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Determine the Right Food Use
Cases for Blockchain & Where
Standards Make the Difference
29 November 2018
Maria Palombini
Director, Opportunities and Initiative Development, GBSI
IEEE-Standards Association
The Romaine Lettuce
Outbreak Trilogy
The journey of STEC O157:H7 from coast to coast
in the US and into Canada without a trace
October 2017 - Present
Is Blockchain the Right Solution?
3
“Leafy Greens”
Outbreak 1
USA – via CDC
5 Nov 2017: Outbreak 1 begins with
1 infection
25 January 2018 – 25 known
infections across 15 states
+ CANADA – via Public Health
Agency of Canada (PHAC)
11 December 2017 – 21 infections
of similar strain in 3 provinces
------------------------------------------
---------------
25 January 2018 – outbreak
appears to be over.
**Canadian provinces not included in the image
Source: US CDC - https://www.cdc.gov/ecoli/2017/o157h7-12-
17/map.html
Outbreak 1: Nov 2017-
January 2018
Source: US CDC-
https://www.cdc.gov/ecoli/2017/o157h7-12-
17/index.html
“This outbreak appears to be over. The likely source of
the outbreak in the United States appears to be leafy
greens, but the investigation did not identify a specific
type of leafy greens as the source of the outbreak. Leafy
greens typically have a short shelf life, and since the last
illness started a month ago, it is likely that contaminated
leafy greens linked to this outbreak are no longer
available. Sometimes outbreaks end before enough
information is available to identify the likely source.”
Multistate Outbreak of Shiga toxin-producing Escherichia coli
O157:H7 Infections Linked to Leafy Greens (Final Update)
Posted January 25, 2018
https://www.cdc.gov/ecoli/2017/o157h7-12-17/index.html
Conclusions: Outbreak 1
“Romaine
Lettuce”
Outbreak 2
USA – via CDC
13 March 2018: Outbreak 2 begins with
1 infection
27 June– 210 known infections, 5
deaths, across 32 states
+ CANADA – via Public Health
Agency of Canada (PHAC)
22 June 2018 – 8 infections of similar
strain in 5 provinces. Declares epidemic
over
---------------------------------------------
28 June 2018 – outbreak appears to be
over.
**Canadian provinces not included in the image
Source: US CDC - https://www.cdc.gov/ecoli/2018/o157h7-04-
18/map.html
Outbreak 2: March 2018- June 2018
Sources: US CDC-https://www.cdc.gov/ecoli/2018/o157h7-04-18/index.html
Canada PHAC
https://www.canada.ca/en/public-health/services/public-health-notices/2018/public-health-
notice-outbreak-e-coli-infections-linked-romaine-lettuce.html
“The FDA and state and local regulatory officials traced the
romaine lettuce to many farms in the Yuma growing
region. According to the FDA, the last shipments of romaine
lettuce from the Yuma growing region were harvested on April
16, 2018, and the harvest season there has ended.
Contaminated lettuce that made people sick in this outbreak
should no longer be available”
Multistate Outbreak of E. coli O157:H7 Infections Linked to
Romaine Lettuce
(Final Update) - Posted June 28, 2018
https://www.cdc.gov/ecoli/2018/o157h7-04-18/index.html
Conclusions: Outbreak 2
“Romaine
Lettuce”
Outbreak 3
USA – via CDC
8 October 2018: Outbreak 3 begins
with 1 infection
26 November 2018– 43 known
infections, deaths unknown, across
12 states
+ CANADA – via Public Health
Agency of Canada (PHAC)
26 November 2018 – 22 infections
of similar strain in 3 provinces.
Investigation ongoing
------------------------------------------
26 November 2018 – Investigation
ongoing
**Canadian provinces not included in the image
Source: US CDC - https://www.cdc.gov/ecoli/2018/o157h7-11-
18/map.html
Outbreak 3: October 2018 - Present
Sources: US CDC - https://www.cdc.gov/ecoli/2018/o157h7-11-18/map.html
Canada PHAC
https://www.canada.ca/en/public-health/services/public-health-notices/2018/public-health-
notice-outbreak-e-coli-infections-linked-romaine-lettuce.html
“The FDA believes it was critically important to have a “clean break”
in the romaine supply available to consumers in the U.S. in order to
purge the market of potentially contaminated romaine lettuce
related to the current outbreak. This appears to have been
accomplished through the market withdrawal request of Nov. 20,
2018…Knowing the growing origin of produce will continue to
play an important role in allowing consumers to avoid
contaminated products and facilitating market withdrawals and
tracebacks….
Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce
E. coli O157:H7 outbreak investigation
Posted 26 November 2018
https://www.cdc.gov/ecoli/2018/o157h7-11-18/index.html
Conclusions Outbreak 3: Part 1
“Preliminary traceback information from the FDA indicates
that ill people in this outbreak ate romaine lettuce harvested
from the Central Coastal growing regions of northern and
central California. At this time, no common grower,
supplier, distributor, or brand of romaine lettuce has
been identified...The investigation is ongoing.”
CDC Food Safety Alert
Posted 26 November 2018
https://www.cdc.gov/ecoli/2018/o157h7-11-18/index.html
Conclusions Outbreak 3: Part 2
The FDA has urged growers, processors, distributors and retailers
to:
- clearly and prominently label all individually packaged romaine
products to identify growing region and harvest date for romaine;
and
- clearly and prominently label at the point of sale the growing
region when it is not possible for romaine lettuce suppliers to label
the package (e.g. individual unwrapped whole heads of romaine
lettuce available in retail stores).
Statement from FDA Commissioner Scott Gottlieb, M.D., on the current
romaine lettuce E. coli O157:H7 outbreak investigation
Posted 26 November 2018
https://www.cdc.gov/ecoli/2018/o157h7-11-18/index.html
Getting to the Core
Recurring Questionable Issues
 Outbreaks declared “to appear as over” although the tracing back of
original source of the infection was not unequivocally verified
 The STEC O157:H7 E.Coli strain was the same in all three outbreaks in
both the US and Canada despite the fact..
– Outbreak 2 was tied to water canal contamination to the Yuma
growers
– Outbreak 3 is currently traced back to central growers region in
California but the source of the strain is not yet identified
 CDC and FDA indicate that it is ok for consumers and restaurants can
consume romaine lettuce but the origin should not be from that region
12
Distributed data structure implementation for a decentralized transparent ledger
Block N
•Transaction 1
•Transaction 2
•Transaction 3
Block O
•Transaction N+1
•Transaction N+2
•Transaction N+3
Block P
•Transaction N+O+1
•Transaction N+O+2
•Transaction N+O+3
Determine the Use Cases and Common
Denominators in the Food Value Chain
©2018 IEEE-SA official presentation by Maria Palombini. 13
suppliers
SOURCE PROCESSING DISTRIBUTOR RETAIL CONSUMER
Learning from
Research in Other
Sectors
Blockchain for Pharma Supply Chain
©2018 IEEE-SA official presentation by Maria Palombini. 14
The State of Blockchain Adoption on
the Pharmaceutical Supply Chain
Published 1 November 2017 by IEEE-SA
 35 Observed References Commonality and
Variance among Manufacturers, Wholesalers,
and Pharmacies
 Six (6) Key Findings
IEEE-SA, The State of Blockchain Adoption on the Pharmaceutical Supply Chain Study
Visit http://bit.ly/Blckchn10 for details.
IEEE-SA, The State of Blockchain Adoption on the Pharmaceutical Supply Chain Study
Visit http://bit.ly/Blckchn10 for details.
IEEE-SA, The State of Blockchain Adoption on the Pharmaceutical Supply Chain Study
Visit http://bit.ly/Blckchn10 for details.
Common Barriers Cited Amongst All Three Groups
 Trust in an autonomous system
 User buy-in/acceptance
 Integration with existing IT networks
 Compliance with regulatory policy
 Technology Cost
 Data ownership
 Visibility throughout the chain
 Governance
 Who will pay for it?
CREDIBILITY&
INTEROPERABILITY
Changeinbusiness
models&thinking
Tech Standards
Industry Guidance
Blockchain for Supply Chain
Management
19
BENEFITS
• Reduce or eliminate fraud or
errors
• Improve inventory management
• Minimize shipping costs
• Reduce delays in paper
documentation
• Reduce waste
• Identify problems or issues faster
CHALLENGES
• Digitizing the records across the
entire supply chain
• Transparency for many parties
with accessibility
• Authenticated autonomous
network
• Integration into existing
Networks
• Buy-in across multiple partners
• Data ownership
• Moving from chain to chain
• Choosing the right platform
Moving from POC to Pilot to the Next
Step…the Buy-In
Benefits of Standards
 Interoperability with existing technology systems
 Reducing the cost of integration by removing the need for customization
 Establish credibility (through consensus-built standards)
 Enable industry-wide adoption
 Drives competition through the creation of open-platform standards
(platform agnostic)
 Offers the ability to harmonize policy specifically around the use of
technologies (where possible)
 Provide support towards change in existing regulatory policy
©2018 IEEE-SA official presentation by Maria Palombini. 21
Blockchain Activities
 IEEE P2418™ Suite of Blockchain Standards Working Group
 P2418.1™ - Standard for the Framework of Blockchain Use in Internet of
Things (IoT)
 P2418.2™ - Standard Data Format for Blockchain Systems
 P2418.3™ Standard for the Framework of Distributed Ledger Technology
(DLT) Use in Agriculture Supply Chain
 IEEE P2418.4™ - Standard for the Framework of Distributed Ledger
Technology (DLT) Use in Connected and Autonomous Vehicles (CAVs)
 P2418.5 – Blockchain & Transactive Energy
 P2418.6 – Blockchain & Healthcare
 P2418.7 – Blockchain & Supply Chain Finance
 P2418.x – Smart Contracts for Track & Trace of Automotive Raw Materials in
a Circular Economy
 Pre-Standards Activities (Industry Connections Programs)
– (IC17-012) Supply Chain/Trials Technology Implementation
– (IC17-017-011-1) Connectivity Harmonization of the Digital Citizen
 IEEE Blockchain Initiative
http://blockchain.ieee.org
©2018 IEEE-SA official presentation by Maria Palombini. 22
(IC17-012) Supply Chain/Clinical Trials
Standardized Technology & Implementation
 Exploring the use of blockchain and/or in combination with
emerging technologies to optimize business operations that lead
to a more inclusive and secure outcome for end-user consumption
of food and medicine.
 Areas of Work
– Clinical Trials /Supply Chain
– Medical Devices Supply Chain
– Techno Legal Standards for Smart Contracts for Supply Chain
– Pharmaceutical Drug Supply Chain
– Agri-Business
See the full ICAID at http://bit.ly/SC-CTIC
Industry Connections Program
Interested in Participating
- Pre-Standards activities are open and inclusive (no
membership or financial commitment)
- Collaborate with like-minded individuals to develop
consensus on addressing pressing challenges
- Underwriting opportunities for global programs are available
https://blockchain-ieee.slack.com
Contact:
MARIA PALOMBINI
Director, Initiative & Community Development, IEEE-SA
m.palombini@ieee.org
@IEEESA
http://blockchain.ieee.org
http://standards.ieee.org
Blockchain Community
https://ieee-collabratec.ieee.org/app/community/102

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The Romaine Lettuce Outbreak Trilogy, Blockchain and Standards

  • 1. Determine the Right Food Use Cases for Blockchain & Where Standards Make the Difference 29 November 2018 Maria Palombini Director, Opportunities and Initiative Development, GBSI IEEE-Standards Association
  • 2. The Romaine Lettuce Outbreak Trilogy The journey of STEC O157:H7 from coast to coast in the US and into Canada without a trace October 2017 - Present Is Blockchain the Right Solution?
  • 3. 3
  • 4. “Leafy Greens” Outbreak 1 USA – via CDC 5 Nov 2017: Outbreak 1 begins with 1 infection 25 January 2018 – 25 known infections across 15 states + CANADA – via Public Health Agency of Canada (PHAC) 11 December 2017 – 21 infections of similar strain in 3 provinces ------------------------------------------ --------------- 25 January 2018 – outbreak appears to be over. **Canadian provinces not included in the image Source: US CDC - https://www.cdc.gov/ecoli/2017/o157h7-12- 17/map.html Outbreak 1: Nov 2017- January 2018 Source: US CDC- https://www.cdc.gov/ecoli/2017/o157h7-12- 17/index.html
  • 5. “This outbreak appears to be over. The likely source of the outbreak in the United States appears to be leafy greens, but the investigation did not identify a specific type of leafy greens as the source of the outbreak. Leafy greens typically have a short shelf life, and since the last illness started a month ago, it is likely that contaminated leafy greens linked to this outbreak are no longer available. Sometimes outbreaks end before enough information is available to identify the likely source.” Multistate Outbreak of Shiga toxin-producing Escherichia coli O157:H7 Infections Linked to Leafy Greens (Final Update) Posted January 25, 2018 https://www.cdc.gov/ecoli/2017/o157h7-12-17/index.html Conclusions: Outbreak 1
  • 6. “Romaine Lettuce” Outbreak 2 USA – via CDC 13 March 2018: Outbreak 2 begins with 1 infection 27 June– 210 known infections, 5 deaths, across 32 states + CANADA – via Public Health Agency of Canada (PHAC) 22 June 2018 – 8 infections of similar strain in 5 provinces. Declares epidemic over --------------------------------------------- 28 June 2018 – outbreak appears to be over. **Canadian provinces not included in the image Source: US CDC - https://www.cdc.gov/ecoli/2018/o157h7-04- 18/map.html Outbreak 2: March 2018- June 2018 Sources: US CDC-https://www.cdc.gov/ecoli/2018/o157h7-04-18/index.html Canada PHAC https://www.canada.ca/en/public-health/services/public-health-notices/2018/public-health- notice-outbreak-e-coli-infections-linked-romaine-lettuce.html
  • 7. “The FDA and state and local regulatory officials traced the romaine lettuce to many farms in the Yuma growing region. According to the FDA, the last shipments of romaine lettuce from the Yuma growing region were harvested on April 16, 2018, and the harvest season there has ended. Contaminated lettuce that made people sick in this outbreak should no longer be available” Multistate Outbreak of E. coli O157:H7 Infections Linked to Romaine Lettuce (Final Update) - Posted June 28, 2018 https://www.cdc.gov/ecoli/2018/o157h7-04-18/index.html Conclusions: Outbreak 2
  • 8. “Romaine Lettuce” Outbreak 3 USA – via CDC 8 October 2018: Outbreak 3 begins with 1 infection 26 November 2018– 43 known infections, deaths unknown, across 12 states + CANADA – via Public Health Agency of Canada (PHAC) 26 November 2018 – 22 infections of similar strain in 3 provinces. Investigation ongoing ------------------------------------------ 26 November 2018 – Investigation ongoing **Canadian provinces not included in the image Source: US CDC - https://www.cdc.gov/ecoli/2018/o157h7-11- 18/map.html Outbreak 3: October 2018 - Present Sources: US CDC - https://www.cdc.gov/ecoli/2018/o157h7-11-18/map.html Canada PHAC https://www.canada.ca/en/public-health/services/public-health-notices/2018/public-health- notice-outbreak-e-coli-infections-linked-romaine-lettuce.html
  • 9. “The FDA believes it was critically important to have a “clean break” in the romaine supply available to consumers in the U.S. in order to purge the market of potentially contaminated romaine lettuce related to the current outbreak. This appears to have been accomplished through the market withdrawal request of Nov. 20, 2018…Knowing the growing origin of produce will continue to play an important role in allowing consumers to avoid contaminated products and facilitating market withdrawals and tracebacks…. Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation Posted 26 November 2018 https://www.cdc.gov/ecoli/2018/o157h7-11-18/index.html Conclusions Outbreak 3: Part 1
  • 10. “Preliminary traceback information from the FDA indicates that ill people in this outbreak ate romaine lettuce harvested from the Central Coastal growing regions of northern and central California. At this time, no common grower, supplier, distributor, or brand of romaine lettuce has been identified...The investigation is ongoing.” CDC Food Safety Alert Posted 26 November 2018 https://www.cdc.gov/ecoli/2018/o157h7-11-18/index.html Conclusions Outbreak 3: Part 2
  • 11. The FDA has urged growers, processors, distributors and retailers to: - clearly and prominently label all individually packaged romaine products to identify growing region and harvest date for romaine; and - clearly and prominently label at the point of sale the growing region when it is not possible for romaine lettuce suppliers to label the package (e.g. individual unwrapped whole heads of romaine lettuce available in retail stores). Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation Posted 26 November 2018 https://www.cdc.gov/ecoli/2018/o157h7-11-18/index.html Getting to the Core
  • 12. Recurring Questionable Issues  Outbreaks declared “to appear as over” although the tracing back of original source of the infection was not unequivocally verified  The STEC O157:H7 E.Coli strain was the same in all three outbreaks in both the US and Canada despite the fact.. – Outbreak 2 was tied to water canal contamination to the Yuma growers – Outbreak 3 is currently traced back to central growers region in California but the source of the strain is not yet identified  CDC and FDA indicate that it is ok for consumers and restaurants can consume romaine lettuce but the origin should not be from that region 12
  • 13. Distributed data structure implementation for a decentralized transparent ledger Block N •Transaction 1 •Transaction 2 •Transaction 3 Block O •Transaction N+1 •Transaction N+2 •Transaction N+3 Block P •Transaction N+O+1 •Transaction N+O+2 •Transaction N+O+3 Determine the Use Cases and Common Denominators in the Food Value Chain ©2018 IEEE-SA official presentation by Maria Palombini. 13 suppliers SOURCE PROCESSING DISTRIBUTOR RETAIL CONSUMER
  • 14. Learning from Research in Other Sectors Blockchain for Pharma Supply Chain ©2018 IEEE-SA official presentation by Maria Palombini. 14
  • 15. The State of Blockchain Adoption on the Pharmaceutical Supply Chain Published 1 November 2017 by IEEE-SA  35 Observed References Commonality and Variance among Manufacturers, Wholesalers, and Pharmacies  Six (6) Key Findings
  • 16. IEEE-SA, The State of Blockchain Adoption on the Pharmaceutical Supply Chain Study Visit http://bit.ly/Blckchn10 for details.
  • 17. IEEE-SA, The State of Blockchain Adoption on the Pharmaceutical Supply Chain Study Visit http://bit.ly/Blckchn10 for details.
  • 18. IEEE-SA, The State of Blockchain Adoption on the Pharmaceutical Supply Chain Study Visit http://bit.ly/Blckchn10 for details. Common Barriers Cited Amongst All Three Groups  Trust in an autonomous system  User buy-in/acceptance  Integration with existing IT networks  Compliance with regulatory policy  Technology Cost  Data ownership  Visibility throughout the chain  Governance  Who will pay for it? CREDIBILITY& INTEROPERABILITY Changeinbusiness models&thinking Tech Standards Industry Guidance
  • 19. Blockchain for Supply Chain Management 19 BENEFITS • Reduce or eliminate fraud or errors • Improve inventory management • Minimize shipping costs • Reduce delays in paper documentation • Reduce waste • Identify problems or issues faster CHALLENGES • Digitizing the records across the entire supply chain • Transparency for many parties with accessibility • Authenticated autonomous network • Integration into existing Networks • Buy-in across multiple partners • Data ownership • Moving from chain to chain • Choosing the right platform
  • 20. Moving from POC to Pilot to the Next Step…the Buy-In
  • 21. Benefits of Standards  Interoperability with existing technology systems  Reducing the cost of integration by removing the need for customization  Establish credibility (through consensus-built standards)  Enable industry-wide adoption  Drives competition through the creation of open-platform standards (platform agnostic)  Offers the ability to harmonize policy specifically around the use of technologies (where possible)  Provide support towards change in existing regulatory policy ©2018 IEEE-SA official presentation by Maria Palombini. 21
  • 22. Blockchain Activities  IEEE P2418™ Suite of Blockchain Standards Working Group  P2418.1™ - Standard for the Framework of Blockchain Use in Internet of Things (IoT)  P2418.2™ - Standard Data Format for Blockchain Systems  P2418.3™ Standard for the Framework of Distributed Ledger Technology (DLT) Use in Agriculture Supply Chain  IEEE P2418.4™ - Standard for the Framework of Distributed Ledger Technology (DLT) Use in Connected and Autonomous Vehicles (CAVs)  P2418.5 – Blockchain & Transactive Energy  P2418.6 – Blockchain & Healthcare  P2418.7 – Blockchain & Supply Chain Finance  P2418.x – Smart Contracts for Track & Trace of Automotive Raw Materials in a Circular Economy  Pre-Standards Activities (Industry Connections Programs) – (IC17-012) Supply Chain/Trials Technology Implementation – (IC17-017-011-1) Connectivity Harmonization of the Digital Citizen  IEEE Blockchain Initiative http://blockchain.ieee.org ©2018 IEEE-SA official presentation by Maria Palombini. 22
  • 23. (IC17-012) Supply Chain/Clinical Trials Standardized Technology & Implementation  Exploring the use of blockchain and/or in combination with emerging technologies to optimize business operations that lead to a more inclusive and secure outcome for end-user consumption of food and medicine.  Areas of Work – Clinical Trials /Supply Chain – Medical Devices Supply Chain – Techno Legal Standards for Smart Contracts for Supply Chain – Pharmaceutical Drug Supply Chain – Agri-Business See the full ICAID at http://bit.ly/SC-CTIC Industry Connections Program
  • 24. Interested in Participating - Pre-Standards activities are open and inclusive (no membership or financial commitment) - Collaborate with like-minded individuals to develop consensus on addressing pressing challenges - Underwriting opportunities for global programs are available https://blockchain-ieee.slack.com Contact: MARIA PALOMBINI Director, Initiative & Community Development, IEEE-SA m.palombini@ieee.org @IEEESA http://blockchain.ieee.org http://standards.ieee.org Blockchain Community https://ieee-collabratec.ieee.org/app/community/102

Editor's Notes

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