Role of Food Safety Commission & Food Risk Assessment Secretariat of Food Safety Commission, Cabinet Office JICA Seminar : February 29th, 2008 1 Contents 1. Establishment of Food Safety Commission (FSC) 2. Role of FSC 3.Food Risk Assessment 4.Risk Communication by FSC 2 １．Establishment of FSC In July 2003, FSC was newly established in the Cabinet office, as an organization that undertakes risk assessment of food. FSC is independent from other food – related ministries such as MHLW and MAFF. MHLW: Ministry of Health, Labour and Welfare MAFF: Ministry of Agriculture, Forestry and Fisheries Similar organizations established abroad ・European Food Safety Authority (EFSA; 2002) ・German Federal Institute for Risk Assessment (BfR; 2002） ・French Food Safety Agency （AFSSA; 1999） 3 Background of Establishment １．Changes in Dietary Life Environment • Increasing availability of food products • Emerging food safety issues, including E.coli O157, BSE, and genetically modified foods • Improved analytical methods enabling to detect formerly hidden hazards such as dioxin ２．Global Trend in Food Safety Issues • With basic concept of No Zero-Risk in food safety • Developing a new framework for risk analysis, • Implement risk assessment scientifically and control the risk reasonably. 4 Key Points of Food Safety Basic Law - 1 ◆Basic Principle Necessary measures shall be taken： • on the basis of the basic recognition that the protection of public health should be given top priority； • at each stage of the food supply chain； and • on the basis of scientific knowledge and in consideration of international trends and public opinion. ◆Responsibilities and roles of stakeholders ・Responsibilities of the National and Local Authorities ・Responsibilities of Food-Related Business Operators ・Roles of Consumers 5 Key Points of Food Safety Basic Law -2 ◆Strategy for Policy Development Implementation of Risk Analysis Methodology • Conducting risk assessment of food • Developing policy based on the results of risk assessment • Promoting risk communication ◆Establishment of FSC 6 What is Risk? Probability of hazards severity of adverse effects 1/1000 1/1million × ＝ Risk 1/200 million 0-157 Both the possibility and the associated severity of adverse effects on public health are considered together in order to determine risk. 7 The Three Factors of Risk Analysis Risk Assessment Risk Management （MHLW, MAFF） （FSC） •Identification of hazard •Analysis of risk characteristics and damage •Exposure assessment Scientific Initial task for risk analysis based on the results of the risk assessment Public sentiment knowledge Implement risk assessment Cost effectiveness Technical feasibility Determine maximum use levels, maximum residue limits, and other standards Risk Communication Sharing of risk information and exchange of opinions with stakeholders (meetings for the exchange of opinions, public comments) 8 ２． Roles of Food Safety Commission 1. Risk Assessment FSC conducts food risk assessment based on scientific information and knowledge, in an objective, independent and fair manner 2. Risk Communication FSC promotes the exchange of information and opinions among stakeholders, including consumers, food business operators and so on, through public meetings, website and other means. 3. Emergency Response FSC immediately responds an emergency situation associated with food-borne hazards, in cooperation with other agencies concerned in order to control damage and prevent recurrence, and disseminates the information to the public. 9 Organization of Food Safety Commission 14 Expert Committees: total 205 members Planning Food Safety Commission 7 Commissioners Emergency Response Chemical Substances, Contaminants Microorganisms, Viruses Veterinary Medicines Pesticides Risk Communication Apparatus, Package Food Additives Natural toxins, Mycotoxins Genetically Modified Foods Novel Foods Prions Fertilizer, Feed Food Safety Commission Secretariat （90 staff） （ February, 2008） 10 New Food Safety Administrative Structure Information Collection/Exchange Cabinet Office FSC Minister in charge ・Risk Assessment Provides Assessment result / Recommendation ・Risk Communication ・Emergency Response MHLW ○Risk Management of Food Sanitation • Formulation of Residual Agricultural Chemical Level , Registration of Food Additives, Standard of Food Process/ Manufacture • Monitoring and Guidance of Food Manufacture, Distribution, Sales • Risk Communication etc. R i s k Request for Assessment Foreign countries, International Bodies etc Other Competent Authorities Provides Assessment result / Recommendation MAFF ○Risk Management of Food Production • Ensuring Safety and Regulation of Production Materials • Ensuring Safety through Improving Primary Food Production, Distribution and Consumption • Risk Communication etc. C o m m u n i c a t i o n Exchange Various Information and Opinion among Stakeholders Consumers / Business Operators etc 11 ３．Food Risk Assessment • FSC’s risk assessment aims to determine how much adverse effects biological/chemical/physical factor or state of food may have on human health via food intake. • The assessment shall be implemented on the basis of the latest scientific knowledge and in an objective, neutral and fair manner. Biological factor: Microorganism, Virus, Parasite, etc. Chemical factor: Pesticide, Veterinary medicine、Food additives, Heavy metal, Mycotoxin, etc. Physical factor: Extraneous material, Irradiation, etc. Biological state: Bacterial flora, Decomposition, etc. Chemical state： ｐH, etc. Physical state: Temperature, etc. 12 Legal Classification of Risk Assessment （１）Assessment requested from risk management organizations ①Assessment in response to Mandatory requests ②Assessment in response to Voluntary requests （２）Assessment made on FSC’s own initiative <Example> • Assessment on Measures against BSE in Japan • Assessment of Microorganisms that cause foodborne illness, such as campylobacter • Assessment of Beef and beef offal imported to Japan 13 Examples of Mandatory Request for Risk Assessment ① Food additive Pesticide, Veterinary medicine, Feed and Fertilizer Policies requiring risk assessment • Designating food additives or establishing standards /specifications of food additives • Registering new pesticides or changing the specification of registered pesticides • Giving approval for new veterinary medicines or conducting a re-examination of veterinary medicines • Designating new feed additives or changing the specification of designated feed additives • Establishing specifications of fertilizers • Establishing or changing residue standards for pesticide, veterinary medicine or feed 14 additives in food/produce Examples of Mandatory Request for Risk Assessment ② Contaminant Policies requiring risk assessment •Establishing or changing standards for contaminants in food or drinking water Apparatus, •Establishing or changing standards for food package or apparatus used in food Package manufacture Microorganism GMO •Establishing or changing micro-biological standards / specification for food •Designating genetically modified food/feed which can be distributed in Japan Novel food •Authorizing food labeling which claims specific health effects •Prohibiting food which could possibly damage human health 15 Examples of Voluntary Request for Risk Assessment •Methylmercury in seafood •Cadmium in food •BSE-risk in U.S. and Canadian beef •Bacterial resistance to antibiotics used as feed additives or veterinary medicine •Safety of so-called “Health food” 16 Assessment made on FSC’s own initiative １. Assessment on Measures against BSE in Japan (interim report) ２. Assessment of Microorganisms that cause food-borne illness, such as campylobacter ３. Assessment of Beef and beef offal imported to Japan 17 Breakdown / Progress of Risk Assessment requested 200 0 Assessment Requested Pesticide 374 934 600 Novel Food 66 400 Veterinary medicine 247 800 GM food 7 Food Additive 80 Other 87 Prion 13 Assessment Completed 529 140 159 Pesticide 64 54 60 41 Food additive Veterinary medicine Novel food Genetically Modified food/feed 11 Prion Other ”Assessment Completed” includes assessments conducted on FSC’s own initiative. 18 as of Feb. 6th, 2008 Further Work for Better Assessment Speeding up risk assessment processes Responding to progress / change in assessment methodology • International harmonization • Responding to the latest scientific knowledge Responding to future needs for risk assessment • Food derived from cloned-animals, etc. 19 Overview of Risk Assessment （１）Pesticides （２）BSE 20 Flow of Assessment for Pesticide MOE Applicant (domestic use) MHLW Applicant (import tolerance) FSC FSC: Food Safety Commission PEC Impact Assessments on Environment MAFF drafting Public comment for 4 weeks FSC Final decision Farmer use MAFF Registered MHLW Setting MRLs PEC: Pesticides Expert Committee MAFF: Ministry of Agriculture, Forestry and Fisheries MHLW: Ministry of Health, Labour and Welfare MOE: Ministry of the Environment Market survey 21 Roles of governmental organizations in pesticide management FSC conducts food risk assessment. Based on the result of the assessment, MHLW and MAFF establish and enforce policies for food safety. FSC （Risk assessment ） Acceptable Daily intake (ADI) of Pesticides MHLW （Risk management） Establishes residue standards (maximum residue limits) for pesticides in food MAFF （Risk management） Registration of pesticides; Provides guidance for 22 producers Data requirements for registration of pesticides ● Acute Toxicity ・Acute oral toxicity ・Acute dermal toxicity ・Acute inhalation toxicity ・Skin irritation ・Eye irritation ・Skin sensitization ・Acute neurotoxicity ・Acute delayed neurotoxicity ● Sub-chronic/chronic toxicity ・90-day repeated oral toxicity ・21-day repeated oral toxicity ・90-day repeated inhalation toxicity ・Repeated oral neurotoxicity ・28-day repeated dose delayed neurotoxicity ・1-year repeated oral toxicity ・Carcinogenicity ・Reproductive toxicity ・Deavelopment toxicity ・Genotoxicity ● Metabolism ・animal metabolism ・plant metabolism ● General pharmacology ・Effects to body function ● Fate in Environment ・ in soil ・ in water ■residue studies ・in crop ・in soil ・in succeeding 23 crop Data submitted to expert committee (for one pesticide) Pesticides Expert Committee 24 ADI : Acceptable Daily Intake ADI is an estimate of the amount of a chemical substance that can be ingested daily over a lifetime without appreciable health risk, which is determined based on the newest and best scientific knowledge. Established based on a scientific review of toxicological data available at the time of assessment, with safety factor taken into consideration. ＡＤＩ food ingested daily over a lifetime 25 NOAEL: No Observed Adverse Effect Level NOAEL is the highest dose at which no adverse effect was observed in a toxicological study of each animal (i.e. mouse, rat, rabbit, dog) Example Animal Species Toxicological study Mouse 18-month study of carcinogenicity NOAEL 13mg/kg bw/day 4.4mg/kg bw/day Rat 24-month study of toxicity Rabbit Developmental toxicity 100mg/kg bw/day Dog 12-month study toxicity 21.8mg/kg bw/day NOAEL in the most sensitive animal species shall be used to determine ADI 26 SF: Safety Factor The difference between animal and human studies, and between the most sensitive and least sensitive individuals, is taken into account by applying a safety factor (usually 100 or more). ADI is determined by dividing the NOAEL by a safety factor . ＝ ADI for humans ÷ ＮＯＡＥＬ in animal studies※ １００(SF) (100=１０：species difference × １０：personal difference) ※the smallest NOAEL in all animal studies considered 27 Intake of hazards & health effects death Health effects １/100 Intake of hazard No effect Lethal dose NOAEL ADI Actual level of pesticide residue 28 Result of Risk Assessment Evaluation report BOSCALID April 2004 Food Safety Commission As the result of the discussion in FSC, overview of studies and conclusion of the risk assessment are documented in “Evaluation report” . The report is sent to risk management organizations and posted on FSC’s website. （A report is normally 30-50 pages long.） English translation is available for important pesticides. 29 http://www.fsc.go.jp/english/evaluationreports/index.html S t a n d a r d s o n P e s t ic i d e u s e & Pesticide Residue Standards (MRLs) International standards Intake of each crop per day (national nutrition survey, etc.) ADI 80 % of ADI Pesticide intake Based on the data of food intake, MHLW confirms that the total of the residue level of each crop does not exceed 80% of the ADI Intake from others Intake from rice Intake from wheat Intake from orange MRL Residue test Standards on pesticide use for each crop • Applicable crops • Amount used • Timing used • # of applications Survey of pesticide residue Guidance for Producers 30 Introduction of Positive List System (since May,2006) In previous regulation, MRLs were established for only limited kinds of chemicals and crops • Establishment of new MRLs for 758 agricultural chemicals used in Japan and abroad （considering Japanese standards, Codex standards and other standards abroad） • The uniform level (0.01ppm) shall be applied to chemicals for which MRLs are not established Chemicals Rice Wheat Soy bean orange A 1 0.6 0.2 3 B 0.2 0.5 0.2 0.2 C 5 (0.01) (0.01) (0.01) D 0.5 2.5 (0.01) 0.5 31 Food containing chemicals above the standards are enjoined from distribution ◆ Distribution of BSE infectivity in BSE positive cattle Brain 66.7% （Trigeminal ganglia contained） Eyeball Dorsal root ganglia 3.8% (Vertebral column includes dorsal root ganglia) 0.04% Spinal cord 25.6% Tonsil Total:９９．４４％ Distal ileum Ileum 3.3% (The last part of small intestine is about 2m in length) Brain:2/3(8/12), Spinal cord:1/4(3/12), Other organs:1/12 32 Reference：Scientific Steering Committee (12/1999). Opinion on the Scientific Steering Committee on human exposure risk (HER) via food with respect to BSE. Food safety：Ban of import beef from BSE positive country Farming cattle using untainted and safe feed Traceability system BSE test for healthy slaughter（Only BSE negative cattle can go for food supply） SRM removal and burn BSE positive countries（No additional condition ） Import ban of Beef Beef Farm Export Import ban of live cattle Import ban of Meat bone meal (MBM) Traceability BSE test of dead cattle Slaughter house BSE test Animal feed Prevention of cross contamination Prevention of cross contamination SRM removal and burn Burn Feed factory Rendering factory Prevention of cross contamination MBM of cattle Fertilizer 33 The Food Safety Risk Assessment on the Imported Beef and Beef Offal from the U.S.A. and Canada The assessment scientifically compared the risk of consuming beef / beef offal regulated by the beef export verification program of the U.S.A / Canada with the risk of consuming beef / beef offal of Japanese cattle” Equivalence of BSE Risk Main Assessment items Comparison of contamination level of BSE prion in live cattle １、External challenge ２、Animal feed regulation ３、Surveillance data ＋ Export Program ・Cattle age: 20 months or less ・SRM removal etc. Comparison of beef and beef offal ４、Ante-mortem inspection ５、Prevention of cross contamination ６、Comparison of risks of beef and beef offal etc. All months Present American, Canadian Domestic Regulations Present Japanese Domestic Regulations Complianc e Japanese Beef and Beef Offal Compliance ？ 20 months or less Beef and Beef Offal of U.S.A., Canada 34 (for Japan) ４．Risk Communication by FSC In collaboration with the risk management bodies, FSC conducts public meetings and briefing sessions to exchange opinions on the details of the risk assessments and other matters related to food safety. In this way, the Commission exchanges information and ideas with many stakeholders, including consumers. ＦＳＣ ＭＨＬＷ ＭＡＦＦ Consumers Producers Food industry Distributors /retailers Scientists 35 FSC’s Effortsー１ Food Safety Commission is basically open to the public and its minutes are put on the website. Holding public meeting Inviting Comments and Information on the assessment from the public Food safety monitors (470 members) 36 F S C ’s E ff o r t s － ２ E-mail news Food Safety hotline Brochures, Quarterlies Food Safety Hotline TEL ０３－５２５１－９２２０・９２２１ Monday to Friday １０：００～１７：００ ←DVD Training programs for rural leaders and risk communicators DVDs on Risk Assessment etc. Press release and information on Website Meeting with media and stakeholders 37 Thank You for Your Attention 38
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