In the next version of my life I want to be a CDC EIS officer chasing foodborne diseases in the footsteps of many of my heroes in the past and in the present who I have gotten to know since the Jack-in-the-Box E. coli Outbreak of 1993.

Being an Epi-wannabe, I do tend to look forward to my Morbidity and Mortality Weekly Reports and articles in Emerging Infectious Diseases.  A recent “novel” article caught my eye today – “Novel Outbreak-Associated Food Vehicles, United States” – here is the abstract – it is well worth the read:

Novel outbreak-associated food vehicles (i.e., foods not implicated in past outbreaks) can emerge as a result of evolving pathogens and changing consumption trends. To identify these foods, we examined data from the Centers for Disease Control and Prevention Foodborne Disease Outbreak Surveillance System and found 14,216 reported outbreaks with information on implicated foods. We compared foods implicated in outbreaks during 2007–2016 with those implicated in outbreaks during 1973–2006. We identified 28 novel food vehicles, of which the most common types were fish, nuts, fruits, and vegetables; one third were imported. Compared with other outbreaks, those associated with novel food vehicles were more likely to involve illnesses in multiple states and food recalls and were larger in terms of cases, hospitalizations, and deaths. Two thirds of novel foods did not require cooking after purchase. Prevention efforts targeting novel foods cannot rely solely on consumer education but require industry preventive measures.

I must admit, I blushed a bit to see Marler Clark, Food Poison Journal and Food Safety News cited as sources – I feel I have died and gone, well, perhaps to heaven:

We then conducted a secondary check of additional sources for all foods initially identified as novel (PubMed, online forums [e.g., Food Safety News, Food Poison Journal, and MarlerClark], and media reports). This check served to identify false-positive results from 2 scenarios: 1) the food had been implicated in an outbreak during 1973–2006, but the outbreak had not been reported to FDOSS; or 2) the food had been reported as part of an outbreak occurring during 1973–2006 with a more generic term. We reclassified foods only if the available information was sufficient to follow our criteria (i.e., there were >2 confirmed cases and an identified implicated food). 

CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) are collecting different types of data to investigate a multistate outbreak of E. coli O121 infections linked to cake mix.

As of July 27, 2021, 16 people infected with the outbreak strain of E. coli O121 have been reported from 12 states. Illnesses started on dates ranging from February 26, 2021 to June 21, 2021.

Sick people range in age from 2 to 73 years, with a median age of 13, and 100% are female. Of 16 people with information available, 7 have been hospitalized. One person has developed a type of kidney failure called hemolytic uremic syndrome (HUS), and no deaths have been reported.

The true number of sick people in an outbreak is likely much higher than the number reported, and the outbreak may not be limited to the states with known illnesses. This is because many people recover without medical care and are not tested for E. coli. In addition, recent illnesses may not yet be reported as it usually takes 3 to 4 weeks to determine if a sick person is part of an outbreak.

State and local public health officials are interviewing people about the foods they ate in the week before they got sick. Of the eight people interviewed, six (75%) reported tasting or eating raw batter made with a cake mix. People reported buying different varieties and brands of cake mix.

Public health investigators are using the PulseNet system to identify illnesses that may be part of this outbreak. CDC PulseNet manages a national database of DNA fingerprints of bacteria that cause foodborne illnesses. DNA fingerprinting is performed on bacteria using a method called whole genome sequencing (WGS). WGS showed that bacteria from sick people’s samples are closely related genetically. This means that people in this outbreak likely got sick from the same food.

FDA is conducting a traceback investigation using purchase records from locations where sick people bought cake mix to try to determine a common cake mix brand or production facility.

CDC advises people not to eat raw cake batter, whether made from a mix or homemade. Eating raw cake batter can make you sick. Raw cake batter can contain harmful bacteria. Bacteria are killed only when raw batter is baked or cooked.

Follow safe food handling practices when you are baking and cooking with cake mixes, flour, and other raw ingredients such as eggs.

COVID has been a curse for most reasons, but it has allowed me to do more speaking with far less travel.  Here is a course I am speaking at on Saturday, and I have already done the speech – virtually.  Link: https://www.cme.ucla.edu/courses/event-description?registration_id=620979&client_view_p=f

To protect Canadians from possible health risks, the Canadian Food Inspection Agency (CFIA) is implementing temporary import conditions for romaine lettuce from the Salinas Valley (Santa Cruz, Santa Clara, San Benito, and Monterey) in California for the 2021 growing season.

Between September 30 and December 31, 2021, importers of romaine lettuce and products containing romaine lettuce from the U.S. are required to provide proof that the product does not originate from counties in California’s Salinas Valley, or an attestation form and certificate of analysis for each shipment to demonstrate that the romaine lettuce does not contain detectable levels of E. coli O157:H7.

Similar temporary import conditions were implemented during last year’s fall season.

The temporary requirements add an extra level of control to the food safety measures already in place under the Safe Food for Canadians Regulations Act (SFCA) and the Safe Food for Canadians Regulations (SFCR).

As of January 15, 2021, SFCR requirements came into force for most businesses in the fresh fruits or vegetables (FFV) sector that import, export or engage in interprovincial trade.

Under the SFCR, FFV businesses, including those who import romaine lettuce, are now required to obtain a Safe Food for Canadians licence and maintain:

  • preventive controls that address food safety hazards;
  • preventive control plans that document risks to food and how they are addressed; and
  • traceability documentation that tracks the movement of food one step forward and one step back in the supply chain.

From 2016 to 2019, romaine lettuce from California was linked to outbreaks of E. coli illnesses in the United States and Canada. Food safety investigations by Canadian and U.S. authorities identified the Salinas Valley growing region as a recurring source of E. coli outbreaks. As a result, the CFIA is working closely and collaboratively with the U.S. Food and Drug Administration (FDA) to identify and respond to any potential outbreaks.

Additional safeguards

Canada maintains specific import requirements to minimize potential hazards associated with romaine lettuce. For example, the importation of leafy greens from California is limited to products supplied by certified members of the California Leafy Greens Marketing Agreement (LGMA). LGMA certified members must adhere to food safety requirements subject to regular audits by the California Department of Food and Agriculture.

The CFIA has a regular monitoring program for E. coli O157:H7 in fresh vegetables. Since April 1, 2019, in addition to the regular monitoring program, the CFIA added 1,000 samples per year of imported romaine lettuce and products containing romaine lettuce.

For more information, read the CFIA’s guidance Import requirements for romaine lettuce from the United States.

Quick Facts

  • The CFIA plays a critical role in safeguarding a healthy food supply system, ensuring the foods Canadians eat are safe and facilitating the trade of food and food products internationally.
  • Due to growing conditions, Canada imports lettuce from Salinas Valley primarily during the fall months.
  • Approximately 40,000 shipments of romaine lettuce or salad mixes containing romaine lettuce were imported into Canada from January to December 2020.
  • Romaine lettuce is associated with elevated food safety risks. In Canada, there have been seven documented outbreaks of illnesses associated with romaine lettuce, and 16 recalls of romaine lettuce or products containing romaine lettuce due to E. coli O157:H7 from 2010 to 2019.
  • Under the CFIA’s temporary import requirements, romaine from Salinas must be tested in a laboratory accredited by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA).
  • In 2020, the CFIA imposed temporary import conditions for romaine lettuce from the Salinas Valley between October 7 and December 31. There were no E. coli outbreaks in Canada related to lettuce from that region.

Related Products or Associated Links

I starting going to this great conference n 2005 or 2006 (the years blend) and we have been proud to be a major sponsor over the years.  Last year I did my speech virtually due to COVID.  This year, likely do to our inability to keep COVID in check in the US, I will likely be banned from attending.

Safe food is essential to everyone’s health. Around the world, governments and businesses share the enormous responsibility for safeguarding food. This challenging job happens to benefit immensely from multilateral knowledge sharing, collaboration, and dialogue. With a focus on professional education and networking, the China International Food Safety & Quality (CIFSQ) Conference brings global experts together to address critical issues and identify recent advances in science, smart technologies, best management practices, risk based strategies, effective communications, and comprehensive legislation that can make a difference towards enhancing food safety. At the upcoming event in Beijing, over 1,000 regulators, scientists, industry executives, technologists, and academics are expected to attend physically or virtually including 150+ talented food safety leaders who will take the stage to share their insights on the latest developments. We welcome your participation on October 27 – 28, 2021.

To those that can attend, I would urge you to do so – http://www.chinafoodsafety.com

August 19, 2021

Ms. Sandra Eskin
Deputy Under Secretary for Food Safety
Food Safety and Inspection Service
331-E Jamie Whitten Federal Bldg.
1400 Independence Avenue, SW
Washington, D.C. 20250

Docket Clerk
U.S. Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue, SW
Mailstop 3782
Room 6065
Washington, D.C. 20250

Re: Requesting a Status Update on the Resolution of Docket No. FSIS-2020-0007; Document ID FSIS-2020-0007-0001 – Petition for an Interpretive Rule declaring ‘Outbreak’ Serotypes of Salmonella enterica subspecies enterica to be Adulterants Within the Meanings of 21 U.S.C. § 601(m)(1) and 21 U.S.C. § 453(g)(1)

Dear Ms. Eskin:

Marler Clark LLP, PS submits this letter requesting a status update relating to the above-referenced docket, Docket No. FSIS-2020-0007; Document ID FSIS-2020-0007-0001 – Petition for an Interpretive Rule declaring ‘Outbreak’ Serotypes of Salmonella enterica subspecies enterica to be Adulterants Within the Meanings of 21 U.S.C. § 601(m)(1) and 21 U.S.C. § 453(g)(1) (hereinafter “Salmonella Petition”).

Over a year and a half ago, on January 19, 2020, Marler Clark submitted its Salmonella Petition on behalf of Rick Schiller, Steven Romes, the Porter family, Food & Water Watch, Consumer Federation of America, and Consumer Reports, requesting that FSIS declare the following “Outbreak Serotypes” to be per se 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.[1]

FSIS posted the Salmonella Petition to its website shortly thereafter, and during the subsequent four-month comment period, the Petition garnered a total of 377 comments. On March 19, 2020, we wrote then-FSIS Administrator Paul Kiecker to reaffirm our request for an expedited review of the Petition. On June 5, 2020, we wrote former Under Secretary for Food Safety Mindy Brashears to supplement the Petition with additional and updated information, as well as to address some issues and criticism raised by comments submitted during the comment period, namely those generated using a template circulated by the Weston A. Price Foundation. A few months ago, on March 12, 2021, we again wrote Mr. Kiecker to request a status update relating to FSIS’s response to and resolution of our Petition. Still, we have yet to receive a clear answer as to when or how our Petition will be addressed.

FSIS is required by the Administrative Procedure Act[2] and the courts[3] to, at the very least, respond to the merits of a petition for rulemaking. 5 U.S.C. §555(b), in particular, requires that “[w]ith due regard for the convenience and necessity of the parties…and within a reasonable time, each agency shall proceed to conclude a matter presented to it.” It is also within the power of the courts to compel “unreasonably delayed” agency actions,[4] and, in determining whether unreasonable delay has occurred, courts are directed to consider, among other factors, whether human health and welfare are at stake as well as the nature and extent of the interests prejudiced by delay.[5]

While we support FSIS’s efforts to gather information about strategies to reduce the significant public health burden associated with Salmonella, including through recent public meetings such as FSIS’s September 22, 2020, “Salmonella-State of Science” seminar, the country’s stalled progress on reducing salmonellosis demands bold action, far beyond the measures included in the agency’s “Roadmap to Reducing Salmonella.” Salmonella is the leading bacterial cause of foodborne illness in the United States, resulting in an estimated 1.35 million illnesses, 26,500 hospitalizations, and 420 deaths, and 130 outbreaks each year[6] [7] and unfortunately, the burden on consumers shows no signs of letting up. In 2021, USDA’s Economic Research Service (ERS) estimated the cost of Salmonella illnesses alone to be a staggering 4.14 billion dollars.[8]

According to Foodborne Diseases Active Surveillance Network (FoodNet), the incidence of salmonellosis was 14.46 cases per 100,000 people in 1996 across FoodNet sites. As of 2019, it was 17.12.[9] New culture-independent diagnostic testing (CIDTs) may account for some of the increase, but CDC researchers have made clear that “identification of infections that might not have been detected before adoption of CIDTs cannot explain this overall lack of progress.”[10] CDC researchers further estimate that for every diagnosed and reported case of Salmonella infection, another 29 go unreported.[11] Foods regulated by FSIS substantially contribute to this public health burden; according to the Interagency Food Safety Analytics Collaboration, over a third of salmonellosis cases can be attributed to chicken (14.0%), pork (10.3%), beef (6.4%), and turkey (6.2%).

Designing Salmonella performance standard to more closely align with the goal of reducing foodborne illness is fundamental to improving food safety. Currently, Salmonella performance standards measure how well an establishment is reducing the frequency with which its products test positive for contamination by any Salmonella species. FSIS verification testing may identify virulent strains of Salmonella that are linked to currently ongoing outbreaks, but the product nevertheless can go into commerce so long as the establishment has a sufficient number of “negative” samples and is otherwise meeting the rules designed to show that its plant conditions are not “insanitary.” This indirect approach is not working.

To protect the public, FSIS needs to acknowledge that certain Salmonella serotypes pose an unacceptable risk to consumers and make rules to keep adulterated products contaminated by these serotypes off the shelves. Accordingly, we again invite you to respond favorably to our Petition.

Very truly yours,

William D. Marler

cc: Mary Porretta, Petitions Manager
Matthew Michael, Director, Regulations Development Staff
Terri Nintemann, Deputy Administrator
Food & Water Watch
Consumer Federation of America
Consumer Reports
Rick Schiller
Steven Romes
The Porter family

FULL PETITION – https://www.fsis.usda.gov/policy/petitions/petition-interpretive-rule-related-certain-salmonella-serotypes

[1]           Thirty of these 31 serotypes are from the Centers for Disease Control and Prevention’s (CDC) Salmonella Atlas, which contains 42 years of laboratory-confirmed research. See Salmonella Atlas at https://www.cdc.gov/salmonella/reportspubs/salmonella-atlas/serotype-reports.html. The only exception, Salmonella Dublin, was added to Petitioners’ list because it is a serotype of increasing public health concern that was recently involved in a foodborne illness outbreak linked to ground beef.

[2]           In addition to 5 USC § 553(e)’s requirement that each agency “shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule,” the Administrative Procedure Act also requires agencies to provide “prompt notice…of the denial in whole or in part of a written application, petition, or other request of an interested person made in connection with any agency proceeding,”5 USC §555(e).

[3]           Horne v. USDA, 494 Fed. Appx. 774 (9th Cir. 2012) (“USDA responded to the Hornes’ rulemaking petition—as it must under the Administrative Procedure Act”); WWHT, Inc. v. F.C.C., 656 F.2d 807, 813 (D.C. Cir. 1981) (“an agency must receive and respond to petitions for rulemaking”); Nat’l Parks Conserv. Ass’n v. Interior, 794 F.Supp.2d 39, 44-45 (D.D.C. 2011) (“[A]n agency ‘is required to at least definitively respond to . . . [a] petition—that is, to either deny or grant the petition.’”); Families for Freedom v. Napolitano, 628 F.Supp.2d 535,540 (S.D.N.Y 2009) (concluding the same and noting “DHS conceded this point at oral argument”); but see Brown v. FBI, 793 F.Supp.2d 368, 375 (D.C. Cir. 2011) (observing, in the context of reviewing petitioner’s standing, that “the APA is less than crystal-clear on plaintiff’s statutory right to a response,” though simultaneously citing WWHT, “an agency must receive and respond”). See also Richard J. Pierce, Administrative Law Treatise 517 (5th ed. 2013) (“At a minimum, the right to petition for rulemaking entitles a petitioning party to a response to the merits of the petition.”).

[4]           In re. Natural Resources Defense Council, 645 F.3d 400, 406 (D.C. Cir. 2011) (applying 5 USC § 555(b) to an FDA citizen’s petition); Fund for Animals v. Norton, 294 F.Supp.2d 92, 112 (D.C. Cir. 2003) (applying 5 USC §§555(b) and 706(1) to review agency delay in responding to a petition); Nat’l Parks Conserv. Ass’n v. Interior, 794 F.Supp.2d 39, 44-45 (D.D.C. 2011) citing 5 USC §§553(e), 555(b), and concluding “an agency is required to at least definitively respond to…[a] petition”).

[5]           Telecommunications Research & Action Center (TRAC) v. FCC, 750 F.2d 70, 80 (D.C. Cir. 1984); Shinnecock Indian Nation v. Kempthorne, 2008 U.S. Dist. LEXIS 75826 (E.D.N.Y. 2008) (following TRAC);

[6]           “Salmonella Homepage.” CDC, 2021.

[7]           Laufer AS, et al. (2015). Outbreaks of Salmonella Infections Attributed to Beef – United States, 1973-2011. Epidemiol Infect. 143(9):2003-13.

[8]           “Cost Estimates of Foodborne Illnesses.” ERS, 2021. https://www.ers.usda.gov/data-products/cost-estimates-of-foodborne-illnesses/

[9]           See FoodNet Fast at https://wwwn.cdc.gov/foodnetfast/.

[10]         Tack DM, et al. (2020). Preliminary Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food – Foodborne Diseases Active Surveillance Network, 10 U.S. Sites, 2016-2019. MMWR. 69(17):509-514.

[11]         Scallan E, et al. (2011). Foodborne Illness Acquired in the United States–Major Pathogens. Emerg Infect Dis. 17(1):7-15.

WASHINGTON—An unprecedented coalition of consumer groups, illness survivors, poultry industry leaders, academic scientists, and other food safety leaders are seeking a meeting with Agriculture Secretary Tom Vilsack to make a united case for a modernized, science-based regulatory approach to ensure the food safety of poultry products.

Poultry producers Butterball, Perdue Farms, Tyson Foods, and Wayne Farms aligned with four consumer groups—the Center for Science in the Public Interest, Consumer Federation of America, Consumer Reports, and Stop Foodborne Illness—on key poultry food safety principles and jointly asked for modernized USDA poultry food safety standards that are “objective, risk-based, achievable, enforceable and flexible” enough to adapt to evolving science.

Illnesses from Salmonella and Campylobacter, which are commonly found on poultry, account for 70 percent of the foodborne illnesses tracked by the Centers for Disease Control and Prevention. These bacteria sicken 3 million people and cost about $6 billion annually. While the federal government set targets for decreased Salmonella and Campylobacter infections as part of its Healthy People 2020 goals, released in 2010, the U.S. failed to meet those targets. Rates of illnesses caused by Salmonella and Campylobacter have remained essentially unchanged.

Besides officials at the companies and the consumer groups, the request to Vilsack was signed by several survivors of foodborne illness, the Association of Food and Drug Officials, Mike Robach, former Cargill food safety quality and regulatory head and former Global Food Safety Initiative Board chairman, and three of the country’s most prominent academic food safety experts, Drs. Craig Hedberg, J. Glenn Morris, and Martin Weidmann. Former senior USDA food safety officials Michael Taylor, Brian Ronholm, and Jerry Mande also added their signatures.

“While progress on reducing foodborne illness has been at a standstill, scientific knowledge of Salmonella has greatly increased and recognized best practices for Campylobacter and other pathogens has advanced,” the parties wrote to Vilsack. “Science tells us that current performance standards do not effectively target the particular types of Salmonella and the levels of bacteria that pose the greatest risks of illness, and the overall regulatory framework does not adequately harness modern tools for preventing and verifying control of the bacteria that are making people sick.”

“Everyone involved in the production and processing of poultry is invested in producing the safest products possible,” said Mike Robach. “But we all recognize that a modern, risk-based and science-based approach to food safety is necessary both to control pathogens and to promote consumer confidence in the safety of the poultry supply.”

“The science has grown by leaps and bounds since I led USDA’s efforts to create the current poultry standards in the 1990s,” said Michael Taylor, who served as Administrator for the USDA’s Food Safety and Inspection Service from 1994 to 1996. “It was the best we could do at the time, but what we know now makes the standards on the books no longer defensible.”

“When the federal government fails to meet its own goals for reducing the incidence of foodborne illness, it’s clear that a new approach is needed,” said CSPI deputy director of regulatory affairs Sarah Sorscher. “Our coalition of consumer groups, academic experts, poultry companies, and survivors of foodborne illness stands ready to support Secretary Vilsack and the USDA team in modernizing our poultry safety system.”

More information about the campaign to reduce Salmonella and Campylobacter illnesses due to poultry is available at https://stopfoodborneillness.org/safer-poultry-for-everyone/.

As I posted yesterday, I am still unclear why the FDA has not used its recall authority to force Felix Custom Smoking to recall the product that the FDA determined to be at risk of being tainted by the deadly pathogen, Listeria monocytogenes.

Taking aside the weakness of the FDA (or whatever the cause of the inaction) and the moral failing of Felix Custom Smoking to recall product that might sicken or kill their customers; since Felix Custom Smoking refused the recall, the questions is: what if the product then caused harm, would it be liable for punitive damages?

I would say – yes.

Listeria monocytogenes is a species of disease-causing bacteria, which can cause an infection called listeriosis. Listeria monocytogenes is generally transmitted when food is harvested, processed, prepared, packed, transported or stored in environments contaminated with Listeria monocytogenes. A listeriosis infection can have serious adverse effects for women who are or may become pregnant, the elderly, and persons with weakened immune systems. There are a range of symptoms for listeriosis. Depending on the severity of the illness, symptoms may last from days to several weeks. Mild symptoms may include a fever, muscle aches, nausea, vomiting, and diarrhea. If a more severe form of listeriosis develops, symptoms may include headache, stiff neck, confusion, loss of balance, and convulsions. For the very young, the elderly, and the immune-compromised listeriosis can result in death.

Punitive damages are damages, other than compensatory or nominal damages, awarded against a person to punish him for his outrageous conduct and to deter him and others like him from similar conduct in the future.

A jury may, in its discretion, render punitive damages in cases in which the defendant is found to have injured the plaintiff intentionally or maliciously, or in which the defendant’s conduct reflected a conscious, reckless, willful, wanton, or oppressive disregard of the rights or interests of the plaintiff.

The amount of a punitive damages award is determined by the jury upon consideration of the seriousness of the wrong, the seriousness of the plaintiff’s injury, and the extent of the defendant’s wealth.

FDA Advisory: On August 27, 2021, the FDA advised consumers not to purchase or eat any seafood products sold or processed by Felix Custom Smoking due to possible Listeria monocytogenes contamination. See, Advisory

Summary of Problem and Scope: The FDA detected the pathogen Listeria monocytogenes and other strains of Listeria during an inspection at Felix Custom Smoking that began on July 19, 2021 and is still ongoing.

As part of the inspection, on July 19, 2021, the FDA collected environmental samples from the firm which consisted of 104 samples from direct food contact surfaces and areas near direct food contact surfaces.  Laboratory analysis shows that of the 104 samples collected, 19 tested positive for the pathogen Listeria monocytogenes and four tested positive for other strains of Listeria.  Of the 19 samples that were positive for Listeria monocytogenes, five were collected from food contact surfaces.

The FDA has notified Felix of its findings, but the company has declined to initiate a recall of its products and is still processing seafood at this time.

FDA Actions: The FDA is issuing this alert to notify consumers, companies, and fishermen who may have received product from Felix because the agency is concerned about the presence of Listeria monocytogenes at the firm and the safety of its products. The FDA is continuing its efforts with Felix and its customers to remove these products from the market.

Product   

Felix Custom Smoking of Monroe, Washington, is a processor of a variety of ready-to-eat salmon, squid jerky, and frozen, hot smoked and cold smoked seafood. The firm also processes seafood products for companies that distribute these products independently.

Some of Felix’s products include:

Felix Northwest Blend Smoked Wild King Salmon
Felix Northwest Blend Smoked Wild Sockeye Salmon
Felix Northwest Blend Smoked Wild Tuna
Felix Pepper Smoked Wild Mixed Salmon Jerky
Felix Wild Keta Teriyaki Smoked Salmon Jerky

One of Felix’s customers, Loki Fish Company, issued its own product recall on August 23, 2021.

So, why not use the authority granted under the FSMA and use the FDA’s mandatory recall authority?

According to the FDA (Food and Drug Administration), before FSMA (Food Safety Modernization Act)was enacted, the FDA relied on responsible parties to voluntarily recall violative food products (except infant formula recalls which are described under section 412 of the FD&C Act – Food, Drug and Cosmetic Act). The FDA continues to rely on responsible parties to voluntarily recall violative food products; however, FSMA’s mandatory recall authority allows the FDA to mandate a recall when a responsible party chooses not to conduct a voluntary recall when the criteria under section 423 of the FD&C Act are met. The FDA can use its mandatory recall authority when the FDA determines that there is a reasonable probability that an article of food is adulterated under section 402 of the FD&C Act and/or misbranded under section 403(w) of the FD&C Act and where there is a reasonable probability that the use of or exposure to such food would cause SAHCODHA ( Serious Adverse Health Consequences or Death to Humans or Animals).

See, Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff

FDA Advisory

On August 27, 2021, the FDA advised consumers not to purchase or eat any seafood products sold or processed by Felix Custom Smoking due to possible Listeria monocytogenes contamination. See, Advisory

Listeria monocytogenes is a species of disease-causing bacteria, which can cause an infection called listeriosis. Listeria monocytogenes is generally transmitted when food is harvested, processed, prepared, packed, transported or stored in environments contaminated with Listeria monocytogenes. A listeriosis infection can have serious adverse effects for women who are or may become pregnant, the elderly, and persons with weakened immune systems. There are a range of symptoms for listeriosis. Depending on the severity of the illness, symptoms may last from days to several weeks. Mild symptoms may include a fever, muscle aches, nausea, vomiting, and diarrhea. If a more severe form of listeriosis develops, symptoms may include headache, stiff neck, confusion, loss of balance, and convulsions. For the very young, the elderly, and the immune-compromised listeriosis can result in death.

Summary of Problem and Scope

The FDA detected the pathogen Listeria monocytogenes and other strains of Listeria during an inspection at Felix Custom Smoking that began on July 19, 2021 and is still ongoing.

As part of the inspection, on July 19, 2021, the FDA collected environmental samples from the firm which consisted of 104 samples from direct food contact surfaces and areas near direct food contact surfaces.  Laboratory analysis shows that of the 104 samples collected, 19 tested positive for the pathogen Listeria monocytogenes and four tested positive for other strains of Listeria.  Of the 19 samples that were positive for Listeria monocytogenes, five were collected from food contact surfaces.

The FDA has notified Felix of its findings, but the company has declined to initiate a recall of its products and is still processing seafood at this time.

FDA Actions

The FDA is issuing this alert to notify consumers, companies, and fishermen who may have received product from Felix because the agency is concerned about the presence of Listeria monocytogenes at the firm and the safety of its products. The FDA is continuing its efforts with Felix and its customers to remove these products from the market.

Audience

The U.S. Food and Drug Administration is alerting consumers who have purchased Felix Custom Smoking branded products directly from the firm, as well as companies and commercial and sports fishermen who have used Felix to process, package, and/or label their seafood.

The FDA is advising consumers not to eat any of Felix’s products or products processed by Felix and to discard any remaining products they may have purchased in the past due to possible Listeria monocytogenes contamination.

The FDA is advising companies and commercial fishermen not to sell or further distribute any products processed by Felix. They also should discard any of their remaining products that were processed by Felix due to possible Listeria monocytogenes contamination.

Product   

Felix Custom Smoking of Monroe, Washington, is a processor of a variety of ready-to-eat salmon, squid jerky, and frozen, hot smoked and cold smoked seafood. The firm also processes seafood products for companies that distribute these products independently.

Some of Felix’s products include:

Felix Northwest Blend Smoked Wild King Salmon
Felix Northwest Blend Smoked Wild Sockeye Salmon
Felix Northwest Blend Smoked Wild Tuna
Felix Pepper Smoked Wild Mixed Salmon Jerky
Felix Wild Keta Teriyaki Smoked Salmon Jerky

One of Felix’s customers, Loki Fish Company, issued its own product recall on August 23, 2021.

So, what’s up FDA?