June 3rd, 2011
The current EHEC (Enterohaemorrhagic Escherichia coli) outbreak in Europe, in which over 1,200 documented cases have now been registered with the Robert Koch Institut (Germany’s equivalent of the U.S. CDC and FDA), provides us with grim, yet stark example of how and why a preventative approach must serve as the primary mechanism for protection of our food supply – and ultimately our health.
According to the Koch Institut, 18 22 persons in Germany have already lost their lives after falling victim to the deadly HUS (Hemolytic-Uremic Syndrome), which rapidly shuts down kidney functions, requiring 50% of patients to undergo dialysis and normally carries a 5% mortality rate. In the current outbreak the numbers are skewed dramatically in the wrong direction. Typically only 15% of the most vulnerable patients (small children and the elderly) would develop HUS as a result of EHEC infection. In this case 512 642 of nearly 2200 infected patients of all ages have developed HUS!
If this were the work of a serial killer, a massive investigation and man hunt would ensue – aimed at preventing further fatalities by capturing, convicting and incarcerating the responsible party, thereby removing the deadly threat from the general public. Foodbourne illnesses don’t work that way. By the time that the current, worldwide forensic investigation has isolated and removed the implicated food, more patients may die or suffer lifelong health consequences, but the sad truth is that this will not remove the threat. The only way to eliminate the threat of deadly food is to prevent it from entering the public food supply in the first place.
Only after identifying the root cause of the contamination and its means of transmission will we even begin to start chipping away at the threat. Long after the media attention surrounding the current EHEC outbreak subsides, farmers, food processors, transporters, retailers and servers will begin to mount the true assault on this and other deadly foodbourne and waterbourne pathogens and contaminants. While the alarming severity of the current outbreak will induce an above-average counterresponse from the EFSA (European Food Safety Authority) and other such agencies around the globe, the truth is that we already have the weapons in our arsenal that could have stopped this killer in its tracks.
By adopting and embracing guidelines published by the World Health Organization’s food safety adjunct, known as the Codex Alimentarius, ongoing and emerging threats to our food supply can be greatly reduced. Many of the Codex elements are already incorporated into food safety regulations worldwide. For example, the recent enactment of the FDA Food Safety Modernization Act in the U.S., adopted in the wake of deaths from leafy greens, peanut products and cilantro, has subjected the preventative concepts of HACCP (Hazard Analysis and Critical Control Points) and the associated prerequisite sanitation and opererational practices to a much larger segement of the food industry than was previously required. Similarly, the EU/EC has already had comparable standards and oversight bodies in place. The problem is not our intentions, our goals or our standards. The problem is the lack of adoption and incorporation of such practices in our globalized food production and distribution systems.
While it’s easy to accuse food producers and suppliers of taking shortcuts or calculated risks with our food in an attempt to maximize profits, the consumer must also accept some of the responsibility. If consumers continue to send the message to producers that larger portions at lower prices are their primary purchasing criteria, producers and retailers will continue to prioritize those attributes – at the expense of food safety. Accordingly, we must all be willing to absorb the front-end costs required to prevent the introduction of dangerous foods if we wish to avoid the seemingly random and often deadly back-end health costs, for which we are currently paying dearly.
Tags: Deutschland, E.coli, EFSA, EHEC, FDA, Food Safety, Germany, HACCP, Koch Institut, USDA
Posted in Codex Alimentarius, EHEC, Food Safety, HACCP, Traceability | No Comments »
December 21st, 2010
After nearly two years of procedural challenges, despite bipartisan sponsorship and both industry and consumer group support, the House today passed the Senate’s version of the Food Safety Modernization Act, which now goes to the President for his expected signature. This version of the bill does include the Tester Amendment language that reduces the scope of some provisions, but the bottom line is that the FDA will now be empowered to protect America’s food supply with real authority and mandates for a science-based approach to the prevention of foodbourne illnesses. Additionally, the FDA will be empowered to require true food traceability and impose manadtory recalls of tainted foods. These are all huge steps forward in removing significant risks from our current food production and distribution system.
The challenge is now for the FDA to work with industry toward practical, economically feasible solutions that not only comply with FSMA, but do so in a manner that streamlines processes rather than encumbering them. The technologies needed to meet these objectives currently exist. Identifying the appropriate methods and developing cost-effective implementation plans are the critical first steps for U.S. food suppliers, both domestic and foreign. Thanks to FSMA, the issue has now become one of when, rather than if these steps will be taken.
Tags: First Steps, Food Safety, Food Safety Modernizationo Act, foodbourne illness, FSMA, HACCP, S.510, Traceabiliy
Posted in Food Safety, Legislation, Technology, Traceability | No Comments »
November 19th, 2010
Yet another compromise has been agreed to on S.510 (FDA Food Safety Modernization Act) in a closed-door session last Thursday night (18-Nov). The bill will be brought to the floor for a vote on Monday, 29-Nov., with an allowance for four or five additional votes on various amendments. The Tester amendment is already in the package as it was brought to the floor on 18-Nov. PMA (Produce Marketing Association) and others have already officially objected to this, and who knows what they did to appease Coburn, who continued to be the one holding up the vote. He’s presented an endless stream of amendments, only one of which is related to S.510 – including an earmark ban – in an effort to stall the bill and have it die a procedural death.
Tags: Coburn, Food Safety Modernization Act, S.510, Tester, Vote
Posted in Food Safety, Legislation, Traceability | No Comments »
October 15th, 2010
Thanks to the latest round of grandstanding by Senator Tom Coburn (R-OK), the FDA Food Safety Modernization Act (FSMA) missed another window for consideration on the Senate floor recently. The bill has now slipped into the lame-duck session due to a procedural maneuver by Coburn ostensibly in the name of budgetary discipline. After holding up the cloture vote on S.510, Coburn then offered his lame substitute, S.3832, which reads in its entirety:
“SEC. 2. ENSURING FEDERAL AGENCIES EFFECTIVELY COMMUNICATE TO ENSURE GREATER FOOD SAFETY.
(a) Notwithstanding any other provision of law, the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) shall establish a plan no later than sixty days after the enactment of this Act to ensure effective information sharing regarding the regulation and inspection of food products and facilities, including violations, in which the FDA and USDA share joint, overlapping or similar responsibility.
(b) Within one year of enactment the FDA and USDA shall issue a joint report to Congress summarizing the effectiveness or lack of effectiveness of this new information sharing arrangement.
(c) The Government Accountability Office shall issue a report to Congress within six months of the report required by paragraph (b) to determine if any inefficiencies or other challenges remain regarding the sharing of information required by paragraph (a).”
Hmmm. With people dying and getting sick on a regular basis following an endless stream of foodbourne Salmonella, E.coli and Listeria outbreaks, Sen. Coburn wants to study the sharing of information between agencies for several months while ignoring the inspection, juristiction and enforcement voids that allow such outbreaks to persist. Coburn’s bill, which has no co-sponsors, is a joke. It’s no accident that bills Coburn has sponsored are 0-for-13 in the Senate. In contrast, six of his Republican Senate colleagues are co-sponsors of FSMA, which has enjoyed wide bipartisan support in both the House and the Senate.
The cost of legislation such as FSMA, which is designed to protect our lives, should be held to the same standards as defense and counterterrorism spending. That being said, the FSMA is not a blank check for government spending on food safety. It calls for very specific measures to counter known and documented holes in the current system and does so in a way that covers much of the front-end costs associated with its implementation. The back-end costs that we continue to incur both in terms of lives lost and healthcare expenditures associated with foodbourne illness are staggering. You would think that an M.D. such as Coburn would understand, or at least acknowledge these back-end costs.
It’s time to stop playing political posturing games with our health and well being. Numerous studies, public meetings, industry forums following decades of deaths and illnesses have been factored into the current FSMA legislation, not to mention the recent revisions designed to lessen the impact on smaller food producers. What we need now is action, not another speed bump from a first-term Senator that’s attempting to equate saving lives with building new roads or libraries.
Tags: Coburn, FDA, Food Safety, foodbourne illness, outbreaks, S.3832, S.510
Posted in Food Safety, Legislation, Traceability | No Comments »
August 18th, 2010
While the FDA Food Safety Modernization Act (FSMA) finally appears to be headed to the Senate floor in September, many new wrinkles in the Manager’s Package released on 12 August by the Senate Health, Education, Labor & Pensions Committee appear to have deliberately muddied the waters in terms of who will be subject to the bill’s provisions. Special considerations and exemptions for “small” and “very small” farms and food processors have been inserted, but without an adequate definition of these relative-size terms. That’s all left for the FDA and the Secretary of Health and Human Services to sort out once the bill is enacted. The thinking here is that this is a thinly-veiled attempt by the bill’s sponsors to soften opposition to the bill by farmers and operators who feel they are too small to withstand the registration fees, inspection/re-inspection provisions and record-keeping requirements mandated by the FSMA.
In short, it’s a weak attempt to kill support for the Tester Amendment, which would outright exempt a substantial number of farms, food processors and food handlers who generate annual gross revenues of $500,000 or less. It’s highly questionable that groups opposed to the bill will buy in to the newly-inserted provisions and trust the Feds to decide who it applies to at a later date. What it might do is provide some Senators with a rationale to support the bill without the Tester Amendment attached, as it would provide them with a story for their constituents about how they “demanded” these concessions as a means of looking out for the little guy.
While this blogger fully supports the FSMA and opposes the Tester Amendment, as it would establish and perpetuate two tiers of food safety in the U.S., the tactics employed in the Manager’s Package are just another example of how ugly and disingenuous the Capitol Hill sausage-making process still is. Maybe the FDA could step in and force them to clean up the rat droppings that line the floor of this Washington facility.
Tags: S.510 Food Safety Modernization Act Tester Amendment FDA
Posted in Food Safety, Legislation | No Comments »
July 7th, 2010
Support or opposition of the FDA Food Safety Modernization Act (FSMA – S.510) has fallen into two distinct camps, with large food entities and associations in favor of the new standards, while most smaller, localized or organic firms and cooperative associations stand in opposition to the FSMA or are seeking exemption from many of its provisions. If we are to avoid creating two tiers of food safety in the U.S., each group will have work cooperatively, both amongst themselves and with the other group as well.
Little Brother Approach
Co-ops, in fact, already have the right model in place to pool resources and share expenses. This model can be applied equally to both the HACCP provisions (joint/shared inspections, plans, verification documentation, etc…) and the traceability provisions (by acting as smaller units of a larger, virtual entity). For example, while many consumers hold the perception that large food entities such as Sun-Maid Raisins are huge agribusiness firms, many such entities are actually cooperatives with infrastructure and operational practices that far exceed the budgets and capabilities of their individual members.
Big Brother Approach
This is where the true agribusiness giants and mid-to-large-sized brokers and agregators need to step up. Adopting and implementing RFID and barcode traceability solutions can be cost-prohibitive and beyond the IT capabilities of many smaller growers, packers and shippers. Nevertheless tracking their goods from field to fork is just as important to our collective health and safety as any other goods in the food chain. By supplying preprinted, serialized barcode and RFID labels and low-cost mobile data collection devices to their suppliers, these “Big Brothers” can ensure the traceability of their source commodities and ingredients in exchange for a modest, equitable discount on these goods to cover the incremental costs of providing these capabilities.
As someone who’s in the business of making these kinds of distributed technology solutions work, I know that these types of solutions are feasible and cost-effective to implement. The questions is: Is there the will and desire in either camp to meet in the middle to make these models work toward the overall goal of ensuring the safety of our entire food chain?
Tags: FSMA S.510 Food Safety RFID Barcode Agribusiness COOP
Posted in Food Safety, Legislation, Technology, Traceability | No Comments »
May 28th, 2010
As it’s now certain that Senate Bill 510, the FDA Food Safety Modernzation Act (FSMA) will not be introduced or passed in the U.S. Senate by the Memorial Day recess, the pattern of piling on both related and unrelated amendments continues, potentially eroding some of the bill’s core support base.
Retiring Senator Byron Dorgan (D-ND) has indicated to his Democratic Caucus colleages that he intends to tack on his foreign-country prescription drug re-importation bill as an amendment to S.510. Add this to the list of scope-reduction, container-related and dietary supplement-focused amendments that have already been proposed or agreed to before the FSMA hits the Senate floor. Both Dorgan’s and Senator Dianne Feinstein’s (D-CA) BPA-ban amendments are attempts to revive separate legislation that failed to succeed on a stand-alone basis.
The longer that Senate leadership allows S.510 to languish in the hallways of Congress, the more last-ditch, unrelated and scope-reducing measures it will attract. This legislation has literally become a host for bill-bourne illness, which left unchecked could eventually kill the bill itself.
Posted in Food Safety, Legislation, Traceability | 4 Comments »
May 18th, 2010
One day we’re told that the E. coli 0145-tainted romaine lettuce has caused serious illnesses in Ohio, New York and Michigan and that the distributors of the implicated product have issued recalls for all states east of the Mississippi River -plus a few Midwestern states. Weeks later we find out that there are further clusters of associated illnesses in Tennessee. Feeling safe yet?
If you’re even considering eating romaine lettuce you might also want to know the answers to these currently-unswered questions:
- Are growers and distributors even testing for E. coli 0145, which is far less common than the E. coli 0157 that’s typically implicated in leafy green situations?
- Do we know which farms the lettuce came from and which additional distributors they supply with the product? If so, which retailers and restaurants sell or serve this product?
- Are we sure that the source suppliers don’t use the same packing facilities and lines for other leafy greens? Could they also be tainted?
There are many other questions related to the growing, packing and distribution environments that will eventually lead us to the root cause, but none of these information holes can be filled until we know where, when and through whom these products orignated and were distributed. These are the essential answers that full-chain traceability can provide – and quickly!
While the U.S. Senate continues to water down the traceability and record-keeping requirements in the pending FDA Food Safety Modernization Act (S.510) prior to its introduction on the floor, we stand yet again in the middle of a foodbourne illness outbreak without the answers needed to confine its scope, duration and impact. If the Tester (D-Montana) Amendment is adopted and food entities with annual gross revenues under $500,000 are exempted from the traceabiliity requirements, would we really be safe? Safer? Less safe? Tell us what you think.
Tags: Food Safety, foodbourne illness, Romaine Lettuce Recall, S.510, Tester Amendment, Traceability
Posted in Food Safety, Traceability | 8 Comments »
April 20th, 2010
According to Food Safety News (FSN), there has been some agreement on key provisions of the pending FDA Food Safety Modernization Act (FSMA) legislation that is once again stalled behind another more-devisive piece of legislation (this time it’s financial regulatory reform). According to FSN, four amendments proposed by Senators Stabenow (D-MI), Boxer (D-CA), Sanders (D-VT)) and Bennet (D-CO) – all aimed at lessening the hazard analysis and inspection burden on small, local and/or orgainic farms have been agreed to and will be part of the bill as it will be introduced on the Senate floor. Another amendment dealing with the traceabiliity requirements for such entities proposed by Senator Brown (D-OH) is still currently under discussion, while a sixth, more-controversial amendment sponsored by Senator Tester (D-MT) will be the primary focus of the debate on the Senate floor. Tester’s amendment would exempt food facilities with gross sales under $500,000 from most of the provisions of the legislation. According to FSN, the National Sustainable Agriculture Coalition (NSAC) has signed off on the four “agreed-to” amendments.
Given this backdrop and the statements by the office of Iowa Senator Tom Harkin (D) that a version of the bill will be passed before the Memorial Day break, the debate over Senator Tester’s amendment will most likely be the only fireworks on display for most Americans who consume their news in headline/sound-byte formats. Lost in this shuffle will be an open and honest discussion on the pros and cons of a hazards-based (traditionally referenced as HACCP [Hazard Analysis and Critical Control Points]) approach to food safety, as well as a debate over full-chain traceability versus the one-up, one-down concept that is already supposed to be in effect based on the Bioterrorism Act of 2002.
The Bioterrorism Act is proof that mereley passing well-intended, consensus-backed legislation will not magically make us safer or revolutionize the way food is grown, processed and distributed in the U.S.. Clearly whatever “solution” is chosen must not only be feasible and cost-effective for the various food industry entities to adopt, but it must also prove to be demonstrably effective and enforceable.
Food Tracker readers are invited to post their comments below on these and other critical factors that will be the key determinators of whether the U.S. food supply will actually become safer as a result of this legislation or not.
Tags: Bioterrorism Act, FSMA, HACCP, S.510
Posted in Food Safety, Traceability | 7 Comments »
April 9th, 2010
The expected upcoming passage of the landmark FDA Food Safety Modernization Act (FSMA) of 2009 will be heralded by most as a quantum leap forward in ensuring the safety of the U.S. food supply. As with most sweeping, new laws it will also require a great deal of on-the-fly refinements and adjustments. Most of these interpretations will be left to the newly-empowered Food and Drug Administration (FDA) to sort out. Several of the provisions that will require further clarification will directly impact the technology decisions and implementation methods that will be adopted in various food industries and entity types (grower/packers, daries, aquaculture firms, food processors, food distributors, etc…
The diversity of the list of industries that will be subject to the provisions of the FSMA is the source of many of the above-mentioned ambiguities. Among the list of questions that may have to be answered on an industry-by-industry basis are:
- In terms of the traceability provisions, “What is a lot?” Is it a labor shift, a processing date, a container, a shipment? Many of the soon-to-be-regulated industries rely on lot controls as a key element of their buisness processes. Do they now have to change their process in order to make their products traceable?
- Regarding the Hazard Analysis and Critical Control Point (HACCP) mandates, “What hazards are ‘likely’ to occcur?“ The first of the seven fundamental principals of HACCP requires process-specific risk assessment. “Who will make the risk assessments, based on what criteria?“
- With entities such as certain food suppliers and dispensers at both ends of the food chain being exempted from some provisions of FSMA, “What does full-chain traceability really mean?” “Does this mean that the FDA’s recall and investigatory authority is only applicable if contamination occurs in the middle of the food chain?“
While this is certainly not an exhaustive list of the potential ambiguities that will have to be resolved before the U.S. food supply truly becomes safer than it is today, the answers to these questions are critical in determining what first steps need to be taken, and by whom.
Tags: FDA, Food Safety Modernization Act, HACCP, Lot Control, S.510, Traceability
Posted in Food Safety, Technology, Traceability | 11 Comments »