Congress Contemplates Hearings As Precautionary Recalls Continue To Expand

Posted on January 30, 2009 by Shawn Stevens

According to reports, Congress will likely hold public hearings on the ongoing salmonella outbreak and recalls.  Representative Henry Waxman (D-California) stated recently that the hearings, anticipated within the coming weeks, will likely focus on the Blakely, Georgia facility owned and operated by the Peanut Corporation of America (“PCA”).

As the FDA continues its investigation into the ongoing outbreak, early reports have suggested that salmonella was isolated, on various dates in 2007 and 2008 from certain PCA products, by private labs PCA employed for routine testing. These reports have also indicated, however, that subsequent testing resulted in negative findings.  Because the specific protocols followed by PCA and the labs in question (along with the specific circumstances surrounding the sampling and testing of such products) are not yet fully understood, all parties will need to wait for the investigation to be completed before any final conclusions can be made regarding the ultimate merits or implications of these reports.  Additional information may also be learned from the proposed hearings, during which it is anticipated that representatives of PCA and the laboratories in question may be called to testify.

On Wednesday, January 28, 2009, PCA expanded its initial recalls (announced on January 13, 2009 and January 18, 2009 respectively) to include additional products produced at the facility since January 1, 2007 (see our reports below).  For continuing updates regarding the growing list of products affected by the expanded recall, please visit the FDA Peanut Butter Recall Website.  The American Peanut Council has also published a list of products reportedly not affected by the ongoing recalls.

To date, more than 500 people may have become sick, and as many as eight people may have died, in connection with the ongoing outbreak.  Although most of these illnesses are presumed to be associated with peanut butter, not all cases may be directly linked.  Early reports have indicated that at least one person from Wyoming (who was carrying the outbreak strain) did not appear to have any known exposure to peanut butter products.

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Salmonella News: Peanut Butter Recalls Continue To Expand

Posted on January 28, 2009 by Shawn Stevens

The Peanut Corporation of America (PCA), in a press release, has announced an expanded recall of peanut butter products produced at its Blakely, Georgia facility. The expanded recall covers products produced at the facility since January 1, 2007 (the previous recalls only involved peanut butter and peanut paste products distributed from the facility since July 1, 2008).  In addition to peanut butter and peanut paste, the expanded recall includes all peanuts (dry roasted and oil roasted), granulated peanuts, peanut meal and similar products.

PCA reports that, although none of the products involved in the expanded recall were distributed for direct consumer sale, the products were distributed to downstream manufacturers for use as ingredients in many other products.  Amended lists of products potentially affected by the expanded recall have not yet been released, and will likely be announced in the coming days. 

For more information on recent developments associated with the ongoing recalls, please visit our Food Recall Tracker, or the FDA Peanut Butter Recall Website.

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Vilsack To Announce New FSIS Chief

Posted on January 27, 2009 by Shawn Stevens

Tom Vilsack, Secretary of Agriculture, promised today to quickly name a new head of the USDA's Food Safety Inspection Service (“FSIS”).

The FSIS, an agency falling within the jurisdiction of the USDA, enforces the Federal Meat Inspection Act, 21 U.S.C. § 601, et seq., by providing continuous on-site federal inspection within meat packing plants. On a daily basis, federal inspectors ensure that all meat products sold in interstate commerce are: (1) produced under sanitary conditions; (2) not adulterated; and (3) properly labeled. In addition to monitoring production, the FSIS also closely regulates meat product labeling. Over the decades, the agency’s policy making and inspection authority has expanded to oversee poultry production under the Poultry Products Inspection Act (21 U.S.C. § 451, et seq.), and egg production under the Egg Products Inspection Act (21 U.S.C. § 1031, et seq).

Leading candidates for the position currently include: (1) Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest; and (2) former FSIS administrator Barbara J. Masters. Ms. Masters currently serves as a senior policy adviser with the Washington law firm Olsson Frank Weeda Terman Bode Matz PC.

Other names that have been considered for the position include Dr. Michael Doyle, Director of the University of Georgia Center for Food Safety (see our post below, highlighting Dr. Doyle’s work on Globalization and Food Safety), Michael Taylor, a veteran of the Food and Drug Administration and George Washington University professor, and Bill Marler, a well-known Seattle-based food-borne illness attorney.

Good luck to all.

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Industry Urges Congress To Adopt Enhanced Food Safety Reforms

Posted on January 26, 2009 by Shawn Stevens

As we continue to comment on food safety litigation avoidance and crisis management, several food industry groups on Friday, in letters to Congress, urged House and Senate leaders to quickly enact enhanced food safety reforms.  The letters announced that, although “Americans continue to enjoy the safest food supplies in the world, . . . new challenges require Congress and the Administration to modernize our food safety net.”  In turn, industry groups urged lawmakers to move forward on the following FDA proposals, originally announced in 2007, as part of the FDA’s Food Protection Plan:

  • Require Domestic Food Safety Plans:  As proposed, the initiatives would require domestic food producers to affirmatively identify potential food safety risks associated with production methods and products, identify and implement enhanced production or other controls, and prepare formalized food safety plans (for FDA review) addressing such risks;
  • Require Foreign Food Safety Plans:  Adoption of the pending initiatives would also empower the FDA to assist foreign governments seeking to adopt robust food safety regulations, and require foreign food product importers to better police foreign suppliers. The initiatives would also, in part, require domestic foreign food product importers to document food safety controls being implemented by foreign suppliers, and require such records to be available for FDA review; and
  • Adopt A More Robust Risk-based Approach to Inspections:  As proposed, the initiatives would also enable the FDA to increase food safety inspections for those facilities and products (both foreign and domestic) that pose, based upon science and risk-based studies, the greatest risk of potential contamination.

In addition to encouraging a more robust food safety inspection system for domestic and foreign products, the letters also urged Congress to better enhance the safety of fruits and vegetables by establishing uniform standards for high-risk products.  In addition, the letters addressed the FDA’s continuing request for mandatory recall authority, which would be available to the agency in those rare circumstances where companies refused, following FDA recommendations, to initiate recalls voluntarily.

The letters were undersigned by numerous industry organizations, including the Grocery Manufacturers Association, the Food Marketing Institute, the American Frozen Food Institute, the International Bottled Water Association, the International Dairy Foods Association, the National Fisheries Institute, the National Restaurant Association, the Retail Industry Leaders Association, the Snack Food Association and the United Fresh Produce Association.  According to Pamela Bailey, President and CEO of the Grocery Manufacturers Association, improved food safety tools would ultimately enable us to better “maintain our position of global leadership and assure consumer confidence.”

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The 2008-2009 Salmonella Outbreak: An Overview Of The Investigation And Precautionary Recalls

Posted on January 24, 2009 by Shawn Stevens

Beginning in August and September 2008, a few, sporadic cases of Salmonella Typhimurium started to appear on the CDC PulseNet radar screen.  This was not unexpected, as numerous cases will exist at any given time throughout any given year. Through October and November 2008, however, the number of cases believed to be associated with this pathogen began to increase. Using Pulse-Field Gel Electrophoresis (“PFGE”) testing of culture-confirmed isolates (taken from various stool samples), the CDC determined that many of the newly-reported cases appeared to be related. In turn, these findings led to the first national case-control study, conducted on January 3 and 4, 2009, associated with the outbreak (learn how food-borne outbreaks are tracked).

According to the CDC, preliminary analysis of the study led investigators to suspect that peanut butter was a likely source of the outbreak. Following the preliminary findings, the Minnesota Department of Agriculture then began testing various peanut butter products, and eventually reported it had isolated the outbreak strain from an open 5-pound container of King Nut creamy peanut butter.  On January 10, 2009, after test results were shared with King Nut, it immediately initiated the first voluntary recall of peanut butter in the investigation.  Soon thereafter, the Connecticut Department of Public Health reported that it had isolated salmonella from an unopened 5-pound container of King Nut peanut butter. According to officials in Connecticut, the salmonella found in the container also appeared, by PFGE, to match the outbreak strain.   

Relying on trace-back efforts, investigators discovered that the King Nut peanut butter at issue was manufactured by the Peanut Corporation of America (PCA) in Blakely, Georgia. These preliminary findings prompted PCA, on January 13, 2009, to initiate the second voluntarily recall in the investigation - this recall included various peanut butter and paste products produced at the facility after July 1, 2008 (as additional information was developed and shared by investigators, this initial recall was later expanded on two occasions). Although these products were not sold directly to consumers, they had been distributed to numerous institutions, food service providers, food manufacturers and distributors.  In turn, because some of these products were also reportedly used, in part, as ingredients in other products (including cookies, crackers, cereal, candy, ice cream, pet treats, and other foods), additional precautionary recalls followed.  The following list outlines the progression of the subsequent voluntary and precautionary recalls (and, some expanded recalls), as industry worked very closely with the CDC and FDA to determine what raw materials and products could potentially be affected:

Friday, January 16, 2009:  

Saturday, January 17, 2009:

Sunday, January 18, 2009:

Monday, January 19, 2009:

Tuesday, January 20, 2009:

Wednesday, January 21, 2009:

Thursday, January 22, 2009:

Friday, January 23, 2009:

Saturday, January 24, 2009:

Although the list of precautionary recalls has been extensive (and could still increase as new information is discovered and shared by investigators), it is important to recognize that all of the recalls were voluntary, and most were precautionary. Although many of the recalled products likely did not carry the bacteria at issue, most recalls were nevertheless announced in an abundance of caution because, at the very least, the possibility was there. Additionally, as to those samples in which the pathogen was isolated, there is a good chance that the bacteria was not evenly distributed; thus impacting only limited products, but not others. For this reason, all parties will need to wait for the investigation to conclude to determine whether only a very few or potentially more of these products actually carried trace elements of the pathogen at issue.

Additionally, as an aside, you may recall that we reported (early on) that at least one American staple - Girl Scout Cookies - was not in any way associated with the ongoing outbreak and recalls.  To learn more about additional products not implicated, please visit the American Peanut Council, which has published a (still growing) list of peanut butter products and brands NOT affected in any way be the current recall.   

In the coming days, we will of course continue to watch and report as this investigation winds down.  We anticipate this will likely be soon, as illnesses associated with the outbreak appear, at this point, to be declining.  For this and many other reasons, we also once again express our gratitude to both industry and public health officials, scattered throughout the country, working collectively to bring this outbreak and investigation to its closure.  
 

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Working With Industry To Protect Our Food Supply. Who Is This USDA Hero?

Posted on January 22, 2009 by Shawn Stevens

I affectionately call him Buck Magnum.  You may know him by some other name.    Whatever his true identity, I would like to thank him for a job well-done.  

Buck’s story begins over one hundred years ago.  At the turn of the Century, we began shipping more and more food products between states.  Due to the emergence of rapid transportation, improved preservation techniques and the ability of media to reach additional consumers, food became more plentiful, affordable and accessible.  For the first time, food processors could viably ship perishable products anywhere in the nation.

While interstate shipments grew, however, food safety regulations became inadequate.  Industrial advances quickly outpaced limited state and local regulations.  In the meat industry, laws defining what constituted “adulteration” or “misbranding” were determined, if at all, by each individual state. Moreover, what was forbidden in one state was lawful in another.  This hodgepodge of inconsistent laws soon made it apparent that, without a national approach to food safety, a single set of rules, and a single agency to enforce them (enter Buck Magnum), American citizens could have no confidence in the origins or safety of their food. 

The federal approach to food safety was solidified in 1906, when Congress passed the Wholesome Meat Act and the Pure Food and Drugs Act.  These Acts (along with their successors) formed the framework for the national food safety policy that continues this day. The 1906 Wholesome Meat Act (now known as the Federal Meat Inspection Act, 21 U.S.C. § 601, et seq.) requires continuous federal inspection in meat packing plants, often times by multiple inspectors, to ensure that meat products are safe and wholesome, not adulterated and marked with the federal legend of inspection verifying the same.  

Today, the federal statutory and regulatory scheme is enforced by the Food Safety Inspection Service (a sub-agency of the USDA), via inspectors such as Buck.  In turn, I have watched quietly over the years as this picture has become, in some sense, legendary.  I have seen the photograph countless times on the internet, and have referenced it in publications, speeches and Powerpoints.  I even have a copy sitting next to the plant on my desk. 

Thus, if you know the true identity of this food safety icon, and can privately express our thanks, we'd be grateful.  Alternatively, if you could land me an autograph, you’d make my day.

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Close Only Counts In Horseshoes And Hand Grenades: Emerging Food Safety Technologies

Posted on January 20, 2009 by Shawn Stevens

Technological advancements have exploded in recent history.  From the internet to non-invasive surgical techniques to credit card size cell phones, we have progressed further in the last fifty years than the rest of history combined.  With the exception of purchasing state of the art electronics that are often obsolete by the time they are opened, such advancements have been exciting and made our lives much easier.

Despite great leaps, however, the threat of contracting a food-borne illness does, and may always, exist.  Because harmful bacteria can be introduced at any point from farm to fork (or, as I say, from "crop to court"), the fight against existing and emerging organisms remains extraordinarily complex.  In turn, the best scientific minds in the world are working feverishly (pun intended), even as you read this, to develop new methods aimed at protecting our food supply from these resilient food-borne pathogens.

Although it seems today that the prevalent and favored practice is indiscriminately to attack and criticize the food industry, it must be recognized that food safety professionals and the companies they work for have in recent years made substantial strides.  From irradiation (still waiting for consumer acceptance) to high-pressure pasteurization to the creative use of nanotechnology, new interventions are continually being developed to improve the safety of our food.

These and other developments merely highlight the technological advances in food safety within the last few years and months.  The food safety technology business is rapidly growing and, to the extent we can figure out this internet thing, we will continue to keep you abreast of the latest innovations.

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Coming Down The Food Pipe: New Rules And Regulations

Posted on January 20, 2009 by Shawn Stevens

While the USDA and FSIS work hard to protect our meat and poultry supply, the FDA works to ensure that the remaining 78 percent of domestic and imported food remains safe.

Although the FSIS maintains a continuous presence in most meat and poultry plants, the FDA typically only visits food processing facilities once a year. Following a number of highly publicized recalls, however, some began suggesting that the FDA should follow the USDA model, requiring more regulation and a more visible federal presence within FDA-regulated food processing facilities. Thus, the question was called: Would the FDA become more like the USDA?

Maybe just a little. In November 2007, the FDA unveiled a new initiative, called the "Food Protection Plan." The plan avowed three “core elements” - prevention, intervention and response - to better ensure a safer quality of food for all Americans (FDA, “Food Protection Plan: One-Year Progress Summary”). While, as part of these efforts the FDA asked Congress for additional regulatory authority, including new mandatory recall powers, most agree it would be far too impractical, expensive and imprudent to demand or even require a significant increase in domestic inspection. In June, for instance, the Government Accountability Office actually condemned the plan for “failing to provide details on the costs or specific strategies.”

In any event, within the coming months, we will see where these efforts lead. Personally, I expect the FDA’s regulatory control to grow significantly in the coming years (resulting, for instance, in the implementation of a mandated HACCP-based system for many new categories of foods). Thus, although it remains unlikely in the near term that federal inspectors will be physically “moving in” to your food production facility (as occurs in slaughter establishments), you may nevertheless find them knocking on your door more often, at the very least, to critique your HACCP plan.

Stay tuned for new developments.

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Are You A Food Safety Hero?

Posted on January 20, 2009 by Shawn Stevens

Each day across America, thousands of people work extremely hard to ensure that the food we eat is as plentiful and safe as it can be. That these incredible contributions often go unrecognized and unappreciated is merely, in my mind, a testament to the safety of our food.  The truth of the matter is that we all expect the food we eat to be safe. The reason we expect it to be safe is because, with very few exceptions, it is.

From the scientist who works in a lab sixty hours a week developing the technology which will continue to ensure that our food is the safest in the world, to the farmer and rancher who follow best practices, to the food processing workers who carefully perform their jobs, to the deli clerk at a grocery store in Cedar Rapids, who each week is responsible for serving countless safe, hot, wholesome lunches, we benefit from all they do each day.

So, for those of you who don’t work in the food industry; maybe the next time you walk through your local grocery store, you could take a second to stop by the deli counter and just say "thanks."  To those of you who do:

Well, Thanks.

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