# Presentation: 042683

## A Pragmatic Approach  

- A Pragmatic Approach

- November 13th  2008

**Product Tracing Systems **
**for Fresh Produce **

## Trace Register

- Headquarters in Seattle
- Offices in China and Japan
- Founded in 2005
- Based on food industry operational experience
- System operational in 2006
- 190 customers
- 13 different countries,
- 5 different languages

- Web-based Traceability
- Low cost, flexible, secure
- Supports leading standards
- GlobalGAP, GS1, etc.
- Mandated by Aquaculture Certification Council
- Traceability for Best Aquaculture Practice certification

**Notes:**
Trace Register
Firstly, let me introduce you to Trace Register and then I will talk about how product tracing systems can be enhanced to help prevent and manage outbreaks of food borne illness. 
Trace Register provides a web based chain traceability system for food. We were founded in 2005 and our system became operational in 2006. We are headquartered in Seattle and have offices in China and Japan.     
Our system supports leading international standards including COOL, Bio Terrorism act, GlobalGAP, GS1 etc. and is being used by the Aquaculture Certification Council as the single required traceability solution for their Best Aquaculture Practice certification program.
We currently have 190 customers in 13 different countries using the system in 5 different languages.
Because of our hands on, operational experience we understand the practical realities of implementing tracing systems that meet real life needs.  

## A Pragmatic Solution

- Systems SHOULD NOT be:
- Complicated
- Difficult
- Expensive
- Systems SHOULD:
- Enhance what you do
- Work with what you have
- Be easy and cost effective

**Notes:**
Introduction
The benefits of effective tracing systems are clear.  Product tracing systems, or product traceability systems as I prefer to call them, are key to preventing and effectively managing outbreaks of food borne illness. Individual companies can use them to track key information about a product as it progresses through the supply chain. Third-party certifiers can use the systems to automatically review shipments, undertake trend analysis, assess risks and better target audit and verification activities. 
The key question is not IF but HOW these systems should be implemented to be truly effective. When asking “HOW?” the key word is PRAGMATIC.  We must balance the need for information and control with the need to run business efficiently and profitably? A PRAGMATIC solution will meet the needs of the FDA for information without being a major burden on industry.  

Based on our experience, we believe that traceability need not be:
Complicated and expensive to install
Difficult to integrate with existing  systems
Expensive and Labor intensive to run
On the contrary, it is our view that traceability can:
Complement what you already do
Work with your existing systems and processes
Be quickly and cost effectively implemented

## Three-legged stool  

- Process

- Traceability

- Verification

**Notes:**
Key Requirements
So let me turn to the key requirements as we see them. 
Firstly, traceability on its own is not the answer or the silver bullet to preventing and minimizing the impact of food borne illnesses. 
3 legs of a stool – process, verification and traceability
Traceability is just one leg of a 3 legged stool. The other two legs being rigorous standardized processes and effective verification.  If any leg is missing or weak the stool will collapse.        
Process needs to incorporate the highest standards of food quality and safety. 
Verification is a point-in-time confirmation that what we expect to happen did actually happen and that it happens to the required standard and quality. If this oversight is not present or is poorly conducted then once again the supply chain is compromised. 
The final leg is traceability. To be widely and successfully adopted traceability must include the following critical components:  

## Key Requirements

- Full Chain Traceability
- Automated and Central repository
- Complement NOT replace
- Scalable and Global
- Interoperate

**Notes:**
Full chain traceability is the objective
First, the objective should be to establish true “chain” traceability. A traceability system should aim to track product at every step of the way in the supply chain from source to shelf. If the chain is broken or a link is missing then the ability to trace back to the source of a problem and track forward to contain that problem is potentially lost.  There are some traceability solutions that rely on uniquely identifying a product at its point of production. These are great if all you want to do is go back to the point of origin of your product. However, they are often ineffective if you need to order the recall. Without chain traceability it will be very difficult to track a product forward through the supply chain. Also, if the problem occurs after harvest then you will have a challenge identifying the interim steps in the supply chain to isolate the source of contamination. 
Traceability must be automated and access a central repository
When there is a problem with a product speed and accuracy are essential. Quickly tracing back to the product source is critical to ensure the problem can be identified, isolated and contained with the minimum of harm. Harm to the consumer through eating contaminated product and harm to industry caused by the costs of uncertainty and delay. An automated, central repository can eliminate the delay and confusion caused by trying to pull together and assess documents from many different sources.  
Traceability systems should complement NOT replace what exists today
Companies have invested heavily in computers, software and training to make their operations efficient and productive. Many companies believe they already have very effective internal traceability systems. It is very important, therefore, that the providers of chain traceability systems minimize disruption to day-to-day business activities by complementing what is already in place. Some solutions only work if everyone in the supply chain conforms to a single, unique numbering scheme or product labeling approach. These systems can be a good approach but they can also be difficult and disruptive to implement because they often require expensive modifications to existing systems and business processes. Current technology makes this unnecessary. We, at Trace Register, are focused on using technology to achieve the same end result without the need to impose one standard approach throughout the end-to-end supply chain. 
Traceability must be scalable and global
The produce supply chain is a complex animal made up of thousands of different companies spread across the globe, ranging from the smallest owner farmer to the most sophisticated and technically advanced retailer. To be truly effective traceability systems must be able to work easily across this entire spectrum from the “one man band” with pencil and paper to the largest international mega corporation with sophisticated and powerful information technology systems. We must also recognize that our food supply is sourced from across the world so that systems must be designed to be easily usable outside the borders of the USA.    
 Traceability systems must be designed to easily work together (interoperate)
It is extremely unlikely that one traceability system will become either the de jure or de facto chain traceability standard across the entire food industry. It is also critical for food companies and major buyers that chain traceability systems work seamlessly with both internal traceability systems and external chain traceability systems.  Achieving this will make it possible to establish a network of traceability solutions that will deliver the holy grail of comprehensive, industry wide, automated traceability.  
I have just outlined the key requirements to gaining general acceptance and implementation of truly effective traceability systems.  In doing so I have focused on the “mechanisms to enhance product tracing systems for fresh produce” as defined in the purpose statement for this meeting.

## FDA

- Reactive
- Speed and Accuracy
- Proactive
- Predict and prevent

**Notes:**
FDA Information
Let me now turn my attention to the second part of the purpose statement, namely the need “to improve the FDA’s ability to use the information in such systems to identify the source of contamination associated with fresh produce-related outbreaks of food borne illness”.
Reactive use of Traceability Information
My first point is that if industry adopts chain traceability based on the principles I have outlined then the job of the FDA immediately becomes easier.  At the first hint of a problem the FDA will be able to work with the affected company to access information from their automated and comprehensive traceability repository. This will enable the company to quickly (in a matter of seconds) trace the product back to its source and then to work with the source company to track that product through the supply chain to determine the extent of distribution of potentially problematic product. 
In this scenario, the FDA and involved companies can immediately spend their valuable time and energy determining where and what caused the problem rather than burning time and effort hunting down the data required to trace and track the product in the first place. Product recall, if required, will be more targeted and specific due to the availability of accurate and timely information. The FDA will be able to rule out companies based on solid data rather than cast the net widely due to lack of information.  This will minimize the likelihood of the widespread, all encompassing recalls that have been so damaging to industry in the past. 
Proactive Use of Traceability Information
There is also the opportunity to proactively use traceability information. The FDA could take traceability information and feed it into risk management systems to help target inspections and testing. Enabling the FDA use its resources more efficiently by targeting and addressing problems early on. 
This could be further developed into an accredited FDA certification program with traceability at its core. Participation would be voluntary and the FDA would work with industry and third party certifiers to develop the program. The use of third party certifiers would augment FDA resources and would significantly extend the coverage and oversight of the FDA.  This approach is very similar to the pilot recently proposed by the FDA to address the safety and quality of imported of shrimp.
The objective of the program would be to ensure that participants are meeting product quality and safety expectations.  The program would include certification augmented by regular product sampling and testing by FDA approved labs. The test results would be electronically filed in the traceability database and available for review and inspection. 
Companies participating in the FDA preferred program will be able to establish a track record of quality and safety and could benefit from preferential treatment with the FDA and expedited entry for product imports. 

## End to End Supply Chain Visibility

**Notes:**
Summary
The implementation of product traceability systems along the lines described, we believe, has the potential to dramatically improve the ability of the fresh produce companies to prevent and manage outbreaks of food borne illness.  However, this will only happen if the systems used are fully automated and are widely adopted throughout the industry. Without this any improvements will be marginal at best and non-existent at worst. 
It is the responsibility of the companies that provide chain traceability systems to encourage this adoption by ensuring that their systems place a minimal burden on industry. To this end, chain traceability systems must work with the way companies do business today, complement not replace what is already in place, be easy to use and easy to operate, and support the needs of all companies in the supply chain no matter where located or how big or small. 
Thank you.

## Slide 8