Proposed changes to food safety import requirements for ... · growing, harvesting and production of bivalve molluscs and bivalve mollusc products. This will align the regulation

Proposed changes to food safety import requirements for bivalve molluscs

Amendments to the Imported Food Control Order 2001


Department of Agriculture and Water Resources ii

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Department of Agriculture and Water Resources iii

Contents 1 Submissions .............................................................................................................................................. 1

1.1 How to have your say ............................................................................................................................. 1

1.2 Publishing of submissions .................................................................................................................... 2

1.3 Next steps .................................................................................................................................................... 2

2 Summary .................................................................................................................................................... 3

3 Introduction .............................................................................................................................................. 5

4 Background ............................................................................................................................................... 6

4.1 Current biosecurity and food safety requirements for imported bivalves....................... 6

4.2 Regulation of bivalve molluscs in Australia .................................................................................. 7

4.3 Bivalve molluscs imported to Australia .......................................................................................... 8

5 Previous consultation and response ............................................................................................. 10

5.1 Comments on proposal to mandate foreign government certification of bivalves ..... 10

6 Hazards associated with bivalve molluscs .................................................................................. 14

6.1 Summary of risk advice from FSANZ on hazards posed by bivalve molluscs ............... 14

7 Risk management ................................................................................................................................ 17

8 Importer obligations and border verification inspection and testing.............................. 19

8.1 Importer obligations ............................................................................................................................. 19

8.2 Border verification inspection and testing .................................................................................. 20

9 Implementation .................................................................................................................................... 24

References ....................................................................................................................................................... 25

Tables Table 1 Key dates for making amendments to the Order ................................................................................ 2

Table 2 Imported bivalve molluscs, by volume (tonnes), 2017–18 ............................................................ 8

Table 3 Imported bivalve molluscs and bivalve mollusc products included or excluded from certification requirements ......................................................................................................................................... 17

Table 4 Australia New Zealand Food Standards Code, contaminant and natural toxicant limits for bivalve molluscs ...................................................................................................................................................... 19

Table 5 Australia New Zealand Food Standards Code, microbiological limits for bivalve molluscs ............................................................................................................................................................................................... 20

Table 6 Imported bivalve molluscs and bivalve mollusc products included or excluded from testing ................................................................................................................................................................................. 21

Table 7 Tests applied to imported bivalve molluscs and bivalve mollusc products ......................... 22


Department of Agriculture and Water Resources iv

Figures Figure 1 Imported bivalve molluscs, by top 5 countries, 2017–18 ............................................................. 9

Figure 2 Imported Food Inspection Scheme, referrals of risk and surveillance food for inspection ............................................................................................................................................................................................... 23


Department of Agriculture and Water Resources 1

1 Submissions The Department of Agriculture and Water Resources is seeking submissions on proposed

changes to food safety import requirements for bivalve molluscs under the Imported Food

Control Order 2001.

Your submissions will help us assess whether we need to amend these proposals to better meet

the needs of stakeholders while still achieving the objectives of the Imported Food Control

Act 1992 (IFC Act 1992).

1.1 How to have your say

The deadline for receipt of all submissions is 5 pm on Friday the 8th of February 2019.

The department will consider all relevant material provided within submissions. There is no set format for a submission. Please ensure you include at least the following information:

the title of this consultation document

your name and title

your organisation’s name if submitting on behalf of an organisation

your contact details.

Mark your submission: Proposed changes to food safety import requirements for bivalve molluscs, December 2018

Post or email your submission to:

Imported Food Section Department of Agriculture and Water Resources GPO Box 858 Canberra ACT 2601

Email [email protected]

If you submit by email, we do not need a hard copy of your submission. The department endeavours to formally acknowledge receipt of submissions within three business days.

Submissions received after Friday the 8th of February 2019 will not be considered unless an extension had been given before the closing date.

Privacy

Personal information collected by the department will only be used to enable us to contact you about your submission and may be disclosed to specialists, another Australian Government agency, a state or territory government agency or foreign government department, provided the disclosure is consistent with relevant laws, in particular the Privacy Act 1988.

The department requests that, as a minimum, you provide your name and contact details with your submission. Please indicate if you do not wish to have personal information published with your submission or disclosed to third parties.

Collected personal information will be used and stored consistent with the Australian Privacy Principles as outlined in the department’s Privacy Policy available on our website.

mailto:[email protected]

http://www.agriculture.gov.au/about/privacy



Confidentiality

Subject to the Freedom of Information Act 1982 and the Privacy Act 1988, content of submissions may be made public, unless you state you want all or part of your submission to be treated as confidential. A claim for confidentiality must be justified and provided as an attachment, marked ‘Confidential’. ‘Confidential’ material will not be made public. The department reserves the right not to publish submissions.

No breach of confidence will occur if the department shares your submission with a third party referred to under ‘Privacy’ in seeking advice in response to your submission.

1.2 Publishing of submissions

We may publish all submissions not marked ‘in-confidence’ on our web page Consultation on

changes to the inspection of risk foods. Submissions or parts of submissions that are provided

in-confidence will be filed and recorded as being held by us. In-confidence submissions may be

subject to release under the provisions of the Freedom of Information Act 1991 (FOI Act).

Submissions may be published as soon as possible after the end of the public comment period.

Where large numbers of documents are involved, we will make them available on CD rather

than on our website.

If you are making a submission, you may wish to indicate any grounds for withholding

information contained in your submission. Reasons could include that the information is

commercially sensitive or that you want us to withhold personal information, such as names

and contact details. An automatic confidentiality disclaimer from your IT system will not be

considered grounds for withholding information if the department receives an FOI Act request.

We will take your indications into account when determining whether to release information

under an FOI Act request. Any decisions to withhold information requested under the FOI Act

may be reviewed by the Ombudsman.

1.3 Next steps

After the consultation period has closed, the department will assess all submissions and

consider what further amendments may be required to address issues raised in submissions,

while still achieving the objectives of the Imported Food Control Act 1992 (Table 1).

The finalised policy for amendments to the Order will then be recommended to the Minister for

Agriculture and Water Resources.

Table 1 Key dates for making amendments to the Order

Date Action

4 December 2018 to 8 February 2019

Public consultation on proposed changes to inspection and analysis of bivalve molluscs

February to March 2019 Finalise amendments to the Order

April to May 2019 Amendments to the Order made

Mid 2019 Commencement of proposed changes to inspection and analysis of imported foods (other than certification for bivalve molluscs and bivalve mollusc products)

Mid 2020 Commencement of certification for bivalve molluscs and bivalve mollusc products



2 Summary This paper provides an opportunity for stakeholders to provide comment on proposed changes to food safety import requirements for bivalve molluscs and bivalve mollusc products under the Imported Food Inspection Scheme (IFIS).

In the financial year 2017–18, Australia imported 5,620 tonnes of bivalve molluscs (excluding imports from New Zealand). China accounted for 55 per cent of these imports, followed by Chile with 16 per cent. Of the 5,620 tonnes of bivalves molluscs imported, the main commodity imported was scallops, with 2,374 tonnes, accounting for 42 per cent of total import volume.

In 2017 the department released a consultation paper, Proposals for changes to the inspection and analysis of imported food, May 2017. The changes were also notified internationally via a WTO/SPS notification (G/SPS/N/AUS/424). One of the proposed changes was to restrict the importation of bivalves and bivalve mollusc products, unless covered by a foreign government certificate. In response to this paper, the department received five submissions, three from peak industry bodies in Australia and two from overseas countries. A letter of inquiry was also received from another country.

In response to the comments received on the May consultation paper, this second consultation paper provides more detail on the scope of products required to have government certification, the certification requirements, hazards required to be managed and details of border verification testing.

In Australia, domestic producers of bivalve molluscs are required to:

implement a documented food safety management system (HACCP-based system) that effectively controls the hazards

comply with the Australian Shellfish Quality Assurance Program Operations Manual.

The Australian Shellfish Quality Assurance Program (ASQAP) is a government-industry co-operative program designed to assure the food safety of shellfish managed in accordance with its operational guidelines. ASQAP is modelled on the internationally accepted United States National Shellfish Sanitation Program. The fundamental premise is that harvesting should only occur from growing areas shown to be free from harmful contaminants and pathogenic micro-organisms.

Food Standards Australia New Zealand (FSANZ) provides risk advice to the department on imported foods that pose a medium to high risk to public health. These foods are classified as ‘risk food’ under the IFIS and subject to increased border controls. For bivalves and bivalve mollusc products, FSANZ has provided advice for the hazards domoic acid, paralytic shellfish toxins (saxitoxin), Listeria monocytogenes, hepatitis A virus and noroviruses. For all of these hazards, the outcome was that these hazards in bivalve molluscs pose a medium to high risk to public health. The department will seek advice from FSANZ on additional identified hazards with bivalve molluscs, as required.

The risk advice already received from FSANZ emphasises the importance of these hazards being mitigated by harvesting bivalve molluscs from approved areas and ensuring producers follow a verified sanitation program. Certification will enable the department to have assurance that through-chain production controls are in place to manage the hazards associated with the growing, harvesting and production of bivalve molluscs and bivalve mollusc products. This will align the regulation of imported bivalves with domestic bivalve mollusc requirements in Australia.

The proposal to require imports of bivalve molluscs and bivalve mollusc products to be accompanied by a foreign government certificate will mean all countries wishing to continue exporting these foods to Australia will need to apply for market access. As part of negotiating certification arrangements, recognition will be given to establishments that are permitted to



export to countries that have equivalent shellfish sanitation programs and competent authority oversight as Australia. This includes the United States and member states of the European Union.

To allow time for exporting countries to apply for certification, the department is proposing that government certification not apply until 12 months after the Imported Food Control Order 2001 is amended. Additionally, the department will not restrict any existing trade in bivalve mollusc and bivalve mollusc products requiring certification, provided the exporting country has applied for certification before the end of the 12-month transition period, anticipated to be mid 2020 (see section 1.3).



3 Introduction This paper provides an opportunity for stakeholders to provide comment on proposed changes

to food safety import requirements for bivalve molluscs and bivalve mollusc products under the

Imported Food Inspection Scheme (IFIS).

The IFIS is the scheme the Department of Agriculture and Water Resources operates to manage

the food safety risks associated with food imported into Australia. Under the IFIS, the Minister

classifies foods as either risk foods or surveillance foods. Risk foods are foods that have been

assessed by Food Standards Australia New Zealand (FSANZ) as posing a medium to high risk to

public health, thereby requiring stricter border controls.

FSANZ is an Australian Government authority that develops food standards for Australia and

New Zealand. FSANZ also provides risk assessment advice to the department on imported foods

that pose a medium to high risk to public health and safety. Completed imported food risk

statements are available at FSANZ advice on imported food.

In 2017 the department released a consultation paper, Proposals for changes to the inspection

and analysis of imported food, May 2017. The changes were also notified internationally via a

WTO/SPS notification (G/SPS/N/AUS/424). The consultation paper outlined changes to the

inspection and analysis of risk foods, following the completion of a review by FSANZ on these

foods. One of the proposed changes was to restrict the importation of bivalves and bivalve

mollusc products, unless covered by a foreign government certificate the department has

negotiated with the exporting country. Submitters on the consultation paper generally

supported this proposal but sought further clarification of the scope of bivalve molluscs and

bivalve mollusc products that would require mandatory government certification and detail of

the certification requirements.

In response to the comments received on the May consultation paper, this second consultation

paper provides detail on the scope of bivalve molluscs and bivalve mollusc products required to

have government certification, the certification requirements, hazards required to be managed

(including biotoxins and viruses in at risk products) and details of border verification testing.

http://www.foodstandards.gov.au/consumer/importedfoods/Pages/FSANZ-advice-on-imported-food.aspx



4 Background

4.1 Current biosecurity and food safety requirements for imported bivalves

Foods imported into Australia are subject to requirements under the Biosecurity Act 2015 to

address biosecurity concerns and the Imported Food Control Act 1992 (IFC Act 1992) for

compliance with Australian food standards and the requirements of public health and safety.

Biosecurity requirements

For bivalve molluscs the following biosecurity requirements apply:

bivalve molluscs, including oyster meat, may be imported from any country and an import permit is not required

only dead molluscs are permitted entry

oysters in half shell or full shell are only permitted from New Zealand.

Food safety requirements

Under the IFC Act 1992, importers are legally responsible for complying with the standards that

apply to their products to ensure they are safe and suitable for their intended use.

To monitor compliance with Australia’s imported food requirements, the department operates a

risk-based border inspection scheme, the IFIS. The Imported Food Control Regulations 1993 set

out the detail on the operation of the IFIS. Food is referred for inspection under the IFIS by the

Department of Home Affairs based on internationally agreed tariff codes. The rate at which food

is referred for inspection depends on its risk. Under the IFIS, food is classified as risk food or

surveillance food.

Risk food is the type of food that has the potential to pose a high or medium risk to public

health. Risk foods are listed in the Imported Food Control Order 2001. FSANZ provides advice to

the Minister for Agriculture and Water Resources on the foods that pose such a risk. Risk food is

initially referred for inspection and testing at a rate of 100 per cent against a published list of

potential hazards (specific to the food), but is decreased if a history of compliance is established.

Bivalve molluscs are currently classified as a risk food under the Order and, depending on the

bivalve mollusc, tested for a range of hazards including biotoxins, E. coli and L. monocytogenes.

The tests applied can be viewed at our web page Bivalve molluscs such as clams, cockles,

mussels, oysters, pipi and scallops.

Under the IFC Act 1992, the minister may mandate a foreign government certificate for a risk

food. Foods requiring foreign government certification are identified in the Order (clause 5).

Foods that are currently being imported that require government certification are beef and beef

products and raw milk cheese.

Surveillance food is considered to pose a low risk to human health and safety. Each consignment

of surveillance food has a 5 per cent chance of being referred for inspection. At inspection,

surveillance foods are visually inspected for obvious signs of contamination or deterioration

and the labels of the food are also assessed for compliance against labelling standards. Samples

of surveillance food may also be analysed for pesticides and antibiotics, microbiological and

https://www.legislation.gov.au/Details/C2016C01051

https://www.legislation.gov.au/Details/F2015C01005

https://www.legislation.gov.au/Details/F2016C00003

http://www.agriculture.gov.au/import/goods/food/inspection-compliance/risk-food/bivalve-molluscs




chemical contaminants. For more information, see our web page Tests applied to surveillance

food.

4.2 Regulation of bivalve molluscs in Australia

In Australia, the domestic regulation of bivalve molluscs is the responsibility of state or territory food safety and fisheries authorities. The primary regulatory reference documents are:

Standard 4.2.1 Primary Production and Processing Standard for Seafood, within the Australia New Zealand Food Standards Code

the Australian Shellfish Quality Assurance Program Operations Manual

Standard 4.2.1 requires businesses engaged in the primary production or processing of or manufacturing activities concerning bivalve molluscs to:



The Australian Shellfish Quality Assurance Program (ASQAP) is a government-industry co-operative program designed to assure the food safety of shellfish managed in accordance with its operational guidelines. The ASQAP has been adopted by each shellfish producing state and territory of Australia. It is overseen by the Australian Shellfish Quality Assurance Advisory Committee, which consists of representatives from FSANZ, this department, state government departments responsible for shellfish safety, and industry representatives from each state (DPIPWE 2017).

The ASQAP is modelled on the internationally accepted United States National Shellfish Sanitation Program. The fundamental premise is that harvesting should only occur from growing areas shown to be free from harmful contaminants and pathogenic micro-organisms. Each growing area must undergo a full and comprehensive sanitary survey, with appropriate classifications and management strategies determined before harvesting is permitted. All the requirements for completing and maintaining sanitary surveys, and the ongoing management of growing areas are laid out in the ASQAP Operations Manual (DPIPWE 2017).

ASQAP requires:

comprehensive growing area sanitary surveys (shoreline and water) in respect of the potential for shellfish contamination by microbiological and chemical hazards (human or environmental)

classification of growing areas based upon the findings of sanitary survey (approved, conditionally approved, restricted, conditionally restricted and prohibited)

a harvest area management plan that identifies controls appropriate to the area

ongoing monitoring of harvest areas

ongoing review of classifications to ensure their appropriateness

adherence to post-harvest handling, storage and labelling

controls for relaying, depuration and wet storage.

The export of Australian grown bivalve molluscs is managed by this department in collaboration with state and territory government agencies. Exporters of bivalve molluscs in Australia must be export registered and meet the requirements of the Australian Shellfish Quality Assurance Program Export Standards and meet importing country food safety requirements. In those states and territories where bivalves are exported, this department is

http://www.agriculture.gov.au/import/goods/food/inspection-compliance/tests-applied-to-surveillance-category-foods

http://www.agriculture.gov.au/import/goods/food/inspection-compliance/tests-applied-to-surveillance-category-foods

https://www.legislation.gov.au/Series/F2012L00291

http://safefish.com.au/Reports/Manuals-and-Technical-Guidelines



responsible for ensuring that the government agencies responsible for shellfish safety have implemented ASQAP, the export establishments are audited to ensure they meet the regulatory requirements of Standard 4.2.1 and that bivalves for export are safe and suitable for consumption.

4.3 Bivalve molluscs imported to Australia

In the financial year 2017–18, Australia imported 5,620 tonnes of bivalve molluscs (excluding imports from New Zealand) with China accounting for 55 per cent (3,104 tonnes) followed by Chile with 16 per cent (879 tonnes) of imports (Table 2). The remaining top ten countries for total import volume (tonnes) and overall percentage were Japan (475 tonnes, 8 per cent), Vietnam (298 tonnes, 5 per cent), United States (238 tonnes, 4 per cent), Thailand (220 tonnes, 4 per cent), Canada (144 tonnes, 3 per cent), Peru (79 tonnes, 1 per cent), Malaysia (47 tonnes, 1 per cent) and Spain (49 tonnes, 1 per cent).

During the 2017–18 financial year, the top imported bivalve mollusc commodity was scallops, with 2,374 tonnes, accounting for 42 per cent of total import volume (Table 2). This was followed by mussels (1,042 tonnes, 19 per cent), clams (971 tonnes, 17 per cent), oysters (610 tonnes, 11 per cent), and other (623 tonnes, 11 per cent). The ‘Other’ category includes seafood products containing bivalve molluscs such as marinara (seafood) mix. Scallops are mainly imported from China and Japan, mussels from Chile, clams from China and Vietnam, and oysters from China (Figure 1).

New Zealand has been excluded as most foods imported from New Zealand, including bivalve molluscs, are not subject to the requirements of the Imported Food Control Act 1992, as per the Trans-Tasman Mutual Recognition Arrangement. This non-Treaty arrangement allows food produced or imported into New Zealand (that meets New Zealand’s food laws) to be legally sold in Australia and vice versa for food exported from Australia to New Zealand. This arrangement is facilitated by Australia and New Zealand sharing the same food standards in the Australia New Zealand Food Standard Code.

Table 2 Imported bivalve molluscs, by volume (tonnes), 2017–18

Country Scallops Mussels Clams Oysters Other Total Total (%)

China 1,512 123 553 579 337 3,107 55.0

Chile 0 857 22 0 0 881 16.0

Japan 418 0 1 29 27 475 8.0

Vietnam 9 1 236 0 52 298 5.0

United States 129 0 105 0 4 238 4.0

Thailand 48 0 7 2 163 220 4.0

Canada 125 0 19 0 0 144 3.0

Peru 79 0 0 0 0 79 1.0

Malaysia 46 1 0 0 0 56 1.0

Spain 0 49 0 0 0 49 1.0

Korea, Republic of 0 0 11 0 22 33 1.0

Taiwan 3 1 0 0 11 15 0.3

Denmark 0 9 0 0 0 9 0.2

Ireland 0 0 7 0 0 7 0.1

Hong Kong 1 0 3 0 1 5 0.1

Netherlands 0 0 5 0 0 5 0.1



Country Scallops Mussels Clams Oysters Other Total Total (%)

New Caledonia 0 0 0 0 5 5 0.1

Singapore 4 0 0 0 0 4 0.1

United Kingdom 0 1 2 0 0 3 0.1

France 0 0 0 0 1 1 0.02

Total 2,374

(42%)

1,042

(19%)

971

(17%)

610

(11%)

623

(11%)

5,634 –

Note: Excludes imports from New Zealand and countries with import volumes of less than 1 tonne.

Figure 1 Imported bivalve molluscs, by top 5 countries, 2017–18



5 Previous consultation and response The department first consulted on mandating foreign government certification for bivalve molluscs in a public consultation paper, Proposal for changes to the inspection and analysis of imported foods, May 2017. This paper was released for public consultation from 31 May to 31 July 2017. The changes were also notified internationally via a WTO/SPS notification (G/SPS/N/AUS/424).

In response to the consultation process, the department received five submissions. Three were from peak industry bodies in Australia and two from overseas countries:

Australian Shellfish Quality Assurance and Advisory Committee

Food and Beverage Importers Association

Seafood Importers Association of Australia

Japanese Government

Canadian Food Inspection Agency.

A letter of inquiry in relation to the WTO/SPS notification was also received from the Republic of Korea.

Section 5.1 summarises comments received from these stakeholders on the proposal to mandate foreign government certification of bivalves.

5.1 Comments on proposal to mandate foreign government certification of bivalves

Australian Shellfish Quality Assurance and Advisory Committee

Comment

ASQAAC supports the principle that all bivalve shellfish sold in Australia, whether they be domestically produced or imported, can demonstrate that they comply with the food safety standards in the food standards code.

ASQAAC also supports the department taking a holistic approach to the risk management of bivalves, particularly the acknowledgement of the importance of classifying growing waters according to pollution and risk.

Response

Noted.

Comment

Queried why the FSANZ risk statements did not include the hazards diarrhetic shellfish toxins (DST), bacterial, viral and chemical contaminants such as E. coli, norovirus, hepatitis A virus, heavy metals and pesticides. The submission refers to the relevant sections in the food standards code that address these hazards.

Response

Since the previous consultation paper was published, the department has received risk advice from FSANZ on hepatitis A virus and norovirus (see section 6). This paper also addresses hazards associated with bivalve molluscs more broadly and the requirements in the food standards code (see section 8.1 and section 8.2).



Comment

Details is needed on the certification arrangements and should include:

growing area classification and review, including sanitary surveys

growing area monitoring and harvest controls

marine biotoxin controls

post-harvest handling, including depuration and wet storage.

As per the ASQAP’s Operation Manual 2016, the Export Control Orders 2005 and the Codex Code of Practice for Fish and Fishery Products.

Response

Certification requirements are outlined in section 7.

Food and Beverage Importers Association

Comment

The FBIA will consult with the department, prior to implementation of the requirement for the certification of bivalves, to ensure the change does not impact trade clearances at the border.

Response

The department will consult with the FBIA on implementation of the certification requirements, to ensure consignments are not delayed at the border.

Seafood Importers Association of Australia

Comment

Supports the requirements for imported bivalve molluscs and bivalve mollusc products to be covered by a foreign government certification arrangement.

Response

Noted.

Comment

Will this apply to roe off scallops? These are clearly a lower risk product.

Response

No. See section 7 for a list of excluded products.

Comment

Is the proposed 50 per cent cut-off the appropriate limit for products containing bivalve molluscs such as marinara mix? Is a 25 per cent cut-off more applicable?

Response

Section 7 lists the products that will be included and excluded.

Marinara mix will be covered by the certification requirements unless the mix contains less than or equal to 5 per cent of bivalve molluscs.

However, border verification testing for PST will not apply to marinara mix comprising less than 50 per cent bivalve molluscs by weight.



Japanese Government

Comment

Japan provided detailed information on their risk management guidelines and measures to address shellfish toxins.

In the submission Japan stated that it ensures the safety of bivalve molluscs from production to consumption and unsafe bivalves are not distributed or exported.

Japan therefore did not consider it necessary to certify the food safety of bivalve molluscs as its existing regulations and controls ensure their safety.

Response

Since the submission was received, the department has had further discussions with Japan to explain the certification process and Japan has expressed a willingness to commence discussions on negotiating certification of bivalve molluscs being exported to Australia.

Canadian Food Inspection Agency

Comment

In its submission the CFIA provided an overview of the Canadian Shellfish Sanitation Program (CSSP). The CFIA, along with other federal departments, jointly administers the CSSP. Under the CSSP, Canada implements controls to verify that only shellfish that meet food safety and quality standards reach domestic and international markets.

Response

Noted.

Comment

Will the proposal to require bivalve molluscs and bivalve mollusc production to be covered by a foreign government certificate allow Canada to export live bivalve molluscs for human consumption to Australia with a CFIA certificate?

Response

No. To export bivalve molluscs to Australia currently, exporting countries must first meet biosecurity requirements and then the requirements under the Imported Food Inspection Scheme.

Comment

Would the existing exporter requirements be superseded by a CFIA certificate if mandatory government certification is adopted?

Response

The existing exporter requirements referred to by CFIA are required to meet Australia’s biosecurity requirements. The proposed requirements for mandatory government certification of bivalves and bivalve mollusc products is to address food safety risks, not biosecurity risks. However, as part of finalising the requirement for mandatory government certification, the department will consider allowing one certificate that covers food safety and biosecurity requirements.

Comment

Canada respectfully requests that a reasonable transition period be implemented to avoid trade disruptions while a new certificate is negotiated, as per Codex Code of Practice for Fish and Fishery Products international guidelines.



Response

Following this second consultation process, the department will finalise border requirements for bivalve molluscs and bivalve mollusc products. Once finalised, exporting countries will have twelve months to apply for an equivalence assessment. Provided an equivalence assessment has been received in this time, trade will not be disrupted even if the assessment process has not been finalised.

Republic of Korea

Comment

Can you provide information about seafood products currently exported to Australia from the Republic of Korea?

Response

Provided separate export data to Republic of Korea.

Comment

Can you provide information about hygienic conditions that will apply to exports of bivalves to Australia including scope of products requiring certification?

Response

See section 7.

Comment

Can you provide information about inspection process at the border including how samples are selected and testing methods?

Response

Provided separate response to Republic of Korea.

Comment

Can you provide clarification on how Korea can obtain market access to export bivalves to Australia?

Response

See section 7.

Comment

Can you provide clarification on exporting repackaged or further processed bivalves from a third country?

Response

It will only be possible to export repackaged or further processed bivalve molluscs and bivalve molluscs imported from the countries classified as eligible for export to Australia by the Australian Government.



6 Hazards associated with bivalve molluscs Bivalve molluscs are filter feeders and therefore filter particles from the seawater during feeding. These particles can include pathogenic bacteria and viruses, algal biotoxins and environmental contaminants and may cause illness if still present when the bivalve is consumed. These hazards may be naturally occurring in the growing water such as algal toxins or may be present due to contamination of the growing water with human sewerage, industrial discharges and agricultural or urban runoff.

The main foodborne hazards of concern associated with bivalves molluscs are:

pathogenic bacteria such as Vibrio cholera O1/O139, Aeromonas hydrophila pathogenic strains of Vibrio parahaemolyticus, Vibrio vulnificus, Escherichia coli, Salmonella spp. Listeria monocytogenes, Campylobacter, Yersinia and Shigella species (FSANZ 2005)

viruses such as hepatitis A virus and noroviruses

algal biotoxins such as okadaic acid (OA) and analogues, azaspiracids (AZA) group toxins, yessotoxins (YTX) group toxins, brevetoxins (BTX) group toxins, saxitoxins (STX) group toxins, pectenotoxins (PTX)-group toxins and domoic acid (DA) (European Food Safety Authority 2009)

environmental contaminants such as mercury, cadmium, lead, arsenic and zinc.

This department has received updated risk advice from FSANZ on domoic acid, paralytic shellfish toxins (saxitoxin) and L. monocytogenes and new advice on hepatitis A virus and noroviruses. The outcome was that all these hazards in bivalve molluscs pose a medium to high risk to public health. Foods that have been assessed by FSANZ as posing a medium to high risk to public health for one or more foodborne hazards are considered risk foods under the IFIS (see section 4.1) and subject to increased border intervention.

The department may request additional advice, as required, from FSANZ on bacterial hazards and algal biotoxins not included within the scope of advice already received.

6.1 Summary of risk advice from FSANZ on hazards posed by bivalve molluscs

Domoic acid

Date advice published: June 2016

Scope of product considered

Bivalve molluscs including whole or portions of bivalve molluscs that are fresh, frozen, dried or canned, such as cockles, clams, mussels, oysters and scallops.

It excludes:

cephalopod molluscs such as squid, octopus and cuttlefish, as well as jellyfish

marinara mix.

Rationale

Consumption of seafood containing DA has resulted in human poisoning incidents and deaths. DA is a potent neurotoxin that causes amnesic shellfish poisoning (ASP) within 24 to 48 hours following ingestion. There is no antidote for ASP.

DA is not destroyed by cooking, freezing or other food processing.



Paralytic shellfish toxins (saxitoxin)

Date advice published: June 2016


Bivalve molluscs includes whole or portions of bivalve molluscs that are fresh, frozen, dried or canned, such as cockles, clams, mussels, oysters, pipis and scallops with roe on.

It excludes:

scallops where the only part of the product consumed is the adductor muscle with roe off

pearl oysters where the only part of the product consumed is the adductor muscle

spat

cephalopod molluscs such as squid, octopus and cuttlefish, as well as jellyfish.

Food mixtures containing bivalve molluscs, such as marinara mix, comprising less than 50 per cent bivalve molluscs by weight.

Rationale

Paralytic shellfish poisoning (PSP) is caused by eating bivalve shellfish and other molluscan shellfish such as mussels, cockles, clams, oysters, pipis and scallops containing paralytic shellfish poisons or toxins (PST). Symptoms of PSP intoxication vary from a slight tingling or numbness to complete respiratory paralysis. In fatal cases, respiratory paralysis occurs within 2 to 12 hours of consumption of the contaminated food.

PST are not inactivated by cooking.

Bivalve molluscs have been identified as the source of PST in Australia, the United States, Chile, Philippines, Taiwan and Nicaragua.

Listeria monocytogenes

Date advice published: November 2016


Ready-to-eat (RTE) processed bivalve molluscs including bivalve molluscs that have undergone a processing step, such as heating or smoking.

Excludes bivalve molluscs that are raw, dried, pickled, fermented and/or in ambient stable sealed packages.

Rationale

L. monocytogenes is a severe hazard for susceptible populations as it can cause life-threatening illness.

Human illness has been associated with RTE processed bivalve molluscs contaminated with L. monocytogenes.

L. monocytogenes is a ubiquitous organism and can become established in the processing environment.

Although processing steps, such as cooking and smoking, involve a heat treatment step which can inactivate L .monocytogenes, post-processing contamination can occur.

RTE processed bivalve molluscs are able to support the growth of L. monocytogenes during the shelf-life of the product and L. monocytogenes is able to grow at refrigerated temperatures.

Compliance and food recall data in Australia and microbiological surveys have shown detections of L. monocytogenes in RTE processed bivalve molluscs.



Hepatitis A virus

Date advice published: July 2017


Bivalve molluscs and seafood mixes containing bivalve molluscs such as marinara mix.

Excludes retorted shelf stable product.

Rationale

HAV is a serious hazard as it causes incapacitating, though not usually life threatening, illness of moderate duration.

HAV has been isolated from bivalve molluscs; areas of higher sanitary classification show less contamination.

HAV is a common cause of foodborne illness associated with consumption of bivalve molluscs.

Bivalve molluscs bioaccumulate HAV from their environment, the surrounding growing waters.

The risk can be mitigated by harvesting bivalve molluscs from approved areas and ensuring producers follow a verified sanitation program. This will reduce, but not eliminate, the risk.

Bivalve molluscs do not usually receive a heat treatment that is sufficient to inactivate HAV (internal temperature of 90 °C for 90 seconds) as this can make the product unpalatable.

Norovirus

Date advice published: July 2017


Bivalve molluscs and seafood mixes containing bivalve molluscs for example marinara mix.

Excludes retorted shelf stable product.

Rationale

Norovirus (NoV) is a moderate hazard as it generally causes illness of short duration and usually no sequelae.

NoV has been isolated from bivalve molluscs; areas of higher sanitary classification show less contamination.

NoV is a frequent cause of foodborne illness associated with consumption of bivalve molluscs.

Bivalve molluscs bioaccumulate NoV from their environment, the surrounding growing waters.

The risk can be mitigated by harvesting bivalve molluscs from approved areas and ensuring producers follow a verified sanitation program. This will reduce but not eliminate the risk.

Bivalve molluscs do not usually receive a heat treatment that is sufficient to inactivate NoV (internal temperature of 90 °C for 90 seconds) as this can make the product unpalatable.



7 Risk management Bivalve molluscs are currently classified as risk foods under the IFIS and initially referred at a rate of 100 per cent for border testing for domoic acid and paralytic shellfish poison, as well as the microorganisms L. monocytogenes and E. coli. The rate of border inspection and testing is reduced following demonstration of compliance. Certification is not currently required.

Following publication of revised risk advice from FSANZ for domoic acid, paralytic shellfish poison and L. monocytogenes for bivalves and bivalve mollusc products (see section 6), the department proposed in May 2017 that these risks should be managed by mandating government certification. FSANZ has since provided additional risk advice for hepatitis A virus and norovirus (see section 6), emphasising the importance of these hazards being mitigated by harvesting bivalve molluscs from approved areas and ensuring producers follow a verified sanitation program.

Certification will enable the department to have assurance that through-chain production controls are in place to manage the hazards associated with the growing, harvesting and production of bivalve molluscs and bivalve mollusc products. This will align the regulation of imported bivalves with domestic bivalve mollusc requirements, which are required to have through-chain controls in place as specified in Standard 4.2.1 Primary Production and Processing Standard for Seafood of the Australia New Zealand Food Standards Code. See section 4.2 for an outline of the domestic regulation of bivalves in Australia.

Table 3 lists all relevant bivalve molluscs and bivalve mollusc products and indicates whether they require certification. This is consistent with the risk advice published by FSANZ (see section 6). Bivalve molluscs and bivalve mollusc products that are not required to be certified are still required to meet relevant requirements in the Food Standards Code and may be subject to border verification testing (see section 8).

Table 3 Imported bivalve molluscs and bivalve mollusc products included or excluded from certification requirements

Category Mollusc/mollusc product Certification requirements

Certification required

All bivalves molluscs such as clams, cockles, mussels, oysters, pipis and scallops, including:

raw, cooked, ready-to-eat, canned and dried bivalve molluscs

foods containing raw, cooked, ready-to-eat, canned and/or dried bivalve molluscs, except where exempted.

A recognised foreign government certificate the department has negotiated with the competent authority in the country exporting bivalve molluscs or bivalve mollusc products.

In negotiating the certificate, recognition will be given to establishments that are permitted to export to countries that have equivalent shellfish sanitation programs and competent authority oversight as Australia. This includes the United States and member states of the European Union.

Certification not required

Molluscs that are not bivalves such as abalone, paua, octopus, squid, sea cucumbers, sea slugs or snails.

Scallops where the only part of the product consumed is the adductor muscle with roe off

Pearl oysters where the only part of the product consumed is the adductor muscle

Shelf-stable sauces, condiments and flavourings

Foods containing less than or equal to 5% of bivalve molluscs

–



Certification requirements

Foreign certification arrangements will be negotiated with countries that can demonstrate the:

production of bivalve molluscs is consistent with the requirements in Standard 4.2.1 Primary Production and Processing Standard for Seafood of the Australia New Zealand Food Standards Code

or

establishment producing or manufacturing the bivalve mollusc or bivalve mollusc product has existing export access to countries that have equivalent shellfish sanitation programs and competent authority oversight as Australia, such as the United States and member states of the European Union.

Standard 4.2.1 requires businesses engaged in the primary production or processing of, or manufacturing activities concerning, bivalve molluscs to:



These requirements are consistent with those in the Codex Alimentarius Code of Practice for Fish and Fishery Products.

To demonstrate equivalence countries will need to:

have systems/programs in place to classify, monitor and control growing areas for bivalve molluscs and bivalve mollusc products

have controls in place for the safe production and processing of bivalve molluscs and bivalve mollusc products, including standards and control measures for

the harvesting, relaying, depuration and storage of bivalve molluscs and bivalve mollusc products that effectively control pathogenic microorganisms (bacteria and viruses) and biotoxins

the temperature control of bivalve molluscs the processing of bivalve molluscs and bivalve mollusc products that effectively control

pathogenic microorganisms and prevent chemical contamination

have government controls and export conditions in place to ensure bivalve molluscs and bivalve mollusc products are not eligible for export to Australia unless

the bivalve molluscs and bivalve mollusc products have been produced under a food safety management system that effectively controls the hazards

the bivalve molluscs and bivalve mollusc products are only harvested from areas that have been classified as suitable for producing bivalves for human consumption

the bivalve molluscs and bivalve mollusc products are monitored to ensure their safety and suitability

have a government authority that

verifies and enforces compliance with national standards, government controls and export conditions for bivalve molluscs and bivalve mollusc products

is able to supply valid government certificates attesting to compliance with primary production (including suitability of growing area, harvesting, relaying and depuration), transport and processing controls for bivalve molluscs and bivalve mollusc products; and is subject to independent audits verifying that the government authority enforces compliance with controls for bivalve molluscs and bivalve mollusc products.



8 Importer obligations and border verification inspection and testing

8.1 Importer obligations

Under section 8 of the Imported Food Control Act 1992, it is an offence for a person to import into Australia, food that the importer knows does not meet the Australia New Zealand Food Standards Code or poses a risk to human health. The parts of the code most relevant to bivalve molluscs are:

Part 1.2 Labelling and other information requirements

Part 1.4 Contaminants and residues

Part 1.6 Microbiological limits and processing requirements

Part 4.2 Primary production and processing standards, specifically Standard 4.2.1 Primary production and processing standard for seafood.

Part 1.2 Labelling and other information requirements

This part of the code sets out the labelling requirements for food for sale in Australia and New Zealand including food identification, warning statements (allergen labelling), ingredients listing, date marking, directions for use and storage, nutrition and health claims and characterising ingredients. See the FSANZ website for labelling standards and guidance material.

Part 1.4 Contaminants and residues

This part of the code includes standards for contaminants and natural toxicants and agricultural and veterinary chemicals.

4 lists the maximum limits applicable to bivalve molluscs as specified in Standard 1.4.1 Contaminants and natural toxicants and Schedule 19 Maximum levels of contaminants and natural toxicants in the food standards code.

Standard 1.4.2 Agvet chemicals and the corresponding Schedules (20 to 22) set out the maximum residue limits and extraneous residue limits for agricultural or veterinary chemicals that are permitted in foods for sale.

Table 4 Australia New Zealand Food Standards Code, contaminant and natural toxicant limits for bivalve molluscs

Contaminant Food Limit

Arsenic (inorganic) Molluscs 1 mg/kg

Cadmium Molluscs (excluding dredge/bluff oysters and queen scallops)

2 mg/kg

Lead Molluscs 2 mg/kg

Mercury Molluscs 0.5 mg/kg (mean level)

Amnesic shellfish poisons Bivalve molluscs 20 mg/kg domoic acid

Diarrhetic shellfish poisons Bivalve molluscs 0.2 mg/kg okadaic acid

Neurotoxic shellfish poisons Bivalve molluscs 200 MU/kg

Paralytic shellfish poisons Bivalve molluscs 0.8 mg/kg saxitoxin

Note: MU means the unit of measurement for neurotoxic shellfish poisons described Irwin, N (ed.) (1970).

http://www.foodstandards.gov.au/code/Pages/default.aspx

http://www.foodstandards.gov.au/code/Pages/default.aspx

http://www.foodstandards.gov.au/consumer/labelling/Pages/default.aspx

http://www.foodstandards.gov.au/consumer/labelling/Pages/default.aspx



Part 1.6 Microbiological limits and processing requirements

Table 5 lists the microbiological limits applicable to bivalve molluscs as specified in Standard 1.6.1 Schedule 27 of the Australia New Zealand Food Standards Code.

Table 5 Australia New Zealand Food Standards Code, microbiological limits for bivalve molluscs

Pathogen Food Limit

E. coli Bivalve molluscs other than scallops n = 5, c = 1, m = 2.3/g, M = 7/g

Listeria monocytogenes Ready-to-eat bivalve molluscs or bivalve mollusc products in which growth of Listeria monocytogenes can occur

n = 5, c = 0, m = 0 cfu/25g

Listeria monocytogenes Ready-to-eat bivalve molluscs or bivalve mollusc products in which growth of Listeria monocytogenes will not occur

n = 5, c = 0, m = 100 cfu/g

n Minimum number of sample units that must be examined from a lot of food. c Maximum allowable number of defective sample units. m Acceptable microbiological level in a sample unit. M Level which when exceeded (the level is greater than M) in one or more samples would cause the lot to be rejected.

Part 4.2 Standard 4.2.1 Primary production and processing standard for seafood

Businesses in Australia that engage in activities related to the primary production and processing of seafood must comply with Standard 4.2.1. This Standard requires businesses engaged in the primary production or processing of, or manufacturing activities concerning, bivalve molluscs to:



Countries wanting to export bivalve molluscs and bivalve mollusc products to Australia will need to demonstrate equivalence to Standard 4.2.1. See section 7 for further details on the certification requirements.

8.2 Border verification inspection and testing

To verify compliance of imported bivalve mollusc and bivalve mollusc products to the legal requirements outlined in section 8.1, these foods will be referred for inspection and analysis at the border. Consignments referred for inspection and analysis will be checked for certification and visually assessed for labelling compliance and any obvious signs of contamination or deterioration. Samples will also be taken for testing against any relevant microbiological and chemical hazards. Table 6 identifies which imported bivalve molluscs and bivalve mollusc products are included or excluded from testing. Table 7 lists current tests applied to bivalves and bivalve mollusc products. The list can also be viewed on our web page Bivalve molluscs such as clams, cockles, mussels, oysters, pipi and scallops. These tests will be reviewed and, if needed, updated in line with risk advice from FSANZ on bivalve molluscs. Access our website for up-to-date information.

The rate of referral will depend on the compliance history of the food being imported. Risk food, such as bivalves, is initially inspected and tested at a rate of 100 per cent of consignments with the referral rate decreasing when consecutive consignments have passed inspection (Figure 2).





Table 6 Imported bivalve molluscs and bivalve mollusc products included or excluded from testing

Species/product Included in testing Excluded from testing

Listeria monocytogenes Ready-to-eat processed bivalve molluscs including bivalve molluscs that have undergone a processing step, such as heating or smoking.

Bivalve molluscs that are raw, dried, pickled, fermented and/or in ambient stable sealed packages.

Domoic acid Bivalve molluscs, including whole or portions of bivalve molluscs that are fresh, frozen, dried or canned, such as cockles, clams, mussels, oysters and scallops.

Cephalopod molluscs such as squid, octopus and cuttlefish, as well as and jellyfish.

Marinara mix.

Paralytic shellfish poisons Bivalve molluscs includes whole or portions of bivalve molluscs that are fresh, frozen, dried or canned, such as cockles, clams, mussels, oysters, pipis and scallops with roe on.

Scallops where the only part of the product consumed is the adductor muscle with roe off.

Pearl oysters where the only part of the product consumed is the adductor muscle.

Spat.

Cephalopod molluscs such as squid, octopus and cuttlefish, as well as and jellyfish.

Food mixtures containing bivalve molluscs, such as marinara mix, comprising less than 50 per cent bivalve molluscs by weight.

Escherichia coli Bivalve molluscs that are raw, cooked or processed including clams, cockles, mussels, oysters and pipis.

Scallops.

Molluscs that are not bivalve; for example, paua, abalone, octopus, squid, sea cucumbers, sea slugs and snails.

Mixed food containing bivalve molluscs as an ingredient.

Retorted bivalve molluscs—the final product is in a hermetically sealed (airtight) container and has been heat treated (retorted) within this container so that the final product is shelf stable (not requiring refrigeration).



Table 7 Tests applied to imported bivalve molluscs and bivalve mollusc products

Species/product Included in testing Border verification

Listeria monocytogenes Ready-to-eat processed bivalve molluscs including bivalve molluscs that have undergone a processing step, such as heating or smoking.

n = 5, c = 0, m=not detected in 25g

Domoic acid Bivalve molluscs, including whole or portions of bivalve molluscs that are fresh, frozen, dried or canned, such as cockles, clams, mussels, oysters and scallops.

Maximum level 20 mg/kg

Paralytic shellfish poisons Bivalve molluscs includes whole or portions of bivalve molluscs that are fresh, frozen, dried or canned, such as cockles, clams, mussels, oysters, pipis and scallops with roe on.

Maximum level 0.8 mg/kg

Escherichia coli Bivalve molluscs that are raw, cooked or processed including clams, cockles, mussels, oysters and pipis.

E. coli (as a hygiene indicator)

N=5, c=1, m=2.3, M=7

n Minimum number of sample units that must be examined from a lot of food. c Maximum allowable number of defective sample units. m Acceptable microbiological level in a sample

unit. M Level which when exceeded (the level is greater than M) in one or more samples would cause the lot to be rejected.



Figure 2 Imported Food Inspection Scheme, referrals of risk and surveillance food for inspection

Note: Compliance is based on the combination of specific food, from a specific producer in a specific country.



9 Implementation The proposal to require imports of bivalve molluscs and bivalve mollusc products to be accompanied by a foreign government certificate will mean all countries wishing to continue exporting these foods to Australia will need to apply for market access. As certification arrangements with exporting countries will need to be negotiated, the department is proposing that government certification not apply until 12 months after the Order is amended to require certification. This commencement date does not prevent any exporting country and the department from commencing voluntary certification arrangements before that date.

The department will only develop certification with an exporting country that can demonstrate the production of bivalve molluscs is consistent with the requirements in Standard 4.2.1 Primary Production and Processing Standard for Seafood of the Australia New Zealand Food Standards Code (see section 7).

The importation of bivalve molluscs and bivalve mollusc products from New Zealand is recognised under the Trans-Tasman Mutual Recognition Arrangement (TTMRA). This is a non-Treaty arrangement between the Australian (Commonwealth), state and territory governments of Australia and the Government of New Zealand, under the Trans-Tasman Mutual Recognition Act 1997. This arrangement recognises that provided food produced or imported into one country meets that country's food standards, it may be legally sold in the other country. This means that separate certification arrangements will not need to be negotiated for bivalve molluscs and bivalve mollusc products imported into Australia from New Zealand.

Once certification of imported bivalves and bivalve products is mandated, products without a recognised foreign government certificate will not be permitted entry into Australia. A recognised foreign government certificate is a certificate the department has negotiated with the competent authority in the country exporting bivalve molluscs or bivalve mollusc products. However, to minimise the disruption of existing trade, imports will not be restricted from exporting countries that have applied for certification before it becomes mandatory, anticipated to be mid 2020 (see section 1.3).



References DPIPWE 2017, Australian Shellfish Quality Assurance Program, Department of Primary Industries, Parks, Water and Environment, Tasmania, accessed 8 October 2018.

European Food Safety Authority 2009, Marine biotoxins in shellfish: summary on regulated marine biotoxins, scientific opinion of the Panel on Contaminants in the Food Chain, Question no. EFSA-Q-2009-00685, Adopted on 13 August 2009, EFSA Journal, 1306, pp 1–23.

FSANZ 2005, Final assessment report, Proposal 265, Primary Production & Processing Standard for Seafood, Food Standards Australia New Zealand, Canberra, 23 March, accessed 18 September 2018.

Irwin, N (ed.) 1970, Recommended procedures for examination of seawater and shellfish, 4th edition, American Public Health Association, New York.

https://dpipwe.tas.gov.au/biosecurity-tasmania/product-integrity/food-safety/seafood/shellfish-quality/australian-shellfish-quality-assurance-program

http://www.foodstandards.gov.au/code/proposals/Pages/proposalp264/P265-PPPStandardSeafood.aspx

http://www.foodstandards.gov.au/code/proposals/Pages/proposalp264/P265-PPPStandardSeafood.aspx

Documents

Proposed changes to food safety import requirements for ... · growing, harvesting and production of bivalve molluscs and bivalve mollusc products. This will align the regulation