How Risk-Based Standards Support Innovation

FOOD AND NUTRITION FLAGSHIP

Prof Martin Cole | Director CSIRO Food and Nutrition

July 2015

Food Regulations and Labelling Standards Conference 2015, Sydney

Overview

• Food scares and the consumer

• National and international response

• Risk based standards

• Innovation & new technologies

• National opportunities

• Summary

Presentation title | Presenter name2 |

Food Safety Scares have led to major reformsat National and International levels

•BSE, dioxin, EFSA, EU•Fresh produce, Peanut Butter, botulism, FSMA, US•Contaminated beef, slice meats, Safe Food for Canadians, Canada•Fake foods, microbial and chemical contamination, FSL, China

New Risk Management Framework, ICMSF/CODEX

Consumer: Food Safety and Outrage

“the affected party’s feelings regarding thevalue of what might be lost.” There can be no greater loss than losing one’s child.

(Benson 2011)

(Source: Foodmagazine)

Risk:Industry/Company Perspective

viruses

‘Real’ ‘Perceived’

Salmonella

Vibrio packaging contaminants

processing contaminants

GMOs

environmentanimal welfare

novel processing

vs

= Business Risk

avian flu

Government Perspective

•Primary role of national governments is to protect the safety and health of its consumers

•Secondary role to facilitate trade

Public HealthFood safetyNutrition (In relation to chronic illness)

TradeSecurity & Sustainability

Reforms to Managing Food Safety

Command & ControlPrescriptivePoint Testing

Constraint to Innovation

Risk basedFlexible

Through ChainSupports Innovation

More Complex

Equivalence: Do two systems of food safety risk management (e.g. inspection, HACCP, processing) provide the same degree of public health protection?

New Approaches to Risk Management

ALARie ‘As low as Reasonable’

BUT:-Technological capabilities vary-Idea of ‘reasonable’ varies

Public Health Based Goals-eg yearly incidence of Listeriosis

below 4 cases/million of pop.BUT:-in terms of population-not related to specific foods

The Issue Behind the Issue:

FSO

FOODBORNE ILLNESS/DEATH

Managing the ‘Food Safety Cliff’

HAZARDPROCESS VARIABILITY

Food Safety Objectives

• FSO = food safety objective• Ho = initial level of the hazard• ΣI = total increase in hazard,through

growth or contamination• ΣR = total death (reduction of hazard;

negative number)

Ho + ΣI + ΣR FSO

HACCPGMPGAP GHP Code of practice

ALOP

Risk analysis Public health burden

Food Safety

Objective

Performance Objectives

??

(Leon Gorris, 2004)

Overview of setting public health targets and performance metrics

Acceptable Level of Protection (ALOP); Food Safety Objective (FSO); Performance Objective (PO); Performance Criteria (PC)

Fazil, 2013

Production & Primary Handling Processing & Packaging Distribution & Shelf-life

Minimizing initial levels Reducing

levels

Minimizing an increase in levels

Minimum Standards

Water managementChoice of fertilizerSanitation of equipmentRapid coolingHygiene of personnelMonitoring

Processing & Washing stepsEnvironmental surveillanceMonitoring

Temperature managementChoice of storage atmosphereShelf-lifeMonitoring

Risk-based use of preventative controls in the production chain of fresh produce

Good Agricultural Practice (GAPs)Good Manufacturing Practice (GMPs)Hazard Analysis Critical Control (HACCP)Performance StandardsGuidelines/Regulations

Testimony before the US House of Representatives

"Food and Drug Administration Globalization Act of 2009”, March 11, 2009 10

Hierarchy of Risk Management Options

Food SafetyObjective

PerformanceObjective

PerformanceCriteria

Process/ProductCriteria

Target level at consumption

Target levelat specific step

Required outcomeAt specific step

Specific process orProduct conditions

‘IncreasingFlexibilityBut also IncreasingComplexity’

Control Options for E.coli 0157:H7 in Fermented

Meat Products (Nickelson, 1996)

•Apply default heat treatment eg

62.8 C for 4 mins - CCP

•Apply validated process to give a

5D kill step - CCP

•Combine raw material testing to control

Initial level < 1/g plus a 2D kill step

-Monitoring plus CCP

•Apply hold and release test program on

finish product eg 30x25g samples

-Monitoring

•Apply alternative technology that gives

equivalent 5D kill step. -CCP

Ho = +3

Reducing the Level of the Hazard

0

10

20

30

40

50

60

70

80

90

1/10Kg 1/Kg 1/100g 1/10g 1/g 10/g 100/g 103/g 104/g 105/g

FSO

Frequency and/or Concentration of Hazard

To reduce initial level of ‘+2’ to meet FSO of ‘-2’ need R of 5

Ho = 0

Controlling Initial Level and a Reduction Step

0

10

20

30

40

50

60

70

80

90

1/10Kg 1/Kg 1/100g 1/10g 1/g 10/g 100/g 103/g 104/g 105/g

FSO

Frequency and/or Concentration of Hazard

If sampling can ensure that the initial number is always < ‘0’ then the FSO can be

met with a smaller reduction R = 2

Impact of New Risk Management

• Increased flexibility….innovation

• Science based & increased transparency

• Will impact • Shared responsibility across chain

• Stringency of HACCP

• Micro Criteria more science based

• Equivalency of new processes

1995 2014

No. Papers with Food Safety Objective in title

NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS

REQUISITE SCIENTIFIC PARAMETERS FOR ESTABLISHING THE EQUIVALENCE OF ALTERNATIVE METHODS OF PASTEURIZATION

ADOPTED AUGUST 27, 2004

WASHINGTON, DC

Presentation title | Presenter name19 |

‘Any process, treatment, or combination thereof, that is applied to food to reduce the most resistant microorganism(s) of public health significance to a level that is not likely to present a public health risk under normal conditions of distribution and storage ‘

‘NACMCF recommends that regulatory agencies establish a Food Safety Objective (FSO) and/or a performance standard for food/pathogen combinations that can be used as the basis for judging equivalency when a proposed process is evaluated as an alternative to traditional pasteurization. ‘

‘Food companies and regulators are

beginning to understand the potential

benefits that technologies such as

ozone, high pressure, pulsed electric

field, aseptic packaging, irradiation and

ultrasound offer- fresher tasting foods

that retain nutritional value and are

safe.’

Editor FoodSafety Magazine, November, 2003

‘Food Safety technologies’

Convergence of major consumer trends

Presentation title | Presenter name

21

Convenience Indulgence Health

Ethical

Convenience

Indulgence

Health

Ethical

Source: Business Insights

Health will continue to be a dominant trend

Food Safety is a Given

High Pressure ProcessingEquipment and developments

Commercial

• Vertical batch vessels to 600 MPa to 215 L

• Horizontal batch vessels to 600 MPa to 420 L

• Semicontinuous enclosed vessels

Under development

• Larger vessels

• Higher pressures (up to 800 MPa)

• Arrays of small, very high pressure vessels at high speed

• Combination of pressure and temperature.

• 700 MPa to 150L

• Vessel temperatures to 95ºC (process temperature >121ºC)

Vessel specifications:

T: up to 50ºC

Typical treatment times: 1-5

min (under pressure, product

specific)

8

24

38

82

1 23

57 7 7 7

911

19

28

37

49

64

79

93

111

124

135

152

Oceania

Asia

Europa

Amer ica

Evolution of HPP industrial machines installed May 2010

Source: NC HyperbaricSource: NC Hyperbaric

24

High Pressure Technology Going Main Stream

Juices and

beverages

13%

Vegetable

products

34%

Meat products

30%

Seafood and

fish

14%

Other products

9%

Source: Andrew Gibb, Coldpress

CSIRO - High Pressure Processing (HPP) - Preshafood

2001 2013

CSIRO HPP technology demonstration

Installation of larger 300L HPP plant to increase capacity.

Opening of $1.4M processing facility with 55L HPP plant

Export to Singapore, Hong Kong and Thailand

First commercial fruit juice contract production at CSIRO pilot plant

2003 2007 2009 2011

Won first prize for Beverage Innovation Awards in Best New Juice or Juice Drink and Best New Beverage Concept categories

Won Panasonic Australia Medium Business Award

Juice, avocado & wet-salad R&D industry projects, demonstration & validation trials by CSIRO.

Export expansion into Europe, USA and Japan

New fruit coulisrange available in Australia

2008 2010

Concept stone fruit, purees for yoghurt and other dairy product trial at CSIRO.

2005

CSIRO, Animal Food and Health Sciences

Current PreshaFruit Juices in Australia

1 L Bottle (triangular) 350 mL bottles (triangular)

New fruit and veg juice product rangeJoint Venture with Reboot Your Life

• vegetable fruit juice mixtures• spinach, carrot, lettuce, beetroot, celery, etc www.jointhereboot.com

Pressure Fresh Australia

Moira Mac’s (Australia)• Hiperbaric 55 para procesado de RTE

Ready to eat

Conventional

Low salt preservative free

CSIRO. Food and Nutritional Sciences – A new Approach to Food and Health

High Pressure processing and the

Megatrends

Product Examples: Seafood

Key Drivers Outputs & Outcomes

Research Challenges

Shucking, Labor intensive

Plus OH&S issues

Export Opportunities

Food Safety Concern

Raw Oysters

HPP in Shell-Shucking

Increased yields

Extended Shelf-life

Enhanced Safety

‘Cold Pasteurization’

Validation of Viral and Bacterial kill step

Optimization of process

Packaging and distribution

Shelf-life & Sensory Studies

www.theperfectoyster.com

Hepatitis A Inactivation

400 MPa

-1.0

0.0

1.0

2.0

3.0

4.0

0 60 120 180 240 300 360 420 480 540 600

Time (s)

Tit

re r

ed

ucti

on

(L

og

TC

ID50/m

l)

ABC

Grove, et al., 2005

HPP Shucked Lobster

Sustainable Shelf-Life Extension (SUSSLE)

CSIRO. Insert presentation title, do not remove CSIRO from start of footer

Source:http://randd.defra.gov.uk/Document.aspx

?Document=FT1568_10136_ABS.pdf

£750k three year research project

Challenges guideline shelf life limits and specified

thermal processes

Aims:

Enhance quality of extended shelf life chilled foods,

assuring safety

Reduce waste

Reduce energy inputs

http://www.foodmanufacture.co.uk

HPT for ESL chilled low acid foods

-5.0

-4.5

-4.0

-3.5

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

0 1 2 3 4 5 6 7 8 9 10

Log 1

0re

du

ctio

n (

cfu

/mL)

F90°C (min)

Heat only

57.5°C 550 MPa

65°C 500 MPa

65°C 600 MPa

72.5°C 450 MPa

72.5°C 550 MPa

72.5°C 650 MPa

80°C 500 MPa

80°C 600 MPa

87.5°C 550 MPa

Significantly less heat is required to

inactivate an equivalent number of spores of

non-proteolytic Clostridium botulinum

HPP and heat could be used to extend

the shelf-life of chilled low acid foods

e.g. beyond 10 day guidelines

OR

Legan, Chapman, Bull, WO2008083216-A1

Microbial spore inactivation by HPT | Michelle Bull35 |

Non-proteolytic C. botulinum Nanaimo in broth model

‘Next generation’ RTE chilled meals

Microbial spore inactivation by HPT | Michelle Bull36 |

30 days, 8°C

Value Added food ProductsFor Asian Market

National Center For Food Safety and Technology

Commercialization of Novel and Nonthemal

Food Processing Technologies

2009, Martin Cole & Larry Keener

Award Nomination Summary

• A seven-year multimillion dollar collaborative effort between scientists and engineers from government, academia and industry

• FDA acceptance for the commercial use of pressure-assisted thermal sterilization (PATS) processes.

• First ever FDA filing for sterilization involving high pressure technology

• Represents a step change in preservation technology

• Allows products with equivalent or better quality to frozen foods to be distributed without the need for refrigeration.

0102030405060708090

100110120130

0 10 20 30 40 50 60 70 80 90 100 110 120 130

time

tem

p

Novel Sterilization Technology

Typical Retort Process

Pressure Assisted Thermal Sterilization (PATS)

(Alfredo Rodriguez, NCFST)

Panel Average, Standard Deviation

Viewing Result Summary Statistics: T09+18A

1 2 3 4 5 6 7 8 9

APPEARANCE Quality

ODOR Quality

FLAVOR Quality

TEXTURE Quality

OVERALL Quality

MRE mashed potato, time=0

HPP mashed potato, time=0

Natick Army Labs Sensory Work

The Proof of The Pudding…..

MATS Technology Development

• Research on Ready Meals for US Defence : 1997 -

• US Research consortium: 2001 - 2013

• Washington State University + Companies

• First commercial trials: 2012 -

• 8 meals per minute pilot R&D

• Commercialisation rollout: 2014 -

• 150 meals per minute full production

• On-going technology improvements 2014-2024

• International applications and regional development centres

• Rapid Microwave UHT and microwave pastuerisation

Microwave Assisted Thermal Sterilisation (MATS)

• A new enabling technology for making high quality processed foods

• Rapid heat treatment preserves food quality

• Can replace canned and frozen food

http://www.army.mil/article/87943/MATS_B_microwave_installed_at_AmeriQual_assists_CFD_at_Natick/

Retort v Microwave sterilised

MATS and PATS in Australia

• Goal • Industry ability to make ready meals with quality edge (before competitors)

• Targeted benefits• Increased value capture and returns

• Competitive exports

– Avoiding higher costs of cool/cold chain

– Flexible multi-product technology

– Regional enterprises making quality meals for higher end food markets

46

New ‘Fresherization’ process delivers fresh vegetables and eliminates food wasteAfter a decade of collaboration a global consortium of food scientists have finally cracked the age old problem of how to deliver fresh foods to the world without the need for freezing or chilling and with zero waste. The new process sterilizes food in an instant at no more than boiling water temperatures and preserves all the natural freshness and goodness of the food. Once processed in the pack, foods remain stable for years thereby eliminating waste and allowing them to be stored at room temperature until needed and distributed globally.

Chefs and culinary experts are especially excited by the quality and year round flexibility of the products and consumers just love the taste and convenience. World health officials have also praised the development as a way to meet global food security and nutritional needs in a more sustainable way.

An NPD Challenge?

Food preservation: finding the balance

Cool Plasma UltrasoundHigh Pressure Pulsed electric field

Assessing the feasibility of processing technologies to deliver quality benefits & safe, shelf-life extension to foods

47 | IFT 2015: High pressure thermal processing for shelf- & chill-stable, low-acid foods | Sandra Olivier

Value-add; safety / stability assured

C o n v e n t i o n a l I n n o v a t i v e

Need to control

/eliminate microbes

(Sandra Oliver, IFT 2015)

Re

se

ar

ch

Fo

cu

s A

re

as

Process EngineeringMake it work on a commercial scale

Commercial ImpactDemonstrate that the process adds value

Food Safety Assured!Gain regulatory approval & establish new guidelines Establish minimum processing conditions to meet FSO

Seek regulatory approval

Establish new processing guidelines/standards

Better quality than thermal processing

HPT synergistic inactivation of spores

Demonstrated reduction in thermal load

Robust equipment & economical processing

Process must be scalable

Suitable packaging material

48 | IFT 2015: High pressure thermal processing for shelf- & chill-stable, low-acid foods | Sandra Olivier

The path to commercialisation

(Sandra Oliver, IFT 2015)

Presentation title | Presenter name49 |

So Why Is This Important to Australia?

Over 2 billion emerging middle class to our north

Australia: the delicatessen of Asia

Our innovation track record is not good ....

10, 81 13, 66 11, 12Innovation Inputs, Innovation Output Efficiency

Australia NetherlandsNew Zealand

National Food and Nutrition Strategy

Presentation title | Presenter name | Page 53

R&D Priorities

•Future markets and competitiveness•Food, nutrition and health•Food safety – integrity & traceability•Resource efficiency – sustainability•Technology translation & adoption•Skills and training

Strategy 2020

Data Australia

National Facilities and Collections

Global

CSIRO Services

Agriculture Energy ManufacturingMineralResources

Land and Water

Oceans and Atmosphere

Health and Biosecurity

Food and Nutrition

CSIRO’s Business Units and focus areas

Enterprise Infrastructure

One-CSIRO support services

55 | Strategy 2020 | Presenter name

Customer First – a decisive shift from science creation as an objective, to value creation for customers from science and technology as our mission

Collaboration Hub – sourcing more capability from our partners, and integrating more students

Global outlook, national benefit –developing offshore businesses in key R&D markets

Breakthrough innovation - develop our entrepreneurial skills, foster new collaborations and provide new funding models and pathways for high potential, high tech ventures

What continues, and what is different?

What stays the same;

• Objective to deliver positive economic, environmental and social impact

• Mission directed R&D delivering projects with customers in industry, government and community

• Standards of science excellence and trusted advice

• Commitments to;

• Health, safety and environment

• inclusion, trust and respect

• Deliver on commitments

56 | Strategy 2020 | Presenter name

Media ‘Scientist”

Various sources, Google Images

Image of Raw Milk

Various sources, Google Images

Image of Irradiated Foods

Variuos sources, Google Images

Image of GM Foods

Various sources, Google Images

Genetically Modified Foods

http://www.gatesfoundation.org/agriculturaldevelopment/PublishingImages/bio-cassava-plus-hero.jpgVarious sources, Google Images

Wrap Up and Future Prospects

• Global Food Safety Challenges

• Paradigm shift in approach to outcome/risk based

• FSO’s allow for innovation and provide basis for equivalency

• New Food safety Technologies & Innovation

• Opportunities for Australia

• But lets bring the consumer with us

Food and Nutrition Flagship Prof Martin ColeDirector | Food and Nutrition Flagship

t +61 2 9490 8465E Martin.Cole@csiro.auw www.csiro.au

FOOD AND NUTRITION FLAGSHIP

Thank you

AcknowledgementsSteve McCutcheon, FSANZ Brian Keating, CSIROKari Gobius and team, CSIROChris DownsICMSF members