Produce traceback - Is PTI good enough for reformers?

Doug Powell of the Food Safety Network finds this gem from the Center for Infectious Disease Research and Policy in Minnesota. This well written piece by Maryn McKenna explores what's ahead for the new Administration, beyond the not insignificant task of fixing the economy.

But simmering in the background is a substantial grassroots movement that is pressing the new administration to enact change within the government as well, at the U.S. Food and Drug Administration (FDA). And a key part of any reform may involve correcting the deficiencies in what is now a complex and fragmented system for tracing contaminated produce items to their source.


TK: the story goes on to examine the Salmonella Saintpaul outbreak, the "one step up and one step back" already in place and the Produce Traceability Initiative. Here is what the report said about PTI:

The initiative, which is voluntary and would roll out between 2009 and 2012, gives reformers some of what they seek: It establishes a universal code that follows produce wherever it goes in the system. But it labels produce only by case, not by individual item. And it does not establish a single database than can be queried in a single step in seconds. The produce industry resisted appeals for that, fearing it would place too great a financial burden on smaller producers. The industry chose instead to have the information on each step of a case's progress reside in the computers of the various businesses it moved through.

That may not be enough to bring produce traceability and food safety in line with a reform agenda. Several recent analyses of what needs to change at FDA insist that guaranteed rapid access to provenance information is the key piece needed to make trace-back work. In September, the GAO recommended that FDA be allowed to access information more directly in emergencies, both to identify suspect foods and to ascertain whether other foods processed in the same facility also pose a threat.

And last May, the Food Safety Research Consortium, a group of researchers from seven institutions who are funded by the Robert Wood Johnson Foundation, called for a fully accessible "network of networks" across the food safety system. "There is no effective system for ensuring rapid government access to critical trace-back information," Michael Taylor, a research professor of health policy at George Washington University and the project's leader, testified in July.

TK: The story concludes with the thought that food safety reform may have to wait in line behind a host of economic issues that Obama must address. But that won't diminish the need, experts say, for a sleeker food safety system that can deal with multi-state foodborne illness outbreaks.

FDA meeting Traceability transcript - Oct. 16

Here is a link to a transcript of the Oct. 16 traceability hearing. The document is 148 pages long.....

You will find this document quite illuminating...

Here is one official with FDA talking about challenges in sharing information with industry:


One of the things that we’ve encountered in almost all of the traceback is being able to share information with industry and how do we legally go about doing that. And I think that was talked about at the 50 state meeting. And I think it’s an issue that we’ll be addressing and hopefully make some new ground, although it may take some time.

Traceregister - FDA hearing

"It's not my fault and I can prove it"

Thoughtful testimony at the Nov. 13 traceability hearing in Oakland from Richard Ross of Tracegains Inc.....



FDA Product Tracing Systems for Fresh Produce
Oakland, California
November 13, 2008

Let me introduce myself. I’m Richard Ross and I’ve been in the agricultural commodity business for thirty years and managed 14 food businesses while with Archer Daniels Midland and ConAgra. I’ve been through recalls and I know your pain.

I have listened to FDA inspectors after each of these high-profile food recalls, and what they hear from grower-packer-shippers is “it’s not my fault.” Wouldn’t these same FDA inspectors like to hear “it’s not my fault and I can prove it!”? The grower-packer-shipper community has within their grasp the ability to make this type of “get out of jail free” comment. Given today’s technology, this goal isn’t out of reach, and I’ll get to that in a moment.

I brought this spinach from my hotel kitchen. I asked the person responsible for receiving shipments into the kitchen what box it came from and who delivered it. The response was, “I don’t know”. I asked, how many deliveries of vegetables the hotel got a week and he said every day, but he didn’t know which day this spinach was delivered. With multiple deliveries, unmarked boxes, comingling and the anonymity of the grower-packer-shipper, we have in place a dangerous, slippery slope. One way to get more traction is to really enforce the Bioterrorism Act. Really enforce the requirement that each member of the supply chain be able to know with certainty from where they received a specific product. The ability to truly understand this information is available today using the services of private companies such as mine, TraceGains.

How is that achieved you ask? Our solution is unique in three distinct ways:
1. You know that traceability is more than slapping a label on a box. You can track and trace rework, repack and reboxing. These are the main difficulties of the investigation of the tomatoes and peppers this summer costing an estimated $150,000,000 or more to the Florida growers.
2. Second our software has the ability to make traceability not only pay for itself, but add profits to the grower-packer-shipper. Traceability must be a profit center, not a cost.
3. And most importantly, you could have answers in seconds. As you have discovered, produce is not a supply chain, it is a supply network. The interoperability of TraceGains would allow you to traceback quickly, letting you save time, money and potentially lives.

Speedy, complete traceback, making more money and allowing companies that have full traceability systems to stay in commerce, that’s the best answer I’ve heard.

“It’s not my fault and I can prove it!”
Would you be interested in accomplishing your work doing something like this?

Richard Ross
Director of Industry Relations
Tracegains Inc.

Tracetracker - FDA traceability hearing

Infratab - FDA traceability hearing

G. Michael McCartney of Naturipe Farms - Electronic Produce Passport

More testimony from the FDA's traceability hearing of Nov. 13, this from
G. Michael McCartney of Naturipe Farms.


Public Meetings about Product Tracing Systems for Fresh Produce
Docket No. FDA-2008-N-0513
November 13, 2008
9:00 a.m. - 5:00 p.m.
Ronald V. Dellums Federal Building
Edward Roybal Auditorium
1301 Clay St.
Oakland, CA 94612

G. Michael McCartney
Vice President of Operations
Local:
Naturipe Farms
2365 Bridgeway
Sausalito, CA 94966
(239) 552-4470

Corporate:
999 Vanderbilt Beach Rd., Suite 102
Naples, FL 34108

Outline of Oral Presentation

Company Profile:

Naturipe Farms is one of the largest privately held berry companies in the world, providing nutritious blueberries, black and red raspberries, and strawberries all year. We have farms in over 60 different growing regions in the United States, and in Canada, Chile, Argentina, Uruguay, Costa Rica, Guatemala and Mexico. We supply the highest quality fruit to nearly every major market in the world, including Europe and Asia. See;
http://www.naturipefarmstrade.com/monthly_maps/growing_regions.aspx

Presenter: Mr. G. Michael McCartney, Vice President Operations, in charge of global food safety and global operations

Headquarters; Naples, Florida

Outline: The Produce Passport -The Need for Electronic Records of Important Trace Back Documents

Food Safety needs to include Good Agricultural Practices, HACCP plans, and industry specific best practices.

• These best practices need to follow commodity specific practices, at a minimum 2 classes one for vegetables and one for fruit.
• In each class the leading trade associations need to participate through a voluntary advisory panel made up of the industry food safety experts who can guide the development of trace back approaches

The Produce Traceability Initiative represents a unified global system that will allow product to be tracked throughout the distribution chain

• It is supported by nearly every major retailer, wholesaler, food service and grower shipper in the United States
• It is based on using the GS1 bar code standard for identifying pallets, SSCC and cases, GTIN.
• It includes a timetable and milestones that will enable trace back to occur on all inbound and outbound cases not later than 2012

At Naturipe Farms we support this initiative and strongly encourage the FDA and related Federal agencies to extend a similar GS1 approach to item level tracking of packaged produce.

• This would include clamshells and all bagged products whether they are fruit or vegetable.

In addition, we believe that when it comes to the public health and safety, the timeliness and accuracy of information are the two key elements in gaining and maintaining the public’s trust and confidence in the nutritious foods we provide.

• The key area of concern in establishing food assurance is being able to electronically submit the critical documents on any commodity as it moves through the supply chain form field to fork
• From a farming perspective that would include a standardized risk assessment and a record confirming the condition and the handling of the product as it moves throughout the cold chain to the point of sale.
• At each point the data collected would be captured and recorded in an electronic produce passport that would follow the product throughout the supply chain.
• At each point of custody the receiver would validate the information received from the sender until the product reached the end point of its journey.

The Electronic Produce Passport would enable all participants to immediately trace forward and trace back any product.

• This would greatly assist the FDA and all parties to discover the root cause of the issue and to identify quickly whether any case is an isolated incident or a public health issue.
• The Advisory Panels could guide the adoption and make commodity specific recommendations.

FDA Testimony - Northrop Grumman

PMA presenttion at FDA hearing - traceability

Center for Science in the Public Interest presentation - FDA public meeting on traceability Oct. 16

More FDA perspective - FDA traceability meeting - Oct. 16

David Acheson presentation - FDA public meeting Oct. 16 public meeting

Traceproduce presentation - FDA public meeting Oct. 16

Natural Light Labeling - FDA Public Meeting on Traceability - Oct. 16

Product Tracing Systems for Fresh Produce - PMA presentation - Oct. 15

FDA Perspective - Produce Challenges - Oct. 16 public meeting

John McClung - FDA public meeting Oct. 16

Comments from John McClung, president of the Texas Produce Association, at the Oct. 16 FDA meeting on traceability. Some excerpts:

--First, our shared objective is to drive all possible threat to consumers from pathogens out of the fresh fruit and vegetable supply. For industry, this is both a moral and an economic necessity.

--But, we must recognize that with fresh product, not all risk can be eliminated given today’s technology. Therefore, accurate and efficient traceback becomes imperative when there is an outbreak. This is particularly true—and more problematic—in the face of the rapid globalization of the produce industry.

--Before we can benefit from traceback technology and commitment, we must have prompt, credible epidemiological analyses. We have to know what food is making people sick before we can ferret out the origin. Not only is there a real assault on public wellbeing and confidence absent that information, but as we have repeatedly seen there is grievous economic damage throughout the industry. I have no illusions this is a simple task, but whether in FDA’s or CDC’s hands, we have to do better with this fundamental piece of the puzzle.

--Finally, we must assign the same safety standards to imported produce—and to the marketing chain for imports—that we do to domestic produce. Easy to say, not at all easy to do.

Later....

In the U.S., and in Mexico, there are grower/shippers who adhere to the highest standards, and fortunately, those suppliers represent the lion’s share of product. As a practical matter, they are the larger, more sophisticated and better financed operations. However, for the foreseeable future we will be sourcing at least some commodities from hundreds upon hundreds of smaller, less science-driven, and less conscientious suppliers. These suppliers represent the greatest challenge to this agency, and to the industry.

As we saw in the recent jalapeno episode, small farmers slowly feeding relatively tiny volumes of tainted product into the marketing chain over an extended time period, have the ability to bring the industry and the FDA to its knees. There are no easy fixes. This produce works its way to consumers through a complex distribution web, involving farmers, field workers, truckers, importers, packing sheds, repackers, customs brokers, other brokers, wholesalers, central warehouses, retailers, food service operators, restaurants, consumers, and others.

So where do we go from here? The only effective way I can envision to minimize risk is to mandate GAP’s and/or similar blueprints for merging good science with good farming and handling practices, and then establishing statistically valid oversight of that system, both domestically and in nations that supply the U.S. But doing so, even if we can get beyond the practical problems, will result in a disproportionate burden on small business, and therefore carries its own social, economic and political downside. And even if we succeed, it won’t be 100 percent successful.

Clearly, traceback is the fallback when good practices fail. It is essential there be a paper trail on all commodities to assure traceback. That paper trail must originate with the farms. Produce comingling is possible, but only when comingled product is properly credentialed.

Even given suitable paperwork, FDA must provide expanded oversight, and that includes additional and more rapid lab results at key ports of entry.

The agency must be prepared to work closely with importers, shippers, customs brokers and others to make certain requirements are clearly understood, to spot check product, and to quickly determine the source during outbreaks. I respect the reluctance of many in the agency to get “too close” to the regulated industry, and I am mindful of the criticism that inevitably comes from Congress, the media and advocacy groups when a perceived unholy alliance is exposed, real or unreal. And I am aware of the agency’s concerns about complying with the federal laws on advisory committees. But it is in the best interests of consumers, government and industry that we find a way to share pertinent information to minimize the scope and result of outbreaks, and I do not accept that it cannot be done.

To minimize the disproportionate economic bruising to small businesses from increased regulations and oversight, the FDA should be prepared to engage in extensive efforts to educate this universe, to explain the need for paper trails and other demands, and to encourage cooperation both in the U.S. and abroad.

As we all know, the Congress is poised to help us all secure food safety as soon after January as possible, and in fact, Congressional zeal may well overwhelm the risk as lawmaking progresses. Whatever the Congress concludes, it must include significant additional support and funding for the FDA, if there is to be any realistic expectation the agency can meet the demands made of it.

For its part, industry must police the paper trail to make certain every participant records the proper data. To do this, we must make quite rigid demands on producers to assure approved GAP’s are followed, and paperwork is accurate and complete.

Additionally, industry must try to eliminate the risky temptation to purchase on the spot market and to make purchases to cover shorts unless the product is accompanied by proper paperwork.

And finally, government and industry should work toward a “crisis management” protocol to minimize the consequences of any future outbreaks.

Lesson Learned - White Paper from TraceGains - Oct. 16 FDA Meeting

From the Oct. 16 FDA public meeting about traceability, a white paper from TraceGains titled Lessons Learned. An excerpt:

The estimated cost to the U.S. bagged spinach industry for failing to quickly pinpoint the source of E. coli contamination during the fall of 2006 was at least $150 million. That figure didn’t include all costs to counter the extreme adverse publicity regarding California spinach specifically and the U.S. fresh bagged salad industry in general. And it didn’t count the cost of defending against the inevitable class action lawsuits. Would traceability have prevented the outbreak? Probably not. What's certain is that a solid traceability system would have dramatically shortened the investigation and solution cycle for this latest food safety debacle.

Later.....


A good traceability system will be flexible enough to allow for collection of new and/or changing data types. It must be expandable and capable of integrating with other systems, including accounting, back office and enterprise resource planning (ERP) systems. And it must be able to accommodate new hardware technologies such as RFID, Bluetooth, Zigbee and so forth. The last thing any company should be doing today is getting bogged down in an argument over which auto-identification technology is the best. Each auto-ID technology (barcode, passive RFID, active RFID) has its own strengths and weaknesses and should be evaluated on the basis of cost-effectiveness. What you want to encourage is selecting technology in a way that makes sense. You should avoid at all costs the “all or nothing”
game, in which you choose either full RFID implementation or do nothing. Sometimes it makes sense to roll out a complete system with RFID, but in other instances it makes sense to use existing technology within the facility, such as barcodes, and expand in the future.

Given the spinach debacle, the time for evaluating and implementing traceability systems is upon us – the “waiting and hoping” costs are only rising. We liken the spinach incident to a
high-stakes game of musical chairs—the music stopped, and that time it was the spinach industry's turn to be left standing as the loser. The music has started once again. Who will be left without a chair when it stops again?

Product Tracing Systems for Fresh Produce - Public Meeting Agenda from Oct. 16

8:30 – 9:00	Registration
9:00 – 9:10	Welcome/Opening Remarks/Overview Stephen Sundlof, D.V.M., PhD., Director, Center for Food Safety and Applied Nutrition (CFSAN), FDA
9:10 – 9:20	FDA Product Tracing David Acheson, M.D., F.R.C.P., Associate Commissioner for Foods, FDA
9:20 – 9:55	FDA Product Tracing Challenges and Successes Ellen Morrison, Director, Office of Crisis Management, FDA Sherri McGarry, Center Emergency Coordinator, OFDCER, CFSAN, FDA
9:55 - 10:10	State Perspective Joanne M. Brown, DVM, MS, DACVPM, Deputy Commissioner, Florida Department of Agriculture and Consumer Services
10:10 – 10:25	Questions from FDA Panel and the Public
10:25 – 10:40	Break
10:40 - 11:00	Specific Industry Initiatives Kathy Means, Produce Marketing Association
11:00 – 11:15	Industry Perspective from Farm to Fork; Grower/Packers and Processor/Shipper/Repacker Robert Guenther, Senior Vice President for Public Policy, United Fresh Produce Association
11:15 – 11:30	Industry Perspective from Farm to Fork; Retail/Foodservice Jeffrey Barach, PhD, Vice President Science Policy, Grocery Manufacturers Association
11:30 – 11:45	Questions from FDA Panel and the Public
11:45 – Noon	Public Comment Stacey Satterlee, Western Growers, Washington, DC Charlotte Walker, Infratab, Inc., Oxnard, CA
Noon – 1:15	Lunch
1:15 – 1:35	International Standards Dr. Wolf Maier, Counselor- Food Safety, Health and Consumer Affairs, Delegation of the European Commission
1:35 – 1:50	Challenges to Tracing Commingled Fresh Produce Reginald Brown, Florida Tomato Exchange
1:50 – 2:05	Consumer Perspective David Plunkett J.D., J.M. Senior Staff Attorney, Food Safety Program, Center for Science in the Public Interest
2:05 – 2:20	Small Business perspective John McClung, President, Texas Produce Association
2:20 - 2:34	Questions from FDA Panel and the Public
2:35 – 2:50	Break
2:50	Public Comment
4:30	Wrap-up/Adjourn Stephen Sundlof, D.V.M., PhD., Director, CFSAN, FDA

---

Moderator:

Stephen Sundlof, D.V.M., PhD., Director, CFSAN, FDA

FDA Panel:

David Acheson, M.D., F.R.C.P., Associate Commissioner for Foods, FDA
Samir Assar, Ph.D., Science Policy Analyst, Office of Food Safety, CFSAN, FDA
Sherri, McGarry, Center Emergency Coordinator, OFDCER, CFSAN, FDA
Ellen Morrison, Director, Office of Crisis Management, FDA
Jeffrey Shuren, M.D., J.D., Associate Commissioner for Policy and Planning, FDA
Steven Solomon, D.V.M., M.P.H., Deputy Associate Commissioner for Compliance Policy, FDA

List of Persons Providing Public Comment:

Stacey Satterlee, Western Growers, Washington, DC
Charlotte Walker, Infratab, Inc., Oxnard, CA
William Pape, TraceGaines, Inc., Longmont, CO
Greg Drouillard and Henry Affeldt, Sunkist Growers, Inc., Peachtree City, GA
Russell Laird, Agricultural and Food Transporters Conference, American Trucking Association, Arlington, VA
John Granich, Del Rey Systems and Technology, Inc., San Diego, CA
Patty Lovera, Food and Water Watch, Washington, DC
Bryant Ambelang, Desert Glory, San Antonio, TX
Joseph Farmer, TraceProduce.com, Nyssa, OR

Desert Glory - voluntary certification system for traceability

Passed along by Sebastian Cianci of FDA, one presentation from the FDA's traceability public meeting on Oct. 16:

Desert Glory

Production Standards and Traceability

Components of a Food Safety Certification System

October 16, 2008

Desert Glory believes that the fresh produce industry needs a system that protects public health and promotes commerce which goes beyond traceability. That is why we are proposing a voluntary pre-certification system for the industry modeled after the successful U.S. Customs Border Patrol process, C-TPAT. The program would provide a meaningful opportunity to increase public safety and expedite return to commerce. The following questions help explain the concept.

1. How does the certification system you’re proposing differ from the traceability proposals put forward by industry leaders under current FDA consideration?

The current proposals focus on traceability and only go as far as “one step forward and one step backward.” Yet, Desert Glory has full product traceability, tracking the tomato from not only from the date it was harvested but to a specific sector of one of our 450 greenhouses and all the way to the consumer who purchases our NatureSweet brand. No, traceability was not the determining factor in clearing tomato products during the recent Salmonella incidents, geography became the eliminating factor in that instance. But geography does NOT take into account production practices and traceability.

Our proposal is to have growers, shippers, distributors and retailers work together on a voluntary certification program that includes best production and distribution practices as well as full product traceability. Then, when a food safety failure occurs, those participants in the certification system have the opportunity to quickly and efficiently show test results and documentation that will expedite their return to commerce and ultimately narrow the governing agency’s search span.

2. Why haven’t industry groups advocated for a certification process?

There are various traceability proposals being floated around which have been in the works for years. It is our belief that they do not go far enough to provide incentive to growers to join such as ensuring early release of safe product. This is why we are advocating for a voluntary certification program that will qualify businesses based on proven production practices and regular random testing.

3. While you are a U.S. company, all your production is in Mexico. What are your peers in Mexico doing to ensure food safety practices for imported product?

Desert Glory has focused on operating our farms based on the highest standards possible. We concentrate our efforts in producing and delivering a safe product. We recently held a food safety session with other farmers in Mexico, helping them to implement the discipline required for best practices.

Please note that in our discussions with other Mexico growers, they were shocked and discouraged that even Desert Glory, with its fully traceable systems, was restricted from commerce of its Roma tomatoes during the recent Salmonella outbreaks. They see little reason to invest in traceability systems if there is no business advantage during a crisis.

4. How are you working with industry groups in moving forward policy changes?

We believe industry groups are working hard for their member organizations. Our practices often exceed the standards being recommended by industry groups and while we support their efforts to generate attention to the need, we advocate an incentive to growers who can qualify for certification.

5. Is certification realistic if you are not a greenhouse grower?

The certification program we are advocating is based on the guidelines for good agriculture practices which can apply to all growers. But ultimately it is up to the FDA to establish the criteria for a certification program that best ensures the safe delivery of produce to market.

6. Can growers of all sizes participate in your proposed voluntary certification program?

Yes, regardless of size or scope any grower can participate. For example, some of the smallest growers today participates in certification when growing Organic produce. Although we do believe a program with a sliding scale is the best approach.

7. Can a traceability system really protect the public?

A traceability program is not enough which is why we are advocating for a voluntary certification process so that producers who have the ability to prove themselves clear of any contamination can do so immediately and continue commerce. This also helps the FDA narrow the search field therefore expediting the identification of the source which ultimately protects human welfare and safeguards the industry from a full shutdown.

8. How do you control product safety once it is in the distribution centers?

Desert Glory works directly with and prequalifies our distribution centers based on a propriety audit of Desert Glory standards. We would advocate that all participants in the supply chain have certification procedures and work together for a seamless system.

9. Should different standards be required of domestic vs. international growers?

A certification system should be passed on standards of production, packing and distribution with verification from third-party sources and random testing. It should not be based on geographical profiling. The difference between tomatoes shipped from Mexico to Michigan and those shipped from California to Michigan is based on how that tomato is produced and shipped, not where it was grown.

10. How much would a certification system based on the C-TPAT model cost?

As the industry works together with the FDA to determine specific required elements the cost of such a program will be better calculated. Much of what should be required is a matter of discipline and not one of capital investment. For instance, tracking tomatoes by a specific growing field or greenhouse means that a packer must incorporate discipline to put a break in the production line, clean it and recode the packaging or boxes when a new greenhouse or field comes on line. It is discipline and standards that will make the biggest difference.

Some of the smallest growers today incur costs of certification when growing Organic produce, typically one percent of their revenue. We believe that a program with a sliding scale is the best approach therefore opening up to all size of growers.

11. Has Desert Glory ever had a recall?

No, Desert Glory has never had a recall. But as part of our best-practices we conduct random product recalls that enable us to account for a product’s full traceability within three hours.

For more information contact:

Janet Greenlee

(512) 495-7165

(512)968-8306