Defending Food Safety : Food Safety Defense Lawyer & Attorney : National Food Industry Counsel : National Food Regulatory Lawyer and Attorney, FDA Lawyer and Attorney. USDA Lawyer and Attorney : Gass Weber Mullins Law Firm

There has been a lot of attention drawn to recent salmonella and listeria outbreaks, and, in turn, those pathogens themselves. In the meantime, the pathogen Campylobacter has worked itself into relative obscurity. This may seem surprising, as CDC estimates that Campylobacter associated illnesses affect as many as 845,000 Americans each year.

Campylobacter is a spiral-shaped bacteria that causes disease (Campylobacteriosis) in both humans and animals and is often found in the intestinal tracts of poultry, cattle, swine, domestic animals, and sometimes humans. The bacteria pass through feces and can also be found in untreated water. It is the leading cause of diarrheal illness in the United States (USDA).

Symptoms of infection due to the bacteria usually occur 2 to 5 days after consuming contaminated food, however, it may take as long as 10 days for symptoms to appear. This is similar to E. coli and the two are often confused for one another. The most common symptom is diarrhea which can often times be bloody. Other symptoms include fever, nausea, abdominal pain, headache, vomiting, and muscle pain. Like most FBIs, those most susceptible to contracting Campylobacteriosis are young children, elderly persons, and pregnant women.

In most instances, campylobacter infections resolve without serious illness occurring. It is important to note, however that even though complications from Campylobacter infections are rare, they can occur. The following are the most common:

• Gullian-Barre´ Syndrome (GBS): most common cause of generalized paralysis. GBS occurs when antibodies built up to fight the disease attack nerve cells.

• Reactive Arthritis: inflammation of the joints, eyes, reproductive or urinary organs.

• Appendicitis

In the event that a widespread outbreak was to occur, even statistically insignificant numbers of individuals affected by such complications could spell disaster for a company. The resulting lawsuits could easily result in millions of dollars in settlements and significant brand damage.

As with preventing all foodborne illnesses, maintaining sanitary conditions and remaining cognizant of potential hazards can make all the difference in preventing Campylobacter outbreaks. With continued awareness of harmful bacteria such as Campylobacter, and how we can prevent it from occurring in our food, we can continue to prevent serious foodborne illnesses from affecting our families and ourselves.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The FDA recently announced the implementation of a fully-staffed network dedicated to rapidly responding to human and animal foodborne illness outbreaks. This group is called the Coordinated Outbreak Response and Evaluation (CORE) Network.

Kathleen F. Gensheimer, formally Maine’s state epidemiologist, will lead CORE, in the new position of Chief Medical Officer/Outbreak Director. Under the leadership of Gensheimer and the FDA, CORE will be staffed by epidemiologists, veterinarians, microbiologists, environmental health specialists and risk communications specialists.

Their primary objectives of the new group are to: (1) rapidly respond to emerging outbreaks; and (2) research past outbreaks in order to develop new preventative methods in the hopes of mitigating or preventing future outbreaks.

Gensheimer, quoted in the FDA’s press release, stated, “A real benefit of the network approach is enhancing communication and coordination with federal, state and local food safety agencies, as well as industry and consumers. Given my background at the state public health level, this is a major priority for me.”

Before CORE was created, there was no centralized staff, but rather various offices of the FDA that responded to incidents. CORE, FDA is hopeful, will provide a more in-depth process of monitoring and evaluating foodborne illness outbreaks as well as facilitating faster responses when outbreaks do occur.

The lack of coordination between the multiple governmental agencies involved in foodborne illness outbreaks has, historically, resulted in a host of problems. In some instances, these have included errors in trace back investigations conducted by local health department personnel which have prevented the true source of an outbreak from being identified.

The FDA confirms that CORE will work closely in all outbreak investigations with the Centers for Disease Control and Prevention (CDC), the U.S. Department of Agriculture (USDA), as well as public health and agriculture agencies.

“The centralized staff of the CORE Network will work closely with FDA’s field emergency response coordinators and the investigative and analytical teams in the District offices and associated laboratories,” said Dara Corrigan, associate commissioner for regulatory affairs. “Working together will help to both standardize and strengthen how we conduct foodborne outbreak activities in the field.”

Ideally, CORE will fundamentally change the manner in which foodborne illness investigations are conducted in a way that allows for faster resolutions, more effective trace back and most importantly, fewer illness.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

“Foodborne diseases cause approximately 76 million illnesses each year in the United States.”

For the past 11 years, this statement has been quoted in countless news stories, scientific studies, legal documents, and arguments for expansive government regulations. The number “76 million” was an estimate calculated by the Centers for Disease Control and Prevention (CDC) in 1999. However, the estimate truly morphed into more of a factual statistic, the perfect lead-in or conclusion to every tale of foodborne illness.

The CDC just completed a second review on the impact of foodborne diseases and has released new figures in two studies published in the journal Emerging Infectious Diseases. The agency now estimates that about 48 million Americans get sick each year from foodborne diseases (a difference of 28 million people). CDC explained that the difference between the 1999 estimate and the current estimate is due to improvements in the quality and quantity of the data used and new methods used to estimate foodborne disease. CDC further described the approximation as follows:

Of the total estimate of 48 million illnesses annually, CDC estimates that 9.4 million illnesses are due to 31 known foodborne pathogens. The remaining 38 million illnesses result from unspecified agents, which include known agents without enough data to make specific estimates, agents not yet recognized as causing foodborne illness, and agents not yet discovered. In both the 1999 and current estimates, unspecified agents were responsible for roughly 80 percent of estimated illnesses.

An estimated 38 million illnesses (out of the total estimated 48 million illnesses) each year are thought to be caused by foodborne diseases that cannot yet be tracked or have not even been discovered.

The scientific guesswork behind “48 million” is hard for me to swallow because this estimate, as its predecessor of 76 million, will be used as a statistic to vilify our food industry. “48 million” will be touted before the masses in newspapers, movies, courtrooms, and Washington, D.C. as evidence that our food manufacturers are not even coming close to doing enough.

CDC is an incredibly valuable institution which has helped advance food safety in many aspects. Industry has learned food safety lessons from CDC’s research, and I concede that CDC’s new studies have value when properly utilized. However, it is a shame that “48 million” will be extrapolated from those studies and regularly, perhaps even exclusively, referenced without a full explanation of the estimation. Rest assured that this number will not be uttered when I am in the courtroom.

Within the CDC’s new studies is hard data evidencing that industry has made significant progress in the war on food safety. CDC stated that FoodNet provides the best measure of trends in foodborne diseases. FoodNet is a surveillance system designed to detect and collect information on every person in 10 states (representing 15% of the U.S. population, or 46 million Americans) with a laboratory confirmed case of foodborne illness. FoodNet completed an analysis comparing its data from 2009 with data from two other time periods and found:

• Rates of infection were at least 25% lower for Shigella, Yersinia, Campylobacter, and Listeria than they were a decade ago.

• Rates of infection with E. coli O157:H7, which causes one of the most severe forms of foodborne illness, decreased by 25% in 2009 compared with the most recent 3 years, reaching the lowest level since 2004.

As always, I am proud to defend the hard working Americans who feed our families and I will not allow their accomplishments to go unnoticed.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

There are endless numbers and statistics thrown around each day by the government, industry and consumers, along with different interpretations and explanations for each.

The CDC recently announced, for instance, that food-borne disease outbreaks and food-borne illnesses dropped by 8 and 15 percent, respectively, in 2007. Although we would like to believe that the reduction is a sign that food safety is headed in the right direction, the CDC has theorized that the decline is due to an increase in immunity to norovirus.

In turn, legislators are calling on the USDA and beef manufacturers to begin testing product for six non-O157 STEC strains. As one justification, rule makers point to the CDC’s estimate that that non-O157 STECs cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths each year. However, legislators fail to mention one key statistic: very few non-O157 STEC outbreaks have been caused by ground beef.

Although numbers and statistics are not always clear cut, and are subject to interpretation, they are increasingly shaping FDA and FSIS policy making.

On March 30, 2010, CDC, FDA and FSIS (the “Agencies”) jointly held their first public workshop on “Measuring Progress on Food Safety: Current Status and Future Directions". The Agencies’ hope to identify the best metrics to better quantify the true incidence of food-borne illness and which pathogens and foods are most at fault. In turn, they plan to use those measurements to directly gauge which policy changes are lowering the incidence of food-borne illness.

Further, the Agencies want to identify the best metrics to monitor food safety at each step in the farm to fork continuum. The FSIS, in its Federal Register Notice, put forth these queries to the industry:

• What metrics do industry members have in place to assess whether suppliers meet purchase specifications that address food safety?
• What metrics do industry members have in place to assess the safety of the finished products?
• What metrics do industry members employ to evaluate the effectiveness of their food safety systems?
• Has industry found some metrics that have been particularly effective in evaluating food safety?
• Are there other metrics that industry has found to be inadequate for measuring food safety?

The Agencies held another public meeting regarding “Measuring Progress” in July and will be holding a final public meeting on October 20, 2010 in Portland.

At this final meeting, industry (and state regulators and consumer groups) are encouraged to make presentations on metrics. The Agencies will also provide updated information about their current thinking on the use of metrics to measure food safety.

Since numbers and statistics can be so ambiguous, it is imperative that industry shares their knowledge of which metrics work – and which do not. The Agencies are looking to tie numbers to their policies. Since we are all strive to lower the incidence of food-borne illness, let’s make sure that meaningful statistics encourage constructive regulations.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Following the 1993 Jack in the Box outbreak, the Food Safety Inspection Service (“FSIS”) issued a policy statement declaring E. coli O157:H7 to be an adulterant in ground beef. Since this announcement, and as things are currently postured, no other non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) are considered adulterants in whole-intact and non-intact beef products.

On May 27, 2010, however, Senator Kirsten Gillibrand (D-N.Y.) proposed new legislation aimed a classifying six additional strains of E. coli as adulterants under the Federal Meat Inspection Act (“FMIA”). Although the text of the proposed bill (S.3435) is not yet available, Sen. Gillibrand announced that, among other things, the legislation would:

• Define “E. Coli” to includ all “enterohemorrhagic (EHEC) Shiga toxin-producing serotypes of Escherichia coli (E. coli)”;
• Specifically include as adulterants the following seven E. coli strains: O157: H7, 026, 045, 0103, 011, 0121, 0145; and
• Require the USDA and beef manufacturers to test product for all seven strains, and dispose of product in which any of the strains are found.

This bill comes on the heels of the Senator’s April 22, 2010 letter to USDA Secretary Tom Vilsack urging the USDA to begin testing for and regulating the additional E. coli strains. And, as we reported previously, Bill Marler (a national plaintiffs’ food lawyer) also petitioned FSIS in October 2009 for an interpretive rule declaring all non-O157 STECs to be adulterants in ground beef.

The FSIS has since announced, however, that it could not “reach a decision about the substance of the petition until it has developed additional laboratory capacity to detect and isolate various non-O157 STEC groups.”

At a 2007 meeting regarding non-O157 STECs, the FSIS noted that since 1990 there were only an handful outbreaks associated with non-O157 STECs in the United States, and none of them were associated with ground beef. This fact, coupled with a lack of data regarding the prevalence of non-O157 STECs in beef products, has prompted the FSIS to examine the feasibility of more thorough research and testing prior to adopting the significant policy changes sought by Mr. Marler and Sen. Gillibrand.

Additionally, at least some questions still remain about the virulence of non-O157 STECs that may in rare instances find their way into beef products. Not all of the strains, even when present in beef (as opposed to other food products), may be able to produce the specific toxins or combinations of toxins necessary to cause the severity of illness sometimes associated with E. coli O157:H7. Here too, knowledgeable experts concede that more research is likely needed.

Finally, according to the American Meat Institute (“AMI”), there is no test currently available to easily detect the six strains included in the bill. Thus, in addition to needing additional research to quantify the prevalence and virulence of these additional strains in beef, additional efforts would likely be needed to ensure not only that an effective test is readily available, but that the test could be easily obtained and quickly administered.

Even with this said, however, experts at USDA have already confirmed that existing food safety interventions already in place work equally well to combat both O157 and non-O157 STECS. And, AMI recently echoed these comments, noting further that, because “food safety resources in the private sector and the public sector are not infinite, it's important to invest in [new] technologies that will provide meaningful food safety benefits." Thus, whether such resources should ultimately be devoted toward the development and implementation of additional interventions to actually combat pathogens, or whether government and industry should instead invest in “additional testing,” will likely depend upon the results and findings of future research.

Sen. Gillibrand is also sponsoring two other pieces of legislation related to food safety. She authored the E. Coli Eradication Act of 2009 (S.2792), which would require additional tests for E. coli O157:H7 in beef facilities, and is also a co-sponsor of the FDA Food Safety Modernization Act, which will likely pass later this year.

Sen. Gillibrand is a member of the Senate Agriculture Committee. She was appointed to the U.S. Senate in January 2009 to fill Secretary of State Hillary Clinton's seat and is a candidate for the seat in the upcoming November 2010 election.

We will, of course, continue to monitor the non-O157 STEC issue, as well as other pending food safety legislation, and will keep you apprised of any new developments.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

According to the CDC, incidence rates of E. coli O157:H7 decreased significantly in 2009 from recent averages, reaching the lowest level since 2004.

Moreover, for the first time, the number of reported cases actually fell below the federal 2010 Healthy People target of less than one case per 100,000 people.

As explained by Dr. David Goldman, assistant administrator of the FSIS Office of Public Health Science, the report “confirms our success in combating food-borne illness by setting an aggressive goal, designing an effective system to meet that goal, and [then] relentlessly implementing it.”

The most recent food-borne illness incidence data was collected and analyzed through FoodNet, a collaborative project including the CDC, USDA, FDA and various state health departments. FoodNet conducts active surveillance for nine pathogens, including Campylobacter, Cryptosporidium, Cyclospora, E. coli O157:H7, Listeria, Salmonella, Shigella, Vibrio and Yersinia. Click on the following link to learn how food-borne illnesses are tracked.

According to Dr. Chris Braden of the CDC, "the report indicates that there have been reductions in illness caused by many of these pathogens." Braden further explained that, “since FoodNet began surveillance in 1996, . . . [most] of the pathogens that we track have all declined."

And, while E. coli O157:H7 and shigella cases showed encouraging recent declines, the federal targets for Campylobacter, Listeria, Salmonella and Vibrio have not yet been met. Vibrio infections, for instance, increased by 85 percent compared with the first three years of surveillance, and Salmonella fell short of the goal.

Many Vibrio infections result from eating raw or undercooked shellfish, especially oysters. In turn, Salmonella is often difficult to combat because it can originate and spread from a wide variety of foods and environmental sources. In addition to foods, Salmonella has been associated with animals like baby chicks, small turtles, reptiles and frogs. And, as noted, while incidence levels for campylobacter and listeria continued to decline significantly, they still did not meet "Healthy People" targets.

In addition to the expected Senate passage of the Food Safety Modernization Act next month, the FDA is also moving forward with additional food safety initiatives aimed at decreasing food-borne illness. Dr. Jeff Farrar, the FDA’s associate commissioner for food protection, noted that the agency is still pursuing new requirements aimed at reducing the incidence of Salmonella during shell egg production. These initiatives are expected to become effective this summer, while FDA also works to develop a proposed rule which will likely include risk-based safety standards for produce.

If we are really serious about reducing food-borne illness, however, such initiatives and regulations are only one part of the overall equation. Much greater progress can likely be achieved – more quickly – if more consumers recognize the importance of properly handling and preparing raw animal foods. If all consumers can be educated to assume raw chicken, meat and eggs carry bacteria that can cause illness, to take additional precautions to avoid cross-contamination, and to cook all raw animal products to a safe temperature, consumers can significantly reduce their risk of becoming ill.

In this regard, better “Educated People” will more quickly and readily translate into far more “Healthy People.”

• Email This
• Print
• Comments
• Trackbacks
• Share Link

According to the Center for Science in the Public Interest (CSPI), Hawaii ranks among the top states for food-borne illness surveillance, investigation and reporting. Other leading states include Maine, Kansas, Wyoming, Vermont, Alaska and North Dakota. Minnesota and Oregon are also regarded as having strong surveillance systems as well.

While many states ranked very high, however, some problems do remain.

According to CSPI, “some states may not have enough investigators or the money to train and equip their staff, which can lead to lower-quality investigations.” In addition to affecting the quality of such investigations, these and other limitations can also lead to mistaken conclusions regarding the source or cause of an outbreak.

CSPI also reports, however, the FDA Food Safety Modernization Act, which passed in the House of Representatives and is now pending in the Senate, will likely help improve national surveillance capabilities. If passed, the Act would require FDA to improve coordination between federal, state and local surveillance systems; develop a national network of laboratories; and improve epidemiological tools available to the states. The bill would also integrate food-borne illness surveillance with other bio-surveillance capabilities

Thus, as we strive to improve the safety of our food, as well as the ability of our food safety system to accurately detect and resolve emerging problems, we send our congratulations to the hard-working professionals in Hawaii and other states who are leading the way.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

According to the FDA, Basic Food Flavors (of Las Vegas, Nevada) has announced a recall of hydrolyzed vegetable protein (HVP) paste and powder. HVP is a common ingredient used most frequently as a flavor enhancer in many processed foods, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings.

The recall of HVP was announced following the discovery of Salmonella Tennessee in certain product samples, along with other samples reportedly collected at the company’s processing facility. In turn, Basic Food Flavors announced a recall all HVP in powder and paste produced and distributed by the company since Sept. 17, 2009. Click on the following links to view a copy of the FDA News Release and FDA Recall Information.

Although, to date, there have been no reported illnesses associated with the consumption of any food products affected by the recall, the FDA and CDC report that they are currently assessing and closely monitoring the potential risks of illness from affected products.

The FDA is also advising industry that any recalled bulk HVP product should be destroyed or reconditioned according to FDA-approved procedures. Click on the following link for Product Handling And Reconditioning Information. Under the guidelines, FDA is allowing companies to recondition potentially affected HVP if thier processing contains protocols validated to inactivate Salmonella. 

Additionally, according to FDA, companies will not be required to recall any food products containing HVP if the products have validated cooking instructions which are sufficient to inactive Salmonella, FDA is recommending that any down-stream food companies that used HVP as an ingredient in food products which might be eaten by consumers without any further processing or cooking to address the potential risk, however, consider recalling such products. Under new FDA guidelines, certian companies may also have reporting obligations under the Reportable Food Registry.

In any event, additional information relating to potentially affected products can be found at www.foodsafety.gov.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

According to the FDA, Wholesome Spice (of New York) has announced a recall of crushed red pepper because of a potential link to illnesses associated with an ongoing nationwide Salmonella Montevideo Outbreak. As of February 24, there had been as many as 238 individuals from 44 states infected with the outbreak strain.  Click on the following link to view a copy of the most recent CDC Outbreak Report.

Wholesome Spice manufactured and then distributed the crushed red pepper to Daniel International for use in the production of various sausage and salami products which had been previously recalled by Daniel. Click on the following link to view Previous Daniel Recall Updates.  According to reports, a broad investigation into the source of the contamination was ongoing, and FDA recently discovered that samples of Wholesome Spice crushed red pepper had tested positive for the outbreak strain. In response, Wholesome Spice immediately announced a recall of all potentially affected products.

The Wholproducts subject to the recall include all lots of 25 pound boxes of Crushed Red Pepper sold by Wholesome Spice between April 6, 2009 and January 20, 2010.

The Crushed Red Pepper was packaged in a clear plastic bag, which was then placed inside a cardboard box marked with an adhesive white label containing a blue border and blue and black lettering. The brand name on the product labels is WHOLESOME SPICES. The product name is listed as CRUSHED RED PEPPER. The 25 pound boxes of Crushed Red pepper were distributed throughout the Northeastern United States. The product was not sold at the retail level or directly to consumers. Click on the following link to view a copy of the FDA Wholesome Spice Recall Release.

In a separate news release posted on the Rhode Island Department of Health website, David R. Gifford, Rhode Island's health director, noted that the recall “confirms that the source of the Salmonella was from outside of Daniele's manufacturing plants." According to additional reports, Wholesome Spice is currently working closely with FDA to determine how the contamination occurred.

In any event, manufacturers who may have purchased any of the recalled products are being urged not to use the products, and to recall any other products which may have used red pepper as an ingredient. Manufacturers with questions may contact Wholesome Spice via telephone at (718) 388-1549, Monday to Friday between 8:30-4:30pm EST.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Shortly after the 1993 Jack in the Box outbreak, the Food Safety Inspection Service (“FSIS”) issued a policy statement declaring E. coli O157:H7 to be an adulterant in ground beef. Since this announcement, and as things currently stand, no other non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) are considered adulterants in whole-intact and non-intact beef products.

In October 2009, however, Bill Marler (a national plaintiffs’ food lawyer) petitioned FSIS to issue an interpretive rule declaring all enterohemorrhagic (EHEC) Shiga toxin-producing serotypes of E. coli, including all non-O157 serotypes, to be adulterants in ground beef within the meaning of the Federal Meat Inspection Act. Click on the following link to view a copy of the Marler Clark Non-O157 STEC Petition.

According to Marler, there have been numerous food-borne illness outbreaks involving non-O157 STECs over the last 20 years which, in his view, justify a change in current FSIS policy. Despite the underlying implication that non-O157 STECs are and will continue to be a growing national problem, however, very few reported outbreaks have been associated with these pathogens in the United States.

Even FSIS agrees that outbreaks may be rare. At its 2007 non-O157 STEC Policy Meeting, FSIS noted that there have been only 13 outbreaks since 1990 associated with non-O157 STECs in the United States. Notably, of the 13 outbreaks that were reported, many were attributable to fresh produce, and none were associated with ground beef. Additionally, in 2005, CDC reported that there had been only 501 confirmed cases nationwide.  While these low numbers may ultimately be explained in part by limited testing, it may also be premature to conclude outright that non-O157 STECs are so predominant as to justify an overhaul of the current FSIS approach to pathogen testing and regulation.

FSIS agrees that available data is sparse and may not support a change at this point in FSIS policy. In its recent response to the pending petition, FSIS confirmed that “the agency cannot reach a decision about the substance of the petition until it has developed additional laboratory capacity to detect and isolate various non-O157 STEC groups.” Click on the following link to view the FSIS Response to Marler Clark Petition.

Although FSIS plans to conduct additional research in this area, the agency concedes that, given the current limits of available data, it cannot effectively identify or even address the potential issues with these organisms. And, although additional research will eventually be completed, it remains to be seen whether the resulting findings will ultimately support the conclusion that non-O157 STECs are and should be treated as a significant and wide-spread public health concern in the United States.

In any event, based upon FSIS’ response, it does not appear that the agency will be taking any action on the petition soon. Thus, at least in the short-term, we will likely be left watching - with interest - as numerous scientists and public health officials continue to chew on this issue.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

In a recent speech, USDA Deputy Under Secretary for Food Safety Jerold Mande outlined various areas of research he believes will help improve food safety.

During his remarks, Mande noted that he would like to push for more rapid and effective testing. "We need better sampling methods, along with tests that more rapidly detect a broader range of harmful pathogens," he said. "We also need stronger assurance that laboratories used by companies have the expertise and experience to do effective food safety testing."

In addition, Mande stated that FSIS inspectors should be given more sensitive and effective ways to detect food-borne hazards. Here too, Mande opined that the agency “needs to do a better job equipping our inspectors with the means to not let harmful pathogens slip by as we stand watch."

Next, Mande called for additional research to better identify what he referred to as “those unidentified pathogens” which could potentially be responsible for a majority of food-borne illnesses in the United States. According to the CDC, as many as 80 percent of illnesses, 70 percent of hospitalizations and 65 percent of deaths could be caused by agents other than the 30 pathogens CDC currently tracks.

Finally, Mande also suggested, and rightfully so, that additional research was needed to give farmers and ranchers better tools in order to fight food-borne pathogens. "To take the next big step forward on food safety we need to do more to have fewer pathogens on food animals when they arrive at the slaughterhouse gate," he concluded.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

According to the USDA, Daniele International (with operations in Pascoag and Mapleville, Rhode Island) has announced a voluntary and precautionary recall of approximately 1,200,000 pounds of sausage products which had been distributed nationwide.

The recall was announced as a precautionary matter, during the course of an ongoing CDC investigation into the source of a Salmonella Montevideo outbreak which has sickened hundreds in over 40 states.

Based upon analysis of preliminary epidemiological data, the CDC and FSIS believed there was a possible association between limited numbers of these illnesses and the consumption of certain sausage products. Some illnesses, however, showed no connection to Daniels or the products it processed. Nevertheless, although the investigation is ongoing, the CDC has posted information about the multi-state outbreak on its website. Click on the following link to view the most recent CDC Outbreak Report.

Because of speculation that the potential source of the salmonella in sausage products may be linked to contaminated pepper, the company elected to recall all products which may be potentially affected. Click on the following link to view the FSIS Recall Release. As the investigation continues, Daniels is working closely with state and federal agencies to help determine the most likely source.

JANUARY 31, 2010 UPDATE:

As the investigation continues into the source of the national Salmonella Montevideo outbreak, Daniels has announced an expansion of its original January 23, 2010 recall. The expanded recall, involving approximately an additional 17,000 pounds of sausage products, was announced after the finding of Salmonella in certain samples of sausage not included in the original recall. Click on the following link to view the January 31, 2010 FSIS Recall Release.

FEBRUARY 4, 2010 UPDATE:

As the investigation continues into the source of the national Salmonella Montevideo outbreak, Daniels announced a second expansion of its ongoing recall. The expanded recall, involving approximately an additional 23,000 pounds of sausage products. Click on the following link to view the February 4, 2010 FSIS Recall Update. FSIS has also published a list of all the retail locations to which these products were distributed and sold. Click on the following link to view the FSIS Retail List.

FEBRUARY 16, 2010 UPDATE:

The FSIS has announced another expansion of the recall originally issued on January 23, 2010.  The expanded recall was triggered after a finding by FSIS of salmonella in an unopened salami product, and involves an additional 115,000 pounds of products.  Click on the following link to view a copy of the FSIS Expanded Recall Release. 

According to the CDC, the outbreak currently involves over 230 people from 44 states. Ove these, approximately 44 people have been hospitalized, and no deaths have been reported. As noted above, however, some individuals have reported no exposure to Daniels or any of its products. For this reason, the CDC, FSIS, countless state and local health officials, as well as Daniels representatives, are continuing to work tirelessly to determine the most likely original source of the contamination. Click on the following link to view the most recent CDC Outbreak Report.

We, of course, wish them luck in their continuing endeavors.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

An outstanding group of international food safety regulators, academics, industry leaders and top food safety lawyers are gathering in Beijing this week for a 2 day conference on food safety.

The Third Annual China International Food Safety and Quality Conference is designed to provide expert perspective on emerging industry trends impacting foreign food product imports, production and safety.

Speakers include Ge Zhirong, President, China Entry-Exit Inspection and Quarantine Association; Wang Yong, Minister, General Administration for Quality Supervision Inspection & Quarantine; David Tharp, International Association for Food Protection; Michael Pulch, European Commission to China, Bernard Kuhnle, German Federal Ministry of Food, Agriculture and Consumer Protection; Murray Lumpkin, FDA; Robert Charlebois, Canadian Food Inspection Agency; Art Liang, CDC and many, many more.

In turn, I will be speaking this year about the impact of food safety litigation in the United States on foreign food product production, imports and safety. Fellow food safety attorneys Bill Marler and David Ernst will offer additional perspective on food safety litigation at home and abroad.

More, of course, to follow.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

With Halloween fast approaching, it would seem the perfect time to worry the masses.

Researchers from the Center for Science in the Public Interest (“CSPI”), for instance, have just compiled nearly twenty years of CDC data, and used it to create a list of the riskiest foods to consume. In turn, some major news outlets, including CNN, quickly publicized the findings. Click on the following link to view the CSPI Study.

The study attempted to determine the relative risk of select foods by examining the frequency of past food-borne illness outbreaks associated with each. The findings, ironically, are nearly identical to the Food Guide Pyramid, which tells us what, and how much, food we should eat in order to stay healthy.

In any event, according to the CSPI study, the ten most risky foods are as follows:

1. Leafy Greens: 363 outbreaks (13,568 reported cases of illness);
2. Eggs: 352 outbreaks (11,163 reported cases of illness);
3. Tuna: 268 outbreaks (2341 reported cases of illness);
4. Oysters: 132 outbreaks (3409 reported cases of illness);
5. Potatoes: 108 outbreaks (3659 reported cases of illness);
6. Cheese: 83 outbreaks (2761 reported cases of illness);
7. Ice Cream: 74 outbreaks (2594 reported cases of illness);
8. Tomatoes: 31 outbreaks (3292 reported cases of illness);
9. Sprouts: 31 outbreaks (2022 reported cases of illness); and
10. Berries: 25 outbreaks (3397 reported cases of illness).

The implied lesson from the findings seems to be that we should, in order to minimize our risk of getting sick, avoid eating fruits, vegetables, dairy products and seafood. In turn, it would seem, a diet which consists strictly of beef, chicken and candy would be exactly what the doctor ordered.

In my view, scaring people away from certian foods doesn’t help promote food safety. And, warning people not to eat fruits and vegetables may be a bit short-sighted. Leafy greens, for instance, are served in virtually every single salad and on every single sandwich; that translates to nearly a billion safe servings every single day. The same is true for other foods on the list, including countless fruits and most vegetables.

So, in twenty years, we have less than 14,000 reported cases of people getting sick from leafy greens? You do the math. This is really no different than arguing that visiting the grocery store (to buy your produce) is an inherently dangerous activity because, every so often, someone trips.

Moreover, in my house, it is not what you eat that determines the risk, but rather who made it. My father, for instance, didn’t stop at just cooking our food. He cremated it. In this regard, most foods we enjoy are perfectly safe when properly handled and cooked to a thousand degrees centigrade (or, 160 degrees fahrenheit as recommended by FSIS).

In any event, recognizing that nothing in our world is without risk, I’ll continue to take my chances with a healthy diet and tasty food. And, despite its safety record, the candy can wait until Halloween. For now, I’m going to go eat a salad.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Health officials throughout the country are investigating a new Salmonella outbreak which has potentially sickened dozens nationwide.

According to the Colorado Department      of Public Health and Environment ("CDPHE"), the outbreak involves an antibiotic-resistant strain of Salmonella Newport. In Colorado, at least 21 people have been sickened in 10 counties, and four of the victims have been hospitalized. Although no conclusions have been issued regarding the source of the outbreak, preliminary indications suggest that the outbreak could potentially be associated with the consumption of undercooked ground beef. Click on the following link to view a copy of the CDPHE News Release.

According to the CDPHE, eight other states have reported cases that are related to the ongoing outbreak. The USDA, CDC and numerous state health agencies are cooperating in the ongoing investigation.

Although the Colorado news release did not specifically identify the other states involved in the investigation, one of them, reportedly, could be Maine.  On July 31st, the Maine Center for Disease Control and Prevention alerted health care providers and lab directors throughout the state to an outbreak of salmonellosis due to "an unusual type of Salmonella." Six cases have been confirmed in three counties. At least two of the isolates recovered from patients in this outbreak are resistant to the antibiotic ampicillin. Click on the following link to view a copy of the Maine News Release.

All of the Colorado and Maine outbreak cases developed in late June and early July.

The CDPHE, of course, is reminding consumers and food handlers to handle ground beef properly to avoid cross contamination, and to cook ground beef thoroughly. The FSIS likewise reminds consumers that thoroughly cooking raw beef products to an internal temperature of 165 degrees will destroy any pathogens that may be present, and will render the products safe.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius have announced that “prevention and partnership” will guide their departments' efforts to safeguard our food supply. These announcements are based on the public health principles embraced by the White House Food Safety Working Group led by Sebelius and Vilsack.

According to Vilsack, "making prevention a priority is critical to reducing food-borne illness and one of the three food safety principles of President Obama's Food Safety Working Group.” In turn, Vilsack and Sebelius announced the following new initiatives designed to accomplish these goals.

Beef Safety - E. Coli Testing Of Bench Trimmings

For starters, the USDA's Food Safety Inspection Service (FSIS) is issuing guidance for inspectors to begin conducting routine sampling of bench trim for E. coli. In the past, the FSIS had not routinely tested bench trim. Rather, FSIS started E. coli O157:H7 testing with ground beef, and expanded testing to other beef components used in ground beef. Bench trim, which will now be tested as well, includes pieces left over from steaks and other cuts that are then used to make ground beef. FSIS is also issuing streamlined, consolidated instructions to its personnel for inspection, sampling and other actions to help reduce E. coli O157:H7 in beef. Click on the following link to view a copy of the FSIS Sampling Notice.

Produce Safety – New Draft Guidance

Secretary Sebelius also praised new draft guidances prepared by the FDA, an agency within HHS, aimed at minimizing contamination in leafy greens, tomatoes, and melons. According to Sebelius, "the proposed controls provide a guide for growers and processors to follow so they may better protect their produce from becoming contaminated." The draft guidances also represent a shift in strategy for the FDA, from a food safety system that often has been reactive to one that is based on preventing food-borne hazards. Click on the following link for information on the Draft FDA Guidances.

Although the new controls are aimed at preventing contamination in the first instance, Secretary Sebelius also confirmed that consumers play a vital role in ensuring the safety of the fresh produce they eat. In turn, she offered the following tips from the CDC:

• Buy wisely. Don't buy produce that is bruised or damaged. When buying fresh cut produce, choose only items that are refrigerated or surrounded by ice.

• Refrigerate promptly. Certain perishable fresh fruits and vegetables (e.g., strawberries, lettuce, herbs, and mushrooms) should be stored in a clean refrigerator at a temperature of 40ºF or below. If you aren't sure whether an item should be refrigerated, ask your grocer. Produce that is purchased pre-cut or peeled should be refrigerated within two hours.

• Prepare produce with clean hands. Wash hands for 20 seconds with warm water and soap before and after preparing fresh produce.

• Wash produce thoroughly. Rinse fruits and vegetables under running water. Scrub firm produce such as melons and cucumbers with a clean produce brush. All unpackaged fruits and vegetables, as well as those packaged and not marked pre-washed, should be thoroughly rinsed before eating. This includes produce grown conventionally or organically at home, or produce from a grocery store or farmer's market.

• Do not cross contaminate. Don't give bacteria the opportunity to spread from one food to another. Consider using one cutting board only for foods that will be cooked such as raw meat, and another one for ready-to-eat foods such as raw fruits and vegetables.

According to FDA Commissioner Margaret A. Hamburg, the new draft guidances embody the Administration’s and FDA’s prevention-oriented food safety strategy.” She also confirmed that, while the proposals are still in draft form, “they will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.”

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The President's “Food Safety Working Group,” chaired by the Secretaries of the Department of Health and Human Services (Kathleen Sebelius) and the Department of Agriculture (Tom Vilsack), was conceived in March 2009 to help modernize our food safety system. In turn, Vice President Biden, Sebelius and Vilsack, have now announced key findings of the Group.

Following numerous meetings, and imput from key stakeholders, the Working Group has recommended a new approach to food safety based on three core principles: (1) prioritizing prevention; (2) strengthening surveillance and enforcement; and (3) improving response and recovery.

"There are few responsibilities more basic or more important for the government than making sure the food our families eat is safe," said Vice President Biden. "Our food safety system must be updated – 1 in 4 people get sick every year due to food-borne illness, and children and the elderly are more at risk. I applaud the Secretaries of HHS and the USDA for tackling this problem head-on, and coming up with key recommendations to ensure the health and safety of our food supply and, with it, the American people."

"Instead of spending their time trying to get kids to eat healthier food, too many parents and families are worrying about whether their food is safe in the first place," said Secretary Sebelius. "In just the past few months since we began work with the Food Safety Working Group, we have seen recalls on everything from spinach to peanut products to now even cookie dough.” According to Sebelius, the Administration believes “that the current system just isn’t working for America’s families, and under the President’s leadership, we are taking action to keep our food supply safe and prevent outbreaks that can impact millions of Americans."

"There isn’t a single American that isn’t impacted by our efforts to protect the food supply," said Secretary Vilsack. "We owe it to the American people to deliver on President Obama’s bold promise to greatly enhance our food safety system, moving our approach into the 21st century, employing the best surveillance techniques available, and ensuring that we are doing all we can to prevent illness before it occurs."

In its announcement, the Working Group outlined specific steps designed to advance its three core principles:

• HHS and USDA are targeting Salmonella contamination by developing tougher standards to protect the safety of eggs, poultry, and turkey.

• To fight the threat of E. coli, USDA is stepping up enforcement in beef facilities and the Food and Drug Administration (FDA) is developing new industry guidance improving protections for leafy greens, melons, and tomatoes.

• The Obama Administration is building a new national traceback and response system including clearer industry guidance, a new unified incident command system, and improved use of technology to deliver individual food safety alerts to consumers.

• Finally, the Administration announced a plan to strengthen the organization of federal food safety functions, including the creation of new positions at key food safety agencies and a continuing oversight role for the Food Safety Working Group.

The Food Safety Working Group is chaired by Secretaries Sebelius and Vilsack, and participating agencies include the FDA, the FSIS, the CDC, the Department of Homeland Security, the Department of Commerce, the Department of State, the Environmental Protection Agency, and several offices of the White House.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

According to the FDA, the Plainview Milk Products Cooperative has announced a voluntary recall of various milk products following the discovery of potential Salmonella contamination. The recall includes all instant nonfat dried milk, whey protein, fruit stabilizers, and gums (thickening agents) produced by the company during the past two years at its facility in Plainview, Minnesota. Click on the following link to view a copy of the FDA News Release.

The investigation which led to the recall is an interesting example of the ways in which the governmental agencies, which oversee the food industry, can and do work together to identify any potential problems which may arise. The investigation began when the USDA found Salmonella in 100-gram pouches of Dairyshake powder that were not for retail sale. The USDA then alerted the FDA, who later discovered salmonella on some of the processing equipment used in the Plainview plant. The FDA conducted the investigation in collaboration with USDA, CDC, the Minnesota Department of Agriculture, and various state and local health departments.

The products which were voluntarily recalled have not been linked to any illnesses, nor did they reach consumers directly. Rather, they were sold to other downstream companies, which then used the ingredients to process other foods.

We will, of course, continue to report on continuing developments.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On June 24, 2009, the JBS Swift Beef Company announced a voluntary recall of approximately 41,280 pounds of beef products. After consultation with the FSIS, and following a thorough review of its own records, the company has voluntarily expanded its initial recall to include an additional 380,000 pounds of select intact beef primal products. Click on the following link to view the FSIS Recall Release.

According to FSIS, the expanded recall was initiated voluntarily by JBS Swift, in an abundance of caution, as a result of an ongoing investigation by the CDC of numerous E. coli O157:H7 illnesses in multiple states. According to the company, the FSIS had indicated that some of these illnesses could potentially be associated with ground beef products further processed (by JBS Swift’s customers) from whole intact cuts. Click on the following link to view the JBS Release.

The beef products affected by the expanded recall were produced in Greeley, Colorado on April 21, 2009, and were distributed both nationally and internationally. Click on the following link to view a list of those products subject to the expanded recall.

Each box of recalled product bears the establishment number "EST. 969" inside the USDA mark of inspection, an identifying package date of "042109," and a time stamp ranging from "0618" to "1130." The recalled products include intact cuts of beef, such as primals, sub-primals, or boxed beef typically used for steaks and roasts (rather than for ground beef). As noted, however, because some of these products may have been further processed by downstream customers into ground beef, the final packaging may not bear the establishment number "EST. 969." As a result, FSIS is advising customers with concerns to contact their point of purchase.

FSIS also reminds consumers that, whether beef products are ground or intact, cooking beef products to 160 degrees will destroy any pathogens that may be present, and will render the products safe.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Defending food-borne illness cases throughout the country, we understand better than anyone the uncertianty surrounding recent reports that raw Nestle cookie dough may be the source of an ongoing nationwide E. coli O157:H7 outbreak. Although, historically, E. coli has been linked to outbreaks involving water, spinach, lettuce, alfalfa sprouts, fruit juices, salami, cheese, and raw (or, undercooked) meat, cookie dough has never been implicated.

Nevertheless, since March 2009, federal and state investigators have been attempting to identify the likely source of a nationwide E. coli outbreak which has affected about 66 people in 28 states. To date, about 25 individuals have been hospitalized.

Although the true source of the ongoing outbreak remains uncertain, health officials recently announced that a number of cases associated with the outbreak reportedly consumed raw Nestle Toll House cookie dough prior to the onset of their illnesses.

In Colorado, for example, of five cases recently linked to the nationwide outbreak, four reported eating raw cookie dough. Nevertheless, although such reports may suggest an association with a particular food, epidemiology alone (without the added benefit of microbiological confirmation in an implicated product) is often insufficient to determine the cause of an outbreak. For this reason, Alicia Cronquist, an epidemiologist with the Colorado Department of Health (“CDH”), stated further that, although we want consumers to be aware, "[w]e can't be certain that raw cookie dough is the source of these infections." Click on the following link to view the CDH Press Release.

Despite lingering uncertainty, these reports prompted an immediate response from Nestle. Noting that the safety of consumers is paramount, and although E. coli has not been isolated from any of its products, the company elected, in an abundance of caution, to issue an immediate, voluntary and precautionary nationwide recall of refrigerated Nestlé Toll House cookie dough products. In turn, Nestle spokeswoman Roz O'Hearn confirmed that "this has been a very quickly moving situation." O'Hearn highlighted further that, after learning of a potential problem, "the company took action in less than 24 hours." Click on the following link to view the Nestle Press Release.

Thus, as the investigation continues, both Nestle and health officials have asked consumers not to eat prepackaged refrigerated cookie dough. The precautionary recall includes refrigerated cookie bar dough, cookie dough tub, cookie dough tubes, limited edition cookie dough items, seasonal cookie dough and Ultimates cookie bar dough. It does not, however, affect any other Toll House products. Click on the following link to view the FDA Recall Release (and list of affected products).

While Nestle is working closely with the FDA to determine whether any of its products are indeed implicated, the Minnesota Department of Health (“MDH”) is testing products collected from retail stores and from ill consumers' homes. Currently, the MDH is investigating six cases with onset dates between May 3 and June 11. Click on the following link to view the MDH News Release.

Finally, it should be noted that, regardless of the ultimate source of the outbreak, consumers should never eat raw cookie dough. According to Carlota Medus, an epidemiologist with the MDH, “cookie dough, whether purchased in a tub from the store, or made at home from scratch, should not be eaten raw.”  This, of course, is because many raw products can potentially carry pathogens that might cause illness if improperly handled and prepared.  This is also why the labels on raw cookie dough clearly state that the products should always be baked before consumption.  When properly handled and prepared (and cooked to an internal temperature of at least 165 degrees), cookies make from raw dough are perfectly safe for consumption.

In any event, the safety and quality of its products, says Nestle, is a non-negotiable priority. For this reason, the company has apologized for any inconvenience caused by the precautionary recall.

And, until a source is conclusively determined, we of course will continue to provide updates on the continuing investigation.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

I just received an update from the CDC, confirming there are now 896 cases of H1N1 (Swine Flu) in 41 states. Interestingly, here in Arkansas (where I spent the last two days mingling with outstanding health professionals), there hasn’t been a single case.

Here’s the current national tally:

•  Alabama:  4
•  Arizona:  48
•  California:  106
•  Colorado:  17
•  Connecticut:  4
•  Delaware:  38
•  Florida:  5
•  Georgia:  3
•  Hawaii:  3
•  Idaho:  1
•  Illinois:  204
•  Indiana:  15
•  Iowa:  5
•  Kansas:  7
•  Kentucky:  2
•  Louisiana:  7
•  Maine:  4
•  Maryland:  4
•  Massachusetts:  71
•  Michigan:  9
•  Minnesota:  1
•  Missouri:  4
•  Nebraska: 4
•  Nevada:  5
•  New Hampshire:  2
•  New Jersey:  7
•  New Mexico:  8
•  New York:  98
•  North Carolina:  7
•  Ohio:  5
•  Oklahoma:  1
•  Oregon:  15
•  Pennsylvania:  2
•  Rhode Island:  2
•  South Carolina:  17
•  Tennessee:  2
•  Texas:  91 (and 2 deaths)
•  Utah:  8  
•  Virginia:  11
•  Washington:  23
•  Wisconsin:  26

In any event, despite the spread of H1N1 throughout the country, I simply wanted to note, once again, that pork products, and Arkansas, remain perfectly safe...

It is also (in my mind) equally important to point out that, wherever we live, we shouldn’t let the flu ruin our fun. Despite 26 confirmed cases in Wisconsin, I look forward to returning home tomorrow (in a small, confined airplane), and promptly ordering myself a cold beverage and, more important, a Johnsonville brat . . .

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The answer, I suppose, depends upon who you ask.

With increased population, improved governmental outbreak surveillance, expanding media coverage, more public awareness, better attentiveness by healthcare professionals and increased frequency (along with substantial improvements) in testing, we might be justified to expect that the numbers of confirmed food-borne illnesses would be climbing like an uncontrolled fever. Nevertheless, according to a recent report issued by the CDC, the incidence of food-borne illnesses over the last three years has actually hit a “plateau.”

The findings are from 2008 data reported by FoodNet, a collaborative project of CDC, FSIS, the FDA and 10 separate states. Click on the following link for a copy of the CDC Report. According to CDC findings, incidence rates in 2008 for Campylobacter, Listeria, E. coli O157:H7, Salmonella, Shigella and other pathogens did not change significantly when compared to the previous three years (2005-2007). Moreover, significant declines since 1996 were reported in the incidence rates involving numerous, other food-borne infections.

Despite these findings, Robert Tauxe, deputy director of CDC's Division of Food-borne, Bacterial and Mycotic Diseases, suggested that we may have “reached a plateau in the prevention of food-borne disease.” In turn, David Goldman, assistant administrator of FSIS, indicated he was “concerned about the lack of progress in reducing the incidence of food-borne illness."  Click on the following link to learn how food-borne illnesses are tracked.

Has prevention really hit a plateau? Or, could the total number of illnesses be falling? Despite dozens of feverish outbreaks (and thousands of reported illnesses) recently associated with a long list of previously never-mentioned foods (such as produce, pot pies and peanut butter), the numbers of most food-borne illnesses (according to the CDC) have been holding firm. Although it might be easy to interpret such studies at face value, the real answer (lurking somewhere in the report’s constituent ingredients) might be far more complex.

Many will admit that, in years past, given considerable limitations in surveillance, testing and reporting, a large percentage of total illnesses simply went unreported. Given better public awareness and recent strides in our ability to detect and identify a greater number of food-borne illnesses and outbreaks, the lack of any perceivable increase in the CDC numbers could actually – in my humble view – represent a decline in total cases.

So, are food-borne illnesses declining, increasing or holding firm? While I doubt (and, there is no evidence) that the incidence rates for food-borne illness are on the rise, there are plenty of reasons to believe that we may have started – at the very least – to get this fever under control.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On the heels of one Salmonella outbreak comes word of yet another. This time, a variety of spices manufactured by the Union International Food Company (and distributed under the Lian How brand name) have been identified as the likely culprits. Investigators with the Oregon Department of Human Services reacted quickly, and were able to isolate the outbreak strain from a sample of ground black pepper. Congratulations for a job well done.

Although Union International has announced a recall of its products, the ultimate origin of the spices has yet to be identified. Could it have come from outside of the United States, we wonder? It will be interesting to find out. In the meantime, we are being told that consumers – especially patrons of Chinese and Vietnamese restaurants – should avoid adding ground pepper or other spices to their prepared dishes. So far, the company has recalled White Pepper, Whole White Pepper, Black Pepper, Whole Black Pepper, Cayenne Pepper, Paprika, Chopped Onion, Onion Powder, Garlic (chopped, minced, powder and granulated), Curry Powder, Mustard Powder and Wasabi Powder.

In related news, the CDC evidently couldn’t wait, in the midst of a pepper recall, to warn us that we’re all eating too much salt. In a new study, released at about the same time as the recalls were being announced, the CDC complained that Americans on average eat twice the daily "recommended" sodium levels. Thanks.

Thus, in addition to not eating pepper, we must also cut back on salt.

So, next time you sit down for a meal, instead of passing the salt and pepper, you might be well advised to just . . . “pass.”

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Over the last decade, there have been numerous attempts to reform our food safety laws. As our ability to identify food-borne illnesses and outbreaks continues to improve (special thanks to the CDC, PulseNet and OutbreakNet), at least some weaknesses that were rarely, if ever, considered are now being found. Thus, although most meals consumed in this country remain perfectly safe, the recent peanut butter recalls have those advocating the need for additional checks and balances, at least for certain segments of industry, finding growing support.

Prompted by the recent recalls, lawmakers have proposed revised food safety legislation – the new FDA Food Safety Modernization Act -- which would give the FDA additional resources to more closely regulate food safety. The bipartisan bill was sponsored by Senators Dick Durbin (D-Ill.), Judd Gregg (R-N.H.), Ted Kennedy (D-Mass.) and Richard Burr (R-N.C.). A parallel bill, the Safe Food Enforcement, Assessment, Standards and Targeting Act of 2009, was also introduced in the House. The new legislation proposes to increase the frequency of inspections at food facilities, give the FDA expanded access to company records and testing results, and allow the FDA to mandate recalls if a food company fails to follow the agency's recommendations. As reported and summarized by Janie Gabbett, from Meatingplace.com, the new bill will specifically:

• Require all food production facilities to implement preventive plans to address hazards and prevent adulteration, and give the FDA access to the plans and relevant documentation;

• Expand the FDA’s access to records in a food emergency;

• Allow the FDA to recognize laboratory accreditation bodies to ensure food testing labs meet high quality standards, and to require test results to be reported to the FDA;

• Allow the FDA to enable qualified third-parties to certify that foreign food facilities comply with U.S. food safety standards;

• Require importers to verify the safety of foreign suppliers and imported food;

• Allow the FDA to require certification for high-risk foods, and to deny entry to any food that lacks certification;

• Increase FDA inspections at all food facilities, including annual inspections of high-risk facilities, and inspections of other facilities at least once every four years;

• Enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses;

• Require the Secretary of HHS to establish a pilot project to test and evaluate new methods for rapidly and effectively tracking/tracing fruits and vegetables in the event of a food-borne illness outbreak;

• Give the FDA the authority to order a mandatory recall of a food product when a company fails to voluntarily recall the product upon the FDA's request;

• Empower the FDA to suspend a food facility's registration if there is a reasonable probability that food from the facility could cause serious adverse health consequences or death;

• Direct the FDA to help food companies protect their products from intentional contamination, and rapidly respond to food emergencies;

• Increase funding for the FDA's food safety activities through increased appropriations and fees for domestic and foreign facilities.

In addition to receiving bipartisan support, many food companies and industry organizations have voiced support for the bill as well. Vocal supporters include General Mills, Kraft Foods and Kellogg's, along with the Grocery Manufacturers Association, the National Restaurant Association and the Produce Marketing Association. As reported by FoodNavigator-USA.com, Kirstie Foster, spokesperson for General Mills, stated:

“We are strong advocates for food safety system modernization and reform. Ensuring food safety is the highest priority of our industry. We support reform that includes both greater authority and greater resources to strengthen our ability to prevent and respond to food safety issues.”

In turn, Kraft spokesperson Susan Davison agreed, indicating that “the proposed legislation will make significant improvements . . .” Such comments were also echoed by the GMA, in a statement issued by president and CEO Pamela Bailey:

“Ensuring the safety of our products is the food industry’s most important priority... In particular, GMA supports proposals requiring all food companies to have a comprehensive food safety plan in place. It is absolutely critical that manufacturers take a preventative approach in identifying and evaluating potential hazards, and building food safety into the manufacturing process from the very beginning.”

Finally, according to Supermarketnews.com, Tom O’Brien, a representative for the PMA, also expressed support:

“I think the bills, if they get enacted, will restore consumer confidence in FDA, which in turn restores confidence in the food supply. They modernize FDA’s authorities, and they tell it that they should regulate based on the risk of any particular commodity. Those are very important things that we look for in legislation.”

Although the proposed legislation, if passed, would likely strengthen what already is a robust food safety system, there is unfortunately no solution that can completely eradicate food-borne illness. Like the common cold, flu and other ailments, illness occurs because microscopic pathogens exist in our world and can very easily contaminate our environment, our bodies and our food. Even if present in only small amounts that avoid detection, these organisms can eventually grow and multiply to levels that cause illness (whether introduced at a production facility or anywhere in the distribution chain). Moreover, despite continued best efforts to test for and find these pathogens, nature will continue to do its best to avoid being caught. Thus, although the proposed legislation will not eradicate illness, we are hopeful the new initiatives will, at the very least, help us more proactively identify and solve potential problems before they occur. 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As fallout continues from the peanut butter recalls originally announced in early January 2009 by the Peanut Corporation of America ("PCA"), some have wondered why the original Salmonella outbreak investigation took so long, and why recalls are still continuing. Unfortunately, most food-borne outbreaks take weeks (and, sometimes months) to identify because of the complexity of the issues involved. Incubation periods (the delay between food consumption and symptom onset) can range from hours to many weeks depending upon the pathogen at issue (Learn about common pathogen incubation periods). Once a pathogen has been isolated from a patient, additional time is needed to perform genetic testing on the samples to determine whether other cases are potentially linked. In turn, if numerous cases are identified and a food-borne illness investigation is initiated, additional days or weeks can be added as state and local health officials attempt to identify a single food (or other) source that is common to all the cases (Learn how food-borne illnesses and outbreaks are investigated and tracked).

This process, of course, becomes exceeding difficult in outbreaks involving common foods – or, as demonstrated in the Salmonella peanut butter outbreak, foods that used the same raw materials but do not appear on their face to have any link (i.e., ice cream, candies, granola bars and even dog biscuits). Thus, although the ongoing salmonella outbreak took significant time to identify, hats off to the CDC and FDA for being able to conclusively establish a common source. Click on the following link to download a PDF of the FDA’s Salmonella outbreak investigation timeline:

After illnesses are reported and confirmed, a common source is found, and recalls are initiated, investigators and industry must then work to remove all potentially implicated product from distribution. Here too, this process becomes extremely difficult when a recalled product is used as a raw material in countless common foods. In this outbreak, the process was confounded further because what began as a recall from a single facility (and involving product produced during a relatively limited period of time) quickly morphed into a recall involving years of production from multiple plants. Following the expended recall at PCA’s Blakely, Georgia production facility (involving all products produced at the plant since January 1, 2007) and the subsequent recall from PCA’s Plainview, Texas facility (involving all products produced at the facility since it opened in March 2005), FDA and industry alike quickly found themselves overwhelmed with the task of determining what downstream food products might potentially be implicated. Click on the link below to download a PDF of the FDA’s “simplified” PCA peanut product distribution flowchart:

As demonstrated by the FDA timeline and distribution chart, investigating the outbreak, and coordinating what will likely be remembered as one of the largest recalls in history, proved extremely complex. To date, more than 2,700 consumer products have been affected, and the recalls are continuing (search for affected food products using the FDA Recall Interface located on the left-hand column of our blog).  Thus, despite the overwhelming frustration experienced by FDA, industry and consumers as a result of the ongoing outbreak, investigation and recalls, we once again express our gratitude to all of those working tirelessly to bring this matter to its closure.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As recalls continue following the discovery in early January 2009 of Salmonella Typhimurium in peanut butter produced by the Peanut Corporation of America (“PCA”) in Blakely, Georgia, the Texas Department of State Health Services (“TDSHS”) has now confirmed that Salmonella was also isolated from peanut meal produced at PCA’s Plainview, Texas facility. Doug McBride, a spokesman for the TDSHS, also confirmed that the sample was the same strain as the ongoing nationwide outbreak.

PCA voluntarily closed its Plainview facility weeks ago, after a private lab sample showed likely Salmonella contamination. Soon thereafter, Texas health officials ordered a recall of all products ever produced at the facility since its opening in March, 2005.

As we reported earlier, the Colorado Department of Public Health and Environment had previously linked as many as six illnesses (that were associated with the national outbreak) to products distributed from PCA's Plainview facility. Additionally, an open container of Vitamin Cottage fresh ground peanut butter, made from raw materials produced at the Texas plant, had previously tested positive for the outbreak strain as well.

PCA also recently announced, in its latest Press Release, that because of continuing bankruptcy proceedings, it is no longer able to communicate with customers of recalled products. As a result, PCA customers should contact FDA Recall Coordinators regarding the proper disposition of any recalled products.

To date, over 2,600 consumer products have been affected by the continuing recalls. The national outbreak is believed to have sickened over 650 people in 45 states, and is suspected of contributing to as many as nine deaths. For the latest information, visit the FDA Peanut Butter Recall Website.  We, of course, will continue to report additional developments as well.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As the CDC outbreak investigation continues, and thousands of products are recalled, reported cases are on the decline. 

In early January 2009, the CDC and public health officials determined that peanut butter products were the likely source of the ongoing national Salmonella Typhimurium outbreak. Product testing eventually prompted recalls of various peanut butter products produced by the Peanut Corporation of America (“PCA”). Crisis management efforts, at all levels, then began in earnest.  On January 28, 2009, PCA recalled all peanuts, peanut meal, peanut paste and peanut butter, distributed from its Blakely, Georgia facility since January 1, 2007. Following additional governmental investigations, PCA also recalled all products, including peanut meal, granulated peanuts and dry roasted peanuts, produced and distributed from its Plainview, Texas facility since the plant opened in March 2005.

PRODUCTS AFFECTED:

Although the majority of products produced by PCA were not distributed for direct consumer sale, most products were distributed to downstream manufacturers for use as ingredients in many other products. As a result, the PCA recalls prompted hundreds of these manufacturers to recall their own products as well. Given the expansive scope of the recalls, and diverse use of PCA’s products as raw materials in many consumer foods, the FDA and industry are continuing their efforts - even to this day - to determine what additional products might potentially be affected. So far, more than 2,000 consumer products have been recalled. To find products affected, use the searchable FDA Recall Interface on our blog (just scroll down the left-hand column).

PRODUCTS NOT AFFECTED:

According to the CDC, major national brands of jarred peanut butter found in grocery stores are NOT affected by the recall. As we reported previously, Girl Scout Cookies are also Not affected. For a list of additional products not affected by the ongoing recalls, please visit the American Peanut Council Website.

CDC INVESTIGATIVE UPDATES:

The following are highlights from the CDC’s most recent investigation update:

• Case count is 642 in 44 states with latest confirmed, most recent reported illness beginning on January 28, 2009;

• Although the outbreak is continuing, the numbers of new cases have declined modestly since December. Many recently ill persons report eating peanut butter and other recalled peanut-containing products; and

• Consumers should continue to check at home for recalled peanut butter containing products, and discard them.

As noted, as of February 15, 2009, 642 persons believed to be infected with the outbreak strain have been reported from 44 states. The number of ill persons identified in each state is as follows: Alabama (2), Arizona (13), Arkansas (6), California (76), Colorado (15), Connecticut (10), Florida (1), Georgia (6), Hawaii (4), Idaho (16), Illinois (9), Indiana (9), Iowa (3), Kansas (2), Kentucky (3), Maine (5), Maryland (8), Massachusetts (48), Michigan (35), Minnesota (39), Missouri (14), Mississippi (7), Nebraska (1), New Hampshire (13), New Jersey (23), New York (28), Nevada (6), North Carolina (6), North Dakota (17), Ohio (94), Oklahoma (4), Oregon (12), Pennsylvania (19), Rhode Island (4), South Dakota (4), Tennessee (13), Texas (9), Utah (6), Vermont (4), Virginia (21), Washington (18), West Virginia (2), Wisconsin (5), and Wyoming (2). Additionally, one ill person was reported from Canada (learn how food-borne illness outbreaks are tracked).

Oregon public health officials also recently confirmed, in a press release, that the ongoing outbreak may have also affected some pets. One laboratory-confirmed case of Salmonella in a dog from an Oregon household was reported, and further characterization of this Salmonella isolate is pending. Salmonella resembling the outbreak strain was also reportedly isolated by a private laboratory from recalled Happy Tails dog biscuits from the dog’s household. 

We, of course, will continue to report new developments.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As many as six cases associated with the ongoing Salmonella outbreak may have been traced to products produced at PCA's Plainview, Texas production facility. According to the Colorado Department of Public Health and Environment, these individuals reported exposure to peanut butter distributed by the Lakewood-based Vitamin Cottage. In turn, an open container of Vitamin Cottage fresh ground peanut butter, made from peanuts distributed from the Texas facility, tested positive for the outbreak strain of Salmonella. Because the container was opened, however, it is not yet known if the peanut butter was potentially contaminated at the Texas facility, or if the product was cross-contaminated with the outbreak strain after distribution (learn how food-borne illnesses and outbreaks are tracked). Vitamin Cottage, in a Recall Notice, announced last week that it was recalling these products.

It is estimated that, since opening in March 2005, PCA's Plainview, Texas facility produced and distributed about one-third of the volume of products that were distributed from the company's Blakely, Georgia plant.  Although Salmonella has not yet been isolated from any non-opened products distributed from the Plainview facility, it has been reported that truck loads of raw peanuts from PCA's Georgia facility were previously sent to the Texas plant.  Currently, the FDA is still waiting on lab confirmation from numerous product and environmental samples taken from the facility determine the extent, if any, of potential contamination. 

In addition to operating plants in Georgia and Texas, PCA also operated a facility in Virginia. The FDA has completed a comprehensive inspection of the Virginia plant, and has reported that all lab results were negative for Salmonella. Although PCA closed this facility following its bankruptcy announcement on February 13, 2009, the FDA has not taken any action against the Virginia plant or any of the products produced there.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

For nearly a decade, our food safety team has worked closely with food companies managing outbreaks and defending claims.  In most cases, outbreaks and recalls can be effectively managed by working closely with governmental agencies to gain a complete picture of an ongoing investigation, while at the same time encouraging investigators to freely and rapidly share developing information 

Unfortunately, however, accurate information regarding the potential sources or scope of an outbreak can sometimes be extremely difficult for companies to obtain.  This is because, once illnesses are identified, the CDC and FDA (along with state and local health departments) are the only entities who have real time access (via PulseNet and OutbreakNet) to the most current and important information regarding the developing outbreak. 

As a result, until developing outbreak information is actually shared by investigative agencies, food companies in the supply chain often have no idea what specific upstream companies, suppliers, product lines and/or lots might potentially be implicated in the ongoing investigation.  This is especially true when multiple companies are involved in the production of a product, and where lots are, in some instances, defined by hours or days.   In turn, most companies must wait for information to be shared by governmental investigators before even becoming aware that their products might potentially be involved - let alone to be in a position to determine whether to issue a precautionary recall of select foods.  This is also why, in our view, it is extremely important for consumers and industry alike to understand fully how food-borne illnesses and outbreaks are identified and tracked.

In the current salmonella outbreak investigation, these efforts, of course, are continuing.  Since our last update, an additional six companies have announced precautionary and voluntary recalls of select products manufactured with raw materials potentially associated with the current outbreak.  These companies include Landies Candies (select peanut butter filled chocolates), Lovin Oven (certain Peanut Crunch Chewy Granola Bars), Best Brands Corp. (peanut butter frozen cookie dough), Aspen Hills (certain cookie dough products), Nash Finch (select bakery products), and Chef Jay's Food Products (select peanut butter bars, cookies and brownies).  In turn, following the expanded recall by the South Bend Chocolate Company (which included various candies containing peanut butter), the Rain Creek Baking Corporation announced a voluntary and precautionary product withdrawal of select Peanut Butter Turtles, Baskets and Princesses. 

Although the CDC reports that it is still working to determine whether any additional food products might be affected, it confirms (as we reported previously) that these and other product manufacturers are working very closely with the agency to identify the existence and scope of any additional potentially affected foods.  We appreciate their joint and continuing efforts.  We also, of course, will continue to report as additional news develops.

• Email This
• Print
• Comments
• Trackbacks
• Share Link