code applies to seafood manufacturing and retail sale activities.

 

Editorial note:

 

This Standard applies to primary production and processing activities as defined in clause 2.  The definition of 'processing of seafood' includes activities such as the killing, gutting, filleting, brining and shucking of seafood and the depuration of shellfish.  However, other than the food safety management system requirements for bivalve molluscs, this Standard does not apply to manufacturing activities. 

 


Manufacturing of seafood is defined in clause 2 as the canning, smoking or crumbing of the seafood or the addition of other foods to the seafood and other like activities.

 

Under the Imported Food Control Act 1992, Standards in this Code apply to imported food.  However, this Standard does not fall within the scope of the ‘Agreement Between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards System’.  Accordingly, this Standard does not apply to food businesses in New Zealand.  Furthermore, the Trans-Tasman Mutual Recognition Arrangement and the Australian and New Zealand legislation giving effect to that Arrangement apply to imported food.

 

This Standard does not apply to persons who harvest or catch seafood for recreational, cultural or traditional purposes, provided the activity does not come within the definition of a ‘seafood business’ – that is, the seafood harvested or taken is not intended for sale.

 

Clause 3 of this Standard does not affect the operation of Standard 3.2.1.

 

2            Interpretation

 

(1)          Unless the contrary intention appears, the definitions in Chapter 3 of this Code apply for the purposes of this Standard.

 

(2)          In this Standard –

 

control means a measure that prevents, eliminates or reduces to an acceptable level, a food safety hazard.

 

depuration means a process using a controlled environment to reduce the level of certain pathogenic organisms that may be present in live shellfish and crustaceans.

 

harvesting means the capture or taking of seafood and includes the capture or taking of seafood from an enclosure or pond used in aquaculture.

 

inputs includes any feed, chemicals or other substances used in, or in connection with, the primary production of seafood.

 

live seafood premises means a premises used for the primary production of live seafood, and includes sea cages.

 

manufacturing of seafood means the canning, smoking or crumbing of seafood or the addition of other food to seafood and other like activities.

 

primary production of seafood means the –

 

(a)          growing, cultivation, picking, harvesting, collection or catching of seafood;  or

(b)          growing on of seafood; or

(c)          transportation or delivery of seafood;  or

(d)         holding of live seafood;


and includes processing of seafood.

 

processing of seafood includes –

 

(a)          the killing, dismembering, filleting or cutting into portions, gill or gutting, or skinning of seafood; and

(b)          the depuration of shellfish and crustaceans; and

(c)          the shucking or peeling of seafood; and

(d)         the cooking, including steaming or boiling, of crustaceans; and

(e)          the brining of seafood; and

(f)          the packing, treating, washing, freezing, refrigeration or storing of seafood; and

(g)          other similar activities.

 

Editorial note:

 

The definitions of ‘primary production of seafood’ and ‘processing of seafood’ operate for the purposes of this Standard and do not affect the definition of those terms in State and Territory Food Acts.  The definitions in this Standard do not affect the legislative or administrative arrangements in the States and Territories concerning the administration and implementation of legislative schemes.

 

seafood means all aquatic vertebrates and aquatic invertebrates intended for human consumption, but excludes amphibians, mammals, reptiles, and aquatic plants.

 

seafood business means a business, enterprise or activity that involves the primary production of seafood intended for sale.

 

seafood handler means a person who engages in or supervises the primary production of seafood, for a seafood business.

 

seafood premises means any premises including land, vehicles, parts of structures, tents, stalls and other temporary structures, vessels, pontoons, and any other place declared by the relevant authority to be a premises under the Food Act, kept or used for the primary production of seafood (exclusively or otherwise), regardless of whether the premises are owned by the proprietor, including premises used principally as a private dwelling.

 

temperature control means maintaining seafood at a temperature of –

 

(a)          5°C, or below if this is necessary to minimise the growth of infectious or toxigenic micro-organisms in the food so that the microbiological safety of the food will not be adversely affected for the time the food is at that temperature; or

(b)          another temperature ¾ if the food business demonstrates that maintenance of the food at this temperature for the period of time for which it will be so maintained, will not adversely affect the microbiological safety of the food.

 


Division 2 – Seafood safety requirements

 

3            General seafood safety management

 

A seafood business must systematically examine all of its primary production and processing operations to identify potential seafood safety hazards and implement controls that are commensurate with the food safety risk.

 

Editorial note:

 

The ‘controls’ referred to in this clause should include –

 

a.            Measures to control hazards from air, soil, water, bait and feedstuffs, fertilizers (including natural fertilizers), pesticides, veterinary drugs and any other agent used in primary production of seafood; and

 

b.           Controls to protect food sources from faecal and other contamination.

 

4            Contamination and handling

 

(1)          A seafood business must take all necessary steps to prevent the likelihood of seafood being or becoming contaminated.

 

(2)          A seafood business must take all reasonable measures to ensure that seafood handlers handle seafood or surfaces likely to come into contact with seafood in a way that is not likely to compromise the safety or suitability of seafood.

 

5            Inputs and harvesting areas

 

(1)          A seafood business must take all reasonable measures to ensure inputs do not adversely affect the safety or suitability of the seafood. 

 

(2)          A seafood business must not harvest seafood in an area if it is known, or ought reasonably be known at the time, that the seafood, if harvested in the area, may not be safe or suitable when sold for human consumption.

 

6            Seafood storage

 

(1)          A seafood business must, when storing seafood, other than live seafood, store the seafood under temperature control and have a means of monitoring the temperature of the seafood.

 

(2)          A seafood business must, when storing live seafood, store the seafood in such a way that the conditions under which it is stored will not adversely affect the safety or suitability of the seafood.

 


7            Seafood transportation

 

(1)          A seafood business must, when transporting seafood, other than live seafood, transport the seafood under temperature control and have a means of monitoring the temperature of the seafood.

 

(2)          A seafood business must when transporting live seafood, transport the seafood under conditions that will not adversely affect the safety or suitability of the seafood.

 

Editorial note:

 

For clauses 6 and 7 -

 

The term ‘temperature control’ is defined in clause 2 of this Standard.

 

8            Seafood packaging

 

A seafood business must, when packaging seafood –

 

(a)          only use packaging material that is fit for its intended use; and

(b)          only use packaging material that is not likely to cause contamination of the seafood; and

(c)          take all reasonable measures to ensure that the seafood does not become contaminated.

 

9            Seafood for disposal

 

(1)          A seafood business must ensure that seafood for disposal is held and kept separate until it is –

 

(a)          destroyed or otherwise used or disposed of so that it cannot be used for human consumption; or

(b)          returned to its supplier; or

(c)          processed in a way that ensures its safety or suitability; or

(d)         ascertained to be safe and suitable for sale.

 

(2)     A seafood business must clearly identify any seafood that is held and kept separate in accordance with subclause (1) as returned seafood, recalled seafood, or seafood that is or may not be safe and suitable.

 

Editorial note:

 

‘Seafood for disposal’ has the same meaning as ‘food for disposal’ as defined in Standard 3.2.2, clause 11 – that is – the seafood is subject to a recall, or has been returned, or is not safe or suitable, or is reasonably suspected of not being safe or suitable.

 

10          Seafood receipt

 

(1)          A seafood business must take all reasonable measures to ensure it only accepts seafood that is protected from the likelihood of contamination.


(2)          A seafood business must, when receiving seafood, other than live seafood, take all reasonable measures to ensure it only accepts seafood that is under temperature control.

 

(3)          A seafood business must, when receiving live seafood, take all reasonable measures to ensure that it receives seafood that has been transported in such a way that has not or will not adversely affect the safety or suitability of the seafood.

 

11          Seafood tracing

 

A seafood business must maintain sufficient written records to identify the immediate supplier and immediate recipient of seafood for the purposes of ensuring the safety of the seafood.

 

12          Skills and knowledge

 

A seafood business must ensure that seafood handlers have –

 

(a)          skills in food safety and food hygiene;  and

(b)          knowledge of food safety and food hygiene matters;

 

commensurate with their work and the food safety risks.

 

13          Health and hygiene requirements

 

(1)          A seafood handler must exercise personal hygiene and health practices that are commensurate with the food safety risks and that do not adversely affect the safety or suitability of the seafood.

 

(2)          A seafood handler who –

 

(a)          has a symptom that indicates the handler may be suffering from a food-borne disease; or

(b)          knows he or she is suffering from a food-borne disease; or

(c)          is a carrier of a food-borne disease;

 

must not engage in any handling of seafood where there is a reasonable likelihood of seafood contamination as a result of the disease.

 

(3)          A seafood business must take all reasonable measures to ensure that seafood handlers exercise personal hygiene and health practices that are commensurate with the food safety risks and that do not adversely affect the safety or suitability of the seafood.

 

14          Seafood premises and equipment

 

(1)                   A seafood business must ensure that seafood premises, including live seafood premises, and equipment used in the primary production of seafood are –

 

(a)          so far as is reasonably necessary, kept clean; and

(b)          designed, constructed, maintained and operated;

 


such that the safety or suitability of the seafood will not be adversely affected.

 

(2)     For the purposes of subclause (1), a seafood business must comply with –

 

(a)          Division 5 of Standard 3.2.2 and Standard 3.2.3 of this Code; or

(b)          a set of requirements recognised by the Authority.

 

Editorial note:

 

Where the cleaning of equipment such as fishing nets and oyster racks would not affect the safety or suitability of the seafood, the cleaning of this equipment will not be necessary to meet the requirements in paragraph 14(1)(a).

 

Division 3 – Specific requirements for bivalve molluscs

 

15          Interpretation

 

In this Division –

 

approved means approved by the Authority.

 

area means an area where bivalve molluscs are grown or harvested.

 

ASQAP Manual means the Australian Shellfish Quality Assurance Program Operations Manual - Version 3 of 2002.

 

Authority means the State, Territory or Commonwealth government agency or agencies having the legal authority to implement and enforce this Division.

 

batch means a quantity of bivalve molluscs which is harvested, depurated or handled from the same lease number and with the same harvest date.

 

bivalve molluscs include cockles, clams, mussels, oysters, pipis and scallops intended for human consumption, but excludes scallops and pearl oysters, where the only part of the product consumed is the adductor muscle, and spat.

 

growing on means the process where juvenile bivalve molluscs are translocated to a classified area for a sufficient period to enable their development prior to sale.

 

relaying means the transfer of bivalve molluscs from one area to another for the reduction of contaminants in the bivalve molluscs.

 

spat means juvenile bivalve molluscs taken for the sole purpose of growing on.

 

Editorial note:

If spat are harvested for human consumption then the product falls within the definition of ‘bivalve mollusc’.  In that case, the requirements in this Division for bivalve molluscs apply to the product.


wet storage means the temporary storage of bivalve molluscs from an area in containers or tanks containing natural or artificial seawater for purposes other than depuration.

 

16          Food safety management systems for bivalve molluscs

 

(1)          A seafood business that engages in the primary production or processing of, or manufacturing activities concerning, bivalve molluscs must implement a documented food safety management system that effectively controls the hazards.

 

Editorial note:

 

‘Hazard’ is defined in Standard 3.1.1 as a biological, chemical or physical agent in, or condition of, food that has the potential to cause an adverse health effect in humans.

 

Under subclause 1(2) of this Standard, the requirement for a food safety management system in subclause 16(1) does not apply to retail sale activities concerning bivalve molluscs.

 

(2)          A seafood business is taken to comply with subclause (1) if it implements –

 

(a)          a food safety program set out in Standard 3.2.1; or

 

(b)          a food safety management system set out in the Commonwealth Export Control (Processed Food) Orders; or

 

(c)          the Codex Alimentarius Hazard Analysis and Critical Control Point System (HACCP) for food safety management set out in Annex C to CAC/RCP 1-1969, revision 4 (2003); or

 

(d)         any other Hazard Analysis and Critical Control Point (HACCP) based food safety management system recognised by the Authority.

 

(3)     For the purposes of subclause (1), a seafood business must comply with –

 

(a)          the conditions of the ASQAP Manual specified in the Schedule to this Standard; or

(b)          conditions recognised by the Authority.

 

Editorial note:

 

The ASQAP Manual is the National guideline for managing risks in the harvesting, relaying, depuration and wet storage of shellfish.

 

Subclause 16(3) does not require producers or processors of bivalve molluscs to classify or close harvesting areas.  Under the ASQAP Manual the classification of these areas is the responsibility of the State Shellfish Control Agency (SSCA).

 

The Australian Shellfish Quality Assurance Advisory Committee (ASQAAC) maintains the ASQAP Manual.

 


‘HACCP’ has a technical meaning commonly understood by the food production and manufacturing industry.

 

17          Co-mingling of bivalve molluscs

 

A seafood business must ensure that each batch of bivalve molluscs harvested must be separated in a manner that prevents co-mingling of batches.

 

Schedule

 

ASQAP MANUAL CONDITIONS

 

Column 1

Activities

Column 2

Conditions

Activity 1

Harvesting

 

The area -

 

(a)              has been classified by the Authority as –

 

(i)               approved; or

(ii)              conditionally approved; or

(iii)             approved as remote; or

(iv)             offshore; and

 

(b)              is subject to a Marine Bio-toxin                 Management Plan; and

(c)              has an open status; or

(d)              is undergoing classification and is approved                 by the Authority subject to conditions, if                 any, specified by the Authority.

 

Activity 2

Harvesting for depuration or relaying                    

 

The area –

 

(a)              has been classified by the Authority as –

 

(i)               approved; or

(ii)              conditionally approved; or

(iii)             approved as remote; or

(iv)             restricted; or

(v)              conditionally restricted; and

 

(b)              is subject to a Marine Bio-toxin                 Management Plan; and

(c)              has an open status for the purposes of                 depuration or relaying; or

(d)              is undergoing classification and is approved                 by the Authority, subject to conditions, if                 any, specified by the Authority.

 

Activity 3

Post harvest temporary wet storage

 

The water used must be -

 

(a)              sourced from an area that satisfies the                 conditions for Activity 1 (other than                 Condition (d)); or

(b)              of a quality that will not adversely affect the                 safety and suitability of the bivalve                 molluscs;

 

and

 

(c)              effectively disinfected or maintained                 during the course of the wet storage in such a              way that it continues to satisfy the                 conditions for Activity 1 (other than                 Condition (d)).

 

 

 


Attachment 2

 

The Policy and Regulatory Framework for the Development of Food Standards

 

1.           Policy and regulatory framework for food standards

 

A broad framework exists in Australia to guide the development of all food regulation.  A review of regulatory arrangements in 1998 resulted in new arrangements for food regulation in Australia and New Zealand, agreed to by the Council of Australian Governments (COAG) in 2000[48].  These arrangements included the formation of the Ministerial Council that provides policy guidance to FSANZ to assist in the development of food standards.

 

The new structure also included the formation of a single agency, FSANZ, a bi-national authority that sets joint food standards for composition and labelling of food for Australia and New Zealand. It sets food safety standards in Australia, and from July 2002, also develops food standards for the primary production sector in Australia.  FSANZ must adhere to specific legislative requirements and guidelines when developing food standards.

 

1.1         Council of Australian Governments

In Australia, there has been a major reorientation of the general regulatory framework and the processes for making regulations as well as to the framework for developing food regulation in Australia and New Zealand, and these have been endorsed by the Council of Australian Governments (COAG, 1997 and 2000[49]).  The broader regulatory framework requires that regulation in Australia is pro-competitive, outcomes focussed, that the costs and benefits of any regulation are appropriately examined with the view to choosing the most effective alternative and that such regulation is regularly reviewed.

 

In 1997, the Prime Minister announced, in his statement More Time for Business, a review of food regulations in Australia[50].  The review aimed to examine the regulatory burden on business and to improve the clarity, certainty and efficiency of food regulatory arrangements, whist protecting public health and safety.  Following a review of the recommendations, the Commonwealth, State and Territory Governments, through COAG, agreed on a national response to the Food Regulation Review.  Included in the significant recommendations flowing from the review was the agreement to a national paddock to plate approach to food regulation to protect public health and safety.  This included the formation of a single national agency, Food Standards Australia New Zealand (FSANZ), to set food standards and the formation of a new Ministerial Council, called the Australia New Zealand Food Regulation Ministerial Council, to consider all food safety matters from paddock to plate.

 

In 2000, a Food Regulation Agreement was signed by COAG, to put in place the new food regulatory arrangements.  The Agreement aimed to:


·         provide safe food controls for the purpose of protecting public health and safety;

  • reduce the regulatory burden on the food sector;
  • facilitate the harmonisation of Australia’s domestic and export food standards and their harmonisation with international standards;
  • provide cost effective compliance and enforcement arrangements for industry, governments and consumers;
  • provide a consistent regulatory approach across Australia through nationally agreed policy, standards, compliance and enforcement procedures;

·         recognise the responsibility for food safety encompasses all levels of government and a variety of portfolios; and

  • support joint Australia and New Zealand efforts to harmonise food standards.

 

The outcome of these arrangements has meant that for the first time in Australia, a single agency (FSANZ) develops all domestic food standards, including those for primary production and processing sectors.

 

The primary focus for these is on the protection of public health and safety.  Under the Treaty arrangement with New Zealand, the promulgation of joint food standards for food hygiene measures is excluded.  Therefore, primary production and processing standards under the Code will apply in Australia only.

 

1.2         Food Standards Australia New Zealand Act 1991

 

Under the FSANZ Act, the objectives for developing all food standards in descending order of priority are:

 

·         the protection of public health and safety;

·         the provision of adequate information relating to food to enable consumers to make informed choices; and

·         the prevention of misleading or deceptive conduct.

 

In developing and varying standards, FSANZ must also have regard to the:

 

  • need for standards to be based on risk analysis using the best available scientific evidence;
  • promotion of consistency between domestic and international food standards;

·         desirability of an efficient and internationally competitive food industry; and

  • promotion of fair-trading in food.

 

Food standards developed under the Act form part of the Australia New Zealand Food Standards Code, which the States and Territories in Australia adopt or incorporate within their food legislation without amendment.  As part of the regulatory reforms, States and Territories have agreed to adopt new model food legislation as part of improving the consistency of food legislation across the country.

 

Food standards developed by FSANZ are also guided by overarching policy guidelines developed by the Ministerial Council and by the legislation under the FSANZ Act.  In the case of Primary Production and Processing Standards, the overarching Ministerial guidelines specify higher order policy principles, which state they will:


  • be a set of outcomes-based national standards for the relevant primary production and processing sectors/commodities;

·         have a consistent regulatory approach across the Standards;

  • be consistent with the s10 objectives of the FSANZ Act, recognising that the protection of public health and safety has priority;
  • be consistent with the approach outlined in Chapter 3 of the Code
  • be consistent with internationally recognised Codex standards, save where, after consideration of a risk assessment, it is clear that the relevant standard does not sufficiently protect public health and safety in Australia;

·         address food safety across the entire food chain where appropriate;

  • facilitate trade;
  • be not more trade restrictive and comply with Australia’s obligations under World Trade Organization agreements;
  • ensure that the regulatory framework promotes consumer confidence;
  • ensure the cost of the overall system should be commensurate with the assessed level of risks and benefits;
  • provide a regulatory framework that applies only to the extent justified by market failure; and

·         provide for collaborative action among enforcement agencies to optimise the use of resources and effectiveness.

 

2.           Development of a Primary Production and Processing Standard for Seafood (Proposal P265)

 

Proposal 265 (P265) ‘Development of a Primary Production and Processing Standard for Seafood’ was raised by FSANZ in December 2002 under its mandate to develop domestic standards for the primary production and processing of food.

 

The seafood sector includes a number of products and activities that, unless well managed, may potentially have serious impacts on public health and safety.  Recently, some State governments have developed seafood safety schemes to ensure that a ‘boat to plate’ (i.e. paddock to plate) approach to seafood safety was implemented across the seafood supply chain.  However, other jurisdictions are not yet at that point, leaving the primary production end of the domestic seafood chain without mandated seafood safety schemes.

 

The seafood sector was also increasingly aware that food safety issues are vital to the continued growth of the industry, and was at an advanced stage of developing a national voluntary seafood safety standard.  The industry has also produced a number of guidance documents on food safety across a range of sectors.  It was therefore considered an opportune time to move these developments forward to a nationally mandated system.

 

As required by the Ministerial guidelines, a Standards Development Committee (SDC) was appointed in September 2002 by the FSANZ Board to provide advice to FSANZ on matters relevant to the standard development process.  The SDC contributes a broad spectrum of knowledge and expertise covering industry, government, research and consumers.

 

In December 2002, the Board prepared a Proposal pursuant to section 12AA of the Food Standards Australia New Zealand Act 1991 for the development of a Primary Production and Processing Standard for seafood. 


The Board approved the Initial Assessment Report (Issues Paper) for release, agreed to seek public submissions, and directed the SDC to consider any available standards, including those developed by Seafood Services Australia Ltd, and the New South Wales and New Zealand Governments during its discussions and provision of advice on development of the mandatory national standard for seafood.

 

Since that time FSANZ, with advice from the SDC, has:

 

  • considered the written submissions  received in response to the public consultation on the Initial Assessment report and the Draft Assessment Report;
  • undertaken an evaluation of public health risks and identified sectors of the seafood industry that pose a potential high risk to safety;
  • considered current strategies to manage those risks and determined, what if any, residual risks need to be managed;
  • considered options for the management of these residual risks that aim to ensure the safety of seafood;
  • conducted an impact analysis of the options to identify the option that meets the minimum effective regulation requirements , but effectively addresses any public health and safety risks associated with seafood;
  • recommended a preferred option;
  • considered the implementation of the preferred option; and

·         drafted a proposed standard consistent with the preferred option.

 

This Report forms the       third stage in the process of developing a Primary Production and Processing Standard for seafood.  It takes into account the matters raised above and other deliberations of the Seafood SDC.


Attachment 3

 

The Seafood Sector

 

1.         Seafood sector

 

Seafood is an important part of the Australian diet.  Domestic demand for seafood continues to grow: between 1991 and 1999, consumption of seafood in Australia increased by 12 percent (from 13.5 kg to 15.1 kg per capita)[51].  Australian households spend about 2.5 per cent of their food budgets on seafood products, which is about the same as expenditure on poultry[52].  The last few decades have also seen changes in the way Australians eat seafood, such as increasing consumption of sushi and smoked fish. 

 

This increase in consumer demand is met to some extent by importing seafood products and by producing seafood through aquaculture.   Approximately half of all seafood consumed in Australia is produced domestically and the other half is imported[53].  This means that any proposed food safety management systems for the primary production sector must adequately address food safety for imported as well as domestically produced seafood and must take into consideration the increasing trend for seafood to be produced through aquaculture.

 

1.1         Consumer attitudes to seafood safety

 

Public health professionals advocate seafood in the diet as a means to address obesity and as a good source of omega-3 fatty acids[54].   A study of consumer attitudes in Sydney and Perth found that the perceptions that fish is healthier than meat and that it adds variety to the diet were major factors influencing consumption.  However uncertainty about safety and contamination, a lack of knowledge about seafood and high prices were major barriers to increased consumption[55].

 

The role of food safety systems is to minimise risks to public health, and in the process, to maintain consumer confidence in the food supply.  Consumers have responded to outbreaks of food-borne illness in the past by reducing their demand for seafood.  For example, following contamination of NSW bivalve molluscs in 1997, NSW consumers immediately reduced their demand for bivalve molluscs by 85 percent.  They also immediately reduced their overall demand for seafood products by 30 percent, indicating that consumers readily generalise a specific seafood risk to all categories of seafood products[56].  Consumers also tend to respond by expressing a lack of confidence in the capacity of industry and government to ensure food safety, a situation that may also impact on trade.

 


Other data, however, indicate that, despite a relatively short-term negative response to outbreaks of food-borne illness[57], there is solid demand for seafood over the medium term.   For example, the share of seafood expenditure in household’s food budgets was similar in 1993-94 to the share in 1998-99[58], indicating solid demand for seafood over the medium term.  This demonstrates consumers perceive the benefits of seafood consumption to be greater than any risks associated with its consumption.  Nevertheless, short-term negative responses can last up to a year and have a significant impact on some seafood producers or sectors, highlighting the importance of consumer confidence as an important issue for industry and government.

 

1.2         Nature of the industry

 

The Australian seafood industry markets a diverse range of approximately 600 marine and freshwater seafood species.  The Australian fishing zone is 11 million square kilometres, the third largest in the world.  Despite the size of the fishing zone, Australia is ranked 52nd in the world with respect to commercial tonnage.  The industry ranges from tropical to sub-Antarctic, open ocean to estuarine, marine to freshwater, and operates in one of the world’s cleanest environments.

 

As the industry is geographically dispersed, it has a predominantly regional and rural workforce.  In 2003, the Australian Bureau of Statistics reported 19 627 people directly involved in the wild catch, aquaculture, and processing sectors.  Indirect employment in the commercial sector, and in compliance, transport, storage, wholesaling, and retailing, is considerably higher, and may approach 80 000 people[59].  A more detailed analysis of the industry was included in the Initial Assessment Report, released for public comment in December 2002.

 

The volume of seafood harvested from the wild is limited by the capacity of fish stocks.  Most stocks are fished at their optimum sustainable level and there is little capacity to expand wild catch volume[60].  However, land and sea-based aquaculture is making an increased contribution to the seafood industry. Between 1991-92 and 2001-02, aquaculture produced approximately 24 percent of the total volume of seafood produced in Australia.

 

1.3         Value of the industry

 

The seafood industry is the fourth largest sector of the Australian food industry (by value) after beef, wheat, and milk.  The gross value of production (GVP) during 2000-01 was estimated at $2.48 billion (adjusted figure)[61].  Since 1992, the GVP increased, on average, by 10 per cent per annum and aquaculture’s share has risen from 15 per cent to 30 per cent.[62] 


Most species cultured in Australia are high unit value species such as southern blue fin tuna, Kuruma prawns, bivalve molluscs and Atlantic salmon.  A breakdown of production by the Australian commercial fishing industry is shown in Figures 1 and 2.

 

Figure 1:    State shares of fisheries production, by value (ABARE, 2003)

 

 

 

 

 

 

 

 

 

 


Figure 2:    Australian seafood production (edible and non-edible), 2001-02 (ABARE, 2003)

 

1.4         Volume produced by the industry

 

Of the 186,677 tonnes of seafood produced in Australia during 2001-02, approximately 66 per cent (122,383 tonnes) was consumed domestically.  During 2001-02, Australia imported 144,474 tonnes of seafood, mainly from Thailand and New Zealand (Figure 3b), which represents approximately half the total seafood consumed in Australia per annum (by volume).  By value, imported seafood represented 77 per cent of the total value of seafood consumed in Australia.

 

Thirty four percent by volume of domestically produced seafood is exported.  The major export markets were Japan, Hong Kong, United States, China, Chinese Taipei, and Thailand, with these six markets making up 82 per cent of the total export volume (Figure 3a). 

 

Figure 3:    Volume of Australian edible fisheries exports (a) and imports (b) by country (ABARE, 2003)

 

 

 

 

 

 

 

 



In terms of the value of seafood produced in Australia, exports represented 87 per cent of total production.  This comparison reflects Australia’s position as an exporter of high value seafood species (e.g. rock lobster and abalone), with lower value species predominantly being traded in the domestic market.

 


Attachment 4A

 

Consultation on Initial Assessment Report

 

FSANZ has a statutory obligation to consult with stakeholders in relation to food regulatory measures.  This is undertaken through two rounds of public consultation: one following release of the Initial Assessment Report, and the other following the release of the Draft Assessment Report, as described on Pages (ii) and (iii).

 

In addition to statutory consultation, further consultative mechanisms have been built into the development process for the Primary Production and Processing Standard for Seafood.  This reflects recognition of the need for close consultation with industry, regulators and consumers throughout the development of the Standard.  This is considered particularly important as the setting of primary production and processing standards is a new function of FSANZ.  Accordingly, in the early stages of standard development, the level of awareness of FSANZ processes in the community and within the primary production sector may be minimal.

 

In recognition of the need for broad and active consultation throughout the development of the seafood standard, FSANZ is committed to seeking stakeholder involvement via the following mechanisms:

 

·                Seafood SDC - the role of the SDC is to provide input and advice from consumer, industry, government and research perspectives to FSANZ in the development of the Standard;

 

·                Working Groups - the Seafood SDC has established working groups to address the health risks associated with seafood, to facilitate risk assessment and to propose and assess risk management measures;

 

·                Meetings coordinated by regulators in partnership with FSANZ, held in each of the jurisdictions, to exchange information and allow consultation with industry and other community members throughout the development of a seafood standard.  Meetings have already been held in many jurisdictions;

 

·                Regular progress updates posted on the Primary Production and Processing Standards section of the FSANZ web site;

 

·                An electronic executive bulletin intended for CEOs and other executives of organisations with an interest in the development of a new national food primary production and processing standard for seafood; and

 

·                Updates and progress reports included in a range of industry publications.

 


Public Consultation

 

Written Submissions in Response to the Initial Assessment Report

 

A total of twenty-five written submissions were received by FSANZ in response to the Initial Assessment Report of Proposal P265.  Submissions originated from a range of organisations and individuals representing industry sectors across the supply chain and all levels of government.  A summary of the individual submissions is presented at Attachment 5.

A compilation of the responses to the specific issues raised for comment in the Initial Assessment Report is presented at Attachment 6.  These issues mainly concerned:

 

·                scope of the Standard, including:

 

-        the inclusion of chemical and biological hazards within the standard and the Code as a whole;

-        at what point within the seafood industry the Standard should commence and cease to apply;

-        the position of ready-to-eat seafood under the Standard; and

-        the position of harvesting, handling and processing seafood on board fishing vessels under the standard;

 

·                definition of seafood, including whether aquatic plants, reptiles and mammals should be regulated under the Standard;

 

·                scientific risk assessment process which underpins FSANZ’s development of regulatory measures, and the provision of technical data for this purpose;

 

·                suitability of existing standards, such as the industry-preferred voluntary standard (the Australian Seafood Standard), any State government standards and any international standards, to form the basis for the national mandatory standard; and

 

·                options available to manage food safety risks, including:

 

-        costs and benefits of management options;

-        compliance and enforcement costs, mechanisms and concerns; and

-        the need for, and development of, guidelines.

 

The range of opinion on each of these issues is presented below, along with a short explanation of the approach taken in this Draft Assessment.

 

The scope of the Standard

 

A wide variety of opinions were expressed concerning the scope of the proposed standard.  In general, submissions supported the principle of an outcomes based, non-prescriptive standard covering the entire seafood industry and focussed on food safety.  Many expressed the view that the standard should impose requirements based on the level of public health risk posed by each industry sector.  Some submissions supported a role for voluntary industry codes of practice and self-regulation.  Divergent views were expressed by industry on the question of whether mandatory names for fish should be included in the standard.


In line with the Ministerial Council Guidelines, other policy advice and FSANZ’s statutory objectives, the draft Seafood Standard (Attachment 1) put forward for comment in this Draft Assessment Report is an outcomes-based, non-prescriptive standard focussed on food safety.  It covers the entire seafood industry to the extent determined by the level of public health risk posed by each industry sector and by the need to avoid duplication of, or inconsistency with, existing standards in the Code.

 

Inclusion of chemical and biological hazards within the Standard

 

Submissions highlighted a number of food safety hazards that were perceived as not being adequately addressed in the Code.  These included allergens and physical hazards (e.g. fish bones), escolar wax esters, ciguatoxin and some microbial pathogens. 

 

It was also suggested that maximum residue levels (MRLs) for pesticides and veterinary chemicals in seafood needed to be reassessed.  A range of strategies to address these various hazards were suggested, including relying on interpretive or advisory guidelines to the standard, referencing relevant sections of other Chapters of the Code, and including specific provisions in the Seafood Standard.  Industry generally preferred that the current provisions in Chapters 1 and 2 of the Code should be relied upon and simply referred to in the Seafood Standard.

 

The scientific evaluation and ranking of the public health risks posed by hazards in seafood in Australia (Attachment 10), conducted by FSANZ to underpin the development of suitable risk management strategies in the seafood sector, did not highlight any hazards that should be addressed by amendment to Chapters 1 and 2 of the Code.  The draft Seafood Standard does not contain requirements concerning maximum levels of physical, chemical or microbiological hazards in seafood.

 

Certain hazards mentioned in submissions cannot routinely be assayed e.g. ciguatoxin, escolar wax esters.  Maximum Residue Levels for pesticides and veterinary chemicals are (re)assessed on a routine basis by FSANZ, in conjunction with the Australian Pesticides and Veterinary Medicines Authority (APVMA), taking into consideration total dietary exposure from all food sources.

 

Coverage of the production and processing supply chain

 

Comments received on the coverage of the production and processing supply chain showed a broad range of opinion.  Several submissions mentioned that the entire chain should be covered from harvest to retail, inclusive.  However, others felt that it should only apply up to, but not including, the point of retail sale, or up to the point at which the Code currently applies.  The question of whether the pre-harvest sector of aquaculture should be regulated also engendered varying opinions, with some believing that production inputs into aquaculture need to be covered by the standard.

 

The Seafood Standards Development Committee (SDC) advised that the seafood PPP Standard should cover all aspects of primary production and processing of seafood, from harvest/ capture (whether wildcatch or aquaculture) through to retail sale, to the extent determined by the level of public health risk posed by each industry sector.

 


The draft Standard covers the pre-harvest sector to the extent that it requires seafood businesses to adopt an ‘inputs’ approach, using only inputs that do not contaminate seafood or adversely affect its safety and suitability.

 

Ready-to-eat seafood

 

The question of whether ready-to-eat seafood should remain covered under existing sections of the Code or be included in the Seafood Standard received comments supporting both views.

 

It is proposed that the primary production and processing of ready to eat seafood is covered in the draft seafood PPP Standard, to the extent determined by the level of public health risk posed by such products.  Provisions elsewhere in the Code applying generally or specifically to such products will continue to apply.

 

Processing on board fishing vessels

 

The extent to which the standard should regulate seafood harvesting, handling and processing on board fishing vessels was the subject of many comments from submitters.  Recommendations ranged from the view that no standard should apply, as the risks were low, to suggestions that food safety plans should be required.  Mandating Good Hygienic Practice, addressing the risks through a voluntary code of practice and implementing a receival standard at the dock were also put forward as options.  Several submissions advised that enforcing a standard on board vessels at sea would be difficult.  The need for awareness programs or accredited food safety training was also raised.

 

The Seafood SDC advised that Good Hygienic Practices can and should be required of fishing vessels, including those only involved in harvesting and minor processing (such as gutting and gilling).  The SDC recommended that the draft Standard require that fishing vessels must be constructed, maintained and used in ways that minimise the risks to the safety of seafood.

 

The definition of seafood

 

Most submissions agreed that the term ‘seafood’ should be defined so as to cover aquatic vertebrates and invertebrates including finfish, molluscs and crustaceans but excluding aquatic plants, reptiles and mammals.  Three submissions suggested inclusion of aquatic plants within the definition, and one suggested inclusion also of aquatic reptiles and mammals, along with a suitable definition of the point at which they are considered to become seafood and thus subject to the provisions of the standard.  Most submissions were in agreement that seafood taken for traditional purposes should also be excluded.

 

The Seafood SDC agreed that ‘seafood’ should be defined as ‘all aquatic vertebrates and aquatic invertebrates, excluding amphibians, mammals and reptiles’.  This definition excludes crocodile meat, seaweed and other aquatic plants, but includes ready-to-eat seafood.  The SDC also recommended that the standard should not cover indigenous or traditional fishers, unless such seafood is offered for sale.


The scientific risk assessment process

The scientific risk assessment process, which underpins the FSANZ regulatory approach, received broad support.  However, comments were received on the need to consider risk assessment work undertaken by others and to apply risk analysis in context.  One submission suggested that the process seemed to be more appropriate to the establishment of food product standards.  Some individuals identified that they were willing to provide data necessary for the risk assessment process, noting that significant data gaps existed.  In one case, data could not be provided unless confidentiality could be assured.

 

In order to estimate and compare the relative risks associated with consumption of seafood in Australia, FSANZ prepared a risk ranking report (Attachment 10).  It takes into consideration the multiple hazards potentially present, and assigns each commodity or group of commodities to a broad risk category: low, medium or high.  Through this process, sectors of the seafood industry posing a higher public health risk were identified.

 

In compiling the risk ranking report, a wide range of literature and information from Australia and overseas was reviewed and evaluated.  The report also drew on recent risk assessments that have been undertaken on Australian seafood.

 

Suitability of existing standards

 

Submissions generally suggested that existing voluntary regulations, codes of practice and guidelines should be recognised, in some form, under the Standard.  The suitability of using the industry-developed Australian Seafood Standard as a basis for development of the Primary Production and Processing Standard for Seafood was discussed, with views ranging across the spectrum.  In general, most submissions suggested it would need modification or could be used, in part or in total, as a guideline to the Standard.

 

Submissions also expressed the view that other regulations and standards, Australian and international, should be taken into account in developing the Seafood Standard, and parts used, as appropriate, in the standard or in the guidelines.  The NSW Seafood Safety Scheme, the AQIS Export Control (Processed Food) Orders and the Codex Code of Practice for Fish and Fishery Products were mentioned as examples of existing measures that might be drawn upon.

 

FSANZ considered all appropriate existing seafood standards, regulations and codes of practice when developing the draft Seafood PPP Standard.  Many of the principles upon which the industry-developed Australian Seafood Standard is based, also underpin the draft Standard.

 

Options available to manage food safety risks

 

Submissions canvassed options for appropriate food safety management systems.  Implementation of HACCP-based systems and food safety plans for areas where the public health risk was judged to be highest received broad support, although questions regarding industry and government support and resourcing were raised.  Industry were concerned about the criteria to be used for determining the extent to which HACCP-based food safety programs would be required of businesses.  Voluntary codes of practice and non-regulatory guidelines were mentioned as being suitable where risks were low.

 


The proposed strategy for management of public health risks in the draft Seafood PPP Standard is based on a requirement for Good Hygienic Practice for all seafood businesses, supported by guidelines and industry codes of practice, and the implementation of HACCP-based systems (food safety plans) for areas where the public health risk is judged to be highest.

 

Compliance and enforcement issues

 

Industry bodies and representatives expressed concern regarding the impact of any standard on the industry and on practices within seafood businesses.  In particular, industry expressed a desire to avoid unnecessary imposts and the potential for excessive cost-recovery revenue-raising by regulators at the expense of industry. 

 

Industry and government submissions expressed the view that compliance and implementation costs associated with HACCP-based food safety plans were significant and had been under-estimated by FSANZ in the past.  Information was provided detailing the costs of complying with current (HACCP-based) export certification schemes.

 

Industry also emphasised the need to avoid duplication of auditing and compliance activities (and hence costs) where a business supplied both domestic and export markets.  Several submissions stated that businesses complying with export requirements should be deemed to comply with the domestic standard.  Submissions also raised questions about the role, extent and system of audits that may be required under the standard.

 

A period of two to three years was generally nominated by industry as a preferred time frame for implementation of the Standard and for stock-in-trade provisions to apply.  The need for government support to provide education and training was also raised.

 

Comment from government bodies covered issues including which level of government, and/or which government department, would have responsibility for regulation, implementation and enforcement of the standard.  Audits were also discussed, incentive-based compliance schemes were generally supported, as was harmonisation with existing audit systems, such as those required by AQIS.  Government bodies expressed a desire to avoid any duplication of current legislation, and to achieve genuine consistency on a national basis under the standard.

 

Once adopted into State and Territory legislation, enforcement of the Standard will become the responsibility of those jurisdictions.  Policies regarding cost-recovery revenue-raising by regulators are set at that level of government in Australia.

 

FSANZ understands that a nationally agreed date for commencement of the Primary Production and Processing Standard will help to ensure national consistency, and will focus industry and regulators on the task at hand. 

 

It is envisaged that a number of tools and resources will be developed to assist both industry and regulators in the implementation of the standard.  A prime tool will be an interpretive guide to the Standard.  This document will be developed by FSANZ in consultation with stakeholders.  In addition, existing codes of practice developed and adopted by jurisdictions and industry, will provide further practical information.  Existing codes of practice may be readily adapted to this purpose.


Responses to Jurisdictional Meetings

 

In the period since commencing the development of a primary production and processing standard for seafood, consultation meetings have been held in the following jurisdictions: Tasmania, Victoria, Queensland, Western Australian, South Australia, New South Wales and the Northern Territory.  Innovative strategies have included the use of video conferencing to engage distant communities in Western Australia (i.e. Broome, Karratha, Carnarvon, Albany, Geraldton, and Esperance).

 

Participants at each consultation were invited to provide their views orally, as well as through written submissions.  Industry participants at the workshops focussed on the impact of any regulatory measures on their businesses, while regulators were interested in jurisdictional issues and the responsibilities.

 

These consultations were held during the period leading up to and following the release of the Initial Assessment Report and prior to the release of the Draft Assessment Report.  In the lead-up to the release of the Draft Assessment Report, consultations have continued and have elicited valuable industry data and considerable feedback on support for the regulatory options being proposed.

 

Identification of Potential Non-Scientific Risks

 

The development and implementation of good regulation can be influenced by a range of factors outside the potential hazards to the food supply that are evaluated in the scientific risk assessment.  This broader set of risks typically includes factors such as community perceptions, political implications, regional implications and industry issues.  In developing options for the regulation of the primary production and processing of seafood, FSANZ discussed this issue with State and Territory regulators, a consumer representative, and various members of the seafood industry.  Such consultation assisted FSANZ to identify a range of non-scientific risks that, potentially, could affect the development and implementation of regulation for the seafood industry.

 

Consumer perceptions of seafood are ambivalent and pose a potential risk to the acceptance by consumers of any improvements to safety that new regulation may offer.   A study of consumer attitudes revealed that, while consumers believe that seafood has some nutritional benefits, they lack sound knowledge about seafood products and are uncertain about the safety and possible contamination of seafood[63]. Furthermore, the study revealed that the correct labelling of fish was very important for 70% of consumers surveyed in Perth, and 73% of those surveyed in Sydney. Communication with consumers during the process of developing new regulation will continue to be important to foster greater consumer confidence.

 

Industry is concerned that implementation of any new regulation may bring with it large compliance costs, either through excessive regulation that is disproportionate to manage the hazards or through excessive government charges.  Such concern, if not addressed, could result in a low level of compliance with new regulation and a lower level of benefit to the Australian community. 

 


This concern can be addressed through a transparent process that demonstrates to all parties how the proposed regulatory measures relate to the scientific risk and provides benchmarks for industry to gauge the likely level of government charges.

 

The seafood industry contains a high proportion of small businesses, dispersed along rural and some remote coastlines, which potentially can make the implementation of any new regulation very difficult.  Many regional communities are highly dependent on the continuing viability of their local seafood industry and may be resistant to change.  These factors can be taken into account in the process of developing a new regulation, through a transparent process that demonstrates minimum effective regulation, and also the benefits to industry of consistently maintaining good hygiene and safety practices.

 

The staged approach to implementing food safety regulations in the NSW seafood industry indicates that regional dispersion of the industry need not be a barrier to the successful introduction of new regulations.

 

A further risk involves the potential for uneven implementation of a new regulation by the States and Territories.  While each jurisdiction has responsibility to determine its priorities for enforcement, and the level of resourcing for its enforcement and auditing activities, there is nonetheless the issue that similar seafood activities anywhere in Australia should be subject to similar regulatory requirements.

 

The consequence of uneven implementation would be to reduce the credibility of the new regulation amongst industry, which would then be sceptical of its claims to be ‘nationally consistent’ and may doubt its other benefits.  This risk can be addressed by clarity in the description of the new regulation, the provision of a comprehensive Interpretive Guide, and coordination between the jurisdictions in their implementation and enforcement of the Standard.


Attachment 4B

 

Consultation on Draft Assessment Report

 

Written submissions in Response to the Draft Assessment Report

 

A total of twenty-nine written submissions were received by FSANZ in response to the Draft Assessment Report of Proposal P265 during the period of consultation held from 26 May 26 through to 6 August 2004. Submitters originated from a wide range of organisations and individuals representing both industry sectors and government. A summary of the individual submissions is presented at Attachment 5B. A summary of the submissions grouped by issue is presented at Attachment 6B.

 

Responses to Jurisdictional Meetings

 

Following the release of the Draft Assessment Report for public comment, a series of consultation meetings were held in the jurisdictions. Meetings were held in Hobart and Launceston (Tasmania), Darwin, (Northern Territory), Brisbane (Queensland), Adelaide (South Australia), Melbourne (Victoria), Sydney (New South Wales) and Perth (Western Australia). Video conferencing was utilised in the WA meeting to engage the distant communities of Broome, Karratha, Carnarvon, Albany, Esperance and Geraldton.

 

Invitations to the meetings were sent out to industry and other interested parties by the hosting jurisdiction. Participants at the consultation sessions were invited to provide their views on the proposed draft standard as included in the Draft Assessment Report. Meeting outcomes notes were circulated to the hosting jurisdictions and the issues raised were noted for consideration during amendment of the drafting.

 

Main issues

 

The main issues raised in the submissions and during the consultation sessions were:

 

·                drafting issues, including:

 

-        divide between Chapter 3 and Chapter 4

-        scope of the Standard for seafood

-        definitions such as ‘frozen’, ‘chilled’, ‘thermal centre’, ‘thawed’ ‘live seafood’

-        the definition of ‘primary production’

 

·                consistent implementation across the jurisdictions

·                audit costs and third party audit arrangements

·                the exclusions of mandatory fish marketing names from the standard

·                labelling of imported product

·                enforcement of the standard at the border

·                risk ranking report

·                risk management

·                fish bone injuries

·                freshwater crayfish requirements in Victoria


·                the use of guard dogs in premises

·                the use of a marketing name for Salmon

 

Drafting Issues

 

Draft Standard 3.3.1 (previously 3.2.1)

 

One submission supported the intent to have 3.2.1 sit alongside of 4.2.1 and the splitting of requirements for shellfish businesses between the two Standards. The submission suggested that the applications of the two Standards should be based on the definition of primary production in the current Food Act and then consistent with the definition of ‘primary production of seafood’ as defined in standard 4.2.1.

 

See below under scope of draft Standard 4.2.1.

 

Scope of Draft Standard 4.2.1.

 

Several submissions noted that one of the major issues in drafting the standard is the setting the scope of primary production and processing for seafood. The definition of the scope has an impact on the divide between Chapter 3 and Chapter 4 of the Code.

 

Provisions in Chapter 3 of the Code are more onerous than those in Chapter 4 of the Code.  An example are the activities undertaken on board fishing boats where seafood is killed, gutted, boiled, frozen etc. According to the primary processing/Chapter 3 divide set out in Standard 3.1.1 these activities would not be primary production. Standards 3.2.2 and 3.2.3 would apply to these activities.

 

Various States and Territories have amended the primary production/Chapter 3 divide.  Queensland, for example, has included a number of substantial transformation type activities in the legislative definition of primary production including filleting, gutting and boiling crustaceans. There have been similar amendments to the divide in other jurisdictions.

 

A practical solution to this issue is to set the scope of the seafood standard around both primary production as one set of activities and processing as another set of activities. It is therefore proposed to amend the definition of primary production to encompass the activities of growing, cultivation, picking, harvesting, collection or catching of seafood. The definition of processing of seafood would define the included activities of processing, such as filleting, gutting, shucking, boiling and freezing of seafood. Chapter 3 of the Code would apply to retail activities and any other activities not mentioned in Standard 4.2.1.

 

1 Application

 

A submission recommended the removal of the words ‘and processing’ from the title of the standard on the basis that processing is not ordinarily associated with primary production.

The redrafting of the definitions for ‘primary production’ and ‘primary processing’, which now clearly define the scope of the standard, has addressed this concern. The removal of the words ‘and processing’ was not considered necessary.

 

One submission stated that the seafood standard should not apply to retail, and that they supported the introduction of the proposed standard from harvest up to but not including retail.


The Standard does not apply to the retail sector. It applies only to the primary production and processing sector up to the back door of retail.

 

2 Interpretation

 

‘control’

One submission requested further explanation of the term ‘control’. This term is used in various places in the Standard, for example, clauses 3 and 20.

 

A definition of ‘control’ has been included in the definitions in Clause 2 Interpretation.

 

‘frozen seafood’

A number of submissions identified problems with the definition of ‘frozen seafood’.

As drafted, the definition included ‘temperature control’ which, according the definition of temperature control as detailed in the Editorial Note to Clauses 6 and 7 meant that seafood at 60 °C would fit the definition of ‘frozen’.

 

The reference to ‘thermal centre’ in the definition of frozen was also considered to be difficult to enforce, as it would require probing at the centre of the product. Various submissions proposed removing the definition of ‘frozen’, ‘thermal centre’ and also ‘chilled’.

The term ‘frozen’ has an ordinary meaning that is enforceable. An important drafting principle is that where a term has an ordinary meaning it should not be assigned a definition, unless there is intention to depart from that ordinary meaning. Therefore, the definition of ‘frozen seafood’ was removed.  As the definition made reference to ‘thermal centre’ and ‘thawed’, those definitions were also been removed. The removal of ‘frozen’, ‘thermal centre’, ‘chilled’ and ‘thawed’ is consistent with the principle of using an ordinary meaning where applicable.

 

‘live seafood premises’

 

One submission suggested this definition be removed, as there is no reference to it in the Standard.

 

This observation is incorrect. Clauses 10 and 14 make reference to the term. Therefore, the definition was retained.

 

‘primary production of seafood’

 

Several submissions raised the issue of the definition of ‘primary production’ and noted the confusion between what was covered by ‘primary production’ and what would be classed as ‘primary processing’. As noted earlier, this impacts on the point at which Chapter 4 no longer applies, and Chapter 3 of the Code commences.

 

The definition of ‘primary production of seafood’ has been amended to specifically encompass those activities considered to be ‘primary production’ and hence encompassed by Chapter 4 of the Code. A definition of those activities considered to be processing has also been included.


‘temperature control’

 

It was noted in one submission that this term was included in the PPP standard as it is defined in Chapter 3, which includes temperatures of 60°C or above. If applied in this way in Chapter 4, seafood would need to be cooked and this would not be appropriate for the seafood PPPS Standard.

 

The definition of ‘temperature control’ was redrafted for the specific purposes of the PPP Standard, with the definition omitting reference to 60°C. This definition is relevant to Clauses 6, 7 and 10 in the General Provisions.

 

3 General seafood safety management

 

One submission suggested it would be difficult for regulators to verify Clause 3, and also difficult for small businesses to follow. It was suggested the clause be removed, with it being replaced by a policy statement in the preamble to the statement. Another submission also suggested that the words ‘and document’ be inserted in the standard after the words ‘systematically examine’.

 

This would, in essence, mandate a de-facto food safety program and this is not the intent of the standard for the low and medium risk products covered by the General Provisions (however, it may be one way that implementation could achieve these outcomes).

It is suggested that the editorial note be amended to state that the measures listed are not exhaustive (the words ‘should include’ have been added) and that the meaning of the word ‘control’ be defined in the Definitions.

 

4 Requirement to prevent contamination

 

Several submissions stated that this requirement is covered by clauses 5 to 14 and that the general provision should be deleted.  It was also noted that the Standard does not contain any general safe handling provision similar to clause 3 of Standard 3.2.2.

 

Clause 4 has now been amended to cover both contamination and handling.

 

5 Inputs and harvesting areas

 

As originally drafted for the Draft Assessment Report, Clause 5 required businesses to ‘only use inputs’ that do not adversely impact on the safety of the seafood. It was noted that as worded this might be too onerous as there are limits in where a food business may exercise control. It was suggested that businesses should be required to take ‘reasonable measures’.

 

The Clause has been amended to state that the business must take ‘all reasonable measures’ to ensure inputs do not adversely affect the safety or suitability of the seafood.

 

6 Seafood storage

 

One submission recommended that the words of 3.2.2 Clause 22 be added to Chapter 4, which would make temperature measuring devices a requirement. The same submitter also noted that there were no requirements to record temperatures.


The Clause makes mention of having a ‘means for monitoring the temperature of the seafood’, which would encompass temperature measuring devices. In regard to introducing requirements for recording temperatures, this would be similar to the requirements of a food safety program, which are not considered necessary for the General Provisions for low and medium risk seafood businesses.

 

Further discussion on this Clause with the SDC resulted in the simplification of the Clause from four parts down to two, covering seafood that is not live, and seafood that is live. It was agreed that the use of the term ‘under temperature control’ would suffice for stored seafood, other than live seafood. It was not necessary to specify chilled or frozen.

 

7 Seafood transportation

 

It was suggested by one submitter that only refrigerated third-party carriers conduct transport of shellfish.

 

It is not practical to mandate the use of third party carriers only, particularly for businesses that are transporting goods within or between the grounds of their company. Businesses need the flexibility of alternative options. No change is suggested.

 

Further discussion with the SDC resulted in the agreement that it would be sufficient to state that transported seafood, other than live seafood, should be under temperature control. It was considered not necessary to mention chilled and frozen, for example.

 

Editorial Note to Clauses 6 and 7

 

The definition of ‘temperature control’ in the Editorial Note made reference to 3.2.2, which made provision for maintenance of food at 60ºC.

 

The definition of temperature that contained reference to food at 60ºC was not appropriate for the seafood PPP standard and was removed in the redrafting of the Editorial Note. The new definition was included in Clause 2 of the standard.

 

8 Seafood packaging

 

Comments from the SDC on this Clause as drafted for the Draft Assessment Report indicated that the words ‘no likelihood’ (in respect to prevention of contamination) could be problematic. It was suggested that words such as ‘all reasonable measures’ (to prevent contamination) might be more appropriate.

 

The Clause has been amended to remove the words ‘no likelihood’. The Clause now requires that businesses ‘take all reasonable measures to ensure that the seafood does not become contaminated’.

 

9 Seafood for disposal

 

The clause requires that seafood for disposal be returned to the supplier.  Submissions pointed out that it is not possible for a fisherperson to do this (as there is no supplier) short of throwing it back into the sea. 

 


This provision would apply where seafood is being transported prior to the wholesale part of the seafood supply chain. The Clause has been retained.

 

A further comment on this Clause was the questioning of the need for different terms for a label. The submitter read the Clause to imply that food had to be labelled as ‘returned’, ‘recalled’ or ‘unsafe’.

 

The Clause does not mean that seafood must be literally labelled as ‘returned’ etc. It is merely a requirement that the seafood be identified as this, which does not necessarily mean labelled. It is up to the business as to how the food is identified.

 

10 Seafood receipt

 

Two submissions queried the necessity of this clause as it was felt that if the standard only applies to seafood primary production, then there is no (second) business that will receive the seafood products. It was recommended that the clause be deleted.

 

The definition of primary production of seafood does allow for a range of activities, which may or may not take place on the same premises or by the same company. Therefore, primary production and processing seafood businesses may be involved in the receipt of seafood and the clause will be required.

 

The Clause has been amended in line with the Editorial Note to Clauses 6 and 7 to remove reference to keeping seafood at 60ºC. In addition, a further part (4) has been added to cover the receipt of live seafood that has been transported.

 

11 Seafood tracing

 

As originally drafted for the Draft Assessment Report, the Clause covered traceability and recall of unsafe seafood. One submission noted that the imposition of a written document places impost on businesses in situations where it might be difficult or impossible to contact sellers. Further, it was noted that it might be, for example in the case of fisherman, not possible for them to initiate recall. The submission made the recommendation to remove reference to ‘recall of unsafe or unsuitable seafood’. In subsequent discussions with the SDC and DFAT, it was noted that there are issues with the use of the term ‘traceability’, which has a distinct meaning in the international Codex arena. It was suggested to use alternatives terms to traceability in the drafting.

 

The Clause has been amended to limit it to seafood tracing and not recall.  A seafood business will be required to maintain records to identify the immediate supplier and immediate recipient of seafood. The keeping of receipts will be adequate to satisfy the requirements for written records.

 

12 Skills and knowledge

 

One submission commented that the wording of this clause was in conflict with Clause 3 of 3.2.2, as it does not apply to the persons supervising food handling operations.

 

The definition of ‘seafood handler’ includes reference to persons who supervise the primary production of seafood. No amendment is considered necessary.


13 Health and hygiene requirements

 

Two submissions noted the differences in health and hygiene requirements between Standard 4.2.1 and Standard 3.2.2. The suggestion was made to either include Clauses 14 and 15 from 3.2.2, or alternatively, amend 3.2.2 in line with the provisions required for 4.2.1 for consistency.

 

It should be noted that the requirements for 3.2.2 in Clause 15 are far more detailed that the equivalent clause in 4.2.1. The distinction is that 4.2.1 is aimed at primary production and processing, whilst 3.2.2 is for an industry that in some cases will be preparing ready-to-eat food and therefore necessarily will need greater food safety requirements. However, it is noted that this Clause, as drafted for the DAR, failed to provide for an important provision contained in Chapter 3 concerning a seafood handler who may have a food borne disease (see paragraph 14(1) of Standard 3.2.2). A similar provision has been added to Clause 13 as a new part (2). Food borne illness is defined in 3.2.2 and the definition applies to Chapter 4.

 

14 Seafood premises and equipment

 

One submission suggested that all operations on fishing vessels should be required to have some form of CODEX/HACCP-based food safety programs in place.

This view is inconsistent with the Ministerial Council guidelines that are based on the principle that risk management strategies should be commensurate with the food safety risk posed.

 

It was also noted that the clause did not have any requirement to use equipment made from materials that will not contaminate seafood or that are fit for use.

It was agreed that the term ‘constructed’ implied that the equipment would be made from appropriate materials.

 

The Clause has also been amended to take into account that some equipment used in the primary production of seafood only need to be kept reasonably clean as appropriate for the working environment. This would be applicable to, for example, scallop trolleys, nets, growing racks.

 

Division 3 – Harvesting and other requirements for bivalve molluscs

 

Incorporation of ASQAP directly into the Standard – the legal issues

 

Two submissions suggested that the Standard should incorporate ASQAP either by reference or by incorporation of the text of ASQAP.

 

Division 3 now references ASQAP in a way that is legally supportable.

 

Discussions will also be held with ASQAAC and the ISC in regard to ASQAP and the ongoing role of ASQAAC in maintaining the manual.

 


Clause 15 Definitions – SSCA, spat, bivalve molluscs

 

‘relaying’

 

It was suggested in one submission to modify the definition of relaying, specifically to remove the words ‘by using the ambient temperature as a treatment process’, as the remaining words adequately convey the intent.

 

The drafting has been amended accordingly.

 

‘bivalve molluscs’

 

The definition of ‘bivalve molluscs’ as drafted for the DAR excluded both scallops and pearl oysters where the only part consumed is the adductor muscle. Some submissions have questioned if is valid scientific evidence to support the exclusion, and pointed out that the ASQAP Manual does not exclude pearl meat in its definition of bivalve molluscs. In other submissions, the pearl industry indicated that they supported the exclusion of the meat, and provided scientific data on heavy metal analysis to support their stance in the two submissions received. They also submitted a proposal for a study into biotoxin accumulation and indicated that they were going to approach ASQAAC to request they change their definition to exclude pearl meat. The study is yet to commence.

 

Further, during a jurisdiction consultation session, SA advised that another bivalve mollusc, razorfish, is marketed for its adductor muscle only. It was suggested to make the exemption more general to include all current and future scenarios where the only part of the product consumed is the adductor muscle.

 

Following receipt of the submissions to the draft assessment report, discussions were held between representatives of the Western Australia pearl industry, the WA Departments of Health and Fisheries and FSANZ on the issue of whether to retain the exclusion for pearl meat.

 

In January 2005, a meeting of the Risk Assessment Working Group for the Seafood Primary Production and Processing standard was convened to discuss the issue.  After considering the scientific issues for pearl meat, application of the risk ranking methodology to algal biotoxins in pearl meat led to a relative risk ranking of Medium on a whole-of-population  basis. It was noted that considerable levels of uncertainty surrounded the ranking for the consuming population due to the lack of scientific literature relating to prevalence, concentration and distribution of algal biotoxins in pearl oysters. It is understood that the industry is prepared to undertake a suitable scientific study to remove the major point of uncertainty. The study will be undertaken in consultation with FSANZ and biotoxin experts during the two year period leading up to the standard taking effect.

 

It was recommended by the Risk Assessment Working Group that the Seafood Standards Development Committee examine specific management strategies for pearl meat. It was recommended and agreed that on the basis of the relative risk ranking of Medium for pearl oyster meat, that the exclusion of pearl oyster meat from the specific requirements of the Seafood Primary Production and Processing Standard should remain.

 


‘spat’

 

It was indicated that spat is being sold in some QLD establishments as bottled oysters.  Where this is the case, under the definition it would not be ‘spat’, and therefore the requirements for bivalve molluscs would apply.

 

For greater clarity, the definition of spat was redefined to clearly spell out that it is product taken solely for the purpose of ongrowing. In addition, an Editorial Note was added to state that if spat are sold for human consumption, then the product falls within the definition of ‘bivalve mollusc’ and the requirements of Division 3 for bivalve molluscs apply.

 

‘SSCA’

 

A number of jurisdictions commented that this definition is not appropriate, as it would require the creation of a new agency. It was noted that the agencies responsible for implementing ASQAP vary from State to State across Australia.

 

Legally, the definition was not acceptable because it attempted to limit the definition to those agencies that perform certain functions of a corresponding nature to those specified in the ASQAP manual.  This type of definition has been held to be unenforceable (Gibbs v FCT per Barwick CJ (1966) 118 CLR 628 at 635).

 

The definition was changed such that it could be legally implemented. References to ‘SSCA’ were changed to ‘Authority’, and a definition of ‘Authority’ – ‘means the State, Territory or Commonwealth government agency or agencies having the legal authority to implement and enforce this Division’ – was included in Clause 15 Interpretation.

 

‘growing on’ and ‘wet storage’

 

It was noted in two submissions that these terms are used in the Division and it was suggested they need defining.

 

Definitions of both of these terms were included in the list of definitions in Clause 15 Interpretation.

 

‘batch’

 

Clause 19 on co-mingling referred to ‘lots’.  One submission suggested this should be ‘batch’ with an appropriate definition.

 

A definition of ‘batch’ was added to the list of definitions in Clause 15 Interpretation.

 

16 & 17 Harvesting – areas undergoing classification

 

One submission noted that it takes two years to classify an area for collecting bivalves and this should be accommodated in the drafting.

 


It was also raised in two submissions that the requirement for bivalve molluscs to be harvested from areas that have been classified subject to a marine biotoxin management plan will have impact on the QLD wild oyster industry. It was suggested that it would be too onerous and uneconomical for the wild oyster industry to meet this requirement.

 

States and territories will be able to set their own requirements for what will be required for a Marine Biotoxin Management Plan, which will allow for flexibility in the implementation of the plans.

 

Clause 16 and 17 have been removed and a general reference to ASQAP has been made.

 

18 Wet storage of bivalve molluscs

 

The wording of the clause was questioned in one submission in regard to the use of the terms ‘effectively disinfected’ and ‘those conditions’.

 

The clause has been removed and a general reference made to ASQAP.

 

19 Co-mingling

 

It is suggested that there be a change to the wording of this clause, specifically the word ‘lot’ be changed to ‘batch’ and the definition of batch included in the Definitions.

 

The Clause has been amended with the use of the word ‘batch’. ‘Batch’ has been defined in the Definitions under Clause 15.

 

A number of submissions also sought a strengthening of the co-mingling clause to take it beyond primary production and into the retail sector.

 

Industry members of the SDC supported the clause to prevent co-mingling and acknowledged this is generally in place in the primary production part of the chain. It was noted that there are no clauses to prevent co-mingling in Chapter 3 and that lack of traceability was flagged at OzFoodNet as being an issue for a whole range of products in relation to the investigation of food-borne illness outbreaks. The possibility of including a clause to prevent co-mingling in Chapter 3 will be investigated. However, the issue of an amendment to Chapter 3 had not been discussed with retailers during the development of the seafood PPP Standard.  As a matter of priority, FSANZ will develop a separate proposal for the prohibition of co-mingling of high risk products at the manufacturing and retail levels.

 

20 Food safety management systems for bivalves

 

It is suggested that Clause 20 and the corresponding clause for Chapter 3 be redrafted to include the editorial material in the actual clause on the basis that the editorial note is not legally binding.

 

The Clause was redrafted such that the content of the editorial note forms part (2) of the actual Clause. The reference to ‘suitability’ in clause 20 was also removed to be consistent with the approach in standard 3.2.1, which deals only with food safety programs for safety purposes.


Miscellaneous amendments to the drafting

 

A number of provisions referred to either ‘practical measures’ or ‘reasonable measures’ where there seems no reason for using different descriptions of the measure.  In the context of the draft standard there appears little difference between ‘practical’ and ‘reasonable’.  ‘Reasonable’ also has a more recognised legal meaning than ‘practical’.

 

All references to ‘practical measures’ were changed to ‘reasonable measures’.

 

The Standard contained a number of references to ‘safe and suitable’. It was suggested these references be amended to ‘safe or suitable’ to convey the disjunctive rather than conjunctive meaning.

 

The Clauses were amended accordingly.

 

Other Issues – Non-drafting

 

Mandatory General Provisions

 

There was the suggestion in one submission that the General Provisions should be voluntary for low and medium risk sectors with mandatory requirements only for bivalve molluscs unless the standard as drafted is supported by industry. However, a submission from the SA Fishing Industry Council indicated that they supported the application of a seafood safety standard provided the Standard prescribes requirements only for the management of high-risk products.

 

The States and Territories that have indicated support in their submission for Option 3 - with General Provisions for the low and medium risk sectors and Specific Provisions for bivalve molluscs - include Tasmania, Qld and WA. In the consultation sessions, NT also indicated their support. Other support came from the Food Technology Association of Victoria, the Tasmanian Fishing Industry Council, Australian Food and Grocery Council, Australian Consumers Association and Seafood Services Australia.

 

Consistent implementation across the jurisdictions

 

Several submissions noted their concerns about the scope for inconsistent application of the standard at the State level. This issue was also voiced at several of the consultation meetings with the States/Territories and by the SDC.

 

FSANZ raised the concerns around potential inconsistent implementation across the jurisdictions was raised with the Implementation Subcommittee (ISC) at their meeting in October. ISC indicated that they would be happy to take part in a meeting to discuss consistent implementation across the jurisdictions. The SDC will be discussing these issues with ISC in early 2005.

 

Other implementation issues

 

One submission urged FSANZ to ensure that the national standard will not compromise regulatory measures already in place in NSW. As drafted, the proposed standard should not compromise the capacity of NSW to enforce their regulatory measures already in place.


One submission stated that is was imperative that FSANZ ensure that there is no duplication between this proposed standard and other standards already in existence or under preparation in South Australia. There are no existing standards in South Australia so there is no risk of duplication in this state.

 

Audits

 

Several submissions made mention of concerns around ensuring recognition of third party audits and a process for recognition of equivalence. Further, there were concerns voiced about the cost of audits.

 

The concerns raised in the submissions around this issue were communicated to ISC at their October 2004 meeting.

 

Currently, ASQAP is in place for export with audits being conducted by AQIS (or by States on behalf of AQIS). Further discussions are occurring between AQIS and the States/Territories in relation to the States recognising AQIS audits without the requirement for further separate State requirements to determine compliance with the domestic standard.

At the national level work is proceeding on the finalisation of food safety auditor competencies and ISC has commenced a body of work in relation to a national food safety auditor policy.

 

Exclusion of mandatory fish names from the Standard

 

Seven submissions made mention of the exclusion of the fish names from the Standard.

 

Following extensive discussions this matter with the SDC an approach to this matter was agreed. This entails the development of an Australian Standard that can be used under fair trading laws as a reference document.

 

Once completed, FSANZ will consider an application to reference the Australian Standard in the Code following FSANZ’s normal assessment processes.

 

To further assist in the process of correct use of fish marketing names, FSANZ has funded the development of posters through Seafood Services Australia and is working with the food industry to support the development of a Standards Australia standard.

 

New Zealand border issues

 

The submission from the New Zealand Food Safety Authority made the suggestion of having a single consistent standard to be applied across Australian export and domestic shellfish products. This would not be appropriate, as the Export Orders require higher level HACCP requirements for all seafood. This would not be in line with the policy of minimum effective regulation across the low and medium risk products.

 

NZFSA also raised the issue of equivalence between the NZ Animal Products legislation and the instruments made under the legislation. It was noted that the proposed standard has far less controls than in New Zealand and that this would mean they have little choice but to continue their risk list protections for shellfish.

 


It is noted that importing countries have the prerogative to impose higher import requirements where justified. The Export Control (Processed Food) Orders require a higher level of requirements for all seafood products and growers who export bivalve molluscs will need to meet these requirements.

 

Imported product

 

Two submissions called for the mandatory labelling of imported seafood at the food service level.

 

The Code stipulates that food must be labelled at the retail level but not at the restaurant level. Food service establishments are obliged to tell the truth when asked about the origin of the seafood.

 

Several submissions also made mention of imported product in terms of how the standard would apply at the border.

 

Discussions are  progressing between AQIS and FSANZ on the development of a system to improve the enforcement of outcomes-bases standards at the border.

 

The Risk Ranking Report and Risk Assessment Issues

 

One submission contended that there were serious flaws in the model used for the Risk Ranking Report and therefore some of the conclusions for the risk rankings would be similarly flawed. It suggested that the RRR could not be used and that other input should be sought before any risk management decisions were made. The suggestion was made to take into consideration the number of seafood meals consumed per year the likelihood of an incident occurring at all. A second submission also called for the risk assessment to be completely reassessed to include the risk of a seafood safety incident happening at all. At the October SDC meeting, various industry members stated that they wanted to ensure recognition of the fact that alternative views to the Risk Ranking Report exist.

 

The Risk Ranking Report was submitted for international peer review.  The results of the review were very positive and lead to minor amendments as appropriate. It is part of FSANZ’s regular responsibilities to keep up to date with emerging scientific issues or data.  FSANZ will also undertake a review of the Risk Ranking Report 3 years after gazettal of the proposed standard.

 

Risk Management issues

 

One submission stated that the risk of a seafood safety accident happening at all should be clearly explained to the consumer in a manner that promotes the health benefits of eating seafood.

 

FSANZ released the Seafood Draft Assessment Report with a press release that emphasised the benefits of eating seafood and with a focus on protecting public health and safety.

 

One submission noted that the proposal deals principally with the high risk seafood and questioned what FSANZ proposes to do with medium risk seafood.

Division 2 of the proposed standard - General Seafood Safety Requirements - addresses the requirements for all seafood (low, medium and high risk).


One submission called for mandatory food safety program for anyone producing hot or cold smoked seafood, together with mandatory instructions.

 

The DAR assessed hot smoked seafood as medium risk and therefore there were no requirements for specific provisions. Cold smoked products were assessed as high risk but in terms of the impact of Listeria monocytogenes in susceptible population groups. Current risk management strategies include requirements in Chapters 1 and 3 of the Code and a pamphlet on Listeria that provides specific advice to the susceptible groups.  The implementation of specific food safety programs would need to be justified by a positive benefit-cost ratio – a policy principle agreed to by the Ministerial Council on Food Regulation in their discussions on the management of food safety in Australia.

 

Storage temperature of oysters

It was noted in a submission that ASQAP has specified storage temperatures and depuration conditions for live oysters, with different types of oysters having different requirements.

This situation is addressed by Clause 6(3). This Clause states that a ‘seafood business must, when storing live seafood, store the seafood at a temperature that will not adversely affect the safety or suitability of the seafood’. Therefore, if certain live oysters require storage at different temperatures, then the onus is on the business to store them at the correct temperature.

 

Maximum Residue Limits

 

One submission supported a review of the Maximum Residue Limits (MRLs) for seafood.

 

MRLs for pesticides and veterinary chemicals are (re)assessed on a routine basis by FSANZ, in conjunction with the Australian Pesticides and Veterinary Medicines Authority (APVMA), taking into consideration total dietary exposure from all food sources.

 

Salmon marketing name

 

One submission stated that the salmon from Tasmania is recognised in Australian and export markets as ‘Tasmanian salmon’ and ‘Tasmanian smoked salmon’. The submitter stated that this is a unique marketing name and indicated that it must be allowed to be used in the future.

This is not a food safety issue.

 

Impact on Yabby farmers

 

Several submissions were received on the issue of impact of the Victorian Government’s implementation of the Seafood Safety Act 2003, and the enforcement of this Act through Primesafe together with the subsequent adoption of the FSANZ PPPS for Seafood. The request was made for the exemption of the sale of live yabbies (freshwater crayfish) from the regulation under the Victorian Seafood Safety Act 2003. It was stated that the yabby industry cannot continue to viably exist under the proposed Primesafe licensing and audit plans.

This is not a matter for FSANZ consideration and has been referred to Victoria.

 


Guard Dogs

 

One submission sought a rewording of Clause 24 in Division 6 of 3.2.2 to permit the use of guard dogs in processing areas under controlled circumstances, but not while processing is occurring.

 

This issue is not related to the Seafood Primary Production and Processing Standard.

 

Indigenous fishers

 

It was noted during a jurisdiction consultation session that there were concerns in the seafood industry that Indigenous fishers may be entitled to higher bag limits than recreational fishers, and that they may then be engaging in trade or exchange with other groups.

 

It was clarified that should Indigenous fishers be engaging in trade with other groups, this would be considered selling and therefore would be covered as retail under the Code. The primary production standards apply up to the start of retail.

 

Fish bone injuries

 

One submission suggested that the proposed standard should address the issue of physical hazards in fish marketed as filleted and boned.

 

Clause 2(4) of 3.1.1 refers to the suitability of food. Food would be deemed unsuitable if it contained an object or agent foreign to the nature of the food. A fish bone in a fish is not a foreign object and therefore does not affect the suitability of the fish for consumption. If fish was marketed as boneless and was found to have bones, this would then constitute a trade description issue. It is not a food safety issue.

 

Country of Origin

 

The question of Country of Origin arrangements was raised at a jurisdiction consultation session. It was queried if the transitional arrangements will prevail or whether FSANZ would go back to review.

 

Advice on the status of this matter was provided directly to the jurisdiction in question.

 

Industry guidelines

 

It was suggested in a jurisdiction consultation that there is a need for industry guides (scallops and calamari in particular) to guide individuals on good industry practice.

Existing industry guidelines address this issue. A list of available industry codes of practice is available at Attachment 8 of this document.

 

Ready to eat Seafood guidelines

 

One submission raised the issue of bacteriological pathogens that are currently absent from the Code (eg. V. parahaemolyticus, V. vulnificans, Yersinia enterocolitica, Clostridium). The submitter indicated that these pathogens need to be addressed in the ready-to-eat food guidelines.


Vibrio parahaemolyticus is referenced for seafood in the User Guide to Standard 4.6.1 – Microbiological Limits for Food with additional guideline criteria. The guide is intended to provide information to help retailers, caterers, manufacturers and food officers to interpret and apply Standard 1.6.1 – Microbiological Limits for Food. Standard 1.6.1 specifies the microbiological standards for nominated foods or classes of foods. Mandatory microbiological standards have been set where risk assessment has shown that the risk of food-borne illness associated with the consumption of certain foods is relatively high and that a standard could contribute to the management of the risks identified.

 


Attachment 5A

 

Summary of Submissions at Initial Assessment

 

A public consultation period occurred from 18 December 2002 to 28 February 2003 for comment on the Initial Assessment of Proposal P265.  During this period, 23 separate submissions were received by FSANZ.  Two late submissions were also received.

 

The list of the submitters and a summary of their submissions is provided in the table below.

 

Organisation / Author (Abbreviation)

Summary / Major Points

Kanins Pty Ltd / Nigel Watt (Kanins)

· comments on the health and safety risks associated with treatment of Black Spot (melanosis) in uncooked prawns in Australia

· notes that they believe there are serious health and safety problems with the current control practice involving dipping in sodium metabisulphite

· suggested alternative is dipping in EverFresh (active ingredient 4-hexylresorcinol), free from health and safety concerns

Tasmanian Fishing Industry Council / Ralph Mitchell (TFIC)

· supports utilisation of the national industry seafood standard (SSA/ASIC application submitted to FSANZ) as appropriate within the standard, perhaps as interpretive guidelines

· suggests marine plants should be included, while crocodile and mammalian meat should be excluded from the scope of the standard

· chemical and biological hazards would not need to be listed specifically in the standard, rather they could be referenced from previous chapters of the Code

· the seafood standard should regulate up to, but not including, point of retail sale

· fishing vessels producing a live product that can demonstrate little or no significant risk of introducing a hazard should be exempt from a certified food safety plan – in line with the theory of minimal impost to industry

· fishing vessels that process or store product on board may not have the facilities to accommodate regulatory inspectors on board, in which case the vessel skippers could be encouraged to obtain accredited training to cover food safety training on board

· an awareness program would be a useful means of reinforcing the basics of food safety on board fishing vessels

· suggests that a receival standard, whereby regulation/enforcement begins at the wharf (the receiver would be responsible for ensuring that seafood received from the vessel is safe to eat), may be used to encourage compliance together with lessening impost

· any risk assessment process utilised in standard development needs to be specific to the situation to which it is being applied, particularly in the case of fishing vessels; a ‘one size fits all’ approach would be inappropriate

· existing standards, such as TASQAP and the NSW Seafood Safety Scheme, should be incorporated into the interpretive guidelines as appropriate

· the industry could utilise industry documents, such as ASIC’s ‘A Code of Conduct for a Responsible Seafood Industry’ to provide objectives and principles, particularly where mandatory measures are ineffective

 

 

· the seafood standard must apply equally to all seafood traded in Australia, regardless of its origin, in line with the WTO rules providing that a country cannot impose regulation on imports that do not apply domestically.

· the time frame for standard implementation must be established through close consultation with industry, in accordance with the range of commodity types, business sizes, vessels and equipment, and communication skills involved in seafood production and processing in Tasmania

· raises questions about the integrity of some aspects of the summary of the Wallis Lakes incident as an illustration of the cost to industry of risks associated with food-borne illness from seafood

Northern Territory Seafood Council (NTSC)

· supports the seafood standard as a means for providing consistency across Australia in regard to the safety of seafood

· supports an outcome based, rather than a prescriptive standard, hence avoiding undue impost to industry and concurrently increasing consumer confidence in seafood

· supports the SSA voluntary industry Australian Seafood Standard, as submitted to FSANZ

· considers it essential that the seafood standard allow businesses to utilise solutions to any food safety risks as appropriate to the level of risk involved e.g. a HACCP plan or GMP may be appropriate in different situations

· the seafood standard should cover from point of harvest through to point of retail

· where there are already standards in place with which the retail sector must comply, the standard should refer to these rather than duplicate them

· supports the SSA submission that the standard should recognise and reference the Australian Fish Names list

· supports the SSA comment that the seafood standard must automatically recognise export establishments as complying with the standard

Seafood Export Consultative Committee (SECC)

Provides comments under two main headings:

·         incorporation of existing regulation into a PP&PS for seafood

o     raises concerns that state regulators would not have the capacity to implement and police a single standard, and that a single mandatory standard may duplicate existing regulation of seafood by AQIS

o     therefore the standard must contain provisions to recognise automatically export establishments as complying with the PP&P Standard

o     or alternately that mutual recognition of audits by AQIS and each state regulator

o     AQIS should become a full member of the FSANZ SDC, given their extensive practical experience

· the costs of existing regulation

o     current costs to industry are presented

o     duplication of existing regulation by State authorities would not be considered good value, or be accepted by industry

City of Unley / S. J. Sowter (Unley)

· raises the issue of which jurisdiction would be responsible for regulation and implementation of the seafood PP&P standard

· suggests that production aspects would be best regulated by PIRSA

· and processing aspects would be best regulated by the Department of Human Services

Food Technology Association of Victoria / David Gill (FTAV)

· the Technical Sub Committee of this association accepts the Issues Paper as presented and without further comment at this stage

Sontari Foods / Hope Kearney (Sontari)

· notes that food safety is a shared responsibility between the government (through FSANZ), industry, and the consumer

· raises concerns about the definition of seafood – suggest that the standard should determine the point that aquatic product becomes food

· notes that ABARE statistics regarding Australian seafood production volumes relate to green weight, hence there is an error in contribution of domestic consumption figures – imported seafood contributes around 65% to Australian seafood consumption volume

· notes that importers may work with overseas suppliers who operate on strict codes of practice that are considerably tighter than those operating in Australia

· agree that quality attributes and methodologies should not be enshrined in the code

· believes that marine animals should be included in the standard

· the seafood standard should apply through to point of sale, and should not exclude fishing vessels

· upon consideration of the proposed SSA/ASIC standard, feels that a wider view is required for the Australian seafood sector than that of SSA, who does not engage with the considerable Australian seafood import sector

· opposes formally incorporating the Australian Fish Names list into the standard, as suggested in the proposed SSA/ASIC standard

· has considered the NSW Safe Food Production system and feels there are various deficiencies:

· as the certificate is issued at time of payment of the fee, it is therefore easy to be deceived into thinking that a food safety plan actually exists

· insufficient industry extension work has been undertaken by Safe Food NSW

· audits are only authorised by Safe Food officers, passing over a wide range and high standard of commercial auditors

· the program does not carry through to the consumer

· notes that import legislation, although not perfect, seems to be working reasonably well

NT Government / John MacCartie (NT Govt)

· raises concerns regarding multiple audits – suggests that auditors need to be accredited to audit against more than one regime, or audit covering a lesser standard

· questions whether consideration will be given to good corporate history e.g. an AQIS type bonus scheme

· questions whether any national standard will have a national accreditation mark, or whether this will be left to individual jurisdictions

· questions whether aquaculture and wildcatch ventures that sell at the door or over the gunwale will be subjected to the PP&PS or the Code

· suggests that aquaculture be regulated from the start of culture

· suggests that if the onus is on the supplier to sell safe food it will negate the need for heavy regulation of the primary production end of the chain

Seafood Council (SA) Ltd (SASC)

· the PP&PS should reference other parts of the Code where appropriate, further requirements should only be added where there are significant risks identified and public health benefits are greater than the cost of implementation

· considers that the standard should not impose food safety regulations on businesses involved in the harvesting, handling and processing of seafood on board fishing vessels, as the public health risk relating to these activities is low

· believes that a number of issues in the proposed SSA Standard need to be addressed prior to it being used to guide the national standard

· specifically, the basis of the SSA Standard is the mandating of food safety programs for the whole seafood chain, whereas the Council believes that the standard should apply only to those elements of the chain that are at risk

· believes that the principles underpinning ASQAP should be mandated through the Standard for all bivalve molluscs collected for human consumption

· suggests that the Standard should not impose further requirements on sectors which are already meeting AQIS or other international requirements for food safety

· believes that the industry should be encouraged to develop voluntary codes and that the Standard should provide for these to be mandated, or provided legislative recognition if requested by industry

· believes there should be an option for sectors to demonstrate compliance with hygiene requirements by voluntary adoption of food safety programs with accredited third party auditors

· does not support imposition of food safety programs on industry sectors unless there are strong public health reasons or there is strong industry support (and agreement by government)

· considers that the frequency of audits should be appropriate to provide confidence that the system is under control, hence in the first instant there would be more frequent audits that would subsequently be reduced to an agreed level, with increased audits if there is evidence that the system is not under the level of control required

Environmental Health Unit, Queensland Health / Kerry Bell (Qld Health)

· concerned that there not be any duplication of existing legislation

· current MRLs for seafood need revisiting:

o     current values have been derived in the main from mammalian studies

o     MRLs do not related directly to health issues particularly when considering the low level of seafood consumption in Australia

o     fish in particular metabolise fats at a much more rapid rate than mammals, therefore some residues can be purged within practical timeframes, as opposed to mammals

· consistency is required between the states and the national standard in relation to the inclusion or exclusion of aquatic plants under the definition of seafood

· questions whether the current Australian Standard for Hygienic Production of Crocodile Meat for Human Consumption is adequate

· suggests that risk profiling is necessary to determine where higher standards are required, such as for ready-to-eat seafood, compared to seafood that has undergone a pathogen reduction step, such as cooking

· suggests aquaculture products should be covered from production to point of retail sale

 

 

· considers that a thorough Risk Assessment process has been applied within the Australian seafood industry, however some areas require attention, specifically aquaculture and chemical/pesticide residue accumulation as a consequence of prior land use

· suggests there are various anomalies within the proposed SSA/ASIC Australian Seafood Standard

· believes that food safety risks should be managed according to the degree of risk

· audits should be seen as one of a suite of tools, there may be room to include incentive based compliance in the form of reduced frequency of audit, or other forms of rewarding good practice

· the plethora of industry Codes of Practice available need to be reviewed for adequacy and equivalence

Tasmanian Salmonid Growers Association (TSGA)

· challenges the FSANZ assumption of the need for a PP&P Standard for seafood

· alternately, believes that by removing the exemption for primary production in Chapter 3 of Code and qualifying the standards to allow for the conditions in primary production of seafood, would sufficiently cover food safety issues for seafood

· believes that Chapters 1 & 2 of Code cover the hazards of concern, or could be easily modified to do so

· the standard should clearly state the seafood species that the histamine requirements apply to, as TSGA members have experienced problems around testing for histamine – as this is expensive and has been demanded by customers and their auditors, despite it being irrelevant to cold-water salmon

· duplication of standards should be avoided, and cost to industry minimised by any standard

· consideration of controls at point of receipt of fish may be an alternative to fishing vessel inspection

· risk assessment must be thoroughly and methodically applied to each seafood group before regulation is proposed

· HACCP and Listeria monitoring programs are recognised as important for cold smoked salmon and any move to mandate food safety plans for these products would be welcomed

· any technical data provided to FSANZ must be maintained in confidence, particularly in relation to individual company data

· self-regulation is encouraged to be considered ahead of government regulation, for example the GMP guidelines produced by SSA and other industry Codes of Practice should be implemented, together with effective training of food handlers

· expresses concern that any FSANZ proposals are not more onerous on Tasmanian processors than those in New Zealand, as the proposed standard will apply only in Australia

Centre for Food Technology, The Agency for Food and Fibre Sciences, QDPI / Clare Winkel (AFFS)

· fishing boats should not be required to have a full food safety plan unless processing occurs on board, otherwise they should only be required to implement Good Hygienic Practices

· the information in the Safe Food NSW Seafood Safety manual should be used as the Australian Standard

· believes that in relation to animals with high value to indigenous communities, such as turtles and dugongs, it is the preparation of these animals rather than their catching that carries food safety risks, and considers that this is covered by local health workers

· the author refers to the ASS and makes the following comments:

· the seafood industry should be asked only to comply with the current version of the Code, i.e.: sections 3.1.1, 3.2.2 and 3.2.3

· chilling temperature should remain between –1°C and 5°C, and the freezing temperature should remain at –18°C

· Section 9 & 10 of the SSA/ASIC Standard, on operational hygiene and construction of premises, seems suitable for use in premises used for live fish and on trawlers

· it is very necessary for harvesters to identify the date and place of the catch to enable identification of product caught in areas found later to be contaminated

SA Department of Human Services / Brian Delroy (SA DHS)

· in addition to those hazards already addressed in the Code, escolar, often sold as ‘rudderfish’, may need to be addressed in the Code

· the seafood standard should not overlap with the matters covered by Chapters 1 and 2 of Code

· the current definition of seafood within Code is considered adequate

· the proposed standard should not cover aquatic plants, reptiles and mammals

· the standard would ideally regulate activities on a fishing vessel, however as it is recognised that there are difficulties with enforcement; a code of practice may need to be developed to assist vessel operators

· DHS has carried out numerous surveys concerning microbiological and heavy metal hazards in oysters, histamine in canned fish, micro in prawns etc., and can provide this information if requested

· the SSA standard is seen as providing helpful input, but is not supported in its present form for a number of reasons, including that it appears to mandate the equivalent of Standard 3.2.1 of Code, and that it overlaps with Standard 3.2.2 and Chapter 1

South Australian Seafood Marketers and Processors Association Inc / Mark Cody (SASMPA)

· suggests that the seafood definition used by Codex would appear to be suitable

· suggests that the scope must be the whole supply chain with emphasis on retail, hospitality sectors

· the standard should apply specifically to those areas that pose a risk, and must pay regard to current arrangements, such as compliance with market driven and AQIS standards

· notes that the risks associated with on-board processing in Australia are negligible, in contrast to those in New Zealand, due to their large scale processing vessels and foreign crews

· notes that sushi and sashimi specialty shops need to be considered in the standard, as these represent raw, ready-to-eat seafood in a fast growing consumer market

· recognise that a risk assessment process is vital in the standard development process, but also suggest that a different approach may need to be adopted for any ‘external’ or ‘end-user’ risks that are evident

· suggest that caution should be exercised in interpreting health outcomes from epidemiological data in a simplistic model

· believe that HACCP must be the base for all food safety management systems, and suggest that AQIS and existing supplier systems must be considered in any management system, and a tailored approach used taking into account whether a high or low risk is involved

· believe that the cost of any proposed management system must be considered, for example duplicate audits must be avoided and there must be interstate consistency

Sydney Fish Market Pty Ltd / Bryan Skepper (SFM)

· believes the proposed standard should apply to all seafood that is produced or traded commercially in Australia, including seafood:

o     produced in Australia by commercial fishing or aquaculture

o     exported from, or imported into Australia

o     sold on the Australian domestic market

· believes the proposed standard should not apply to:

o     recreational catch (unless sold for consumption)

o     seafood taken by Aboriginal or Torres Strait Island people for traditional or cultural reasons (excluding sale for consumption)

o     crocodile and seaweed

· believes that the definition of seafood should not include crocodile and seaweed

· believes that the standard should regulate the production of seafood through to the final retail sale, and that this should be further reinforced with a public education program

· agrees that the proposed standard must be outcomes based, but suggests that fishing vessels may not require a full Codex HACCP system e.g. where risk to food safety is low, instead utilising other features

· for such activities and products that carry a high food safety risk, a full HACCP plan would be warranted

· risk assessment and profiling should rely on work that has already been undertaken by various authorities and the seafood industry

· is prepared to assist where possible with the provision of technical data for incorporation into the scientific risk assessment process

· the industry developed Australian Seafood Standard (SSA) should form the basis of a regulatory PP&P Standard as it was developed through an exhaustive consultative process, and most of the issues have already been debated and agreed during its development

· believes that the work undertaken by Safe Food Production NSW should also be taken into account in development of a national PP&P Standard for seafood, as well as the issues raised in the ‘Section 73’ review into the Integration of the NSW Food Safety System (conducted by the Hon. John Kerin, published Nov. 2002)

· believes the standard must be outcomes focused and based on food safety risk

· where risk to food safety is demonstrated to be low, non-regulatory guidelines and codes of practice could be an effective means of achieving the overall outcome of providing safe seafood for customers

· raises concern that multiple audits be imposed on industry by both government and other industry sectors, and therefore suggests that mutual recognition of audits by government agencies and acceptance of third party audits conducted by competent auditors must be considered

o      past audit performance of a seafood business must also be taken into account as well as the food safety risk profile of the business

· Includes the following relevant points from the NSWSIC submission to the Kerin ‘Section 73’ Review:

o               food safety should be managed using a preventative approach based on through-chain risk management, with standards implemented in consultation and partnership with industry

o               believes that scientific risk assessment of food safety risks is needed for each industry and for each link in the chain, and that the management focus and costs should be directed towards those segments that present the greatest risk

o               suggests an increase in public good e.g. education and training, which must be supported by a significant increase in government contribution

o               believes that there should be a national approach aimed at eliminating inconsistencies between states

Master Fish Merchants’ Association of Australia / John Roach (MFMAA)

·         believes the proposed standard should apply to all seafood that is produced or traded commercially in Australia, including seafood:

  • produced in Australia by commercial fishing or aquaculture
  • exported from, or imported into Australia
  • sold on the Australian domestic market

·         believes the proposed standard should not apply to:

  • recreational catch (unless sold for consumption)
  • seafood taken by Aboriginal or Torres Strait Island people for traditional or cultural reasons (excluding sale for consumption)
  • crocodile and seaweed

·         believes that the definition of seafood should not include crocodile and seaweed

·         believes that the standard should regulate the production of seafood through to the final retail sale, and that this should be further reinforced with a strong, well funded public hygiene education program specifically aimed at handling of food for ‘in home’ consumption, as well as an education program for food service businesses

·         agrees that the proposed standard must be outcomes based, but suggests that fishing vessels may not require a full Codex HACCP system e.g. where risk to food safety is low, instead utilising other features

·         for such activities and products that carry a high food safety risk, a full HACCP plan would be warranted

·         risk assessment and profiling should rely on work that has already been undertaken by various authorities and the seafood industry

·         the MFMA is prepared to assist where possible with the provision of technical data for incorporation into the scientific risk assessment process

·         the industry developed Australian Seafood Standard (SSA) should form the basis of a regulatory PP&P Standard as it was developed through an exhaustive consultative process, and most of the issues have already been debated and agreed during its development

·         believes that the work undertaken by Safe Food Production NSW should also be taken into account in development of a national PP&P Standard for seafood, as well as the issues raised in the ‘Section 73’ review into the Integration of the NSW Food Safety System (conducted by the Hon. John Kerin, published Nov. 2002)

·         believes the standard must be outcomes focused and based on food safety risk

·         where risk to food safety is demonstrated to be low, non-regulatory guidelines and codes of practice could be an effective means of achieving the overall outcome of providing safe seafood for customers

 

·         raises concern that multiple audits be imposed on industry by both government and other industry sectors, and therefore suggests that:

o     mutual recognition of audits by government agencies and acceptance of third party audits conducted by competent auditors must be considered

o     past audit performance of a seafood business must also be taken into account as well as the food safety risk profile of the business

·         Australian Institute of Environmental Health, South Australian Division / Michael Livori (AIEH SA)

·         acknowledges that there are some areas of the food industry where sections are now not regulated in relation to food safety, such as seafood

·         agrees that an outcome-based standard focusing on food safety for sectors that are currently unregulated will help improve food safety

·         believe that the new standard should apply only to seafood production, including fishing, cultivating, growing and harvesting,

·         suggests further discussion and agreement is required with regard to enforcement and implementation

·         suggests that seafood production activities (including fishing, cultivating, growing, harvesting) would be best regulated by PIRSA, whereas regulation of activities involving substantial transformation of seafood (processing or storage on land prior to distribution) would fall within the jurisdiction of the local authority and the Department of Human Services

·         believe that all businesses involved in handling and selling seafood, including retail and businesses selling ready-to-eat seafood should remain covered under the current arrangements

Safe Food Queensland / John Burke (SFQ)

· believes that the current MRLs for seafood need to be revisited:

o     current values have been derived in the main from mammalian studies

o     MRLs do not related directly to health issues particularly when considering the low level of seafood consumption in Australia

o     fish in particular metabolise fats at a much more rapid rate than mammals, therefore some residues can be purged within practical timeframes, as opposed to mammals

· believes the scope will inevitably involve some crossover into quality aspects, and regards this as not undesirable

· supports the inclusion of aquatic plants, as they are already included in Queensland legislation

· believes that crocodile processing contains inputs very similar to aquaculture inputs, and though already included in meat standards is not adequately dealt with there

· believes that food safety objectives are still relevant to Native Rights, and that the seafood involved will generally have a low risk profile, and hence is best addressed through risk communication

·  believes that aquaculture should be covered from production inputs to point of retail sale

· industry should be encouraged to fill the few existing gaps in the current Australian risk assessment data

· one area that requires attention relates to residue accumulation as a consequence of prior land use in aquaculture

· regards SSA’s industry preferred standard as a good framework for a national standard, but perceives various anomalies in this standard

· believes that food safety risk in the seafood industry should be managed according to the degree of risk

· audits should be seen as one of a suite of tools, there may be room to include incentive based compliance in the form of reduced frequency of audit, or other forms of rewarding good practice

· the plethora of industry Codes of Practice available need to be reviewed for adequacy and equivalence

Springs Smoked Salmon (Springs)

· believes the Code should be reviewed and readdressed, as it does not allow for health claims associated with the positive health benefits of Omega 3 oil content in certain fish products

· all foods should come under the proposed food standard, as the current food standard addresses food consumed by humans

· the standard should cover the entire seafood industry, as the quality and food safety status of the food is affected from the point of harvest, and any resulting processes will be carried through the processing and to the retail point

· businesses carrying ready-to-eat seafood should be considered under the same food standard regulations as other food establishments, as they carry the same, if not higher, risks to the eating public

· the regulation should address the activities on board fishing vessels at point of harvest, in the same manner as that of food processing establishments 

New Zealand Food Safety Authority / Carole Inkster (NZFSA)

· no specific comments at this stage

· a reference to the New Zealand standards for seafood provided

Simplot Australia Ltd (Simplot)

· raises concerns with the potential lack of harmonisation between Australian states and territories, New Zealand and other countries – this is relevant as a significant portion of seafood is caught internationally and may undergo a range of processes, hence necessitating a very broad approach

· agrees with the principles of minimum effective regulation and an outcome based approach

· welcomes legislation that promotes consumer understanding and acceptance of a highly skilled and sophisticated seafood industry is welcomed

· raises concerns relating to any erosion of the trans-Tasman principle that may occur as a result of the seafood standard applying to Australia only

· recommends that assessment is required of special techniques, the use of antibiotics, hormones and GM,

· of particular note are the ongoing processes re mercury in ‘predatory’ fish – suggests that this be resolved through advisory guidelines

· recommends that the scope of the standard follows that Codex Alimentarius Draft Code of Practice unless it is agreed that a particular section is too vague (such as micro standards)

· believes that EU or FDA regulations are acceptable in such cases as they are accepted internationally for export / import

· believes that issues of deceptive or misleading conduct should be left to the Trade Practices legislation to regulate and control

· believes that an outcomes based approach is preferred

· suggests that the seafood definition should be revisited to provide clarity for the various seafood groups, and that the definition should not include aquatic plants, reptiles and mammals

· believes that the standard across the supply chain of aquaculture should commence at the point of harvest and end at point of sale

· recommends an outcome based approach for harvesting, handling and processing of seafood at sea

· suggests that businesses selling ready-to-eat seafood should remain covered by the PP&P standard with reference to Chapter 3 of the FSC

· believes that the same standards that apply to land based processing of seafood should also apply to seafood aboard fishing vessels, and these should be based on HACCP principles

· cold chain compliance throughout the supply chain is recommended

· believes the FSANZ Risk Assessment process is acceptable, and does not recommend that prior studies be duplicated except where gaps are identified

· attention should be given to particular allergen issues related to seafood where they are not covered by the Code

· risks beyond microbiological factors must be addressed e.g. dangerous bones in a food product can be highly hazardous and may require specification in the standard

· believes that Australia must create a single, comprehensive seafood standard so that any state and territory legislation can be repealed, and duplication for industry is avoided

· considers that the standard should preferably have international recognition, especially from New Zealand

· sees a need for greater awareness and training in the use of HACCP, especially in small business

· believes that any import legislation should be based on Codex, and that strengthening of micro criteria should be in line with EU or FDA requirements if this is required

· any legislation should not extend labelling obligation beyond those in the existing Code

· suggests a three year compliance time frame, with a two year stock in trade provision

· suggest that auditing should remain in the realm of market forces, and believes that non-compliance is already covered under provisions already in place under the Food Act

· raise concern that the number of skilled auditors for seafood in Australia is very small

· considers guidelines a vital support for any legislation, to provide clarity for industry and visibility throughout the primary production process for the public

South Australian Department of Primary Industries and Resources / Barry Windle (PIRSA)

· suggested hazards for which appropriate process controls should be implemented are:

o     scombrotoxin – histamine poisoning

o     microbiological, biotoxin and heavy metal contamination of shellfish

o     ciguatera toxins

o     Vibrio and prawns

o     ag and vet chemical residues, especially antibiotics, in aquaculture

· believes that the standard should apply to known/identified food safety hazards within the entire seafood industry (whole of chain)

· believes that a sufficient definition for seafood would include: fish, crustaceans, molluscs and other marine invertebrates

· believes that aquatic plants, reptiles and mammals should not be included in the standard unless significant risks to public health are identified e.g. the risk assessment should consider heavy metals in aquatic plants (such as arsenic in seaweed sold in health stores)

· believes that if the risk mitigation processes that are proposed do not fit readily within the overall Standard then it may be more appropriate to develop a separate Standard

· believes that the Standard should regulate seafood production (aquaculture) to the point of retail sale, if hazards are identified that require additional process controls for the retail sector

 

 

 

· believes that food safety standards 3.1.1, 3.2.2 and 3.2.3 should continue to apply to all ‘food businesses’ and the PP&P Standard should only add requirements where there are specific risks identified and public health benefits are greater than the cost of implementation, and that the Standard should reference other parts of the Code where appropriate

· believes that in general the government should not be imposing food safety regulations to the harvesting, handling and processing of seafood on board fishing vessels, given the public health risk for these activities is low

· recognises that there may be specific risks identified that may require mandated controls e.g. cooking prawns of boats

· suggests that a voluntary code of practice for good handling and hygiene, and vessel design, may also be useful

· will support provision of technical data for incorporation into the FSANZ scientific risk assessment process

· believe that industry may support mandating of hygiene standards for some sectors, to minimise the current low level of risk;

· and note that it there is broad government and industry support for these sectors around Australia - SA would support including them in the Standard, provided industry is prepared to meet the regulatory costs attributable to industry

· in general, supports industry developing and implementing voluntary industry standards e.g. the SSA Standard;

· however, do not support currently using the SSA Standard as a voluntary basis for a national mandatory PP&P Standard for seafood, for the following reasons:

o      it mandates food safety programs for the whole seafood chain, which is not believed to be in line with the principle of minimum effective regulation and may not demonstrate a positive cost-benefit ratio (based on public health savings versus the cost of implementation)

o     would not accept SSA, a non-government body, developing and maintaining the guideline documents that would form the basis for regulatory application of a Standard

o     believes there are definitions and principles in the SSA Standards that appear to be in conflict with the Food Act, with which all regulatory instruments should comply

·         believes that in general, for specific hazards identified as a significant risk there should be mandated control processes in addition to existing controls specified in the FSC

·         recommends the following food management systems

o     mandating the principles underlying ASQAP for all bivalve molluscs collected for human consumption

o     food safety programs mandated for bivalve mollusc production, harvesting, processing and distribution

o     food safety programs mandated for control of Listeria in cold smoked salmon, as a high risk operation

o     mandated controls for retail outlets to minimise the risk of rudderfish ‘poisoning’ e.g. mandating correct identification of fish and/or warning signs

o     development of a voluntary code for all harvesters and catchers of seafood as, in general, most sectors are low risk

·         believes that compliance with food safety programs should be by third party auditors, approved by government, paid for by the industry, with reporting protocols to the regulators:

 

o     this audit system would be flexible enough to allow for government and contracted audit services, and validation systems should be part of the whole system

· believes that compliance with mandated hygiene requirements in the catching and harvesting sectors should occur through government inspection, and that there should be an option for sectors to demonstrate compliance with hygiene requirements by voluntary adoption of food safety programs with accredited third party auditors

· believes there are significant additional costs for successful implementation of food safety programs, and that these programs should not be implemented unless there is strong industry and government leadership supported by appropriate resources

· believes that imposition on industry sectors should not occur unless there are strong public health reasons or there is strong industry support (and agreed to by government)

· supports mechanisms that allow recognition of industry systems that demonstrate compliance with the Standard

· notes that currently the PP&P Standard for seafood would be given legal effect via the SA Food Act

· notes the SA is considering development of primary industry legislation to cover the pre-harvest part of the seafood chain, in which case the part of the Standard applicable to the pre-harvest sector would be applied under this legislation and the remainder under the Food Act

· believes that implementation time frames for food safety systems will vary according to the food safety system required and the starting point of the industry sector

o        notes that an industry with a low level of preparedness would need over two years for implementation

· believes that audit frequency should be necessary such as to provide confidence that the system is under control - in general there would initially be more frequent audits that would reduce to an agreed level, with more frequent audits if there is evidence that the system is not under control, and that regulators would determine the frequency of audit, based on reports from auditors and other agencies

· supports the use of supporting guidelines for an outcome based Standard, and suggests that it would aid national consistency to have them developed nationally wherever possible

Seafood Services Australia / Ted Loveday  (SSA)

· detailed comment is provided on the position of the ASS in relation to the various issues raised in the Issues Paper throughout the submission

· believes that the proposed PP&PS for seafood should rely on relevant provisions in the Code to ensure that chemical and biological hazards associated with seafood are adequately expressed

· the provisions in the Code relating to chemical and biological hazards associated with seafood, within the agreed definition of seafood, should be checked for accuracy and reviewed consistent with normal FSANZ processes

· believes that the scope of the proposed PP&PS for seafood should cover the entire seafood industry

· the proposed PP&PS and the ASS should have consistent definitions, and an agreed process for considering proposals to change definitions should be developed

· believes that the PP&PS for seafood should also recognise the status of the Australian Fish Names list and reference it in the standard

 

· notes that the PP&PS for seafood should not consider policy and regulatory issues other than food safety e.g. native fishing rights are considered in other fora

· notes that the ASS has worked in consultation with government and industry to establish agreed definitions for inclusion in the ASS, that there have been many comparative studies of definitions used internationally and nationally, and that SSA has established the Fish Names Committee to act as a forum for initial debate on definitions to be considered for the ASS

· notes that the underlying policy principle for the ASS is for jurisdictional issues not to be embedded in the Standard, rather, the Standard is outcome focused, takes a ‘water to waiter’ approach and in based on management of risk

· believes that, similar to the ASS, the PP&PS for seafood should not allow jurisdictional issues to compromise integrity and focus

· believes that with respect to regulation of harvesting, handling and processing of seafood onboard fishing vessels, the PP&PS for seafood should consider the approach taken by the ASS

o     the ASS is not prescriptive about how a seafood business should achieve the required seafood safety and suitability outcomes, thereby providing flexibility

· believes that the Issues Paper does not properly consider risk analysis in context or have regard to the significant amount of data already available to seafood businesses to assist them in implementing a HACCP based standard, rather, it appears to place undue emphasis on a sub-set of risk assessment more appropriate to the establishment of food product standards

· believes that under a risk management system (consistent with Chapter 3 of the Code), the analysis required to relate production processes to hazards identified should be undertaken after the standard is established and should not impede the development of a uniform national standard

· comments that the ASS is the industry preferred food safety standard, development of which has involved significant time and effort of industry members while utilising input from Commonwealth government agencies as well as state and territory regulatory bodies

· notes that the ASS will continue to be developed and implemented by SSA Ltd as a voluntary food safety standard for seafood businesses

· it is expected that the process will run concurrently with any PP&PS for seafood, such that a seafood business demonstrating compliance with the ASS will achieve recognition as complying with any nationally mandatory PP&PS for seafood

· believes that all existing standards applying to seafood should be considered as part of the process of developing a national mandatory PP&PS for seafood, such as the NSW Food Production (Seafood Safety Scheme) Regulation 2001, and any international standards

· suggests that when considering the suitability of any particular standard as a model it is important that the SDC consider an approach with maximum flexibility without compromising the achievement of food safety outcomes; an overly prescriptive standard may impose unnecessary costs on individual seafood businesses

· considers that the Regulatory Impact Statement (RIS) prepared by FSANZ in support of the adoption of Chapter 3 of the CODE is relevant to consideration of the benefits/risks of possible risk management approaches

o     the RIS asserts that HACCP-based food safety programs, in combination with good hygienic practices and education of food handlers, are seen as pivotal to reducing the incidence of food-borne illness

· comments that Ministerial Council has established that risk management in relation to PP&P standards is to be consistent with Chapter 3 of the Code i.e.: HACCP based, and uses a model requiring businesses to implement HACCP based food safety programs based upon their risk classification (with high risk business to being required to implement first), and indicates that ASS has taken this approach in regard to fishing, farming, harvesting and processing businesses

· notes that SSA will continue to help industry sectors to develop codes and guides based on industry demand and available resources

· comments in relation to the costs and benefits of the food management systems, that consumer confidence that seafood is ‘safe’, ‘clean’ and ‘green’ is vital to the well-being of the seafood industry, the tens of thousands of jobs it supports, and regional coastal communities around Australia, and notes that ASS reflects the industry’s commitment to providing seafood for human consumption that is produced in accordance with internationally recognised standards and which meets and where possible exceeds the requirements of domestic and international customers and food safety authorities

· believes that agreement on national standards for seafood safety and suitability would facilitate establishment of a national and compatible certification framework that enables seafood businesses to demonstrate compliance with regulatory requirements in all relevant jurisdictions, through a single audit

· suggests that the PP&PS for seafood must include provisions that automatically recognise export registered establishments as complying with the standard, inclusive of those establishments registered for export by AQIS or under AQIS approved arrangements such as state or third party certification

· note that SSA is working with the Joint Accreditation System Australia and New Zealand (JAS-ANZ) and participating in the intergovernmental process for developing a national framework for food safety auditing, to help develop an accreditation and certification system that enjoys the confidence of the public, seafood consumers, the industry and government

· believes that codes of practice or guides to best management practice need to be developed, in conjunction with industry, and that risk assessments that identify hazards and CCPs that will apply to all businesses in particular industry sectors need to be undertaken – these initiatives will avoid unnecessary duplication of efforts at the business level

· note that several codes of practice and guides already exist as a consequence of projects such as the Australian Seafood Industry QA Program (ASIQAP), Australian Prawn Promotion Association’s code of practice for wild caught prawns, etc

· states that SSA will continue to help industry sectors develop GMP guidelines and other resources based on industry priorities, demand and availability of resources, and has a number of guidelines currently available, which are currently being reviews to ensure consistency with the ASS and the PP&PS for seafood, and to incorporate outcomes from industry case studies that are piloting the adoption of the ASS

Australian Government Department of Agriculture, Fisheries & Forestry (DAFF)

· supports access to safe food products

· supports outcomes based regulations, based in science

· recognises the Australian Seafood Standard (ASS), and the consultative process through which it was developed, as well as its broad industry acceptance

· recommends the ASS should at least be a starting point from which to develop the Seafood Standard

· suggests FSANZ clarify the intent of the statement ‘Primary Production and Processing Standards shall apply in Australia only’ - will the Seafood Standard will apply in Australia but not New Zealand, or in Australia but in no other country?

· believes general provisions for microbiological criteria should be included, similar to those in Chapters 1 and 2 of the Code for food chemicals, i.e.: no residues are allowed unless there is a specific permission

· reminds FSANZ that enforceability at the border must be considered, and sees competing requirements if FSANZ is to move away from such general provisions and criteria as are currently required

· suggests the Standard should address the hazard ciguatera, perhaps through ancillary risk management programs such as size limits, or prohibitions on the sale of some species, or avoidance of harvesting hot spots etc

· public health issues surrounding consumption of escolar and other oilfish species that contain indigestible wax ester oils should be considered

· recognises parasites, including nematodes, cestodes, trematodes as significant potential hazards in raw, cold-smoked and undercooked fish and fish products

· suggests the Standard should address bacterial pathogens currently absent from the Code, such as Vibrio parahaemolyticus, V. vulnificus, Yersinia enterocolitica, Clostridium botulinum (type E in particular), Salmonella spp., Staphylococcus aureus (except in the cases of raw and cooled crustacea with respect to the latter two microbes)

· suggests that the Australian Shellfish Quality Assurance Program (ASQAP) be cited within the Standard

· other aquaculture situations, including farming of crustaceans and finfish, may require consideration with respect to animal health concerns, as viruses can replicate in these intensive farming situations

· suggest that ‘seafood sold in Australia’ may be better worded ‘For sale in Australia’ or ‘intended for sale in Australia’

· advise that the term ‘cold-blooded’ is technically incorrect for seafood, and the term ‘shellfish’ is ambiguous

· suggests a definition for ‘seafood’ or for ‘fish’ – ‘aquatic vertebrates and aquatic invertebrates, including finfish, molluscs and crustacea, but excluding aquatic mammals’

· advise that the regulation of crocodiles is already addresses under the Australian Standard For The Hygienic Production of Crocodile Meat for Human Consumption

· consider that there is little need for regulatory control of aquatic plants in a food safety context

· suggest that if crocodiles and aquatic plants are to be considered under the Standard, risk profiling should be conducted for these products

· advise that Australia does not currently commercially harvest mammals, hence their inclusion in the Standard would not be appropriate

· suggests that the Standard should consider pre-harvest conditions such as growing and feeding in relation to aquaculture

· believes the Standard should reference other appropriate standards in the Code, in relation to standards for retail sale

· recognises that feedstuffs are covered by current state regulations, sees development of the Standard as an opportunity to include feedstuff issues, or to call up and reference feedstuffs

 

· regulation of harvesting, handling and processing of seafood onboard fishing vessels should be determined according to the extent to which specific onboard practices might introduce new hazards or compromise the safety of the final product (as determined by risk analysis)

· supports FSANZ’s current approach to scientific risk assessment

· indicates that AQIS provides data associated with analysis of imported food to FSANZ on a regular basis

· indicates that the Export Control (Processed Food) Orders should be considered as a base for the Standard

· indicates also that the Codex Code of Practice for Fish and Fishery Products has useful elements that could be considered

· suggests that AQIS may have useful information to contribute regarding compliance, as has regulated the export sector for approximately 15 years

· suggests that industry compliance with export legislation should be deemed to comply with the food safety management options

· consideration should be given to Commonwealth recognition of equivalent enforcement systems; enforcement of the national Standard should be consistent across all jurisdictions

· the framework for judging the ability of a system to deliver the same level of food safety should be adapted from the CCFICS Draft Guidelines on the Judgement of Equivalence of Sanitary Measures Associated with Food Inspection and Certification Systems

· notes that the Export Control (Processed Food) Orders rewards high level compliance with reduced audit system, as does the Imported Food Inspection System, where good compliance history reduces the rate of inspection

· notes that comprehensive guidelines are useful as support for regulations – both for compliance and for interpretation

· suggests that the level of prescription contained in the Standard will affect whether guidelines are needed

· DAFF is more than happy to provide assistance to the SDC or FSANZ on any matter pertaining to the experience gained during the evolution of the Export Fish Program, with regard to the strengths and weaknesses in the current system, industry compliance and enforcement issues

Coles Supermarkets (Coles)

· strongly feels that the Standard should not apply to retail

· notes that the primary control over seafood safety at retail relates to temperature control, and existing standards in the Code are adequate and well enforced

· notes also that any significant hazards after delivery of stock is accepted are already identified and appropriately addressed through hazard analysis

· notes that if the Standard apply to retail, it would add another layer of enforcement and auditing fees for supermarkets, which they believe to be unreasonable when they believe the risk is being adequately managed

· is concerned about duplication of activity if a separate enforcement agency is introduced for seafood, which is a small segment of the supermarket product range

· believes that the need for specific expertise in the enforcement agency is restricted to the primary production sector of the seafood industry

· believes that businesses selling ready-to-eat seafood should remain under the current arrangements

· strongly believes that the Standard should cover activities on board fishing vessels, through requiring implementation of HACCP based food safety systems

· considers the ASS a sound basis for the Standard

· supports the requirement of HACCP based food safety programs (Std 3.2.2) for all seafood businesses, rather than just those demonstrating the highest risks

· recommends that a Code of Practice or guidelines incorporating generic templates be developed, in conjunction with industry

· believes businesses should also have the option of developing their own food safety programs and having them independently approved

· believes the Standard should recognise other similar existing schemes and auditing bodies, to allow compliance to be achieved through a single audit

· believes FSANZ has consistently underestimated costs to industry associated with implementation of HACCP based food safety programs

· nonetheless believes that the benefits, in terms of food safety, outweigh the costs

· notes benefits such as increased consumer confidence, fewer resources required to investigate complaints, lower likelihood of litigation etc

· suggests a minimum of 2 years compliance period upon introduction of the Standard

· notes a general concern that not all States and Territories may chose to adopt the FSANZ Standard; leading to national inconsistencies

· believes the normal FSANZ review process should apply to any future amendments to the Standard

· believes identification and nomenclature is an important issue not sufficiently addressed in P265

· suggests that the Australian Fish Names list (SSA) should be recognised/referred to by the Standard, and believes this would help prevent deceptive conduct associated with the naming and sale of seafood, as well as providing a means of consumer education

 


Abbreviations used:

 

ASQAP- Australian Shellfish Quality Assurance Program

GMP – Good Management Practice

PP&P – Primary Production and Processing

PP&PS – Primary Production and Processing Standard

MRL – Maximum Residue Limit

TASQAP – Tasmanian Shellfish Quality Assurance Program

 


Attachment 5B

 

Summary of Submissions at Draft Assessment

 

A public consultation period occurred from 26 May through to 6 August 2004 for comment on the Draft Assessment Report. During this period, 29 separate submissions were received by FSANZ.

 

The list of the submitters and a summary of their submissions is provided in the table below.

 

Organisation / Author

Summary / Major Points

Dr Christine Halais

 

Comments that whilst it is clear that Option 3 would provide maximum public health protection, she understood that there were no plans to impose similar standards on imported seafood.  Remarks that if this were indeed the case, seafood in Australia would fall into two safety categories with the onus being on the consumer to distinguish between these – ‘a poor public health strategy’.

 

The DAR identifies bi-valve molluscs, with some exceptions, as high risk product, internationally. The priority is to introduce higher standards for this category of seafood (e.g. Option 2) and to apply these uniformly to domestic and imported products.

 

Comments that only after this measure has been successfully implemented should we move on to Option 3, with similar restrictions on all imported seafood products.

 

Mike Oakley

Manager

Oakley Food Advisory Services

Provides comments under two main headings:

 

·         RE: Subdivision 3 Health and Hygiene Requirements

o    Comments that the Editorial Note states that seafood businesses must comply with Div 4 of  Std 3.2.2.  References Division 6 of 3.2.2 regarding not permitting live animals in areas in which food is handled, other than seafood or other fish or shellfish.

o    Seeks a rewording of this clause to have guard dogs in seafood processing areas under controlled circumstances and not while processing is going on, but in remote areas where security is required in the seafood, other fish and shellfish industry.

 

·         Shellfish (oysters & mussels)

o    Comments that shellfish (oysters & mussels) must enter the cold chain within 24 hrs of harvest.

o    Recommends a labelling amendment to verify this in terms of a harvest time being added to the label so that random checks could be made.

o    Recommends transport of shellfish should be by a refrigerated vehicle (3rh part carriers) and should only be accepted if product is less than 10 deg at time of collection.  Refrigerated transport should not be used as the first point of cold chain management.

 

David Gill,

President - FTA Vic

Food Technology Assoc. of Victoria Inc

 

Agrees with Option 3 – to approve the introduction of a risk-based Primary Production and Processing Standard to improve the overall safety in the seafood supply chain.

Neil R Smith

Principal Policy Officer

Dept. Primary Industries and Fisheries, Queensland

Provides comments against three headings:

·   Div. 3 – Harvesting and other requirements for bivalve molluscs

             15 Interpretation

o   Suggests a definition of ongrowing is included as this term is referred to in the definition of spat.  Ongrowing is defined in the Australian Shellfish Quality Assurance Program (ASQAP) Operations Manual as the process whereby shellfish are translocated to a classified area for a sufficient period to permit their development as a marketable product.  The period shall not be less than 60 days.

 

o   Definition of bivalve molluscs excludes spat, scallops and pearl oysters where the only part of the product consumed is the abductor muscle.  ASQAP Operations Manual differs to this and excludes only spat and scallops when the consumed product is only the abductor muscle. Scallop abductor muscle is exempt based on scientific evidence showing the deposition of algal biotoxins and other contaminants is considerably less in the abductor muscle. Pearl oyster meat is not excluded under ASQAP Operations Manual as there is no such evidence available for pearls.

 

·                 16 Harvesting bivalve molluscs for human consumption

o    Standard requires a seafood business may only harvest bivalve molluscs for sale for human consumption from areas that have been classified, subject to a marine biotoxin management plan – believes this requirement will have major ramifications for Queensland’s oyster industry and will represent a significant cost to harvesters and any new operations that commence and may delay harvesting of product until classification of their area is complete. Believes this increase in costs may detract people from entering the industry.

 

o    Talks about oyster areas in Queensland with 111 areas in Central Queensland that harvest wild oysters from natural stocks on rocky headlands.  All of these areas would need to be classified under this standard, probably as remote areas.

 

o    Due to the remoteness of the wild oyster areas of central Queensland, (there is no human habitation and no impact of actual or potential pollution sources), it is reasonable to expect that oysters would be safe from non-biotoxin hazards.  The practical limitations imposed by the total distance the oyster areas cover make it impossible to classify all areas as remote.

 

o    Queensland Shellfish Quality Assurance Monitoring Program (QSWAMP) is administered by Fisheries and is responsible for classification of oyster growing areas in Queensland.

 

o    States that given the distance the oyster areas are spread over, many of the areas would need to be classified individually and this would represent a substantial task for the authority responsible for administering the QSWAMP.  Remarks in many cases it would simply not be practical given the costs involved to classify areas to enable the harvester to sell product for human consumption.

 

o    Believes that the need to apply the monitoring required under this Standard is excessive and there should be some acknowledgement of the reduced food safety risk for these operations.

 

o    Suggests a less comprehensive monitoring program for these oyster areas could be included as part of the oyster harvester’s food safety program which is required for all food businesses that handle bivalve molluscs.

 

o    States that the standard will not impact on Queensland’s scallop industry as all product is marketed as abductor muscle only and is therefore exempt.

 

o    States that any future marine aquaculture planning will need to consider the need for classification of growing areas as this will influence possible locations of new areas.

 

·                  18 Wet Storage

o    No wet storage of bivalve molluscs.

 

Dr David Mills

Manager – R&D

Paspaley Pearling Company Pty Ltd

Supports the current recommendation in the DAR regarding the classification of pearl meat using solely the abductor muscle.  Specifically that it has been excluded, along with other similar products, from the high risk ‘Bivalve Mollusc’ class of product.

 

Attaches a draft review completed by WA Fisheries showing that bivalve abductor muscle, such as pearl meat and scallops, are one of the safer forms of seafood available.

 

To their knowledge, there have been no instances of food poisoning or other illness caused by consumption of pearl adductor meat in over 50 years.

 

Over 1000 people working for or with the company with access to pearl meat with no ill effects.

 

Pearl farms are located in remote pristine wilderness areas in northern Australia, with no permanent populations or pollution sources.

 

Paspaley Pearling has also commissioned a heavy metal analysis from pearl farms across 5 sites carried out by NT Environmental Laboratories (NATA accredited) and the results show all of the values for heavy metals in the pearl meat at all sites are below the maximum limits as outlined in the Code – attaches a copy of analysis report.

 

Heavy metal analysis results: inorganic arsenic (max 1 mg/kg) – results 0.17-0.89; cadmium (max 2 mg/kg) – results 0.20-0.62; lead (max 2 mg/kg) – results <0.01-0.04; zinc (no max) – results 10.3-75.2

 

Also attached – an outline of a proposal to do laboratory-based feeding experiments to quantify any accumulation of algal biotoxins in the adductor and viscera of pearl oysters. Experiment proposal submitted by Janet Howieson and Walter Arrow.

 

Ralph Mitchell

Executive Officer

Tasmanian Fishing Industry Council

Endorses the Standard in its current form, recommending that (7.4) Option 3 be adopted.

 

Raises a concern about ‘co-mingling’.   Believes that while co-mingling of seafood from different sources may not in itself present an elevated level of risk of food safety, for traceability and consumer confidence reasons, the Standard should ensure that co-mingling is not permitted in the market place.

 

States that from a state/region perspective, traceability via the provision of not permitting the practice of co-mingling produce from various sources at the market, would allow adaptive management of the program to prevent any further illness in the event of food-borne illness.

 

Cassandra Melrose

Assistant Manager

Melshell Oysters, Tasmania

Applauds the introduction of a nationally mandated standard for the seafood industry. Provides comments on two issues:

·         The regulation of the proposed Standard

o   Disappointed that the standard is outcome based not directional or prescriptive. Believes this causes ambiguity for auditing and will add expense to producers with numerous audits required to understand what is expected.

 

o   Concerned with regard to bivalve production and processing that the individual states will interpret the standard differently. For example, the problem of Tasmanian products not being accepted by Victorian processors may arise.

 

·     Clause 19 – co-mingling of bivalve molluscs

o   Pleased to see the introduction of Clause 19.

o   Believes clause as it stands will not aid the tracing of contaminated products to their origin. The lease number and harvest date is critical information required to identify lots. Therefore the definition for lots as in standard 1.1.1 is not appropriate for this clause.

 

o   Suggests that a definition is added to Clause 15 – interpretation, to read:  ‘Batches – means a quantity of food which is harvested, depurated or handled from the same lease number with the same harvest date.’

 

o   Suggests changing Clause 19 to read:  ‘For the purposes of clause 11, each batch of bivalve molluscs harvested must be separated in a manner that prevents co-mingling of batches.’

 

Geoff Raven

Manager Food Safety Program

Primary Industries and Resources SA

In considering the DAR, the Department of Primary Industries & Resources SA consulted with the Department of Health. Both agencies support the attached submission.

 

General Recommendations: South Australia supports:

o   mandatory requirements for bivalve molluscs;

o   the gazettal, as a voluntary standard, of the requirements for the remaining seafood businesses; and

o   the splitting of the requirements for shellfish businesses between standards 3.2.1 and 4.2.1 and the imposition of food safety programs (standard 3.2.1) on shellfish food businesses up to the back door of retail premises.

 

Discussion:

o   SA agrees with the assessment of bivalve molluscs in uncontrolled waters as a potentially high public health risk and supports the application of draft standard 4.2.1 to bivalve molluscs.

 

o   SA does not have intensively farmed or contaminated estuarine harvest waters for  prawns and as such does not see a public health need for mandatory requirements for prawn harvesting in SA. Notes that most harvesting of prawns in SA is covered by AQIS systems.

o   SA supports the assessment of finfish as medium risk for ciguatera toxin, mercury and arsenic, but notes that draft standard 4.2.1 does not address these risks as they are managed by alternate strategies.

o   SA acknowledges the potential risk to abalone and roe-off scallops from algal biotins, but notes that abalone and roe-off scallops are excluded from the relevant risk management tool i.e. application of Division 3 in 4.2.1. SA supports the exclusion but notes that if further data indicates an increased risk this may need to be reassessed.

o   Notes that the risk assessment did not identify any high or medium risks for primary seafood production, beyond bivalve molluscs, that would be mitigated in SA by application of draft standard 4.2.1.

o   SA contends that the contribution from poor handling and primary risks in primary seafood production, apart from estuarine/farmed prawns and bivalve molluscs and ciguatera toxin, is a minor contributor to food-borne illness and that post-harvest cross-contamination and poor handling is by far the major contributor.

o   States that if the food-borne illness risk from the low risk sectors in primary seafood production is significant, then so too will be the costs to correct them. However, if there are minimal public health issues with primary seafood production than the implementation and compliance costs will be relatively low, but then the rationale for imposing the standard is also limited.

o   On the basis of a limited positive benefit cost ration, the SA government does not support the mandating of hygiene requirements for primary seafood production apart for bivalve molluscs.

o   SA will reassess its position if data is presented that supports the contention that the poor handling of primary seafood production, excluding shellfish, makes a significant contribution to food borne illness.

o   Notes that there are indirect benefits for industry in implementing 4.2.1 eg improved consumer perception and improved shell-life, that may improve the benefit-cost ratio. As such, if primary seafood production sectors believe that the benefits outweigh the costs and support implementation of the standards, then SA would not oppose implementation of 4.2.1 for non-shellfish primary seafood production.

·                 DPIR South Australia provided specific comments on the draft standard.  These are detailed below:

 

Defining the split between standards 3.2.1 and 4.2.1

The split between applications of 4.2.1 and 3.2.1 needs to be based on, and consistent with , the definition of ‘primary food production’ in the current Food Act and then be consistent with the definition of ‘primary production of seafood’ in standard 4.2.1.

 

Currently the words in clause 15 of 4.2.1 mean that bivalve molluscs are extended beyond the definition of ‘primary production of seafood’.  They also conflict with the words ‘primary production of bivalve molluscs’ under the table in clause 20.  The additional words also seem to be superfluous for applying the clauses relevant to bivalve molluscs under 4.2.1

·   Suggests the definition of bivalve molluscs under clause 15 has the following words removed, ‘… either shucked or in the shell, fresh or frozen, ….., or processed….’.

 

The current words in the table to paragraph 2(2)(b) in 3.2.1 extend the application of 3.2.1 to the production of bivalve molluscs, as ‘handling’ includes production.  As the intent is to now have 3.2.1 and 4.2.1 sit alongside each other then this table needs to be amended to exclude the primary production of bivalve molluscs from standard 3.2.1.

 

·   Suggests the words be added: ‘other than the primary production of bivalve molluscs’ after ‘handling of bivalve molluscs’ in the table.

 

Frozen Seafood

Suggests that the following words could be removed as the remaining words adequately convey the intent:

 

frozen seafood remove ‘…has been changed into a different state by the reduction in temperature and…’.

 

It is unclear why there is a need to have a definition for ‘frozen seafood’, ‘thermal centre of seafood’ and ‘thawing’.  In general, unless there has been penetration of a seafood animal, microbiological contamination will not occur in the centre of the animal and hence the need to ensure a specific temperature is achieved at the core of an animal would not seem to help in significantly reducing any public health risk. Enforcement would also be an issue as an inspector would need to probe into the centre of an animal to verify compliance with the standards. Appropriate chilling soon after capture or harvest would seem to be sufficient.

 

suggests the definitions for ‘frozen seafood’, ‘thermal centre of seafood’ and ‘thawing’ be removed.

 

Live Seafood Premises

It appears that there may have been a need in earlier versions of the standard for the definition of live seafood premises.  However now it appears that there is no longer a need as there is no longer a reference to live seafood premises in the standard.

 

suggests the definition for live seafood premises be removed.

 

Seafood Safety Management and Preventing Contamination

 

 

Clauses 3 and 4 will be difficult to verify by regulators in the absence of a documented program.  Clause 3 will also be difficult for small operators who will tend to seek a list of actions, or advice on actions, that they need to follow, rather than doing a primary assessment of the hazards.  Both clauses also seem to be covered by subsequent clauses 5 to 14.

 

suggests clauses 3 and 4 be deleted.  Clause 3 may become a policy statement in the preamble to the standard.

 

Storing at High Temperature

The Editorial Note for clause 6 and 7 indicates that temperature control means maintaining food at or above 60 degrees Celsius.  South Australia was unable to think of an example where pre-harvest seafood would be held at a high temperature.  This is a requirement for retail or food service businesses that cook and hold food.  Even where animals are cooked on board boats, eg prawns, the animals are then cooled for transport and storage.

Suggests the Editorial Note reflect this standard is for pre-harvest seafood.

 

Seafood for Disposal

As primary seafood production businesses are the primary (first) businesses in the food chain they are unable to return seafood products to a supplier.

 

Suggests clause 9(1)(b) ‘returned to its supplier’ be removed.

 

Seafood Receipt

This clause was relevant when the standard was likely to extend beyond primary production, i.e. when product would be received by a seafood business up the food chain.  However now that the standard only applies to seafood primary production there are no (second) businesses that will receive seafood products.  There could be packing or grading operations but they will be part of the same seafood business.

 

Suggests clause 10 be deleted.

 

Recall

SA supports the recall provisions in clause 11 for bivalve molluscs as there are significant risks that may lead to recall of product.  However believes there are no other high risks identified in the risk assessment that would be expected to lead to a recall by the operator.  Difficult to envisage a situation where a fisher would know their product has become dangerous to the public and order retailers, wholesalers and processors to return or dispose of the product.  As such, the requirement for a documented recall system means that an operator without the paperwork commits an offence.  This imposition is significant with limited or no public health benefit.

 

Believes, however, there may be situations where seafood becomes contaminated through the chain and having a mechanism to trace the product back would aid in establishing the potential source of the contamination.

 

Suggests clause 11 becomes ‘a seafood business must have in place a system for ensuring the traceability of their products.’

suggests the current clause 11 be moved to Division 3 and be made specific for bivalve molluscs.

 

Division 3 – Interpretations

Suggests the following words could be removed as the remaining words adequately convey the intent:

Spat    ‘…not immediately intended for human consumption…’

Relaying        ‘…by using the ambient environment as a treatment process…’

 

States that there appears to be no evidence that pearl oyster meat will not accumulate biotoxins or heavy metals as has been shown by the abductor muscle of scallops.  Believes FSANZ should consider deleting the reference to pearl oyster flesh from the definition.

 

Suggests the following change could add clarity to the definition for bivalve molluscs:

 

Change bivalve molluscs to ‘… but excludes scallops where the only part of the product consumed is the abductor muscle, and spat.’

 

Believes a definition for ‘wet storage’ will aid clarity, suggests:

 

Wet storage means the temporary storage of shellfish from classified areas in containers or tanks containing natural or artificial seawater for purposes other than depuration.  Wet storage may be used to purge sand.’

 

Division 3 – Sale from areas under classification

States that it usually takes 2 years to classify an area for the collection or harvest for sale of bivalve molluscs for human consumption.  For wild shellfish that have been collected from existing fisheries for a number of year, clause 16 and 17 will, in effect, close the fisheries until classification is complete.  Also new aquaculture leases will be unable to sell shellfish for 2 years.  The authority responsible for food safety should be able to allow existing wild fisheries to continue and new aquaculture operations to sell some product during the start up phase.  Data collected during the first year will assist in deciding the conditions under which sales could be permitted.

 

Suggests clauses 16 and 17 be amended by adding: ‘(d) is undergoing classification and has the approval of the appropriate authority, subject to specified conditions’.

 

Division 3 – State Shellfish Control Authority

The State Shellfish Control Authority (SSCA) is an effective term in the ASQAP Manual.  However there may be difficulty with using SSCA, as defined, as a legal entity in legislation.  Particularly where the legal authority is split between agencies and/or legislation.

 

Suggests the term ‘SSCA’ is replaced by the term ‘appropriate authority’ or ‘controlling authority’.

 

Seafood Management Systems

This clause is in division 3 that is specific for bivalve molluscs.  As such it should specifically refer to primary production of bivalve molluscs and the table removed.

However, the clause and table are obviously structured for future flexibility so that, if agreed, seafood management systems can be applied to another category of seafood business.  In this case, clause 20 should be shifted out of division 3 and be placed after clause 15, i.e. in the general seafood businesses section of the standard.

 


 

Organisation / Author

Summary / Major Points

Ian Doughty

Laister Consulting Services P/L

Carole Theobald

Cormorant Technical Services P/L

Comments provided on DAR identify areas where industry may find it difficult to comply with the standard and areas where enforcement officers may find it difficult to enforce them.

 

Standard 4.2.1 Primary Production & Processing Standard for Seafood

This title includes the word ‘processing’ which is not ordinarily associated with primary production.  No definition is provided in Standard 4.2.1 to differentiate the use of this word in this Standard to the use of the word “process” in Standard 3.2.2.

 

-           recommends the words “and processing” be removed from the title of the Standard.

 

2 Interpretation / Clause 6 Seafood Storage

o Temperatures referenced in Standard (where it is stated “unless the contrary intention appears, the definitions in Chapter 3 of this Code apply for the purposes of this Standard”).

 

Questions whether there is a need for a chilled or frozen seafood definition.  States they are only referenced in clauses 6 & 7 as examples of types of food.  These definitions may lead to enforcement difficulties as an enforcement officer would not know which standard to apply.

For example:

-    should a frozen product be hard, below -18°C or another temperature that ensures the safety of the food;

-    if the product is between -2°C and -17°C it is under temperature control, is safe and suitable, but is outside the definitions of chilled seafood or frozen seafood.  How would this be enforced?  In reality, there would be a conflict of standards so standard 3.2.2 (temperature control definition) would prevail (clause 1(2)).  Therefore, why put the conflicting definitions in the Seafood Standard in the first place?

 

Believes the reference to the thermal centre of the seafood after thermal stabilisation adds unnecessary complexity to the standard.  The thermal centre is not always easily and readily identifiable and will be dependent on external influences at the time of freezing.  Every block of fish will be different.  It would therefore be virtually impossible to demonstrate compliance with this requirement and similarly difficult to enforce it.

 

States that in Standard 3.2.2 there is no reference to thermal centres for either hot or cold foods, so to maintain consistency, the reference to thermal centre after thermal stabilisation should be removed.

 

-           recommends these definitions/descriptions be removed or replaced as editorial notes as guidance for good practice

 

Seafood Storage (Clause 6(4)

Notes that Food Safety Standard 3.2.2 clause 22 requires food businesses to have a temperature measuring device where potentially hazardous food is handled that is: readily accessible and can accurately measure the temperature of potentially hazardous foods to +/- 1°C.

 

Comments that given Standard 4.2.1 is also measuring potentially hazardous food, it would seem appropriate that the same standard applies i.e. device accessible and accurate.

 

-           recommends the wording from 3.2.2 clause 22 be included in 4.2.1

 

Notes that temperatures are monitored and are not recorded.  This is in line with 3.2.2 but is not an acceptable standard as a business is unable to demonstrate they have complied without written records.

 

3 General seafood safety management

Comments that the current wording does not require a business to document that it has systematically examined its operations.  Therefore, a business will not be able to demonstrate that it has complied with the standard.

 

-           recommends that the words “and document” be inserted in the Standard after “systematically examine”

or alternatively:

-           delete clause 3 as it would be impossible to enforce.

 

5 Inputs and harvesting areas / Division 3 (16) harvesting bivalve molluscs for human consumption and (17) harvesting bivalve molluscs for depuration or relaying

Comments that Clause 5(2) adequately addresses the issue of harvesting seafood from only ‘safe areas’.

 

Believes these clauses duplicate this requirement in much unnecessary detail for bivalve molluscs.  Clause 5(2) and clauses 16 and 17 provide the same outcome.  Believes the reference to the SSCA requirements may place an unnecessary financial burden on small fishermen.

 

Cites an example if a scallop fisherman was harvesting scallops from many different areas, he would be required to supply and pay for the water analysis from each place the scallops were caught.  This could involve many areas on one trip.  Results of analysis would only be available after the fresh scallops had been sold which makes the results superfluous to the fisherman especially if the fisherman may never return to exactly the same area.

 

Samples from geographic areas need to be interpreted with weather conditions, currents and tides and the sea is an ever-moving object.  In addition, fishermen would need to be trained on how water samples should be collected, stored and transported to ensure handling does not compromise results.  However, the scallop fisherman would be able to demonstrate that scallops were not caught in restricted areas by recording the areas in which the catch was made and comparing them against the latest list of restricted areas.   If State/Territory government(s) require water samples to be taken to provide them with more information to identify restricted areas, this would be outside the scope of the seafood standard.

 

      As all States/Territories already operate the ASQAP, questions whether it is necessary to bring this quality requirement into a food safety standard?

9 Seafood for disposal

Comments that the wording in this clause implies that food must be labelled “returned”, “recalled”, or “unsafe” or “unsuitable”.

 

States that the outcome required is that food for disposal is not accidentally used, so questions why specify the different terms for a label.  Some businesses have marked ‘quarantine’ areas – these would not technically comply.

 

10 Seafood Receipt

Comments that this clause implies that food is being received by the primary seafood business.  A primary industry is one at the beginning of the chain.  If a business is receiving food it is actually the second link in the chain not the first, and does not fall under the definition of primary producer in 3.1.1.

 

In addition, if food is received at 60°C or above it must have undergone substantial transformation.  Therefore, the businesses would not satisfy the definition of primary producer.

 

-           recommends that the clause be deleted.

 

12 Skills and knowledge

Believes the wording is in conflict with clause 3 of Standard 3.2.2 as it does not apply to persons supervising food handling operations.

 

-           recommends the wording be the same in both Standards to avoid confusion along the food chain.

 

13 Health and hygiene requirements

Questions who determines which hygiene and health practices are commensurate with the food safety risks, especially if the supervisors are not required to have skills and knowledge of food hygiene or food safety matters.  In addition, no guidance is provided about what the term “health practices” means.

 

The editorial notes reference Division 4 of 3.2.2 for processing, but any contamination will already be in the seafood by the time the food reaches the processor, unless clear guidance is provided to the primary producers.

 

-           recommends that the following requirements be included in the seafood standard:

Standard 3.2.2 clause 14

Standard 3.2.2 clause 15(1) a-g

Standard 3.2.2 clause 15(2)

Standard 3.2.2 clause 15 (3)

 

Believes this will provide seafood businesses with the necessary guidance to supervise seafood handlers and protect food from contamination.

18 Wet Storage of bivalve molluscs / 19 Co-mingling of bivalve molluscs

Questions whether these items need to be listed separately, especially if the seafood business is required to have a food safety program based on HACCP principles.  The food safety program would identify all hazards and provide ways to control their risks.

 

-           recommends these clauses be deleted.

 

15 Interpretation

States that if clauses 16-19 were removed, this clause would be redundant.

 

20 Specified seafood safety management systems

Notes the editorial note provides a list of acceptable systems.

 

-           believes a reference to at least Standard 3.2.1 should be put in clause 20 (preferably Commonwealth Export Control Orders as well) as the editorial notes are not enforceable.

-           in addition 3.2.1 refers to ‘food safety programs’, but this draft standard refers to ‘safety management system’.  Believes this inconsistency in the use of terms may cause unnecessary confusion.

 

Naming of seafood

Comments that this has not been included in the Seafood Standard on the grounds that it is considered a consumer fair trading issue.

 

Believes this misses the main point of traceability.  If seafood is called by different names along the food chain, it will be impossible to recall it at the consumer level.  The primary producers are the ones who identify the fish for sale, so it would make sense to include reference to fish names in the primary producers’ standard.  This would help address traceability issues and the reference could be amended if an Australian Standard is developed.

 

Unloading seafood in Victoria and New South Wales

Comments that both Victoria and New South Wales require seafood businesses to have in place a food safety program.  If a fisherman on the state borders is forced by bad weather to land and sell fish in another state, they would fall foul of local state laws.

 

Questions whether Victoria and NSW will accept the Primary Production and Processing Standard for Seafood for foods sold in their jurisdiction under such circumstances.

 

If not, believes consideration should be given to applying the food safety programs requirement to the entire sector around Australia in the interests of consistency and in order to overcome any internal trade barriers that may develop.

 

Imported Foods

Questions whether seafood imported into Australia will be required to demonstrate it has been grown/collected/harvested in accordance with this standard.  Also questions whether food imported into NSW and Victoria and all bivalve molluscs imported into anywhere in Australia be required to demonstrate that they have food safety programs that comply with Standard 3.2.1.  If not, believes we have a double standard and the local industry is being disadvantaged.

 

 

 


 

Organisation / Author

Summary / Major Points

Roy Palmer

Director

Fishy Business

A Division of Tigrey Pty Ltd

 

Congratulates FSANZ on this the first Primary Production and Processing Standard. Makes the following comments and requests that these be taken into consideration before the Standard is finalised:

 

Fish Names

States the clearly on the record was the agreement that Fish Names would not be included in the Standard on the proviso that an acceptable method to all parties be found to ensure that Imports do not escape control. Believes at this time, no advice has been given that such a method has been found, and this puts the agreement in jeopardy. Subject to this issue being resolved, it is their clear understanding that compliance and enforcement issues would be addressed. Express their opinion that whilst some states are looking to address these issues, some are showing clear reluctance to do this. Would appreciate FSANZ making it very clear to all jurisdictions that their efforts in this area are very important and not to be diminished.

 

Mandatory labelling of Imported Seafood at the point of sale

States that this has taken on major significance and has been subject of many press releases by the Minister for Fisheries. States that it is difficult for the retailer to have knowledge of whether some product has been imported and that information must be passed on down the food chain. States that they have not heard any comment that sways them from their request that the provision of adequate information and prevention of false and deceptive conducted by the food service sector be mandated.

 

National Standard across the jurisdictions

Fully endorse the concept of a National Standard as the aim is to create a level playing field. However, if the states/territories interpret the regulations in different ways, charge differing fees, create Audit strategies that are not risk-based, then the whole concept will be lost. Believes the industry will be in a worse position and the consumers will be more confused.  Believes that FSANZ and all Ministers responsible for the standard in each state/territory must work through these issues with industry and ensure that the level playing field is created. Also believes that FSANZ should carry out a survey before the standard is actioned, taking real examples of similar situations in each state and territory, analysing the costs. The examples should be revisited annually over a 3 to 5 period to ensure there is real success in the creation of a level playing field.

 

Third party audits across the jurisdictions

State that it has been brought to their attention that one jurisdiction has told operators that they will be required to have 3 or 4 audits, without looking at the risk elements involved. Consider this unacceptable as it adds unreasonable and unnecessary costs. Believe that the audit process must be orchestrated in accordance with the risk involved. The same jurisdiction also appears to have a willingness to create duplication in the audit process. Believe that FSANZ should ensure that where a business has a third party audited seafood safety plan that satisfies the conditions of the new Standard, the business will be deemed to be complying with the Standard.

 

Promotion of health benefits of seafood and Listeria

Believes that the risk of a seafood safety accident happening should be clearly explained to the consumer in a manner that promotes the excellent health benefits of eating seafood, rather than in a manner that creates public uncertainty.

 

Is at a loss to understand the need to highlight the issue of Listeria and certain seafoods when the risk assessment cannot demonstrate incidents in Australia. The industry welcomes the opportunity of partnerships with FSANZ and other jurisdictions when it comes to educating and promoting the health benefits of eating seafood.

 

Australian Food and Grocery Council

 

 

Welcomes the opportunity to make a submission in response the to Proposal P265 and compliments FSANZ on the preparation of a such a detailed and thorough Draft Assessment Report. Makes comments under the following headings:

 

Options

The AFGC has long supported a total through chain food safety system from raw material through the chain to final delivery to the customer. Although AFGC would prefer to see mandatory food safety programs in all areas of primary production, they support option three, as recommended by FSANZ.

 

Drafting – Clause 13

This clause contains health and hygiene requirements that are broad and generic in nature. Considers a specific prohibition on a person suffering from a food-borne disease from handling any seafood where there is a reasonable likelihood of seafood contamination as a result of the disease, similar to that of subclause 14(1)(b) of Standard 3.2.2, should also be included. States that if FSANZ considers the generic provisions of Clause 13 are sufficient to control this then the provisions of 3.2.2 should also be made generic for consistency.

 

Drafting – Clause 15

Considers that in the third line of the definition of State Shellfish Control Authority, ‘control and relaying’, is a typographical error and should read ‘and control relaying’.

Considers also that there is a typographical error in line 4 and ‘that is contaminated or has’ should read ‘that are contaminated and have’.

 

Drafting - Subclause 18(a)

Considers subclause 18(a) does not read correctly and the word ‘continue’ at the start of the second line should be preceded by the word ‘must’.

 

Ray Brown

Manager

Tasmanian Shellfish Quality Assurance Program

Tasmanian Dept of Health and Human Services

 

Supports submission from the Chairman of ASQAAC that went to FSANZ in November 2003, and notes that the recommendations of that committee were supported in the recent draft. Aware that these comments, on behalf of DHHS, are duplication the ASQAAC input, but wishes to make them on behalf of this agency.

 

Under Division 3 Clause 15 the definition of ‘bivalve molluscs’ excludes pearl oyster where the only part consumed is the adductor muscle. This exclusion is based on the assumption that there are no biotoxin issues with adductor meat of pearl oysters as is the case with scallop adductor muscle. Issue was raised at the last ASQAAC meeting and it was agreed that there was insufficient toxin data at this stage to exclude the adductor muscle.

Recommends to not exclude pearl oyster adductor muscle meat from the definition until this work has been done and endorsed by ASQAAC.

The intent of Division 3 Clause 19 to prevent co-mingling of lots of bivalves is strongly supported. No doubt that this will represent an inconvenience to certain sectors of the seafood industry but the benefits to industry as a whole will outweigh this.

States it is important that there are labelling requirements on the product through to the retail end to prevent co-mingling of molluscs. In addition to any general labelling provisions of the FSC, molluscan shellfish (not just oysters) should have the name of the harvest area and date of harvest attached to any containers/packets right through to retail outlets.

 

Strongly supports the requirement for all food businesses handling bivalve molluscs for sale to have a food safety management system.

 

Notes that an emerging issue for some states will be the shortage of appropriately trained and qualified food safety auditors.

 

Hans Heilpern, Chairperson

for Warren Matthew

Executive Officer, Operations

NSW Seafood Industry Conference

NSW Food Authority

 

Notes that the draft standard requires live seafood to be stored at a temperature that will not adversely affect the safety and suitability of the seafood (Sec 6(3)), and businesses involved in primary production of bivalve molluscs to implement a documented seafood safety management system (Sec 20). ASQAP has specified storage temperature and depuration conditions for live oysters and different types of oysters have different requirements. The optimal storage temperature for live Sydney Rock oysters is still a matter of some debate. States that FSANZ’s clear guidance on this matter will be essential for consistent implementation and enforcement of the relevant provisions of the standard.

 

The definition of bivalve molluscs in Sec 15 excludes pearl oysters. This would effectively exempt pearl oysters from the provisions specific to bivalve molluscs, including requirement of a marine biotoxin management plan. Seeks confirmation from FSANZ that there is sufficient scientific justification for the exemption.

 

Concerned about the increased audit costs as a result of the introduction of the PPPS for Seafood. States that it is important that mutual recognition arrangements are put in place between states, commonwealth (AQIS) and commercial organisations to minimise duplication.

 

The requirements of Division 3, subdivision 3 for a ‘seafood business’ are less stringent than the corresponding requirements in Chapter 3 of the Code for a ‘food business’. Considers this appropriate when applied to primary production environments such as those found on fishing vessels, sea cages and live seafood premises. Notes that the Editorial Notes to Clauses 13 and 24 emphasis the point that any businesses engaging in activities beyond primary production will have to comply with Standard 3.2.2 and Standard 3.2.3. It is requested that FSANZ provide very clear criteria as to the boundary of ‘primary production’. For example, questions if heading, gutting and/or filleting of fin fish onboard a vessel is within the scope of primary production.

 

States that it is not clear how far down the supply chain the prohibition f co-mingling (sec 19) is intended to apply. Notes that as this requirement is only proposed for the PPPS for Seafood but is not currently in Chapter 3 of the Code, presumes that it is FSANZ’s intent to allow co-mingling beyond primary production. Seeks FSANZ’s advice on the rationale of this. Also reinforces the need to have a clear distinction between what is considered primary production. Questions whether shucking of oysters is considered primary production or processing.

Draw’s FSANZ’s attention to the fact that NSW is well underway in implementing the Seafood Safety Scheme developed by NSW Food Authority in consultation with industry.

Urges FSANZ to ensure that the national standard will not compromise regulatory measures already set in place in NSW.

 

Looks forward to receiving information on the status of ASQAP requirements in the draft standard and the time-line for the Transitional Standard for Country of Origin Labelling Requirements.

 

Congratulates FSANZ on having made good progress on the development of the PPPS for Seafood, which is essential for ensuring consistent production of safe seafood in Australia.

 

Second letter of 18 August 2004

Discussion at the last meeting of the NSW Seafood Industry Conference on August 9 concerning fish naming conventions and strategies to assist reducing fish substitution. Convention generally agreed that fish substitution could potentially lead to food safety issues and damage the good reputation of the seafood industry.

 

Numerous examples of potential food safety issues through the misnaming of fish or fish substitution. Well known that some fish species contain higher levels of mercury than others and incorrect naming of fish may result in pregnant women consuming higher levels of mercury than expected thus increasing the risk of complications to the foetus. Other fish species are known to be associated with ciguatera poisoning. The main control in preventing ciguatera poisoning relies on banning these species from sale and restricting the sale of others based on size. Eating escolar or rudderfish may cause keriorrhoea (passing of oil) due to the presence of waxy oils. Correct naming of these fish allows the consumer to make an informed decision and not suffer potential embarrassment or concern

 

These three examples demonstrate how incorrect naming of seafood can adversely affect the consumer and the reputation of the seafood industry.

 

Believes that there is a need for legislative support for the adoption of common fish names across Australia. States that the Code would appear to be the most appropriate legal document for this purpose.

 

Recommends the adoption of common fish names either in the Food Product Standard Section of the Food Standards Code, or within the proposed Primary Produce and Processing Standard (P265) with naming based on the work already undertaken by the Fish Names Committee.

 

Believes that a mandatory requirement to correctly name fish would lead to better food safety protection for the general public and increase consumer confidence in seafood and in the seafood industry.

 


 

Organisation / Author

Summary / Major Points

Gary Bielby

Assistant Director, Food Services

Kerry Bell

Principal Adviser, Foods

Public Health Services

QLD Health

 

Preferred option

Supports option 3. Prefers the wording on page 8 of the proposal as opposed to the wording on page 35.

 

Spat

Believes that the mandatory requirements of a food safety program for bivalve molluscs should include spat with the exclusion of those bivalves where only the adductor muscle is consumed (eg roe-off scallops). The exclusion of spat from the definition is a food safety concern for QLD since the bulk of the industry in SE QLD relies on the relaying of spat from NSW. Currently, those ‘not for sale as food’ spat are transhipped to Qld and are required to have a minimum of 60 day depuration or equivalent on-growing period, prior to harvest and sale. As the shipped spat are not technically for human consumption, their movements are regulated by NSW Fisheries which has no jurisdiction in food safety matters. This anomaly results in a loophole of traceability whereby it has been impossible to adequately reconcile the movements of all spat across the border with the quantity of spat that is placed out on oyster leases. It is also known that product marked as spat has been processed in SE QLD as bistro and bottled small oysters.

 

Wild oysters

Believes that the requirement of a biotoxin monitoring program and classification of areas of ‘wild’ oyster harvesting areas will be too onerous and uneconomical for North Qld oyster harvesters. As there has not been a proven record of serious food-borne illness associated with the northern industry, and as the harvest area is normally in isolated, more pristine areas, argues that the risk is reduced compared to the much larger southern aquaculture oyster industry that resides closer to large human population and recreational use areas.

 

Medium risk seafood

Notes that the proposal deals principally with high risk seafood and there is little information addressing medium risk seafood.  Views medium risk seafood to include:

warm water ocean (reef) fish as a consequence of risk of ciguatera;

shark and billfish due to potential heavy metal contamination; and

scombroid species (eg tuna) due to potential formation of histamine as a consequence of improper temperature control.

 

Questions what FSANZ proposes to do in respect to the issue of this medium risk seafood and how processing will have to meet the requirements of the Standard. Suggests that additional education might be considered.

 

Cold smoked seafood

Believes that the mandatory requirements of a food safety program should be necessary for anyone producing hot or cold smoked seafood. This form of processing is ‘technologically’ advance and relies on compliance with a number of vital aspects of technology to achieve food safety. Notes that this is complicated further  since smoked product is not usually cooked or heated again before consumption. Believes that there must be mandatory cooking instructions to accompany cold smoked seafood.

 

 

Voluntary adoption

Suggests that based on the risk assessment presented, other businesses could be encouraged to adopt these measures as a voluntary standard. This could include the acceptance of the industry supported Australian Seafood Standard.

 

Believes such action would allow businesses to willingly accept a level of food safety management even where product risks are not currently high risk. Provides example of a number of aquaculture businesses have agreed to voluntarily implement Codes of Practice, monitor and control inputs and to report on contaminant residues to Safe Food Qld. Reports used to build an informed database and businesses provide d with Certificates of Endorsement by SafeFood Qld.

 

Maximum residue levels

Seeks assurance that the MRLs for pesticides and veterinary chemicals relative to seafood will be reviewed by FSANZ in conjunction with the Australian Pesticides and Veterinary Medicines Authority, in an appropriate timeframe. Seeks advice when this review is proposed.

 

Fish bone injuries

Believes the proposed standard needs to address the issue of physical hazards in fish marketed as filleted and boned.

 

Ready-to-eat seafood guidelines

Believes that the issue of bacteriological pathogens currently absent form the Code, such as Vibrio parahaemolyticaus, V. vulnificans, Yersinia enterocolitica, Clostridium botulinum (type E in particular) and Salmonella spp. needs to be addressed in the ready-to-eat food guidelines. The recent outbreaks of norovirus in Australia from Japanese oyster meat demonstrates the need exists, as well as the need for importers to demonstrate the safety of this product.

 

General comments

Believes the proposed Standard must be capable of being applied to imported seafood.

 

Subclause (2) of Clause 2 Interpretation

In (b) of the Editorial note defining ‘primary food production’, there is a need for activities listed to apply to ‘on premises’ as well as ‘off site’. As an example, the wild harvesting of oysters in natural open areas would not be included in the definition as it presently appears.

 

Clause 15 Interpretation in Division 3

‘bivalve molluscs’ – the word ‘processed’ as used in this definition appears unwarranted particularly where there is reference to ‘shucked’ product. This definition also seems out of context with [c] of the Editorial note which defines ‘primary food production’

 

Gillian Parton

Quality Control Services Manager

Coles Myer Ltd

 

Thanks FSANZ for opportunity to make comments, and also for taking on board comments provided in previous submission March last year.

 

Would like to reiterate that the Seafood Standard should not apply to retail, which generally only involves the storage and display of seafood. Supports the introduction of proposed Standard from harvest, up to by not including retail sale. The Food Safety Standard 3.2.1 adequately addresses the issue of temperature requirements as do own good manufacturing practices (GMP) and food safety programs.

 

With regard to fishing vessels and the regulation of harvesting, handling and on board processing of seafood, previously recommended that all these operations should be required to have some form of (CODEX) HACCP based food safety program in place. Notes that unfortunately the revised Standard does not reflect this, but rather states simple that ‘vessels must be constructed, maintained and used in ways that minimise the risks to safety’.

Notes the omission from the revised Standard of reference to the book of Approved Fish Names. States that one of the obligations of FSANZ in creating standards is to minimise the possibility of misleading and deceptive conduct in the food industry. Believes that to some extent this could be achieved by mandating the use of this publication for the naming and sale of fish, via the Seafood Standard. States that if FSANZ still believes that this matter is more appropriately dealt with under trade practices law, the government support and resources will still be required to ensure that the development of an appropriate Australian Standard eventuates and within a reasonable time frame (i.e. 12 months).

 

Clare Hughes

Food Policy Officer

Australian Consumers’ Association

 

Supports ANZFRMC decision to develop through-chain standard to manage the safety of poultry meat (sic – seafood) from primary production to consumers.

 

Believes it will enhance consumer confidence in the safety of seafood products and could result in increased sale and consumption of seafood.

Supports mandatory food safety requirements for all seafood businesses.

Feels there is a gap that needs to be addressed at the primary production and processing level and that the proposed standard will help achieve this.

 

ACA’s Preferred Regulatory Option

·     Supports preferred regulatory Option 3 as the approach will result in seafood safety management systems that are commensurate to risk, with those products and sectors of the industry more likely to cause food-borne illness and/or create severe adverse health effects will require a greater degree of regulation.

·     Agrees that higher-risk seafood products should require a greater level of safety management and regulation.

·     Do not believe that lower-risk products should be exempt from implementing food safety schemes. Consumers have a right to expect that their food is safe and that governments will do everything in their power to ensure that the industry provides a safe and hygienic product.

 

 

·     Believes that all seafood businesses must meet some minimum level of food safety management. Understands that many seafood businesses will already meet the minimum requirements. Believes consumers will welcome the requirement for businesses that don’t already have safety management systems in place to change their practices.

Fish Names

Believes that a mandatory fish names list will meet all three of the FSANZ objectives:

  • The protection of public health and safety
  • The provision of adequate information relating to food to enable consumers to make informed choices
  • The prevention of misleading and deceptive conduct

Believes that members of the seafood industry at all levels of the supply chain should be required to label fish correctly.

 

Acknowledges that a primary production and processing standard may not be the only place to incorporate a mandatory fish names list. Believes that a mandatory fish names list has a place in the Food Standards Code. Disappointed that FSANZ has decided not to address the issue.

 

Prepared to accept the compromise position of the development of the Australian Standard for fish names through the Standards Australia process. Notes that at the last SDC meeting, FSANZ gave an undertaking to revisit the issue in the future once the AS had been developed and implemented.

 

Peter Clarke

Australian Freshwater Crayfish Association

Yabby Growers of Victoria

 

Expresses grave concerns over the regulatory impact of the Victorian government’s implementation of the Seafood Safety Act 2003 and the enforcement of this Act through Primesafe and this dept’s subsequent adoption of the FSANZ Primary Production and Processing Standard for Seafood.

Not the view of the stakeholders in the Yabby industry to undermine nor underestimate the importance of food safety throughout the food production chain. It is the regulatory impact and associated costs of the enforcement of the food safety laws that threaten the potential of the yabby growing industry.

 

Background

·     Currently approximately 60 licensed growers in Victoria. Yabby farming is often carried out at the lowest and easiest level known as extensive aquaculture. Offers farmers a way of diversifying their income through the utilisation of existing dam structures that are primarily used for stock watering.

·     Environmentally friendly as inputs are minimal. Yabbies are particularly sensitive to pesticides and herbicides.

·     The sale of yabbies in Victoria is almost exclusively through the trade of live product. Believes that food safety risks associated with live yabbies are extremely low.

·     Microbial risks associated with yabbies are negated given that yabbies are fully cooked in boiling water prior to consumption. Believes the low fat content of yabbies means that they are at low risk of bioaccumulation of chemical hazards either through environmental or through farming practices. The physiological nature of the animal is such that the animal will die when exposed to even low levels of toxicants used in the agricultural sector or naturally occurring in the environment.

·     Minimal risks are supported by:

Ø  FSANZ DAR P265 where yabbies are ranked as low risk

Ø  Fisheries Victoria Research Report Series 12 ‘Risk Assessment of Pesticides for Yabby Farmers April 2004’

Ø  National Residue Survey

·     The subsequent costs of government regulating these risks to the yabby aquaculture industry is disproportionately high considering the transport and sale of live finfish (including eels which are grown under similar farming conditions and have a much higher fat content) are exempt from regulation under the Victorian Seafood Safety Act 2003

·     Requests this burden be eased by exempting the sale of live yabbies from the regulation and that any food safety risks be controlled through agreed industry codes of practice. The Victorian Yabby Producers manual (NRE) provides a code of practice that could be considered by government and industry in this context.