GLOBEFISH Insight - Issue 2 - Export of Fish and Fish Products From India - Non-Tariff Measures

Export of fish and fish products from India Non-tariff measures Food and Agriculture Organization of the United Nations Rome, 2021 with the technical support of

Table of Contents BACKGROUND ...................................................................................................................................... 1 INTRODUCTION ..................................................................................................................................... 1 METHODOLOGY .................................................................................................................................... 2 FOOD SAFETY AND TECHNICAL BARRIERS ................................................................................... 3 2.1 OVERVIEW OF TECHNICAL MEASURES APPLICABLE TO FISH AND FISH PRODUCTS ........................... 3 2.1.1 Factors affecting the selection of technical measures ........................................................ 3 2.1.2 Impact of the source of supply for fish and fish products on SPS and TBT measures ....... 4 2.1.3 Sanitary measures in the fishery sector ............................................................................. 4 2.2 CHINA: IMPORT CONTROLS FOR FISHERY AND AQUACULTURE PRODUCTS...................................... 8 2.2.1 Control system .................................................................................................................... 8 2.2.2 Food safety requirements for fishery business operators................................................. 11 2.3 EUROPEAN UNION: IMPORT CONTROLS FOR FISHERY AND AQUACULTURE PRODUCTS .................. 16 2.3.1 Control system .................................................................................................................. 16 2.3.2 Food safety requirements for fishery business operators................................................. 20 2.3.3 Requirements for aquaculture products ........................................................................... 25 2.4 USA: IMPORT CONTROLS FOR FISHERY AND AQUACULTURE PRODUCTS ...................................... 27 2.4.1 Control system .................................................................................................................. 27 2.4.2 Food safety requirements for fishery business operators................................................. 32 2.4.3 Additional controls for specific products ........................................................................... 34 2.5 HISTORY OF ENFORCEMENT OF TECHNICAL BARRIERS ............................................................... 35 2.5.1 Exports of Indian fishery products .................................................................................... 35 2.5.2 Rejects of Indian seafood products in international markets ............................................ 36 2.5.3 Effectiveness of export controls in Indian fishery products............................................... 40 2.6 CONCLUSIONS AND RECOMMENDATIONS .................................................................................. 42 2.6.1 Losses associated with non-compliance .......................................................................... 42 2.6.2 Estimates of losses ........................................................................................................... 43 2.6.3 Strategic response of exporting countries ........................................................................ 46 3

OTHER NON-TARIFF MEASURES............................................................................................. 52 3.1 TBT MEASURES ...................................................................................................................... 52 3.1.1 Controls on IUU Fishing ................................................................................................... 52 3.1.2 Sustainability measures (bycatch protection) ................................................................... 53 3.1.3 Biosecurity and biodiversity .............................................................................................. 53 3.2 PRIVATE STANDARDS IN FISHERIES AND AQUACULTURE ............................................................. 53 3.2.1 Private food safety and quality standards......................................................................... 55 3.2.2 Presence of private food safety standards by country...................................................... 59 3.2.3 Ecolabeling and certification schemes: ............................................................................ 61 3.2.4 International sustainability movement and implications: ................................................... 64 3.3 NON-TRADITIONAL NON-TARIFF MEASURES ............................................................................. 66 3.3.1 United States of America .................................................................................................. 66 3.3.2 China ................................................................................................................................ 68 3.3.3 European Union – Denmark, in this case ......................................................................... 69 3.3.4 Conclusions and Recommendations ................................................................................ 69

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3.4 ANTI-DUMPING MEASURES ...................................................................................................... 70 3.4.2 Conclusions and Recommendations ................................................................................ 72 3.5 SPECIFIC TRADE CONCERNS ................................................................................................... 73 3.5.1 European Union – Prohibition of the Marketing of Food from Animal Clones, including Fish 73 3.6 TRADE AGREEMENTS .............................................................................................................. 74 3.6.1 Comprehensive Economic Partnership with Japan .......................................................... 74 3.6.2 Conclusions and Recommendations ................................................................................ 75 3.7 REGIONAL FISHERIES BODIES .................................................................................................. 76 3.7.1 Asia-Pacific Fishery Commission (APFIC) ....................................................................... 76 3.7.2 Bay of Bengal Programme – Intergovernmental Organization (BOBP-IGO) .................... 77 3.7.3 Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR) ...... 78 3.7.4 Indian Ocean Tuna Commission (IOTC) .......................................................................... 79 3.8 OCEAN AND FISHERIES GOVERNANCE FRAMEWORK ................................................................. 82 3.8.1 Conservation and sustainable use of oceans and their resources ................................... 82 3.9 ANALYSIS OF NTMS ON SELECT FISH AND FISH PRODUCTS IMPORTED INTO CHINA, THE EUROPEAN UNION, AND THE UNITED STATES OF AMERICA BASED ON THE MAST CLASSIFICATION............................ 86 3.9.1 Types of applied NTMs ..................................................................................................... 86 4

ANNEXES .................................................................................................................................... 90 4.1 REJECTIONS OF FISHERY AND AQUACULTURE PRODUCTS FROM INDIA ........................................ 90 4.1.1 EU RASFF Notifications ................................................................................................... 90 4.2.1 US FFDA Alerts ................................................................................................................ 96 4.3 FDA AND EPA SAFETY LEVELS IN REGULATIONS AND GUIDANCE............................ 104 4.4 STATUS OF IMPLEMENTATION OF THE RECOMMENDATIONS/RESOLUTIONS OF THE IOTC............ 113 4.5 RESOLUTIONS OF THE IOTC THAT ARE RELATED TO INTERNATIONAL FISH TRADE ...................... 116 4.6 ANALYSIS OF NTMS ON SELECT FISH AND FISH PRODUCTS IMPORTED INTO CHINA, THE EUROPEAN UNION, AND THE UNITED STATES OF AMERICA BASED ON THE MAST CLASSIFICATION.......................... 118 4.6.1 Distribution of NTMs applied by China, the European Union and the United States of America on selected imported fish and fish products ................................................................. 118 4.6.2 Distribution of NTMs applied by China, the European Union and the United States of America on selected imported fish and fish products from India ................................................ 121

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List of Tables Table 1

Chinese requirements for physical and chemical parameters in aquatic products ........... 13

Table 2

Microbiological standard for seafood in China .................................................................. 13

Table 3:

EU limits for shellfish toxins in bivalve molluscs ............................................................... 21

Table 4

EU Histamine limits for fishery products ........................................................................... 23

Table 5

Pharmacologically active substances not permitted for use in food animals .................... 26

Table 6

Rejections of Indian fishery products (HS3) on entry to EU, USA, Japan and Australia, 2010 to 2018 .............................................................................................................................. 37

Table 7

Indicators for rejection of Indian fishery products (HS3) on entry to EU, USA, Japan and Australia, 2010 to 2018 ..................................................................................................... 38

Table 8

Reject performance of some major fish exporting countries 2010-2018........................... 38

Table 9

RASFF Alerts published by the European Commission in respect of Indian seafood (2015 to 2020) ............................................................................................................................. 38

Table 10

Import Alerts published by the FDA in respect of Indian seafood (2017 to 2019)............. 39

Table 11

Summary of EU DG SANTÉ audit reports on Indian fish export controls ......................... 40

Table 12:

Structure and nature of additional costs sustained in strengthened SPS controls ........... 44

Table 13

Differences between mandatory and voluntary standards and standards set by public and private organizations ......................................................................................................... 54

Table 14

Functions associated with standards schemes................................................................. 55

Table 15

Number of certification entities accredited in the selected standards by countries........... 60

Table 16

Number of certification entities accredited in the selected standards by countries in Europe .............................................................................................................................. 60

Table 17

Global Production of tuna and tuna-like species............................................................... 80

Table 18

India's landing of tuna and tuna-like species in 2018 (tonnes) ......................................... 81

List of Figures Figure 1

Exports of fishery products from India to main markets 2015-2019 ................................. 36

Figure 2

Historical production trends of Tuna and Tuna-like species in India ................................ 81

Figure 3

India's export of tuna and tuna-like species by value ....................................................... 82

Figure 4

Most common types of SPS and TBT Measures .............................................................. 88

Figure 5

Most common types of NTM other than SPS and TBT measures .................................... 89

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List of Abbreviations AAH AQSIQ CA CCP CFDA EU EPA FAO FDA FBO FIAM FSMA FSVP GACC HAACP HQ ISA IUU MCS MOA MRL OIE PAH PCBs RFMOs SAMR SARs SPS TBT TLV UNCLOS UNCTAD USA USD VMS VQIP WTO

Aquatic Animal Health General Administration of Quality Supervision, Inspection and Quarantine of China Competent Authority Critical Control Point China Food and Drug Administration European Union Environmental Protection Agency (of the United States of America) Food and Agriculture Organization of the United Nations Food and Drug Administration (of the United States of America) Food Business Operator Products, Trade and Marketing Branch Food Safety Modernisation Act Foreign Supplier Verification Programs China’s General Administration of Customs Hazard Analysis and Critical Control Points Head Quarters Infectious Salmon Anaemia Illegal, Unreported and Unregulated Monitoring Control and Surveillance Ministry of Agriculture Maximum Residue Limit World Animal Health Organisation Polycyclic Aromatic Hydrocarbons Polychlorinated Biphenyls Regional Fisheries Management Organisations State Administration for Market Regulation of China Special Autonomous Regions Sanitary and Phytosanitary Technical Barriers to Trade Tilapia Lake Virus United Nations Convention on the Law of the Sea United Nations Conference on Trade and Development United States of America United States Dollars Vessel Monitoring System Voluntary Qualified Importer Program World Trade Organisation (WTO)

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BACKGROUND

1.1 Introduction This report was developed by the Products, Trade and Marketing Branch of the Food and Agriculture Organization of the United Nations (FAO) with the support of an external consultant and in collaboration with the United Nations Conference on Trade and Development (UNCTAD). It provides technical inputs to support the FAO Investment Centre and the World Bank in the formulation of a project to accelerate the development of the Blue Economy in India. The development phase took place in August 2020.

This report analyses the current fish quality and safety standards and other nonstandard barriers required by the largest seafood1 importing countries and the potential export barriers requiring adjustments of domestic regulations, processes, and capacities to cope with these importing countries' market requirements.

During their business, exporters usually seek to consign their products to different markets at different times for many reasons – to supply specific demands, to optimise revenues in fluctuating market conditions, among other causes, and therefore have to deal with the requirements of more than one global seafood trading market. China, the United States of America and the European Union, are the strategically important destination markets for many exporters of fish and fish products.

This report comprises a detailed review of the non-tariff trade measures applied by these three major importing markets. It focuses on technical measures in general and sanitary measures in particular. As well as defining the measures, the report also considers how India has performed so far in meeting these conditions and sets out some of the challenges which face countries wishing to access these markets, in terms of the legal, institutional, technical and capacity building, both for governments as well as fishery and aquaculture business operators at all levels of the supply chain.

The study considers only the regulatory non-tariff measures required for products to access markets combined with specific private standards information. It should be noted that to achieve a successful seafood export business also involves compliance with numerous additional requirements to meet government obligations, as well as the quality demands of the customer, which are not subject to regulation but may effectively limit access to markets. One example is in relation to the Hazard Analysis and Critical Control Points (HACCP) system.2

1

This study uses the generic term “fish and fish products” to denote fish, mollusca and crustacea (and other aquatic animals) derived from either capture fisheries or aquaculture (from marine and/or other sources) 2 An enterprise-level food safety risk management system, often the subject of regulations and voluntary certification e.g. under the ISO 22000 Food Safety Management System

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1.3 Methodology The work was conducted entirely as a desk exercise from the home office and through constant consultations and meetings among FAO and UNCTAD staff and the external consultant using Zoom and other online platforms. UNCTAD provided access to the UNCTAD TRAINS database3, setting out the main non-tariff measures.

Much of the data concerning the detailed measures of the literature was sourced online from the websites of the various regulatory authorities involved, particularly the European Commission, the United States (US) Food and Drugs Administration, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) of China4. In addition, some regulatory websites at a country level were accessed for the European Union and State level legislation for the United States of America. References are inserted at appropriate points in the text. Import rejection and notification portals provided data on rejections in the United States of America and the European Union. China does not publish such data. The United Nations Industrial Development Organization (UNIDO) granted access to its Trade Compliance Database5, which provided analysis in relation to the degree of India’s relative compliance with international requirements and allowed benchmarking of its SPS export performance. An analysis of these requirements (in terms of potential losses) is also based on published literature.

The final part of the section, considering the range of activities required for implementation by exporting countries, draws on the collective experience in providing technical support to developing countries seeking to strengthen and sustain seafood export performance through improved compliance with sanitary measures and sets out the range of strategic responses to be considered in the intervention design.

Section 3 analyses additional non-tariff measures, including private standards, but not directly associated with the Sanitary and Phytosanitary and Technical Barriers to Trade Agreements and not notified under these agreements to the World Trade Organization (WTO).

Within this framework, Section 3 does not cover all trade measures. It only covers the most relevant trade measures implemented since January 2007 by the United States of America, the European Union and China with possible impacts on the exports of fish and fish products from India.

The trade measures enumerated in Section 3 are measures or programs enacted by governments – at any level of a country – with direct or indirect impacts on imported products, including consumer perception.

3

The UNCTAD Trade Analysis Information System (TRAINS) is a comprehensive computerized information system at the HSbased tariff line level (HS 6-digit). The database provides data on trade control measures, including tariffs, para-tariffs, non-tariff measures and imports by suppliers at HS 6-digit level. It is available at https://trains.unctad.org.

4 The study excludes the Special Autonomous Regions, which have specific import and customs requirements.

5 The UNIDO Trade Compliance Database provides import rejection data from the EU, Japan, Australia and USA, and under pins UNIDO’s periodic analyses published in Trade Standards Compliance Reports. More information can be found here: www.unido.org/our-focus/advancing-economic-competitiveness/meeting-standards/meeting-standards-winning-markets

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2 FOOD SAFETY AND TECHNICAL BARRIERS

2.1 Overview of technical measures applicable to fish and fish products 2.1.1 Factors affecting the selection of technical measures Most countries apply technical trade measures to trade in goods to protect human and animal life, protect against transmission of diseases, and protect the environment. These measures are addressed by two international agreements under the World Trade Organisation (WTO), the Technical Barriers to Trade (TBT) Agreement and the Sanitary and Phytosanitary (SPS) Agreement. The SPS Agreement addresses those measures where the objective is to protect against hazards to food safety, animal health and welfare and plant health. The TBT measures are imposed for a variety of policy objectives, such as national security requirements, prevention of deceptive practices and protection of the environment, as well as safety issues other than those addressed by the SPS Agreement.

Therefore, the application of import measures concerning sanitary conditions in imported fish and fish products is conditioned by the SPS Agreement.

The SPS Agreement recognises that countries have a right to determine the “appropriate level of protection” to protect human, animal or plant life or health within their territory. However, the measures applied to achieve this must be based on science, should be applied only to the extent necessary to protect human, animal and plant life or health (i.e., they must be proportionate) and they should not arbitrarily or unjustifiably discriminate between countries where identical or similar conditions prevail (i.e., they must be non-discriminatory, crucially, when compared to measures applied domestically in the importing country).

The SPS Agreement recognises that standards set by international bodies play an important and defined role. Countries adopting measures set out in established international standards may be assumed to meet the conditions of the Agreement. In this respect, the standards developed by the FAO/WHO Joint Codex Alimentarius Commission6 (in relation to food safety) and the World Organisation for Animal Health7 (OIE), (concerning animal health) assume an ultimate importance. They provide a basis for optimal harmonisation of food safety conditions in the agricultural and food supply chains in general, including for trade in fish and fish products.

Whilst many countries adopt measures that are in line with international standards, there are frequent variances and not all countries apply the same requirements.

Differences may arise when a country chooses to apply a level of protection that differs from the relevant international standard or where a standard does not exist.

The SPS Agreement requires that the measure should be able to be scientifically justified, if formally challenged in such cases. Another central area of variance is in the control system's organisational aspects and its application to imports. An understanding of both the technical requirements and the institutional and procedural systems through which they are applied is necessary if exporting countries are to be 6 7

www.fao.org/fao-who-codexalimentarius www.oie.int

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able to ensure that their exports can fully comply with SPS measures set by importing countries.

2.1.2 Impact of the source of supply for fish and fish products on SPS and TBT measures An important feature in the sanitary controls applied is the changing nature of the source of supply of fish and fish products. Aquaculture production is rapidly outpacing capture fisheries as a source of supply for fish and fish products for human consumption. It now accounts for 52 percent of consumption, as indicated by the FAO publication The State of World Fisheries and Aquaculture 20208.

Global fish production in 2018 The FAO Report on State of World Fisheries indicates that global fish production is estimated to have reached about 179 million tonnes in 2018, with a total first sale value estimated at USD 401 billion, of which 82 million tonnes, valued at USD 250 billion, came from aquaculture production. Of the total, 156 million tonnes were used for human consumption, equivalent to an estimated annual supply of 20.5 kg per capita. The remaining 22 million tonnes were destined for non-food uses, mainly to produce fishmeal and fish oil. Aquaculture accounted for 46 percent of the total production and 52 percent of fish for human consumption. China has remained a major fish producer, accounting for 35 percent of global fish production in 2018.

Trade in aquaculture products presents a new set of SPS hazards that are not relevant to capture fisheries. From an SPS hazards point view, aquaculture products have more in common with other farmed animal production systems than with the products of capture fisheries (for example, in terms of transmission of animal diseases, contaminants in feeds, controls on the use of veterinary medicines and concerns about anti-microbial resistance). These differences impact on the technical conditions applied, and thus on the admissibility of imports. However, different importing countries apply widely different approaches to the management of sanitary conditions of imported aquaculture products.

2.1.3 Sanitary measures in the fishery sector 2.1.3.1 The challenge of ensuring safe seafood Fish is unique amongst modern food products in that it is the only one that depends on hunting in the natural environment for much of its supply, although this is changing with the progressive extension of modern aquaculture. The nature of capture fisheries renders additional challenges in ensuring the safety of the resulting 8

FAO The State of World Fisheries and Aquaculture 2020. Sustainability in action. Available at http://www.fao.org/3/ca9229en/ca9229en.pdf

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food (with much production undertaken remotely and in a highly variable and uncontrolled environment). To this complexity should be added the vast range of species consumed as food by humans (with thousands of species across three major Phyla of the animal kingdom – Mollusca and Arthropoda, as well as several classes of the phylum Chordata), each with its unique biological characteristics that impact on their fitness for consumption. The technical challenge of ensuring the safety of this valuable, nutritious and sustainable food source is considerable.

2.1.3.2 Compositional requirements The most straightforward controls are those that specify compositional requirements for food safety in the product, usually in terms of the maximum concentration permitted of an identified hazardous substance. For example, most countries apply maximum limits for specified heavy metals (typically lead, mercury and cadmium) in different fish and fish products. The approach raises questions as to how such levels should be set, since, for many hazards, there is no guaranteed safe level of consumption. Whilst Codex Standards provide international standards for many such measures in fishery products, countries are free to determine their own sciencebased appropriate levels of protection. Ideally, they should also specify sampling methods, test methods and tolerances, all of which can affect results.

There are established risk assessment procedures that help to understand the science in terms of food safety impacts of the different policy choices, balancing the interests of consumers and business operators. Building an effective national food safety risk assessment mechanism is one of the significant challenges in strengthening food safety control in developing countries.

2.1.3.3 Hygiene and HACCP conditions Other than compositional requirements, operators are also subject to requirements for conditions in the supply chain. These address not only the basic sanitary conditions relating to hygienic plant design and construction, staff hygiene, etc., but also apply to the installation and operation of a HACCP-based food safety management system, which is an increasingly common regulatory requirement applied to food business operators in many jurisdictions.

Increasingly food safety requirements (hygiene and HACCP) are applied along a whole supply chain; a concept often referred to as from “net to plate” in the aquatic sphere. Thus, not only food businesses may be subject to food safety requirements, but also producers and their input suppliers. In the case of capture fisheries, the primary producers are the fishers themselves, and hygiene and HACCP requirements may be applied to vessels, landing sites, auctions, cold stores, processing and distribution facilities. In the case of aquaculture inputs, operations such as hatcheries, feed-mills and veterinary medicine suppliers are subject to regulatory controls to prevent their products impacting negatively on the food safety of the final products.

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Hazard Analysis and Critical Control Point System The HACCP system is a science-based and systematic process which identifies specific hazards and measures for their control to ensure the safety of food.

HACCP is a tool to assess hazards and establish control systems that focus on prevention rather than relying mainly on end-product testing. The HACCP system is capable of accommodating change, such as advances in equipment design, processing procedures or technological developments. It comprises five preliminary steps and seven principles.

Preliminary steps: - Assemble HACCP team - Describe product - Identify intended use - Construct flow diagram - On-site confirmation of flow diagram Principles of HACCP - Conduct a hazard analysis.

- Determine the Critical Control Points (CCPs).

- Establish critical limit(s).

- Establish a system to monitor control of the CCP. - Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.

- Establish procedures for verification to confirm that the HACCP system is working effectively.

- Establish documentation concerning all procedures and records appropriate to these principles and their application.

HACCP can be applied throughout the food chain from primary production to final consumption and its implementation should be guided by scientific evidence of risks to human health. Successful application of HACCP requires the full commitment and involvement of management and the work force. It also requires a multidisciplinary approach; this multidisciplinary approach should include, when appropriate, expertise in agronomy, veterinary health, production, microbiology, medicine, public health, food technology, environmental health, chemistry and engineering, according to the particular study. The application of HACCP is compatible with the implementation of quality management systems, such as the ISO 9000 series, and is the system of choice in the management of food safety within such systems.

Source: Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application, Annex to CAC/RCP 1-1969, Rev. 3 (1997), Codex Alimentarius - Food Hygiene - Basic Texts - Second Edition.

2.1.3.4 Traceability systems Traceability requirements in the seafood supply chain are driven not only by the food safety needs (with a view to preventing unsafe products from reaching the market, through trace-back, trace-forward and recall), but also (in the case of capture fisheries) by the need to control imports of products derived from Illegal Unreported and Unregulated (IUU) fishing. As a result, catch certificates required by import authorities in the US and EU and some Regional Fisheries Management

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Organisations (RFMOs) demand traceabilityto the production unit (vessel and catch location).

Meeting the need for traceability demands that government authorities take a more proactive role in ensuring that suitable conditions exist. This means having an effective system for registration of vessels and fish farms, and especially in the case of vessels, systems to spatially locate the place of catch, e.g., through satellite Vessel Monitoring Systems (VMS), along with effective catch and landing recording systems, subject to verification.

2.1.3.5 Official control systems to ensure compliance In addition, in specifying compositional requirements and the conditions under which products are produced, some importing countries require that official control systems are in place in the exporting country to ensure that the export supply chain is subject to lawfully enacted and technically competent inspections and enforcement, with specific approvals to exporters issued to guarantee compliance. In some countries, which have not developed a compliant system of official controls, this situation can effectively prevent exports, even though good quality and safe products are available.

Another way import requirements are applied to exports is through a system of officially mandated pre-shipment inspections. Agents in the exporting country may be nominated by the importing country competent authority9 to perform the specified checks prior to the export of each consignment. This may include checks on records in the exporting establishment, supervision of packing, sampling and testing, and export batch certification. In many situations, international quality assurance service providers10 in the exporting country are selected by the importing country authorities and provide these services at a fee to exporters.

2.1.3.6 Sanitary measures in aquaculture Some specific hazards arise when fish are grown for food in aquaculture systems.

Use of aquaculture inputs such as feed materials (of which, for some formulations, fish is an important component) and veterinary medicines can lead to the presence of undesirable substances in the final product. Food safety risk managers seek to ensure that the risks are controlled by regulating these inputs. Systems for the registration of veterinary medicines and the setting of maximum residue limits and monitoring requirements frequently form an important part of the control system.

Fishmeal production conditions and compositional limits (in terms of environmental contaminants) may also be specified.

In many countries, the growth in aquaculture has also been accompanied by the emergence of important pathogenic diseases (viral, bacterial and parasitic), which have undermined production and caused significant losses, in some cases sufficient to effectively kill the sector. Important aquaculture diseases include Infectious Salmon Anaemia (ISA) in salmonids, white sport virus in shrimp and Tilapia Lake Virus (TLV) in tilapia. These diseases may be transmitted across borders, both via natural means (e.g., in escapes to water bodies), but also by trade in live fish for 9

The official authority or authorities charged by the government with the control of food hygiene as well as/or with sanitation in aquaculture.

10 Examples are Bureau Veritas, SGS, Intertek, Control Union etc, who frequently also provide certification services to private standards (food safety, sustainability and other CSR conditions)

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aquaculture (broodstock, gametes, ova, juveniles) and potentially in harvested fish for human consumption.

The World Animal Health Organisation has developed the Aquatic Animal Health (AAH) Code, a series of international standards that set out the requirements for surveillance and control systems for fish diseases, with particular reference to trade measures. Thus, import regulations may variously require information regarding the disease status of the originating region, import permissions, sampling and testing of batches, vaccination and quarantine conditions on arrival in the destination market, all to avoid transmission of infections to the fish populations (wild or farmed) of the importing country. Aquatic animal health may also be a concern in live fish trade (for either human consumption or the aquarium market).

2.2 China: Import controls for fishery and aquaculture products 2.2.1 Control system 2.2.1.1 Overview China’s food safety controls system is undergoing a decade-long reform process following several notable failures in the early 2000s. The Food Safety Law of the People's Republic of China11 was adopted by the Standing Committee of the 12th National People's Congress at its 14th session on 24 April 2015 and entered into full effect on 1st December 2019. The Law provides a modern framework for food safety, and Chapter 6 deals with Food Import and Export. The competent authority for the purposes of food safety is nominated as the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ). However, China is also undergoing a concurrent institutional reform for the food safety system and ASQIQ is now absorbed by the State Administration for Market Regulation (SAMR) created in 2018 under the State Council, as a general market regulation authority. SAMR also absorbed the food safety functions of the former China Food and Drugs Administration (CFDA). Implementation at the border of the SPS controls set by the AQSIQ is the responsibility of the General Administration of Customs. Relevant bodies are in the process of updating regulations and procedures to reflect the change in governing authorities. It should be noted that the Special Autonomous Regions (SARs) apply different control systems (due to the other legal systems applicable) and, in some cases, different standards (for example, concerning maximum limits for some contaminants).

Chapter 6 of the Food Safety Law addresses the controls of imports. On 16 October 2017, the AQSIQ adopted the Entry-Exit Inspection and Quarantine Process Management Rules12 , which define the detailed procedures for the import inspection and controls. China’s General Administration of Customs (GACC) must authorise each importing country to supply specific types of seafood. Authorisations are provided for different categories of products: fish; crustacea; molluscs; echinoderm; 11

Available at https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Amended Food Safety Law of China_Beijing_China - Peoples Republic of_5-18-2015.pdf 12 Available at https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=China Entry-Exit Inspection and Quarantine Process Management Rules_Beijing_China - Peoples Republic of_12-21-2017.pdf

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jellyfish; aquatic plants; fish oil and shrimp oil. Lists are disaggregated to species (with a separate list for live species). The exporting country should file a written aquatic product export application to the GACC and complete a risk evaluation questionnaire for each class of seafood. GACC experts will evaluate risks.

Furthermore, AQSIQ is authorised under Article 101 of the Food Safety Law to assess and review the food safety management system and food safety status of countries and regions that export food to China and determine the corresponding inspection and quarantine requirements based on the assessment and review results. During the evaluation process, GACC may dispatch a group of experts, with the exporting country's permission for on-site assessment of operations.

On this basis, China seeks to develop bilateral protocols with Competent Authorities of exporting countries, which set out formal conditions and procedures governing the export and import processes. For example, in November 2019, China and India signed a protocol governing Indian fish meal and fish oil imports into China and granting ASQIQ the right to inspect directly Indian producers registered to supply to China. This approach should allow expedited import procedures on entry to China (for example, by limiting sampling and testing on the arrival of consignments originating from inspected fishmeal plants).

The competent authority in the exporting country must supply the list of authorised fish and fish products (and other) establishments (processing plants, freezer and factory vessels and cold stores) approved to export products to China. This list, submitted quarterly, is accompanied by a guarantee as follows: “The (Competent Authority) of (Country) communicates the following updates to the list of approved fishery products establishments registered to the People’s Republic of China. The establishments have been verified by the competent authority and we declare that they comply with Chinese laws, regulations and standards. We promise the information in the following list is true and accurate, and we will undertake the responsibility for information supplied.”

The Food Safety Bureau (FSB) of the GACC maintains the listing of registered establishments. The lists are published by the GACC and products consigned from any other establishment cannot be admitted. Cancelled or withdrawn authorisations are also published. The current list for India (dated 28th July 2020) contains 620 authorised suppliers approved by the Export Inspection Council, Ministry of Commerce and Industry, Government of India (the competent authority).13 Separate authorised country lists are held for imports of live aquatic products (seven genera are authorised from India14).

The Administrative Measures of Inspection, Quarantine, and Supervision on Entry and Exit Aquatic Products (AQSIQ Decree 13515) provides the umbrella regulation overseeing seafood imports and exports. In addition to listing by their national competent authority, under Article 96 of the Food Safety Law overseas exporters or agents exporting food to China are required to register individually with GACC and provide details of their operations and obtain their registration number. China implements this measure through the Administrative Measures for Registration of 13

See: http://www.customs.gov.cn/spj/zwgk75/2706880/2811812/2812040/index.html Anguilla and Monopterus spp (eels), Babylonia and Natica spp (marine gastropods) and Homarus, Panulirus and Scylla spp (lobsters and crabs) 15 Available at https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=China Administrative Measures on Entry Aquatic Animals_Beijing_China - Peoples Republic of_10-28-2016.pdf 14

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Overseas Manufacturers of Imported Foods (AQSIQ Decree 145 from 2012, as amended16).

Imports of animal feeds and ingredients (including fishmeal) are controlled by the Ministry of Agriculture. Similar registration requirements (country and individual establishment listings) are in place. The process is governed by State Council Decree 60917 on Regulation on the Administration of Feed and Feed Additives, in force since 2012. The regulations also set requirements on feed and feed additives.

2.2.1.2 Certification and import procedures In July 2016, AQSIQ launched the System of Designated Ports for Entry of Edible Aquatic Animals (AQSIQ Public Notice [2016] No.74). The Notice sets out the requirements for and lists those ports that are designated to accept imports of edible aquatic animals.

The Food Safety Law requires that imported consignments must be accompanied with a certificate. On 26 July 2016, AQSIQ published the Administrative Measures for the Inspection, Quarantine and Supervision of Imports of Aquatic Animals (AQSIQ Decree No.18318). These measures went into effect on 1st September 2016.

The measures stipulate the inspection, quarantine and supervision requirements for the entry of aquatic animals in China. The Entry-Exit Inspection procedures are defined along with the form and content of the certification (these details may also be the subject of a bilateral protocol). The fishing zones should also be declared on the health certificates. There are different certification requirements for live fish from aquaculture. Assuming that documentary checks are satisfactory, the Rules stipulate that shipments should be subject to different frequencies of sampling and testing on the presentation for clearance in China, based on the operators' risk and track record.19 For seafood, nominally 30 per cent of consignments should be checked at the border inspection post, and 5 per cent should be subject to laboratory testing for compliance with the compositional requirements. There are no specific regulatory requirements for nomination and accreditation of testing laboratories, although these details may potentially be expressed in bilateral agreements between the parties.

China does not define additional specific controls beyond the specified system, except as set out in bilateral agreements with exporting competent authorities.

16

Available at https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=AQSIQ RevisedImplementation Catalogue for Registration_Beijing_China - Peoples Republic of_12-18-2015.pdf 17 Available at http://english.www.gov.cn/archive/state_council_gazette/2015/06/08/content_281475123347596.htm 18 Available at https://www.aqsiq.net/aquatic-animals-inspection-policies.htm 19 More information is available at https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=China Entry-Exit Inspection and Quarantine Process Management Rules_Beijing_China - Peoples Republic of_12-21-2017.pdf

GLOBEFISH Insight 10

OFFICIAL ATTESTATIONS FOR EXPORT OF FISHERY PRODUCTS IN TO CHINA For live products, the certificate contains the following attestations: - The above fishery products come from an establishment approved by the competent authority - The products were produced, packed, stored and transported under sanitary conditions, under the supervision of the competent authority.

- In accordance with the inspection system regulated by the competent authority, the products were not found to contain pathogenic bacteria, harmful or foreign substances or chemicals - The export country maintains a system that meets OIE requirements for the notification of diseases and epidemiological information in aquatic animals.

In respect of farmed aquatic animals, these were examined prior to harvesting for processing or transport and found to be healthy - To the best of my knowledge, the products meet veterinary sanitary requirements and are fit for human consumption For non-viable seafood products from aquaculture, the exporting competent authority must define on the certificate the area and farm(s) from which the product is supplied. For non-viable capture products, the certificate should list of the names and numbers of the harvest vessels of the products. The fishing zones should also be specified on the health certificates. The attestation certifies that: - The above fishery products come from an establishment approved by the competent authority - The products were produced, packed, stored and transported under sanitary conditions, under the supervision of the competent authority - In accordance with the inspection system regulated by the competent authority, the products were not found to contain pathogenic bacteria, harmful or foreign substances or chemicals inspected and quarantined by competent authority and not found any pathogenic bacteria, harmful substances and foreign substances regulated in the Peoples Republic of China - To the best of my knowledge, the products meet veterinary sanitary requirements and are fit for human consumption.

2.2.2 Food safety requirements for fishery business operators 2.2.2.1 HACCP and Hygiene conditions in the supply chain The hygienic requirements for food production and operation or good manufacturing practices are set out in the National Food Safety Standards and Codes of Practice issued by the China Food and Drug Administration (CFDA). The key requirements for hygiene and food safety conditions in the supply chain and which determine the conditions applied to import are: 20

GB14881- 2013 General Hygiene Regulation for Food Production20

Available at https://www.aqsiq.net/pdf/China_GB_14881-2013_National_Food_Safety_Standard-General_Hygienic_Reg.pdf

GLOBEFISH Insight 11

-

GB 20941- 2016 Code of Hygienic Practice for the Production of Aquatic Products21 GB 8950- 2016 Code of Hygienic Practice for the Production of Canned Foods22

China is also expediting the development of several other hygienic regulations for food production. The Code of Hygienic Practice for Quick Frozen23 and Code of Hygienic Practice for Food Additives Products are reported to be in development and have been notified to the WTO. The national codes of practice are based substantially on Codex Alimentarius Commission Standards.

2.2.2.2 Compositional requirements In terms of environmental contaminants, fishery products should comply with the National Food Safety Standard GB 276224. Pesticide residue content should meet the requirements of National Food Safety Standard GB 276325 (which came into force in 2020). These are described in section 2.2.2.4. Maximum Residue Limits for Veterinary Drugs in Foods are set in GB 13650-201926 (section 2.2.2.5). Food additives shall be used in accordance with the provisions in GB 276027.

On 13 November 2015, China’s National Health and Family Planning Commission (NHFPC) published the National Food Safety Standard for Fresh and Frozen Aquatic Animal Products (GB 2733-201528), which came into force in November 2016. It applies to edible fresh and frozen aquatic animal products, including marine and freshwater products. It sets out fishery specific requirements according to a wide range of different parameters. Organoleptic requirements are specified, as are several physical and chemical hazards.

Available at https://www.aqsiq.net/pdf/China_GB_209412016_National_Food_Safety_Standard_Hygienic_Practice_of_Aquat.pdf 22 Available in Chinese at https://www.anan.gov.cn/anan/cpbz/201801/ce5924055f234f43a09d0f88f00df5bb/files/6c5a122722dd4775860f6a92d352c6c7. pdf 23 WTO notification available at https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/SPS/NCHN860.pdf&Open=True 24 Available at https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Maximum Levels of Contaminants in Foods _Beijing_China - Peoples Republic of_12-11-2014.pdf 25 Available at https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=National Food Safety Standard Maximum Residue Limits for Pesticides in Foods _Beijing_China - Peoples Republic of_11-18-2019 2626 Available at https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=China Publishes Maximum Residue Limits for Veterinary Drugs in Food_Beijing_China - Peoples Republic of_11-30-2019 27 Available at https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Standard for Food Additive Use - GB2760-2015_Beijing_China - Peoples Republic of_4-28-2015.pdf 28 Available at https://www.aqsiq.net/pdf/China_GB_27332015_National_Food_Safety_Standard_Fresh_Frozen_Aquatic_Products.pdf 21

GLOBEFISH Insight 12

Table 1

Chinese requirements for physical and chemical parameters in aquatic products Item

Index

Analysis Method

Total volatile basic nitrogen (mg / 100g) Seawater fish

<30

Crab

<25

Freshwater fish

<20

Frozen shellfish

<15

GB 5009.228

Histamine (mg/100g) High histamine fish1

<40

Other sea fish

<20

GB/T 5008.208

Maximum limits of shellfish toxin in fish and shellfish (mouse units/g) Paralytic shellfish poison (PSP)

≤ 4.0

GB/T 5009.213

High histamine fish: Refers to mackerel, carangidae, scad, bonito, tuna, saury, sardines and other sea fish with blue skin and red flesh.

Source: National Food Safety Standard for Fresh and Frozen Aquatic Animal Products (GB 2733-2015

2.2.2.3 Microbiological standards On December 26, 2013, the Ministry of Health released the national food safety standard of Pathogen Limits for Food (GB 29921-201329). This standard provides limits for microbial pathogens in foods and limits and testing methods which apply to pre-packaged foods (not including canned foods). The standard became effective on 1st June 2014. Standards for fish and fish products address the pathogens Salmonella, V. parahaemolyticus and S. aureus only (Table 2) Table 2 Food Category

Fish and fish products • Processed • •

Ready to eat raw Ready to eat algae products

Microbiological standard for seafood in China Pathogen

Sampling Method and Limits (Each sample is /25g or /25 ml, if not specified

Testing method

n

c

m

M

Salmonella

5

0

0

Vibrio parahaemolyticus

5

1

100 MPN/g

1000 MPN/g

GB 4789.7

S.aureus

5

1

100 CFU/g

1000 CFU/g

GB 4789.10 Second method

GB 4789.4

Note: n=no.samples; c= no.permitted above lower limit (m) but below higher limit (M).

29

Available at https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/SPS/NCHN354.pdf

GLOBEFISH Insight 13

2.2.2.4 Environmental contaminants30 On March 17, 2017, the Ministry of Health released the National Food Safety Standard of Maximum Levels of Contaminants in Foods (GB 2762-201731), which sets maximum levels for a range of harmful substances in foods. The ones relevant to fishery and aquaculture products are lead, cadmium, mercury, arsenic, tin, and polychlorinated biphenyls (PCB)s an environmental pollutant. Limits for benzo (a) pyrene (a carcinogen from smoking processes) are also set under this standard. The standard became effective on 17 September 2017.

On August 15, 2019, China's National Health Commission, Ministry of Agriculture and Rural Affairs, and the State Administration for Market Regulation jointly released the National Food Safety Standard - Maximum Residue Limits for Pesticides in Foods (GB 2763-201932), which came into force on 15 February 2020. This Regulatory standard sets 7,107 maximum limits for 483 pesticides in 256 categories of foods, including fish and fish products.

2.2.2.5 Requirements for aquaculture products Residues of veterinary medicines In 2019, China undertook a significant revision of the national food safety standards on maximum residue limits for veterinary drugs in products of animal origin, with the publication of the National Food Safety Standards – Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods (GB 13650-201933) of October 2019, issued jointly by MARA, NHC, and SAMR. This came into force on 1st April 2020. These new standards set 2 191 MRLs and use requirements for 267 veterinary drugs in animal production. The Ministry of Health claims that over 90 percent of the MRLs in the new standard coincide with Codex standards34. In theory, veterinary medicines not listed under GB 13650-2019 may not be applied to aquaculture products exported to China.

Animal feeds In 2012, the Ministry of Agriculture (MOA) published Decree No. 1773, the Feed Ingredient Catalogue (subsequently revised), which lists 87 permitted feed ingredients requiring product registration before they can be imported or marketed in China. A separate Feed Additive Catalogue (2013) lists the permitted additives (MOA Public Notice No. 2045, which became effective on 01 February 2014)35.

Administrative Measures for Inspection, Quarantine of Imports and Exports of Feed and Feed Additives (AQSIQ Decree 11836) address the inspection and quarantine of feeds and feed additives in international trade. Feed and feed additives may only be imported from foreign facilities that are registered with

30

Information in this section is derived from the reports issued by the US Department of Agriculture Foreign Agricultural Service Available at https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Maximum Levels of Contaminants in Foods _Beijing_China - Peoples Republic of_12-11-2014.pdf 32 Available at https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=National Food Safety Standard Maximum Residue Limits for Pesticides in Foods _Beijing_China - Peoples Republic of_11-18-2019 3333 Available at https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=China Publishes Maximum Residue Limits for Veterinary Drugs in Food_Beijing_China - Peoples Republic of_11-30-2019 34 Source: US Department of Agriculture, Foreign Advisory Service GAINS Report CH2019-0176, December 11,2019 https://www.fas.usda.gov/data/china-china-publishes-maximum-residue-limits-veterinary-drugs-food 35 More information at https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=China Regulatory System on Imports of Feed_Beijing_China - Peoples Republic of_12-7-2015.pdf 36 Available at https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=New Feed Quarantine Regulation_Beijing_China - Peoples Republic of_9-8-2009.pdf 31

GLOBEFISH Insight 14

AQSIQ. Implementing Rules for the AQSIQ Decree 118 are set out in AQSIQ Notice (2009) No. 37237, which includes labelling requirements.

Feeds and feed additives that are produced from, or contain genetically modified animal, plants or micro-organisms, must first obtain a biosafety certification and apply for approval according to Measures for Administration of New Feeds and New Feed Additives (MOA Decree [2012] No. 4). China has also notified a Hygienic Standard for Feeds (G/SPS/N/CHN/105238) to the WTO. This standard includes the maximum limits of toxic and hazardous substances and microorganisms in animal feed (such as mycotoxins) and test methods.

2.2.2.6 Labelling Labelling requirements are set out in the Food Safety Law Article 97, which requires that imported pre-packaged food shall be provided with labels and instructions in Chinese and shall indicate the country of origin and name, address, and contact information of the domestic agent. Pre-packaged food without labels or instructions in Chinese or their labels or instructions that do not comply with the law may not be imported.

Pre-packaged food must be labelled and must include the following information:39 -

name, specification, net content, and date of production table of ingredients or formulation country of origin producer name, address and contact information production date storage requirements shelf life code of product standard(s) generic name of the food additives as used in the national standard production Establishment Registration Number name and address of the Chinese distributor other information that must be indicated in accordance with applicable laws. regulations, and food safety standards

In 2018, AQSIQ adopted the Administrative Measures for Inspection and Supervision on Labels of Imported and Exported Pre-packaged Foods. The Measures require foreign exporters to ensure compliance of the label with Chinese regulations and standards; set out the documentary and other checks to be made on import, and actions to be taken in case of non-compliance with relevant regulations and standards.

2.2.2.7 Traceability In 2017, the CFDA published the Provisions for establishment of food safety traceability systems by food production and trading companies. Operators are required to implement traceability systems to the specifications set out. They are 37

Available at https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Implementation Feed Quarantine Regulation 118_Beijing_China - Peoples Republic of_9-25-2009.pdf 38 Available at https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/SPS/NCHN1052.pdf&Open=True.

39 The general label rules for pre-packaged food can be found at http://ccilc.pt/wpcontent/uploads/2017/07/general_rules_for_the_labeling_of_prepackaged_foods_gb7718-2011.pdf.

GLOBEFISH Insight 15

also obliged to collaborate with Provincial Government traceability schemes. Several Provinces have adopted traceability regulations which require Food Business Operators (FBOs), including importers, to upload information about suppliers and receivers for each batch of product consigned. For exporters of food to China, subject to bilateral protocols, a traceability requirement is applied to products, to allow checks that operators are respecting the list of permitted exporters.

2.3 European Union: Import controls for fishery and aquaculture products 2.3.1 Control system The EU defines official controls as “activities performed by the competent authorities, or by the delegated bodies or the natural persons to which certain official control tasks have been delegated in order to verify: (a) compliance by the operators with this Regulation; and (b) that animals or goods meet the requirements laid down in the rules including for the issuance of an official certificate or official attestation”.

They are governed by the Official Controls Regulation (EU) 2017/625. This addresses official controls and related activities (such as certification for international trade) performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products (in other words, SPS measures). Competent authorities must regularly perform official controls on all operators, on a risk basis and with appropriate frequency and at any stage of production, processing, distribution, and use. The controls must be performed following documented procedures and written records kept. The competent authority must designate testing laboratories. Their operation should be accredited to demonstrate compliance with the standard EN ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories). Additional requirements are specified for controls of products of animal origin.

The form and content of certificates providing the guarantee of compliance of imports from third countries are also specified (requiring an attestation by a named authorised officer). The procedures for documentary, identity checks and physical checks on imports at EU border posts are specified. Additional controls may be specified to safeguard consumers where higher risks are identified.

2.3.1.1 Overview The principles of food safety in the EU are set out in Regulation (EC) No 178/2002 of the European Parliament and of the Council, laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety40.

Article 11 requires that “[f]ood and feed imported into the Community for placing on the market within the Community shall comply with the relevant requirements of food law or conditions recognised by the Community to be at least equivalent thereto 40

Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32002R0178&from=EN

GLOBEFISH Insight 16

[…]”. In this way, the EU creates a level regulatory playing field between exporters in third countries and European operators. However, the measures have profound implications. It requires exporters to meet the same standards and production conditions and requires their governments to implement a system of official controls at least equivalent to that applied by the governments of EU Member States. Without the formal designation of a competent authority that implements official controls in line with the EU requirements (see box on the next page), fish and fish products cannot be exported (even if fully compliant supply chains are in place).

The European Commission DG SANTÉ41 is empowered to perform initial and periodic on-site audits of the sanitary controls applied by third countries to export fishery (and other food) products. The Official Control Regulation 2017/62542 (Article 120) requires these audits to take account of legislation, organisation of the competent authorities, powers and independence, supervision enforcement powers, training of staff in the performance of official controls, resources including analytical, testing and diagnostic facilities and the existence and operation of documented control procedures and control systems, extent and operation of controls on products arriving from other third countries. The reports of the audit missions are published at https://ec.europa.eu/food/audits-analysis/audit_reports/index.cfm and provide a detailed and standardised analysis of the sanitary conditions and controls applied in the third country.

The third country is required to meet the minimum condition of “at least equivalent” in all the areas mentioned in the previous paragraph. The Commission maintains a positive list of third countries that are determined to have met the requirements. The list is periodically updated43 and India is on the list without restrictions. Countries may be formally delisted for persistent failure to meet the requirements. However, to avoid formal alteration of a published regulation, the Commission and third-country often agree to voluntarily suspend export certification until corrective actions are implemented.

Detailed implementing measures for official controls of fishery products are laid down in Annex II of Commission Regulations (EC) No 2074/200544, which sets out the requirements for inspection of parasites, checks on spoilage indicators, testing methods for marine biotoxins, listing of approved establishments, freezer and factory vessels and model health certificates. Third country Competent Authorities need to consider all of these issues in the implementation of the official controls for fish and fish products (both wild and farmed) consigned to the EU. Imports of fish and fish products (and other products of animal origin) are only authorised from approved processing plants, freezer or factory vessels or cold stores. Approval signifies that inspection has taken place and confirms compliance with the hygiene and HACCP requirements. Fishing vessels supplying exports (and which are not factory or freezer vessels) need not be approved, but they must be subject to inspection for compliance. A list of approved vessels and establishments in each country is maintained by the European Commission and is published on its website.45 Consignments from any other origin are not allowed entry at the EU border control posts.

The Commission's Directorate-General for Health and Food Safety Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0625&from=EN 43 Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R0626&from=EN 44 Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32005R2074&from=EN 45 Available at: https://ec.europa.eu/food/safety/international_affairs/trade/non-eu-countries_en 41

42

GLOBEFISH Insight 17

2.3.1.2 Marine biotoxins in shellfish Specific control conditions apply for imports of live or processed bivalve molluscs (e.g., mussels and clams), echinoderms (e.g., sea urchins), or marine gastropods (e.g., sea-snails and conch). These present additional risks due to their method of feeding on marine algae (either sessile or free-floating), which may contain biotoxins causing shellfish poisoning. Such products may only be imported into the EU if they come from production areas competent authorityapproved by the competent authority and are subject to close monitoring for microbiological and biotoxin contamination, and for toxic algae in spatially defined shellfish production areas. The system of controls should allow for area closures if toxin levels are detected that exceed specified limits. A separate country listing is required for third countries wishing to export these products to the EU and is found at the same website as noted above47. Currently, only 17 countries are permitted to export live bivalve molluscs to the EU. India is not on this list.

2.3.1.3 Aquaculture products Additional controls are required for aquaculture products to address the particular hazards associated with the farming of products of animal origin.

The Official Control Regulation (EU) 2017/62546 sets out the requirement for Competent Authorities to perform official controls “at any stage of production, processing and distribution, on relevant substances including substances to be used in food contact materials, contaminants, non-authorised, prohibited and undesirable

46

Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0625&from=EN

GLOBEFISH Insight 18

substances whose use or presence on crops or animals or to produce or process food or feed may result in residues of those substances in food or feed”. This includes a requirement for monitoring of residues of veterinary medicines and other compounds in animals, products and feeds (see Box).

Substances to be subject to monitoring under Directive 96/23/EU1 GROUP A — Substances having an anabolic effect and unauthorized substances (1) Stilbenes, stilbene derivatives, and their salts and esters (2) Antithyroid agents (3) Steroids (4) Resorcylic acid lactones including zeranol (5) Beta-agonists (6) Compounds included in Annex IV to Council Regulation (EEC) No 2377/90 of 26 June 1990 GROUP B — Veterinary drugs (1) and contaminants (1) Antibacterial substances, including sulphonamides, quinolones (2) Other veterinary drugs (a) Anthelmintics (b) Anticoccidials, including nitroimidazoles (c) Carbamates and pyrethroids (d) Sedatives (e) Non-steroidal anti-inflammatory drugs (NSAIDs) (f) Other pharmacologically active substances (3) Other substances and environmental contaminants (a) Organochlorine compounds, including PCBs (b) Organophosphorus compounds (d) Chemical elements (d) Mycotoxins (e) Dyes (f) Others 1

COUNCIL DIRECTIVE 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (continues to define residue monitoring requirements)

Only those third countries which are able to demonstrate the performance of such activity are listed as being able to supply the EU with aquaculture products. The authorised country list is published under Commission Decision 2011/163/EU47 on the approval of plans submitted by third countries. Monitoring is required at all production stages to detect substances that are not permitted and measure the concentrations of permitted substances in final products to ensure that they do not exceed MRLs. Therefore, to export aquaculture products to the EU, to meet the conditions of “at least equivalence”, a third country must have in place a veterinary drug registration scheme, which includes drugs used in aquaculture (banned and permitted lists with MRLs in place), as well as an implemented residue monitoring plan for aquaculture feed, animals and products, as well as official controls on feed producing establishments and feed materials (including speciality materials, e.g., for juveniles).

India is listed in Decision 2011/163/EU since it meets these conditions for 47

Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011D0163&from=EN

GLOBEFISH Insight 19

aquaculture products (as well as for eggs and honey) and can supply these products to the EU market.

2.3.1.4 Certification and import procedures The EU requires an export certificate issued by a national competent authority that should accompany each consignment. When the export health certificate is signed, the competent authority officer must personally attest that specific EU measures associated with the consignment are complied with (see box).

Public Health Attestation* I, the undersigned, declare that I am aware of the provisions of Regulations […..], and certify that the fishery products described above were produced in accordance with those requirements, in particular that they: - Come from an establishment implementing a programme based on the hazard analysis and critical control points principles - Have been caught and handled on board vessels, landed, handled and where appropriate prepared, processed, frozen and thawed hygienically in compliance with the requirements laid down in […..]

- Satisfy the health standards laid down in […..]

- Have been packaged, stored and transported in compliance with […..]

- Have been marked in accordance with […..]

- Fulfil the guarantees covering live animals and products thereof, if of aquaculture origin, provided by the residue plans submitted in accordance with […..]

- Have satisfactorily undergone the official controls laid down in […..]

Source: COMMISSION IMPLEMENTING REGULATION (EU) 2019/628 of 8 April 2019 concerning model official certificates for certain animals and goods *Lengthy references to EU documents are redacted for convenience

For regular export flows, third countries are encouraged to participate in the EU’s TRACES system. This is an online platform for sanitary and phytosanitary certification required to import animals, animal products, food and feed of non-animal origin and plants into the European Union. It provides for a streamlined process concerning all entry procedures with digitised and paperless workflow and secure ecertification. The system has more than 42 000 users from about 85 countries worldwide, including the Export Inspection Council of India, the national competent authority.

2.3.2 Food safety requirements for fishery business operators 2.3.2.1 HACCP and Hygiene conditions in the supply chain The food safety obligations of all food business operators are set out in Regulation (EC) No 852/200448 of 29 April 2004 on the hygiene of foodstuffs whilst operators dealing with products of animal original must additionally comply with Regulation (EC) No 853/200449 of 29 April 2004 laying down specific hygiene rules for food of animal origin. The former sets out basic hygienic requirements relating to location, structure, design, layout, materials, facilities and personnel hygiene. Examples are the use of non-hand operated taps on wash hand basins, provision of hot water, use 48 49

Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R0852&from=EN Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R0853&from=EN

GLOBEFISH Insight 20

of temperature recording devices on cold stores and chill rooms. Crucially it requires that FBOs (except primary producers) should implement a permanent procedure or procedures based on the HACCP principles. The principles are set out and correspond closely to the HACCP system described previously. However, there is no strict requirement for a certified HACCP system, per se. The Annex to 853/2004 sets out the sanitary conditions applicable to production and placing on the market of fish and fish products from processing establishments, freezer vessels and factory vessels, as well as auctions and cold stores (and hence approval conditions for listing).

2.3.2.2 Water supply The EU regulates water supplies used for human consumption, including those used in food processing. The conditions are set out in Council Directive 98/83/EC50 of 3 November 1998 on the quality of water intended for human consumption. The conditions are applicable at the point of compliance, defined as “in the case of water used in a food-production undertaking, at the point where the water is used in the undertaking”. The Annex sets a wide range of chemical and microbiological criteria with which water must comply. It also requires regular monitoring of certain indicators and provides action levels. The monitoring of the water quality to ensure compliance is the responsibility of the business operator, but the competent authority must also ensure that these checks are undertaken by the FBO and will also undertake its own official controls.

2.3.2.3 Marine biotoxins in shellfish Regulation (EC) No 853/200451 of 29 April 2004 lays down specific hygiene rules for food of animal origin and also sets out requirements for live bivalve molluscs with regard to ensuring that the harvest areas are subject to official monitoring, classification and control, and subsequent depuration or heat treatment operations ensure that the product is rendered microbiologically safe. In this respect the Regulation contains the health standards for filter feeding bivalve molluscs in terms of limits of marine biotoxins.

Table 3: EU limits for shellfish toxins in bivalve molluscs Toxin

Maximum limit

paralytic shellfish poison (PSP

800 µg/kg

amnesic shellfish poison (ASP),

20 mg/kg domoic acid

okadaic acid (plus dinophysistoxins and pectenotoxins)

160 µg/kg okadaic acid equivalents

yessotoxins

3.75 mg/kg yessotoxin equivalent

azaspiracids

160 µg/kg azaspiracid equivalents

There are no limits set for ciguatoxin, another marine biotoxin of great public health significance (and possibly an emerging hazard for India). Ciguatoxin is a marine biotoxin secreted by the sessile marine algae Gambierdiscus toxicus that enters the 50 51

Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0083&from=EN Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R0853&from=EN

GLOBEFISH Insight 21

human food supply when consumed by certain species of coral browsing reef fish, which are then subsequently eaten by humans. Several reported incidents of noncompliant products entering the EU market from India have been recorded (Annex 4.1). The EFSA and EU Member States are undertaking a risk assessment exercise (due to be delivered in 2020) to provide scientific advice to the Commission that may result in maximum limits being established in the future.

2.3.2.4 Microbiological standards The EU’s microbiological standards for foods are set out in Commission Regulation (EC) No 2073/200552 of 15 November 2005 on microbiological criteria for foodstuffs, as amended.

Chapter 1 of the annex addresses food safety criteria and sets out limits for Salmonella, E.coli and Listeria monocytogenes in ready-to-eat foods, live bivalve molluscs and live echinoderms, tunicates and gastropods, and cooked crustacea and shellfish. Annex 4.3 specifies process criteria standards for E.coli and Coagulase-positive staphylococci in cooked crustaceans and molluscan shellfish.

There are no safety standards set for raw fish that is to be cooked before consumption. This regulation also sets out the limits for histamine in different fishery products (Table 4). In all cases, sampling and testing procedures are set out. This is particularly important for hazards such as histamine (with a required nine samples per batch) due to the high variance in test results from fish to fish (see Table 4).

52

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Table 4

EU Histamine limits for fishery products

Microorganism s/thei toxins, metabolit es

Sampl ing plan1 a

c

n

M

Fishery products from fish species associated with a high amount of histidine4

Histamine

93

2

100 mg/k g

Fishery products, except those in food category (below) which have undergone enzyme maturation treatment in brine, manufactured from fish species associated with a high amount of histidine2

Histamine

93

2

200 mg/k g

Fish sauce produced by fermentation of fishery

Histamine

1

0

Food category

Analytic al referenc e method

Stage where the criterion applies

200 mg/k g

EN ISO 19343

Products placed on the market during their shelf-life

400 mg/k g

EN ISO 19343

Products placed on the market during their shelf-life

EN ISO 19343

Products placed on the market during their shelf-life

Limits

400 mg/kg

1

n = number of units comprising the sample; c = number of sample units giving values between m and M

2

Particularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae

3

Single samples may be taken at the retail level. In such a case, the presumption laid down in Article 14(6) of Regulation (EC) No 178/2002, according to which the whole batch should be deemed unsafe, shall not apply unless the result is above Source: Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs

2.3.2.5 Environmental contaminants Limits for several important contaminant hazards found in fishery products are defined by Commission Regulation (EC) No 1881/200653 setting maximum levels for certain contaminants in foodstuffs. This addresses heavy metals (with speciesspecific limits for lead, cadmium, mercury and tin in canned foods). It also sets limits for dioxins and dioxin-like PCBs in the muscle meat of fish and fishery products grouped by species and the category of product (e.g., concentration limits in fish oils are set correspondingly higher). The regulation also set limits for PAHs in the muscle meat of smoked fish and smoked fish products, with higher limits set for certain traditional products.

2.3.2.6 Labelling The European Union has introduced specific labelling requirements for fish products placed on the market, which are also applied to products entering the EU as imports.

Article 35 of Regulation (EU) No 1379/201354 of the European Parliament and of the Council of 11 December 2013 “on the common organisation of the markets in fishery and aquaculture products” sets out the information requirements applicable to all 53 54

Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006R1881&from=EN Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32013R1379&from=EN

GLOBEFISH Insight 23

products supplied at both wholesale and retail, irrespective of their origin or their marketing method, and therefore is applicable to imports: -

the commercial designation of the species and its scientific name the production method, in particular by the following words "[…..] caught […..]" or "[…..] caught in freshwater […..]" or "[…..] farmed […..]" the area where the product was caught or farmed, and the category of fishing gear used in the capture of fisheries whether the product has been defrosted the date of minimum durability, where appropriate

In addition, Regulation (EU) No 1169/201155 of the European Parliament and of the Council on the provision of food information to consumers sets out the general food labelling rules. Frozen fishery products must be labelled with the date of freezing (or the date of first freezing), and if fish products are glazed, the name of the food needs to include an indication of the presence of added water, if the added water makes up more than 5 percent of the weight of the finished product. Article 9 of the Regulation also requires allergen labelling on products containing the foods listed in Annex II which include: crustaceans; fish (except fish gelatine when used as a carrier for vitamin preparations or as fining agent in beer and wine); molluscs, and sulphur dioxide and sulphites at concentrations of more than 10 mg/kg.

2.3.2.7 Poisonous fish EU Regulation 853/200456 prohibits certain poisonous fish being placed on the market. This includes fish of the families Tetraodontidae, Molidae, Diodontidae and Canthigasteridae. In addition, fresh, prepared and processed fish products belonging to the family Gempylidae, in particular, Ruvettus pretiosus and Lepidocybium flavobrunneum, may only be placed on the market in wrapped/packaged form and must be labelled with information on preparation and the risk of adverse gastrointestinal effects. The scientific name of the fish products must accompany the common name on the label.

2.3.2.8 Spoilage indicators (total volatile basic nitrogen, etc.)

Some additional requirements for fish products are set out in Commission Regulation (EC) No 2074/200557 laying down implementing measures for certain products. For fish products, the regulation requires the FBO to visually inspect for the presence of visible parasites by a suitably qualified person on board factory vessels or in processing establishments.

The same regulation also sets the total volatile basic nitrogen (TVB-N) in unprocessed fish products at which the product shall be regarded as unfit for human consumption. Depending on the product, these are set at levels between 25 mg and 35 mg of nitrogen/100 g of flesh. Up to 60 mg is permitted in whole fish products used directly for the preparation of fish oil for human consumption. The requirement is only applicable to listed species, including cold-water species from the North Atlantic. The testing method is described. Given this, DG SANTÉ seems to require tropical countries to perform this test for their species, although the validity of using 55

Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011R1169&from=EN Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R0853&from=EN 57 Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32005R2074&from=EN 56

GLOBEFISH Insight 24

TVB-N as an indicator in tropical species may not be validated for the species concerned.

2.3.2.9 Additives

Regulation EC 1333/200858 on food additives sets the rules on food additives: definitions, conditions of use, labelling and procedures. It includes an EU list of approved food additives (of different classes, such as preservatives, colours, emulsifiers, anti-oxidants, etc.) and conditions of use and labelling requirements. The European Commission maintains a database with a permitted list of additives in different foodstuffs.59 In addition to common additives to fish and fish products, such as sulphur dioxide and polyphosphates, some food colours in processed products are permitted. Some common additives permitted in the USA and China are not allowed in the EU. Notable in this category is the application of carbon monoxide treatment to fresh tuna.

2.3.2.10 Food contact materials Food contact materials are regulated in the EU by Commission Regulation (EC) No 1935/200460 on materials and articles intended to come into contact with food. This sets out requirements for the safety and inertness for all food contact materials.

Exporters should ensure that their packaging materials meet these requirements.

2.3.3 Requirements for aquaculture products 2.3.3.1 Residues of veterinary medicines The EU applies both Positive Listing and Negative Listing approaches to the control of veterinary medicines used in food animals. The approach is set out in Commission Regulation (EU) No 37/201061 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin that sets out the Maximum Residue Limits for permitted substances. In relation to specific compounds, requirements may be applied to all farmed food-producing animals, or just certain classes or species. The regulation also specifies the marker residue and the target tissues to be analysed during controls. The list applicable to aquaculture animals is substantial. The Commission’s database can be accessed at https://data.europa.eu/euodp/en/data/dataset/eu-veterinary-medicinal-productdatabase. Operators must ensure that dosage and withdrawal periods for permitted medicines will ensure that MRLs in the final products do not exceed those set out in the regulation.

Commission Regulation (EU) No 37/2010 also prohibits certain substances from being used as veterinary medicines in food animals. This applies to compounds with an anabolic effect (hormonal or thyrostatic action or beta-agonists) as well as others that are not authorised for use as medicines in food animals (certain dyes and pharmacologically active substances that may precipitate the development of antimicrobial resistance (AMR) and where an MRL cannot be established) (Table 5).

58

Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008R1333&from=EN Available at: https://ec.europa.eu/food/safety/food_improvement_agents/additives/database_en 60 Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R1935&from=EN 61 Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010R0037&from=EN 59

GLOBEFISH Insight 25

Table 5

Pharmacologically active substances not permitted for use in food animals Aristolochia spp. and preparations thereof Chloramphenicol Chlorpromazine Colchicine Dapsone Dimetridazole Metronidazole Nitrofurans (including furazolidone) Ronidazole

Source: Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin

In addition, several non-veterinary substances should not be used (as listed in Group A in the Box in Section 2.3.1.3). These include industrial dyes with pharmacological effects commonly used in aquaculture, such as malachite green and crystal (gentian) violet. Aquaculture operators should demonstrate compliance with all of these requirements through their system of internal controls.

Reference points for action (RPA) are defined for some of the banned substances.

Detection of non-permitted substances at concentrations below the RPA would not normally be pursued as an offence. These are laid down in Commission Regulation (EU) 2019/187162 on reference points for action for non-allowed pharmacologically active substances present in food of animal origin.

2.3.3.2 Animal feed controls

Feed business operators should comply with Regulation (EC) No 183/200563 of the European Parliament and of the Council laying down requirements for feed hygiene.

The regulation establishes the conditions for approval of animal feed establishments.

This includes suppliers of fishmeal intended for use as animal feed. This sets out the requirement for hygiene and HACCP conditions during the production of animal feeds and feed ingredients. The third country of supply must be listed by the Commission, and the establishment itself must also be approved by its national competent authority. The Commission has published a "Guidance document on the implementation of certain provisions of Regulation (EC) No 183/2005 laying down requirements for feed hygiene".64 Food safety aspects of the composition of fishmeal and fish oils are set by Directive 2002/32/EC65 (as amended) on undesirable substances in animal feed. This covers a range of food safety hazards potentially present in animal feeds and feed ingredients (including fishmeal and fish oils), and include heavy metals, melamine, mycotoxins and PCBs and dioxin-like and non-dioxin-like PCBs.

62

Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R1871&from=EN Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32005R0183&from=EN 64 Available at: https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=uriserv:OJ.C_.2019.225.01.0001.01.ENG&toc=OJ:C:2019:225:TOC 65 Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02002L0032-20191128&from=EN 63

GLOBEFISH Insight 26

2.4 USA: Import controls for fishery and aquaculture products 2.4.1 Control system The US Food and Drug Administration (FDA) is the federal authority responsible for the safety of imported foods. The FDA checks compliance with the import requirements set out under the Federal Food, Drug and Cosmetic Act66, the Food Safety Modernisation Act67 and the Code of Federal Regulations68.

Under the U.S. Federal Food, Drug and Cosmetic Act, importers of food products are responsible for ensuring that the products are safe, sanitary, and labelled correctly.

The Bioterrorism Preparedness and Response Act69 requires foreign suppliers of food to the US to be registered. The US Food Safety Modernisation Act (FSMA)70, adopted in 2017, has significantly strengthened the measures used to ensure that imported foods meet the same requirements as domestic production.

2.4.1.1 US Food Safety Modernisation Act (FSMA) The Federal Food, Drug and Cosmetic Act Chapter VIII: Imports and Exports sets a new framework for controlling the safety of imported foods. The FSMA introduced the requirement for Foreign Supplier Verification Programs (FSVP). This requires the US-based importer to hold all the relevant food safety data on their foreign suppliers and must include a hazard analysis – an evaluation of the risk of the food and foreign supplier – and a record of verification activities to confirm the hazard analysis and controls introduced. The importer must demonstrate that one or more defined affirmative steps have been implemented to verify compliance (see next box).71 This methodology reflects the HACCP approach's requirement and will be satisfied with a successful audit of HACCP implementation by the export supplier. The resulting audit dossier is subject to inspection and verification by the FDA at any time. FDA holds an inventory of FSVP importers and their supply chain linkages with FDA-regulated foreign food facilities and farms. This approach extends FDAs’ HACCP-based control model previously applied only to the seafood, low acid canned foods and juice sectors to all imported foods. Until now, over 24 000 US importers participate in the FSVP. Therefore, it is notable that in the US system, providing that the export country facility is registered, there is no strict requirement for an official FDA or national approval of the supply chain conditions. It is exclusively the importers' legal responsibility to demonstrate to the FDA that suppliers' food safety conditions meet the requirements.

66

Available at https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act More information at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernizationact-fsma.

68 https://www.archives.gov/federal-register/cfr 69 More information at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-110300-registrationfood-facilities-under-public-health-security-and-bioterrorism 70 More information at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernizationact-fsma.

71 FSMA Final Rule on Foreign Supplier Verification Programs, US Food and Drug Administration https://www.fda.gov/food/food-safetymodernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals 67

GLOBEFISH Insight 27

(A) (B)

(C) (D)

(E)

(F)

Affirmative steps under the Foreign Supplier Verification Programs Obtaining from the foreign processor the HACCP and sanitation monitoring records required by this part that relate to the specific lot of fish or fishery products being offered for import.

Obtaining either a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported fish or fishery product is or was processed in accordance with the requirements of this part.

Regularly inspecting the foreign processor's facilities to ensure that the imported fish or fishery product is being processed in accordance with the requirements of this part.

Maintaining on file a copy, in English, of the foreign processor's HACCP plan, and a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of the part.

Periodically testing the imported fish or fishery product, and maintaining on file a copy, in English, of a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of this part or, Other such verification measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of this part.

To supplement the FSVP approach, the FDA recognizes a Voluntary Accredited Third-Party Certification scheme. FDA has approved four accreditation bodies that undertake the accreditation of third-party certification bodies. US importers can then hire these certification bodies to undertake audits of export country supply chains.

Twelve of these certification bodies are accredited, which are thus authorised to conduct food safety audits (for six different standards, for example, regarding compliance with HACCP conditions, or low acid canned foods) and issue relevant certification of foreign food facilities.

Participation in the third-party certification scheme is a requirement for eligibility to participate in a Voluntary Qualified Importer Program (VQIP), which offers expedited import procedures (essentially reduced risk profiling) for operators with a minimum three-year history of importing compliant food into the United States of America. Until now, only one importer is recognized under the VQIP (Costco).

2.4.1.2 Bioterrorism Preparedness and Response Act As the food regulatory agency of the Department of Health and Human Services, the US FDA also implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which sets out additional steps to protect the public from attacks on the U.S. food supply. The Act requires that originating establishments be registered with the FDA and that the importer provides Prior Notice of each consignment before food is imported, allowing time for risk management decision making. The system is described in Title 21 Code of Federal Regulations (21 CFR, Part 1, Subpart I72). Prior notice (to be submitted no more than 15 calendars days before arrival) can be provided either via an authorized broker to the U.S. Customs and Border Protection or directly via an online interface. Participation in the 72

Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1&showFR=1&subpartNode=21:1.0.1.1.1.8

GLOBEFISH Insight 28

Voluntary Qualified Importer Program (VQIP) also facilitates the Prior Notice procedures under the Bioterrorism Act.

2.4.1.3 Systems Recognition and Equivalence The US FDA recognises two mechanisms for further streamlining the application of sanitary standards to imports. Where the FDA recognizes that an export country’s food safety system achieves food safety outcomes comparable to those of the FDA, it may determine “System Recognition”. The process involves reviewing a foreign country’s food safety regulatory system and using this information to make riskbased decisions regarding foreign inspections, import examination, and responses to food safety incidents, thus avoiding duplication of effort (for example, obviating the need for supplier verification). Systems recognition for fishery product controls is in place between the US and Australia, Canada and New Zealand, The Code of Federal Regulations allows importers to alternatively obtain the fish or fishery products “from a country that has an active memorandum of understanding (MOU) or similar agreement with the Food and Drug Administration, that covers the fish or fishery product and documents the equivalency or compliance of the inspection system of the foreign country with the US system”. For the most part, until now, this approach has not been widely employed. Negotiations for equivalence are underway with the EU in respect of bivalve molluscs.

Equivalence as a concept is recognised by Article 4 of the World Trade Organization (WTO) Agreement on Sanitary and Phytosanitary Measures (SPS Agreement), which states: “Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member’s appropriate level of sanitary or phytosanitary protection.”

2.4.1.4 Imported Seafood Safety Program Given that the USA is a major importer of seafood, and in recognition of the challenge in ensuring good food safety conditions, the FDA has packaged a series of measures within a specially focused programme on seafood.73 The measures aim to ensure a high level of compliance, including with the HACCP requirements. For imported seafood, these measures include: -

direct FDA inspections of foreign processing facilities, structured risk-based sampling of seafood offered for import into the United States of America, domestic surveillance sampling of imported products, inspections of seafood importers assessment of Foreign Supplier Verification Programs assessment of foreign country control programmes; and relevant information from foreign Competent Authorities and FDA overseas offices.

Since 2008, the FDA has directly operated posts in countries which export fishery products and other high-risk products to the USA. India was one of the first. FDA's 73

See: Imported Seafood Safety Program https://www.fda.gov/food/importing-food-products-united-states/imported-seafoodsafety-program

GLOBEFISH Insight 29

India Offices are located in New Delhi and Mumbai and are staffed by US and national technical experts. These staff develop relations with national authorities, undertake inspection of facilities producing goods destined for the United States of America, and link with the in-country representatives of the U.S. Department of Agriculture and the Foreign Agricultural Services. An important part of the work of the FDA India Office is implementing the Imported Seafood Safety Program, which includes conducting country assessments of the country’s industry and regulatory infrastructure to control aquaculture drugs. Knowledge of the system helps to focus the import controls (sampling and testing) regarding of drug residues in aquaculture products shipped to the United States of America and allows FDA to work directly with countries to resolve drug residue problems. A country assessment for India was conducted in 2010 (but not published).

2.4.1.5 Certification and import procedures Providing that a supplier is registered (and subject to the additional provisions of the Bio-terrorism Act described below) the procedure for importation is to provide prior notice to FDA (minimum 5 days) of incoming shipments of imported food products.

The procedures are described in the next box. This can be done online by registered suppliers via the Prior Notice System Interface. Unless agreed by the parties in an inter-governmental protocol, there is no US requirement for the exporting country authority to issue a certificate (although exporting country rules may require this step). A person submitting prior notice of imported food, including animal feed, is required to report the name of any country to which the article has been refused entry. FDA may detain shipments of products offered for import if a decision is made to take samples from the shipments for testing. If the shipments are found not to be in compliance with US requirements, then an alert notice is issued for the rejection and/or recall of the consignment.

GLOBEFISH Insight 30

Step 1 Step 2

Step 3 Step 4a Step 4b

Step 5 Step 6b

Step 7 Step 8

Import procedures for entry of seafood to the US Market Importer or agent need to file entry documents with US Customs Service within five working days of the date of arrival of a shipment at a port of entry.

FDA is notified of an entry or a regulated food through: -

Duplicate copies of Customs Entry Documents (CF 3461, CF 3461 ALT, CF 7501 or alternative)

-

Copy of commercial invoice; and

- Surety to cover potential duties, taxes and penalties.

FDA reviews the entry documents received from Customs for all seafood entries. The Agency then decides whether to release, visually examine, or sample a given shipment.

If a decision is made not to collect a sample the FDA sends a ‘May Proceed Notice’ to US Customs and the importer of record. The shipment is released as far as FDA is concerned.

A decision to collect a sample is based on: -

Nature of the product;

-

FDA priorities; and

-

Past history of the commodity

FDA sends a ‘Notice of Sampling’ to US Customs and the importer of record. The shipment must be held intact pending further notice. A sample is collected from the shipment. The importer of record may move the shipment from the airport to another port or warehouse.

If FDA obtains a physical sample it is sent to an FDA district laboratory for analysis.

Step 6a: If analysis finds the sample in compliance with requirements the FDA sends a ‘Release Notice’ to US Customs and the importer of record.

If analysis determines that the sample ‘appears to be in violation of the Food, Drug and Cosmetic Act and other Acts’ the FDA sends US Customs and the importer a record of Notice of Detention and Hearing which -

Specifies the nature of violation(s); and

-

Gives the importer of record 10 working days to introduce testimony as to the admissibility of the shipment.

The hearing is the importer’s only opportunity to present a defence of the importation and/or present evidence as to how the shipment may be made eligible for entry. The importer has the choice of reconditioning the product (i.e. bringing the article into compliance, if this can be done), destroying it or re-exporting it.

If FDA approves the importers proposed reconditioning procedure, the reconditioning may then proceed under FDA supervision.

If the reconditioning is successful, FDA may release the goods; if not, the goods must be re-exported or destroyed, under US Customs supervision.

GLOBEFISH Insight 31

2.4.2 Food safety requirements for fishery business operators The technical requirements for food safety that food business operators must comply with are set out in the Code of Federal Regulations Title 21 Part 123 (Fishery Products).

2.4.2.1 HACCP and Hygiene conditions in the supply chain

Hygienic and HACCP conditions are a requirement under CFR2174: “Every processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur.”

The required elements of the HACCP plan are described. The importer’s Foreign Supplier Verification Program is required to demonstrate that a HACCP system is implemented in the export establishment.75 This is typically interpreted as being able to show the HACCP Plan, with evidence of implementation, as well as evidence of direct audits of the foreign facility and supply chain, of sampling and testing of fish and fish products in the country of origin and of imported products.

As well as implementation of the HACCP plan, the operator is required to apply a written Sanitation Standard Operating Procedure (SSOP) or similar document that is specific to each location where fish and fish products are produced. The SSOP should specify how the processor will meet the sanitation conditions and practices that are to be monitored. It should consider cleanliness, cross contamination risks, personnel hygiene, pest control and all other relevant good practices to minimise the risk of bacterial, chemical and physical hazards being present.

2.4.2.2 FDA and EPA levels relating to safety attributes of fish and fishery products The regulatory FDA and Environmental Protection Agency (EPA) levels relating to safety attributes of fish and fishery products are set out in the 21 CFR. The USA uses the concept of Food Defect Action Levels, which are the safety criteria used in food ingredient and finished food product evaluations. The levels are the limits at or above which the FDA can take regulatory action to remove the offending food from the market under the general powers granted by the Federal Food, Drug and Cosmetic Act and the CFR. Action levels for fish and fishery products are summarised in the Fish and Fishery Products Hazards and Controls guide76 published by the Center for Food Safety and Applied Nutrition of the FDA. Not all action levels have their origins in regulatory measures, but they represent the point at which the agency could take legal action and that includes removing product from the market. Regardless of an established level or not, FDA may take legal action against food that is deemed to be adulterated, as defined by the Federal Food, Drug and Cosmetic Act. The tables of action levels are set out under the headings of animal drugs, microbiology, chemical (pesticides), natural toxins and physical hazards. A copy of the requirements is shown in Annex 2 showing the limits for certain veterinary medicines, heavy metals, histamine, microbiological hazards in different foods, shellfish toxins and pesticide residues.

74

Available at https://www.govinfo.gov/content/pkg/CFR-2013-title21-vol2/pdf/CFR-2013-title21-vol2-sec123-6.pdf The FDA’s Center for Food Safety and Applied Nutrition publishes a superb guidance document “Fish and Fishery Products Hazards and Controls” (now in its 4th edition), which provides step by step guidance to design and implementation of a seafood HACCP Plan. https://www.fda.gov/food/seafood-guidance-documents-regulatory-information/fish-and-fishery-products-hazardsand-controls 76 Available at https://www.fda.gov/media/80637/download 75

GLOBEFISH Insight 32

2.4.2.3 Labelling Country of Origin Labelling requirements require retailers to label all unprocessed, fresh and frozen fish and fish products with a declaration of country of origin and method of production, including a specification of ‘wild’ or ‘farm-raised.’ Processed fish, that is any that has been cooked, cured or canned, and fish that has been combined with other foods, are exempt from this requirement.

2.4.2.4 Filth

According to the possible codes assigned by FDA to violation, “filth” 77 is defined as a condition when “the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.” It will cover issues such as decomposed food and contamination with insect parts, which although the food may not be injurious to health, render it, in law, to be considered unfit for human consumption. It is a commonly stated reason for rejection of imported fish and fish product consignments, for example, due to the presence of foreign material.

2.4.2.5 Food contact materials Requirements concerning food contact materials are set out in the CFR 21 CFR Parts 170-19978, which addresses established food contact materials, and specifying compositional requirements in terms of contaminant levels in different plastics, paper products, polymeric coatings, additives and adhesives. For new food contact substances, manufacturers must register the product with the FDA, including submission of a relevant scientific dossier.

2.4.2.6 Allergens The FDA enforces the Food Allergen Labelling and Consumer Protection Act of 2004 (the Act)79. The Act applies to the labelling of foods regulated by FDA. Food labels must clearly identify the names of any ingredients that are one of the major food allergens or contain any protein derived from a major food allergen, and this includes fish and fish products.

2.4.2.7

Traceability - Seafood Import Monitoring Program

The strengthened Foreign Supplier Verification Programs introduced by the FSMA, and the Public Health Security and Bioterrorism Preparedness and Response Act of 200280 both require the identification of the foreign supplier, providing basic traceability conditions. Except as set out below, there is no other traceability obligation for suppliers.

The Seafood Import Monitoring Program81 is a risk-based traceability program requiring the US importer to provide and report key data—from the point of harvest to the point of entry into US commerce. This covers thirteen imported fish and fish products identified as vulnerable to illegal, unreported and unregulated fishing and/or fish fraud. It is thus a TBT measure, not being directly related to food safety. The 77

Available at https://www.accessdata.fda.gov/scripts/importrefusals/ Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=170 79 Available at https://www.fda.gov/media/77570/download 80 Available at https://www.govinfo.gov/content/pkg/PLAW-107publ188/pdf/PLAW-107publ188.pdf 81 More information at https://www.fisheries.noaa.gov/international/seafood-import-monitoring-program 78

GLOBEFISH Insight 33

Program requires consignments of these species to be accompanied by a catch certificate identifying the catching vessel. The requirement applies to: -

Abalone Atlantic cod Blue crab (Atlantic) Dolphinfish (Mahi Mahi) Grouper King crab (red) Pacific cod

-

Red snapper Sea cucumber Sharks Shrimp Swordfish Tuna (Albacore, Bigeye, Skipjack, Yellowfin, Bluefin)

Compliance for the first eleven species began on 01 January 2018. Compliance for shrimp and abalone became effective on 31 December 2018. The program is administered and enforced by the National Oceanic and Atmospheric Administration (NOAA) of the US Department of Commerce. NOAA has announced the launch in 2019 of the Seafood Traceability Program, which will apply traceability requirements to domestic production, initially concerning farmed shrimp and abalone.

2.4.3 Additional controls for specific products 2.4.3.1 Siluriformes Since September 2017, fish and fish products from the order Siluriformes (which includes many species of catfish) can only be exported to the USA if they are produced in an establishment listed with the US Food Safety and Inspection Service (FSIS) under the US Department of Agriculture.82 To obtain a listing, exporting countries must submit adequate documentation showing the equivalence of their Siluriformes fish inspection system with that of the US. Conditions for listing take into account compliance with labelling requirements, sanitation performance standards and SSOPs, HACCP requirements, product sampling and testing requirements, and written recall and food defence plans83. Only China, Thailand and Vietnam are currently eligible to export Siluriformes fish and fish products to the United States of America.

2.4.3.2 Low Acid Canned Foods The USA has additional and specific requirements in relation to Low Acid Canned Foods to reflect the hazardous nature of these products. The Code of Federal Regulations (21 CFR 10884) require establishments producing shelf-stable acidified foods and low-acid canned foods in a hermetically sealed container to be registered.

Operators (including exporters) must file their thermal processes with the FDA for each product, product style, container size and type and processing method. The products may only be imported and distributed in the USA after approval of the production process forms by the FDA, which publishes specific guidance notes.85

82

A list species concerned is provided at https://www.fsis.usda.gov/wps/portal/fsis/topics/inspection/siluriformes/FAQSiluriformes 83 More information at https://www.govinfo.gov/content/pkg/FR-2015-12-02/pdf/2015-29793.pdf 84 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=108 85 See: https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/acidified-lowacid-canned-foods-guidance-documents-regulatory-information

GLOBEFISH Insight 34

2.4.3.3 Bivalve molluscs Individual operators must address the biotoxin hazards in their HACCP plans, which must either demonstrate effective controls of the harvest area (under CFR21), or participation in the US National Shellfish Sanitation Program (NSSP)86. The policy of the FDA is that the import of (most) bivalve molluscs must be subject to a control system which can demonstrate full compliance with the NSSP. US National Shellfish Sanitation Program The US National Shellfish Sanitation Program (NSSP) is the federal/state cooperative program recognized by the FDA and the Interstate Shellfish Sanitation Conference (ISSC) for the sanitary control of shellfish produced and sold for human consumption. The purpose of the NSSP is to promote and improve the sanitation of shellfish (oysters, clams, mussels and scallops). Participants in the NSSP include agencies from shellfish producing and non-producing States, FDA, EPA, NOAA, and the shellfish industry. Under international agreements with FDA, foreign governments also participate in the NSSP. Key operational components include defined growing area classification, dealer certification programs, monitoring of shellfish toxins and microbiological conditions.

An exception to this requirement is granted for the import of roe-off scallop adductor muscle meat. In all other cases, the exporting country must sign a Memorandum of Understanding (MoU) with the FDA that guarantees the implementation of the controls. Until now, MoUs are only in place with Canada, New Zealand, Chile, Mexico, Peru, Argentina, Japan and Korea. The only bivalve molluscs that are permitted to be exported to the USA from these countries at present are cooked or processed bivalve molluscs (not live bivalves or frozen unprocessed). The FDA and the EU have discussed and agreed an equivalency arrangement for such products, which remains subject to ratification.

2.4.3.4 Live products Imports of live fish and live bivalve molluscs are controlled by the US Fish and Wildlife Service. Imports are subject to licence under Title 50 of the CFR. These are issued primarily on consideration of environmental criteria. Permit conditions include specific certification requirements, extended notice and importing to designated ports.

2.5 History of enforcement of technical barriers 2.5.1 Exports of Indian fishery products In the period 2015 to 2019, according to UN ComTrade Database,87 India exported seafood products to 154 countries, with export value rising from USD 4.8 billion to 6.8 billion over the period (for all categories of fish and fish products covering HS03, HS1604 and 1605 and HS230120).Error! Reference source not found. Figure 1 86 87

More information at https://www.fda.gov/media/117080/download See: https://comtrade.un.org/

GLOBEFISH Insight 35

shows the trends in Indian seafood exports to the top 10 main markets. The USA is the main market and has grown strongly over the period, with imports from India almost doubling to more than USD 2.5 billion in 2019. The European Economic Area (EU plus Norway, Liechtenstein and Iceland) imports have remained relatively stable at around USD 1 billion, with Japan also stable but much lower at around USD 400 million. Exports to China have grown phenomenally, from around USD 150 million during the period 2015 to 2017, but then rising to USD 1.4 billion in 2019. However, exports to Viet Nam have declined by a similar amount during the same period, suggesting that Vietnamese operators engaged in reprocessing for export may have lost some of their export business to Indian national producers. It remains clear that the export markets of major strategic importance to the Indian fishery sector are the United States of America, the EEA (including Norway) and China.

Figure 1

Exports of fishery products from India to main markets 2015-2019

Exports from India (USD 2015-2019) to main markets 3.000.000 2.500.000 2.000.000 1.500.000 1.000.000 500.000

2016

2017

2018

rs Ot he

er at io n

sia n Ru s

d Un ite

d Un ite

2015

Fe d

Ca na da

Em ira te s

Ar ab

Th ai lan d

tN am Vi e

Ja pa n

Ch in a

EE A

St at es

of Am er ica

-

2019

2.5.2 Rejects of Indian seafood products in international markets 2.5.2.1 Overview of rejections The impacts of controls applied by key export markets can be profound and significant. Rejections of Indian seafood exports consigned to the USA, EU, Japan and Australia88 over the last decade are shown in Table 6 and Table 7. Indian exporters have suffered rejections in the regions averaging 150 consignments per year. Bacterial contamination, hygiene failures and veterinary drug residues account for 87 percent of the rejections, suggesting that these hazards are where export 88

China does not publish rejection data in a way which is amendable to comparative analysis

GLOBEFISH Insight 36

control systems would need to be focused. Table 7 suggests that the annual value of these rejected consignments has averaged about USD 2.5 million (although value data was not always available for each consignment).

The rate of rejections (per million dollars of trade) has varied quite substantially from year to year (by a factor of 10 in some cases) but has averaged 0.3 rejections for every USD 1 million of exports. However, considering the overall volume of exports, even in years in which high numbers of rejected consignments were experienced (e.g. 2018) the actual value of rejected product is negligible (c.0.05 percent of exports). In terms of international benchmarks amongst some major fish exporting nations, this rejection rate compares favourably with Vietnam (0.39 rejected consignments for every USD 1 million of exports) but not so favourably with other Asian and South American competitors (see Table 8).

Table 6

Rejections of Indian fishery products (HS3) on entry to EU, USA, Japan and Australia, 2010 to 2018

Reason for rejection

Year 2010

2011

2012

2013

2014

2015

2016

2017

2018

Hygienic condition/controls

25

59

75

31

39

28

38

72

48

Bacterial contamination

31

54

66

52

36

30

34

31

67

Veterinary drugs residues

8

26

15

16

51

54

125

34

32

Labelling

0

0

37

1

4

2

8

4

1

Heavy metal

4

6

1

5

5

2

7

10

10

Other contaminants

0

1

3

1

4

2

4

2

2

Adulteration/missing document

2

5

1

6

0

0

2

0

2

Additive

1

0

6

5

0

1

0

0

1

Others

1

0

1

0

0

0

4

0

1

Pesticide residues

1

0

3

0

0

0

0

0

0

Other microbiological contaminants

1

0

0

0

1

0

0

0

0

Packaging

1

0

1

0

0

0

0

0

0

75

151

209

117

140

119

222

153

164

Total

Source: UNIDO Trade Compliance Database, 2020

GLOBEFISH Insight 37

Table 7

Indicators for rejection of Indian fishery products (HS3) on entry to EU, USA, Japan and Australia, 2010 to 2018

Indicator

Year 2010

2011

2012

2013

2014

2015

2016

2017

2018

Mean

Reject values USD million)

1 366

1 802

1 752

2 228

2 899

2 622

2 884

3 646

3 493

2 521

Number of rejections valued

74

86

126

61

83

67

108

91

98

88

Number of rejections per US$ million

0.612

0.138

0.229

0.080

0.082

0.070

0.088

0.844

0.740

0.320

Source: UNIDO Trade Compliance Database, 2020

Table 8

Reject performance of some major fish exporting countries 2010-2018 Country

Number of rejections per USD million exports (2010-2018)

Viet Nam

0.390

India

0.320

Indonesia

0.299

Thailand

0.247

China

0.189

Ecuador

0.058

Argentina

0.024

Source: UNIDO Trade Compliance Database, 2020

2.5.2.2 Rejections in the EU An analysis of the rejections of Indian fishery products by the EU during the period 2015 to 2020 (see Table 9 and Annex 4.1.1) shows an average of 6 consignments rejected each year.

GLOBEFISH Insight 38

Table 9

RASFF Alerts published by the European Commission in respect of Indian seafood (2015 to 2020)

Product

Reason Abnormal colour

cadmium

ciguatera

histamine

Total mercury

poor temp control

anchovy

Vibrio cholerae

1

barracuda

1

2 5

kingfish

1

1

fish

1

6

1

mackerel

1 2

1

marlin molluscs

spoilage

3

1 1

3

1 2

6

sardine

1

1

sardines

1

1

shrimp

1

snapper

3

3

surimi tuna Total

1 1

3

5

1

3

2

1

1

3

4

14

2

1

31

Source: EU RASFF Portal https://ec.europa.eu/food/safety/rasff/portal_en

Poor temperature control is an issue for all categories of products. For fish, the presence of histamine in tuna and mackerel and (surprisingly) ciguatoxins in reef fishes are also important issues, clearly identifiable in the product range exported by India. For cephalopod molluscs, the main issue is the presence of cadmium in frozen squid and cuttlefish. For crustaceans, the main issue is the presence of nitrofuran and furazolidone in frozen shrimps (of farmed origin). The presence of Vibrio alginolyticus, Vibrio parahaemolyticus and Vibrio cholerae in frozen raw shrimps is also reported.

2.5.2.3 Rejections in the USA Details of import alerts issued by the US FDA from 2017 to 2019, on entry of Indian seafood are shown in Annex 1. In total over the three years there were an average of 66 consignments rejected each year. The top three reasons identified were salmonella, filth (extraneous matter) and nitrofuran metabolites (indicative of treatment with non-approved veterinary medicines). In terms of products, shrimp accounts for the majority of the rejections (75 percent) and mahi mahi accounted for about 10 percent (HACCP failure i.e. histamine and filth).

Table 10

Import Alerts published by the FDA in respect of Indian seafood (2017 to 2019) Hazard identified

Year

Total

GLOBEFISH Insight 39

2017 Chloramphenicol Filth

2018

2019

1 7

21

1 17

45

1

1

Listeria monocytogenes MfrHACCP

12

Nitrofuran

6

No process

2

12 24

30 2

Salmonella

8

63

20

91

Vet drugs

1

4

10

15

Total

16

109

72

197

Source: US Food and Drugs Administration Import Refusal Reports https://www.accessdata.fda.gov/scripts/importrefusals/

2.5.3 Effectiveness of export controls in Indian fishery products As described in Section 2.3, the European Commission performs audits of third country official controls systems for food safety conditions of fishery products. These audits are part of the process of ensuring that the products exported to the EU are produced under sanitary conditions that are at least equivalent to those set out in the EU regulations. Once the resulting plan of corrective actions proposed by the third country is accepted by the Commission, these mission reports are published. These reports represent a highly accurate, detailed, and third-party assessment of the status of the control system and its effectiveness. The audits thus provide a most valuable indicator of the effectiveness of the control system and pinpoint areas of weakness. The results of five DG SANTÉ missions conducted during the period 2011 to 2018 are shown in Table 11.

Table 11

Summary of EU DG SANTÉ audit reports on Indian fish export controls

Title

Summary

FINAL REPORT of an audit carried out in India from 14 to 25 November 2011 in order to evaluate the control systems in place governing the production of fishery and aquaculture products intended for export to the European Union

The mission found that official controls were still not applied effectively to fishing vessels, landing sites and auction markets, and that there was no testing for PCB and dioxin contents in wild caught fishery products. Testing methods for histamine and heavy metal analyses were found in some cases not to meet EU requirements. The competent authority was recommended to provide Commission services with a plan of corrective actions.

GLOBEFISH Insight 40

FINAL REPORT of an audit carried out in India from 03 to 14 March 2014 in order to evaluate the control systems in place governing the production of fishery products intended for export to the European Union

The mission found that the official control system has changed little since the previous inspection mission. Controls over primary production, landing and first sale had only recently started; aquacultures farms and fishing vessels had been approved without being subject to official inspection. Approved landing sites were found to have several sanitary defects. Processing establishments visited were found to be in good condition regarding structure, equipment, maintenance and hygiene and own-check programmes were in line with EU requirements. No official organoleptic examinations were undertaken, and there were shortcomings in the laboratory testing for cadmium, dioxins and polychlorinated biphenyls. The report concluded that the Central Competent Authority, the Export Inspection Council, is not able to guarantee that non-eligible fishery products are excluded from export to the EU market.

FINAL REPORT of an audit carried out in India from 03 to 14 March 2014 in order to evaluate the control of residues and contaminants in live animals and animal products including controls on veterinary medicinal products

The objective of this audit was to evaluate the performance of competent authorities in the implementation of official controls concerning residues and contaminants in aquaculture animals. The mission found that the system in place was broadly in line with EU requirements for aquaculture shrimp, but not finfish. Only a narrow range of substances was tested in the residue monitoring, and no account was taken of the substances used in aquaculture.

There was excessive reliance on pre-harvest and pre-export testing programmes. Official follow-up at primary producer level to identify the root cause of non-compliance was almost non-existent. Deficiencies in laboratory quality control and management of the analytical integrity of samples undermined the effectiveness of the residue monitoring plan. The system for authorisation of, and controls on veterinary medicinal products was deficient in many respects. The many non-compliances identified, and overall poor awareness and enforcement of the legislation were found to collectively weaken the effectiveness of the residue control system.

FINAL REPORT of an audit carried out in India from 20 November 2017 to 30 November 2017 in order to evaluate the control systems in place governing the production of fishery products intended for export to the European Union

The mission found that the official control system is based on legislation and control procedures which, if implemented as foreseen, should be capable of providing adequate assurance that such exports meet the requirements set out in the EU health certificate. However, implementation of the system was found to be wanting in relation to the aquaculture sector, where there was insufficient inspection and control, and farms producing for export were subject to potential contamination from uncontrolled adjacent aquaculture activity. Insufficient resources were applied to controls of primary products (aquaculture and fishing vessels). In addition, there was poor coordination between competent authorities applying sanitary controls on fishing vessels and landing sites. The recording of inspections was also insufficient. The mission concluded that the deficiencies noted do not allow the competent authority, the Export Inspection Council (EIC) within the Ministry of Commerce and Industry, to guarantee that all of the relevant EU conditions are met, and recommended a series of corrective actions, subsequently addressed to the Commission's satisfaction in an action plan agreed between the parties.

GLOBEFISH Insight 41

FINAL REPORT of an audit carried out in India from 16 to 27 April 2018 in order to evaluate the control of residues and contaminants in live animals and animal products including controls on veterinary medicinal products

In this mission DG SANTE audited the residue controls implemented by Indian Competent authorities for a range of farmed animal products, including aquaculture products. For aquaculture products the systems continued to rely on extensive additional pre-harvest and pre-export testing programmes which focus on a limited range of substances. However, the effectiveness of the monitoring and control was weakened by the fact that many pharmacologically active substances available on the market are not currently included in the scope of testing. There was found to be widespread over-the-counter availability of veterinary medicinal products with no requirement to keep purchase records, and insufficient legal tools to sanction non-compliant producers. Laboratory performance with regard to testing for the currently listed commodities had improved and was, with a few exceptions, largely satisfactory. Regarding distribution controls on veterinary medicines, withdrawal periods were included in the labelling of veterinary medicines. However, prescription requirements remained weak, and there was a no enforced requirement for keeping treatment records, with the result that malpractices in the use of veterinary medicinal products had not changed substantially from the situation described in 2014. Given that many pharmacologically active substances which are banned for use in foodproducing animals in the EU are freely available on the Indian market and may be purchased over the counter, the mission concluded that the residue control system in India remains weak.

Source: DG SANTÉ Audit reports https://ec.europa.eu/food/audits-analysis/audit_reports/index.cfm

Whilst India, in common with many other third countries, was able to develop modern and fully compliant export establishments (in terms of hygiene and HACCP system), establishing effective controls within the supply chain, and especially during production, have remained a challenge, both in capture fisheries and aquaculture.

2.6 Conclusions and Recommendations 2.6.1 Losses associated with non-compliance Although the individual losses associated with a rejected consignment may be considerable, especially for smaller operators, the impact of rejections goes further.

Authorities in importing countries track compliance conditions closely and seek to manage risk by excluding access to their market by specific value chains. Noncompliant exporters may find their consignments targeted for additional checks, which could be in the form of higher sampling rates. This could be at the individual level, or at the sector level, affecting all operators supplying that market. In some cases (for example the EU), where the safeguard measures are applied to high risk countries, the testing may be undertaken at the cost of the importer. Such additional compliance costs reduce competitiveness and can make a major difference in low margin competitive markets.

India is currently subject to such a measure in terms of exports of aquaculture products to the EU. Commission Decision 2010/381/EU89 on emergency measures applicable to consignments of aquaculture products imported from India and intended for human consumption requires that consignments should be accompanied by the results of an analytical test carried out at the place of origin to ensure that they do not present a danger to human health in terms of residues of chloramphenicol, tetracycline, oxytetracycline and chlortetracycline and of 89

Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010D0381&from=EN

GLOBEFISH Insight 42

metabolites of nitrofurans. In addition, official sampling and testing must be made on at least 50 percent of consignments entering the EU. The impact of such measures, which are generally only applied as a result of persistent non-compliance (to ensure that they remain proportionate, as required under the SPS Agreement), is that importers seek price discounts, not only to compensate for the cost of additional controls, but also to provide a margin of error in case of problems with the consignment at the border, or later in the value chain.

In extremis, where controls applied to exports are not effective and the risk is considered to be too high, importing countries can and do apply import bans to prevent exports of the substandard products. These may be selective (applicable to only certain products considered to present the risk) or a total ban (where fundamental conditions are not met, for instance by a competent authority). Some major fish producing countries are banned completely from access to some export markets e.g. Sierra Leone and Liberia are not able to export any fish products to the EU, and Pakistan may only export non-histamine producing species from marine capture fisheries. The consequence is that non-compliant products may be sold into alternative markets with weaker controls with lower prices (which can include the domestic markets).

In this way, even with relatively low rates of rejection, where persistent and serious problems are not addressed by exporters, non-compliance can have a significant impact on value added generated. This impact is much greater than suggested by the value of rejects alone. Reduced value added undermines the profitability of investments and reduces the incentive for investment. New investment, particularly to upgrade food safety and quality conditions and management systems, is therefore undermined, since non-compliant operators (who do not sustain such costs) will always operate at a significant cost advantage to compliant ones (who do). By ensuring that non-compliant operators are excluded from supply chains, governments create the environment for investment in improved food safety systems by responsible operators.

2.6.2 Estimates of losses As noted above, losses due to non-compliance are associated with price discounts sustained by a sector, and by a suppression of exports. These represent opportunity costs which can be recovered through improved SPS conditions. However, it should be noted that improved SPS conditions do not come for free; improved compliance requires additional finance for investment and operating costs, both by government and fishery business operators. Table 12 shows a classification of the additional costs usually involved in strengthened SPS controls.

GLOBEFISH Insight 43

Table 12: Structure and nature of additional costs sustained in strengthened SPS controls Type of costs

Sector Private sector

Non-recurring (investments)

•

Recruitment and training of staff Upgrading of internal controls (HACCP)

• • •

•

Upgrading of plant and equipment

• •

• •

Additional hygiene measures Additional QC controls (HACCP systems) Increased rejections/ withdrawals

• •

•

Recurring (operating cost)

Public sector

•

Upgrading of controls Upgrading of laboratories Recruitment and training of inspectors Equipment for inspectors Risk assessment institution

•

Sampling and testing Inspector & risk manager salaries Monitoring programme

• •

Risk assessment studies Enforcement actions

Source: Adapted from World Bank Report No.31207, Food Safety and Agricultural Health Standards: Challenges and opportunities for developing country exports, 2005

There have been few studies that analyse the export-related costs and benefits of investment in improved sanitary conditions. However, a recent study was conducted

by UNIDO in Sri Lanka (in 2019) and although it considered all agricultural and fishery exports, it provides useful insights into the economic and financial impacts, and the relative benefits and costs of sanitary improvements (see next box). In 2018, Indian seafood exports were USD 6.8 billion (compared to Sri Lankan exports of all food and fisheries products of USD 2.3 billion). Assuming that strengthening sanitary controls in the Indian Seafood sector could be expected to deliver proportionate benefits, suggests that just through SPS compliance-focused investments alone, the Indian seafood sector could raise exports to USD 8.4 billion in 2028 (with a corresponding increase in value added of about USD 1.3 billion).

GLOBEFISH Insight 44

Socioeconomic Costs and Benefits of Food Safety Reform in Sri Lanka EU-Sri Lanka Trade-Related Assistance Project In a study conducted in late 2019, the EU-Sri Lanka Trade-Related Assistance Project, sought to assess the costs and benefits and employment impacts by modelling two scenarios concerning the export of agricultural and fishery products.

Scenario 1 represented the status quo, in which there is no investment in food safety conditions, with no additional costs sustained, nor any benefits delivered.

Scenario 2 represented new investment in food safety conditions, as well as increased operating costs, but allowing increased penetration of export markets (increased volume sales) as well as increased unit prices. Benefits of improved health of the general population were also used to estimate domestic (non-export) benefits. These costs and benefits were estimated over a nominal10-year period.

Overall the study found that an investment in improved food safety risk management by Government of USD30 million and an annual net budgetary commitment of USD9 million, with modest annual growth in prices and volume (of 1.5 per cent and 0.75 percent respectively) would lead to a significant increase in annual export values over 10 years (by 24 percent) and reduction in national annual foodborne illnesses (by 934 000 cases and 113 deaths). These benefits are expected to add approximately 2.5 percent to GNP, and secure employment for 122 236 persons in the agricultural and food industries, corresponding to nearly 6 percent of the sector employment. However, to obtain these benefits, export FBOs and their suppliers will need to accompany strengthened controls with an estimated investment totalling USD 822 million (for upgrading 3 823 establishments, equipment, staff training and strengthened control systems).

Operators in export supply chains will also sustain additional annual operating costs of 0.5-1.0 percent, averaging USD 43 million/year. The total cost of food safety reform over the 10 years, including all investment and operating costs, was estimated to be in the region of USD1.4 billion. Nevertheless, even with such substantial financial inputs required to improve food safety, the net benefits are highly positive, with USD 2.6 in benefits delivered for every USD1 spent overall.

The study provided a clear economic rationale for investment in strengthened food safety controls for both export and the domestic market. It is notable that only 30 percent of the economic benefits were expected to be derived from improved population health, with the balance derived from improved export performance.

The study also highlighted that reform of food safety controls alone cannot deliver the benefits identified. Increased investment and operating costs to the food industry of USD 1.25 billion over the 10-year period will need to be financed, and policy should clearly also consider how this need is met, and include a commitment from Government to support the development of the necessary financial instruments. The study also identified the need to ensure that smaller operators are not put out of business by the demands of more rigorous and effective official controls, even if this means that some current food safety risks are sustained in the short term.

Source: Goulding, Ian C. Socioeconomic Costs and Benefits of Food Safety Reform in Sri Lanka, EU-Sri Lanka Trade-Related Assistance Project, United Nations Industrial Development Organization, March 2020.

GLOBEFISH Insight 45

2.6.3 Strategic response of exporting countries The US FDA introduced strengthened requirements for imported seafood in the 1980s, and the EU introduced its concept of control in third countries in 1991. This trend was followed by Japan and most recently in the last decade by China. Other developed countries have also strengthened controls in this period (e.g. Canada, Australia and New Zealand). In response, seafood exporting countries and operators have been forced to develop export controls to meet the requirements of these major importers. Response to these dynamic requirements has been necessary, both on the part of governments and their inspection and control systems, fishery business operators and their input suppliers, as well as laboratories (as service providers to both).

2.6.3.1 Institutional and legal framework Countries with business operations intending to export fishery and aquaculture products find it increasingly difficult to do so without formal governmental institutions for official food safety controls for the relevant sectors. Such an institution is a requirement to meet the EU conditions, and whilst strictly not a legal requirement for entry to the US or Chinese markets, the reliance of these countries on intergovernmental protocols to address food safety during production means that a competent authority needs to be in place with meaningful powers. Many export markets require an official certificate from a government authority that has a lawful and technical capacity to issue such certificates. Legislation is therefore required to establish and/or nominate and empower a suitable body. This can be a body created especially for the purpose, or one integrated with other functions, which increasingly is a dedicated food safety agency (see section 2.6.3.3).

Legislation is also required to set up the system of controls (registration, approvals, certification) as well as powers of the competent authority and its inspectors (e.g. powers to enter, seize, sample). A suite of enforcement tools is required. In modern systems, these are designed primarily to be preventative and to make food safe, rather than solely punitive measures such as fines and imprisonment, which only make food safer by creating a disincentive to others. A modern food safety enforcement toolkit will encourage improvement and develop cessation, recall and emergency closure procedures. Monitoring programmes are required to enable the competent authority to assess the effectiveness of its control activities by measuring their impact on food safety indicators (such as frequency of non-compliance).

Legal measures are required to express the obligations of FBOs in terms of the food safety requirements that they should comply with in their business activities. These may address practices such as design, construction and hygienic operations of food establishments and extend to food safety management system requirements such as HACCP, and standards that define maximum levels of undesirable substances.

2.6.3.2 Competent Authority operations As well as providing the legal framework, the competent authority needs to be effective and efficient in its operations. It needs technically competent staff, procedural and technical guidelines for different kinds of inspections, along with checklists. The staff need to be equipped appropriately to perform inspections hygienically, to conduct field tests and to take samples for laboratory testing.

GLOBEFISH Insight 46

Export controls The systems developed by the competent authority should reflect the different hazards to be controlled. For example, the hazard profiles of capture and aquaculture production systems differ greatly. Where aquaculture is the main source of new production for export, food safety controls need to be focused on veterinary medicines and animal feeds. If tropical freshwater systems are employed, then hazards such as trematode parasites may become an important hazard to control.

Each situation is unique, and the management challenge is to use legal and bureaucratic tools and the technical resources available to minimise the public health impacts of unsafe food. In all cases, a risk-based approach (in which the objects of control are profiled according to risk) is a useful and under-utilised tool for resource constrained competent authorities. Active steps also need to be taken to ensure that system integrity, including personnel, are maintained at a high level and to ensure that outcomes are not determined by non-professional influences. Corruption is one such hazard, but pressure on frontline inspectors to take a softer approach towards well connected business operators is not uncommon.

In relation to controls of the export supply chain, attention should be paid to stringent non-compliance procedures that result in the desired corrective action. Some authorities choose to develop software for recording inspection findings and managing compliance decisions and follow-up. Staff have to be located temporally and spatially to interact with fish sector activities where and when they take place (often remote and in out-of-office hours), which can pose a challenge to more rigid resource-limited governments.

Jurisdictional boundaries may need to be actively managed and coordinated, especially where a central competent authority relies on other bodies, such as other agencies or provincial governments, for some of the inspections. Examples include the inspection of conditions of production by fishing vessels or aquaculture farms, or controls on the distribution and use of veterinary drugs. The system should provide for sampling and laboratory testing for different purposes (monitoring, compliance and investigative). Emergency procedures need to be defined and tested, to allow for rapid responses when the systems in place fail to deliver the degree of protection required.

Import controls Many fish exporting business are not able to operate at full capacity due to a shortage of local raw materials (due to, for example, seasonal fluctuations, or declining stocks), and they need to source alternative inputs via imports. Some countries have developed themselves as processing “platforms”, a strategy that uses their processing skills and marketing linkages to add value to the raw materials produced by others.

Secure and effective import control systems need to be developed to ensure the sanitary origin of products that may be processed for re-export, e.g. landings from foreign vessels. Biosafety issues may also need to be addressed in the case of imports of live fish, to protect aquaculture systems against the introduction of alien pathogens, as well as protecting the natural environment, e.g. to preserve biodiversity.

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2.6.3.3 Integration with national food safety risk management system Ensuring the inspection and control of large numbers of small producers (both fishers and fish farmers) is a major logistical exercise, which demands an effective field network of technically competent inspectors. Where such controls, at the level of the producer, are applied by bodies other than the central competent authority (such as provincial or local governments), it is a major challenge of organisation and communication between and within different levels of government to ensure that they are applied in an effective, valid, consistent and reliable way.

In India, a similar problem is encountered in the apparent disconnect (highlighted by the DG SANTÉ audit reports described in 2.5.3) between veterinary drug residue monitoring in aquaculture (undertaken by the Export Inspection Council and Marine Product Export Development Authority - MPEDA) and the authorisation, distribution and use of veterinary medicinal products for aquaculture under the Central Drugs Standard Control Organisation of the Ministry of Health and Family Welfare. Until now, the competent authority has not been able to ensure that Ministry of Health and Family Welfare delivers the improvements promised to the EU (there are other evident priorities that demand its resources).

In terms of effectiveness, there is a clear need to develop and strengthen controls in the supply chain, including improved inspection of fishing vessels, landing sites and distribution and use of veterinary medicines. Traceability tools are required to ensure than products from non-compliant operators /vessels or farmers do not leak into export supplies. A difficult to detect, but common feature of the seafood business is collusion to allow the export of a consignment from a non-authorised supplier under the approval granted to another (possibly giving rise to the rejects seen in important global markets). Traceability tools need to be sufficiently robust to allow for forensic accounting methods and mass balance calculations to identify such fraudulent activity.

However, the reform of sanitary controls in the fishery and aquaculture sector also need to account for reforms of food safety systems in general. In many countries, the need to build exports in the short term has led to the development of dual control systems whereby SPS conditions of fish and fish product exports are reasonably well developed by a specially created competent authority for fish exports, and those for the domestic market (controlled by the national food safety bodies) are not. The division of control mandates between different branches of government on the basis of product type (with, for example, separate controls systems for meat and dairy, fish, vegetables, as well as for hazards such as pesticides and veterinary medicines, etc.) further complicates the picture. Such systems do not reflect the risk analysis approach implicit in the application of the SPS Agreement (with defined functions of risk management, risk assessment and risk communication).

Many countries have responded to such institutional dysfunction by reforming food safety control systems to create a central food safety agency as the only body with food safety risk management functions. India is one such country, which has set up the Food Safety and Standards Authority of India (FSSAI) as an autonomous body established by the Food Safety and Standards Act, 2006, operating under the Ministry of Health & Family Welfare. However, the reform has not yet integrated export controls implemented by the Ministry of Commerce, and as a result there are two control systems currently applied to the fishery sector, one responding to domestic food safety needs, the other to export needs, yet both demand safe food from the same food producers.

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2.6.3.4 Upgrading of laboratories Testing laboratories with the capacity to undertake valid and reliable analyses of all relevant hazard parameters are essential tools for inspectors and FBOs alike.

ISO1702590 defines the management standards that guarantee validity and reliability of testing activities, and accreditation to this standard is an explicit requirement in some systems e.g. EU. Even where laboratory accreditation is not mandatory, for official control actions (which may involve legal sanctions, or their defence, based on test results) the lack of accreditation opens presented evidence to challenge. Most countries recognise the need to upgrade testing capacities in terms of the range of tests parameters, the use of modern equipment and the quality of testing (i.e. accreditation, participation in proficiency testing, installations of LIMS91).

However, there is a risk that investment in laboratory capacity may be mis-directed, especially when donors and governments fail to consider that testing is simply a service which can be delivered by any technically competent provider. Competent authorities should ensure that the choice of laboratory reflects market forces rather than automatically supporting laboratories internal to the competent authority or its host Ministry. Experience suggests that many countries have many options for testing services (whether public or private sector, national or foreign) that are not always fully considered. Laboratories are not only expensive to build and equip, but also expensive to operate - with annual operating costs typical reaching 30-40 percent of invested capital and being mostly fixed costs. Expectations of full cost recovery are often impossible to meet and impact on the competitiveness of the fish export sector. A critical pre-condition for laboratory investment is an annual budgetary commitment for testing, which is best provided to the service user, i.e. the client competent authority and inspection service, to purchase tests as and when they require.

2.6.3.5 Building capacity of human resources Science of food safety hazards and controls All countries need to plan for the long-term supply of human resources with appropriate scientific and technical skills to deliver inspection and risk management functions in relation to food safety hazards in the fish supply chain. Suitable backgrounds for such persons are veterinary science, environmental health, food science, microbiology, toxicology, etc. However, additional education and training is required to develop the application of their knowledge to the specific hazards encountered in the fishery and aquaculture sectors, and how to control them, for example through HACCP and traceability systems. Development of new or adjusted educational provision is therefore often needed. These skills are equally elevant to, for example, quality control positions in the fishery and aquaculture industries.

2.6.3.6 Vocational training In parallel, attention needs to be paid to the vocational training of food handling personnel, who will work at all levels of the supply chain, including fishers and port workers. This training should reflect the need for knowledge of the principles of basic hygiene and ensuring the safety and quality of the product. Thus, vocational courses 90 91

More information at https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100424.pdf Laboratory Information Management Systems

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on fisheries and aquaculture may need to be adjusted to provide improved specific training on food safety for both operators and supervisors.

2.6.3.7 Investment Need for accompanying financial instruments Where governments and donors seek to strengthen competent authorities, it is essential to consider the impacts of stronger controls on FBOs and rural/coastal employment. Compliance with new sanitary requirements (or more effectively enforced existing ones) imposes costs on operators. Investment is required but the resources needed to comply are often orders of magnitude greater than that required to build the control system. The impacts are greatest on those with least access to capital and ability to pay, typically small-scale operators. Due to its export linkages, the fishery sector is often much more exposed to compliance costs for international trade than, for example, terrestrial farmers who can rely more on domestic markets often with lower or less well policed standards. Unless financial instruments are put in place to support investment, the outcome will be that new measures will either put operators out of business (if enforced) or the measures will not be enforced, creating uneven implementation and bringing the control system into disrepute.

Whilst building a competent authority is a relatively low-cost operation, upgrading a fishery sector in a developing country to meet modern food safety standards is an enormous task. Meeting this requires new approaches to investment support that overcome some of the barriers involved with loan finance to small scale operators such as lack of collateral. Loan guarantee schemes and shared cost grants are options.

Infrastructure Compliance usually requires installation of new infrastructure. For capture fisheries this can include hygienic port facilities for landing and first sale of fish, with facilities for the provision of inputs and services (fuel, ice, fishing gears, etc.). There are options of public, private sector or mixed operations. Similarly, distribution facilities such as markets and cold/chill storage may be required, including at ports for export (sea, land or air). Border inspection posts with adequate facilities for checks on consignments of fishery products, or live fish quarantine facilities may be required.

Upgrading conditions in fishery businesses Fishery business operators along the supply chain may need to upgrade their facilities to comply with hygiene rules. Vessels may need to upgrade fish holds (e.g. insulation and hygienic linings), ports may have to replace wooden boxes with plastic for improved handling, processing and distribution facilities may need to redesign their layout and upgrade equipment e.g. to stainless steel or install refrigeration facilities. In all cases, personnel will need to be trained in hygienic operations, improved cleaning and sanitising, and personal hygiene.

2.6.3.8 Management systems (HACCP and traceability) As well as upgrading plant, equipment and food hygiene capacity of the workforce, operators of fishery businesses are required by export market requirements to apply new management tools to provide the guarantees of product safety that cannot be delivered by other means, such as end-product testing and certification. This includes HACCP and traceability systems, which involve investment to establish new data recording procedures and increased operating costs for their routine

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implementation. HACCP provides a technical challenge for many operators due to the level of scientific knowledge that is needed. If it is to be more than a paper exercise (which is a major risk), there is a need for a high level of technical expertise, which most small-scale businesses do not possess. This is one of the reasons to develop training and educational provision at an early stage. The establishment of a corps of HACCP and quality management consultants, with relevant experience is often needed to deliver this technology transfer to the level of the business operator.

Governmental extension services have rarely proven to be effective in this task.

To meet traceability requirements, all operators in the supply chain will need to have a unique identifier, keep records to identify suppliers and customers for every batch of product that they manage, as well as operating an internal tracing procedure to ensure that batch separation is maintained, or where this is not feasible, recording of the splitting and/or merging of batches.

In capture fisheries, the origin of the product is the fish stock, caught by the fishing vessel. In aquaculture, the value chain extends to before the production of the fish.

The traceability requirement applies to the producers and distributors of aquaculture inputs such as fish fry (from hatcheries), animal feeds and veterinary medicines.

Ensuring functional traceability of fishery and aquaculture products presents immense challenges for the fishery and aquaculture sectors, especially where there may be large numbers of small suppliers, which is often the case in developing countries. For a generation this has been, and remains, one of the major challenges to the integration of small-scale operators into international trade.

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3 OTHER NON-TARIFF MEASURES 3.1 TBT measures Technical measures other than those addressed by the SPS agreement are frequently applied to imported fish and fish products. Many of these measures concern sustainability and avoidance of the products of IUU fishing.

Nevertheless, these measures can also address product features such as quality, traceability and labelling. Some countries require specific quality grading systems to be applied, specifying for example size grades or defining certain presentations.

Traceability is often an explicit requirement, so that the origins of any food safety (or other) non-compliance can be identified, corrected and, if needed, impacts mitigated through recall. Many countries apply labelling requirements that require common and scientific nomenclatures for fish names to help counter fraudulent declarations.

Labelling of country of origin, production/catch method, additives, and storage and usage conditions may also be required.

3.1.1 Controls on IUU Fishing The EU has led the development of catch certification systems for international trade in fishery products as a means of countering products from IUU fishing. Other countries, such as the USA, and several RFMOs are also developing checks on traded fishery products to help reduce this threat to sustainability.

Council Regulation (EC) No 1005/200892 sets out a regime for ensuring the imports of fishery products to the EU are not the products of IUU fishing. Governments of exporting countries are required to notify the Commission of their competent authorities responsible for vessel registration and ensuring that their vessels operate in line with international obligations (e.g., United Nations Convention on the Law of the Sea (UNCLOS) and the terms of the RFMOs to which they have committed).

Each consignment exported to the EU should be accompanied by a catch certificate, which indicates the supplying vessels and certifies that they were properly authorised to take the catch concerned. The importing EU Member States can challenge the certification by requesting the evidence on which it is based. In cases of non-compliance, the EU may notify the exporting country that it is subject to consideration of being a potential non-cooperating third country in the fight against IUU fishing (the EU “yellow card”). If apparent deficiencies are not corrected (for example, in terms of legislation, organisation of fisheries monitoring, control and surveillance (MCS), or prosecution of IUU offenders), then the Commission can decide to declare non-cooperation (the EU “red card”) and can ban imports and access to EU ports by vessels from that country.

For example, Sri Lanka was issued a yellow card in 2012 and, failing to undertake corrective actions, received a red card in February 2015. It was not allowed to export any fishery products to the EU until the decision was revoked in April 2016, after the Sri Lanka Government amended its legislation and commenced investment in an upgraded satellite vessel monitoring system for distant water fishing.

92

Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing

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3.1.2 Sustainability measures (bycatch protection) Special measures are sometime introduced to protect vulnerable species which may be subject to incidental catches. To ensure that shrimps imported by the USA have not been caught by methods which could result in a bycatch of turtles, shrimp exporters must make a declaration (to be held on file by the importer) to the effect that shrimp boats took necessary precautions to avoid harming sea turtles, or example by employing a Turtle Exclusion Device. This declaration form is to be retained by the importer for three years after entry and must be made available to the Customs and Border Protection (CBP) or the State Department upon request.

Other countries may require cetacean (mostly dolphins) protection measures in tuna fisheries, or for seabirds in long-line fisheries.

3.1.3 Biosecurity and biodiversity There is an international trade in live fish for the aquarium trade, for human consumption, as well as inputs to aquaculture (gametes, eggs and juveniles). With such products, whether from capture fisheries or from aquaculture, the biosecurity (animal health) concerns may also be compounded with those concerning biodiversity, where there are risks to natural populations through the introduction of non-native DNA. For this reason, some countries may apply strict controls to the import of live fish and genetic material (as a TBT measure). In this respect the same measures may serve both biosecurity and biodiversity policies.

It is important to note that for access and utilisation (for research and development purposes) of marine genetic resources within national jurisdiction, Parties to the Convention of Biological Diversity (1982) and the Nagoya Protocol on Access and Benefit Sharing (2010) have to comply with “prior informed consent” and “mutually agreed terms” requirements in light of the relevant national legislation. For nonParties, national legislation will also apply when seeking access in third countries.

Such requirements may be very important for the transfer of samples of genetic and biological resources, parts thereof, fragments, extracts and raw materials when the users plan to undertake research and development activities within the scope of Article 2 of the Nagoya Protocol. National legislation may incorporate additional verification and monitoring systems applicable to those flows. In order to guide interested users and companies engaged in trade of marine biodiversity, UNCTAD has developed a Blue BioTrade approach (UNCTAD, 2018) through the application of BioTrade principles and criteria (2007 and revised 2020).

3.2 Private standards in fisheries and aquaculture Standards, and related certification, are developed by various public and private organizations, target a variety of objectives and cover a variety of industrial activities.

Consequently, the terminology is varied and rich and can lead to confusion.

According to the ISO (2004), a standard is: “A document established by consensus and approved by a recognized body, that provides for common and repeated use, rules, guidelines, or characteristics for activities or their results, aimed at the achievements of the optimum degree of order in a given context.” It also notes that:

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“Standards should be based on the consolidated results of science, technology and experience, and aimed at the promotion of optimum community benefits.”

The World Trade Organization Agreement on Technical Barriers to Trade (TBT) distinguishes mandatory standards (or technical regulations) from voluntary standards as: “A standard is a document approved by a recognized organization or entity, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory under international trade rules. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.”

In contrast, a technical regulation is defined as: “a document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.”

Making a standard operational requires different functions (standard-setting, adoption, implementation, conformity assessment and enforcement) to be set up and carried out by either the public or private sector entities. Figure 2 highlights entities associated with each function depending on the nature of the standard.

Standards pertaining to food safety and environmental sustainability or ecolabels in fisheries and aquaculture are presented herein.

Table 13

Differences between mandatory and voluntary standards and standards set by public and private organizations Public

Private

Mandatory

Regulations

Legally-mandated private standards

Voluntary

Public voluntary standards

Private voluntary standards

Source: Henson et Humphrey, 200993

93

Spencer Henson, and J. Humphrey. “The impacts of private food safety standards on the food chain and on public standardsetting processes.” Joint FAO/WHO Food Standards program, Codex Alimentarius Commission. Thirty-second session, Rome, Italy, 29 June–4 July 2009. Available online: ftp://ftp.fao.org/Codex/CAC/CAC32/al329Dbe.pdf

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Table 14 Functions associated with standards schemes Function

Regulations

Public Voluntary Standard

LegallyMandated Private Standards

Private Voluntary Standards

Standard Setting

Legislature and/or public regulator

Legislature and/or public regulator

Commercial or non-commercial private body

Commercial or non-commercial private body

Adoption

Legislature and/or public regulator

Private firms or organisations

Legislature and/or public regulator

Private firms or organisations

Implementation

Private firms or public bodies

Private firms

Private firms

Private firms

Conformity assessment

Official inspectorate

Public/private auditor

Public/private auditor

Private auditor

Enforcement

Criminal or administrative courts

Public/private certification body

Criminal or administrative courts

Private certification body

Source: Henson et Humphrey, 200994

3.2.1 Private food safety and quality standards Over the last three decades, several private food standards have been developed to reduce the cost of the client´s audits from retailers to suppliers and simplify procedures to ensure food safety. The creation of these standards simplified second party audits and reduced the costs and frequency.

During the first two decades, a number of food safety standards consolidated their presence in the certification market, namely IFS-Food, BRC-Food (BRCGS now), ISO 22000, Global G.A.P and FSSC 22000, but the diversity of schemes created a challenge for food producers and processors, who were requested to become certified using different food safety standards to have access to different retailers.

Multiple certifications were a challenge for the industry for a period of time. In 2000, the Global Food Safety Initiative (GFSI) started working in benchmarking and harmonization to foster mutual acceptance among standards. Nowadays, GFSIrecognized programmes95 are accepted by most food retailers. GFSI recognized standards for food processing and packaging are IFS-Food, BRC-Food, FSSC 22000 and SQF. The only GFSI recognized food safety standard for fish farming is Global G.A.P. Other food safety standards have only been benchmarked for the processing of perishable animal products. This is the case of the Global Aquaculture Alliance (GAA) - Best Aquaculture Practices (BAP) and the Japan Food Safety Management Association (JFSM). As of today, ISO 22000 has not been benchmarked by GFSI. Certification to these standards is achieved by undertaking a third-party audit against the specific standard requirements by an accredited certification body (CB). The cost 94

Spencer Henson, and J. Humphrey. “The impacts of private food safety standards on the food chain and on public standardsetting processes.” Joint FAO/WHO Food Standards program, Codex Alimentarius Commission. Thirty-second session, Rome, Italy, 29 June–4 July 2009. Available online: ftp://ftp.fao.org/Codex/CAC/CAC32/al329Dbe.pdf 95 https://mygfsi.com/wp-content/uploads/2019/09/CPO_printable-version_A3_20200424.pdf

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of certification depends on many factors surrounding the different facilities, including the size of the facility and the scope that the certification needs to cover. The most common requisites of these standards are the following: -

Senior management responsibility; Quality and food safety management systems; Resource management; Planning and production process; Measurements, analysis, improvements; Food defence.

3.2.1.1 British Retail Consortium (BRC) In 1998, the BRC Global Standard for Food Safety began in the UK to help the food industry meet the legislative requirements of the EU General Product Safety Directive and the UK Food Safety Act. Since that time, the Standard has received global recognition with over 20,000 certified sites worldwide. As mentioned above, the Standard is a Global Food Safety Initiative (GFSI) recognised certification program.

The BRC Global Standard for Food Safety (BRCGS) is a product and process certification standard and is HACCP-based. Requirements are risk-based to fit individual operations and provide the necessary level of assurance. The last version of the scheme, BRC Food Safety Standard Issue 8, was published in August 2018.

An auditors' checklist can be found online96.

3.2.1.2 International Featured Standard – Food (IFS - Food) In 2002, German food retailers developed a common audit standard on food safety called the International Food Standard (later rebranded International Featured Standard), designed to bring transparency to the supply chain. In 2003, French food retailers and wholesalers joined the IFS Working Group, in the same year, the GFSI recognized the standard. The IFS operates as a uniform tool to ensure food safety and to monitor the quality level of producers of retailer-branded food products.

Rebranded as the International Featured Standard Food, version 6.1 is the latest version and can be found online97.

3.2.1.3 ISO22000: 2018 The ISO is a network of national standards bodies based in Geneva, Switzerland. It is an NGO that is the product of collaboration between public and private sector bodies. Its members include national standardization bodies as well as industry associations. Despite this public-private mix, the WTO recognizes the ISO as providing internationally recognized standards, which allows some assurance of safety and quality across national borders. In the late 1980s, the ISO developed the ISO 9000 series for quality management in all sectors. Although ISO 9000 helped food companies to improve the organizational and operational aspects of quality management, it lacked food safety specifics, especially with reference to HACCP requirements. Subsequently, ISO 22000 was developed in 2005, building on 96

https://1ilncn2ptox93ih9e41q8but-wpengine.netdna-ssl.com/certification/wp-content/uploads/sites/24/2018/08/food-safetyissue-8-checklist-english.pdf 97 https://www.ifs-certification.com/index.php/en/download-standards?item=251

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previous food-safety-related standards as an attempt to establish one internationally recognized standard for food safety management systems. However, to date, it sits alongside the range of other private and public schemes. The ISO 22000 family of standards contains a number of standards, each focusing on different aspects of food safety management. ISO 22000 contains the overall guidelines for food safety management.

In June 2018, ISO 22000:2018 was published, replacing ISO 22000:2005. The 2018 version places a greater focus on risk-based thinking and is aligned to ISO’s highlevel structure. The new ISO 22000 Food Safety Management Systems can deliver additional benefits to organizations of all sizes throughout the food chain: -

improved control over food safety activities customer, statutory and regulatory compliance facilitated market growth increased customer, stakeholder and consumer confidence in products improved risk management integration with other ISO management system

Manufacturers that are ISO 22000 certified can obtain full GFSI recognized FSSC 22000 certification by meeting the requirements of the technical specifications for sector Pre-Requisite Programs (PRPs) and additional FSSC 22000 scheme requirements. When converting an ISO 22000 certification to FSSC 22000 certification, a full stage 1 and 2 audit will not be required to transfer the ISO 22000 part of the FSMS to FSSC 22000. The transition audit can be combined with a scheduled ISO 22000-surveillance audit or recertification audit, which must be performed at the premises of the organization.

ISO 22000 scheme documents are not available online and need to be purchased.

3.2.1.4 FSSC 22000 Developed through extensive and open consultation with many global stakeholders, the Scheme uses international and independent standards such as ISO 22000, ISO 9001, ISO/TS 22003, and technical specifications for sector-specific PRPs, such as ISO/TS 22002-1. Besides these standards, the Scheme contains FSSC Additional Requirements, which can be found in the FSSC 22000 Scheme documents. The latest version of the standard is FSSC 22000 Scheme Version 5. The Scheme documents are available online98.

The FSSC 22000 Food Safety Management System provides a framework for effectively managing food safety and quality responsibilities. The GFSI fully recognizes FSSC 22000 since 2010. It demonstrates a company has a robust and effective food safety management system (FSMS) in place to meet the requirements of regulators, food business clients and consumers. The audit process for FSSC 22000 is based on the ISO 22000 framework.

3.2.1.5 Global G.A.P EurepGap was developed in 1997 by the Euro-Retailer Produce Working Group (Eurep), a private-sector body driven by a group of European retailers. In late 2007, it changed its name to GLOBALG.A.P. to reflect its more international focus.

EurepGap was initially designed as a standard for good agricultural practices 98

https://www.fssc22000.com/scheme/scheme-documents/

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(GAPs). Its food safety criteria are based on the HACCP system. Originally applied to fruits and vegetables, Eurep-Gap was later extended to fish farming practices. It was the first to develop an integrated aquaculture assurance standard (in late 2004).

In addition to the general code of practice, specific criteria have also been developed for salmonids, tropical shrimp, Pangasius and tilapia. Its aquaculture standard covers the entire production chain, from broodstock, seedlings and feed suppliers to farming, harvesting, processing and post-harvest handling operations. It serves as a practical manual for any aquaculture producer, ensuring food safety, minimal environmental impact and compliance with animal welfare and worker health and safety requirements. It is of interest in developing countries because it now offers localg.a.p., a stepping stone towards certification and includes the aquaculture sector.

GLOBALG.A.P. is the world’s leading private sector farm assurance standards organization offering several different types of certification programs. The Integrated Farm Assurance (IFA) scheme is recognized by the GFSI; it is based on good agricultural practices (GAPs) to produce crops, fish and livestock.

Certification to the IFA Standard is currently against v5.3 and it is made available on the GLOBALG.A.P. website99.

3.2.1.6 Global Aquaculture Alliance (GAA) - Best Aquaculture Practices (BAP) Global Aquaculture Alliance (GAA) is a 23 year old organization, whose main goals are pre-competitive advocacy and education work as well as its industry-leading third-party aquaculture certification program, Best Aquaculture Practices (BAP).

Each activity supports progress toward GAA’s vision: a world that embraces and enables the role of responsibly farmed seafood in meeting global nutrition needs.

It is important to highlight that GAA is not a GFSI benchmarked scheme for fish farming but fish processing. The Seafood Processing Standard Issue 5 is the latest version of a standard, recognised by GFSI in 2018.

BAP standards and guidelines are made available online100.

3.2.1.7 Japan Food Safety Management Association (JFSM) In 2016, the Japan Food Safety Management Association (JFSM), a general incorporated foundation formed under Japanese law, was established. JFSM published a certification program for food safety management systems called the “JFS-C scheme”. The JFS-C scheme is an internationally harmonized certification program referring to ISO/IEC 17011:2017, ISO/IEC 17021-1:2015, and ISO/TS 22003:2013 and the related standard consists of the Good Manufacturing Practice (GMP), the Hazard Analysis and Critical Control Point (HACCP) system and the Food Safety Management System (FSMS). In addition to the JFS-C scheme, JFSM has the JFS-A/B program. The related standards include a stepwise process for FBOs, including SMEs, to effectively and efficiently improve their food safety management systems.

It is important to underline that, as of today, although JFS-C is a GFSI benchmarked scheme, it is mostly applied in Japan and not relevant to other markets.

99

https://www.globalgap.org/uk_en/documents/#fq=gg.subscope:(%22fruit%22)&fq=con_locales:(%22en%22)&fq=gg.document.t ype:(%22checklist%22+OR+%22regulations%22+OR+%22cpacc%22)&fq=gg.standard.gg:(%22ifa5%22) 100 https://www.bapcertification.org/Standards

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3.2.1.8 SQF First developed in Australia in 1994, the SQF program has been owned and managed by the Food Marketing Institute since 2003 and was first recognized in 2004 by the GFSI as a standard that meets its benchmark requirements for food manufacturing.

The SQF Code is a site-specific process and product certification standard emphasizing the systematic application of CODEX Alimentarius Commission HACCP principles and guidelines for control of food safety and food quality hazards.

The Safe Quality Food Institute’s (SQFI) SQF Codes, Edition 8, were updated and redesigned in 2017 for use by all sectors of the food industry from primary production to storage and distribution and included a food safety code for retailers. They replaced the SQF Code, edition 7 and the document can be found online101.

3.2.2 Presence of private food safety standards by country Although there are no data available on the number of companies certified in each standard, we can expect retailers to request the same standards for national and international suppliers. the presence in a country of certification bodies accredited to certify a specific standard is very indicative of its use in a country. For instance, IFS Food is only certified by eight certification bodies in China, and there are no Chinese Certification entities accredited for Global G.A.P, for which we can deduce that its presence in the country is limited and it is not a major requirement for companies exporting to China.

Data shows that FSSC 22000 is the most widely accepted private food safety standard, with the number of accredited companies the highest in China, and together with BRCGS is the highest in the EU. It is also well-positioned in the USA, with a similar level of implementation to BRCGS. The second most widely accepted standard is BRCGS, with a higher number of accreditation bodies present in the EU, surpassed only by IFS-Food in this area and

by SQF in the USA. It is well-positioned in China, being the most offered food safety standards in the country, jointly with FSSC 22000. In the EU, BRCGS has a strong presence in Italy, Spain, Germany, France, Poland and the Netherlands.

IFS-Food finds its niche market in the EU, being the most offered food safety standard and having a strong presence in Spain, Germany, France, Italy and Poland.

SQF is the food safety standard with the most certification bodies accredited in the USA. It is the least implemented food safety scheme used for food manufacturing in China and the EU. Global G.A.P is the only GFSI scheme recognized for fish farming. Other schemes, such as BAP, are not benchmarked for this specific scope. The highest number of accredited certification bodies for aquaculture is found in EU countries.

The following table shows the number of accredited certification entities by standard and by the country where data were available. Only GFSI benchmarked standards were included.

101

https://www.sqfi.com/wp-content/uploads/2018/08/SQF-Code_Ed8Manufacturing1212017.pdf

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Table 15

Number of certification entities accredited in the selected standards by countries

Country

BRCGS

IFS- Food 6/6.1

Global G.A.P. IFA v5 & 5.3 Aquaculture Base

SQF

FSSC 22000

China

20

8

0

7

20

EU countries

186

208

7

2

230

USA

24

12

1

30

22

Total

230

228

8

39

272

Sources: https://www.ifs-certification.com/index.php/en/industry-en/certification-bodiesen?filter=&standard=ifs_food6&country=SE&FLD_COUNTRY=0&FLD_STANDARD=ifs_food6&SUB_SEARCHPREUFINSTITU TE=Search https://www.globalgap.org/es/what-we-do/the-gg-system/certification/Approved-CBs/index.html https://brcdirectory.co.uk/ https://www.fssc22000.com/partners/certification-bodies/ https://www.sqfi.com/how-to-get-certified/find-a-certification-body/

Table 16

Number of certification entities accredited in the selected standards by countries in Europe

EU Countries

BRCGS

IFS- Food 6/6.1

Global G.A.P. IFA v5 & 5.3 Aquaculture Base

SQF

FSSC 22000

Austria

6

7

0

1

7

Belgium

9

6

0

0

10

Bulgaria

3

8

0

0

16

Croatia

4

5

0

0

3

Cyprus

0

1

0

0

5

Czechia

6

8

0

0

8

Denmark

4

3

0

0

5

Estonia

2

1

0

0

1

Finland

3

4

0

0

4

France

14

18

0

0

15

Germany

15

24

1

1

21

Greece

6

6

2

0

13

Hungary

6

9

0

0

8

Ireland

2

0

0

0

5

Italy

29

16

1

0

15

Latvia

3

4

0

0

2

Lithuania

2

2

0

0

3

Luxembourg

0

1

0

0

1

Malta

0

0

0

0

0

GLOBEFISH Insight 60

Netherlands

14

12

1

0

18

Poland

15

15

0

0

16

Portugal

6

8

0

0

5

Romania

5

12

0

0

16

Slovakia

4

5

0

0

7

Slovenia

1

4

0

0

4

Spain

20

26

2

0

13

Sweden

7

3

0

0

9

Total

186

208

7

2

230

3.2.3 Ecolabeling and certification schemes: While safety and quality are of primary concern, consumers in developed and emerging economies are also increasingly interested in the social or environmental impacts of the food they consume. This trend is also starting to take hold in emerging and developing countries. In terms of fish, this means that more and more consumers are concerned that capture stocks are managed sustainably, that wider ecosystems and related plant and animal life are protected, and that social responsibility is exercised throughout the value chain, from production through to distribution.

As such, ecolabels and aquaculture certification schemes came into play as marketbased incentives for better management of fisheries as a result of consumer demand for fish products that come from well-managed stocks or from sustainable aquaculture. These schemes are set to encourage businesses to pursue sustainable procurement practices from the supply side, thus enhancing their reputation. These features are particularly appealing to retailers that emphasize and communicate sustainability to consumers, and securing supplies in the long term and maintaining and protecting their brand is paramount. These commitments expand to the various value chain actors and act as a risk-reduction tool for shareholders and investors, giving assurances for business longevity.

From the demand side, ecolabels are intended to make provisions for informed purchasing decisions and thus promote and stimulate the sustainable use of fishery resources and improve consumers’ confidence in aquaculture production practices and products.

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Third-party seafood certification Theory of Change - There is a demand for sustainable/responsible seafood from both consumers and businesses. An increasing number of customers ask for sustainable/responsible products and will preferentially purchase those products given the choice. Businesses care about seafood sustainability/responsibility because they want to assure a long-term supply of seafood and reduce the risk to their brands.

- This provides a motivation for producers to improve their practices such that they are more sustainable/responsible, and this improved practice can be verified through a third-party certification process. Fisheries and farms that meet the certification standard are independently certified.

- Actors in the supply chain, including retailers and restaurants, choose to preferentially supply certified sustainable seafood. A traceability system verifies the custody of certified products through the supply chain to ensure that seafood sold as certified actually comes from the certified farm or fishery and can be reliably identified (labelled) as such.

- Consumers preferentially purchase labelled seafood. Market demand for certified seafood increases. More fisheries and farms choose to improve their practices and seek recognition of this through voluntary assessment against the certification standard.

3.2.3.1 The interplay between public and private standards: The interplay and interface between public regulations and private standards in governance and sustainability of fisheries and aquaculture has been the subject of long debates in international fora. As a market-based mechanism, ecolabels and certification schemes were set up in response to perceptions that governments were not doing enough to ensure the sustainability of the world’s marine resources and therefore were designed to incentivize good management with potential market rewards. As such, these schemes can complement public measures, and their limits might serve to highlight gaps in those public measures and the overall governance framework for fisheries management. The role of aquaculture is part of the equation, in the first instance, due to the sector’s reliance on fish meal and fish oil, and secondly, due to the need to minimize potential negative environmental impacts of aquaculture production, address animal welfare, food safety and socio-economic issues.

3.2.3.2 Certification, business to business and consumer-facing options: Similar to private standards for food quality and safety, a certification process (conformity assessment) sits behind ecolabelling in fisheries and aquaculture certification, whereby compliance with a set of criteria has to be met for the products to be labeled. Inherent to this process is a chain-of-custody that guarantees the ability to trace products and ensure their integrity throughout the value chain.

Certification is conducted by a certification body or entity that is competent, recognized, independent and accredited to do so by an accreditation body.

While voluntary, these schemes differ in terms of the type of owners or standard setting entity; we can find government or public authority owned national ecolabels, private companies, industry groups, NGOs as well as a combination of stakeholders.

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There also are differences in the areas covered by the schemes, their criteria, assessment processes and levels of transparency. Furthermore, ecolabelling and certification schemes could be designed as a Business-to-Business (B2B) model aimed at commercial buyers whereby assurances of the product’s source and the production process are not promoted to consumers through a label, but still is part of the business’s corporate procurement framework. This is mainly the case for schemes developed by industry groups. Business-to-consumer (B2C) models are also widely adopted and certification is marketed to consumers at point-of-sale through the medium of a label attached to the product.

3.2.3.3 The proliferation of certification schemes and the Global Seafood Sustainability Initiative: The increase of seafood certification schemes has led to claim confusion among producers, retailers and consumers over how to recognize a credible certification scheme. This perceived confusion has made decision making more difficult and seafood more costly. To address such concerns, seafood companies, NGOs, experts, governmental and intergovernmental organizations have created the Global Sustainable Seafood Initiative (GSSI)102, a global platform and partnership working towards sustainable seafood supply. These various stakeholders have come up with a collective, non-competitive approach to provide clarity on seafood certification and ecolabelling and ensure confidence in certified seafood.

Through a consultative process that extended for nearly three years, GSSI developed a Global Benchmark Tool for seafood certification schemes launched in 2015. The GSSI Benchmarking Tool operated on the FAO Guidelines and the Code of Conduct for Responsible Fisheries (CCRF) to assess the conformity of public and private fisheries ecolabelling and aquaculture certification schemes with the FAO Guidelines for Ecolabelling of Fish and Fishery Products from Marine and Inland Capture Fisheries and the FAO Technical Guidelines for Aquaculture Certification.

The GSSI Benchmark Framework includes 186 Essential Components based on the CCRF and the FAO Guidelines for Ecolabelling and technical guidelines for Aquaculture certification, which schemes must meet to be recognized by GSSI. The Framework also includes 137 Supplementary Components, which allows schemes to show their diverse approach and helps stakeholders understand where differences exist. The Supplementary Components are grounded in the CCRF and related FAO documents, ISO normative standards and ISEAL codes. At the time of writing, the 2nd version of the Benchmark Framework is undergoing revision for its launch after approval by the GSSI Steering Board in November 2020. The review process was agreed to take place every three years. This first revision is focused on three areas: improvement of benchmark component language, reduction of the number of components to reduce complexity while maintaining the benchmark standard, and finally, the inclusion of new FAO guidelines as additional components.

3.2.3.4 GSSI recognized schemes:

To date, nine fisheries and aquaculture schemes have achieved recognition103, with more under consideration. Of the nine GSSI recognised schemes, four cover wild 102 103

http://www.ourgssi.org https://www.ourgssi.org/gssi-recognized-certifcation/

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capture fisheries only, four cover aquaculture only and one covers both fisheries and aquaculture. The first two schemes were recognized in 2016, both in fisheries: the Alaska Responsible Fisheries Management (RFM) and Iceland Responsible Fisheries Management (IRFM). Five more schemes were recognized in 2017 and 2018: two in fisheries - the Marine Stewardship Council (MSC) and Audubon G.U.L.F. RFM Certification Program; and four in aquaculture - Global Aquaculture Alliance (GAA), Best Aquaculture Practice (BAP) Certification, GLOBALG.A.P. Aquaculture Certification and Aquaculture Stewardship Council (ASC). Two more were added in 2019: BIM Certified Quality Aquaculture (CQA) scheme and Marine Eco-Label Japan (MEL) V2 Scheme for Aquaculture and Fisheries.

3.2.4 International sustainability movement and implications: There is no evidence that sustainability certification will be phased out in the near future, given consumers’ increasing demand for sustainable seafood and the absence of a better alternative. A significant proportion of global seafood production is not ready to engage with the available sustainability ecolabelling and certification schemes.

COVID-19 is reshaping food supply chains that were already in transition before the pandemic. Improved resilience of supply chains and increased momentum for transparency, sustainability and accountability is an ultimate objective in countries’ economic policies post-COVID. More emphasis is put on digital technologies in supply chain management to improve operations, decision-making and reduce costs and risks. With a wide array of applications pertaining to both the public and private domains, digital technologies can alleviate some of the disruptions food value chains are experiencing where there is capacity, in the long term, to adopt and apply such solutions in low-income countries and small-scale production contexts. The current pandemic’s potential implications for food security, the sustainability of aquatic resources as well as livelihoods, calls for a more coordinated and collaborative approach between governments and industry and greater collaboration among companies - suppliers, exporters, importers, distributors, retailers, etc. - is key in addressing challenges and changing patterns in global trade.

While there are indications for more localization of value chains, be they domestic or regional, global trade, inherent to aquatic products, is witnessing disruptions in how procurement policies are being conducted, with more openness and diversification of suppliers as a means of de-risking strategies. In the context of sustainable certification, the landscape and goals will more likely remain with more push from end-markets to engage in and emphasize responsible sourcing practices, including social responsibility.

3.2.4.1 Continuous market commitments to sustainability: It is estimated that 37 percent of global fish production is certified, rated (including red-rated) or in a Fishery Improvement Project (FIP) or Aquaculture Improvement Project (AIP). Meanwhile, in aquaculture, estimates indicate a higher percentage in farms certified or rated (43 percent) (Certification and Ratings Collaboration, 2019).

The demand for sustainable food is conducive to support the continued existence of

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ecolabelling, certification schemes or other rating systems104. As mentioned in the previous section, this is primarily an imperative for retailers, especially in Europe and North America, who remain the main buyers of certified fish and have formulated and communicated on their sustainable seafood commitments either with or without NGO partnerships. A case in point is the Target 75 initiative launched by the Sustainable Fisheries Partnership (SFP)105 and the Conservation Alliance for Seafood Solutions’ 5-year strategic plan (2020-2025),106 whereby value chain stakeholders capitalize on their partnerships to foster large-scale uptake of corporate sustainable seafood commitments and reach the 75 percent mark point of global seafood production that is environmentally sustainable or making verifiable improvement, and also that adequate safeguards are in place to ensure social responsibility by 2030.

David and Lucille Packard Foundation’s recently released “Progress Towards Sustainable Seafood – By the Numbers” report107 indicated that several major North American retailers promote seafood sustainability practices on their websites or in press releases and that 81 percent of the top 25 retailers have sustainable seafood partnerships with NGOs, nine percent have commitments without NGO partnerships.

On the other hand, in the EU, the six largest retailers have sustainable seafood partnerships with NGOs, representing a 25 percent increase in total sales covered by partnerships since 2017. Beyond these two traditional homes of certification and labelled products, there is an emerging buyer demand for sustainable seafood in Japan, instilled not only in the GSSI recognition of Marine Eco-Label Japan (MEL Japan) in 2019 but also in Japanese market operators joining global initiatives and partnerships through adopting sustainability programs that better fit with domestic consumer preferences, and the industry’s culture and way of doing business.

3.2.4.2 Tapping into non-certified seafood While ecolabelling certification has proven to be challenging in developing countries and the context of small-scale fisheries and farms due to (a) high costs associated with the certification process, and (b) a low economic imperative and the high-bar requirements that do not translate well into typical conditions of the fisheries environment in developing countries. These concerns have been taken on board by some certification schemes in order to allow for an entry point and models better suited to data-deficient and highly fragmented value chains. One example is the Risk-Based Framework developed within the Marine Stewardship Council’s World Fisheries Programme108. In aquaculture, Group Certification models developed by the Aquaculture Stewardship Council (ASC)109 and GLOBAL G.A.P110 are examples of how schemes engage small-scale producers to collectively implement standards requirements while reducing costs and resources.

Another model that emerged in the early 2000s has evolved from a partnership to a more structured vehicle that engages fishing communities, processors, exporters, 104

Rating systems are not covered in this analysis. While both rating systems and certification schemes share similarities in some of their sustainability criteria, there are major differences in: how the conformity assessment is conducted (rating systems rely on experts and scientists to assign light-traffic rates, while ecolabelling/certification use an accredited third party certification body), whether chain of custody is part of the certification process or not, and the use of a label.

105 https://www.sustainablefish.org/Programs/Target-75 106 http://solutionsforseafood.org/wp-content/uploads/2020/01/Alliance-Strategic-Plan-2020-2024-Executive-Summary.pdf 107 https://oursharedseas.com/wp-content/uploads/2020/06/2020-Progress-Toward-Sustainable-Seafood-%E2%80%93-By-theNumbers.pdf 108 https://www.msc.org/for-business/fisheries/developing-world-and-small-scale-fisheries/our-approach-to-data-limited-fisheries 109 https://www.asc-aqua.org/what-you-can-do/get-certified/about-our-certification/, 110 https://www.globalgap.org/.content/.galleries/documents/Aquaculture_Booklet_en.pdf

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seafood buyers, NGOs, academia and governments in a collaborative platform that would bring about long-term supply by improving fisheries management and environmental performance, whether certification is the end goal or not. Set as “a collaboration between relevant stakeholders to influence policies and management practices and to improve the sustainability of fishing operations” (GEF, 2019)111, FIPs have gained traction amongst major seafood buyers for how their business model is structured, and more importantly, the online tools developed to access reliable information on FIP’s progress thus allowing the business to make betterinformed decisions on their sourcing or participating in a given FIP112. Underpinning the FIP process is a MSC-based needs and pre-assessment, although MSC certification is not always the final output, thus defining two types of FIPs: comprehensive (explicit goal of near-term MSC certifiability) and basic FIPs (focusing on improving specific environmental challenges and FIP participants commit to long-term sustainability).

Regardless of the objective, the FIP process is based on the following five stages: First, value chain actors, which might include suppliers, retailers, food services and fishworkers, must actively participate in the FIP. Participation can take the form of financial or in-kind contributions to the project. Second, the FIP’s stakeholders must commit to improving the fishery (through a signed memorandum of understanding, published participant list, etc.). Third, the FIP must define the short-term scope of the project with a set of time-bound objectives. Fourth, a workplan must be made publicly available. And last, the FIP management must regularly track and report progress, including 1) publicly reporting progress on actions and their results, with supporting documentation every six months; and 2) updating indicator scores.

3.3 Non-Traditional Non-Tariff Measures 3.3.1 United States of America The majority of non-traditional non-tariff measures are concentrated on additional requirements at the level of some States or posing restricted or zero access to imported products in the case of government procurement. Many of the measures with product-specific coverage deal with crustaceans (crawfish or shrimp, mainly) or species with strong national production and organized producers to engage in lobbying power (catfish).

3.3.1.1 Specific Labelling Requirements for Imported Fish Products In the case of specific labeling requirements for imported fish products, Louisiana and Arkansas have implemented specific legislation to address this issue, but with different approaches.

In Louisiana, a region in the United States of America with an extensive production of shellfish, since June 2019, there is state legislation113 requiring that food service 111

GEF (Global Environment Facility). 2019. Global Sustainable Supply Chains for Marine Commodities [online]. [Cited 15 September 2020]. (available at https://www.thegef.org/ project/global-sustainable-supply-chains-marine-commodities).

112 Fishery Progress (https://fisheryprogress.org) is the main platform designed for retailers and importers to make sourcing decisions based on FIP reporting.

113 ACT 372 (HN 335), available at http://www.legis.la.gov/legis/ViewDocument.aspx?d=1146071.

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establishments serving imported crawfish or shrimp have to inform patrons that the seafood is of foreign origin, identifying the country of origin of the imported product.

In this case, the requirement is only applicable to food service establishment preparing food for human consumption, either for individual service or for a group of people, whether consumption is on or off the premises and whether there is a charge for the food114.

The 2019 Arkansas Code115, when dealing with public health and welfare in the area of fish and seafood, establishes a mandatory identification by restaurants for catfish and catfish-like species. The measure requiring additional information for imported products was introduced in such regulation in April 2015. In Arkansas's legislation, “catfish” means any species of the scientific family Ictaluridae, and “catfish-like” species means any species of the scientific genus Pangasius, family Claridae, or family Siluridae. The labeling identification requirement only affects direct retail sale for human consumption. The Arkansas Code creates labeling categories for catfish, focusing on two aspects – the origin of the product in terms of the type of production and national and non-national products. The first aspect creates specific labeling requirements for US catfish originated from (1) river or lake; (2) farm-raised or (3) ocean; while the second criteria states that imported catfish, regardless of the type of production, must state the word “imported” followed by the country of origin.

3.3.1.2 Preference in Government Procurement to Buy Local or National Products The States of California and Arkansas and the city of New York enacted specific legislation creating mandatory buying procedures for food and food products, including fish, aimed for use at government entities setting privileges for local or national products.

In California, the added Section 49563 to the Education Code116 implements a specific provision of the Federal Child Nutrition Reauthorization Act of 1998117, known as the “Buy American Provision”, by requiring school food authorities to purchase, to the maximum extent possible (i.e., over 51 percent), domestic commodities or food products, including fish and fish products.

In March 2017, the Arkansas Code118 was amended to create a subchapter on “local food, farms and jobs act” in the chapter of “development of business and industry” under “natural resources and economic development”. This addition creates a minimum percentage of funds (20%) for local government agencies to purchase food products associated with local farms or food products. In addition, the regulatory framework also established that the government must use internet resources to promote local food producers, including a list of local providers of food and food products.

In the city of New York, since August 2011, its Administrative Code119 created an incentive for municipal agencies to buy local food products. Following the regulation, the procurement officer shall encourage municipal agencies to make the best efforts 114

More detail of this legislation is available on a flyer of some associations of local producers available at https://www.lafisheriesforward.org/wp-content/uploads/2019/07/HB335FactSheet_REV.pdf The specific section dealing with catfish of the 2019 Arkansas Code is available at https://law.justia.com/codes/arkansas/2019/title-20/subtitle-4/chapter-61/subchapter-2/section-20-61-206/ 116 This section addressed meals for needy pupils in kindergarten and grades 1 to 12, available at https://law.justia.com/codes/california/2019/code-edc/title-2/division-4/part-27/chapter-9/article-11/section-49563/ 117 Available at https://www.govinfo.gov/content/pkg/FR-1998-02-26/pdf/98-4949.pdf 118 Available at https://law.justia.com/codes/arkansas/2019/title-15/subtitle-1/chapter-4/subchapter-38/ 119 Section 6-130 available at https://nycadmincode.readthedocs.io/t06/c01/index.html 115

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to purchase New York state food, including minimum share. For fish, this regulation only applies for processed products, i.e., all fish that have been altered from their natural state, using methods including, but not limited to, canning, freezing, cooking, mixing, chopping, refrigeration, dehydration, liquefaction, and emulsification.

3.3.1.3 Additional Record-Keeping and Reporting for Imported Fish and Fish Products The U.S. Seafood Import Monitoring Program (SIMP)120 establishes permitting, data reporting, and recordkeeping requirements for importing thirteen fish and fish products identified as vulnerable to illegal, unreported, and unregulated fishing and/or seafood fraud. Since January 2018, the species covered by the SIMP are abalone, Atlantic cod, Atlantic blue crab, dolphinfish (Mahi Mahi), grouper, red king crab, Pacific cod, red snapper, sea cucumber, sharks, shrimp, swordfish, tunas (albacore, bigeye, skipjack, yellowfin and bluefin). To fulfill its end, SIMP requires catch certificate forms containing information on the full traceability of the covered products to be imported in the United States of America.

3.3.1.4 Annually Renewable Permits Since September 2016, the import of specific fish, crustaceans, molluscs, in particular formats and processed forms, including products unfit for human consumption, requires annually renewable International Fisheries Trade Permits (IFTP)121. These fish and fish products122 are subject to trade monitoring programs and/or subject to trade documentation requirements under the domestic law of the United States of America, including registration and transparency procedures on catch certificates and traceability documentation. Those government programs aim to exclude products that do not meet the criteria for admissibility in the United States of America's national markets, including products resulting from illegal, unregulated, and unreported (IUU) fishing activities.

3.3.2 China 3.3.2.1 Delays in costumes clearance Recently, India’s seafood exports and especially shrimp, have been facing significant delays in China's customs clearance. There seem to be delays in inspections by customs officers due to increased measures related to COVID-19 supervision.

Reports indicate that delays can take over ten cargo days against standard threeday procedures123with effects on prices124.

120

Available at https://www.govinfo.gov/content/pkg/FR-2016-12-09/pdf/2016-29324.pdf Trade Monitoring Procedures for Fishery Products; International Trade in Seafood; Permit Requirements for Importers and Exporters available at https://www.govinfo.gov/content/pkg/CFR-2009-title50-vol7/pdf/CFR-2009-title50-vol7-part216.pdf 122 Fish and fish products are concentrated on tuna and tuna-like species, Salmonidae, squids and cuttlefish.

123 China delaying clearance of Indian seafood consignments, exporters worried. The Hindu, Business Line, July 08 2020. See: https://www.thehindubusinessline.com/economy/agri-business/china-delaying-clearance-of-indian-seafood-consignments-sayworried-exporters/article32019470.ece 124 Coronavirus shadow over seafood exports to China. The Hindu. See: https://www.thehindu.com/news/national/andhrapradesh/coronavirus-shadow-overseafood-exports-to-china/article30706245.ece 121

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3.3.3 European Union – Denmark, in this case 3.3.3.1 The incentive for Organic Product Consumption in the Public Sector In January 2015, Denmark implemented a plan called “Økologiplan Danmark Sammen om mere økologi”125, with 67 points, focusing on increasing the amount of organic food, including fish and fish products, served in the public sector (daycare centers, government institutions and hospitals). The Danish plan aimed to improve the sustainability of national food production by creating incentives for increased public procurement of Danish organic foods, associated with specific policies focusing on waste reduction. It was interesting to note that the focus of the plan was concentrated on government support towards the training of workers in public kitchens to master the preparation of organic food, but no support was given to compensate for the price premiums usually associated with organic food.

Innumerous academic studies stated that this plan, associated with other measures implemented by the Danish government, led to a widespread consumer consciousness in the Danish society of prioritizing organic food towards non-organic.

3.3.4 Conclusions and Recommendations These measures implemented by the United States of America and the European Union (Denmark) might have the following effects on the exports of fish and fish products of India: -

-

-

-

For crawfish and shrimp, the specific requirements of informing patrons of imported products in restaurants and other similar food facilities might create a reduction or even the absenteeism of buying those products from particular countries, including India. This change in the buying pattern can be explained by consumer perception – some restaurants and food facilities might exclude specific countries they consider might have a negative impact on buying perception in consumers due to the association with low quality, hygiene issues, labor issues associated with the production, among other factors; For catfish and catfish-like species, similar labelling requirements in restaurants, with the word “imported” following by the country of origin, might create a similar distortion in buying those products from specific countries due to biased consumer perception of low quality and other associated aspects of products from a particular origin; In the case of government procurement in some states of the United States of America, although the potential of affecting imported products in terms of scale can be considered limited, the additional corollaries can be potentially problematic for the beginning of wrong consumer perception towards imported products. In government cafeterias, including school canteens, the fact of only having national or local products available for consumption can create, particular among the youth, a natural prejudice towards imported products or biased associations of imported products and quality and safety; The stricter U.S. requirements in comparison with other fish and fish products, where it is imposed the need of having an equivalent system of fish inspection of the exporting country and the United States of America can be particularly problematic for exports of catfish and catfish-like species;

125

The plan is available in Danish at https://mfvm.dk/fileadmin/user_upload/FVM.dk/Dokumenter/Landbrug/Indsatser/Oekologi/OekologiplanDanmark.pdf

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-

-

-

SIMP is a relatively new and comprehensive program implemented by the United States of America to fight IUU fishing and fraud. Nevertheless, it is crucial to observe that, even with a reduced number of species being monitored by this program, the thirteen species in that list are key products for many developing countries, particularly India. Having regard that SIMP focuses on full traceability to fill the appropriate certificate by the exporting country to enter the market of the United States of America, this aspect can pose insurmountable operational challenges for specific producers in India, particularly of shrimp; These import clearance delays in China are not in the spirit of the WTO Agreement on Trade Facilitation and raise costs and risks cost for both exporters and importers of a perishable product.Customs authorities should consider food urgency and food security aspects. It is also important to stress that COVID-19 is not known to infect aquatic food animals or their products126. Some Indian exporters consider that some of these delays are associated with the consequences of recent border disputes between the two nations. These problems, however, may be only temporary nature.

The program implemented in Denmark emphasizing the use of organic food in government canteens and cafeterias, associated with other measures, created value for “organic shopping” in the Danish society that implemented a de facto market access restriction for non-organic products.

3.4 Anti-Dumping Measures 3.4.1.1 United States of America Anti-dumping measures cannot be considered a conventional non-tariff measure because the result of an anti-dumping investigation is the imposition of a duty to offset the dumping margin. However, they are indeed trade measures and taking into consideration the importance of shrimp in the export profile of India, as well as the long-lasting existing anti-dumping case, the essential associated elements will be presented herein.

In summary, according to the rules of WTO, dumping is a situation of international price discrimination driven by exporting companies. Dumping occurs when the price of a product sold by the exporting company in the importing country (export price) is lower than the price of the like product destined for consumption in the export country (normal value). The determination of the existence of dumping and the calculation of the dumping margin is not so straightforward and it involves a series of complex methodologies and analyses, including visits to the companies in the exporting country. The WTO Agreement on the Implementation of Article VI of the General Agreement on Tariffs and Trade 1994, known as the WTO Anti-Dumping Agreement, contains detailed information on the definition of dumping and how to calculate the dumping margin127.

126

Asian Fisheries Society (2020). SARS-CoV-2 (The Cause of COVID-19 in Humans) is Not Known to Infect Aquatic Food Animals nor Contaminate Their Products. Asian Fisheries Science. See: https://www.asianfisheriessociety.org/publication/downloadfile.php?id=1291&file=Y0dSbUx6QTJPRFF5Tnpjd01ERTFPRGMyT kRnM01qY3VjR1Jt&dldname=Viewpoint:%20SARS-CoV-2%20(The%20Cause%20of%20COVID19%20in%20Humans)%20is%20Not%20Known%20to%20Infect%20Aquatic%20Food%20Animals%20Nor%20Contaminate% 20Their%20Products%20(Revised%2023%20April%202020).pdf 127 The Agreement is available at https://www.wto.org/english/docs_e/legal_e/19-adp_01_e.htm

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Current anti-dumping duties in force in the United States of America on exports from India account for 21 groups of products. Still, only two are non-industrial products (preserved mushrooms and frozen warm-water shrimp and prawns).

In the area of fish and fish products, in December 2003, the Ad Hoc Shrimp Trade Enforcement Committee (AHSTEC) lodged a complaint of injury to the domestic shrimp industry in the United States of America due to imported shrimp being sold below fair value.

This anti-dumping duty encompasses certain frozen warm-water shrimp and prawns, whether wild-caught (ocean harvested) or farm-raised (produced by aquaculture), head-on or head-off, shell-on or peeled, tail-on or tail-off, deveined or not deveined, cooked or raw, or otherwise processed in frozen form128. The products are processed from warm-water shrimp and prawns through freezing and sold in any count size, and they may be processed from any species of warm-water shrimp and prawns129.

In 2005, the initial anti-dumping duty on exports of certain frozen warm-water shrimp was set at 4.94% on exports from Devi Sea Foods Ltd, at 15.36% on exports from Hindustan Lever Ltd, at 9.71% on exports of Nekkanti Seafoods Ltd, and 10.17% on exports from all other companies(residual duty)130.

Subsequently, the U.S. Department of Commerce published in the Federal Register periodical notices of opportunity to request an administrative review of the antidumping order on shrimp from India for specific annual periods. Since the United States of America uses a retrospective assessment system, under which final calculation of anti-dumping duties is determined only after the products are effectively imported in the U.S. territory in a particular method involving shipment by shipment calculation, the most frequently used procedure for determining the final and effective anti-dumping duty is to demand an administrative review. An administrative review can be requested each year during the anniversary month of the publication of an anti-dumping order by the U.S. government and it can be requested by any U.S. interested party, including the importer, or foreign entities, such as a foreign government, or the exporters or producers covered by the order.

In March 2020, the U.S. Department of Commerce published the preliminary results of the 14th administrative review of the anti-dumping duty on shrimp from India covering 183 producers and/or exporters131. For all investigated companies, the dumping margin was calculated at 3.57%. It is still pending by the Department of Commerce the final result132 based on this current review. Nevertheless, suppose the Department of Commerce confirms this preliminary dumping margin in its final result. In that case, it will be the highest anti-dumping duty on shrimp originated from India since the fourth administrative review in 2010, when one Indian company (the Liberty Group) had assigned a 4.44% anti-dumping duty.

128

Those products are classified under the following item numbers of the Harmonized Tariff Schedule of the United States of America (HTSUS): 0306.17.00.03, 0306.17.00.06, 0306.17.00.09, 0306.17.00.12, 0306.17.00.15, 0306.17.00.18, 0306.17.00.21, 0306.17.00.24, 0306.17.00.27, 0306.17.00.40, 1605.21.10.30, and 1605.29.10.10.

129 Warm-water shrimp and prawns are generally classified in, but are not limited to, the Penaeidae family. Some examples of the farmed and wild-caught warm-water species include, but are not limited to, whiteleg shrimp (Penaeus vannemei), banana prawn (Penaeus merguiensis), fleshy prawn (Penaeus chinensis), giant river prawn (Macrobrachium rosenbergii), giant tiger prawn (Penaeus monodon), redspotted shrimp (Penaeus brasiliensis), southern brown shrimp (Penaeus subtilis), southern pink shrimp (Penaeus notialis), southern rough shrimp (Trachypenaeus curvirostris), southern white shrimp (Penaeus schmitti), blue shrimp (Penaeus stylirostris), western white shrimp (Penaeus occidentalis), and Indian white prawn (Penaeus indicus).

130 Notice of Amended Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order: Certain Frozen Warmwater Shrimp from India available at https://www.govinfo.gov/content/pkg/FR-2005-02-01/pdf/E5-370.pdf.

131 Available at https://www.govinfo.gov/content/pkg/FR-2020-03-06/pdf/2020-04625.pdf.

132 The anti-dumping duty is only definitely set in its final results.

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Associated with the imposition of anti-dumping duties by the United States of America on exports of shrimp from India, it is important to analyze the recent investigation to assess a possible evasion133 of anti-dumping duties by importing Indian-origin frozen shrimp transshipped through Viet Nam into the United States of America. In October 2019, the U.S. Customs and Border Protection (CBP) had commenced a formal investigation under the Enforce and Protect Act (EAPA)134 to assess if a U.S. importer (MSeafood Corporation) evaded the anti-dumping duty imposed on certain frozen warm-water shrimp (frozen shrimp) from India, by importing frozen shrimp into the United States of America from Viet Nam. The allegation brought by the Ad Hoc Shrimp Trade Enforcement Committee (AHSTEC) is that MSeafood imports of frozen shrimp from its parent company and its affiliates in Viet Nam, are not only produced by those companies, but also include frozen shrimp imported into Vietnam from India, including products with minimum processing, for the purposes of transshipping it to the United States of America. In addition, AHSTEC argued that the Indian frozen shrimp imported into Viet Nam was originated from companies that have not qualified for the “Green List” under the FDA’s Import Alert135.

In this regard, under such investigation of evasion, in addition of having a product subject to an anti-dumping duty, the issue of false statement or act could be present.

In addition, in this particular case, two elements argued by AHSTEC are involved: (1) not paying the relevant anti-dumping duties by utilizing Viet Nam as the origin of an Indian product; and (2) the possible detention of those products if they have been correctly documented as being originated from India, since their Indian producers are not in the FDA’s Green List.

Based on all information received, the U.S. Customs and Border Protection (CBP) preliminary determined that frozen shrimp originated from Viet Nam imported by MSeafood Corporation will be rate-adjusted to reflect that they are subject to antidumping duty on frozen shrimp from India. In addition, all imports by MSeafood will be subject to a system of “live entry”, meaning that all entry documents and payments must be provided before cargo is released by CBP into U.S. commerce.

3.4.2 Conclusions and Recommendations Anti-dumping cases can hit particularly hard the exporting countries for issues not associated directly with the reduction of competitiveness. Since, anti-dumping cases take a long time to be decided by national authorities, with long on-site investigations at the exporting country, the trade can be immediately affected. Importers are usually risk-avoiders and there will have a great probability of a shift to new sources of supply from different countries. This shift can be temporary or even perennial, when the new supplier of products provides a product at competitive prices, with good quality and safe.

133

Evasion is defined as “the entry of covered merchandise into the customs territory of the United States of America for consumption by means of any document or electronically transmitted data or information, written or oral statement, or act that is material and false, or any omission that is material, and that results in any cash deposit or other security or any amount of applicable antidumping or countervailing duties being reduced or not being applied with respect to the covered merchandise.”

Available at the Code of Federal Regulations Part 165—Investigation of Claims of Evasion of Antidumping and Countervailing Duties, at https://www.govinfo.gov/content/pkg/CFR-2017-title19-vol2/xml/CFR-2017-title19-vol2-part165.xml.

134 Available at https://www.congress.gov/114/plaws/publ125/PLAW-114publ125.pdf.

135 The Green List enumerates companies that are excluded of having their products detained without physical examination.

More information available at https://www.accessdata.fda.gov/cms_ia/importalert_43.html.

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In the particular case of shrimp and prawns anti-dumping duty, the production sector in the United States of America is well organized with strong lobbying power, particularly involving some southern states.

The aspect of evasion being investigated by the U.S. authorities involving crossexports of shrimp from India and Viet Nam can cause additional negative reactions by the U.S. producers and related associations. It can indeed shift the discussion from a technical aspect of international trade to a criminal level. The issue of rules of origin is a critical aspect of international trade, in particular for fish and fish products.

The import of a product from a third origin but being in fact originated from a country with an anti-dumping duty currently in force, is a serious threat to the tax system and the safety of consumers, since other regulatory aspects are also involved. Exporters in India, and their associations, can play a significant role in reducing the possibility of such evasions, by taking advantage of their privileged position in close contact with the buyers. For example, Indian exporters can get ex-ante information regarding the final destination of exports to neighboring countries of products subject to antidumping duties in order to avoid any potential liability or image threat in the U.S. market.

Notwithstanding the arguments raised in the evasion case, it is important to notice that the Indian companies may not be involved in this circumvention, but indeed Vietnamese companies. In addition, it will be relevant to verify for the products involved, if there was or not a certain level or processing carried out in Viet Nam to ensure a new origin of the product being exported to the United States of America.

Finally, the Indian rupee depreciation against the U.S. dollar, particularly in the last 5 years, associated with the withdrawal of India from the Generalized System of Preferences of the United States of America, since May 2019, might generate an increasing trend of anti-dumping cases targeting India.

3.5 Specific Trade Concerns Specific Trade Concerns (or “STCs”) are aspects raised by WTO countries during the sessions of the WTO Technical Barriers to Trade (TBT) Committee focusing on questioning the scope and implementation of regulation by another WTO member.

STCs focus on the core obligations of countries under the TBT Agreement, with a specific emphasis on possible negative impacts of the proposed measures on consumers and companies. STCs are a very important and pragmatic aspect of the WTO since it allows other countries to express their concerns of the possible impact a proposed regulation may have usually before it comes into effect.

3.5.1 European Union – Prohibition of the Marketing of Food from Animal Clones, including Fish In November 2015, Brazil and the United States of America raised a Specific Trade Concern involving the European Union and a proposal for a regulation on the prohibition of placing on the market food from animal clones, including fish. Both arguing countries stressed that the measure at stake would be discriminatory, lack legitimacy, or rationale, and it might constitute an unnecessary barrier to trade. The EU informed that the proposed measure was duly notified to the WTO Technical

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Barriers to Trade (TBT) Committee in March 2014. In addition, it was also informed that the European Parliament proposed to incorporate a traceability system that would extend to third-country trade partners to implement this measure effectively.

However, the internal discussions of this regulation at the EU level between the Council, the Commission and the Parliament were halted.

Nevertheless, there is an EU legislation136 requiring that food produced for nontraditional breeding techniques require a pre-market authorization in order to be imported or sold in the European Union.

3.6 Trade Agreements At a global level, trade agreements at a bilateral or plurilateral137 level continue to proliferate, the issue of rules of origin and other specific provisions applicable to trade of fish and fish products can become a complex aspect to manage by developing countries. Many recent agreements have traditional market access issues, including tariffs and non-tariff barriers, but also, they have started to incorporate non-traditional areas such as sustainable development, environmental and social provisions and fisheries subsidies disciplines.

Among the analysed countries, India only has a trade agreement with Japan.

3.6.1 Comprehensive Economic Partnership with Japan The Comprehensive Economic Partnership between India and Japan covers the reduction of import duties for the trade in goods between the two countries, including many fish species and products. In the case of fish and fish products there are many species not included in the product coverage of the agreement. Many of these excluded species are of interest to India, including tuna and tuna-like species (including swordfish) and mackerels, among others.

As in all trade agreements giving preferential duties, there is a long section on “rules of origin”. To have the benefit of this tariff reduction or exemption, the product exported must comply with the agreed specific requirements of origin.

In the case of the Comprehensive Economic Partnership between India and Japan, the “rules of origin” applicable to fish and fish products eventually exported from India are: The following products are considered to be wholly obtained or produced in India: (a)

live animals born and raised in India;

(b)

animals obtained by hunting, trapping, fishing, gathering or capturing in India;

(c)

goods obtained from live animals in India;

(d)

plants and plant products138 harvested, picked or gathered in India;

[…..] (f) goods of sea-fishing and other goods taken by vessels of India from the sea outside the territorial seas of the India or Japan;

136

Regulation (EU) 2015/2283 of the European Parliament and of the Council, of 25 November 2015, on “novel foods” Plurilateral is used herein to indicate any agreement involving more than one country, but not all countries of the WTO. 138 The term “plant” refers to all plant life, including fruit, flowers, vegetables, trees, seaweed, fungi and live plants 137

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(g) goods produced on board factory ships of India, outside the territorial seas of India or Japan from the goods referred to in subparagraph (f); (h) goods taken from the sea-bed or subsoil beneath the sea-bed outside the territorial sea of India, provided that India has rights to exploit such sea-bed or subsoil in accordance with the provisions of the United Nations Convention on the Law of the Sea, done at Montego Bay, December 10, 1982; […..] (l) goods obtained or produced in India exclusively from the goods referred to in subparagraphs (a) through (k).

The term “factory ships of India” or “vessels of India” respectively means factory ships or vessels (i) which are registered in India; (ii) which sail under the flag of India; (iii) which are owned to an extent of at least 50 percent by nationals of India or Japan, or by a juridical person with its head office in India or Japan, of which the representatives, chairman of the board of directors, and the majority of the members of such board are nationals of India or Japan, and of which at least 50 percent of the equity interest is owned by nationals or juridical persons of India or Japan; (iv) of which at least 50 percent of the total of the master and officers are nationals of India and Japan; and (v) of which at least 25 percent of the crew are nationals of India or Japan.

Based on these rules of origin, fish and fish products exported from India benefit from the tariff reduction of the Comprehensive Economic Partnership between India and Japan if they are wholly obtained or produced entirely in the territory of India or Japan. Fish, shellfish, and other marine life products are considered wholly obtained if they are taken from the sea, seabed, or subsoil outside the territories of India or Japan by vessels complying with specific requirements. This includes processed fish produced from these goods on board a factory ship.

There are additional requirements of giving origin to an Indian product when a vessel is involved. The origin of fish and fish products when it involves a vessel operation includes the flag of the vessel, the crew nationality and aspects of the registration, ownership, and head office siege of the fishing company in Japan or India.

These cumulative requirements can indeed create problems in conferring origin to India for some fish and fish products, and therefore not being able to benefit from the duty reduction in accessing the Japanese market due to many complying aspects, particularly in the case of vessels. Restrictive rules of origin combined with significant exceptions on the product coverage considerably reduce the benefits to India of preferential market access for fish and fish products under this trade agreement.

3.6.2 Conclusions and Recommendations In the case India is planning to engage in new trade agreements with other partners, it is important to observe that recent agreements are increasingly incorporating nontraditional disciplines such as binding environmental provisions, or disciplines that prohibit certain forms of fisheries subsidies.

For example, the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), a free trade agreement among 11 Members including Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, Peru, Singapore and Viet Nam, was the first to establish binding and enforceable disciplines on fisheries subsidies. It also contains a series of new commitments to

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eliminate IUU fishing and re-build stocks under its environmental chapter. Other trade agreements are also incorporating fisheries subsidies disciplines and environmental clauses for fish and fish products.

In this regard, India must be ready to fulfil those non-traditional disciplines of these new generations trade agreements if planning to expand the market opportunities of its products at preferential rates at traditional fishing importing countries.

3.7 Regional Fisheries Bodies Regional fisheries bodies (RFBs) are international bodies composed of member countries for the purpose of collaborative management of marine resources. The underlying importance of safeguarding marine ecosystems coupled with the mobility and location of fish stocks, which often move between or beyond the jurisdictional waters of different countries, makes prudent having cooperation in their conservation and management. It should be noted that provisions may also be made for aquaculture and inland waters. Since the first RFBs were established in the 1940s the number and scope of these organisations has expanded significantly. There are currently 50 RFBs in operation, 13 of which have been established since 2000.

Regional fishery advisor bodies (RFABs) monitor and manage stocks. Regional fisheries management organizations (RFMOs) play a similar role, with the distinction that RFMOs may set binding quotas and control measures for their members, while RFABs play a purely an advisory role.

India currently participates in five RFBs, of which three are RFMOs and two RFABs. India’s marine capture fisheries currently operate entirely within the Indian Ocean.

The mandates of each RFB with Indian participation is unique, yet as is often the case their coverage of both resources and geographic areas may often be seen to overlap. This is particularly so along India’s West coast, where fisheries operating in the Bay of Bengal fall within the mandate of three RFBs.

3.7.1 Asia-Pacific Fishery Commission (APFIC) Year established

1948

Type of body

RFAB

Membership

21 members

Areas of competence main FAO MFASP

Aquaculture practices Areas beyond national jurisdiction Exclusive economic zones Inland waters

Areas of competence, zones

Indian Ocean, Western Pacific, Western Central

Resources covered

Living aquatic resources

APFIC is one of the oldest RFBs in current operation, with a wide mandate covering inland and marine capture fisheries as well as aquaculture. As an RFAB the decisions of the APFIC are non-binding, rather the focus is on active country participation and support for implementing better practices that are mutually

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beneficial for all parties. Over the years the focus of recommendations of the Commission to its members have evolved, shifting from stock evaluation (19491962) to productive capacity development in the region (1962-1980) and on to developing regional and interregional programmes to enable capacity development for fisheries management and development (1980-1990).139 The current activities of the APFIC complement all prior areas of focus, with additional emphasis on achieving sustainable fisheries development and rational management of fishery resources by member countries. This includes workshops for implementing ecosystem approaches to fishery management, port inspection training and guidelines for fisheries management.

The APFIC is one of two RFABs to operate within India’s jurisdictional waters, and the only one with relevance to aquaculture to do so. India is an active participant in APFIC consultations and sessions, having most recently hosted the 33rd session of the commission. The APFIC has assisted in the implementation of several projects in India, with the focus often being shrimp farming and associated best practices.

Shrimp farming will remain a key focus of APFIC work in India going forward, especially mitigation of Anti-Microbial Resistance in aquaculture.

3.7.2 Bay of Bengal Programme – Intergovernmental Organization (BOBP-IGO) Year established

2003

Type of body

RFAB

Membership

4 members

Areas of competence main FAO MFASP

Indian Ocean, Western Indian Ocean, Eastern

Areas of competence, zones

Areas beyond national jurisdiction Exclusive economic zones

Resources covered

Marine fish stocks

Central actions

Port state measures

India is a founding member of the BOBP-IGO, which is one of only two RFBs to operate within India’s jurisdictional waters. The BOBP-IGO was established following the dissolution of the Bay of Bengal Programme in 1999, with the mandate to enhance cooperation among member-countries, other countries and organisations in the region and provide technical and management advisory services for sustainable marine fisheries development and management, with a focus on small-scale and artisanal fishers, in the Bay of Bengal region. Projects include enhanced training and technology transfer, as well as support for improved coastal fisheries management, regional cooperation and promoting women’s participation in coastal fisheries development.

139

Menasveta, D. (n.d.). APFIC: Its Evolution, Achievements and Future Direction http://www.fao.org/3/X6942E/x6942e08.htm#bm08.6

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3.7.3 Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR) Entered into force

1982

Type of body

RFMO

Membership

26 acceding and member states140 10 acceding states only

Areas of competence main FAO MFASP

Atlantic, Antarctic Indian Ocean, Antarctic and Southern Pacific, Antarctic

Areas of competence, zones

Areas beyond national jurisdiction Exclusive economic zones

Resources covered

Marine living resources

Central responsibilities

Vessel licensing IUU vessel list Transhipment regulation Port state measures Establish MPAs Vessel monitoring system Catch documentation scheme Bycatch and incidental mortality

CCAMLR was a pioneer in the implementation of an ecosystem approach to fisheries management, going beyond monitoring a set of species fished to also take into consideration the direct and indirect impacts of harvesting on marine ecosystems. The measures adopted by CCAMLR therefore cover a wide range of species, from finfish to molluscs and crustacean, while also aiming to preserve all other living organisms, such as sea birds. The central responsibilities of CCAMLR are quite extensive, and include an IUU vessel list, transhipment regulation and port state measures. While India is a longstanding member of CCAMLR, they are not thought to currently operate any capture fisheries within the area of the Commission.

140

Full members participate in the decision-making process and give financial support. Acceding states abide by the requirements of the commission.

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3.7.4 Indian Ocean Tuna Commission (IOTC) Entered into force

1996

Type of body

RFMO

Membership

32 members 3 cooperating non-contracting parties

Recent changes in membership

South Africa: joined 2016 Belize: joined 2007, withdrew 2016 Vanuatu: joined 2002, withdrew 2015

Areas of competence main FAO MFAP

Indian Ocean, Western Indian Ocean, Eastern

Areas of competence, zones

Areas beyond national jurisdiction Exclusive economic zones, national waters

Resources covered

Tuna and tuna-like species; currently 16 stocks

Central responsibilities

Record of authorised vessels IUU vessel list Transhipment regulation Port state measures Observers

In volume terms, tuna and tuna-like species do not consist of a substantial proportion of total Indian production, but due to geographic adjacency and the economic significance of tuna and tuna-like species, it is worthwhile to investigate how IOTC has affected the overall fish trade of India. Table 17 below, shows global production of tuna and tune like species in tonnes (2010-2018).

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Table 17

Global Production of tuna and tuna-like species

Countries

2010

2011

2012

2013

2014

2015

2016

2017

2018

Indonesia

1 084 716

1 135 284

1 205 790

1 351 108

1 380 479

1 266 304

1 298 592

1 252 419

1 257 261

Philippines

496 435

385 097

423 395

423 337

478 106

439 528

405 310

378 298

553 937

China

618 454

632 347

616 688

663 882

598 124

588 984

495 691

519 597

505 495

Ecuador

212 655

294 483

332 015

309 176

326 970

396 590

359 010

373 400

385 416

Korea Republic of

359 578

277 166

341 436

309 059

361 270

372 003

397 316

336 970

378 777

Viet Nam

42 890

297 528

322 027

368 980

391 928

406 776

460 378

457 196

357 240

Spain

290 423

324 905

312 926

340 261

316 917

299 702

309 832

313 575

350 755

Taiwan Province of China

371 949

360 134

412 271

398 464

402 690

365 736

365 429

337 369

345 543

Japan

570 231

499 000

500 084

488 012

463 361

449 826

413 970

406 661

322 261

Iran (Islamic Rep. of)

163 670

181 861

206 642

208 654

246 915

230 214

231 453

273 028

273 750

the United States of America

141 497

135 202

164 400

160 372

327 619

282 678

224 490

225 896

233 374

Papua New Guinea

208 633

165 028

240 634

194 703

237 224

215 923

289 182

304 681

230 916

India

140 083

156 384

181 261

185 560

187 353

154 085

190 638

143 517

194 019

Kiribati

38 957

59 624

74 201

77 863

114 238

143 136

169 742

158 089

193 841

Mexico

153 961

148 912

149 102

167 378

178 614

178 678

160 516

195 336

179 323

Others

1 790 783

1 889 288

1 903 583

1 925 946

1 869 710

1 957 492

2 056 972

2 126 842

2 197 948

World

6 684 915

6 942 243

7 386 455

7 572 755

7 881 206

7 747 655

7 828 521

7 802 874

7 959 856

As of 2018, the landings of tuna and tuna-like species in India totalled approximately 194 019 tonnes141, of which over 40 percent were fished by gillnets. Considerable spatial variation was seen in the landings along the coastline, proportionally, the western coast of India (FAO area 51) registered over 60 percent, with the rest from the east coast (FAO area 57).

The total landings of tuna and tuna like species of India in 2018 consists of eleven species, of which seven species reported landings over 10 000 tonnes. Yellowfin tuna, Skipjack tuna and Kawakawa lead the production. Worldwide, India was ranked as the 13th largest producer of tuna species.

141

The volume here is slightly different from the result of IOTC, where reports India’s landing at 208 928, mainly because of the inclusion of species categorized as tuna and tuna-like species.

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Table 18

India's landing of tuna and tuna-like species in 2018 (tonnes) Species

Volume

Yellowfin tuna

37 488

Skipjack tuna

36 388

Kawakawa

33 208

Narrow-barred Spanish mackerel

29 960

Frigate and bullet tunas

17 103

Indo-Pacific king mackerel

15 101

Indo-Pacific sailfish

10 026

Longtail tuna

7 678

Black marlin

3 579

Swordfish

2 877

Bigeye tuna

611

It is notable that production of tuna species in India has witnessed a continuous and stable progress from 1950s thought with seasonal oscillations. Higher fluctuation was observed more ostensibly starting from 2005.

Figure 2

Historical production trends of Tuna and Tuna-like species in India

Per FAO database, there is no record of Indian imports of tuna species, while exports information has been well kept. However, the export performance was quite lacklustre until entering into the 21 century, and peaked at 2013 when the total export value reached USD 89 million.

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Figure 3

India's export of tuna and tuna-like species by value

The resolutions that may directly and indirectly affect Indian exports of fish and fish products, in particular related tuna species, corresponding measures and resolutions that may have an impact on global fish trade is compiled in Annex 4.4, together with the results that reported by India in compliance.

3.8 Ocean and Fisheries Governance Framework The fisheries sector and related trade activities could play a significant role in realizing economic benefits from the sustainable use of marine resources and adopting evidence-based and policy-coherent fisheries management and trade strategies. Key international instruments constitute the global governance framework and also establish the legal and institutional framework in many countries, including India.

The Indian government delineated the importance of developing a sound national policy framework based on sustainable development principles along with a peoplecentric and participatory approach grounded in equity and equality in the formulation of the 2020 National Fisheries Policy. This government policy clearly sets a multifaceted and nuanced development of the sector, which combined with an enhanced legal and governance framework can be foundational to effectively achieving such objectives in a perennial basis.

3.8.1 Conservation and sustainable use of oceans and their resources 3.8.1.1 Strengthening Biodiversity and Conservation measures In accordance with the articles of 61 and 62 of United Nations Convention of the Law of the Sea (UNCLOS), the countries have obligations to oversee and promote the sustainable use and conservation of marine resources. The following international

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instruments further elaborate on key obligations and standards geared toward safeguarding biodiversity.

-

-

-

-

-

-

Declaration of the UN Conference on the Human Environment (the Stockholm Declaration), 1972: establishes general responsibility to protect and improve the environment for present and future generations. The Declaration also highlights the duty to safeguard the natural resources and natural ecosystems through carefully designed management plans and maintain, restore and improve the capacity of the earth to produce vital renewable resources.

Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), 1973: India has been a party to CITES since 1976 and the government of India has brought into force numerous laws for conservation, with designation of a management authority and scientific authority. In addition, relevant national instruments require provision of necessary monitoring and enforcement power to relevant authorities to prohibit, penalize or confiscate the trade in specimens in violation of the Convention.

Convention on the Conservation of Migratory Species (CMS), 1979: aims to conserve terrestrial, aquatic and avian migratory species throughout their range. This Convention is concerned with the conservation of wildlife and habitats on a global scale including marine species.

Rio Declaration on Environment and Development: while reaffirming and reiterating the principles of the Stockholm Declaration, applies the precautionary principle that has been incorporated in several subsequent international and regional fisheries management instruments.

Convention on the Conservation of Biological Diversity (CBD), 1992: Pursuant to the CBD, a first major step was the development of the National Policy and Macrolevel Action Strategy (1999) that called for consolidating existing biodiversity conservation programmes and initiating new steps in conformity with the spirit of the Convention.

This was followed by implementation of an UNDP/GEF-sponsored NBSAP Project (2000-2004) that yielded micro-level action plans adequately integrating crosscutting issues and livelihood security concerns. Following the ratification of CBD and after widespread consultations, India also enacted the Biological Diversity Act in 2002 and notified the Rules in 2004, to give effect to the provisions of the CBD, including those relating to its third objective on Access and Benefit Sharing (ABS). India was one of the first few countries to enact such legislation. The Act is to be implemented through a three-tiered institutional structure: National Biodiversity Authority (NBA), State Biodiversity Boards (SBBs), Biodiversity Management Committees (BMCs) at the local level, in line with the provisions for decentralized governance contained in the Constitution. The Biological Diversity Act is a path-breaking and progressive legislation which has the potential to positively impact biodiversity conservation in the country.

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity is a supplementary agreement to the CBD. It provides a transparent legal framework for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources. India has recently issued a set of Guidelines on Access to Biological Resources and Associated Knowledge and Benefits Sharing Regulations, 2014. The purpose of these guidelines to bring administrative practice in compliance with the provisions of the Biological Diversity Act, 2002 and in pursuance of the Nagoya Protocol. India has issued about 10 Internationally Recognised Certificates of Compliance (IRCC) under the Access and Benefit Sharing Clearing House Mechanism of the CBD mostly linked to plant and microorganisms.

GLOBEFISH Insight 83

3.8.1.2 Strengthening the Sustainable Management of fish stocks and Combatting Illegal, Unreported and Unregulated (IUU) Fishing India is already a party to several international agreements to deter, prevent and eliminate IUU fishing. In Article 9(xv) of the NFP 2020, the Indian government states that it “will establish a sound mechanism to ensure that the Indian fishing fleet does not engage IUU fishing in contravention of any national laws and any bilateral, international or regional conventions or obligations or agreements concerning fisheries which are applicable to India.”

Instruments specifically designed to address IUU fishing build on an existing international governance framework rooted in the adoption of UNCLOS 1982 and an array of fisheries management instruments. This framework is comprised of both binding and voluntary instruments that facilitate the management of fisheries at national, regional and global levels. Furthermore, the implementation of these various instruments contribute to enhanced national legal frameworks and enforcement capacities. The number of provisions and requirements specifically addressing IUU fishing elaborate on the various responsibilities attributed to port, flag, coastal and market states. Together the following instruments briefly outlined below constitute a suite of tools to combat IUU fishing and promote the legal trade of fish products: -

-

-

-

The Agreement to Promote Compliance with International Conservation and Management Measures by Fishing Vessels on the High Seas (The Compliance Agreement): aims to enhance the role of flag states and control over its vessels to ensure compliance with international conservation and management measures; seeks to prevent the “re-flagging” of vessels fishing on the high seas under the flag of States that are unable or unwilling to enforce international fisheries conservation and management measures; requires maintenance of records of fishing vessels; and promotes international cooperation, information sharing and enforcement matters The Agreement for the Implementation of the Provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks (UN Fish Stocks Agreement): aims to ensure the long-term conservation and sustainable use of straddling and highly migratory fish stocks within the framework of UNCLOS; elaborates on the duties of flag States that require strengthened national legal and policy frameworks to include registration and records of vessels, authorisations, monitoring, control and surveillance and other enforcement matters; promotes cooperation in sub-regional, regional and international enforcement initiatives and information sharing; and promotes strengthened enforcement and inspection procedures, particularly for port states.

The 1995 FAO Code of Conduct for Responsible Fisheries: a voluntary instrument that establishes international standards of behaviour for various states and stakeholders to promote responsible practices to ensure the effective conservation of biodiversity, management and development of living aquatic resources International Plan of Action to Prevent, Deter and Eliminate Illegal, Unreported and Unregulated Fishing (IPOA-IUU): establishes a comprehensive toolbox, for use in a number of different situations to combat IUU fishing; encompasses flag, port, coastal and market State responsibilities; envisages broad participation and coordination among States, as well as representatives from industry, fishing communities and NGOs and the use of a comprehensive and integrated approach; calls upon States to develop and adopt their own NPOAs, addressing flag State responsibilities, coastal,

GLOBEFISH Insight 84

-

-

-

port and market State measures and the role of RFMOs in the implementation of the NPOA. The Agreement on Port State Measures (PSMA): promoting more effective cooperation and information exchanges amongst coastal, flag, port and market states and RFMOs and enhance greater control over vessels; contributes to strengthened fisheries management and governance at all levels. Implementing port state measures through national legislation will give an incentive to establish coordinated procedures and facilitate intra-agency cooperation; promote more accurate and comprehensive data collection, enhancing vessel reporting to national administrations and RFMOs, permitting assessments concerning the extent to which vessels have complied with operational authorizations and licenses to fish, promoting regional fisheries cooperation and harmonization among coastal States and RFMO Members, and facilitating the more rigorous implementation of international labour, safety and pollution standards on vessels; can prevent or deter the trade of fish products derived from IUU fishing.

Voluntary Guidelines for Flag State Performance (VGFSP): provides guidance to strengthen and monitor compliance by flag States with their international duties and obligations regarding the flagging and control of fishing vessels; promotes MCS and cooperation between states by elaborating on a range of actions/regulation/policies that states could incorporate into their governance frameworks and enforcement capacity to ensure that vessels registered under their flags do not conduct IUU fishing; promote information exchange and cooperation among countries so that flag states are in a position to refuse to register vessels that are “flag-hopping” by attempting to register with another flag state or to refuse vessels that have been reported for IUU fishing; elaborates on recommendations on how countries can encourage compliance and enforce against non-compliance by vessels.

FAO Voluntary Guidelines for Catch Documentation Schemes: represents the first international policy document that seeks to provide assistance to States, RFMOs, regional economic integration organizations and other intergovernmental organizations when developing CDS (system to determine throughout the value chain whether fish originate from catches are consistent with applicable national, regional and international conservation and management measures), which serves a trade measure tot prevent IUU fishing.

3.8.1.3 Conclusions and Recommendations India is not a party to the PSMA. However, the policy interventions identified in the NFP 2020 delineate the Indian government’s priority in strengthening its legal framework to “cater to the needs of the sector and also to meet the applicable international standards and norms.” (9ii). Furthermore, 9(ix) states “the Central, State/UT Governments will put in place a sound and effective Monitoring, Control and Surveillance (MCS) system with necessary legal backing. All fishing vessels will abide by MCS requirements and have suitable transponders/communication systems when out at sea which reveal the latitude-longitude of vessel adequately.” 9(xi) highlights the need to enhance the capacity of regulatory and enforcing agencies, including training and strengthening of the MCS system.

GLOBEFISH Insight 85

3.9 Analysis of NTMs on select fish and fish products imported into China, the European Union, and the United States of America based on the MAST Classification Using the NTM chapters given in the Multi-Agency Support Team (MAST) classification for NTMs142, 52 pre-selected fish and fish products were analyzed in terms of NTMs in these three importing markets.

Based on this analysis, it was identified that the most common NTMs are SPS and TBT measures, i.e. measures belonging to chapter A and B of the MAST classification. This is a common pattern for all three partners.

China imposes the highest number of NTMs, and European Union the fewest. China applies an average of 15.9 SPS measures and 16.8 TBT measures on fish and fish product imports from India. The EU applies an average of 10.06 and 3.02 SPS and TBT measures respectively, while the U.S, the average number of applied measures is 16.13 and 8.31, respectively.

Exports to China are less diversified then those to the European Union – only 11 products are exported to China, and 31 to the European Union. There are 22 products exported to the United States of America.

3.9.1 Types of applied NTMs 3.9.1.1 SPS Measures All markets apply measures in the form of prohibitions, permits or authorizations; tolerance limits for residues and restricted use of substances; and labeling (MAST groups A1, A2 and A3), as well as conformity assessment (certification, inspection, testing and traceability – MAST group A8). The United States of America imposes measures of every group of SPS in the MAST classification, including hygienic requirements, treatment for elimination of animal pests and disease-causing organisms, among other not specific measures (MAST groups A4, A5, A6 and A9).

The European Union also apply measures for hygienic requirements (MAST group A4) and China on production or post-production processes (MAST group A6).

The most common SPS measures applied to almost 100% of the selected products in these specific markets are: -

A21 Tolerance limits for residues of or contamination by certain (nonmicrobiological) substances; A31 Labelling requirements; A33 Packaging requirements; and A85 Traceability requirements;

For the other measures, there are some variances in the types of measures countries apply: -

142

A12 Geographical restrictions on eligibility requirements and A83 Certification requirements are applied to nearly all imported products by the European Union and China. However, the United States of America does not apply these SPS measures to any imported product;

Available at https://unctad.org/en/PublicationsLibrary/ditctab2019d5_en.pdf

GLOBEFISH Insight 86

-

-

-

A64 Storage and transport conditions is applied by both China and the United States of America to over 90% of the imported fish and fish products from India, however, the European Union does not apply these measures at all; A14 Authorization requirement for sanitary and phytosanitary reasons for importing certain products, is applied by China. However, neither the European Union nor the United States of America require Indian exporters to comply with this requirement on any product; A42 Hygienic practices during production related to sanitary and phytosanitary conditions and applies A22 Restricted use of certain substances in foods and feeds and their contact materials are required by the United States of America, while China or the European Union do not necessitate any such requirements.

3.9.1.2 TBT Measures All markets apply measures in the area of labeling and conformity assessment (MAST groups B3 and B8). In addition, the United States of America and China impose measures on production or post-production requirements (MAST group B4).

However, China imposes measures on all group types of the MAST classification, including import authorization or licensing, product identity requirements, and product quality, safety or performance requirements, among others (MAST groups B1, B4, B6, B7 and B9).

The most common TBT measures applied by all three markets to over 90% of the imported products are B31 Labelling requirements and B33 Packaging requirements.

Some of the differences in the regulation patterns for TBT: -

-

-

While China and the United States of America both apply B82 Testing requirements to over 100% of the imported products, the European Union does not apply this measure on any of the imported product; B83 Certification requirements are applied to over 90% of imported products in China and the European Union but to only 18% of the imported products in the United States of America; B41 Technical barriers to trade regulations on production processes is applied only by the United States of America, while B42 on transport and storage only by China; There are no measures that the European Union or the United States of America apply but China does not.

GLOBEFISH Insight 87

Figure 4

Most common types of SPS and TBT Measures China

European Union

United States

100% 80% 60% 40% 20% 0% A1

A2

A3

A4

A5

A6

A8

A9

B1

B3

B4

B6

B7

B8

B9

A1: Prohibitions/restrictions of imports for sanitary and phytosanitary reasons; A2: Tolerance limits for residues and restricted use of substances; A3 Labelling, marking and packaging requirements for SPS reasons; A4 Marking requirements for SPS reasons; A5 Treatment for elimination of plant and animal pests and disease-causing organisms in the final product or prohibition of treatment; A6 Other requirements relating to production or postproduction processes; A8 Conformity assessment related to sanitary and phytosanitary conditions; A9 Sanitary and phytosanitary measures not elsewhere specified; B1 Import authorization/licensing related to technical barriers to trade; B3 Labelling, marking and packaging requirements; B6 Product identity requirements; B8 Conformity assessment related to technical barriers to trade; B9 Technical barriers to trade measures not elsewhere specified

3.9.1.3 Measures other than SPS and TBT For measures other than SPS and TBT, the most frequently used type of measures, are: -

-

-

E1 Non-automatic import-licensing procedures other than authorizations covered under the chapters on sanitary and phytosanitary measures and technical barriers to trade is the most commonly used measure aside form SPS and TBT measures. This measure is applied by China and the European Union to nearly 100%, and by the United States of America to over 85% of the imported fish and fish products; F6 Additional taxes and charges levied in connection with services provided by the Government is applied by both China and the United States of America to nearly 90% of the imported products, while the European Union does not; C3 Requirement to pass through specified port of customs and C9 Pre-shipment inspection formalities not elsewhere specified is applicable by the United States of America to 80% and 100% of imports of select products, respectively.

In terms of the more specific measures, -

-

The European Union, and to some extent, the United States of America, both apply E32 Prohibition for non-economic reasons, while China does not prohibit imports of any of the select products; E125 Import licensing for the protection of public health is applied by the European Union on near 100% of the imported fish and fish products, whereas China or the United States of America do not apply any such requirement on any of the select product.

Almost all measures applied to India by China, European Union and United States of America on imports of the select fish and fish products are applied to all other countries as well.

GLOBEFISH Insight 88

The only exception are measures of B42 Technical barriers to trade regulations on transport and storage, B33 Packaging requirements and B83 Certification requirements imposed by the U.S. only on imports from some countries, including India, for the following products: -

-

030749 Molluscs, whether in shell or not, live, fresh, chilled, frozen, dried, salted or in brine; smoked molluscs, whether in shell or not, whether or not cooked before or during the smoking process; flours, meals and pellets of molluscs, fit for human and consumption (Other) 230120 Flours, meals and pellets, of fish or of crustaceans, molluscs or other aquatic invertebrates

Figure 5

Most common types of NTM other than SPS and TBT measures China

European Union

USA

100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% C3

C4

C9

E1

E3

F6

H1

C3 Requirement to pass through specified port of customs; C4 Import monitoring, surveillance and automatic licensing measures; C9 Other pre-shipment and inspection formalities; E1 Non-automatic import-licensing procedures other than authorizations covered under the chapters on sanitary and phytosanitary measures and technical barriers to trade; E3 Prohibitions; F6 Additional taxes and charges levied in connection with services provided by the Government; H1 Statetrading enterprises, for importing; other selective import channels (Measures affecting competition)

GLOBEFISH Insight 89

4 ANNEXES 4.1 Rejections of fishery and aquaculture products from India 4.1.1 EU RASFF Notifications Product Category

fish and fish products

fish and fish products

fish and fish products

Date

Notification Type

Notification Basis

Notified By

Countries Concerned

Subject

Action Taken

Distribution Status

Risk Decision

19/01/2015

information for attention

border control consignment released

United Kingdom

Commission Services, India (O), United Kingdom (D)

histamine (296 mg/kg - ppm) in chilled mackerel (Rastrelliger spp.) from India

informing authorities

distribution restricted to notifying country

serious

29/04/2015

border rejection

border control consignment detained

United Kingdom

India (O), United Kingdom

poor temperature control of mackerel and other fish products from India

import not authorised

product not (yet) placed on the market

not serious

border rejection

border control consignment detained

United Kingdom

India (O), United Kingdom

poor temperature control of chilled tuna (Thunnus albacares) from India

destruction

product not (yet) placed on the market

not serious

21/05/2015

GLOBEFISH Insight

90

Product Category

Date

Notification Type

Notification Basis

Notified By

Countries Concerned

Subject

Action Taken

Distribution Status

Risk Decision

fish and fish products

06/07/2015

border rejection

border control consignment detained

United Kingdom

India (O), United Kingdom

poor temperature control of chilled fish from India

destruction

product not (yet) placed on the market

not serious

informing authorities

product not (yet) placed on the market

undecided

fish and fish products

01/09/2015

border rejection

border control consignment detained

Spain

India (O), Spain

poor temperature control - rupture of the cold chain (clear signs of defrosting) of frozen croaker, cuttlefish and squid from India

fish and fish products

22/09/2015

border rejection

border control consignment detained

Italy

India (O), Italy

thawed frozen cuttlefish (Sepia aculeata) from India

re-dispatch

product not (yet) placed on the market

not serious

border rejection

border control consignment detained

United Kingdom

India (O), United Kingdom

poor temperature control (between 5.6 and 7.8 °C) of various chilled fish from India

import not authorised

product not (yet) placed on the market

not serious

Switzerland

Commission Services, INFOSAN, India (O), Switzerland (D)

mercury (0.92 mg/kg - ppm) in frozen barracuda (Seela cut) from India

informing authorities

distribution restricted to notifying country

serious

France

Belgium (D), France (D), Germany (D), INFOSAN, India (O), Netherlands

ciguatera poisoning suspected to be caused by frozen red snapper (Lutjanus spp.) from India, via the Netherlands

withdrawal from the market

distribution to other member countries

serious

fish and fish products

fish and fish products

fish and fish products

13/10/2015

13/06/2016

14/07/2016

information for attention

alert

official control on the market

food poisoning

GLOBEFISH Insight

91

Product Category fish and fish products

fish and fish products

fish and fish products

Notification Type

Notification Basis

19/08/2016

information for attention

border control consignment released

22/08/2016

information for attention

border control consignment released

border rejection

border control consignment detained

Date

10/11/2016

Notified By

Countries Concerned

Subject

France

France (D), INFOSAN, India (O)

ciguatoxins in frozen whole barracuda (Sphyraena jello) from India

France

France (D), INFOSAN, India (O)

ciguatoxins in chilled kingfish (Caranx spp) from India

Norway

Distribution Status

Risk Decision

information on distribution not (yet) available

serious

recall from consumers

distribution restricted to notifying country

serious

India (O), Norway

Vibrio cholerae (presence /20g) in frozen raw shrimps (Penaeus vannamei) from India

re-dispatch

product not (yet) placed on the market

serious

cadmium (up to 1.3 mg/kg - ppm) and mercury (up to 2.8 mg/kg - ppm) in fish products from Vietnam and India, via Belgium

informing authorities

distribution to other member countries

serious

ciguatoxins in frozen red snapper fillets (Lutjanus spp) from India

recall from consumers

distribution restricted to notifying country

serious

fish and fish products

30/06/2017

alert

company's own check

Netherlands

Belgium, Denmark (D), Estonia, France (D), Germany (D), Hungary (D), INFOSAN, India (O), Italy (D), Latvia (D), Lithuania (D), Netherlands (D), Romania (D), Slovenia (D), Switzerland (D), United Kingdom (D), Vietnam (O)

fish and fish products

27/07/2017

information for attention

food poisoning

France

France (D), INFOSAN, India (O)

Action Taken

GLOBEFISH Insight

92

Product Category

fish and fish products

fish and fish products

fish and fish products

fish and fish products

fish and fish products

fish and fish products

Date

Notification Type

Notification Basis

border rejection

border control consignment detained

27/10/2017

border rejection

border control consignment detained

03/05/2018

information for attention

border control consignment released

border rejection

border control consignment detained

23/05/2017

22/05/2018

03/07/2018

border rejection

border control consignment detained

06/08/2018

border rejection

border control consignment under customs

Countries Concerned

Subject

Action Taken

Distribution Status

Risk Decision

India (O), United Kingdom

poor temperature control (between 8 and 11.2 °C) of chilled yellowfin tuna loins (Thunnus albacares), swordfish (Xiphias gladius) and kingfish (Scomberomorus Spp) from India

import not authorised

product not (yet) placed on the market

undecided

Spain

India (O), Spain

poor temperature control - rupture of the cold chain (signs of thawing) of frozen sardines from India

import not authorised

product not (yet) placed on the market

undecided

Spain

INFOSAN, India (O), Spain (D)

cadmium (1.5 mg/kg - ppm) in frozen calamars from India

distribution restricted to notifying country

serious

Spain

Commission Services, India (O), Spain

cadmium (1.5 mg/kg - ppm) in frozen indian squid (Loligo duvauceli) from India

import not authorised

product not (yet) placed on the market

serious

Spain

India (O), Spain

poor temperature control (-9.7; -10.5; -11.8; -12; -12.2 °C) of frozen yellowfin tuna from India

official detention

product not (yet) placed on the market

not serious

Portugal

India (O), Portugal

abnormal colour and abnormal smell of frozen cuttlefish from India

re-dispatch

product not (yet) placed on the market

not serious

Notified By

United Kingdom

GLOBEFISH Insight

93

Product Category fish and fish products

fish and fish products

fish and fish products

fish and fish products

fish and fish products

Notification Type

Notification Basis

border rejection

border control consignment detained

27/08/2018

information for attention

border control consignment released

27/09/2018

border rejection

border control consignment detained

03/07/2019

14/10/2019

Date

20/08/2018

Notified By

Countries Concerned

Subject

Action Taken

Distribution Status

Risk Decision

United Kingdom

India (O), United Kingdom

poor temperature control (8.9, 7.6, 7.5, 8.1, 8.2 °C) of chilled fishery products from India

destruction

product not (yet) placed on the market

serious

United Kingdom

Commission Services, INFOSAN, India (O), United Kingdom (D)

histamine (171 mg/kg - ppm) in frozen raw mackerel from India

distribution restricted to notifying country

serious

Spain

India (O), Lithuania, Spain

poor temperature control (-9.8; -12.6; -13.2 °C) of frozen surimi from India

import not authorised

product not (yet) placed on the market

not serious

border rejection

border control consignment detained

United Kingdom

India (O), United Kingdom

poor temperature control (between 4.1 and 10.7 °C) of chilled sardines (Sardinella spp.) from India

import not authorised

product not (yet) placed on the market

not serious

border rejection

border control consignment detained

United Kingdom

Sri Lanka (O), United Kingdom

spoilage of chilled Indian anchovy (Stolephorus indicus) from Sri Lanka

destruction

product not (yet) placed on the market

not serious

re-dispatch

product not (yet) placed on the market

not serious

destruction

product not (yet) placed on the market

not serious

fish and fish products

17/12/2019

border rejection

border control consignment detained

Spain

India (O), Spain

poor temperature control (between -8 and -4.7 °C) of frozen sepia officinalis from India

fish and fish products

11/02/2020

border rejection

border control consignment detained

United Kingdom

India (O), United Kingdom

spoilage of chilled mixed fish from India

GLOBEFISH Insight

94

Product Category

fish and fish products

fish and fish products

fish and fish products

fish and fish products

Date

29/04/2020

01/06/2020

22/06/2020

28/07/2020

Notification Type

alert

alert

Notification Basis

official control on the market

food poisoning

information for attention

border control consignment released

border rejection

border control consignment detained

Notified By

Countries Concerned

Subject

Action Taken

Distribution Status

Risk Decision

Germany

Belgium (D), France (D), Germany (D), INFOSAN, India (O), Ireland (D), Italy (D), Luxembourg (D), Netherlands

mercury (1.4 mg/kg - ppm) in frozen marlin chunks (Makaira indica) from India, via the Netherlands

withdrawal from recipient(s)

distribution to other member countries

serious

Netherlands

Austria (D), Belgium (D), Finland (D), France (D), Germany (D), INFOSAN, India (O), Italy (D), Luxembourg (D), Netherlands, Sweden (D), Switzerland (D), United Kingdom (D)

ciguatera poisoning suspected to be caused by frozen red snapper steaks (Lutjanus bohar) from India, via France

informing recipient(s)

distribution to other member countries

serious

Italy

INFOSAN, India (O), Italy (D)

histamine (387 mg/kg - ppm) in frozen yellowfin tuna (Thunnus albacares) from India

official detention

distribution restricted to notifying country

serious

United Kingdom

India (O), United Kingdom

poor temperature control (between 13.4 and 14.8 °C) of various chilled fish products from India

destruction

product not (yet) placed on the market

undecided

GLOBEFISH Insight

95

4.2.1 US FFDA Alerts Year 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9

Causes

Type of causes

Product

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Year 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9

Causes

Type of causes

Product

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

GLOBEFISH Insight

96

Year 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9

Causes

Type of causes

Product

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Vet drugs

Shrimp

Chemical

Vet drugs

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Other causes

Filthy

Cuttlefish

Microbiologica l

Salmonella

Shrimp

Other causes

Filthy

Shrimp

Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l

Year 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9

Causes

Type of causes

Product

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l

GLOBEFISH Insight

97

Year 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9

Causes

Type of causes

Product

Chemical

Vet drugs

Shrimp

Other causes

Filthy

Lobster

Microbiologica l Microbiologica l

Salmonella

Shrimp

Listeria monocytogenes

Shrimp

Chemical

Vet drugs

Shrimp

Chemical

Vet drugs

Shrimp

Chemical

Vet drugs

Shrimp

Chemical

Vet drugs

Shrimp

Chemical

Vet drugs

Shrimp

Chemical

Vet drugs

Shrimp

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Year 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 9 201 8 201 8

Causes

Type of causes

Product

Chemical

Vet drugs

Shrimp

Other causes

Filthy

Cuttlefish

Other causes

Filthy

Cuttlefish

Other causes

Filthy

Cuttlefish

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Other causes

Filthy

Shrimp

Microbiologica l

Salmonella

Shrimp

Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l

GLOBEFISH Insight

98

Year

Causes

201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8

Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l

Type of causes

Product

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Squid

Year

Causes

Type of causes

Product

201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8

Microbiologica l

Salmonella

Squid

Other causes

Filthy

Mahi mahi

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l

GLOBEFISH Insight

99

Year

Causes

Type of causes

Product

201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8

Microbiologica l Microbiologica l Microbiologica l

Salmonella

Bass

Salmonella

Pompano

Salmonella

Mackerel

Other causes

No process

Shrimp

Other causes

No process

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l

Year

Causes

201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8

Microbiologica l Microbiologica l Microbiologica l

Type of causes

Product

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Other causes

Filthy

Other causes

Filthy

Other causes

Filthy

Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l

Mahi mahi Mahi mahi Mahi mahi

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

GLOBEFISH Insight

100

Year 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8

Causes

Type of causes

Product

Chemical

Nitrofuran

Shrimp

Salmonella

Fish

Salmonella

Shrimp

Salmonella

Prawn

Salmonella

Prawn

Salmonella

Prawn

Salmonella

Prawn

Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l

Mahi mahi Mahi mahi Mahi mahi

Other causes

Filthy

Other causes

Filthy

Other causes

Filthy

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Year 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8

Causes

Type of causes

Product

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Other causes

Filthy

Prawn

Other causes

MfrHACCP

Other causes

MfrHACCP

Other causes

MfrHACCP

Other causes

MfrHACCP

Other causes

MfrHACCP

Other causes

MfrHACCP

Other causes

MfrHACCP

Other causes

MfrHACCP

Other causes

MfrHACCP

Mahi mahi Mahi mahi Mahi mahi Mahi mahi Mahi mahi Mahi mahi Mahi mahi Mahi mahi Mahi mahi

GLOBEFISH Insight

101

Year 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8

Causes

Type of causes

Other causes

MfrHACCP

Other causes

MfrHACCP

Other causes

MfrHACCP

Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l

Product

Year

Causes

Mahi mahi Mahi mahi Mahi mahi

201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8 201 8

Microbiologica l Microbiologica l

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Chemical

Vet drugs

Shrimp

Chemical

Vet drugs

Shrimp

Chemical

Vet drugs

Shrimp

Chemical

Vet drugs

Shrimp

Chemical

Chloramphenicol

Shrimp

Type of causes

Product

Salmonella

Shrimp

Salmonella

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Chemical

Nitrofuran

Shrimp

Other causes

Filthy

Shrimp

Other causes

Filthy

Shrimp

Chemical

Nitrofuran

Shrimp

Other causes

Filthy

Mahi mahi

Other causes

Filthy

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Microbiologica l Microbiologica l

GLOBEFISH Insight

102

Year

Causes

Type of causes

Product

201 8 201 8 201 8 201 7 201 7 201 7 201 7 201 7 201 7 201 7 201 7 201 7 201 7

Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l Microbiologica l

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Fish

Salmonella

Fish

Salmonella

Shrimp

Salmonella

Shrimp

Chemical

Vet drugs

Shrimp

Other causes

Filthy

Squid

Other causes

Filthy

Squid

Other causes

Filthy

Squid

Other causes

Filthy

Cuttlefish

Other causes

Filthy

Cuttlefish

Year 201 7 201 7 201 7 201 7 201 7 201 7

Causes

Type of causes

Product

Other causes

Filthy

Cuttlefish

Other causes

Filthy

Cuttlefish

Salmonella

Shrimp

Salmonella

Shrimp

Salmonella

Squid

Salmonella

Squid

Microbiologica l Microbiologica l Microbiologica l Microbiologica l

GLOBEFISH Insight

103

4.3

FDA AND EPA SAFETY LEVELS IN REGULATIONS AND GUIDANCE ANIMAL DRUGS Products.

Levels.

References.

All fish 10.

Drugs prohibited for extra-label use in animals: • No residue permitted for the following: o Chloramphenicol; o Clenbuterol; o Diethylstilbestrol (DES); o Dimetridazole, Ipronidazole, and other Nitroimidazoles; o Furazolidone, Nitrofurazone, and other nitrofurans; o Fluoroquinilones; o Glycopeptides.

21 CFR 530.41.

Finfish and lobster.

Sum of tetracycline residues, including oxytetracycline, chlortetracycline, and tetracycline 1: • ≥ 2.0 ppm (muscle tissue).

21 CFR 556.500.

Azamethiphos 9: • ≥ 0.02 ppm (muscle/adhering skin).

Import Tolerance (https://www.fda.gov/ animalveterinary/products/importex ports/ ucm315830.htm).

Atlantic salmon and Rainbow trout.

Benzocaine 9: • ≥ 0.05 ppm (muscle with adhering skin).

Import Tolerance (https://www.fda.gov/ animalveterinary/products/importex ports/ ucm315830.htm).

Salmonids and Walleye.

Chloramine-T 1 (para-toluenesulfonamide-marker residue): • ≥ 0.90 ppm (muscle/skin)

Salmonids.

GLOBEFISH Insight

10

ANIMAL DRUGS Products.

Freshwater-reared finfish (other than catfish) and salmonids, and catfish.

Levels.

Florfenicol (florfenicol amine-the marker residue): • Freshwater-reared finfish (other than catfish) and salmonids ≥ 1.0 ppm (muscle/skin); • Catfish ≥ 1.0 ppm (muscle).

References.

21 CFR 556.283.

Import Tolerance (https://www.fda.gov/ animalveterinary/products/importex ports/ ucm315830.htm).

Salmonids.

Lufenuron 9: • ≥ 1.35 ppm (muscle/adhering skin).

Salmonids and catfish.

Sulfadimethoxine/ormetoprim combination 1: • ≥ 0.1 ppm for each drug (edible tissue).

21 CFR 556.640.

Trout.

Sulfamerazine 1: • No residue permitted.

21 CFR 556.660.

Atlantic salmon.

Import Tolerance (https://www.fda.gov/ animalveterinary/products/importex ports/ ucm315830.htm).

Telflubenzuron 9: • ≥ 0.5 ppm (muscle/adhering skin).

BIOLOGICAL Products.

Socioeconomic Costs and Benefits of Food Safety Reform in Sri Lanka

Levels.

Clostridium botulinum: • Presence of viable spores or vegetative cells in products that will support their growth; OR • Presence of toxin 12.

References.

International Commission on Microbiology Specifications for Food (ICMSF).

1996.

Microorganisms in Food 5.

Microbiological specification of food pathogens.

London: Blackie Academic and Professional.

GLOBEFISH Insight

10

BIOLOGICAL Products.

Levels.

References.

Listeria monocytogenes: • Presence of organism 12.

Shank F.R., E. L. Elliot, I. K. Wachsmuth, and M. E. Losikoff. 1996. US position on Listeria monocytogenes in foods. Food Control. 7: 229234.

All fish 10.

Salmonella spp.: • Presence of organism 12.

Sec. 555.300 Compliance Policy Guide.

All fish 10.

Staphylococcus aureus: • Positive for staphylococcal enterotoxin; OR • ≥ 10 4/g (MPN); OR • Levels indicative of insanitary conditions 12.

Compliance Program 7303.842.

All fish 10 that has been previously cooked.

Vibrio spp.: • Presence of organism 12.

International Commission on Microbiology Specifications for Food (ICMSF. 1996.

Microorganisms in Food 5.

Microbiological specification of food pathogens.

London: Blackie Academic and Professional.

Raw bivalve shellfish 11.

Vibrio cholerae: • Presence of toxigenic organism.

National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

EU-Sri Lanka TradeRelated Assistance Project

GLOBEFISH Insight

10

BIOLOGICAL Products.

Levels.

References.

Raw fish 10 other than raw bivalve shellfish that is ready-to-eat (RTE) as defined in 21 CR 117.3.

Vibrio cholerae: • Presence of organism 12.

International Commission on Microbiology Specifications for Food (ICMSF. 1996.

Microorganisms in Food 5.

Microbiological specification of food pathogens.

London: Blackie Academic and Professional.

Post-harvest processed clams, mussels, oysters, and whole and roe-on scallops, fresh or frozen, that make a label claim of “processed to reduce Vibrio parahaemolyticus to non-detectable levels.”

Vibrio parahaemolyticus: • ≥ 30 MPN/g.

National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

Raw bivalve shellfish 11.

Vibrio parahaemolyticus: • ≥ 1 x 10 4/g.

National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

Post-harvest processed clams, mussels, oysters, and whole and roe-on scallops, fresh or frozen, that make a label claim of “processed to reduce Vibrio vulnificus to non detectable levels.”

Vibrio vulnificus: • ≥ 30 MPN/g.

National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

GLOBEFISH Insight

10

CHEMICAL Products.

Levels.

References.

Fish and shellfish 13.

2,4-Dichlorophenoxyacetic acid (2,4-D)1: • Fish > 0.1 ppm; • Shellfish > 1.0 ppm.

40 CFR 180.142.

All fish 10.

Aldrin and dieldrin: • ≥ 0.3 ppm (edible portion).

Sec. 575.100 Compliance Policy Guide.

Frog legs.

Benzene Hexachloride (BHC): • ≥ 0.3 ppm (edible portion).

Sec. 575.100 Compliance Policy Guide.

Fish freshwater13.

Bispyribac-sodium 1: • > 0.01 ppm.

40 CFR 180.577.

Oysters 13.

Carbaryl 1: • > 0.25 ppm.

40 CFR 180.169.

Fish and shellfish 13.

Carfentrazone-ethyl 1: • > 0.3 ppm.

40 CFR 180.515.

All fish 10.

Chlordane: • ≥ 0.3 ppm (edible portion).

Sec. 575.100 Compliance Policy Guide.

All fish 10.

Chlordecone: • Crabmeat ≥ 0.4 ppm; • Other fish ≥ 0.3 ppm (edible portion).

Sec. 575.100 Compliance Policy Guide.

All fish 10.

DDT, TDE, and DDE: • ≥ 5.0 ppm (edible portion).

Sec. 575.100 Compliance Policy Guide.

Fish and shellfish 13.

Diquat 1: • Fish > 2.0 ppm; • Shellfish > 20.0 ppm.

40 CFR 180.226.

Fish – freshwater finfish, farm raised 13.

Diuron and its metabolites 1: • > 2.0 ppm.

40 CFR 180.106.

Fish 13.

Endothall and its monomethyl ester 1: • > 0.1 ppm.

40 CFR 180.293.

All fish 10.

Ethoxyquin: • > 0.5 ppm (edible muscle).

21 CFR 172.140.

GLOBEFISH Insight

10

CHEMICAL Products.

Levels.

References.

Fish, freshwater 13.

Flumioxazin 1: • > 1.5 ppm.

40 CFR 180.568.

Crayfish, and Fish 13.

Fluridone 1: • > 0.5 ppm.

40 CFR 180.420.

Fish – freshwater finfish and Fish – shellfish, crustacean 13.

Fluxapyroxad 1 (fungicide): • > 0.01 ppm.

40 CFR 180.666

Fish – freshwater finfish, Fish – shellfish, crustacean, and Fish – shellfish, mollusc 13.

Florpyrauxifen-benzyl 1: • Freshwater Finfish > 2.0 ppm; • Shellfish, crustacean > 0.5 ppm; • Shellfish, mollusc > 20.0 ppm.

40 CFR 180.695.

Fish, and shellfish 13.

Glyphosate 1: • Fish > 0.25 ppm; • Shellfish > 3.0 ppm.

40 CFR 180.364.

All fish 10.

Heptachlor and heptachlor epoxide: • ≥ 0.3 ppm (edible portion).

Sec. 575.100 Compliance Policy Guide.

Scombrotoxin-forming fish, e.g., Tuna, mahi mahi, and related fish.

Histamine: • ≥ 500 ppm - toxic; • ≥ 50 ppm - decomposed.

Sec. 540.525 Compliance Policy Guide.

Fish and shellfish 13.

Imazapyr 1: • Fish > 1.0 ppm; • Shellfish > 0.1 ppm.

All fish 10.

Methylmercury 2: • ≥ 1.0 ppm.

Sec. 540.600 Compliance Policy Guide.

All fish 10.

Mirex: • ≥ 0.1 ppm (edible portion).

Sec. 575.100 Compliance Policy Guide.

Fish, Fish – shellfish, crustacean, and Fish – shellfish, mollusc 13.

Penoxsulam 1: • Fish > 0.01 ppm; • Shellfish, crustacean > 0.01 ppm; • Shellfish, mollusc > 0.02 ppm.

40 CFR 180.500.

40 CFR 180.605.

GLOBEFISH Insight

10

CHEMICAL Products.

Levels.

References.

All fish 10.

Polychlorinated Biphenyls 1 (PCBs): • ≥ 2.0 ppm (edible portion).

21 CFR 109.30.

Fish – freshwater finfish, and Fish – Shellfish, crustacean 13.

Saflufenacil 1: • > 0.01 ppm.

40 CFR 180.649.

Fish, Fish – Shellfish, crustacean, and Fish – shellfish, mollusc 13.

Spinosad 1: • > 4.0 ppm.

40 CFR 180.495.

Fish 13.

Triclopyr and its metabolites and degradates 1: • > 3.0 ppm.

40 CFR 180.417.

Fish – freshwater finfish, Fish – saltwater finfish, Fish – shellfish, crustacean, and Fish – shellfish mollusc 13.

Topramezone 1: • > 0.05 ppm.

40 CFR 180.612.

NATURAL TOXINS.7, 8 Products.

Levels.

References.

Bivalve shellfish 11.

Azaspiracid 3, 6 (Azaspiracid Shellfish Poisoning (AZP)): • ≥ 0.16 mg/kg azaspiracid-1 equivalents (i.e., combined azaspiracid-1, -2, and -3).

National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

Clams, mussels, oysters, and whole and roe on scallops, fresh, frozen, or canned 11.

Brevetoxin 5, 6 (Neurotoxic Shellfish Poisoning (NSP)): • ≥ 0.8 mg/kg (20 mouse units/100 g) brevetoxin-2 equivalent or 5,000 cells/L.

National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

GLOBEFISH Insight

11

NATURAL TOXINS.7, 8 Products.

Levels.

References.

Ciguatoxin 4 (Ciguatera Fish Poisoning (CFP)): • Caribbean ciguatoxins: ≥ 0.1 µg/kg Caribbean ciguatoxin-1 (C-CTX-1) equivalents; • Indian ciguatoxins: Guidance levels have yet to be established; • Pacific ciguatoxins: ≥ 0.01 µg/kg Pacific ciguatoxin-1 (P-CTX-1) equivalents.

Dickey, R.W. and S.M. Plakas.

2010. Ciguatera: A public health perspective.

Toxicon 56(2): 123-136.

Dickey, R. W. 2008. Ciguatera toxins: chemistry, toxicology, and detection, p.

479-500. In L. M. Botana (ed.), Seafood and freshwater toxins: pharmacology, physiology, and detection, 2nd ed. CRC Press/Taylor & Francis.

All fish 10.

Domoic acid 6 (Amnesic Shellfish Poisoning (ASP)): • ≥ 20 mg/kg domoic acid (except Dungeness crab viscera); • > 30 mg/kg domoic acid (Dungeness crab viscera ONLY).

Compliance Program 7303.842.

National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

FDA Memorandum, Director, Office of Seafood.

Marine Biotoxins in Dungeness Crab. January 14, 1993.

Clams, mussels, oysters, and whole and roe on scallops, fresh, frozen, or canned 11.

Okadaic acid 3 (Diarrhetic Shellfish Poisoning (DSP)): • ≥ 0.16 mg/kg total okadaic acid equivalents (i.e., combined free okadaic acid, dinophysistoxins-1 and -2, and their acyl-esters).

National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

All fish 10.

Saxitoxin 3, 6 (Paralytic Shellfish Poisoning (PSP)): • ≥ 0.8 mg/kg saxitoxin equivalent (80 µg/100 g).

Sec. 540.250 Compliance Policy Guide.

Compliance Program 7303.842.

Finfish (primarily reef fish).

GLOBEFISH Insight

11

PHYSICAL Products.

All fish 10.

Levels.

Hard or sharp foreign object: • Generally 0.3 (7 mm) – 1.0 (25 mm) in length.

References.

Sec. 555.425 Compliance Policy Guide

ACRONYMS: MPN = Most probable number; CTX = ciguatoxin.

FOOTNOTES: 1. These values are tolerances. (Reference: 21CFR 109, 21CFR 556 and 40 CFR 180).

2. Refer to Chapter 10 – Methylmercury for additional information.

3. AZP, DSP, and PSP equivalents are based on chemical abundance as determined by instrumental analysis. In some cases (i.e. AZP, DSP, and PSP), toxicity equivalent factors (TEFs) may be available and should be considered in determining total toxin equivalents.

4. CFP equivalents are based on in vitro (cell culture bioassay) toxicity.

5. NSP equivalents are based on in vivo (mouse bioassay toxicity).

6. Refer to the National Shellfish Sanitation Program: Guide for Control of Molluscan Shellfish for details on approved methodologies for Biotoxin analysis of molluscan shellfish. (https://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2006754.htm).

7. Refer to Chapter 6 – Natural Toxins for additional information.

8. Guidance levels used to confirm illnesses (i.e., CFP), inform advisories for at risk harvest areas (i.e., CFP) and/or make a determination for harvest area closures (i.e., ASP, AZP, DSP, NSP, and PSP.) Guidance levels are not intended to be identified in the HACCP plan as a control measure.

9. These values are import tolerances (Reference: https://www.fda.gov/animalveterinary/products/importexports/ucm315830.htm) 10.The term “fish” and “fishery products” are defined in the Fish and Fishery Products Regulation (21 CFR 123.3(d) and 123.3(e)) 11. The term “shellfish” is defined in the NSSP as all species of (a) Oysters, clams, or mussels, whether: shucked or in the shell; raw, including post-harvest processed; frozen or unfrozen; whole or in part; and (b) Scallops in any form, except when the final product form is the adductor muscle only.

12. Detectable by methods equivalent to FDA’s Bacteriological Analytical Manual.

GLOBEFISH Insight

11

4.4 Res. No.

11/04

Status of implementation of the recommendations/Resolutions of the IOTC Resolution

On a regional observer scheme

Scientific requirement

Paragraph 9

CPC progress

All authorized tuna longliners are covered by the observer programme and the information is provided to IOTC in the prescribed format. Further, the requirements for monitoring the artisanal fishing vessels landing at the landing place are also carried out by the field samplers.

All the five species of marine turtles reported from the Indian waters are protected under the law.

The authorised longliners regularly record and report interactions with marine turtles and this information is reported to the IOTC. The Central Institute of Fisheries Technology is carrying out research on use of circle hooks and the findings have been reported in Journal of Fishery Technology (53 (2016): 284 – 289) and the Indian Journal of Fisheries (Vol. 60(1), 2013 Pp 2127).

12/04

On the conservation of marine turtles

Paragraphs 3, 4, 6–10

FSI also carries out research on the use of circle hook and research finding have been published in the Journal ‘Current Science’ (Vol. 98, No. 10, Pp – 1378-1384).

To create awareness, FSI also brings out popular articles in its in house publications namely, Meena News and Bulletin of Fishery Survey of India.

The entire stretch of the coastline where mass stranding of turtles takes place in India is protected through national and state legislation and no fishing activity is permitted to be carried out in such areas. Further, the Department of Forest and the Indian Coast Guard monitors the implementation of the conservation measures for protection of marine turtles.

The coastal states where mass stranding take place have also made the use of Turtle Excluder Devices in trawl nets mandatory.

12/06

On reducing the incidental bycatch of seabirds in longline fisheries.

Paragraphs 3–7

There were no reported instances of sea bird interactions in any of the Indian tuna fishery.

12/09

On the conservation of thresher sharks (family Alopiidae) caught in association with fisheries in the IOTC area of competence

Paragraphs 4–8

The Indian authorized longline vessels are implementing this resolution and the same is reported to IOTC.

13/04

On the conservation of cetaceans

Paragraphs 7– 9

The national legislation prohibits capture and trade of marine mammals in Indian waters.

GLOBEFISH Insight 113

Res. No.

Resolution

13/05

On the conservation of whale sharks (Rhincodon typus)

Scientific requirement

CPC progress

Paragraphs 7– 9

The national legislation prohibits capture and trade of whale sharks in Indian waters.

13/06

On a scientific and management framework on the conservation of shark species caught in association with IOTC managed fisheries

Paragraph 5–6

The Wild Life (Protection) Act, 1972 and various orders issued by the Ministry of Environment and Forest and the Ministry of Commerce provide for conservation of shark species in Indian EEZ. Further, a National Plan of Action (NPOA) on Conservation and Management of Sharks is under finalization.

15/01

On the recording of catch and effort by fishing vessels in the IOTC area of competence

Paragraphs 1–10

The authorized longline vessels are collecting the catch and effort data and providing the same to the IOTC on regular basis.

15/02

Mandatory statistical reporting requirements for IOTC Contracting Parties and Cooperating NonContracting Parties (CPCs)

Paragraphs 1–7

The mandatory statistical reporting is carried out on regular basis.

15/05

On conservation measures for striped marlin, black marlin and blue marlin

Paragraph 1

The authorized longlining vessels are undertaking conservation measures for striped marlin, black marlin and blue marlin and the data is provided to the IOTC on regular basis.

The data collected from the authorised longlining vessels are submitted to IOTC to meet the reporting requirements.

17/05

On the conservation of sharks caught in association with fisheries managed by IOTC

Paragraphs 6, 9, 11

The national legislation provided for conservation of shark species including landing of sharks with fin attached.

India has a national programme on elasmobranchs that includes stock assessment and conservation. A decision on India’s participation in the proposed project will be taken after the details on the project are known.

GLOBEFISH Insight 114

Res. No.

Resolution

Scientific requirement

Gillnet: CPCs whose Gillnet catches of yellowfin reported for 2014 were above 2000 MT to reduce their Gillnet catches of yellowfin by 10 percent from the 2014 levels.

18/01

On an Interim Plan for Rebuilding the Indian Ocean Yellowfin Tuna Stock in the IOTC Area of Competence

Longline: CPCs whose Longline catches of yellowfin reported for 2014 were above 5000 MT to reduce their Longline catches of yellowfin by 10 percent from the 2014 levels

CPC progress

This Resolution is applicable to the vessels in the IOTC list of authorized vessels, and since India does not have any gillnet vessels in this category, the catch reduction is not applicable to Indian gillnet fishery.

Catch by Indian longline vessels in the IOTC registry during 2014 was <5000 mt Catch by Indian vessels in the IOTC registry using other gears during 2014 was <5000 mt

CPCs’ other gears: CPCs whose catches of yellowfin from other gears reported for 2014 were above 5000 MT to reduce their other gear

18/02

18/05

On Management Measures for the Conservation of Blue Shark Caught in Association with IOTC Fisheries

On Management Measures for the Conservation of the Billfishes: Striped Marlin, Black Marlin, Blue Marlin and Indo-Pacific Sailfish

Paragraph 2 Paragraph 3 Paragraph 4

Data is recorded and furnished to the IOTC Data collection programmes are in place Catches are being monitored domestically

Paragraph 5

Scientific research on blue sharks is being undertaken and results has been published (e.g., Varghese et al., 2017)

Paragraph 2

India is adopting a number of management measures for conservation of fishery resources (including billfishes) in its seas, most important of which is annual ban on fishing for two months.

Paragraph 8

Catches are being monitored and reported to the IOTC

Source: India’s National Report to the Scientific Committee of the Indian Ocean Tuna Commission, 2019

GLOBEFISH Insight 115

4.5

Resolutions of the IOTC that are related to international fish trade Resolution number

Main requirements

19/03

FURTHER NOTING that the mobulid rays are also listed in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) for which trade shall be closely controlled under specific conditions including, inter alia, that trade will not be detrimental to the survival of the species in the wild

19/05

Contracting Parties and Cooperating Non-Contracting Parties shall require all purse seine vessels to retain on board and then land, to the extent practicable, the following non-targeted species or species group ; other tunas, rainbow runner, dolphinfish, triggerfish, billfish, wahoo, and barracuda, except fish considered unfit for human consumption as defined in paragraph 4b (i), and/or species which are prohibited from retention, consumption, or trade through domestic legislations and international obligations. (Para 2)

18/03

Without prejudice to the rights of flag States and coastal States to take action consistent with international law, CPCs shall not take any unilateral trade measures or other sanctions against vessels included in the Draft and/or Provisional IUU Vessel Lists, pursuant to paragraphs 8 and 16 on the grounds that such vessels are involved in IUU fishing activities, or against those vessels removed from the IUU vessels list by the Commission. (Para 39)

17/05

RECOGNISING the need to improve the collection of species specific data on catch, discards and trade as a basis for improving the conservation and management of shark stocks and aware that identifying sharks by species is rarely possible when fins have been removed from the carcass ; FURTHER RECALLING that the FAO International Plan of Action for Sharks calls on States to encourage full use of dead sharks, to facilitate improved species-specific catch and landings data and monitoring of shark catches and the identification and reporting of species-specific biological and trade data ;

16/11

review all other relevant documentation and records held onboard, including, to the extent possible, those in electronic format and vessel monitoring system (VMS) data from the flag State or IOTC Secretariat or other relevant regional fisheries management organizations (RFMOs). Relevant documentation may include logbooks, catch, transshipment and trade documents, crew lists, stowage plans and drawings, descriptions of fish holds, and documents required pursuant to the Convention on International Trade in Endangered Species of Wild Fauna and Flora; Appendix II (d); Appendix III (34)

12/04

FURTHER RECALLING that marine turtles, including all species in the family Cheloniidae and Dermochelys coriacea (leatherback turtles) are listed in Appendix I of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) and that all species of marine turtles are listed on Appendix I or II of Convention on the Conservation of Migratory Species of Wild Animals;

10/10

CONSIDERING the calls of the United Nation General Assembly, included in particular in the UNGA Resolutions on Sustainable Fisheries N° 61/105 of 6 December 2006 and N° 62/177 of 18 December 2007, urging States, individually and through Regional Fisheries Management Organisation to adopt and implement trade measures in accordance with international law, including principles, rights and obligations established in World Trade Agreements;

07/01

CONCERNED that vessels that carry out activities in the area of competence which do not comply with the IOTC Conservation and Management Measures are benefiting from the support provided by persons subject to the jurisdiction of Contracting Parties and Cooperating NonContracting Parties (CPCs), including, inter alia, through participation in transhipment, transport and trade of illegally harvested catches or engagement on board or in the management of these vessels;

GLOBEFISH Insight 116

Resolution number

Main requirements

03/03

Contracting Parties, Non-Contracting Parties, Entities, Fishing Entities having vessels that harvest species whose international trade must be accompanied by Statistical Documents are requested to submit the information on this sheet to the Executive Secretary of IOTC*, and to ensure that any changes to the above are also transmitted to the IOTC Executive Secretary on a timely fashion. (Appendix IV, instruction)

01/06

RECOGNISING ALSO that there is uncertainty on the catch of Bigeye tuna in the Convention Area and that the availability of trade data would greatly assist in reducing such uncertainty;

99/02

The Commission instructs the IOTC Secretariat to prepare possible measures including trade restrictive measures to prevent or eliminate FOC fishing activities. (Para 7)

Source: compiled by FAO

GLOBEFISH Insight 117

4.6 Analysis of NTMs on select fish and fish products imported into China, the European Union, and the United States of America based on the MAST Classification

HS code

4.6.1 Distribution of NTMs applied by China on selected fish and fish products 230120 160540 160529 160521 160510 160420 30749 30617 30572 30564 30563 30561 30559 30544 30542 30531 30499 30493 30491 30484 30469 30454 30451 30445 30439 30389 30357 30356 30355 30354 30353 30351 30349 30343 30342 30325 30289 30273 30247 30245 30244 30243 30242 30241 0

5 SPS

10 TBT

15

PreShipment

20 Quantity

25

30

Price

Other

35

40

GLOBEFISH Insight 118

HS Code

4.6.2 Distribution of NTMs applied by the European Union on selected fish and fish products 230120 160540 160529 160521 160510 160420 30749 30617 30572 30564 30563 30561 30559 30544 30542 30531 30499 30493 30491 30484 30469 30454 30451 30445 30439 30389 30357 30356 30355 30354 30353 30351 30349 30343 30342 30325 30289 30273 30247 30245 30244 30243 30242 30241 0

5 SPS

10 TBT

15 PreShipment

20

25

Quantity

Price

30

35

40

Other

GLOBEFISH Insight 119

HS Code

4.6.3 Distribution of NTMs applied by the United States of America on selected fish and fish products

230120 160540 160529 160521 160510 160420 30749 30617 30572 30564 30563 30561 30559 30544 30542 30531 30499 30493 30491 30484 30469 30454 30451 30445 30439 30389 30357 30356 30355 30354 30353 30351 30349 30343 30342 30325 30289 30273 30247 30245 30244 30243 30242 30241 0

5 SPS

10 TBT

PreShipment

15

20 Quantity

25 Price

30

35

Other

GLOBEFISH Insight 120

CHN

4.6.4 Distribution of NTMs applied by China on selected imported fish and fish products from India 230120 160540 160529 160521 160510 160420 30749 30617 30572 30564 30563 30561 30559 30544 30542 30531 30499 30493 30491 30484 30469 30454 30451 30445 30439 30389 30357 30356 30355 30354 30353 30351 30349 30343 30342 30325 30289 30273 30247 30245 30244 30243 30242 30241 0

5 SPS

10 TBT

15 PreShipment

20

25

Quantity

Price

30

35

40

Other

GLOBEFISH Insight 121

EUN

4.6.5 Distribution of NTMs applied by the European Unions on selected imported fish and fish products from India 230120 160540 160529 160521 160510 160420 30749 30617 30572 30564 30563 30561 30559 30544 30542 30531 30499 30493 30491 30484 30469 30454 30451 30445 30439 30389 30357 30356 30355 30354 30353 30351 30349 30343 30342 30325 30289 30273 30247 30245 30244 30243 30242 30241 0

2 SPS

4 TBT

6

8

PreShipment

10 Quantity

12 Price

14

16

18

20

Other

GLOBEFISH Insight 122

USA

4.6.6 Distribution of NTMs applied by the United States of America on selected imported fish and fish products from India 230120 160540 160529 160521 160510 160420 30749 30617 30572 30564 30563 30561 30559 30544 30542 30531 30499 30493 30491 30484 30469 30454 30451 30445 30439 30389 30357 30356 30355 30354 30353 30351 30349 30343 30342 30325 30289 30273 30247 30245 30244 30243 30242 30241 0

5

10 SPS

TBT

15 PreShipment

20 Quantity

25

30

35

Price

GLOBEFISH Insight 123