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Western Australian Shellfish Quality Assurance Program (WASQAP) Operations Manual

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Western Australian Shellfish Quality Assurance Program (WASQAP)

Operations Manual

Foreword

A number of sections of the 2001 WASQAP Operations Manual have been revised, particularly the sections dealing with sampling procedures and farm management. This manual is intended to apply to the aquaculture industry for the production of mussels and edible oysters for domestic and international consumption. The operations manual should be read in conjunction with the Australian Shellfish Quality Assurance Program Operations Manual. The operations manual will be reviewed every two years with amendments being adopted on an as-needs basis. This is the third revision of the Operations Manual, replacing the second revision of the Operations Manual published in 2001. Amendment History 1999: First publication of the WASQAP Operations Manual. 2001: First revision of the WASQAP Operations Manual February 2004: Second revision of the WASQAP Operations Manual.

WASQAP Operations Manual 2004 ii

Table of Contents LIST OF ACRONYMS......................................................................................................................................... V

1 INTRODUCTION .......................................................................................................................................... 1 1.1 PROGRAM SCOPE.................................................................................................................................. 1 1.2 PROGRAM OVERVIEW ......................................................................................................................... 1

2 ROLES & ADMINISTRATIVE RESPONSIBILITIES................................................................................. 2 2.1 DEPARTMENT OF FISHERIES (DOF) .................................................................................................. 2 2.2 HEALTH DEPARTMENT OF WESTERN AUSTRALIA (DOHWA)...................................................... 2 2.3 AUSTRALIAN QUARANTINE INSPECTION SERVICES (AQIS).......................................................... 3 2.4 INDUSTRY.............................................................................................................................................. 3 2.5 AUSTRALIAN SHELLFISH QUALITY ASSURANCE ADVISORY COMMITTEE (ASQAAC) ............ 3 2.6 CONTACT DETAILS .............................................................................................................................. 4

3 LEGISLATION AND POLICIES APPLICABLE TO THE WASQAP ........................................................ 6 3.1 NATIONAL ............................................................................................................................................. 6 3.2 WA HEALTH DEPARTMENT (DOHWA ).......................................................................................... 6 3.3 DEPARTMENT OF FISHERIES (DOF) .................................................................................................. 6

3.3.1 Harvesting Areas ............................................................................................................................ 6 4 SAMPLING OF WATER AND SHELLFISH FLESH.................................................................................. 7

4.1 INTRODUCTION..................................................................................................................................... 7 4.2 SAMPLING LOCATIONS........................................................................................................................ 7 4.3 SAMPLING REGIME .............................................................................................................................. 8

4.3.1 Areas Classified by AQIS for Export .............................................................................................. 8 4.3.2 Harvest Areas Not Approved for Export by AQIS. ....................................................................... 11

4.4 COLLECTION OF SAMPLES. ............................................................................................................... 11 4.4.1 Water Samples .................................................................................................................................. 11 4.4.2: Shellfish Flesh Samples. ................................................................................................................... 12

5 CLOSED SAFETY ZONES......................................................................................................................... 17 5.1 WOODMAN POINT CLOSED SAFETY ZONE. ................................................................................... 17 5.2 POINT PERON OUTFALL CLOSED SAFETY ZONE. ......................................................................... 17

6 LABORATORY ANALYSES ..................................................................................................................... 18 6.1 BACTERIOLOGICAL EXAMINATION OF WATER AND SHELLFISH................................................. 18 6.2 ENUMERATION OF PHYTOPLANKTON ............................................................................................. 18 6.3 ALGAL BIOTOXINS IN SHELLFISH FLESH........................................................................................ 19 6.4 CHEMICAL CONTAMINANTS............................................................................................................. 19

7 MANAGEMENT PLANS FOR HARVEST AREAS.................................................................................. 22 7.1 MANAGEMENT OVERVIEW ............................................................................................................... 22 7.2 CESSATION OF HARVESTING ............................................................................................................ 22

7.2.1 Unsatisfactory results from Systematic Random Sampling........................................................... 22 7.2.2 Adverse Conditions in Conditionally Approved Harvest Areas.................................................... 22 7.2.3 Unique Situation as Identified by the WASQAP Manager. ........................................................... 27

7.3 FORMAL CLOSURE OF HARVEST AREA .......................................................................................... 27 7.3.1: Procedures for Closures of Harvest Areas......................................................................................... 28 7.3.2: Closures of Harvest Areas with Product Destined for Export............................................................ 29

7.4 FORMAL RE-OPENING OF HARVEST AREAS .................................................................................. 29 8 HARVESTING, TRANSPORT AND IDENTIFICATION OF SHELLFISH ............................................. 31

8.1 GENERAL REQUIREMENTS................................................................................................................ 31 8.1.1 Mussels ......................................................................................................................................... 31 8.1.2 Oysters .......................................................................................................................................... 31

WASQAP Operations Manual 2004 iii

8.2 WASHING SHELLFISH....................................................................................................................... 32 8.3 VESSELS AND VEHICLES ................................................................................................................... 32 8.4 SHELLFISH IDENTIFICATION ............................................................................................................. 32

9 MARINE BIOTOXIN CONTROL MANAGEMENT PLAN. .................................................................... 34 9.1 MARINE BIOTOXIN CONTROL MANAGEMENT PLAN FOR WASQAP ......................................... 34

9.1.1 Roles and Administrative Responsibilities ........................................................................................ 34 9.1.2 Growing Areas and Sampling Sites .............................................................................................. 34 9.1.3 Contingency Plan for Toxic Algal Blooms (summarised in Figure 7) .......................................... 34

10 PRODUCT RECALL PROCEDURE....................................................................................................... 38 10.1 RECALL CATEGORIES .................................................................................................................... 38 10.2 DOMESTIC RECALL........................................................................................................................ 38 10.3 EXPORT RECALL ............................................................................................................................ 38

10.3.1 AQIS Notification Requirements................................................................................................... 39 10.4 OTHER COMMENTS........................................................................................................................ 39 10.5 PRODUCT TRACEABILITY.............................................................................................................. 39

11 REFERENCES ......................................................................................................................................... 41

12 APPENDICES.......................................................................................................................................... 42 APPENDIX 1 MEMORANDUM OF UNDERSTANDING ................................................................................... 43 APPENDIX 2: MUSSEL GROWERS DOF LICENSE CONDITIONS.................................................................. 49 APPENDIX 3 NOTIFICATION, CLOSURE AND RE-OPENING NOTICES .......................................................... 52 APPENDIX 4 SURVEILLANCE PLAN FOR HARVESTING AREAS ................................................................... 56 APPENDIX 5 SYMPTOMS OF TOXIC SHELLFISH POISONINGS ................................................................... 60 APPENDIX 6 SAMPLE COLLECTION INFORMATION AND LABORATORY FORMS......................................... 61 APPENDIX 7 SAMPLING TIMETABLE ......................................................................................................... 65

List of Figures and Tables

Figure 1 Location map showing sampling sites and lease areas in Cockburn Sound. Figure 2 Location map showing sampling sites and lease areas in Oyster Harbour and

Mistaken Island. Figure 3 Location map showing sampling sites and lease areas in Warnbro Sound. Figure 4 Location map showing the Closure Safety Zones around Woodman Point

Emergency Outfall and the Point Peron Outfall. Figure 5 Schematic representation of assessment of adverse conditions for Kwinana

Grain Terminal Harvesting Area Figure 6 Schematic representation of assessment of adverse conditions for Oyster

Harbour Harvesting Area Figure 7 Process of a Lease Closure in the Event of an Algal Bloom Table 1 Contact personnel for the WASQAP Table 2 List of laboratories used in the WASQAP Table 3 Licensed Shellfish Harvesting Areas in WA Table 4 GPS co-ordinates for sampling sites in WASQAP lease areas. Table 5 GPS co-ordinates for Closure Safety Zone around Woodman Point Table 6 List of laboratory analyses as part of the WASQAP Table 7 Phytoplankton species and trigger levels for the WASQAP Table 8 Threshold limits to instigate formal closure of lease areas

WASQAP Operations Manual 2004 iv

List of Acronyms ACWA Aquaculture Council of Western Australia AFFA Agriculture, Fisheries and Forestry Australia; Department of AOAC Association of Official Analytical Chemists AQIS Australian Quarantine Inspection Service ASP Amnesic shellfish poisoning (domoic acid) ASQAAC Australian Shellfish Quality Assurance Advisory Committee ASQAP Australian Shellfish Quality Assurance Program ASS Adverse Sampling Strategy CBH Co-operative Bulk Handling Grain Facilities, Kwinana DEH Director, Environmental Health Service DoE WA Department of Environment DOF Department of Fisheries WA DOHWA Department of Health WA DSP Diarrhoetic shellfish poisoning (okadaic acid) EDPH Executive Director, Public Health ELISA Enzyme Linked Immuno-sorbant Assay EU European Union FPA Fremantle Port Authority FRMA Fish Resources Management Act 1994 FSANZ Food Standards Australia and New Zealand GSAA Great Southern Aquaculture Association HACCP Hazard Analysis Critical Control Point HPLC High Performance Liquid Chromatography IMVS Institute for Medical and Veterinary Science KGS King George Sound - Albany KGT Kwinana Grain Terminal - ship loading jetty in Cockburn Sound NATA National Association of Testing Authorities, Australia NSP Neurotoxic shellfish poisoning (brevetoxins or polycyclic polyethers) OC Organochlorine (pesticides) OFI Ocean Foods International Pty Ltd OH Oyster Harbour - Albany OP Organophosphate (pesticides) PCB Polychlorinated biphenyls PSP Paralytic shellfish poisoning (saxitoxin) SF Southern Flats - in Cockburn Sound adjacent to Garden Island SRS Systematic Random Sampling SSCA State Shellfish Control Authority TSP Toxic Shellfish Poisoning USFDA United States Food and Drug Authority WAMPA WA Mussel Producers Association WASQAP Western Australian Shellfish Quality Assurance Program

WASQAP Operations Manual 2004 v

1 Introduction 1.1 Program Scope

In liaison with Industry, the Western Australian Shellfish Quality Assurance Program (WASQAP) was established by the WA Department of Fisheries (DOF) and the WA Health Department (DOHWA) to administer the sanitary controls for shellfish in accordance with the Australian Shellfish Quality Assurance Program (ASQAP). ASQAP was developed as a guide to industry in implementing a risk-based assessment of production and harvesting areas in accordance with the United States Food and Drug Administration (USFDA) National Shellfish Sanitation Program. ASQAP includes controls for the growing, harvesting, and shipping of shellfish. The WASQAP is primarily focused on the application of the ASQAP to mussels and edible oysters grown in Western Australia. The WASQAP is administered with the full support and involvement of the mussel and edible oyster aquaculture industry of Western Australia. The WASQAP addresses the requirements of the Australian Quarantine Inspection Service (AQIS) for export to European and Asian markets, but does not presently address United States Food and Drug Administration (USFDA) requirements for export to the United States of America.

1.2 Program Overview

AQIS has the statutory authority to administer the export inspection system and to provide certification for shellfish exports. This authority is vested under the Export Control Act 1982 and related Orders. Export certification of molluscan shellfish is issued on the basis of compliance with the requirements of the ASQAP, Export Control (Processed Food) Orders 1992 (under revision) and relevant State legislation. Food Standards Australia and New Zealand (FSANZ) Food Codes have been adopted into food regulations by the Australian States and Territories and are therefore legally enforceable under relevant provisions of the Health Act in each particular state. A Memorandum of Understanding (MOU) was signed between DOF, DOHWA and AQIS which details the administrative responsibilities for the implementation of the ASQAP sanitary controls for exported shellfish harvested in Western Australia (Appendix 1). DOHWA and DOF are responsible for the survey and classification of shellfish growing areas, and post-harvesting controls for shellfish, except for controls that apply to the preparation of shellfish in AQIS registered export plants in Western Australia. The WASQAP was established by DOF and DOHWA with the support of the mussel and edible oyster aquaculture industry to administer these controls.

WASQAP Operations Manual 2004 1

2 Roles & Administrative Responsibilities

Contact details for personnel involved in WASQAP are summarized in Table 1 and Table 2. 2.1 Department of Fisheries (DOF)

DOF administers the Fish Resources Management Act 1994 (FRMA). The FRMA gives DOF the authority to issue aquaculture licenses and leases that permit aquaculture operations. It also empowers the DOF to control the harvesting of shellfish on the basis of the sanitary quality of the shellfish harvesting areas. Hence, DOF imposes a condition on the aquaculture licence of the shellfish farmer that compels the farmer to “establish and at all times maintain in force a health and quality assurance programme”. An example of the general DOF licence conditions for culture of mussels is shown in Appendix 2. Note that licence conditions may vary slightly according to individual characteristics identified at each growing site. DOF is responsible for the oversight of the WASQAP sampling programme from harvestable shellfish and their growing waters to ensure public safely. Industry members in Cockburn Sound contract the WA Mussel Producers Association (WAMPA) to undertake the sampling programme on their behalf. However Ocean Foods International (OFI ), who operate the lease areas in Oyster Harbour, undertake the sampling themselves. All samples must be taken in the presence of a DOF Officer from the relevant regional office (Fremantle and Albany respectively). In the event of a closure event, under direction from the WASQAP Manager (DOHWA ) the DOF is responsible for the serving of a Harvest Area Closure Notice (see Appendix 3) to the appropriate industry representative. It is also the responsibility of regional DOF officers to initiate a surveillance program to ensure that no illegal harvesting of product occurs (Appendix 4). Similarly, under direction from the DOHWA, DOF will serve a Harvest Area Re-Opening Notice to the appropriate industry representative (see Appendix 3).

The preparation of Sanitary Survey Reports for new shellfish growing areas and Sanitary Survey Updates and Triennial Reports for existing growing areas is the responsibility of DOF in consultation with the DOHWA . The organisation of the AQIS audits is shared between DOF and DOHWA. DOF retains records of aquaculture licences, licence conditions and official notice of closures and openings of growing areas. In the absence of DOHWA representatives, DOF also ensures State representation at the Australian Shellfish Quality Assurance Advisory Committee (ASQAAC) meetings.

2.2 Health Department of Western Australia (DOHWA)

The Food Safety Branch of the DOHWA in conjunction with DOF and industry, is responsible for the survey and classification of the shellfish growing areas in WA. Under the Health Act 1911, the DOHWA has the statutory authority to control post-harvesting and transport of shellfish and the ability to detain and recall shellfish considered to be unfit for human consumption. The DOHWA also has the authority to enforce the necessary sanitary controls for processing plants and vehicles handling shellstock. In addition to the sanitary controls, DOHWA maintains records, as a hardcopy and electronic data base, of bacteriological and phytoplankton data, heavy metal and organic chemicals data and adverse meteorological conditions, using data from the Bureau of Meteorology, relevant to the sites. Rainfall figures are also kept for the days that sampling takes place. DOHWA maintains a central filing system of information relevant to the WASQAP as required by the ASQAP Manual.

WASQAP Operations Manual 2004 2

DOHWA also maintains epidemiological data for notifiable diseases and analyses the data for trends and, wherever possible, follows up individual cases. In conjunction with DOF, DOHWA also organises provisions of training to industry members on correct microbiological and phycological procedures for the collection of water and shellfish samples.

2.3 Australian Quarantine Inspection Services (AQIS)

AQIS is the national agency responsible for the administration of the export controls for food commodities from Australia, including seafood. The agency administers the export inspection system and provides the certification for shellfish exports. AQIS administers the export inspection program which includes provision for : (a) the registration of premises, including vessels, which prepare shellfish intended for export ; (b) the inspection of registered establishments for implementation of good food processing audits ; and (c) conducting audits of Hazard Analysis Critical Control Point (HACCP) based food and safety plans. AQIS staff based in Perth, conduct compliance inspections and audits of land based shellfish processing establishments in accordance with the compliance history of the establishment and the food safety risk associated with the food being prepared for export. The Export Control (Processed Food) Orders 1992 also regulates the application controls for shellfish handling, processing, purification, packing, storage, shipping, the labelling of shellstock to enable source identification and the recall, detention, seizure or destruction of shellfish unfit for human consumption. Currently, AQIS also provides an audit role for the WASQAP.

2.4 Industry

The WASQAP is fully supported and partially funded by the associated industry members. These include the Aquaculture Council of WA (ACWA), the WA Mussel Producers Association (Inc) (WAMPA), Ocean Foods International Pty. Ltd., Albany (OFI) and the Great Southern Aquaculture Association (GSAA). The industry partners conduct the collection of water and mussel samples. In export approved classified sites (Oyster Harbour, Cockburn Sound) the sample collection is supervised by a DOF Officer to ensure compliance with ASQAP requirements. During periods of adverse weather conditions, industry takes responsibility to initiate a voluntary cessation of harvesting from the affected lease sites. The Industry representatives advise the WASQAP Manager of all such occurrences. Industry nominates a member as a representative on ASQAAC.

2.5 Australian Shellfish Quality Assurance Advisory Committee (ASQAAC)

The role of the ASQAAC is to provide a national overview of shellfish safety and quality, and to provide a set of minimum requirements agreed to by all states and territories (refer to ASQAAC Terms of Reference) .

WASQAP Operations Manual 2004 3

2.6 Contact Details Table 1: Contact details for WASQAP GROUP CONTACT PHONE (land) PHONE (mobile) FAX E-MailGovernment Agency DOF (Head Office Janet Howieson 08 94827396 08 94827390 [email protected] ) Ms Jo McCrea 08 94827361 08 94827390 [email protected] Mr Peter Millington 08 94827322 08 94827390 [email protected] (Albany) Mr. Phil Shaw 08 98417766 08 98421112 [email protected] (Fremantle) Mr. Tony Cappelluti 08 93356800 08 94304736 [email protected] Mr. Todd A’Vard 08 93356800 0419953511

08 94304736

[email protected]

DOHWA Mr. Walter Arrow (WASQAP Manager) 08 93884921 0419946053 08 93828119 [email protected] Mr. Kim Leighton 08 93884920 0418948186

08 93828119

[email protected]

AQIS (Perth) Mr. Greg Waller 08 93115412 08 9455 4145 [email protected] (Canberra) Mr Mark Kelly 02 62724978 [email protected] Mr. Andrew Buckley 02 62724017 02 62716522 [email protected]

(Canberra EXDOC) Mr. Les Johns 02 62724978 02 62723682

[email protected]

Department of Environment (DoE)

Dr. Ray Masini Marine Protection Branch

08 92227046 08 92227000

08 93221598 [email protected] 08 93221598

Dr. Jane Latchford Mr. Vas Hosja

08 92780463 08 62508060

08 92780586 [email protected] [email protected]

FPA Ms. Leigh Smith-Knox 08 94303314 LSmith-

[email protected] City of Rockingham City of Albany

Mr Mike Guthrie Mr Gregg Harwood

08 95280333 08 98419333

08 95921705 [email protected] 98419222

[email protected]

Industry

ACWA Mr. Dan Machin 08 92442933 08 92442934 [email protected] [email protected]

WAMPA Mr. Glenn Dibbin 08 94346118 041 1224682

08 94346119 [email protected]

OFI Mr. Phil Button Mr. Eu Meng

08 98447311 08 98448311 [email protected]

GSAA Mr Scott Fisher 08 98415253 [email protected]

WASQAP Operations Manual 2004 4

Table 2: Contact details for laboratories used for WASQAP analyses. LABORATORY CONTACT PHONE FAX E-Mail AnalysisAGAL (Perth) PO Box 83 Cottesloe. 6011

Mr Spiro Grammatikos 09 93841511 0412633252

[email protected] Heavy metals, OC/OP Pesticides, PCB’s and TBT

Cawthron Institute Private Bag 2 Nelson. New Zealand

Dr. Paul McNabb Dr. Patrick Holland

64 3 5482319 64 3 5469464 [email protected]

ASP/PSP/NSP/DSP toxins

Dalcon Environmental Unit 10/72 Walter Rd. Bedford. 6052

Mr. Stuart Helleren 08 92716776 08 92711389 Phytoplankton enumeration

Microserve 181 Claisebrook Rd. Perth 6000

Ms. Elizabeth Frankish 08 92276499 08 92276455 [email protected] E. coli/Salmonella/MPN on mussel flesh E. coli/total coliforms on water samples

PathCentre QE11 Medical Centre Hospital Ave. Nedlands. 6009

Mr Ray Mogyorosy Ms Jennifer Green (foods) Ms. Emma Plumb (water)

08 93462167 08 93462165 08 93462583

08 93817139 08 9381 7594

[email protected] [email protected] [email protected]

E. coli/Salmonella/MPN on mussel flesh E. coli/total coliforms on water samples

QLD Govt. Scientific Service 39 Kessels Rd. Coopers Plain. QLD. 4108

Mr. Geoff Eaglesham 07 32749085 07 32748700 [email protected] ASP/DSP toxins

Aqua-Biotoxin ESR AgriQuality PO Box 41 Auckland Private Bag 11030 Palmerston North

Mr. Cliff Bancroft Dr. David Woollard

64 9 6272549 64 9 6272508

64 9 6279750 [email protected].

NSP/PSP/ASP/DSP toxins

[email protected]

WASQAP Operations Manual 2004 5

3 Legislation and Policies Applicable to the WASQAP 3.1 National

Food Standards Australia and New Zealand Code 2001 • • • •

• •

• • •

Export Control Act, 1982 Export Control (Processed Food) Orders 1992 ASQAP Operations Manual

3.2 WA Health Department (DOHWA )

Western Australian Health Act 1911 Health (Food Hygiene) Regulations 1993

3.3 Department of Fisheries (DOF)

Fish Resources Management Act, 1994 Fish Resource Management Regulations 1995 Regulation 69H Conditions imposed on Aquaculture Licences issued under S.92 of the Fish Resources Management Act 1994 Ministerial Policy Guideline No. 8: Assessment of applications for authorisations for aquaculture and pearling in coastal waters of Western Australia

3.3.1 Harvesting Areas

The harvesting of shellfish by aquaculture or commercial wild-capture industries may only be conducted in areas which are permitted under DOF legislation and which are specified on the licenses issued by the DOF. Table 3 describes the harvest areas in WA currently licensed for shellfish culture. Some of these areas have been classified by AQIS and have export approval, whereas other areas are currently developing quality assurance programs for the sale of their product on the domestic market. Table 3: Licensed Shellfish growing areas in WA. Region Harvest Area No. of licenses Approved for Export by

AQIS. Perth Kwinana Grain Terminal

(Cockburn Sound) 8 Yes

Southern Flats (Cockburn Sound)

7 Yes

Warnbro Sound 3 No Garden Island 2 No Albany Oyster Harbour 1 Yes Mistaken Island (King

George Sound) 6 No

Flinders Peninsula (King George Sound)

1 No

Wilson Inlet 1 No Note that there is a small industry associated with the domestic consumption of pearl meat following harvest of pearl oysters. There is also a small commercial domestic wild catch industry of mussels in Cockburn Sound and cockles in Oyster Harbour. WASQAP personnel are investigating quality assurance programs for these industries at the present time. Details will be included in the next edition of the 2004 WASQAP Operations Manual. Recreational take of wild shellfish is not within the scope of the WASQAP.

WASQAP Operations Manual 2004 6

4 Sampling of Water and Shellfish Flesh 4.1 Introduction

Sampling of water and shellfish flesh from growing areas is carried out to ensure that shellfish harvested from licensed growing areas is safe to eat. In areas approved by AQIS for export, the sampling program (including locations, sampling dates and types of analyses) is carried out under requirements and procedures outlined in the ASQAP Operations Manual, with some alterations associated with local conditions. Of the other harvest areas, where product is only sold for domestic consumption, the Mistaken Island and Warnbro Sound farmers have developed quality assurance programs utilizing many of the requirements of the ASQAP operations Manual. These programs are described in Section 4.3.2.1. Quality assurance programs for product from Wilson Inlet are currently being developed. Details of these programs will be added in this WASQAP Manual as they become operational. In the interim, Wilson Inlet will be managed under the programs described in Section 4.3.2.2: Sampling strategies for harvest areas undergoing infrequent or short-term harvest.

4.2 Sampling Locations

Sampling locations are chosen on the recommendation of DOHWA and DOF and located to reflect adverse water quality that may affect the harvesting areas. Sites are identified by GPS positioning. Table 4 records GPS positioning for sample sites in the AQIS classified areas at Cockburn Sound (Kwinana Grain Terminal and Southern Flats) and Oyster Harbour, and also for Mistaken Island and the type of samples collected from each site. Lease areas and sample sites are shown on location maps - Figure 1 : Cockburn Sound and Figure 2 : Oyster Harbour and Mistaken Island, King George Sound and Figure 3 : Warnbro Sound. Descriptions of sample sites follows:

Cockburn Sound Kwinana Grain Terminal (KGT) Five routine monitoring points for bacteriological water quality are positioned around KGT (KGT1-5). Six additional monitoring points are used in assessing impact of severe adverse conditions: three sites across the middle of the lease perpendicular with the shoreline (KGTA, KGTB and KGTC) and three shoreline water samples (SL1, SL2 and SL3). A 10L phytoplankton sample is taken from KGT3 (see Figure 1). Live mussel samples are taken from within lease areas located both north and south of the Grain Terminal. The sampling site for the live mussels may vary slightly according to harvesting regimes. Southern Flats (SF) Five routine monitoring points for bacteriological water quality include, two in close proximity to the lease area (SF9 and SF11), one midway between the Southern Flats lease and the Kwinana Grain Terminal site (SF10), one near the Garden Island Bridge on the Rockingham side of the bridge (SF6) and one midway between Collie Head on Garden Island and John Point on Cape Peron (SF8). A 10L sample for phytoplankton is taken from SF11 (see Figure 1). Live mussel samples are taken from within the lease area. The sampling site for the live mussels may vary slightly according to harvesting regimes.

WASQAP Operations Manual 2004 7

Albany Oyster Harbour (OH) Samples for routine monitoring for bacteriological water quality are taken from four sites in or bordering three lease areas (OH1-4), one site midway between the entrance of the Kalgan and King rivers (OH5) and one site at the shoreline at Emu Point and near the mouth of Yakamia Creek (OH6). A 10L sample for phytoplankton monitoring is taken from Lease A at 5 metres depth (OH1) and another 10L sample is taken from a 2 metre water column in Lease C (OH7) (see Figure 2). Live mussel samples are taken from Lease A of Oyster Harbour and live oyster samples from Lease C. Mistaken Island. Samples for routine monitoring for bacteriological water quality are taken from three sites – MI1 (Light at Northwest corner of northern lease area), MI2 (Light at NorthEast corner of northern lease area and MI3 (light by southeast corner of southern lease area) (see Figure 2). Live mussel samples for bacteriological and heavy metal analysis are taken from the centre of the lease area. Phytoplankton samples (10L) are taken fortnightly from the centre of the lease area. Warnbro Sound Samples for routine monitoring for bacteriological water quality are taken from five sites :- WS1-4, and WS 6 (see Figure 3). 10L phytoplankton samples are taken from the centre of the lease area.

4.3 Sampling Regime

The sampling regime for each area differs depending on whether the harvesting areas are classified by AQIS for export (4.3.1) or whether the area is not classified by AQIS and producing shellfish solely for the domestic market (4.3.2). Water and shellfish samples for all areas may be collected under several different protocols, including systematic random sampling and an adverse sampling strategy. In addition a protocol has been developed to maintain export access to the European Union for Cockburn Sound product.

4.3.1 Areas Classified by AQIS for Export

4.3.1.1 Systematic Random Sampling (SRS) In areas classified by AQIS as being approved for export, water and/or shellfish flesh samples are collected routinely for bacterial, phytoplankton and chemical analysis under a Systematic Random Sampling (SRS) regime. The sampling dates for 2004 and 2005 are described in Appendix 7. Bacteriological Analysis Water

WASQAP Operations Manual 2004 8

Table 3: WASQAP Sample sites with GPS Identification

Sample Point

GPS: AGD 84 GPS:GDA 94 (WGS 84) Sample Type

Latitude South

Longitude East Latitude South

Longitude East

COCKBURN SOUND Kwinana Grain Terminal SL1 32° 15.825` 115° 44.593` 32° 15.752` 115° 44.682` Modelling SL2 32° 15.531` 115° 44.893` 32° 15.458` 115° 44.982` Modelling SL3 32° 15.258` 115° 44.119` 32° 15.185` 115° 44.208` Modelling KGTA 32° 15.518` 115° 44.874` 32° 15.445` 115° 44.963` Modelling KGTB 32° 15.418` 115° 44.666` 32° 15.345` 115° 44.755` Modelling KGTC 32° 15.176` 115° 44.398` 32° 15.103` 115° 44.487` Modelling KGT1 32° 15.330` 115° 44.955` 32° 15.257` 115° 44.044` SRS/ASS Water (bacterial) KGT2 32° 15.692` 115° 44.596` 32° 15.619` 115° 44.685` SRS/ASS Water (bacterial) KGT3 32° 15.323` 115° 44.746` 32° 15.250` 115° 44.835` SRS/ASS Water (bacterial and

phytoplankton) KGT4 32° 15.844` 115° 44.758` 32° 15.771` 115° 44.847` SRS/ASS Water (bacterial) KGT5 32° 15.579` 115° 44.071` 32° 15.506` 115° 44.160` SRS/ARS Water (bacterial) KGT North Dependent on harvesting regime SRS/ASS Mussels (bacterial) KGT South Dependent on harvesting regime SRS/ASS Mussels (bacterial,

chemicals and biotoxins) Southern Flats SF6 32° 16.129` 115° 41.963` 32° 16.056` 115° 42.052` SRS/ASS Water (bacterial) SF8 32° 15.288` 115° 41.076` 32° 15.215` 115° 41.165` SRS/ASS Water (bacterial) SF9 32° 14.473` 115° 42.291` 32° 14.400` 115° 42.380` SRS/ASS Water (bacterial) SF10 32° 15.305` 115° 43.359` 32° 15.232` 115° 43.448` SRS/ASS Water (bacterial) SF11 32° 14.596` 115° 43.198` 32° 14.523` 115° 43.287` SRS/ASS Water (bacterial and

phytoplankton) SF Dependent on harvesting regime SRS/ASS Mussels (bacterial,

chemicals and biotoxins) OYSTER HARBOUR OHA1 35° 58.667` 117° 57.100` 35° 58.594` 117° 57.192` SRS/ASS Water (bacterial and

phytoplankton) OHA2 35° 58.450` 117° 56.900` 35° 58.377` 117° 56.992` SRS/ASS Water (bacterial) OHB3 35° 59.033` 117° 57.533` 35° 58.960` 117° 57.625` SRS/ASS Water (bacterial) OHC4 35° 58.150` 117° 57.933` 35° 58.077` 117° 58.025` SRS/ASS Water (bacterial) OH5 35° 57.633` 117° 57.633` 35° 57.094` 117° 57.725` SRS/ASS Water (bacterial) OHEP6 35° 56.467` 117° 56.467` 35° 59.594` 117° 56.559` SRS/ASS Water (bacterial) OH7 34° 58.56` 117° 58.74` SRS/ASS Water (phytoplankton) Lease A Dependent on harvesting regime SRS/ASS Mussels Lease B Dependent on harvesting regime SRS/ASS Oysters MISTAKEN ISLAND MI1 35° 03.300` 117° 56.1000` 35° 03.227` 117° 56.191` SRS Water (bacterial) MI2 35° 03.400’ 117° 56.8500` 35° 03.327` 117° 56.941` SRS Water (bacterial) MI3 35° 04.080’ 117° 56.8000` 35° 04.007` 117° 56.891` SRS Water (bacterial) MI4 35° 03.600` 117° 56.4500` 35° 03.527` 117° 56.541` SRS Water (bacterial and

phytoplankton) Lease area Dependent on harvesting regime SRS Mussels WARNBRO SOUND WS1 32° 21.318` 115° 43.175` 32° 21.245` 115° 43.264` SRS Water (bacterial) WS2 32° 21.387` 115° 43.076` 32° 21.314` 115° 43.165` SRS Water (Bacterial) WS3 32° 21.135` 115° 42.933` 32° 21.062` 115° 43.022` SRS Water (bacterial and

phytoplankton) WS4 32° 20.520` 115° 42.153` 32° 20.447` 115° 42.243` SRS Water (bacterial) WS6 32° 21.712` 115° 42.538` 32° 21.640` 115° 42.627` SRS Water (bacterial) Lease Area Dependent on harvesting regime SRS Mussels

Under the SRS sampling protocol one 200mL water sample is collected from each sampling site for bacteriological (coliforms, thermotolerant coliforms and E. coli) analysis.

WASQAP Operations Manual 2004 9

Samples are collected 13 times each year. Sampling dates are randomly generated by computer. Sampling dates for 2004/2005 are shown in Appendix 7. Shellfish Flesh Also under SRS, two 100g samples of shellfish are taken and submitted for bacterial analysis (E. coli, total aerobic count (TAC) and Salmonella if E. coli is present) from each nominated sampling site. Samples are collected 13 times each year. Sampling dates are randomly generated by computer. Sampling dates for 2004/2005 are shown in Appendix 7. Phytoplankton and Biotoxins. Phytoplankton Under SRS, samples for phytoplankton identification and enumeration are collected fortnightly on the dates shown in Appendix 7. A 10L integrated 5 or 2 m water column sample is collected and submitted for analysis from each nominated site. In the case of Oyster Harbour the 10L sample is concentrated prior to transport to Perth. Samples are collected from sites OHA1 (5 metre), OHC7 (2 metre), KGT3 (5 metre) and SF11 (5 metre). Algal Biotoxins in Shellfish Flesh Samples of shellfish are collected at the same time as the water samples are taken. These samples are stored chilled for 48 hrs until phytoplankton counts are known and it is determined if toxin testing is required (see Section 9). If toxin testing is not warranted, samples are stored frozen for 6 months. Samples are to be collected as close as possible to water sample sites. Heavy Metals and other Chemicals. Mussel and oyster flesh samples are tested annually for the presence of the heavy metals inorganic arsenic, copper, zinc, cadmium, lead, mercury, organochlorine (OC) an organophosphate (OP) pesticides and polychlorinated biphenyls (PCB’s. Samples are to be collected during summer months (December to February). One sample of mussels is to be taken from each of SF, KGT. Lease A of Oyster Harbour and Mistaken Island and one sample of Oysters is to be taken from Lease C of Oyster Harbour.

4.3.1.2 Adverse Sampling Strategy (ASS) AQIS classifies export areas based on an assessment of the possibilities that adverse environmental conditions may affect the water quality and therefore the flesh quality of the harvested shellfish. Oyster Harbour and KGT harvesting areas are affected by adverse conditions and have been classified as conditionally approved by AQIS. In these areas, samples are also collected under the Adverse Sampling Strategy 24-48 hours after adverse conditions are deemed to have occurred. Adverse conditions are defined under a number of environmental factors for each harvest area (see Section 7). The factors that make up these adverse conditions for Cockburn Sound are described in Figure 5 and those for Oyster Harbour in Figure 6 (see Section 7). Adverse sampling sites are the same as for SRS sampling. The types of samples collected under ASS will depend on the nature of the adverse conditions, although in general water and mussel samples will always undergo bacteriological analysis.

4.3.1.3 Sampling for European Union (EU) Listed Area Requirement

The KGT and SF harvest areas has been listed for export to the European Union. A requirement for this listing is that shellfish flesh from this harvest area are to be tested for

WASQAP Operations Manual 2004 10

ASP, DSP and PSP once per month during the period October to March with an additional sample to be tested in June.

4.3.2 Harvest Areas Not Approved for Export by AQIS. 4.3.2.1 Mistaken Island and Warnbro Sound

The Mistaken Island and Warnbro Sound harvest areas are not at present classified by AQIS. However farmers in these areas, under the auspices of the Great Southern Aquaculture Association (GSAA) (Mistaken Island) and the WAMPA (Warnbro Sound), are developing a SRS sampling program based on that in place for AQIS classified areas in Cockburn Sound and Oyster Harbour. These programs will be undertaken as described in Section 4.3.1.1 including sampling of water for faecal contamination and phytoplankton, and sampling of mussels for faecal contamination, TAC and heavy metals and chemicals. Sampling is completed on or close to dates as described in Appendix 7.

4.3.2.2 Sampling strategies for Harvest Areas undergoing infrequent or short-term harvests.

If harvesting only occurs on a limited basis (i.e. for one or two months per annum) then samples should be taken fortnightly for one month prior to harvesting and fortnightly during the harvesting period. At each sampling time there should be at least three water samples and one meat sample for faecal bacterial analysis and one water sample for phytoplankton analysis taken from sampling sites located within or near to the harvest area. Location of the sampling sites must be approved by the WASQAP Manager.

4.4 Collection of Samples.

Sampling and analyses for the Cockburn Sound mussel growing areas are co-ordinated by the chair of WAMPA. OFI organise their sampling. All sampling in AQIS classified areas must be taken under the supervision of a DOF Fisheries and Marine Officer. This supervision requirement does not apply to areas supplying the domestic market (Warnbro Sound, Mistaken Island).

4.4.1 Water Samples

a. Bacteriological Testing Water samples are tested for total coliforms, thermotolerant coliforms and E. coli. One 200mL sample is collected at each nominated sampling site for bacterial analysis. The sample collection method is in accordance with “Microbiological Sampling and Monitoring of Environmental Waters” produced by the Applied Environmental Health Section of the Health Department of Western Australia. This guideline incorporates the Australian Standard ASNZF 5667.9-1998 Part 9 Guidance on Sampling from Marine Waters as well as other relevant information and guides. As part of these guidelines water samples must be collected in sterile bottles supplied by the analytical laboratory. The bottles have labels which must be completed with a water proof pen. The labels must include information on the harvesting area and sampling site code, the date of sampling, and any other relevant information. Accompanying the sample must be the laboratory sample form for the particular analytical laboratory (for examples see Appendix 6). The form needs details of date and time, harvest area and sample point code, current weather, and previous 24 hours weather and rainfall. All samples are to be received at the respective laboratories within 24 hours of collection.

WASQAP Operations Manual 2004 11

b. Phytoplankton Testing Water samples are collected fortnightly for enumeration and speciation of phytoplankton. In Cockburn Sound and Warnbro Sound, a 10L water sample is collected from a 5 m water column (from sampling sites KGT3, SF11 and WS3) and all samples are delivered to the analytical laboratory without concentration. Samples must be delivered to the laboratory on the day of collection. In Oyster Harbour a 10L sample is collected from a 5 metre water column in Lease A (OH1) and a 10L sample is collected from a 2 metre water column in Lease C (OH7) (see Table 4 and Figure 2). At Mistaken Island a 10L sample is collected from a 5 metre water column from sample site MI4. All water samples are concentrated through a 20µm phytoplankton net to a volume of approximately 1L, preserved with the addition of formalin to a concentrations of ~2% and then transported to the analyst in Perth. In case the concentration of the 10L water sample results in phytoplankton numbers too large to enumerate, a 1L non-concentrated water sample is also preserved and transported to Perth. A sample of mussels for biotoxin testing must be collected at the same time as the phytoplankton sample. This sample of mussels must be frozen so that flesh samples for analysis of biotoxins are available if toxic phytoplankton are present at above trigger concentrations. These frozen mussel samples are held on rotation for a minimum of six months as this also establishes a library of samples to do retrospective testing in the event that the phytoplankton analysis does not detect a problem at the time.

4.4.2: Shellfish Flesh Samples.

a. Bacteriological testing. Mussel flesh samples are tested for total aerobic bacteria and E. coli. If E. coli is present flesh samples are also tested for Salmonella. Mussel samples (~30 shells) are collected in each of two sterile bags. One of the bags is submitted for analysis whilst the other is frozen and kept for 6 months in case further bacteriological or testing for phytoplankton toxins is necessary. From the collected samples, two 100g samples of mussel tissue are taken and submitted for bacterial sampling from each nominated site (KGT North, KGT South, SF and OH1). Oyster samples from lease C in Oyster Harbour are not routinely sampled as mussels are recognised internationally as the most specific indicators of contamination. However, oyster samples are taken under adverse condition sampling. The bags containing the shellfish must be labelled with a waterproof pen. The labels must include information on the harvesting area and sampling site code, the date of sampling, and any other relevant information, particularly information relating to rainfall and weather conditions. Accompanying the samples must be the laboratory sample form for the particular analytical laboratory (for examples see Appendix 6). The form needs details of date and time, harvest area and sample point code, food type/brand, type of shellstock (mussels or oysters), water temperature, current weather, and previous 24 hours weather and rainfall. In addition to the industry address, the forms must also have the address of the WASQAP Manager, Walter Arrow, Food Safety Section, Health Department of WA, Grace Vaughan House. Shenton Park. Email: [email protected]. Samples should be stored in a cold esky immediately after collection and during transport to the laboratory, to minimize deterioration and/or inaccurate results. All samples are to be received at the respective laboratories within 24 hours of collection.

WASQAP Operations Manual 2004 12

b. Testing for Chemical Contaminants.

Mussel and oyster flesh samples are tested annually for the presence of the heavy metals inorganic arsenic, copper, zinc, cadmium, lead, mercury, organochlorine (OC) an organophosphate (OP) pesticides and polychlorinated biphenyls (PCB’s). At the discretion of the WASQAP Program Manager shellfish flesh samples may also be taken for tributyltin testing. Samples are to be collected during summer months (December to February). One sample of mussels is to be taken from Southern Flats, Kwinana Grain Terminal and Lease A of Oyster Harbour and one sample of Oysters from Lease C of Oyster Harbour. The minimum requirement is an annual mussel and oyster flesh test, although additional testing may be required should results show elevated levels or it has been determined by the WASQAP Program Manager that there is an elevated risk of pollutants affecting the area.

c. Testing for Algal Toxins.

Mussel samples for algal biotoxin testing are shucked by the WAMPA contractor, frozen and despatched to the relevant analytical laboratories.

.

WASQAP Operations Manual 2004 13

Figure 1: Sampling sites and lease areas in Cockburn Sound.

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Figure 2: Sampling sites and lease areas in Oyster Harbour and Mistaken Island.

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Figure 3: Sampling sites and lease areas in Warnbro Sound

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5 Closed Safety Zones

Closed safety zones are designated areas around recognized contamination points that should not be considered as potential sites for shellfish aquaculture. Two closed safety zones have been declared in the Cockburn Sound area. These zones are described in more detail below and are represented in Figure 1. 5.1 Woodman Point Closed Safety Zone. The Woodman Point Emergency Waster Water Treatment Outfall is located at the northern end of Cockburn Sound. This outlet is an emergency-only outfall for the Water Authority for the disposal of human effluent. Such emergencies are rare and limited to situations where the emergency release of effluent is required due to failures in other parts of the system, such as electricity supply or water pumps. However, as emergencies are by their very nature unpredictable is important that an appropriately sized area around the outfall be designated a closed safety zone, thereby ensuring these areas are not considered as potential sites for shellfish aquaculture. This is shown in Figure 4. The area has been selected on the basis of navigation markers in the area and these are located at the following grid references: Table 5: GPS Co-ordinates for Woodman Point at Closed Safety Zone. AGD 84 Navigation Marker

Latitude South

Latitude East

1 32°07.70’ 115°43.91’ 2 32°08.22’ 115°42.14’ 3 32°08.75’ 115°42.29’ 4 32°09.37’ 115°44.00’ 5 32°09.00’ 115°44.92’

5.2 Point Peron Outfall Closed Safety Zone.

Sewerage from the Rockingham residential and industrial area is treated at the Cape Peron Waste Water Treatment Plant and discharged approximately 4 km offshore into the Sepia Depression (Indian Ocean) (Figure 1). Currently, the quality of the discharge is being improved progressively from full primary to full secondary treatment (expected completion date 2010). Discharge from the Cape Peron/Sepia Depression outfall pipe is shifted in a northwards direction by longshore currents (DEP, 1996), and is not considered to pose a risk to shellfish quality in Cockburn Sound. Also, any contamination entering Cockburn Sound from the Indian Ocean should be detected at Sample point SF8.. Nonetheless a proposed closed safety zone has been established in an area surrounding the outfall. This zone is shown in Figure 1. Further analyses of data will result in a formal established boundary.

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6 Laboratory Analyses

Table 6 summarises the laboratory analysis, the relevant analytical laboratory, methods, frequency of sampling etc. for the SRS monitoring programmes undertaken as part of the WASQAP. Table 2 summarises the contact details for all the analytical laboratories used as part of the WASQAP.

6.1 Bacteriological Examination of Water and Shellfish

Water samples are analysed for total coliforms, thermotolerant coliforms and E. coli. Shellfish flesh samples are analysed for TAC (total aerobic bacteria count) and E. coli and for Salmonella if the E. coli concentrations are greater than 2.3.g-1. These organisms are indicator bacteria, their presence will suggest that faecal contamination of the area has occurred. The methods used for the bacteriological analysis of water and shellfish flesh samples are described in Table 6.

6.2 Enumeration of Phytoplankton

Phytoplankton samples are analysed for phytoplankton species known to produce toxins which may be concentrated in shellfish. Consumption of shellfish containing such toxins may result in food poisoning. Different phytoplankton produce different toxins and the type of food poisoning is dependent on which phytoplankton toxin has been concentrated (see Table 7 and Appendix 5). The four types of food poisoning associated with consumption of shellfish containing phytoplankton toxins are PSP (paralytic shellfish poisoning), ASP (amnesic shellfish poisoning), NSP (neurologic shellfish poisoning) and DSP (diarrhoetic shellfish poisoning). Further detail of these shellfish toxins the phytoplankton which produce them and illnesses associated with their consumption can be found in Appendix 5. Identification of toxic species as a result of enumeration of phytoplankton may be an indication of a public health risk. Trigger cell counts for each type of toxic phytoplankton have been established at levels where appropriate action should be taken (see Table 7) (see Section 9 for Marine Biotoxin Management Control Plan). In Cockburn Sound a 10L water sample is collected from a 5 metre water column from both KGT and Southern Flats and both samples are delivered to the analyst without concentration. A similar sample is collected from Warnbro Sound. In Oyster Harbour a 10L sample is collected from a 5 metre water column in Lease A and a 10 litre sample is collected from a 2 metre water column in Lease C. A 10L water sample is also collected from the Mistaken Island lease area. All samples are concentrated through a 20µm phytoplankton net to a volume of approximately 1L, preserved by the addition of ~20mL of formalin and transported to the analyst in Perth. Note that a 1L undiluted sample is also preserved and transported to Perth,. This sample safeguards against occasions when undiluted samples contain very high numbers of microalgae: concentration of such samples may result in microalgal numbers too high to enumerate. On receipt of the water samples at Dalcon Environmental samples are filtered through a 10µm phytoplankton net and concentrated to 100mL. The concentrate is then filtered through a 0.8µm cellulose nitrate membrane under positive pressure. The material retained on the membrane is resuspended in 10mL of filtered seawater. A 0.11mL subsample is then placed on a Palmer-Maloney Nanoplankton counter and 4 transects across the diameter of the chamber are scanned and the species identified and enumerated quantitatively. The resulting detection limit for samples treated in this manner is 74cells.L-1.

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Although all species of phytoplankton are enumerated and identified by the analyst, the phytoplankton genera or species reported in Table 7 are recorded on the WASQAP database for use in tracking and annual reports. Trigger limits for each chosen species (where applicable) are also included.

6.3 Algal Biotoxins in Shellfish Flesh

When trigger limits for a particular phytoplankton species are double the trigger level (see Table 7) or if the threshold level is exceeded in two consecutive samples (the second taken almost immediately after the first) then mussels collected at the same time as the phytoplankton samples and stored frozen are despatched for testing of toxins in the shellfish flesh. Shellfish may also be tested for toxins when a food poisoning outbreak has occurred. European Union (EU) requirements for biotoxin testing require that PSP, DSP and ASP toxins must be tested. Currently PSP toxins are tested by mouse bioassay, and DSP/ASP toxins are tested by Liquid chromatography/mass spectrometry (LC-MS). Where necessary NSP toxins are tested by mouse bioassay.

6.4 Chemical Contaminants

Whilst the sanitary surveys have demonstrated that the WASQAP harvesting areas are substantially unaffected by chemical contaminants, shellfish are to be tested on an annual basis to demonstrate continued compliance and low level of contamination. Shellfish are to be tested for the presence of a variety of metals (inorganic arsenic, copper, zinc, lead, cadmium, mercury), organochlorine (OC) and organophosphate (OP) pesticides residuals and polychlorinated biphenyls (PCB). The Mistaken Island lease area is also to be tested for tributyltin. These chemicals and metals may occur as a result of industrial and agricultural pollution or accidental contamination from industrial sources, shipping, stormwater effluent and groundwater seepage and tend to be highly persistent in the environment. As such there are maximum permitted levels which are specified in the FSANZ Code (see Table 8). The minimum requirement is an annual shellfish meat test, although additional testing should be completed if results from the annual test show elevated levels or alternatively if there has been an indication of elevated risk of pollutants affecting the area .

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Table 6: Laboratory Analysis of Water and Shellfish flesh as part of the WASQAP Programme. Analysis Frequency Methods Comments WATER SAMPLES Bacteriological Water Quality Total coliforms and E. coli

Monthly (SRS) or under ASS

AS4276.5-1995 ( MF: coliforms) AS4276.7 – 1995 (MF: Thermotolerant coliforms and E. coli )

Confirmation of coliforms and E. coli by growth in selected media.

Phytoplankton Enumeration See Table 6

Fortnightly (SRS) or under ASS

See Section 6.2.1

FLESH SAMPLES Bacteriological E. coli

Monthly (SRS) or under ASS

AS1766.2.3- 1992 (MPN: Coliforms and E. coli)

Total Aerobic Bacteria Monthly (SRS) or under ASS

AS 1766.2.1-1991 (Standard Plate Count)

Salmonella If E. coli is present AS 1766.2.5-1991 (Salmonella)

Flesh is tested for Salmonella if E. coli is present at above threshold levels.

Phytoplankton Biotoxins PSP toxins (saxitoxins and derivatives)

Phytoplankton over trigger levels (see Table 6), or for EU requirement (Section 4.2.3)

Paralytic Shellfish Toxin Method – AOAC 15th Edition Section 959.08 (Mouse)

Flesh is tested for paralytic shellfish toxin if phytoplankton levels are double the trigger level or above the threshold on two consecutive sampling dates. Presumptive results from the mouse bioassay are confirmed by HPLC.

ASP toxins (domoic acid and derivatives)

Phytoplankton over trigger levels (see Table 6), or for EU requirement (Section 4.2.3)

LCMS Flesh is tested for amnesic shellfish toxin if phytoplankton levels are double the trigger level or above the threshold on two consecutive sampling dates.

NSP toxins (brevetoxins and derivatives)

Phytoplankton over trigger levels (see Table 3)

Mouse bioassay Flesh is tested for neurological shellfish toxin if phytoplankton levels are double the trigger level or above the threshold on two consecutive sampling dates.

DSP toxins (okadoic acid, Pectenotoxin-2, PTX-2 seco acid)

Phytoplankton over trigger levels (see Table 5), or for EU requirement (Section 4.2.3)

LCMS Flesh is tested for diarrhoetic shellfish toxin if phytoplankton levels are double the trigger level or above the threshold on two consecutive sampling dates.

Heavy Metals Hg, As (total) Cd, Pb, Zn

annually

AAAS, HPLC-FL, HPLC-UV.

Pesticides OP and OC Pesticides Polychlorinated biphenyls (PCB’s)

annually

HPLC-FL, HPLC-UV.

INVESTIGATION OF HUMAN OUTBREAK Faecal pathogens Faecal Toxins Norwalk Virus

As necessary

Culture and Isolation PCR

WASQAP Operations Manual 2004 20

Table 7: Phytoplankton species enumerated as part of the WASQAP and threshold limits to trigger testing of flesh.

Phytoplankton Species

Type of Microalgae

Toxin Phytoplankton trigger concentration for flesh testing (cells.L-1)

Alexandrium fundyense lusitanucum minitum ostenfeldii catanella acatenella tamarense cohorticula tamiyavanachi

Dinoflagellate PSP (saxitoxins and derivatives)

100

Gymnodinium catenatum Dinoflagellate PSP (saxitoxins) 1000 Karenia brevis brevis-like mikimotoi

Dinoflagellate NSP (brevetoxins and derivatives)

1000

Dinophysis fortii acuta norvegica

Dinoflagellate DSP (okadoic acid and deriviatives, pectenotoxins)

500

Dinophysis acuminata Dinoflagellate DSP) (okadoic acid and deriviatives, pectenotoxins)

3000

Prorocentrum lima mexicanum minimum

Dinoflagellate DSP (okadoic acid and deriviatives),

500

Pseudonitzschia australis delicatissima fraudulenta pseudodelicatissima pungens turgidula

Diatom ASP (domoic acid and derivatives)

(>50% total phytoplankton)5 000

(<50% total phytoplankton)50 000

Nitzschia spp Diatom Rhizosolenia spp Diatom NSP(brevetoxins and

derivatives)

Dictyocha spp silicoflagellate

PSP : Paralytic shellfish poisoning (saxitoxin), ASP : amnesic shellfish poisoning (domoic acid), DSP : diarrhoretic shellfish poisoning, NSP: neurotoxic shellfish poisoning

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7 Management Plans for Harvest Areas 7.1 Management Overview

Successful management of shellfish harvesting areas is reliant on a good understanding of risk factors, and the actions of the proponents (industry, DOHWA and DOF) if situations which threaten the food safety of the product are identified. Generally the identification of any potential risk factor results in a cessation of harvesting by the mussel farmers. These potential risk factors may include unsatisfactory results from routine sampling (see Section 7.2.1), prevailing adverse environmental conditions known to impact on the harvest area (see Section 7.2.2), or a unique situation which is assessed by the WASQAP Program Manager as having a possible impact on the harvest area (see Section 7.2.3). Based on the results from analysis of subsequent water and/or flesh samples, and /or risk assessment by the WASQAP Program Manager, harvesting may recommence or a formal closure of the harvesting area will be implemented (see Section 7.3). The WASQAP Program Manager will also assess whether a product recall is necessary. Product recall protocol is covered in Section 10.

7.2 Cessation of Harvesting

Cessation of harvesting may be invoked under conditions outlined below. Note that situations/conditions leading to a cessation of harvesting may vary depending on the AQIS classification of the harvest area and also prevailing environmental conditions.

7.2.1 Unsatisfactory results from Systematic Random Sampling

Maintenance of AQIS export approval is dependent on the results of an extensive sampling program (see Section 5 for details). If the results from this routine sampling fall outside threshold concentrations set by ASQAP and summarised in Table 8, then the WASQAP Program Manager will implement a cessation of harvesting and order follow up sampling and analysis. This outcome may pertain to above threshold levels of faecal bacteria, chemical and/or pesticide residuals and/or toxic algae. It should be noted cessation of harvest due to toxic microalgae are dealt with separately and in more detail as part of the Marine Biotoxin Control Management Plan developed for WASQAP (see Section 9). Depending on the results of follow-up analysis harvesting may recommence or a formal closure may be invoked. When a public health risk has been identified, the WASQAP Program Manager may implement a formal closure without awaiting the results of follow-up sampling.

7.2.2 Adverse Conditions in Conditionally Approved Harvest Areas

The Southern Flats harvest areas has been classified by AQIS as unconditionally approved. This classification follows risk analyses, shoreline surveys and sampling programs which indicate that the area is well removed from most point sources of contamination and is not subject to predictable adverse conditions. Product can be directly marketed from this area at any time. The harvesting areas at KGT and Oyster Harbour however, have been classified by AQIS as conditionally approved. With such a classification (see ASQAP Manual) shellfish may be harvested for direct marketing when the product from the area is considered safe for

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Table 8: Threshold Limits for SRS sampling Analyses. Results over the threshold limits may result in cessation of harvesting, resampling and possibly mandatory closure of harvesting will be implemented. Threshold Limit according to WASQAP Programme Source of Threshold Limit WATER SAMPLES Thermotolerant faecal coliforms (E. coli)

14 cfu.mL-1 (by membrane filtration from any single sampling point)

ASQAP Operations Manual (2002)

Total coliforms 70 cfu.mL-1 (by membrane filtration from any single sampling point)

ASQAP Operations Manual (2002)

FLESH SAMPLES Bacteriological Thermotolerant faecal coliforms (E. coli) 2.3.g-1 (wet weight) FSANZ Volume 2/ASQAP Operations

Manual Standard Plate Count 1,000,000.g-1 (wet weight) ASQAP Operations Manual Salmonella <2 org.25g-1 (wet weight) ASQAP Operations Manual Phytoplankton Biotoxins PSP (saxitoxins equivalents) 0.8mg saxitoxin eq.kg-1 FSANZ Volume 2 NSP (NSP toxins) 200 mouse units.kg-1 FSANZ Volume 2 ASP(domoic acid equivalents) 20mg.kg-1 FSANZ Volume 2 DSP (okadoic acid, pectenotoxins) 0.2mg.kg-1 FSANZ Volume 2 Heavy Metals and Chemical Contaminants Arsenic (inorganic) 1 mg.kg-1 FSANZ Volume 2 Cadmium 2 mg.kg-1 FSANZ Volume 2 Lead 2 mg.kg-1 FSANZ Volume 2 Mercury 0.5 mg.kg-1 FSANZ Volume 2 Polychlorinated biphenyls 0.5 mg.kg-1 FSANZ Volume 2 (for fish) Tributyl tin 400 mg.kg-1 (as per Naval waters Agreement) Pesticide residues (organochlorines and organophosphates)

As per FSANZ Food Standards Code A14

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human consumption. The shellfish harvesting area is safe when it meets approved harvesting area criteria as determined by the SSCA (State Shellfish Control Authority) for a predictable period. The period depends upon acceptable performance standards specified by a management plan. In the case of KGT and Oyster Harbour the SSCA is defined by a MOU between AQIS, the DOHWA and DOF. The criteria for the management plans for KGT and Oyster Harbour are described below.

KGT The sanitary survey and analysis of past data from water and mussel samples indicates that there is only one major point source of pollution that has a direct and predictable impact on the mussel harvesting areas adjacent to the KGT. This point source is the storm water discharge pipes from the CBH grain storage facilities. It is recognised that there is an increased risk of contamination of harvesting area waters with faecal bacteria from pigeons that are attracted to the grain debris present around the storage buildings. Under certain environmental conditions (heavy rainfall and wind speed and direction) high levels of thermotolerant faecal coliforms originating from the pigeons may wash into the harvest area waters via the adjacent storm water discharge pipes.

Mussel farmers using the KGT harvest site impose a voluntary cessation of harvesting under the adverse conditions of rainfall and wind strength and direction outlined in Figure 5. This cessation of harvesting is undertaken on a precautionary basis and does not necessarily mean that the harvesting area has become unsafe, only that it is at risk. Subsequent bacteriological and phytoplankton enumeration in the water on samples collected by the mussel farmers under supervision of DOF Officers will then determine whether a formal closure of the harvest area should be imposed (see Section 7.3). The rainfall and wind strength triggers used to impose a voluntary cessation of harvesting at KGT have been extremely successful in predicting possible coliforms numbers in the water and hence public health and safety is well protected by this system. Oyster Harbour The sanitary survey and analysis of past data from water and mussel samples indicates that the potential point sources of pollution that may have direct and predictable impact on the Oyster Harbour Harvest Areas are the King and Kalgan Rivers which are the principal source of freshwater into the harbour. These rivers drain through extensive and intensive agricultural and horticultural areas before entering the harbour on the northern shoreline. In addition, Yakamia Creek which drains intensive horticultural areas, as well as industrial and residential zones, also has emerged as a potential source of contamination. At present, WASQAP personnel are trialling two models for predicting adverse conditions in Oyster Harbour. In the past, OFI which operate all leases in the harbour, have undergone a voluntary cessation of harvesting under the rainfall and salinity conditions described in Figure 6. This cessation of harvesting is taken on a precautionary basis and does not necessarily mean that the harvesting area has become unsafe, only that it is at risk. With these conditions, OFI will organise to take water samples for bacteriological testing and if faecal contamination is evident then a mandatory closure of the harvesting can be imposed.

WASQAP Operations Manual 2004 24

Figure 5: Closure procedures at Kwinana Grain terminal

WASQAP Operations Manual 2004 25

This rainfall and salinity model was developed to predict a large runoff of freshwater into the harbour (as indicated by a decrease in the salinity) from heavy rain in the catchments of the King and Kalgan Rivers both of which drain into the Harbour. High flow rates in these rivers increase the possibility of faecal contamination from the agricultural and horticultural industries in the catchments. However the measurement of salinity was found to be subject to inaccuracies and misinterpretation due to incorrect calibration of equipment, stratification of the water body and the effect of winds and tides on the path of freshwater through the harbour.

A WASQAP study investigated alternative water quality parameters (pH, salinity, nitrogen, phosphate, turbidity, and flow rate from Western Australian Department of Environment (DoE) gauging stations on the King and Kalgan Rivers and on Yakamia Creek) and alternative rainfall parameters (from Albany and towns in the rivers catchments) that could be used to predict when shellfish quality from the Ocean Harbour leases may be at risk. Off all parameters investigated, flow rate from the gauging station on the Kalgan River had the highest correlation with the Oyster Harbour water and shellfish bacteriological results. This correlation was considerably better than that achieved using rainfall and/or salinity data. More elaborate analyses indicated that the flow rate data could be used to predict the likelihood of unsatisfactory levels of faecal contamination in the Oyster Harbour water. These results may be extended to predicting faecal contamination in the shellfish, as retention rates in Oyster Harbour incorporating seasonal fluctuations in tides, winds and currents, as well as depuration rates in mussels and oysters have been studied in some detail.

Using mobile phone telemetry, the DoE established a system to present data from the Kalgan River on their website each morning using a custom plot showing the most recent 21 days of flow rate data with a threshold line equal to 3 times the lowest flow rate in the preceding 21 day period. When the flow rate is above the threshold line the harvest area may be at risk of contamination and harvesting should not occur. This threshold limit was based on correlation of the results from the DoE flow rate data sourced from the gauging station and the faecal coliform results from the commercial operator Ocean Food International (OFI) sampling program. Basing the threshold line on the previous 21 days takes into account antecedent factors in the catchment area, and negates seasonal variation as well as the effects of low and high rainfall years. Results from an initial six-month validation trial comparing the waterflow and salinity models demonstrated that water flow was an accurate indication of unsatisfactory coliform levels in the lease areas. OFI personnel and staff from DOF and DOHWA can now conveniently electronically access the water flow results each morning and using these results and the predictive model, make an informed decision on whether harvesting should be completed. The two predictive models will continue to be used concurrently for another six to twelve months, and then a decision may be made on which is the better method.

WASQAP Operations Manual 2004 26

Figure 6: Schematic representation of assessment of adverse conditions for Oyster Harbour Harvesting Area.

More than20mm of rain in last 2 days

More than 40mm of rain in last 7 days

AREA REMAINS OPEN FOR HARVESTING

NO

NO

RAINFALL

Salinity (1 metre) falls 25%

SALINITY

NO RECOMMEND CEASE HARVEST(see Section 7.2)COLLECT WATER SAMPLES AND MUSSEL SAMPLES AND SUBMIT FOR ANALYSIS

YES

WATER SAMPLES (24 HOURS)

All 6 samples <14cfuE. Coli .mL-1

Or <70cfu total coliforms.mL-1HARVEST MAY RESUME PENDING MUSSEL RESULT

LAB MUSSEL RESULT

Both mussel results <2.3 E. coli.g-1

FORMAL CLOSURE OF HARVEST AREA

NO

YES

NO

HARVESTING AREA OPEN BUT KEPT UNDER REVIEW SUBJECT TO FURTHER ADVERSE CONDITIONS

YES

PRODUCT RECALL NECESSARY?

(WASQAP MANAGER WILL ADVISE)

SECTION 7.3 OF WASQAP MANUAL

SECTION 10 OF WASQAP MANUAL

YES

YES

Flow rate > threshold line

YESNO

7.2.3 Unique Situation as Identified by the WASQAP Program Manager

Growing areas classified by AQIS as well as those growing areas still developing a quality assurance program, may be advised to cease harvesting if the WASQAP Program Manager identifies a unique situation, which, based on risk analysis and discussion between the DOF and DOHWA, is considered to put the safety of product at risk or indicates that contaminated product may be in the marketplace. Some examples of such a situation may be a sewage, oil or marine chemical spill, identification of new species of toxic phytoplankton, reports of food poisoning incidents associated with the consumption of shellfish etc. In such an incident the WASQAP Program Manager may order a cessation of harvesting and/or follow-up sampling before imposing a formal closure or re-opening the growing area. When a public health risk has been identified, the WASQAP Program Manager may implement a formal closure without awaiting the results of follow-up sampling.

7.3 Formal Closure of Harvest Area

The WASQAP Program Manager will establish and coordinate harvest area closure and re-opening procedures in consultation with AQIS, DOF and industry. On the recommendation of the DOHWA and using the legislative power of DOF, licence areas will be closed if it is considered that the shellfish may be contaminated. Industry must immediately cease all harvesting, processing, distribution and sales of shellfish until otherwise advised. Procedures for licence area closure are outlined below. If at the time of receiving the analytical results the mussels/oysters have been

WASQAP Operations Manual 2004 27

released for sale, a product call may be initiated. The details for carrying out a product recall are outlined in Section 10.

7.3.1 Procedures for Closures of Harvest Areas.

A mandatory closure of harvest areas involves the following procedure. 1. Recommendation of formal harvest area closure is issued by the WASQAP Manager. 2. This recommendation is communicated to the DOF and a representative of the shellfish industry in the affected area via telephone and email. 3. Individual licensees in the affected area are contacted immediately by telephone and/or email by personnel from the DOF Regional Branch or by a nominated industry representative. Details of notification to each licensee is recorded in the notification form in Appendix 3. 4. Notice of the formal closure is communicated by email to a prescribed list of stakeholders as detailed below: a. Closure in Cockburn Sound, Warnbro Sound. [email protected].; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected];; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected], [email protected], [email protected], [email protected]; [email protected];. with copies to [email protected];[email protected]; [email protected] b. Closure in Oyster Harbour, Mistaken Island [email protected].; [email protected]; [email protected]; [email protected]; [email protected]; [email protected] [email protected]; [email protected]; [email protected];; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected]; [email protected] with copies to [email protected];[email protected]; [email protected] 5. The appropriate regional DOF office (Albany for Oyster Harbour and Mistaken Isalnd, or Fremantle for Cockburn Sound or Warnbro Sound) then serves a Harvest Area Closure Notice (located in Appendix 3 of this copy of the WASQAP Operations Manual) to the appropriate industry representative.

6. The appropriate regional DOF office also initiates a surveillance program to ensure that no shellfish is being harvested. This program is specified in Appendix 4 of this copy of the WASQAP Operations Manual.

WASQAP Operations Manual 2004 28

7. In conjunction, the Executive Director of DOF and the WASQAP manager will assess if the risk is sufficient to warrant closing the area to commercial and recreational fishing (a Section 43 Order). If a section 43 Order is gazetted, the DOF Corporate and Community Relations Branch will arrange a media release stating the area is closed for commercial and recreational fishing. 8. The WASQAP Program Manager will assess if contaminated food has reached the marketplace and a recall may be required. If a general recall is necessary the DOHWA and DOF may issue a joint media statement advising the public, otherwise Industry will place a Recall Notice in the relevant newspapers in the format described in the Recall protocol. Recall procedures and protocol are described in Section 10 of this Operations Manual. 9. Recall of all potentially affected product is undertaken (see Product Traceability Section 10.5), in accordance with the FSANZ guidelines. 10. FSANZ is to be notified by the WASQAP Manager of all audit results for all affected product. 11. Harvested product that is deemed to be contaminated and unfit for human consumption is to be disposed of under supervision by an authorised officer at a registered sanitary land-fill.

7.3.2: Closures of Harvest Areas with Product Destined for Export

In circumstances where product sampled through batch testing for export final testing occurs, AQIS will notify DOHWA . A formal recommendation of closure to harvesting is initiated by the protocol described above and a sampling program is begun to assess the potential public health hazard of chemical and/or biological contamination. If the problem represents a health hazard and product has been sold in the market- place the WASQAP Program Manager is to advise AQIS who then advises the Health Authorities in the countries of product destination and requests assistance for providing appropriate public notification and recall of product. Industry notifies the Minister for Consumer Affairs of the recall. Industry trace of tagged product is to be undertaken to assist in the identification of all potentially affected stock. Further details of these protocols are described in Section 10.

7.4 Formal Re-Opening of Harvest Areas 1. The WASQAP Manager will liaise with DOF, EPA and Industry to determine the potential source of the contamination. 2. Under the supervision of DOF and DOHWA , industry undertakes daily water testing for the relevant indicator organisms or pathogens, or flesh samples for the relevant biotoxins or chemical pesticide residuals. 3. After repeat laboratory analysis the WASQAP Program Manager must confirm that the quality of shellfish in the affected area has returned to normal. The confirmation that the quality of shellfish in the affected area have returned to normal varies according to the type of contamination.

WASQAP Operations Manual 2004 29

a) Faecal Bacterial Contamination: when the bacterial concentrations of E. coli in water samples from the harvesting area falls below 14 org.100mL-1 (and is free of enteric pathogens should these have been previously identified) industry, under the supervision of DOF and DOHWA undertakes testing of mussel meat for the presence of E. coli and pathogens. Leases may be re-opened after results of flesh testing shows the absence of enteric bacterial pathogens if previously identified and have less than 2.3 E. coli per g-1 a nominated shellfish sample. b) Viral Contamination: Should viral pathogens (eg Hepatitis A or Norwalk) be identified or suspected from epidemiological evidence then the harvest area shall remain closed for 21 days before re-testing may be undertaken. c) formal closures due to phytoplankton toxins are described in Section 9. d) closures due to other compounds at toxic levels (see Table 8) will be re-opened after advice from the WASQAP Program Manager. After confirmation of acceptable shellfish quality by the WASQAP Program Manager, the appropriate DOF Regional Office serves a Harvest Area Re-Opening Notice (see Appendix 4) to the appropriate industry representative. Notification that the formal closure has been lifted must also be given to the agencies/personnel detailed in 4a or 4b above. 4. The routine surveillance report completed by the appropriate regional DOF office must be filed in an appropriate location in the regional office.

5. If a section 43 Order was issued, a media release must be issued stating that the areas are now open for commercial and recreational fishing.

WASQAP Operations Manual 2004 30

8 Harvesting, Transport and Identification of Shellfish 8.1 General Requirements

Shellfish that are harvested under an aquaculture licence and in accordance with WASQAP may only be harvested from the harvesting areas designated on the licence and covered by the harvesting areas described in Table 3. Shellfish that are improperly stored and handled after being harvested from approved harvesting areas can present a risk to consumers, particularly when consumed raw. Shellfish need to be protected from contamination and adverse conditions that are likely to result in a public health risk.

8.1.1 Mussels

• Shellfish is to be shaded from the sun and kept cool either by covering with clean wet sacks sprayed with fresh seawater prior to being received at the land based depot.

• If it is likely that more than 6 hours will elapse between harvesting and

delivering the shellfish to its' final destination then shellfish will need to be chilled to a temperature of not more than 5ºC.

• Mussels that are to be chilled shall be packed into double plastic lined foam

eskies and placed into a 4ºC chiller prior to transportation. Shellfish must be at a temperature of 5ºC or less before leaving the chiller.

• Chilled shellfish shall be transported in such a manner as to maintain the

temperature at 5ºC or less until arrival at the final destination. • Shellfish SHALL NOT be held in the chiller for more than 48 hours. At the

end of this period shellfish must either be frozen or discarded. 8.1.2 Oysters

• Harvested oyster shellfish for both domestic and export markets shall be

shaded from the sun and sprayed with fresh sea water prior to being received at the land based depot. The oysters are to be graded and sorted the day before transportation and then placed back onto the lease site.

• The oyster shellfish is to be removed from the water on the day of

transportation, sprayed with fresh sea water and taken to the land based depot.

• The oysters shall be packed into double plastic lined foam eskies and within 4

hours, chilled to 10 - 12ºC prior to transportation. From the time of harvest it generally takes less than 24 hours for the oysters to reach a final domestic retail destination, and less than 48 hours to reach a final export retail destination.

WASQAP Operations Manual 2004 31

8.2 Washing Shellfish

All shellfish harvested from Cockburn Sound and the Albany harbours shall be washed with fresh sea water, under pressure, to remove mud, bottom sediments, detritus and seaweed during harvest. No shellfish is washed with recirculated water.

8.3 Vessels and Vehicles

Vessels used to harvest and vehicles used to transport shellfish shall be constructed, operated and maintained to prevent contamination and deterioration of the shellfish. The following applies:

Decks and storage bins are constructed and located to prevent bilge water or polluted water from coming into contact with the shellfish.

Bilge pump discharges are located so that the discharge does not contaminate shellfish.

Bags or other containers used for storing shellfish are clean and fabricated from safe materials.

Vessels, decks, vehicles and storage bins used in the harvest or transport of shellfish are:

1) Kept clean with potable water or water which meets the approved

harvesting area criteria 2) Provided with effective drainage.

Vessels and all other equipment coming in contact with shellfish during handling or transport for relaying or depuration, are thoroughly cleaned before the vessels or equipment are used to transport or handle shellfish. When necessary, effective coverings are utilised on harvest boats to protect shellfish from exposure to the sun, birds and other adverse conditions. Cats, dogs and other animals are not allowed on vessels. Human excreta is not discharged overboard from a vessel used in the harvesting of shellfish when the vessel is in or adjacent to a shellfish harvesting area. Any ice used to cool shellfish during transport meets the potable water standard (Australian Food Standards Code, Standard S5 - Potable water and Ice)

8.4 Shellfish Identification

All harvested shellstock are to be clearly identified as follows:

WASQAP Operations Manual 2004 32

A durable waterproof label is affixed to the exterior of the container or bag, at the time of filling, once the shellstock has been graded and cleaned. If shellfish are harvested at more than one licensed site, each container is labelled at its harvesting area. The label contains the following information:

The name of the licence holder or nominated trading company on the licence; • • •

• •

The name of the geographic area (ie. Cockburn Sound or Albany.); Relevant site code: SF (Southern Flats), KGT (Kwinana grain terminal) or OH (Oyster Harbour). The date the shellfish is harvested; and The type and quantity of shellfish (eg. mussels (10kg).

Once the shellstock are removed from the original container for packing, it is recommended that the purchaser retain the label for 90 days. Records are kept of all lots of shellfish harvested including information from the labels, and the destination of each shellfish lot. If any intermediate stage of processing occurs, each lot of shellstock is kept separate and identified to prevent mixing or misidentification.

WASQAP Operations Manual 2004 33

9 Marine Biotoxin Control Management Plan.

Due to the fact that they are filter feeders, edible shellfish are vulnerable to contamination from toxins associated with certain algal blooms. Extraction and accumulation of the toxins in shellfish flesh may render them hazardous for human consumption. Extensive testing has shown that Western Australian shellfish are rarely exposed to blooms of potentially toxic algae as indicated by trigger levels in Table 7. Phytoplankton produce toxin only under certain conditions and in WA implementation of the threshold trigger levels is a precautionary measure to safeguard the viability of the shellfish stocks. A marine biotoxin management plan has been developed to ensure regular industry monitoring within these areas such that proliferation of harmful species likely to cause problems are detected early enough to ensure contaminated shellfish will not be consumed by the public.

9.1 Marine Biotoxin Control Management Plan for the WASQAP

A Marine Biotoxin Management Plan has been developed for the WASQAP Program. This plan was developed based on information provided in Part B of the Cawthron report (No. 645) entitled Australian Marine Biotoxin Management Plan for Shellfish Farming.

9.1.1 Roles and Administrative Responsibilities

Roles and administrative responsibilities for the WA Marine Biotoxin Control Management Plan are the same as for the WASQAP and are summarised in Section 2 of this document. In the case of an algal bloom in the vicinity of lease areas, additional management support may be provided by the WA Hazardous Algal Blooms Committee (currently chaired by Dr. Jane Latchford, WRC). Contact details of all relevant personnel are shown in Table 1, Section 2.

9.1.2 Growing Areas and Sampling Sites

Harvest areas and sampling sites for the WASQAP program are shown in Figure 1 for KGT and SF, Figure 2 for Oyster Harbour and Mistaken Island, and Figure 3 for Warnbro Sound. Phytoplankton sampling protocols are described in Section 4 of this document. In summary, phytoplankton samples are collected fortnightly as per the schedule shown in Appendix 7. In Cockburn Sound and Warnbro Sound, one 10L sample is collected from Sample Points KGT3, SF11and WS3. At Oyster Harbour 10L samples are collected from OHA1 and from OH7, and from Mistaken Island from MI4. Procedures for sample collection and despatch to the analytical laboratory are detailed in Section 4. Laboratory analysis of samples is described in Section 6.

9.1.3 Contingency Plan for Toxic Algal Blooms (summarised in Figure 7) Closure Procedures

1. A water sample is taken by Industry and sent to Dalcon Environmental (see Table 2 for contact details) for species enumeration and broad identification. The analytical procedure is described in Section 6. Samples are analysed within 24 hours of arrival

WASQAP Operations Manual 2004 34

at the laboratory. At the time water samples are taken , a mussel sample is also collected and held chilled at 5°C until results from Dalcon are provided. 2. If no potentially toxic species are identified at levels that exceed the recommended trigger levels the industry representative is to freeze the chilled samples and hold in frozen storage for 6 months. 3. If a potentially toxic species is identified at levels that exceed the recommended trigger levels (see Table 7) the analyst will immediately notify the WASQAP Program Manager. Notification containing the specified subject heading is to be sent to the following address: To: [email protected], Subject: Algal Bloom Shellfish Hazard; Importance: High.

4. If the phytoplankton count is more than double the trigger levels the WASQAP Manager must recommend that the chilled sample of shellfish be immediately sent for toxin testing and recommend the voluntary cessation of harvesting pending biotoxin results. 5. If the phytoplankton levels are exceeded but are not double the trigger levels the WASQAP Manager may either recommend that the chilled sample of shellfish is to be sent for toxin testing or the collection of an additional water and shellfish sample is to be taken 48-72 hours after the initial sample. If the subsequent sample shows that the phytoplankton levels exceed the trigger levels on both occasions, the WASQAP Manager must recommend that the chilled sample of shellfish be immediately sent for toxin testing and recommend the voluntary cessation of harvesting pending biotoxin results. 6. If algal biotoxins are determined to be present at levels which exceed the maximum permitted concentrations specified in Table 7 the WASQAP Program Manager is to advise DOF and a mandatory closure is to be enforced and the protocols for surveillance, communication, media release and product recall as described in Section 7.3 will be carried out. The size and extent of the closure is to be determined in liaison between DOHWA , DOF, Industry, WRC and AQIS. A formal closure may also be invoked after the reporting of cases of human illness consistent with the case definition for PSP, NSP, DSP and/or ASP (see Appendix 5) have resulted from the consumption of shellfish from a particular area or if the WASQAP Program Manager determines a closure is necessary for other reasons (eg. toxins present in neighbouring areas, reporting of a potentially toxic phytoplankton species not previously reported from the harvest area). A summary of the marine biotoxin management plan for WASQAP is shown in Figure 7. Lease Re-Opening Procedures

. The WASQAP Manager liaises with DOF and other appropriate authorities to determine the potential source. Once identified, sampling is undertaken as follows: (a) The mussel tissue sample that provided the basis for determining that a biotoxin producing bloom affected the harvesting area (prior to closure) is used to provide the baseline concentration of toxin present. (b) 1x10L water sample for phytoplankton enumeration is to be taken 48 hours post-closure. If counts show that the phytoplankton levels have fallen below the threshold triggers in Table 7 then proceed to test shellfish samples for presence of toxin as

WASQAP Operations Manual 2004 35

noted in (c) below, otherwise wait 48 hours and collect another water sample for phytoplankton enumeration and speciation. (c ) 3 x 100g shellfish tissue samples are collected and a 1 x 10L water sample is collected for phytoplankton enumeration. Phytoplankton enumeration is to be undertaken before toxin testing to confirm that the levels for the species of concern are below the trigger levels in Table 7, otherwise revert to (b) above. (d) Toxin testing is undertaken on the three shellfish tissue samples for the relevant biotoxin (refer to Appendix 5). • for PSP 3 x 100g shellfish samples are taken 14 days after closure. • All other algal biotoxins require 10 days before testing 3 x 100g shellfish tissue. If the biotoxin levels are higher than the maximum levels prescribed in Section 9 then wait a minimum of 48 hours and revert to (c ) above. (e) if the shellfish area has been demonstrated to have biotoxins below maximum permitted levels, it may be re-opened. However as there has been a biotoxin producing algal bloom, four weekly samples are to be collected for phytoplankton speciation and enumeration before reverting to the fortnightly sampling program.

When the WASQAP Program Manager confirms that the quality of shellfish in the affected area have returned to normal then the protocol for Lease re-opening as described in Section 7.4 will commence. Normally the lease areas may be re-opened when 3 consecutive samples in a minimum 14 days (for PSP) or 10 days (ASP, NSP and DSP) show that the toxins in the shellfish are below regulatory levels as described in Table 8, and that the levels of toxic phytoplankton show a clear downward trend and the cell counts are below the limit in Table 7. A re-opening will also be dependent on there being no reports of shellfish poisoning once the toxin and phytoplankton counts are below regulatory levels.

Recreational Shellfish Samples.

When the closure is due to phytoplankton blooms the WRC (Dr. Jane Latchford) as Chairman of the Hazardous Algal Blooms Committee must also be informed. If DOHWA determines that a public health hazard exists, a recall of potentially affected product is undertaken in accordance with the FSANZ guidelines. In addition, if the trigger levels for potentially toxic phytoplankton species are exceeded in recreational areas shellfish are not to be collected for consumption from affected waterways. Shellfish likely to be collected by recreational uses may be analysed during the bloom event or once monitoring indicates that levels have returned to pre-bloom conditions. It should be noted that recreational wild-capture of shellfish is not within the scope of WASQAP. However, illness arising from consumption of affected recreational wild-capture stocks may impact on public confidence in commercially produced product and therefore strategies to minimise such an event should be in place.

WASQAP Operations Manual 2004 36

Figure 7: Process of lease closure in the event of toxic algal bloom

No Yes

N

N

Water samples sent for phytoplankton count. Mussel samples held chilled while waiting results.

re

Waters & Rivers Commission

WASQAP Operations Manu

Phytoplankton count identifiedpotentially toxic species.

o

Industry Representative

WASQAP Manager

Results over the trigger level?

Normal monitoring program

Yes

o

Yes Yes

NoYes

AQIS

F

Industry Representative

Toxin Detected

Results exceed trigger level on two consecutive occasions or if the phytoplankton

count is more than double the trigger level

Recommend cease harvesting. Take chilled shellfish previously collected and

send to laboratory for toxin test.

al 2004

Recommend closureof harvest area

Regional DOF Office

Surveillance PlanAppendix 3

ormal Closure of Harvest Area

Fisheries HealthDEH & ED

37

Recommend ProductRecall

Recommend sume harvesting.

Resample Water NO CLOSURE

Chilled shellfish frozen and held 6 mths

rs

PH

FSANZ

See Section 10

10 Product Recall Procedure 10.1 Recall Categories There are two levels of recalls : Consumer Level Recall. This occurs where the shellfish have exceeded contaminant

criteria specified in Table 8 and have been distributed to the retail trade industry, including restaurants. This level of recall requires that the public is advised through advertisement and notices.

Trade Level Recall. This occurs where the shellfish have exceeded contaminant criteria

specified in Table 8 and have ONLY been distributed to the wholesale trade industry, no product has reached the retail-level. This level of recall does not require public advice but does require that FSANZ is notified.

10.2 Recall from Domestic Market

Under the circumstances of a domestic product contamination or recall or on the recommendation of the DOHWA, the following procedure is followed. Note that the procedure follows the recommendations of the Food Industry Recall Protocol (ANZFA 2001) : 1. Industry is advised to immediately cease harvesting, processing, distribution and

sales by the WASQAP Program Manager. 2. WASQAP Program Manager advises FSANZ, DOF, DOHWA of the full

particulars of the shipment.

3. DOHWA and DOF will issue a joint media statement advising the public if it is considered appropriate, otherwise Industry will place a Recall Notice in the relevant newspapers in the format prescribed in the Recall Protocol. Public notification occurs for Consumer Level Recalls except where all the stock is accounted for or when all stock is likely to have been recalled.

4. For all classes of recall, the grower, wholesaler, retailer, shipper and/or importer

are advised of all details necessary to identify and withdraw produce from sale. 5. The return or site disposal of the contaminated product is arranged by a

competent independent authority to an approved sanitary site. The authority will provide an appropriate ‘Condemnation Certificate’ or ‘Disposal Certificate’ for Consumer Level or Trade Level recalls.

6. A monitoring program is implemented to determine the extent of the problem

and ensure product is cleared and available for sale. 7. The Recall Cover Record is signed off by the WASQAP Program Manager once

all actions are completed and the procedure ends. FSANZ/DOHWA /DOF are provided with a detailed summary of the full scope of the problem and the eventual outcomes in a Recall Report.

10.3 Recall of Exported Product

WASQAP Operations Manual 2004 38

Under the circumstances of an export product contamination or recall or on the recommendation of the ASQAP/AQIS, the following procedure is followed :

1. Industry immediately ceases further shipments, harvesting, distribution and

sales.

2. The WASQAP Program Manager advises the FSANZ, AQIS, DOF and DOHWA of full particulars of the shipment. Public notification may be required by the Health Department of the country of destination. (Determined on a case-by-case basis).

3. For all classes of recall, the grower, wholesaler, retailer, shipper and/or importer

are advised of all details necessary to identify and withdraw product from sale.

4. The Industry Representative coordinates through AQIS for the return or site disposal of the contaminated product by arrangement with the Health Authority in the country of destination. The authority is requested to provide an appropriate ‘Condemnation Certificate’ or ‘Disposal Certificate’.

5. FSANZ, AQIS, DOHWA and DOF are provided with a detailed summary of the

full scope of the problem and the eventual outcomes (Recall Report).

6. A monitoring program is implemented to determine the extent of the problem and to ensure that product is cleared and available for sale. For Class 1 and Class 2 recalls, clearance must approved by AQIS and the DOHWA .

7. The Recall Cover Record is signed off by WASQAP Program Manager once all

actions are completed and the procedure ends.

10.3.1 AQIS Notification Requirements

AQIS Export Fish Program has introduced an electronic documentation system, EXDOC for the issue of all export clearance notices and health certificates. This system is automated as far possible with validation of information by data stored in tables within the system. To enable the export of shellfish to be automated AQIS Canberra needs to be notified of closures and re-openings of ASQAP classified growing areas. Contact details for the EXDOC Officer are in Table 1.

10.4 Other Comments

It should be clear that the re-commencement of further shipments would need to be negotiated with the relevant authorities. Additional sampling with satisfactory results would be the minimum that could be expected. It should be noted that the above procedure is only applicable to product destined for markets other than the USA and EU. The USA and EU markets require a specific classification of the relevant licences and the development of a formal ‘Memorandum of Understanding’ covered under the ASQAP.

10.5 Product Traceability

All sales to restaurants and retail outlets (domestic and export) must be traceable to the farm. All packaging carries an identification label or tag in accordance with the following procedures:

All harvested shellstock are to be clearly identified as follows:

WASQAP Operations Manual 2004 39

A durable waterproof label is affixed to the exterior of the container or bag, at the time of filling, once the shellstock has been graded and cleaned. If shellfish are harvested at more than one licenced site, each container is labelled at its harvesting area. The label contains the following information:

The name of the licence holder or nominated trading company on the licence; • • •

• •

The name of the geographic area (ie. Cockburn Sound or Albany.); Relevant site code: SF (Southern Flats), KGT (Kwinana grain terminal), OH (Oyster Harbour), WS (Warnbro Sound), MI (Mistaken Island). The date the shellfish is harvested; The type and quantity of shellfish (eg. mussels (10kg).

1. The tag is applied to a container of shellfish at the time of harvest once the

shellstock are cleaned. 2. These details are inscribed on all documentation and packaging to the final

point of consumption and accompany individual consignments.

All industry members maintain effective record keeping, showing information on date of sale, quantity and where the product is distributed. This information can be made available on request to the WASQAP Manager and the DOF. Records of all customer complaints are also maintained. Once the shellstock are removed from the original container for packing, it is recommended that the purchaser retain the label for 90 days. Records are kept of all lots of shellfish harvested including information from the labels, and the destination of each shellfish lot. If any intermediate stage of processing occurs, each lot of shellstock is kept separate and identified to prevent mixing or misidentification.

WASQAP Operations Manual 2004 40

11 References

1. Operations Manual of the ASQAP 2. The Australia New Zealand Food Standards Code. 3. Export Control Act 1982 4. ANZFA 5667-9, 1998 Guidance on Sampling from Marine Waters 5. New Zealand Fishing Industry Agreed Implementation Standards

6. Busby, P. National Marine Biotoxin Mamangement Plan, New Zealand. (Draft

1999). Ministry of Agriculture and Forestry, New Zealand. March 1999.

7. Hosja, W and Deeley, D. Harmful phyotplankton surveillance in Western Australia. Waterways Commission. Report No. 43. 1994.

8. ANZFA (2001) Food Industry Recall Protocol 9. Cawthron Report No 645 (2002) Australian Marine Biotoxin Management Plan for

Shellfish Farming.

WASQAP Operations Manual 2004 41

12 Appendices

WASQAP Operations Manual 2004 42

Appendix 1 Memorandum of Understanding

MEMORANDUM OF UNDERSTANDING CONCERNING THE SANITARY CONTROL OF

FRESH AND FROZEN BIVALVE MOLLUSCAN SHELLFISH INTENDED FOR EXPORTATION FROM AUSTRALIA

between the

Australian Quarantine and Inspection Service Department of Agriculture, Fisheries and Forestry - Australia,

Commonwealth of Australia

and the

Health Department of Western Australia

and

Fisheries Western Australia The Commonwealth Department of Agriculture, Fisheries and Forestry - Australia (AFFA), Health Department of Western Australia (DOHWA) and Fisheries Western Australia (DOF) affirm by this Memorandum of Understanding their intention to co-operate in seeking to assure that fresh and frozen bivalve molluscan shellfish exported from Australia are safe, wholesome, and have been harvested, processed, transported and labelled in accordance with the provisions of the Australian Shellfish Sanitation Control Program (ASQAP), the requirements of the (Commonwealth) Export Control Act 1982 and certain requirements of foreign countries to which Australian shellfish are exported This document also defines terms and describes the responsibilities of AFFA, DOHWA and DOF in the operation and management of this Memorandum of Understanding. I. FRAMEWORK 1. The export of shellfish from Australia is controlled by the Export Control Act

1982 and subordinate Export Control (Processed Food) Orders 1992 as amended, which are administered by AFFA.

2. The culturing, harvesting and relaying of bivalve molluscan shellfish in

Western Australia are controlled under the Fisheries Resources Management Act 1995 and the processing, packaging, labelling and distribution of harvested shellfish are controlled under the Health Act 1911 and the Australian Food Standards Code.

3. The ASQAP is administered as a co-operative arrangement where the

Australian Quarantine and Inspection Service (AQIS), State government agencies and the shellfish industry participate to ensure that Australian shellfish are essentially free from pathogenic micro-organisms, hazardous chemicals and marine biotoxins, and are wholesome for human consumption.

WASQAP Operations Manual 2004 43

The requirements, procedures and guidelines for the ASQAP are described in the ASQAP Operations Manual.

II. DEFINITIONS 4. "shellfish" means edible species of bivalve molluscs such as oysters, clams,

mussels, scallops* and cockles. *does not include scallops when the final product is the adductor muscle only. 5. "state enforcement agencies" means government departments within Australia that

have regulatory authority over production, harvesting, and/or processing of shellfish and the classification, monitoring and control of harvest areas, and that have entered into an agreement with AFFA, DOHWA or DOF for the purposes of this memorandum.

6. "central file" means the single location where shellfish control program

information, data and reports are stored and maintained. III. DOHWA and DOF RESPONSIBILITIES 7. DOHWA and DOF will work toward the objectives of the MoU in so far as these are

consistent with the ASQAP Operations Manual and any changes to the manual that are endorsed and approved by the Australian Shellfish Quality Assurance Advisory Committee.

8. DOHWA will classify growing areas in accordance with the requirements of the

ASQAP. 9. DOHWA will collate and file sanitary survey reports, reports of laboratory evaluations

conducted by NATA, results of routine laboratory analyses, enforcement action and data from quality assurance programs, and maintain this data and information in a central file to facilitate easy access by AFFA officials or officials of a foreign importing country authority for the purpose of review and evaluation.

10. DOF, with the assistance of DOHWA, will update survey data annually and review

the classification status of each harvest area at least annually in accordance with the requirements of the ASQAP Manual.

11. DOF will supervise and regulate, in accordance with the requirements of the ASQAP

Manual, Export Control Act 1982 and related Orders and relevant State legislation:

the relaying of shellfish; and the sampling of shellfish and environmental monitoring of growing areas.

12. DOHWA and DOF will ensure that any shellfish harvested from any unapproved

harvesting areas shall not be prepared for export. 13. At the request of AFFA, DOHWA and DOF will participate in joint inspections of

growing and relaying areas used for the production of fresh and frozen shellfish destined for export.

14. DOF, with the assistance of DOHWA , will provide for review by AFFA an annual

report that includes information on:

WASQAP Operations Manual 2004 44

(a) updated sanitary survey data; (b) classification status of all growing areas; (c) any closures/subsequent reopening of harvest areas; (d) enforcement action against violators; (e) laboratory evaluations; (f) laboratory analysis results; (g) existing and potential public health problems (eg marine toxins affecting

shellfish); and (h) any other pertinent information.

15. DOHWA and DOF will develop and maintain an interagency agreement

under the Western Australian Shellfish Quality Assurance Program (WASQAP) to co-ordinate the implementation of ASQAP controls.

16. DOHWA and DOF, through WASQAP, will develop and maintain interagency

agreements with other Western Australian state enforcement agencies and industry to co-ordinate the implementation of ASQAP controls, as necessary.

Additional Foreign Country Requirements 17 DOHWA and DOF agree to comply, as far as their responsibilities are

described in this MoU, with the particular foreign country requirements specified by relevant importation authorities as a condition of market access.

IV. AFFA RESPONSIBILITIES 18. AFFA will register and inspect shellfish processing plants in accordance with the

requirements of the Export Control Act 1982 and related Orders. 19. AFFA will administer regulatory controls, in accordance with the requirements of the

ASQAP Manual, for the post-harvest storage, transport and handling of shellstock intended for export.

20. AFFA will advise DOHWA and DOF of the status of international shellfish export

agreements in particular with the European Union, Japan and other member countries of the Association of South East Asian Nations.

21 AFFA will participate with DOHWA and DOF in joint evaluations of the ASQAP as it

pertains to exports of fresh and frozen shellfish from Western Australia; and 22. AFFA will provide DOHWA and DOF with inspection results as appropriate and other

program information, including foreign country authority evaluation reports, interpretations and laboratory quality assurance program information.

Additional Foreign Country Requirements 23. AFFA will provide DOHWA and DOF with information that will include, but

may not necessarily be limited to, specific foreign country requirements related to the classification of growing areas, methods and procedures for sampling, methods of analysis, specification standards, inspection procedures, relaying, depuration, harvesting, transport, handling and storage

WASQAP Operations Manual 2004 45

of shellfish, and other matters relevant to specific conditions of market access.

V. SHARED RESPONSIBILITIES Additional Foreign Country Requirements 24. As requested, all parties shall make travel arrangements in Australia for, and

conduct joint inspections with, importation officials of foreign countries. 25. Subject to paragraph 31 of this Memorandum of Understanding, the liaison

officers will be:

(a) for DOHWA Principal Food Scientist Environmental Health Services Health Department of Western Australia PO Box 8172 Stirling Street PERTH WA 6849 Current Contact Officer:

Food Scientist: Mr Walter Arrow Phone: 08 9388 4921 Fax: 08 9382 8119 (b) for DOF Aquaculture Program Manager Fisheries Western Australia 3rd Floor, SGIO Atrium 168 St George’s Terrace PERTH WA 6000 Current Contact Officer:

Project Officer: Ms Jo McCrea Phone: 08 9482 7361 Fax: 08 9482 7389 (c) for AFFA

Processed Food Policy Section Food Policy Branch Australian Quarantine and Inspection Service Department of Agriculture, Fisheries and Forestry - Australia GPO Box 858 CANBERRA ACT 2600

Current Contact Officer: Mr Andrew Buckley Phone: (02) 6272 4017 Fax: (02) 6271 6522

26. Either party may change liaison officers, notifying the other party in writing,

without otherwise changing the provisions of the Memorandum of Understanding.

WASQAP Operations Manual 2004 46

VI. PERIOD OF AGREEMENT 27. This document will become effective upon acceptance by both parties and

will remain in effect indefinitely. It may be modified by mutual consent or terminated by either party upon a thirty (30) day advance written notice to the other party.

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Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs Official Journal L 268 , 24/09/1991 p. 0001 - 0014 http://europa.eu.int/eur-lex/en/lif/dat/1991/en_391L0492.html CHAPTER V REQUIREMENTS CONCERNING LIVE BIVALVE MOLLUSCS Live bivalve molluscs intended for immediate human consumption must comply with the following requirements: 1. The possession of visual characteristics associated with freshness and viability, including shells free of dirt, an adequate response to percussion, and normal amounts of intravalvular liquid. 2. They must contain less than 300 faecal coliforms or less than 230 E. Coli per 100 g of mollusc flesh and intravalvular liquid based on a five-tube, three-dilution MPN-test or any other bacteriological procedure shown to be of equivalent accuracy. 3. They must not contain salmonella in 25 g of mollusc flesh. 4. They must not contain toxic or objectionable compounds occurring naturally or added to the environment such as those listed in the Annex to Directive 79/923/EEC in such quantities that the calculated dietary intake exceeds the permissible daily intake (PDI), or that the taste of the molluscs may be impaired. In accordance with the procedure laid down in Article 12 of this Directive, the Commission shall determine the testing methods for checking the chemical criteria and the limit values applicable. 5. The upper limits as regards the radionuclide contents must not exceed the limits for foodstuffs as laid down by the Community. 6. The total Paralytic Shellfish Poison (PSP) content in the edible parts of molluscs (the whole body or any part edible separately) must not exceed 80 microgrammes per 100 g of mollusc flesh in accordance with the biological testing method - in association if necessary with a chemical method for detection of Saxitoxin - or any other method recognized in accordance with the procedure laid down in Article 12 of this Directive. If the results are challenged, the reference method shall be the biological method. 7. The customary biological testing methods must not give a positive result to the presence of Diarrhetic Shellfish Poison (DSP) in the edible parts of molluscs (the whole body or any part edible separately). 8. In the absence of routine virus testing procedures and the establishment of virological standards, health checks must be based on faecal bacteria counts. Examinations for checking compliance with the requirements of this Chapter must be carried out in accordance with proven methods which are scientifically recognized. For the uniform application of this Directive sampling plans as well as the methods and analytical tolerances to be applied in order to check compliance with the requirements of this Chapter must be established in accordance with the procedure laid down in Article 12 of this Directive. The effectiveness of the faecal indicator bacteria and their numerical limits as well as the other parameters laid down in this Chapter must be kept under constant review and, where scientific evidence proves the need to do so, be revised following the procedure laid down in Article 12 of this Directive. When there is scientific evidence indicating the need to introduce other health checks or to amend the parameters in this Chapter for the purpose of protecting public health, such measures must be adopted in accordance with the procedure laid down in Article 12.

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Appendix 2: Mussel Growers DOF License Conditions

WASQAP Operations Manual 2004 49

WASQAP Operations Manual 2004 50

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Appendix 3 Notification, Closure and Re-opening Notices

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Department of Fisheries

Fish Resources Management Act 1994 Section 102, Regulation 64

NOTIFICATION

CESSATION OF HARVESTING/CLOSURE OF FARM SITE WA SHELLFISH QUALITY ASSURANCE PROGRAM On the day of month year, the WA Shellfish Quality Assurance Program Manager advised: (Tick relevant) that all farmers were to cease harvesting product until further notice

12.1 OR That a mandatory closure on the site has been put into place until further notice

12.1.1.1 PERSONS NOTIFIED OF THE ABOVE DETAILS 13 Name 14 Company Method of communication 15 Email Telephone Fax Letter

16 Email Telephone Fax Letter

17 Email Telephone Fax Letter

18 Email Telephone Fax Letter

19 Email Telephone Fax Letter

20 Email Telephone Fax Letter

21 Email Telephone Letter

22 Email Telephone Fax Letter

23 Email Telephone Fax Letter

Fax

23.1.1 23.1.2 23.1.3 Signature ___________________________ Date:

___________________________

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WESTERN AUSTRALIAN SHELLFISH QUALITY ASSURANCE PROGRAM

HARVEST AREA CLOSURE NOTICE

The Department of Fisheries hereby gives formal notice of the closure of shellfish harvesting areas -

In accordance with the requirements of the Australian Shellfish Quality Assurance Program and in accordance with the requirements of the Food Standards Code and the Health Act that shellfish shall be safe for consumption, the following area and aquaculture licence areas contained therein are designated to be closed until further notice. Harvesting, relaying or the movement of shellfish is not to occur within this harvest area and from these aquaculture licence areas until receipt of a Re-opening Notice from this office. Name of harvest area:

Licence numbers:

District Office Responsible for surveillance:

Date and time closure is to take effect:

Reasons for Closure

Name of Regional Manager:

Signature of authorising officer:

Date and Time:

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WESTERN AUSTRALIAN SHELLFISH QUALITY ASSURANCE PROGRAM

HARVEST AREA RE-OPENING NOTICE

The Department of Fisheries hereby gives formal notice of the re-opening of shellfish harvesting areas -

In accordance with the requirements of the Australian Shellfish Quality Assurance Program and in accordance with the recommendations of the re-opening criteria of the Western Australian Shellfish Quality Assurance Management Plan, the following harvesting area and aquaculture licence areas contained therein are declared to be re-opened. Harvesting, relaying or the movement of shellfish is now able to take place, subject to the normal operating restrictions of this area. Name of harvest area:

Licence numbers:

District Office Responsible for surveillance:

Date and time Re-opening takes effect:

Re-opening criteria

And summary of results on which assessment for basis of re-opening

Name of Regional Manager:

Signature of authorising officer:

Date and Time:

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Appendix 4 Surveillance Plan for Harvesting Areas

Background The Western Australian Shellfish Quality Assurance Program (WASQAP) was established to administer the sanitary controls for shellfish in accordance with the Australian Shellfish Quality Assurance Program (ASQAP). Included in this program are controls for the growing, harvesting and shipping of shellfish. In accordance with requirement of Part 3.2.3 of the ASQAP Manual, the WASQAP is required to implement surveillance activities in each shellfish growing area to ensure compliance with harvesting criteria, closure status, identification of shellfish, handling and transport requirements. The WASQAP currently uses the legislative framework of the Fish Resources Management Act 1994 to ensure that shellfish growers in Western Australia are operating in accordance with the requirements of the WASQAP. This includes the following activities: 1. The imposition of conditions on aquaculture licences to ensure active involvement

in the quality assurance program; 2. Undertake the supervision of personnel collecting samples for the WASQAP as

per the schedule in Annex 6 for bacteriological tests. 3. Ensure shellfish growers comply with the requirements set down for the handling,

identification and transportation of shellstock; and 4. Ensure that no illegal harvesting occurs during lease closures. Surveillance Plan The Aquaculture Program of the Department of Fisheries provides the administrative oversight of the Surveillance Plan as required by the ASQAP and provides the financial resources to fund the Plan. The activities undertaken under the Surveillance Plan are performed by Fisheries Officers of the Regional Services Division in accordance with a Compliance Plan negotiated between the Program Manager Pearling and Aquaculture and the Metropolitan and Albany Regional Managers. To ensure compliance with the requirements of the WASQAP the following activities are undertaken: • Aquaculture licence conditions

When issuing aquaculture licenses for mussels or edible oysters the Aquaculture Program imposes a condition on the licence that requires the licence holder to establish and maintain at all time a ‘health and quality’ assurance program for all shellstock produced. This condition ensures that the licence holders actively participate in WASQAP and pay for the sampling and laboratory analysis of water and shellstock. Breaching this condition may result in the aquaculture licence being cancelled or not renewed.

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• Supervision of sampling program

To ensure that water and shellstock samples are taken in an approved manner from the correct location, Fisheries Officers from the Fremantle and Albany District Offices accompany the industry on the boat on the day of the sampling run.

• Ensure shellfish growers comply with the requirements set down for the

handling, identification and transportation of shellstock

Fisheries Officers based in the Fremantle and Albany Regional Offices are required to undertake inspections on shellfish farmers operating in their respective areas. The inspections are random in nature, but equate to the site being inspected an average of once every two weeks. Fisheries Officers are required to check that all shellstock is handled, identified and transported in accordance with the procedures outlined in the WASQAP Manual and to produce a written report of the routine surveillance activities after each inspection. In addition, the Regional Manager with oversight for each of the shellfish growing areas is required to produce an annual report of the surveillance activities that have occurred at each shellfish growing area and to forward the report to the Aquaculture Program. A model of the Routine and Annual Surveillance Reports utilised by Fisheries Officers is shown on pages 3-3 and 3-4.

• Ensure that no illegal harvesting occurs during lease closures.

Shellfish growing areas may be closed for harvesting during times of adverse weather conditions, when levels of contaminants exceed recommended levels or in the event of an emergency (i.e. toxic algal bloom, oil spillage etc). Closures on shellfish growing areas are instigated by the WASQAP Manager, who in turn notifies the Department of Fisheries, industry representatives and other relevant government agencies as necessary (see list of personnel on page 5). Once the Department of Fisheries receives notification of a closure, the Aquaculture Program requests that the Regional Manager with responsibility for the area direct Fisheries Officers to inspect the site immediately to ensure no illegal harvesting is occurring and to regularly monitor the site from the time of closure to reopening.

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Western Australian Shellfish Quality Assurance Program

Routine Surveillance Report

Date of Inspection: Shellfish Growing Area: Date Area Closed for Harvesting: Illegal Activities Detected?: Name of Licensee: Licence Number: Shellfish Species: Boating Activities in Area: Shoreline Activities: Comments: To Whom Illegal Activities Reported: Name of Investigating Inspector: Signature:

WASQAP Operations Manual 2004 58

Western Australian Shellfish Quality Assurance Program

Annual Surveillance Report

Name of Growing Area: District Office Responsible for Surveillance:

Period Covered by Surveillance Report: Number of Days the Area was Closed:

Dates and Reasons for Closure (routine management or emergency closure): Dates the Area was Monitored: Methods of Monitoring: Log of Complaints re Illegal Harvesting: Comments: Name of Regional Manager: Signature:

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Appendix 5 - Symptoms of Toxic Shellfish Poisonings The following information is provided by Australian Research Network on Algal Toxins (ARNAT). ASP Amnesic Shellfish Poisoning Causative algal species include Pseudo-nitzschia diatoms, such as P.multiseries, P. australis, P.pseudodelicatissima (some strains), P.delicatissima, P.pungens (some strains), and P. turgidula. The causative toxins for this affliction are domoic acid and their isomers. Domoic acid is an unusual amino acid structurally related to the neurotransmitter glutamic acid. It is able to compete with glutamic acid for a number of neurological receptors which are triggered by glutamate. Typical symptoms are amnesia (which may last days, if not longer), nausea, vomiting, abdominal cramps, diarrhoea, seizures and disorientation. In severe cases, coma may occur followed by death. PSP Paralytic Shellfish Poisoning Causative dinoflagellate species include Alexandrium catenella, A. minutum, A. ostenfeldii, A. tamarense, Gymnodinium catenatum and Pyrodinium bahamense var. compressum (tropical species). Freshwater cyanobacteria such as Anabaena circinalis produce identical toxins. The causative toxin for this affliction is saxitoxin and its congenors. Saxitoxin blocks sodium ion flow through voltage-sensitive sodium channels thereby inhibiting conduct of cellular action potential in excitable tissues such as nerve or muscle. Victims typically experience tingling and numbness of the mouth, tongue and extremities, nausea and vomiting. In severe cases, the patient will exhibit more severe neurological symptoms such as ataxia, weakness, dizziness, a sense of dissociation followed by complete paralysis. Death may result from respiratory paralysis. DSP Diarrhoetic Shellfish Poisoning Causative organisms include the dinoflagellates Prorocentrum lima, P. elegans, P. hoffmannianum and P. concavum, Dinophysis acuminata, D. fortii, D. hastata, D.mitra, D. rotundata, and D. tripos (some strains only). The major causative toxin for DSP is okadaic acid and is derivatives. This toxin inhibits several classes of protein phosphatases, enzymes that remove phosphate from other proteins to regulate their function. Typical symptoms are vomiting and diarrhoea which may become so severe as to incapacitate the patient. DSP is never fatal. NSP Neurotoxic Shellfish Poisoning Causative organisms are the dinoflagellate Gymnodinium breve and related species. NSP results from consumption of shellfish contaminated with the dinoflagellate toxin, brevetoxin. Brevetoxin binds to the voltage-gated sodium channel and cause increased sodium ion conductance and nerve cell depolarisation. Typical symptoms are tingling, dizziness, fever, chills, muscle pains, nausea, diarrhoea, vomiting, headache, reduced heart rate and pupil dilation. NSP is never fatal.

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Appendix 6 - Sample Collection Information and Laboratory Forms

WASQAP Operations Manual 2004 61

WASQAP Operations Manual 2004 62

WASQAP Operations Manual 2004 63

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Appendix 7 - Sampling Timetable

Year 2004 – Sampling Program for Growing Areas

Bacteriological Tests Mussel and Water Samples

Phytoplankton Water Samples

Month Day Date Week No 1st Sample of Month

2nd Sample of Month

January Thursday 29 Jan 2004 4 13 Jan 2004 29 Jan 2004 February Tuesday 10 Feb 2004 2 10 Feb 2004 24 Feb 2004 March Thursday 25 Mar 2004 4 8 Mar 2004 25 Mar 2004 April Thursday 1 Apr 2004 1 1 Apr 2004 19 Apr 2004 May Thursday 20 May 2004 3 6 May 2004 20 May 2004 June Tuesday 8 Jun 2004 2 8 Jun 2004 23 Jun 2004

Wednesday 7 Jul 2004 2 July Tuesday 13 Jul 2004 3

7 Jul 2004 20 Jul 2004

August Thursday 12 Aug 2004 2 12 Aug 2004 25 Aug 2004 September Wednesday 8 Sept 2004 2 8 Sep 2004 23 Sep 2004 October Wednesday 27 Oct 2004 3 12 Oct 2004 27 Oct 2004 November Thursday 11 Nov 2004 3 11 Nov 2004 26 Nov 2004 December Tuesday 7 Dec 2004 2 7 Dec 2004 20 Dec 2004

Chemical Tests Mussels and Oyster Samples

Month Day Date Notes December Tuesday 7 Dec 2004 Test for heavy metal, pesticides and PCB

Notes: 1. Adverse conditions are most likely to occur May to October in areas that are classified

as 'Conditionally Approved'. If water and mussel samples have been collected, as a result of sampling recommendations under adverse conditions as shown in Figure 1, then the above scheduled samples do not require to be collected in that month.

2. Water and mussels samples for bacteriological tests are to be collected under the DOF

supervision. 3. All samples must arrive at the relevant laboratory as soon as practical and under

temperature control. 4. A Monthly Sampling Program Information Sheet must be faxed to the WASQAP

Manager each and every time that samples are collected. 5. If weather conditions are unsafely to take samples on the scheduled day then the

collection shall be deferred to the day immediately after weather has abated. 6. ANY DEVIATION FROM THE SAMPLING PROGRAM MUST BE WITH THE

AGREEMENT OF THE WASQAP MANAGER.

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Year 2005 – Sampling Program for Growing Areas

Bacteriological Tests Mussel and Water Samples

Phytoplankton Water Samples

Month Day Date Week No 1st Sample of Month

2nd Sample of Month

January Tuesday 11 Jan 05 2 11 Jan 05 20 Jan 05 February Thursday 24 Feb 05 3 10 Feb 05 24 Feb 05 March Tuesday 22 March 05 4 9 March 05 22 March 05 April Wednesday 13 April 05 2 13 April 05 28 April 05 May Thursday 12 May 05 2 12 May 05 23 May 05 June Monday 27 June 05 4 13 June 05 27 June 05

Tuesday 12 Jul 05 2 July Monday 18 Jul 05 3

8 Jul 05 18 Jul 05

August Thursday 4 Aug 05 1 4 Aug 05 16 Aug 05 September Monday 26 Sept 05 3 13 Sept 05 26 Sept 05 October Monday 10 Oct 05 2 10 Oct 05 26 Oct 05 November Wednesday 2 Nov 05 1 2 Nov 05 15 Nov 05 December Thursday 22 Dec 05 3 9 Dec 05 22 Dec 05

Chemical Tests Mussels and Oyster Samples

Month Day Date Notes December Friday 9 Dec 05 Test for heavy metal, pesticides and PCB

Notes: 7. Adverse conditions are most likely to occur May to October in areas that are classified

as 'Conditionally Approved'. If water and mussel samples have been collected, as a result of sampling recommendations under adverse conditions as shown in Figure 1, then the above scheduled samples do not require to be collected in that month.

8. Water and mussels samples for bacteriological tests are to be collected under the DOF

supervision. 9. All samples must arrive at the relevant laboratory as soon as practical and under

temperature control. 10. A Monthly Sampling Program Information Sheet must be faxed to the WASQAP

Manager each and every time that samples are collected. 11. If weather conditions are unsafely to take samples on the scheduled day then the

collection shall be deferred to the day immediately after weather has abated. 12. ANY DEVIATION FROM THE SAMPLING PROGRAM MUST BE WITH THE

AGREEMENT OF THE WASQAP MANAGER.

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