INTRODUCTION TOINTRODUCTION TO

RISK ANALYSISRISK ANALYSIS

Maximilian P.O. Baumann & KarlMaximilian P.O. Baumann & Karl--Hans Hans ZessinZessinPostgraduate Studies in International Animal Health

baumann@vetmed.fu-berlin.de

Participatory Risk Analysis Course, ILRI – BMZ Project, 2008

II SETTING THE SCENESETTING THE SCENECHANGES IN ‚VETERINARY‘ / FOOD SAFETY SECTORS:

- global, WTO-SPS- European Union (EU)

EUROPEAN UNION (EU): - „Farm-to-Fork“ Policy

-RISK ANALYSIS (principles):

- RA model types- Model parameters:

- Principle constraints

IIII RISK ANALYSIS PROPERRISK ANALYSIS PROPERHISTORY/DEFINITIONS:

- zero vs. acceptable risk– „Risk“, „Hazard“, ...

COMPONENTS OF RA (OIE, FAO/WHO, CAC)

QUALITATIVE/QUANTITATIVE RA

PATHWAYS / event and faulttrees: qualitative RA: Example Parma Ham

quantitative RA: microbiological RA; Different examples and exercises

VARIABILITY, UNCERTAINTY, DISTRIBUTIONS:- way to quantitative RA

Factors driving changes in food safety systems

TRENDS IN THE FOOD INDUSTRY

AddedValue

Improving manufacturingefficiencyBatch-continuousReduce waste

FoodserviceEating out Snacking

Clean labelMilder processing

1970 1980 1990 2000

10 years 2 years

ProductNutritional sciencesuccessfully linkednutritional habit to health

‚Naturalness‘increasingly important in relation to health/vitality

Consumer morequality conscious

201520

‚MAKE‘

‚SERVICE‘

‚CARE‘ProcessProcess

Speed of product innovation (half-life of product innovation)

Animal Protein Trade

Rabobank, 2003Poultry trade flow Beef trade flow Pork trade flow

Russian Federation

USA

Brazil

Canada

Mexico

Japan

Argentina

India

Australia

Source: Rabobank and Dutch Dairy Board (2006); Achterbosch: IPC Issue Brief 24, August 2007

WORLD DAIRY MAP

INCOME TRENDS AND MEAT CONSUMPTION

2015: World‘s food system must feed an additional 750 million people

UNDERNOURISHED POPULATION, 2004: 840 Million

SELF CONSUMPTION

DOMESTIC MARKETS

INTERNATIONAL MARKETS

LINKING SMALLHOLDERS TO MARKETS

Subsistenceproducerswith smalllandholdings

Agricultural householdsproducing formarkets, also forsubsistence

Commercial producers, competitive

Source: modified after Orden et al. 2006

PHYSICAL INFRASTRUCTURE INSTITUTIONS

MARKET ACCESS FOOD REGULATION

Source: Trienekens, 2006

GLOBALIZATION

Winners ?

Loosers ?

„GLOBALIZATION“

‚The increasing world-wideintegration of markets forgoods, services (people?) and capital‘

? The integration of economic, cultural, political, and socialsystems across geographicalboundaries ?

GLOBALIZATION (1)

1944

1945

GATT: 1947

GLOBALIZATION (2)

GLOBALIZATION (3)

1947: GATT: Tariffs (steel, coal): Geneva: 1947, Annecy: 1949; Torquay: 1950/51; Geneva: 1955:56; Dillon-Round: 1961/62; Kennedy-Round: 1964/67; Tokyo-Round: 1973/79

1986 - 1995: Uruguay Round: AGRICULTURE FULLY INCLUDED “main agreement on animal health”

147 Member Countries, 90% of WORLD TRADE

1995: WORLD TRADE ORGANISATION (WTO)

GLOBALISATION (4)

World Trade Organization (WTO):

More free and safer trade by reduction of tariffs (taxes) and Reduction of ´non-tariff barriers` (! Animal Diseases, Sanitary Controls !)

Integration of Nations in “Free Trade Areas / Common Markets”

WTO rules can be enforced through sanctions. This givesthe WTO more power than many other international bodies.

The WTO's authority even eclipses national governments?

1999: Seattle 2001: Quatar

- Dohar Development Agenda2003: Cancun2005: Hong Kong

2008: failure of the Dohar Round

WTO

SPS: facilitate tradewhile safeguarding human, animaland plant health

Manifestation of multilateral trade facilitation and liberalization

Rule-based world trade

Cancun Ministerial Conference:

Begin elimination of farm subsidies of developed countries

The Need For International RegulationThe 1920 Rinderpest outbreak in Belgium highlightedthe need to have an international body to regulate tradein animals and animal products

In 1924 the Office International des Epizooties (OIE) was created

- 28 countries

Rinderpest Belgium: zebus, originating from India and destinedfor Brazil, transiting via the port of Antwerp

WORLD ORGANISATION FOR ANIMAL HEALTH

Animal Health, Zoonoses, AnimalWelfare

OIE is the standard settingorganisation for animal health, zoonoses and animal welfarein international trade

OIE Animal Health Code contains guidelines for importrisk analysis. Structureequivalent to import-scenario(release, exposure, consequence)

CODEX ALIMENTARIUS COMMISSION (CAC)

Food Safety

CAC is the standard settingbody for microbiological hazardsin international trade with foods

CAC guidelines describequantitative microbiological riskassessment and the principles of risk analysis: Differenciation in hazard-identification, hazardcharacterisation, exposureassessment, risk characterisation

TERMINOLOGY AND DEFINITIONS: World Trade Organisation (WTO): The WTO Agreement on the Applicationof Sanitary and Phytosanitary Measures(SPS Agreement) was drawn up to ensure that countriesapply measures to protect human andanimal health (sanitary measures) andplant health (phytosanitary measures)

CONCERNS/‘THREATS‘

Food safety/agricultural health measures: applied in discriminatory manner

Dev. countries: Lack of administrative, technical, and other capacities

Costs incurred to reach compliance (undermine com-parative advantage of dev.countries

Institutional weaknesses and compliance costs weakenweaker economic players (smallercountries, enterprises, farmers)

WTO/SPS

Demands on veterinary services infrastructure: functionality throughout the food chain

PURPOSEPURPOSE OF THE SPS AGREEMENT

SANITARY AND PHYTOSANITARY (SPS) AGREEMENT

(Article 5.1)

„Members shall ensure that their sanitary orphytosanitary measures are based on an risk

assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques

developed by the relevant international organizations.“

SANITARY AND PHYTOSANITARY (SPS) AGREEMENT(Article 5.1 – 5.3)

Article 5.1

Article 5.2

Article 5.3

measure has to be based on a riskassessment

what to take into account(available scientific evidence, etc.)

for animal and plant health, whateconomic factors to take intoaccount

LIMITSLIMITS SET BY SPS AGREEMENT

EUROPEAN UNION (EU)EU = single market

27 countries, 497 Mill. consumers164 Mill. ha agricultural areaJobs in agriculture: 9,5 Mill. full-time

jobsFood- & Beverage Industry:

15% of GNP Food Industry:

3rd largest industrial sector; 2,6 Mio. employees

EU

SELF-SUFFICIENCY

% self-sufficiency

100

EUSelf-Sufficiency

Example: Germany

Grains

Sugar

Beef

Milk

Pork

Eggs

Poulty meat

Mutton

Vegetables

Fruits

0 50% 100% 150%

EUWorld biggest importer of foodstuff(61 billion €/year) - 36 billion € from develop. countries= net importer of agricultural products

Imports at zero/low tariff (Generalised Preference System (GSP))

Main EU agricultural imports

EU

MAJOR WORLD TRADERS AND DEVELOPING COUNTRIES (Average 2000-2002)

World 2nd largest exporter of food products(61 bill. €/year) = Net-Exporter of processed food products

EU

CAP fundamental reforms (2007 – 2013)

Common Agricultural Policy (CAP): -costs 50 billion €/year= 43% of total EU budget; 2013: 33%= € 2/week/citizen

Directorate General Health and ConsumerProtection (DG SANCO)- integrates food safety, animalhealth, animal welfare, plant health= ‘farm to fork’ strategy

EUFOOD SAFETY

2004: REJECTIONS ACCORDING TO IDENTIFIED RISK

SOURCE: EU Rapid Alert System For Food and Feed (RASFF, 2005

EUCONSUMER SURVEYS

Foods: safe?

Foods: good quality?

Foods: healthy?

Foods: reasonable price?

Farm animals: well treated?

Information about production and processing?

35%

33%

26%22%

19%

22%

Difference in perceptions associated with a variety of potential food hazards

Source: Fife-Schaw and Rowe, 2000

EUIMPORT OF FOOD

Imported product standards at least equivalent to those for trade between EU member state

o comply with EU food law

or

o conditions recognised as equivalent

DG HEALTH AND CONSUMER PROTECTION (DG SANCO):

„FARM TO FORK“-POLICY, RISK ANALYSIS-METHOD

EUPOLICY (1) (http://europa.eu.int/comm/food)

2000: WHITE BOOK FOOD SAFETY

2002: Regulation 178/2002:

General principles and requirements of food law

Primary production included in food safety(‚stable to table‘ concept) Process control priority over end-product control(HACCP, GMP, GVP, QM-systems)Responsibility for food safety with producers at eachproduction stageObligatory self-controls by producers themselves

Government: ‚Control of (self-) controls‘

EUPOLICY (2)

2004: Regulations 852/853/854/2004:

Organisation of official controls on products of animal origin (=‚hygiene package‘)

(Start 2006)

Dramatic effects on primary production: complete information flow along food chains(forwards and backwards)

EUPOLICY (3)

Brucellosis, Tuberculosis, Trichnellosis, Echinococcosis, Salmo-nellosis, Campylobacteriosis, verotoxin-forming E. coli, Listeriosis

Directive 99/2003: monitoring of zoonoses and zoonotic agents

Regulation 2160/2003: control of salmonella and other specified food-borne zoonotic agents

Animal feed manufacturers

Primary Production (FARM) e.g. breeding, rearing, fattening

Transport of animals, of raw products

Slaughtering and processing

Transport of processed products

Wholesale

Transport of processed products

Retail e.g restaurants, cateringservices, food stores

Consumer (FORK)

RenderingPlants

= GOLD

STANDARD

Total transpa-rency:

- Animal ID

- Surveill. (sampling)

- ....

RISK MGMT.

„FARM TO FORK“ APPROACH

I “FARM TO FORK”: FOOD CHAIN: technical

Primary-production

Slaughterabc

Processingabc

Retail, tradeabc

Consumptionxy

Food safety

Curativepractice

“FARM TO TABLE”: FOOD-CHAIN: technical

Primary Production

Slaughterxx

Processingxx

Retail, Trade

Consumptionxy

Food-Safety

CurativePractice

Primary Production

Slaughterxx

Processingxx

Retail, Trade

Consumptionxy

OLD:

Inspection: check only of effect, not of mechanismspossible

“FARM TO FORK”: FOOD CHAIN: Quality Cascade

Primary-Production

Slaughterabs

Processingabc

Retail, Trade abc

Consumptionxy

Primary-Production

Slaughterabc

Pro-cessing

Retail, Trade

Consumptionxy

NEW APPROACH:

= Quality demands= Quality supply

Intervention: permits Risk-Management

Host environment of the food supply chain regarding emerging risks

Science, Technology & Industry

new scientificknowledge,

new technolopgies, processing & distribution

Science, Technology & Industry

new scientificknowledge,

new technologies, processing & distribution

Nature & Environment

climate, pollution, natural

Government & Politics

new legislation, supervision/enforcement,

trade barriers, food terrorism

Consumer Behaviour

perception, diet,

attitude

Culture & Demography

lifestyle, mobility,

education, ageing

Public Health & Welfare

infrastructure, lifestyle, diseases

Agriculture

plant & animal health, production systems,

biodiversity

Economy

trade, supply & demand,

wealth & income level, globalisation

Information

media, communication interest,

expert rolesFOOD CHAIN

Source: Voedsel en Waren Autoriteit, The Hague, 2005

Risk assessment on Campylobacter jejuni in chicken products in chicken slaughter-house/consuminghousehold (Denmark, 2001)

NEED FOR AN INTEGRATED APPROACHFeed

Manufacturing

Farm

Slaughter

Retail

Consumers

Numerous possible routes for introduction and transmission of pathogens

Coordinated multi-disciplinary and inter-sectoral response necessary

Levels of national and interna-tional collaboration/coordination:

- Microbiology - Epidemiology

-Veterinary - Food Hygiene - Medical

-Government - Industry - Research -NGO - etc

MEAT CHAIN AND ASSOCIATED HAZARDS

MEAT CHAIN

Environment

Animal feeds

Animals on farm

Transport

Markets/lairage

Abbatoir

Processing

Storage & retail

Domestic, tradeand retail catering

CONSUMERS

Source: Buncic, S., 2006

MEAT CHAIN AND ASSOCIATED HAZARDS

MEAT CHAIN

Environment

Animal feeds

Animals on farm

Transport

Markets/lairage

Abbatoir

Processing

Storage & retail

Domestic, tradeand retail catering

CONSUMERS

Source: Buncic, S., 2006

CHEMICAL AGENTS

Industry Heavy metals, PAHs, Radionuclides

AgriculturePesticides, Myxcotoxins, Phytotoxins,

Fertilizers

Veterinary MedicineDrugs, Growth promoters

Tranquillizers

Preservatives, additives, biogenic amines

Packaging compoundsPlasticisers, Inks

MEAT CHAIN AND ASSOCIATED HAZARDS

MEAT CHAIN

Environment

Animal feeds

Animals on farm

Transport

Markets/lairage

Abbatoir

Processing

Storage & retail

Domestic, tradeand retail catering

CONSUMERS

Source: Buncic, S., 2006

CHEMICAL AGENTS

Industry Heavy metals, PAHs, Radionuclides

AgriculturePesticides, Myxcotoxins, Phytotoxins,

Fertilizers

Veterinary MedicineDrugs, Growth promoters

Tranquillizers

Preservatives, additives, biogenic amines

Packaging compoundsPlasticisers, Inks

BIOLOGICAL AGENTS (bacteria, viruses, parasites)

Water- and soil-bornepathogens

Rodent-, bird- and insect-borne pathogens

Vertical and horizontal transmission of pathogens

Horizontal transmission of pathogens

Faecal and cross-contamination

Cross-contamination, re-contamination, human-

borne pathogens, micro-bial growth

FOOD CHAIN: Tools

PROCESSING

PRE-HARVEST

TRANSPORT

HARVEST

RETAIL

CONSUMERS

INTEGRATED MONITORING – the food-chain approach -

Active monitoring: all stages of chain

Samples representative of population

Harmonized laboratory methodsand quality assured

No. tests sufficient to produceprecise measure of prevalence

Data pooling, coordinated analysisand reporting

Non-Trade concerns („NTBs“):PROCESS RATHER THAN PRODUCT REQUIREMENTS- Animal welfare

- Environmental protection

- Food Safety (GMOs)

- Corporate Social Responsibility (CSR)= transparent business operation

workers rightspromotion of environment

THE WAY AHEAD?

Package of safety, quality, environmental, social, ethical standards

COMPLEXITY of standard setting for high-valuefoods will increase