Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs by Nanie Gonzales

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs Copyright ÂŠ 2017 Published by Bureau of Fisheries and Aquatic Resources Fisheries Resources Management Division 3rd Floor, PCA Annex Building, Elliptical Road, Diliman, Quezon City Telephone Nos. +632 929-9597, +632 929-8074, +632 929-4894 Email address: bfar_hab@yahoo.com Website: www.bfar.da.gov.ph/www.bfar-frmdhabtoxin.ph All rights reserved. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the publisher. ISBN: 978-971-8722-46-6 Citation: Bureau of Fisheries and Aquatic Resources. 2017. Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs. Fisheries Resources Management Division, Bureau of Fisheries and Aquatic Resources, Department of Agriculture, Quezon City. (52 pages) Disclaimer: This publication has been produced with assistance from The European Union â&#x20AC;&#x201C; Trade Related Technical Assistance Project 3. The contents of this publication are the sole responsibility of the Philippine Bureau of Fisheries and Aquatic Resources, and can in no way be taken to reflect the views of the European Union.

Bureau of Fisheries and Aquatic Resources

Foreword

eafood can generally be considered to be a safe, healthy and nutritious food. However, the consumption of raw or undercooked filter-feeding bivalve molluscs harvested from faecally contaminated waters may result in illness due to the presence of harmful microorganisms. Filter-feeding bivalve molluscs may also pose a risk to public health when they are havested during periods of harmful algal blooms or red tides when shellfish concentrate marine biotoxins and become toxic. This manual details the components of the Philippine National Shellfish Sanitation Programme (NSSP) which will be implemented by the Bureau of Fisheries and Aquatic Resources (BFAR) in collaboration with the municipal and city governments - the Local Government Units (LGUs). The aim of the programme is to protect consumersâ&#x20AC;&#x2122; health, to facilitate both domestic and international trade and to protect the reputation of the Philippines as a producer of safe and nutritious seafoods. An evaluation of the sources and types of faecal and other types of contamination in the vicinity of harvesting areas through structured sanitary surveys, combined with microbiological monitoring based on the use of indicator organisms (Escherichia coli), provides an assessment of the risk of contamination with bacterial and viral pathogens and is the basis for public health controls. Continuous microbiological monitoring of growing areas provides a basis for the classification of shellfish growing areas and determines whether the areas can be used for harvesting and what level of post-harvest treatment is needed to reduce the risk to a level which is regarded as acceptable. In addition to testing for the presence of marine biotoxins toxins in live bivalve molluscs, production areas are periodically monitored to check for the presence of certain toxin containing phytoplankton which provide an early warning of the occurrence of a red tide event. The NSSP requires the constant sampling and testing for a range of marine biotoxins which provides the basis for opening or closing shellfish growing areas and alerting the public of possible risks to health. Periodic monitoring and testing for heavy metals, such as cadmium, lead and mercury are also included as part of the NSSP. The NSSP provides the best independent scientific advice to underpin food safety policy and risk management decisions regarding the classification of shellfish growing waters and the degree to which shellfish have to be treated before they are safe to eat. The programme also provides the scientific evidence that informs decisions regarding the open or closed status of growing areas for harvesting of shellfish and the risks to consumer health. This Manual is intended to assist both BFAR and the LGUs in implementing a scientifically based food control programme for the protection of public health and the promotion of domestic and international trade in seafoods. The Manual was prepared as part of the European Union (EU) Trade Related Technical Assistance Project 3 to the Philippines and provides the basis for establishing equivalent hygiene and safety standards for live bivalve mollusc production and oďŹ&#x192;cial controls to those implemented in the EU.

Atty. Asis G Perez Director Bureau of Fisheries and Aquatic Resources

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

Acknowledgements

his Manual was published by the Trade Related Technical Assistance Project 3 (TRTA 3) as one of its outputs. TRTA3 is a development cooperation project by and between the Government of the Philippines and the Commission of the European Communities. The Manual was produced by Professor Alan Reilly (Adjunct Professor, Institute of Food and Health, University College Dublin, Ireland), a consultant employed by ACE International Consultants, Spain, in cooperation with staff from the Fisheries Resources Management Division (Sandra Victoria R.Arcamo, Juan Relox Jr., Leah Mora T. Cabella, Marc Lawrence J. Romero, Lovella C. Carolino, Lourdes C. Legazpi, Khistian E. Escasa, Alvin G. Awatin, Aira May M. Seguerra, Edcel May N. Llemos, Chona I S. Levardo, Glizdale N. Lo, Guillermo M. Tabora) and the Fisheries Product Testing Laboratory (Freda V. Roxas, Owen Camu, Randy Ramos, Gina Dongaol, Jo Ann Torno, Cassandra Lousie Domingo, Anne Lorraine Santiago, Ivy Dyan P. Banogon) of the Bureau of Fisheries and Aquatic Resources Central Office, BFAR Region V (Irmi B. Mora and staff), BFAR Region VI staff, and Capiz Office of the Provincial Agriculture (Audie Belargo, Florie May Calmorin and staff).

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Table of Contents

Foreword ................................................................................................................................................................................................................................................................................................................................................................................5 Acknowledgements .......................................................................................................................................................................................................................................................................................................................................... 6 1.

Glossary of Terms and Abbreviation ..........................................................................................................................................................................................................................................................9

Background and Introduction ................................................................................................................................................................................................................................................................................11 2.1 2.2 2.3 2.4 2.5 2.6 2.7

Scope ....................................................................................................................................................................................................................................................................................................................................................11 Aim............................................................................................................................................................................................................................................................................................................................................................12 Stakeholders ..........................................................................................................................................................................................................................................................................................................................12 Legislation Governing Production of Bivalve Molluscan Shellfish ..................................................................................................................................13 Microbiological Standards for Bivalve Mollusc Harvesting Areas ...................................................................................................................................15 Management of the National Shellfish Sanitation Programme (NSSP) ..............................................................................................................16 European Union Legislation......................................................................................................................................................................................................................................................................16

Code of Practice for the Microbiological Monitoring of Bivalve Mollusc Growing Areas ........................................................18 3.1 3.2 3.3 3.4

Sampling Plans for Classified Shellfish Production Areas..............................................................................................................................................................18 Selecting sampling point location ................................................................................................................................................................................................................................................18 Sanitary surveys .............................................................................................................................................................................................................................................................................................................18 Sampling and Sample Transportâ&#x20AC;Ś...............................................................................................................................................................................................................................................22 3.4.1 Selection of bivalve species to be monitored 3.4.2 Depth of sampling 3.4.3 Sampling frequency 3.4.4 Short-term classifications 3.4.5 Time of sampling 3.4.6 Recording of the sampling plan 3.4.7 Sampling and sample transport protocols 3.4.8 Provision of samples by industry 3.4.9 Training of samplers 3.4.10 Audit of sampling and transport procedures 3.4.11 Provision of sample results by industry 3.5 Microbiological Testing.......................................................................................................................................................................................................................................................................................24 3.5.1 Methodology 3.5.2 Accreditation 3.5.3 Internal Quality Controls 3.5.4 Comparative testing 3.5.5 Sample condition 3.6. Data Handling and Storage ......................................................................................................................................................................................................................................................................24 3.6.1 Storage and validation of data 3.6.2 Dissemination of Results 3.7. Classification of Growing Areas ........................................................................................................................................................................................................................................................25 3.7.1 Interpretation of monitoring programme data 3.7.1.1 Preliminary classification 3.7.1.2 Full classifications 3.7.1.3 Short Term Classifications 3.7.1.4 Seasonal Classifications

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

3.8

3.7.1.5 Dormant Production areas 3.7.1.6 Interpretation of data in a classification area with several monitoring points 3.7.1.7 EďŹ&#x20AC;ect of environmental factors 3.7.1.8 Responding to out of range or elevated E. coli results from the monitoring program 3.7.1.9 Criteria for discarding results from the classification process 3.7.1.10 Closure of areas around outfalls, harbours and marinas 3.7.1.11 Classification review procedures Communication.................................................................................................................................................................................................................................................................................................................27 3.8.1 Publication of the List of Classified Shellfish Production Areas 3.8.2 Publication of maps of Classified Shellfish Production Areas

Code of Practice for the Biotoxin Monitoring Programme.......................................................................................................................................................................28 4.1

4.2

4.3 4.4

4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13

Phytoplankton Monitoring ............................................................................................................................................................................................................................................................................28 4.1.1 Sampling points and procedures 4.1.2 Mandatory Phytoplankton Sampling 4.1.3 Phytoplankton Analysis and Reporting Shellfish Sampling, Analysis and Reporting ..............................................................................................................................................................................................................29 4.2.1 Organisation of Shellfish Sampling 4.2.2 Responsibilities of the shellfish managers 4.2.3 Responsibilities of shellfish samplers Shellfish Species .............................................................................................................................................................................................................................................................................................................30 Sampling Frequency................................................................................................................................................................................................................................................................................................30 4.4.1 Sampling frequency required for samples to be valid 4.4.2 Pre-Harvest Sampling in order to Open an Area 4.4.3 Changes to the Sampling Frequency Shellfish Production Areas and Sampling Points.............................................................................................................................................................................................31 Sampling for Specific Toxin Groups ...........................................................................................................................................................................................................................................31 Sample Size, Quality and Packing Requirements ...........................................................................................................................................................................................31 Sampling for specific toxin groups ..............................................................................................................................................................................................................................................32 Analysis and Reporting on Samples .........................................................................................................................................................................................................................................32 Assigning a growing area status ....................................................................................................................................................................................................................................................33 Live Bivalve Molluscs from non-classified areas ............................................................................................................................................................................................33 Responsibilities of Harvesters and Processors....................................................................................................................................................................................................33 Communication.................................................................................................................................................................................................................................................................................................................34

Appendices Appendix 1: Appendix 2: Appendix 3: Appendix 4: Appendix 5: Appendix 6: Appendix 7: Appendix 8: Appendix 9:

Standard Operation Procedure for conducting a Shoreline Survey ..................................................................................................................35 Sampling Protocol for Collection and Testing of samples for Microbiological Testing ...............................................37 Format for Sanitary Survey Report .................................................................................................................................................................................................................................40 Shellfish Species and Minimum Sample Size for Biotoxin Testing .....................................................................................................................41 BFAR and LGU Regional Marine Biotoxin Laboratories..............................................................................................................................................................42 Guide to the requirements for Bivalve Molluscs in EU Legislation....................................................................................................................43 Biotoxin Methods of Analysis and EU Regulatory Limit ..........................................................................................................................................................44 BFAR Sampling Procedures for Marine Biotoxins and Plankton for Monitoring Purposes.....................................45 Specimen Shellfish Registration Document ....................................................................................................................................................................................................50

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1. Glossary of Terms and Abbreviations

Aquaculture ASP AZP BFAR Bivalve mollusc

Biotoxins Classification of bivalve mollusc harvesting areas DSP Escherichia coli or E. coli

Esters FAO FPTL Geographical Information System (GIS) HAB HACCP

Hydrodynamic models

ISO TS 16649-3

ISO/IEC17025:2005

With respect to this Manual, it is the raising of bivalve molluscs from the juvenile state in controlled conditions. Amnesic Shellfish Poisoning Azaspiracid Shellfish Poisoning (part of the Lipophilic Group) Bureau of Fisheries and Aquatic Resources Any marine or freshwater mollusc of the class Pelecypoda, having a laterally compressed body, a shell consisting of two hinged valves, and gills for respiration. The group includes clams, cockles, mussels, oysters, and scallops and similar shellfish. A group of toxic substances produced by phytoplankton and accumulated in the bodies of bivalve molluscs which are filter feeders. A system for grading harvesting areas based on levels of indicator organisms (Escherichia coli or E. coli) Diarrhetic Shellfish Poisoning (part of the Lipophilic Group) A species of bacteria that is a member of the faecal coliform group. It is more specifically associated with the intestines of warm-blooded animals and birds than other members of the faecal coliform group, and is used as an indicator of faecal contamination. Traditionally, E. coli produce indole from tryptophan at 44OC. Now, determined on the basis of the possession of ß-glucuronidase activity. Naturally occurring derivatives of toxins which are also toxic. Fisheries Administration Order Fisheries Product Testing Laboratory under the Post-Harvest Division of BFAR A computer based system that combines mapping and data storage functions in order to manipulate, analyze, display, and interpret spatially referenced data. Harmful Algal Bloom Hazard Analysis and Critical Control Point is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. In the context of this Manual, numerical models that approximate flow of seawater, i.e. velocities and water depths as functions of time and space. Output from these models can then be used together with a representation of diﬀusion processes in the water column to represent the fate and dispersion of bacteria. “Microbiology of food and animal feeding stuﬀs - Horizontal method for the enumeration of ß-glucuronidase-positive Escherichia coli - Part 3: Most probable number technique using 5-bromo-4-chloro-3-indolyl-ß-D-glucuronide” is the reference method for enumerating E. coli for classifying shellfish harvesting areas and for testing products to be placed on the market. It is the international standard for use by laboratories in developing their management system for quality, administrative and technical operations. It specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, nonstandard methods, and laboratory-developed methods.

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

Lipophilic toxins

This grouping is comprised of the following groups of toxins: okadaic acid, esters of okadaic acid, pectenotoxins, yessotoxins, and azaspiracid. LGUs Local Government Units (LGUs) are the municipal and city governments that have jurisdiction over municipal waters which include streams, lakes, inland water bodies, and tidal zones in which bivalve molluscs are cultivated. LBM Live Bivalve Molluscs NGR National Grid Reference NSSP National Shellfish Sanitation Programme is managed by BFAR with the aim of protecting consumer health and maintaining the excellent reputation and sustainability of the shellfish industry in the Philippines, and facilitation of both domestic and international trade. Phytoplankton Microscopic plants that live in water PSP Paralytic Shellfish Poisoning Pseudonitizschia spp. Phytoplankton species associated with ASP PTX Pectenotoxins, included in the Lipophilic Group Production Area Any sea, estuarine, or lagoon area, containing either natural beds of bivalve molluscs; or sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken. Relaying The transfer of shellfish from restricted areas to areas approved for natural biological cleansing using the marine environment as a treatment system. Relaying area Any classified sea, estuarine, or lagoon area with boundaries clearly marked and indicated by buoys, posts, or any other fixed means; and used exclusively for the natural purification of live bivalve molluscs. Representative A specified geographical location from which samples are taken to represent either Sampling Point a single or several wild bivalve mollusc beds, or aquaculture sites. The representative sampling point should reflect the location at highest risk of faecal pollution within a classified production area. Sanitary Survey An evaluation of the sources of faecal contamination in or near a harvesting area together with an assessment of the potential impact of these sources on the microbial status of the harvesting area. Shellfish Advisory An official statement declaring a certain water area to be either toxin free or positive for toxic red tide rendering shellfish therein unfit for human consumption. Shellfish Bulletin An official statement issued regularly declaring specific water areas of the country to be either toxin free or positive for toxic red tides. Shellfish Sampling The BFAR/LGU staff officer or the industry representative who carries out sampling in Officer a production area. Shellfish Manager The BFAR/LGU staff officer responsible for overseeing shellfish sampling in a specific area or locality. This task may fall on the Municipal Agriculturist in the LGU. Shellfish Sampling BFAR staff officer who is responsible for overseeing the operation of sampling in the Coordinator Philippine Shellfish Sanitation Programme. Shoreline Survey A physical survey of the shoreline and area adjacent to the shore to confirm the presence of potentially contaminating sources identified through a desk-based study and to identify additional potential sources of contamination. YTX Yessotoxins, included in the Lipophilic Group

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2. Background and Introduction

he Philippine Constitution of 1987 declares that the State shall protect and promote the right to health of the people, and shall protect consumers from trade malpractices and from substandard or hazardous products. Toward these ends, the State has introduced a farm-to-fork food safety regulatory system that ensures a high level of food safety, promotes fair trade, and advances the global competitiveness of Philippine foods and food products. Philippine shellfish are wholesome quality products and it is important that the shellfish industry is supported by a robust monitoring programme so that consumers, both in Philippines and in other countries, can have confidence that the Philippine shellfish products they are purchasing are safe. Philippine regulations exist to control the public health risks associated with consumption of both chemically and microbiologically contaminated shellfish. Ongoing monitoring establishes if the level of risk is such that short-term controls i.e. closing areas for harvesting or recalling products from the market, need to be applied. Many estuaries and coastal areas used for bivalve mollusc cultivation and harvesting in the Philippines, Europe, and elsewhere in the world are also used for sewage disposal. Bivalve molluscs obtain their nutrients by sieving particles from the water column, thus any contaminants are concentrated and retained. Bivalve molluscs are oďŹ&#x2026;en eaten raw or lightly cooked, so there is no final opportunity to kill any pathogenic bacteria or viruses of faecal origin concentrated in the digestive systems of the shellfish before consumption. Additional public health issues are also associated with harmful algal blooms (HABs) or red tides which occur in many parts of the world, including the Philippines and Europe. As bivalve molluscs are filter feeders, they can bio-accumulate particulate matter such as toxic marine plankton from the growing waters during periods of HABs. DiďŹ&#x20AC;erent species of marine plankton produce a range of biotoxins, many of which are heat stable and will not be destroyed or inactivated by cooking. Both European Union (EU) and Philippine regulations exist to control the public health risks associated with the consumption of shellfish contaminated by pathogenic microorganisms, biotoxins, and other possible chemical contaminants. The risk of contamination of shellfish with bacterial and viral pathogens is evaluated with reference to the sources and types of faecal contamination both human and animal in the vicinity of shellfish production areas, and the results obtained based on the indicator bacteria E. coli from samples taken in the area. Areas are classified following a full assessment of this risk and the classification given to an area determines whether shellfish harvested in that area require post-processing treatment and, where appropriate, the level of such treatment. The risk of contamination of shellfish with biotoxins is evaluated by testing growing waters for the presence of toxin producing phytoplankton, and analyzing the flesh of bivalve molluscs for the presence and levels of biotoxins. Based on the results of biotoxin monitoring, decisions will be made whether to close a growing area or whether it is safe to continue harvesting shellfish. 2.1 Scope The National Shellfish Sanitation Manual consists of two monitoring elements that contribute to consumer safety: a.) a code of practice for the microbiological monitoring, and b.) a code of practice for biotoxin monitoring of bivalve mollusk production areas. It is intended to assist both BFAR and the LGUs in implementing a scientifically-based shellfish sanitation control programme.

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

The National Shellfish Sanitation Programme (NSSP) draws on national statutory requirements and on best international practices, and outlines procedures as follows. 2.1.1 Microbiological Monitoring • Producing sampling plans and conducting sanitary surveys • Requirements for sample collection and testing • Procedures for making classifications including data interpretation • Communication of results 2.1.2 Biotoxin Monitoring • Collection and delivery of shellfish and phytoplankton samples • Analysis of shellfish samples • Assigning a status to a production area • Communication of results 2.2 Aim The primary aim of the NSSP is the protection of human health with the view to maintaining the excellent reputation and sustainability of the shellfish industry in the Philippines, and facilitation of both domestic and international trade. 2.3 Stakeholders There are a number of public and private sector stakeholders with interests related to the production and marketing of bivalve molluscs, both at central and local government levels. Those stakeholders that contribute directly to the monitoring programme are as follows. 2.3.1 Department of Agriculture (DA) The Department of Agriculture (DA) is the executive department of the Philippine government responsible for the promotion of agricultural and fisheries development and growth. Its principal functions are the sustainable development of the agricultural and fisheries sectors, formulation of national policies, and the promotion of rural development. The DA has eight bureaus, one of which is the Bureau of Fisheries and Aquatic Resource (BFAR). 2.3.2 Bureau of Fisheries and Aquatic Resources (BFAR) The Bureau of Fisheries and Aquatic Resources (BFAR) is an agency under the DA responsible for the development, improvement, management and conservation of the fisheries and aquatic resources sectors. The functions of BFAR broadly include the preparation and implementation of the Comprehensive National Fisheries Industry Development Plan (CNFIDP), the enforcement of laws and regulations except in municipal waters, and the monitoring and regulation of import and export of fishery and aquaculture products and of fish processing establishments. BFAR is the central competent authority for verifying and certifying compliance of fishery products with EU requirements. It is mandated to support, coordinate, and consult with Local Government Units (LGUs) in matters relating to the management and control of shellfish farming in municipal waters. Under BFAR, the Marine Biotoxin Monitoring Section (MBMS) of the Fisheries Resource Management Division (FRMD) is responsible for the implementation of the HABs or Red Tide monitoring programme while the Fisheries Product Testing Laboratory (FPTL) under the Post-Harvest Division is responsible for the microbiological monitoring. The BFAR Regional Fisheries Management, Regulatory and Enforcement Divisions are in charge of implementing the standards by which the shellfish growing areas in their respective region are classified. 2.3.3 Municipal and City Governments: Local Government Units (LGUs) Municipal waters are defined in Republic Act 8550 (RA 8550) as the general coastline areas including oﬀshore islands up to 15 kilometers from the shoreline. The Local Government Units (LGUs) i.e. municipal and city

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governments have jurisdiction over municipal waters which include streams, lakes, inland water bodies, and tidal zones as defined in RA 7160 and recognized in RA 8550. The LGUs, in consultation with the Fisheries and Aquatic Resource Management Councils (FARMCs), are responsible for the management, conservation, development, protection, utilization, and disposition of all fish, fishery and aquatic resources within their respective municipal/ city waters. Bivalve mollusc farming is carried out exclusively in municipal/city waters. Authorizations to engage in and set up an aquaculture facility are granted by the LGU that has jurisdiction over the site of the aquaculture operation. Likewise the LGUs are responsible for implementing controls associated with the construction and operation of fish pens, fish cages, fish traps, and other structures for the culture of fish and other fishery products. 2.3.4 Fisheries and Aquatic Resource Management Councils (FARMCs) The Fisheries and Aquatic Resource Management Councils (FARMCs) are advisory bodies set up under Fisheries Administrative Order No. 196 of 2000, both at national and municipal levels, with the aim of institutionalizing the role of fisherfolk and other resource users in the planning and formulation of policies and programmes for the management, conservation, protection, and sustainable development of fisheries and aquatic resources. 2.3.5 Environmental Management Bureau (EMB) The Environmental Management Bureau (EMB) is a line bureau within the Department of Environment and Natural Resources (DENR). It is a statutory national authority with independent enforcement powers and has responsibility for pollution prevention and control, and environmental impact assessment. Its mission is to restore, protect, and enhance environmental quality towards good public health, environmental integrity, and economic viability. The EMB is the national authority that sets air and water quality standards, and monitors ambient and point source pollutants. The areas where the jurisdictions of BFAR and EMB intersect with reference to shellfish farming are the classification of fishery areas and the formulation of an integrated coastal management framework; and the setting, monitoring, and evaluation of water quality standards respectively. 2.4. Legislation Governing Production of Bivalve Molluscan Shellfish The current legislative structure governing the production and marketing of molluscan shellfish consists of a number of basic Acts dating back to the mid-1970s and involves a number of government departments, agencies of those departments, and local governments. The functioning of the current multi-agency official food control system is addressed in the Philippine Food Safety Act of 2013 that coordinates the role of all government agencies involved in official food controls and establishes a mechanism for coordination and accountability in the implementation of regulatory functions. A summary of the current legislative systems are described in the next sections. 2.4.1 Republic Act 8550: The Philippine Fisheries Code of 1998 The Republic Act (RA) 8550 or The Fisheries Code of 1998 is the legal basis covering the organization of the BFAR as the competent authority for fish and fishery/aquatic products in the country. It sets out its organization, duties and functions, competencies, rights, and powers. The DA Administrative Order (DAO) No. 3 s. 1998 stipulates the Implementing Rules and Regulations pursuant to RA 8550. This regulation prescribes the procedures and guidelines for the implementation of RA 8550 to facilitate compliance and to achieve the objectives of the Act. 2.4.2 Fisheries Administrative Orders (FAOs) The main legal texts which specifically regulate the official control of bivalve molluscs and other legal texts regulating general fishery products that include provisions for bivalve molluscs, such as hygienic handling and food safety management systems based on the Hazard Analysis and Critical Control Point (HACC) principles are the following Fisheries Administrative Orders (FAOs):

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

FAO No. 196 s. 2000 – Guidelines on the creation and implementation of Fisheries and Aquatic Resource Management Councils (FARMCs) FAO No. 209 s. 2001 – Guidelines on the production, handling and transportation of shellfish for implementation of the local government FAO No. 213 s. 2001 – Establishment and maintenance of BFAR’s quality control laboratories and collection of fees and charges for examination services FAO No. 214 s. 2001 – Code of Practice for Aquaculture FAO No. 234 s.2010 – Accreditation of Marine Biotoxin Centers FAO No. 235 s. 2010 – Safety and Quality Control Standards for PSP Two FAOs that came into force in 2009 lay down specific requirements for exports of seafood to the EU. These set down rules governing the organization and implementation of official controls for fishery products intended for export to the EU, and the rules and regulations governing the export of fishery products to the EU market. These are: • FAO No. 227 s. 2008 - Rules and regulations governing the export of fish and aquatic products to the European Union Member States • FAO No. 228 s. 2008 - Rules governing the organisation and implementation of official controls on fishery and aquatic products for human consumption intended for export to the EU market Both of these FAOs are accompanied by detailed Codes of Practice that establish specific standards for live bivalve mollusc export, and standards for the organization and implementation of official food controls to meet equivalent standards as those in the EU. 2.4.3 Basic Municipal Fisheries Ordinance The DAO No. 3 s. 1998 provides the powers for LGUs to promulgate regulations and to implement all such regulations for fisheries activities taking place in the municipal waters. It requires the LGUs to consult with BFAR and FARMCs when introducing new regulations governing municipal waters. The LGUs enforce all fisheries laws, rules and regulations as well as valid fisheries ordinances enacted by the municipality or city council. The Basic Municipal Fisheries Ordinance (BFMO) covering bivalve shellfish farms promulgated under this DAO includes provisions for the rules and regulations for licensing and issuance of permits, licensing fees, maintaining a registry of fisherfolk, identify areas for mariculture operations, and establish linear boundaries for these areas. 2.4.4 Presidential Decree (PD) 856: The Philippine Code of Sanitation 1975 Presidential Decree (PD) 856 deals with basic public sanitation and the roles of public health agencies in protecting the health of citizens. It deals with water quality, hygiene standards in food processing establishments, and the regulatory role of different government agencies. In relation to molluscan shellfish, it details requirements for designation of oyster beds and fish marketing requirements. 2.4.5 Republic Act 10611: Philippine Food Safety Act 2013 The Republic Act (RA) 10611 or FSA is a comprehensive legislative framework that aims to address the challenges of a multi-agency official food control system which currently exists in the Philippines. The Act is based to a large extent on EU food legislation, and the guidelines and recommendations of the Codex Alimentarius. The overall objective is “to maintain a farm-to-fork food safety regulatory system that ensures

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a high level of food safety; promotes fair trade, and advances the global competitiveness of Philippine foods and food products”. It places the responsibility for the production and marketing of safety food with the food business operator (FBO); requires the FBO to have full traceability systems in place which are based on a “one up – one down” principle; and requires the FBO to notify the competent authority when they find that they have placed unsafe food on the market. There are also provisions to delineate and coordinate the role of all government agencies involved in oﬃcial food controls and to establish a mechanism for coordination and accountability in the implementation of regulatory functions. 2.5 Microbiological Standards for Bivalve Mollusc Harvesting Areas Classification of shellfish harvesting and growing areas according to the microbiological quality of the water is an essential element of the NSSP. Currently, national microbiological standards for shellfish growing waters are based on data from the 1980s. The FAO No. 227 s. 2008 on the Rules and Regulations Governing the Export of Fish and Aquatic Products to EU Member Countries requires that Philippines introduce equivalent standards that would mirror those of the EU for fish and fishery products. For the purposes of this Manual, the microbiological classification of shellfish growing waters will be based on those of the EU. Table 1. Classification of bivalve mollusc harvesting areas based on current EU regulations Standard per 100g of Live Bivalve Mollusc (LBM) flesh and intra-valvular fluid

Treatment required

<230 E. coli per100g of flesh and intra-valvular liquid1

None

LBMs must not exceed the limits of a five-tube, three dilution Most Probable Number (MPN) test of 4,600 E. coli per 100 g of flesh and intra-valvular liquid.2

Purification, relaying in class A area or cooking by an approved method

LBMs must not exceed the limits of a five-tube, three dilution MPN test of 46,000 E. coli per 100 g of flesh and intra-valvular liquid.

Relaying for a long period or cooking by an approved method

>46,000 E. coli per 100g of flesh and intra-valvular fluid3

Harvesting not permitted

Classification

Prohibited

Notes: 1 By cross-reference from Regulation (EC) No 854/2004, via Regulation (EC) No 853/2004, to Regulation (EC) 2073/2005. Areas for which the limit of 230 MPN E coli per 100g but less than 1000MPN E coli per 100g are not exceeded in 10% of samples shall continue to be classified as Class A. 2 By way of derogation from Regulation (EC) No 854/2004, the competent authority may continue to classify as being of Class B areas for which the relevant limits of 4,600 E. coli per 100g are not exceeded in 90% of samples. 3 This level is by default as it is above the highest limit set in legislation.

2.5.1. Designation and Licensing of Estuarine and Coastal Areas for Farming Bivalve Molluscs Shellfish farming takes place in municipal waters and this activity is regulated by the LGUs. Under Section 17 of the Fisheries Code and Section 149 of the Local Government Code, each LGU is empowered to grant fishery rights and privileges, issue fishery licenses, and set license fees, rentals and charges for fishery privileges. In municipal waters, the LGU is responsible for designation and licensing of shellfish farms and for licensing shellfish gatherers, landing sites, and dispatch centers. The LGU maintains a local registry of municipal fisherfolk and municipal fishing vessels, and are responsible for issuing Shellfish Registration Documents (Appendix 8). All shellfish gatherers, be they shellfish farmers or fisherfolk involved in harvesting shellfish, must be registered with the LGU. The local Fisheries Management Oﬃce issues shellfish gatherers with a Shellfish Gatherer’s Book which contains registration documents. A registration document must be completed for each batch of shellfish harvested. The registration document ensures traceability of a batch as the document must accompany the batch from harvest until it is sent to an approved dispatch center.

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

2.6 Management of the National Shellfish Sanitation Programme (NSSP) The overall responsibility for managing the NSSP resides with BFAR as the central Competent Authority for fish and fishery products. As different central and regional divisions of BFAR are involved in the implementation of the NSSP, a management group consisting of an Assistant Director and the Heads of the responsible BFAR Divisions needs to be set up to ensure overall management and coordination of the programme and ensuring a unified approach to classification and monitoring of growing areas. 2.7 European Union Legislation FAO No. 227 of 2008 on the Rules and Regulations Governing the Export of Fish and Aquatic Products to European Union Member Countries requires that fish and aquatic business operators and their products exported to the European Union must meet the same or equivalent hygiene and safety standards as those produced in the EU. Similarly, FAO No. 228 of 2008 on the Rules Governing the Organisation and Implementation of Official Controls on Fishery and Aquatic Products Intended for Export to the EU Market for Human Consumption require that similar or equivalent official controls are put in place and implemented by the government agencies responsible for official controls in the sector. It is the intention of the Philippine Government to develop the bivalve mollusc sector into a robust export industry which targets the EU single market. The EU Food Legislation relevant to this NSSP is shown in Table 2. All the legislation in the table are Regulations, apart from the Shellfish Water Quality and Animal Health Rules which are both Directives. The EU has produced consolidated versions for all the legislation, apart from the Animal Health Rules. These consolidated versions include all the amendments to each piece of legislation. Table 2: Guide to the Requirements for Bivalve Molluscs in EU Food Legislation Area

Legislation

General Principles of Food Law Traceability Responsibilities for FBOs

178/02 - Article 18 - Article 17 & 19, 852/2004 Article 1

All FBOs Primary Producers All other food operators, including transport HACCP

852/04 Article 4 - Annex I - Annex II - Article 5

Registration & approval of establishments General requirements Registration and where approval is required Approval of establishments

852/04 Article 6 853/04 Article 4 854/04 Article 3

Identification Marking General requirements Identification and labelling of live bivalve molluscs

853/04 Article 5 & Annex II, Section I 853/04 Annex III, Section VII, Chpt VII

Live Bivalve Molluscs Specific Hygiene Rules - General requirements, wrapping, transport - Production & harvesting requirements - Purification & dispatch centers - Health standards - Requirements for wild scallops Oﬃcial Controls - Classification & monitoring of areas - Controls on wild scallops and gastropods Biotoxin Methods Microbiological Criteria

853/04 Annex III, Section VII - Chapters I, VI & VIII - Chapter II - Chapters III & IV - Chapter V - Chapter IX 854/04 Annex II - Chapter II - Chapter III 2074/05 Article 3, Annex III* 2073/05 Annex I, Chpt I (1.17,1.24)

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Area

Legislation

Fishery Products Specific Hygiene Rules - Requirements for vessels - Landing and first sale - Establishments and vessels - Cooked crustaceans and molluscs - Health standards including biotoxins - Wrapping, storage & transport OďŹ&#x192;cial Controls Microbiological Criteria

853/04 Annex III, Section VIII - Chapter I - Chapter II - Chapter III - Chapter IV - Chapter V - Chapters VI, VII & VIII 854/04 Annex III 2073/05 Annex I (1.2, 1.16, 1.25, 1.26, 2.4)

Animal Health Rules Aquaculture Diseases

2002/99 (Directive) Annex I

Water Water Framework Directive

2000/60

OďŹ&#x192;cial Controls Verification of compliance

882/04

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

3. Code of Practice for the Microbiological Monitoring of Bivalve Mollusc Growing Areas 3.1 Sampling Plans for Classified Shellfish Production Areas A microbiological sampling plan will be maintained for all classified shellfish production areas and amended as necessary to record bivalve species, sample location code, position of sampling points and frequency of sampling. The sampling plan is the basis of the microbiological monitoring programme of classified shellfish production areas, and the results from such programmes are used in the annual review of classifications. The sampling plan must ensure that the results of the analysis carried out will be as representative as possible for the area considered 3.2 Selecting Sampling Point Location Representative sampling points should reflect the location at highest risk of faecal pollution within a classified production area. To determine this, a sanitary survey of the area should be undertaken. To comply with the best international practice, a sanitary survey must be undertaken to determine the sampling plan for a new harvesting area prior to classification. 3.3 Sanitary Surveys Sanitary surveys involve the identification of potential sources of faecal contamination of bivalve mollusc harvesting areas and an assessment of the likely impact of the sources on the microbiological quality of the fisheries. A sanitary survey is the first step in establishing a classification and a monitoring programme for a bivalve mollusc harvesting area. It provides an overview of pollution influences that serves as scientific basis for subsequent establishment of representative sampling points and a sampling plan. The BFAR will organise to have sanitary surveys for shellfish harvesting areas undertaken for all newly classified shellfish production areas, and establish a programme to conduct sanitary surveys of all existing classified shellfish production areas. This will be achieved in conjunction with LGUs. A sanitary survey usually involves four elements: 1. A desk based study to identify pollution source 2. A shoreline survey to confirm initial findings of the desk based study 3. A bacteriological survey 4. Data assessment 3.3.1. Desk Based Study The following steps should be undertaken during the desk-based phase: Characterization of the production area Through consultation with the LGUs, local oďŹ&#x192;ces of BFAR, industry representatives, and other relevant interested parties, the following characteristics should be identified and recorded for the production area: 1. Location and extent 2. Bivalve species 3. Aquaculture or wild stocks 4. Capacity of area

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5. Whether it is a production area or relaying area 6. Seasonality of harvest 7. Growth and harvesting techniques 8. Any conservation controls (e.g. closed season) 9. Existing classification data Identification of pollution sources An inventory of pollution sources of human and animal origin likely to be a source of contamination for the production area should be made. Where possible, information on the seasonal variation of quantities of such organic pollutants should be gathered. All existing information should be obtained from local and national sources in order to minimize the resources needed to conduct a sanitary survey. The information to be obtained and recorded should, where practically possible, include: 1. Continuous sewage discharges a) Location (Latitude/longitude and/or relevant National Grid Reference - NGR) b) Size in cubic metres per day (dry weather flow, maximum flow; population equivalent if other information not available) c) Treatment level (e.g. untreated, primary, secondary, tertiary, disinfected, septic tank, soak-away) d) Tidal phasing or other periodicity if relevant e) Microbial content (results of any monitoring undertaken on the discharge together with information on the pertinent flow conditions pertaining) f) Sanitary content as surrogate if microbial content not available (measured levels of ammonia, biochemical oxygen demand (BOD), suspended solids together with information on the flow conditions pertaining) g) Seasonal variations in any of the above. 2. Rainfall-dependent sewage discharges (combined sewer overflows or storm tank overflow) and other rainfall-dependent discharges (storm water discharges) a) Location (latitude/longitude and/or relevant NGR) b) Measured or predicted spill frequency (per annum) c) Treatment level (if any) d) Tidal phasing or other periodicity if relevant e) Maximum flow rate (litres per second) f) Microbial content (results of any monitoring undertaken on the discharge together with information on the flow conditions pertaining) g) Sanitary content (as surrogate if microbial content not available) measured levels of ammonia, biochemical oxygen demand (BOD), suspended solids together with information on the flow conditions pertaining) h) Seasonal variations in any of the above. 3. Emergency discharges a) Location (Latitude/longitude and/or relevant NGR) b) Circumstances under which the discharge may operate c) Maximum predicted flow rate (litres per second) d) Microbial content of the associated continuous flow (results of any monitoring undertaken on the discharge together with information on the flow conditions pertaining) e) Sanitary content of the associated continuous flow (as surrogate if microbial content not available) measured levels of ammonia, biochemical oxygen demand (BOD), suspended solids together with information on the flow conditions pertaining) f) Seasonal variations in any of the above. Industrial discharges that have significant sewage content should be assessed as for a continuous sewage discharge but the proportion of sewage, and the eďŹ&#x20AC;ects of any antibacterial action of the chemical constituents should be estimated.

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

4. Land use: a) Pasture land b) Cattle c) Sheep d) Pigs e) Poultry f) Other livestock g) Arable (rice fields) h) Grassland i) Horticulture j) Forest/Woodland k) Urban areas, roads and other impermeable cover. 5. Other pollution sources such as: a) Ships or boats b) Wild animal such as birds c) Spreading of bio solids on land. 3.3.2. Shoreline Survey A shoreline survey should be undertaken by BFAR in consultation with the LGUs and shellfish producers in order to determine whether all significant sources of contamination have been identified by the desk-based study, and whether previously identified sources are still present. The whole shoreline in the vicinity of the bivalve mollusc growing area should be subject to a survey with a view to identifying the pollution sources listed above. As part of the desk study, an assessment needs to be made as to the extent that the survey needs to extend beyond the immediate vicinity of the growing area. A detailed Standard Operation Procedure (SOP) for conducting a shoreline survey is given in Appendix 1. 3.3.3 Bacteriological Surveys If the appropriate location for one or more sampling points for an area is not clear aﬅer completing the deskbased study and any shoreline survey, a bacteriological survey may be undertaken by BFAR in consultation with the LGUs to obtain a more accurate assessment of the location and extent of contamination. 3.3.4 Hydrography / Hydrodynamics It may assist in deciding on sampling points to have information on the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal cycle in the production area should be determined where practically possible using the available information. These may include: • • • •

Nautical charts either within a GIS or hard copy Tidal Atlas Tidal charts/tidal stream soﬅware or simple hydrodynamic modelling Complex hydrodynamic models

Where available this information may be used to interpret the significance of the data gathered during the sanitary survey. 3.3.5 Compilation of Sanitary Survey Report A standardized report format (Appendix 3) which includes the following details should be prepared: a. b. c. d.

Overview of the fishery/production area Hydrography / hydrodynamics Human sources of contamination Agricultural sources of contamination

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e. f. g. h.

Significant wild animal/bird populations Records of shoreline surveys Records of baseline bacteriological monitoring results Assessment of eﬀect on contamination of shellfish

The report should contain maps indicating the location of inputs into the production area, fisheries and other relevant information to aid interpretation and include details of any seasonal effects on contamination. The Sanitary Survey Report will be held centrally by the local BFAR Office and the Office of the LGU. It will be made available to all stakeholders. 3.3.6 Assessment of Sanitary Survey Data and Selection of Sampling Locations The data produced and recorded in the sanitary survey will be assessed to determine representative sampling points within the production area, and appropriate boundaries for the production area. For each potential pollution source, an assessment should be made as to whether it will contribute to the microbial load in the production area. This assessment should consider the microbial load of the source, the distance from the production area and associated dilution. If impact is considered to be likely, a subsequent hydrodynamic assessment may be made to see whether there is still an impact when currents are taken into account. Particular attention to the number and location of sampling points should be given to circumstances where intermittent sources of contamination may not be covered by the regular monitoring program or where the monitoring programme based on E. coli may not adequately reflect the pathogen risk. 3.3.7 Recommendations for Sampling Points: If an area is divided into separate sites each capable of being classified at a different category or subject to short term closures, there must be at least one sampling point per site. Each sampling point should be at a fixed geographical location, identified by latitude/longitude reference to an accuracy of 10 metres. Samples should be taken within an identified distance of this location: a. For hand-picked samples from stake or hanging growing areas, within a maximum of 100 metres. b. For dredged samples this should be within a maximum of 250 metres. c. For wild fisheries in offshore sites, a virtual sampling point may be identified at the center of the production area. Any agreed changes to these maxima should be formally acknowledged in the sampling plan. If it is difficult to obtain sufficient shellfish on a number of occasions, a new point may be identified in consultation with local industry. The old point should then be discontinued. The local office of BFAR and the LGU will be notified of the selection of the sampling points and boundaries. Reduced sampling frequency may also be considered on the basis of the sanitary survey findings. 3.3.8 Review of Sanitary Survey Reviews of Sanitary Surveys will be undertaken by the BFAR to ensure that the environmental conditions have not changed and that the classifications are still valid. This process includes: a. File review on the status of all bivalve mollusc growing areas b. Performance records for all sewage treatment works and industrial discharges c. A status report on abatement of pollution from sources identified during past sanitary surveys d. Evaluation of new pollution sources e. Licence from the LGU It is recommended that a complete re-evaluation of sanitary surveys be undertaken by the BFAR once every six years. Results from both the annual review and the re-evaluation will be made publically available.

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

3.4 Sampling and Sample Transport 3.4.1 Selection of Bivalve Species to be monitored In order to provide the highest standards of food safety, the Philippine national shellfish monitoring programme samples all harvested shellfish species within each production area. DiďŹ&#x20AC;erent bivalve species can vary in the levels of E.coli contamination and in the time of response to uptake and removal of faecal contamination. In wild bivalve mollusc fisheries, where a number of diďŹ&#x20AC;erent species exist, a single indicator species may be sampled to monitor the microbiological quality of the production area. 3.4.2 Depth of Sampling Where bivalve species are grown on ropes or stakes, samples should be taken at the depth that generally yields the highest E. coli results. 3.4.3 Sampling Frequency Preliminary Classification For preliminary (provisional) classification of an area, at least 12 samples should be taken from each identified sampling point not closer together than every two weeks. Ongoing Monitoring of Classified Production Areas The minimum sampling frequency for ongoing monitoring at classified production areas should be at least monthly on a year-round basis. Stable Areas The sampling frequency for areas with greater than three years sampling data, including a minimum of 30 samples, may be reduced to a bimonthly frequency if the site is shown to be stable based on the following criteria: 1.

CLASS A - where the site was subjected to a sanitary survey which confirmed the location of the representative sampling point and that no result >230MPN E.coli /100g was detected in the previous three years. CLASS B - where the site was subjected to a sanitary survey which confirmed the location of the representative sampling point and that no result >4600 MPN E.coli/100g was detected in the previous three years.

This status will be reviewed annually as part of the classification review process. 3.4.4 Short-Term Classifications Where there are clear seasonal patterns to commercial activity in Class A or B areas, preferably enforced by local fishery regulations, monitoring may be considered for a reduced period of the year. This should start at least 1 month prior to the harvesting season for Class A areas and two months prior to the season for Class B areas and then continue throughout the season. 3.4.5 Time of Sampling For the protection of public health, sampling should either be undertaken on as random a basis as possible with respect to likely influencing environmental factors e.g. tidal state, rainfall, wind, etc, so as to avoid introducing

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any bias to the results. Alternatively, sampling should be undertaken under conditions that have been identified as producing the highest levels of contamination. However, it is recognised that samplers are constrained by logistical considerations and it may not be reasonably practical to undertake sampling on this basis. 3.4.6 Recording of the Sampling Plan When decisions have been taken on sampling location, frequency, time and species sampled a sampling plan should be drawn up for each area. The plan will include the following information: a. Production area name b. Unique sampling point identifier c. Geographical location of each sampling point (latitude/longitude) d. Frequency of sampling e. Other relevant information A record of the sampling plan should be held by the relevant BFAR or LGU office and centrally by the BFAR Central Office. Revisions to sampling plans should be reported to all relevant stakeholders as soon as reasonably possible. 3.4.7 Sampling and Sample Transport Protocols • All samples will be taken according to the sampling protocol (Appendix 2) • The maximum elapsed time between sampling and arrival at the laboratory must be 48 hours. • The temperature on receipt in the laboratory must be ≤15˚C unless the transit time from sampling to arrival at the laboratory is <4 hours. • Samples may be stored in the laboratory for up to 24 hours at <8˚C before analysis provided the total time between sample collection and commencing analysis does not exceed 48 hours. All samples must be accompanied by a sample submission form. Complete sample details including the following should be recorded on the sample submission form: a. Sample point identification number and name b. Time and date of collection c. Species d. Method of collection (hand-picked, dredged, etc.) e. Any other information deemed relevant (e.g. unusual events, adverse weather conditions, seawater temperature etc.) may also be recorded The sampling protocol will be available to all samplers. 3.4.8 Provision of Samples by Industry Members of the industry may provide samples. Arrangements for industry sampling should be drawn up on a local basis. In such cases all the arrangements must comply with all aspects of the sampling requirements. A level of supervision by official samplers should be maintained during these arrangements. This level of supervision should form part of the sampling plan and be audited to ensure compliance. 3.4.9 Training of Samplers All samplers should receive formal training before commencing sampling under the monitoring programme. Samplers should also have relevant sampling and safety equipment, and receive, for their area of competence, appropriate training to enable them to undertake their duties competently and to carry out official controls in a consistent manner.

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

3.4.10 Audit of Sampling and Transport Procedures A programme of audits will be drawn up by BFAR and regular audits should be carried out by BFAR Central OďŹ&#x192;ce to ensure a consistent operation of the Bivalve Mollusc Sanitation Programme. 3.4.11 Provision of Sample Results by the Industry Where it is decided to take into account results obtained by industry, it is necessary to ensure that all available data is taken into account for the purposes of determining the classification status. All results submitted by the industry must come from samples that reflect the contaminating sources and have been sampled, transported, and analysed according to standard protocols. Industry samplers should receive training prior to oďŹ&#x192;cial samples being taken. 3.5 Microbiological Testing The Fisheries Product Testing Laboratory (FPTL) under the Post-Harvest Division of BFAR is responsible for the microbiological monitoring while the Inland Fisheries and Aquaculture Division is in charge of establishing standards by which the shellfish growing areas are classified. 3.5.1 Methodology All testing laboratories must use the five-tube three-dilution most probable number technique based on ISO TS 16649-3 for detection of E. coli. All shellfish must be analysed within 24 hours of receipt in the laboratory. Results of analysis are reported by the FPTL of BFAR which is responsible for communication of results to the relevant LGU. 3.5.2 Accreditation All laboratories undertaking testing of bivalve molluscs under the national bivalve mollusc sanitation programme must be accredited to EN ISO/IEC 17025 for the specific method used for E. coli in bivalve molluscs. The status and continued compliance of accredited laboratories is monitored by the BFAR. 3.5.3 Internal Quality Controls Internal quality control procedures are specified in ISO TS 166649-3 and must be complied with. 3.5.4 Comparative testing All laboratories undertaking testing of bivalve molluscs for inclusion in the national bivalve mollusc sanitation programme must participate in proficiency testing/ring trials for E coli in bivalve molluscs specified in EN ISO/IEC 17025. The BFAR central reference laboratory evaluates regional laboratory performance in such proficiency testing and ring trials. 3.5.5 Sample condition All samples not complying with sampling criteria will not be included in the classification process. The sampling coordinator must be informed on receipt of such samples. 3.6 Data Handling and Storage 3.6.1 Storage and Validation of Data Data relating to the monitoring programme will be stored in a database form.

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The following information will be held: a. b. c. d. e. f. g.

Sampling plan information Sample information Results Results from sanitary survey Information on pollution events Results of investigations of pollution events Anomalous E.coli results

3.6.2 Dissemination of results The FPTL will communicate the results of the microbiological monitoring of bivalve mollusc production areas programme on a monthly basis to all stakeholders. 3.7 Classification of Growing Areas Delineation of Classified Areas A classified production area is defined by precise geographical limits relative to the coastline and, where necessary, toward the open sea. It will ideally constitute a coherent entity based on the following: 1. Access 2. Production activity 3. Demarcation of boundaries 4. Hydrological features 5. Characteristics of the circulation of microbiological pollutants Data gathered from the sanitary survey, sampling programme and local information from industry will be used to decide on the boundaries of the classified area. The boundaries will be decided by the local BFAR/LGU offices in conjunction with local industry. The agreed classification will be notified to BFAR Central Office 3.7.1 Interpretation of Monitoring Programme Data 3.7.1.1 Preliminary Classification The results of 12 samples taken not closer together than every two weeks should be assessed against the criteria presented in Table 1 (Section 2.5) for the purpose of preliminary classification. Aﬅer two years, a full classification may be determined on the basis of the criteria given in Table1 (Section 2.5) taking into account a minimum of one (1) sample per month over a period of at least two years, and allowing for any anomalous results. 3.7.1.2 Full Classifications Results from each monitoring point should be reviewed on an annual basis, taking into account the last three (3) years’ data, or all data if there is less than three (3) years’ worth is available. The classification should be determined on the basis of demonstrating compliance with the criteria in Table 1 (Section 2.5.1), and allowing for any anomalous results. If significant changes in contaminating sources have occurred within this period, then only the data obtained since the change(s) should be included in the review. A full classification established on the basis of this, will normally last at least one (1) year. A review should not be undertaken if there are less than 24 results available for three (3) years or the appropriate proportion of this if the period is less than three (3) years. In such a case, consideration should be given to suspension or downgrading of the classification until sufficient additional samples have been taken at the prescribed intervals.

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

3.7.1.3 Short Term Classifications Where there are clear seasonal patterns to commercial activity in Class A or B areas, classification may be considered for a reduced period of the year. In such cases sampling must start at least one month prior to harvesting for Class A areas and two months prior to the season for Class B areas. 3.7.1.4 Seasonal Classifications At least three (3) years’ worth of data showing a clear seasonal trend of E coli results is necessary to establish a seasonal classification. The minimum number of samples required will be 24 samples. The intended transition must be preceded by two (2) months satisfactory sample results when changing from Class C to B and one (1) month satisfactory results when changing from Class B to A. (i.e. the historical results during this period must also conform to the better classification category). The minimum period to be considered for a seasonal classification will be three months. In addition to the transition period from one classification to another, the microbiological results obtained from the microbiological monitoring programme for the period under consideration for seasonal classification must be 100% compliant with the higher classification. Additionally, the overall % compliance from the three (3) year data set for the production area must be > 80% compliance with the higher classification. Reduced frequency (stable area) cannot be applied to production areas with a seasonal classification 3.7.1.5 Dormant Production Areas On information supplied by the local BFAR/LGU office confirming that a production area has ceased production, and that the producer(s) in the area are unlikely to resume production for at least one (1) year, the microbiological sampling programme will be reduced to once per quarter to monitor the microbiological contamination of the production area, and in the case of an A classified production area, it’s classification will be reduced to B classification at the next review of Classifications. A Dormant production area that has been downgraded from A classification to B will require a minimum of 12 samples taken not closer together than fortnightly to be eligible for consideration by the implementation team for upgrading at the annual review of classifications 3.7.1.6 Interpretation of Data in a Classification Area with Several Monitoring Points Where multiple sampling points are used to represent a single classified area, usually because of the presence of multiple contaminating sources, the results from each point should be assessed on the basis of compliance with the legislative criteria given in Table 1 (Section 2.5.1), and allowing for any anomalous results. The classification for the zone should be based on the worst case scenario obtained from all of the monitoring points (i.e. the most contaminated). 3.7.1.7 Effect of Environmental Factors In production areas where the trend of results has been shown to be markedly affected by either individual rainfall events or the total annual rainfall, and the most recent two years’ have had lower annual rainfall than average, the number of years to be included in the analysis should be extended by two. 3.7.1.8 Responding to out-of-range or elevated E. coli results from the Monitoring Programme When E. coli results are obtained during the routine monitoring programmes that are above the upper limit for the classification of the area, immediate action should be undertaken. BFAR Central Office should be informed. The local BFAR/LGU office should immediately inform the producer of the out of range result. Where such out of range results originate from an A classified production area, the BFAR/LGU office will advise that out of range A classification product cannot be placed directly on the market for human consumption. However such product may be placed on the market if subjected to additional treatment consistent with the E. coli levels detected, for

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instance purification in an approved purification center or heat treatment by an approved process. Additionally where such out of range results originate from an A classified production area, and the producers in the area are harvesting or intending to harvest, harvesting operations should cease until a follow up sample taken by the BFAR/LGU indicates that the E. coli levels are within range. In all cases the appropriate BFAR/LGU oﬃce in conjunction with the producer will conduct an investigation into the likely cause of the elevated microbiological result. The nature and extent of the investigation will vary on a local basis but the following should be considered. 1. 2. 3. 4. 5.

Contacting sewage treatment works in the areas to ascertain if any sewage spills may have occurred Rainfall in the period preceding the high result Changes in agricultural practices (e.g. slurry spreading) Any other exceptional activities (e.g. dredging) Industry view on any cause

3.7.1.9 Criteria for Discarding Results from the Classification Process 1. Failure to comply with sampling or laboratory protocols 2. Failure of a sewage treatment system that has been rectified, and where the authority responsible for controlling pollution identifies that such a failure is not expected to recur 3. Extreme rainfall event with a determined on a case by case basis and with reference annual weather reports 4. Clearly identified one-oﬀ pollution event that is unlikely to recur 3.7.1.10 Closure of Areas around Outfalls, Harbours and Marinas Where it is intended to harvest areas from within active harbours and marinas, an assessment of the likely risk should be undertaken to establish their suitability for use. Where sewage or animal slurry inputs discharge directly into a classified area, a risk assessment should be undertaken to establish the impact on the shellfishery. Where considered necessary, an exclusion zone for harvesting may be placed around the point of such inputs. The extent of any such exclusion zone will be decided on a case by case basis considering all relevant information including the size of the input and expected extent of the impact of the discharge in the area. 3.7.1.11 Classification Review Procedures The status of all classified areas will be reviewed annually. Classifications will normally last for a period of one year and, where the data shows clear seasonal trends of E. coli results, the appropriate classification for each season will be considered as described in 3.7.1.4. The BFAR/LGU local oﬃce will make an initial assessment of the data at hand and will assign a classification category (or categories) to each area. As part of the annual classification review, maps of production areas and their associated sampling locations will be reviewed and amended as necessary to ensure that the sampling locations are as representative as possible of the likely pollution sources entering the area. 3.8 Communication 3.8.1 Publication of the List of Classified Shellfish Production Areas The current list of classified live bivalve mollusc production areas in the Philippines will be made available on the BFAR website. BFAR will issue regular update through Shellfish Advisories and Shellfish Bulletins. 3.8.2 Publication of Maps of Classified Shellfish Production Area All maps will be published on the BFAR website.

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

4. Code of Practice for the Biotoxin Monitoring Programme

his Code of Practice specifically relates to biotoxins in live bivalve molluscs and reflects current best international practice and the legal requirements. It outlines the procedures for: a. Collection and delivery of phytoplankton and shellfish samples b. Analysis of shellfish samples c. Assigning a status to a production area d. Communication of results

4.1 Phytoplankton Monitoring Biotoxins are produced by some phytoplankton species found in seawater. If the toxic phytoplankton is ingested by filter feeding shellfish the biotoxins are assimilated into the body of the shellfish. The shellfish are unaﬀected by the biotoxins and will clear the biotoxins from their system if they continue to feed. Fisheries Administration Orders 227 and 228 require that, in addition to checks for the presence of the toxins in live bivalve molluscs, production areas must be periodically monitored to check for the presence of certain toxin containing phytoplankton. The Technical Manuals of the BFAR Marine Biotoxin Monitoring Laboratory (MBML) provides details of the species of phytoplankton that are of significance in Philippine waters, along with their associated toxins. Phytoplankton cell counts are an essential part of the monitoring programme to support shellfish testing. The supply of phytoplankton samples is an important part of the programme and samples should be supplied from each production area to correspond with shellfish samples. In conjunction with other indicators, phytoplankton monitoring provides the following benefits: • an essential early warning of the potential occurrence of toxins in shellfish • assistance with the decision making process on which type of toxin analysis should be carried out • prompts additional or increased frequency of testing of shellfish samples • provides scientific evidence to supplement the results of the toxin analysis of the shellfish • an essential element of risk managing the appropriate shellfish testing requirements While these phytoplankton samples cannot replace shellfish samples, they are a very important second line of defence to indicate the potential toxins that may be present in a production area, and give a useful early warning to producers. They are essential for BFAR/LGUs in planning the frequency of shellfish testing, and in deciding what analysis to prioritize in an area. Rapid increases in toxin producing phytoplankton can indicate the need for additional sampling and/or tests to identify potential harmful toxicity in shellfish. Phytoplankton cell counts are always included in the decision making process to give a more informed picture upon which to base conclusions. 4.1.1 Sampling Points and Procedures Water samples for phytoplankton analysis must be collected according to the Sampling Procedures for PSP, DA and DSP described in the Technical Manuals of the BFAR Marine Biotoxin Monitoring Laboratory (Appendix 8). Phytoplankton sites are located in or adjacent to shellfish production areas taking into account the hydrography of the area. Phytoplankton samplers should ensure that samples are representative of the water column using a vertical haul 20 micron mesh sized plankton net and by following the procedures of the BFAR MBML Appendix 8).

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Plankton samples collected from the provinces should be analysed at the nearest local LGU red tide testing centre or at BFAR regional laboratories (laboratory locations in Appendix 5). The analytical procedures described in the Technical Manuals of the BFAR Marine Biotoxin Monitoring Laboratory should be followed. If submission of samples to a laboratory for analysis is not possible right aﬅer collection, the plankton samples should be preserved using either of the following methods: • For every 90 mL of plankton sample add 10 mL of reagent grade formalin • For every 50 mL concentrated plankton sample, add 0.70 mL acidified Lugol’s Solution. 4.1.2 Mandatory Phytoplankton Sampling Samples of water from each designated phytoplankton sampling point shall be tested for all potentially toxic phytoplankton species on a weekly sampling frequency as required by Fisheries Administrative Order 235. Every classified shellfish production area must collect weekly phytoplankton samples in order to remain on an open status. This requirement applies regardless of the sampling frequency for the shellfish species in the production area. A minimum of three weekly samples will be required in every rolling 4 week period. If the frequency of sampling drops below this level the area harvesting from the area will be prohibited. Dormant areas that wish to re-open, must send in three (3) weekly samples of phytoplankton (in addition to the shellfish samples) in advance of their expected week of recommencing harvesting. Areas that are not in production are not required to take weekly phytoplankton samples. 4.1.3 Phytoplankton Analysis and Reporting Phytoplankton analysis is carried out by laboratories designated by BFAR. Results are typically available within two days of receipt of a sample. The presence of toxic species in phytoplankton samples is an important trigger for additional phytoplankton and shellfish monitoring. A trigger level of greater than 200 cells per litre of Alexandrium, Pyrodinium or Gymnodinium spp has been set for the commencement of shellfish sampling for PSP. If phytoplankton cell counts of Pseudonitzschia spp. reach a level of greater than 1 million cells per liter, this will trigger a requirement for taking shellfish samples for ASP analysis from that production area. 4.2 Shellfish Sampling, Analysis and Reporting A biotoxin sampling plan will be maintained for all classified shellfish production areas and amended as necessary to record bivalve species, sample location code, position of sampling points and frequency of sampling. The sampling plan is the basis of the biotoxin monitoring programme and the results are used to classify growing areas as open or closed for harvesting. The sampling plan must ensure that the results of the analysis carried out will be as representative as possible for the area considered. 4.2.1 Organization of Shellfish Sampling Shellfish production areas are under the official control of BFAR and the LGUs. BFAR Regional Directors/LGU Provincial Aquaculture Officers have responsibility for the overall supervision of production areas within their region and for ensuring that official control samples are taken at the required frequencies. Shellfish managers and shellfish samplers are assigned to each production region/area. 4.2.2

Responsibilities of shellfish managers

Responsibilities of the shellfish managers include: a. Appointing shellfish samplers and back-up samplers for each designated production area b. Ensuring that shellfish samplers are trained commensurate with their responsibilities c. Supervising shellfish samplers in their area. Managers shall verify that samplers collect samples and that samples have been collected according to the defined sampling procedure

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

d. Supplying shellfish samplers with all the equipment required for shellfish/water samples in their production area(s) e. Surveillance of production areas during closed periods to ensure no illegal harvesting of shellfish occurs f. Maintaining records of shellfish samplers and all other relevant documents 4.2.3 Responsibilities of shellfish samplers Shellfish samplers carry out sampling in a production area as assistance to the industry. Shellfish samplers may be an industry representative or other persons. The responsibilities of the shellfish samplers include: a. Collection of shellfish samples and phytoplankton samples from designated sampling points according to the procedures and schedules set down in this Code of Practice b. Forwarding the shellfish samples and phytoplankton samples to the specified laboratory in accordance with the sampling frequency specified Training and information workshops for samplers will be organized by BFAR/LGU as appropriate. 4.3 Shellfish Species The Philippine Biotoxin Monitoring Programme covers all live bivalve molluscs and also live echinoderms and live marine gastropods. The full list of species analysed under the programme is shown in Appendix 4. The regulatory limits apply to both wild and farmed shellfish. Gastropods such as periwinkles and abalone are included in the programme. 4.4 Sampling Frequency The frequency of shellfish sampling is based on an assessment of the available up-to-date toxicity information and seasonal trends (see FAO 235). Sampling frequencies are generally set at weekly, every two weeks or monthly for each shellfish species in a production area. Other frequencies may also be set if conditions necessitate. Sampling should only take place when shellfish harvesting is expected. 4.4.1 Sampling frequency required for samples to be valid For a sample to be valid it must be taken at least 48 hours aďŹ&#x2026;er any previous valid sample. The maximum gap allowed between valid samples will depend on the sampling frequency in force: - When the sampling frequency is weekly a sample should be submitted each week, with no more than 12 days between sample dates. The sampling week starts on a Sunday and ends the following Saturday. - When the sampling frequency is fortnightly a sample should be submitted each week, with no more than 19 days between sample dates. The sampling week starts on a Sunday and ends the following Saturday week. - When the sampling frequency is monthly a sample should be submitted each calendar month, with no more than 38 days between sample dates. The maximum gap specified between samples does not include the days of sampling. For example, when the sampling frequency is monthly, if a sample is taken on the 3rd January then the next sample must be taken during the calendar month of February, on or before the 11th of the month.

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If the period of validity of a sample has finished and no new valid sample has been taken then the production area defaults to a closed status. 4.4.2 Pre-Harvest Sampling in order to open an Area When there are no valid samples submitted the default biotoxin status of an area is closed. As per section 4.1.2 Mandatory Phytoplankton Sampling, dormant areas that wish to re-open, must send in three (3) weekly samples of phytoplankton (in addition to the shellfish samples) in advance of their expected week of recommencing harvesting. Before harvesting from any production area may commence, three (3) shellfish samples must have been analyzed and have tested below the relevant regulatory limits. Samples to open an area for harvesting must have been taken a minimum of 48 hours and a maximum of 12 days apart. Once the area is assigned an Open status the sampling frequency will revert to the relevant frequency (generally weekly, fortnightly or monthly) in place for that species and production area. 4.4.3 Changes to the Sampling Frequency The BFAR continually monitors the results from the analysis of shellfish and phytoplankton. It uses these results along with other information such as seasonal toxicity trends to carry out risk assessments. The BFAR then identifies when sampling frequency should be increased or decreased for shellfish species in production areas. Where such a risk assessment is carried out and used as the basis for varying an areaâ&#x20AC;&#x2122;s sampling frequency it will be kept under review to ensure it reflects the current risk status of the area in question. When the BFAR has identified that changes should be made to the sampling frequency it shall inform the relevant Shellfish Co-ordinator who will in turn inform all the Sample Managers and Samplers. The interval between any decision on sampling frequency variation and its application is normally at least (2) weeks to allow the necessary arrangements be made to ensure a smooth transition. This interval may be reduced, as necessary. 4.5 Shellfish Production Areas and Sampling Points The BFAR has identified shellfish production areas and designated appropriate sampling points within those areas. Maps showing the locations of the shellfish production areas and the sampling points are available on the BFAR website. Each sample point is identified by a code and shellfish samplers must ensure they use the correct code on the sample identification label. The appropriate national sampling code will be agreed by BFAR and published on their web site. Any requests for changes should be sent to the BFAR Shellfish Coordinator in the first instance, who will review the request and consult as necessary. The BFAR and relevant LGU will agree on any changes to the shellfish production areas or sampling points. The BFAR Shellfish Coordinator will inform the relevant shellfish managers and shellfish samplers of the outcome of the review. 4.6 Sampling for Specific Toxin Groups The procedures for sampling of specific toxin groups can be found in the Technical Manuals of the BFAR MBML under the section on Sampling Procedures for PSP, DA and DSP (Appendix 7). The sampling frequency is kept under review and will change in response to changes in phytoplankton counts or the toxicity profile of other species. All shellfish samples must be collected in accordance with these procedures. 4.7 Sample Size, Quality and Packing Requirements Sample size is defined by the number of individual shellfish for each species. Samplers should refer to Appendix 4 for the appropriate number of individual shellfish per sample for each species sampled. Samples must be of an adequate size. Samples should be clean and taken from stock with a good meat yield and that represent

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

commercial product that will be sent to market. Samples containing small meats that take an exceptional length of time to obtain a suﬃcient sample may be rejected, leading to a delay in the reporting of results. The packing requirements for transporting samples to the laboratory are described in the Technical Manuals of the BFAR MBML under the section on Sampling Procedures for PSP, DA and DSP Appendix 8). Samples not adhering to these requirements will be rejected. 4.8 Sampling for Specific Toxin Groups The sampling points for specific toxin groups will be the same as those for phytoplankton sampling (Appendix 8). Details of sampling sites for PSP, ASP and DSP are provided in Appendix 8. The frequency of sampling will vary from twice weekly to monthly. The frequency of sampling is increased when growing areas are positive for biotoxins. The methods used for sample collection and the materials required for sampling are provided in Appendix 8. The methods for handling and storing samples are also included in Appendix 8 Section 7. The salinity and temperature will be recorded at each sampling point on each sampling occasion. Municipal waters in coastal areas are at certain times of the year impacted by rainfall-associated discharges (sewage or surface waters). Salinity readings will give useful information on the degree to which freshwater associated inputs impact on a harvesting area. Such information may be used in the microbiological classification of growing waters and may contribute to shoreline surveys. It may be relevant to take salinity readings at diﬀerent depths or states of tides. 4.9 Analysis and Reporting on Samples FAO 227 sets the standards for acceptable levels of marine biotoxins. Samples of bivalve molluscs must not contain marine biotoxins in total quantities (measured in the whole body or any part edible separately) that exceed the following limits: Biotoxin Methods of Analysis and EU Regulatory Limits Toxin Group

Toxins

Method of Analysis

Regulatory Limit

Reported As

Okadaic acid group*

OA, DTX1, DTX2, including their esters

LC-MS/MS EURL-LCMSMS

0.16 µg/g (160µg/kg)

OA equivalents

Azaspiracids group*

AZA1, AZA2 and AZA3

LC-MS/MS EURL-LCMSMS

0.16 µg/g (160µg/kg)

AZA-1 equivalents

Pectenotoxins group*

PTX1 and PTX2

EURL-LCMSMS

0.16 µg/g (160µg/kg)

PTX Equivalents

Yessotoxins group*

YTX, 45 OH YTX, homo YTX and 45 OH homo YTX

LC-MS/MS EURL-LCMSMS

3.75 µg/g (3.75 mg/kg)

YTX equivalents

Paralytic Shellfish Poison

dcGTX23, dcSTX, GTX2, 3, GTX5, STX, C1,2, GTX1,4, NEO, dcNEO

HPLC FD Lawrence Method AOAC 2005/06

800 µg/kg

STX diHCl equivalents

DA and epi-DA

AOAC 2006/02 HPLC UV

20mg/kg (20 mg/kg)

Amnesic Shellfish Poison

(800 µg/kg) Sum of Domoic Acid & epi Domoic acid.

Bureau of Fisheries and Aquatic Resources

4.10 Assigning a Growing Area Status Production area status (Open/Closed for harvesting) is assigned based on the results of the analysis of samples taken under the Philippine National Shellfish Sanitation Programme. The Philippine regulatory level for PSP in 60 microgram STX equivalent per 100 g of shellfish meat. If toxicity exceeds this regulatory level, BFAR will issues a Shellfish Advisory to the concerned LGU and will also disseminate this information as a national notification in a Shellfish Bulletin. This will notify publicly a ban on harvesting shellfish and warning consumers about the risks of marketing and consuming shellfish from the implicated area. Areas under a shellfish ban will be monitored on a weekly basis. When the results of monitoring show levels of PSP in shellfish meat to be below 60 microgram SYX/100g for three consecutive weeks, BFAR will declare the area open for harvesting. Laboratory testing for PSP takes place in regional laboratories in the Philippines which are recognized by BFAR. Testing for ASP and DSP only takes place in the BFAR Central Laboratory in Manila. PSP is the most common biotoxin currently found in Philippines waters and is the primary cause of growing areas being closed for harvesting. While phytoplankton associated with the production of DSP and ASP have been identified by BFAR during routine monitoring of phytoplankton samples, the levels at which these are found are low and are of no public health concern. 4.11 Live Bivalve Molluscs from Non-classified Areas Some bivalve shellfish species are harvested from offshore wild fisheries that are not classified. These include such species as scallops (Pectinidae spp), pen shells (Pinnidae spp), carpet shells (Phaphia spp) and different species of cockles belonging to the family Cardiidae. These species are harvested by small scale fishermen using traditional harvesting techniques. Shellfish such as scallops and pen shells are usually shucked and the adductor muscle is the sole part of the shellfish that will be exported. All batches of bivalves from offshore wild fisheries may only be placed on the market for human consumption if they are accompanied by a completed Shellfish Registration Document or a Shellfish Gatherers Document (see Appendix 9). This document will record the name and address of the gatherer, date of harvesting, quantities harvested, species harvested, location of harvesting, name of the fishing vessel as appropriate. For traceability purposes, all batches must comply with the requirements of BFAR Administrative Circular number 251 of 2014 that governs traceability systems for fish and fishery products. Bivalves harvested from offshore sites can only be placed on the market for human consumption via a processing establishment approved for the shucking of bivalves, a fish auction approved for the handling of bivalves or a dispatch center. Bivalves from offshore sites being placed on the market via approved establishments must not contain marine biotoxins in total quantities (measures in the whole body or any part edible separately) that exceed the limits set out BFAR Administrative Order number 235 of 2010 that governs the safety and quality standards for PSP. 4.12 Responsibilities of Harvesters and Processors It is a requirement of Philippine national law that producers, manufacturers, distributors, retailers and caterers bear the primary responsibility, individually or, as appropriate, collectively, for the safety and suitability for human consumption, of any food placed on the market by them. Anyone involved in the placing of food on the market is required to take all reasonable steps, insofar as they are concerned, to ensure the safety and hygienic standard of that food. Food processors shall ensure that food satisfies the requirements of food law and that control systems are in place to prevent, eliminate or reduce risks to consumers. Controls in this area are derived under the Food Safety Act 2013, various Fisheries Administration Orders and Local Government Ordinance. Food processors involved in primary production and post-harvest stages of the food supply chain should implement food safety management systems based on HACCP principles. The food safety management system must include clear specifications for incoming raw material and fished product,

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

along with procedures and instructions to be followed in the event of a batch of raw material or processed product failing to meet the requirements of regulations. Primary producers and processors must ensure they are aware of the current status of a production area and all up-to-date relevant results of the NSSP. All current relevant information on the status of growing are published on the BFAR web site. Harvesting of shellfish for placing on the market must only take place from classified production areas, except for harvesting shellfish from wild offshore fisheries. Harvesting can only take place when growing areas are classified as open for harvesting on the basis of biotoxin results. Before processed shellfish are placed on the market, processors must have robust recall and traceability procedures in place in accordance with the requirements of the Food Safety Act 2013. Processors handling shellfish from wild offshore fisheries should only place product on the market when the sample biotoxin results for the batch are available. If shellfish have leﬅ the control of the processor, and are found to not meet the legal requirements or product specification, they should be recalled and withdrawn from the market and the BFAR should be immediately notified. Harvesting techniques must not cause contamination or excessive damage to shells or tissues of live bivalve molluscs or result in changes significantly affecting their suitability for processing, or as appropriate for purification of relaying. Fish processors must adequately protect live bivalve molluscs from crushing, abrasion or vibration; avoid exposure to extreme temperatures; must not re-immerse live bivalve molluscs in water that could cause additional contamination; and avoid contamination during transport. 4.13 Communication In the interests of consumer safety and protection, the widest practical dissemination is given to biotoxin data from the Philippine National Shellfish Monitoring Programme. In order to promote confidence in the programme, stakeholders and particularly producers are given the widest possible access to results and the other associated information. The BFAR is responsible for the management of all biotoxin data and it publishes the results on the HABs section of the BFAR website. The criteria for issuing communications in the form of advisories and bulletins by the BFAR are outlined in Fisheries Administrative Order 235 on Safety and Quality of Control Standards for PSP. Shellfish Advisories are issued based on supporting monitoring data which declare certain areas are either positive for red tide toxins (PSP) when the level for PSP is 60 microgram or above of STX equivalent per 100 g of shellfish meat or free from PSP toxins (less than 60 microgram STX/100g shellfish meat for three consecutive weeks at all sampling stations). The responsibility for ensuring the quality of data that are included in the Shellfish Bulletins belongs to the Marine Biotoxin Section of BFAR. Once data are verified the BFAR Director issues the Shellfish Bulletin which is disseminated to Fisheries Regional Offices, LGUs, print and broadcast media, the Philippine Information Agency and the Department of Health.

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Appendices

Appendix 1: Standard Operation Procedure (SoP) for Conducting a Shoreline Survey Document:

Standard Operation Procedure

Version 1

Section:

Conducting a Shoreline Survey

Title:

Bureau of Fisheries and Aquatic Resources

Approved:

1 March 2015

1.0

PURPOSE To define the procedure for carrying out a shoreline survey of bivalve mollusc production areas

2.0

SCOPE Planning, carrying out and reporting on a shoreline sanitary survey of bivalve mollusc production areas as part of a sanitary survey required by the Bureau of Fisheries and Aquatic Resources

3.0

RESPONSIBILITY It shall be the responsibility of the BFAR and the LGU to organize to have shoreline surveys undertaken as part of a Sanitary Survey when deemed necessary.

4.0

DEFINITIONS Shoreline Survey: A shoreline survey is an investigation of a defined coastal region to identify actual or potential sources of pollution in that area. It will identify all properties/ significant structures of the shoreline, and quantify, in so far as is reasonably practicable all potential or actual sources of pollution in the region.

Page 40 of 62

Actual Pollution Source: A known source of pollution, which is, or is capable of, causing the microbiological standards for classified shellfish areas to be exceeded. A source can only be described as actual if: 1. It has been found to have consistently high microbiological levels, or 2. It is determined, beyond a reasonable doubt, that the source is polluting, or capable of polluting the surrounding area, e.g. a sewage treatment works outfall or failing septic system. Actual pollution sources should be re-evaluated a minimum of every six years. Potential Pollution Source: Any source found which has the potential to infrequently and/or unpredictably release contaminants to the surrounding shellfish growing waters, at levels, which may cause the microbiological standards for classified shellfish production areas to be exceeded. Examples include storm water overflows, agricultural runoff, marinas, domestic dwellings, etc. During an initial shoreline survey all sources found may be classified as potential until further bacterial or other investigations can be conducted. Potential pollution sources should be re-evaluated, through sampling or other means, at least every six years. Point Sources: Identifiable single sources of effluent which is discharged via pipes or drains or similar, e.g. discharges from industrial facilities and waste water treatments plants. Non-point source: diffuse source(s) of effluent which cannot be traced back to a single source, e.g. land runoff, precipitation, atmospheric deposition, drainage, seepage, etc. Live Bivalve Molluscs: Filter-feeding shellfish with two shells. The legal requirements for LBM also relate to live echinoderms, live tunicates and live marine gastropods

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

5.0

RELEVANT LEGISLATION • DENR Administrative Order No 34 Series of 1990 Revised Water Usage and Classification/ Water Quality Criteria • Fisheries Administration Order 227 • Fisheries Administration Order 228

6.0

RELATED DOCUMENTS • Republic Act No 8550: The Philippine Fisheries Code • A Handbook on Preparing Municipal Fisheries Ordinance: BFAR 2004

7.0

MATERIALS AND EQUIPMENT 1. Map of the area to be surveyed 2. GPS 3. Notebooks and writing materials 4. Digital camera 5. Personal protective equipment as required

8.0

PROCEDURE For practical and logistical reasons the survey area must be clearly defined and identified on a map of the production area. This defined area will be given a particular designation which must be detailed on all reports and data associated with the survey. Information and assistance should be sought from the local BFAR and LGU Oﬃce. 1. Assemble and assess existing background information, including historical survey findings where available. 2. Determine whether the area is to be surveyed on foot or by boat or both. 3. Determine the appropriate health and safety procedures and ensure necessary arrangements are in place in advance of the on-site visit. 4. On-site survey: a. Identify the location of each wastewater treatment plant, domestic, industrial or agricultural pollution source. b. Describe in as far as is practicable the nature and extent of the discharge. c. Identify sources of eﬄuent which require sampling for analysis. d. Describe weather conditions pertaining during the survey period. e. Evaluate the numbers and types of farm animals, in so far as is reasonably practicable. f. Identify the location of marinas and evaluate in so far as is reasonably practicable associated discharges. g. Note any flocks of wild fowl/populations of wild animals evident and where possible include an estimation of their numbers. h. Identify and evaluate drainage ditches. i. Identify and evaluate any other significant sources of pollution observed. 5. A report shall be compiled describing each pollution source identified. 6. A map of the area shall be produced clearly identifying each of the pollution sources found. 7. Recommendations for further investigations, including sampling of discharges shall be included in the Shoreline Survey report, where deemed necessary.

Bureau of Fisheries and Aquatic Resources

Appendix 2: Sampling Protocol for Collection and Testing of Samples for Microbiological Testing Document:

Standard Operation Procedure

Section:

Sampling Protocol for the Collection and Transport of Shellfish Samples for E. coli Testing

Title:

Bureau of Fisheries and Aquatic Resources

Approved:

1 March 2015

Version 1

Page 43 of 60

1. 1.1

Purpose and Scope All bivalve mollusc shellfish harvesting areas must be classified according Table 1 in Section 2.5 of this Manual. In order to undertake classification, samples of shellfish are required for E. coli analysis. Samples should be collected according to individual sampling plans for each harvest area. Sampling officers will normally be officers of BFAR or the relevant LGU but may include additional sampling officers authorized by BFAR. This protocol sets out requirements for collection of samples which must be followed by all authorized samplers.

2. 2.1

Responsibility It is the responsibility of the BFAR/LGU to make arrangements for the collection of samples for E. coli testing. The BFAR will arrange training for sampling officers. It is the responsibility of all designated sampling officers to comply with this SoP. Sampling officers must notify the BFAR/LGU shellfish sample coordinator immediately where it is not possible to do so or where they experience problems. It is the responsibility of the Fisheries Product Testing Laboratory under the Post-Harvest Division of BFAR to ensure all testing laboratories adhere to appropriate parts of this SoP. It is the responsibility of the BFAR Central Office to monitor compliance with this SoP.

2.2

2.3 2.4 3.

Safety Determine the appropriate health and safety procedures and ensure necessary arrangements are in place in advance of sampling.

4. 4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.1.7 4.1.8 4.1.9 4.1.10 4.1.11

Procedure The following Equipment will be supplied to all sampling oﬃcers Bivalve Mollusc Shellfish harvesting sampling plan Suitable protective clothing / equipment Thermometer Handheld GPS Sample advice notes Gloves Cool boxes and chill packs Heavy duty plastic sample bags and ties Clippers for opening oyster bags Waterproof marker pen Spade, trowel or rake where appropriate

4.2 4.2.1

Sampling points All sampling points are at fixed geographical locations and are listed in the shellfish sampling plans established for individual harvesting areas. Samples must be collected within 100 meters of the fixed location for hand-picked or raked samples. Samples must be collected within 250 meters of the fixed location for dredged samples. Where it is not possible to collect samples within these limits the BFAR/LGU shellfish sample coordinator and local industry must be informed and alternative sampling locations agreed.

4.2.2 4.2.3 4.2.4

4.2.5 4.2.6

4.2.7

4.3 4.3.1

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

When a sample is taken outside of these limits the coordinates of the actual sampling point shall be taken and notified to the shellfish sample coordinator. All sampling points have been given a unique reference code. The reference code is identified in the sampling plan for the shellfish area. This reference code should be used at all times to identify the sampling location. Changes to sampling locations must be agreed with the BFAR/LGU shellfish sampling coordinator in order for the sampling plan to be updated. Sample Size The following minimum quantities of shellfish must be taken from each sampling location to constitute an individual sample. Shellfish Species

Minimum Number

Minimum Shellfish Size

Native Oysters

Ostrea edulis

7.5 cms

Pacific Oysters

Crassostrea gigas

8 cms

Mussels

Mytilus edulis

4 cms

Cockles

Cerastoderma spp.

3 cms

King Scallops

Pecten maximus

10 cms

Manila Clams

Tapes semidcussatus

4 cms

Pallourdes

Tapes decussatus

4 cms

Razor Clams

Ensis spp.

10 cms

4.3.2 4.3.3

For other species contact the BFAR/LGU sample coordinator to discuss requirements for sample size. If problems are encountered in obtaining the minimum shellfish numbers from a particular sampling location contact the shellfish sample coordinator to consider moving the sampling location.

4.4 4.4.1 4.4.2

Sampling Frequency The sampling frequency for each sample location is recorded in the sampling plan for the shellfish area. If planned samples are missed the BFAR/LGU sample manager should be informed and alternative arrangements for sampling considered. Additional samples may be required following high E. coli results. The shellfish sample coordinator will advise of such occasions. Sample Collection Shellfish samples should be collected by dredging, hand-picking, raking or other suitable means. Once the minimum numbers of shellfish have been collected, as much mud and debris as easily possible should be removed by rinsing with water. Shellfish must not be completely re-immersed in water at any time between sampling and testing. Shellfish should be placed into heavy duty sample bags which prevent leakage. The samples should be clearly marked with the sample point reference code and date and time of sampling using waterproof markers. The bag should be sealed using a tie to prevent possible cross contamination with other samples. Fully complete the BFAR/LGU Shellfish Sample Advice Note and place in a waterproof document wallet. Place samples in a suitable chilled/refrigerated container containing chill packs. Shellfish samples must not be frozen and should not come into direct contact with the chill packs.

4.4.3 4.5 4.5.1 4.5.2

4.5.3

4.5.4 4.5.5 4.5.6

Bureau of Fisheries and Aquatic Resources

4.6 4.6.1

Sampling from Wild Fisheries. In general it is desirable for official samples to be taken by BFAR/LGUs. This may not always be practical in the case of wild fisheries conducted by vessels at sea, with particular regard to health and safety issues. It is therefore not specifically required in those instances that official sampling personnel go to sea in order to perform the actual sampling. In such circumstances, samples may be taken by arrangement from the fishing vessel on landing. When collecting the sample from the vessel, coordinates of the actual point from where the sample were fished should be obtained. Sampling officers should take any additional steps available to confirm that vessels are fishing in the areas indicated.

4.7 4.7.1

4.7.3

Sample Storage and Transport Shellfish samples must be transported to the testing laboratory within 48 hours of sampling. Samples received aﬅer this time may not be tested or if tested the results may not be used in the classification programme. During transport samples must be maintained below 15ºC. Testing laboratories will record the temperature of the sample on receipt. Samples received above 15ºC may not be tested or the results may not be used in the classification programme. If samples are transported to the laboratory within 4 hours the temperature on receipt in the laboratory does not have to be below 15ºC. On receipt in the laboratory samples must be accompanied with a fully completed sample advice note.

CONTACT DETAILS (SEE APPENDIX 5)

4.7.2

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

Appendix 3: Format for Sanitary Survey Report The following outline contains the requirements for the written harvesting area sanitary survey report. 1. Executive Summary 2. Overview of the Fishery/Production area: 2.1. Location Map or chart showing the location/extent of growing/harvesting area 2.2. Description of the area and its functions (e.g. production/relaying) and boundaries: including the capacity of the area 2.3. Description of the species concerned, growth and harvesting techniques, whether aquaculture or wild stocks, and any conservation measures in place 2.4. Current Classification of the Production Area if already an existing classification 3. Hydrography/Hydrodynamics: 3.1. Tides (type and amplitude), and currents (velocity and direction) 3.2. Rainfall data: 3.2.1. Amount 3.2.2. When (e.g. time of year) 3.2.3. Frequency of significant rainfalls 3.3. Winds (seasonality and eďŹ&#x20AC;ects on pollution dispersion) 3.4. River discharges (volume and seasonality) 3.5. Discussion concerning eďŹ&#x20AC;ects of pollution distribution and hydrographic factors (dilution, dispersion, and time of travel) on water quality throughout the growing area 3.6. Salinity, depth, and stratification characteristics 3.7. Simple/Complex models if available. 4. Identification of Pollution Sources: 4.1. Summary of sources and location 4.1.1. Information gathered under the desktop survey procedures, including sewage discharges, industrial discharges, land use and so forth 4.1.2. Map or chart showing the location of major sources of actual or potential pollution in the area (all categories identified). This information may be incorporated in the Location Map as described at 2.1 above 4.1.3. Table of sources of pollution cross referenced to the area map 4.1.4. Shoreline survey report where a shoreline survey has been carried out 5. Sampling Information: 5.1. Location of sampling points and reasons for selection, including map/chart showing sample point locations 5.2. Results of any microbiological analysis/ bacteriological survey undertaken (if any)

Bureau of Fisheries and Aquatic Resources

Appendix 4: Shellfish Species and Minimum Sample Sizes for Biotoxins Testing No. of individual shellfish per sample

Scientific name

Common name

Local Name

Perna viridis

Green Mussel

Tahong

30 - 50

Crassostrea sp.

Oyster

Talaba

20– 40

Paphia undulata

Carpet Shell

Badoy

50 – 100

Tapes literatus

Lettered Venus Shell

Andres-andres

30 - 50

Pinna sp.

Pen Shell

Wasay-wasay/Baloko

20 – 30

Spondylus squamosus

Ducal Thorny Oyster

Lamorok

20 – 40

Chama pacifica

Reflexed Jewel Box/Rock Oyster

Tikod-tikod

20 – 40

Mytilus modiolus

Brown Mussel

Bahong/Amahong

50 – 70

Venerupis philippinarum

Quahog Shell/Venus clam

Bug-atan

50 – 100

Anadara sp.

Blood Cockle

Litob

50 – 70

Soletellina violacea

Sunset shell

Balisara

50 – 100

Cyrtopleura costata

Angel wing clam

Diwal

50 – 100

Saccostrea sp.

Wild Oyster

Sisi

50 – 100

Katelysia sp.

Sunray Venus

Punao/Boyboy

50 – 100

Strombus carium

Dog conch shell

Bongkawil

30 – 40

Lambis sp.

Spider conch shell

Lima-lima/Sa-ang

30 – 40

Placuna placenta

Windowpane shell/Capiz shell

Lampirong

50 - 100

Atrina pectinata

Comb Pen Shell

Sarad

20 – 40

Strombus labiatus

Plicate Conch

Aninikad

50 – 100

Strombus erythrinus

Conch Shell

Dao dao

20 - 40

Ensis directus

Bamboo Shell

Suliot

50-100

Haliotis sp.

Abalone/Ear Shell

Abulon/Kapinan

50-100

Telescopium telescopium

Horn Snail

Barurong/Tubing-tubing

50-100

Pinna nobilis

Black Leaf

Tipay

30-50

Bractechlamys vexillum

Distant Scallop

Tarab/Tika

50-70

Decatopecten radula

Flatribbed Scallop

Tarab/Tika

50-70

Soletellina sp.

Sunset shell

Paros/Sulib

50-100

Venus mercenaria

Round/Hard Shelled Clam

Tuway

30-50

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

Appendix 5: BFAR and LGU Regional Marine Biotoxin Laboratories List of BFAR Regional Marine Biotoxin Laboratories BFAR Regional Marine Biotoxin Laboratories

Address

Contact No.

Regional Oﬃce No. 1

Lucap, Alaminos City, Pangasinan

Tel. no. 075-6324243

Regional Oﬃce No. 3

San Fernando City, Pampanga

Tel. No. 045-455083

Regional Oﬃce No.5

Cabid-an, Sorsogon City, Sorsogon

Cp No. 09289721566

Regional Oﬃce No. 7

Cebu City, Cebu

Tel. No. 032-256-2773

Regional Oﬃce No. 8

Tacloban City, Leyte

Tel. No. 053-321-173

Regional Oﬃce No. 9

Dipolog City, Zamboanga del Norte

Tel. No. 212-8262

Regional Oﬃce No. 10

Ozamis City, Misamis Occidental

Tel. No. 088-564-0690

Regional Oﬃce No. 11

Ramon Magsaysay Ave., Davao City

Tel. No.082-306-4331

Regional Oﬃce No.13

Butuan City,

Tel. No. 086-826-1811

List of Local Government Units Red Tide Centers/Marine Biotoxin Laboratories List of LGUs Marine Biotoxin Laboratories

Address

Contact Nos.

Cavite Red Testing Center

Binakayan, Kawit, Cavite

Tel. No. 434-3740

Bataan Red Tide Testing Center

Balanga, Bataan

Tel. No. 791-4839

Palawan Red Tide Testing Center

Puerto Princesa City, Palawan

Tel. No. 433-2976

Capiz Red Tide Testing Center

Roxas City, Capiz

Tel. No. 621-0042

Bacolod Red Tide Testing Center

Bacolod City, Negros Occidental

Tel. No. 434-5325

Leyte Red Tide Testing Center

Palo, Leyte

Tel. No. 321-2026

Western Samar Red Tide Testing Center

Catbalogan, Samar

Tel. No. 356-1455

Zamboanga del Sur Red Tide Testing Center

Pagadian, Zamboanga Del Sur

Tel. No. 215-2000

Davao Oriental Red Tide Testing Center

Mati, Davao Oriental

Tel. No. 388-4837

Bureau of Fisheries and Aquatic Resources

Appendix 6: Guide to the Requirements for Bivalve Molluscs in EU Legislation Area

Legislation

General Principles of Food Law Traceability Responsibilities for Food Business Operators All FBOs Primary Producers All other food operators, including transport HACCP

178/02 - Article 18 - Article 17 & 19, 852/2004 Article 1

All FBOs Primary Producers All other food operators, including transport HACCP

852/04 Article 4 - Annex I - Annex II - Article 5

Registration & Approval of Establishments General requirements Registration and where approval is required Approval of establishments

852/04 Article 6 853/04 Article 4 854/04 Article 3

Identification Marking General requirements Identification and labelling of live bivalve molluscs

853/04 Article 5 & Annex II, Sectn I 853/04 Annex III, Section VII, Chpt VII

853/04 Annex III, Section VII - Chapters I, VI & VIII - Chapter II - Chapters III & IV - Chapter V - Chapter IX 854/04 Annex II - Chapter II Chapter III 2074/05 Article 3, Annex III* 2073/05 Annex I, Chpt I (1.17,1.24)

853/04 Annex III, Section VIII - Chapter I - Chapter II - Chapter III - Chapter IV - Chapter V - Chapters VI, VII & VIII 854/04 Annex III 2073/05 Annex I (1.2, 1.16, 1.25, 1.26, 2.4)

Animal Health Rules Aquaculture Diseases

2002/99 (Directive) Annex I

Water Water Framework Directive

2000/60

Oﬃcial Controls Verification of compliance

882/04

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

Appendix 7: Biotoxin Methods of Analysis and EU Regulatory Limit Toxin Group

Toxins

Method of Analysis

Regulatory Limit

Reported As

Okadaic acid group*

OA, DTX1, DTX2, including their esters

LC-MS/MS EURL-LCMSMS

0.16 µg/g (160µg/kg)

OA equivalents

Azaspiracids group*

AZA1, AZA2 and AZA3

LC-MS/MS EURL-LCMSMS

0.16 µg/g (160µg/kg)

AZA-1 equivalents

Pectenotoxins group*

PTX1 and PTX2

EURL-LCMSMS

0.16 µg/g (160µg/kg)

PTX Equivalents

Yessotoxins group*

YTX, 45 OH YTX, homo YTX and 45 OH homo YTX

LC-MS/MS EURL-LCMSMS

3.75 µg/g (3.75 mg/kg)

YTX equivalents

Paralytic Shellfish Poison

dcGTX23, dcSTX, GTX2,3, GTX5, STX, C1,2, GTX1,4, NEO, dcNEO

HPLC FD Lawrence Method AOAC 2005/06

800 µg/kg (800 µg/kg)

STX diHCl equivalents

Amnesic Shellfish Poison

DA and epi-DA

AOAC 2006/02 HPLC UV

20mg/kg (20 mg/kg)

Sum of Domoic Acid & epi Domoic acid

*Lipophilic Toxin Group

Bureau of Fisheries and Aquatic Resources

Appendix 8: BFAR Sampling Procedures for Marine Biotoxins and Phytoplankton for Monitoring Purposes Marine Biotoxin Laboratory WRITTEN INSTRUCTIONS

Document Number: Instruction 3.1 Revision Eﬀectivity Date

Bureau of Fisheries and Aquatic Resources 3F Quezon Avenue Quezon City

Sampling Procedures for PSP, DA and DSP

Chapter 1

Review on/Before

Section

Supersedes:

Sub-Section

Page

1. Purpose To provide a standard sampling procedure for the collection of plankton samples harmful algal bloom species and shellfish samples for toxicity analysis intended for monitoring purposes. 2. Scope 2.1 Procedures listed will apply for all samples collected by the Marine Biotoxin Monitoring Laboratory 2.2 Procedures described in this chapter will cover collection of fish, shellfish and seaweed for toxin analysis 2.3 Shellfish collection samples for PSP, ASP and DSP will be provided for monitoring purposes 2.4 Plankton sample collection protocols for the identification of harmful algal bloom species will be provided 3. Sampling Method 3.1 Method used for plankton collection is vertical haul using a 20 micron mesh sized plankton net. 3.2 Simple random sample collection will be employed for collecting shellfish 4. Sampling Sites 4.1 PSP sampling sites for Manila Bay 4.1.1 BataanShellfish Sampling Stations Planters, Lamao - 14°31.40N, 120°37.03E Bo. Luz, Limay - 14°33.12N, 120°36.07E Puting Buhangin, Orion - 14°35.05N, 120°36.12E 4.1.2 Bataan Plankton Sampling Stations Planters, Lamao - 14°31.40N, 120°37.03E Bo. Luz, Limay - 14°33.36N, 120°24.30E Puting Buhangin, Orion - 14°35.05N, 120°36.12E 4.1.3 Bulacan Shellfish Sampling Stations Binuangan, Obando - 14°40.32N, 120°51.18E Masukol, Paombong - 14°43.54N, 120°44.48E Santa Cruz, Paombong - 14°43.16N, 120°46.06E 4.1.4 Bulacan Plankton Sampling Stations Pamarawan - 14°42.52N, 120°47.42E Masukol, Paombong - 14°43.54N, 120°44.48E Santa Cruz, Paombong - 14°43.16N, 120°46.06E 4.1.5 Cavite (Bacoor Bay) Shellfish Sampling Stations Pelayo Farm - 14°28.58N, 120°56.63E Las Piñas - 14°28.89N, 120°56.73E Parañaque - 14°29.40N, 120°56.84E

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

4.1.6

4.1.7

4.1.8

4.2 4.2.1

4.2.2

4.2.3

4.2.4

4.2.5

4.2.6

4.2.7

4.2.8

Cavite Plankton Sampling Stations Pelayo Farm - 14°28.58N, 120°56.63E Bautista Farm - 14°29.52N, 120°56.38E Philippine Navy - 14°29.06N, 120°55.68E Sangley Point - 14°29.42N, 120°55.68E Las Piñas - 14°28.89N, 120°56.73E Parañaque - 14°29.40N, 120°56.84E Navotas Shellfish Sampling Stations San Jose, Navotas - 14°40.12N, 120°53.12E Smokey Mountain, Navotas - 14°37.36N, 120°54.04E Navotas Plankton Sampling Stations San Jose, Navotas - 14°40.12N, 120°53.12E Smokey Mountain, Navotas - 14°37.36N, 120°54.04E PSP sampling sites for Provincial Areas Pangasinan – Shellfish and Plankton Sampling Sites Luciente I, Bolinao - 16°23.27N, 119°55.36E Luna, Bolinao - 16°19.40N, 119°55.48E Culang, Bolinao - 16°18.48N, 119°55.00E Catubig, Bolinao - 16°17.67N, 119°54.96E Awag, Anda - 16°20.03N, 119°56.47E Siapar, Anda - 16°20.97N, 119°56.38E Wawa, Bani - 16°15.91N, 119°56.53E Zambales – Shellfish and Plankton Sampling Sites Bamban, Masinloc - 15°30.33N, 119°57.37E Matalvis, Masinloc - 15°31.08N, 119°57.47E Oyon, Bay - 15°34.17N, 119°56.43E Luan, Palauig, - 15°29.05N, 119°56.15E Sorsogon – Shellfish and Plankton Sampling Sites Pier, Sorsogon City 12°57’30”N, 124°00’08”E Waray Dahon, Sorsogon City 12°57’32”N, 123°59’23”E Casiguran, Sorsogon 12°57’03”N, 123°58’05”E Cambulaga, Sorsogon 12°56’34”N, 124°00’50”E Rizal, Sorsogon Juag Lagoon Matnog, Sorsogon Station I - 12°33’30”N, 124°06’45”E Station II - 12°33’22”N, 124°06’37”E Davao Oriental - Shellfish and Plankton Sampling Sites Balite Bay – Bigue 06°54.15N, 125°09.67E, Balite Bay – Mamali 06°52.82N, 126°10.25E Honda Bay, Puerto Prinsesa City Shellfish Sampling Sites Salvacion - 09°55.732N, 118°48.125E Luli Honda Bay, Puerto Prinsesa City Plankton Sampling Sites San Jose - 09°49.308N, 118°45.958E Santa Lourdes - 09°50.800N, 118°45.409E Bacungan - 09°54.014N, 118°45.45.279E Santa Cruz - 09°55.480N, 118°46.761E Salvacion - 09°55.732N, 118°48.125E Manalo - 09°56.436N, 118°50.340E Malampaya Sound, Taytay Shellfish Sampling Sites New Guinlo 10°47.383N, 119°25.817E Agpay 10°50.283N, 119°20.483E Malampaya Sound, Taytay Plankton Pancol 10°50.933N, 119°22.317E New Guinlo 10°47.383N, 119°25.817E Old Guinlo 10°48.533N, 119°25.050E Gamao 10°50.050N, 119°23.083E Agpay 10°50.283N, 119°20.483E

Bureau of Fisheries and Aquatic Resources

4.2.9 4.2.10

4.2.11

4.2.12

4.2.13

Zamboanga del Sur – shellfish and plankton sampling sites are located within Dumanquillas Bay – Margosatubig Samar Lamningao, villareal 11°35’59”N, 124°55’58”E Buad Channel 11° 38’ 00”N, 124° 54’ 08”E Calbiga 11° 38’11”N, 124° 57’14”E Hitaasan san Sebastian 11° 40’22”N, 124° 56’00”E Jiabong 11° 41’26”N, 124° 58’03”E Majaba cat. 11° 43’29”N, 124° 58’11”E Darahuway cat 11° 43’32”N, 124° 55’11”E Buri cat. 11° 43’22”N, 124° 52’00”E Cagduyong cat 11° 47’32”N, 124° 50’29”E Old mahayag cat. 11° 47’07”N, 124° 48’00”E Mancares tarangnan irong irong bay 11° 50’34”N, 124° 49’01”E Cambatutay tarangnan 11° 50’26”N, 124° 45’25”E Tigdaranao 11° 53’07”N, 124° 43’01”E Pagsangjan 11° 55’15”N, 124° 42’16”E Irong irong point tarangnan 11° 49’48”N, 124° 49’12”E Mandaon, Masbate – shellfish and plankton collection sites Malopoy - 12°14.33N, 123°17.68E Laguinbanwa - 12°13.75N, 123°17.49E Nanipsan - 12°13.245N, 123°17.51E Milagros - shellfish and plankton collection sites Calasuchi - 12°8.24N, 123°32.08E Poblacion - 12°8.42N, 123°29.03E Tinaclipan - 12°8.36, 123°23.14E Surigao del Sur – Plankton and shellfish sample collection sites (Shellfish samples are collected within the vicinity of the listed coordinate and is subject to availability since samples are collected in the wild) Lianga Bay Liatemco, Lianga - 08° 33’54”N, 126° 07’22”E Talisay, Barobo - 08° 32’58”N, 126° 07’50”E Rizal, Barobo - 08° 32’43”N, 126° 09’56”E Sua, Barobo - 08° 32’47”N, 126° 10’54”E Gamut, Barobo - 08° 32’13”N, 126° 12’26”E Bislig Bay - 08° 13’25.65”N, 126° 18’55.27”E Hinatuan Bay - 08° 21’29.45”N, 126° 19’58.89”E Cagwait Bay - 08° 54’11.26”N, 126° 18’43.63”E

4.3 ASP and DSP sampling sites 4.3.1 Manila Bay Sampling Stations 4.3.1.1 Shellfish Sampling Stations – Stations will be limited to the following sampling areas and will have the same coordinates as the PSP sampling stations: Pelayo Farm Las Piñas Binuangan Masukol Bo. Luz 4.3.2 Plankton Sampling Stations – Stations for the identification of ASP and DSP causative organisms will be the same as the PSP sampling stations 4.3.3 Provincial Sampling Stations 4.3.3.1 Shellfish sampling stations - Stations will be limited to the following sampling areas and will have the same coordinates as the PSP sampling stations Culang Luciente Siapar Wawa 4.3.3.2 Plankton sampling stations – Stations for the identification of ASP and DSP causative organisms will be the same as the PSP sampling stations

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

Sampling Frequency 5.1 Manila Bay – samples will be collected twice a week 5.2 Province – samples will be collected once a month when free from PSP toxin and weekly if positive for PSP toxin 5.3 ASP and DSP Sampling Frequency– Manila Bay and provincial sampling stations will be once a month. Samples will be collected during the first week of the month and will coincide with PSP monitoring activities

Sample Collection 6.1 Materials Motorized boat Plankton net (20µm mesh size) with 10 meter rope calibrated at 1.0 meter interval Polypropylene/polyethylene sampling bottles Plastic bags Permanent Markers Masking tape for labeling Sample Containers – plastic bags Station Map Global Positioning System 6.2 Material Preparations 6.2.1 Consult the sampling stations map prior to departure 6.2.2 Prepare plankton sampling bottles and shellfish containers corresponding to the number of stations as listed in the sampling area map 6.2.3 Label each of the sampling bottles and shellfish containers with the following information: Sampling Station ID Sampling Date Sampling Depth 6.2.4 Permanent markers should be used in labeling sample containers. 6.2.5 Masking tapes can be used in making labels.

6.3 Shellfish collection 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6

Collect shellfish samples at random. Service of a diver can be hired Shellfish collected must be enough for PSP, ASP and DSP analyses, approximately 250 grams shellfish meat (See Appendix 4 for information on approximate number of shells). Rinse the shellfish with water to remove dirt. Transfer the shellfish in the labeled shellfish container. Shellfish meat can be removed from shell on site. Follow procedures in Chapter 1 of Instruction 4. Transfer the shellfish meat in the respective properly labeled containers.

6.4 Plankton collection 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 6.4.7 6.4.8

Cast the plankton net into the water at the desired depth As the plankton net is being lowered, take note of the calibration marks of the rope. This will be the record of the sampling depth. Slowly raise the plankton net at an approximate rate of half meter per minute When the plankton net is above allow the water to drain up to a volume less than that of the available plankton bottle Collect the concentrated sample in the plankton bottle (Close the stopcock aﬅer) Rinse the plankton net by dipping and shaking in water. Do not submerge the plankton net. Collect samples from rinsing in the plankton net bucket and add it to the water collected in the plankton bottle Repeat steps 6.4.6 and 6.4.7 until the plankton bottle is full

Bureau of Fisheries and Aquatic Resources

Sample Handling 7.1 Shellfish Samples 7.1.1 Sample should be submitted to the laboratory immediately aﬅer collection 7.1.2 If submission of samples is not possible right aﬅer collection, shellfish samples should be frozen 7.1.3 Samples coming from the provinces could be sent via bus or plane 7.1.4 Samples to be sent should be frozen and packed in Styro box with ice. The label of the box should contain the following information Type of Sample Number of Samples Name of Consignee 7.1.5 If samples are to be sent, the following information must be provided to the laboratory: Method of Transport Name of Courier (airline/bus company) Expected time of arrival at airport or bus station Type of Sample Number of Samples Name of Consignee 7.2 Plankton Samples 7.2.1 7.2.2

7.2.3

7.2.4

7.2.5

7.2.6

Manila Bay sample should be submitted to the laboratory within the day aﬅer collection Plankton samples collected from the provinces should be analyzed at the nearest local red tide testing center or at BFAR regional laboratories. Follow the same analytical procedures in instruction 4.0. If submission of samples is not possible right aﬅer collection, Preserve the plankton samples using either of the following methods: 7.2.3.1 For every 90 mL of plankton sample add 10 mL of reagent grade formalin 7.2.3.2 For every 50 mL concentrated plankton sample, add 0.70 mL acidified Lugol’s Solution. Samples coming from the provinces could be sent via bus or plane with the following information provided to the laboratory: Carrier Flight No. / Bus number Name of Consignee Estimated time of arrival Waybill number Preserved samples must be put in appropriate storage box. The label of the box should contain the following information: Type of Sample Number of Samples Recipient laboratory Name of consignee If samples are to be sent, the following information must be provided to the laboratory Method of Transport Name of Courier (airline/bus company) Expected time of arrival at airport or bus station Type of Sample Number of Samples Name of Consignee

Environmental Parameters 8.1 Sampling Areas 8.1.1 Salinity and temperature are measured at each of the sampling areas. Handheld refractometer will be used for salinity measurement and a thermometer for temperature measurement. 8.1.2 The same coordinates for the sampling stations at each of the sampling areas will be used for the measurement of salinity and temperature. 8.2 Sampling Frequency 8.2.1 Manila Bay – weekly 8.2.2 Provinces - monthly

Philippine National Shellfish Sanitation Manual for the Production of Safe Bivalve Molluscs

Appendix 9: Specimen Shellfish Registration Document Date of Harvest Production

Classification of Production Area Biotoxin Status Previous

Place Harvested Harvest

Location Code

Week/Month Number

C Test Status

Fishing Vessel Details

Name and Registration of Vessel

LGU Vessel Number

LGU Municipal WaterArea

Shellfish Species Harvested Common Name

Destination of Shellfish Harvested (Name and Address: Block Capitals)

Scientific

Quantities (Kg)

Destination 1

Destination 2 (If applicable)

Gathererâ&#x20AC;&#x2122;s Name (Block Capitals) Gathererâ&#x20AC;&#x2122;s Address

Company Stamp Telephone No.

Date:

Signature Date This form must accompany each hatch of shellfish harvested and a copy should be retained for inspection in the document book for a minimum of 3 years from the date of harvest.