Since the last update on December 30, 2021, CDC updated the case definition and removed three illnesses from this outbreak investigation. These three people were infected with E. coli bacteria that were not as closely related genetically to the rest in this outbreak. None of the three sick people reported eating Organic Power Greens.

As of January 6, 2022, a total of 10 people infected with the outbreak strain of E. coli O157:H7 have been reported from four states. Illnesses started on dates ranging from November 27, 2021, to December 9, 2021.

Alaska – 2
Ohio – 1
Oregon – 1
Washington – 6

Sick people range in age from 26 to 79 years, with a median age of 59, and 100% are female. Of ten people with information available, four have been hospitalized and one person developed a type of kidney failure called hemolytic uremic syndrome (HUS). 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 interviewed people about the foods they ate in the week before they got sick. Nine people reported eating Organic Power Greens sold under the Simple Truth Organic brand (8) and the Nature’s Basket brand (1), and seven people’s shopper records showed the purchase of these products. Both brands of Organic Power Greens have the same mix of leafy greens: organic spinach, mizuna, kale, and chard.

53 sick, 30 hospitalized, 4 with kidney failure and 3 dead

E. coli and Lettuce 1: As of December 29, 2021, 13 people infected with the outbreak strain of E. coli O157:H7 have been reported from six states. Illnesses started on dates ranging from November 27, 2021, to December 9, 2021. Sick people range in age from 4 to 79 years, with a median age of 54, and 92% are female. Of 12 people with information available, four have been hospitalized and one person developed a type of kidney failure called hemolytic uremic syndrome (HUS). No deaths have been reported.

CDC is advising not to eat Simple Truth Organic Power Greens and Nature’s Basket Organic Power Greens with “best if used by” dates through December 20, 2021. Investigators are working to determine if additional products may be contaminated.

E. coli and Lettuce 2: As of December 3, 2021, a total of 14 people infected with the outbreak strain of E. coli O157:H7 have been reported from nine states. Illnesses started on dates ranging from October 13, 2021, to October 27, 2021. Sick people range in age from 2 to 76 years, with a median age of 26, and 79% are female. Of 12 people with information available, 4 have been hospitalized and 3 developed a type of kidney failure called hemolytic uremic syndrome (HUS). No deaths have been reported.

CDC reported that officials in Minnesota found E. coli O157:H7 in a package of leftover Josie’s Organics baby spinach collected from a sick person’s home. Whole genome sequencing (DNA fingerprinting for bacteria) showed that the E. coli O157:H7 in the leftover package of spinach is closely related to bacteria isolated from ill people. This means that the person likely got sick from eating the spinach.

Listeria and Lettuce 1:  As of Dec. 23, 2021, the CDC reported that there are sixteen illnesses related to this outbreak in thirteen states. Twelve people have been hospitalized. Two deaths have been reported.

Dole Fresh Vegetables, Inc., is voluntarily recalling from the market all Dole-branded and private label packaged salads processed at its Bessemer City, NC and its Yuma, AZ production facilities due to possible contamination with Listeria monocytogenes. and is also suspending operations at both facilities to conduct an extensive cleaning and sanitation protocol. Products subject to the voluntary recall are identified by a product lot code beginning with either the letter “N” or “Y” in the upper right-hand corner of the package (see examples below) and will have a “Best if Used By” date between November 30, 2021, and January 8, 2022.

Listeria and Lettuce 2:  According to the CDC, as of December 21, 2021, 10 people infected with the outbreak strain of Listeria monocytogenes have been reported from eight states. One death has been reported. Illnesses started on dates ranging from July 26, 2016 to October 19, 2021.

As a part of routine sampling, the Michigan Department of Agriculture and Rural Development (MDARD) collected a product sample of Fresh Express Sweet Hearts salad mix with a Use-By-Date of December 8, 2021 for testing. The sample tested positive for Listeria monocytogenes and subsequent whole genome sequencing (WGS) analysis determined that the Listeria monocytogenes present in the samples matches the strain that has caused illnesses in this outbreak. In response to the sample results and the ongoing outbreak investigation, Fresh Express voluntarily ceased production at the Streamwood, IL, facility and initiated a recall of certain varieties of its branded and private label salad products produced at the company’s Streamwood, Illinois facility. The recall includes all Use-By Dates of fresh salad items with product codes Z324 through Z350.

I suppose it should not be a surprise. E. coli outbreaks associated with lettuce, specifically the “pre-washed” and “ready-to-eat” varieties, are by no means a new phenomenon. In fact, the frequency with which this country’s fresh produce consuming public has been hit by outbreaks of pathogenic bacteria is astonishing. Here are just a sample of E. coli outbreaks based on information gathered by the Center for Science in the Public Interest, Kansas State University and the Centers for Disease Control and Prevention:

Date Vehicle Etiology Confirmed
Cases		 States/Provinces
July 1995 Lettuce (leafy green; red; romaine) E. coliO157:H7 74 1:MT
Sept. 1995 Lettuce (romaine) E. coliO157:H7 20 1:ID
Sept. 1995 Lettuce (iceberg) E. coliO157:H7 30 1:ME
Oct. 1995 Lettuce (iceberg; unconfirmed) E. coliO157:H7 11 1:OH
May-June 1996 Lettuce (mesclun; red leaf) E. coliO157:H7 61 3:CT, IL, NY
May 1998 Salad E. coliO157:H7 2 1:CA
Feb.-Mar. 1999 Lettuce (iceberg) E. coliO157:H7 72 1:NE
Oct. 1999 Salad E. coli O157:H7 92 3:OR, PA, OH
Oct. 2000 Lettuce E. coli O157:H7 6 1:IN
Nov. 2001 Lettuce E. coli O157:H7 20 1:TX
July-Aug. 2002 Lettuce (romaine) E. coliO157:H7 29 2:WA, ID
Nov. 2002 Lettuce E. coli O157:H7 13 1:Il
Dec. 2002 Lettuce E. coli O157:H7 3 1:MN
Oct. 2003-May 2004 Lettuce (mixed salad) E. coliO157:H7 57 1:CA
Apr. 2004 Spinach E. coli O157:H7 16 1:CA
Nov. 2004 Lettuce E. coli O157:H7 6 1:NJ
Sept. 2005 Lettuce (romaine) E. coli O157:H7 32 3:MN, WI, OR
Sept. 2006 Spinach (baby) E. coli O157:H7 and other serotypes 205 Multistate and Canada
Nov./Dec. 2006 Lettuce E. coli O157:H7 71 4:NY, NJ, PA, DE
Nov./Dec. 2006 Lettuce E. coli O157:H7 81 3:IA, MN, WI
July 2007 Lettuce E. coli O157:H7 26 1:AL
May 2008 Romaine E. coli O157:H7 9 1:WA
Oct. 2008 Lettuce E. coli O157:H7 59 Multistate and Canada
Nov. 2008 Lettuce E. coli O157:H7 130 Canada
Sept. 2009 Lettuce: Romaine or Iceberg E. coli O157:H7 29 Multistate
Sept. 2009 Lettuce E. coli O157:H7 10 Multistate
April 2010 Romaine E. coli O145 33 5:MI, NY, OH, PA, TN
Oct. 2011 Romaine E. coli O157:H7 60 Multistate
April 2012 Romaine E. coli O157:H7 28

1:CA

Canada
June 2012 Romaine E. coli O157:H7 52 Multistate
Sept. 2012 Romaine E. coli O157:H7 9 1:PA
Oct. 2012 Spinach and Spring Mix Blend E. coli O157:H7 33 Multistate
Apr. 2013 Leafy Greens E. coli O157:H7 14 Multistate
Aug. 2013 Leafy Greens E. coli O157:H7 15 1:PA
Oct. 2013 Ready-To-Eat Salads E. coli O157:H7 33 Multistate
Apr. 2014 Romaine E. coli O126 4 1:MN
Apr. 2015 Leafy Greens E. coli O145 7 3:MD, SC, VA
June 2016 Mesclun Mix E. coli O157:H7 11 3:IL, MI, WI
Nov. 2017 Leafy Greens E. coli O157:H7 67 Multistate and Canada
Mar. 2018 Romaine E. coli O157:H7 219 Multistate and Canada
Oct. 2018 Romaine E. coli O157:H7 62 Multistate and Canada

 

Washington – 7, Alaska – 2, California – 1, Mississippi – 1, Ohio – 1, Oregon – 1

Simple Truth Organic Power Greens and Nature’s Basket Organic Power Greens sold at grocery stores and supermarkets, including Fred Meyer, QFC, and Giant Eagle – no recall as of yet.

As of December 29, 2021, 13 people infected with the outbreak strain of E. coli O157:H7 have been reported from six states. Illnesses started on dates ranging from November 27, 2021, to December 9, 2021.

Sick people range in age from 4 to 79 years, with a median age of 54, and 92% are female. Of 12 people with information available, four have been hospitalized and one person developed a type of kidney failure called hemolytic uremic syndrome (HUS). No deaths have been reported.

State and local public health officials are interviewing people about the foods they ate in the week before they got sick. Of 12 people interviewed, all reported eating packaged salads. Of 10 people who provided brand information, 6 ate or bought Simple Truth Organic Power Greens and 1 ate Nature’s Basket Organic Power Greens. Both Organic Power Greens salads have the same mix of leafy greens: organic spinach, mizuna, kale, and chard. Several sick people reported using these salads in smoothies.

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 suggests that people in this outbreak got sick from the same food.

CDC is advising not to eat Simple Truth Organic Power Greens and Nature’s Basket Organic Power Greens with “best if used by” dates through December 20, 2021. Investigators are working to determine if additional products may be contaminated.

I could not have said it better and PEW’s conclusion is spot on:

Current poultry policies and regulations treat all Salmonella serotypes and strains as if they pose equal risks to people, despite science showing this is not the case. Food safety interventions on farms, such as vaccines targeting harmful serotypes, have likely contributed to meaningful reductions in product contamination and human illness. FSIS should revise its rules to focus more intensively on the serotypes causing more frequent or severe infections, and implement other policies to prompt poultry operations to adopt on-farm practices that control these hazards. Such a risk-based approach would help prevent illnesses and outbreaks linked to poultry products and drive down the nation’s unacceptably high number of Salmonella illnesses.

Here is the story visually:

I agree with PEW’s concern, as I recently noted in a letter to USDA/FSIS:

Marler Clark LLP, PS submits this letter requesting a definitive and prompt response 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” or “Petition”).

As stated in our November 12, 2021, letter, nearly two years have elapsed since the submission of our SalmonellaPetition 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 seadulterants 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].

Since then—although 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—we have yet to receive a clear response as to when or how FSIS intends to address our Petition.

We write to supplement the November 12, 2021, letter with new research. In their newly published review paper[4], O’Bryan et al. explain that, although the current USDA qualitative performance standards have lowered the prevalence of Salmonella found on raw poultry products, progress has stalled on lowering the cases of salmonellosis associated with poultry. They write, “the incidence of salmonellosis (most recent data indicates 15.3 cases per 100,000) is still well above CDC’s Healthy People 2030 objective of 11.5 cases per 100,0000 population and has not experienced substantial reductions in the last two decades, despite the prevalence data exhibiting a steady decline[5].”

The authors list several reasons for this standstill, many of which are further detailed in the Marler Clark Petition: there are numerous means for birds to be contaminated by Salmonella during the production cycle, especially within the processing environment (e.g., during picking, evisceration, and immersion in the chiller tanks); there is a high prevalence of unsafe behaviors[6] (e.g., undercooking and poor handwashing technique) when cooking poultry, as well as a lack of consumer education; and the current routine monitoring of Salmonella occurrence in poultry processing is seriously lacking. To remedy the latter, they suggest that “the food and poultry industry … undertake a more proactive stance” and develop “a much more complete evaluation of Salmonella population concentrations on a carcass testing positive for Salmonella[7].”

Despite its confirmation of the continuing food safety crisis caused by the failure of the USDA to adequately address the contamination of poultry with Salmonella outbreak strains, the authors still make a glaring error in critiquing the position taken by the Petition. Specifically, the authors assert “that the inherent presence of Salmonella in poultry means it cannot be an ‘added substance’ and it therefore should not be considered an adulterant[8].” The FMIA unambiguously defines an adulteration standard for substances that are “not added” and a different standard for those that are “added[9].” Further, the USDA has itself repeatedly rejected the argument that a bacterial pathogen cannot be deemed an adulterant “because the organism may be inherent in raw meat and poultry when produced under current technology[10].” Indeed, in rejecting this argument, the USDA cited to its own court victory in defending its decision to treat E. coli O157:H7 as an adulterant, despite vociferous industry objections[11]. Thus, having rejected these arguments before, the USDA must do so again. And, finally, the USDA would lack the authority to seek the recall of Salmonella-contaminated ground beef and poultry—recalls that it has done repeatedly—if there was no basis under the FMIA to treat Salmonella, in those instances, as an adulterant.

The other arguments made against the Petition are no better than the inherency one[12]. Although there are no serotype-specific interventions, each of the 31 Outbreak Serotypes of Salmonella we seek be deemed adulterants has a demonstrable history associated with either an illness outbreak or a product recall and are proven to be injurious to human health. Altogether, these 31 Outbreak Serotypes currently account for the greatest number of Salmonella illnesses[13]. As Salmonella evolve, however, serotypes of public concern could be added (as was the case with the “Big Six” non-O157 strains of STEC E. coli) or subtracted from a variable list of outbreak serotypes.

Each year, CDC’s Interagency Food Safety Analytics Collaboration (IFSAC) generates a report that uses outbreak data to produce annual estimates for foods responsible for foodborne illnesses caused by four pathogens, including Salmonella[14]. In its latest publication[15], IFSAC, using data from 1,532 foodborne disease outbreaks that occurred from 1998 through 2019, reported that chicken is responsible for 16.8% of all Salmonella illnesses, making it the single most important source of Salmonella illnesses of any food category. Chicken and turkey, taken together, account for over 23% of those illnesses.

The percentage of Salmonella illnesses associated with poultry has increased year-over-year. In 2015[16], IFSAC reported that chicken was the second largest source of Salmonella illnesses, responsible for 11.8% of Salmonella illnesses. The following year, IFSAC reported that chicken was responsible for 12.7% of Salmonella illnesses[17]. In 2017, chicken was linked to 14% of foodborne illnesses attributed to Salmonella[18]. The following year, in 2018[19], chicken became the number one source of Salmonella illnesses (dethroning seeded vegetables), responsible for 14.3% of illnesses.
In its October 19, 2021, press release, the USDA announced that “it is mobilizing a stronger, and more comprehensive effort to reduce Salmonella illnesses associated with poultry products,” with the goal of “mov[ing] closer to the national target of a 25% reduction in Salmonella illnesses[20].” In doing so, “FSIS will focus on the Salmonellaserotypes and the virulence factors that pose the greatest public health risk.” Although we support the USDA’s efforts, we do not consider this announcement to be responsive to our Petition.

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 urge you to grant our Petition. If we do not receive a definitive response within 140 days, we will assume that you have denied our petition and proceed with judicial remedies.

_______________________
[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]           O’Bryan, C. A., S. C. Ricke, J. A. Marcy (2021). Public health impact of Salmonella spp. on raw poultry: Current concepts and future prospects in the United States. Food Control. 132:108539. https://doi.org/10.1016/j.foodcont.2021.108539
[5]           Id.
[6]           See, e.g., Kirchner, M. K., R. M. Goulter, B. J. Chapman, J. Clayton, L. Jaykus. (2021). Cross-Contamination on Atypical Surfaces and Venues in Food Service Environments. J Food Prot. 84(7):1239-51.Verrill, L., et al. (2021). Hand Washing Observations in Fast-Food and Full-Service Restaurants: Results from the 2014 U.S. Food and Drug Administration Retail Food Risk Factors Study. J Food Prot. 84(6):1016-22.Cardoso, M. J., V. Ferreira, M. Truninger, R. Maia, P. Teixeira. (2021). Cross-contamination events of Campylobacter spp. in domestic kitchens associated with consumer handling practices of raw poultry. Int J Food Microbiol. 338:108984.Mihalache O. A., D. Borda, C. Neagu, P. Teixeira, S. Langsrud, A. I. Nicolau. (2021). Efficacy of Removing Bacteria and Organic Dirt from Hands—A Study Based on Bioluminescence Measurements for Evaluation of Hand Hygiene When Cooking. Int J Environ Res Public Health. 18(16): 8828.Cohen, N. L., R. B. Olson. (2016). Compliance With Recommended Food Safety Practices in Television Cooking Shows. J Nutr Educ Behav. 48(10): 730-34.Oscar, T. P. (2013). Initial contamination of chicken parts with Salmonella at retail and cross-contamination of cooked chicken with Salmonella from raw chicken during meal preparation. J Food Prot. 76(1):33-9.Carrasco, E., A. Morales-Rueda, R. M. Garcia-Gimeno. (2012). Cross-contamination and recontamination by Salmonella in foods: A review. Food Res Int. 45(2):545-56.
[7]           O’Bryan, C. A., S. C. Ricke, J. A. Marcy (2021). Public health impact of Salmonella spp. on raw poultry: Current concepts and future prospects in the United States. Food Control. 132:108539. https://doi.org/10.1016/j.foodcont.2021.108539
[8]           Id.
[9]           21 U.S.C. § 601(m)(1); see also Young v. Community Nutrition Institute, 476 U.S. 974, 977 (1986) (addressing regulatory requirements for “adulterants,” like aflatoxins, that are “not added,” and noting the requirements are more strict for substances that are added)
[10]         USDA, Recent Developments Regarding Beef Products Contaminated with E. coli O157:H7, 65 Fed. Reg. 6881, 6884 (Feb. 11, 2000)
[11]         Id. (citing Texas Food Industry Ass’n v. Espy, 870 F. Supp. 143 (WD Tex. 1994)).
[12]         “There are no serotype-specific interventions for Salmonella, and there are no practical or reliable ways to rapidly identify serotypes in-plant, much less to have a high degree of confidence that all serotypes present in a flock have been identified. Furthermore, it would also be impractical to declare 31 serotypes of Salmonella as adulterants while ignoring the other roughly 2,500 serotypes. The evolution in Salmonella over time would suggest that this would not remain a static list of Salmonella serovars but would likely change the number of distinctive strains for a given serotype over time and the pathogenesis characteristics in different serovars could evolve over time.”
[13]         We explain this point further on page 14 of the Petition: “According to a recent report by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), highly virulent strains are virtually indistinguishable from non-virulent ones because ‘virulence markers for gastroenteritis are not serotype specific.’ Nevertheless, certain serotypes of NTS (Heidelberg, Sandiego, Schwarzengrund, Panama, Poona, Oranienburg) are ‘more likely to escape the gastrointestinal tract and cause systemic disease.’ Moreover, according to the report, a few serotypes are ‘consistently associated with the greatest incidence of human disease,’ including Salmonella enterica serotypes Newport, Enteritidis, Javiana, Typhimurium, Infantis, Muenchen, and I 4,[5],12:i:-. These serotypes (and others) are thoroughly documented in CDC’s Salmonella Atlas and are readily identifiable using Whole Genome Sequencing (WGS).”
[14]         See IFSAC’s reports at https://www.cdc.gov/foodsafety/ifsac/annual-reports.html
[15]         “Foodborne illness source attribution estimates for 2019 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States.” IFSAC, October 2021. https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2019-report-TriAgency-508.pdf
[16]         “Foodborne illness source attribution estimates for 2015 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States.” IFSAC, November 2018. https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2015-report-TriAgency-508.pdf
[17]         “Foodborne illness source attribution estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States.” IFSAC, November 2018. https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2016-report-TriAgency-508.pdf
[18]         “Foodborne illness source attribution estimates for 2017 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States.” IFSAC, September 2019. https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2017-report-TriAgency-508-revised.pdf
[19]         “Foodborne illness source attribution estimates for 2018 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States.” IFSAC, December 2020. https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2018-report-TriAgency-508.pdf
[20]         “USDA Launches New Effort to Reduce Salmonella Illnesses Linked to Poultry.” USDA, October 19, 2021. https://www.usda.gov/media/press-releases/2021/10/19/usda-launches-new-effort-reduce-salmonella-illnesses-linked-poultry

I got this not from former client on Christmas Day:

Merry Christmas Bill! It’s been 5 years since getting sick and this time of year I’m reminded of how thankful I am for all the good people I met since then, including you and your team. Words truly can’t do justice to how I feel. I hope your Christmas was wonderful- you deserve it

Best gift ever. Thank you.

Wishing all a happy holiday season and looking forward to the best New Year.

Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

Fresh Express Lettuce – 10 sick with 1 death in 8 states – 2021

Illnesses: As of December 21, 2021, 10 people infected with the outbreak strain of Listeria monocytogenes have been reported from eight states: Illinois, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania and Virginia. Illnesses started on dates ranging from July 26, 2016 through October 19, 2021. Sick people range in age from 44 to 95 years, with a median age of 80, and 60% are female. All 10 people have been hospitalized. One death has been reported from Pennsylvania. 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.

Traceback and Recall: On December 16, 2021, the Michigan Department of Agriculture identified the outbreak strain of Listeria in a bag of Fresh Express Sweet Hearts packaged salad. On December 20, 2021, Fresh Express recalled several brands of packaged salad products. The recall includes all Use-By Dates with product codes Z324 through Z350.

Dole Lettuce – 16 sick with 2 deaths in 13 states – 2021

Illnesses: As of December 17, 2021, 16 people infected with the outbreak strain of Listeria monocytogenes have been reported from 13 states: Idaho, Iowa, Maryland, Michigan, Minnesota, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Utah and Wisconsin. Illnesses started on dates ranging from August 16, 2014, to October 17, 2021. Sick people range in age from 50 to 94 years, with a median age of 76, and 81% are female. Of 14 people with information available, 12 have been hospitalized. Two deaths have been reported from Michigan and Wisconsin. WGS showed that bacteria from sick people’s samples are closely related genetically. This suggests that people in this outbreak got sick from the same food.

Traceback and Recall: In October 2021, the Georgia Department of Agriculture identified the outbreak strain of Listeria in a Dole brand garden salad as part of a routine sampling program of food at grocery stores. As a result, Dole recalled some of their garden salad products that are now past their “best if used by” dates. This sampling was not part of this outbreak investigation, but WGS later showed that the Listeria bacteria in the garden salad were closely related to the outbreak strain. After CDC reopened this outbreak investigation, Michigan Department of Agriculture and Rural Development collected samples of packaged salads from retail stores for testing and identified the outbreak strain of Listeria in a Marketside brand package of shredded iceberg that was produced by Dole. On December 22, 2021, Dole recalled all Dole-branded and private label packaged salads processed at the two facilities that produced the contaminated packaged salads.

The legal jargon aside, if you are a producer of food and knowingly or not sell adulterated food, you can (and should) face fines and jail time.  Mr. Dole, Mr. Fresh Express, I might suggest a good lawyer.

Here are some recent cases where prosecutors brought criminal charges:

  • In 2012 Eric Jensen, age 37, and Ryan Jensen, age 33, brothers who owned and operated Jensen Farms, a fourth generation cantaloupe operation, located in Colorado, presented themselves to U.S. marshals in Denver and were taken into custody on federal charges brought by the U.S. Attorney’s Office with the Food and Drug Administration – Office of Criminal Investigation. According to the six-count indictment, Eric and Ryan Jensen unknowingly introduced adulterated (Listeria-tainted) cantaloupe into interstate commerce. The indictment further stated that the cantaloupe was prepared, packed and held under conditions, which rendered it injurious to health.  The outbreak sickened over 147, killing over 33 in 28 states in the fall of 2011.  The Jensen’s faced up to six years in jail and $1,500,000 in fines each. They eventually pleaded guilty and were sentenced to five years probation.
  • In 2013 Austin “Jack” DeCoster and his son, Peter DeCoster, both faced charges stemming from a Salmonella outbreak caused by their Iowa egg farms in 2010.  The Salmonella outbreak ran from May 1 to November 30, 2010, and prompted the recall of more than a half-billion eggs. And, while there were 1,939 confirmed infections, statistical models used to account for Salmonella illnesses in the U.S. suggested that the eggs might have sickened more than 62,000 people. The family business, known as Quality Egg LLC, pleaded guilty in 2015 to a federal felony count of bribing a USDA egg inspector and to two misdemeanors of unknowingly introducing adulterated food into interstate commerce. As part of the plea agreement, Quality Egg paid a $6.8-million fine and the DeCosters $100,000 each, for a total of $7 million.  Both DeCosters were sentenced to three months in jail.
  • In 2014 former Peanut Corporation of America owner Stewart Parnell, his brother and one-time peanut broker, Michael Parnell, and Mary Wilkerson, former quality control manager at the company’s Blakely, Georgia, plant, faced a federal jury in Albany, Georgia. The 12-member jury found Stewart Parnell guilty on 67 federal felony counts, Michael Parnell was found guilty on 30 counts, and Wilkerson was found guilty of one of the two counts of obstruction of justice charged against her. Two other PCA employees earlier pleaded guilty. The felony charges of introducing adulterated food into interstate commerce, “with the intent to defraud or mislead,” stemmed from a 2008 to 2009 Salmonella outbreak that sickened 714 and left nine dead. Stewart Parnell, Michael Parnell, and Mary Wilkerson were all found guilty on multiple charges.  Stewart and Michael are spending decades in prison.
  • In 2015 ConAgra Foods agreed to plead guilty and pay $11.2 million in connection with the shipment of Salmonella contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of that sickened over 700. ConAgra signed a plea agreement admitting that it unknowingly introduced Peter Pan and private label peanut butter contaminated with Salmonella into interstate commerce during the 2006 through 2007 outbreak.
  • In 2020 Chipotle was ordered to pay $25 million to resolve criminal charges related to the company’s involvement in foodborne illness outbreaks that sickened more than 1,100 people between 2015 and 2018. Chipotle was implicated in at least five foodborne illness outbreaks between 2015 and 2018 connected to restaurants in the Los Angeles area, Boston, Virginia, and Ohio.  These incidents primarily stemmed from store-level employees’ failure to follow company food safety protocols at company-owned restaurants, including a Chipotle policy requiring the exclusion of employees who were sick or recently had been sick. For example, in August 2015, 234 consumers and employees of a Chipotle restaurant in Simi Valley, California reported becoming ill.  Although company policies required the restaurant to report certain employee illnesses to Chipotle safety officials and to implement enhanced food safety procedures, the restaurant did not pass along information regarding an ill employee until multiple consumers already had reported being sick. In December 2015, a norovirus incident at a Chipotle restaurant in Boston sickened 141 people.  According to the DPA, that outbreak likely was the result of an ill apprentice manager who was ordered to continue working in violation of company policy after vomiting in the restaurant.  Two days later, the same employee helped package a catering order for a Boston College basketball team, whose members were among the consumers sickened by the outbreak. In July 2018, approximately 647 people who dined at a Chipotle restaurant in Powell, Ohio reported illness related to Clostridium perfringens, a pathogen that grows rapidly when food is not held at appropriate temperatures.  The local health department found critical violations of local food regulations, including those specific to time and temperature controls for lettuce and beans.
  • In 2020 Blue Bell pleaded guilty in May 2020 to two misdemeanor counts of distributing adulterated ice cream products.  The sentence, imposed by U.S. District Judge Robert Pitman in Austin, Texas, was consistent with the terms of a plea agreement previously filed in the case.  The $17.25 million fine and forfeiture amount is the largest-ever criminal penalty following a conviction in a food safety case. In March 2015, tests conducted by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) linked the strain of Listeria in one of the Blue Bell ice cream products to a strain that sickened five patients at a Kansas hospital with listeriosis, the severe illness caused by ingestion of Listeria-contaminated food.  The FDA, CDC, and Blue Bell all issued public recall notifications on March 13, 2015.  Subsequent tests confirmed Listeria contamination in a product made at another Blue Bell facility in Broken Arrow, Oklahoma, which led to a second recall announcement on March 23, 2015. According to the plea agreement with the company, FDA inspections in March and April 2015 revealed sanitation issues at the Brenham and Broken Arrow facilities, including problems with the hot water supply needed to properly clean equipment and deteriorating factory conditions that could lead to insanitary water dripping into product mix during the manufacturing process.  Blue Bell temporarily closed all of its plants in late April 2015 to clean and update the facilities. Since re-opening its facilities in late 2015, Blue Bell has taken significant steps to enhance sanitation processes and enact a program to test products for Listeria prior to shipment. Paul Kruse, President and CEO of Blue Bell Ice Cream, is facing a felony trial in 2022.

Over the last week both the CDC and FDA, along with various State Departments of Health and Agriculture, have been investigating two Listeria outbreaks linked to the consumption of various leafy greens.  Using Whole Genome Sequencing (WGS), product testing and clinical (human) sampling, health authorities have both determined that the source of the infection is Fresh Express and Dole and that the outbreaks are linked to illness that have been occurring since 2014.

A common question is why did it take so long to link all the illnesses?

It is likely that there have been low-level, but persistent Listeria contamination in both processing facilities that was not being picked up in the first epidemiological investigations.  It is most likely that the outbreaks were noticed, and the illnesses linked – both past and present – when product samples from various states were uploaded to CDC PulseNet.

I must admit that I am familiar with both Fresh Express and Dole:

Fresh Express Lettuce – 10 sick with 1 death in 8 states – 2021

Illnesses: As of December 21, 2021, 10 people infected with the outbreak strain of Listeria monocytogenes have been reported from eight states: Illinois, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania and Virginia. Illnesses started on dates ranging from July 26, 2016 through October 19, 2021. Sick people range in age from 44 to 95 years, with a median age of 80, and 60% are female. All 10 people have been hospitalized. One death has been reported from Pennsylvania. 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.

Traceback and Recall: On December 16, 2021, the Michigan Department of Agriculture identified the outbreak strain of Listeria in a bag of Fresh Express Sweet Hearts packaged salad. On December 20, 2021, Fresh Express recalled several brands of packaged salad products. The recall includes all Use-By Dates with product codes Z324 through Z350.

Dole Lettuce – 16 sick with 2 deaths in 13 states – 2021

Illnesses: As of December 17, 2021, 16 people infected with the outbreak strain of Listeria monocytogenes have been reported from 13 states: Idaho, Iowa, Maryland, Michigan, Minnesota, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Utah and Wisconsin. Illnesses started on dates ranging from August 16, 2014, to October 17, 2021. Sick people range in age from 50 to 94 years, with a median age of 76, and 81% are female. Of 14 people with information available, 12 have been hospitalized. Two deaths have been reported from Michigan and Wisconsin. WGS showed that bacteria from sick people’s samples are closely related genetically. This suggests that people in this outbreak got sick from the same food.

Traceback and Recall: In October 2021, the Georgia Department of Agriculture identified the outbreak strain of Listeria in a Dole brand garden salad as part of a routine sampling program of food at grocery stores. As a result, Dole recalled some of their garden salad products that are now past their “best if used by” dates. This sampling was not part of this outbreak investigation, but WGS later showed that the Listeria bacteria in the garden salad were closely related to the outbreak strain. After CDC reopened this outbreak investigation, Michigan Department of Agriculture and Rural Development collected samples of packaged salads from retail stores for testing and identified the outbreak strain of Listeria in a Marketside brand package of shredded iceberg that was produced by Dole. On December 22, 2021, Dole recalled all Dole-branded and private label packaged salads processed at the two facilities that produced the contaminated packaged salads.

Listeria Information:

Listeria Website

Listeria video

Marler Clark Listeria Litigation: 

Abbot Cheese

Jensen Farms Cantaloupe

Dole Lettuce

Marte Brand Cheese 

Sangar Produce 

Whittier Farms Milk

Vulto Creamery Cheese

Blue Bell Ice Cream

South Africa Tiger Brand Polony

The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response

“The FDA, along with the CDC and our state and local partners, is working to investigate a multistate outbreak of Listeria monocytogenes infections. To date, a positive sample of Fresh Express Sweet Hearts salad mix has been reported to match the outbreak strain. Fresh Express has voluntarily recalled products and consumers are advised not to eat, sell or serve any recalled products. Our investigation is ongoing, and we will continue to communicate should additional products be implicated.

“Ten people infected with the outbreak strain have been reported from eight states. A sample of Fresh Express prepackaged romaine and sweet butter lettuce was collected by the Michigan Department of Agriculture and Rural Development as part of their routine sampling efforts. The sample tested positive for Listeria monocytogenes and was a match to the outbreak strain. Given this, Fresh Express voluntarily ceased production at their Streamwood, Illinois, facility and initiated a recall of certain varieties of its branded and private label salads produced in that facility.

“We will continue to work with our partners and with Fresh Express to determine the source of this outbreak. We remain committed to transparency and providing updates as we learn more during our continuing traceback investigation.”

Additional Information:

  • The U.S. Food and Drug Administration, along with the U.S. Centers for Disease Control and Prevention and our state and local partners, is working to investigate a multistate outbreak of Listeria monocytogenes infections associated with the consumption of packaged salad.
  • To date, this outbreak has been associated with 10 illnesses, 10 hospitalizations and one death spanning the following states: IL, MA, MI, NJ, NY, OH, PA and VA. Illnesses started on dates ranging from July 26, 2016, to Oct. 19, 2021.
  • Consumers who have symptoms of listeriosis infection should contact their health care provider. Most people with listeriosis include a fever, muscle aches, nausea, vomiting and diarrhea. If the 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.
  • Fresh Express voluntarily ceased production at their Streamwood, Illinois, facility and initiated a recall of certain varieties of its branded and private label salad products produced at the company’s Streamwood, Illinois, facility. The recall includes all Use-By Dates of fresh salad items with product codes Z324 through Z350.
  • Consumers, restaurants and retailers, should not eat, sell or serve recalled packaged salads. A full list of recalled products is available on the FDA’s website.
  • The FDA recommends that anyone who received recalled products use extra vigilance in cleaning and sanitizing any surfaces and containers that may have come in contact with these products to reduce the risk of cross-contamination. Listeria can survive in refrigerated temperatures and can easily spread to other foods and surfaces.
  • This is an ongoing investigation, and additional information will be provided as it becomes available.

This review is part of FDA’s “New Era of Smarter Food Safety: FDA’s Foodborne Outbreak Response Improvement Plan” that also requires a hard look and the support by those concerned about improving the safety of our food and driving the numbers of ill consumers down.

Thanks to the deep dive by Craig Hedberg.  Here is the Full Report: NewEra-OutbreakResponseIndependentReview-102621

Here are some of my takeaways from the review and my thoughts:

  1. Surveillance – we need to use the power of Whole Genome Sequencing (WGS) of food products and environmental testing to help prevent and identify outbreaks.With WGS the ability of scientifically linking pathogens and people will allow government, the food industry, and consumers more certainly to know what the most likely cause of a foodborne illness was. I am certain that genetically linking illnesses to products – and possibly the environment – will allow for a common understanding of the likely cause of an outbreak.
  2. There is an ongoing need for coordination of outbreak response within the FDA and with other federal and state agencies that touch on food safety.There is clearly an ongoing need to more effectively coordinated the multiple acronyms that make up governmental food safety responses at the federal, state, and local levels.  This one is well “above my pay grade” to figure out.
  3. Traceback – The technology does exist to track food products from “farm to fork.” The real question is when it will be implemented so a pathogen tainted product can be traced quickly and accurately to the likely source.  Electronic records and Block Chain are coming.  We just need to speed it up.
  4. Transparency – FDA and other acronyms need to rethink what should and should not be made public.Other that patient identities, in my experience reading years of governmental redacted reports, there is frankly little that should not be made public.  Being transparent build trust between all the people that grow, manufacture, ship, sell and consume food.
  5. Root Cause Analysis – “Root cause analysis (RCA) is a method of problem-solving used to isolate the central “how” and “why” a given event occurred. While root cause analysis is used in various industries already, it has strong implications for helping researchers and investigators understand the central causes of events like food contamination and foodborne illness outbreaks. RCA is also useful for clarifying steps needed to correct the cause of a problem to prevent recurrence.”FDA need to be able to fully assess the “root cause” of an outbreak without limitations.  A concern noted in Dr. Hedberg’s review:

“Efforts are made to identify farm sources, or production sources depending on the commodity, so that farm or facility visits, and environmental assessments can be made to identify the source of the contamination event.”

“Farm visits and sample collections have become an increasing part of outbreak investigations involving REP strains and recurrent settings. Getting to farms while produce is still being grown and harvested has been a challenge.”

“Given the challenges inherent in identifying farms and fields during the course of outbreak investigations, it is not reasonable to expect to be able to link every case to a specific source, or to isolate the outbreak-associated strains from product or environmental samples collected from the farms. The biology of the organisms and ecology of the fields challenges the limits of our laboratory methods. This is compounded by the lack of access to animal and environmental samples from adjacent fields managed by different owners.”

Question – does anyone know why FDA can’t go on adjoining land – especially during an outbreak investigation?  Does another acronym have access – EPA?  Has there ever been any proposed legislation to allow access?  Not being allowed to search for the root cause dooms the process from ever finding the root cause.

Here is the Executive Summary:

As the federal food regulatory agency with oversight for the large majority of commercially distributed foods, FDA plays a key role in conducting multistate outbreak investigations and in translating investigation results into prevention activities. The importance of this role is highlighted in the development of FDA’s blueprint for the future, the “New Era of Smarter Food Safety.”

The development of whole genome sequencing (WGS) has improved foodborne illness surveillance and led to the recognition that some pathogenic strains are causing reoccurring, emerging, and persisting (REP) food safety problems. Outbreaks of shigatoxin-producing E. coli associated with leafy green vegetables have been a particular concern in recent years.

FDA established the Coordinated Outbreak Response and Evaluation (CORE) Network to coordinate its outbreak response efforts with subject matter experts from the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Regulatory Affairs (ORA) and Centers for Disease Prevention and Control (CDC). CORE Teams take food exposure information from CDC, make assignments for record and sample collection by ORA field staff, and identify outbreak sources through the convergence of product distributions across multiple legs of a traceback, supported by epidemiology and laboratory data. Tracebacks are time and labor intensive and frequently limited by inadequate records and comingling of product in distribution. Efforts are made to identify farm sources, or production sources depending on the commodity, so that farm or facility visits, and environmental assessments can be made to identify the source of the contamination event. In some outbreak response efforts, root cause investigations are conducted to collect information that can be used “to develop and recommend risk mitigation strategies for industry to reduce the risk of repeated food contamination events.” (FDA, Office of Regulatory Affairs, Procedure Manual for Fresh Produce Root Cause Investigation).

A review of FDA’s outbreak response activities was conducted to explore the dynamics of FDA’s relationships with federal, state and industry partners during and after these investigations. The review included documents related to outbreak investigation procedures, policies, and outcomes with interviews of key stakeholders identified by FDA.

Findings and recommendations presented in the report were related to the following areas:

  • Initiation of the outbreak investigation and assignment of investigation tasks.
  • Role of CORE in traceback activities.
  • Factors used to determine whether or not to conduct a root cause investigation.
  • Translation of outbreak investigation findings to prevention activities.
  • Evaluation activities and systems improvement.

The report reached the following conclusions:

FDA has made considerable investments in recent years to improve its outbreak investigation processes with the establishment of CORE. Its integration of activities through an incident command system has provided a structure for coordinating traceback activities across FDA. The process of making record collection assignments involves multiple steps that must be coordinated across different parts of the agency, with inherent delays built into the process.

Technological and operational innovations provide opportunities to shorten response times. In particular, the identification of REP strains and reoccurring outbreak settings provide investigators with ready hypotheses to test at first recognition of the outbreak.

Improvements in outbreak detection will continue to advance with application of WGS to surveillance of pathogens by public health agencies. Turn-around times in public health laboratories have limited the speed of outbreak detection, but these have decreased in states with adequate resources to perform WGS in real time. Improving the capacity of state and local public health epidemiologists to conduct detailed exposure interviews may depend on additional support through CDC’s epidemiology and laboratory capacity (ELC) grants. While ELC grants are not within FDA’s jurisdiction, helping to ensure the effective coordination of federal outbreak response resources is.

Because tracebacks require exposure assessments conducted by state and local health departments, the speed and effectiveness of FDA activities will always depend on the capacity of the public health system. Expanding the number and distribution of FDA-supported Rapid Response Teams (RRTs) to enhance coordination of investigation activities between FDA and state partners is warranted.

A complementary method of outbreak identification, through environmental and food product sampling by FDA or a federal or state regulatory partner, is becoming more common. When a reportable foodborne pathogen is identified, a search of PulseNet data for matching human isolates may indicate the occurrence of a foodborne outbreak. Investigation of the human case exposures is needed to confirm the source of such a “retrospective” outbreak. This depends on the same public health resources needed for conventional surveillance activities.

A key implication of the expanding use of WGS for foodborne illness surveillance will be the need to investigate more frequent but smaller clusters of cases. Prioritizing traceback of small clusters can lead to earlier detection of outbreaks before they manifest as large, multistate outbreaks. However, this would likely increase the need for informational tracebacks early in the hypothesis generation process. This could be accomplished either by more formal engagement of CORE Response while clusters are still being followed by the Signals Team, earlier transfer of cluster investigations to CORE Response Teams or more formal reliance on CDC and state partners to conduct these informational tracebacks.

The development of improved traceability with electronic records could significantly reduce the burden of investigation required to collect records to document the movement of products in a traceback. This would both speed up tracebacks and permit a larger range of products to be traced. At the same time, prioritizing traceback analyses based on the probability of product availability would improve the efficiency of source identification and better inform the transition from response to prevention. Establishing performance measures for outbreak response activities and outcomes should be established within the CORE database system.

Resource constraints are a limiting factor in many outbreak investigations. Staffing levels for CORE, the Office of Regulatory Affairs (ORA) investigators, produce safety specialists, laboratory support systems and other program areas are not adequate to respond to the growing number of outbreaks associated with REP strains and recurrent settings. Consideration for how to add capacity to CORE and increase the ability of CORE Response Teams to directly interact with outbreak investigation partners outside of FDA is warranted.

Farm visits and sample collections have become an increasing part of outbreak investigations involving REP strains and recurrent settings. Getting to farms while produce is still being grown and harvested has been a challenge. For most produce associated outbreaks, the majority of cases have already occurred by the time the outbreak is recognized. Environmental assessments conducted during these visits, but after the outbreak has ended still need to document conditions that can be directly related to the specific event, and also put them into context of the larger population of similar outbreaks that have been investigated. Integration of these data should be viewed as a routine investigation method. This could help identify factors, such as the presence of animal production facilities on lands adjacent to produce fields that can be compared across multiple investigations and evaluated during applied research studies and long-term environmental assessments. These post hoc environmental assessments can also help develop plans for seasonal surveillance during subsequent harvests.

Earlier and more open communication with industry, public health and regulatory partners would enhance the collaborative nature of outbreak investigations and likely produce meaningful results faster. Trust between partners is needed to effectively solve problems and identify solutions. While there remain questions about how, when and to whom information can be disclosed, the default setting should be to disclose information whenever it can advance the progress of the investigation. Outside of specific regulatory directives, behavioral change by industry requires the understanding of investigation findings and insights on how to implement changes within existing production systems. Timely release of investigation findings to the public and discussion of the implications of the findings directly with the affected industry is critical for effective communication and widespread acceptance of results. While the New Era of Smarter Food Safety seeks to “bend the curve” of foodborne illness, successful outbreak investigations can lead to better prevention methods that may lead to “canceling the curve” of many potential outbreaks.