2019 K-V FTA Economic Cooperation Work Program Strengthening K-V Fishery Cooperation by Improving Viet Nam's Aquaculture Safety Funded by ▏ Ministry of Economy and Finance(MOEF), Republic of Korea
Project Director ▏ Soodeuk Sohn, Executive Vice President for Ecomomic Cooperation & Trade Affairs Chulho Park, Director General, Development Cooperation Office, KOTRA
Project Manager ▏ Sunyoung Chang, Deputy Director, Development Cooperation Office, KOTRA Jiwon Lee, Project Manager, Development Cooperation Office, KOTRA
Project Officer ▏ Boyoung Chung, Project Officer, Development Cooperation Office, KOTRA Jihwan Boo, Project Officer, KOTRA HANOI
In cooperation with ▏ Ministry of Industry and Trade(MOIT), Socialist Republic of Viet Nam KOTRA HANOI
Conducted by ▏ Inha University Research and Business Foundation
Researchers ▏ Mingyu Park, Professor, Inha University (Principal Investigator) Korea Dukhyun Yoon, Researcher, Aqua International Co.,Ltd. Myoungae Park, Researcher, Fisheries Science Museum Jungbae Song, Research Assistant, Inha University
Researchers ▏ Le Hong Phuoc, Researcher, Research Institute for Aquaculture No.2 Vietnam Phan My Binh, Consultant, Ministry of Industry and Trade Nguyen Thi Bang Tam, Consultant, D-FISH Nguyen Ngoc Tien, Consultant, DAH Vu Thi Huyen Vinh, Consultant, NAFIQAD
▏DISCLAIMER▕
The opinions expressed in this document are the sole responsibility of the author and do not necessarily represent the official position of the Korean government. Reproduction and translation for non-commercial purposes are authorized, provided the source is acknowledged and the publisher is given prior notice and sent a copy. Table of Contents
2019 K-V FTA Economic Cooperation Work Program Strengthening K-V Fishery Cooperation by Improving Viet Nam's Aquaculture Safety
Ⅰ. Introduction
1. Research Purpose and Background ························································· 3 2. Methods, Literature Review, and Organization ······································ 7
Ⅱ. Safety Management of Farmed Fishery Products in Korea
1. Korea’s Safety Management of Imported Fishery Products ··············· 15 2. Korea–Vietnam Fishery Trade and Safety Issues ································ 38
Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
1. Status of Vietnamese Aquaculture and Disease Control ····················· 55 2. Disease Prevention and Control of Vietnamese Aquatic Animals ····· 61 3. Management of Vietnamese Veterinary Medicines ······························ 74 4. Safety Management of Vietnamese Fishery Products ························· 81 5. Safety Management of Fishery Products ·············································· 96
Ⅳ. Value Chain Analysis and Investigation of Antibiotic Use in Vietnam Shrimp Farms
1. Value Chain of Farmed Shrimp ··························································· 127 2. Investigation of Antibiotic Use on Small Shrimp Farms in Vietnam ····· 136
List of Chemicals and Veterinary Drugs Prohibited from Use in Aquaculture ··· 79
Major Veterinary Drug Groups Used in Veterinary Medicine ······················ 80
Substances to be Tested for Antimicrobial Resistance (27) ·························· 81
Food Safety Legislation in Vietnam ·························································· 82
Composition of Vietnamese Food Safety Legislation ··································· 83
Enforcement Decree on Vietnamese Food Safety Legislation ······················· 84
Food Safety Management Duties and Items in Charge, by Department ········· 86
Ministries in Charge of Aquatic Product Safety by Distribution Stage ·········· 87
Food Safety Management of the MARD ··················································· 89
The MARD’s Fishery Product Safety Management: Duties by Department ···· 90
Functions of the NAFIQAD ···································································· 94
Prohibited Substances in Feed and Environmental Management of Farming ··· 97
Areas of Hazardous Residues Monitoring Program in Vietnam (as of 2017) ··· 99
Hazardous Substances Maximum Residue Limit ········································· 99
Hazardous Residues in Monitored in Vietnamese Items ····························· 101
iii Tables 2019 K-V FTA Economic Cooperation Work Program Strengthening K-V Fishery Cooperation by Improving Viet Nam's Aquaculture Safety
Production and Sampling Amounts for Major Farming Species (as of 2018) ···· 102
Annual Inspection and Number of Noncompliant Cases (2010–2017) ·········· 104
Rating and Inspection Cycle of Export Processing Facilities ······················ 106
Inspection Targets and Items for Fishery Products (cook-before-eating) ······· 107
Inspection Targets and Items for Fisheries Products (ready-to-eat) ·············· 108
Korean Government’s Inspections of Registered Facilities in Vietnam (2002–2019) ··· 109
Checklist for Registered Facilities ··························································· 110
Main Results of Registered Facilities Inspection in Vietnam (2013–2019) ···· 111
Vietnamese Organizations in Charge of Import and Export Safety Fishery Products ··· 113
Approved Fishery Product Processing Facilities in Vietnam, by Nation (as of March 2020) ······························································· 114
Status of SPS Agreements between Vietnam and Other Nations (as of 2018) ···· 115
Status of Vietnam’s Shrimp Imports by Nation ········································ 116
Vietnamese Legislation Related to Quarantine ·········································· 118
Aquatic Animals for Quarantine in Vietnam ············································ 119
Disease Markers for Tests and Monitoring of Vietnamese Crustaceans ········ 120
Criteria for Checking and Evaluating Aquatic Animal Products ·················· 121
Status of Registered Facilities of Exporters According to the Agreement ····· 123
Legislation on Quarantine of Vietnamese Aquatic Animals ·························· 133
Status of Small-scale Farms in Vietnam ··················································· 136
Inspection Results for Residual Antibiotics ················································ 138
Differences Between Shrimp Farmers According to Detection of Antibiotics ···· 140
Differences Between Shrimp Farms According to Whether Antibiotics Were Detected ···· 141
Information Channels Used by Shrimp Farmers ········································· 143
iv Tables 2019 K-V FTA Economic Cooperation Work Program Strengthening K-V Fishery Cooperation by Improving Viet Nam's Aquaculture Safety
Opportunities and Challenges for the Safety Improvement of Vietnamese Aquaculture Products ····························································· 150
How to Overcome Challenges to Vietnamese Aquaculture Product Safety ··· 152
Roadmap for the Implementation of Policy Suggestions ······························ 153
Safety Management during the Production Stage ········································ 157
v Figure 2019 K-V FTA Economic Cooperation Work Program Strengthening K-V Fishery Cooperation by Improving Viet Nam's Aquaculture Safety
< Figure Ⅱ-1 > Korea’s Departments for the Safety Management of Fishery Products ··········· 16 < Figure Ⅱ-2 > Fishery Product Safety Management Organization of the MFDS ··················· 26 < Figure Ⅱ-3 > Korea’s Imported Food Inspection Procedure ·············································· 33 < Figure Ⅱ-4 > US Imports of Vietnamese Shrimp and Number of Rejections (2004–2016) ··· 45 < Figure Ⅱ-5 > EU Imports of Vietnamese Shrimp and Number of Rejections (2004–2016) ··· 47 < Figure Ⅱ-6 > Japanese Imports of Vietnamese Shrimps and Number of Rejections (2004–2016) ··· 48
< Figure Ⅲ-1 > Organization of the DAH ········································································ 62 < Figure Ⅲ-2 > Vietnamese Veterinary Management System ··············································· 63 < Figure Ⅲ-3 > Areas of WSD Emergence in Vietnam in Hectares (2012–2018) ·················· 69 < Figure Ⅲ-4 > Reduction in Production and Losses Due to AHPND in Whiteleg Shrimp ····· 70 < Figure Ⅲ-5 > Areas of AHPND Emergence in Vietnam in ha (2012–2018) ······················· 70 < Figure Ⅲ-6 > Disease Outbreak Reporting System in Vietnam ········································· 73 < Figure Ⅲ-7 > Vietnamese Medicines and Vaccine Management Structure ··························· 74 < Figure Ⅲ-8 > Vietnamese Central Government’s Food Safety Control System ···················· 85 < Figure Ⅲ-9 > Vietnamese Local Governments’ Food Safety Control System ······················ 87 < Figure Ⅲ-10 > Organization of the MARD ···································································· 88 < Figure Ⅲ-11 > The MARD Fisheries Products Safety Management Organization ················ 91 < Figure Ⅲ-12 > Organization of the D-Fish ····································································· 92 < Figure Ⅲ-13 > Organization of the NAFIQAD ····························································· 93 < Figure Ⅲ-14 > Re-Exportation Process after Processing Imported Fishery Products ············ 118
< Figure Ⅳ-1 > Supply Value Chain of Vietnamese Shrimp ·············································· 131 < Figure Ⅳ-2 > Map of Ca Mau Province in Vietnam ····················································· 137
vi ■ Acronyms ■
Acronym Meaning AAHS Aquatic Animal Health Service DAH Department of Animal Health D-Fish Directorate of Fisheries ELISA Enzyme-Linked Immuno-Sorbent Assay EU European Union EU RL European Union Reference Laboratory HACCP Hazard Analysis and Critical Control Points ISO International Organization for Standardization LC-MS/MS Liquid Chromatography-(Tandem) Mass Spectrometry MARD Ministry of Agriculture and Rural Development ML Maximum Level MRL Maximum Residue Limit
MRPL Minimum Required Performance Limit NAFIQAD National Agro-Forestry-Fisheries Quality Assurance Department NCVHI 1 National Center for Veterinary Hygiene Inspection No. 1 OIE World Organization for Animal Health RAHO6 Regional Animal Health Office No. 6 RASFF Rapid Alert System for Food and Feed VS Veterinary Services WSD White Spot Syndrome Virus TS Taura syndrome virus YHD Yellow head virus IMN Infectious Myonecrosis Virus IHHN Infectious Hypodermal and Hematopoietic Necrosis Virus AHPND Acute Hepatopancreatic Necrosis Disease (Vibrio parahaemolyticus-carrying virulence genes) LMD Lobster Milky Disease (Rickettsia-like) EHP HPM-EHP (Hepatopancreatic microsporidiosis caused by Enterocytozoon hepatopenaei)
vii 2019 K-V FTA Economic Cooperation Work Program Strengthening K-V Fishery Cooperation by Improving Viet Nam's Aquaculture Safety
Ⅰ.
Introduction
Ⅰ. Introduction
Ⅰ. Introduction
1. Research Purpose and Background
A. Purpose
Article 3, Clause 3 of the Implementation Arrangement for Economic Cooperation (hereinafter the “Agreement”)1) pursuant to Chapter 13 (Economic Cooperation) of the Free Trade Agreement between the Government of the Republic of Korea and the Government of the Socialist Republic of Vietnam (“Vietnam”) specifies that Korea and Vietnam will discuss and develop areas of mutual interest in the fisheries and aquaculture industry sectors and facilitate cooperation based on their mutual agreement. The areas of shared interest in the fisheries and aquaculture industry sectors are improvement of investment opportunities, satisfying the needs of investors, the exchange of information, and the exchange of views on matters relevant to regional and international fishery organizations. The Introduction specifies that both parties carry out economic cooperation activities under the Agreement in accordance with domestic laws and regulations, taking into account the different levels of development and capacity and making efforts to foster trade-driven economic growth. Over the long term, doing so will facilitate the joint entry of both parties into the global market by building supply chains between the two parties. The purpose of this project is to explore measures that might facilitate economic cooperation between the two countries and promote the economic growth of Vietnam by expanding bilateral trade through the improvement of the safety management system for Vietnamese aquaculture products (shrimp). To this end, we examine the issues that need to be addressed in order to improve the safety
1) Notification of the Ministry of Foreign Affairs (MOFA) of Korea, No. 2015-874, Legislated on December 23, 2015.
3 management system for Vietnamese aquaculture products, since this is the biggest obstacle to future trade between Korea and Vietnam. In November 2019, we held a seminar in Busan to attract investment to the Vietnamese fishery industry, improve the investment environment, and promote investment as prescribed in Article 5, Clause 2(d) of the Agreement. Six Vietnamese public officials in charge of fishery product safety management were invited to the seminar to learn about Korea’s experiences and receive information on safety management and developing capacity.
B. Background
Fishery production in Vietnam in 2017 totaled approximately 7.11 million tons, with aquaculture products accounting for around 54% (3.83 tons) of production, according to global fishery statistics from the Food and Agriculture Organization (FAO) of the United Nations. Vietnam was the fourth biggest aquaculture producer in the world. Its major aquaculture products include catfish (approximately 1.13 million tons), shrimp (approximately 940,000 tons), tilapia (approximately 240,000 tons), and carp (approximately 110,000 tons). Catfish is mostly farmed in the southern region of the Mekong River, shrimp in the central and southern regions, and tilapia in the northern region of the country. The most common marine shrimp species farmed in Vietnam are the native black tiger shrimp (Penaeus monodon) and the non-native whiteleg shrimp (Litopenaeus vannamei). For shrimp farmed in the southern regions, maturation takes about three months from stocking to harvesting, and up to 80% of the shrimp stock can be harvested three times a year, making shrimp the main species that is farmed and exported in Vietnam. According to the imported food statistics of Korea’s MFDS, in 2017, there were 70 cases of nonconforming imported fishery products, out of which nine (or 13%) were from Vietnam, which therefore ranked second after China in the number of nonconforming imported fishery products. In 2018, the total number of nonconforming fishery products was 95, out of which 13 (or 14%) were from Vietnam, again ranking it second (see Table I1). These statistics show the need for improvement in the safety management of Vietnamese aquaculture products for the purpose of revitalizing economic cooperation between Korea and Vietnam.
4 Ⅰ. Introduction
▏Table Ⅰ-1▕ Status of Nonconforming Fishery Products by Nation (2017, 2018)
Producer Number of Cases Weight (kg) Amount ($) Sum 70 607,781 2,099,369 China 25 255,093 738,684 2017 Vietnam 9 65,148 468,433 US 5 52,272 140,753 Others 31 235,269 751,500 Sum 95 947,208 5,611,264 China 36 514,357 3,920,129 Vietnam 13 108,040 785,033 2018 India 7 168,019 317,149 US 4 27,350 109,390 Indonesia 4 12,345 49,449 Others 31 117,097 430,113
Source: Yearbook of Imported Food Inspection, 2018, 2019.
Table Ⅰ-2 shows the number of nonconforming cases of Vietnamese fishery products imported to Korea between 2010 and 2019 that were found in safety inspections by Korea’s MFDS.
▏Table Ⅰ-2▕ Status of Nonconforming Fishery Products Imported from Vietnam (2010–2019) Unit: metric tons, 1,000$
Source: MFDS fishery statistics, available at https://impfood.mfds.go.kr/#!CFCAA01F040 (accessed February 2020).
6 Ⅰ. Introduction
Of the 328 imported fishery products, 52 (16%) were judged to be nonconforming more than once. Over the 11 years since 2010, the number of overall nonconforming cases reached 168 (0.26%) of the total. The weight of nonconforming products was 1020 tons (t) (0.18%) of total imports, 7.22 million US dollars (USD), or 0.2% of total imports. By item, frozen whiteleg shrimp (peeled) was judged the highest number of times to be nonconforming (19), followed by frozen, boiled whiteleg shrimp peeled (16), frozen black tiger shrimp (11), frozen catfish (10), and frozen poulp squid (9). The number of nonconforming cases for shrimp is overwhelmingly higher than other products; shrimp products ranked first to third on the list and took six places out of the 10 most frequently nonconforming items. This is partly because so many shrimp products are imported; however, at the same time, it illustrates the fact that the safety management system requires improvement. Frozen whiteleg shrimp peeled, with 12,888 cases imported, showed the highest level of nonconformity with 19 cases. The shrimp products were judged as nonconforming mostly because of the detection of prohibited veterinary drug substances or because the number of microorganisms exceeded the allowable standards.
2. Methods, Literature Review, and Organization
This study presents an assessment of the improvements that should be made to the safety management system for Vietnamese aquaculture products to expand economic cooperation between Korea and Vietnam in the fishery market. First, we examine the laws and regulatory framework for safety management of Vietnamese fishery products from farm to fork. We analyze the Vietnamese government’s safety management system, organization, and personnel. We investigate the health requirements for aquatic animals and veterinary drug management at the production stage, overall sanitary conditions during the processing and distribution stage, and distribution practices. This study focuses on the safety management of shrimp, which is exported to the global market and form the bulk of fishery products imported by Korea from Vietnam. The percentage of nonconforming Vietnamese shrimp products imported by Korea is higher than that of other fishery products from Vietnam.
7 A. Methods
This study presents a literature review (i.e., a desk study) on the safety management of fishery products. It then presents the results of a field study in Vietnam, the goals of which were as follows: to improve safety management status by means of counseling and seminars, to investigate the obstacles to exporting Vietnamese aquaculture products, to perform a value chain analysis of Vietnamese fishery products, and to conduct a survey among small-scale shrimp farmers to discern the directions for improving the safety management of Vietnamese aquaculture products. First, the literature review examines the related laws and regulations and reviews materials from relevant organizations in Korea, including the Prime Minister’s Office, the Ministry of Food and Drug Safety (hereinafter the MFDS), the Ministry of Oceans and Fisheries (MOF), Korea Maritime Institute, and the Board of Audit and Inspection. Reports on overseas business trips and training of MFDS and MOF officials in Vietnam are included. In addition, we examine the government organizations that oversee safety management in Vietnam and their safety control acts. The materials on Vietnamese aquaculture products’ diseases, published by the Food and Agriculture Organization of the United Nations (FAO) and the World Organization for Animal Health (OIE), as well as governmental institutions and private organizations in Vietnam are also analyzed. Second, we present the results of a field study. To investigate the safety management and control process in Vietnam, we visited government organizations including the Department of Animal Health (DAH) of the MARD, National Agro-Forestry-Fisheries Quality Assurance Department (NAFIQAD), Directorate of Fisheries (D-Fish), and shrimp farms and processing factories. The goal of the field study was to visit farms, hatcheries, and national research institutes in charge of environmental monitoring (RIA 1 and 3), distributors of feed and veterinary medicines, private companies diagnosing diseases, and national institutions. The purpose of the field study was to understand the status of aquatic animal disease management and safety management during the production stage and to examine the use and management of antibiotics, since these are frequently detected during safety inspections of major Vietnamese aquaculture importers. We also visited processing factories to investigate the safety management of microorganisms, which are often detected by Korea’s MFDS safety inspections and lead to fishery products being classified as nonconforming. Because domestically distributed fishery products
8 Ⅰ. Introduction
in Vietnam can often be a blind spot for safety management, we explored the distribution process to determine if sample collection and inspection were being properly conducted. During the field study, the following issues were investigated: the Vietnamese government’s plans and standards for the safety management of fishery products; safety inspections during the production stage; sample collection and inspection during the distribution stage; pre-export verification of imported fishery products; the management of safety management blind spots (whether infected aquaculture products were domestically distributed for food purposes or were mixed with the fishery products for export); and the management of aquatic animal drug safety, including the prescription of veterinary medications. At the same time, we conducted in-depth interviews with public officials, aquaculture producers and distributors, and veterinary medicine dealers. We also hired external experts who have studied for many years the conditions of stakeholders in shrimp farming and diseases and had conducted research on the use of veterinary drugs on small-scale farms. In this study, we hired a Japanese researcher, an expert on the safety of Vietnamese farmed shrimp, to identify the usage patterns of veterinary drugs on small-scale farms.2) This expert visited small shrimp farms in Ca Mau Province to conduct surveys in 2015, 2017, and 2019. A simple random sampling method was used to avoid selection bias. The population of this sample is 1,546 whiteleg shrimp farms in County A, Ca Mau Province, and the sample size is 147 or 9.51% of the population. Among the surveys that the expert conducted, this study focuses on the analysis of the current state of veterinary drug use. Third, we created reports and held validation workshops. During this stage, the value chain of Vietnamese shrimp farms was analyzed. The analysis focused on government institutions, among other operators, influencers, and supporters because such supporters, including financial institutions, research institutes, and associations are indirectly associated with safety management. We then can reflect in our reports the expert opinions obtained in these counseling and validation workshops. Finally, we report on the research results and make suggestions on how to enhance economic cooperation between Korea and Vietnam through the improvement of fishery safety management.
2) Lee, Guenwoo, Aya Suzuki, and Vu Hoang Nam(2019a), "The determinants of detecting veterinary drug residues: Evidence from shrimp farmers in southern Vietnam." Aquaculture Economics & Management 23, no. 2 PP. 135-157.
9 B. Literature Review
Jung Myung-hwa et al. (2018) analyzed the Vietnamese government’s plans for the major developed nations to enter the Vietnamese fishery market to formulate practical cooperative measures with Korea’s fishery industry. To facilitate the entrance of Korean companies into the Vietnamese fishery market, the authors suggest the strategic use of development cooperation projects. Jung Myung-hwa et al. (2018) analyzed all aspects of Vietnamese fisheries and the measures required for Korean companies to enter this market; however, in this study, the safety management of Vietnamese aquaculture products and the expansion of bilateral trade are considered to be prerequisites to entrance. In regard to the value chain of Vietnamese aquaculture products, we refer to research on Vietnamese fisheries conducted by the European Parliament.3) European nations have previously conducted a range of studies, including value chain analysis, to enhance the competitiveness of Vietnamese fishery products.4) The statistics on imported food in Korea that are used in this study are taken from Korea’s food safety portal5) and Yearbook of Imported Food Inspection. Statistical data on quarantine are from the Import Quarantine Statistics compiled by the National Fishery Products Quality Management Service.6) The 2018 Audit Report on the Safety and Quality Management of Fisheries Products was published by the Board of Audit and Inspection of Korea, which provides detailed explanations of the current status, problems, and improvement measures for the safety management of the country’s fishery products. In creating the MFDS and MOF officials’ business trip reports on food safety in Vietnam, the authors refer to information available on the public website.7) In addition to Vietnamese government materials, related laws, and data collected in the field study, we also used data from food safety portals in the United States (US) and the European Union (EU) (EU RASFF),8) along with the results of safety
3) Priit Ojamaa (2018), Research for PECH Committee - Fisheries in Vietnam, Policy Department for Structural and Cohesion Policies, European Parliament. 4) See also, Nguyen Thi Le Hoa (2020), Sustainable and Equitable Shrimp Production and Value Chain Development in Vietnam (SUSV), Oxfam and ICAFIS, EU SWITCH Asia Programme. 5) https://www.foodsafetykorea.go.kr/main.do 6) https://www.nfqs.go.kr/ 7) https://btis.mpm.go.kr. 8) RASFF portal https://ec.europa.eu/food/safety/rasff_en
10 Ⅰ. Introduction
inspections of Vietnamese fishery products conducted by the US and the EU. For reference, we use EU data (2017) on residual chemicals and contaminants in Vietnamese aquaculture products and the results of the evaluation of the veterinary medicine management systems. In addition, a number of papers related generally to Vietnamese fisheries, the value chain of Vietnamese fishery products, diseases in Vietnamese shrimp, and the use of veterinary drugs are used as references.
C. Organization of this Report
This report comprises this chapter and four additional chapters. Chapter 2 describes Korea’s safety management system for fishery products. In Chapter 3, the Korean safety management system is used as a reference point for understanding the current status of Vietnamese aquaculture products and identifying problems therein. Korea’s safety management system for fishery products has achieved its current status by means of continuous improvement. Chapter 4 examines the safety management process of the Vietnamese aquaculture products throughout the value chain, namely, from production, collection, processing, to export. Finally, Chapter 5 describes the key findings of this study along with corresponding policy suggestions. We also suggest a priority roadmap for the most important policies that should be implemented.
11 2019 K-V FTA Economic Cooperation Work Program Strengthening K-V Fishery Cooperation by Improving Viet Nam's Aquaculture Safety
Ⅱ.
Safety Management of Farmed Fishery Products in Korea
Ⅱ. Safety Management of Farmed Fishery Products in Korea Ⅱ
Ⅱ. Safety Management of Farmed Fishery Products in Korea
1. Korea’s Safety Management of Imported Fishery Products
A. Korea’s Safety Management of Fishery Products Departments and Legislation
Food safety management and control, including that of seafood and fishery products, is overseen by the Committee for Food Safety Policy chaired by the Prime Minister under the Framework Act on Food Safety. The heads of the central administrative agencies must submit safety control plans on the food products that they oversee to the Prime Minister every five years. The Prime Minister then deliberates, integrates, and formulates these plans and re-submits them to the heads of the relevant central administrative agencies.
15 ▏Figure Ⅱ-1▕ Korea’s Departments for the Safety Management of Fishery Products
Committee for Food Safety Policy
Ministry of Food and Drug Safety Ministry of Oceans and Fisheries Local Governments (MFDS) (MOF)
Local branches of the National Fishery Products Quality Si/do Management Service (NFQS) and Food and Drug Administration National Institute of Fisheries (Si, gun, and gu (FDA) Science (NIFS) administrative districts)
- Oversight of fishery product safety - Safety control at the ∙ Establishment of basic plans for production phase ∙ fishery product safety control NFQS Safety checkups on ∙ Criteria and standards for the marine farms - Fishery product safety control safety of food ∙ Quality management, in the relevant jurisdiction - Safety control of the supply such as certifications - Fishery products control process at the production and ∙ Collection and testing of fishery distribution stage products at the distribution stage - Ex-post management of - Safety control of imported marine noncompliant fishery products products - Management of ∙ Disposal, delayed ∙ Local safety control in the NIFS shellfish-producing consignments, and returns exporting country marine areas ∙ Safety inspection at customs ∙ Collection and testing at the distribution stage
Under the Food Sanitation Act, the MFDS oversees the safety control of food, including legislating and revising criteria and standards, and provides for the safety control of fishery product distribution. The MFDS enforces the safety control of imported fishery products under the Special Act on Imported Food Safety Control. The head of MFDS must establish and implement safety control plans for the production and distribution of fishery products every year.9) Governors of si/do administrative districts, mayors, gun governors, and heads of gu districts must establish and implement detailed action plans to secure the safety of the agricultural and fishery products that are produced and distributed in their jurisdictions.10) The safety control and detailed action plans must include safety inspection plans, risk assessments of harmful substance residues, the education of farmers and fishermen, and other matters prescribed by the Ordinance of the Prime Minister.
9) Article 60, Section 1 of the Agricultural and Fisheries Products Quality Control Act. 10) Article 60, Section 2 of the same law.
16 Ⅱ. Safety Management of Farmed Fishery Products in Korea
▏Table Ⅱ-1▕ Related Laws on the Safety Management of Fishery Products
Agency Laws under Tasks Related to Fishery Product Safety Jurisdiction ∙ Establishment of basic plans for food safety management ∙ Emergency responses to foods that are likely to pose major public hazards, such as prohibition of production or sale Framework Act on ∙ Evaluation of food hazards based on scientific evidence Food Safety ∙ Plans and implementation for the safety control of new food products ∙ Introduction and implementation of intensive control systems to prevent food hazards ∙ Provide information on food safety policies ∙ Standards and specifications for food and food additives ∙ Food hazard evaluations ∙ Emergency responses to foods that are likely to pose health Ministry of Food Sanitation Act hazards Food ∙ Presentation of intensive systems for food hazard management and Drug and safety evaluation of hazard levels Safety ∙ Administrative measures such as the tracking and management (MFDS) of food history and the cancellation of permits ∙ Establishment and implementation of safety control plans for fishery products Agricultural and ∙ Fishery Products Safety control for fishery products at the production stage (Rules Quality Control Act on the Safety Control, etc.) of Agricultural and Fishery Products (Ordinance of the Prime Minister) and operation of fishery product safety evaluations ∙ Pre-import management (registration of foreign manufacturing sites) Special Act on ∙ Import English administration (operation and registration) Imported Food ∙ Customs management (import declaration) Safety Controls ∙ Distribution-stage management (tracking of distribution history of imported products, etc.) ∙ Establishment of standard specifications for fishery products Agricultural and ∙ Establishment of geographical indications and establishment and Fishery Products implementation of a comprehensive plan for sanitation management Quality Control Act ∙ Inspections of quality, specifications, ingredients, and harmful residues in fishery products Ministry of ∙ Establishment and implementation of disease management plans Oceans and for aquatic life Fisheries ∙ Conducting epidemiological investigations when aquatic disease (MOF) occurs or is suspected of occurring Aquatic Life ∙ Disease Control Act Testing and drug administration for farming facilities for fishery products ∙ Isolation and movement restrictions on aquatic life ∙ Testing for infectious diseases in discharged aquatic life ∙ Analysis of risk from imports Source: Korea Institute of Public Administration, (2018) “Organizational Diagnosis to Support National Collaborative Projects: Study on Fishery Products Safety Management System Improvement” (reconstructed from the Board of Audit and Inspection, Audit Report on Fishery Product Safety and Quality Management Inspections, p. 10).
17 B. Quarantine of Aquatic Animals and the Safety Management of Fishery Products
1) Epidemic prevention and management of aquatic life
There is no definition of epidemic prevention in the Aquatic Life Disease Control Act. The definition of preventing epidemics in aquatic life refers to the prevention of the occurrence and outbreak of infectious diseases in aquatic life. In Korea, the prevention of epidemic infectious aquatic diseases is carried out by the Department of Fishing Villages and Farming Policy under the MOF and the Department of Aquatic Epidemic Prevention by NIFS. The MOF establishes policies for preventing aquatic epidemics and NIFS engages in epidemiological investigation and disease identification. Disease identification refers to pathological diagnostic activities conducted to discover the cause of a contagious disease through autopsy or other biochemical testing of aquatic organisms in situations where reasonable grounds exist to suspect that said organism is infected with a contagious disease. Epidemiological investigation comprises the activities performed to prevent outbreaks and the spread of a contagious aquatic organism disease. An investigation takes place when a contagious aquatic organism disease has broken out or is likely to break out and may involve interventions such as determining the scale of the outbreak, tracing the source of the disease, and discovering the cause of allergic reactions that may appear after vaccination. Key policies and systems under the Aquatic Life Disease Control Act include instituting aquatic disease control plans, establishing national aquatic organism disease control information systems, employing aquatic organism disease control officers and controllers, identifying disease in aquatic organisms, and epidemiological investigations. To prevent outbreaks and the spread of aquatic organism diseases, the Minister of Ministry of Oceans and Fisheries is required to establish and implement measures for the control of aquatic organism diseases every five years. These measures include the establishment of a reporting system for prevention and early detection, the establishment and implementation of emergency measures, cooperation with related agencies, education and public relations activities, collection and analysis of information, nurturing of professional human resources, and other matters related to necessary measures.
18 Ⅱ. Safety Management of Farmed Fishery Products in Korea
If deemed necessary, an aquatic organism disease control officer in charge of the prevention of aquatic organism diseases (disease inspector or veterinarian) and an aquatic organism disease controller (supporting worker), may enter a place in which aquatic organisms are gathered, such as aquaculture facilities and facilities for gathering aquatic organisms. They may inspect aquatic organisms or other products or collect necessary samples with as little interference as possible, free of charge, to ensure whether an aquatic organism disease has broken out. When an aquatic organism disease control officer conducts an inspection or collects samples for the prevention of an aquatic organism disease, a person cannot refuse, interfere with, or evade such inspection or collection without justifiable grounds. As a result of an epidemiological investigation or a close examination, or in view of clinical symptoms, upon the determination that an aquatic organism has died of an unidentified disease, or if an organism is discovered or believed to have been infected with a contagious aquatic disease, the aquaculture business entity and aquatic organism disease inspector who found such an organism must report it to the heads of the si, gun, and/or gu. Those who do not report dead or diseased aquatic organisms can be punished by imprisonment with labor for a year or by a fine of up to 10 million won. A person who has filed a report or the head of a si, gun, or gu who has received a report may request that the head of a state agency that conducts the control of aquatic organism diseases or the head of an institution specializing in the disease identification of aquatic organism diseases conduct the disease identification of the aquatic organism in question. The Minister of Oceans and Fisheries needs to conduct an epidemiological investigation without delay if they discover that a contagious aquatic organism disease specified by ordinance of the MOF has broken out or is likely to break out. The head of a si, gun, and/or gu may order an aquaculture business entity to isolate, or refrain from transporting, aquatic organisms if deemed necessary for preventing the spread of a contagious aquatic organism disease. This could be because an aquaculture facility is in the proximity of another aquaculture facility where it is has been found or believed, as a result of an epidemiological investigation or close examination or in view of clinical symptoms, that aquatic organisms are infected with a contagious aquatic organism disease that causes mass mortality and is within the area to which the contagious aquatic organism disease is likely to spread. If deemed necessary for preventing the spread of a contagious aquatic organism disease, because it is found or believed, as a result of an epidemiological investigation
19 or close examination or in view of clinical symptoms, that aquatic organisms in an aquaculture facility are infected with a contagious aquatic organism disease, then the head of a si, gun, and/or gu shall order the relevant aquaculture business entity to cull such aquatic organisms. Any person who fails to comply with a culling order can be punished by imprisonment with labor for not more than three years or by a fine not exceeding 30 million won. An aquaculture business entity that culls aquatic organisms because it was found or believed, as a result of an epidemiological investigation or close examination or in view of clinical symptoms, that aquatic organisms were infected with a contagious aquatic organism disease must incinerate or bury such organisms without delay, overseen by a disease control officer.
▏Table Ⅱ-2▕ Reporting and Punishments for Aquatic Life Diseases
Violation Punishment Imprisonment with labor for a year or a fine of Failure to report a dead or diseased aquatic organism up to 10 million won Refusal to participate in, interference with, and/or A fine not exceeding three million won evasion of epidemiological investigations Failure to follow an order for isolating or Imprisonment with labor for a year or a fine of refraining from transporting aquatic organisms up to 10 million won Imprisonment with labor for three years or a fine Failure to follow a culling order of up to 30 million won Failure to incinerate or bury aquatic organisms Imprisonment with labor for a year or a fine of with aquatic organism diseases up to 10 million won
Source: Regulations on Punishment in Aquatic Life Disease Act.
The state or local government can cover all or part of the cost of culling, incinerating, or burying diseased aquatic organisms.
2) Safety control of fishery products
The Agricultural and Fishery Products Quality Control Act’s Fishery Product Safety Assessment Guidelines, which is an MFDS publication, do not define safety control. However, fishery product safety control refers to engaging in safety assessments through the collection and analysis of specimens for the presence of harmful substances, to assess if they comply with the safety standards set for fishery
20 Ⅱ. Safety Management of Farmed Fishery Products in Korea
products. If they are found to be noncompliant, then delaying the consignment or disposal of such products can be undertaken.11) The Fishery Product Safety Assessment refers to the process of investigating for safety controls compliance during the production phase. This includes investigation for excess amounts of harmful residues, etc., as defined by relevant legislation such as the Food Sanitation Act, food storage and consignment prior to transactions, the maintenance of fishery farms and water sources, and materials used in fishery product production. Such investigation is conducted by the head of MFDS or si/do governors.12) The safety standards for the production stage refer to Article 7 of the Food Sanitation Act regarding the standards and specifications for food and food additives. Safety standards for fishery products after their production, storage, and shipment and prior to the transaction are governed by the Food Sanitation Act.13) The safety management and quality control of production-stage fishery products is managed by the Minister of Oceans and Fisheries, as entrusted by the Minister of Food and Drug Safety (entrusted to the MOF under Article 18, Section 5 of the Commission and Delegation of Administrative Powers). The National Fishery Products Quality Management Service (NFQS), under the MOF, is engaged in production-stage safety control. NIFS oversees the management of shellfish production areas. Local governments test and engage in follow-up measures for fishery products produced and distributed within their jurisdictions. The MOF (headquarters of the NFQS and 14 local branches) and local governments (departments in charge of production) collect and conduct safety tests for fishery products in the production, storage, and pre-transaction stage from fish farms and storage facilities. The MFDS and its six local branches and local governments (i.e., the departments in charge of sanitation) collect samples of fishery products in distribution from wholesale markets, food production and processing facilities, and retail shops, and engage in sample testing and delivering appropriate measures in response corresponding to the results. The specific safety control responsibilities for each institution are listed in Table Ⅱ-3.
11) The Fishery Product Safety Assessment Guidelines (2019-85), Article 2, Section 3 utilizes the term “safety investigation” instead of “safety control”, containing both the safety assessment and follow-up measures. 12) Article 61, Section 1 of the same law. 13) Fishery Product Safety Assessment Guidelines, Article 4.
21 ▏Table Ⅱ-3▕ Various Responsibilities of Korea’s Fishery Safety Management Organizations
Ministry of Food and Local Branches of Ministry of Oceans and Si/Do (Si/gun/gu) Drug Safety (MFDS) the MFDS Fisheries (MOF) General oversight of Safety control of Safety control of fishery Safety control of local fishery fishery product safety distribution of fishery products products in a local jurisdiction control products according to risk information Establish safety control Establish and implement Establish plans for safety plans safety control plans for control of fishery products Plan investigations and Safety investigation of fish fishery products produced General oversight of collection inspections farms and materials used and distributed in a specific direction, collection, and Direct testing of fishery in fishery products and local jurisdiction testing related to fishery products, producers, and their production Investigate and implement products sellers Investigate the causes measures for fishery product General oversight of all Emergency responses to behind noncompliant safety control tasks related to risk incidents related to fishery products in Collect fishery products for assessments of fishery fishery products distribution and safety investigation and result product production control measures for those under Collaborate with related environments distribution agencies and provide Designate, cancel, and General oversight and risk support for investigations manage safety control Provide guidance to and assessment of harmful and testing testing institutions perform inspections of residues in fishery Direct and educate producers, distributors, products and harmful producers (groups) and and sellers substances in fish farms, the general public Implement prohibitive waters, and materials measures regulating utilized in their production Collaborate with related agencies and provide distribution to prevent Educate and promote support for testing the sale of poor-quality personnel related to fishery products production and distribution Educate and promote of fishery products fishery product safety Coordinate and provide Collaborate with related general oversight of agencies and provide cooperation between support for investigations departments and and product testing organizations
Source: MFDS, Food Safety Control Guidelines, 2019, p. 499.
Safety control measures target production-stage fishery items with annual consumption rates of 500 tons or more. This includes surface ocean farmed fish (e.g., halibut and 22 other products), inland waters farmed fish (e.g., eel and 10 other products), deep-sea fishery products (e.g., sharks and 12 other products), littoral sea fish in pre-transaction, commissioned, or joint markets (e.g., mackerel and 33 other products), and non-edible fishery products (e.g., scallop shells and
22 Ⅱ. Safety Management of Farmed Fishery Products in Korea
one other product), totaling 78 products. Crustaceans, such as the whiteleg shrimp, which belong to the surface ocean farmed fish group, are subject to safety control during the production stage.
▏Table Ⅱ-4▕ Product Items Subject to Safety Inspection in Korea
Investigation Phase Type of Fish Product Type and Items (78 items) Fish (7): Platichthys stellatus, Acanthopagrus schlegelii, Paralichthys olivaceus, Lateolabrax japonicus, Mugil cephalus, Sebastes schlegelii, Pagrus major Surface ocean Shellfish (6): Crassostrea gigas, Ruditapes philippinarum, Nordotis farmed fish discus discus, Scapharca subcrenata, Mytilus edulis (22) Linne, Megacardita ferruginea koreana Production Crustaceans (1): Litopenaeus vannamei phase Tunicate (3): Halocynthia roretzi, Styela clava, Styela plicata Algae (5): seaweed, kelp, seaweed, hijikia, green algae Fish (9): Channa argus, Pseudobagrus fulvidraco, Eutropiichthys vacha, Inland waters Misgurnus mizolepis, Anguilla japonica, Carassius auratus, farmed fish (10) Oncorhynchus masou masou, Cyprinus carpio Shellfish (1): Corbicula fluminea Fish (11): Cololabis saira, Tuna (Katsuwonus pelamis, Thunnus obesus, Thunnus albacares, etc.) Theragra chalcogramma, croaker Deep-sea Storage phase caught (12) species, sharks (Sphyrna zygaena, Isurus oxyrinchus, Prionace glauca, Carcharhinus melanopterus, Alopias pelagicus) Mollusks (1) : Squids Fish (14): Halibut, Trichiurus lepturus, Scomber japonicus, Gadus macrocephalus, Engraulis japonicus, Seriola quinqueradiata, Conger myriaster, Scomberomorus niphonius, Lophiomus setigerus, Branchiostegus japonicus, Konosirus punctatus, Trachurus japonicus, Larimichthys polyactis, Clupea Surface ocean pallasii caught Shellfish (4): Saxidomus purpuratus, Mytilus coruscus (wild), conches Pre-transaction (littoral sea) and gastropods, Atrina pectinate stage (33) Mollusks (7): Sepia esculenta, Octopus minor, Enteroctopus dofleini, squid species, Octopus ocellatus, baby octopus species, Loligo bleekeri Crustaceans (4) : Chionoecetes opilio, Charybdis japonica, Chionoecetes japonicus, Portunus trituberculatus Algae (4): kelp, seaweed, hijikia, green algae Non-Food (1) Scallop shells Common between assessment Fish products requiring safety control due to their extraction from institutions potentially polluted waters or due to other potentially hazardous factors. Source: Ministry of Oceans and Fisheries (reconstructed from Board of Audit and Inspection).
23 The NFQS and other assessment institutions conduct tests according to the established standards and specifications for food products, to evaluate the presence of heavy metals (e.g., mercury and four other metals), animal-grade medicine residues (e.g., oxytetracycline and 55 others), microorganisms (e.g., E. coli and six others), toxins (e.g., paralytic shellfish poisons and three others), radioactive materials (e.g., iodine and two others), materials that should not be found in food (e.g., malachite green and 18 others), melamine, and other chemicals.
▏Table Ⅱ-5▕ Product Items Subject to Hazardous Chemical Inspection
Substance Investigation Items Heavy metals (4) Mercury, lead, cadmium, and methyl mercury Vibrio parahaemolyticus, Staphylococcus aureus, Salmonella, and Food poisoning bacteria (4) Listeria monocytogenes Animal-grade drug residues (55) Oxytetracyclines and others Microorganisms (2) E. coli, bacteria count Toxins (3) Paralytic, diarrhea, shellfish poison, and globefish poison Radioactivity (2) Iodine, cesium Prohibited substances (18) Malachite green, chloramphenicol, nitrofuran metabolites, and agents Melamine, praziquantel, bithionol, dehydrocholic acid, isoeugenols, Other Materials (14) and others
Source: MFDS Food Safety Control Guidelines, 2019, p. 528.
Local governments and Food and Drug Administration (FDA) branches selected methyl mercury (heavy metals) and amoxicillin (animal medicine) as key indicators of management for 21 fishery product items, such as sharks and flounders, at the distribution stage of fishery products. If these are found at noncompliant levels in the collection inspection, the data are input and disclosed in the noncompliance emergency notification system, and the products are immediately subject to recalls and disposal. Simultaneously, the NFQS is notified to conduct a safety investigation of the fish farm in violation.
24 Ⅱ. Safety Management of Farmed Fishery Products in Korea
▏Table Ⅱ-6▕ Priority Control Target Fishery Products During the Distribution Stage
Category Products Items Heavy metals (methyl mercury, lead, total mercury, Shark, flounder, eel, Pangasius, muddy loaches, sea cadmium), animal medicine (quinolone and nine Domestic bass, rockfish, trout, starry flounder, snakeheads, other similar types, sulfa drugs, amoxicillin, (21 products, mystus, carp, red seabreams, Mytilus edulis Linne, trimethoprim, ampicillin, oxytetracycline), malachite 26 items) oysters, halibut, common carp, seaweed, octopi, green, chloramphenicol, nitrofuran metabolite, yellowtail, and shrimp. paralytic shellfish poisons, saccharin sodium, and harmful bacteria (bacteria count, E. coli).
The NFQS and local governments conducted of a total of 39,803 production-stage product investigations between 2015 and 2017 and issued orders, such as shipment delays, for 367 cases of noncompliance (0.9%). Regional FDA branches and local governments conducted of a total of 39,387 distribution-stage product investigations and issued orders, such as recalls and disposals, for 148 noncompliant cases (0.4%).
▏Table Ⅱ-7▕ Results of Fishery Product Safety Inspections
Production Phase (Safety Investigation) Distribution Stage (Collection Inspection) Category Number of Number of Total noncompliant cases (%) Total noncompliant cases (%) Total 39,803 367 (0.9) 39,387 148 (0.4)
2015 12,759 157 (1.2) 13,056 50 (0.4)
2016 13,268 89 (0.7) 14,295 32 (0.2)
2017 13,776 121 (0.9) 12,036 66 (0.5)
Source: Yearbook of Imported Food Inspection, data from the MOF and the MFDS (reconstructed from the Board of Audit and Inspection).
C. Safety Management of Imported Fishery Products
The safety control of imported fishery products is overseen by the MFDS in Korea. Safety control policies, including the testing of imported foods, are carried out by the Imported Food Safety Policy Bureau of the MFDS. The Imported Food Policy Department oversees imported food policies (i.e., regulations and systems) and international cooperation (WTO/SPS). The Imported Food Distribution Safety Department oversees the management of customs-cleared imported fishery products,
25 collects overseas information on testing—which includes the planning, control, and management of random sampling plans for imported products—and operates the import/export examination information system. Local due diligence departments are engaged in a variety of activities such as research and evaluating the sanitary conditions of manufacturers and processors in exporting countries. They are also responsible for the registration and management of high-quality foreign manufacturers, high-quality importers, foreign manufacturers, and foreign business facilities. They investigate why imported foods might be determined to be noncompliant and conduct on-site overseas research. Under the Special Act on Imported Food Safety Control, external parties are commissioned to oversee some of the on-site due diligence of foreign manufacturers. The due diligence of on-site manufacturers under the notification of sanitation and safety management of fishery products is carried out by local due diligence departments.
▏Figure Ⅱ-2▕ Fishery Product Safety Management Organization of the MFDS
Imported Food Safety Policy Bureau, Ministry of Food and Drug Safety (MFDS)
Imported Food Imported Food Import Inspection Local Due Diligence Distribution Safety Management Policy Department Department Department Departments
The Special Act on Imported Food Safety Control (the “Act”)14) and the subordinate legislation constitute the basic regulations governing imported fishery products. The Act was enacted in 2015 and was put into force in 2016. It secures the safety of imported foods by supervising all steps prior to importation, strengthening the safety controls over import operations, and constructing a mutually connected system of customs and commercial distribution. In addition to the Act, there are other pieces of legislation that govern food safety, such as the Food Sanitation Act and the Act on Testing and Inspection in the Food
14) Law No. 13201, ‘15.2.3 Enacted, ’16.2.4. Enforcement.
26 Ⅱ. Safety Management of Farmed Fishery Products in Korea
and Drug Industry. The notices from the government that outline detailed guidelines for managing imported food safety include the Regulations on the Inspection of Imported Food and the Regulations on the Inspection of Imported Fishery Products. For the safety control of fishery products in Vietnam, key pieces of legislation include the agreement on fishery products sanitation, food safety management, and the quarantine between the NFQS, the MOF, the Republic of Korea and the National Agro-Forestry-Fisheries Quality Assurance Department, the Ministry of Agriculture and Rural Development, and the Socialist Republic of Vietnam.
▏Table Ⅱ-8▕ Current Legislation and Notifications Related to Imported Fishery Products
Category Title ∙ Special Act on Imported Food Safety ∙ Customs Act Control ∙ Inter-Korean Exchange and Cooperation ∙ Food Sanitation Act Act ∙ Health Functional Foods Act ∙ Civil Petitions Treatment Act ∙ Act on Testing and Inspection in the ∙ Agricultural and Fishery Products Quality Food and Drug Industry Control Act ∙ Foreign Trade Act ∙ Special Act on Safety Management of Regulations Children’s Dietary Lifestyle
∙ Agreement on fishery product sanitation, food safety management and quarantines between the National Fishery Products Quality Management Service, Ministry of Oceans and Fisheries, the Republic of Korea, and the National Agro-Forestry-Fisheries Quality Assurance Department, Ministry of Agriculture and Rural Development, and the Socialist Republic of Vietnam
∙ Regulations on the inspection of imported food, etc. ∙ Regulations on the inspection of imported fishery products ∙ Regulations on food under testing orders and other imported food ∙ Regulations on the designation and management of business training and training Notices institutions for imported foods ∙ Methods and standards for on-site due diligence of foreign manufacturers
Notification of fishery product sanitation, food safety management, and quarantines between Korea and Vietnam
Source: 2018 Yearbook of Imported Food Inspection.
The Special Act on Imported Food Safety Control mandates the registration of foreign manufacturers prior to importation. A person who intends to import food (or other items) into the Republic of Korea or a person who establishes and operates
27 a foreign food facility must register the matters prescribed by the Ordinance of the Prime Minister. This includes the name, location, and items manufactured by the foreign food facility concerned with the Minister of Food and Drug Safety before filing an import declaration.15) Foreign manufacturers must file a registration online or by mail seven days prior to filing an import declaration. The registration period is two years and any changes must also be registered. If any registration or registration of changes is conducted in an illegal manner, the registration is automatically canceled. If the registered foreign manufacturer fails to comply with data requests or completes a data request in an illegal manner, the import declaration is rejected. As of September 2019, there were 832 registered Vietnamese manufacturers.
▏Table Ⅱ-9▕ Registered Foreign Manufacturers
Category Details Importer or establisher/operator of a foreign food facility (importers, etc.) completes Registration a registration form and files it via mail or online at least seven days prior to an import declaration
Changes Application for changing registered information
Application for renewal of registration must be filed seven days prior to the expiration Renewal of the initial two-year registration
Cancellation of Any registration or application for registration changes completed in an illegal registration manner is canceled
Refusal of import declaration Data submission rejected or completed in an illegal manner
Source: 2018 Yearbook of Imported Food Inspection.
The sanitary criteria for the registration of overseas foreign aquatic farm manufacturers are classified as facilities/general sanitation, drug sanitation, and shipment sanitation.
15) Article 5, Section 1, Special Act on Imported Food Safety Control.
28 Ⅱ. Safety Management of Farmed Fishery Products in Korea
▏Table Ⅱ-10▕ Sanitary Requirements for Foreign Manufacturers (Farms)
A. Facilities/General Sanitation 1) The location of the fish farm shall be at a distance from the wastewater of livestock, chemicals, and other pollutant-producing facilities so that it does not negatively impact the farming of fishery products. 2) Chemical substances that may be toxic or flammable must be stored and managed in a location separate from fish farms. 3) Toilets must be kept separate from breeding areas and must be equipped with sanitary and hand-washing facilities. 4) Invasion by pests and rodents must be prevented in the storage of foodstuffs. Fodder manufacturing (mixing) rooms must be maintained in a clean manner so that deposits of water do not accumulate on the floor. 5) Dead or diseased fish must be promptly selected, stored in a designated storage, or disposed of, and the business must have dedicated tools for this purpose. 6) Breeding water tanks must have tank numbers, feeding dates, water capacity, and tank sizes marked upon them. 7) Regular sanitary checks must be completed for each breeding water tank and the records must be recorded and stored. 8) Surfaces that may come into contact with farmed fish must be kept clean. 9) The water used for fish farming must be of a quality that is suitable for the protection of human health and regular test results from national or otherwise certified institutions must be maintained and stored. B. Drug Sanitation 1) A drug storage unit sufficient for animal medicine for marine use and other non-medicines for marine use must be installed and locked when not in use. 2) Details regarding the purchase and usage of all stored drugs must be recorded. Drugs must be labeled with usage information and expiration dates for storage and management. 3) Drug usage details must be recorded, kept, and managed for each breeding water tank. 4) Drugs used in fish farming must also be approved for domestic use. The use of drugs, etc., must be completed with the appropriate measuring tools in compliance with usage and dosage and adhere to drug holiday periods and expiration dates. C. Shipment Sanitation 1) Production and shipment volumes must be recorded and kept for each breeding water tank and shipped products must be tested for animal medicine residue on a regular basis and records must be stored. 2) Prior to shipment, drug holiday periods must be confirmed, and the details must be recorded and stored.
Source: MFDS Notification No. 2017–81 (October 31, 2017). Appendix 1 Sanitary standards for overseas manufacturers and overseas workplaces.
29 There are 11 sanitary standards for foreign manufacturers that cover the environment, manufacturing sites, raw ingredients, and manufacturing and processing sanitation. Detailed standards are presented under each of the overall sanitary standards. Sanitation on the manufacturing site includes 17 detailed standards. The Special Act on Imported Food Safety Control heightened the on-site due diligence of foreign manufacturers. Field due diligence was originally mandated only for processed foods, but it was expanded to all imported foods, including health supplements. The Minister of Food and Drug Safety may conduct an on-site inspection of a foreign food facility through prior consultation with the government of an exporting country or the foreign food facility where the Minister of Food and Drug Safety deems that an on-site inspection is necessary to prevent any hazards in imported food, etc., and in cases that the Minister deems it necessary to confirm facts regarding the safety information about imported food and other items that are collected at home and abroad. If the government of an exporting country or a foreign food facility refuses, interferes with, or evades an on-site inspection (including non-responses without reasonable grounds), or a hazard is likely to occur in imported food, etc., as a result of the on-site inspection, the Minister of Food and Drug Safety may request the facility to comply with a priority correction order. The Minister may take measures to ensure non-recurrence or to suspend the importation of imported food, etc., of the foreign food facility concerned if such orders are not followed. If the government of an exporting country, a foreign food facility, a business entity that has imported food, etc., identify any cause of a problem in imported food, etc., the importation of which has been suspended and suggests improvements, or if such imported food is deemed non-hazardous, the Minister of Food and Drug Safety may revoke the importation suspension. The Minister of Food and Drug Safety shall require a relevant public official or inspection officer, or an inspection agency, to conduct necessary inspections before customs clearance formalities for imported food, etc., are completed. The tests include document, field, laboratory and random sampling tests.16) There are no declarations or tests required for imported foods for individual consumption. This includes imported foods used by the national and local
16) Enforcement Rule of the Special Act on Imported Food Safety Control [Appendix 9] Testing methods for foods, etc.
30 Ⅱ. Safety Management of Farmed Fishery Products in Korea governments, carried as personal belongings by travelers, or sent through international mail or post (excluding cases in which food was imported by a business entity registered as Internet purchase agents for imported foods, etc.). The Minister of Food and Drug Safety may conduct differential inspections by classifying entities according to the inspection results of imported food, etc., violation history, and domestic and international food safety information, etc., for the safety and quality control of imported food, etc. The following are the criteria for imported foods, etc., to determine the targets and the number of laboratory tests. Imported Class 2 foods with issues identified under domestic and international food safety information products for which laboratory tests are deemed necessary by the Minister of Food and Drug Safety, are subject to testing by the Minister of Food and Drug Safety with the number of times and testing periods separately set. Foods imported by entities that have received administrative dispositions and are undergoing repeals belong to Class 3 in Table II-11. Ten tests are conducted for each import declaration for each product.
▏Table Ⅱ-11▕ Classifications of Imported Foods
Category Details ∙ Imported foods that have been imported for the first time or that were subject to a first-time import laboratory test, but later, subject to new or strengthened regulations and standards (for livestock, this includes feed for manufacturing own products). Class 1 ∙ Imported food, etc., returned from a foreign country (excluded if subject to document review). ∙ Imported food, etc., for which the head of the local FDA requires a laboratory test as a result of a field test.
∙ Imported foods for which laboratory tests are deemed necessary by the Minister of Food and Drug Safety, with issues identified under domestic and international food safety information. Class 2 ∙ Foods deemed noncompliant from laboratory tests, random sample tests, or sample inspections, and then re-submitted for imports for the same importer and the same imported food product.
∙ Food imported by specially managed importers. ∙ Imported food manufactured or exported within two years of a noncompliance order from a foreign manufacturer of imported products contaminated with Class 3 hazardous substances, as determined and notified by the Minister of Food and Drug Safety (exporters for agricultural, forest, and fishery products; foreign businesses for livestock).
31 Category Details ∙ Food (excluding agricultural, forest, and fishery products) or food additives: Food with the same manufacturing country, place of manufacture, product name, manufacturing method, or raw ingredients that underwent laboratory testing at the time of first import and was re-imported within five years. However, wine is regarded to be the same product even though the year of manufacture, age, and alcohol content might differ. ∙ Agricultural, forest, and fishery products: Food with the same manufacturing country, item name, exporter, and packaging location (except fishery products) that underwent laboratory testing at the time of first import and were re-imported within five years. ∙ Containers and packaging: Products with the same manufacturing country, place Same importer, of manufacture, material, and color that underwent laboratory testing at the time same imported of first import and were re-imported within five years. food item ∙ Health supplements: Products with the same manufacturing country, place of manufacture, product name, manufacturing method, ingredients, and composition of active ingredients (principal ingredients that make the product functional) that underwent laboratory testing at the time of first import and were re-imported within five years. ∙ Livestock: In case of meat for consumption, raw milk, and eggs for consumption: Same manufacturing country, item type, and place of business (manufacturing and processing that underwent laboratory testing at the time of first import and were re-imported within five years); for other livestock, the same manufacturing country, place of business (manufacturing and processing), item name, processing method, and principal ingredient name that underwent laboratory testing at the time of first import and was re-imported within five years.
If a problem occurs with imported food (excluding imported beef and pork), the Minister of Food and Drug Safety might require business entities to register traceability by prescribing imported food, etc., that is subject to traceability if deemed necessary to manage imported food, etc., and so that such imported product might be tracked, the cause of such problem identified, and necessary measures taken.
32 Ⅱ. Safety Management of Farmed Fishery Products in Korea
Document test Field test Laboratory test Random sampling test
Field test (specimen collection)
Targets for Prior to Sample test field test laboratory test, (by MFDS or food delivery of import sanitation testing agency) declaration confirmation
Decision on compliance
Compliant Noncompliant
Issuance of certificate of completion for food import Notification of non-compliance declaration
Return, disposal, and switching to Customs clearance non-food use
Domestic distribution
Follow-up management on domestic distribution
17) 2019 Yearbook of Imported Food Inspection
33 The following figure illustrates Korea’s food inspection procedures. Imported foods are subject to document reviews, field tests, laboratory tests, and random sampling tests. The document review comprises inspections to judge the compliance of a product by reviewing the submitted documents, which are checked by the MFDS. The field test consists of testing through the five senses and the product’s import declarations. The product is deemed compliant or noncompliant by means of random sample testing by the MFDS or food sanitation testing agencies. If a product is found to be noncompliant, the importer and the head of the customs office are notified, and it is subject to return, disposal, or a switch to non-food use. Once the imported food is deemed to be compliant, it is subject to follow-up management as it goes through the domestic distribution process.
D. SPS Agreement for Fishery Products
The Agreement on Fishery Products Sanitation, Food Safety Management, and Quarantine between, on the one hand, the NFQS, the MOF, and the Republic of Korea, and, on the other hand, the National Agro-Forestry-Fisheries Quality Assurance Department, the Ministry of Agriculture and Rural Development, and the Socialist Republic of Vietnam was signed on December 9, 2016. The purpose of the agreement was to strengthen cooperation between Korea and Vietnam on the sanitation and food safety of fishery products and processed fishery products and to ensure food safety and disease management in live fishery products. The agreement, hereafter known as the “Korea–Vietnam Seafood Safety Management Notification,” was enacted in 2017. According to Article 4 of the Korea–Vietnam Seafood Safety Management Notification, Korea and Vietnam will cooperate on the sanitation and food safety of the products exported to each country; ensure food safety management and disease prevention in live fishery products; exchange information on the enactment and enforcement of laws, enforcement rules, and related legislation on sanitation, food safety, and disease prevention in live fishery products; guarantee travel between the two countries to facilitate the evaluation of sanitation and food safety for entities registered in each respective country, product inspections, the quarantine of live fishery products, and the confirmation of data on testing and quarantine methods; and host workshops, seminars, and conferences to facilitate collaboration between the two countries.
34 Ⅱ. Safety Management of Farmed Fishery Products in Korea
The Korea–Vietnam Seafood Safety Management Notification mandates the testing and quarantine of export/import products and live fishery products depending on the conditions of the importing country. The testing, quarantine, and issuance of certificates of sanitation and quarantine for export/import products are handled by the NFQS in Korea and the National Agro-Forestry-Fisheries Quality Assurance Department in Vietnam. Article 9 of the Korea–Vietnam Seafood Safety Management Notification states that when issues of sanitation or safety occur in imported products or live fishery products, the importing country must provide information on causes of the issues investigated to prevent recurrence of similar incidents in the exporting country’s products and live fishery products. The importing country is able to cease imports until the registered importer facility completely resolves any production, processing, product packaging, and live fishery product issues. The Korea–Vietnam Seafood Safety Management Notification classifies noncompliance into general and major factors, setting forth five noncompliance elements for each type of factor. Specific items of noncompliance for testing of fishery products are as follows. The general factors (Class 1) are biotoxins, antibiotics, microorganisms, other toxic substance residues, and foreign matter. Major factors (Class 2) include internationally prohibited materials, antibiotics, microorganisms, other toxic substance residues, and foreign matter. The foreign matter for Class 1 is non-artificial metallic matter and, for Class 2, artificial injection of metallic material and other foreign matter.
▏Table Ⅱ-12▕ Nonconforming Items in K-V Fishery Product Inspection Safety Management Category Noncompliant Element Details Biotoxins Paralytic shellfish poisons, globefish poison Oxytetracyclines, Oxolinic acid, Spimamycin, Antibiotics Eno/ciprofloxacin, sulfamethazine, Flumequine, etc. Class 1 Bacteria counts, E. coli groups, Staphylococcus Microorganisms (General Factors) aureus, Vibrio parahaemolyticus, Listeria Sulfur dioxide, radioactive substances, tar pigments, Other toxic substance residue heavy metals (mercury, lead, cadmium) Foreign matter Foreign metallic substances (non-artificial) Internationally prohibited Chloramphenicol, Nitrofuran, malachite green, etc. substances Antibiotics Ofloxacin, Norfloxacin, Pefloxacin Class 2 Microorganisms Salmonella, cholera (Major Factors) Other toxic substances Carbon monoxide Metallic and other substances (artificial), Foreign matter forced water injection Source: Korea–Vietnam Seafood Safety Management Notification.
35 If noncompliance is found in general factors (Class 1) and major factors (Class 2), the noncompliant item is temporarily suspended from imports. The registered exporter then researches the causes of noncompliance and implements a plan for the improvement and supplementation of safety controls. After researching the cause of noncompliance and monitoring the plan, improvement and supplementation of safety controls is carried out by the registered export facility. The exporting country is then able to inform the importing country of the subsequent actions and request the retraction of the cease-import order after one month in the case of general factors of noncompliance and after three months for major factors. The importing country then reviews the retraction request from the exporting country and retracts the cease-import order. The difference between the subsequent actions following general and major factors is that general factors are only subject to one month of management whereas major factors are subject to three months. The authorities of the importing country are able to cease importing from the said registered facility if the products or live fishery product therefrom are found to be noncompliant. Once the importing country accepts the inspections and results of subsequent actions undertaken by the exporting country, the cease-import order is retracted. When necessary, Korea and Vietnam may hold working-level meetings regarding sanitation and product safety control, as well as on testing and quarantine of live fishery products. The working-level meetings cover standards for inspections and quarantine, certification formats for sanitation and quarantines, processing methods for noncompliant products and live fishery products for importing countries, and points of interest on the products and live fishery product sanitation and food safety, including the prevention of diseases in live fishery products.
E. Quarantine of Imported Aquatic Animals
The law that oversees the quarantine of imported fishery products is the Aquatic Life Disease Control Act.18) The NFQS is responsible for the quarantine of imported fishery products. Aquatic animals for consumption that are likely to spread pathogens of a contagious aquatic organism disease are designated for quarantine. Aquatic organism diseases that relate to crustaceans include yellow head disease,
18) Law No. 16209.
36 Ⅱ. Safety Management of Farmed Fishery Products in Korea
white spot disease, infectious subcutaneous and hematopietic necrosis, infectious myonecrosis, and white tail disease.19) Aquatic animals infected with pathogens of the aquatic organism diseases cannot be imported.20) A person who intends to import a product designated for a quarantine purpose shall submit a quarantine certificate issued by a governmental agency of the exporting country to certify that the product is free from the likelihood of spreading the pathogens of a contagious aquatic organism disease.21) A person who intends to import a product designated for a quarantine purpose shall submit an application, without delay, to the head of an agency for the quarantine of aquatic organisms to apply for a quarantine inspection and shall undergo the quarantine inspection conducted by an aquatic organism quarantine officer (import quarantine).22) An aquatic organism quarantine officer can find that a product subject to quarantine inspection does not meet the sanitary conditions if it is found or believed to be contaminated by the pathogens of a contagious aquatic organism disease, found or believed to contain a toxic or hazardous substance, found to have become stale or spoiled and therefore likely to cause a hazard to public health, or believed to cause a hazard to public health because of adulteration by or addition of other substance or other cause. While conducting a quarantine inspection, quarantine officers can order the consignee to return, incinerate, bury, or dispose of it wholly or partially.23) If an imported product designated for a quarantine purpose is prohibited from being imported, not accompanied by a quarantine certificate, or where importing a product designated for a quarantine purpose is likely to cause a serious hazard to the domestic control of contagious aquatic organism diseases, a competent aquatic organism quarantine officer may order its consignee to return it. If it is deemed that returning it will hinder the control of a contagious aquatic organism disease or that it is impractical to return it, its consignee may be ordered to incinerate, bury, or dispose of it by the method determined and announced by the Minister of Oceans and Fisheries as safe for the purpose of disease control.24)
19) Article 2, Section 6, Aquatic Life Disease Control Act; Article 2, Section 2, Enforcement Rule of the same Act. 20) Article 24 of the same law. 21) Article 26, section 1 of the above law. 22) Article 27, section 1 of the above law. 23) Article 34, section 1 of the above law. 24) Article 25, section 1 of the above law.
37 2. Korea–Vietnam Fishery Trade and Safety Issues
A. Status of Korea–Vietnam Fishery Trade
Korea has increased its food imports year upon year. According to the MFDS, the major food exporters to Korea have been fixed in order since 2014 as the US, China, Australia, and Vietnam, and trade volumes continue to increase. Considering the size of Vietnam’s economy, it is conceivable that Vietnam’s food exports to Korea are very important to the country.
▏Table Ⅱ-13▕ Status of Korea’s Food Imports (Units: millions of USD) Rank 2013 2014 2015 2016 2017 US 4,433 US 5,125 US 5,218 US 4,862 US 5,433 1 (20.6%) (22.2%) (22.4%) (20.7%) (21.8%) China 3,931 China 4,072 China 4,030 China 4,104 China 4,196 2 (18.2%) (17.6%) (17.3%) (17.5%) (16.8%) Australia 2,013 Australia 2,163 Australia 2,244 Australia 2,933 Australia 2,552 3 (9.3%) (9.4%) (9.6%) (12.5%) (10.2%)
Source: 2018 Yearbook of Imported Food Inspection.
The number of fishery products inspections has increased year upon year in Korea, with 82,081 cases in 2015; 87,783 cases in 2016; 95,769 cases in 2017; and 99,920 cases in 2018. Prior to 2017, the numbers of inspections from the largest to smallest were as follows: field tests, laboratory tests, document reviews, and random sampling tests. In 2018, there were more document reviews than field tests because of streamlining import procedures, and the number of random sampling tests dropped.
38 Ⅱ. Safety Management of Farmed Fishery Products in Korea
▏Table Ⅱ-14▕ Status of Imported Fishery Product Inspections (2015–2018) (Units: number of cases)
Source: 2019 Yearbook of Imported Food Inspection.
A large portion of Vietnamese exports to Korea are fishery products. From 2010 to 2019, Korea imported 328 different fishery products from Vietnam, almost all with HS codes. The majority of imported items comprises frozen baby octopuses, frozen shrimp peeled, frozen whole shrimp, frozen octopuses, frozen cuttlefish, salted shrimp, dried sardinella, dried squid, frozen tritons, frozen catfish, and frozen stingrays. The import item with the highest monetary volume among Vietnamese fishery products is frozen whiteleg shrimp peeled, followed by frozen baby octopuses, dried spear squids, frozen cooked whiteleg shrimp, and frozen octopuses. The top 20 imported Vietnamese fishery products are all shrimp products, except for baby octopus, dried spear squids, octopus, cuttlefish, sardinella, catfish, and stingrays. Shrimp is the highest volume imported food item from Vietnam. Frozen shrimp imports range from 6,000 to 8,000 tons. There is a limited volume of exports of processed and fresh/chilled shrimp. Korea imports large volumes of frozen shrimp (56%), but it also imports fresh/chilled shrimp (19%), and processed shrimp (25%). Shrimp imported from Vietnam includes frozen shrimp, salted shrimp, dried shrimp, live shrimp, and refrigerated shrimp. Imported frozen shrimp constitutes a variety of shrimp species, including whiteleg shrimp, green tiger prawn, Argentine red shrimp, pink shrimp, white shrimp, Kuruma shrimp, spear lobster, freshwater prawn, giant river prawn, Alaskan pink shrimp, and Japanese fan lobsters. Shrimp products include shrimp peeled, shrimp peeled packaged for sashimi, cooked shrimp peeled for sashimi, cooked shrimp peeled, and cooked shrimp. There are some 30 different frozen shrimp products imported from Vietnam. From 2010 to 2019, non-frozen shrimp from Vietnam included 1,227 tons of salted shrimp (shrimp for jeotgal). Other types included refrigerated shrimp peeled, dried shrimp, live shrimp, and salted shrimp, in limited volumes.
39 ▏Table Ⅱ-15▕ Status of Imported Fishery Products from Vietnam (2010–2019)
▏Table Ⅱ-16▕ Status of Frozen Shrimp Imported from Vietnam (2010–2019) Total Import Total Import Total Import Value Product Cases Weight (in tons) (in thousands of USD) Frozen shrimp (whiteleg shrimp) 13,547 125,218.5 1,111,279.14 Frozen shrimp (whiteleg shrimp, cooked) 4,310 31,543.26 258,572.85 Frozen shrimp (green tiger prawn) 2,003 14,246.68 168,821.61 Frozen shrimp (whiteleg shrimp) 2,212 19,526.98 153,326.59 Frozen shrimp 2,055 8,795.33 140,997.77 (whiteleg shrimp, cooked, packaged for sashimi) Frozen shrimp (green tiger prawn) 1,456 8,886.38 91,394.56 Frozen shrimp peeled 805 10,590.39 61,987.21 Source: MFDS, Statistics on Fish Products, retrieved February 2020 from https://impfood.mfds.go.kr/#!CFCAA01F040.
40 Ⅱ. Safety Management of Farmed Fishery Products in Korea
B. Vietnamese Fishery Product Safety Issues
1) Identified safety noncompliance in Vietnamese fishery products
According to MFDS data, the number of identified noncompliant cases of Vietnamese fishery products was 203 in 2013, representing 0.3%; decreasing to 87 cases (0.11%) in 2015; 64 cases (0.07%) in 2016; and 70 cases (0.07%) in 2017. These cases increased slightly to 95 (0.10%) in 2018. Korea enacted the Special Act on Imported Food Safety Control in 2015, which came into effect in 2016. While Korea’s food imports are on the rise, the strengthening of safety inspections and management by the Korean government has led to lower numbers of noncompliant cases.
▏Table Ⅱ-17▕ Status of Noncompliant Imported Fishery Products
Number of Weight Amount Year Cases Percentage (in kg) Percentage ( in USD) Percentage 2013 203 0.30 1,751,363 0.19 7,985,044 0.27 2014 122 0.16 1,246,227 0.12 5,695,088 0.16 2015 87 0.11 986,725 0.09 2,783,682 0.08 2016 64 0.07 510,696 0.05 3,074,696 0.08 2017 70 0.07 607,781 0.06 2,099,369 0.05 2018 95 0.10 947,000 0.08 5,611,000 0.12
Source: 2019 Yearbook of Imported Food Inspection.
The yearly counts of noncompliant imported fishery products continuously decreased, but it then increased slightly in 2018. There were 141 cases of noncompliance in 2013; 51 in 2014; 47 in 2015; 31 in 2016; 26 in 2017; and 28 in 2018. In particular, there were significant decreases in 2016 and 2017, when the Special Act on Imported Food Safety Control came into effect, as compared to 2013–2015. These statistics appear to be due to higher overall levels of safety management in Korea and Vietnam.
▏Table Ⅱ-18▕ Number of Noncompliant Items of Imported Fishery Products by Year
Source: 2019 Yearbook of Imported Food Inspection.
In 2017, there were 26 cases of noncompliant fishery products imported from Vietnam, including four cases of nitrofuran metabolites, four cases of listeria, three
41 cases of bacteria count, three cases of total mercury, and three cases of ofloxacin. For shrimp products, there were two cases of nitrofuran metabolites and two cases of bacteria count.
▏Table Ⅱ-19▕ Number of Noncompliant Items of Imported Fishery Products, 2017
Item Number of Cases Detected Substance Frozen shrimp (whiteleg shrimp) 1 Frozen shrimp (whiteleg shrimp) 1 Nitrofuranic metabolites Golden clams (live) 2 Frozen swordfish (swordfish, F, sashimi) 4 Listeria Frozen octopus (cooked, S, packaged for sashimi) 1 Frozen shrimp peeled 1 (whiteleg shrimp, cooked, packaged for sashimi) High bacteria count Frozen shrimp peeled 1 (whiteleg shrimp, packaged for sashimi) Frozen shark (pelagic thresher shark, F) 1 Total mercury Live eel (salad eel) 2 Frozen carp (roundtailed paradise fish) 1 Ofloxacin Live muddy loach 1 Live catfish 2 Enrofloxacin/ciprofloxacin Frozen turban shell meat (triton, cooked) 1 Cadmium Frozen marlin (swordfish) 1 Frozen globefish (purple puffer) 1 Globefish poison Frozen octopus (cooked, S, packaged for sashimi) 1 E. coli Frozen shrimp (whiteleg shrimp) 1 Norfloxacin Frozen cod (southern hake, neck meat) 1 E. coli Live catfish 1 Malachite green Live muddy loach 1 Pefloxacin Total 26 Source: 2018 Yearbook of Imported Food Inspection.
In 2018 there were 28 cases of noncompliance found in Vietnam-sourced fishery products, with six cases of nitrofuranic metabolites, 11 of salmonella, three of bacteria count, and eight of other antibiotics. All six cases of nitrofuranic metabolites and three bacteria counts were shrimp-related, and norfloxacin was found in frozen whiteleg shrimp (cooked).
42 Ⅱ. Safety Management of Farmed Fishery Products in Korea
In 2018, there are 95 noncompliant cases in 42 items. By item, frozen octopus had the most cases at 21. This was followed by seven cases of frozen globefish, four of frozen tuna, four of marlin, and four of frozen fish eggs. In terms of shrimp, there were three cases of frozen red shrimp peeled and three of whiteleg shrimp peeled.
▏Table Ⅱ-20▕ Number of Noncompliant Items of Imported Fishery Products, 2018
Item Number of Cases Detected Substance Frozen whiteleg shrimp for sushi (peeled, kuruma prawn) 1 Frozen shrimp peeled (whiteleg shrimp, cooked) 1 Frozen cocktail shrimp 1 (frozen whiteleg shrimp cooked, peeled, with tail) Nitrofuran agents Frozen cocktail shrimp 1 and metabolites (frozen whiteleg shrimp peeled/cooked, peeled, with tail) Frozen whiteleg shrimp peeled (no head, peeled, with tail) 1 Frozen whiteleg shrimp peeled 1 (peeled, intestines removed, with tail) Frozen tuna head (small), for sashimi 1 Frozen bluefin tuna head, for sashimi 1 Frozen bluefin tuna cheeks, for sashimi 1 Frozen bluefin tuna cheeks, for sashimi 1 Frozen bluefin tuna cheeks, for sashimi 1 Salmonella Frozen bluefin tuna chin, for sashimi 1 Frozen bluefin tuna chin (small), for sashimi 1 Frozen tuna (bluefin tuna, F, for sashimi) 2 Frozen tuna (bluefin tuna, head, for sashimi) 2 Frozen whiteleg shrimp peeled 1 (cooked, for sushi, packaged for sashimi) Bacteria count Frozen octopus (cooked, S, packaged for sashimi) 1 Frozen whiteleg shrimp (cooked, packaged for sashimi) 1 Frozen red tilapia 1 Enrofloxacin/ciproflox Frozen large yellow croaker 1 acin Live eel (Japanese eel) 2 Isoeugenol Live eel (Japanese eel) 1 Methylene blue Frozen snakeheads 1 Ofloxacin Frozen filefish fillet 1 Dehydrocolic acid Frozen whiteleg shrimp - cooked 1 Norfloxacin Total 28
Source: MFDS, 2019 Yearbook of Imported Food Inspection.
43 According to the Korea–Vietnam Seafood Safety Management Notification, nitrofuran found in imported shrimp from Vietnam is an internationally prohibited substance and is classified as Class 2: Major Factors. Bacteria count is classified as Class 1: General Factors. Of the total 27,922 cases of frozen shrimp exported from Vietnam in the 11 years since 2010, the number of noncompliant cases is very low at 79 (0.28%). Of the total import dollar volume and weight, noncompliant shrimp represented only 0.18% and 0.22%, respectively, very small percentages. There was a total of 160 noncompliant cases of Vietnamese frozen fishery product imports, and among them, 79 cases (49%) were for frozen shrimp. There were 12 shrimp items found to be noncompliant: three frozen shrimp products (whiteleg shrimp, green tiger prawn, and cooked whiteleg shrimp), and nine frozen shrimp peeled products.
▏Table Ⅱ-21▕ Status of Noncompliant Vietnamese Frozen Shrimp Products (2010–2019) Total Import Noncompliant Total Imports Total Import Noncompliant Noncompliant Item Number of Total Weight Amount Number of Total Weight Amount (in thousands (in thousands Cases (in tons) USD) Cases (in tons) of USD) Frozen shrimp 13,547 125,219 1,111,279 19 131 1,172 (whiteleg shrimp) Frozen shrimp 4,310 31,543 258,573 8 47 328 (whiteleg shrimp, cooked) Frozen shrimp 2,003 14,247 168,822 11 77 888 (green tiger prawn) Frozen shrimp 2,212 19,527 153,327 3 34 662 (whiteleg shrimp) Frozen shrimp 2,055 8,795 140,998 16 65 929 (whiteleg shrimp, cooked) Frozen shrimp meant 1,456 8,886 91,395 3 5 55 (green tiger prawn) Frozen shrimp peeled 805 10,590 61,987 3 17 85 Frozen shrimp (whiteleg shrimp, 1,288 4,714 55,357 7 23 299 packaged for sashimi) Frozen shrimp (green tiger prawn, 821 2,206 27,754 7 23 260 packaged for sashimi) Salted-preserved shrimp 1,227 31,998 24,401 2 38 28 (for jeotgal) Total 29,724 257,725 2,093,891 79 460 4,706 Noncompliance rate 0.27% 0.18% 0.22%
Source: MFDS, Statistics on Fish Products https://impfood.mfds.go.kr/#!CFCAA01F040 (visited February 2020).
44 Ⅱ. Safety Management of Farmed Fishery Products in Korea
2) Noncompliance with Vietnamese fishery products in the US, the EU, and Japan
The following figure shows total Vietnamese shrimp exports and the number of rejected cases of Vietnamese shrimp due to the detection of antibiotics in the US. In 2014, the US imported 73,000 tons of Vietnamese shrimp, which was 1.7 times its average annual import volume of 42,000 tons between 2004 and 2012. With an increase in imports, the number of rejections also increased significantly in 2014. In 2014, the US rejected 47 cases, which was 5.7 times the average annual number of rejections, seven, occurring between 2004 and 2012. While the number of rejections declined to 37 in 2015 and to nine in 2016, these are still higher than the 2004–2012 average. As such, the US strengthened food safety regulations for Vietnamese shrimp in 2018. This regulation appears to have had a negative impact on US imports of Vietnamese shrimp.25)
▏Figure Ⅱ-4▕ US Imports of Vietnamese Shrimp and Number of Rejections (2004–2016)26)
25) Chin, S. (2018) “Vietnam’s shrimp exports at risk”, The Asean Post, 8 October. Retrieved from https://theaseanpost.com/article/vietnams-shrimp-exports-risk. 26) The volume of Vietnam's shrimp export is calculated based on NOAA data, and the refusals of shrimp entry lines for veterinary drug residues is calculated based on FDA data.
45 Due to its stringent food safety regulations, the EU has the highest food safety standards in the world.27) A core instrument that guarantees the flow of information, enabling a quick response to any public health risk factors in the food product value chain, is the Rapid Alert System for Food and Feed (RASFF). The RASFF promotes effective information sharing between EU member states (food safety authorities and committees in the member states, the EFSA, the ESA, Norway, Liechtenstein, Iceland, and Switzerland), and enables efficient group alerts and responses, 24 hours per day. The RASFF has prevented numerous food safety risks to European consumers. The RASFF portal also has an online database that allows for conversation-style searches and provides open access to the most recent RASFF notifications and information regarding previous notifications. There have been 104 notifications related to Vietnamese crustacean imports over the past 10 years on the RASFF (2010–2019).28) There were 27 cases in 2014, 17 cases in 2015, and 19 cases in 2016. Of these, 23 notifications were determined to be serious, 50 not serious, and 31 were deferred decisions. Among these cases, 38 were rejected at the border.
▏Table Ⅱ-22▕ RASFF Notifications for Vietnamese Fishery Products (2010–2019)
Border Rejection Alert Information for Information for Total Attention Follow-Up 38 6 41 19 104 Source: EU RASFF portal located at https://ec.europa.eu/food/safety/rasff_en.
A 12-year period (2004–2016) was analyzed with regard to imports and rejected imports, in line with statistics from Japan and the US. This yielded no significant differences in the 119 total cases of Vietnamese shellfish notifications. The RASFF indicates that Vietnamese shellfish was found with residue levels above the MRL for veterinary medicinal products and animal medicines such as oxytetracycline, doxycycline, and tetracycline, as well as internationally prohibited substances such as chloramphenicol, nitrofuran, and bacteria—salmonella and vibrio, in particular.
▏Table Ⅱ-23▕ RASFF Detection Items in Noncompliant Vietnamese Fishery Products
Oxytetracycline Salmonella Vibrio Doxicycline Tetracycline Chloramphenicol Nitrofuran 24 20 11 6 5 5 5 Source: EU RASFF portal located at https://ec.europa.eu/food/safety/rasff_en.
27) EU RASFF portal https://ec.europa.eu/food/safety/rasff_en (last visited February 18, 2020). 28) Ibid. https://webgate.ec.europa.eu/rasff-window/portal/?event=searchResultList
46 Ⅱ. Safety Management of Farmed Fishery Products in Korea
The RASFF indicates that there continue to be cases of animal medicines, prohibited substances, and bacteria that threaten human health and safety in Vietnamese fishery products. EU imports of Vietnamese shrimp constantly increased from 2004 to 2011. While imports dropped in 2012, they began to rise in 2013. In 2016, the EU imported the same volume of Vietnamese shrimp—57,000 tons—as in 2011. The number of rejections of Vietnamese shrimp in the EU increased rapidly in 2014 to 26 cases. The number of rejections decreased sharply in 2015 to seven cases; however, this represents an increase equivalent to 3.5 times the number of yearly average rejections between 2004 and 2013 of two cases each year. The EU strengthened food safety regulations for Vietnamese shrimp in 2018, which appears to have had a negative impact on EU imports of Vietnamese shrimp.29)
▏Figure Ⅱ-5▕ EU Imports of Vietnamese Shrimp and Number of Rejections (2004–2016)30)
29) Chin, S. (2018). 30) The volume of Vietnam's shrimp export is calculated on Eurostar data, and the refusals of shrimp entry lines due to veterinary drugs are calculated based on EU RASFF data.
47 The US and the EU strengthened their food safety regulations for imported foods in 2018.31) Japan strengthened its inspections for antibiotic residue in Vietnamese shrimp in 2006.32) Japan’s imports of Vietnamese shrimp have continued to decline since these inspections were strengthened.33) In 2004, Japan imported about 56,000 tons of Vietnamese shrimp, which was greater than both the US (38,000 tons) and the EU (13,000 tons). However, Japan’s imports of Vietnamese shrimp began to decline in 2005. In 2016, Japan imported 30,000 tons of shrimp from Vietnam, half of that of the US (63,000 tons) and the EU (57,000 tons). The decline in Vietnamese shrimp imports by Japan was, to some degree, impacted by the overall lower demand of a decreasing population; however, it appears to have also been influenced by the inspections of all Vietnamese shrimp imports that started on October 25, 2006. In addition, there has been negative press coverage regarding the detection of bacteria in Vietnamese shrimp.34)
▏Figure Ⅱ-6▕ Japanese Imports of Vietnamese Shrimps and Number of Rejections (2004–2016)35)
31) Chin, S. (2018). 32) Suzuki, A., & Vu, H. (2016). Food quality awareness: Cases from shrimp producers in Thailand and vegetable producers in Vietnam. IDE Discussion Paper, No. 569. 33) Lee, Guenwoo, Aya Suzuki, and Vu Hoang Nam. "The determinants of detecting veterinary drug residues: Evidence from shrimp farmers in southern Viet Nam." Aquaculture Economics & Management 23, no. 2 (2019a): 135-157. 34) Lee et al. (2019a). 35) The volume of Vietnam's shrimp export is calculated based on MAFF data, and the refusals of shrimp entry lines for veterinary drug residues is calculated based on MHLW data.
48 Ⅱ. Safety Management of Farmed Fishery Products in Korea
During the past decade, the production and export volumes of farmed shrimp in Vietnam have rapidly increased. However, the shrimp export industry has been hindered by the overuse of antibiotics on shrimp farms and in processing facilities to combat an increase in shrimp disease.
C. Quarantine of Vietnamese Fishery Products and Status of Noncompliant Items
The following table shows a total of 982 quarantines of Vietnamese fishery products between 2008 and 2019 in Korea. Quarantines of these products focused on live fish and frozen shrimp imports. The fish type with the highest number of quarantines was the salad eel. This was followed by live freshwater tropical fish, crustaceans, shellfish, and crabs. Quarantine of frozen fishery products focused on shrimp—frozen whiteleg shrimp, frozen green tiger prawn, and frozen giant river prawn. The quarantines of frozen whiteleg shrimp and green tiger prawn are more significant in terms of their weights and the volume of imports compared with other types of fish. Particularly, the quarantine of Vietnamese shrimp was likely to increase after a 2019 KBS(Korean Broadcasting System) network broadcast of a program about the quarantine of imported Vietnamese shrimp.
▏Table Ⅱ-24▕ Quarantine Status of Vietnamese Fishery Products
Total Inspection Volume Name Number of Cases Weight (in kg) Amount (in USD) Eptatretus burgeri (live) 351 549,422 4,693,873 Ornamental fish (live, tropical fish, freshwater) 225 3,560 524,552 Frozen whiteleg shrimp 212 2,250,253 16,519,175 Ornamental fish (live, tropical fish, seawater) 48 120 25,941 Ornamental shellfish 26 651 17,015 (bivalve molluscan shellfish, seawater) Frozen tiger prawn 23 201,839 2,630,047 Live eel (middle seeds) 23 5,581 955,894 Ornamental crustaceans (shrimp, freshwater) 18 27 6,876 Giant river prawn (Live, baby prawn) 8 2,367 28,976 Frozen giant river prawn 5 14,483 131,637 Koi (Live) 5 7 2,016
49 Total Inspection Volume Name Number of Cases Weight Amount (in kg) (in USD) Giant river prawn (Live) 5 732 9,185 Ornamental crustaceans (crabs, seawater) 4 13 243 Giant mud crab (live) 4 1,315 15,968 Spotted grouper (live) 3 426 6,142 Frozen shrimp (Acetes indicus)2 115 24 Frozen Argentinean red shrimp 2 40,036 465,601 Frozen tiger prawn 2 4,914 13,986 Ornamental shellfish (gastropods, seawater) 2 3 253 Brown marbled grouper (live) 2 250 6,800 Frozen barley shrimp 1 11 11 Hippocampus kuda (live) 1 7 2,205 Tridacna crocea (live) 1 1 150 Tridacna maxima (live) 1 1 266 Ornamental crustaceans (live, crabs, freshwater) 1 1 21 Japanese spiny lobster (live) 1 10 384 Asian swamp eel (live) 1 150 150 Salad eel (live, Eptatretus stoutii) 1 240 2,280 Glass eel (live) 1 43 295,550 Giant prawn (live) 1 120 1,260 Longtooth grouper (live) 1 104 1,440 Green tiger prawn (live, middle seeds) 1 200 2,200 Total 982 3,077,002 26,360,121
Source: Data derived from the NFQS Import Quarantine Statistics, available at www.nfqs.go.kr/2013/contents.asp? m=5&s=8&s2=3#.
All Vietnamese fishery products that were determined to be noncompliant were shrimp: four types of frozen shrimp, whiteleg shrimp, tiger prawn, Acetes indicus, and barley shrimp and two live types, giant prawn and giant river prawn. The number of imports and noncompliant cases was the highest for whiteleg shrimp. White spot disease (WSD), native to Vietnamese shrimp, detected at the customs stage was the cause of all noncompliant cases.
50 Ⅱ. Safety Management of Farmed Fishery Products in Korea
▏Table Ⅱ-25▕ Status of Noncompliant Vietnamese Fishery Products in Quarantine (2008–2019)
Total Inspection Volume Noncompliant Name Number of Weight Amount Number of Weight Amount Cases (in kg) (in USD) Cases (in kg) (in USD) Frozen whiteleg shrimp 212 2,250,253 16,519,175 15 173,169 1,298,039 Frozen tiger prawn 23 201,839 2,630,047 6 62,220 836,380 Giant river prawn 8 2,367 28,976 2 8 3,061 (live, baby prawn) Giant river prawn (live) 5 732 9,185 2 325 4,400 Frozen shrimp 2 115 24 2 115 24 (Acetes indicus) Frozen barley shrimp 1 11 11 1 11 11 Giant prawn (live) 1 120 1,260 1 120 1,260 Total 252 2,455,436 19,188,678 29 235,967 2,143,175
Source: NFQS Statistics on Import Inspection, available at www.nfqs.go.kr/2013/contents.asp?m=5&s=8&s2=3#.
51 2019 K-V FTA Economic Cooperation Work Program Strengthening K-V Fishery Cooperation by Improving Viet Nam's Aquaculture Safety
Ⅲ.
Safety Management of Aquaculture Products in Vietnamese Aquatic Products
Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
1. Status of Vietnamese Aquaculture and Disease Control
A. Production and Export of Fishery Products
Vietnam is a tropical country with one million hectares (ha) of inland water surface and 3,260 kilometers (km) of coastline, which is demarcated into one million square meters (m2) of exclusive economic zones. These features make it a country with one of the largest areas available for aquaculture in the world. In 2019, Vietnam produced 8.2 million tons of seafood, a 5.5% increase from 2018. Of this amount, 3.8 million tons were derived from fishing. Farmed seafood production in Vietnam has rapidly increased over the last 10 years, reaching 4.4 million tons as of 2019. The Mekong River Delta supplied between 1.7 and 2.4 million tons, or between 68% and 71%, of total production; farming in this brackish water zone represents 70% of the total seafood farming area in Vietnam. A wide variety of seafood is farmed in the Mekong Delta region, including catfish, shrimp, freshwater shrimp, shellfish, ocean-based seafood, and indigenous freshwater fish. Vietnam’s main aquaculture species are catfish (pangasius), shrimp, and tilapia. Farming of bivalves and ocean-based species such as kovia, perch, and starfish is also increasing. Freshwater eel is also farmed, but this cannot be done on a large scale due to glass eel supply issues.
55 ▏Table Ⅲ-1▕ Production of Marine Products in Vietnam (2019) (Units: thousands of tons) All Seafood Fish Shrimp Change Change Change Output (Compared Output (Compared Output (Compared with 2018) with 2018) with 2018) Aquaculture 4,432.5 6.5% 3,080.4 5.8% 877.2 +8.4% Capture 3,768.3 4.5% 2,844.9 4.6% 157.6 - 1% Total 8,200.8 5.6% 5,925.3 5.2% 1,034.8 +6.8%
Source: General Statistics Office of Vietnam (2020).
According to Table III-1, shrimp production in Vietnam was 1.3 million tons in 2019. Shrimp production from fishing ships was 157,000 tons, and farmed shrimp production was 877,000 tons. Shrimp production through fishing fell 1%, and farmed shrimp production in 2018 was 737,000 tons in 2019, representing a year-on-year increase of 8.4%. Vietnam’s seafood exports in 2019 were $8.759 billion, down 2.5% from 2018. The major export markets from the largest to smallest are the US, Japan, China, EU, Korea, and the Association of Southeast Asian Nations (ASEAN). The export value of the top six markets represents 83% of the entire export volume. Exports to Korea amounted to $787 million, down 9.5% from 2018 and accounting for 9% of the total exports. Exports to the US, the EU, and Korea decreased in 2019, but these increased 17% for China and 6.1% for Japan.
▏Table Ⅲ-2▕ Exports of Vietnamese Marine Products by Nation (2019) (Units: millions of USD)
Country Value Change (Compared with the Same Period in 2018) US 1,474 -9.2% Japan 1,462 +6.1% China 1,417 +17% EU 1,297 -11.9% Republic of Korea 783 -9.4% ASEAN 692 +3.4% Total 8,578 -2.5%
Source: Vietnam Association of Seafood Exporters and Producers (VASEP), 2019.
56 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
Vietnam’s main exports are shrimp (39%), catfish (27%), tuna (23%), and other fish (19%); the country also exports mollusks (8%) and crustaceans (2%). In terms of exports of shrimp, 70% are whiteleg shrimp, followed by green tiger prawn at 20%, and other types of shrimp at 10%. Exports of processed tuna (16 types) and frozen tuna are also increasing.
Source: Vietnam Association of Seafood Exporters and Producers (VASEP), 2019.
B. Policy and Status of Shrimp Farming
The shrimp industry in Vietnam constitutes a very important part of the country’s economy. Green tiger prawn (Penaeus monodon) farming started in the 1990s and whiteleg shrimp (Litopenaeus vannamei) farming started in 2010. Since then, the Vietnamese shrimp farming industry has made significant advancements. Vietnamese shrimp production increased from 280,000 tons in 2004 to 737,000 tons in 2018.
57 In 2018, the Vietnamese government established and implemented an overall plan for the development of shrimp farming into a national strategic export product by 2025.36) The goal of this plan is to improve the productivity, production, and commercial value of shrimp products.37) It focuses on the development of whiteleg shrimp and green tiger prawn in coastal regions and cities with natural brackish water resources suitable for the growth and development of shrimp. The goal of the plan is to increase shrimp production to 1,153,000 tons, representing a twofold increase, and increase the shrimp farming area to 800,000 ha.38)
▏Table Ⅲ-4▕ Developmental Plan for Shrimp Farming in Vietnam (2016–2025)
Category Units 2016 2020 2025 Shrimp farming area ha 714,239 740,000 800,000 Black tiger shrimp ha 600,000 600,000 600,000 Whiteleg shrimp ha 94,246 110,000 150,000 Harvest output tons 668,814 832,500 1,153,000 Black tiger shrimp - 263,853 320,000 400,000 Whiteleg shrimp - 393,429 480,000 700,000 Export turnover Millions of USD 3,650 5,500 10,000 Black tiger shrimp - 930 1,500 2,900 Whiteleg shrimp - 1,956 3,000 5,500
Source: Nguyen Tan Sy, (2018), Shrimp farming in Vietnam: current status, potential, and investment opportunities.
According to statistics from FAO GLOBEFISH, global shrimp production increased between 3% and 5% from 2017 to 2018, reaching four million tons.39) Until 2017, China was the world’s largest producer of shrimp, followed by India. In 2018, Vietnamese shrimp production increased and production in India decreased, making Vietnam the second largest producer of shrimp in the world. In India, the
36) Decision 79/QD-TTg of the Prime Minister promulgating the National Action Plan to develop Vietnam's shrimp industry until 2025. 37) Priit Ojamaa (2018) supra note. 38) D-Fish, to develop Vietnam's brackish shrimp industry to 2030 https://tongcucthuysan.gov.vn/en-us/aquaculture/doc-tin/011404/2018-09-20/to-develop-viet-nams-brackish-shrimp-in dustry-to-2030 39) FAO (2019), GLOBEFISH Highlights April 2019 ISSUE, with Jan. – Dec. 2018 Statistics – A quarterly update on world seafood markets. Globefish Highlights no. 2-2019. 3.0 IGO. Available at http://www.fao.org/3/ca5307en/ca5307en.pdf
58 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
production area has increased, but production volume has declined. In the case of Thailand, there have been no production increases, which can be attributed to lower whiteleg shrimp prices leading to less whiteleg shrimp farming. In South America, Ecuador’s farmed shrimp production increased in 2018 to 500,000 tons, making it the fourth largest producer of shrimp in the world. According to the FAO, Vietnam exported 570,000 tons of shrimp in 2018, making it the second largest shrimp exporter in the world. There is a production difference of approximately 40,000–50,000 tons as compared to India, which is the world’s largest producer. Among countries involved in shrimp production and export, countries that also import shrimp include Vietnam and China. Compared to its production volume, China does not have significant export and import volumes. Vietnam exports more than 77% of its production, and most imported shrimp is processed and re-exported.
▏Table Ⅲ-5▕ Status of Global Shrimp Farming and Trade, by Nation (Units: thousands of tons) Country 2017 2018 2016 Production Export Import Production Export Import China 800 700 200.7 375.5 800–850 202.3 458 Vietnam 240 600 530 441.2 520–750 570 360 India 400 700 575.9 610–670 617.4 Ecuador 439.7 500 508.9 Indonesia 390 450 181 315–355 196.9 Thailand 300 305 207.8 300 171.6 Mexico 165 Philippines 60 70 72 Bangladesh 50 60 35 Malaysia 30 35 48 3480–3860(e) World Total 2870 3720 +3.8%
Source: Aqua Culture Asia Pacific Magazine and industry sources (2019).
59 Vietnam’s shrimp farming area was 771,700 ha as of 2019. The farming area for whiteleg shrimp is approximately 100,000 ha and 620,000 ha for green tiger prawn. In 2018, the total area of brackish water shrimp farming was about 705,900 ha, of which the green tiger prawn farming area accounted for 595,800 ha (a 1.3% year-on-year increase) and the area for whiteleg shrimp farming was 1,100,100 ha (a 10.1% year-on-year increase).40) The VASEP estimates that the actual shrimp farming area is larger than government estimates.41) Prior studies have shown that Vietnam’s population of shrimp farmers is one million, of which 80% are small-scale farmers.42) In addition, about three million workers are employed by the shrimp processing industry.43) There are no official statistics on the number of shrimp farmers or shrimp farms in Vietnam. Under the Veterinary Law, starting in 2020, farm statistics will be compiled.
▏Table Ⅲ-6▕ Status of Shrimp Farming in Vietnam
Black Tiger Shrimp Whiteleg Shrimp Total
Hatcheries 1,750 612 2,362 Number Local authorities are compiling statistics based on the registration of farmers, Farms according to the Fisheries Law 2017, valid since January 1, 2020.
These data are not yet available. Vietnam manages shrimp hatchery conditions Hatcheries Area and statistics regarding capacity data. (ha) Farms 619,887 99,740 717,070
Number of PL (millions) 28.5 70.8 99.3
Source: Directorate of Fisheries, 2019.
40) Vietnam Directorate of Fisheries (2018), Vietnamese aquaculture sector in 2017, https://tongcucthuysan.gov.vn/en-us/ aquaculture/doc-tin/009677/2018-01-10/vietnamese-aquaculture-sector-in-2017 41) Priit Ojamaa (2018) p. 17. 42) Nguyen Thi Le Hoa (2020), Sustainable and Equitable Shrimp Production and Value Chain Development in Vietnam (SUSV), Oxfam and ICAFIS, EU Switch Asia Programme. 43) Ibid. p. 5.
60 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
2. Disease Prevention and Control of Vietnamese Aquatic Animals
A. Laws Related to Disease Control of Fishery Products
The most relevant law governing the control of aquatic animal diseases in Vietnam is the Veterinary Law and its enforcement decree.44) Chapter 2, Part 3 of the Law on Veterinary Medicine provides for the prevention and control of aquatic animal diseases. Chapter 3, Part 2 provides for the quarantine of aquatic animals and aquatic animal products. Chapter 5 details oversight of veterinary drug management. The most important administrative regulations that the DAH of the MARD oversees relates to the control of aquatic animal diseases, “regulations on prevention and control of aquatic animal diseases.”45) There are other regulations overseeing the designation of disease-free zones and provisions for production chain forecasts. In addition, there are regulations regarding the establishment of central and provincial operational committees for cooperation between the ministries overseeing disease prevention and control.46)
▏Table Ⅲ-7▕ Vietnamese Legislation Related to Aquatic Animal Diseases
Statute English Statute Number Law on Veterinary Medicine Law No. 79/2015/QH13 June 19th, 2015
Enforcement Decree of the Law on Veterinary Medicine Decree No. 35/2016/ND-CP
Regulations on the Prevention and Control of Aquatic Circular 04/2016/TT-BNNPTNT Animal Diseases
Regulations on Animal Disease-Free Zones and Facilities Circular 14/2016/TT-BNNPTNT
Regulations on Production Chain Forecast to Guarantee Decision 4088/QD-BNN-TY Disease-free Shrimps
Regulations on the Installation of Operational Committees Decision 16 /2016/QD-TTg for Prevention and Control of Diseases
44) In Vietnam, the Veterinary Law is sometimes called the Law on Veterinary Medicine or the Law on Animal Disease Control. 45) Circular 04/2016/TT-BNNPTNT. 46) Decision 16 /2016/QD-TTg.
61 B. Disease Control Organization for Aquatic Animals
The DAH of the MARD has overseen the prevention and control of aquatic biological diseases in Vietnam since its reorganization in 2008. The MARD currently operates seven regional offices and three quarantine offices. Its main tasks include imported animal quarantines, infectious disease prevention, management of pharmaceuticals, and the operation of veterinary hospitals and aquatic animal health offices. The regional office manages 63 prefectures. The tasks are managed by veterinarians or on-site extension officers. The DAH of the MARD conducts import quarantines in Vietnam. Unlike other countries, export quarantine and import quarantine agencies are separate in Vietnam. The NAFIQAD oversees quarantines for the export of animals.
▏Figure Ⅲ-1▕ Organization of the DAH
MARD
Department Department of National Institute of National Agriculture Animal Health Veterinary Research Livestock & Extension Center Production DAH NIVR DLP NAEC
Sub NIVR Regional DAH (Na Trang) Province Province
Sub DAH District District
District Veterinary Station Commune
Extension centers, which provide direct guidance to fish farmers, are located in each province, district, and commune (Xã) of the central government. Each province has its own SDAH, with stations in each district and veterinary teams in villages and towns. The National Institute of Veterinary Research, a specialized veterinary research institute, is in Hanoi. There are regional quarantine offices in three regions: Lang Son, Lao Cal, and Quang Ninh.
62 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
The SDAH is responsible for sanitary testing as well as issuing certificates to local private corporations and entities that handle veterinary medication. The SDAH is also responsible for any oversight of pharmacists and collection services for each regional sales office. Collected products are sent to the National Veterinary Medicine Research Center for testing and the results are reported to the DAH.
▏Figure Ⅲ-2▕ Vietnamese Veterinary Management System
DAH
Provincial Department National Institute I. Divisions of the DAH of Agriculture and of Veterinary 1. Personnel and Administration Rural Development Research 2. Epidemiology 3. Aquatic Animal Health 4. Inspection & Quarantine 5. Drug & Vaccine Management Provincial 6. Veterinary Public Health Sub-Department of Animal Health Institute of 7. Legislation & Inspection Veterinary 8. Planning & Science Research and 9. International Cooperation and Communication Development of 10. Finance Central Vietnam District Veterinary Stations II. Institutions of the DAH Domestic Inspection - Regional Animal Health Office No. I–VII Stations - Regional Sub-departments of Animal Quarantine and Veterinary Inspection: Quang Ninh, LangSon, and Lao Cai) Schools - National Center for Veterinary Diagnosis Communal Veterinary - National Center for Vet. Drugs Control No. I, II) Teams - National Center for Vet. Hygiene Inspection No. Veterinary Drug I, II) and Vaccine Companies
63 C. Disease Prevention and Control of Aquatic Animals
1) Principles for preventing and controlling aquatic animal diseases
Regulations on the prevention and control of aquatic animal diseases focus on disease prevention activities, including proactive monitoring of etiological agents, environmental monitoring, gathering information on diseases, communications related to farming activities, and transmission of guidance on proactive disease prevention and control for farmers.47) Regulations stipulate that the prevention and control of aquatic animal diseases is the responsibility of aquaculture operators, sellers, logistics operators, handling/processors, and government institutions.48) Per the DAH’s guidelines, information and data on aquatic animal diseases must be recorded, managed, analyzed, and reported in a timely and accurate manner. Aquaculture information, data, and environmental monitoring must be conducted in accordance with D-Fish guidelines. Owners of aquaculture facilities, private aquatic animal health experts, or others confirming diseased aquatic animals, mass mortality disease of aquatic animal groups, or clinical signs of such mass mortality or disease must inform the veterinary station staff (provincial, town, or village), provincial people’s committee, or the nearest aquatic animal health agency. Veterinary stations must provide reports on disease conditions on a monthly, semi-annual, and annual basis. The DAH must compile a report for the minister of the MARD on the forecast, disease occurrences, and prevention and control measures reported by subordinate agencies.
2) List of aquatic animal diseases for mandatory disclosure
Annex I of the Regulations on the Prevention and Control of Aquatic Animal Diseases contains a list of 12 aquatic animal diseases that must be announced as epidemics. There are six shrimp-related diseases, white spot disease (WSD), acute hepatopancreatic necrosis disease (AHPND), IHHN, yellow head disease (YHD), IMN, and Taura syndrome (TS). There is one disease for lobsters, two for carp, one for koi, one for shellfish, and one for grouper fish.
Common carp (Cyprinus carpio), Spring viraemia of carp koi carp (Cyprinus carpio koi), 8 Spring viraemia of carp virus (SVCV) yellow fish (Carassius auratus), grass carp (Ctenopharyngodon idellus)
Catfish (Pangasius hypophthalmus), 11 Enteric septicemia of catfish Edwardsiella ictaluri basa fish (Pangasius bocourti), catfish (Pangasius krempfi)
Geo duck (Lutraria philipinarum), 12 Infection with Perkinsus Perkinsus marinus, P. olseni oyster at estuary (Crasostrea rivularis), clam (Meretrix sp.)
65 Annex II-V of the Regulations on the Prevention and Control of Aquatic Animal Diseases contains guidelines on the prevention and notification of the four diseases listed in Annex I. These include guidelines on preventive and control measures for shrimp WSD, AHPND, enteric septicemia of catfish, and milky haemolymph disease of spiny lobsters (MHDSL).
▏Table Ⅲ-9▕ Diseases with Guidance on Prevention and Control Measures
Annex Ⅱ Guidance on Some Measures for Prevention and Control of WSSD in Shrimp
Annex Ⅲ Guidance on Some Technical Measures for Prevention and Control of Acute Hepatopancreatic Necrosis Disease in Farmed Shrimp
Annex Ⅳ Guidance on Some Measures for Prevention and Control of Eteric Septica of Catfish, Hemorrhagic Disease of Catfish
Annex Ⅴ Guidance of Some Measures on Techniques for Prevention and Control of Milky Disease in Farmed Lobster
3) Disease prevention and forecasting
Before aquatic resources can be used for production, they must meet conditions on pathogenic material processing, environmental indicator management, and veterinary hygiene requirements. Wastewater and solid waste disposal must be in accordance with specified hygiene standards before discharge.49) Juvenile fish must be derived from healthy stock and must be disease-free and meet the requirements set forth in the national technical procedures for juvenile fish. Aquatic animal health forecasts are conducted by aquaculture owners, veterinary officials, veterinary stations, and provincial sub-DAHs. The DAH and D-Fish require that information regarding transmission, communication, and education be provided on aquatic animal disease prevention and control by means of brochures, media, seminars, and educational sessions.
49) Article 8, Section 3 of above regulations.
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4) Harvesting and processing aquatic animals in areas of disease occurrence
Aquaculture owners harvesting aquatic animals in areas of disease occurrence must inform their veterinary station of the purpose of harvest, volume, treatment measures, implementation plans, and monitoring measures for the consumption of diseased aquatic animals. Aquaculture owners are prohibited from using diseased aquatic animals in the propagation of other aquatic animals or in live feed. Furthermore, diseased aquatic animals must only be transferred to aquatic animal handling and processing facilities or related commercial facilities to avoid epidemiological spread during transport.50) Aquaculture owners and government/private aquatic animal health staff must only use registered medicines, chemical products, and biological products that are legally distributed for aquatic animal health in Vietnam. Dosages must be in accordance with the guidelines of manufacturers and aquatic animal health research institutes and usage must be recorded.51) The regional SDAH must inform the DARD, and the DARD must submit to the head of the regional people’s committee a report on the decision to handle diseased aquatic animals and treatment team formation. Disposal of diseased aquatic animals and disinfection of diseased pools are covered by local government budgets in accordance with relevant regulations.52) Annex VI of the Regulations on the Prevention and Control of Aquatic Animal Diseases provides guidelines on technical measures for processing aquatic animals killed by diseases.
D. Status of Disease Occurrences
Vibrio disease, a type of bacterial disease, is common in hatcheries, but it can be prevented by adhering to strict management guidelines. Viral diseases such as WSD, YHV, IHHN, and IMN occur on farms. AHPND, a bacterial disease, and HPM-EHP,53) a parasitic disease, also kill aquaculture products. WSD and AHPND have the most impact and often cause mass mortality. In 2012, 8,734 ha of shrimp farms were infected with WSD, which increased significantly in 2014 to 23,872 ha.
50) Article 16 of the above regulations. 51) Article 17 of the above regulations. 52) Article 18 of the above regulations. 53) Hepatopancreatic microsporidiosis caused by Enterocytozoon hepatopenaei.
67 AHPND infection first occurred in Vietnam in 2010 and caused serious damage to shrimp of up to 45 days of age. Whiteleg shrimp and green tiger prawn can be affected, and the mortality rate can increase up to 100% within two to five days of infection. APHND infected an area of 28,000 ha in 2012 but decreased to approximately 5,000 ha in 2018. Lobster epidemics first occurred in 2007 and have caused 80%–100% mortality upon occurrence. The cause of the disease is Rickettsia-like bacteria and it has a high mortality rate.54) The main diseases impacting shrimp in Vietnam are as follows.
1) White Spot Disease (WSD)
WSD first appeared in Chinese barley shrimp in 1992 and rapidly spread across China, infecting most of the farmed species such as jumbo shrimp, whiteleg shrimp, and green tiger prawn. In 1993, WSD originating in imported seed stock from China struck Japanese barley shrimp and by 1994, it had spread to most countries in Southeast Asia. In 1995, the spread of the virus in the Americas is thought to have originated in frozen shrimp imported from Asia. Although not previously found in Australia, WSD was recently found (between December 2016 and January 2017) and resulted in losses of US$25 million. WSD has been an epidemic in Vietnam since the 1990s and has caused serious damage to shrimp farming. It is characterized by white spots found in cuticles. Shrimp that survive the disease have white spots that negatively impact their product value.
54) Interview with Dr. Dang Thi Lua, RIA No 1.
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▏Figure Ⅲ-3▕ Areas of WSD Emergence in Vietnam in Hectares55) (2012–2018)
Recently, AHPND has caused mass mortality in major shrimp farming countries such as Vietnam, Thailand, China, and Malaysia, making it a serious issue. It first occurred in China in 2009 and then spread to Vietnam (2010), Malaysia (2011), and Thailand (2012). An increasing number of countries have required import bans and disease controls for shrimp coming from countries and regions that have experienced outbreaks of AHPND. Countries such as Mexico, the Philippines, Ecuador, and Brazil have implemented emergency bans on imports because of the disease. The OIE and the Network of Aquaculture Centres in Asia-Pacific have mandated the maintenance of strict oversight and the immediate reporting among member states. They are striving to curb outbreaks of AHPND, implementing measures such as banning the movement of live shrimp from a country with an outbreak to countries without the disease and preparing emergency response plans. The OIE listed AHPND as a designated disease in 2016. In Vietnam, AHPND has been occurring on an annual basis since 2010, and upon its occurrence, an urgent response is required. The spread occurs through contaminated feed, seed, or mother shrimp, as well as water, bio-transportation, and stress. Clinical symptoms and mortality occur 10 days after feeding. Infected shrimp sink to the river or sea bottom and lose their energy, their digestive tracts are partially empty, and they finally turn white and die. To date, there have been no reported cases of AHPND in humans.56)
55) Dr. Dang Thi Lua, 2019. 56) Mohammad Jalil Zorriehzahra and Reza Banaederakhshan (2015).
69 ▏Figure Ⅲ-4▕ Reduction in Production and Losses Due to AHPND in Whiteleg Shrimp57)
▏Figure Ⅲ-5▕ Areas of AHPND Emergence in Vietnam in ha (2012–2018)58)
57) Andrew Shinn, et al. 2018. 58) Dang Thi Lua (2019).
70 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
3) Hepatopancreatic Microsporidiosis Caused by Enterocytozoon Hepatopenaei (HPM-EHP)
Enterocytozoon hepatopenaei59) is a type of parasitic microcyte that was first found in green tiger prawn in Thailand in 2004 and thereafter found in Vietnam, Australia, India, and Indonesia. Whiteleg shrimp, which is an introduced species farmed in Asia, is particularly vulnerable to the disease, and the disease has been confirmed as orally transmissible in shrimp. While mortality does not result in shrimp infected with HPM-EHP, it causes a substantial slowing of their growth. Most shrimp farms worldwide focus only on AHPND and overlook the gravity of this disease, which has led many shrimp farming experts to raise concern. Shrimp infected with HPM-EHP can be fragile and more easily infected with AHPND, leading to mass mortality, which underlies these concerns. This disease is prevalent not only in Vietnam but also in China and Thailand. Researchers suspect that live polychaeta (earthworms, etc.) and shellfish imported from foreign countries with shrimp seedling production plants are linked to the disease. According to the ShrimpVet Institute of Vietnam (Dr. Tran Huu Loc), the disease showed positive reactions to polychaeta, oysters, squids, and farming water supply (TARS, 2018).
E. OIE Reports
The OIE divides crustacean diseases into nine designated diseases (TS, WSD, YHD, IHHN, IMN, WTD, NHP, AHPND, Crayfish plague) and four non-designated diseases (HPM-EHP, VCMD, SE, SHIV); it provides national reports on each. Monodon Slow Grow Syndrome (MSGS) was considered a non-designated disease before 2016 and was removed in 2017 (OIE, 2017). Table Ⅲ-10 lists the crustacean diseases in Vietnam reported to the OIE between 2010 and 2019.
59) HPM-EHP, Hepatopancreatic microsporidiosis caused by Enterocytozoon hepatopenaei.
71 ▏Table Ⅲ-10▕ Status of OIE Disease Emergence Reports in Vietnam
※ + = Disease reported or known to be present; +() = Occurrence limited to certain zones; *** = No information available; 0000 = Never reported; - = No reported (but disease is known to occur). ※ Non OIE-listed diseases: HPM-EHP (Hepatopancreatic microsporidiosis caused by Enterocytozoon hepatopenaei), VCMD(Viral covert mortality disease of shrimp), SE (Spiroplasma eriocheiris infection), SHIV (Shrimp haemocyte iridescent virus), MSGS (Monodon slow grow syndrome), before 2016.
According to recently reported data, WSD has occurred consistently for the past 10 years and AHPND occurrence has been confirmed since 2013. While YHD and WTD were not reported, they were found to have occurred. While HPM-EHP has not been reported to have occurred, researchers indicate that it has indeed been occurring on farms (TARS, 2018). The disease outbreak reporting system in Vietnam, as shown in Figure III-6, is structured such that the owner of an aquaculture farm is required to contact the regional research institute or the local government to report to the DAH, and then to the OIE and the MARD, any occurrence of a mass mortality or notable disease.
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▏Figure Ⅲ-6▕ Disease Outbreak Reporting System in Vietnam60)
An early, proactive response to a disease in Vietnam involves the identification of the pathogen causing it through cooperation between the government and related industry organizations. Epidemiological blocking of the disease to minimize damage to the shrimp industry then follows. Upon the initial occurrence of AHPND, the Vietnamese government formed a national task force team to identify the spread of the disease and the extent of its damage on a bi-weekly basis. The My Thanh Shrimp Farmers Association also held bi-weekly regional meetings to overcome the emergency in a timely manner in conjunction with government efforts. However, due to unstructured research methods and a lack of experts, the Vietnamese government requested aid from the FAO to assist with the technical aspects of research and epidemiological prevention. The FAO Health Crisis Management Center utilized its international network to deploy experts and analyze the situation jointly with the Vietnamese government, confirming unusually fast spreading of infection and high mortality rates in the key farmed species, whiteleg shrimp and green tiger prawn.
60) Research Institute for Aquaculture No. 1.
73 3. Management of Vietnamese Veterinary Medicines
A. Related Laws and Organizations
The management of veterinary medicine and vaccines is provided by the Department of Drug & Vaccine Management of the DAH. There are four specialized centers, including the National Center for Vet drugs and Bio-Product Control (NCVC) Nos. 1 & 2 and the National Center for Vet Hygiene Inspection Nos. 1 & 2. In addition, there are seven regional animal health offices (RAHOs) and local animal health offices.
▏Figure Ⅲ-7▕ Vietnamese Medicines and Vaccine Management Structure
MARD
↓
The Department of Drug & Vaccine ← Management (DAH)
Specialized Centers: - National Center for VET drugs and - Manufacturers of veterinary Bio-Product Control (NCVC) Nos. 1 & 2 medicine and vaccines - National Center for Vet Hygiene Inspection - Importers and exporters of Nos. 1 & 2, 07 Regional Animal Health veterinary medicine and vaccines Offices (RAHOs) - Companies testing and experimenting with veterinary medicine
Local People’s Committees Sub-MARDs SDAH ↓ - Veterinary pharmacies, dealers in jurisdictions - Testing and experimentation facilities for veterinary medicine
Laws related to veterinary medicine for aquatic animals include the Law on Veterinary Medicine, the enforcement decree of the Law on Veterinary Medicine, a circular covering the list of veterinary drugs permitted for sale, and another circular related to the management of veterinary drugs.
74 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
▏Table Ⅲ-11▕ Vietnamese Legislation Related to Veterinary Medicines
Statute Regulations Veterinary Medicine Law Veterinary Medicine Law Enforcement Decree of the Law on Decree 35/2016/NĐ-CP Veterinary Medicine Circular No. 10/2016/TT-BNNPTNT dated 01/6/2016 of the List of veterinary drugs permitted or MARD promulgating the List of Veterinary Drugs permitted banned for circulation in Vietnam or banned for circulation in Vietnam. Circular No. 13/2016/TT-BNNPTNT dated 02/6/2016 Management regulations of veterinary Circular No. 18/2018/TT-BNNPTNT dated 15/11/2018 of drugs the MARD on the management of veterinary drugs.
The management of veterinary medicine is presented in Chapter 5 of the Veterinary Medicine Law. The chapter on veterinary medicine includes five sections on the management, registration, testing, manufacturing, transaction, export and import, and return and disposal of veterinary medicine.
B. Management and Registration of Veterinary Medicines
Veterinary drugs that are newly produced or imported for the first time to Vietnam for transaction and production need to be registered with the DAH.61) Once an application is submitted to the DAH, the DAH reviews and issues a sales certificate within six months, which is valid for five years. The validity period of the sales certificate can be extended; an extension application must be filed three months before its expiry. The DAH reviews the application and grants an extension within 20 days of extension application submission. Once approved for an extension, the validity of a sales certificate is extended by five years. As of 2018, there were 11,884 registered drugs. There were 8,820 drugs produced in Vietnam and 3,064 were imported. There were 864 types of veterinary drugs for aquatic animals produced in Vietnam and 106 were imported. As of 2019, there were 1,534 types of medicines for aquatic animals and 185 imported veterinary medicines.
61) Article 80-83 in Veterinary Law.
75 ▏Table Ⅲ-12▕ Status of Registered Veterinary Medicines
Domestically Produced Imported Year Total Total Terrestrial Vaccine Aquatic Total Terrestrial Vaccine Aquatic Animals Products Animals Animals Products Animals 2018 11,884 8,820 7,818 138 864 3,064 2,508 450 106 2019 9,251 1,534 3,669 185
The DAH will cancel a veterinary drug sales certificate if any of the following apply: - The contents of the sales certificate are deleted or otherwise modified; - The approved sales certificate contains false information or documentation; - The veterinary drug on the certificate is banned in Vietnam; - There is scientific evidence suggesting that the veterinary drug poses a high risk to the health of humans, animals, or the environment; - Two continuous batches of drugs do not match quality standards, or production batches of drugs have been found to be in serious violation of the national quality standards of the agencies in charge of veterinary drug quality; - The institution or individual that holds a veterinary drug sales certificate in Vietnam applies for the cancellation of the certificate; - The veterinary drug sales certificate in the manufacturing/exporting country has been canceled; - The veterinary drug was found to be in violation of intellectual property laws; or - The institution or individual with a veterinary drug sales certificate in Vietnam has violated relevant regulations.
The requirements for veterinary drugs or vaccines can be classified into the following categories: Vietnamese manufacturer, foreign manufacturer, chemical manufacturer, and in vitro diagnostic reagent manufacturer. Traders and importers of veterinary drugs must meet the requirements of the veterinary drug trade.62)
62) Circular No.13/2016/TT-BNNPTNT dated 02/6/2016 of MARD.
76 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
▏Table Ⅲ-13▕ Registration Requirements
Manufacturer Classification Requirements In compliance with veterinary drug production 1 Vietnamese manufacturer requirements or GMP certification 2 Foreign manufacturer GMP certification Chemical or in vitro diagnostic reagent 3 GMP/ISO or equivalent standards manufacturer
C. Import and Export of Veterinary Medicines and Their Ingredients63)
Veterinary drugs with appropriate sales certificates in Vietnam can be exported. Vaccines and microorganisms used in veterinary practice must be cleared for import by the DAH. Veterinary drugs without sales certificates can be imported in the following cases: - For the prevention and emergency eradication of infectious animal diseases, or disaster recovery; - As samples for analysis, testing, and sales registration, or for use in trade shows, exhibitions, and scientific research; - To treat animals that are temporarily being imported or transported through the territories of Vietnam; - Temporary import or export processing under contract with a foreign institution or individual; - For diagnosis, testing, or analysis for veterinary science; and - Provided in the form of aid from international organizations and other non-profit importation methods.
D. Management of Veterinary Medicine
High-density breeding and high production volumes, like livestock production methods, are common to Vietnamese shrimp farming. These methods have led to the pollution of the coastal environment and an increase in disease outbreaks, which are issues of concern. Diseases that occur in shrimp not only cause direct financial damage resulting from shrimp mortality, but also lead to unforeseen larger costs for drugs and personnel that reduce farm profit.
63) Vietnam Veterinary Law art. 100.
77 The drugs used in shrimp farming are generally for the treatment of bacterial infections. Once a bacterial disease occurs, it tends to infect an entire farm in a short period of time; as such, it is common for farms to immediately deploy a drug in the form of feed additives for all shrimp as soon as an infection is found. This lack of management and control of veterinary medicines for aquatic animals leads to misuse, resulting in pollution and subsequently requiring long-term effort for environmental recovery. Veterinary drugs can be purchased or used by almost anyone without any restrictions. Because a variety of veterinary drugs are being used without appropriate control procedures in place, they are likely to be misused. Most of the veterinary medicines used in aquaculture have been developed as veterinary antibiotics and are administered in aquatic environments according to fish body weight. There are many drugs for which the efficacy and pharmacological benefits for aquatic organisms remain unknown. Therefore, aquaculture farms typically use relatively cheap veterinary drugs such as oxytetracycline and enrofloxacin or veterinary drugs that have been experientially proven to be effective but are not approved for use (e.g., drugs in the nitrofuran family). Generally, veterinary drug use often involves securing and using drugs that can be easily sourced through a supplier’s network that are regionally available, instead of through veterinary prescriptions that state the correct dosages. In Vietnam in particular, cases of veterinary drug residue discovery are commonly found in shrimp products for export. This appears to be due to the ease of access to illegal drugs through the Internet, pharmacies, and hospitals without distribution route visibility. By strengthening the functions and monitoring capabilities of the NAFIQAD, the Vietnamese government is attempting to prevent the introduction of veterinary medicines and other harmful chemicals from the production to distribution processes. Considering that farmed shrimp comprises a significant proportion of Vietnam’s exports, the government strives to protect this domestic industry by strengthening collaboration between the Ministry of Industry and Trade, in charge of distribution and exports, and the Ministry of Health. The MARD also manages the circulation list of veterinary drugs permitted, banned, and restricted for distribution.64) There are 24 chemicals and veterinary medicines that are prohibited from use in aquaculture.
64) Circular No. 10/2016/TT-BNNPTNT dated 01/6/2016 of MARD promulgating the list of veterinary drugs permitted or banned for circulation in Vietnam.
78 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
▏Table Ⅲ-14▕ List of Chemicals and Veterinary Drugs Prohibited from Use in Aquaculture
Names of Chemicals and Veterinary Drugs Scope 1 Aristolochia
2 Chloramphenicol
3 Chloroform
4 Chlorpromazine
5 Colchicine
6 Dapsone
7 Dimetridazole
8 Metronidazole
9 Nitrofuran (bao gồm cả Furazolidone)
10 Ronidazole
11 Green malachite (Xanh Malachite) Hatchery, all stages of production, food, veterinary, 12 Ipronidazole chemical, environmental treatment, disinfectants, preservatives, hand cream, aquatic and aquatic 13 Các Nitroimidazole khác animal amphibian breeding, fishery services, preservation, and processing 14 Clenbuterol
15 Diethylstilbestrol (DES)
16 Glycopeptides
17 Trichlorfon (Dipterex)
18 Gentian Violet (Crystal violet)
19 Trifluralin
20 Cypermethrin
21 Deltamethrin
22 Enrofloxacin
23 Ciprofloxacin
24 Nhóm Fluoroquinolones
79 Circular No. 10 classifies the list of veterinary drugs permitted for distribution into 10 groups.
▏Table Ⅲ-15▕ Major Veterinary Drug Groups Used in Veterinary Medicine
Little is known about resistance to antimicrobial drugs in Vietnam. This is due to the weak enforcement of regulations relating to the use of veterinary drugs, limited quality assurance and management of pharmaceuticals, lack of sufficient forecasts and research and a lack of laboratories that can identify resistant microbes. The level of resistance to antimicrobial drugs is escalating for several reasons, including the misuse of veterinary drugs, the overuse of such drugs on farms, and the bacterial contamination of foods. The World Health Organization warns that Vietnam is among the countries whose livestock and aquatic organisms have a high resistance to veterinary drugs. On June 21, 2017 the Ministry of Agriculture and Rural Development adopted a national action plan to reduce resistance to antimicrobial drugs by managing the use of veterinary drugs in livestock production and aquaculture. To forecast resistance to antimicrobial drugs in Vietnamese aquatic organisms, monitoring programs are now underway for nine types of fish, including catfish (Pangasius), tilapia, and whiteleg shrimp, on 166 farms located in 37 provinces and cities.
80 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
▏Table Ⅲ-16▕ Substances to be Tested for Antimicrobial Resistance (27)
To manage resistance to veterinary drugs, the DAH conducted three tests on 714 aquaculture farms in the two shrimp farming regions in Sóc Trăng and Bạc Liêu, and on three catfish farming regions (Ben Tre, Dong Thap, and An Giang). Among the 272 farms in the three catfish producing regions, 216 (or 79.4%) utilized at least one type of veterinary drug. In the two shrimp farming regions, there were 256 shrimp farms out of 436 that also utilized at least one type of veterinary drug. This indicates that veterinary drugs are used extensively and frequently in aquaculture and that these drugs are used without prescription for prevention and treatment.65)
4. Safety Management of Vietnamese Fishery Products
A. Safety Management Laws
In Vietnam, the Law on Food Safety was enacted by the National Assembly on June 17, 2010 to enforce effective food safety management.66) These regulations
65) Nguyen Van Long (2017), Aquatic AMR Workshop. 66) Law on the Food Safety, FSL, Order No.06/2010/L-CTN.
81 include enforcement decrees for the food safety and orders on violations of food safety. In addition, there are a variety of circulars on the monitoring of harmful substances in aquatic animal products, the quality and safety of aquatic products, and the testing and certification of aquatic products for export.
▏Table Ⅲ-17▕ Food Safety Legislation in Vietnam
Food Safety Statute Name English Statute Number Law on Food Safety Law 55/2010/QH12(June 17, 2010) Enforcement decree on various items under the Law on Food Safety Decree 15/2018/ND-CP Enforcement decree on administrative violations on food safety Decree 115/2018/ND-CP Rules for the inspection and certification for the quality and Circular 55/2011/TT-BNNPTNT safety of aquatic products Rules for the monitoring of harmful residues in animals and Circular 31/2015/TT-BNNPTNT aquatic animals Rules on sanitary monitoring for bivalve shellfish production zones Circular 33/2015/TT-BNNPTNT Rules on the management of facilities not subject to inspection Circular 17/2018/TT-BINNPTNT and certification Rules on the supervision of domestically distributed aquatic products Circular 08/2016/TT-BINNPTNT Circular 48/2013/TT-BINNPTNT Rules on pre-export inspection and certification for food safety Circular 02/2017/TT-BINNPTNT Circular 16/2018/TT-BINNPTNT Rules for inspection and certification of production and sales Circular 38/2018/TT-BINNPTNT facilities of agricultural and aquatic products Rules for the traceability and retrieval of aquatic products that Circular 03/2011/TT-BNNPTNT do not meet food quality and safety requirements Ordinance on the issuance of GAP, a Vietnamese national standard Decision 3824 /QD-BNN-TCTS Rules on the maximum permissible amount of pesticide residue Circular 50/2016/TT-BYT in food National technical regulations on the limitations of chemical Circular 02/2011/TT-BYT contamination of food for safety National technical regulations for the presence of microbial Circular 05/2012/TT-BYT contaminants in food Regulations on the maximum residue limits for veterinary medicine Circular 24/2013/TT-BYT in food Regulations on the maximum residue limits for pesticides in food Circular 50/2016/TT-BYT Circular 27/2012/TT-BYT Rules on food additive management Circular 08/2015/TT-BYT Regulations on the maximum level of biological and chemical Decision No. 46/2007/QD-BYT contamination of food General ordinance on food safety for aquatic product companies QCVN 02 - 01: 2009/BNNPTNT HACCP program for guaranteeing the quality and safety of QCVN 02 – 02: 2009/BNNPTNT aquatic product companies
82 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
Vietnam’s Law on Food Safety came into force on July 1, 2011, and replaced the Vietnam Food Ordinance (2003). The Law on Food Safety comprises 11 chapters and 72 articles, as shown in Table III-18.67)
▏Table Ⅲ-18▕ Composition of Vietnamese Food Safety Legislation
Chapter 1 General provisions Chapter 2 Rights and obligations of companies and individuals for food safety Chapter 3 Conditions for food safety Chapter 4 Conditions for ensuring food safety at the production and distribution stages Chapter 5 Certificate of facilities meeting the conditions of food safety at the production and distribution stages Chapter 6 Import and export of food Chapter 7 Advertising and labeling of food Chapter 8 Food inspection, food safety risk analysis, prevention and treatment of food safety incidents Chapter 9 Information, education, and communication regarding food safety Chapter 10 Food safety management Chapter 11 Enforcement regulations
The Law on Food Safety bestows rights and responsibilities on companies and individuals to secure food safety. Rights and responsibilities include conditions for food safety, production and trade, import and export, advertising and labeling, food inspection, risk analysis, prevention of safety accidents, information exchange and training relating to food safety, and food safety management. The Law on Food Safety also governs all imported and exported food products. All foods imported into Vietnam are subject to inspection. Under Chapter 6 (Article 39) of the Law on Food Safety, inspections are mandatory for all imported foods, food additives, ingredients, tools, and packaging ingredients. However, exceptions are made when the food safety inspections are exempted under government regulations. Imported foods must be checked to see whether they meet import requirements and the results must be communicated to consumers. The Law on Food Safety stipulates that food should be inspected by one of three inspection methods: rigorous, normal, or loose inspections. In other words, depending on the food product, the MARD, the Ministry
67) Vietnam Law on the Food Safety, http://vanban.chinhphu.vn/portal/page/portal/chinhphu/hethongvanban?_search=Tìm&_page= USDA FAS, Vietnam Food and Agricultural Import Regulation and Standards Report https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Food%20and%20Agricultural%2 0Import%20Regulations%20and%20Standards%20Report_Hanoi_Vietnam_4-18-2019.pdf
83 of Health, and the Ministry of Industry and Trade must prepare detailed guidelines for food safety inspection. The enforcement decree of the Law on Food Safety was enacted in 2012 to provide details on implementing the regulations set forth in the law.68) The enforcement decree was revised on February 2, 2018 and is currently in effect.69) The 2018 revisions of the enforcement decree simplified the registration process for foods and processed foods before packaging and established a new import inspection system. The enforcement decree strengthened existing registration requirements for the export of animal and plant foods to Vietnam and entrusted the responsibility for establishing residual allowance standards for agricultural chemicals (e.g., animal pharmaceuticals and pesticides) to the MARD from the Ministry of Health. The enforcement decree, which was created for the purpose of ensuring compliance with the Food Safety Act, comprises 13 chapters (43 articles), as shown below in Table III-19.70)
▏Table Ⅲ-19▕ Enforcement Decree on Vietnamese Food Safety Legislation
Chapter 1 General provisions Chapter 2 Self-reporting procedures for products Chapter 3 Product registration procedure Chapter 4 Securing the safety of genetically modified foods Chapter 5 Issuance of certificates for facilities meeting food safety conditions Chapter 6 Food safety inspections of foods for export or import Chapter 7 Food product labeling Chapter 8 Food product advertising Chapter 9 Food safety conditions for the production of health supplements Chapter 10 Food safety requirements for food additives Chapter 11 Food product traceability Chapter 12 Food safety management Chapter 13 Enforcement
Regulations related to the production and food safety of aquatic products include the Law on the Quality of Products and Goods, the Law on Inspection, the Law on Standards and Technical Regulations, and the Law on Administration Penalties.
68) Decree 38/2012/ND-CP. 69) Decree 15/2018/ND-CP. 70) https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Nghi-dinh-15-2018-ND-CP-huong-dan-Luat-an-toan-thuc-pham-341254.aspx Vietnam Reformed Decree Guiding the Law on Food Safety. 2018. https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=GVN%20Reformed%20Decree%20Guidi ng%20the%20Law%20on%20Food%20Safety_Hanoi_Vietnam_4-4-2018.pdf
84 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
Regulations also include the Law on Food Safety, the Law on Fisheries, and the Law on Veterinary Medicine. The Law on the Quality of Products and Goods is designed to manage the quality of products, including food, and went into force on July 1, 2008, replacing the Ordinance on the Quality of Goods. This law states that the central and regional governments must adhere to a unified system for managing the quality of goods. However, if there are differences between the law and international treaties, international treaties prevail. This law states, “Manufacturers and sellers must take responsibility for the quality of the products they produce or sell in order to strengthen the productivity, quality and competitiveness of Vietnamese products and secure safety of people, animals, plants, property and the environment.” This law entrusts the responsibility of quality assurance for goods, including food, to the Ministry of Science and Technology.
B. Organizations and Functions
1) Food Safety-related Agencies and Functions
Under the Law on Food Safety, tasks relating to the safety management of food, including seafood, are carried out jointly between the Ministry of Health (MOH), the MARD, and the Ministry of Industry and Trade (MOIT). The Vietnamese government instituted the Operational Committee on Food Safety to coordinate the control of food safety issues between a few different government agencies. The MARD’s participation is coordinated by the NAFIQAD and the other bodies participating include the D-Fish, the PPD, the DAH, the DCP, the DLP, and the DFPT. The DST coordinates the participation of the Ministry of Industry and Trade with the DDM and the DMC. The Ministry of Health coordinates its own participation with the VFA.
▏Figure Ⅲ-8▕ Vietnamese Central Government’s Food Safety Control System
Operating Committee Composition of Food Safety-Related Agencies
85 Furthermore, the tasks are divided up by types and forms of foods for each ministry (Ministry of Industry and Trade, Ministry of Health, and MARD). The Ministry of Health is responsible for the following: drinking water (e.g., bottled water and mineral water) and edible ice, functional food, micronutrients for food additives, food additives and various food processing ingredients, and packaging materials in direct contact with food. The Ministry of Industry and Trade oversees the food safety for specific food types including beer, alcoholic beverages (e.g., wine and fruit wine), beverages, processed milk (including fermented milk, cream, butter, and cheese), vegetable oil, flour and starch, and confectionery.
▏Table Ⅲ-20▕ Food Safety Management Duties and Items in Charge, by Department
Ministry Task - General tasks: Responsible for preparing and distributing food safety policies, comprehensive plans, and regulations. - Main duties related to food safety: Food safety management during the production, harvesting, handling (slaughtering, etc.), processing, preservation, distribution, export, Ministry of import, and trade of agricultural, forestry, livestock, aquatic products, and salt under law. Agriculture ① ② and Rural - The ministry is in charge of food safety for the following: grains, meats and Development related products, ③ seafood and related products, ④ horticultural products (e.g., (MARD) vegetables and fruits) and related products, ⑤ eggs and related products, ⑥ fresh milk (e.g., raw milk), ⑦ honey and related products, ⑧ genetically modified food, ⑨ salt, ⑩ spices (including sauces), ⑪ sugar, ⑫ tea ,⑬ coffee ,⑭ cocoa, ⑮ pepper, ⑯ cashews, ⑰ other agricultural products (e.g., various seeds and edible insects), ⑱ food packaging equipment entrusted to the MARD, and ⑲ processed ice. - General tasks: Responsible for the development, distribution, and implementation of national strategies and comprehensive plans for overall food safety. The ministry oversees food safety standards for food products, food manufacturing equipment, and food packaging and container materials. - Main duties related to food safety: Management of food safety during the production, Ministry of Health processing, preservation, transportation, export, import, and trade of food and (MOH) products entrusted by law. - The ministry is in charge of food safety for the following: ① drinking water (e.g., bottled water and mineral water) and edible ice, ② functional food, ③ micronutrients for food additives, ④ food additives and various food processing ingredients, ⑤ packaging materials in direct contact with food, and ⑥ items otherwise not belonging to the MARD or the MOIT. - General tasks: Responsible for preparing and distributing food safety policies, comprehensive plans, and regulations. - Main duties related to food safety: Management of food safety during the production, Ministry of collection, processing, preservation, distribution, export and import of foods and Industry and Trade products entrusted by law. (MOIT) - The ministry is in charge of food safety for the following: ① beer, ② alcoholic beverages (e.g., wine and fruit liquor), ③ beverages, ④ processed milk (including fermented milk, cream, butter, and cheese), ⑤ vegetable oil, ⑥ flour and starch, ⑦ confectionery, and ⑧ food packaging equipment entrusted to the MOIT.
86 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
In terms of food safety management functions by each ministry, the MARD is engaged in the safety management of production, processing, import and export, and the domestic distribution and wholesale of aquatic products, including farmed seafood. However, the retail aspect of domestic distribution (i.e., markets, large-scale discount stores, and supermarkets) is handled by the MOIT. However, restaurants, large-scale restaurants, and food material suppliers are handled by the MOH.
▏Table Ⅲ-21▕ Ministries in Charge of Aquatic Product Safety by Distribution Stage
Distribution Stage Primary Preparation, Processing, Storage, Import and Export Wholesale Retail Restaurants Ministry MARD MARD MARD MOIT MOH
The regional food safety control system is overseen by provincial-level operating committees that are composed of food safety departments’ regional offices; sub-divisions of the MARD departments such as the NAFIQAD, the PPD, and the DAH at the provincial level; sub-divisions of the MOH departments such as the VFA, the Preventive Health Management Center, and the Regional Preventive Health Management Centers; sub-divisions of MOIT departments, such as the DDM and DMC, and by the market control committees.
▏Figure Ⅲ-9▕ Vietnamese Local Governments’ Food Safety Control System
PPC Provincial Operating Committee Composition of Food Safety-Related Agencies
DARD DOH DOIT Provincial NAFIQAD, Provincial VFA, Preventive Health Provincial PPD, DAH Management Center DDM, DMC
Regional Department of Regional Preventive Health Market Control Agriculture Regional PPD, Management Center Committee DAH offices
In relation to this study, the MARD is responsible for food safety management during the production, harvesting, handling, processing, preservation, distribution,
87 export, import, and wholesale distribution of aquatic products. The following section provides a detailed overview of the organization and function of the MARD and its sub-organizations.
2) The Ministry of Agriculture and Rural Development (MARD)
(1) Organization
▏Figure Ⅲ-10▕ Organization of the MARD
MARD Ministerial Non-Productive Unit (5)
General Offices Departments Professional Departments ↓↓↓ Administration of Ministry Administrative Department of Forestry Office Crop Production
Organization and Department of Directorate of Fisheries Personnel Department Plant Protection
Directorate of Water Planning Department Department of Resources Livestock Husbandry
Disaster Management Finance Department Department of Authority Animal Health
Agro-Processing and Science, Technology and Environment Department Market Development Department
International Cooperation National Agro-Forestry-Fisheries Department Quality Assurance Department
Legislation Department Department of Cooperatives and Rural Development
Ministry Inspectorate Department of Construction Management
Enterprise Management Department
88 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
The MARD was created in 1995 when the Ministry of Agriculture and Food Industry, the Ministry of Forestry, and the Ministry of Irrigation were combined. On January 31, 2007, the MARD also absorbed the MOF. The main task and function of this ministry is the management of public services and the national management functions for areas related to agriculture, forestry, fisheries, salt industries, water resources, and agricultural development.71)
(2) Function Regarding management of food safety, the MARD oversees the production stages of agricultural and aquatic products (i.e., growing, production, farming, and fishing), as well as the safety management of processing, distribution, and export and import, as shown in Table III-22.
▏Table Ⅲ-22▕ Food Safety Management of the MARD
- Operating food sanitation and safety systems of good manufacturing practices (GMP), good agricultural practices (GAP), good hygiene practices, and hazard analysis and critical control points (HACCP) in the production, processing, and distribution processes - Monitoring and inspection of antibiotics, hazardous substances, toxic substances, and pathogenic factors as ingredients in the processing and pre-harvest stages of animal and plant products - Preparation of standards and regulations related to food quality, safety, and disease in the production, preservation, processing, and trading stages - Inspection and approval of food safety in processing plants and fish farms and in the stages of harvesting, purchasing, transporting, preserving, and raw material stages (e.g., processed agricultural and aquatic products and salt products) - Approvals for food quality, safety, and hygiene for imported products (e.g., agricultural, forest, aquatic, and salt products) and domestically produced products prepared for export - Quarantines and issuing certificates for imported and exported live animals, animals, and plant products
71) No. 01/2008/ ND-CP, 2007.1.3.
89 The NAFIQAD, the D-Fish, and the DAH oversee aquatic product safety management under the MARD and the specific roles of each department are detailed below in Table III-49.
▏Table Ⅲ-23▕ The MARD’s Fishery Product Safety Management: Duties by Department
Category Task Department Department of Disease management of farmed aquaculture products; production, Animal Health sales, utilization, and management of aquatic veterinary medicines (DAH) Management of aquatic organisms to improve the aquaculture Directorate of environment; registration and management of fish farms; Fisheries production, sales, utilization, and management of feed and (D-Fish) Aquaculture chemicals products Directorate of Sanitary and safety inspection of seedling culture and fish farms; Fisheries preparation and oversight of Vietnam GAP guidelines (D-Fish) Operating a monitoring program for hazardous substances (e.g., chemicals and antibiotics) on fish farms, and a sanitary survey NAFIQAD program for bivalve shellfish production zones Directorate of Fished aquatic products Sanitary and safety inspection of fishing boats, ports, and wharfs Fisheries (D-Fish) Sanitary and safety inspection of facilities involved in all Distribution and pre-processing stages of aquatic products and processing facilities processing NAFIQAD aquatic products Sanitary and safety inspection of facilities involved in the collection, handling, processing, and sale of aquatic products Inspection and issuance of certification for aquatic products for NAFIQAD export (including edible live aquatic animals) Aquatic products for export Department of Export quarantine and issuance of certification of live aquatic Animal Health products (for non-edible purposes) (DAH) Noncompliant Tracking and retrieval of noncompliant aquatic products and NAFIQAD aquatic products appropriate improvement measures Department of Safety inspection, quarantine, and certificate issuance of imported Animal Health aquatic products Imported aquatic (DAH) products Safety inspection and management of imported aquatic products for processing NAFIQAD
90 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
The two organizations—the NAFIQAD and the DAH—that oversee the safety of farmed aquatic products, exports, and diseases have sufficient personnel in provincial areas. The D-Fish, which manages production (and production education), does not have enough regional personnel since it merged with central headquarters and requires outside support from the DAH’s regional offices.
▏Figure Ⅲ-11▕ The MARD Fisheries Products Safety Management Organization
MARD
NAFIQAD DAH D-Fish
- Seven regional animal health offices - Three regional sub-departments of animal - Two regional agencies health quarantine and inspection in Lao Cai, Lang Son, and Quang Ninh provinces
Provincial sub-departments Provincial sub-departments of Provincial of Agro-Forestry-Fisheries sub-departments of Quality Assurance (63) animal health (63) fisheries (63)
District veterinary stations, animal disease diagnosis, and quarantine stations
In the case of shrimp farming, the D-Fish is in charge of farmed aquatic products, including sanitary checkups for improving farming environment; the DAH is in charge of disease and veterinary management for live farmed products; and the NAFIQAD oversees the monitoring of hazardous substances in fish farms. Regional governments oversee aquatic products for domestic consumption. The NAFIQAD and the DAH inspect and certify aquatic products for export. The MARD has three Research Institutes for Aquaculture - RIA Nos. 1, 2, and 3. An RIA conducts research on inland and ocean aquaculture, including disease, environment, medicines, and feed.
91 3) The Directorate of Fisheries (D-Fish)
Vietnam’s Directorate of Fisheries (D-Fish) is a sub-organization of the MARD and is responsible for the management of aquatic products during the production stage, encompassing fishing production, aquatic resource management, and improvements to the aquaculture environment.72) Regarding the safety management of aquaculture products, the D-Fish covers the following activities. (1) It manages aquatic products to improve the aquaculture environment, such as the registration and management of fish farms and production, sales, and use of feed and chemicals. (3) It conducts sanitary and safety inspections of seedling farms, aquaculture farms, and wharfs, and prepares and manages Vietnamese good agricultural practices (GAP) guidelines. (3) It provides aquaculture technique training. Furthermore, the D-Fish is engaged in aquaculture production-related tasks in conjunction with the People’s Committees in each province. The Department of Agriculture and Rural Development (DARD) of each province is responsible for aquaculture-related work.
▏Figure Ⅲ-12▕ Organization of the D-Fish73)
D-Fish (Director General)
Deputy Director General Deputy Director General Deputy Director General
Scientific, Aquatic technological, Legislation resources Fishery Administration Planning & and Aquaculture Capture & conservation resources financial international fisheries inspection and surveillance cooperation development
Center for registration of Analysis and verification center Fishery information center fishing vessels for aquaculture
72) Decision No. 578/QD-TCTS-VP dated September 21, 2015 amending, supplementing decisions on defining the functions, tasks, powers and organizational structure of some units under Directorate of Fisheries. 73) https://tongcucthuysan.gov.vn/en-us/Introduction/Organizational-Chart
92 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
4) The National Agro-Forestry-Fisheries Quality Assurance Department (NAFIQAD)
(1) Organization The NAFIQAD’s central headquarters (HQ) is in Hanoi with eight HQ divisions, two regional authorities, six branches, and one center. Within the NAFIQAD, there are six regional branches—(1) Hai Phong, (2) Da Nang, (3) Nha Trang, (4) Ho Chi Minh Hamni, (5) Ca Mau, and (6) Ho Chi Minh Binh Thủy—in charge of actual analysis with central and southern regional authorities, as well as a Reference Testing and Agrifood Quality Consultancy Center (RETAQ) in Hanoi. In addition, the NAFIQAD has a department in each regional government at the provincial level.
▏Figure Ⅲ-13▕ Organization of the NAFIQAD
NAFIQAD (Director General)
Deputy DGs
Division of Division of Quality Quality Assurance Assurance for Division of Quality Laboratories Management Assurance for for Fishery Agro-Forestry Non-Food Products Division Products Products & Salt
Planning & General Finance Department Administrative Branches Division Division Inspectorate Office (9)
NAFIQAD Branches (9)
Central Region South Region Authority Authority Branch 1 Branch 2
Branch 3 Branch 4 Branch 5 Branch 6 RETAQ
93 (2) Function The NAFIQAD is a national organization responsible for the quality and safety of Vietnamese agricultural, forestry, aquatic, and salt products. Its main tasks are the quality control of agricultural products, management of food safety in the handling and processing of animal and plant products, food safety inspections of aquatic products for export, the operation of a national monitoring program and risk analyses, and evaluations of food quality and safety qualifications. In addition, it oversees domestic and foreign inspection standards, establishes laboratory standards, and manages registered facilities.
▏Table Ⅲ-24▕ Functions of the NAFIQAD
- Prepare a national monitoring program for aquatic product safety in the stages of farming, collection, harvesting, preserving, supplying, semi-processing, and processing of imported aquatic products or aquatic products for wholesale; program is then reported to the MARD and approved program is delivered by the NAFIQAD. - Provide technical regulations for the quality and safety of various aquatic products facilities: fish farms, collection and harvesting sites, ports, markets, ships, collectors, suppliers, preservers, and processing and wholesale facilities for the purpose of creating national standards. - Identify and transmit national standards, technical regulations, and requirements Quality and safety of international organizations and importing countries regarding the quality and management of safety of aquatic products. aquatic products - Inspection of sanitary conditions and subsequent issuance and withdrawal of hygiene certificates related to the safety of aquatic products at farms, fishing boats, wharfs, markets, harvesters, suppliers, preservers, and processing and wholesale facilities. - Inspection of food safety and subsequent issuance of certificates for imported and domestically produced aquatic products for further processing prior to export or domestic distribution. - Issuance of certificates through the quarantine of aquatic organisms for import, export, or customs clearance in accordance with Vietnamese law, requirements of international organizations, or bilateral agreements with importing countries.
94 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
- Supervise the implementation of monitoring programs, national standards, and technical regulations for the quality, sanitation, and safety of agricultural, forestry, and salt products by relevant government agencies. - Prepare the MARD regulations on the verification and tracking of noncompliant products. - Identify and distribute Vietnamese and international regulations on the quality, Quality and safety hygiene, and safety of agricultural, forestry, and salt products. management of - Inspect the sanitary status of manufacturers, growing facilities, cultivators, agricultural, breeders, suppliers, preservers, slaughterhouses, processors, and wholesalers of forest, and agricultural, forestry, and salt products. salt products - Inspect and certify food safety for imported and domestically produced agricultural, forestry, and salt products for further processing prior to export or domestic distribution in accordance with Vietnamese law, requirements of international organizations, or bilateral agreements with importing countries. - Track and confirm the causes of contamination of agricultural, forestry, and salt products, report the relevant agencies to the MARD, and take necessary follow-up measures. - Prepare programs, policies, national standards, and technical regulations for the quality management of non-food, agricultural, forestry, and aquatic products. - Propose measures to guarantee quality in the entire production chain of Quality control of non-food, agricultural, forestry, and aquatic products, and monitor and verify non-food agricultural, forestry, their implementation. and aquatic products - Inspect and certify food safety for imported and domestically produced non-food, agricultural, forestry, and salt products for further processing prior to export or domestic distribution in accordance with Vietnamese law, requirements of international organizations, or bilateral agreements with importing countries. - Identify and distribute Vietnamese, international, regional, and importing country requirements for inspection standards, residue limits, and inspection and test methods in relevant domains. - Instruct and supervise inspections on the quality and safety of agricultural, forestry, aquatic, and salt products. Testing and - Establish a national standard laboratory for establishing quality and safety inspections standards of aquatic products and certify laboratories with domestic and international standards for quality and safety standards for agricultural, forestry, aquatic and salt products. - Oversee the implementation of national standards and technical regulations for the quality assurance systems of testing laboratories for agricultural, forestry, aquatic, and salt products. - Evaluate and approve laboratory systems for inspecting agricultural, forest, aquatic, and salt products; prepare requirements and technical regulations for the evaluation and approval of capabilities of certification institutions for the Other quality and safety of agricultural, forest, aquatic, and salt products; implement testing methods, standard testing rules, and on-site testing equipment; participate in the establishment of an aquatic organism disease testing network.
95 5. Safety Management of Fishery Products
A. Safety Management of Fishery Products at the Production Stage
1) Safety Management of Seedlings and Seedling Farms
The Law on Fisheries oversees the safety management of seedling farms and seedlings (i.e., shrimp). Aquatic breeds must be on the list of aquatic organisms licensed for business in Vietnam before market distribution. They must adhere to applicable standards and technical regulations and be of a quality that meets the applicable standards. They must be quarantined in accordance with relevant laws. The MARD approves and distributes national technical regulations for aquatic breeds and submits to the government its list of aquatic breeds’ expiry dates and approved aquatic breeds for business in Vietnam. The ministry publishes guidelines on the quality of aquatic breeds for production, import, and export, as well as on the inspection of hatcheries and cultivating centers in adherence with the Law on Fisheries and Law on the Quality of Products and Goods. Organizations and individuals that produce aquatic breeds are required to obtain a certificate of eligibility that meets the conditions set forth in the relevant laws, including securing facilities and equipment for producing aquatic breeds and preparing isolated places to monitor the health of newly imported aquatic breeds.
2) Safety Management at the Farming Stage
Article 38 of the Law on Fisheries provides conditions for aquaculture farming facilities. They must have materials, facilities, and technical equipment suitable for aquatic breeds and farming methods; maintain adherence to laws related to environmental protection, veterinary drugs, and labor safety; and meet the requirements for laws on food safety. Furthermore, they must register the type of aquaculture and species farmed. The list of prohibited substances for aquaculture as managed by the DAH and the list of prohibited substances for aquaculture feed and the aquaculture environment as managed by the D-Fish are similar.74)
74) Circular No. 26 /2018/TT-BNN.
96 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
▏Table Ⅲ-25▕ Prohibited Substances in Feed and Environmental Management of Farming
Name of Chemical, Probiotic, or Microorganism Name of Antibiotic or Chemical Aristolochia spp and their preparation Aristolochia spp and their preparation Auramine (another name is yellow pyoctanine; glauramine) Chloramphenicol Chloramphenicol Chloroform Chloroform Chlorpromazine Chlorpromazine Ciprofloxacin Ciprofloxacin Clenbuterol Clenbuterol Colchicine Colchicine Cypermethrin Cypermethrin Cysteamine Dapsone Dapsone Deltamethrin Deltamethrin Diethylstilbestrol (DES) Diethylstilbestrol (DES) Dimetridazole Dimetridazole Enrofloxacin Enrofloxacin Fluoroquinolones group Fluoroquinolones Gentian violet (Crystal violet) Gentian violet (Crystal violet) Glycopeptides Glycopeptides Green malachite Green malachite Ipronidazole Ipronidazole Metronidazole Metronidazole Nitrofuran (including Furazolidone) Nitrofuran (including Furazolidone) Nitroimidazole group Nitroimidazole group Ronidazole Ronidazole Trichlorfon (Dipterex) Trichlorfon (Dipterex) Trifluralin Trifluralin Vat Yellow 1(other names are flavanthrone, flavanthrene, sandrothrene) Vat Yellow 2 (another name is Indanthrene) Vat Yellow 3 (another name is Mikethrene). Vat Yellow 4 (other names are Dibenzochrysenedione, Dibenzpyrenequinone)
97 3) Monitoring of Harmful Substance Residues in Farmed Aquatic Products
Vietnam operates a residue monitoring program, as well as a separate monitoring program that covers the sanitary inspection of bivalve shellfish production areas at the national level of food safety monitoring.75) Under the relevant regulations, these programs ensure food safety across all areas of aquatic products comprising farming, fishing, and processing, and the programs provide information on food safety during the production and transaction stages. Furthermore, they ensure that food safety conditions are met for aquatic products as requested by importing countries (the EU, the US, Korea, and New Zealand). They also provide data in recognition of safety management of aquatic products, as outlined in bilateral agreements between Vietnam and importing countries. The Residue Monitoring Program for Vietnamese farmed aquatic products and habitats is carried out under MARD-approved plans.76) The monitoring program is conducted by the relevant departments as per regulations.77) The detailed processes outlined in the Residue Monitoring Program are compiled according to the residues substance management manual and relevant guidelines provided by the NAFIQAD, and the manual and guidelines must be in compliance with relevant EU guidelines. The NAFIQAD develops a program plan every year that reflects the relevant EU regulations and guidelines on imported aquatic products,78) the monitoring results of previous years, and requests from importing countries (noncompliant items and species). The monitoring plan can be modified given the status of farming in a particular year, status of diseases, and monthly reports on the use of aquatic veterinary drugs, feed, chemicals, and probiotics.
(1) Institutions and Regions Responsible for Program Operations The NAFIQAD of MARD (i.e., the regional authority) provides oversight of the Residue Monitoring Program as its coordinating agency and residue monitoring (including sampling) is conducted by NAFIQAD-affiliated agencies in each city and province.79) NAFIQAD-affiliated laboratories conduct analyses of hazardous
75) NAFIQAD, 2019. Monitoring Program. http://www.nafiqad.gov.vn/monitoring-program_t229c102. 76) Circular No. 31/2015/TT-BNNPTNT dated October 6, 2015 of the Ministry of Agriculture and Rural Development, Provisions on monitoring of hazardous substances in animals and aquatic animal products. 77) Circular No. 31/2015/TT-BNNPTNT dated 06 October 2016. 78) Directives 96/22/EC, 96/23/EC, Regulation (EC) 2377/90, (EC) 470/2010, (EC) 37/2010, etc. 79) NAFIQAD, 2019. Monitoring Program. http://www.nafiqad.gov.vn/monitoring-program_t229c102
98 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
substances. As of 2017, residue monitoring is being carried out in eight cities and provinces in the northern region (36 farms), 11 cities and provinces in the central region (49 farms), and 18 cities and provinces in the southern region (81 farms), totaling 37 cities and provinces and 166 farms.80)
▏Table Ⅲ-26▕ Areas of Hazardous Residues Monitoring Program in Vietnam (as of 2017)
Region City and Province Number of Farms
Northern region Quang Ninh, Hai Phong, Thai Binh, Nam Dinh, Ninh Binh, (Eight cities and 36 provinces) Thanh Hoa, Nghe An, Ha Tinh
Central region Quang Binh, Quang Tri, Thua Thien Hue, Quang Nam, Quang Ngai, (11 cities and 49 provinces) Binh Dinh, Kontum, Daklak, Phu Yen, Khanh Hoa, Ninh Thuan Ben Tre, Tien Giang, Long An, Ho Chi Minh City, Dong Nai, Southern region Ba Ria - Vung Tau, Binh Thuan, Tay Ninh, Ca Mau, Bac Lieu, (18 cities and 81 provinces) Soc Trang, An Giang, Can Tho, Dong Thap, Hau Giang, Kien Giang, Tra Vinh, Vinh Long Total 37 cities and provinces 166
(2) Analysis Items and Residue Standards The monitoring items for aquaculture products, including prohibited chemicals, veterinary drugs, and pollutants (e.g., heavy metals and pesticides), are listed in Table III-27.
▏Table Ⅲ-27▕ Hazardous Substances Maximum Residue Limit
80) The results up to 2016 of the monitoring program in English can be found on the NAFIQAD website, http://www.nafiqad.gov.vn/the-residues-monitoring-program-for-certain-harmful-substances-in-aquaculture-fish-and-pr oducts_t221c102n187(visited 2019. 12. 15).
- Group A6 (Prohibited substances): Chloramphenicol, nitrofurans, nistroimidazoles. - Group B1 (Antibacterial substances): Tetracyclines, quinolones, sulfonamide, trimethoprim, florfenicol, neomycin - Group B2a (anti-worm substances, parasiticides and trifluralin): Praziquantel, ivermectin, trichlorfon, trifluralin. Intensive - Group B3a (organochlorine pesticides): Aldrin, dieldrine, endrine, heptachlor, Aquaculture Farms DDT, chlordane, hexachorobenzen, lindane - Group B3c (heavy metals): Pb, Cd, Hg - Group B3e (dyes): Malachite green/leucomalachite green - Group A1 (stilbens): Diethylstilbestrol - Group A3 (steroids): Methyltestosterone
(3) Research Items and Sampling Criteria Sampling is performed by regional authorities based on plans approved by the MARD. Based on monthly results, the NAFIQAD headquarters and regional authorities for the central and southern regions control the monthly sampling plans depending on the status of aquaculture in each relevant (i.e., provincial) government region. Monitoring of aquaculture products targets farmed aquatic organisms with high production volumes (e.g., shrimp, tilapia, and catfish), with a number of samples, as shown in Table III-29.
101 ▏Table Ⅲ-29▕ Production and Sampling Amounts for Major Farming Species (as of 2018)
Estimated Aquaculture Production in 2018 Aquaculture Fish Species Intensive Extensive Number of Farming Farming Total Samples (in tons) (in tons) (in tons) Black tiger shrimp (Penaeus monodon) 55,353 157,719 213,072 569
White shrimp (Penaeus vannamei) 208,837 100 208,937 1,387 Giant prawn (Macrobrachium rosenbergii) 800 - 800 8 Tilapia (Oreochromis spp) 23,494 - 23,494 83 Red Tilapia (Oreochromis spp) 22,858 - 22,858 79 Tra catfish (Pangasius hypophthalmus) 511,181 - 511,181 1,024 Other fish (Tre Catfish, Climbing perch, 18,460 - 18,460 95 Snakehead, Bronze featherback) Crab (Scylla serrata) 1,190 - 1,190 14 Juvenile fish ---60 Water at shrimp hatcheries ---66 Total 840,983 157,819 998,802 3,371
In principle, the sampling rate for residue monitoring for aquaculture farms is one sample per 100 tons of production volume. The sampling rates are controlled for each species based on the actual status of farming based on the NAFIQAD’s risk assessments. Currently, the modifications are based on farmed production volumes and are implemented as follows. For intensive shrimp farming, the sampling rate of green tiger prawn is one sample per 100 tons and for whiteleg shrimp is one sample per 150 tons. This is because whiteleg shrimp is intensively farmed on high-density farms. In other words, eight to 12 tons of whiteleg shrimp are produced in a one-hectare aquaculture farm, which is twice the production volume of green tiger shrimp. As such, the sampling rate applied for whiteleg shrimp is appropriate for effectively managing residual chemicals and antibiotics. Extensive shrimp farms can only be set up in a small number of provinces that have forests and extensive water surface area with the appropriate salt content. In other words, extensive shrimp farms cover large areas over five hectares and the shrimp are raised naturally. Due to the large area and low density, farmers with extensive farms do not use feed or aquatic veterinary drugs to treat and prevent
102 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products diseases. Therefore, on intensive shrimp farms, samples are taken one to two times per year during the period in which commercial-sized shrimp are being raised and only environmental contaminants are analyzed from these samples. In the case of catfish (e.g., Tra catfish), the sampling rate is one sample per 500 tons of production. This low sampling rate is due to the high-density farming method that produces more than 500 tons of catfish per one hectare. Therefore, this sampling rate can guarantee the effective management of residual chemicals and antibiotics for Tra catfish. The sampling rates for other farmed aquatic organisms (e.g., snakeheads, tilapia, anabas, and black knife) are one sample per 200 tons of production, which can guarantee the effective management of residual chemicals and antibiotics.
(4) Number of Inspections and Noncompliant Cases by Year (2010–2017) The 2010–2017 results for residual harmful substances in farmed aquatic products in Vietnam indicate that noncompliant samples occurred at an annual rate of between 0.78% and 1.46%. The A1 (diethylstilbestrol) and A3 (methyltestosterone) group’s substances were identified in three samples in 2013 but were not detected in any other years. This indicates that the use of prohibited hormones or growth promoters in Vietnamese aquaculture is currently being appropriately managed. Prohibited antibiotics in the A6 group (e.g., chloramphenicol, nitroimidazole, and nitrofuran), were detected almost every year. Therefore, it appears that aquaculture farmers were illegally utilizing these prohibited substances, which indicates that the relevant authorities need to further strengthen supervision, management, and education. Tetracycline- and sulfonamide-based antibiotics from the B1 antibiotic substances group were detected, so ongoing guidance and management is required to prevent the shipping of noncompliant aquatic products. In March 2012, Vietnam banned the use of the antibiotic substances enrofloxacin and ciprofloxacin in aquaculture. Nonetheless, their continued detection suggests that these banned substances are still being used to treat diseases in aquaculture organisms, so strengthening their monitoring, management, and supervision is necessary. Trifluralin was banned from aquaculture in Vietnam in 2010, but this substance nonetheless continues to be detected. Therefore, further control and supervision of this substance is also required.
103 Malachite green, a type of dye, and its metabolites were also detected. Since this substance continues to be used for disease prevention and treatment of aquatic organisms, government control of its illegal use should also be further strengthened.
▏Table Ⅲ-30▕ Annual Inspection and Number of Noncompliant Cases (2010–2017)
Number of Number of Year Inspections Noncompliant Cases Noncompliant Items (%)
(5) Measures Undertaken for Noncompliant Farms that Exceed Allowable Limits The discovery of noncompliant samples by the Residue Monitoring Program prompts the following measures being implemented in aquaculture facilities.
104 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
For small facilities, regional authorities require the facility owner to identify the cause of contamination, launch follow-up measures, and strengthen sampling. For commercial-scale facilities, the facility owner should cease harvesting, identify the cause of contamination, launch follow-up measures, and strengthen the monitoring and sample collection of pre-harvested farmed aquatic products. Harvesting is only allowed once the strengthened sampling process yields satisfactory results. However, if harvesting is already completed, local authorities require the facility owners to identify the cause of contamination and take corrective measures. In addition, the contaminated batch of aquatic products must be retrieved, sampled, and investigated. Once the sample tests are satisfactory, the batch will be released for distribution. For intermediaries and processing-stage products, regional authorities require intermediary and processing plant owners to identify the cause of contamination and take corrective measures. In addition, the contaminated batch of aquatic products should be retrieved, sampled, and investigated. Once the sample tests are satisfactory, the batch will be released for domestic distribution. If test results are unsatisfactory, the batch can be exported to other countries or its use may be modified.
B. Safety Management of Fishery Products During the Processing and Distribution Stages
1) Safety Management
(1) Safety Inspection and Certificate Issuance for the Production and Storage of Aquatic Products Safety inspection and certificate issuance for production stage facilities (e.g., farming, capture) is managed by the D-Fish of MARD and implemented by the D-Fish or subsidiary regional authorities.81) Inspection and certificate issuance for collection, storage, and processing facilities is managed by the NAFIQAD. These are the responsibilities of the NAFIQAD’s subsidiary regional authorities.82)
105 (2) Safety Inspection and Certificate Issuance of Export Processing Facilities Vietnam’s export processing facilities have different standards for sanitary management under MARD regulations.83) The NAFIQAD inspects and issues certificates for export processing facilities, assigns sanitary grades84) to processing facilities that intend to export, and conducts regular monitoring of exported products.
▏Table Ⅲ-31▕ Rating and Inspection Cycle of Export Processing Facilities
Grade Inspection cycle A Inspected every 18 months after certificate issuance (once per year) B Inspected every 12 months after certificate issuance (twice per year) C Failing grade
Facilities that achieve the grades of A and B are given priority for registration and are able to apply for export. Furthermore, exporting aquatic products to Korea and other foreign countries requires online registration prior to export. Sanitary certificates are issued through document reviews and field tests.
2) Inspection Items and Standards for Vietnamese Aquatic Products
The inspection items and criteria for Vietnamese aquatic products are prepared in accordance with the Agreement on Aquatic Product Sanitation between Korea and Vietnam.85)
(1) Aquatic Products and Processed Products (cook-before-eating)
The inspection items for refrigerated and frozen natural aquatic products and refrigerated and frozen aquaculture products are the same, with the exception of nitrofuran detection. Nitrofuran must not be detected in aquaculture products. Clostridium perfringens (Cl. Perfringens) levels are included for dried products. Salmonella and antibiotics such as chloramphenicol and nitrofuran should not be detected in natural, aquaculture, or dried aquatic products.
83) Circular 48/2013/TT-BINNPTNT. 84) Circular 48/2013/TT-BINNPTNT. 85) Overseas business trip information system: Overseas business trip report, https://btis.mpm.go.kr/rpt/selectRptList.do
106 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
▏Table Ⅲ-32▕ Inspection Targets and Items for Fishery Products (cook-before-eating)
Number Target Inspection Item Standard Total plate count (CFU/g) 1,000,000
E. coli (CFU/g) 100 Refrigerated and Salmonella (in 25g) Negative 1 frozen aquatic products (Excluding aquaculture products 100 and bivalve shellfish) S. aureus (CFU/g) V. parahaemolyticus (CFU/g) 100 Chloramphenicol ND Total Plate Count (CFU/g) 1,000,000
E. coli (CFU/g) 100 Salmonella (in 25g) Negative Refrigerated and frozen 2 aquaculture products S. aureus (CFU/g) 100 V. parahaemolyticus (CFU/g) 100 Chloramphenicol ND Nitrofurans (AOZ, AMOZ, SEM, AHD) ND Total Plate Count (CFU/g) 1,000,000
E. coli (CFU/g) 10 Coliform 100 3 Dried products (Pre-treated products) Cl. Perfringens 20 Salmonella (in 25g) Negative
S. aureus (CFU/g) 100
(2) Processed Aquatic Products (ready-to-eat) Ready-to-eat aquatic products are required to meet higher inspection standards as compared with cook-before-eating aquatic products. The total plate count is 100,000, which is 10 times lower than that of cook-before-eating aquatic products. The standard for E. Coli is three, which is lower than the criteria for cook-before-eating natural and farmed products (i.e., 100).
107 ▏Table Ⅲ-33▕ Inspection Targets and Items for Fisheries Products (ready-to-eat)
Number Target Inspection items Standard Total Plate Count (CFU/g) 100,000
E. coli (CFU/g) 3 Refrigerated and Salmonella (in 25g) Negative 1 frozen aquatic products (Excluding aquaculture products 10 and bivalve shellfish) S. aureus (CFU/g) V. parahaemolyticus (CFU/g) 10 Chloramphenicol ND Total Plate Count (CFU/30℃/g) 50,000
E. coli (CFU/g) Negative
S. aureus (CFU/g) 10 2 Dried products Salmonella (in 25g) Negative Shigella (in 25g) Negative V. parahaemolyticus (CFU/g) Negative Fungi (CFU/g) Negative
3) Issues Found by Korean Authorities’ Inspections of Vietnamese Processing Facilities
The following was prepared based on NFQS inspection reports on registered export facilities in Vietnam.86)
(1) Agreement on Fishery Product Sanitation Korea and Vietnam signed the Korea–Vietnam Agreement on Sanitation of Import and Export Fisheries on July 6, 2000 in Hanoi, Vietnam. The agreement has since been revised three times—in 2002, 2004, and 2007—and the official name changed to the Korea–Vietnam Agreement on Fisheries Products Quality Management and Sanitation (November 14, 2007). In 2016, the Korea–Vietnam Agreement on Fisheries Product Quality Management and Sanitation Safety (2007) and the Agreement on Live Animal Sanitation (2013) were combined to create the Korea–
86) Source: Overseas business trip information system: Overseas business trip report. https://btis.mpm.go.kr/rpt/selectRptList.do
108 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
Vietnam Agreement on Fisheries Products Sanitation (September 12, 2016). This new agreement covers the sanitary requirements for aquatic product transactions between the two countries; guaranteed live aquatic product disease prevention; the cessation of imports in the event of any sanitary or safety issues; regular sanitary inspections for aquatic product export processing facilities; and systems for the sanitation, safety, quarantine, and inspection of aquatic products.
(2) Inspection Standards and Items for Processing Facilities In accordance with Article 4 (Registration and Management of Facilities) of the Korea–Vietnam Agreement on Fisheries Products Sanitation, Korean sanitation authorities will conduct periodic sanitary inspections of registered facilities in the country of import. To this end, Korean authorities regularly inspect the sanitation management of registered Vietnamese export facilities to ensure imported aquatic product safety. Korean authorities conducted a total of 35 inspections of 219 registered facilities in Vietnam between 2002 and 2019.
▏Table Ⅲ-34▕ Korean Government’s Inspections of Registered Facilities in Vietnam (2002–2019)
2002– Category 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Total Number of inspections 1822212222235 Inspection areas 2265434554462
Inspection criteria are based on the Sanitary Management Standards of Production and Processing Facilities of Fisheries Products and Production Zones (MOF Notification 2015-3) and On-Site Due Diligence Methods and Criteria of Foreign Manufacturing Facilities (MFDS Notification 2017-81) and are categorized into the following inspection areas: work site, equipment, sanitation management, record management, and laboratories, as shown in Table III-35.
109 ▏Table Ⅲ-35▕ Checklist for Registered Facilities
Category Main Inspection Items - Measures to prevent cross-contamination such as separation of processes Work site - Status of sanitation management around the facility - Appropriateness of product packaging and transportation methods - Adequacy of building structures and equipment, such as water pipes Equipment - Cleanliness of surfaces that come into contact with food - Installation and operation of metal detectors - Status of sanitary management for processing water and ice supplies Sanitation management - Status of sanitary management and supervision of employees - Proper labeling, storage, and use of toxic substances Records - Status of management, including self-inspection, to remove harmful substances management - Status of various records regarding sanitary management Laboratory (own) - Operation and management of laboratories; export inspections and history
(3) Inspection Results Korea conducted a total of 35 inspections of 219 registered Vietnamese companies between 2002 and 2019. Of these, 13 inspections were performed in 70 facilities between 2013 and 2019. The inspections primarily took place in facilities with a history of noncompliance with Korea’s import inspection regulations. The main products produced at the facilities inspected were simple frozen processed foods, including frozen shrimp, peeled shrimp, cephalopods (e.g., squids, octopus, and baby octopus), catfish, and snakeheads. Vietnam’s aquatic product export processing facilities are enforced by mandatory HACCP according to EU regulations,87) with comprehensive sanitary management systems including regular HACCP training. Furthermore, HACCP’s critical control points (CCP) include the temperature of raw materials at time of input, antibiotics for farmed aquatic products, parasites, and metal detection. The water supply used for processing is generally groundwater, although some facilities use public water supplies. The processing water sources for all supplies is inspected by designated inspection agencies, such as the NAFIQAD, for water quality (microorganisms, etc.), with inspection histories to be kept in good order. Employees are subject to regular annual health inspections and provided with education from nationally
87) Decision 2004/267 / EC, Regulations on the Import Conditions of Vietnamese Aquatic Products, 2004.3.17.
110 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
designated educational institutions. Companies with their own laboratories conduct inspections for microorganisms in both their raw material inputs and completed products. They outsource inspections to the NAFIQAD or external analysis partners for the inspection of items such as antibiotics and other situations that make self-inspection difficult. Furthermore, the NAFIQAD regularly monitors products designated for export. However, many registered facilities lack the proper management of insects, high temperatures inside and outside of work sites, and equipment and containers for work processes, which indicates risk for cross-contamination. The key noncompliant inspection items for each facility, by year, are listed in Table III-36.
▏Table Ⅲ-36▕ Main Results of Registered Facilities Inspection in Vietnam (2013–2019)
Period Target Major Noncompliant Items - Lack of separation between water (groundwater) intake pipes and Fourteen8 external storage areas and ice manufacturing facilities for processing 2013.11.24–11.30 facilities - Poor drainage (leakage, etc.) of handwashing facilities (14) - Insufficient separation of exterior and interior of the facility for prevention of insects and to accommodate high temperatures Seven - Poor drainage (leakage, etc.) of handwashing facilities 2014.12.7–12.13 facilities - Insufficient separation of exterior and interior of the facility for (7) prevention of insects and to accommodate high temperatures - Poor drainage (leakage, etc.) of handwashing facilities Eleven - Poor measures for preventing contamination of processing water 2015.11.8–11.14 facilities (11) - Risk of cross-contamination and poor management of facilities for accommodating hot weather - Equipment damage and risk of cross-contamination from washing Ten water (extended drainage) 2016.12.5–12.8 facilities (10) - Lack of pedal-type trash cans in washrooms and work areas, poor storage and management of disinfectants, and poor sanitary conditions - Poor management of processing water tank and sanitary management Twelve during ice manufacturing 2017.12.6–12.11 facilities - Poor pest management (i.e., cracks between insect proof nets) - Damage to equipment (sewage pipes, etc.) - Poor exterior and interior management of work sites for the prevention of insects and to accommodate high temperatures Eight 2018.10.15–10.19 facilities - Improvements required for work sites, including temperature management - Risk of cross-contamination due to poor management of work equipment and containers Eight - Poor pest management in some registered facilities 2019.11.18–11.22 facilities - Poor waste management in some registered facilities
111 (4) Implications Improvements that should be made to registered facilities in Vietnam include the following. (1) The separation of work sites between work processes and the maintenance of sanitation to prevent cross-contamination with other materials. (2) In the case of facility equipment, the materials, equipment, tools, and containers that directly contact food must be composed of stainless steel or plastic, materials that can prevent contamination. Furthermore, strict sanitation management by cleaning and disinfecting before and after work processes is necessary to prevent cross-contamination. Wastewater from cleaning facilities must be discharged directly to exterior areas through pipes. Drying devices are necessary to ensure that hand-washing is undertaken under sanitary conditions. (3) Aquatic product processing facilities often use groundwater for processing water and ice supplies, so more attention must be paid to sanitation management in this respect. Furthermore, when processing ice is manufactured on site or externally purchased, it must be inspected by accredited institutions and records must be kept. (4) To maintain employee hygiene, employees must be subject to regular health checkups (once or twice annually, depending on the type of work) and hygiene management training. They must also wear protective clothing, including hats, shoes, and gloves, before and after work, depending on personal hygiene management standards. (5) Insect and heat prevention must be provided to accommodate the local climate and prevent conditions in which rodents and insects can thrive; as such, insect nets and window screens must be installed and managed to prevent pests.
C. Safety Management of Fishery Products Exports
The NAFIQAD and the DAH are responsible for the import and export of Vietnamese aquatic products. The DAH conducts inspections and issues import sanitation certificates for aquatic products imported into Vietnam. The NAFIQAD is responsible for on-site inspections and the registration of imported aquatic products companies. In addition, the NAFIQAD is responsible for the safety inspections of aquatic products exported from Vietnam, issuance of sanitation certificates, and registration of exporting companies.
112 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
▏Table Ⅲ-37▕ Vietnamese Organizations in Charge of Import and Export Safety Fishery Products
Facility Authority Cargo inspection upon arrival (document inspection, sample testing), import DAH hygiene certificate issuance Import Confirmation of registration documents, including export approvals to Vietnam NAFIQAD On-site inspection of the exporting country (if necessary) Inspection of food safety in producers Export NAFIQAD Approval and inspection of exporting companies, issuance of sanitary certificates in accordance with importing country’s requirements
1) Issuance of Sanitation Certificates for Aquatic Products for Export
Vietnamese legislation mandates inspections prior to export.88) The MARD inspects aquatic products for export and issues sanitation certificates.89) The certificate refers to the document required by the importing country, or a certificate that is required under the agreement between NAFIQAD and the authorities of the importing country (EU, Korea, China, Russia, Brazil, Indonesia, etc.). Furthermore, under these regulations, the ① registered facilities on the list are issued sanitation certificates after the collection and testing of samples within 1% to 20% of the production lots, and ② unregistered facilities are issued sanitation certificates after testing of each export shipment. The inspection items are subject to the MARD regulations and NAFIQAD inspection guidelines. Fish and crustaceans are commonly tested for chloramphenicol, etc.,90) with fish further tested for mercury, lead, and cadmium, and crustaceans tested for doxycycline and oxytetracycline.91) Some importing countries (Japan, the US, etc.) do not require NAFIQAD sanitation certificates, but sometimes exporters require a certificate. Most countries that import aquatic products only import products produced by registered facilities with guaranteed safety. The registration of processing facilities for export purposes is handled by NAFIQAD; as of 2020, a total of 709 facilities
88) Circular No. 48/2013/TT-BNNPTNT, 11 November 2013; Decision No. 2864/QĐ-BNN-QLCL, 14 November 2012; Decision No. 1471/QĐ-BNN-QLCL, 20 June 2012; official letters No.2440/QLCL-CL1 of 18/11/2014, No.157/QLCL-CL1 of 19/01/2015 and No. 1243/QLCL-CL1 of 13/5/2015. 89) Circular No. 48/2013/TT-BINNPTNT, 02/2017/TT-BINNPTNT. 90) Chloramphenicol, nitrofurans, malachite green, leucomalachite green, enrofloxacin, trifluralin. 91) EU report p. 7.
113 have been registered after meeting the Vietnamese guidelines. Among them, 748 have been registered for export to Indonesia, followed by China (737), Korea (728), and the EU (562).
▏Table Ⅲ-38▕ Approved Fishery Product Processing Facilities in Vietnam, by Nation (as of March 2020)
Exporting Country Number of Establishments 1 The EU 562 2 Korea 728 3 China 737 4 Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan 32 5 Brazil 161 6 Argentina 206 7 Indonesia 748
2) Management of Exported Non-compliant Products and Production Facilities
The NAFIQAD of the MARD requires the exporting company to track, identify cause, implement follow-up measures, and demonstrate the implementation of non-compliant products as notified by the importing country.92) Even after the exporting company has identified the cause of contamination and implemented their follow-up measures, the NAFIQAD collects and tests samples on five consecutive occasions for export products produced by the same company. Furthermore, it retracts certificates for the export of aquatic products for noncompliance based on the request of an importing country and engages in corrective measures. In the cases of countries with sanitation agreements for aquatic products, they are notified of the corrective actions and testing results for non-compliant aquatic product exports under their respective agreements.
114 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
▏Table Ⅲ-39▕ Status of SPS Agreements between Vietnam and Other Nations (as of 2018)
Country Details EU EU regulations on seafood imports (Decision 2004/267 / EC) Agreement on the sanitation of imported and exported aquatic products (first in Korea 2000, 2002, 2004, 2007, 2013, 2016) Agreement for mutual cooperation on the safety management of import and export China aquatic products (2014) Protocol on quality and safety management of exported seafood products from Russia Russia; Memorandum of Understanding between FSVPS and NAFIQAD on trade marine product safety Agreement on sanitary measures applied to products imported to New Zealand New Zealand with the New Zealand Food Safety Authority Agreement on the implementation of quality and safety management of marine Indonesia products (2011) SENASA-NAFIQAD Protocol on animal- and plant-based import and export Argentina products
As per EU regulations, exporters are responsible for the requirements and corrective measures related to the use of prohibited substances. Farmed fishery products containing prohibited substances are not excluded from the food chain.93) An operator can continue to engage in aquaculture until no prohibited substances are detected or sample testing verifies levels below minimum residue performance limits. Farmed aquatic products containing prohibited substances can be distributed domestically in Vietnam or exported to countries that do not control the use of prohibited substances. Aquatic products exported to other countries could possibly be re-imported to the EU or Korea after processing.
D. Safety Management of Fishery Product Imports
1) Import Status and Customs Process
While Vietnam is an exporter of aquatic products, it also imports large quantities of aquatic products, such as tuna and shrimp, which are used mainly as raw materials
93) EU report p. 10.
115 in processing. The following table shows the status of shrimp imports by source country. Vietnam imports more than $300 million of shrimp from India annually. Although Vietnam imports shrimp from neighboring Southeast Asian countries such as Indonesia, Myanmar, Thailand, and Malaysia, it also imports significant volumes from Ecuador, Argentina, Mexico and the US. Maintaining quarantine and safety management is important when importing shrimp from other countries.
▏Table Ⅲ-40▕ Status of Vietnam’s Shrimp Imports by Nation (Units: USD) Country 2014 2015 2016 2017 Total India 345,403,720 317,171,218 263,263,985 333,359,228 1,259,198,151 Ecuador 22,387,470 13,506,457 5,021,459 32,060,776 72,976,162 Argentina 7,129,539 5,819,862 9,701,251 19,514,236 42,164,888 Indonesia 19,516,033 6,353,744 8,655,546 4,732,520 39,257,843 United Kingdom 6,773,677 7,263,050 8,626,505 6,998,810 29,662,042 Thailand 1,187,539 2,794,586 6,465,013 2,915,670 13,362,808 Australia 1,241,048 1,747,431 2,656,241 3,581,229 9,225,949 Bangladesh 1,782,336 366,339 4,939,166 1,816,776 8,904,617 Pakistan 2,874,197 2,022,688 1,590,132 1,385,327 7,872,344 Myanmar 4,538,912 667,431 526,009 1,904,998 7,637,350 Malaysia 2,882,408 1,105,771 584,252 1,657,269 6,229,700 Saudi Arabia 184,015 356,034 699,634 1,057,728 2,297,411 Sri Lanka 1,449,079 79,495 1,528,574 United States 312,120 711,795 448,891 1,472,806 Canada 100,671 33,691 760,301 149,165 1,043,828 Japan 188,512 4,255 39,425 464,301 696,493 China 151,909 136,823 204,281 493,013 UAE 483,876 483,876 South Africa 443,906 443,906 Belgium 421,447 421,447 Russia 4,545 228,296 232,841 Mexico 89,414 137,735 227,149 Philippines 180,402 14,284 194,686 Nicaragua 162,275 162,275 Honduras 149,891 149,891 Singapore 110,713 110,713
116 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
Country 2014 2015 2016 2017 Total Ghana 91,590 91,590 Brunei 91,200 91,200 Korea 88,393 88,393 Denmark 60,950 60,950 Mozambique 42,429 42,429 Nigeria 6,175 6,358 17,459 29,992 Suriname 9,932 9,932 Norway 7,000 7,000 Cote D’Ivoire 6,705 6,705 Peru 3,746 3,746 New Zealand 250 250 Other 18,025,850 24,693,352 17,245,482 16,905,996 76,870,680 Total 436,451,201 385,597,171 331,651,140 430,054,118
Source: GSOVietNam, available at https://www.gso.gov.vn/xnkhh/Default.aspx.
The typical import customs clearance process in Vietnam follows this order: (1) import declaration (submission of documentary evidence) → (2) customs document review → (3) inspection of items → (4) payment of customs duties → (5) export of goods. Importers can declare their imports with paper documents or electronically. Customs clearance is carried out at the port of entry. Customs inspection comprises a customs declaration from the importer and an actual inspection to confirm whether declarations match the imported goods. Furthermore, the declared goods under electronic customs (i.e., e-Customs) are classified into the following three types: Green Flow goods are accepted as declared on electronic customs forms; Yellow Flow goods are subject to document review to verify the goods and submitted documents; and Red Flow goods are subject to both document review and the inspection of goods. The inspection of goods takes place in designated areas such as customs-controlled docks or storage areas, and goods that are delivered door to door, customs officers are dispatched to inspect them on site.94) Figure III-14 illustrates the process for importing, processing, and exporting aquatic products. The DAH performs the quarantine and safety inspections of imported aquatic products and the NAFIQAD oversees the safety inspections of exported processed products.
94) TradeNavi (Ministry of Trade, Industry and Energy and Korea International Trade Association): Customs procedures by country, http://www.tradenavi.or.kr/CmsWeb/viewPage.req?idx=PG0000001827&natnCd=VN
117 ▏Figure Ⅲ-14▕ Re-Exportation Process after Processing Imported Fishery Products95)
The quarantine of imported aquatic animals is regulated by the Law on Veterinary Medicine and the Circular on the Quarantine of Aquatic Animals and Aquatic Animal Products. Under the Law on Veterinary Medicine, aquatic animals moving from one province to another and those that are imported or exported must be subject to quarantine.96) Aquatic animals and animal products that are imported, temporarily imported, temporarily exported, or transported through the territory of Vietnam; aquatic animals required for expos, exhibitions, sporting competitions, and art exhibitions; and pathological specimens of aquatic animals and their products must be subject to quarantine under the regulations (Article 44–Article 52).97)
▏Table Ⅲ-41▕ Vietnamese Legislation Related to Quarantine
Animal health Law on Veterinary Medicine No. 79/2015/QH13, June 19, 2015 Management of feed for farmed products Decree 39/2017/ND-CP Quarantine and safety inspection of aquatic animals and products Circular 26/2016, June 30, 2016
Management of animal-based feed for Circular 35/2018 farmed products
Annex II of circular 26 of the Law on Veterinary Medicine on the quarantine of aquatic animals and aquatic animal products lists the products subject to quarantine (exemptions).98) Scaled fish, catfish, other fish species, crustaceans including shrimp and crabs, amphibians, reptiles, aquatic animals requiring quarantine in the importing country, and aquatic animals requiring quarantine under international treaties are all subject to quarantine in Vietnam.
95) USAID Oceans and Fisheries Partnership (2018), Vietnam CDT gap analysis and partnership appraisal, p. 22. 96) See Law on Veterinary Medicine Chapter 3 section 2. 97) Ibid. art. 58. 98) Circular No. 26/2016/TT-BNNPTNT, dated June 30, 2016, Appendix I, List of aquatic animals and aquatic animal products subject to quarantine, exempted from quarantine.
118 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
▏Table Ⅲ-42▕ Aquatic Animals for Quarantine in Vietnam
Fish Scaled fish, catfish, and other fish Crustaceans Shrimp, crab, spider crab, and other crustacean species that live underwater Squid, octopuses, snails, mussels, scallops, and other mollusk species that live Mollusks underwater Amphibians Frogs, paddocks, and other amphibian species Turtles, tortoises, alligators, and reptilian species that live underwater or other Reptiles amphibian reptiles Coelenterata Jellyfish, zooplankton, and coral Echinoderms Nudibranchs and sea urchins Sponges Mammals that live in the water Whales, seals, otters, and other mammalian species that live in the water Other aquatic Other aquatic animals subject to quarantine as required by the importing countries animals or the provisions of international treaties to which Vietnam has signed or acceded.
Aquatic animals and aquatic animal products imported through diplomatic channels and imported simply processed aquatic animal products for individual consumption (i.e., weighing less than 0.5 kg), are exempt from quarantine.99) The list of quarantined aquatic animals and aquatic animal products, and the lists of disease-causing crustaceans, fish, mollusks, amphibians, reptiles, pathogenic microorganisms, and parasite-causing diseases can be found in Annex III. A. in Circular 26 of the Law on Veterinary Medicine. There are 23 crustacean diseases that are subject to quarantine, including WSD, AHPND, and EHP. There are 23 diseases registered for fish, 11 for mollusks, three for amphibians, six for reptiles, and six common to all aquatic animals. Circular 26, Annex IV A. 1. of the Law on Veterinary Medicine includes the criteria for the testing and surveillance of aquatic animals. There are eight crustacean diseases, five fish diseases, and one mollusk disease subject to testing and surveillance. There are eight crustacean diseases subject to testing and surveillance, including WSD, TS, YHD, AHPND, EHP, and lobster milky disease.
99) Ibid.
119 ▏Table Ⅲ-43▕ Disease Markers for Tests and Monitoring of Vietnamese Crustaceans
No. Name of Disease Pathogenic Agent Raised Aquatic Animals with Susceptibility Giant tiger prawn (Penaeus monodon), White spot disease White spot syndrome 1 pacific white shrimp (Litopenaeus vannamei), (WSD) virus (WSSV) tôm hùm (Panulirus sp.), cua biển (Scylla serrata)
Circular 26, Annex IV. A. 2 of the Law on Veterinary Medicine defines the monitoring cycles. Sampling for regulated pathogens should be conducted once every two months for farms that are not perceived as diseased in terms of their collection and sales facilities, or those that are not monitored for diseases. If the owner of the facility does not conduct regular monitoring, the regional animal quarantine agency collects samples to confirm each shipment’s standards. The number of samples collected for monitoring related to pathogens with 10% prevalence must adhere to the guidelines presented in Annex IV, Section 3. Prior to the transport of aquatic animals from the region, if the animal is found to be
120 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
healthy and free of pathogens based on pathogen monitoring and clinical tests, the regional animal quarantine agency must issue a quarantine certificate to transport the aquatic animal from the region. Circular 26, Annex IV. A. 2. defines the criteria for the testing and monitoring of aquatic animal products. The inspection criteria for cook-before-eating fishery products include salmonella and E. Coli. These evaluation standards comply with Vietnamese standards and technical regulations, as well as international regulations on food safety.
▏Table Ⅲ-44▕ Criteria for Checking and Evaluating Aquatic Animal Products
Types of Products Checked Criteria Criteria for Evaluation Total aerobic bacteria Salmonella Fresh fish and seafood: Frozen E. coli fish, fresh fish, mollusks, fish products (heat treated prior to use) Cl. perfringen S. aureus V. parahaemolyticus Total aerobic bacteria Coliforms E. coli Products made from fish and S. aureus seafood (direct use, not Cl. perfringens heat-treated before use) The regulations, standards, Salmonella and technical regulations V. parahaemolyticus of Vietnamese international regulations on food safety. TSBTNM-M Total aerobic bacteria Coliforms Dried aquatic products simply E. coli prepared (must be heat-treated S. aureus before use) Cl. perfringens Salmonella V. parahaemolyticus E. coli Crustaceans and mollusks with Staphylococci (Positive with coagulase) shells or heated and peeled Salmonella
121 The inspection standards for ready-to-eat aquatic products include monitoring for E. coli (Coliforms) and TSBTNM-M, in addition to the cook-before-eating product inspection standards. The monitoring criteria for residual chemicals, antibiotics, heavy metals, and plant protectant chemicals comply with Vietnamese standards for prohibited drugs, chemicals, and antibiotics for veterinary and fishery purposes and the Vietnamese standards for the use of antibiotics for veterinary and fishery purposes. The monitoring criteria for heavy metals and plant protectant chemicals comply with Vietnamese standards for heavy metals and plant protectant chemicals. On an annual basis, the DAH must provide specific guidelines for monitoring indicators and the number of samples in accordance with actual circumstances to control the pathogens and residual toxins (e.g., heavy metals, plant protectant chemicals, veterinary drugs, and other hazardous substances) for commercial aquatic animals and imported aquatic animal products. One shipment is sampled to confirm the monitoring indicators for six shipments of imported goods in the same category, of the same origin, and from the same owner. If an indicator is deemed to be unsatisfactory, the border animal quarantine agency increases the sampling rate by sampling one in three shipments for the indicator. If the results of testing for that indicator continue to be unsatisfactory, the border quarantine agency samples all imported goods for quarantine. If satisfactory results are found in three consecutive inspections, the import inspection is waived until completion of the next level of monitoring.
3) Safety Inspection of Imported Aquatic Products
Food companies in an exporting country that seek to export goods to Vietnam must be registered and on the list of imported aquatic products facilities.100) All imported food must be inspected under the Law on Food Safety, unless specifically exempted by Vietnamese authorities. Inspections regarding food safety require the use of one of three inspection methods: (1) rigorous, (2) normal, (3) or loose. In other words, depending on the food product, the MARD, the MOH, and the MOIT must prepare detailed guidelines for food safety inspection.
100) Article 22, enforcement decree on Law on Food Safety.
122 Ⅲ. Safety Management of Aquaculture Products in Vietnamese Aquatic Products
Aquatic organisms and products imported into Vietnam must be inspected in accordance with the food safety and quarantine standards prepared by the MARD (the DAH). Imported aquatic foods need to be inspected to determine if they meet import requirements and the results must be immediately communicated to consumers.
4) Management of Registered Production Facilities of Imported Aquatic Products
Aquatic animals and aquatic animal products to be exported to Vietnam must be registered with Vietnamese authorities.101) Table III-45 shows the number of currently registered facilities as per agreements with China, Indonesia, and Korea.
▏Table Ⅲ-45▕ Status of Registered Facilities of Exporters According to the Agreement
Country Registered Facility As of Date China 744 December 3, 2018 Indonesia 406 May 17, 2019 278 (168 for aquatic Korea products) January 11, 2019
Exporting countries that wish to export to Vietnam must submit a registration document to the NAFIQAD for the export facility and obtain approval in accordance with Vietnam’s relevant regulations.102)
101) The status of registered facilities for aquatic products can be found in http://cucthuy.gov.vn/Pages/danh-sach-thuy-san.aspx Exporting facilities are registered by 38 countries, including Korea. 102) Circular No.13/2011/TT-BNNPTNT, 2011.3.16.
123 2019 K-V FTA Economic Cooperation Work Program Strengthening K-V Fishery Cooperation by Improving Viet Nam's Aquaculture Safety
Ⅳ.
Value Chain Analysis and Investigation of ntibiotic Use in Vietnam Shrimp Farms
Ⅳ. Value Chain Analysis and Investigation of Antibiotic Use in Vietnam Shrimp Farms
Ⅳ. Value Chain Analysis and Investigation of Antibiotic Use in Vietnam Shrimp Farms
1. Value Chain of Farmed Shrimp
Value chain refers to the process and activities of a business that add value (production, services, and marketing) to an article.103) When the values are analyzed and their contributions to the business are identified, we can assess how to improve unsatisfactory links in the chain using models such as strengths, weaknesses, opportunities and threats (SWOT) analysis. In the next section on value chain operators, we conduct a value chain analysis of shrimp farming in Vietnam. Chapter 5 then identifies the strengths and weaknesses and the opportunities and challenges to core values in shrimp farming, also making suggestions for improvement. A variety of studies on Vietnamese aquaculture product value chains have been conducted.104) A literature review indicates that these value chains have undergone substantial changes over time. The CBI (2012) performed an analysis with the aim of overcoming impediments to the export of central Vietnamese fish species (e.g., shrimp, catfish, tuna, and shellfish). Export-related bottlenecks included disease, lack of sustainability, lack of vertical cooperation within the chain, poor investment in infrastructure, and lack of cooperation between value chain operators and business support organizations. Nguyen (2018) explained the value chain to attract investment. This study analyzed the value chain and cooperative relationships between government institutions in charge of aquaculture product safety management— influencers and supporters of previous research—and the safety management system. We monitored every step of the value chain from farm to table and reviewed the role of government institutions in safety management and the government’s safety control systems.
103) Porter, Michael E. (1985). Competitive Advantage: Creating and Sustaining Superior Performance. New York. 104) Arie Pieter van Duijn et. al. The Vietnamese seafood sector - A value chain analysis, CBI, 2012.
127 A. Value Chain Operators
The CBI (2012) categorizes value chain actors or operators into four groups: input suppliers, farmers, middlemen, and processors/exporters. In this study, we subdivided input suppliers to examine safety management by government institutions. Among inputs, hatcheries, post larval (PL), and feed are managed by the D-Fish while veterinary drugs, chemical substances, and other additives are controlled by the DAH. Farming equipment is under the control of the government organizations in charge of general industrial product management. Large-scale growers often purchase inputs directly from producers; they buy directly in bulk for a good price. Small and medium-sized farms, however, generally buy products from local dealers or intermediaries. Some dealers sell products only to specific companies, while others deal with all companies. Most dealers carry all kinds of products, including feed, veterinary drugs, and equipment. Some distribute aquaculture products and supply materials to small farms on credit. Although the CBI (2012) describes black tiger and whiteleg shrimps’ distribution systems differently, there are no major differences in species or type of farming (whether extensive or intensive). The most significant divergences concern scale rather than method. Large-scale growers tend to buy PLs directly and sell their products without the intervention of middlemen. Little research has been done on the Vietnamese value chain that is analyzed in this study, including wholesale markets, retail markets, restaurants, and dealers. Although 90 to 95% of the shrimp currently produced in Vietnam is exported, the domestic market is expected to grow as income levels increase throughout the country, making domestic safety management as important as that of export.
B. Influencers and Supporters
According to the CBI (2012), influencers and supporters in the value chain can be classified into five groups: government authorities, research institutes, producer and exporter associations, certification agencies, and financial institutions. In this study, we examine the roles and range of responsibilities of government authorities. As shown in Figure Ⅳ-1, the production stage is controlled by the D-Fish; processing, export, and domestic distribution by the NAFIQAD; retail distribution by the MOIT; and consumer distribution by the MOH. At the production stage,
128 Ⅳ. Value Chain Analysis and Investigation of Antibiotic Use in Vietnam Shrimp Farms
aquatic animal diseases are controlled by the DAH. The quarantining of import and export products is managed by the DAH and the NAFIQAD, respectively.
C. Problems
A major problem is a lack of vertical integration or systematization in shrimp farming, as compared to catfish farming. The CBI (2012) explains that shrimp farms should be vertically integrated due to factors such as a higher harvesting failure rate as compared to catfish farming, and a high ratio of small farms in the business. In Vietnam, shrimp are farmed by a handful of large corporate growers, but the majority is comprised of small-scale farms. Overall, 70%–80% of Vietnamese small shrimp farms are located on an area of 1.5 ha or less. Since small farms cannot be vertically integrated, they have become heavily dependent on middlemen in conducting their business. According to a study by Lee et al. (2019a), the average aquaculture area of a small aquaculture farmer in Ca Mau Province is 1.3 ha, and the number of ponds is three.
Small scale shrimp farm in Vietnam
Lee et al. (2019a) found that the average small shrimp farm in Ca Mau Province covers an area of 1.3 ha and has an average of three farming ponds that cover approximately 0.4 ha. Farmers buy PLs for 62–65 PL/dong, and farming density was 70–78 PL/m2. Small farms spend 222–370 million dong per ha annually, and the average annual income is between 219 and 273 million dong. Average income is often less than expenses. In most cases, family members run the farm, and only 37 of all farms employed any non-family members. As well as full-time workers, part-time workers are employed during harvesting season. The average wage of a shrimp farm worker is 43.5 million dong. The smartphone ownership rate for household heads was 52%
The first problem faced by small shrimp farmers is that there are many operators, or middlemen, between producers and exporters, which increases end-product prices and makes it more difficult to control safety and maintain a product history. Shrimp farmers sell harvested shrimp to middlemen because they can earn money quickly, and the middlemen often buy their product regardless of size or potential disease. Those farmers who have started their businesses with a loan from a bank, friends, or family tend to prefer middlemen over processors and exporters, since they are
129 assured of immediate revenue for making loan payments. Middlemen collect a small number of shrimp from several small farms, storing them separately before re-selling them to large collectors and processors. During storage, they may take measures to increase their weight or add substances to keep the shrimp fresh and prevent disease. A second problem for small shrimp farmers is a lack of investment in infrastructure, including hatcheries, farms, processing factories, exporting facilities, and other farming facilities. More than anything else, farms desperately need irrigation systems and logistics centers. Maintaining separately installed wastewater treatment facilities and wastewater drainage passages is critical in areas where shrimp farms are concentrated. In such areas, farms often share water intake and wastewater drainage, which accelerates the spread of disease to neighboring farms. Better road infrastructure, refrigerated storage, and logistics vehicles and facilities are also needed. Farms are mostly located near rivers and seas, and their roads are often unpaved and in poor condition. In many cases, middlemen use ordinary trucks to transport harvested shrimp and keep them fresh on ice. Building refrigerated warehouses where middlemen can store harvested shrimp before delivering them to processing factories is critically needed. The third problem is controlling shrimp diseases. The two most important factors that influence food safety in the shrimp value chain are prohibited substances and microbial organisms. The presence of prohibited substances indicates shrimp diseases. Even with the current level of science and technology, not much can be done once disease occurs in a shrimp population. Consequently, prevention is considerably important in disease control. Shrimp diseases can arise anywhere in a farm’s infrastructure, such as facilities, water quality, PL, and stocking density. The infrastructure and environment around a farm are critical. If the wastewater is not properly treated, the farm might be exposed to pathogens even before stocking. The importance of drainage management cannot be exaggerated, and monitoring and warning systems for the surrounding environment are also necessary. No matter how well the farming facilities and water quality are managed, if a pond is stocked with infected PL, it is to no avail. Therefore, it is important to manage hatcheries and have an efficient quarantine process for imported PL. This is an area in which the latest hatchery technology is required to produce specific pathogen free (SPF) PLs, which requires investment from the private sector and international investors.
130 Ⅳ. Value Chain Analysis and Investigation of Antibiotic Use in Vietnam Shrimp Farms
Finally, there is room for improvement in the cooperation between operators and supporters (i.e., government institutions) in the shrimp value chain. In Vietnam, aquaculture product safety management is under the control of the NAFIQAD. However, safety management at the production and consumption stages is inadequate and, in some cases, controlled by other institutions, including the MOIT and the MOH. Imported shrimp are quarantined by the DAH, while the NAFIQAD oversees safety management and quarantine at processing factories.
▏Figure Ⅳ-1▕ Supply Value Chain of Vietnamese Shrimp105)
Environment monitoring & Warning D-Fish, RIA 123
Hatcheries (D-FISH)
PL collectors (D-FISH)
Feed, Drug other inputs Big companies Farmers (D-FISH, DAH) shrimp growers (D-FISH) (D-FISH)
Imported shrimps Disease Prevention & Control (DAH) DAH, DARD
131 D. Cooperation between Safety Management Organizations in the Value Chain
1) Hatcheries
The Law on Fisheries of Vietnam specifies the criteria for producers and breeders of aquatic species.106) Production facilities of aquatic species should be suitable for the specific needs of the species. In addition, there should be a separate space to monitor the health of larvae. The production facilities should have trained personnel in the fields of aquaculture, aquatic pathology, and biology, and should have quality and biological safety management systems in place. When a facility produces a breed stock of an aquatic species, producers should be recognized by the authorizing body or acknowledged scientific standards testing. The breeders that satisfy the criteria prescribed by the law will be issued with a government certificate. The MARD has the authority to issue, reissue, or cancel a certificate for producing and growing aquatic species breed stock.107) The Provincial People’s Committee can issue, reissue, or cancel a certificate for producing and growing aquatic species. Imported aquatic species are subject to obligatory quality inspection as prescribed by law.108) Upon an authority’s request, or if complaints are filed by an institution or an individual, the relevant aquatic species must be assessed (diagnosed).109) The MARD is obligated to announce the agencies qualified to assess aquatic species. When aquatic species are transported, they should be labeled as prescribed by law.110) Currently, there are 2,362 shrimp hatcheries in Vietnam: 1,750 for black tiger shrimp and 612 for whiteleg shrimp. There are no government statistics available on the sie of the hatcheries’ geographic area. Whiteleg shrimp SPF brood stock, which have an average weight over 50 grams (g), is imported from Hawaii, Thailand, and Singapore. Mature brood stock, which have an average weight over 200 g, of black tiger shrimp is collected in inland areas to be used in the production of post-larvae for stocking ponds. Between 2018 and 2019, 198,400 brood stocks of whiteleg shrimp were imported. The number of shrimp hatcheries has been
106) Law on Fisheries of Vietnam, Law No. 18/2017/QH14 Hanoi, November 21, 2017), Article 24 107) Ibid. Article 25 108) Ibid. Article 27 109) Ibid. Article 29 110) Ibid. Article 30
132 Ⅳ. Value Chain Analysis and Investigation of Antibiotic Use in Vietnam Shrimp Farms
decreasing while their size is increasing. Historically, there have been more multi-national than domestic hatcheries, but the number of large-scale domestic hatcheries has recently been increasing.
Vietnam shrimp hatchery
Starting in 2016, Viet UC Seafood Corporation in Bac Lieu, Vietnam, has produced brood stock and PL shrimp after conducting research (2011–2016) on SPF whiteleg shrimp brood stock. Originally founded as a hatchery in 2001, Viet UC expanded into breeding through a joint investment with an Australian company in 2014. Currently, the company produces 50 billion PLs (25% of Vietnam’s total output) in its 160 hatcheries.
2) Farming
Safety management of aquaculture products at the production stage is set forth in the Law on Fisheries and in its sub-statutes. The feed and products to manage the farming environment are controlled pursuant to a notification from the D-Fis h111) and substances prohibited from use in aquaculture products are defined in a DAH notification.
▏Table Ⅳ-1▕ Legislation on Quarantine of Vietnamese Aquatic Animals
Laws No. Law on Fisheries Law 18/2017/QH14 Enforcement Decree of the Law on Fisheries Decree 26/2019/ND-CP Regulations on farming species, feed, and farming Circular No. 26 /2018/TT-BNN environment management products
The Law on Fisheries of Vietnam defines the criteria for organizations or individuals engaged in the farming business.112) First, farms are required to comply with the regulations on the use of water for land and ocean aquaculture pursuant to the related law. Farming facilities should suit the needs of the aquatic species and breeding methods and they should comply with the laws and regulations related
133 to environmental, veterinary drug, industrial, and food safety. Cage farming and farming of the main species of aquatic animals should be registered for business. The main species of aquatic animals are defined by the Prime Minister. Organizations or individuals engaged in ocean farming are obligated to create a business plan for ocean farming and obtain permission from the authority in charg e.113) The Law on Fisheries details the specifications for ocean farming but contains only general facts on land farming. The Law on Fisheries also defines the rights and responsibilities of farmers. The rights of organizations or individuals that engage in farming, related to this study, include access to notifications about the farming environment and infectious diseases, instructions about farming technology, and information on the fishery markets.114) Also, they are eligible for government support for recovery, pursuant to related laws, in the event of an epidemic outbreak or a natural disaster from which they incur damage.115) The responsibilities of those engaged in farming, related to this study, include the following. Farmers should: (1) use aquatic species, aquatic equipment and feed, and veterinary medicines and products to create a farming environment that is in compliance with the law;116) (2) retain and store any documents related to those practices; (3) be held legally accountable for farming activities, food quality, and the safety of fishery products and be under the mandatory inspection and supervision of relevant authorities while in the farming business.
3) Monitoring the Farming Environment
According to the Law on Fisheries of Vietnam, monitoring the environment, disseminating warnings, and preventing infectious diseases should be conducted in compliance with the Veterinarians Law and related regulations.117) The Regulations on the Prevention and Control of Aquatic Animal Diseases prescribes the specifications for monitoring the farming environment and giving warnings.118)
134 Ⅳ. Value Chain Analysis and Investigation of Antibiotic Use in Vietnam Shrimp Farms
According to these regulations, in principle, aquaculture environmental monitoring and warnings should be carried out in a way that ensures regularity and continuity and that is systematic in determining risk factors; the organization responsible for aquatic animal health care should be informed in a timely manner; and farmers should be alerted and guided in implementing the necessary treatment and adjustment measures. The D-Fish is responsible for instructing sub-D-fish and other related agencies on the parameters for selecting regions, locations, indicators, frequency, methods, and environmental monitoring news, and is responsible for providing information on aquaculture, data on monitoring, and alerts. In 2014, the MARD approved the 2015–2020 Aquaculture Environmental Monitoring Project. The D-Fish, in collaboration with local governments, approved plans for 38 provinces and cities to conduct aquaculture production environmental monitoring.119) As of 2018, there were 236 monitoring points, including shrimp farms in the 12 provinces (except for Hau Giang) and cities in the Mekong Delta, including 98 catfish farms, two bivalve (shellfish) farms, 24 tilapia net-cage farms, and 19 other aquaculture locations. Provincial governments coordinate the efforts between central and local fishery management institutions and local farmers to implement environmental monitoring and disease prevention in aquaculture. Provincial governments have established a system for sampling, analyzing, adjusting, and mitigating any negative results (i.e., measures to limit the impact of announcements of results, warnings, and recommendations). The D-Fish works with the Research Institutes of Aquaculture (RIA 1, 2, 3) to run short-term training courses to improve manager competencies for conducting regional environmental monitoring. The D-Fish publishes a guidance manual for the environmental monitoring process in aquaculture, and it maintains an environment, monitoring database that includes data from the central government and local governments. Monitoring data is reported to the D-Fish on a monthly basis and collected and systemized into a database for assessing environmental developments over time. Each province estimates environmental development in line with a production direction according to the data. Regular monitoring of the water supply to aquaculture areas is important not only for the production and supply of information
119) D-Fish, Monitoring environment is critical factor for development of fisheries
135 for those in the aquaculture business, but also for maintaining transparency regarding the production conditions for customers of Vietnamese shrimp and catfish products.120)
2. Investigation of Antibiotic Use on Small Shrimp Farms in Vietnam
The Japanese research team (Lee et al.) visited small shrimp farms in Ca Mau Province in 2015, 2017, and 2019 to conduct surveys on the use of antibiotics. A simple random sampling method was used to avoid selection bias. The population of this sample is 1,546 whiteleg shrimp farms in County A, Ca Mau Province, and the sample size is 147, or 9.51% of the population. Table Ⅳ-2 shows that small farms in Vietnam have an area of 1.3 ha on average, with three farming ponds. There are 72 PLs stocked per one meter squared (㎡) and the price of PL was 63 dong per individual. Large-scale biofloc farming has been known to grow more than 200 shrimp per square meter. Feeding accounts for the highest proportion of the total cost of 340 million dong/ha. Labor costs were relatively low, since family members work on the farm. The average annual income of small farms was 262 million dong/ha. This means that small farmers in Vietnam suffer total losses of over 100 million dong a year, excluding feed and labor costs.
▏Table Ⅳ-2▕ Status of Small-scale Farms in Vietnam
Description Average Value Unit Area of land 1.34 ha Farm area 1.30 ha Number of pools 2.95 Breeding density 72.03 PL/㎡ PL purchase cost 62.74 dong/PL Feed purchase cost 340.62 Million dong/ha Labor costs 18.24 Million dong/ha Profit 262.21 Million dong/ha
Source: Lee et al. (2019a) survey data.
120) Ibid. interview with Le Thi Kieu Trang, Deputy head of Dong Thap Department of Fisheries.
136 Ⅳ. Value Chain Analysis and Investigation of Antibiotic Use in Vietnam Shrimp Farms
Ca Mau Province is a peninsula surrounded by the Mekong Delta of southern Vietnam located about 300 km south of Ho Chi Minh City. During the 2000s, Ca Mau Province took advantage of their geographically advantageous location to nurture shrimp farming by converting approximately 150,000 ha of rice fields into shrimp farms by 2008. As of 2016, there are 300,000 ha of shrimp farms in Ca Mau Province, which is equivalent to 50% of the entire area of Ca Mau Province.121)
▏Figure Ⅳ-2▕ Map of Ca Mau Province in Vietnam
The production of shrimp in Ca Mau Province has steadily risen over the years. In 2016, about 150,000 tons of shrimp were harvested, which was 23% of Vietnam’s total shrimp yield. In the same year, the province’s shrimp exports amounted to approximately one billion US dollars (USD), or 33% of Vietnam’s total shrimp exports.122)
121) General Statistics Office of Vietnam (2018). Statistical Data. Retrieved from www.gso.gov.vn/default_en.aspx?tabid=774. 122) VASEP. (2017). Available Fish Sources. Retrieved from http://seafood.vasep.com.vn/ ?ni1⁄499&p1⁄42&&go1⁄4search&key1⁄4ca%20mau.
137 A. Antibiotic Testing
Lee et al. (2019a) commissioned the Food Safety Research Team of Can Tho University to collect whiteleg shrimp samples from 147 farms in County A, Ca Mau Province to test for residual antibiotics. The research team used liquid chromatograph-mass spectrometry (LC-MS) to determine the residual amounts of chloramphenicol, enrofloxacin, ciprofloxacin, and oxytetracycline in 147 samples. Table IV-3 lists the results of tests conducted on whiteleg shrimp by the research team in 2015 and 2017. In 2015, one or more antibiotics were detected over the maximum residue limit (MRL) in 29 specimens, or 20% of the total number of specimens, 147. By type of antibiotic, the detection rate was highest for enrofloxacin with 11% (16), followed by chloramphenicol with 8% (12), ciprofloxacin with 7% (10), and oxytetracycline with 5% (7).
▏Table Ⅳ-3▕ Inspection Results for Residual Antibiotics123)
Number of Rate of Number of Rate of Detected Substances Non-Detected Non-Detected Detected Detected Cases Cases Cases Cases 2015 Number of Shrimp Specimen (N = 147) One or more antibiotics 118 80% 29 20% chloramphenicol (CML) 135 92% 12 8% ciprofloxacin (CIPRO) 137 93% 10 7% enrofloxacin (ENR) 131 89% 16 11% oxytetracycline (OTC) 140 95% 7 5% 2017 Number of Shrimp Specimen (N = 125) One or more antibiotics 109 87% 16 13% chloramphenicol (CML) 123 98% 2 2% ciprofloxacin (CIPRO) 120 96% 5 4% enrofloxacin (ENR) 111 89% 14 11% oxytetracycline (OTC) 125 100% 0 0%
※ Residue was analyzed using LC-MS. The MHLW allows less than 200 ppb of oxytetracycline residues. The MHLW rejects shrimp imports depending on the presence of chloramphenicol, enrofloxacin, and ciprofloxacin residues.
123) Lee et al. (2019a).
138 Ⅳ. Value Chain Analysis and Investigation of Antibiotic Use in Vietnam Shrimp Farms
The sample size in 2017 was 125, reduced by 22 from 2015 because 22 shrimp farms went out of business due to financial difficulties between 2015 and 2017. In 2017, one or more antibiotics were detected over the MRL in 16 specimens, or in 13% of the 125 total specimens. This represents a decrease of 7% from 2015. Enrofloxacin was the most frequently detected substance above the MRL at 11% (14), followed by ciprofloxacin 4% (5), and chloramphenicol 2% (2). Meanwhile, oxytetracycline was not over the MRL in any of the specimens.
B. tibiotics Levels and MRL: Properties of Items Above and Below the Limits
Tables Ⅳ-4 and Ⅳ-5 show the characteristics of shrimp farmers and farms in the group in which antibiotics were detected over the MRL as compared with the group in which antibiotics were not detected, along with their t-test results. Data collected by Lee et al. (2019a) in 2015 were used to conduct a t-test. In this test, the null hypothesis assumes that no difference exists between the two groups, whereas the alternative hypothesis assumes that some difference exists between the two groups. The sample size is 147, the same as in the 2015 sample, and includes 118 specimens with detected antibiotics and 29 specimens in which no antibiotics were detected. The properties of the shrimp farmers in the detected group and the non-detected group are listed in Table Ⅳ-4 below. The results show that, by gender grouping, males account for the majority of shrimp farmers, at approximately 90%. The average age of a shrimp farmer was 50, with eight years of formal education. According to the t-test results, the alternative hypothesis was rejected, and the null hypothesis—that there are no differences between the two groups—was supported for all three properties. Unlike the properties listed above, for the number of years in shrimp farming, the difference between the two groups was statistically significant at 10%, implying that those farmers with more experience were less willing to use veterinary drugs. The ratio of the subjects who answered “yes” to the question “Do you know what antibiotics are prohibited?” in the survey conducted by Lee et al. (2019a) was 19% in the non-detected group and 10% in the detected group. Although this difference is not statistically significant, the non-detected group was 9% more
139 knowledgeable about prohibited antibiotics than the detected group. In addition, the workshop participation rate of the non-detected group was approximately 17% higher than that of the detected group. This difference is statistically significant at the 10% level. This result implies that shrimp farmers might be unaware that they are using prohibited substances or lack knowledge regarding alternative technologies that can instead be used. According to Holmström et al. (2003), those farmers who had prior experience with shrimp epidemics were more likely to use veterinary drugs to prevent or treat diseases.124) However, Table Ⅳ-4 shows that the non-detected group had 9% more experience with shrimp epidemics than the detected group. Although the difference is not statistically significant, it is still noteworthy because it contradicts the results of previous research.
▏Table Ⅳ-4▕ Differences Between Shrimp Farmers According to Detection of Antibiotics
(a) Non-Detected (b) Detected Difference Units Number of Number of Subjects Average Subjects Average (a)-(b) Female = 0 118 0.94 29 0.90 0.04 Gender Male = 1 [0.24] [0.31] (0.05) In years 118 48.62 29 52.28 −3.66 Age [11.99] [11.04] (2.45) Number of years in In years 118 7.89 29 8.07 −0.18 formal education [2.94] [3.21] (0.62) Number of years in In years 118 8.56 29 5.86 2.69* shrimp farming [8.07] [5.05] (1.57) Experience with No = 0 118 0.68 29 0.59 0.10 shrimp epidemics Yes = 1 [0.47] [0.50] (0.10) Shrimp farming Not participated = 0 118 0.75 29 0.59 0.17* workshop Participated = 1 [0.43] [0.50] (0.09) Knowledge of No = 0 118 0.19 29 0.10 0.08 prohibited antibiotics Yes = 1 [0.39] [0.31] (0.08) ※ Standard deviation is reported in brackets. Standard error is reported in parentheses. * significant at the 10% level; ** significant at a 5% level; *** significant at a 1% level. Source: Lee et al. (2019a)
124) Holmström, Katrin, Sara Gräslund, Ann Wahlström, Somlak Poungshompoo, Bengt‐Erik Bengtsson, and Nils Kautsky (2003), “Antibiotic use in shrimp farming and implications for environmental impacts and human health.” International Journal of Food Science & Technology, 38, no. 3 pp: 255-266.
140 Ⅳ. Value Chain Analysis and Investigation of Antibiotic Use in Vietnam Shrimp Farms
Table IV-5 shows the properties of the group of farms in which antibiotics were detected compared with the group in which they were not detected. The table shows that the average area of the land owned by a shrimp farm is 1.4 ha, out which the farm takes up 1.3 ha, or 93%, of the land. This ratio indicates that shrimp farmers in Ca Mau Province prefer monoculture that is focused on shrimp. A farm has three ponds, on average, in both groups, and the average area of a pool is about 0.4 ha. The breeding density was approximately 8 PL/m2 higher for the detected group (78 PL/m2) than for the non-detected group. Despite the lower breeding density, the non-detected group spends 1.7 times more on feed than the detected group. This result implies that the non-detected group may use a higher-priced feed than the detected group. Lastly, the profit difference between the two groups demonstrates that the non-detected group generates higher profits than the detected group by about 60 million dong (KRW three million, based on the exchange rate on February 3, 2020). This result is not statistically significant, but it can be presumed that contrary to expectations, the use of veterinary drugs may reduce shrimp farms’ profits.
▏Table Ⅳ-5▕ Differences Between Shrimp Farms According to Whether Antibiotics Were Detected
(a) Non-Detected (b) Detected Difference Unit Subjects Average Subjects Average (a)-(b) ha 118 1.31 29 1.44 −0.13 Area of land [1.66] [1.80] (0.35) ha 118 1.27 29 1.44 −0.17 Area of farm [1.57] [1.80] (0.34) 118 2.95 29 2.97 −0.02 Number of Pools [2.28] [1.59] (0.45) PL/m2 118 70.54 29 78.10 −7.57 Breeding density [77.56] [96.66] (16.91) dong/PL 118 62.10 29 65.32 −3.22 PL purchase cost [76.42] [69.80] (15.58) Million 118 369.85 29 221.66 148.19 Feed purchase cost dong/ha [597.59] [251.28] (113.59) Million 118 19.98 29 11.16 7.92 Labor costs dong/ha [62.40] [35.39] (12.06) Million 118 272.87 29 218.86 54.02 Profit dong/ha [499.66] [260.39] (96.00)
Source: Lee et al. (2019a). The number of observations is reported in brackets. Standard error is reported in parentheses. * significant at a 10% level; ** significant at a 5% level; *** significant at a 1% level.
141 C. Status of Information Use
Table Ⅳ-6 lists the shrimp farming information channels used by shrimp farmers in Ca Mau Province. Regarding advice on shrimp farming technology, in the non-detected group, shrimp farmers asked acquaintances (88%), input dealers (3%), shrimp farming instructors (5%), and others (4%). However, 100% of the respondents in the detected group indicated that acquaintances were their main source of information, which is 12% higher than the non-detected group. This difference is statistically significant at the 10% level. For advice on the prevention and treatment of shrimp epidemics, in the non-detected group, 71% of shrimp farmers asked acquaintances, while only 19% turned to shrimp farming instructors for advice, and those who depended on input dealers and others were 6 % and 5%, respectively. Meanwhile, 83% of the respondents in the detected group choose acquaintances, while only 7% chose shrimp farming instructors as their advisors; 3% and 7% of the respondents asked input dealers and others, respectively. There are slight differences between the two groups in terms of their main sources of information, but the differences are not statistically significant. These findings illustrate that shrimp farmers in both groups relied more on unofficial sources of information, including acquaintances, than on official sources, including shrimp farming instructors, when seeking information on shrimp farming technology or shrimp epidemics. This tendency was more apparent in the detected group than in the non-detected group. Although the difference is not statistically significant, this dependence on unofficial information sources seems to be closely related to shrimp farmers’ use of veterinary drugs.
142 Ⅳ. Value Chain Analysis and Investigation of Antibiotic Use in Vietnam Shrimp Farms
▏Table Ⅳ-6▕ Information Channels Used by Shrimp Farmers
Source: Lee et al. (2019a). The number of observations is reported in brackets. Standard error is reported in parentheses. * significant at a 10% level; ** significant at a 5% level; *** significant at a 1% level.
143 2019 K-V FTA Economic Cooperation Work Program Strengthening K-V Fishery Cooperation by Improving Viet Nam's Aquaculture Safety
Ⅴ.
Key Findings and Policy Suggestions
Ⅴ. Key Findings and Policy Suggestions
Ⅴ. Key Findings and Policy Suggestions
1. Key Findings
Our literature review and field study of the Vietnamese aquaculture industry value chain identified several key areas that require improvement—laws and regulations, social infrastructure, aquaculture practices, and the perceptions of those engaged in the aquaculture industry—to promote the enhancement of product safety management in Vietnam. Despite impressive improvements in aquaculture product safety management resulting from the consistent efforts of the Vietnamese government, many issues still exist that need to be addressed. This includes the lack of a social infrastructure, insufficient government personnel for the guidance and management of the industry, underfunded budgets, as well as the lack of disease and food safety issue awareness among aquaculture farmers. However, these obstacles are not insurmountable. Based on these findings, our suggestions can be summarized as follows. First, one of the most fundamental reasons for the persistence of disease in Vietnamese aquaculture products is the lack of knowledge about aquaculture diseases and product safety among farmers who are new to aquaculture. In most cases, small farms cannot afford to invest in facilities and purchase large quantities of PL to generate profits in the shortest amount of time. By contrast, large-scale farms can minimize, or even avoid, the use of prohibited substances, including antibiotics, because of their ability to invest in facilities. According to this study’s survey and statistics from South Korea, the US, the EU, and Japan regarding rejected imports of Vietnamese fishery products, it appears that small farms in Vietnam are using prohibited veterinary drugs to prevent and treat fishery diseases. Without a change in perception on the use of veterinary drugs among these farmers, these safety issues will persist. Second, due to a lack of investment in infrastructure by the central and local governments, water quality on aquaculture farms tends to be poorly managed. This is partly because influent and effluent water streams are not separated in the areas
147 in which farms are concentrated. In the shrimp farm clusters in Ca Mau and Trang Tien Provinces, it is not uncommon to discover that influent and effluent water is not separately managed. The Law on Fisheries of Vietnam prescribes that organizations or individuals engaged in the aquaculture industry should be notified of environment in the aquaculture farming. The Vietnamese government conducts environmental monitoring of farming areas. Monitoring the farming environment in the Mekong Delta area by the D-Fish was performed simultaneously and in multiple sites with remarkable results. However, environmental monitoring in these farming areas failed to gain the attention of aquaculture farmers because of their meager investment, poor human resource training, and lack of work experience. The database software used for environmental monitoring does not enable the integration and provision of information between central and local governments. The environmental warning and alert systems through which monitoring results are sent to government agencies and agricultural facilities are too slow to meet the needs of a production field in which urgent response measures are vital. Third, the government still has a way to go when it comes to managing the aquaculture industry, controlling diseases, and providing aquaculture statistics. The Law on Fisheries of Vietnam stipulates facilities, personnel, and quality management in hatcheries, but there are still many hatcheries that do not satisfy the criteria. Medium- and large-scale farms can obtain certified evaluations to determine whether PLs are infected with pathogens before they are stocked in a breeding pond. This certification ensures that their PLs are healthy. Unfortunately, this is not the case for their smaller counterparts. The Law on Fisheries stipulates that ocean aquaculture businesses obtain permission and register for cage farming before starting a business, but land aquaculture is not subject to these prerequisites. The findings of this study show that approximately 15% of shrimp farmers in Ca Mau Province gave up farming within two years. Low entrance barriers lure many farmers to the aquaculture business, but they do not have sufficient information or training and often end up leaving the business for various reasons, including disease outbreaks. The Veterinarians Act and its sub-statutes stipulate that in the case of a disease outbreak, farms must report it to the authorities, but most farmers release their farmed aquatic animals earlier than scheduled or administer veterinary drugs to the ponds instead. The law does not include any punishment if an aquatic animal disease outbreak is not reported. In addition, Vietnam is lenient with regard to the treatment of infected aquaculture products as compared to other aquaculture producers. In
148 Ⅴ. Key Findings and Policy Suggestions many countries, including South Korea, aquaculture products with diseases are totally prohibited from distribution and are discarded under the supervision of the government. In Vietnam, diseased fishery products are used as material for processed products or sold for domestic use. Currently, the statistics on aquaculture products in Vietnam are insufficient. The area covered by shrimp farms is known, but statistics regarding the number of farms or farmers engaged in farming have only been gathered since 2020. The rules for the prevention and control of aquatic animal diseases stipulates that the DAH and the D-Fish should inform, educate, and communicate with aquaculture farmers on the prevention and control of aquatic animal diseases by means of various measures, including brochures, media, seminars, and training. Government-led education is often provided in urban areas in the form of lectures but is not easily accessible from the rural areas where many aquaculture farmers live. Instead, many growers relay on large-scale feed suppliers or acquaintances for information on diseases. Those who do not buy feed from specific major brand dealers have few opportunities to participate in any kind of training. In Vietnam, aquatic animals can be moved from infected areas after the local veterinary office is notified. Most farmers freely move or sell these animals without making any notification. Also, local governments are required to use their budgets to dispose of aquatic animals that have died from disease. Some provinces with budget constraints, however, prefer to let producers sell or distribute the diseased aquatic animals rather than spend their budgets on disposal costs. On large-scale aquaculture farms, there are separate pools for treating influent and effluent water, whereas on smaller farms, water from farming ponds is discharged without any further treatment. Along with many opportunities (the potential for change), we discovered several bottlenecks in the improvement of aquaculture product safety management in Vietnam. This includes aquaculture market saturation, large numbers of poor aquaculture farmers, low expected revenue, and lack of management of middlemen and dealers. Opportunities for Vietnam to improve aquaculture product safety follow. First, the number of non-compliant cases of aquaculture products imported from Vietnam by South Korea, Japan, the US, the EU, and other countries has continuously decreased over the years. This can be attributed to importers tightening safety controls, as well as efforts by the Vietnamese government to enhance fishery product safety. Second, large-scale farms and aquaculture product processing factories are following the safety management standards required by the global market and advanced countries.
149 Research team confirmed their determination and the efforts being made to improve safety controls through interviews with officers in charge and site visits. Third, the findings of this study revealed that Vietnamese safety management authorities work hard to maintain the country’s reputation as a marine product exporter, maintain their global market share, and increase the level of exports. The Vietnamese government has been continuously revising and complementing the Law on Fisheries and food safety laws to reflect the demands of importing countries. Fourth, Vietnamese governance and society are becoming more transparent due to the increased smartphone penetration rate. According to the results of this study, the smartphone ownership rate of aquaculture farmers exceeds 50%. Communication between aquaculture farmers through social media might enable them to share information on the emergence of aquaculture product diseases and response measures and enable them to more effectively address potential risks.
▏Table Ⅴ-1▕ Opportunities and Challenges for the Safety Improvement of Vietnamese Aquaculture Products
Opportunities Challenges • Requirements of the market and major global • Many poor aquaculture farmers (beyond government importers management capacity) and avoidance of • Enhanced government capacity to manage information-sharing aquaculture product safety • Low expected income and frequent business • Science and technology development for early closures of aquaculture farms due to aquatic detection of PL diseases animal diseases • Stricter requirements for safety management laws • Low entrance barriers to aquaculture (no criteria for • Reputation of Vietnamese marine products in permission, registration, education, or facilities) the global market • Insufficient government budgets for infrastructure • Increased national transparency investment • Science and technology development, increase in • Lack of interdepartmental government cooperation smartphone penetration rate, activation of social • No management of middlemen (collectors) dealers, networking site (SNS) communities and online drug sales • Government too lenient regarding regulation violations (disease notification, limit on the movement of diseased shrimp, distribution of diseased shrimp, use of prohibited veterinary medicines) • Insufficient safety management of fishery products for domestic use • Insufficient information-sharing (results of environmental monitoring, water quality, outbreak of farmed aquatic animal diseases, safety inspection results, etc.) • Inadequate systems for aquaculture product traceability • Lack of awareness of the dangers of veterinary drugs • Lack of extension officers
150 Ⅴ. Key Findings and Policy Suggestions
By improving aquaculture product safety management, Vietnam will be able to expand exports as well as maintain its reputation as a reliable aquaculture product exporter through increased consumer trust. Many safety problems can be addressed if the Vietnamese government increases investment and strengthens industry controls. We recommend that the government expand their investment in aquaculture, which is a strategic export industry, despite the potential for fiscal difficulties. Small aquaculture farms are highly likely to go out of business within two years of starting up due to aquatic animal diseases and, even if they manage to stay in business, are expected to have very low incomes. The failure of small farmers, who tend to jump into business with loans from families and friends, affects family members and local communities. Therefore, it is important for the government, in cooperation with the aquaculture industry, to help newcomers—who are inexperienced and uninformed regarding technology and education about potential diseases—to minimize their possibility of failure. One obstacle to improving Vietnamese aquaculture product safety management is a lack of entrance barriers to aquaculture. This allows those without the necessary knowledge of farming methods and diseases to start farms with poor facilities. As farmers tend to avoid meeting with each other in order to prevent the spread of disease, they keep know-how to themselves, and often rely on feed suppliers for information and materials (i.e., medicines) when they need to respond to diseases. It is critical to mandate that those farmers who start or continue farming should register with authorities and receive the required education on the minimum criteria for aquaculture facilities. In addition, an alliance between research and education institutions through which farmers can access information on disease control and effective farming should be established. Alongside increased smartphone penetration among aquaculture farmers, it is important to build communities on social platforms that encourage community partnership. In terms of safety management, the most neglected elements in the aquaculture product value chain are the collectors and middlemen. They usually do not own refrigerated or deep-freeze transport vehicles, so they use ice to keep their products fresh. Sometimes they mix harvests from several farms into one collection, which makes it difficult to trace products. Some collectors, feed and materials dealers, and suppliers provide prohibited veterinary medicines to farms. Some farmers also
151 buy banned drugs online. Against this backdrop, the tightened control of collectors, feed and material suppliers, and online stores is urgently required.
▏Table Ⅴ-2▕ How to Overcome Challenges to Vietnamese Aquaculture Product Safety
Challenges Solutions • Expected low income and frequent aquaculture • Providing orientations on disease management farm failure due to aquatic animal diseases and offering mentors in alliance with research and education institutions • Building SPF PL supply systems and facilitating public and private PL diagnosis services • Large numbers of poor aquaculture farmers • Promotion of farming producer associations, encouraging (beyond the capacity of government management) social platform communities, and partnerships with major and avoidance of information-sharing consumer cities and communities • Low entrance barriers to aquaculture (no criteria • Introducing report and registration systems for for permission, registration, education, or facilities) government management • Establishing minimum criteria for facilities, education, and personnel for farms bigger than a specified size • Insufficient government budgets for social • Expanding investment in social infrastructure infrastructure investment needed for production (drainage, roads, logistics, warehouses) considering the contributions made to the national economy • No safety management of middlemen (collectors), • Setting standards for mandatory refrigeration facilities, dealers, and online drug sales obligatory reporting by middlemen (collectors), increasing educational opportunities, strengthening control of the distribution of prohibited substances by feed and medicine dealers • Government lenient with violators of regulations • Legislation on punishment regulations for not reporting (disease notification, limit on the movement of the emergence of diseases, violating limitations on the diseased shrimp, distribution of diseased shrimp, movement and sales of diseased aquatic animals, and use of prohibited veterinary medicines) tightening controls of prohibited veterinary medicine distribution • Insufficient safety management of fishery • Strengthening safety management of fishery products for products for domestic use domestic use, enhancing interdepartmental cooperation on safety inspections, and tightening controls on the transition of products for domestic use into export use • Insufficient information sharing (results of environmental • Publishing results of environmental water quality monitoring, water quality, outbreaks of farmed aquatic real-time monitoring by the D-Fish and RIA, and animal diseases, safety inspection results, etc.) sharing information through an integrated disease and safety management system • Inadequate aquaculture product traceability • Building a traceability system for small- and systems medium-processing factories as well as for larger ones
152 Ⅴ. Key Findings and Policy Suggestions
Challenges Solutions • Lack of awareness of the dangers of veterinary • Strengthening education on diseases and drug use drugs and stricter punishments for users of prohibited veterinary drugs • Lack of extension officers • Increasing the number of public officials to respond to issues by aquaculture type and quality • Lack of government interdepartmental cooperation • Facilitating interdepartmental cooperation and in safety management unifying food safety management procedures
2. Policy Suggestion
Table Ⅴ-3 details the roadmap for improvement of the safety management of aquaculture products in Vietnam. This roadmap can be used as a reference for government administration of the safety management system and to formulate plans to enhance it. It is designed to provide support and direction to the MARD and local governments when establishing medium-term plans to improve safety management systems.
▏Table Ⅴ-3▕ Roadmap for the Implementation of Policy Suggestions
Term Activities Responsibility Establish education on farming diseases and public relations (PR) system for small farms through YouTube and other social media D-Fish, DAH platforms One Build communities on social media platforms (producers, research year D-Fish, DAH, Province institutes, educational institutes) Guide and supervise the implementation of safety requirements NAFIQAD for exporters Introduce a registration system for aquaculture D-Fish General investigation of persons involved in the aquaculture industry D-Fish Develop an application for issuing alerts and sharing real-time D-Fish, DAH, Province Three information on environment, water quality, and diseases years Strengthen residue inspection through the aquaculture value chain D-Fish, NAFIQAD Improve disease reporting system (introduce punishment provisions) DAH Strengthen the management of the distribution of veterinary DAH medicines (producers, dealers, and online sales)
153 Term Activities Responsibility Introduce mandatory registration of collectors, strengthen traceability NAFIQAD system, build refrigerated transport systems Review, legislate, and revise the standard operating procedures (SOP) DAH for those working in disease prevention, control, and termination Three years Monitor and research antibiotic resistance DAH Prepare standard procedure and strengthen active surveillance, DAH promote close cooperation with related agencies Develop standard management procedures and test systems for DAH the disease prevention organization Enact a comprehensive adjustment law on food safety management MOH, MARD, MOIT Build infrastructure to improve the farming environment MARD Long Increase government personnel for disease guidance and residue term MARD inspection Establish a consistent refrigerated supply chain MARD
A. Legislation for Integrating and Coordinating Food Safety Management
In South Korea, food safety management functions are distributed across several departments, making it difficult to respond quickly when prohibitions on the production and sale of potentially harmful food products need to be implemented. Consequently, gaps exist in the safety management system. To address this problem, the Framework Act on Food Safety was enacted in 2008 to build a system framework that creates and implements food safety management plans, conducts mandatory evaluation of food risks, and promotes consumer engagement in food safety management for public health. In Vietnam, food safety is managed by several departments, including the MARD, the MOH, and the MOIT. The production and export of fisheries products are controlled by MARD, while domestic distribution of fisheries products is managed by the MARD, the Ministry of Industry, or the MOH according to the type of distribution—wholesale or retail. Safety management of the retail sector, including markets and supermarkets, is the responsibility of the Ministry of Industry, while restaurants, food suppliers, and food courts are supervised by the MOH. However, the MOH defines the MRLs (Maximum Residue limits) for additives and pesticides in food. According to the enforcement decree on the Food Safety Law, revised in 2018, reduced inspections for imported food products are conducted by customs. To ensure food safety in government institutions, the National Inter-Sector Steering
154 Ⅴ. Key Findings and Policy Suggestions
Committee on Food Safety was instituted under the supervision of the MOH. We recommend that the Prime Minister’s office or an independent committee supervise and coordinate all food safety efforts.
B. Strengthening Aquatic Life Disease Management
Disease outbreaks of unknown or foreign origin can occur in aquatic animal farming facilities. Once these diseases have emerged, early response and prevention might be difficult because the diseases are transmitted through water systems. Unlike the control of livestock on land, it is extremely difficult to prevent the spread of new and unknown diseases through isolation due to the environmental requirements of aquatic species. Techniques are required to prevent disease emergence and spread to other species so that disease does not become rampant and difficult to treat. It is important to establish systems and policies to suppress and prevent disease outbreaks rather than only treating diseases after they have broken out. To this end, regionalization or zoning of diseases is needed and territories should be divided into clean and contaminated zones. Clean zones should be constantly monitored for the inflow of external diseases, while contaminated zones should be closely and intensively surveyed to diminish the emergence of aquatic species diseases by type. However, it is also important to continue to strengthen disease prevention systems after an outbreak. The government needs to establish advanced disease prevention systems that balance preventative and follow-up measures that effectively address disease emergence. Quarantine measures for infectious diseases should include an official declaration that a country is free of an aquatic disease, along with strengthening inspections of the aquatic species flowing into the country. It is also important to train professionals with expertise in the relevant areas of disease management, prepare detailed SOP for each stage, develop and manage medicines to treat diseases, and enact legislation for efficient and effective disease prevention systems. First, it is important to strengthen the obligations and roles of practice for aquatic diseases prevention authorities. High priority should be given to the review, legislation, and revision of the SOP for those working in the area of development and implementation of diseases prevention, control, and termination programs. Second, antibiotic resistance, which is globally recognized as a critical problem,
155 should be addressed. As a growing number of countries tighten controls on the use of antibiotics and the OIE Aquatic Animal Health Code (the Aquatic Code) recommends monitoring of antibiotic resistance, it is necessary to establish plans and conduct research that addresses the issue. Third, active surveillance standard procedures should be prepared and strengthened in tandem with improvement of the cooperation of related agencies. Some aquaculture farmers may not realize the need or their responsibility to provide specimens, let alone understand the concept of surveillance. Communication with on-sites stakeholders is needed, including aquaculture farmers. We recommend listing the range of stakeholders and providing them with necessary information, such as hygienic conditions for aquatic species, information on dangerous pathogens, and agencies’ activities for disease prevention in accordance with regulations such as surveillance implementation. Stakeholders’ opinions should also be collected. Subsequently, disease prevention agencies should develop standard management procedures and verification systems. To do this, such agencies need to organize a consultative body consisting of expert groups to review directions for fisheries disease prevention initiatives and to understand the trends in advanced countries. Additionally, standard management procedures for aquaculture farms should be created.
C. Small Aquaculturist Training and Strengthening Safety Management for Domestic-Market Fishery Products
Fisheries products exported from Vietnam are managed through the registered farms and factories in each province. When safety issues occur, NAFIQAD oversees follow-up management. However, small farms with an area of 3 ha or less are not properly managed by the central government. When there are not enough fisheries products produced by registered farms, farmed shrimp for domestic use are processed for export. Superior processing factories manage fisheries products systematically, including testing for residues four times before processing products supplied by farms. However, this is not the case for small- and medium-processing factories. Such factories exclude products from the collection when veterinary drug residues are detected, and the residue-detected fisheries products are then sold for domestic use. If residues are not detected in the products from the excluded farm in the next collection process, then their products are used for processing. Until the same standards are applied to products for both export and domestic use, safety issues for products exported from Vietnam will continue to resurface.
156 Ⅴ. Key Findings and Policy Suggestions
D. Strengthening Fishery Product Residue Management and Safety Control at All Stages of the Value Chain
To ensure disease safety at the production stage, the following preventative measures should be taken.
▏Table Ⅴ-4▕ Safety Management during the Production Stage
Measures
The most critical role of the government in aquaculture is in building aquaculture infrastructure and managing environment and water quality around farms. The Environment Vietnamese MARD and the D-Fish conduct water quality inspections around farms and Water through RIA 1, 2, and 3. However, inspections are limited to certain areas and the Quality inspection results are not disclosed. Expansion of water quality inspection areas, the Management publication of results, and provision of guidance so that appropriate measures can be taken, such as delaying stocking, prohibition of inflow water, or early shipment, in accordance with the results of water quality inspections are necessary.
Vietnam’s shrimp hatcheries are scaling up to large and super large sizes. These are well-equipped with facilities, management, disinfection, and educated employees. These large-scale farms have a lower incidence rate of diseases, while in smaller hatcheries, the incidence of diseases is still high. Despite new trends in implementing preventative measures, some small farms face failure due to high costs (facilities, personnel, chemicals, etc.), lack of facilities (infrastructure, no laboratories or located too far away), and lack of technical training. Most infections start with brood stock feed for shrimp, since this requires the use of safety methods such as gamma irradiation or frozen products. Methods for reducing and controlling the emergence of diseases in hatcheries are as follows: Hatcheries ① Aquaculture environment: Prepare standard procedures according to the characteristics of each hatchery, including instituting basic rules for entering and exiting each facility and building (disinfection of hands and feet, disinfection of work clothes, accessibility, etc.), behaviors for visitors entering and exiting the site, and entering and exiting vehicles (classification of accessible facilities and buildings, action guide). ② Water treatment: Since it is impossible to keep hatcheries sterile, all water for farming that flows into the facility should be filtered and chlorinated to block the introduction and survival of a virus-host and the virus by using a water treatment system or prevention protocol. Water for farming should be monitored for the bacteria in the genus Vibrio and discharged twice per week.
157 Measures
③ Spawning ground: Brood stocks should be isolated and sterilized after stocking. In the SPF brood stock, HPM-EHP can be detected in a PCR test without AHPND. Before entering clean and sterilized brood stock/hatchery facilities, SPF brood stock should be checked for this infection with HPM-EHP. This should be done during the quarantine process as well. Live worms, used as feed for brood stock, should be sufficiently disinfected and placed in running water for several days before being fed to brood stock. ④ Hatcheries: Diatoms and artemias, used as food for larvae, should be disinfected. For the prevention of viruses, artemias should be hulled before use. In hatcheries, if the growth rate of PL is lower than expected, they should be considered to be infected. After removing the shrimp, fill the tank with 2.5% sodium hydroxide (NaOH), drain it after three hours, wash it with clean water, dry it for seven days, and then re-wash it with acidified chlorine (pH4 or less).
The following measures should be taken to minimize the emergence of disease on small farms: ① Disease inspection: Before stocking PL in a pond, check the disease infection certificate. PLs should never be stocked in a farming pond without an inspection. ② Disinfection: It is important to thoroughly clean, dry, and disinfect all surfaces and equipment inside the pond or breeding tanks before the aquaculture period begins. The spores of HPM-EHP have very thick cellular walls and they are difficult to eradicate, since they do not die even in high chlorine concentrations. It should be noted that there is also a potential for entry through carriers and spores can remain in the pond after harvest. Spray 6t/ha of quicklime and leave some water to activate for one week before drying and filling the tank with water again. Farms ③ Water quality improvement: Water quality improvers are used to control bacteria in the same way as a probiotic top coating. This is a mixture of probiotic bacteria that helps to decompose organic matter, including the peels and solids of dead shrimp. ④ Farming environment: Block the surface of the breeding tank or pond with a liner to reduce the risk of pathogen infections by reducing water exchange. The passages for influent and discharged water should be separated to minimize disease re-infection by preventing wastewater from re-entering the inlet. A device should be installed in the inlet to block and disinfect disease carriers. Do not put this directly into the pond but use it only after it has been housed in another pond for one to two days. ⑤ Education: Participate in aquaculture and disease education conducted by the government or local government and use the new disease information, veterinary drugs use information, and aquaculture protocols that are provided.
158 Ⅴ. Key Findings and Policy Suggestions
Veterinary drugs have been continuously detected in the residue inspections of foods imported from Vietnam conducted by Korea’s Food and Drug Administration. According to the monitoring of residual harmful substances in Vietnamese aquaculture products during the production stage between 2010 and 2017, between 0.78% and 1.46% of fishery products proved to be non-compliant every year. It was confirmed that prohibited antibiotics (e.g., chloramphenicol, nitroimidazole, and nitrofurans) were detected almost every year on Vietnam’s farms. In addition, malachite green and its metabolites, banned from use on farms, were continuously detected. It is believed that these prohibited substances are illegally and inappropriately being used to prevent and treat diseases in aquaculture species. Further strengthening the supervision and education by related authorities is urgently needed. In addition, non-compliant specimens for tetracycline-based and sulfonamides, among the approved antibiotics, are continuously detected, so continued guidance and management is needed to prevent the release of non-compliant aquaculture species. Enrofloxin/ciproxin has been prohibited from use in aquaculture in Vietnam since March 2012. Nevertheless, these substances are still being illegally used. In Vietnam, 50%–60% of shrimp farms use environmentally friendly farming methods with biofloc; however, smaller farms use regular farming methods because they are less expensive. In this method, farmers seem to illegally administer nitrofurans, since they are affordable and effective for controlling various diseases. Without strong guidance and supervision from sanitation authorities, the illegal use of nitrofurans in shrimp farming is likely to continue, which should be appropriately addressed. Reportedly, in EU inspections of imported food in 2016, prohibited substances, including nitrofurans, malachite green, and tetracycline, were detected in 12 cases.125) To prevent the export of fishery products containing prohibited substances, strengthening residue inspection in the sampling process is necessary. This should be based on principles and standards, paying special attention to hatcheries that supply PL, as well as the residue inspections of many farms.
125) European Commission Directorate-General for Health and Food Safety, Final report of an audit carried out in Vietnam from 15 to 24 November 2017 in order to evaluate the control of residues and contaminants in live animals and animal products including controls on veterinary medicinal products. DG(SANTE) 2017-6185. 3.
159 E. Strengthening Safety Management of Fishery Products at the Processing Stage
Registered Vietnamese facilities that produce processed shrimp products exported to Korea and other countries are operated according to established Critical Control Point (CCP) in compliance with the HACCP regulations for each production process. However, since nitrofurans are continuously detected in Vietnamese shrimp processed products exported to Korea, safety management should be further strengthened. Nitrofurans that are banned internationally should be given special attention. Among the aquaculture products exported to Korea between 2014 and 2019, the number of non-compliant cases (14) caused by nitrofurans (including metabolites) made it the second-highest ranked residual harmful substance. Nitrofurans were detected in zero cases in 2014; three in 2015; zero in 2016; two in 2017; six in 2018; and four in 2019. Non-compliant cases were found every year except for 2014 and 2016. Notably, all 12 cases since 2017 occurred in frozen shrimp, so this product should be appropriately examined. Korea conducted an inspection of Vietnamese shrimp processing facilities in 2018 and confirmed that the main reason for nitrofuran residue was that shrimp purchased from small farms (known for the customary illegal use of nitrofurans) was mixed with other shrimp. In addition, processors did not have contracts to supply raw materials, thus creating issues in receipt management at processing facilities. To prevent harmful substance residues, such as nitrofurans, being detected in raw materials, processing facilities should undertake sanitary controls and hygiene management by establishing harmful substances, such as nitrofurans, as the main CCP for raw materials. Strengthening the training of the employees in charge of purchasing raw materials after pre-inspection and cross-validation is also important. Quinolone antibiotics, a medicine for fishery products, were detected in zero cases in 2014; five in 2015; zero in 2016; one in 2017; two in 2018; and zero in 2019. Although the rate of non-compliance has been falling since 2015, stronger management measures are still needed, since non-compliance is still detected intermittently. According to Korean authorities’ inspection reports from 2002 to 2019, there were numerous non-compliant cases of microbial organisms in frozen packaged shrimp exported from Vietnam to Korea. Between 2014 and 2018, there were 15 total non-compliant bacteria cases and 13 of those were found in frozen shrimp. It is
160 Ⅴ. Key Findings and Policy Suggestions
presumed that Korean importers purchased frozen shrimp for cooking at low prices and imported them to be eaten as raw. When the Korean authorities inspected them as such, the result was a rise in the number of non-compliant microbial cases. The reasons for these cases include unclear specifications on the products’ sanitary certificates regarding whether products were to be eaten raw or cooked; multiple, confusing descriptions of how the products could be eaten raw; and lack of communication between the different sanitary authorities in the two countries about specifications on how the products should be eaten, raw or cooked. In June 2018, Korean authorities requested that Vietnamese fishery products be labeled as suitable for eating raw in the description field on hygiene certificates. Accordingly, Vietnamese authorities enacted the English descriptions “ready to eat” and “ready to eat (sushi, shasimi)” for products to be eaten as raw on July 1, 2018. Subsequently, there was a reduction in non-compliant cases of microbial numbers in frozen packaged fishery products, including frozen ready-to-eat shrimp, and in 2019, there was only one non-compliant case. The Vietnamese government should provide training, guidance, and control on how to fill out hygiene certificate forms for ready-to-eat fishery products.
F. Improvement of the Veterinary Medicine Prescription System
Overall, the veterinary drug approval system in Vietnam is well implemented, but there are no strict regulations when drugs are not used as prescribed. Many small farms appear to use veterinary drugs without realizing their role or effect on humans and the environment. In the current system, in which aquaculture farmers order veterinary medicines from local dealers who also deliver the drugs, there is plenty of scope for misuse. It is not uncommon for farmers to use these drugs without knowing the exact dosage or proper use. Against this backdrop, providing education on the use of veterinary drugs for farming, especially to farmers in areas with a high probability of disease, is necessary.
G. Online Community Promotion and Training Enhancement
The Vietnamese government delivers information and technology on shrimp farming to small farms through government instructors, called extension officers. However, the number of small shrimp farms is far greater than the number of large
161 farms in Vietnam, so it is difficult for instructors to provide adequate coverage to all small shrimp farms needing help.126) It is especially difficult for them to provide information where they are most needed. As mentioned in Chapter 3, only six out of 145 (4%) shrimp aquaculture farmers that responded to the survey said that they obtained information about shrimp farming technology from extension officers. Only 24 farmers (16%) obtained information on the prevention and treatment of shrimp disease from extension officers. There are similar problems in land agriculture and research in that area has discovered that sharing information between farms can provide a solution for disseminating information and technology if there is a lack of extension officers. The research examined the effect of smartphone use in improving price negotiation between farms127) and the distribution of agricultural information and technologies through social networks.128) However, when farmers relied on information about technology through social networks or smartphones, the quality and quantity of the information they were able to access varied depending on the source. It is possible that this horizontal exchange of information could widen the information divide between classes. Information asymmetry or concentration problems can be solved using social networks or a virtual community of practice (i.e., an online community). Such communities enable many people to access information and technology simultaneously and to ask questions and get answers from people who they have never met. Therefore, online communities of shrimp aquaculture farmers could be a suitable way to make up for the lack of extension officers. Online communities might also be a way to improve return on investment (ROI) and distribute environment-friendly farming technologies in which antibiotics are not used.
126) Lee and Suzuki (2020). 127) Aker, Jenny C. and Isaac M. Mbiti (2010). “Mobile phones and economic development in Africa.” Journal of Economic Perspectives, 24, no. 3, pp. 207-32. 128) Conley, Timothy G. and Christopher R. Udry (2010), “Learning about a new technology: Pineapple in Ghana.” American Economic Review, 100, no. 1, pp. 35-69.
162 Ⅴ. Key Findings and Policy Suggestions
Information sharing in Thailand
Lee and Suzuki (2020) surveyed the shrimp farmers’ online community in Thailand to understand the status of information sharing among community members in a Facebook private group created in 2011. Started as a university alumni community, it has many active members, including shrimp farmers, professors in the Department of Fisheries and Aquaculture, and others in the shrimp farming industry across the country. This community is operated and managed by seven shrimp farmers (as of May 2017), and they were upgraded from members to operators in recognition of their degrees in fisheries and biology from prestigious Thai universities or for their excellent knowledge of shrimp aquaculture. 1Lee and Suzuki (2020) documented and systematized the posts from November 2011 to May 2017 to examine the status of information sharing and inquiries. The information was divided into two categories –information sharing and inquiry– according to the posting’s purpose. From November 2011 to May 2017, the community members posted 6,368 information-sharing posts. These posts were uploaded in a variety of formats including photos, documents, videos, and text. Also, using the Facebook Live function, they broadcasted live shrimp farming workshops. The largest share of information was communicated in 2014, when there were 2,465 posts. Shrimp producers’ price information made up the largest portion of the posts, and these were assumed to have a positive impact on members’ price bargaining power. Of the information sharing posts posted in 2017, 33% included content on shrimp sellers, buyers, and market prices, and 27% on shrimp technology, inputs, and equipment. Sharing this information could help to improve the productivity of shrimp farms and prevent shrimp diseases. Among the inquiry posts, inquiries on shrimp farming technology were always the highest ranging from 46% to 70% (excluding 2011). Inquiries on shrimp diseases accounted for more than 10% in all years. These numbers imply that there were many shrimp farmers who suffered with shrimp disease outbreaks and indicate that they needed knowledge for solving infectious disease problems and increasing productivity. On the other hand, only about 2% of the information inquiry posts in 2017 related to shrimp sellers and buyers, and market prices. It is presumed that there were only a few members who inquired directly because the information about shrimp sellers, buyers and market prices was sufficiently posted in the community by multiple members. Otherwise, It seems that the rate of inquiries about shrimp sellers, buyers and market prices was low, as they are using this online community for the purpose of obtaining information about the shrimp disease.
According to Lee et al. (2019a), 52% of Vietnamese aquaculture farmers own smartphones. If expanded to family members, that percentage increases. It would be a milestone in disease control and safety management if Vietnam could build a real-time smartphone system for disseminating notifications and environmental consultations, water quality surveys, disease surveillance results, disease outbreak status, and food safety surveys. Some Vietnamese companies already consult on
163 shrimp diseases through social network platforms;129)however, there is a concern that information-sharing among online community members might enable the spread of inaccurate information. When proposing online communities to serve as alternative information channels, considering how the spread of inaccurate information might be prevented in online communities is necessary.
H. Infrastructure Investment
First, building infrastructure for the supply and management of influent and effluent water from farms in areas with concentrated farming facilities is necessary. Most farms operate on a small scale, and because the number of farms is so large, accurate statistics are not available. Small farms often purchase PL without testing it for disease. In many cases, several aquaculture farms share a single canal, and the access and drainage channels are not separated, exposing them all to disease. When treating diseased shrimp or using veterinary drugs for preventative purposes, farmers often do not know which ones are prohibited or the exact method for use. Sometimes, they administer drugs incorrectly by following the recommendations of feed or PL dealers that do not have specialist training.
129) (last visited February 20, 2020).
164 References
References
Chin, S. (2018). “Vietnam’s Shrimp exports at risk”. Available at https://theaseanpost.com/article/vietnams-shrimp-exports-risk, The Asian Post, October 8, 2018. EU RASFF portal. Available at https://ec.europa.eu/food/safety/rasff_en. Food Safety Portal. Available at https://www.foodsafetykorea.go.kr/main.do. Lee, Guenwoo, Suzuki, Aya, & Vu, Hoang Nam. (2019). “The determinants of detecting veterinary drug residues: Evidence from shrimp farmers in southern Vietnam.” Aquaculture Economics & Management, Vol. 23, No. 2, 135-157. Import Quarantine Statistics, National Fishery Products Quality Management Service https://www.nfqs.go.kr/ Jeong Meyong-hwa et al. (2018). A Study on the Fisheries Development Cooperation between Korea and Vietnam for the Implementation of the Korean New South Policy, Korea Maritime Institute. Ministry of Food and Drug Safety of Korea (2016-2019). Yearbook of Imported Food Inspection. Nguyen, Tan Sy. (2018). Shrimp farming in Vietnam: currently status, potential and investment opportunities. Nguyen, Thi Le Hoa. (2020). Sustainable and equitable shrimp production and value chain development in Vietnam (SUSV), Oxfam and ICAFIS, EU Switch Asia Programme. Porter, Michael E. (1985). Competitive advantage: Creating and sustaining superior performance. New York. Priit, Ojamaa. (2018). Research for PECH Committee – Fisheries in Vietnam, Policy Department for Structural and Cohesion Policies, European Parliament, October 2018.
165
Suzuki, Aya and Vu, Hoang Nam. (2016). “Food quality awareness: cases from shrimp producers in Thailand and vegetable producers in Vietnam,” IDE Discussion Papers, Institute of Developing Economies, Japan External Trade Organization (JETRO). Suzuki, A., & Vu, H. (2016). Food quality awareness: Cases from shrimp producers in Thailand and vegetable producers in Vietnam. IDE Discussion Paper, No. 569. USAID Oceans and Fisheries Partnership (2018). Vietnam CDT gap analysis and partnership appraisal. VASEP (2020). Report on Vietnam seafood export in 2019.
166 발간번호 KOTRA자료 20-183
2019 K-V FTA Economic Cooperation Work Program Strengthening K-V Fishery Cooperation by Improving Viet Nam’s Aquaculture Safety
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