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Role of Food Safety Commission & Food Risk Assessment

Secretariat of Food Safety Commission, 　Cabinet Office

JICA Seminar : February 29th, 2008

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Contents

1. Establishment of Food Safety Commission (FSC)

2. Role of FSC3.Food Risk Assessment4.Risk Communication by FSC

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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 ）

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.

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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 for

merly 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.

Background of Establishment

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Key Points of Food Safety Basic Law - 1Key Points of Food Safety Basic Law - 1

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.

◆Basic Principle

・ Responsibilities of the National and Local Authorities ・ Responsibilities of Food-Related Business Operators ・ Roles of Consumers 　

◆Responsibilities and roles of stakeholders

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Key Points of Food Safety Basic Law -2Key Points of Food Safety Basic Law -2

Implementation of Risk Analysis Methodology• Conducting risk assessment of food• Developing policy based on the results of

risk assessment• Promoting risk communication

◆Strategy for Policy Development

◆Establishment of FSC

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What is Risk?

＝×

Both the possibility and the associated severity of adverse effects on public health are considered together in order to determine risk.

Probability of hazards

1/1million

1/200 million

1/1000

0-157

severity of adverse effects

Risk

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Risk CommunicationSharing of risk information and exchange of opinions with

stakeholders (meetings for the exchange of opinions, public comments)

The Three Factors of Risk AnalysisRisk Assessment

（ FSC ）

Scientific

knowledgeImplement risk assessment

Risk Management（ MHLW, MAFF ）

Publicsentiment

Cost effectivenessTechnical feasibility

Determine maximum use levels, maximum residue limits, and

other standards

•Identification of hazard•Analysis of risk characteristics and damage•Exposure assessment

Initial task for risk analysisbased on the

results of the risk assessment

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1. Risk AssessmentFSC conducts food risk assessment based on scientific information and knowledge, in an objective, independent and fair manner

2. Risk CommunicationFSC 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 ResponseFSC 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.

２． Roles of Food Safety Commission

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Organization of Food Safety Commission

7 Commissioners

14 Expert Committees: total 205

members Risk CommunicationPlanning Emergency

Response

Microorganisms, Viruses

Pesticides

Chemical Substances, Contaminants

Veterinary Medicines

Apparatus,Package

Food Additives

Natural toxins, Mycotoxins

Genetically Modified Foods

Novel Foods Fertilizer,Feed

Food Safety

Commission

Food Safety Commission Secretariat （ 90 staff ） （ February,

2008 ）　

Prions

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New Food Safety Administrative Structure

Cabinet Cabinet OfficeOffice

Minister in chargeMinister in charge

○○Risk Management of Food Risk Management of Food SanitationSanitation　　

• Formulation of Residual Agricultural Formulation of Residual Agricultural Chemical Level , Registration of Food Chemical Level , Registration of Food Additives, Standard of Food Process/ Additives, Standard of Food Process/ Manufacture Manufacture • Monitoring and Guidance of Food Monitoring and Guidance of Food Manufacture, Distribution, SalesManufacture, Distribution, Sales• Risk Communication etc.Risk Communication etc.

○○Risk Management of Food Risk Management of Food ProductionProduction 　　

• Ensuring Safety and Regulation of Ensuring Safety and Regulation of Production MaterialsProduction Materials• Ensuring Safety through Improving Ensuring Safety through Improving Primary Food Production, Distribution and Primary Food Production, Distribution and ConsumptionConsumption• Risk Communication Risk Communication etc.etc.

・・ Risk AssessmentRisk Assessment・・ Risk CommunicationRisk Communication・・ Emergency ResponseEmergency Response

Foreign Foreign countries,countries,International International Bodies etcBodies etc

Information Collection/Exchange

Consumers / Business Operators etcConsumers / Business Operators etc

Request for Assessment

Exchange Various Information and Opinion among Stakeholders

Other CompetentOther Competent AuthoritiesAuthorities

Other CompetentOther Competent AuthoritiesAuthorities

Provides Assessment result / Recommendation

FSC

Provides Assessment result / Recommendation

MAFFMHLW

Risk Communication

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• 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.

３． Food Risk Assessment

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 ：　ｐ H, etc.Physical state: Temperature, etc.

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　　　　　　（１） Assessment requested from risk management

organizations　　① Assessment in response to Mandatory request

s　　② Assessment 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 food-bo

rne illness, such as campylobacter• Assessment of Beef and beef offal imported to Jap

an

Legal Classification of Risk Assessment

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Examples of Mandatory Request for Risk Assessment ①

Policies requiring risk assessment

Food additive

• Designating food additives or establishing standards /specifications of food additives

Pesticide, Veterinary medicine,

Feed and

Fertilizer

• 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 additives in food/produce

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Policies requiring risk assessment

Contami-nant

•Establishing or changing standards for contaminants in food or drinking water

Apparatus,

Package

•Establishing or changing standards for food package or apparatus used in food manufacture

Micro-organism

•Establishing or changing 　 micro-biological standards / specification for food

GMO •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

Examples of Mandatory Request for Risk Assessment ②

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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”

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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

Assessment made on FSC’s own initiative

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Assessment Requested

AssessmentCompleted

Pesticide Veterinary medicine

Food additive Novel food

Genetically Modified food/feed

Prion Other

”Assessment Completed” includes assessments conducted on FSC’s own initiative.

934

529

0 200 400 600 800

Pesticide374

Veterinary medicine

247

Food Additive

80

Novel Food 66 GM food 7

Prion 13

Other87

140 159 64 54 60

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Breakdown / Progress of Risk Assessment requested

as of Feb. 6th, 2008

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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.

Further Work for Better Assessment

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Overview of Risk Assessment

　（１） Pesticides

　（２） BSE

21Market survey

MAFF

MHLW

FSC

MHLWSetting MRLs

MOE

Impact Assessments on Environment

Registered

draftingPEC

Final decision

Public comment for 4 weeks

Applicant (domestic use)

FSC: Food Safety Commission

PEC: Pesticides Expert Committee

MAFF: Ministry of Agriculture, Forestry and Fisheries

MHLW: Ministry of Health, Labour and Welfare

MOE: Ministry of the Environment

FSC

Applicant (import tolerance)

Farmeruse

MAFF

Flow of Assessment for Pesticide

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Registration of pesticides;Provides guidance for producers

Establishes residue standards (maximum residue limits) for pesticides in food

FSC conducts food risk assessment.Based on the result of the assessment, MHLW and MAFF establish and enforce policies for food safety.

Roles of governmental organizations in pesticide management

Acceptable Daily intake (ADI) of Pesticides

FSC（ Risk assessment ）

MHLW（ Risk management ）

MAFF（ Risk management ）

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Data requirements for registration of pesticides

・ Acute oral toxicity ・ Acute dermal toxicity

・ Acute inhalation 　toxicity

・ Skin irritation

・ Eye irritation

・ Skin sensitization

・ Acute neurotoxicity

・ Acute delayed neurotoxicity

・ 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

・ Effects to body function

・ animal metabolism

・ plant metabolism

・ in soil

・ in water

・ in crop・ in soil

● Acute Toxicity ● Sub-chronic/chronic toxicity ● Metabolism

● Fate in Environment

■residue studies

● General pharmacology

・ in succeeding crop

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Data submitted to expert committee(for one pesticide)

Pesticides Expert Committee

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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.

ingested daily over a lifetimefood

ＡＤＩ

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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)

Mouse 　　 18-month study of carcinogenicity

Rat 　　　 24-month study of toxicity 　　Rabbit 　 Developmental toxicity 　　　　　　Dog 　　　 12-month study toxicity 　　　　

13mg/kg bw/day

100mg/kg bw/day

4.4mg/kg bw/day

21.8mg/kg bw/day

Example

NOAELToxicological study

AnimalSpecies

NOAEL in the most sensitive animal species shall be used to determine ADI

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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

＝

※the smallest NOAEL in all animal studies considered

ＮＯＡＥＬ in animal studies※

÷　　　

(100= １０： species difference × １０： personal difference)

１００(SF)

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Intake of hazards & health effects

１ /100

AD

I

NO

AE

L

Lethal dose

Intake of hazard

He

alth

effe

cts

death

No effect

Actual level of pesticide residue

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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. ）

http://www.fsc.go.jp/english/evaluationreports/index.htmlEnglish translation is available for important pesticides.

Result of Risk Assessment

Evaluation report

BOSCALID

April 2004

Food Safety Commission

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Standards on Pesticide use & Pesticide Residue Standards (MRLs)

MRLMRLADIADI

International standards

Standards on pesticide use for

each crop

Residue test

Survey of pesticide residue• Applicable

crops• Amount used• Timing used• # of applications

Guidance for Producers

80 % of ADI

Pesticid

e in

take

Intake from rice

Intake from wheat

Intake from orange

Intake from others

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 of each crop per day

(national nutrition survey, etc.)

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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 WheatSoy 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) 0.5Food containing chemicals above the standards are enjoined from distribution

Introduction of Positive List System (since May,2006)

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Eyeball

0.04%

Brain（ Trigeminal ganglia contained）

66.7%

Dorsal root ganglia(Vertebral column includes dorsal root ganglia)

Spinal cord 25.6%

3.8%

Tonsil

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

◆ 　 Distribution of BSE infectivity in BSE positive cattle

Total: ９９．４４％

Reference ： Scientific Steering Committee (12/1999). Opinion on the Scientific Steering Committee on human exposure risk (HER) via food with respect to BSE.

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Feed factory

Animal feed

Burn

SRM removal and burn

Export

Import ban of Meat bone meal (MBM)

Import ban of live cattle

MBM of cattle

Farm

Traceability Slaughter houseBSE testBSE test of

dead cattle

Beef

Prevention of cross contamination

Fertilizer

BSE positive countries （ No additional condition ）

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 　　　　　　　　　　

Import ban of Beef

Prevention of cross contamination

Rendering factory

Prevention of cross contamination

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The Food Safety Risk Assessment on the Imported Beef and Beef Offal from the U.S.A. and Canada

Comparison of beef and beef offal４、 Ante-mortem inspection ５、 Prevention of cross contamination６、 Comparison of risks of beef and beef offal etc.

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”

Main Assessment itemsComparison of contamination level of BSE prion in live cattle１、 External challenge２、 Animal feed regulation３、 Surveillance data 　　　　　 etc.

Equivalence of BSE Risk

Export Program・ Cattle age: 20 months or less・ SRM removal

Compliance

？

Japanese Beef and Beef Offal

Beef and Beef Offal of U.S.A., Canada

(for Japan)

＋

Present American, Canadian Domestic

Regulations 　

Compliance

All months

Present Japanese Domestic

Regulations 　

20 months or

less

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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.

ＦＳＣＭＨＬＷＭＡＦＦ

ConsumersProducers

Food industryDistributors

/retailersScientists

４． Risk Communication by FSC

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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)

FSC’s Efforts ー１

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E-mail news Food Safety hotline

Food Safety HotlineTEL 　０３－５２５１－９２２０・９２２１

Monday to Friday 　１０：００～１７：００

Training programs for rural leaders and risk communicators

DVDs on Risk Assessment etc. Press release and information on Website Meeting with media and stakeholders

Brochures, Quarterlies

　　　　　←DVD

FSC’s Efforts －２

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Thank You for Your Attention