May 2015

GTY_listeria_jef_150409_16x9_992On February 12, 2015 the South Carolina Department of Health & Environmental Control, during routine product sampling at a South Carolina distribution center, found three strains of Listeria monocytogenes that would later be shown to be related to illnesses reported in Kansas and four other rare strains of Listeria monocytogenes in samples of Blue Bell Creameries single serving Chocolate Chip Country Cookie Sandwich and Great Divide Bar ice cream products. These products were manufactured at Blue Bell’s Brenham facility.

The Texas Department of State Health Services subsequently collected product samples from the Blue Bell’s Brenham facility. These samples yielded Listeria monocytogenes from the same products tested by South Carolina and a third, single-serving ice cream product, Scoops, which is also made on the same production line.

On March 13 the CDC announced a link between five Kansas cases of Listeriosis (including three deaths).

On March 13 Blue Bell announced a limited product recall by removing from the market the Scoops ice cream product and other products made on the same Brenham production line.

On March 22 the Kansas Department of Health & Environment reported one positive test for Listeria monocytogenes on a chocolate institutional/food service cup recovered from a hospital in Wichita, Kansas. The cup was produced in the Broken Arrow Oklahoma plant on April 15, 2014. CDC searched the PulseNet database and identified six patients with Listeriosis between 2010 and 2014 who had Listeria monocytogenes isolates with PFGE patterns indistinguishable from those of Listeria monocytogenes isolated from Blue Bell brand 3 oz. institutional/food service chocolate ice cream cups.

On March 23 Blue Bell issued a second recall, recalling three flavors of 3 oz. institutional/food service ice cream cups—chocolate (SKU #453), strawberry (SKU #452) and vanilla (SKU #451).

On April 3 Blue Bell suspended operations at its Broken Arrow plant.

On April 7 the CDC expanded the outbreak case count to include the five Kansas cases of Listeriosis (including three deaths), three cases in Texas, one in Arizona and one in Oklahoma. Illness onset dates range from January 2010 to January 2015.

On April 7 FDA notified Blue Bell that Listeria monocytogenes was present in samples of Blue Bell Banana Pudding Ice Cream pints.  FDA collected the samples as part of a joint inspection with the Oklahoma Department of Agriculture, Food and Forestry of the Broken Arrow plant, which began on March 23, 2015.

On April 7 Blue Bell expanded the recall of ice cream manufactured in its Broken Arrow plant to include additional products that have the potential to be contaminated with Listeria monocytogenes. Blue Bell reported that the recalled products were manufactured on the same production line that produced the ice cream that showed the presence of Listeria monocytogenes and that the products were manufactured between February 12, 2015, and March 27, 2015.

On April 20 Blue Bell recalled all of its products on the market made at all of its facilities.

On May 7 the U.S. Food and Drug Administration released the findings from recent inspections at the Blue Bell production facilities in Brenham, Texas[PDF 4 pages], Broken Arrow, Oklahoma[PDF – 11 pages], and Sylacauga, Alabama[PDF – 5 pages], including the Broken Arrow plant where 17 separate positive tests for Listeria were found on equipment and in other locations from March 2013 through February 2015.

On May 14 Blue Bell signed agreements with health officials in Oklahoma and Texas requiring that the company would inform the states whenever there is a positive test result for Listeria monocytogenes in its products or ingredients.

On May 20 the FDA released inspectional observations of FDA inspections at Blue Bell Creameries facilities in Brenham, Texas in 2009 (PDF – 170KB), Broken Arrow, Okla., in 2012 (PDF – 328KB), Houston, Texas in 2007 (PDF – 196KB), and San Antonio, Texas in 2014 (PDF – 159).

Screen Shot 2015-05-28 at 7.40.38 PMAP reports today that U.S. District Court Judge Louis Sands Thursday refused to throw out criminal convictions in a Salmonella outbreak traced to Former Peanut Corporation of America after the court investigated defense attorneys’ claims of jury misconduct.

Former Peanut Corporation of America owner Stewart Parnell, his food broker brother, Michael Parnell, and the former quality assurance manager of the company’s Georgia plant, Mary Wilkerson, were convicted in September on charges related to a salmonella outbreak in 2008 and 2009 that was blamed for 714 illnesses nationwide.  Two other defendants pleaded guilty before the trial.

Court records unsealed Thursday show that months ago defense attorneys for all three defendants asked the judge to overturn the convictions after one juror came forward saying other jury members had researched the case outside the courtroom and discussed deaths that had been blamed on the outbreak. Deaths were not part of the trial evidence.

In his ruling, U.S. District Court Judge Louis Sands revealed that he had called all jury members back to court and interviewed them in closed-door sessions with attorneys in October and November. Sands said only the juror who initially approached defense attorneys — whom he referred to only as Juror 34 — claimed there was any misconduct that might jeopardize the verdicts.

“Throughout the sealed proceedings held on alleged juror misconduct, the court only uncovered one juror who could be termed biased: Juror 34,” Sands said in his ruling. He also concluded that, during the trial, “the evidence against the Defendants was overwhelming.”

Here is the Court’s Ruling.

Jose-Madrid-salsa-jar-200x300Jose Madrid Salsa of Zanesville, OH, has recalled its mild salsa because the jars are not properly sealed and therefore present a health risk. Improperly sealed jars can lead to product spoilage or contamination by the bacteria that cause botulism.

Jose Madrid salsa jar lids may have been convex instead of vacuum sealed, according to the company. Compromised seals or seams could result in product contamination by spoilage organisms or pathogens and may lead to illness if consumed. These jars were distributed in the Zanesville and Baltimore, MD, areas.

Approximately 96 jars of product sold are involved in this recall. Individual jars will show product lot code:

601 0101
04/20/16

There have been no reports to date of any illness associated with these products.

7255_largeI must admit that I have been focused on the disasters that are the recently produced 483 Inspection Reports from the three Blue Bell ice cream plants, that I hade not had a chance to review the recently received (and not publically available) 483 Inspection Report and the Establishment Inspection Report done after the CDC announcement of a 12 state, 35 person (including 7 deaths) Listeria outbreak linked to caramel apples.

Here are the 483 findings:

Food that has been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Listeria positives were found on food contact surfaces: black polishing brush, red drying brushes, auto line REDACTED lane, main packing line drain between the north and south flumes and inside area of non-painted Bidart wooden bin.

Direct food contact areas of packing equipment constructed and/or maintained in a manner so that they cannot be properly cleaned and sanitized.

Here is the full Establishment Inspection Report with a lot of redaction. A couple of things jumped out at me:

“sanitation training was not documented.”

“no cleaning and sanitation is conducted between packaging of lots.”

“conditions observed may, after further review by the Agency, be considered to be violations of the Food, Drug and Cosmetic Act or other statutes and legal sanctions available to the FDA my include seizure, injunction, civil money penalties and prosecution.”

“the Pulsed-field gel electrophoresis (PFGE) patterns of the seven positive Listeria monocytogenes environmental swabs matched the PFGE patterns from outbreak patient isolates.”

Another unnecessary, tragic outbreak.

recall-signWe hear about them so often these days–recalls of all kinds of products, from foods, to medications, to kids toys–that “recall” has become a working concept in everybody’s vocabulary.  But what is a recall?  Who has the legal obligation to announce them?  And, what legal ramifications are there of being involved in one?

First, despite having recently the legal authority to actually recall products, the FDA seldom does.  FSIS (food safety arm of the USDA) does not have the authority.

The FDA defines three kinds of recall actions that can fairly be included under the same umbrella.  A “Class I recall” should occur in “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”  (Note: “should” is italicized because sometimes food product manufacturers do not issue class I recall even when circumstances require it.)  Under this definition, a Class I recall should occur any time a food product is known or suspected to be contaminated with any foodborne pathogen, whether bacterial or viral.  The reason:  bacteria and viruses make people sick, and as a result, food contaminated by them will make people sick.

A “Class II recall” should occur in “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”  This is a little less clear than the definition of a Class I recall, but I certainly believe that the consequences of foodborne disease are simply too extreme for food companies to play fast and loose under these definitions.

A “Class III recall” is defined as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

A Class I recall should occur every time a food manufacturer knows, or has reason to know; that a product it has produced is or may be contaminated with a foodborne pathogen.  Every time!

Finally, a “market withdrawal” occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

A “market withdrawal” has no place in the world of food contamination.  Again, Listeria, Salmonella, E. coli, Campylobacter and Hepatitis A and every other foodborne pathogen are simply too dangerous for companies to try to avoid their obligations by calling what should be a recall a “market withdrawal”–something done purely to avoid the media ramifications of saying that you’re product has been recalled.  However, this has been done before under circumstances where a Class I recall was surely warranted.

So, who has the legal obligation to recall a food product when it is known or suspected to be contaminated with something that will make people sick?  The answer is that it is not the USDA for most meat, but not fish (except catfish). And, it is only the FDA until recently.  Nor, is it any other state or federal regulatory body.  The answer is that the company who produced the contaminated product is the only entity with the legal authority to recall a product.  The CDC can announce that the product has caused an outbreak (remember the Foster Farms Outbreak), but the company itself is the only entity that can truly and effectively act.

A recall is a firm’s action to remove product from commerce (e.g., by manufacturers, distributors, or importers) to protect the public from consuming adulterated or misbranded products. Although it is a firm’s decision to recall product, the FSIS and FDA coordinates with the firm to ensure it has properly identified and removed recalled product from commerce by verifying the effectiveness of the firm’s recall activities. FSIS and FDA also notify the public about product recalls.

Aside from lawsuits (which are an insufficient check, by themselves, on food safety because they are largely reactive rather than preventative) FSIS and FDA may issue public health alerts or perform product detentions and seizures, to mitigate the risk to the public when firms have inadequately removed recalled product from commerce. The Agency will investigate if it appears that a firm’s recall strategy or execution of that strategy is ineffective and, based on its findings, FSIS and FDA may seek enforcement action against the recalling firm or its consignees.

Finally, with regard to the legal ramifications of announcing a recall, again the real threat comes from the private sector.  Penalties and fines are not necessarily assessed simply because a recall happens.  Often, it is only private citizens who have been injured by the contaminated product that take legal action against a company that has recalled its product.

snba-dining-jenis_0In 2008 the FDA inspected Jenis plant and found:

  • Effective measures are not being taken to exclude pests from the processing areas.
  • Failure to provide adequate screening or other protection against pests.
  • Employees in contact with food-contact surfaces and food-packaging materials were not maintaining adequate personal cleanliness.
  • Plumbing constitutes a source of contamination to food and equipment.Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, arc unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are unnecessary for use in plant operations.
  • Employees were observed to be drinking beverages in areas were food is exposed and equipment or utensils are washed.
  • Failure to wear beard covers and hair restraints where appropriate.
  • Lack of backflow protection from piping systems that discharge waste water and sewage.

And, in 2015 after Missouri Department of Agriculture found Listeria in finished product the FDA inspected Jenis again and this time found:

  • Responsibility for assuring compliance with current good manufacturing practices relating to personnel has not been assigned to competent supervisory personnel.
  • Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.
  • Failure to provide sufficient space for placement o f equipment and storage o f materials as necessary for the maintenance o f sanitary operations and the production of safe food.
  • Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.
  • Non food-contact equipment in manufacturing and food handling areas is not constructed so that it can be kept in a clean condition.
  • The design and workmanship o f equipment does not allow proper cleaning.
  • Failure to store raw materials in a manner that protects against contamination.
  • Failure to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surfaces.
  • All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source.
  • Suitable outer garments are not worn that protect against contamination of food, food contact surfaces, and food packaging materials.
  • Failure to perform filling and packaging in a manner that protects food from becoming contaminated.

Perhaps its just me, but doesn’t the Jenis logo look a bit different if you changed the J to a P?

Perhaps because it was “Draft Guidance” and “Contains Nonbinding Recommendations”

fda-logoLets go back to February 2008 and FDA’s publication of its Draft Guidance which was published to seek comments from consumers and industry – more on that in another post.

Question? Would the Blue Bell Listeria outbreak happen if the “Draft Guidance” had been final and followed? According to the FDA:

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.

The purpose of this document is to provide guidance to industry on how to control Listeria monocytogenes (L. monocytogenes) in refrigerated or frozen ready-to-eat (RF-RTE) foods. Specifically, this document provides guidance on:

  • The formulation of RF-RTE foods to prevent the growth of L. monocytogenes;
  • Treatment of foods to destroy viable cells of L. monocytogenes;
  • Controls on ingredients;
  • Controls on storing RF-RTE foods;
  • Controls on:
    • Employee hygiene;
    • Design, construction, and operation of your physical plant;
    • Design, construction and maintenance of equipment; and
  • Sanitation controls and monitoring;
  • Monitoring critical surfaces and areas to detect locations that harbor Listeria species or L. monocytogenes;
  • Corrective actions to consider if you detect Listeria species or L. monocytogenes on critical surfaces or areas or in food;
  • Recommended training;
  • Methods for collecting environmental samples;
  • Methods for preparing environmental samples for analysis;
  • Recommended methods to detect or enumerate Listeria species or L. monocytogenes;
  • Recommended records of the controls that you establish and implement.

We recommend that you assess this guidance as it relates to each of your operations and tailor your control strategies to the specific circumstances of each operation.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

So, this is all about draft good ideas that are not required and not enforceable. I would if Blue Bell followed them – likely not.

Keep reading – Draft Guidance

CDC is collaborating with public health officials in several states and the U.S. Food and Drug Administration (FDA) to investigate a multistate outbreak of Salmonella Paratyphi B variant L(+) tartrate(+) infections. The investigation has not conclusively identified the source of this outbreak, but most ill people interviewed reported eating sushi made with raw tuna in the week before becoming ill. The investigation is ongoing and has not identified a common brand or supplier of raw tuna linked to illnesses.

This outbreak is caused by Salmonella Paratyphi B variant L(+) tartrate(+) bacteria. The illness caused by this bacteria typically includes diarrhea, fever, and abdominal cramps 12-72 hours after being exposed. Salmonella Paratyphi B variant L(+) tartrate(+) does not cause paratyphoid fever, enteric fever, or typhoid fever.

Public health investigators are using the PulseNet system to identify illnesses that may be part of this outbreak. PulseNet is the national subtyping network of public health and food regulatory agency laboratories coordinated by CDC. DNA “fingerprinting” is performed on Salmonella bacteria isolated from ill people by using a technique called pulsed-field gel electrophoresis, or PFGE. PulseNet manages a national database of these DNA fingerprints to identify possible outbreaks. This PFGE pattern has never been seen before in the PulseNet database.

As of May 21, 2015, a total of 53 people infected with the outbreak strain of Salmonella Paratyphi B variant L(+) tartrate(+) have been reported from 9 states. Most of the ill people have been reported from the southwestern United States, or reported travel to this part of the country in the week before they became ill. The number of ill people reported from each state is as follows: Arizona (10), California (31), Illinois (1), Mississippi (1), New Mexico (6), South Dakota (1), Virginia (1), Washington (1), and Wisconsin (1).

map

Illness onset dates range from March 5, 2015 to May 3, 2015. Ill people range in age from younger than 1 to 83 with a median age of 31, and 47% are female. Among 46 people with available information, 10 (22%) have been hospitalized, and no deaths have been reported.