Saturday, December 12, 2009
Jennifer McEntire Presentation to FDA
Thursday, December 3, 2009
What Where and When of SB510 ?
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.

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Thursday, November 5, 2009
FDA & FSIS Joint Meetings on Traceability Announced for December 9 & 10, 2009
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
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
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/