Global Regulatory Systems in the Supply Chain

Food Safety Systems Recognition

Donald A. Prater, DVMAssistant Commissioner for Food Safety Integration

Food Safety SummitRosemont, IL

May 8, 20181

FDA’s Imported Food Safety ToolkitEnsuring safe food is offered for import• Foreign inspections, facilities and farms• Partnerships and collaborations – SYSTEMS RECOGNITION• Importers: Foreign Supplier Verification Program, VQIP• Third-Party Certification – FDA’s Accredited TPCP, Reliable audits• Import certification, export programs • Outreach, education, training, capacity buildingInterdicting unsafe food at the port of entry• Facility registration, prior notice• Examination, sampling, detention• Import alerts, bulletinsResponding to unsafe food that has entered the market• Outbreak response• Recalls 2

Food Safety Systems Recognition• Background• Systems Recognition Assessment• Systems Recognition Implementation

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Background: What is Systems Recognition?

• A tool for regulatory cooperation and partnership

• Systems recognition describes whether a country’s food safety system provides a similar, though not necessarily identical, system of protections; and the food safety authority provides similar oversight and monitoring resulting in comparable food safety outcomes.

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How does Systems Recognition Differ From Equivalence?

• Systems recognition is an assessment of an overall food safety system and is not required to access to the U.S. market for FDA-regulated foods.

• Equivalence determinations are: an obligation under the WTO-SPS Agreement; can be accepted for a specific measure or measures related to a certain product or category of products, or on a system-wide basis; and are a market access tool.

• Equivalence can be one-way. Unlike equivalence, systems recognition is intended to be a two-way partnership. 5

How Does Systems RecognitionBenefit FDA?

• Systems recognition allows us to:

– Allocate our resources, including inspectional and port of entry resources, in a more risk-based manner

– Identify those partners we can rely on for follow-up

– Offers the prospect of sharing data and information to enhance food safety activities

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What is the Assessment Process?• Pre-Screen• Completion of International Comparability Assessment

Tool (ICAT), which contains 10 core elements:– Regulatory Foundation (Includes Preventive Controls) – Training/Human Resource– Inspection Program– Program Assessment/Inspection Audit Program– Food related Illness and Outbreaks– Compliance and Enforcement (Includes Verification Activities) – Industry and Community Relations– Program Resources– International Communications and Harmonization– Laboratory Support

• Documentation review – Are programs in place?• In-country audit – Does the reality align with what is on

paper? 7

Scope of Assessments• All foods for human consumption under FDA regulation except for

Grade A dairy and dairy products and molluscan shellfish and dietary supplements. Animal feed excluded as well.

• Certain product specific regulatory requirements and standards are not included in the scope.*

• Food contact substances• Maximum residue levels for pesticides and veterinary drugs• Food additive approvals• Labeling requirements*Exporters need to meet the requirements of the importing country, as a matter of compliance

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Implementation• Resource allocation decisions

– foreign inspections, border activities, other– maintenance of regulatory oversight

• Enhancing channels of communication for sharing data and information– outbreak response– recalls– emerging risks in the supply chain

• Foreign supplier verification programs– modified requirements

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Food Safety Systems Recognized Countries

• New Zealand – 2012• Canada – 2016• Australia - 2017

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Thank you!

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NATIONAL AND GLOBAL TRENDS AFFECTING SUPPLY CHAIN AND RESTAURANT FOOD

SAFETY

MANDY SEDLAK, RS/REHS

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FOOD SAFETY AND PUBLIC HEALTH MANAGER, ECOSURE May 8, 2018

© 2017 Ecolab USA Inc. All rights reserved.

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Our Shared PurposeTHE WORK WE DO MATTERS

Every day Ecolab makes the world cleaner, safer and healthier

Protecting people and vital resources

REALITIES AND TRENDS

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Realities We’re Facing: Society Has Much Less Tolerance for any Type of Hazard

Today’s food consumer demands variety and wants an “experience”

- Global food, prepared locally- Fresh, organic, fewer ingredients, chemical free

Widespread availability of information can give the appearance of more issues and demand quick response - Social media

More sensitive agent detection technology

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Global Food Service Trends

Overall West stresses menu and variety; East stresses health and natural Strong emphasis on consumer’s new expectations - transparency

Restaurants Most growth is in Asia and Middle East and in QSR, followed by fast

casual Fastest growth by food type – Coffee (7%) > Pizza ( 5%) > Chicken

( 3%) > Sandwich ( 2.4%) > Burgers ( 1.8%)

Dining trends Delivery gaining in prominence – especially in Asia Ordering preferences vary– online is highest in Asia; Americas mainly

by phone; Europe/Australia mainly in restaurants “Window cooking” – consumers want to be able to see their food

prepared

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Source – https://emarketing.alixpartners.com/rs/emsimages/2016/pubs/EI/AP_Global_Restaurant_Outlook_Oct_2016.pdf

Shifting dining preferences impact how foodservice operators address food safety

FOOD SAFETY FACTS AND FIGURES

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The Global Burden of Foodborne Diseases is Substantial

Every year foodborne diseases cause:

in10almost

people to fall ill33 m llion

healthy life years lost

Foodborne diseases can be deadly, especially in children <5

420,000deaths

Children account for almost1/3

of deaths from foodborne diseases

Source: http://www.who.int/foodsafety/areas_work/foodborne-diseases/infographics_global_en.pdf?ua=1

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Global Foodborne Illness Data Spurs Development of Targeted Actions

WHO has estimated the global burden of diseases from foodborne illnesses 31 agents (bacteria, toxins, parasites, chemicals)

African region has highest disease burden

Global Variability in What Causes Illness Developed World - Norovirus, Campylobacter, E. coli and Salmonella

Developing World expanded to also include hazards from chemicals

Agents responsible for most deaths Typhoidal and non typhoidal Salmonella

Taenia solium (tapeworm) Hepatitis A virus Aflatoxin

http://www.who.int/foodsafety/areas_work/foodborne-diseases/ferg/en/

Knowing causes leads to targeted actions to reduce risk8

Foodborne IllnessComposite of Contributing Factors (when known)

0

10

20

30

40

50

60

70

Poor PersonalHygiene

ImproperHolding

ContaminatedEquipment

UnsafeSource

InadequateCooking

Other

% o

f Tot

al

USEUChina

9© 2017 Ecolab USA Inc. All rights reserved.

US Reported Foodborne Illness2015: Attributed to Food Commodity Groups

Rank Order and Number Of Outbreaks Attributed To Food Groups

0

5

10

15

20

25

30

35

40

Source: https://www.cdc.gov/foodsafety/pdfs/2015FoodBorneOutbreaks_508.pdf

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MORE SENSITIVE TOOLS

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Whole Genome Sequencing

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More precise

Relatively fast and inexpensive1995 – first sequence generated for $1 million, took ~1 year2015 – about $50, takes just 1 day

Microbiology is evolvingCultural techniques - Very different specialized typing systems for different microorganismsToday - One test fits all (virus, bacteria, fungi, parasites), regardless of the source

Food Safety and Social Media

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Information travels far and fast

It’s global & it’s 24/7

Food Safety in Social Media

Can facilitate information exchange and often serve as early-warning systems for emerging issues

Availability of information and data to the consumer has grown in leaps and bounds over the last 10 years

Consumers sphere of influence has increased drastically as they become more “connected” and “well informed”

New wave of “experts” who can alter public opinion

Introduction of crowd sourcing websites to track food safety concerns

Imperative that we start factoring social media not just marketing plans, but also their crisis preparation and response plans

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Need to Follow Food from Farm to Fork and Have Visibility Along the Chain

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Reality… 3 restaurants, 18 distributors, 2 consolidators, 4 growers…

Salmonella outbreak linked to hot peppers, 2016. 32 cases. CDC report

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Global Supply Chain Risks

A shorter supply chain doesn’t

mean a less complicated one.

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S o u r c e : U S D A E c o n o m i c R e s e a r c h S e r v i c e – L e t t u c e

T r a d e M a p – V i n e g a r a n d W h e a t G l u t e n

B e e f 2 L i v e – B e e f

U S D A F A S G l o b a l A g r i c u l t u r a l T r a d e S y s t e m –

W h e a t G l u t e n , P a p r i k a , a n d G a r l i c P o w d e r

2 0 1 5

PaprikaBosnia and Herzegovina

BrazilChina

Ecuador

FranceGermany

HungaryIndia

Israel

NetherlandsPeru

PolandPortugal

Serbia

SpainSouth Africa

South KoreaThailand

Turkey

VinegarCanada China

France Germany

Greece

Hong KongItaly

Japan Peru

Philippines

South KoreaSpain

TurkeyUnited Kingdom

Garlic PowderCanadaChina

GermanyIndia

Israel

ItalyJapan

MexicoTaiwan

Vietnam

Lettuce

Belgium

CanadaCosta Rica

Dominican Republic

GuatemalaEcuador

Israel

ItalyMexico

Netherlands

Peru

Beef

Australia

Brazil Canada

Chile

China Costa Rica

Croatia Ireland

Japan

MexicoNew Zealand

Nicaragua

Poland Thailand

Uruguay

Wheat Gluten

Australia

AustriaBelgium

Canada

ChinaCzech Republic

GermanyFrance

Italy

Lithuania

NetherlandsPoland

Russia

SwedenTaiwan

VietnamUnited Kingdom

GLOBAL SUPPLY CHAIN COMPLEXITY

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How do you safely follow from farm to fork with differentiating regulations & cultures

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Allergens Differ Regionally

Hong Kong Top 8 Plus+Sulfites+Gluten

U.S. Top 8+ Fish+ Crustacean

Shellfish+ Egg+ Milk+ Peanuts+ Tree-nuts+ Soy+ Wheat

+ Gluten ?

CanadaTop 8 Plus+ Sesame+ Molluscs+ Sulfites+ Gluten

E.U.Top 8 Plus+ Sesame+ Molluscs+ Sulfites+ Gluten:

• wheat rye,

• barleyoats

• speltkamut

+ Celery+ Mustard+ Lupin

ChinaTop 8 Plus+ Gluten+ Sulfites

Japan4 of Top 8+ Milk+ Egg+ Peanuts+ WheatPlus+ Buckwheat+ 20 allergens

possible

Australia/NZ Top 8 Plus+ Sesame+ Molluscs+ Sulfites+ Gluten

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DIFFERENTIATING REGULATIONS

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Food Code Adoption by State

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Food Code Adoption by Population

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66.29% of Population is covered under 2009 or 2013 Food Code

WHO Food Handler Messages

Consistency

1. Keep clean

2. Separate raw and cooked

3. Cook thoroughly

4. Keep food at safe temperatures

5. Use safe water and raw materials

Source: http://www.who.int/foodsafety/areas_work/food-hygiene/5keys_2017.pdf

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Reducing Risks of Food Safety Globally

Strong partners across the supply chain can help identify, prevent and resolve issues

Diverse Cultures, Regulations and Global Foodborne Illness Risks Call for:

ConsistencyTrusted Practices

Awareness and Adjustments

Risk management strategies are becoming more complex

Critical item tracking Sanitation compliance

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Is the food supply less safe than it used to be?

No, but food safety incidents are increasingly more visible

Improved detection & surveillance identifies broad issuesGood news = from a public health standpoint

Emphasizes need for flawless execution of food safety programs across supply chain

Food safety facts can help direct efforts appropriately What agent caused illnesses? What food was implicated? Where did illnesses occur? What factors contributed to the illnesses?

Greater awareness is shifting perception of food safety at the consumer level26

Response Recommendations

Assess and Take Action In your locations Along whole supply chain

Strengthen Verification Training Inspections Enhance in-process, finished product and environmental monitoring at appropriate

points in supply chain

Invest in Food Safety Tools and technology Partnerships and approaches

Build Connections

Be Persistent

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Be Consistent

Mandy Sedlak, REHS Manager of Public Health and Food Safety EcoSure a Division of Ecolab

WHAT MATTERS TO YOU

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