The Consumer Federation of America (CFA) presented an installment of its Virtual National Policy Conference series, titled “A New Day at USDA for Food Safety?” on Tuesday.

Speakers included Dr. Patricia Griffin, chief of the Enteric Diseases Epidemiology Branch at the Centers for Disease Control and Prevention; Sarah Sorscher, deputy director of regulatory affairs at the Center for Science in the Public Interest (CSPI); and Mike Robach, CEO of the Robach Group and former vice president of corporate food safety at Cargill.

The name Mike Robach sounded familiar, so I ran a quick search of my desktop and stumbled upon Marler Clark’s 2020 Salmonella Petition. As mentioned in the Petition, Robach, in his former role at Cargill, partnered with The Pew Charitable Trusts in 2014 to develop a set of recommendations to “improve the food safety oversight system for meat and poultry” and to “transform the current system into one that is more science and risk-based.” The project came after Cargill was implicated in Salmonella outbreaks in 2009, 2011 and 2012. The executive summary of the 2014 stakeholders’ meeting states, “Cargill Inc. and the Pew Charitable Trusts identified the following reasons for believing that the time was ripe for this initiative: 

  1. Public health-based: While there has been some progress, meat and poultry products remain significant vehicles for foodborne illnesses in the United States;
  2. Science-based: The inspection system developed more than 100 years ago does not employ the most science-based means to protect consumers from pathogenic contamination; and
  3. Fiscal: Taxpayers spend $1 billion each year on an inspection system that cannot effectively assure the desirable level of safety.”

Now, seven years after this initiative, Robach, Sorscher and Griffin expressed similar concerns at the CFA Conference. They say USDA’s meat and poultry inspections system, which was implemented to combat animal disease, not to ensure the safety of the nation’s food supply, more than a century ago, is outdated and “archaic.” They also say chicken-associated Salmonella and Campylobacter are now responsible for an estimated 635,000 illnesses each year in the United States. Salmonella remains the leading cause of bacterial foodborne illness in the United States, followed by Campylobacter, with the incidence of Salmonella illnesses remaining virtually unchanged in the past 20 years. 

Each panelist also offered potential solutions. Robach recommended that the USDA enhance the role of risk-assessment in its oversight system — possibly by creating a new, independent risk-assessment agency — and update its current inspections program to account for these varying risks rather than keep its current “one-size-fits-all” program. He also suggested the agency implement preharvest interventions and update the labels on meat and poultry products to reflect safe handling practices. 

Griffin proposed a multi-pronged approach involving “farm measures,” such as hygiene and vaccination; “slaughterhouse methods,” such as modernized performance standards; and “retail methods,” such as buying agreements and industry standards. She said France and the United Kingdom have markedly decreased Salmonella infections by using vaccination of poultry, targeting of particular serotypes, hygiene measures on farms, legislation and investigation. Similarly, Sorscher advocated for “enforceable, risk-based standards that target Salmonella types of greatest public health concern and Campylobacter.” 

On Jan. 19, 2020, Marler Clark LLP submitted the above-mentioned Salmonella Petition, on behalf of CFA and others, requesting that the USDA’s Food Safety and Inspection Service declare the following “Outbreak Serotypes,” considered to be serotypes of public health concern, to be adulterants in meat and poultry products: Salmonella Agona, Anatum, Berta, Blockely, Braenderup, Derby, Dublin, Enteritidis, Hadar, Heidelberg, I 4,[5],12:i:-, Infantis, Javiana, Litchfield, Mbandaka, Mississippi, Montevideo, Muenchen, Newport, Oranienburg, Panama, Poona, Reading, Saintpaul, Sandiego, Schwarzengrund, Senftenberg, Stanley, Thompson, Typhi and Typhimurium.

About the author: Ilana Korchia is a law clerk at the Marler Clark law firm in Seattle. She is a second-year law student at Seattle University School of Law. Korchia earned a bachelor’s degree in food science from the University of Florida in 2019. She has previous experience working as a public affairs intern for the U.S. Food and Drug Administration and as a laboratory research assistant for the University of Florida.

Editor’s note: Bill Marler of Marler Clark LLP is publisher of Food Safety News.

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Most days during the coronavirus crisis, the parking lot at the big JBS beef plant in Greeley, CO, is full, a sign of normalcy. The exception was this past Monday when the union president claimed 1,000 of the people who slaughter and process beef at the plant walked out because of fear that as many as 10 JBS employees who work at the  Greeley plant have tested positive for COVID-19.

JBS spokesman Cameron Bruett told local media that since school closures went into effect about 500 employees have been absent at some point during recent weeks. He suggested the absences and Monday walk out together topped at around 830 employees

Food processing is defined as essential work, according to all the executive “stay at home orders.” The trick for JBS, Tyson Foods, Cargill Meat Solutions, and other meat and poultry producers is keeping enough of their workforce healthy to meet the demand that’s out there.  A lot of people are involved, those top three companies together employ 359,000.

Demand is tricky to figure out. Two weeks ago, all the fresh beef, pork, and poultry were being swept up along with toilet paper by spooked consumers. More recently, however, beef futures have slumped and producers are worried about the loss of restaurant customers.

JBS has temporarily cut back production at Souderton, PA, because several senior managers at the plant are experiencing “flu-like” symptoms. And there are spotty reports of meat and poultry industry employees testing positive for COVID-19, also known as coronavirus. Posted COVID-19 information on the JBS website says it follows emergency protocols “for any team member who shows symptoms.”

Kim Cordova, president of the United Food and Commercial Workers Local 7 in Greeley, said JBS does not provide paid sick leave, but should for the COVIG-19 cases. Further, the union wants the company to identify the location(s) in the plant where any persons sickened with COVID-19  worked.

About 3,000 JBS employees are represented by Local 7.

No less a figure than Secretary of Agriculture Sonny Perdue has urged the people “at the front lines of our food supply chain” to “stay on the job.”

Tyson Foods is hoping to do just that with a promise to pay $500 in July to all its 116,000 drivers and production personnel who continue “feeding the nation” through the outbreak.

“We’re proud of how our team members have stepped up during this challenging time to make sure we continue fulfilling our critical mission of feeding people across America,” said Noel White, Tyson’s CEO.

The $500 payments will be made during the first week of July, according to the company. Tyson Foods previously waived copays for COVIG-19 testing and eliminated the 5-day waiting period for disability payments. It also contributed $13 million to local communities where it operates.

Springdale-AR-based Tyson employs 114,000 including 2,900 drivers.

Since the rapid global spread of the COVID-19 virus, the demand for disinfecting alcohol — to sanitize surfaces — has increased dramatically with many health institutions throughout Europe are facing imminent shortages.

The privately held Cargill said it was skipping its third-quarter financial report in part because it is busy caring for its employees.

“As we work to keep our employees healthy and safe during the COVID-19 pandemic — and prioritize all 160,000 Cargill employees on the work that needs to be done to deliver on our purpose and produce the ingredients, feed, and food to nourish people and animals — we have decided to forgo our Q3 public earnings release,” Cargill said.

“We are working around the clock with farmers and our customers — the nation’s food retailers, service providers, and restaurant chains — to feed the world safely and responsibly during this unprecedented time. Our eye is on making the right day-to-day decisions to keep the food system moving during the pandemic — and looking to the future to ensure the food system stays viable around the world.”

The company runs on a June 1 to May 31 fiscal year. The third quarter is normally reported on March 31.

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USDA’s Food Safety and Inspection Service took 31 administrative actions against 21 of the nation’s largest meat and poultry facilities during the second quarter of of the federal fiscal year.

Those included 17 Notices of Intended Enforcement (NOIE) and nine suspensions that were all apparently held in abeyance. The actions came during the Jan. 1 to March 31 period.

According to the quarterly report, four Cargill Meat Solutions plants in Fresno, CA, Friona, TX, Springdale, AR, and Fort Morgan, CO, were cited for violating Sanitation Performance Standards and Inhumane Treatment during Slaughter.

Cargill had two suspensions in abeyance.

Two Clemens Food Group plants, one in Hatfield, PA, and the other in Coldwater, MI, were also targets of NOIE’s for violations of Sanitation Performance Standards and Inhuman Treatment during Slaughter. Clemens also had tow suspensions in abeyance.

Foster Poultry Farms in Turlock, CA, was cited for violating Sanitation Standard Operating Procedures (SSOPs); Hazard Analysis and Critical Control Points (HACCP); and Sanitation Performance Standards.

SSOP and HACCP infractions for George’s Processing in Springdale, AR, led to an NOIE appeal, which went in the company’s favor and the violations were rescinded.

House of Raeford Farms in Arcadia, LA, had SSOP, HACCP, and SPS violations with further action apparently deferred.

JBS plants in Plainwell, MI; Souderton, PA; Grand Island, NE; and Tolleson, AZ, were also among the violators during the period. The Plainwell, Souderton, and Grand Island plants all received NOIEs for Inhumane Treatment during Slaughter.

The JBS Tolleson facility took home a trifecta for SSOP, HACCP. and SPS. Only the Souderton plant was suspended.

The Jennie O Turkey Store in Faribault, MN, also was on the receiving end of an NOIE for SSOP, HACCP, and SPS

Two Pilgrim’s Pride facilities, one in Moorefield, WV, and one in Guntersville, AL, made the quarterly enforcement report. SSOP, HACCP, and SPS violations were involved.

The final five to make the list of 21 large establishments include:

  • Sam Kane Beef Processors, Corpus Christi, TX
  • Seaboard Triumph Foods, Sioux City, IA
  • SFC Global, Pasadena, TX
  • Smithfield Foods, Tar Heel, NC
  • Zorro Leasing, Fresno, CA

An open case of Inhumane Handing against Sam Kane Beef was closed on March 19 when the business was sold. Zorn Leasing violated a “regulatory control action.” Inhuman Treatment was charged against Smithfield.

Sanitation and HACCP concerned earned NOIE’s for SFC Global and Seaboard.

In other enforcement action during the quarter, the FSIS Office of Investigation, Enforcement, and Audit (OIEA) issued 285 warning notices.  A total of 507 food businesses under USDA jurisdiction received such FSIS warnings during the first half of the federal FY 2019.

FSIS enforcement involves both civil and criminal law. Food safety adjudicatory actions during the period included:

  • Bridge Foods Inc. in New Orleans was hit with an FSIS complaint last March 29, seeking to withdraw federal inspection services because of the firm’s repetitive violations of food safety regulations.
  • Harmon Brother Meat in Warsaw, KY also received notice last Feb. 7 that FSIS wants to indefinitely suspend and permanently withdraw federal inspection services because of the firm’s inhumane handling and slaughter of livestock. FSIS and Harmon Brothers entered into a Consent Decree that will allow USDA inspections to continue so long as the business agrees to adopt humane handling practices. Conditions include hiring an expert in humanity and being subjected to outside audits,
  • Market Meat in Canby, OR, was also subject to an FSIS complaint threating to removed federal inspection services. The Oregon company agreed to a consent decree that binds it to reform its animal handling practices, including the hiring of an outside expert for humane practices and subjecting the company to outside audits.

In actions involving civil injections, FSIS also won the following actions:

  • The U.S. District Court for Massachusetts permanently enjoined J/W Aseda Plaza along with owners Vida and Welton Causey of Worchester, MA, from selling transporting, offering for sale, or receiving any non-federally inspected meat products. The judge also instructed J&W and the Causeys on record keeping.
  • The U.S. District Court for the Southern District of New York permanently enjoined the George Meat Mark in New York City from selling, transporting, offering for sale or transportation of any non-federally inspection poultry products or doing any preparing or processing of poultry products.
  • The U.S. District Court for Massachusetts permanently enjoined the New England Market in Brockton, MA, from selling, transporting, offering for sale or transport or receiving any non-federally inspected meat or poultry. The judge also ordered proper record-keeping,

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A week after Cargill Meat Solutions recall of 66 tons of ground beef, some concerns remain. Experts at Consumer Reports suggest tossing out any ground beef in your freezer purchased between June 21 and July 11 of this year “out of an abundance of caution.”

And a top food safety advocate in Congress, Rep. Rosa DeLauro, D-CT, is demanding more information from the USDA about the associated outbreak of E. coli O26, which has caused 18 illnesses and one death.

The recalled meat, produced at Cargill’s Fort Morgan, CO, facility, was sold nationally at retail outlets during the summer. None is currently being sold, but there’s concern some of the ground beef was likely purchased for future use and remains stored in both home and commercial freezers.

In a Sept. 26 letter to Secretary of Agriculture Sonny Perdue, DeLauro demanded more information on the recall and outbreak investigation.

“I write today out of concern regarding the USDA’s investigation into the ongoing multistate outbreak of Escherichia coli O26, which has been linked to ground beef,” DeLauro wrote. “According to the Food Safety and Inspection Service (FSIS), the agency was notified of an investigation of E. coli O26 illnesses on Aug. 16, 2018.

“However, it was not until Aug. 30, 2018, that the first recall related to this outbreak was initiated by Publix Super Markets Inc.,” continued DeLauro. “At that time, according to FSIS, the source of the outbreak was ‘yet-to-be-determined.’ Then, twenty days later on Sept. 19, 2018, 132,606 pounds of ground beef products from Cargill, the apparent source of the outbreak, were finally recalled. In total, it was more than 35 days from when FSIS first learned of the outbreak when the traceback investigation was able to identify the source. Such a timeline is simply unacceptable and unnecessarily jeopardizes public health.”

In the letter, DeLauro tells Perdue that “prolonged traceback investigations are not just risks to consumer safety.” She cites USDA’s Economic Research Service’s work showing the negative consequences of food illness outbreaks and recalls in the food and agriculture business sectors.

DeLauro asked Perdue to respond to her questions about the timeline. She wants to know what FSIS knew by specific dates as the traceback investigation continued, such as when did the agency become aware the Publix Super Markets recalls involved Cargill.

Cargill’s Sept. 20 recall notice includes a product list of the specific brands and labels for consumers to use in checking their home or rental freezers. However, Consumer Reports (CR) issued its broader warning because some bulk purchasers likely repackaged the ground beef into units, not on the recall list.

“E coli O26 is quite serious, ” said James E. Rogers, CR’s director of food safety testing and research. “You don’t want to risk your health, or your family’s.” CR’s recommends tossing any ground beef stored in a freezer that was purchased between June 21 and July 11.

“If the meat has been repackaged, the brands and codes provided on the FSIS list so far won’t help consumers figure out if their purchase was part of this ground beef recall,” Rogers said. “This combined with the fact that people may take meat out of its packaging and wrap it themselves before they freeze it means many consumers may have no way of knowing if they purchased affected Cargill beef, or know the use-by date that was on the original package.”

Food Safety News previously published the entire recall list here.

The FSIS also warns that some recalled Cargill beef could be in people’s freezers and if so, it should be thrown out and not consumed.

According to the federal Centers for Disease Control and Prevention in Atlanta, the recalled Cargill beef is associated with a four-state outbreak of E. coli O26 involving 18 illnesses and one death. In a Sept. 20 Food Safety Alert, the CDC said the multistate incident is probably over. Fifteen of the illnesses and the death were in Florida. Colorado, Tennessee, and Massachusetts each reported one O26 case.

FSIS has released a list of retail outlets that sold the Cargill beef.

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Just as the late, great Johnny Cash once sang about having traveled every road in the land, those 66 tons of ground beef recalled on Sept. 20 by Cargill Meat Solutions after a deadly E. coli O26 outbreak also went “everywhere” or pretty close to it.

The U.S. Department of Agriculture’s Food Safety Inspection Service(FSIS) on Sept. 23 came out with a list of retailers that received the recalled product. It includes every Safeway, Meijer, and Sam’s Club store in the nation along with some others.

FSIS says it has “reason to believe” the beef contaminated with O26 went to the retail stores on the list, but the agency cautions that other unnamed outlets might also have received the recalled ground beef.

Here’s the list as FSIS has been able to determine currently:

▪ Safeway — All stores nationwide.
▪ Meijer — All stores nationwide.
▪ Sam’s Club — All stores nationwide.
▪ Target — All stores in Florida; Iowa; California; and the Denton, TX, Target store at 5452 Corbin Way; and the West Jefferson, OH, Target store at 4 Walker Way.
▪ Central Meat & Provision Co. — 1603 National Ave., San Diego
▪ Save Mart — 9999 Niblick Dr., Roseville, CA.
▪ Canal Fulton Provision — 2014 Locust St., Canal Fulton, OH

USDA is the only federal food safety agency that routinely tells the public where sales of recalled food occurred. FSIS adopted the practice during the administration of President George W. Bush when Dr. Richard Raymond was USDA’s Under Secretary for Food Safety.

The U.S. Food and Drug Administration (FDA) does not provide the public with retail lists, saying it would breach the right of food manufacturers to protect proprietary information.

Cargill Meat Solutions recalled the beef produced by its troubled Fort Morgan, CO, plant after the four-state outbreak of E. coli O26 involving 18 illnesses and one death, which also promoted a Food Safety Alert by the federal Centers for Disease Control and Prevention in Atlanta.

FSIS associated the 66 tons of ground beef with the July 5-25 outbreak that, except for three cases, was centered on Florida.

CDC said the outbreak now appears to be over, but it did not end before causing one death in Flordia and causing kidney failure in another victim who developed hemolytic uremic syndrome (HUS).

FSIS says consumers are still at risk if they earlier purchased the recalled ground beef and stored it in a freezer for future use. Consumers who may have purchased ground beef for their fridge or deep freeze from retailers on the list are urged to make sure it wasn’t a recalled product. Food Safety News previously published the entire recall list here.

The ground beef items listed on the Cargill Sept. 20 recall were produced and packaged on June 21.  The recalled products bear the establishment number “EST. 86R” inside the USDA mark of inspection.

A month earlier, on Aug. 23, Cargill recalled 12.64 tons of ground beef also produced at the Fort Morgan, CO, because of potential E. coli O157:H7 contamination. Presumptive positive tests for the pathogen was the reason for that earlier recall.

Cargill Meat Solutions, a unit of Minneapolis-based Cargill Corp., agreed earlier this month to pay $1.5 million to 138 former Somali employees over the company’s pray-break policy for Muslims.

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A four-state outbreak of E. coli O26 with 18 illnesses including six hospitalizations and one death was reported late Thursday by the federal Centers for Disease Control and Prevention, which issued a Food Safety Alert about the incident. CDC’s alert followed by several hours the announcement by Cargill Meat Solutions of a recall of beef produced in Colorado that was likely contaminated with E. coli O26.

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) said the Cargill recall was associated with an epidemiological investigation into illnesses with onset dates ranging from July 5 to July 25.   CDC said that outbreak “appears to be over.”   One death in Florida is associated with the outbreak. Also, CDC reported one person developed hemolytic uremic syndrome (HUS), which results in kidney failure.

CDC also said 15 of the 18 illnesses involved people in Florida. Colorado, Massachusetts and Tennessee each reported one case.

Cargill early Thursday recalled approximately 132,606 pounds, or 66.3 tons, of ground beef produced at its Fort Morgan, CO, facility. Cargill shipped the recalled beef to retailers nationwide. Made from the chuck portion of the carcass, the recalled beef may be contaminated with Escherichia coli O26, according to FSIS.

Public health officials are concerned that some product may be frozen and in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS learned of the outbreak investigation of the E. coli O26 illnesses on Aug. 16. FSIS, the federal CDC, and state public health and agriculture partners determined that raw ground beef was the probable source of the illnesses.

Investigators determined that Cargill supplied ground beef that was recalled on Aug. 30 by Florida’s Publix Super Markets Inc. for E. coli O26-contamination. Traceback showed that patients had consumed ground beef purchased at various retail stores that were supplied by Cargill Meat Solutions. The outbreak was centered on Florida.

The ground beef items listed in Cargill’s Sept. 20 recall and associated with the illnesses were produced and packaged on June 21, 2018. The following products are subject to recall:

  • 3-lb. chubs of “OUR CERTIFIED 73/27 FINE GRIND GROUND BEEF” with a USE OR FREEZE BY JUL/11/18 and case code 00228749057646.
  • 3-lb. chubs of “OUR CERTIFIED 73/27 FINE GRIND GROUND BEEF” with a USE OR FREEZE BY JUL/11/18 and case code 00228749002653.
  • 10-lb. chubs of “EXCEL 73/27 FINE GRIND GROUND BEEF” with a Use/Frz. By Jul 11 and case code 00228749089098.
  • 10-lb. chubs of “EXCEL 73/27 FINE GRIND GROUND BEEF” with a Use/Frz. By Jul 11 and case code 90028749002751.
  • 10-lb. chubs of “EXCEL 81/19 FINE GRIND GROUND BEEF” with a Use/Frz. By Jul 11 and case code 90028749003536.
  • 10-lb. chubs of “EXCEL GROUND BEEF 81/19 FINE GRIND” with a Use/Frz. By Jul 11 and case code 00228749003568.
  • 10-lb. chubs of “EXCEL CHUCK GROUND BEEF 81/19 FINE GRIND” with a Use/Frz. By Jul 11 and case code 90028749402773.
  • 20-lb. chubs of “EXCEL 81/19 FINE GRIND GROUND BEEF COMBO” with a Use/Frz. By Jul 11 and case code 90028749073935.
  • 10-lb. chubs of “Sterling Silver CHUCK GROUND BEEF 81/19 FINE GRIND” with a Use/Frz. By Jul 11 and case code 00228749702416.
  • 10-lb. chubs of “CERTIFIED ANGUS BEEF CHUCK GROUND BEEF 81/19 FINE GRIND” with a Use/Frz. By Jul 11 and case code 90028749802405.
  • 10-lb. chubs of “CERTIFIED ANGUS BEEF CHUCK GROUND BEEF 81/19 FINE GRIND” with a Use/Frz. By Jul 11 with case code 00228749802413.
  • 10-lb. chubs of “Fire River Farms CLASSIC GROUND BEEF 81/19 FINE GRIND” with a USE/FREEZE BY: 07/11/2018 with case code 90734730297241.

The recalled products bear establishment number “EST. 86R” inside the USDA mark of inspection. Cargill shipped the products to retail locations nationwide.

E. coli O26, like the more common E. coli O157:H7, is a serovar of Shiga toxin-producing E. coli (STEC). People usually become sick for a few days after exposure to the organism.

Most people infected with STEC O26 develop diarrhea that is often bloody, and vomiting. Some illnesses last longer and can be more severe. Infection is usually diagnosed by testing patients’  stool samples. Vigorous rehydration and other supportive care is the usual treatment; antibiotic treatment is generally not recommended.

Many people recover within a week, but some develop a more severe infection. Hemolytic uremic syndrome (HUS), a type of kidney failure, is common with STEC O26 infection. HUS can occur in people of any age but is most common in children younger than 5 years old, older adults, and people with weakened immune systems. It is marked by easy bruising, pallor and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website.

Cargill Meat Solutions in Fort Morgan, CO late Thursday recalled approximately 25,288 pounds of ground beef products that may be contaminated with E. coli O157: H7, according to the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS).

The ground beef items were produced on Aug. 16, 2018. The following products are subject to recall:

  • 10-lb. chubs of “EXCEL 93/7 FINE GRIND GROUND BEEF” with “Use/Frz. By Sep 05” on the chub label and a “PACK DATE 08/16/2018” on the box label.

The recalled beef products bear the establishment number “EST. 86R” inside the USDA mark of inspection. These items were shipped to warehouses in California and Colorado.

The problem was discovered on Aug. 22 by the establishment when they reviewed their records and determined that the product may be associated with the product that was presumptive positive for E. coli O157: H7. The company then notified FSIS. There have been no confirmed reports of adverse reactions due to consumption of these products.

Anyone concerned about an illness should contact a healthcare provider. E. coli O157: H7 is a potentially deadly bacterium that can cause dehydration, bloody diarrhea and abdominal cramps 2–8 days (3–4 days, on average) after exposure the organism. While most people recover within a week, some develop a type of kidney failure called hemolytic uremic syndrome (HUS). This condition can occur among persons of any age but is most common in children under 5-years old and older adults. It is marked by easy bruising, pallor, and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.

FSIS is concerned that some product may be frozen and in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list will be posted on the FSIS website at

FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef that has been cooked to a temperature of 160°F. The only way to confirm that ground beef is cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature,

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As the world’s population balloons, agriculture and science have converged to create sustainable, innovative solutions to food production. The fruits of this “Ag Tech” evolution includes groundbreaking technology that has fomented the production of “clean meat” via cellular agriculture as a viable alternative to conventional animal agriculture.  Given the novelty of how clean meat is produced, a key question is which federal agency will take the lead in regulatory oversight.

Clean meat
Clean or cultured meat refers to meat produced ex vivo, or grown outside the animal, from cell cultures sourced from healthy livestock or poultry. The finished product replicates the characteristics of muscle harvested from food-producing animals. 

Product development efforts are well underway across the globe. In 2016, for example, San Francisco-based Memphis Meats unveiled the first meatball produced with clean meat technology. In 2017, Memphis Meats debuted its “clean” chicken nuggets and duck à l’orange. Significant investments from Tyson Foods’ venture capital arm Tyson Ventures, Cargill, Bill Gates and Richard Branson — among others — are helping clean meat start-ups to reduce cost and scale up production. 

Clean meat could hit supermarket shelves as early as 2021. Before that happens, clean meat stakeholders must confront regulatory realities. In recent days, both the U.S. Department of Agriculture and the Food and Drug Administration have been on record stating that they think clean meat falls within their regulatory purview.  The White House Domestic Policy Council is set to hash out the Administration’s approach in the coming weeks, and the FDA has scheduled a public meeting on July 12 to kickstart the conversation. 

Regardless of which agency takes the lead, developing a regulatory pathway for clean meat — preferably one that falls within the existing federal framework — is essential to providing this burgeoning industry with regulatory certainty.

USDA’s Food Safety and Inspection Service (FSIS) has jurisdiction over meat, poultry, and certain egg products pursuant to the Federal Meat Inspection Act (FMIA) (21 U.S.C. § 621, et seq.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. § 451, et seq.), and the Egg Products Inspection Act (EPIA) (21 U.S.C. § 1031, et seq.). FDA has jurisdiction over all other food products pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 301, et seq.). Importantly, the FDCA authorizes the FDA to oversee the safety of all food ingredients used in both FDA and USDA-regulated foods.

Clean meat may be said to qualify as “meat” as USDA currently defines it. At the same time, FDA has significant experience with regulating the introduction of novel foods. Irrespective of whether FDA or USDA takes the lead on clean meat, these foods can be managed within the current statutory framework in a manner that ensures consumer safety and confidence.

Any product that meets the definition of “meat” or “poultry” as defined under current USDA law triggers USDA-FSIS jurisdiction.

In the case of “meat,” USDA adheres to the following definition (9 C.F.R. § 301.2.): 

“The part of the muscle of any cattle, sheep, swine, or goats which is skeletal or which is found in the tongue, diaphragm, heart, or esophagus, with or without the accompanying and overlying fat, and the portions of bone (in bone-in product such as T-bone or porterhouse steak), skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and that are not separated from it in the process of dressing.”

For USDA’s purposes, meat does not include “the muscle found in the lips, snout, or ears.” Also, the definition specifies meat may not include “significant portions of bone, including hard bone and related components, such as bone marrow, or any amount of brain, trigeminal ganglia, spinal cord, or dorsal root ganglia.” 

Stem cells cultured to produce clean meat are sourced from the species of livestock and authorized parts of the animal enumerated above. Likewise, the stem cells cultured to produce poultry are sourced from the species of domestic birds that qualify as poultry under current USDA regulation (9 C.F.R. § 381.1). The definitions of meat and poultry assume that the finished product sold to consumers is non-living. Clean meat satisfies this “non-living” criterion. On these bases, meat and poultry produced via clean meat technology could be construed as meeting USDA definitions for meat and poultry.

Clean meat may also be said to qualify as “meat food product” under the FMIA. 21 U.S.C. § 601(j) of the FMIA provides: 

“[A]ny product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, excepting products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry, and which are exempted from definition as a meat food product by the Secretary under such conditions as he may prescribe to assure that the meat or other portions of such carcasses contained in such product are not adulterated and that such products are not represented as meat food products.” 

The definition excludes products that have not historically been considered by consumers as products of the meat industry. The definition does not speak to production method per se. Rather, the key question is whether a reasonable consumer would perceive clean meat to be a product of the meat industry. Analogous reasoning applies to fitting poultry produced with clean meat technology within USDA’s definition for “poultry product” (defined at 21 U.S.C. § 453(f)).

Does the production method matter?
Notwithstanding the novel production method, a case can be made that clean meat and poultry qualifies as “meat,” “meat food products” and “poultry products.” At the genetic and cellular level, clean beef and beef derived from a slaughtered cow share a common source. Unlike plant-based meat substitutes that mimic the appearance and taste of meat but are compositionally directly produced from plants, clean meat is actual animal meat and would be expected to be perceived by consumers as such. 

The U.S. Cattlemen’s Association (USCA) disagrees. The USCA contends that clean meat is not meat within the meaning of the FMIA, and in a recent petition asked the USDA to limit the term “meat” to mean the “tissue of flesh of animals that have been harvested in the traditional manner.” 

Clean meat is certainly distinguished by its production method, i.e., it is produced ex vivo rather than via conventional animal agriculture. But new meat production methods do not, per se, alter a products’ status as meat within the meaning of the FMIA. As noted by the Good Food Institute and Memphis Meats in recent comments on the USCA petition, “the methods used to raise and kill animals for food have significantly evolved over time, and current production today would have been unthinkable to previous generations.” 

Over the years, USDA has deemed various new technologies as acceptable to produce meat for food, effectively interpreting its existing regulatory framework as one which accommodates innovations in meat production practices. Perhaps the clearest example is cloning technology. The FDA collaborated with USDA using existing authorities to evaluate the safety and suitability of cloning technology. The end result was that FDA found meat derived from cloned animals to be safe and USDA accepted the product as meat within the meaning of the FMIA. The FDA and USDA worked together. FDA assessed the safety of meat derived from cloned animals. Once the science was settled, the labeling and marketing of clone-derived meat landed at USDA’s doorstep.

USDA did initially recommend a voluntary moratorium to support consumer acceptance of meat derived from animal clones and clone progeny, but this had no bearing on the agency’s acceptance of the product as meat. The use of cloning and clone progeny for meat production of course differs from conventional animal agriculture production. But FDA aptly explains that “cloning could be thought of as an extension of the assisted reproductive technologies that livestock breeders have been using for centuries.” Importantly, both USDA and FDA have found that meat sourced from cattle, swine and goat clones are no different than food from conventionally bred animals, “and therefore do not require special or different labeling.” USDA has not issued new rules specifically tailored to the production and marketing of clone-derived meat and poultry. 

USDA could apply this thinking to clean meat — that is, clean meat is no different from meat from conventionally bred animals. Doing so would represent a consistent approach to regulation that fosters innovation. 

Historically, it has been possible to regulate the products of biotechnology within the existing federal framework. One example is federal regulation of plant-based food products developed using novel tools of biotechnology. FDA’s Biotechnology Policy, published in the Federal Register in 1992, was created to clarify FDA’s interpretation of the FDCA for food products developed using novel tools of biotechnology. Rather than issue a new set of rules expressly for biotech foods, FDA simply chose to develop this policy to support an innovative approach to food production. Core to FDA’s policy is the agency’s stance that foods produced via the novel tools of biotechnology, including products of intentional genetic alteration, have the same objective characteristics and are just as safe as conventionally produced foods. 

Clean meat is certainly distinct from plant-based biotech foods with respect to how the food is produced and its fundamental identity. But like plant-based biotech foods which are equivalent to their non-biotech counterparts, clean meat possesses the food and nutritional characteristics of slaughtered meat. Cellular agriculture has no adverse bearing on product quality or safety. Assuming USDA concurs that clean meat is safe and equivalent to traditionally sourced meat, the agency could conceivably interpret the FMIA and the PPIA to encompass clean meat and poultry. 

Challenges with a USDA approach to regulation
The challenge for this emerging industry — insofar as a USDA-managed approach is concerned — lies primarily in the breadth of USDA’s inspection requirements. 

Inspection oversight forms a key aspect of USDA regulation. FSIS maintains an ongoing inspection presence in meat packing and processing facilities.

Pre-market inspection for clean meat could be construed as an unnecessary regulatory burden, particularly because many of the safety concerns present in traditional meat slaughter and processing do not apply to the clean meat production paradigm. Nevertheless, clean meat producers may find it desirable from a marketing standpoint to have their products bear the USDA inspection legend like traditionally sourced meats. Due to the manner in which clean meat is produced, if USDA moves forward with pre-market inspection for clean meat, new, science-based inspection standards to ensure safety and facilitate innovation should be developed in consultation with industry and the FDA. This could mean undertaking an administrative rulemaking for requirements tailored to clean meat.   

FDA appears poised to take the lead on clean meat. In announcing the upcoming public meeting, FDA noted that it “has extensive experience applying its existing authority flexibly and effectively to rapidly evolving areas of technological innovation such as plant biotechnology” and looks forward to sharing its “experiences in evaluating and ensuring the safety of novel technologies in the food sector at this upcoming public meeting, while … also discuss[ing] these issues with, and gather[ing] relevant data and information from stakeholders.” Along similar lines, this past spring, FDA stated that “it seems reasonable to think that cultured [i.e., clean] meat, if manufactured in accordance with appropriate safety standards and all relevant regulations, could be consumed safely.”

The FDA’s June 18 press release announcing the July 12 meeting states that “[u]nder the Federal Food, Drug, and Cosmetic Act, the FDA has jurisdiction over “food,” which includes “articles used for food” and “articles used for components of any such article. Thus, as a starting point, both substances used in the manufacture of these products of animal cell culture technology and the products themselves that will be used for food are subject to the FDA’s jurisdiction.” Pronouncements like this could be an early indication that FDA will seek to place clean meat squarely under its jurisdiction.  

In any novel biotech space, the largest threat is regulatory uncertainty. FDA’s willingness to hear from novel product producers directly, consider their input, and offer reasonable pathways to market using existing authority is incredibly innovative and welcome. 

FDA premarket oversight compared to USDA
A key difference between FDA and USDA-FSIS oversight is the level of premarket inspection. For FDA, the Food Safety Modernization Act (FSMA) mandates inspection frequency based on risk for food facilities. Rather than risk, USDA-FSIS interprets its statutory mandate to mean that FSIS inspectors must be physically present at every FSIS-regulated establishment during that establishment’s operating hours regardless of risk. FDA-regulated producers are not subject to the same level of premarket inspection as USDA-FSIS regulated establishments. 

What an FDA program might look like
Under the traditional FDA approaches to regulation, producers can opt to engage in voluntary premarket reviews to assure consumer confidence. FDA’s Biotechnology Policy could serve as a blueprint for FDA’s approach to regulating clean meat. This policy provides for a voluntary consultation process through which developers may consult with FDA to address safety, nutritional, and related issues for a given bioengineered food. This voluntary mechanism affords developers the opportunity to have FDA review its scientific and regulatory assessment. If the review does not raise any safety or regulatory concerns, FDA issues a “No Questions” letter. FDA maintains a publicly available database of all biotech foods that have been the subject of this voluntary review. Applying this approach to clean meat could be a prudent step from a consumer relations standpoint to demonstrate that clean meat is just as safe as traditionally sourced meat. 

In any event, FDA will have to develop a regulatory approach for clean meat additives, i.e., the cell culture medium constituents. Because FDA is charged with regulating food additives for all foods — subject to USDA or FDA jurisdiction — industry should engage with the FDA early on and establish the safety of the cell culture medium constituent additives required to promote the growth of clean meat to the extent any such constituents are not approved as food additives or deemed generally recognized as safe (GRAS). Clean meat producers may consider a voluntary submission to FDA via the GRAS Notice review process to support the safety of the culture medium feedstock that promotes the growth of the clean meat product. This assumes, of course, that FDA will not require the submission of a food additive petition to establish the safe use of the culture medium constituents.  

Skirting regulatory uncertainty
Assuming clean meat and poultry fit within the existing statutory definitions, USDA-FSIS would be charged with regulatory oversight. 

But given the novelty of clean meat and poultry and FDA’s extensive experience with regulating novel foods and production methods closely analogous to the clean meat paradigm, FDA and USDA could enter into a Memorandum of Understanding (MOU) transferring regulatory oversight to FDA. 

Such an MOU would not be without precedent, but could require limited congressional action. In a reverse scenario transferring jurisdiction from the FDA to USDA, catfish became subject to USDA-FSIS jurisdiction due to congressional mandates in the 2008 and 2014 Farm Bills. The 2008 Farm Bill amended the FMIA to make “catfish” a species amenable to the FMIA and, thus, subject to FSIS inspection. The 2014 Farm Bill amended the FMIA to remove the term “catfish” and to subject “all fish of the order Siluriformes” to FSIS jurisdiction and inspection. A subsequent MOU between the USDA and FDA facilitated the transfer of jurisdiction from FDA to USDA-FSIS. Seafood is otherwise subject to FDA oversight. It remains to be seen whether the regulators will follow a similar path for clean meat – but, in this case, to transfer jurisdiction to FDA.   

Clean meat is set to stake out its place in the American marketplace. Before it hits American grocery shelves and dinner plates, industry must work with FDA and USDA to map out an appropriately tailored regulatory approach that gleans insights from prior collaborations between these agencies that is both transparent and readily understood.  

Assuming clean meat and poultry are accepted as fitting within USDA’s regulatory definitions, narrowly tailored congressional action could transfer oversight to FDA. On the other hand, if USDA takes the lead, to avoid the criticism that USDA jurisdiction sets an unnecessarily high pre-market inspection bar, USDA could design an inspection program in consultation with FDA and industry that is tailored to clean meat production.

The question of jurisdiction cannot properly be addressed without stakeholder feedback as some legislators recently sought to do via an Agriculture Appropriations bill. Rather, FDA, USDA, policymakers and industry must work together to develop a science-based solution within established legal frameworks as has been done in past cases involving novel foods.  Any legislative alternative should be expressly designed to foster continued innovation in this burgeoning sector.

Brian P. Sylvester

About the author: Brian P. Sylvester, former USDA regulatory lawyer and special counsel in Wiley Rein’s Food, Drug and Medical Device Law Practice, advises emerging and established companies in the food, beverage, and agricultural biotechnology sectors, with an emphasis on innovative foods.


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Remember the Minnesota dance instructor who was made paraplegic by eating a hamburger from Sam’s Club? Almost a decade after Stephanie Smith of Cold Spring, MN, and others were tragically damaged by eating those hamburgers, the courts may have finally decided where financial responsibility is going to rest. This week, the U.S. Court of Appeals for the 8th Circuit upheld the “compromised” verdict by a federal jury in Nebraska that ruled the Greater Omaha Packing Co. must share that responsibility to the tune of $9 million. greater-omaha-packing_406x250Cargill Meat Solutions, which sued Greater Omaha, responded to the three-judge appellate court decision by saying “justice has been served.” Greater Omaha says the $9 million verdict is unfair and it might yet ask for review by all of the 8th Circuit’s judges. Greater Omaha, along with Beef Products Inc., Lone Star Beef Processors, and a foreign producer called Frigorifico PUL, provided beef used to make hamburger at Cargill’s meat grinding plant in Butler, WI, on Aug. 16, 2007. That’s when the poison hamburgers were produced. On Oct. 6 that year Cargill recalled 845,000 pounds of frozen ground beef made at the Butler plant. In 2015 a jury had to decide if beef from Greater Omaha that was used in the mix that day was contaminated, and if so what, if any, financial penalty should be imposed. Cargill had already paid out almost $25.3 million in nine settlements for personal injuries. Cargill’s recall and associated business costs were almost $550,000. Cargill also reached a settlement with Smith for an undisclosed amount in June 2010. After a three week jury trial last year, the U.S. District Court for Nebraska returned a general verdict for Cargill and awarded it $9 million in damages. Greater Omaha appealed, saying “the jury reached an impermissible compromise verdict…” That left it to the three-judge appeals panel to wade into the science of E. coli O157:H7, and tools like the “line list” used by the federal Centers for Disease Control and Prevention (CDC), which in this case tracked  people who were infected the rare strain of E. coli O157:H7 that made Smith and others so seriously ill. At both the trial and appellate court levels several aspects of the outbreak investigation came into question, including epidemiological work, pulsed-field gel electrophoresis (PFGE) technology with its DNA fingerprinting, and the involvement of state and federal agencies. hamburger-patties-featured All four companies providing Cargill with beef had submitted “certificates of analysis” showing samples of their beef had tested negative for E. coli O157:H7. The appeals court found “it is undisputed the raw materials caused the contamination.” The appeals panel also found Cargill discovered Greater Omaha was using a new sampling procedure that did not comply with the procedure Cargill required. Greater Omaha resumed using the previous procedure in October 2007. Cargill claims Greater Omaha experienced a spike in E. coli O157 positives. Cargill threatened to drop Greater Omaha as a supplier in December 2007. The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a Notice of Intended Enforcement (NOIE) against Greater Omaha on Dec. 20, 2007. The NOIE covered the period from June 1, 2007, to Nov. 29, 2007, for failing to meet regulatory requirements “for pre-operational sanitation, on average, 48 percent of the time.” The FSIS notice found Greater Omaha had experienced a spike in E. coli O157 samples from mid-October through November 2007. Greater Omaha said a fan its kill floor, which was subsequently removed, was responsible for the spike. Greater Omaha disputed CDC findings The CDC put 54 cases from the outbreak on the “line list,” with 27 exposures traced to the Sam’s Club beef burger brand, known as American Chef’s Selection. Another 14 had no food history information and 13 had partial food history information. In three patients, from Hawaii, Missouri and New York, the epidemiological investigations revealed the Sam’s Club brand of beef patties had not been consumed, but the patients had eaten beef that came directly from Greater Omaha. “The Hawaii case patient was a seven-year old girl who had consumed a raw beef dish at a restaurant on Aug. 30, 2007,” Judge Roger Wollman writes. “She became ill four days later and was diagnosed with E. coli O157:H7. PFGE testing revealed that the Hawaiian patient had the same PFGE pattern as the Minnesota case patients, and further genetic sub typing, know as multiple locus variable-number tandem repeat analysis (MLVA), revealed that she also had the same MLVA results as the Minnesota case patients.” The Hawaiian restaurant’s California distributor confirmed that Greater Omaha was the source of the beef served to the young girl, adding that it did not use any of the other three suppliers — BPI, Lone Star or Frigorifico — used by Cargill. A 24-year-old Missouri man who was also stricken ate ground beef from a Schnucks grocery store that grinds beef in-house. The beef was suppled by Greater Omaha and not any of the other three Carill suppliers. Cargill’s expert witnesses at trial testified that it is likely the E. coli O157 bacteria “originated from the same source.” Greater Omaha attorneys tried unsuccessfully to get the Cargill experts excluded from testifying. Greater Omaha claimed that since not all 54 cases on the “line list” could be traced back to its product, such as two Ohio cases, the company cannot be found responsible for the outbreak. Cargill’s epidemiologists, however, said they were just not able to trace back all of the cases. The rare E. coli strain involved dated back to about 2004, suggesting multi-causes were possible for those on the list of 54. “That Greater Omaha’s August 9 or 10, 2007, beef production could not have caused the two Ohio patients’ E. coli O157:H7 infections does not invalidate the experts’ conclusion that the Greater Omaha production was the source of the E. coli O157:H7 bacteria found in the Cargill patties,” Judge Wollman added. (To sign up for a free subscription to Food Safety News, click here.)

Cargill Meat Solutions of Wyalusing, PA, is recalling approximately 8,294 pounds of ground beef products that may be contaminated with blue string, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced Friday.

Cargill meat labelsThe ground beef patties were produced on April 6, 2015. The following products are subject to recall:

  • 5.3-lb. trays containing sixteen pieces of “85% Lean | 15% Fat MEADOWLAND FARMS Ground Beef 1/3 LB. PATTIES,” with a use or freeze by date of April 18, 2015.

The products subject to recall bear the establishment number “EST. 9400” inside the USDA mark of inspection. These items were shipped to warehouse locations in Connecticut and Maryland. The problem was discovered when the establishment was being cleaned and a cotton/poly blend blue string was observed in one of the machines. The company then contacted the FSIS District Office, as it had reason to believe that some of the string may have ended up in the final product. FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. Consumers with questions about the recall can call Cargill at 1-877-596-4069. Consumers who have purchased the affected products have been directly contacted by the retailer.