Wednesday, December 30, 2009

2009 Traceability & Food Safety - Here's one comment from each month

Traceability & Food Safety in 2009 - Bits & Pieces - One for each month

January 27, 2009 - Reuters News Service
"The latest U.S. salmonella outbreak could spur food safety reform in Congress, but the process will be slow and consumers will remain at risk until the shattered regulatory regime can be fixed"

February 16, 2009 - New York Times
"The more investigators look into the latest food-safety scandal involving Peanut Corporation of America, the worse it gets. It now appears that as many as nine people have died and 19,000 have been sickened after eating cookies, crackers or institutional peanut butter tainted with salmonella from a plant in Georgia owned by the company"

March 2009 - Office of the Inspector General
The report "Traceability in the Food Supply Chain". Objectives of the report "1. To assess the traceability of selected food products. 2. To determine the extent to which selected food facilities maintain information required byt he FDA in a food emergency"

April 3, 2009 - Los Angeles Times
"Food Safety reform is on the table again. The pistachio warning, coming not long after the peanut product recall, may lead to legislative changes"

May 14, 2009 - Dr. David Acheson Testimony, Subcommittee on Horticulture and Organic Agriculture, House Committee on Agriculture
"We also note that traceback investigations for contaminated food, which we discussed with this Subcommittee last year, are more difficult when they involve fresh produce because the food is perishable ann the produce item (along with any packaging or labels) is usually no longer avaialable for testing by the time the illnesses are reported.

June 3, 2009 Grocery Manufacturers Association, Pamela Bailey, Pres. & CEO testimony before the U.S. House of Representatives Energy and Commerce Subcommittee on Health
(Regarding HR2749) "We strongly support in concept many of the proposals in the draft, including those that require food companies to have a food safety plan; proposals for FDA to set safety standards for fruit and vegetables; proposals to improve the safety of imported food and food ingredients;....."

July 7, 2009 Food Safety Working Group Announcement, comment by Vice President Joe Biden
"It's not unusual for us to snack on vegetables from South America and turn and pick up some fruit from the South Pacific and then go to have a dinner with beef from Brazil"

August 5, 2009 Keep Our Food Safe.org
"Secondly, the working group (Food Safety Working Group) discussed the importance of a national traceaback and response system to help identify the source of an outbreak quickly and efficiently"

September 2009 IFT Report Given to FDA
The Institute of Food Technologists delivered a report compiled over a year to the FDA regarding traceability systems currently in use in the United States, systems and technologies available and recommendations for moving forward in the area of traceability.

October 22, 2009 Senate Bill 510 discussed on the hill
Hearings were held on SB510. This followed passage on July 29, 2009 of HR2749 in the House of Representatives. HR2749 and SB510 will be the basis for a final food bill that is expected to go to the Presidents desk in early 2010.

November 14, 2009 IFT Report, Task Order 6, released by FDA
The report released today by the FDA included 5 parts..Executive Summary, Technical - Executive Summary, Economic - Tactics fro Improving Food Product Traceability - Economic Report and Technical Report

December 9 & 10, 2009 Joint FDA/FSIS meetings in DC
A two day public session regarding food safety and specifically traceability were discussed at the first joint meeting of the FDA and FSIS as the two agencies vow to work together in the area of food safety moving forward.

FoodTRACE wishes everyone a safe and happy new year. In many ways, 2009 was an informational year in the area of food safety and traceability. In 2010 much of that information will be finalized and actions will be implemented. We leave you with this final thought for 2009 ---Improvment in traceability is needed and will happen - That doesn't mean it has to be expensive....at less than 1/2 cent per carton for any organization, you can help in supplying full supply chain traceability, fully forward and fully back, from any point in the supply chain.

Wednesday, December 16, 2009

New IFT Report Released - Task Order 7

The last report on tracing submitted to the FDA on Tracing is Task Order 7: Tracing Systems: An Exercise Exploring Data Needs and Design. This 43 page report is the culmination of exploration into tracing specifically with tomatoes because of their complexity with repacking needs and because they took the brunt of focus during the 2008 Salmonella Saint Paul Event which cost the tomato industry in excess of $100 million dollar. In doing Task Order 7, there was input taken and utilized from approximately 10 various traceability projects. FoodTRACE was one of those that provided input. The FoodTRACE system, capabilites and methodologies are referenced in several areas of this report although in keeping with IFT's policies, no specific names such as FoodTRACE or other companies are mentioned when those references are discussed. The FoodTRACE system, even moreso following this report, does provide the capabilities that the FDA is looking for in moving forward and we are prepared as such. The entire report can be viewed at http://www.ift.org/traceability/IFT_FDA_TO7FinalReport.pdf.

Tuesday, December 15, 2009

Sherri Mc Garry Center For Food Safety And Applied Nutrition FDA

Sherri is the lead on traceability with the FDA - this is her presentation which shows concerns and expectations of the produce industry regarding this area.

Deborah White SVP And CLO, FMI

A very good perspective on traceability presented by FMI SVP & CLO, FMI, Deborah White

Dave Elder, Office Of Regional Ops And Regulatory Affairs, Fda

An additional presentation by FDA regarding traceability shown at the recent FDA/FSIS meeting in Washington on Dec. 9 & 10

Sunday, December 13, 2009

Link to all submitted presentations at the FSIS/FDA Meetings from Dec. 9 & 10, 2009

The direct link to the submitted presentations is: http://www.fsis.usda.gov/News_&_Events/Agenda_&_Presentations_Traceability/index.asp

IF the link doesn't work (it was sporadic) then you can reach the presentations this way:
1. Go to http://www.fsis.usda.gov/
In the center area, the 3rd current heading is "Joint FDA/FSIS Public Meeting....
Click on "Meeting Materials"
2. In the first section there are clickable listings...
Click on "Presentations"
Enjoy the read.....

Saturday, December 12, 2009

Jennifer Mc Entire, Ph.D Costing Evaluation of Traceability Programs

Jennifer McEntire, Ph.D. submitted this report regarding the costs associated with produce traceability programs at he FDA/FSIS meetings held in Washington D.C. on December 9 & 10, 2009

Florida Tomato Growers Exchange submitted this recent Harvard Report

Reggie Brown of the Florida Tomato Growers Exchange discuss their findings regarding efficient methods of achieving traceability with cost effective means.

Ian Williams CDC Chief, Outbreak Response And Prevention

Here is the presentation submitted by Dr. Ian Williams, Chief, Outbreak Response and Prevention Branch, CDC, to the joint FDA/FSIS meetings in Washington D.C. on December 9, 2009

Jennifer McEntire Presentation to FDA

Here is the presentation given by Jennifer McEntire, Ph.D., IFT, to the joint FDA FSIS meetings held in Washington D.C. on December 9 & 10, 2009

Thursday, December 3, 2009

What Where and When of SB510 ?

As he portrays himself as a "fresh-faced-recent-law-school-graduate", Mr. Alex Ferguson has written not only an exceptionally fresh view of his reading of SB510 but he also includes a chart that is eye-opening in many respects. This is one of the best summaries of SB510 that we have come across with and it is both interesting and insightful reading. We encourage reading the entire article, but at least take a close look at the chart. The article which includes the chart can be seen at http://foodsafetynews.com/2009/11/s-510-laws-without-effective-timelines/ ... enjoy the read.

FDA/FSIS Agenda for Dec 9 & 10

The following is the announced agenda for the joint meetings in Washington D.C. on Dec. 9 & 10.

Dec 9 Morning Session Topics
Intro - David Goldman, FSIS
Welcome- Jerry Mande, Acting Undersecretary, USDA Office of Food Safety
Mike Taylor, Senior Advisor to the Commissioner, FDA
Framing the Issue - David Goldman, FSIS and Sherri McGarry, FDA
Stage 1 - Epidemiology and Identify the Food
Robert Teclaw, FSIS
Katie Vierk, FDA
Ian Williams, CDC
Other panel members TBD
Stage 2 - Identify the Product, Jurisdiction (Traceback)
Ellen Morrison, FDA
Bill Smith, FSIS
Anna Hooper, Darden Restaurants
Craig Wilson, Costco

Dec 9, Afternoon Session Topics
Morning Wrap-up and Afternoon Logistics
Stage 3 - Identify the Source and Distribution (Traceforward)
Ken Petersen, FSIS
FDA - TBD
Sarah Geisert, General Mills
Mark Schad, Smart Food Safety, Inc.
Consumer Perspectives -
Panel Members TBD
Pre-registered Public Comment - David Goldman, FSIS, Moderator
Day 1 Wrap-up David Goldman FSIS


Dec 10, Morning Session Topics
Welcome Back
Steven Sundlof, FDA
Framing the Issue: FDA's Perspective on Product Tracing and Highlights of Federal Register Notice Sherri McGarry - FDA
IFT Summary Jennifer McIntire, IFT
Core Elements in Effective Tracing Systems
Benjamin Miller, Minnesota Dept. of Ag
Donna Garen, Global Food Safety Initiative
Howard M. Magwire, United Egg Producers & Association
Steve Mavity, National Fisheries Institute
Achieving Full Supply Chain Traceability (Emphasizing Linages between Data Elements
Kathy Means, PMA
Other Panel Members TBD
Leveraging and Harnessing Existing Systems and Enabling Technology
Ed Beckman, California Tomato Growers Assn.
Larry Kohl, FMI
Other Panel Members TBD

Dec 10, Afternoon Session Topics
Challenges in Tracing Animal Feed
Chris Melluso, FDA
Randy Gordon, National Grain and Feed Assn.
Richard Sellers, American Feed Industry Assn.
Other Panel Members TBD
Feasibility, Costs and Potential Benefits of Establishing a Tracing System
Doug Bailey, Agricultural Marketing Service
Other Panel Members TBD
FDA and FSIS Next Steps
TBD, Food Safety and Inspection Service
Faye Feldstein, FDA
Pre-registered Public Comment - Steven Sundlof, Moderator
Closing Remarks
- Steven Sundlof, FDA

Saturday, November 14, 2009

IFT Report Released






The IFT Report is extensive and contains an immense amount of information. There are several parts that should be reviewed to have a comprehensive understanding of the report.
1. Executive Summary - Technical
2. Executive Summary - Economic
3. Tactics for Improving Food Product Traceability
4. Economic Report
5. Technical Report

To read the Exec summaries and the full economic and technical reports with highlights you can view them at our website http://www.usfoodtrace.com/ under "Current Updates". It's a lot of reading but scan thru the highlights and focus on areas you feel important to you.

FoodTRACE is VERY pleased with the IFT report....we are acknowledged as potential solution providers and described in the grouping of Information Transfer Platform systems.
















Also, a joint FDA/FSIS meeting in D.C. is being held on December 9 and 10.... FoodTRACE will be there and presenting as well. If you have any questions or comments please write to us at info@usfoodtrace.com.


















Thursday, November 5, 2009

FDA & FSIS Joint Meetings on Traceability Announced for December 9 & 10, 2009

The FDA & FSIS have announced meetings for December 9th and 10th in Washington D.C. These are public meetings both attendance and participation is allowed. FoodTRACE, as we have done in the past with other FDA meetings, will be attending and openly discussing traceability needs for food. You can see the entire 26 page announcement which include their questions of concern at this link:

http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/Docket_no_FDA-2009-0523.htm

Other than focus on the questions, below are some statements included in the above referenced announcement. As you read this, we hope you can see how fully FoodTRACE has been developed to be the most effective form of traceability available for food.

The purpose of the meeting is to stimulate and focus a discussion about mechanisms to enhance product tracing systems for food. This discussion will help FDA and FSIS determine what short and long term steps the two agencies should take to enhance the current tracing system.

Federal food safety agencies need to increase the speed and accuracy of traceback investigations and traceforward operations. FDA and FSIS intend the public meeting to stimulate and focus a discussion about the core elements of product tracing systems, and mechanisms to enhance product tracing systems for food.

The public meeting is intended to address product tracing systems to facilitate traceback investigations and traceforward operations for food products. A traceback investigation is an investigation to determine and document the distribution and production chain, and the source(s), of contaminated (and potentially contaminated) food, often in the context of an outbreak of foodborne illness. A traceforward operation is an operation to determine the distribution of contaminated (and potentially contaminated) food.

Food contamination events, often involving foodborne illnesses, have emphasized the importance of efficient and effective product tracing systems, particularly the importance of linking shipments of contaminated (and potentially contaminated) food backward and forward through the supply chain through the efficient assembly and review of product tracing records.

Timely and accurate information gained from records available during a traceback investigation or traceforward operation may:
Help limit the public health impact of a foodborne illness outbreak
Enable public health authorities and the food industry to provide targeted and accurate information about affected food to consumers, and, as a result, restore or enhance consumer confidence in food safety
Help limit the source of the problem to a particular food or to a particular region or locality
Help prevent future outbreaks by enabling the applicable Federal or State regulatory agency to more rapidly investigate firms where contamination may have occurred

In practice, reviewing multiple records to find information relevant to a particular traceback investigation or traceforward operation takes time and decreases the efficiency of product tracing.

Recent traceback investigations conducted by FDA demonstrate the the FDA's ability to identify the source of an outbreak can range from days to months after CDC notifies FDA that a specific food has been implicated in an outbreak.

Traceback investigations and traceforward operations have demonstrated that FDA needs to be able to respond to the size and complexity of the food supply chain with a product tracing system that is more sophisticated, effective, and efficient in its capacity to link the contaminated food along the distribution chain and that reflects and responds to changing production and distribution patterns.

Considerations for an Effective Product Tracing System
A whole chain product tracing system consists of information elements provided by persons in the supply chain to other persons in the supply chain or to regulatory officials (e.g., during a traceback investigation). Key information elements of a whole chain product tracing system may include:
Who manufactured the product
Who is sending the product forward in the supply chain and who is receiving the product
Who is transporting product in the supply chain
The physical location at which food is received or released
An adequate description of the food that is received or released
The date and time food is received or released
A lot or code number (or other identifier of the food)
The quantity of food and how it is packaged
The specific source of each ingredient used to make every lot of finished product
A shipment identifier (such as an invoice number, airway bill number, or bill of lading, and,
A means to link information about food that is received to food that is released both internally and externally throughout the distribution chain

Most product tracing systems (including FDA's regulations in 21 CFR part 1, subpart J) are designed and implemented as one up/one down systems rather than as whole chain systems. In a one up/one down system, the focus is on the immediate previous source of food an the immediate subsequent recipient of food, as well as the immediate previous transporter and the immediate subsequent transporter.

In section V.A. 4 of this document, FDA is seeking comment on whether some information in the product tracing systems should be sent further in the supply chain than one down.

Traceback investigations for fresh produce have highlighted several particular challenges associated with tracing fresh produce back through the supply chain (73FR at 55115 at 55118). For example:
Fresh produce is perishable and may no longer be available for testing by the time the outbreak is detected
Fresh produce is often sold loose, without any packaging that would provide information about its source
Containers in which the fresh produce was shipped, which may have provided information about its source, may also have been discarded by the consumer or end user long before a traceback investigation is initiated

Common industry practices add a layer of complexity. Examples of such practices are:
Repacking fresh produce from multiple sources
Commingling food from different sources, shipments or lots
Exchanging food with other local farms or businesses
Re-using and sharing shipment containers from other farms/businesses
Using different names for the same fresh produce as it travels throughout the supply chain
Substituting a different variety or size of fresh produce without documentation
Not assigning a lot or code number (or other identifier of the food) to the fresh produce that goes forward into the supply chain

Thursday, October 22, 2009

Food Safety Legislation in Senate Committee Hearings

Food Safety discussed in the Senate today as SB510, The Food Safety Modernization Act is discussed.....see the review here and the link to the video of the hearing....it is a good view!

Date: 10/22/09
Committee: Senate Committee on Health, Education, Labor and Pensions
Title: Keeping America’s Families Safe: Reforming the Food Safety System
Subject: Discussion of SB510 – Food Safety Modernization Act
View the Hearing: http://help/senate.gov/Hearings/2009_10_22/2009_10_22.html

Partial Highlights of Chairman’s Statements:
The chairman indicated in his opening statement that with more ingredients used, various methods of processing, products traveling thousands of miles and many times from countries with less vigorous standards than ours that is it past time to modernize our laws.
At one point in the hearing, the chairman stated that they intended to move ahead with mark-ups and get the bill to the floor as soon as possible.

Partial Highlights of Senator Durbin’s Statements:
He indicated his encouragement that many groups and organizations, such as FMI, GMA, NRA and others were supportive of the legislation. He put the numbers we continually hear into another perspective by stating that every 5 minutes 3 people rush to the hospital with foodborne illness and each day 13 people die.
He stated that FDA, in his opinion was working with limited staff and outdated laws.
He also expressed concern for the industry and public when he stated that 6 weeks after the tomato recall was when jalapenos had been discovered as the cause and significant industry losses had occurred.

Partial Highlights of Senator Dodd’s Statements:
This legislation has a sense of urgency.

Partial Highlights of Margaret Hamburg’s Comments (Commissioner of the FDA)

President O’Bama has stated that food safety is one of the most fundamental responsibilities of government. His Food Safety Working Group point to three areas and the bill addresses many of the concerns.
1. Prioritize Prevention
This bill does move the focus of the system to prevention. It shifts the FDA’s approach from one that reacts to outbreaks to one that seeks to prevent them in the first place.
2. Strengthening Surveillance and Enforcement
It does not supply all of the legal tools needed as it stands. Sections 301 regarding foreign supplier verification and Section 207 regarding detention of food need review. Also the bill does not mandate access to food records during routine inspections.
3. Improving Response and Recovery
Resources need to be addressed. Section 201 mandates inspections based on risk. However, although the intent is embraced, it doesn’t guarantee consistent fund resources.
When asked about the importance of HAACP, she indicated it was extremely beneficial. The legislation allows the FDA to re-focus on prevention and provides a systematic way of working with producers to shore up points of vulnerability and agreed that a risk based approach was the way to go.
She expressed concern that the mandates and responsibilities far outstripped resources and the FDA needed sustained and predictable funding.

NOTE: At various points there were comments regarding small and organic farmers and there was a difference of opinion as to the extent of their needed participation from a legislation standpoint. The bill as it is currently writing only applies to food produced for interstate commerce.
Margaret Hamburg noted that most actions currently are complaint based. This legislation provides for proactive actions such as testing and access to company files in this bill.

Partial Highlights of Caroline Smith DeWaal’s Statements (Director of CSPI):
Reform is long overdue.
Costs of foodborne illnesses range from 40 billion to 100 billion annually.
Need for a tracing system to trace back to source
Growers need to meet more standards
The bill needs minor changes in inspection systems, import provisions and other areas
On the issue of traceability, its critical, and traceability needs to be on food products from the consumer all the way back through the production cycle.
Needed improvements to bill need to include:
1. Frequency of inspections-Need categories of risk and associated frequencies of inspections
2. Testing – Want mandatory testing criteria built in together with reporting of positive test results
3. Imports- Review determination of accreditation body and responsibilities.

Partial Highlights of Tom Stenzel’s Statements (President of United Fresh):
He stated that the industry is well along in a multi-year produce traceability initiative committed to driving a standardized system of case coding for total supply chain traceability.
The FDA must determine appropriate national safety standards with full input from state, industry, academia and the consumer.
There are failures evident in outbreak management. He used spinach as an example stating it was one field, one lot, one day of shipments and the industry has never recovered based on the actions of government. He pointed out that the tomato industry was basically shut down for 6 weeks in pursuit of the wrong product.
He indicated that small farms should comply just as others.
The current system doesn’t use valuable industry expertise.
FDA lacks accountability when in error to the industry
The produce industry is totally committed to total supply chain traceability of our products. “We do have the technology today to supply a total traceability system”.

Partial Highlights of Michael Robertson’s Statements (Representing FMI, Director of Corporate Quality Assurance with Publix Supermarkets
The FDA needs adequate authority
The FMI supports the requirement that every requested facility have a HAACP preventative control plan.
They support the development of standards for product safety as well as inspections based on risk.
FMI supports enhancing traceback requirements, specifically the legislations establishment of pilot projects. Our industry recognizes that current traceability systems are not uniformly meeting the needs of the industry, the consumer and the government. We understand that there will be technical challenges and significant costs associated with the implementation of traceability throughout the supply chain infrastructure, and that is why we see the pilot program approach as being crucial.
FMI supports mandatory recall authority to FDA and supplier 3rd party certification audits.

Wednesday, October 21, 2009

Recent News Articles Regarding Food Safety

Although the health care issue has taken front and center stage, the area of food safety is far from being overlooked and although food safety legislation is on the back burner, be assured that the burner is far from turned off. IN addition to these, there is a meeting tomorrow, 10/22 in Washington D.C.Committee: Senate Committee on Health, Education, Labor, and Pensions
Title: Keeping America’s Families Safe: Reforming the Food Safety System
Date: Thursday, October 22, 10:00 a.m.
Place: SD-430

News

10/19/2009
Foodborne Illness Victims Meet With White House To Push For Food Safety ReformRepresenting the millions of Americans who fall ill each year from contaminated food, victims and relatives of victims appealed to the Obama administration to urge congressional lawmakers to pass food safety legislation this year

10/06/2009
New CSPI Report Highlights Ten Riskiest Foods Regulated by the U.S. Food and Drug AdministrationThese ten foods account for nearly 40 percent of all foodborne outbreaks linked to FDA-regulated foods since 1990.

10/12/2009
Are we all crash test dummies for the food industry?As the lead author of the new report just released from Center for Science in the Public Interest, The Ten Riskiest Foods Regulated by the U.S. Food and Drug Administration, today is another day when I'll have a tough time putting anything in my mouth.

09/09/2009
Make Our Food Safe Coalition Asks Senators "What's Hiding in Your Lunch?"Foodborne Illness Victims, Family Members and Advocates Urge Senate to Pass Food Safety Legislation

09/08/2009
Large Majority of Americans Want Stronger Food Safety RulesAmong likely voters surveyed across the nation, about 9 in 10 support the federal government adopting additional food safety measures.

Those and other information can be found at: http://www.makeourfoodsafe.org/

Saturday, October 17, 2009

FoodTRACE vs. PTI - Dollars and Sense

Why FoodTRACE® vs. PTI?
Here are just a few reasons……..
1. Cost - PTI estimated at 10 to 20 cents per carton---- FoodTRACE® less than a penny per carton
2. No infrastructure changes – companies already have what’s needed
3. Implementation time – PTI, up to 2012 – FoodTRACE® - about 90 days
4. FoodTRACE® addresses imports
5. FoodTRACE® traces to item level
There is much more – email us at info@usfoodtrace.com with any questions or comments!

Review the following article that was in the Perishable Pundit recently as well….


Despite Progress Made, Feedback On PTI Reveals Real Problems

Our coverage of traceability has been extensive, and our recent piece brought much controversy. In fact some of the association folks weren’t all that happy that we ran the piece, expressing to us a wish that we had exercised “more discretion.”

Of course, when a person holding a responsible position in the industry is willing to sign his or her name to a letter commenting on an important industry issue, we would be doing an enormous disservice to our readership, and to the industry at large, to squelch such opinions.
And, in fact, one thing the associations need to look at concerning traceability now and also for future initiatives is how to do things like the Produce Traceability Initiative in an environment in which people feel free to speak the truth throughout the process.

Immediately after we ran Dan Sutton’s letter, we received calls from a number of mid-size shippers that wanted to thank us. The problem they felt is that, in their opinion, they had been de facto frozen out of the discussions. Large companies with prominent food safety experts can speak in these meetings without fear that anyone will doubt their commitment to food safety. So if Alec Leach from Taylor Farms or Jim Lugg from Fresh Express voice a problem with a proposal, it is clear that this is because there is a problem with the proposal.

In contrast, mid-size shippers are all too easily dismissed as not being concerned with food safety. So they tend to clam up in the meetings if they are there at all.

There was a well-attended workshop on PTI at the recent PMA convention. The workshop was supposed to be a kind of “nuts & bolts” how-to, yet the questions from the floor seemed more focused on “should we?” rather than “how-to.”

Now Gary Fleming, Vice President of Industry Technology and Standards at PMA, emphasized that “Should we?” is not really the question as, speaking of PTI, he emphasized that it was definitely happening.

He may be right, especially depending on what definition of “happening” one chooses to adopt.
Still, right or wrong, it is vaguely reminiscent of Richard Nixon declaring, “I am not a crook” — true or not, the fact that Nixon had to say it indicated he was in a lot of trouble.

Our sense is that the Produce Traceability Initiative is in a lot of trouble.

In the first place, the association of PTI with Mom and Apple Pie has simply made honesty impossible for many companies. We had a chance to sit down with several of the signatories to the PTI on the buy side; these were folks who had previously expressed concern about the initiative privately to the Pundit. When we inquired about why they signed, given the reservations they had expressed, we got basically the same answer from each: That their competitors had signed and that they didn’t want to appear not progressive or not caring about food safety and so they signed.

All have some kind of traceability programs right now and are thus in varying degrees of compliance with the initial stages of PTI, but none of them have appropriated the money to conform to the latter stages of PTI and tell us they have no definitive plans to do so.
There are also whole sectors of the industry that seem to have no intention of implementing PTI. Is there, for example, even one terminal market wholesaler who is doing anything to implement PTI?

There is a whole roster of technical issues: For example, some say field packers have problems with it, as do those who sell or receive mixed pallets.

Yet even if the technical problems could be solved, the signatories to the agreement actually spend the money to implement it, and if the sectors not participating in the agreement could be persuaded to join in, there is still a major question necessary to accomplish the realization of PTI: Will buyers constrain their supply chains to PTI-compliant product? No buyer has made a public commitment to do so and few, on either the buy or sell side, seem to believe it likely.
In other words, one can put all the scanners in and rewrite programs to accommodate GTINs but, in the end, if PTI-compliant product costs $8 a case and non-PTI-compliant product costs $7.50 a case, if the buyer purchases the cheaper product, the whole system breaks down.
Although cost is a major issue, there is also a major feeling that the whole thing is unnecessary. Part of it is the sense that those switching over to PTI already have excellent traceability. If one is selling direct to a major retailer, that is a pretty easy thing to trace. In many ways, the PTI is sort of backward, starting with the sectors of the industry that have the best traceability. Maybe we should have started with a bunch of small restaurants and local purveyors and built a system from there.

The other big question, repeated over and over again by shippers of every size, was whether all the specificity that the PTI aims for would actually make any difference. Imagine a shipper who is selling to Wal-Mart, say 10,000 cases a day. This shipper has to call up Wal-Mart and explain that 692 cases, identified with specificity due to the PTI, are possibly laced with E. coli 0157:H7 and are being recalled.

Will Wal-Mart, or any other buyer, accept the specificity of this case-level initiative? Or will they, to use the phrase ubiquitous in these circumstances, “err on the side of caution” and throw every box delivered that day or maybe every box from that shipper in the dump?
Remember the buyer will bill back any costs related to this recall or dumping to the seller, so what incentive does the buyer have to not be ultra-cautious? But if it doesn’t make a difference and buyers are going to dump everything regardless of the traceability system, then why is it essential to spend a lot of money to get down to the case level?

PTI is far along now and, good or bad, we doubt it will be changed much simply because we could not imagine getting industry consensus on an alternative. The degree to which it will actually “happen” is very dependent on what the government does. If the government leaves many options for companies, we suspect that various companies will use those various options. Big buyers such as Wal-Mart may demand GTINs and such for their own internal systems, but others will be more flexible and whole sectors of the industry will be on different systems.
Our real concern is that this process has revealed a problem that will arise again: The associations try to nudge the industry in a positive direction; the identification of the direction as positive creates PR difficulties for companies concerned about the initiatives, and this shuts off important feedback that the associations need to hear. This limitation of the feedback loop results in less-than-optimal outcomes, including “façade outcomes” in which consensus is thought to exist but actually does not.

How to avoid this is tricky. Clearly a demand for specific commitments that have consequences if not followed could surface some of the hidden problems. For example, the associations could have said, “We can’t ask producers to spend money on PTI unless they have an assurance that those who don’t spend money on PTI can’t under-price them, so we need a commitment from buyers to constrain their supply chain to PTI-compliant product, or we can’t proceed.” Such a declaration would have surfaced the actual willingness of the buying community to commit to PTI. It would have answered the question as to whether buyer commitment was shallow or deep. After all, a public commitment to vendors could result in lawsuits if the buyers renege later, so it would be a real measure of seriousness.

Beyond demanding commitments with consequences, there may be methodological initiatives that could help surface real feelings. Although meetings, e-mails and conference calls can seem to be good exchanges, perhaps methodologies need to be developed for people to submit anonymous feedback, even if for credibility sake we restrict the anonymity to members of a task force or board. Perhaps even votes on whether to propose something should have to pass an anonymous vote.

As an industry, we may want to consider consulting some game theorists to discuss how these negotiations can be designed to not only get an agreement, but to sustain complete and honest input throughout the process.

Another update soon as we finish gathering the results of our very successful test of the FoodTRACE® system!

Thursday, October 1, 2009

FoodTRACE Press Release

The following press release was issued on October 1, 2009 by FoodTRACE.


October 1, 2009
PRESS RELEASE – Condensed
FOR IMMEDIATE RELEASE


HEADLINE
FoodTRACE® launches electronic true traceability solution for the Produce Industry.

SUMMARY
FoodTRACE® announces the availability of its true traceability solution to the produce industry. The industry, the government and the consumer are all concerned over the continuing problems with food safety and now it is addressed in a more efficient and effective way.

BODY
ALM, Alternate Logistics Marketing ( www.almconsult.com ) and DRS&T, Del Rey Systems and Technologies ( www.delreysys.com ), both in San Diego, California, have completed two years of development collaboration, and testing resulting in the announcement of a critical application designed to address the two areas that need to consistently operate more efficiently in the case of a food borne illness event; traceability and epidemiology. The companies have created FoodTRACE® (www.usfoodtrace.com).
FoodTRACE® addresses these issues with their program that is currently being launched. The issue of traceability is addressed in the Bio-Terrorism Act of 2002 but those criteria have proven inadequate by themselves. However, companies currently complying with the Bio-Terrorism Act of 2002 already have everything in place in order to utilize the FoodTRACE® program and become part of an instantaneous traceability network. Companies can submit that data, electronically and automatically to FoodTRACE®. That's it. Whatever information a company is currently maintaining, in whatever format that it is in, FoodTRACE® can accept that information and create a single language for all. There is no software, hardware or numbers to buy, there is no additional personnel required, simply a low cost monthly fee, and FoodTRACE® does the rest….and all for much less than one cent per carton. FoodTRACE® also makes available at little or no cost, various custom designed reports to provide exception reporting and other trace-back or informational capabilities. This is especially valuable to smaller companies that can benefit from a variety of professionally designed traceability reports. Most importantly, in the case of an event, FoodTRACE®, within 24 hours of awareness of an event, will advise companies if they are potentially implicated, absolutely implicated, potentially exonerated or absolutely exonerated regarding all of the products that have been reported into the system.
"Other programs being offered to the industry currently require another number to be applied to every carton of product that is packed" stated Mike Domingos, President of ALM. "This is extremely cumbersome, expensive and difficult to maintain, ours is not”. John Granich of DRS&T commented, "Our program is affordable to all size companies and no infrastructure needs changing with ours. All companies have the capability of utilizing only our system or ours as an enhancement to other systems. Based on our conversations on the hill, with the FDA, CDC and others, we believe we exceed all current and anticipated coming requirements of the Government”.
FoodTRACE® is U.S. based as opposed to some others that are being offered. Summarily, it creates electronic traceability for food products, fully up and down the chain from any point in the chain, addresses epidemiology and works to protect both the consumer and the industry.

END

Contact: miked@almconsult.com (831-229-2331) jgranich@delreysys.com (703-851-0986)

Sunday, September 27, 2009

TRACEABILITY UPDATE

The following article was in the Packer last week...... The headline states that the FDA is waiting on more input...and they refer to the IFT report as part of that input.... If you are wondering what direction to go on traceability for the food industry, FoodTRACE is the only complete package available at a reasonable price to meet all current and expected government criteria. We continue to communicate with the FDA and others and our confident that we are ready to announce and release our program very soon.

Top Stories
FDA awaits more input on traceability solutions
Published on 09/21/2009 10:52am By Tom Karst

COLLEGE PARK, Md. — While praising the industry’s efforts on the Produce Traceability Initiative, Food and Drug Administration officials told the Washington Public Policy Conference that the agency continues to study the issue as it considers future guidance.

The FDA is trying to be more proactive in working with industry to determine distribution patterns of fresh produce items potentially linked to foodborne illnesses.

"We’ve had some real issues with traceback,” said Sherri McGarry, food safety official with the Center for Food Safety and Applied Nutrition. One specific challenge is trying to “connect the dots” of all the handlers throughout the distribution chain, she said. “Very often, growers will say when they know what we are receiving and what we send out, but we can’t link the
shipments up,” she said.

The FDA began talking with the industry in 2008 about product tracing technology. In addition, the FDA has contracted for studies on traceability, including one soon to be released report that examines industry practices regarding traceability.

That report will look at the costs and benefits of traceability, and McGarry said that study from the Institute of Food Technologists is expected to be issued sometime in September.
“Essentially, we really need to improve product tracing,” she said. McGarry also briefed attendees on the nature of produce outbreaks since 1996. From 1996 to 2008, she said that the FDA investigations have counted 77 foodborne illness outbreaks related to fresh produce and another 27 outbreaks attributed to fresh sprouts. Among other FDA-regulated food, that
compares with 207 outbreaks associated with eggs, 21 linked to dairy products, 37 tied to processed food and 114 connected with seafood.

The U.S. Department of Agriculture regulates meat and those statistics were not included in the FDA presentation. Meanwhile, McGarry said the FDA has estimated that fresh produce has resulted in the most confirmed illnesses during the 1996 to 2008 period. With 9,000 attributed illnesses, fresh produce compares with eggs (6,609), dairy (349) and processed foods (3,684) among FDA regulated foods.

Overall, fresh produce accounted for about 16% of foodborne illness outbreaks among FDA regulated products, but 39% of illnesses. Fresh produce accounted for 15 deaths from 1996 to 2008, she said. She said sprouts accounted for 5.7% of the outbreaks and 6.3% of the illnesses.
Among fresh produce commodities, she said leafy greens accounted for 34% of the outbreaks, tomatoes 17% and melons 16%.

For additional information regarding the FoodTRACE system...please email us at info@usfoodtrace.com.

Wednesday, September 16, 2009

DOLLARS and SENSE

There have been more questions than answers to this question and searching for an accurate answer is not easy but it is possible. There have been two publicly made statements regarding the cost of traceability with regard to the PTI.

One was made by the PMA in their submission to the FDA in early 2008. This refers to the cost to the industry as "hundreds of millions" of dollars and the submission indicated years to implement.

More recently on a webcast by Redline solutions, a major grower shipper representative indicated that the Redline solution would work and he estimated the cost of compliance to the PTI would be between $0.10 and $0.20 per carton.

That same company using the FoodTRACE system would pay LESS than 1/2 cent per carton for full compliance.

Although the PTI initiative won't be implementable for quite some time, FoodTRACE next week is running a live test for the purpose of final preparation of readiness for implementation. We will be tracing electronically product from Mexico, across the border into a U.S. facility, to a distribution center and on to stores.

Tuesday, August 18, 2009

FoodTRACE UPDATE

FoodTRACE currently keeps dozens of companies updated via email on a regular basis regarding traceability and the FoodTRACE program. If you would like to be added to the list, please email us at info@usfoodtrace.com. The following is an update that was sent out today to give you an idea of the type of information that is included in our updates which go out on the average of one to three times per month depending on the level of activity happening in traceability.

FoodTRACE® Update


The FoodTRACE® traceability program has made much progress since the last update.

There was obviously a flurry of news as the Food Safety Enhancement Act of 2009, called HR2749, was being discussed and finally passed through the House of Representatives. It will be brought up in the Senate probably sometime in September or October but as we all know the health issue has taken main stream currently.

To our knowledge, FoodTRACE® is the only traceability system that fully complies with every nuance that is currently written into HR2749 with regards to section 107 of the bill which addresses traceability.

Additionally, on July 7, 2009, during a press conference on food safety in Washington D.C., Kathleen Sebelius, Secretary of Health and Human Services (the cabinet department which oversees the FDA) made the following statement:

"In the next three months the Food and Drug Administration will issue draft guidance on steps the food industry can take to create tracing systems that will allow us to more quickly detect the sources of contamination and more quickly remove the unsafe food from store shelves".

Also, the IFT (Institute of Food Technologists) is close to their deadline coming up in September in which they are to submit a report to the FDA following a one year project to inform the FDA of various traceability systems available and supply their recommendations based on their study.

There continues to be recalls in produce as many of you are aware. In several cases, the recalls were initiated by the source as opposed to the government. In those cases, it is good to note that all the products that were recalled were done so timely and to the best of our knowledge accurately and efficiently. In 2007, the PMA surveyed 128 growers, shippers and 58 retailers…I was reading an old article in the Perishable Pundit that referenced a letter from CPMA that referenced that survey and a portion of that indicated that 77% of the companies surveyed CAN CURRENTLY track one step up, one step back on their products. That is an amazingly high percentage that should be used as a base and built UP from, not discarded to start a new program for every company in the United States for traceability.

Also, various estimates indicate that approximately 15% of the nations supply of fruits and vegetables are imported and on some fruits that number is in the 50% to 60% range. Vice President of the United States, Joe Biden, stated in the same press conference referenced above the following:

"The truth is it’s not unusual for us to snack on vegetables from South America, then pick up some fruit from the South Pacific and then go have a dinner with beef from Brazil”.

The message here is that when we consider traceability on fruits and vegetables consumed in the United States, we have to have a program in place that will accommodate imports as well as domestic products. FoodTRACE® addressed and resolved this issue in the initial development of our system. 100% of the bananas and pineapples for example are imported and they need to be traced just as importantly as does iceberg lettuce from California.

FoodTRACE® has collaborated with the University of Georgia to do a case study on the Salmonella Saint Paul event of 2008 which cost the tomato industry estimated losses of between $100 million and $250 million. The case study has been underway for several weeks at this point and we will update you when we have more definitive information on its finalization as well as the results.

Additionally we are scheduling a source to shelf real time trace back/trace forward project to trace product from a foreign country to a U.S. supermarket.

As a reminder, here are just a few of the highlights of the FoodTRACE® system….

· A centralized data base
· 24 Hour Traceability
· Department of Defense Security Levels on data
· Anomaly Detection
· Event Prediction
· Event Forecasting
· Access to your information in a variety of queries reporting levels
· Assistance with mock recalls
· Notifications of government requirements, guidelines, fees
· NO internal changes to your software
· NO hardware to buy
· NO numbers to buy

Easy to understand cost formula……..
1. A setup fee equal to your monthly fee
2. Monthly fee structure based on your annual sales
· Annual Sales <$5,000,000 $100 per month
· $5 to $10 Million $200 per month
· $10 to $25 Million $400 per month
· $25 to $50 Million $600 per month
· $50 to $100 Million $800 per month
· Annual Sales >$100 Million $1,000 per month

Reporting Locations over 1 @ $25.00 per month each

We will update you again soon …… Don’t forget to keep up to date as well with our blog -- www.usfoodtrace.blogspot.com
Feel free to leave comments on our blog or via our website www.usfoodtrace.com or simply by email to info@usfoodtrace.com.

Saturday, August 1, 2009

Food Safety Bill Passes on Second Round

One day after the food bill was brought to the floor of the House of Representative with a 2/3 required majority vote that failed.....it went again to the floor under a rules so that a simple majority was needed to pass the bill and it did pass. Now it will be on to the Senate, more committees, more hearings, more adjustments and the talk on the "hill" is that it might be up for a vote by the Senate possibly in late September but that is just talk. We'll follow it and update as it moves thru committee.

Wednesday, July 29, 2009

SPECIAL UPDATE: HR2749 Fails to Pass Today

The House of Representatives voted today on H.R. 2749, The Food Safety Enhancement Act of 2009 by 6 votes. The vote was as follows:

The electronic vote was: Yes: 280 No: 150 Not Voted: 4


The vote required at 2/3 majority which would have been 286 votes.
Further updates will follow as things progress.

Monday, July 27, 2009

Food Safety Bill Update

UPDATE on H.R. 2749, July 27, 2009


WASHINGTON - Today, Ranking Member Frank Lucas sent a letter to his colleagues in the U.S. House of Representatives urging them to not rush the Dingell-Waxman bill, H.R. 2749, through Congress. The bill is scheduled to be considered by the full House as early as tomorrow under suspension of the rules. This means that debate on this bill will be limited to twenty minutes, and there will be no opportunity to offer amendments.

"Our nation has the safest food supply in the world. Even so, we must continually examine our food production and regulatory system, and move forward with changes that improve food safety. But to do so without thoughtful and careful deliberation is simply irresponsible. H.R. 2749 is the result of a flawed and incomplete process. It will lead to huge regulatory burdens on our nation's farmers and ranchers, and it contains very little that will actually contribute to the goal of safer food.

"During a recent Committee hearing on the general topic of food safety, not a single producer witness would support this bill in its current form. Now Members of the House are being asked to vote on this bill without consideration, debate, or the opportunity to improve it. Worst yet, we haven't even seen the bill and we can't even obtain a copy of it.”

"For these reasons, I urge my colleagues to vote against rushing H.R. 2749 through Congress. I urge my colleagues to vote against H.R.
2749. Our nation's farmers, ranchers, packers, processors, retailers, and consumers deserve better," said Ranking Member Frank Lucas.


We at FoodTRACE urge caution and restraint as well in determining what your next steps regarding food safety, traceability and other cost areas that need to be addressed. Keep these FACTS in mind before committing dollars to the PTI initiative or any other programs that are being discussed.

1. Secretary of Health and Human Services stated on July 7, 2009 – “In the next 3 months, the Food and Drug Administration will issue draft guidance on steps the food industry can take to create tracing systems that will allow us to more quickly detect the sources of contamination and more quickly remove the unsafe food from store shelves. To hear her directly, go to http://usfoodtrace.blogspot.com/ and scroll down to the July 8 posting and watch a 1 minute 42 second clip where her statement as well as statements regarding food safety and traceability are also made by Secretary of Agriculture Tom Vilsack and Vice President Joe Biden.
2. IFT Report Due in September to the FDA. The FDA authorized IFT (Institute of Food Technologists) last September to analyze the various forms of traceability systems currently being used or in development. FoodTRACE® was one of those systems. The IFT was given one year to examine those systems and make their recommendations to the FDA this coming September. This ties in very well with the above comment made by Secretary Sebelius. The produce industry should NOT be jumping into anything, especially as costly as the PTI before understanding what the needs, requirements or at least guidance as stated is made.
3. FoodTRACE has not requested of any company to this point to sign on for our system although we are capable of accepting data and providing reporting options at this time. We firmly believe and continue to be proven by statements and actions in the industry and politically, that we are the best approach regarding traceability, and we go much further than the PTI regarding traceability at a fraction of the cost of overall implementation of the PTI option.

Tuesday, July 14, 2009

FoodTRACE - How it works

The following video will provide you with an understanding of how the FoodTRACE program works. In addition to the traceability features, reporting, notifications, compliance information, recall assistance and much much more is provided by FoodTRACE all at one low monthly price. No hidden costs, just a data analysis fee to get the proper fields of data determined and a low monthly fee is it. No numbers to buy which can be thousands of dollars, no software modifications to your current systems, no software to buy, no hardware or scanners to purchase, no additional labor required for managing and implementing additional systems, no syncronization fees or any other hidden or ancillary costs -- you want transparency --- here you get it. See how the program works here:








Additionally, FoodTRACE is very clear on what it costs. See the schedule below and you can see for yourself, that literally any company in the United State OR abroad can participate in this program. We GUARANTEE that we meet all current requirements of the U.S. Government regarding traceability. Based on the current laws being discussed as of this posting, FoodTRACE also EXCEEDS every nuance of every law that is being discussed that includes any parameters regarding traceability. FoodTRACE is here, it is now - Welcome to the end of traceability confusion.

FoodTRACE does MORE for LESS!

Wednesday, July 8, 2009

Take the Government's Word For What's Going On

These videos speak for themselves.... The first one is "snippets" of portions of the speeches on July 7th regarding traceability and tracking. The link below the video will take you to the entire 21 1/2 minute announcement by Secretary Sebelius, Secretary Vilsack and Vice President Joe Biden

To see the full announcement click here ---> http://www.whitehouse.gov/blog/Blogging-to-the-Middle-Improving-Food-Safety

Tuesday, July 7, 2009

FoodTRACE exceeds current Government Direction
















FoodTRACE™ meets EVERY suggested requirement of the comments made today in Washington D.C.

IMPORTANT information announced today by, from left to right above, Vice President Joe Biden, Secretary of Health and Human Services Kathleen Sebelium and the Secretary of the Department of Agriculture Tom Vilsack.

On July 1, 2009, the Working Group submitted its general principles to the President. The Working Group identified three core food safety principles to guide the development of a modern, coordinated food safety system.

• Principle 1: Preventing harm to consumers is our first priority: Too often in the past, the food safety system has focused on reacting to problems rather than preventing harm in the first place. The Working Group recommends that food regulators shift towards prioritizing prevention and move aggressively to implement sensible measures designed to prevent problems before they occur. Key to this approach is setting rigorous standards for food safety and providing regulatory agencies the tools necessary to ensure that the food industry meets these standards.

• Principle 2: Effective food safety inspections and enforcement depend upon good data and analysis. High-quality information will help leading agencies know which foods are at risk; which solutions should be put into place; and who should be responsible. The Working Group recommends that the Federal government prioritize crucial inspection and enforcement activity across the world; support safety efforts by States, localities and businesses at home; and utilize data to guide these efforts and evaluate their outcomes.

• Principle 3: Outbreaks of foodborne illness should be identified quickly and stopped. The Working Group recommends the establishment of a food tracing system that shortens the time between outbreak detection, resolution, and recovery. It is in everyone’s interest for outbreaks to be rare in number, limited in scale, and short in duration.

NOTE: FoodTRACE is the ONLY system available for traceability today that combines traceability with epidemiology. As we have continually stated, part of our program includes working with illness data to assist in shortening the time of the overall impact of an outbreak.

An additional statement made today in this announcement was:
Developing Industry Product Tracing Systems: Within three months, FDA will issue draft guidance on steps the food industry can take to establish product tracing systems to improve our national capacity for detecting the origins of foodborne illness.


Also today in a press release by the PMA’s President, Bryan Silberman stated the following as a part of his comments:

“Similarly, the traceback announcement appears consistent with our efforts on the Produce Traceability Initiative, though we will need to review the details as they emerge. The recognition of the clashing jurisdictions and the resulting disruptions to agencies charged with food safety is an important step toward creating a more rational and workable regulatory system.”

NOTE: The PMA cannot state as a fact that the GS standard or PTI as proposed, will, as a certainty, meet government guidelines.

FoodTRACE™ continues to be the only program being offered that has, and still, meets every nuance and area that has been or currently is in discussion regarding the requirements of the government regarding traceability. FoodTRACE™ offers a much more in depth program and at a fraction of the cost of the PTI.

We have been and will continue to follow the developments at government levels, but at FoodTRACE™, compliance with government guidelines, we have exceeded every area that has been discussed and continue to be affordable to all size companies.

Thursday, June 25, 2009

FoodTRACE and the Food Bill - In Sync!





THE food bill, HR2749 has completed it's review and markups in committee and will be headed to the house floor soon for a vote. FoodTRACE was easily fully compliant with the bill BEFORE the markups and the reduction of restrictions that were in the original draft --- so now the FoodTRACE program EXCEEDS all aspects of the bill as it is currently written. Companies will be able to be in compliance through FoodTRACE at the minimal monthly price level indicated in our program which you can see on http://www.usfoodtrace.com/, under US FoodTRACE program. Basically the parameters are that any company with sales OVER $100 MILLION annually will pay the maximum amount of $1,000/month....and companies UNDER $5 MILLION annually will pay the lowest amount, $100/month. No extras, no additional charges, nothing..... VERY affordable for all size companies with NO intrusion into your systems --- No software to buy...No hardware to buy... No numbers to buy....No additional personnel needed...No data syncronization to buy....No additional annual fees....No set up fees...plain and simple pricing for the most effective traceability option available.


Read the bill ---- It DOES affect every company in the United States. The MAJOR focus of the traceability area has been highlighted in red.


SEC. 107. TRACEABILITY OF FOOD.
(a) Prohibited Act- Section 301(e) (21 U.S.C. 331(e)) is amended by inserting ‘, the violation of any requirement of the food tracing system under section 414(c);’ before ‘or the refusal to permit access to or verification or copying of any such required record’.
(b) Imports- Section 801(a) (21 U.S.C. 381(a)) is amended by inserting ‘or (4) the requirements of section 414 have not been complied with regarding such article,’ before ‘then such article shall be refused admission’.
(c) Product Tracing for Food- Section 414 (21 U.S.C. 350c), as amended by section 106, is amended--
(1) by redesignating subsections (c) and (d) as subsections (d) and (e), respectively; and
(2) by inserting after subsection (b) the following:
‘(c) Tracing System for Food-
‘(1) IN GENERAL- The Secretary shall by regulation establish a tracing system for food that is located in the United States or is for import into the United States. Such regulations shall require each person who produces, manufactures, processes, packs, transports, or holds such food-- ‘(A) to maintain the full pedigree of the origin and previous distribution history of the food;
‘(B) to link that history with the subsequent distribution history of the food;
‘(C) to establish and maintain a system for tracing the food that is interoperable with the systems established and maintained by other such persons; and‘(D) to use a unique identifier for each facility owned or operated by such person for such purpose, as specified under section 911.

‘(2) INFORMATION GATHERING- ‘(A) TRACING TECHNOLOGIES- Before issuing a proposed regulation under this subsection, the Secretary shall--
‘(i) identify technologies for tracing the distribution history of a food that are, or may be, used by members of different sectors of the food industry; and
‘(ii) to the extent practicable, assess--
‘(I) the costs and benefits associated with the adoption and use of such technologies;
‘(II) the feasibility of such technologies for different sectors of the food industry; and
‘(III) whether such technologies are compatible with the requirements of this subsection.
‘(B) PUBLIC MEETINGS- Before issuing a proposed regulation under this subsection, the Secretary shall conduct not less than 2 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to provide input and information to the Secretary.‘(C) PILOT PROJECTS- The Secretary shall conduct 1 or more pilot projects in coordination with 1 or more sectors of the food industry to explore and evaluate tracing systems for food.
‘(3) ADDITIONAL AUTHORITY- In establishing a tracing system for food, the Secretary shall require--
‘(A) the establishment and maintenance of such additional information, including lot numbers, as the Secretary deems appropriate;‘(B) a standardized format for pedigree information; and

‘(C) the use of a common nomenclature for food.
‘(4) EXEMPTIONS-
‘(A) DIRECT SALES BY FARMS- Food is exempt from the requirements of this subsection if such food is--
1‘(i) produced on a farm; and
‘(ii) sold by the owner, operator, or agent in charge of such farm directly to a consumer or restaurant.
‘(B) OTHER FOODS- The Secretary may by notice in the Federal Register exempt a food from the requirements of this subsection if the Secretary determines that a tracing system for such food is not necessary to protect the public health.
‘(C) PREVIOUS SOURCES AND SUBSEQUENT RECIPIENTS- For a food covered by an exemption under subparagraph (B), the Secretary shall require each person who produces, manufactures, processes, packs, transports, or holds such food to maintain records to identify the immediate previous sources of such food and its ingredients and the immediate subsequent recipients of such food.

Sunday, June 14, 2009

"Welcome to the End of Traceability Confusion"




Over the last year members of the FoodTRACE team have had the opportunity to visit numerous facilities in various phases of the produce industry. We have been to grower/shippers, consolidators, terminal markets, foodservice operations, retail operations and processors of varying sizes.

One of the purposes for the visits, in every case, was to determine various companies current capabilities when it came to traceability. Every single company that we visited was capable of tracing a product in their system both forward and backwards (one-step-up, one-step-down) as required by the Bio-Terrorism Act of 2002. Most were capable of doing that in under 15 minutes but certainly all were more than capable of doing it within the requirments of the act of 24 hours. Two shippers, in tracing back to the grower, were able to also identify indepth to the crew and time of day that the product was packed. One traceback even went to a grower location, crew and time frame in Mexico.

This reaffirms our consensus that traceability is well entrenched in many companies currently. What is lacking is the full pedigree accessibility as is being discussed in the Food Enhancement Act of 2009, now being discussed in Congress. For example, although many of "links" in the flow of a product might be able to access the traceability in minutes, being able to see the whole picture, both backwards and forwards, is what would really make traceability complete. This is what FoodTRACE offers as only a part of its benefits to members.

The true effectiveness of any program, ours included, is the level of participation. That is why the cost structure has been developed so that literally EVERY facility as defined by the government could afford our program. It is designed so that the smallest of companies can pay as little as $100 per month for ALL of the benefits of the FoodTRACE program. There are NO other expenses, we simply require companies take the data they currently already have, in the format they already use, in tracking their one-step-up, one-step-down information, and electronically transmit that to us.

If a company is so small that all of their reporting is on paper only, FoodTRACE will even provide a computer!

Although the more facilities that register certainly provide more of the full pedigree traceability, each company, as soon as information is being provided, is under the FoodTRACE umbrella and FoodTRACE will monitor any potential problems reported at a government level and companies will know if they need to be aware or if they are not implicated in any potential event. That is only one of the benefits provided by FoodTRACE. To see additional benefits and features of the program, please visit http://www.usfoodtrace.com/ or email us any questions you may have to info@www.usfoodtrace.com.

While there is certainly NO legal requirement for any company to do anything OTHER than follow the Bio-Terrorism Act of 2002 at this time, all facets, features, nuances and concepts being discussed in Congress are all currently covered by the FoodTRACE program and more.

Sunday, June 7, 2009

Food Safety Enhancement Act of 2009

This appears to be the bill that will make it through Congress. I'm copying the summary points here but you can view the entire bill at the link below. There have been initial hearing and the bill will be discuss, questioned, changed, and updated starting next week and it is the hope of the committee that it will be voted on this summer, relatively quickly.
The traceability section, #107, is one of the areas that will have some discussion. We will point out to you that every single concept, nuance, intention, and manner in which this bill is written is easily capable of being managed by the USFoodTRACE program PLUS more. That includes an area that Tom Stenzel, President of United Fresh, found disturbing in that the bill as the initial draft is written calls for EVERY step in the supply chain to be able to access a full pedigree of the product. There's a reason for that. Let's say a product goes from Grower (1) to Processor (2) to Shipping Facility (3) to a Consolidator (4) to a Distribution Center (5) to a Store/Restaurant (6). Now let's say that there is a problem brought to the attention of the FDA regarding the Consolidator (4). (Sorry, I don't mean to pick on consolidators). The Act as it is written means that the Consolidator would be able to access the entire flow for immediate traceability. That is not a problem with our system. To read the entire act the way it is drafted, just go to this link: http://energycommerce.house.gov/Press_111/20090526/fsea_draft.pdf

Here is a summary of the contents of this bill:


May 26, 2009
Summary of Discussion Draft of the Food Safety
Enhancement Act of 2009
Committee on Energy and Commerce
Food Safety
1. Creates an up-to-date registry of all food facilities serving American consumers: Requires all
facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually.
2. Generates resources to support FDA oversight of food safety: Requires registered facilities to pay an annual registration fee of $1,000 in order to generate revenue for food safety activities at the FDA; requires registered facilities to pay for FDA’s costs associated with reinspections and food recalls; allows FDA to charge a fee to domestic firms requesting export certificates for exported food.
3. Prevents food safety problems before they occur: Requires all facilities operating within the U.S. or importing food to the U.S. to implement safety plans that identify and protect against food hazards. FDA would have the authority to specify minimum food safety plan requirements and to
audit food safety plans.
4. Requires safety plans for fresh produce: Directs FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables.
5. Increases inspections of food facilities: Sets a minimum inspection frequency for all registered facilities. High-risk facilities would be inspected at least once every six to 18 months; low risk facilities would be inspected at least once every 18 months to three years; and warehouses that
store food would be inspected at least once every three to four years. Refusing, impeding, or delaying an inspection is prohibited.
6. Improves traceability of food: Enhances FDA’s ability to trace the origin of tainted food in the event of an outbreak of foodborne illness. FDA would be required to issue regulations that require food producers, anufacturers, processors, transporters, or holders to maintain the full pedigree of the origin and previous distribution history of the food and to link that history with the subsequent distribution history of the food; and to establish an interoperable record to ensure fast and efficient traceback (current law permits facilities to hold a record in any format — paper or electronic —
making efficient tracing of foods difficult for FDA). Prior to issuing such regulations, FDA would be required to conduct a feasibility study, public meetings, and a pilot project.
7. Enhances the safety of imported food: As an additional layer of protection, FDA can require food to be certified as meeting all U.S. food safety requirements by the government of the country from which the article originated or by certain qualified third parties. Third party certifying
entities must meet strict requirements to protect against conflicts of interest with the firm seeking certification.
8. Expands laboratory testing capacity: Requires FDA to establish a program to recognize laboratory accreditation bodies and to accept test results only from duly accredited laboratories. Gives FDA the ability to require laboratories to send test results to FDA.
9. Provides strong, flexible enforcement tools: Provides FDA new authority to issue mandatory recalls of tainted foods. Strengthens criminal penalties and establishes civil monetary penalties that FDA may impose on food facilities that fail to comply with safety requirements.
10. Creates fast-track import process for food meeting security standards: Permits FDA to develop voluntary security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing.
11. Enhances the safety of infant formula: Enhances FDA’s ability to assure the safety of new infant formulas before they go on the market.
12. Advances the science of food safety: Directs the Secretary to include food in an active surveillance system to assess more accurately the frequency and sources of human illness. The Secretary is also directed to identify industry and regulatory approaches to minimize hazards in the
food supply.
13. Enhances FDA’s ability to block unsafe food from entering the food supply: Strengthens FDA’s authority to administratively detain unsafe food products. Grants FDA “quarantine” authority under which the agency may restrict or prohibit the movement of unsafe food products from a particular geographic area.
14. Directs FDA to assess the use of carbon monoxide in certain foods: Requires FDA to conduct a safety review of the use of carbon monoxide in meat, poultry, and seafood products.
15. Enhances transparency of GRAS program: Requires posting on FDA’s website of documentation submitted to FDA in support of a “generally recognized as safe” (GRAS) notification.
16. Requires country-of-origin labeling and disclosure: Requires all processed food labels to indicate the country in which final processing occurred. Requires food manufacturers to identify the country of origin for all ingredients on their websites. Requires country-of-origin labeling for
all produce.
General Provisions
1. Creates an up-to-date registry of importers: Requires all importers of drugs, devices, and foods to register with the FDA annually and to pay a registration fee.
2. Requires unique identification numbers for facilities and importers: To enhance information about FDA-regulated entities, creates unique identification numbers for all drug, device, and food facilities and importers.
3. Creates a dedicated foreign inspectorate: Requires FDA to establish and maintain a corps of inspectors to monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers.
4. Grants FDA new authority to subpoena records related to possible violations.
5. Provides protection for whistleblowers that bring attention to important safety information: Prohibits entities regulated by the FDA from discriminating against an employee in retaliation for
assisting in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of federal law.