Wehah Farms of Richvale, CA is recalling 4600 cases of Lundberg Family Farms Sustainable Wild Blend Gourmet Rice because the product may contain a foreign object that appears to be of rodent origin.

According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on May 10, 2024, and is ongoing.

The product was distributed in California, Oregon, Wisconsin, Maine, Florida, Arizona and New Hampshire.

Recalled products:

Lundberg Family Farms Sustainable Wild Blend Gourmet Rice, 1 lb poly bag

  • Product Quantity: 4600 cases (6 bags per case)
  • Code Information: Lot Code: 231004, BBD 10/04/24

Consumers and retailers should not use this product. 

I have been at IAFP this week and learned of the tragic passing of someone I have called a friend. I first met Will on the opposite side of a terrible E. coli outbreak and tragedy. I grew to respect his kindness, humanity and integrity. Thanks to CCOF for posting this.

The CCOF community is saddened by news of the passing of Will Daniels, a champion of the organic movement whose passion, vision, and leadership inspired many people in the field of organic agriculture. Will served for 13 years on the CCOF Board from 2001–2014, which included the role of board chair.

John Foster, former director of supply chain strategy at Earthbound Farm (a position Will recruited John into), recalls his time working with Will. “Will was one of the key people who navigated the survival and resurgence of Earthbound Farm after the E. coli outbreak in 2006. If it weren’t for that team, Will included, Earthbound Farm wouldn’t have re-emerged. Most companies who have a food safety problem with that kind of national prominence wouldn’t survive it. Will was one of the reasons it did.”

Will was instrumental in the development of the Leafy Greens Marketing Agreement (LGMA), which emerged after the spinach outbreak as the current standard for leafy greens food safety. Will’s involvement in the LGMA took food safety for the fresh cut produce industry to a new level.

“Will took a scientific but humane approach to problems,” John recalls. “He held a steadfast dedication to the use of testing not just to prove safety, but to verify the process. He codified programs that produced data-driven results. He gave a programmatic approach to food safety on leafy greens. Now, nearly 20 years later, it’s just part of the fabric of the industry, and no one can imagine how it didn’t always exist.”

John says, “Will is a wonderful model for me in terms of raw leadership ability. He doesn’t get enough credit for that, I think, since he was so well-regarded in more technical areas. He launched and nurtured the careers of hundreds of people in the organic produce and food safety industries. He judged people fairly and spoke with them respectfully. He embodied the best of leadership qualities of doing right for the right reasons. My time working with him was a gift. He was very humble, which made him all the better of a leader. So many people who worked with Will are just shattered by this loss.”

In one example John recalls, Earthbound Farm conducted a full-scale, minutely detailed exercise to test response systems in the event that a recall were issued and the CEO wasn’t available for guidance. “There were more than a dozen of us in the conference room when the [randomly timed mock emergency] call came in. Will became the leader of that room in an instant, without discussion or contention. He didn’t demand it. Everyone just knew. We went through the following hours and days with everyone playing their parts well, but with Will at the helm. In that moment, I thought, ‘That’s leadership right there.’ Will’s passing is a tremendous loss, but there’s some comfort in knowing he’s left a well-entrenched legacy and a long list of us whom he helped inspire to be agents for positive change in produce, food safety, organics, and beyond.”

Cathy Calfo, former CCOF CEO, recalls her time working with Will. “When I joined CCOF in 2011, Will had served on the board and as chair for more than a decade. He helped navigate us through tedious implementation of the National Organic Program rule. But more importantly, under Will’s leadership, CCOF met the moment by becoming the largest organic certifier in the United States while maintaining its strong connection to its farmer-based membership.”

“Will believed, as we all do, that organic is the answer to building a better planet. Sharing his deep understanding of organic processes and injecting patience, kindness, and vision along the way, Will was the leader that CCOF needed at a critical time. We wouldn’t be who we are today without him, and as an organic community, we’re going to miss him.”

John McKeon, director of organic integrity and compliance at Taylor Farms, recalls the first time he met Will, which was during one of John’s first PrimusGFS inspections as an organic inspector. “For me, as an apprentice inspector at that time, it was a big deal seeing one of the big guys in organics—Earthbound Farm was quite an operation even then, around 2001. I didn’t know that seven years later I’d be working for him. I was particularly intrigued because when we were driving around the facility, Will pulled up in his red Subaru with his Grateful Dead sticker on it. I thought, this seems right for an organic inspection.”

“Will just had such a presence. He was very logical and very transparent in all of his activities. When the spinach outbreak happened, Will stepped into the bigger industry as a responsible entity for food safety. I witnessed his pragmatic, scientific approach to problem solving. It was really something to be able to work under Will. That’s where I learned how to balance food safety and organic, regenerative, sustainable practices—working to use our production methods with the planet instead of in dominance over it.”

“Beyond all that, he was a guy you could see in his office, or run into at a restaurant, and sit down and have a conversation with or just goof off. He was human. That was the thing that helped congeal our Earthbound Farm department around him. His mentality of ‘we’re all in it together’ carried a lot of people forward. He was the basis for so many people who are now driving quality, food safety, and organic integrity; he allowed them to come forward.”

“It was a real pleasure to hang out with him. I really miss him.”

If you would like to show support for Will’s family, please visit their GoFundMe.

I would urge everyone to read our petition to FSIS and then this recent article from the University of Illinois.

Raw poultry is one of the main causes of Salmonella poisoning, which affects thousands of people in the U.S. every year. A new study from the University of Illinois Urbana-Champaign shows that few products with high levels of very virulent Salmonella strains are responsible for most of the illnesses from raw chicken parts. The researchers suggest regulation efforts should focus on detecting and preventing those types of high-risk contamination. 

“Over the last 20 years, the poultry industry has done a really good job of lowering the frequency of Salmonella in poultry. However, the number of people who are getting sick from these pathogens hasn’t declined. The U.S. Department of Agriculture is considering changes to how they regulate Salmonella based on level and serotype, and our research supports those efforts,” said study co-author Matt Stasiewicz, an associate professor in the Department of Food Science and Human Nutrition (FSHN), part of the College of Agricultural, Consumer and Environmental Sciences (ACES) at Illinois.

There are over 2,600 serotypes, or sub-groups, of Salmonella bacteria and they differ in their capacity to make people sick. Salmonella Kentucky is one of the most common serotypes in U.S. chicken, but it is less likely to cause human illnesses compared with three more virulent strains linked to multiple outbreaks of salmonellosis.

The researchers wanted to assess the public health risk from Salmonella contamination of chicken parts, comparing the impact of high- and low-virulence serotypes at different levels.

“We applied a mathematical method called Quantitative Microbial Risk Assessment, using datasets on contamination from the USDA Food Safety and Inspection Service as input. We set different levels and serotype thresholds to estimate the risk of getting ill from each of them,” explained lead author Minho Kim. He conducted the study as a doctoral student in FSHN, and now works as a postdoctoral research fellow with the USDA Agricultural Research Service.

The baseline calculations yielded an estimate of about two salmonellosis cases per 1 million servings of chicken consumed. In all the scenarios, risk was concentrated in a few products with high levels of highly virulent serotypes. Less than 1% of illnesses were attributed to Salmonella Kentucky, while 69% to 83% of illnesses were attributed to products with high levels of Enteritidis, Infantis, or Typhimurium serotypes. These findings are consistent with what seems likely to be the proposed changes in regulations, the researchers stated.   

The next step is to figure out how to specifically target those virulent strains. Kim and Stasiewicz suggest possible approaches such as using statistical processing control to monitor Salmonella, a test-and-hold procedure for batches of products, or vaccinating chickens against the high-virulence serotypes.

However, they emphasize that their research focuses on estimating the risk, and it is up to the poultry industry — which knows best how to improve its processes — to find strategies to manage it.

“Our research helps to align regulations with public health, and then the industry will figure out the right way to do it,” Stasiewicz said. “These findings support the USDA’s initiative to shift regulation towards high-level, high-risk contamination events rather than frequency of detection. I hope this will help consumers understand it’s a good strategy that’s designed to protect public health. The layperson could think the new regulations are letting the industry off the hook, because they only target specific pathogens and allow contaminated chicken to get through production. But it makes sense to focus on the strains that are actually making people sick.” 

Stasiewicz said you can think of it as a three-step process: the science shows where the risk is, the government sets the regulatory policy, and the industry figures out how to manage risk reduction.

The researchers stressed that consumers should still follow food safety guidelines when preparing poultry, such as washing their hands, avoiding cross-contamination, and ensuring the meat is properly cooked.

The paper, “Risk Assessment Predicts Most of the Salmonellosis Risk in Raw Chicken Parts is Concentrated in Those Few Products with High Levels of High-Virulence Serotypes of Salmonella,” is published in the Journal of Food Protection [DOI: 10.1016/j.jfp.2024.100304]. This study was supported by a U.S. Poultry and Egg Association grant. 

I am speaking at IAFP in Long Beach in the morning, perhaps I will get some answers?

In October, San Diego County and Orange County Department of Health issued public notifications about a Salmonella Typhimurium outbreak investigation linked to Raw Farm LLC brand unpasteurized milk and milk products. At the time of those public notifications, 16 persons with Salmonella Typhimurium infections had been identified among residents of those counties, nine in San Diego and seven Orange County. Fresno County did not issue a press release, but two Fresno County residents with Salmonella Typhimurium infections linked to the outbreak were identified in October and December, 2023. 

When the public notifications were issued, all nine cases identified by San Diego County in October, 2023, reported consuming Raw Farm LLC brand raw milk or raw milk products. According to the FoodNet Population survey, 1.9% of people in California reported consuming raw milk, and 8.4% reported eating raw cheese in the 7 days prior to being surveyed. Therefore, 9 of 9 persons with the same strain of Salmonella Typhimurium reporting raw milk or milk products is much higher than expected by chance (statistically significant using a binomial probability model, p <0.0001). Furthermore, all the cases mentioned the same brand of product. The evidence linking these illnesses to Raw Farm LLC brand raw milk or raw milk products was already overwhelmingly strong when the public notifications were issued.

CDPH’s reported that as of January 4, 2024, the number of people that became ill as part of this outbreak had grown to 151, including 18 persons who required hospitalization. Persons became ill from September through November, 2023. Seventy-two percent of the persons who became ill with the same strain of Salmonella Typhimurium reported consuming raw milk. Among the California cases that reported consuming raw milk and remember the brand, 93% reported Raw Farm LLC brand raw milk. At that point in the investigation, raw milk consumption among ill persons in the outbreak continued to be much higher than expected based on the background raw milk consumption of 1.9% in California (statistically significant using a binomial probability model, p <0.0001).

Samples of milk collected on October 19 and 25, 2023 at the farm as part of the investigation tested positive for Salmonella Typhimurium of the outbreak strain. A retail sample of Raw Farm LLC raw milk with a best by date of October 27 also tested positive. The information on the report is consistent with the raw milk sequences on NCBI, which were indistinguishable (0 SNPs) and highly related to the other clinical samples that were part of this outbreak. The raw cheese sample on NCBI was uploaded after the report was written.

The California interim outbreak report was written when the outbreak was on-going. According to the PowerPoint summary of the investigation, as of February, 2024, the number of people ill had grown to 165, including 20 hospitalizations in four states, California, New Mexico, Washington and 1 unidentified (Mark, you are not stupid enough to sell milk illegally across state lines), nearly 40% of the ill children aged five or younger. The sequence data on NCBI shows that the most recent upload associated with this outbreak occurred in June, 2024; therefore, the outbreak may still be still on-going.

It is important to note that four cases in the outbreak had co-infections-they had Salmonella Typhimurium and at least one other pathogen: Campylobacter and/or Shiga toxin-producing E. coli (STEC). Co-infections and/or outbreaks caused by more than one pathogen are not uncommon when the illnesses are associated with raw milk consumption.

Whole Genome Sequencing (WGS) is the analysis of the DNA of the organism of interest, in this case, Salmonella Typhimurium. It determines the order or sequence of almost all the bases that make up the organism’s genome. There are several ways to analyze the genomic sequencing data. One of those methods analyzes single nucleotide polymorphisms (SNPs) or differences in single base pairs (the DNA building blocks). This incredibly detailed information about the organism, the genetic sequence of bacteria, helps epidemiologists identify which illnesses may come from the same source. All the sequences from bacteria that are isolated from human samples, and from food or environmental sources are uploaded to a public facing database at the NCBI, where the relatedness of sequences can be easily evaluated. When people become ill from a common source, the bacteria isolated from their specimens are closely related (zero to a small number of SNP differences). WGS is a very powerful tool when used in conjunction with epidemiological data for identifying and solving outbreaks.

An NCBI search revealed 162 uploaded sequences that were highly related (0 to 6 SNPs, average 0 SNPs) from October, 2023 to June, 2024. Of the 162 sequences, 157 were listed as clinical (i.e., from human specimens). Four of the uploaded sequences (PNUSAS404312, PNUSAS404313, PNUSAS404314, PNUSAS408523) were environmental samples labeled as raw milk, uploaded on November 28 and December 13, 2023, by the CDPH Food and Drug Laboratory Branch (FDLB). The remaining one (PNUSAS419013) was from raw cheese, uploaded by FDLB on February 7, 2024. The high degree of relatedness among the isolates on NCBI means they were all part of a common-source outbreak. The Salmonella Typhimurium isolated from raw milk and cheese, or their production environment, conclusively links those 157 Salmonella Typhimurium isolates from clinical samples to those products.  In sum, the sequencing data confirm that approximately 157 persons were part of a common-source outbreak, and raw milk and raw cheese from Raw Farm LLC were the source of those illnesses.

The overwhelmingly high number of ill persons reporting consuming raw milk from Raw Farm LLC in the week prior to their illness, coupled with the positive raw milk and cheese samples and the WGS data conclusively linked the illnesses to consumption of those products.

Anyone have some answers?

Actually, No.

Readers, can you help me understand why CDPH would not tell the public that there had been an outbreak liked to raw milk with at least 165 sick, 20 hospitalized with nearly 40% being children 5 or younger?

I will also be at IAFP this week, so stop by the Food Safety News booth and we can chat.

Here is the press statement:

CDPH takes its charge to protect public health seriously and works closely with all partners when a foodborne illness outbreak is identified. After being alerted by San Diego County Public Health last October about multiple Salmonellosis cases, CDPH conducted a robust public health investigation in concert with local officials and the California Department of Food and Agriculture (CDFA), which regulates raw milk producers in California. On October 24, 2023, CDPH posted a food recall notice on its website (see attachment). (That notice was later archived upon conclusion of the investigation.) The department also notified the public of the recall on social media multiple times (see links below). CDPH, working with CDFA asked firm management at Raw Farm for a voluntary recall. Raw Farm was cooperative and posted a recall on October 25. Because the majority of illnesses were reported in San Diego county, San Diego County Public Health led the public notification process (media releases are available on their website, including one on October 20 and October 25). The outbreak and case investigation handled by CDPH ended on May 4, 2024. Centers for Disease Control and Prevention (CDC) was aware of the investigation and assisted with some coordination with cases in other states.

Social media posts related to recall:

Thank you,

California Department of Public Health / Office of Communications

www.cdph.ca.gov

In addition to the one that has sickened at least 165 and was recalled in October 2023.

2024 Raw Farm LLC Recalls and Outbreaks:

February 2024 E. coli Raw Milk Cheese Outbreak and Recall

Other 2023 Raw Farm LLC Recalls and Outbreaks:
May 2023 Campylobacter Raw Milk Recall
August 2023 Salmonella Cheese Recall 

Here is bit(e) of history:

Organic Pastures Dairy Company (OPDC) & Raw Farm 
Started OPDC in 2000 – Changed name to Raw Farm LLC in 2020

Organic Pastures Dairy Company Recalls and Outbreaks:
September 2006 Raw Milk E.coli Outbreak: 6 ill/2 HUS 
September 2007 Raw Cream Listeria Recall
December 2007 Raw Milk Campylobacter Outbreak: 8 ill 
September 2008 Raw Cream Campylobacter Recall
November 2011 Raw Milk E.coli Outbreak: 5 ill/3 HUS 
May 2012 Campylobacter Raw Milk/Cream Outbreak: 10 ill, reported illnesses from Jan. thru April
October 2015 Campylobacter Raw Milk Recall
January 2016 E.coli Raw Milk Outbreak: 9 ill/2 HUS

On October 18, 2023, an investigation of an outbreak associated with Raw Farm, LLC products was initiated. At least eight Salmonella cases who had reported consuming raw milk from Raw Farm, LLC of Fresno County, California, were discovered and reported to the California Department of Public Health (CDPH). Another nine cases from another county were discovered to be infected with Salmonella Typhimurium. Local health departments, CDPH, and the California Department of Food and Agriculture (CDFA) investigated this outbreak. This outbreak was assigned the CDC ID 2310MLJPX-2.

For this investigation, a confirmed case was defined as a laboratory confirmed infection of S. Typhimurium, within 2 alleles of code SALM1.0 – 6745.4.2.1x, that was highly related (within 4 SNPs) based on whole-genome sequencing (WGS) to the outbreak strain in a person with symptom onset since September 15, 2023. A probable case was defined as a laboratory-confirmed Salmonella infection, in a person who reported consumption of Raw Farm raw milk and had symptom onset since September 15, 2023.

As of February 12, 2024, 165 cases have been reported from four states: CA (162), NM (1), WA (1), and PA (1). Illness onsets ranged from September 21 to December 20, 2023. Symptoms included fever, bloody or watery diarrhea, nausea, vomiting, and headache. The age range of cases was <1 to 87 years (median 7). Sixty-five percent of cases were male. Twenty cases (14%) were known to require hospitalization; no deaths were reported. Four cases were discovered to have co-infections with S. Typhimurium and Campylobacter and/or STEC.

All cases who met the confirmed case definition, regardless of raw milk exposure, and all cases who met the probable case definition were also interviewed with a raw dairy supplemental questionnaire to ascertain the brand and purchase location of their exposure and whether they had any leftover product, along with any other details of raw dairy exposures prior to illness onset. Seventy-two percent (91/127) of cases reported consuming raw milk in the initial and/or supplemental questionnaire. Eighty-five percent (46/54) of California cases, in interviews with the supplemental questionnaire, reported consuming raw milk. Of those who consumed raw milk and recalled brand information, 93% (41/44) consumed Raw Farm brand raw milk. 

The proportion of confirmed patients who reported raw milk consumption during the week prior to illness was significantly higher (binomial p-value <0.001) than expected by chance alone, compared to the estimated 1.9% background rate of raw milk consumption during the prior week based on 2018 and 2019 FoodNet CA population survey estimates. All five patients who reported consuming or likely consumed other types of raw dairy products (including various cheeses, cream, and butter) also confirmed drinking Raw Farm raw milk.

Based on epidemiologic, laboratory, and traceback investigations conducted by local and state officials that indicated that raw milk consumed by cases was produced at Raw Farm, Raw Farm, LLC recalled their raw milk and raw heavy cream on October 24, 2023, including products with best by dates from October 11, 2023 to November 6, 2023. Products were sold at the following locations: Bristol Farm, Clark’s Nutrition, Elliott’s Natural Foods, Erewhon Market, Frazier Farm Market, Jimbo’s, Lassen’s Natural Foods, Lazy Acres, Lunardi’s, Mother’s Market, Nugget Market, and Sprouts Farmers Market locations. Specifically, the recalled products included the Raw Whole Milk in a gallon container (128 ounce) with item number 1000 and the barcode 835204006004, the Raw Whole Milk in half gallon (64 ounce) container with item number 1005 and the barcode 835204000095, the Raw Whole Milk in quart containers (32 ounce) with item number 1010 and the barcode 835204000019, and Raw Heavy Cream in 16 ounce containers with item number 3050 and the barcode 835204000132.

Beginning October 19, 2023, the CDPH, CDFA, and local health departments collected Raw Farm product samples (raw milk, cream, kefir and cheese) from the Raw Farm dairy, retail stores, and patients’ homes. Samples were tested for Salmonella and underwent WGS if positive. A total of four samples were found to be positive for the outbreak strain: A sample of raw milk collected by CDFA at the Raw Farm dairy in Fresno, CA on October 19, 2023, was found to be positive for S. Typhimurium matching the outbreak strain; Another sample from the Raw Farm dairy, collected by CDFA on October 25, 2023, was also positive for the outbreak strain of S. Typhimurium; One other sample collected on an unknown date from the dairy farm was also found to be positive for the outbreak strain; One retail sample of raw milk in a 64 oz. container with a best by date of 10/27/2023 tested positive for the outbreak strain of S. Typhimurium. The remaining samples from retail stores and patients’ homes were negative for Salmonella. 

Epidemiologic, laboratory, and traceback investigations have identified Raw Farm brand raw (unpasteurized) milk as the source of this outbreak. The investigation was ongoing as of February 2024.

Dairy products from Raw Farm LLC in Fresno, CA were previously recalled in May 2023 following detection of Campylobacter, and later recalled in August 2023 due to Salmonella in cheese products. A plethora of other outbreaks (STEC O157, STEC O103, Campylobacter) associated with Raw Farm products have been detected since 2006.

As of July 9, 2024, Seattle-King County Health Department investigators reported 6 people sick with Salmonella linked to the Bellevue IHOP. According to the DOH:

  • After being notified of three people who became sick after eating at the IHOP in Bellevue in October and November 2023, Public Health investigators requested source information and food receipts from the restaurant on January 11, 2024. Investigators visited the restaurant on January 16, 2024. Investigators reviewed the restaurant’s food preparation processes and did not identify factors that may have contributed to illnesses.
  • On March 18, 2024, Public Health learned of someone who became sick after eating at this IHOP in Bellevue on February 26, 2024. Laboratory testing confirmed that this person had the same strain of Salmonella as the other people who became sick in this outbreak. In response, we re-opened this outbreak investigation.
  • On April 2, 2024, Public Health visited the restaurant to take environmental samples. This means we tested various surfaces looking for Salmonella. We sent the samples to the Washington State Public Health Lab for testing.
  • On April 10, 2024, one of the environmental samples came back positive for Salmonella which also matched the outbreak strain. That same day, Public Health ordered IHOP to close and conduct a thorough cleaning and disinfection.
  • On April 12, 2024, Public Health visited the restaurant to confirm the deep cleaning was done appropriately, and the facility opened the same day.
  • On May 24, 2024, Public Health learned of someone who became sick after likely eating at the IHOP in Bellevue on May 7, 2024. Laboratory testing confirmed that this person had the same strain of Salmonella as the other people who became sick in this outbreak. In response, Public Health ordered the IHOP in Bellevue to close until further notice.
  • On Friday, June 7, 2024, the IHOP in Bellevue reopened after Public Health verified the facility had conducted extensive cleaning.
  • On Thursday, June 27, 2024, Public Health ordered the IHOP in Bellevue to close again. This came after Public Health learned of another person who became sick after eating at this location. This person ate there on June 8, 2024, one day after the restaurant reopened after Public Health verified the facility had conducted extensive cleaning. Public Health will conduct environmental sampling of the location, to test various surfaces for Salmonella, before the facility is able to reopen.
  • On Friday, June 28, 2024, Public Health tested various environmental surfaces at IHOP. All results came back negative for Salmonella (this does not completely rule out the possibility that Salmonella may still exist in the environment). Public Health required IHOP to do a thorough cleaning and disinfection of the restaurant. Public Health verified that the cleaning and disinfection had taken place, and IHOP was allowed to reopen Friday, July 5.
  • This investigation is ongoing and we will continue to monitor the situation and provide further updates.

However, in documents we received in our investigation of the IHOP outbreak we learned that at least 11 people were sickened as of April 2024. It would be interesting to see if in fact that number has grown. See Report.

Seattle King County Department of Public Health investigated an outbreak of salmonellosis (caused by Salmonella bacteria) associated with IHOP in Bellevue. The people who became sick reported eating a wide variety of breakfast foods at IHOP. Public Health reopened the investigation on March 27, 2024, after another person tested positive with same strain of Salmonella. Additionally, we have received confirmation that IHOP in Bellevue received onions that was part of a national recall. We were able to positively detect the same strain of Salmonella at the facility that since closed and did a thorough cleaning before reopening.

11 people from 11 separate households reported becoming sick. The people who became sick ranged in age from 17 to 70 years old. All 11 people developed one or more symptoms consistent with salmonellosis, including nausea, vomiting, abdominal cramps, diarrhea, bloody stool, and fever. We did not identify any ill employees.

At the time of our initial posting, we disclosed three cases linked to this outbreak. Since we were able to detect Salmonella Thompson in the facility, and since the facility received onions linked to a larger outbreak, we are including cases that were not previously confirmed to be part of this outbreak.

Public Health conducted interviews with the people who became sick to identify potential common exposures and identified that six became sick after eating at IHOP in Bellevue. No specific food was identified. Environmental Health Investigators requested source information and food receipts from the restaurants on January 11, 2024. Investigators visited the restaurant on January 16, 2024. Investigators reviewed the restaurant’s food preparation processes and did not identify factors that may have contributed to the outbreak. The facility conducted a thorough deep cleaning and reinforced food safety training with staff. After receiving notice of the positive case in late March, Environmental Health Investigators visited the facility on April 02, 2024, to test for the Salmonella strain. After detecting Salmonella Thompson in the facility, the food service facility closed on April 10, 2024, to complete a thorough cleaning and disinfection. Environmental Health Investigators revisited the facility on April 11, 2024, and verified proper compliance with cleaning and disinfection. The food facility reopened on Friday, April 12th.

All 11 cases had testing that identified Salmonella infections via culture. Further testing found all 11 cases had the same strain of Salmonella based on genetic fingerprinting (whole genome sequencing or WGS) at the Washington State Public Health Laboratory.

California Department of Health – you are complicit in this bullshit. CDOH – you should be embarrassed.

Watch the videos and read the articles here: https://realrawmilkfacts.com

This just popped into my inbox:

ANTI-RAW MILK AGENDAS, DIRTY TRICKS, AND CORRUPT FDA/MEDIA

Kaleigh Stanziani — July 11, 2024

FDA and affiliated “Food Safety Attorney” attempting to punish RAW FARM by rehashing 10-month-old news. There is NO RECALL.

Let this be clear, we have been in a battle for years with the FDA over your right to access clean delicious raw milk.  This is just the most recent of a long history of dirty tricks. IF YOU SEE CONCERNING AND QUESTIONABLE HEADLINES, PLEASE BE VERY CLEAR WE ARE IN A WAR ZONE WITH A CORRUPT SYSTEM THAT HATES RAW MILK.

We are disappointed that the media has taken an old story of our 2023 salmonella recall and made it appear to be a new issue.  

There is no “new recall”, our products are safer and more delicious than ever.  

There is a long-standing hatred of raw milk by a particular publicity-seeking, “food safety attorney” with close connections to the FDA.  Your support of our family farm allows us to continue this important battle for your freedom to choose nourishing and whole foods for your family.  Our hearts are filled with purpose and we will never stop fighting for your health and immune system.  

Mark, first, my beef is with the California Sate Health Department that spiked that your products sickened at least 165 people in four states with a combination of Salmonella, Campylobacter and E. coli (you are not illegally selling raw milk across state lines again?).

BTW, Mark, have I missed any outbreaks and recalls linked to your product?

In addition to the one that has sickened at least 165 and was recalled in October 2023.

2024 Raw Farm LLC Recalls and Outbreaks:

February 2024 E. coli Raw Milk Cheese Outbreak and Recall

Other 2023 Raw Farm LLC Recalls and Outbreaks:
May 2023 Campylobacter Raw Milk Recall
August 2023 Salmonella Cheese Recall 

Here is bit(e) of history:

Organic Pastures Dairy Company (OPDC) & Raw Farm 
Started OPDC in 2000 – Changed name to Raw Farm LLC in 2020

Organic Pastures Dairy Company Recalls and Outbreaks:
September 2006 Raw Milk E.coli Outbreak: 6 ill/2 HUS 
September 2007 Raw Cream Listeria Recall
December 2007 Raw Milk Campylobacter Outbreak: 8 ill 
September 2008 Raw Cream Campylobacter Recall
November 2011 Raw Milk E.coli Outbreak: 5 ill/3 HUS 
May 2012 Campylobacter Raw Milk/Cream Outbreak: 10 ill, reported illnesses from Jan. thru April
October 2015 Campylobacter Raw Milk Recall
January 2016 E.coli Raw Milk Outbreak: 9 ill/2 HUS

See you in court brother.

WARNING LETTER
CMS #679972

June 12, 2024

Dear Mr. Laguarta:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) food manufacturing facility located at 1703 East Voorhees Street, Danville, IL 61834 from December 19, 2023, through February 2, 2024. Your facility manufactures RTE granola bars and RTE cereals. During the inspection of your facility, FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). This inspection was initiated in response to a Reportable Food Registry (RFR) report and recall of your granola bars and granola cereals announced on December 15, 2023. FDA also collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Salmonella Cubana, a human pathogen, in your facility.

Based on FDA’s inspectional findings and analytical results for the swabs collected at your facility, we have determined that the RTE granola bars and cereals manufactured in your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Codes (U.S.C.) § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links on FDA’s website at http://www.fda.gov.

At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at your facility. We received your written response dated February 23, 2024, which included statements regarding evaluation of the violations and promised future corrections and received further information regarding your intentions for the facility dated April 3. After reviewing the inspectional findings and the response provided by your firm, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Reportable Food Registry Report and Recall

The Quaker Oats Danville facility (you) performed (b)(4) finished product testing of your chewy granola bars from (b)(4) Chewy lines in the facility (i.e., Chewy (b)(4)). On November 22 and 23, 2023, you collected a (b)(4) sample of “Chewy Chocolate Chip Granola Bars” from Chewy Line (b)(4), which was reported as a presumptive positive on November 25, 2023. The positive sample was later confirmed on December 11, 2023, following an investigation of a suspected (but not confirmed) laboratory error concerning the initial results. On December 12, 2023, your corporate Research & Development laboratory in Plano, TX, confirmed the finished product sample as positive for Salmonella Cubana and that the isolate matched (via (b)(4)) previous isolates identified in the facility during your routine environmental monitoring of areas upstream to Chewy Lines (b)(4)on as recently as September 7 and October 4, 2023, near the (b)(4) and the RTE area on the (b)(4) floor, respectively. On December 14, you notified FDA of your decision to recall specific granola bars and granola cereals due to the potential of being contaminated with Salmonella and filed an RFR report. We remind you that under Section 417(d) of the Act [21 U.S.C. 350f(d)], an RFR report must be filed within 24 hours of determination of a reportable food.

On December 19, 2023, FDA collected samples (environmental swabs) of your production environment. FDA analysis of sample INV 1234817 confirmed one swab was positive for Salmonella spp. The swab was collected in a crack on the floor in the (b)(4); the investigator noted that apparent food residue was observed at the sampling location. Whole genome sequencing (WGS) was conducted on the Salmonella isolate obtained from the FDA environmental swabs. The WGS analysis confirmed the isolate to be SalmonellaCubana and the isolate did not match other food, environmental, or clinical isolates in the database. We advised you of the WGS results via a conference call on January 3, 2024. You acknowledged that you had identified historical isolates of Salmonella Cubana in your facility since at least 2020. These findings may indicate that the same strain of SalmonellaCubana has survived since 2020.

On January 11, 2024, your laboratory analysis identified that Salmonella Cubana that originated in the (b)(4) Room and contaminated the granola line had spread to (b)(4)areas of the extruded RTE cereal line, (b)(4). This included areas where extruded material is exposed to the environment without an additional kill-step. That same day you expanded your recall to cover all RTE cereals, bars, and snacks within shelf-life manufactured at the Danville facility or manufactured with ingredients manufactured at the Danville facility.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)

Your corrective action procedures did not ensure appropriate action was taken, when necessary, to reduce the likelihood that environmental contamination will recur, as required by 21 CFR 117.150(a)(2)(ii), when you detected Salmonella in your facility’s environment.

You found Salmonella Cubana in 13 environmental samples since June 2022, including on September 7, 2023, and October 4, 2023. The positive swabs were located on floors (b)(4)of the facility, including the (b)(4), the RTE area on the (b)(4), and Quaker Natural Granola areas (b)(4). All (b)(4) of these Salmonella Cubana isolates share the same pattern via (b)(4) conducted by your firm. Finding Salmonella Cubana with the same (b)(4) pattern over this period of time indicates you likely had a resident strain, and you should have developed your corrective actions accordingly.

Your records of corrective actions included cleaning/sanitizing the affected area and additional (b)(4) swabbing, but they did not include corrective actions that that would have reduced the likelihood that the problem would recur. For example, your “Pathogen Environmental Monitoring (PEM)” investigation worksheet dated September 15, 2023, identified potential harborages or niches associated with buildup or water pooling in pathways on the floor under the (b)(4) and at the “sandwich point” (b)(4) in the (b)(4)Room on the (b)(4) floor (zone (b)(4) areas) but did not consider other areas as potential sources of contamination. Your PEM investigation worksheet dated October 11, 2023, identified potential harborages or niches associated with buildup or water pooling in pathways (b)(4). Your root cause analysis identified the leaking HVAC pipe as the source of water in the area, but a leaking pipe would not be the source of Salmonella. Furthermore, your corporate PEM program states that “repeat positive results typically indicate further deep dive,” but you did not have any records indicating corrective actions beyond normal cleaning/sanitizing and maintenance (e.g., “deep dive” corrective actions) were taken at your facility.

The repeated findings of Salmonella Cubana in your facility demonstrate that your corrective action procedures taken in response to environmental contamination in 2022 and before November 2023 were not sufficient to reduce the likelihood that environmental contamination would recur, as required by 21 CFR 117.150(a)(2)(ii). It is essential to identify the areas of the food processing plant where Salmonella can survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.

We received your notice dated April 3, 2024, stating your intention to cease operations at the Danville facility. However, you have other manufacturing facilities and should evaluate if such corrective actions are necessary in your other plants to reduce the likelihood of a similar event. Furthermore, given the apparent ongoing contamination of SalmonellaCubana in the Danville facility, special care should be taken if you determine that any equipment or utensils from the Danville facility can be safely utilized at other food manufacturing facilities.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)

Your plant equipment and utensils used in manufacturing and processing were not designed and of such material and workmanship as to be adequately cleanable, or adequately maintained to protect against contamination, as required by 21 CFR 117.40(a)(1).

(b)(4).

Previous to notifying FDA on April 3, 2024, of your intention to cease operations at the Danville facility, you acknowledged gaps in the (b)(4), which is (b)(4). You stated that you were evaluating approaches to modify this system if you resumed use of the (b)(4)equipment at the facility, including using a combination of timing and recirculation to prevent downstream contamination and completing run time studies to scientifically define appropriate run times with a combination of intermittent and extensive cleaning. You also stated that you were considering design and product flow changes to the equipment that will improve raw to RTE segregation.

Although you intend to cease operations at the Danville facility, you have other manufacturing facilities and should evaluate if similar corrective actions are necessary in your other plants to reduce the likelihood of contamination.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

In addition, we have the following comment:

We recommend that you consider incorporating WGS as a tool to investigate pathogen isolates obtained in your environmental monitoring program and/or your finished product testing program. The use of WGS to analyze and investigate any pathogen isolated from your production environment or RTE food products would provide the most complete information available to identify and implement appropriate and effective corrective actions, including steps to prevent the contamination from recurring and steps to ensure contaminated product does not enter commerce.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to Lauren Crivellone, Compliance Officer, 550 W. Jackson Blvd., Chicago, IL 60661. If you have any questions about this letter, please contact Lauren Crivellone 312-206-5264 or via e-mail at Lauren.Crivellone@fda.hhs.gov.

Sincerely,
/S/

William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food East
Division 6

Cc: Mr. Steven Williams, CEO
PepsiCo Foods North America
7701 Legacy Drive
Plano, Texas 75024
Steven.Williams@pepsico.com

Mike Klein, Site Director
The Quaker Oats Company
1703 E. Voorhees St.
Danville, IL 61834
Mike.Klein@pepsico.com

Over the last 30 plus years of practice I have been a vocal advocate for robust public health involvement in disease – especially foodborne illness – prevention. It is beyond me to comprehend why public health would remain mute in the face of at least 165 sick, 20 hospitalized and 40 percent of the ill five years or younger – especially raw milk – a risky elixir.

The more I think about this the harder it is to figure out why public health would sit on the scientific fact that a food producer of a known high-risk food is sickening hundreds. This includes overwhelming epidemiological evidence of the same WGS pattern in both humans and in milk. Setting aside the “food freedom” argument for a moment that people should be able to eat or drink what they want and feed their kids the same; what about simply informing the public of the facts and letting the public decide for themselves?

CDPH Mission Statement: “To advance the health and well-being of California’s diverse people and communities.”

CDPH failed in its Mission when it failed to alert the public that a producer of raw milk in the State of California had sickened at least 165 (likely larger) with Salmonella, Campylobacter or E. coli both in the State of California and three other unnamed Sates. And, nearly 40% of those sickened were 5 or younger. And, all sickened by Salmonella people’s stool cultures were a whole genome sequence match to each other and to samples of raw milk. These facts would have been an opportunity to both alert the public to the risk and to educate and “[t]o advance the health and well-being of California’s diverse people and communities.”

Instead CDPH sends out this sad excuse of a public announcement yesterday – still saying nothing of value “[t]o advance the health and well-being of California’s diverse people and communities.”

CDPH takes its charge to protect public health seriously and works closely with all partners when a foodborne illness outbreak is identified. After being alerted by San Diego County Public Health last October about multiple Salmonellosis cases, CDPH conducted a robust public health investigation in concert with local officials and the California Department of Food and Agriculture (CDFA), which regulates raw milk producers in California. On October 24, 2023, CDPH posted a food recall notice on its website (see attachment). (That notice was later archived upon conclusion of the investigation.) The department also notified the public of the recall on social media multiple times (see links below). CDPH, working with CDFA asked firm management at Raw Farm for a voluntary recall. Raw Farm was cooperative and posted a recall on October 25. Because the majority of illnesses were reported in San Diego county, San Diego County Public Health led the public notification process (media releases are available on their website, including one on October 20 and October 25). The outbreak and case investigation handled by CDPH ended on May 4, 2024. Centers for Disease Control and Prevention (CDC) was aware of the investigation and assisted with some coordination with cases in other states.

Interestingly today Harvard Health published the following – Why drinking raw milk can be dangerous.

Despite some claims to the contrary, drinking raw milk is not safe. Health experts say that germs in raw milk could make you seriously ill.

What is raw milk?

Raw milk comes from animals such as cows and goats. It is not pasteurized to kill germs.

Some people think raw milk tastes better than milk that has been pasteurized. Among the health claims surrounding raw milk are that it can cure lactose intolerance, treat allergies, and support gut health. However, extensive research has shown that none of these myths are true.

In fact, drinking raw milk can be hazardous to your health, explains infectious disease specialist Dr. Michelle Chan of Beth Israel Deaconess Hospital. “I’m alarmed that drinking raw milk has become a trend,” she said. “There’s a good reason why foods and drinks are pasteurized now.”

What are the health risks of consuming raw milk?

Raw milk can carry dangerous germs that can cause food poisoning. Most people with food poisoning experience some combination of abdominal cramping, vomiting, and diarrhea.

Germs that may be found in raw milk and that can cause food-borne illness include SalmonellaE. coliListeria, and Campylobacter.

Anyone who drinks raw milk can become sick. But it is especially dangerous to:

  • babies, young children, and teenagers
  • pregnant women
  • older adults
  • people with a weakened immune system, including those with cancer, diabetes, or HIV/AIDS, and those who have had an organ transplant.

In the U.S., it is illegal to sell raw milk across state lines, and raw milk is banned in about half of U.S. states. Among states that allow it, most specify that it must come directly from a farmer.

Good hygiene practices on farms can lower the risk of contamination; however, they cannot guarantee that their raw milk is safe from dangerous germs.

Bird flu and raw milk

In March 2024 there was a multistate outbreak of bird flu in dairy cows, the first time that bird flu viruses had been found in cows.

There currently is limited information about whether the virus could be transmitted to humans through raw milk from infected cows. A letter published in the New England Journal of Medicine reported high levels of the virus in raw milk from infected cows. And the FDA recommends that farmers not manufacture or sell raw milk from cows showing symptoms of bird flu, or cows who have been exposed to it.

In a study designed to simulate commercial milk processing, the FDA and USDA found that the most commonly used pasteurization time and temperature requirements effectively inactivated the bird flu virus in pasteurized milk.

What is pasteurization?

Pasteurization is a process that kills germs in foods by using heat. Pasteurized milk is heated to at least 145° Fahrenheit and then quickly cooled. The process was invented by scientist Louis Pasteur in 1864.

Does pasteurized milk have the same nutritional benefits as raw milk?

Multiple studies have found no evidence that raw milk is more nutritious than pasteurized milk. According to the CDC and FDA, pasteurized milk offers the same nutritional benefits as raw milk, but without the risks.

Drinking raw milk means taking a big chance with your health, Dr. Chan believes. “My advice,” she said, “is to take heed of the research, be aware of the risks associated with drinking raw milk, and in general, avoid drinking it.”

Also today Physician’s Weekly posted – “Less than Half of Adults Know Dangers of Raw Milk.”

Few Americans understand the health risks of drinking raw milk, a new survey shows, so experts are redoubling efforts to get the word out on its dangers.

The push dovetails with the discovery this spring of bird flu virus in milk from infected cows. The H5N1 virus is widespread in wild birds worldwide and is causing outbreaks in poultry and U.S. dairy cows. As of June 21, four human cases of the H5N1 flu had been reported in the United States.

“It is important that anyone planning to consume raw milk be aware that doing so can make you sick and that pasteurization reduces the risk of milk-borne illnesses,” said Patrick Jamieson, director of the Annenberg Health and Risk Communication Institute at the University of Pennsylvania.

Milk from cows, sheep, goats and other animals that has not been pasteurized to kill harmful germs is called raw or unpasteurized. The U.S. Centers for Disease Control and Prevention says consuming unpasteurized milk and products made from it can expose people to germs such as E. coli, listeria and salmonella.

While the U.S. Food and Drug Administration says the commercial milk supply — which is pasteurized — is safe from the H5N1 virus, raw milk is another story.

In June, before the four human cases of bird flu were reported, the Annenberg Institute surveyed 1,031 American adults online and by phone to gauge their knowledge about the risks associated with unpasteurized milk.

While 47% of respondents knew that raw milk is less safe to drink, 24% either wrongly believed that pasteurizing milk does not effectively kill bacteria and viruses or were unsure whether it does.

Respondents who were 65 or older, college-educated or who lean Democrat were more likely to understand the benefits of pasteurization and to believe that it does not destroy nutrients in milk. City dwellers were more likely to consider raw milk less safe, compared to rural counterparts (49% versus 32%).

Meanwhile, only 4 in 10 Republicans (37%) said they believe raw milk is less safe than pasteurized.

“The difference in views of raw milk that we see between Democrats and Republicans is difficult to disentangle from the difference between rural and urban dwellers,” Kathleen Hall Jamieson, director of the Annenberg Public Policy Center, said in a center news release. “Those in rural areas are both more likely to identify as Republicans and to consume raw milk.”

A separate analysis showed that where one lives does not predict beliefs about pasteurization. Still, many Americans have misguided notions about it.

Fewer than half (43%) knew that pasteurization “does not destroy nutrients” in milk; 16% think it does and 41% were unsure.

Interestingly, 18- to 29-year-olds were more likely than seniors to believe pasteurizing milk destroys nutrients (25% versus 5%), and Republicans were much more likely to believe that than Democrats (23% versus 8%).

The survey was conducted June 7-10 and has a margin of error of plus or minus 3.5 percentage points.