The Status of the Organizational System for Food Risk Analysis in Korea and Tasks ahead

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Working Paper 2011-03

The Status of the Organizational

System for Food Risk Analysis in

Korea and Tasks ahead

Kim, Jeong Seon

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WORKING PAPER 2010-03

The Status of the Organizational System for Food Risk Analysis in Korea and Tasks ahead Kim Jeong Seon, Research Fellow

Korea Institute for Health and Social Affairs

Korea Institute for Health and Social Affairs Jinhungro 28, Eunpyeong-gu, Seoul 122-705, Korea http://www.kihasa.re.kr

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CHAPTER 1

Introduction ··· 3

A. Necessity and background of the study ··· 3

B. Purpose of the study ··· 4

C. Details and methods of the study ··· 5

CHAPTER 2

Systems and Status of Risk Analysis in Korea ··· 9

A. Food safety environment and conditions ··· 9

B. Organizational system ··· 11

C. Operational system ··· 16

D. Implications ··· 27

CHAPTER 3

Risk Aanalysis Systems of Foreign Countries and Status ·· 33

A. Codex ··· 33

B. Organizational system ··· 38

C. Operational system ··· 41

C. Implications ··· 49

CHAPTER 4

Improvement Methods for the Organizational and

Operational Systems of Risk Assessment and Risk

Management of Korea ··· 55

A. Result of surveying experts ··· 55

B. Analysis of the advantages and the disadvantages of each organizational system for risk analysis ··· 66

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C. Organizational systems ··· 71 D. Operational system ··· 76

CHAPTER 5

Conclusion and Policy Suggestion ··· 81

A. Organizational system ··· 82 B. Operational system ··· 84

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List of Tables

〈Table 1〉Subjects and scope of risk assessment under the domestic law ··· 10 〈Table 2〉Work scope of each risk management organization ··· 13 〈Table 3〉Risk assessment-related work scope of each organization ··· 15 〈Table 4〉Status of domestic researches on the human health risk assessment of microorganisms ··· 16 〈Table 5〉Status of domestic researches on the risk

assessment of chemical substances ··· 19 〈Table 6〉Status of studies conducted by the Korea Food and Drug Administration on risk analysis of microorganisms, chemical substances, new types of food, etc. and risk analysis data ··· 22 〈Table 7〉List of risk analysis training programs of the Korea Food and Drug Administration ··· 25 〈Table 8〉The risk assessment data management system of the Korea Food and Drug Administration ··· 26 〈Table 9〉Recommendation of the Codex regarding risk assessment and risk management ··· 34 〈Table 10〉Comparison of the organizational systems for risk assessment and risk management in Korea and foreign countries ··· 36 〈Table 11〉Comparison of the risk assessment commissions of each country. ··· 43 〈Table 12〉Comparison of the risk assessment commission of each country ··· 45

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〈Table 13〉The JIFSAN (Joint Institute For Food Safety and Applied Nutrition) of the United States ··· 46 〈Table 14〉Status of deliberations of the health effect assessment of food in Japan (July 2010) ··· 47 〈Table 15〉Characteristics and implications of each country ··· 49 〈Table 16〉Comparison of perceptions of the risk

management and risk assessment of each

organizational system ··· 58 〈Table 17〉Standards to analyze the advantages and the disadvantages of organizational systems ··· 66 〈Table 18〉Analysis of the advantages and disadvantages of each organizational system ··· 67 〈Table 19〉Analysis of each system based on the

evaluation standards for organizational systems ··· 68 〈Table 20〉Consumer confidence in food safety ··· 72 〈Table 21〉Outstanding issues in Korea and improvement methods ··· 76

List of Pictures

〔Fig 1〕Flow chart of risk management and risk

assessment ··· 35 〔Fig 2〕Comparison of the organizational operation

systems for risk assessment and management ·· 36 〔Fig 3〕The roles of the Consumer Affairs Agency of Japan and its collaborative relationship with

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01

Introduction

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3 CHA P T E R 1 In tr od uct ion

CHAPTER 1 Introduction

A. Necessity and background of the study

The Agreement on Sanitary and Phytosanitary Measures (SPS) of the WTO now requires that sanitation inspection should be implemented based on risk assessment in accordance with the international norms of the Codex. Accordingly, it is now required to strengthen scientific analysis research capability in order to protect domestic industries, and risk analysis needs to be implemented in order to improve our response to protectionism. In addition, due to the emergence of a growing number of new hazardous materials, such as environmental contaminants caused by industrial development and hazardous materials generated in the process of food production, risk assessment is gaining more importance.

In Korea, while government departments governing food and their affiliated research institutes are in charge of both risk management and risk assessment, private councils have recently suggested, based on the recommendation of the Codex for the functional separation of the food risk assessment body and the risk management body, that the organizational system of Korea should be restructured in

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4 Th e S ta tus of th e Or ga niza tion al S ys te m fo r Food R isk An al ys is in K ore a a nd T as ks

order to achieve the efficiency, objectivity and accuracy of risk assessment based on the structure of the organization.

Food safety management requires implementation of proper prevention and management based on scientific and objective risk assessment result. Scientific assessment should be implemented on the extent of the harmful effect of hazardous materials on health and their risks, and then, risk management, such as establishment of standards and introduction of regulations, should be implemented depending on the results.

Thus, it is necessary to assess the systems, standards, procedures, methods, rules, records, etc. of international bodies and foreign countries regarding risk assessment and risk management and to compare them with those of Korea, in order to find appropriate improvement methods.

B. Purpose of the study

The primary purpose of this study is to research and analyze the systems and the status of food risk assessment and food management in Korea and foreign countries to explore their implications, and thus, to develop appropriate food risk assessment and risk management methods for Korea.

Detailed goals are as follows: first, survey and analysis of international norms regarding risk analysis such as the Codex; second, comparison and analysis of the risk assessment and management status of foreign countries; third, survey and analysis of the risk assessment and risk management status in Korea; and last, exploration of improvement methods for the organizational system for risk assessment and risk management of Korea and suggestion of policies.

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5 CHA P T E R 1 In tr od uct ion

C. Details and methods of the study

1) Examination of international norms regarding risk

analysis such as the Codex

－ Comparison and analysis of the regulations of international bodies for each item and their recommendations

－ Risk assessment and risk management for each item

2) Survey and analysis of the organizational systems

for risk assessment and risk management in Korea

and foreign countries

－ Food safety environment and conditions

－ Status of risk management bodies, management procedures, methods, rules, records, etc.

－ Status of risk assessment bodies, assessment procedures, methods, standards and records

－ Cooperative systems, etc. between risk assessment bodies and risk management bodies

－ Assessment of functional and actual implementation, and historical circumstances

－ Assessment of the organizational culture and decision-making structure regarding implementation of governmental functions

3) Survey of domestic and overseas food risk

assessment-related administrative (support) systems

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systems regarding risk assessment (alliance of the industry, the academy and the research institutes) and status of risk assessment data management systems and training programs

4) Comparison of the advantages and disadvantages

of the risk assessment and management systems

of each country, and analysis of the confidence

level of each country in food safety

5) Assessment of the status of risk assessment and

risk management systems and collection of opinions

on the directions ahead by interviews with and

survey of domestic and overseas experts

6) Suggestion of polices to draw up methods to improve

the organizational system for risk assessment of Korea

－ Methods to efficiently manage organizations regarding risk assessment

－ Systems for organic cooperation between risk assessment and risk management

－ Methods to facilitate risk communication

－ Methods to strengthen technical cooperation of relevant organizations in food safety R&D for scientific and rational risk assessment, etc.

－ Methods to operate risk assessment data management systems and to improve training programs

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K I H A S A

02

Systems and Status of Risk

Analysis in Korea

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9 C H A P T E R 2 S y st e m s a n d S ta tus o f R isk A n a ly sis in Kor e a

CHAPTER 2 Systems and Status of Risk

Analysis in Korea

A. Food safety environment and conditions

Analysis of the food safety environment in Korea shows that novel food such as genetically modified food and new types of hazardous substances such as dioxin and acrylamide are continuously detected. In addition, the growing use of hazardous substances such as pesticide to improve productivity for expansion of food production will aggravate the risk, coupled with the climate change. Also, while the likelihood of massive food poisoning has increased due to the shifts in the dietary lives and tastes of consumers, the improved living standards driven by economic development have made consumers more concerned about food safety and more sensitive to potentially harmful substances; they have developed a tendency to demand psychologically and subjectively absolute safe food rather than scientific and objective safety.

As many food-related incidents such as the BSE and detection of pathogenic coliform bacillus and dioxin have occurred recently, it is now required that overall reviews of the food safety management system be undertaken, and then, conduct in-depth and systematic studies on improving

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Department Name of law Subject Scope and details

Ministry of Health and Welfare

Framework Act On Food Safety Food

Whether a hazardous element is harmful to health and its extent. Pre-and post-risk assessment is available.

Food Sanitation Act Food

The effect of hazardous elements in food, food additives, devices and packages on health Ministry for Food, Agriculture, Forestry and Fisheries Agricultural Products Quality Control Act

Agricultural products

Residual hazardous substances such as pesticide, heavy metal, antibiotics, persistent organic pollutants, pathogenic microorganisms, mycotoxin, radioactive farmland, water and materials Quality Control of

Fishery Products Act

Marine products

Heavy metal, radioactivity, antibiotics, pathogenic microorganisms and toxic materials

Livestock Processing Act

Livestock

products Hazardous elements with potential risk Act on the Prevention Imported Risk analysis of contagious diseases,

related systems in order to efficiently carry out food safety management on a scientific basis.

As the government departments governing food and their affiliated research institutes are in charge of both risk management and risk assessment, consumer confidence in the result of risk assessment is below average; to improve the consumer confidence in the result of risk assessment, implementing systematic and institutional changes is required.

<Table 1> shows the subjects and scope of risk assessment of each government department under the domestic law. Currently, the hierarchy of the food safety management system in Korea is divided into the Food Safety Policy Commission, central administrative bodies and local governments. And horizontally, various government agencies are involved including the Korea Food and Drug Administration of the Ministry of Health and Welfare and the Ministry for Food, Agriculture, Forestry and Fisheries depending on the type of food.

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Department Name of law Subject Scope and details of Livestock Epidemics animal/livestock _products etc.

Plant Protection Act Pests and diseases

Effect of imported crops on the natural environment

Marine Animal Disease Control Act

Importation of marine products

Marine animal epidemics of imported marine products Ministry of Knowledge Economy Transboundary Movement, etc. of Living Modified Organisms Act Genetically modified organisms

Effect on the human body and the environment

Ministry of Environment

Toxic Chemicals

Control Act Chemicals

The extent of the effect of hazardous chemicals on health and the environment

B. Organizational system

Risk analysis is composed of risk assessment, risk management, and risk communication.

Risk assessment, which refers to the study that estimates the possibility of harmful effect that would be caused by identified exposure to chemical, biological and physical risk factors, provides scientific basis; and risk management supports policies by drawing up, implementing and evaluating policy alternatives required to improve the condition that causes harmful effect and to remove risk factors. And risk communication ensures the participation of risk managers, risk assessors, consumers, the academy, stakeholders, etc. in the process of risk analysis and exchanges overall information and opinions during the risk analysis process.

As the food safety management system involves various bodies in Korea, the risk analysis system also involves several organizations depending on the food items or phases. While a single organization is in charge of both risk

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management and risk assessment for the food items that the Ministry for Food, Agriculture, Forestry and Fisheries is in charge of, the Korea Food and Drug Administration is in charge of risk management with the National Institute of Food and Drug Safety Evaluation being responsible for risk assessment, within the Ministry of Health and Welfare–the organizational system for risk analysis is consolidated and divided at the same time. And as the National Institute of Food and Drug Safety Evaluation in charge of the risk assessment part of the Korea Food and Drug Administration has been separated to become an independent organization, it is getting increasingly independent.

1) Risk management bodies

Risk management encompasses a number of procedures including system planning, rules/standards establishment, quarantine, monitoring, supervision, etc. <Table 2> shows the subject items and risk management items of each risk management body. As the management of agricultural products distribution has been transferred from the Korea Food and Drug Administration to the Ministry for Food, Agriculture, Forestry and Fisheries, the two bodies are negotiating over the scope of jurisdiction such as direct transaction markets.

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13 C H APTER 2 Syst ems an d St at us o f Ri sk A n a ly s is in K orea O rgani zat ion Sub ject i te m s Ac tiv itie s Mi n is tr y o f Hea lt h a n d We lf ar e Kor ea F oo d a n d Dr u g Ad m ini st rat io n A g ricu lt u ra l p rodu cts (sa le s, con su m ption) Live stock Pr odu cts (co nsu m p tion ) M ar ine p ro du ct s (d is tr ib ut io n an d co ns umpt io n) P roce sse d fo od, im ported food, fo od addit ive s, re sidua l pe stic ide , G M O s (im p or te d) Estab li shm en t o f st andards an d sp ecifications D ev elopm ent of g uideli n es such a s HA C C P In vest ig ati o n in to f o o d poiso n ing a n d m o nit o ri ng M in is tr y f o r F o o d , A g ri cu lt u re , F o re st ry a n d Fi sh er ie s A g ricul tur al p roducts (production, p roc es si n g, d is tr ibu tion, d ire ct transaction an d sale in tradit ion al m arke ts) Live stock produ cts (produ cti o n , proce ssing , di st ribu ti o n a nd im p o rt at ion ) M ari n e p ro d u ct s (p ro d u ct io n a n d im p o rt at io n ) Ba y sa lt Estab li shm en t o f st andards an d sp ecifications D ev elopm ent of g u idelin es su ch a s G A P Mi n is tr y f o r F ood, _Agri cu lt u re , F o res try an d Fi sh er ie s Nat io n al V et er in ar y R ese ar ch & Qu ar an ti ne S er v ic e Live stock produ cts (produ cti o n , proce ssing , di st ribu ti o n a nd im p o rt at ion ) Vet er in ar y m ed ic in es , ma ri n e v et er in ar y me d ic in es Im po rt ed li v estoc k p roducts Estab li shm en t an d re vision o f li v estoc k p ro d u ct s s ta n d ar d s a n d s p ec if ic at io n s Estab li shm en t an d re vision o f li v estoc k labeli n g s tan d ards San itation m o n it o ring and ap prova l o f v ete ri n ary m ed ic in es Na ti o n al A g ric ul tu ra l Pr odu ct s Qu al it y Ma n ag eme n t S er v ic e A g ricul tur al p roducts (production, p roc es si n g, d ir ec t transacti on an d di st ributi o n i n tradit ion al m arke ts) and anim al fee d Safe ty i n spe cti o n, standa rds, ce rt ification, an d indica ti on o f p la ce of o rigin N at ion al P lant Q uaran tine Se rv ic e P lant p est s and d is eases Q u ar an ti n e, and prev entive m ea su res for plan ts N at io n al A ca d em y o f A g ri cu lt u ra l Scien ce Pest icide (reg is tr ation an d m ana ge m en t) GM O Pesticide and G M O r egistrati o n N at ion al F ishe ri es P roducts Q u alit y In spe cti o n S ervice M ar ine p ro du ct s (q uarant ine an d pro d uc ti on) , Ba y sa lt Q u ar an ti n e and q u ali ty c ert ification N at io n al F is h er ie s R es ea rc h & D ev elopm ent In st itute M ar ine p ro duc ts (p ro duc tion a n d di st ributi o n ) Ba y sa lt Pr ev ent iv e m easu res fo r th e na ti o n , m anag em ent o f epidem ic s and sa nit at ion sa fety 〈 Ta bl e 2〉 W or k s co pe o f ea ch r is k m an ag em en t o rg an iza tio n

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2) Risk assessment bodies

While food risk assessment functions are divided among the National Institute of Food and Drug Safety Evaluation, the Rural Development Administration, the National Veterinary Research & Quarantine Service, etc., Codex-based health effect assessment - human health risk assessment - is carried out mostly by the National Institute of Food and Drug Safety Evaluation and the National Veterinary Research & Quarantine Service. For reference, the Ministry for Food, Agriculture, Forestry and Fisheries announced in 2010 that the safety assessment functions conducted by three of its affiliated organizations (the National Veterinary Research & Quarantine Service, the National Plant Quarantine Service and the National Fisheries Products Quality Inspection Service) would be consolidated into a quarantine inspection body–which is underway now–and will strengthen the current risk assessment function that requires improvement.

<Table 3> shows the work scope of each organization regarding risk assessment. Its details show the scope of risk assessment-related functions such as subjects for assessment, risk assessment supervision, test analysis, monitoring, toxicity test, exposure assessment, etc. and whether risk management is carried out.

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15 C H APTER 2 Syst ems an d St at us o f Ri sk A n a ly s is in Ko re a 〈 Ta bl e 3〉 Ri sk a ss essm ent -re la te d w or k sco pe of each or gani zat io n C la ssif ica tio n Ite m s M in ist ry o f H ea lth a nd W el fa re M ini st ry f or F ood , Ag ric ul tu re, F or es try a nd Fi sh er ie s Nati on al I ns tit ut e of Fo od an d Dr ug S af ety Ev alua tion N at ion al V eteri na ry Res ea rch & Q uar an tine Se rvi ce Na tion al Ag ricu ltur al Pr od uc ts Q ua lity Man ag em ent Ser vi ce Na tion al P la nt Q uar an tine Se rvi ce Nat io na l Aca de m y of Agri cu ltu ral Scien ce Na tion al F ish er ies Pr od uct s Q ua lit y In sp ec tio n Ser vi ce Nat iona l Fi she rie s Re se ar ch & Dev el op m en t Ins titute Ri sk As se ss me nt Su bj ec t of as ses sm en t Co nta m ina n ts Environm ental con ta m inan ts Ne w ty p es o f ha za rd ou s su bs ta nce s He av y m et al Fu ran Resi dual p est icide Resi dual v eterinary me d ic in es Pa th og enic m icroorg anism s Fo od addit ive s GMO V eterinary m edicines Env iron m en ta l co ntam ina n ts (dioxin) Pesticides Pe stic ide He av y m et al An im al f ee d P ests an d disea ses We ed s Pest ic ide GM O He av y m et al An ti b io ti cs Fo od b o rn e p at h og en s S h el lf is h to xi ns Gl o b ef is h t o xi n M al achite gree n Ri sk a ss ess m ent sup ervision ○○ × ○○ ×× T est ana ly sis ○○ ○ × ○○ ○ Mo ni to ri n g ○○ ○ × ○ × ○ Toxic it y t es t ○○ ×× × × × Ex po su re ass ess m ent ○○ ×× × × × R isk m an ag em ent × ○○ ○ × ○○ N ote: ○ Ye s, × No

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Research project (year)

Risk assessment Subject food Subject foodborne

pathogens Details of researches Risk assessment of foodborne

pathogens and researches on food-poisoning management (2000 and 2001)

Dried seaweed rolls

S. aureus Foodborne pathogens were

detected

Used Food Micromodel and risk Monitoring and Risk Assessment of

Major Foodborne Pathogenic Microorganisms in Foods with Frequent Food Poisoning Outbreaks (2002, 2003, 2004 and 2005) Dried seaweed rolls, hamburgers, sushi, frozen processed meat products, dried seasoned marine products, ham, and soy sauce

S. spp., S. aureus E. coli O157:H7 V. parahaemolyticus Y. enterocolitica L. monocytogenes C. jejuni C. perfringens B. cereus

Foodborne pathogens were detected (monthly inspection) Food Micromodel:

estimating the maximum edible time of dried seaweed rolls Pathogen modeling program

Monitoring and risk assessment of highly hazardous foodborne pathogens, Salmonella and Campylobacter (2003 and 2004)

Chicken Salmonella Campylobacter

Research on the biochemical and molecular biological

characteristics of isolated strains. Food Micromodel/Gompertz model

Environmental factors (food matrix, pH, Aw and temperature)

Examination of Microbiological Salad (fully S. spp., S. aureus Foodborne pathogens were

C. Operational system

1) Risk analysis-related R&D

The National Institute of Food and Drug Safety Evaluation and the National Veterinary Research & Quarantine Service are conducting food risk analysis-related R&D projects through in-house research projects or outsourcing research projects.

<Table 4> and <Table 5> show lists of researches on the human health risk assessment of microorganisms and chemical substances, which are included in the list of subjects for risk assessment.

〈Table 4〉Status of domestic researches on the human health risk assessment of microorganisms

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pathogens Details of researches Contamination of Ready-to-eat Vegetable Salad (2004) packaged) Salad bar E. coli O157:H7 L. monocytogenes B. cereus detected. Assessment of Contamination Levels of Foodborne Pathogens Isolated in Major RTE Foods Marketed in Convenience Stores (2005) Triangle-shaped dried seaweed rolls and sandwiches Total aerobic bacteria, coliform group S. aureus, B. cereus

Foodborne pathogens were detected.(qualitative and quantitative analysis)

Microbial Contamination Levels of Fresh Vegetables Distributed in Markets (2005) Lettuce, sesame leaf and cucumbers Total aerobic bacteria, coliform group L. monocytogenes

Foodborne pathogens were detected.

Quantitative Evaluation of Foodborne Pathogenic Bacteria in Commercial Sangshik (raw food) (2006) Raw food (brown rice, carrots, adlay, corns, kale, dropwort beans, etc.) B. cereus, S. spp. S. aureus E. coli O157:H7 V. parahaemolyticus Y. enterocolitica L. monocytogenes C. jejuni C. perfringens

Development of an HACCP plan for sandwiches and quantitative risk assessment (2006)

Sandwiches General bacteria, coliform group, colon bacteria O157:H7 Staphylococcus aureus, salmonella and Listeria

Gompertz model Environmental factors (temperature and time), the first model was developed. Analysis of Microbiological

Contamination in Ready-to-eat Foods and risk assessment (2004)

Sushi Dried seaweed rolls (packed meals) General bacteria, coliform group, colon bacteria. B. cereus S. spp., S. aureus V. parahaemolyticus Y. enterocolitica L. monocytogenes C. perfringens

Researched changes of the number of general bacteria and coliform group bacteria in dried seaweed rolls (storing for 24 hours at 10, 20 and 30℃)

Quantitative Microbial Risk Assessment Model for Staphylococcus aureus in Kimbab (dried seaweed roll) (2005)

Dried seaweed rolls

S. aureus Conducted S. aureus

microorganism risk assessment of dried seaweed rolls through literature.

- Researched S. aureus contamination of dried seaweed rolls

- Researched bacteria growth data on the roll storing time at store/after purchasing and temperature

- Dose-response model data of S. aureus

- The intake level of the dried seaweed rolls contaminated by S. aureus

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pathogens Details of researches of Listeria monocytogenes in meat

and meat products Using Probability Approaches (2003)

the amount of hazardous microorganisms required for exposure assessment, and estimated the contamination level of L. monocytogenes in meat based on the method Predicting the Contamination of

Listeria Monocytogenes and Yersinia enterocolitica in Pork Production Using Monte Carlo Simulation (2003)

Pork L. monocytogenes,

Y. enterocolitica

Predicted the contamination level in the process of pork production, and presented a method for exposure assessment by identifying factors affecting contamination

Development of a predictive Mathematical Model for the Growth Kinetics of Listeria monocytogenes in Sesame leaves (2007)

Sesame leaves L. monocytogenes A model to predict the lag time and specific growth rates of L. monocytogenes in sesame leaves at different temperatures using Response Surface Model Development of Predictive

Mathematical Model for the Growth Kinetics of Staphylococcus aureus by Response Surface Model (2007)

Tryptic soy broth

S. aureus A model to predict the

maximum growth rates of S. aureus at different temperatures, NaCls and pHs in a broth system using Response Surface Model

Predictive modeling for the growth of Listeria monocytogenes as a function of temperature, NaCl, and pH (2005)

Tryptic soy broth

L. monocytogenes A model to predict the lag time

and specific growth rates of L. monocytogenes at different temperatures, NaCls and pHs in the broth system using Response Surface Model

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19 C H A P T E R 2 S y st e m s a n d S ta tus o f R isk A n a ly sis in Kor e a Subjects of risk

assessment Details of researches

Residual pesticide (Cyenopyrafen)

○ Pesticide to remove mites in fruits. The residual quantities permitted are 1.0 mg/kg for pears, 1.0 mg/kg for apples and 0.05 mg/kg for other agricultural products. It is safe to expand the application of the standards as follows: 1.0 mg/kg for strawberries, 0.5 mg/kg for mandarin oranges, 1.0 mg/kg for melons and 1.0 mg/kg for tea leaves.

Veterinary medicine (trimethoprim)

○ Used for cows, pigs, lambs, goats, horses, fowls and fish

- Withdrawal period: varies depending on the kind of livestock since it is used in combination with sulfanomide.

- Milch cows for milking: 3 days/ cows: 3～35 days/ pigs and chickens: 12 days/ fish : 12 days

○ EMEA’s standard of 0-0.0042 ㎎/kg bw/day was applied as ADI. And TDMI was calculated through exposure assessment using residue limits standards (proposed) established based on GVDP data for each part of cows, pigs, chickens, lambs, horses and fish. And the results were 8.17% of ADI.

○ Although an extreme assumption that all the related foods supplied (food supply) were taken was applied to this risk assessment, safety is not at risk.

Aflatoxin in spice and dried fruits

Based on the results of monitoring conducted over the last 4 years, risk assessment was carried out to review “the establishment of standards for aflatoxin in spice and aflatoxin.”

○ Spice: 100/262 cases (38.2%), dried fruits: 29/157 cases (18.5%), aflatoxin was detected.

- Spice: aflatoxin B1 : ND~13.074μg/kg, total aflatoxin: ND~18.445μg/kg - Dried fruits: aflatoxin B1 : ND~0.176μg/kg, Total: ND~1.053μg/kg ○ Exposure of aflatoxin in spice to the human body:

- Aflatoxin B1 was 0.011 (average) ~ 0.037 (95th percentile)ng/kg bw/day

- Total aflatoxin was 0.018(average) ~ 0.067 (95th percentile)ng/kg bw/day

○ Calculation of exposure of aflatoxin in dried fruits to the human body:

- Aflatoxin B1 was 1.0E-04 (average) ~ 3.7E-04 (95th percentile)ng/kg bw/day

- Total aflatoxin 2.9E-04 (average) ~ 1.1E-03 (95th percentile)ng/kg bw/day

○ Calculation of margin of exposure (MOE) by comparing Benchmark Dose lower limit 10(BMDL10) and exposure to the human body - Management priority: soy sauce and its likes > cereals and processed

cereals > spice > pulses and processed pulses > seeds nuts > peanuts and processed nuts > fried fruits

☞ The MOE calculation result indicates that spice is deemed to require more attention for management than other kinds of food because it has relatively low MOE even though its intake is low.

Diarrheal shellfish poison in shellfish

○ No sample exceeded standard (proposed) scenarios for diarrheal shellfish poison (no standard was applied, 0.16 ㎎/㎏ and 0.2 ㎎/㎏), and there was no difference between each standard (proposed) scenario (Table 1). And the analysis result shows that no sample exceeded the EU and the Codex standards (0.16 ㎎/㎏).

○ Monitoring data was compared with each other based on standard

〈Table 5〉Status of domestic researches on the risk assessment of chemical substances

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20 Th e S ta tus of th e Or ga niza tion al S ys te m fo r Food R isk An al ys is in K ore a a nd T as ks Subjects of risk

(proposed) scenarios (no standard was applied, 0.16 ㎎/㎏ and 0.2 ㎎/㎏), and the result was that there was no big difference. The standard of Japan (0.05MU) multiplied by 3.2 ㎍ DTX-1 equals 0.16 ㎎/㎏, which is the proposed standard.

- PTX-2, which has relatively lower toxicity than Okadaic acid, was excluded because there is no accurate data on its toxicity yet. - The estimated daily intakes were calculated using the standards

(proposed) of 0.16 ㎎/㎏ and 0.2 ㎎/㎏, and there was no big difference.

○ Standards were established for Okadaic acid and DTX-1, which fell into the group 1 of diarrheal shellfish poison.

- Mostly, DTX-1 was detected in Japan and Okadaic acid was detected in Europe.

○ Give the intake amount of a foreign (FAO) standard (eating 250g in a meal) and the maximum detection rate in the data of the Korea Food and Drug Administration, it was lower than or similar to 0.33 ㎍ OAeq/kg bw of aRfD; so it is lower than that of foreign countries. - Toyofuku’s activity report for FAO/WHO/IOC suggests that the

standards (proposed) calculated by applying the size of a meal (100g, 250g and 380g) were 0.2, 0.08 and 0.05 ㎎/kg shellfish meat respectively.

․The standard (proposed) similar to the foreign standard (0.16 ㎎/kg) was eating 100g a meal.

Heavy metal in fish(lead)

○ In accordance with Article 2(2) of the enforcement ordinance the Food Sanitation Act and “Statement of Principle Relating to the Role of Food Safety Risk Assessment" of Codex, four detailed procedures were conducted: risk identification, determination of risk, exposure assessment and determination of the extent of risk

○ Age and gender of the Koreans were considered to calculate the food intake amount applied to the exposure assessment. Recent data was used for the lead contamination level in the fish to be used for calculation of exposure rate of fish to lead. And additional factors regarding exposure such as food other than fish and environment were also considered to calculate the total exposure rate of lead to the human body.

○ Gender, the intake amount of each age group and weight of the Koreans were considered,

The report on the Korea National Health & Nutrition Examination Survey (2005), assessment of contaminants intakes and risk in the staple diet of the Koreans (2005)

○ Estimating the harmful effect of fish on the health of the Koreans through exposure assessment based on a statistical technique (distribution estimation)

○ The level of risk from lead at the current contamination level - The estimation of probability distribution of the lead intake of

people aged 3 or over, with the intake of fish and other food and environmental exposure considered, indicates that Koreans (aged 3 or over) take 21% of PTWI (provisional tolerable weekly intake) set by the JECFA on average and the group with a high intake rate of fish (95th percentile) takes 42% of the standard, suggesting that the lead intake level (neurotoxicity) is not deemed to be harmful. ○ The risk level of lead in each scenario

- On the assumption that the standards for lead in fish are set at 0.2, 0.3, 0.5 and 1.0 mg/kg or less (scenario 1～4) and no fish exceeding the lead standard of each scenario is distributed, the lead intake rate

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21 C H A P T E R 2 S y st e m s a n d S ta tus o f R isk A n a ly sis in Kor e a Subjects of risk

of the Koreans (age 3 or over) was 14 to 22% of PTWI and that of the group with a high intake rate of fish (95th percentile) was 37 to 42%, suggesting that the lead intake level (neurotoxicity) of each scenario is not deemed to be harmful.

DEHA in PVC wrap (Di(2-ethylhexyl) adipate)

○ DEHA is a kind of plasticizer used to soften polyvinyl chloride used for “wrap” and “bottle cap gasket.”

○ The TDI of the EFSA is 0.3 mg/kg bw/day, and the migrant specification for devices, containers and package is set at 18 mg/L in Europe.

○ Monitoring of the PVC “wrap” in the market indicated that DEHA was detected in 3 items out of 46 items when n-heptane was used as a diluent and dissolution medium, and the maximum amount detected was 211 mg/L.

○ The EDI (Estimated Daily Intake) of DEHA calculated using the amount of DEHA detected, 211 mg/L, was 0.0039 mg/kg bw/day, which is 1.3% of the TDI of the EFSA, 0.3 mg/kg bw/day, suggesting that there was no harmful effect of DEHA in “wrap” on food. 3-MCPD in

food in the market

○ Soy sauce was included in the 2005 Korea National Health & Nutrition Examination Survey.

Considering the general demographic group and the group at a high risk (95th%), the 3-MCPD exposure level to the human body is not deemed to be harmful.

<Table 6>, which shows the status of studies conducted by the Korea Food and Drug Administration on risk analysis and risk analysis data management systems, indicates that several studies were conducted in 2010, particularly on international exchange to improve risk assessment capacity and to facilitate risk communication.

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Classification Risk analysis Exposure Risk analysis data system Chemical substances and contaminants Pesticide - Construction of Monitoring database for hazardous substances (II) -29 chemicals excluding pesticide residues (2009, Chem,I,Net) - International standardization for safety management of toxic substances in pesticides (2009, Seoul National University) Others - Study on analysis of

macromolecular specific hazardous substances using molecular biology techniques (2010, Eulji University) - Dietary Intake and

Risk Assessment of Heavy Metals (TDS) (2009, Korea University) - Dietary Intake and

Risk Assessment of Contaminants in Korean Foods (2008, Korea University) - Synthesizing new illegal analogues of drugs and standard maintenance and distribution system (2008, the Seoul National University) - Study on post-generation effects of exposure to hazardous substances during pregnancy (2010, Kwandong University) - Study on complex exposure evaluation of endocrine disruptor chemicals (2010, SungKyunKwan University) - Assessment of exposure of phthalate in human serum (2010, Eulji University) - Assessment of Exposure levels of PBDEs in each food group and human serum (2010, POSTECH) - Exposure amount change of Dioxins and related compounds in the Korean population (2008, Kyungnam University) - Development of Food-CRS (Chemical Ranking & Scoring) system associated with environmental pollutants (2008, Yonsei University)

Microorganisms - Study on growth factors for microorganisms in livestock products and development of a model to assess the exposure of key antibiotic resistant bacteria to the human body (2010, the Korea Food Research Institute) Others - Study on building a

risk assessment capability measuring - Study on the exposure assessment of hazardous - Development of a hazardous substances monitoring data

〈Table 6〉Status of studies conducted by the Korea Food and Drug Administration on risk analysis of microorganisms, chemical substances, new types of food, etc. and risk analysis data

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Classification Risk analysis Exposure Risk analysis data system system (2010,

Myongji University) - Content development

for risk management and risk communication (2010, Korea Institute of Environment and Health) - Analysis of examples of hazardous elements in food management (2010, the Pukyong National University) - Study on technical coordination of the risk assessment of hazardous substances and international exchange (2010, Korea University) - Development of

General Model for Hazards Analysis at a Manufacturing Process (2008, the Korea Food Industry Association)

substances-focusing on the dietary life (2010, the Seoul National University) - Study on the food

intake of sensitive groups for risk assessment (2010, Dankook University) - Development of risk

outlines for each food (2010, the Seoul National University of Science and Technology) - Development of risk profile for 200 popular foods (2009, Seoul National University of Science and Technology) management system and a exposure assessment model (2010, Chem,I,Net) - Study on the mid-

and long-term development direction of the sophistication of safe management of hazardous substances (2010, the Seoul National University) - Development of risk profile in food (2008, the Seoul National University of Science and Technology) - Medical supplies ADR reporting system research of the international standard (2008, Fivetech.net) - Expansion and improvement of DB for reliability enhancement of risk assessment (2008, the Seoul National university) - Monitoring data warehousing and validation of hazardous substances to vitalize dietary exposure assessment system for Korean (2008, Chem,I,Net)

2) Risk assessment data system

While the data on risk assessment is open to the public in principle, only limited information is available in reality.

The department at the National Institute of Food and Drug Safety Evaluation in charge of risk assessment for microorganisms, chemical substances, contaminants, etc. provides risk assessment outcomes to the department in

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charge of risk management without disclosing the data to the public, and it is used as the basis for risk management. When an urgent response is required, the department of risk analysis and research at the National Institute of Food and Drug Safety Evaluation conducts risk assessment and provides related data to risk managers. In general, risk managers participate in the food sanitation deliberation committee, along with the department of risk assessment, the department of hazardous contaminants and assessors, to decide whether to apply the results of risk assessment to risk management. While risk managers cannot make public risk assessment data, risk assessors have the authority to disclose the data; but the data is made public only when necessary.

Recently, the National Institute of Food and Drug Safety Evaluation is conducting the following studies regarding the risk assessment data management system:

· Development of risk profiles of hazardous substances for each food

· Hazardous substances monitoring data management system · Development of outlines of hazardous substances for high

demand food

3) Risk analysis and food safety-related training programs

The Risk Prevention Policy Bureau of the Korea Food and Drug Administration provides training programs for risk analysis and food safety through E-books and PDF files in its web site. <Table 7> shows a short list of textbooks for the training.

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25 C H A P T E R 2 S y st e m s a n d S ta tus o f R isk A n a ly sis in Kor e a Textbook Details Story of evaluation of economics for food safety management

The basic concept of cost/benefit analysis Introduction of cost/benefit analysis concept

Application of cost/benefit analysis to food safety management

Textbooks on food risk analysis (2007)

Outline of food risk analysis - Outline of food risk analysis - Outline of food risk assessment Theory of food risk assessment - Basic theory of toxicology

- Pharmacokinetic study of animals for risk assessment of the human body

- Properties and behaviors - Identification of risk

- Identification of exposure factors and analysis of the characteristics of the demographic groups to be assessed - Exposure assessment for environmental risk assessment - Exposure assessment and statistical concepts

Exercising risk assessment

- Methods to determine the level of risk - Exercise

- The basic setting methods for users of play 8 version

Textbooks on food risk analysis (2008)

Food risk analysis Part I

Outline of carcinogenicity for food risk analysis

Information on toxicology required for risk assessment

Risk assessment of carcinogens Benchmark Dos software Comparative risk analysis Food risk analysis

Part II

Understanding risk management Risk management of the Codex

The risk analysis system of the Korea Food and Drug Administration

Food risk analysis Part III

Introduction of risk communication Risk Perception & Comm.

Media coverage and risk management communication

Risk communication-Don'ts&Dos

〈Table 7〉List of risk analysis training programs of the Korea Food and Drug Administration

Data: http://safefood.kfda.go.kr/safefood/user/bbs/pdsEbookList.jsp

And some of the basic data for risk analysis is provided in the form of E-books in Foodnara (food safety information service) as shown in the list on <Table 8 >.

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26 Th e S ta tus of th e Or ga niza tion al S ys te m fo r Food R isk An al ys is in K ore a a nd T as ks No Tile Remark

1 Food risk analysis training textbook

2 2006 FAO WHO report Food Safety Risk Analysis Translated 3 Foreign country No.1-translated (Japan)[1]

4 Foreign country No.1-original (Japan)[1] 5 Foreign country No.2-translated (Canada)[1] 6 Foreign country No.2-original (Canada)[1] 7 Foreign country No.3-translated (Europe)[1]

8 CFSAN 2002 - Risk Assessments Original 9 CFSAN 2002-Risk Analysis Framework Translated 10 2006 FAO WHO report Food Safety Risk Analysis Original 11 Story of evaluation of economics for food safety management

12 Foreign country No.3-original (Europe) 13 Foreign country No.3-translated (Europe) 14 Foreign country No.1-translated (Japan) 15 Foreign country No.2-translated (Canada)

16 CFSAN 2002-Risk Analysis Framework Translated 17 CFSAN 2002-Risk Analysis Framework Original 18 WHO_risk analysis system Food Safety Risk Analysis Translated 19 Outline of carcinogenicity for food risk analysis Ryu Deok-young 20 Information of toxicology required for risk assessment Hwang Jin-hee 21 Risk assessment of carcinogens Yeom Tae-gyeong 22 Benchmark Dose Software Choi Si-nae 23 Understanding risk management Sohn Moon-gi 24 Risk management of the Codex Yoon Hye-jung 25 The risk analysis system of the Korea Food and Drug

Administration Kim Hee-sun 26 Introduction of risk communication Park Seong-chul 27 Risk Perception & Comm Cha Yong-jun 28 Media coverage and risk management communication Choi Hong-rim 29 Risk Communication_Don'ts & Dos Choi Joon-hyeok 30 Comparative risk analysis Kim Ye-shin 31 Food risk analysis_Part I

32 Food risk analysis_Part II 33 Food risk analysis_Part III 34 Terminology for risk analysis

35 Japan_food safety terminology (the 4th edition)

〈Table 8〉The risk assessment data management system of the Korea Food and Drug Administration

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D. Implications

1) Organizational system

While Korea has a multilateral food safety management system, the risk assessment and the risk management functions of the Ministry for Food Agriculture, Forestry and Fisheries are consolidated, and the two functions of the Ministry of Health and Welfare are divided between the Korea Food and Drug Administration and the National Institute of Food and Drug Safety Evaluation.

As the Ministry for Food Agriculture, Forestry and Fisheries is recently pushing ahead with a plan to consolidate organizations for safety inspection and quarantine and to strengthen the role of risk assessment, the risk analysis system of the ministry could develop into a functionally separate system.

According to recommendations of the Codex, it is not always necessary to divide the functions among different organizations if the risk assessment function is performed consistently and independently.

The problem of the multilateral food safety management system of Korea is the insufficient cooperation among different departments. As risk assessment of food is directly related to the health of the population, the complicated conflict of interest among departments and selfish responses need to be resolved. Accordingly, each department is required to have a capability for coordination and to reach a wide-ranging consensus that would ensure the safety of food from production to consumption.

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As the Food Safety Policy Commission is currently in charge of coordination of the conflict of interest, it is necessary to expand and strengthen the coordination role in the risk assessment section.

2) Operation methods

First, it is necessary to improve and facilitate the process of risk communication.

As the risk assessment review process of each agency, such as the food sanitation deliberation committee is not disclosed, there is doubt as to whether the result of risk assessment is accurately applied to risk management. Thus, it is necessary to get rid of distrust by making the process and system of risk management clearer and allowing access to it. In this case, intentional selection and partial reporting should be avoided.

Second, exchange of information among the academy, the government, the industry, consumers and the media is insufficient.

It is recommended that a consultative body be established among the academy, the industry, the government and consumers in order to exchange information at each phase of risk analysis when necessary.

Third, it is required to secure advanced technologies to communicate information.

As there is relatively insufficient early response based on scientific information provided by experts, it is necessary to dispel the concerns of the consumers and to increase the effectiveness of trust restoration by improving expertise

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level, instead of simply making information public.

Fourth, it is urgent to improve scientific risk assessment techniques.

It is necessary to improve the inter-departmental or inter-divisional consistency by unifying different risk assessment procedures and methods. Currently, Korea has insufficient quantitative data to classify risk factors and to assess exposure and insufficient data on health risk from intakes of contaminants. In addition, there is no data on the exposure level of pathogens required to evaluate dose-response and on disease frequencies. And there is no clinical data to predict side effects or no data on animal model tests.

Fifth, as risk assessment is currently conducted separately for each item or compound, it is recommended that a single organization–or more than one organization when necessary –specializing in the risk assessment of specific items or compounds should conduct their risk assessment, rather than outsourcing research projects.

As risk assessment requires expertise, it is possible to outsource a whole task to an external specialized agency when necessary.

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K I H A S A

03

Risk Analysis Systems of

Foreign Countries and Status

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33 CHAPTER 3 Ri sk A na ly si s Sy st ems of F or ei gn C oun tri es a n d St at u s

CHAPTER 3 Risk Aanalysis Systems of Foreign

Countries and Status

As environmental pollution gets accelerated with climate change, and new technologies such as biotechnology and nanotechnology and new types of food such as GMO food and irradiated food emerge, the environment around food safety is changing dramatically.

Against this backdrop, the following section looks into the status of the risk analysis systems of foreign countries composed of risk assessment, risk management and risk communication that would ensure food safety, and to review their implications that could be applied to Korea.

A. Codex

The Codex Alimentarius Commission was created in 1963 by FAO and WHO under the Joint FAO/WHO Food Standards Programme, as unified international food standards to protect health of the consumers and ensure fair trade practices in the food trade. The World Trade Organization has allowed it to gain more importance as international standards to resolve controversies from the viewpoints of food safety and consumer protection.

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Year Source Statement 1995

Expert consultation report

An important principle is the functional separation of risk assessment from risk management. 2006 A guide for national food authorities

3.4.2 Functional separation of risk assessment and risk management the functions of risk assessment and risk management should be carried out separately to the extent practicable

Functional separation may be more obvious when different bodies or officials are responsible for risk assessment and risk management tasks. However, Functional separation can also be achieved in countries with limited resources and personnel where risk assessments are undertaken by people who act as both risk assessors and risk managers. What is important in these cases is to have conditions in place which ensure that risk assessment tasks are carried out separately from risk management tasks.

2007Official standard

11. Functional separation

16. Determination of risk assessment policy should be included as a specific component of risk management.

17. Risk assessment policy should be established by risk managers 18. The mandate given by risk manager

19. Risk managers should ask risk assessors to evaluate the potential changes in risk

2008 Risk Analysis General Aspects

9. There should be a functional separation of risk assessment and risk management to the degree practicable, in order to ensure the scientific integrity of risk assessment, to avoid confusion over the functions to be performed by risk assessors and risk managers and to reduce any conflict of interest. However, it is recognized that risk analysis is an interactive process, and interaction between risk managers and risk assessors is essential for

International NGOs and intergovernmental bodies are participating in the activities of the Codex, and Korea joined in 1971.

In <Table 9>, the Codex recommends the functional separation of risk management and risk assessment. It emphasizes that it is required to have conditions in place which ensure that risk assessment tasks are carried out separately from risk management tasks.

〈Table 9〉Recommendation of the Codex regarding risk assessment and risk management

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Year Source Statement

practical application. STATEMENT OF PRINCIPLE CONCERNING THE

ROLE OF SCIENCE IN THE Codex

DECISION-MAKING PROCESS AND THE EXTENT TO

WHICH OTHER FACTORS ARE TAKEN INTO ACCOUNT

Consideration of other factors should not affect the scientific basis of risk analysis; in this process, the separation between risk assessment and risk management should be respected, in order to ensure the scientific integrity of the risk assessment

STATEMENT OF PRINCIPLE RELATING TO THE ROLE OF FOOD SAFETY RISK ASSESSMENT

3. There should be a functional separation of risk assessment and risk management, while recognizing that some interactions are essential for a pragmatic approach

The diagram in [Fig 1] below shows a cooperative system of each function of risk assessment and risk management.

〔Fig 1〕Flow chart of risk management and risk assessment

[Fig 2] shows a simple diagram of the organizational systems for risk assessment and risk management in Korea and foreign countries. And <Table 10> classifies the organizational systems into consolidated, functional separation and separation, and

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Risk assessment Country System Risk management Under the Department of

Health and Human Services: - FDA

The Center for Food Safety and Applied Nutrition (CFSAN)

The Center for Veterinary Medicine (CVM) Under the Department of Agriculture (USDA): - The Food Safety and

Inspection Service (FSIS) - The Animal and Plant

Health Inspection Service (APHIS)

The Environmental Protection Agency (EPA)

The U.S.A,

Consolidated

Under the Department of Health and Human Services:

- The FDA and The CFSAN Under the USDA:

- The FSIS and the AMS (Agricultural Marketing Service) - The GIPSA (Grain Inspection

Packers and Stockyards Administration)

- The APHIS (Animal and Plant Health Inspection Service) Under the Department of Commerce: the NOAA (National Oceanic and Atmospheric Administration)

Independent department within the Food Standards Agency

England

The Food Standards Agency (including veterinary medicine and pesticide)

The Department for Environment, Food and Rural Affairs

The Department of Health Independent department

within the Food Standards Australia New Zealand (Under the Australia Department of Health and Ageing)

Australia

The Food Standards Australia New Zealand

cabinet council meeting (Food-related law cabinet meeting)

The National Institute of Food Functional The Ministry of Health and welfare

shows the list of countries and government organizations that fall under each classification.

〔Fig 2〕Comparison of the organizational operation systems for risk assessment and management

〈Table 10〉Comparison of the organizational systems for risk assessment and risk management in Korea and foreign countries

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Risk assessment Country System Risk management and Drug Safety Evaluation

(Under the Ministry of Health and Welfare)

The National Veterinary Research & Quarantine Service

The National Academy of Agricultural Science

(Under the Ministry for Food, Agriculture, Forestry and Fisheries)

Korea

separation

and the Korea Food and Drug Administration (headquarters) The Ministry for Food, Agriculture, Forestry and Fisheries,

- The National Veterinary Research & Quarantine Service

- The National Agricultural Product Quality Management Service (labeling)

- The National Fisheries Products Quality Inspection Service (Quarantine)

The Federal Institute for Risk Assessment (BfR, under the Federal Ministry of Consumer Protection, Food and Agriculture )

Germany

The Federal Office of Consumer Protection and Food Safety (BVL, under the Federal Ministry for Food, Agriculture and Consumer Protection ) The French Agency For Food

Safety

(AFSSA, jointly supervised by the Ministry of Agriculture and Fisheries, the Ministry for Employment and Solidarity, the Ministry of Health and the Ministry of Economy, Finance, and Industry)

France

The French Ministry of Food, Agriculture and Fisheries (DGAL) The Economic and International Policy Directorate (DPEI, policy planning)

Provincial Directorate of Agriculture and Forestry (DDAF)

Provincial veterinary directorate (on the spot)

The French Health Authority (DGS) The French Directorate General for Competition, Consumer Affairs, and Repression of Fraud (DGCCRF, economic support)

Health Canada

Canada

Separation

The CFIA (Under the Agriculture and Agri-Food Canada, supervised by the Health Canada)

The National Food Institute The National Veterinary Institute (Under Technical University of Denmark that belongs to the Ministry of Science, Technology and Innovation)

Denmark

The Danish Veterinary and Food Administration (DVFA, under the Ministry of Food, Agriculture and fisheries)

The European Food Safety Authority (EFSA)

EU

The European Commission's Directorate General for Health and Consumer Policy

The EU and the EU Council The EU Public Health Commission The Food Safety Commission

(Under the Cabinet Office) Japan

The Ministry of Health, labour and Welfare The Ministry of Agriculture, Forestry and Fisheries

The Consumer Affairs Agency, Cabinet Office (headquarters)

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B. Organizational system

1) The consolidated systems of the United States and

England

While the risk assessment and risk management functions for food items are divided among several agencies depending on the jurisdiction over each item under the U.S. system, the FDA has the authority for the risk management – the authority to establish standards - of most food items. The weakness of the system is that information sharing among government departments or between the federal and local governments is guaranteed only when joint research projects are conducted with the grant from the federal government.

Under the system of England, an independent department under the risk management agency is in charge of risk assessment. In addition, while a specialized commission composed of members from the private sector independently performs the risk assessment function, the FSA participates in the final determination process of risk assessment such as exposure assessment.

2) Functionally separate Germany

Under the functionally separate system of Germany, while the risk assessment agency belongs to a federal agency that belongs to the risk management agency, a legal basis to ensure the independence of risk assessment is put in place to make up for its weakness.

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3) Separate Japan and the EU system

The EU has separate agencies for risk assessment and risk management. While the EFSA is in charge of risk assessment, the risk management function is performed jointly by the EU Commission, the European Parliament and the Council of the EU and member countries. And the operation of the EU Scientific Committee on Emerging and Newly Identified Health Risks, which is at the forefront of risk assessment, is closely connected to the member countries of the EU.

Japan has established “the Japanese Food Safety Standard Law” for the purpose of comprehensively implementing food safety management policies, created “the Food Safety Commission” under the Cabinet Office to strengthen its risk assessment function, and set up the Consumers Affairs Agency under the Cabinet Office in accordance with the enforcement of “the Act on the establishment of the Consumer Affairs Agency and the Consumer Commission.” While the previous system of Japan was similar to that of Korea where each government agency is in charge of risk assessment, risk management and risk communication, “the Food Safety Commission” is in charge of risk assessment, risk management functions are divided among agencies depending on the item, and risk communication is performed by each agency under the current system.

The Food Safety commission strives to enhance the awareness of the public and to restore credibility through transparent information disclosure. While the independent Food Safety Commission is solely performing the risk

The Status of the Organizational System for Food Risk Analysis in Korea and Tasks ahead