History of Produce Safety

1906
PURE FOOD AND DRUG ACT

Prior to 1906 there was little to no oversight of the food produced and sold to consumers within the United States. This all changed in 1906 with the passage of the Pure Food and Drug Act, the first law in the U.S. to provide regulations to the food industry and protection for consumers against adulterated and misbranded foods.

In the years leading up to 1906, Dr. Harvey Wiley, a chemist at the USDA conducted a series of experiments evaluating the effect of various food preservatives on human volunteers. This group became known as the “Poison Squad”, consuming foods laced with preservatives or additives such as formaldehyde, borax, or sawdust that were commonly found in food at the time. These experiments illustrated the need for oversight and control of the safety of the US food supply.

Simultaneously, in 1904, Upton Sinclair, a young journalist, went undercover in Chicago’s meat packinghouses, experiencing first-hand horrific practices that were unsanitary and unsafe for both the workers and consumers of the products. His fictionalized account of Chicago’s meatpacking industry was first released in a magazine in 1905 and subsequently in 1906 as a book (The Jungle). After catching the attention of President Roosevelt, the packinghouses were further investigated, and the Federal Meat Inspection Act was quickly passed. The passage of this act opened a door for the Pure Food and Drug Act, spearheaded by Dr. Wiley, whose work for years prior had shown the need for such regulations.

Ultimately, the Pure Food and Drug Act prohibited the sale of misbranded or adulterated food and drugs. At its core the act promoted transparency from the industry to the consumer. Initially administrated by the Bureau of Chemistry, the act also paved the way for the establishment of the FDA as we know it today. In 1907, a Board of Food and Drug Inspection was established to help create policy to enforce this new act with Dr. Wiley appointed as the first commissioner. In 1930 the Board of Food and Drug Inspection became The Food and Drug Administration.

1938
FOOD, DRUG, AND
COSMETIC ACT

Establishment of Food Standards

This act replaced the 1906 Pure Food and Drug Act, and while it took years to develop, it gained significant momentum in 1937 after the horrific death of 107 people due to a widely used drug formulated with a highly toxic chemical. In addition to granting FDA the authority to regulate drugs, medical devices, and cosmetics, The Food, Drug, and Cosmetic Act established the definition of “adulterated” foods. It also established three standards for food that are still seen today: standard of identity, standard of quality, and a standard regulating the fill of the container.

The first set of standards centered around the use of sodium benzoate as a preservative in tomato products, namely ketchup. Shortly after, standards were established for a host of other products including jams, juices, canned goods, and dairy products.

1993
E. COLI O157:H7
JACK IN THE
BOX OUTBREAK

Between 1992 and 1993, over 700 people across Washington, Idaho, California, and Nevada became infected with E. coli O157:H7, and 4 died after eating undercooked beef patties from a popular fast food chain.

In 1997, President Clinton announced the “Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables,” also known as the Fresh Produce Safety Initiative. As the name implies, the goal was to work towards improving the safety of produce, both domestic and imported, consumed within the United States.

The Department of Health and Human Services in collaboration with the Secretary of Agriculture and the wider agricultural community were tasked with issuing guidance on good agricultural practices (GAPs) as well as good manufacturing practices (GMPs) for fruits and vegetables. As a result of this collaboration, the Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables was released.

1998
FDA RELEASES GAP GUIDELINES

2000
ESTABLISHMENT OF THE GLOBAL FOOD SAFETY INITIATIVE

The Global Food Safety Initiative (GFSI) is a private organization that maintains a benchmarking scheme for food safety management systems with the goal of creating a common set of requirements for food safety standards .

GFSI was established in 2000 by The Consumer Goods Forum to address food safety incidents that had become increasingly frequent. In addition, GFSI hoped to address ‘audit fatigue’ in which suppliers were required to prepare for multiple, nearly identical food safety audits for different customers. Through its maintenance of a benchmarking system, GFSI aims to support the development of gold-standard 3rd party food safety audits.

Every 5 years, a new guidance document is released on “conforming food safety management standards”. This document is used to compare to and approve auditing bodies with the intention of increasing consistency in food safety practices. Today, GFSI recognized auditing schemes are widely accepted by major buyers of fresh produce.

While a wide variety of menu items at Sheetz were initially associated with the outbreak, the common factor between all implicated products was produce, namely lettuce and tomatoes. Epidemiological traceback initially linked 5 different serotypes of Salmonella enterica to the outbreak; however, later investigation found Salmonella Anatum in an unopened bag of tomatoes, and PFGE matched some of the strains from infected patients to those isolated from the tomatoes.

FDA, along with state health departments, conducted further traceback investigations at the level of the distributor, packers, and growers. Environmental sampling of the packing houses and associated farms did not show a clear source of contamination at the tomato slicing facility.

2004
SALMONELLA CONTAMINATED TOMATOES

In 2004, a Salmonella outbreak linked to fresh, sliced Roma tomatoes on deli sandwiches sold at Sheetz convenience stores on the East Coast caused 429 illnesses across 9 states.

2006
E. COLI O157:H7 IN SPINACH

In the summer of 2006, a large E. coli O157:H7 outbreak resulting in over 200 illnesses and 5 deaths across 26 states was traced back to contaminated fresh spinach.

On September 14, the FDA issued a public warning against bagged spinach advising consumers not to eat the product. As the case counts grew, the FDA took drastic actions and on Sept. 16 issued a revised warning against the entire commodity, asking the public to avoid any type of fresh spinach or spinach-containing product. Epidemiological traceback determined the source of the outbreak to be from a single farm in San Benito County, California.

Upon further investigation of the farm and surrounding environment it was noted that the farm was near the San Benito River which cattle and pigs in the area had ready access to. PFGE found that E. coli positive samples of cattle feces and river water matched the outbreak strain. While the farm used well water, not river water, later studies suggested that when ground water levels fall below that of the riverbed, the river water can flow into the groundwater source. Water level and rainfall reports later analyzed provided evidence that this phenomenon was suspected to have occurred in the summer of 2006.

2008
SALMONELLA SAINTPAUL OUTBREAK LINKED TO TOMATOES AND PEPPERS

Salmonella Saintpaul caused 1,300 illnesses (with additional cases in Canada) over 3 months with 252 hospitalizations across 43 states and 2 deaths. While initially linked to raw tomatoes, extensive epidemiological and microbiological testing provided significant evidence against tomatoes as a likely source and revealed that jalapeño and serrano peppers grown in Mexico were in fact the original source of contamination.

On June 7, the FDA issued a nationwide warning against 3 types of tomatoes thought to be implicated in the outbreak. The MN Department of Health determined that it was not tomatoes but rather peppers after illnesses continued to come in weeks after tomatoes were no longer sold in stores and restaurants. They alerted FDA of this trend, suggesting peppers were the real source after conducting a traceback investigation that led them to distributors in California and Texas who purchased product from farms in Mexico.

Finally, on July 17 the tomato warning was lifted after the mounting evidence was obtained. Soon after, on July 21, the FDA isolated the outbreak strain from jalapeño peppers as well as from an irrigation water sample on one of the farms suspected to be a part of the outbreak. In an epidemiological case study conducted following this outbreak, it was noted that cases were significantly associated with eating raw tomatoes, eating at a Mexican-style restaurant, and eating salsa or having raw jalapeño peppers in the household. Items more often used as ingredients in various products- such as peppers- create even more problems as consumers may not be aware of everything they are consuming.

Impact:

Fresh produce is seldom consumed in a vacuum, and more frequently is consumed as an ingredient or in combination with other fresh products. This can pose a challenge in identifying which item the outbreak originated from, and it highlights the necessity of each leg in the outbreak investigation process: epidemiology, traceback, and food and environmental testing data.

Unfortunately, public health decisions must often be made when outbreak data is ambiguous or incomplete. This event illustrates the delicate balancing act that the FDA faces between promoting public health and preventing unnecessary negative impacts on companies and commodity industries as a whole through the issuance of broad public advisories.

2008-2009
PEANUT CORPORATION OF AMERICA SALMONELLA OUTBREAK

In 2011, whole cantaloupes from Colorado contaminated with L. monocytogenes caused 147 cases of listeriosis across 28 states, and led to 33 deaths.

Environmental and product sampling yielded positives for L. monocytogenes and PFGE illustrated that these were a match to the outbreak strain collected from patients. FDA investigations pointed to two probable opportunities for cross-contamination: the use of wash water without antimicrobial treatment, and the use of processing equipment formerly used for rarely consumed raw produce without adequate sanitation between use. Reports of an audit conducted in the weeks leading up to the outbreak noted that wash water was a potential problem due to the use of recirculated water without any antimicrobial treatment to eliminate potential pathogen cross-contamination.

Further, FDA investigation and evaluation of the growing and processing environments noted equipment that was difficult to appropriately clean and sanitize, as well as improper draining on the processing floor which led to standing pools of water. The lack of a pre-cooling step prior to cold storage was later understood as a compounding factor, creating an ideal environmental for the proliferation of Listeria.

2011
LISTERIA MONOCYTOGENES OUTBREAK IN WHOLE CANTALOUPE

2011
FSMA: PRODUCE SAFETY RULE

In 2011 the Food Safety Modernization Act (FSMA) was signed into law, the first major change to food safety policy in the US since the 1938’s Food Drug and Cosmetic Act over 70 years prior. The act ushered in a new wave of food safety policy that employs preventative rather than reactive measures to ensuring the safety of the food supply chain.

The Produce Safety Rule is the first regulation to establish minimum safety standards for the growing, harvesting, packing, and storing of produce and was published in its final form in 2015. Exemptions to the rule include produce that is rarely consumed raw (a list of these products can be found on the FDA’s website) as well as farms with annual sales averaging <$25,000 over the past three years.

The rule is made up of several parts including agricultural water; biological soil amendments; domesticated and wild animals; worker training, health, and hygiene; equipment, tools, and buildings; and the production of sprouts.

2015
LISTERIA MONOCYTOGENES
IN CARAMEL APPLES

In 2015, contaminated caramel apples led to a multistate listeriosis outbreak resulting in 35 illnesses and 7 deaths.

2018
CYCLOSPORA OUTBREAKS IN SALAD AND VEGETABLE TRAYS

Impact:

Until 2018, Cyclospora had been considered a risk primarily on fresh produce imported from tropical countries. These outbreaks were the first major indication that Cyclospora may be present in the U.S., either endemic within the population or within the growing environment. An industry-led Blue Ribbon Panel was formed to address these challenges and to identify research needs, as much is still unknown about Cyclospora presence within the U.S. or how producers can prevent or treat the parasite within the production chain.

2018
ROMAINE LETTUCE E. COLI O157:H7 OUTBREAKS

In April 2018, an outbreak linked to romaine lettuce resulted in 210 cases of E. coli O157:H7 with 96 hospitalizations and 5 deaths.

Epidemiological and traceback evidence indicated the Yuma, AZ growing region as the likely source of the outbreak. FDA also used whole genome sequencing to link the clinical strain to E. coli found in water samples taken from an irrigation canal in the Yuma growing region.

A large concentrated animal feeding operation (CAFO) was located directly adjacent and uphill from the same irrigation canal, leading many to suspect the CAFO as the ‘smoking gun’ for contamination. However, the exact route of transmission was ultimately undetermined.

2019
ROMAINE LETTUCE E. COLI O157:H7 OUTBREAK

An FDA investigation determined that one of the outbreak strains was detected in a fecal-soil sampling on public land with grazing cattle. This land was located upslope from the produce farm and suggested to be the source of contamination onto the lettuce. FDA reports of the investigation note that larger cattle operations, located within a closer proximity to the implicated produce field were also sampled and did not contain any strains associated with the outbreak.

In the fall and winter of 2019 we once again see issues arise with the contamination of E. coli O157:H7 on romaine lettuce grown in the Salinas Valley of California. WGS revealed that three unique strains resulted in three separate outbreaks (167, 11, 10 illnesses respectively) occurring over November and December of that year.