And, they forgot the eight sick in Canada.

Today, the FDA came out with its “Environmental Assessment of Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in a Multi-State Outbreak of E. coli O157:H7.”

I shortened it a bit and bolded the highlights.

In early April 2018, the Food and Drug Administration (FDA), in conjunction with the Centers for Disease Control and Prevention (CDC) and state partners, began to investigate a multi-state outbreak of E. coli O157:H7 infections. When this outbreak was declared over by the CDC two months later, it was the largest outbreak of E. coli O157:H7 infections in the United States since 2006, with 210 reported illnesses from 36 states, resulting in 96 hospitalizations, 27 cases of hemolytic uremic syndrome (HUS) and five deaths.

Traceback of the romaine lettuce consumed by ill people determined that it originated in the Yuma produce growing region which consists of farms in Imperial County, California, and Yuma County, Arizona. The traceback identified a total of 36 fields on 23 farms in the Yuma growing region as supplying romaine lettuce that was potentially contaminated and consumed during the outbreak. With the exception of one instance where one of the legs of the traceback led to a single farm, it was not possible to determine which, or how many, of these farms shipped lettuce that was contaminated with the outbreak strain of E. coli O157:H7.

The epidemiological and traceback analyses performed during this outbreak informed an FDA-led Environmental Assessment (EA) of the Yuma produce growing region in collaboration with CDC and state partners from June through August 2018. The EA was conducted to assist FDA in identifying factors that potentially contributed to the introduction and spread of the outbreak strain of E. coli O157:H7 that contaminated the romaine lettuce associated with this outbreak.

The EA team made several visits to the Yuma growing region to conduct its work. During these visits, the team collected numerous environmental samples. Three of these samples were found to contain E. coli O157:H7 with the same rare genetic fingerprint (by whole genome sequencing) as that which made people sick. These three samples were collected in early June from a 3.5 mile stretch of an irrigation canal near Wellton in Yuma County that delivers water to farms in the local area, including several identified in the traceback as having potentially shipped romaine lettuce contaminated with the outbreak strain.

The romaine lettuce that ill individuals consumed was likely harvested between early March and mid-April 2018 based on the fact that reported illness onset dates occurred from March 13 – June 7, 2018. The traceback indicates that the contaminated lettuce had to have been grown on multiple farms and processed at multiple off-farm fresh-cut produce manufacturing/processing facilities.

FDA considers that the most likely way romaine lettuce became contaminated was from the use of water from this irrigation canal, since the outbreak strain of E. coli O157:H7 was found in the irrigation canal and in no other sampled locations. How this process occurred is uncertain, but based on interviews with growers and pesticide applicators, plausible explanations include direct application of irrigation canal water to the lettuce crop or the use of irrigation canal water to dilute crop protection chemicals applied to the lettuce crops through both aerial and land-based spray applications.

Information collected by the EA team indicates that, among the Yuma area farms identified in the traceback and that were interviewed, irrigation canal water was only directly applied during germination. However, aerial and ground-based spraying of crop protection pesticides diluted with irrigation canal water occurred at various times during the growing season on a number of these farms, including after a freeze event that occurred in late February. This freeze event likely led to damage of some portion of the romaine lettuce crop, which may have rendered it more susceptible to microbial contamination.

It is uncertain how the outbreak strain of E. coli O157:H7 was introduced into this 3.5-mile stretch of irrigation canal water. The first illnesses in this outbreak occurred in March 2018, and therefore the outbreak strain may have been present in the irrigation canal months before the EA team collected the positive samples, or the outbreak strain may have been repeatedly introduced into the irrigation canal. A large concentrated animal feeding operation (CAFO) is located adjacent to this stretch of the irrigation canal. The EA team did not identify an obvious route for contamination of the irrigation canal from this facility; in addition, the limited number of samples collected at the CAFO also did not yield the outbreak strain.

Low-level E. coli O157:H7 contamination of the romaine lettuce from some of the growing fields identified in the traceback could have been amplified by commingling cut romaine lettuce in wash systems at fresh-cut produce manufacturing/processing facilities. Washing of romaine lettuce either at a fresh-cut produce manufacturing/processing facility or at home by consumers may reduce but will not eliminate pathogens, including STEC, from romaine lettuce. The commingling of romaine lettuce from various farm growing fields at fresh-cut produce manufacturing/processing facilities complicated traceback efforts and made it impossible for FDA to definitively determine which farm or farms identified in the traceback supplied romaine lettuce contaminated with the E. coli O157:H7 outbreak strain.

FDA recommends that growers and processors of leafy greens:

  • assure that all agricultural water (water that directly contacts the harvestable portion of the crop) used by growers is safe and adequate for its intended use (including agricultural water used for application of crop protection chemicals);
  • assess and mitigate risks related to land uses near or adjacent to growing fields that may contaminate agricultural water or leafy greens crops directly (e.g. nearby cattle operations or dairy farms, manure or composting facility);
  • verify that food safety procedures, policies and practices, including supplier controls for fresh-cut processors, are developed and consistently implemented on farms (both domestic and foreign) and in fresh-cut produce manufacturing/processing food facilities to minimize the potential for contamination and/or spread of human pathogens;
  • when a foodborne pathogen is identified in the growing or processing environment, in agricultural inputs (e.g., agricultural water), in raw agricultural commodities or in fresh-cut ready-to-eat produce, a root cause analysis should be performed to determine the likely source of the contamination, if prevention measures have failed, and whether additional measures are needed to prevent a reoccurrence; and
  • Local in-depth knowledge and actions are critical in helping resolve potential routes of contamination of leafy greens in the Yuma growing region, including Imperial County and Yuma County moving forward. FDA urges other government and non-government entities, produce growers and trade associations in Yuma and Imperial Counties to further explore possible source(s) and route(s) of contamination associated with the outbreak pathogen and with other foodborne pathogens of public health significance. This information is critical to developing and implementing short- and long-term remediation measures to reduce the potential for another outbreak associated with leafy greens or other fresh produce commodities.

See www.fair-safety.com

Utah public health officials are investigating an increase in Shiga toxin-producing Escherichia coli (STEC) infections across the state. While the source of these infections has not been identified, several ill individuals reported visiting petting zoos, corn mazes, and farms.

Since October 1, 2018, 20 cases of STEC have been reported along the Wasatch Front and in the Central and Southwestern regions of Utah. Cases range in age from 10 months to 71 years old. Eleven cases are younger than 18. Six people were hospitalized and no deaths have been reported. “For the past five years, Utah has averaged about 13 cases of STEC during the month of October,” said Kenneth Davis, epidemiologist with the Utah Department of Health (UDOH). “An average of 113 STEC cases and 25 hospitalizations are reported each year in Utah. This increase in October is higher than normally expected,” said Davis. UDOH is working with Utah’s local health departments to investigate the illnesses and determine the source of infection.

E. coli is a bacteria spread by consuming contaminated food or water, unpasteurized (raw) milk, contact with cattle, or contact with the feces of infected people. People visiting petting zoos and areas where cattle have been are at greater risk of contracting E. coli, especially if they are not practicing good hand hygiene. Symptoms usually appear 3–4 days after exposure and can vary, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. Most people get better within 5–7 days, but some infections are severe or even life-threatening. Hemolytic uremic syndrome (HUS), a type of kidney failure, is a potentially life-threatening complication of E. coli infection. Very young children and the elderly are more likely to develop severe illness and kidney failure than others, but even healthy, older children and young adults can become seriously ill.

Practicing good hand hygiene is one of the best ways to reduce your chance of getting and spreading E. coli infection. Always wash your hands:

  • Before and after preparing or eating food
  • After using the bathroom or changing diapers
  • After touching or being around animals or places where animal feces may be present (e.g., farms, petting zoos, fairs, corn mazes, or even your own backyard)

Other protective measures include:

  • Stay home from school or work while you have diarrhea. Most people can return to work or school when they no longer have diarrhea, but special precautions are necessary for food handlers, healthcare workers, and childcare providers and attendees. Check with your employer before returning to work, and check with your child’s child care center before resuming child care.
  • Follow the four steps to food safety when preparing food: clean, separate, cook, and chill.
  • Avoid raw (unpasteurized) milk, unpasteurized dairy products, and unpasteurized juices (such as fresh apple cider).
  • Don’t swallow water when swimming and when playing in lakes, ponds, streams, swimming pools, backyard “kiddie” pools, and splash parks.

Contact your healthcare provider if you have diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine. Antibiotics should not be used to treat this infection. There is no evidence that treatment with antibiotics is helpful, and taking antibiotics may increase the risk of HUS. Antidiarrheal agents may also increase that risk.

Sixty-three more ill people from 14 states were added to this investigation since the last update on October 4, 2018. Six more states reported ill people: Hawaii, Kansas, New Mexico, Oklahoma, Texas, and Washington.

As of October 23, 2018, 120 people infected with the outbreak strain of Salmonella Newport have been reported from 22 states.  Thirty-three people have been hospitalized. No deaths have been reported.

Illnesses started on dates ranging from August 5, 2018 to September 28, 2018. Ill people range in age from less than one year to 88, with a median age of 42. Fifty-nine percent are male. Of 95 people with information available, 33 (35%) have been hospitalized. No deaths have been reported.

State and local health departments continue to ask ill people questions about the foods they ate and other exposures in the week before they became ill. Sixty-six (93%) of 71 people interviewed reported eating ground beef at home.

Epidemiologic and traceback evidence indicates that ground beef produced by JBS Tolleson, Inc. is a likely source of this outbreak. On October 4, 2018, JBS Tolleson, Inc. recalled approximately 6.5 million pounds of beef products that may be contaminated with Salmonella Newport.

A preliminary settlement of up to $4,500,000.00 has been reached in a class action lawsuit filed on behalf of those who were exposed to hepatitis A related to eating at Genki Sushi restaurants in Hawaii in 2016, but who did not become ill with hepatitis A. The class is represented by Seattle based, Marler Clark, the nation’s food safety law firm, Perkin and Faria, and Starn, O’Toole, Marcus, and Fisher, respected Hawaii firms.  See www.HawaiiHepA.com 

Genki-Stipulation for Order Stipulating Class filed 10.12.18

Genki-Order Approving Stipulation for Class Certification filed 10.12.18

Qualified class members are entitled to receive up to either $350, $250, or $150 by submitting a claim form available at www.HawaiiHepA.com or by calling 1-800-532-9250.

The hepatitis A outbreak:

On August 15, 2016, the Hawaii Department of Health (HDOH) identified raw scallops served at Genki Sushi restaurants on Oahu and Kauai as a likely source of an ongoing hepatitis A outbreak. The product of concern was identified to be Sea Port Bay Scallops that originated in the Philippines and were distributed by Koha Oriental Foods.

The class is defined as follows:

All persons who: (1) as a result of the 2016 Hepatitis A Outbreak infections linked to consuming food at thirteen Genki Sushi restaurants located on the islands of Oahu, Kauai, and Maui, were exposed to the hepatitis A virus (“HAV”) through one of three exposure-mechanisms (defined in the Exposure Subclasses), but did not become infected, and (2) as a result of such exposure, after learning of the requirement of treatment from an announcement of public health officials or a medical professional, obtained preventative medical treatment within 14 days of exposure, such as receiving immune globulin (“IG”), HAV vaccine, or blood test.

The preliminary settlement covers three subclasses:

Exposure Subclass 1 – up to $350: All Class Members who were in contact with one of the 292 persons who the Hawai’i Department of Health identified as infected with HAV as part of the 2016 Hepatitis A Outbreak. A contact is defined as:

  • All household members of one of the 292 persons
  • All sexual contacts with one of the 292 persons
  • Anyone sharing illicit drugs with one of the 292 persons
  • Anyone sharing food or eating or drinking utensils with one of the 292 persons
  • Anyone consuming ready-to-eat foods prepared by one of the 292 persons

Exposure Subclass 2 – up to $250: All Class Members who as a result of consuming food on or between August 1 to August 16, 2016, were exposed to HAV at one of the thirteen Genki Sushi restaurants located on the islands of Oahu, Kauai, and Maui, implicated in the summer 2016 outbreak of HAV.

Exposure Subclass 3 – up to $150: All Class Members who as a result of consumption of food or drink from one or more of the Secondary Establishments identified below, where an employee infected as part of the 2016 Hepatitis A Outbreak (one of the 292 persons) was found to have worked on the Identified Dates, were exposed as a result of consuming food or drink at the Secondary Establishment during one or more of the Identified Dates. The Secondary Establishments and Identified Dates are as follows:

  • Baskin Robbins located at Waikele Center, HI 96797: June 30 and July 1, 2, 2016;
  • Taco Bell located at 94-790 Uke’e St., Waipahu, HI 96797: July 1, 3, 4, 6, 7, 11, 2016;
  • Sushi Shiono located at 69-201 Waikoloa Beach Drive, Waikoloa, HI 96738: July 12, 13, 14, 15, 18, 19, 20, 21, 2016;
  • Chili’s Grill & Bar located at 590 Farrington Hwy, Kapoelei, HI 96707: July 20, 21, 22, 23, 25, 26, 27, 2016;
  • Twelve Hawaiian Airlines flights (24) flight 118 on July 24; (25) flight 117 on July 24; (26) flight 382 on July 24; (27) flight 383 on July 24; (28) flight 396 on July 24; (29) flight 365 on July 24; (30) flight 273 on July 25; (31) flight 68 on July 25; (32) flight 65 on July 25; (33) flight 147 on July 26;; (36) flight 18 on August 10; and (37) flight 17 on August 12, 2016;
  • Tamashiro Market located at 802 N. King St., Honolulu, HI 96817: July 23, 2016;
  • Papa John’s located at 94-1012 Waipahu St., Waipahu, HI 96797: August 2, 2016;
  • New Lin Fong Bakery located at 1132 Maunakea St., Honolulu, HI 96817: July 27, 29, 30, and August 1, 3, 5, 6, 2016;
  • Hokkaido Ramen Santouka, located at 801 Kaheka St., Honolulu, HI 96814: and August 3, 4, 5, 6, 9, 10, 11, 2016;
  • Kipapa Elementary School located at 95-76 Kipapa Dr., Mililani, HI 96789: August 10, 11, 12, 13, 14, 15, 16, 2016;
  • Zippy’s Restaurant located at 950 Kamokila Blvd., Kapolei, HI 96707: August 14, 18, 19, 21, 23, 25, 26, 2016;
  • Harbor Restaurant at Pier 38 located at 1133 North Nimitz Hwy, Honolulu, HI 96817: August 30-31 and September 1- 12, 2016;
  • Ohana Seafood at Sam’s Club located at 1000 Kamehameha Hwy., Pearl City, HI 96782: September 1- 11, 2016;
  • Chart House Restaurant located at 1765 Ala Moana Boulevard, Honolulu, HI 96815: September 4, 8, 9, 10, 11, 2016; and
  • McDonald’s Restaurant located at 4618 Kilauea Avenue, Honolulu, HI 96816: October 5, 7, 11, 2016.

Key dates for claimants to be aware of:

On October 15, 2018, the Notice Company will establish a website for this Settlement at www.HawaiiHepA.com which will include electronic copies of the Claim form, the Notice of Settlement for publication, the Preliminary Approval Order, and other information pertaining to the Settlement.

Beginning on or promptly after October 15, 2018, the Notice Company shall commence an online or social media campaign, to include Facebook, Instagram, or such other social media as the Notice Company deems appropriate, to disseminate notice of the Settlement

Beginning on or promptly after October 15, 2018, the Notice Company shall cause the Notice of Settlement for publication to be published once a week for two consecutive weeks in the Honolulu Star Advertiser on Oahu, Hawai’i, and Maui as a paid legal advertisement

The deadline for Class Members to request exclusion from the Class, to file objections to the Settlement, or to submit a Claim Form, shall be November 29, 2018.

A Final Approval Hearing shall be held on December 11, 2018 in the Circuit Court of the First Circuit, Hawaii, before the Honorable Judge James H. Ashford for the purpose of determining: (a) whether the proposed settlement is fair, reasonable, and adequate and should be finally approved by the Court; and (b) whether to issue a final judgment order.

The below from Dr. Scott Gottlieb just dropped into my inbox.  We all will miss Dr. Stephen Ostroff.  He has been a great champion for food safety for many years and will be missed.  I wish him well.  However, pulling Frank Yiannas from Walmart to the FDA is a brilliant move.  I have known and respected Frank for years.  His commitment to changing the culture of food safety – specifically through transparency – will be welcome at the FDA.

Dear Colleagues,

I’d like to share with you some important changes to our FDA food safety leadership team – changes that build on the program’s outstanding strength, but are also, for me, bittersweet.

Dr. Stephen Ostroff will be retiring from the agency on January 5th, after a distinguished and dedicated career in public service, including over five years of exceptional service to FDA.

Since joining the FDA in 2013, Dr. Ostroff has epitomized our commitment to the public health and science-based decision making, through his work across all of our product areas, and especially his work on modernizing the FDA’s – and the nation’s — food safety activities.

During his time at the FDA, Dr. Ostroff has served as a dedicated leader, first at the Chief Medical Officer in the Center for Food Safety and Applied Nutrition and then as the agency’s Chief Scientist.  Most recently, Steve has been instrumental in his role as Deputy Commissioner for Foods and Veterinary Medicine.

Notably, Dr. Ostroff served twice for a total of 15 months as the FDA’s Acting Commissioner, guiding the Agency through periods of transition, advancing its mission, and ensuring we upheld the FDA’s public health mission during times of change. Throughout my time as Commissioner, I’ve relied on Dr. Ostroff’s deep experience, thoughtful perspective, and strong leadership during many complicated and pivotal policy discussions, food outbreaks, and recall events.

Irrespective of his role at the Agency, Dr. Ostroff’s work advanced the FDA’s public health prerogatives and upheld its vital consumer mission. I’m immensely grateful for his many contributions. I know he’ll continue to have an important influence on the public health.

I’m delighted to announce that we’ll be welcoming Frank Yiannas to the FDA leadership team as Deputy Commissioner for Food Policy and Response. In this role, Mr. Yiannas will report directly to me, and he’ll head the Office of Foods and Veterinary Medicine.  Dr. Ostroff was instrumental in recruiting Mr. Yiannas to the Agency. Dr. Ostroff will remain at the FDA until January as a senior advisor to me, and will help Mr. Yiannas transition into his new role.

Mr. Yiannas is a globally renowned food safety and supply chain expert and thought leader.  Throughout his private sector career – most recently as Vice President of Food Safety and Health for Walmart, he’s been a food safety champion and instrumental in forging public-private collaborations to advance public health.

He’s been recognized for his role in elevating food safety standards and building effective food safety management systems based on modern science and risk-based prevention principles. Mr. Yiannas is a globally acknowledged pioneer in using blockchain technology to strengthen food traceability capabilities and enable greater food system transparency.

In addition to his food safety leadership roles at Walmart and Disney, Mr. Yiannas previously served as the president of the International Association for Food Protection. He’s an Adjunct Professor in the Food Safety Program at Michigan State University, and the author of many scholarly papers on food safety and books on food safety culture and behavior.

As Deputy Commissioner for Food Policy and Response, Mr. Yiannas will assume a critical set of charges related to food safety, first and foremost, leading the continued implementation of the Food Safety Modernization Act. In this role, he’ll work in close collaboration with the leadership of Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the food components of the Office of Regulatory Affairs. Mr. Yiannas’s deep knowledge and diverse experience will support our continued efforts to advance the FDA’s strategies for continuing to reduce food safety risks and achieving high rates of compliance with our modernization standards.

Mr. Yiannas also will serve as a senior scientific advisor to the Commissioner on various food safety and supply chain matters, including FSMA implementation. Additionally, he’ll help lead and coordinate certain cross-cutting policy activities and associated external engagement activities related to food safety and animal health. We’ll also leverage his experience and leadership across the Agency, and all product areas, on the issues of supply chain security and the use of new tracking technology, recall effectiveness, and traceback investigation processes.

We look forward to his contributions to our food safety mission and our efforts to keep families safe. Please join me in wishing Dr. Ostroff well and welcoming Mr. Yiannas to FDA.

Sincerely,

Dr. Scott Gottlieb
Commissioner of Food and Drugs

As of October 4, 2018, 57 people infected with the outbreak strain of Salmonella Newport have been reported from 16 states. A list of the states and the number of cases in each can be found on the Map of Reported Cases page.

Illnesses started on dates ranging from August 5, 2018, to September 6, 2018. Ill people range in age from less than one year to 88, with a median age of 33. Sixty-one percent are male. Of 45 people with information available, 14 (31%) have been hospitalized. No deaths have been reported.

Illnesses might not yet be reported due to the time it takes between when a person becomes ill and when the illness is reported. This takes an average of 2 to 4 weeks. Please see the Timeline for Reporting Cases of Salmonella Infection for more details.

Epidemiologic and traceback evidence indicates that ground beef produced by JBS Tolleson, Inc. of Tolleson, Arizona, is a likely source of this outbreak.

In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Thirty-six (92%) of 39 people interviewed reported eating ground beef at home. This percentage is significantly higher than results from a survey[PDF – 787 KB] of healthy people in which 40% of respondents reported eating any ground beef at home in the week before they were interviewed.  Also, several ill people ate ground beef at the same events or purchased ground beef at the same grocery store chains. When several unrelated ill people ate at the same event or shopped at the same store within several days of each other, it suggests that the contaminated food item was served or sold there.

USDA-FSIS and state partners traced the source of the ground beef eaten by ill people in this outbreak to JBS Tolleson, Inc. On October 4, 2018, JBS Tolleson, Inc. recalled approximately 6.5 million pounds of beef products that may be contaminated with Salmonella Newport.

Johnston County Hams, a Smithfield, N.C. establishment, is recalling approximately 89,096 pounds of ready-to-eat ham products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat deli-loaf ham items were produced from April 3, 2017 to Oct. 2, 2018. The following products are subject to recall:

  • Varying weights of 7 to 8-lbs. plastic-wrapped “JOHNSTON COUNTY HAMS, INC. COUNTRY STYLE FULLY COOKED BONELESS DELI HAM.”
  • Varying weights of 7 to 8-lbs. plastic-wrapped “Ole Fashioned Sugar Cured The Old Dominion Brand Hams Premium Fully Cooked Country Ham” with Sell-By dates from 4/10/2018 to 9/27/2019.
  • Varying weights of 7 to 8-lbs. plastic-wrapped “Padow’s Hams & Deli, Inc. FULLY COOKED COUNTRY HAM BONELESS Glazed with Brown Sugar.”
  • Varying weights of 7 to 8-lbs. plastic-wrapped “Premium Fully Cooked Country Ham LESS SALT Distributed By: Valley Country Hams LLC” with Sell-By dates from 4/10/2018 to 9/27/2019.
  • Varying weights of 7 to 8-lbs. plastic-wrapped “GOODNIGHT BROTHERS COUNTRY HAM Boneless Fully Cooked.”

The products subject to recall bear establishment number “EST. M2646” inside the USDA mark of inspection. These items were shipped to distributors in Maryland, North Carolina, New York, South Carolina and Virginia.

On September 27, 2018, FSIS was notified that a person ill with listeriosis reported consuming a ham product produced at Johnston County Hams. Working in conjunction with the Centers for Disease Control and Prevention and state public health and agriculture partners, FSIS determined that there is a link between the Listeria monocytogenes illnesses and ham products produced at Johnston County Hams. The epidemiologic investigation identified a total of four listeriosis confirmed illnesses, including one death, between July 8, 2017 and August 11, 2018. FSIS collected two deli ham product samples from the Johnston County Hams, Inc. facility in 2016 and in early 2018. Whole genome sequencing results showed that Listeria monocytogenes identified in deli ham both years was closely related genetically to Listeria monocytogenes from ill people. FSIS is continuing to work with federal and state public health partners to determine if there are additional illnesses linked to these products and will provide updated information should it become available.

I took the time to fully read FDA Warning Letter sent to Kerry, Inc., that manufactured Honey Smacks for Kellogg’s.  Here is the somewhat redacted beginning:

The United States Food & Drug Administration (FDA) inspected your Kerry, Inc. facility, located at 320 West Gridley Road, Gridley, IL 61744-8723 from June 14 to 29, 2018. The inspection was initiated as (b)(4) in three environmental swabs taken from your (b)(4) cereal (“cereal”) production rooms during FDA’s inspection. Further, FDA’s Whole Genome Sequencing (WGS) analysis of the three isolates of (b)(4).

Here are the highlights/lowlights of the Warning Letter:

Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing), including four Salmonella (b)(4) samples in the cereal coating room (Line (b)(4)) and one Salmonella (b)(4) sample in the cereal (b)(4) room (Line (b)(4)). Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan as required by 21 CFR § 117.170(b)(4) and the identification of contamination of RTE cereal with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation preventive control).

So, in the coming days, as I explain to clients how a company, like Kerry, can seem to ignore 113 positive Salmonella samples and continue to manufacture and ship the Sugar Smacks. The Kerry, the FDA and Kellogg’s will need to explain this to the general public.  My clients and a part of the public is included in:

Total Salmonella Illnesses: 135
Hospitalizations: 34
Last illness onset: 8/29/2018

From Food Safety News:

By Dan Flynn on September 24, 2018

A new edition of “Poisoned: The True Story of the Deadly E. Coli Outbreak That Changed the Way Americans Eat” by Jeff Benedict has been shipped to distributors by book publishers Thomson-Shore.

In the new edition, Benedict catches up with America’s best-known food safety lawyer in South Africa where the world’s largest ever listeriosis outbreak was underway with eerie parallels to America’s 1993 E. coli outbreak, which “Poisoned”explores in detail.

Twenty-five years after that game-changing E. coli O157: H7 outbreak, Benedict finds food safety lawyer Bill Marler older and grayer, but still going from one food safety crisis to another. And South Africa’s listeriosis outbreak is the worst of its kind ever, according to the World Health Organization.

The new edition of “Poisoned” is the first since the original hardback came out in 2011, followed by the paperback in 2014. Its release comes as Benedict, one of America’s top nonfiction writers, finds his book, “Tiger Woods,” riding atop the New York Times Best Seller list.

In the new second edition of “Poisoned,” he reports on Marler teaming up with South African human rights lawyer Richard Spoor to seek justice for more than 1,000 Listeria victims, including the more than 200 that died. “Nearly half of the victims were newborns that had been infected during gestation,” Benedict reports.

Benedict took some time out of one of his increasingly busy days to answer a few questions from Food Safety News (FSN). Here’s what we learned:

FSN: Jeff, we did not know just how busy you’ve been. Congratulations sir, on your new book, “Tiger Woods.” It’s a No. 1 New York Times bestseller with stunning reviews. How does that feel?

JB: “It was a privilege to write the biography of the world’s greatest golfer. Tiger is a Shakespearian figure whose popularity transcends sport. The great thing is that his comeback is a triumphant tale that has captured the attention of the world.”

FSN: About half of your books involve the world of sports. In addition to golf, you’ve authored serious works about college and pro football, the NBA, Indian gaming, and domestic violence involving athletes. How do you follow so many sports and still get anything done?

JB: “It’s not so much about following so many sports. When I write a book, I do full immersion into the subject matter, whether it’s a biography about a famous athlete or an exposé on a phony Indian tribe that built the world’s largest casino. Once I’m into a book, I pretty much block out everything else.”

FSN: You also made famous action on the Supreme Court with “Little Pink House,” the takings case out of New London, CT. Your book was made into a movie that was in theaters earlier this year. What was your role in that?

JB: “I was an executive producer on the film, which starred Catherine Keener and Jeanne Tripplehorn. One of my responsibilities was to persuade David Crosby to compose an original theme song, which turned out to be one of my favorite aspects of working on the film.”

FSN: In returning to “Poisoned” to write for the new edition, were you surprised to find so many instances of foodborne illness still occurring 25 years after the events your first wrote about?

JB: “Not really. What’s interesting is the diversity of foods that are now responsible for E. coli outbreaks. When the Jack in the Box outbreak, which is the subject of “Poisoned,” happened 25 years ago, E. coli poisoning was traced to contaminated ground beef. That used to be the norm. Now E. coli is found in leafy greens and other foods. It shows, in part, how complex our food system has become.”

FSN: Poisoned is a must read for anyone in the food safety community and many will likely want to read the updated version. Beyond this professional community, do you know who makes up the audience for a book like “Poisoned” with it’s behind the scenes look at food safety?

JB “I chose a narrative style that I thought would appeal to parents, especially mothers. I also tried to write the story in a cinematic way. It’s a very visual story. And I remain hopeful that one day it will find its way to the screen.

FSN: Jeff, you’ve been highly productive as an author and producer during the past decade and longer. What’s next for you?

JB:   “The biography of LeBron James.”

Editor’s notes: Jeff Benedict is licensed to practice law in Connecticut. He’s a distinguished professor of writing and mass media at Southern Virginia University. He is represented by Richard Pine at InkWell Management in New York City.

Poisoned FOREWARD 6-29-18

I have been a frequent advocate for more transparency at the FDA when it comes to outbreaks and recalls – especially of Class I Recalls – and a frequent critic of its failure to disclose retailers – where the recalled product was sold – and its failure to disclose manufacturers – where the product was produced.  Commissioner Gottlieb seems to be taking a major leap forward in allowing consumers more information on at lease where tainted product has been sold.

I had just finished by speech at the South American IAFP Conference, when the FDA Alert fell into my in box – Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety.

So, here is Commissioner Gottlieb’s press statement in part.

A bit of History –The agency has not traditionally released lists of specific retailers where recalled foods may have been purchased. This is because certain supply chain information is confidential between the supplier and retailer…. But there are some cases where additional information about the retailers selling potentially harmful product may be key to protecting consumers such as when the food is not easily identified as being subject to a recall from its retail packaging and the food is likely to be available for consumption. It is particularly important in situations where the product has already been linked to foodborne illness.

Retail Disclosure –… That’s why today the FDA issued new draft guidance that describes situations when disclosing retail information for products undergoing recalls is appropriate. The draft guidance outlines the circumstances when the FDA intends to make public the retail locations that may have sold or distributed a recalled human or animal food. These circumstances will particularly apply in situations associated with the most serious recalls, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

Retail Disclosure continued –… Based on this new policy, moving forward the FDA intends to publicize retail consignee lists for food recalls when the food is not easily identified as being subject to a recall from its retail packaging, or lack thereof, and if the food is likely to be available for consumption…. The new draft guidance also states that the FDA may disclose retail consignee lists in certain recall situations, including when a recalled food is related to a foodborne illness outbreak and where the information is most useful to consumers….

Perhaps, this says it all? –… I remain committed to investing in the FDA’s food program, building on our successes, and to applying the FDA’s food safety expertise to protect American families and keep our Nation safe.