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.

warning_0The Dallas Morning Tribune posted this morning:

The FDA published the four inspection reports on its web site this morning in response to a request by The News under the Freedom of Information Act, reports that joined the three others from 2015 the FDA had previously released.  The state inspections were done under contract with the FDA, a spokeswoman said this morning. They show that:

In 2009 an inspection of the company’s Brenham plant, an inspector dinged the plant for failing to take “all reasonable precautions to ensure that production procedures do not contribute contamination from any source.” On July 23, a stainless steel pipe conveying liquid caramel was located directly over a three-gallon filler station for Triple Caramel Ice Cream. Condensate had collected on the pipe and about 1 drop of condensate per minute was observed falling into the empty three gallon carton just prior to shipping and packaging. Condensation was also observed dripping onto an ice cream sandwich wafer just before it was filled with ice cream and packaged.

In 2012, inspectors checking the Broken Arrow, Okla., plant observed: An employee was witnessed repeatedly handling raw ingredients, or touching surfaces that would come into contact with food, with a hand that was also scratching his head, touching his waistband, and adjusting his cap. Several buckets of ingredients that were to be added directly to the food mix were kept in buckets with dried yellow or reddish residue on their sides and lids, in violation of safety and cleanliness standards.

The newly released reports also include two inspections of warehouses, one in San Antonio and one in Houston.

In 2007, an inspection of a Houston warehouse found that ice build-up, condensation and a broken light shield directly above 3-gallon containers or cases of frozen Vanilla Ice Cream were observed.

In 2014, at an San Antonio warehouse, inspectors found “pallet debris” mixed with some food ingredients at the rear side of the frozen storage area.

Noted food safety attorney Bill Marler told my colleague Karen Robinson-Jacobson said that reports like these that highlight condensation and the handling of raw ingredients should have been considered “warning lights,” for Blue Bell.  “That’s the thing you’d be worried about: cross contamination,” Marler said. “The reports don’t mention Listeria but [they’re] telling you that your plant processes are not up to par. You have a risk of moving pathogens from non [foods] contact surfaces to contact surfaces.”

As I said to the Austin American-Statesman:

“These two observations from 2012 don’t indicate that there is a good understanding of the fact that you need to use good hygiene and cleanliness to make sure you are not cross-contaminating,” said Bill Marler, a Seattle-based food-borne illness attorney.

The findings, which are not glaring clues that listeria could follow, could still signal “warning lights” of potential problems later found at both plants, Marler added.

The listeria outbreak has idled operations at Blue Bell’s four production facilities, triggered layoffs of hundreds of workers and sparked a nationwide recall of 8 million gallons of its ice cream, frozen yogurt, sherbet and frozen snacks.

Thursday’s release by the FDA also included two Texas state health department inspections at Blue Bell’s warehouses in Houston in 2007 and San Antonio in 2014, where condensation and minor issues, such as a broken light shield, were found.

The reports precede an FDA visit to Blue Bell’s manufacturing plants earlier this year, in which evidence of listeria was found, among other extensive concerns.

“These (earlier) inspection reports — they certainly aren’t as extensive or as bad as the 2015 reports — but these certainly show that you’ve got these two plants where the FDA is addressing concerns that they think the way the plant is constructed could lead to bacterial contamination,” Marler said, referring to the 2009 report. The reports, overall, “are warning lights.”

While the earlier reports stop short of mentioning listeria, it’s the dangerous bacteria that inspectors worry can be spread by leaky condensation, plant construction and cleanliness issues. The leaky condensation concern is tantamount to a leaky roof and a familiar theme to the FDA’s 2015 reports, Marler added.

“They are not specifically saying they are worrying about listeria, but the reason you would be worried about condensate dripping on food is because you are worried about listeria,” he said.

 

cdc bmp logoI was watching a King 5 TV report this evening regarding the ongoing E. coli outbreak north of Seattle that has sickened dozens – some who never even attended the event (secondary cases).  The tragedy reminded me that the Centers for Disease Control and Prevention (CDC), in its journal “Emerging Infectious Diseases,” published a study recently on “secondary” E. coli O157:H7 infections.  A “secondary” infection is roughly defined as a person who is part of an outbreak that did not consume the implicated food or was exposed to an E. coli source, but rather fell ill through exposure to an ill person who did consume the food or was exposed to E. coli.

Lead author Mary E. Locking and her colleagues reviewed E. coli outbreaks in Scotland from 1999-2008.  The authors found that 11% of the cases in the outbreaks they reviewed were secondary.  It was also reported that factors that increased the likelihood of secondary transmission included the “presence of siblings, young age of persons with primary or potential secondary cases, and waterborne compared with foodborne transmission in outbreaks.”

Person-to-person transmission in E. coli O157:H7 outbreaks has been documented in the past.  These reports include:

  • K. Ludwig, “Outbreak of Escherichia coli 0157:H7 Infection in a Large Family,” Eur. J. Clin. Microb. Infect. Dis. Vol. 16, at 238-41 (1997);
  • P. Rowe, “Diarrhea in Close Contacts as a Risk Factor for Childhood Hemolytic Uremic Syndrome,” Epidem. Infect. 110:9-16 (1993).
  • E. Belongia, et al., “Transmission of Escherichia coli 0157:H7 Infection in Minnesota Child-Care Facilities,” JAMA, at 887 (Feb. 17, 1993) (describing the inevitable spread of illness from primary to secondary cases).

Secondary cases have been recognized in the legal context as well.   Nearly a decade ago, MarlerClark took the claim of a young girl who was a secondary case in an outbreak to trial, and then up on appeal.   The Court upheld the girl’s claim.  Almquist et al. v. Finley Sch. Dist., 57 P. 3d 1191 (Wash. App. 2002) Cert Denied 75 P.3d 968 (2003).

peter-pan-captain-hookAP reports again today that ConAgra Foods agreed Wednesday to pay $11.2 million, a sum that includes the highest criminal fine ever in a U.S. food safety case, to settle a federal charge that the company shipped Peter Pan peanut butter tainted with salmonella from a plant in Georgia, sickening more than 600 people and triggering a massive recall eight years ago.

Federal prosecutors filed a single misdemeanor charge of shipping adulterated food against the Omaha, Nebraska, based company along with a plea deal Wednesday in U.S. District Court in Georgia. No company executives were charged.

The company agreed to pay $8 million in criminal fines, which the Justice Department called the highest criminal fine ever in a food investigation, plus an additional $3.2 million in forfeitures to the federal government.

It’s the latest in a series of recent prosecutions of manufacturers linked to food poisoning that has companies “taking notice in a big way,” said Bill Marler, an attorney who has represented victims of food-borne illnesses for two decades, including more than 100 sickened in the Peter Pan outbreak.

“Manufacturers are talking about the risk of misdemeanors and criminal fines and jail time,” Marler said. “The fine and this plea agreement send an incredibly powerful message to food producers across the county that they have to watch their Ps and Qs.”

In 2007, a salmonella outbreak blamed for sickening at least 625 people in 47 states was traced to the Sylvester, Georgia, plant where ConAgra made Peter Pan and Great Value peanut butter. As a result, the company recalled all of its peanut butter that had been manufactured since 2004.

U.S. Attorney Michael Moore of Georgia’s middle district, which handled the prosecution, said in a statement the plea and fine “should sound the alarm” to U.S. food producers.

“A lot of people got very sick because of the conduct in this case and we are committed to doing all we can to make sure that does not happen again,” Moore said.

The fine may do little to ConAgra’s bottom line. The company earned more than $303 million in fiscal 2014, and those results were weighed down by restructuring charges. In the latest quarter, ConAgra reported revenue of $3.88 billion.

ConAgra Chief Operations Officer Al Bolles said the company didn’t know its peanut butter was contaminated with salmonella before it was shipped.

“We did not, and never will, knowingly ship a product that is not safe for consumers,” Bolles said. “We’ve invested heavily in leading-edge food safety technology and practices over the past eight years, and we are thankful for all of the people who recognize that.”

However, the plea agreement notes that ConAgra knew peanut butter made in Georgia had twice tested positive for salmonella in 2004. Prosecutors said the company destroyed the tainted peanut butter and identified likely sources of contamination. The plea document says ConAgra had not finished fixing those problems by the time of the 2007 outbreak.

The plea deal, which still must be approved by a federal judge, extends a recent string of high-profile food safety prosecutions.

Two former Iowa egg industry executives were sentenced to three months in jail earlier this year, and their company agreed to a $6.8 million fine, for their roles in a 2010 salmonella outbreak. Last year, two Colorado cantaloupe farmers received probation and were ordered to pay $150,000 in restitution apiece after being convicted in a deadly 2011 listeria outbreak.

And last fall, the former owner of Peanut Corporation of America, Stewart Parnell, was convicted of felony charges in a 2008 salmonella outbreak also linked to peanuts processed in Georgia. Parnell awaits sentencing and could face prison. Unlike the ConAgra case, prosecutors had evidence Parnell knew he was shipping contaminated peanut butter and tried to cover it up using fake lab tests.