Our barfblog.com French correspondent, Albert Amgar, send along this excellent talk by Peteer Fng of the U.S. Food and Drug Administration about Shiga-toxin producing E. coli in produce, including this, maybe real, photograph.
Escherichia coli O157:H7 is an important foodborne pathogen that causes severe bloody diarrhea, hemorrhagic colitis, and hemolytic uremic syndrome.
Ruminant manure is a primary source of E. coli O157:H7 contaminating the environment and food sources. Therefore, effective interventions targeted at reducing the prevalence of fecal excretion of E. coli O157:H7 by cattle and sheep and the elimination of E. coli O157:H7 contamination of meat products as well as fruits and vegetables are required.
Bacteriophages offer the prospect of sustainable alternative approaches against bacterial pathogens with the flexibility of being applied therapeutically or for biological control purposes.
This article reviews the use of phages administered orally or rectally to ruminants and by spraying or immersion of fruits and vegetables as an antimicrobial strategy for controlling E. coli O157:H7. The few reports available demonstrate the potential of phage therapy to reduce E. coli O157:H7 carriage in cattle and sheep, and preparation of commercial phage products was recently launched into commercial markets.
However, a better ecological understanding of the phage E. coli O157:H7 will improve antimicrobial effectiveness of phages for elimination of E. coli O157:H7 in vivo.
Use of bacteriophages to control Escherichia coli O157:H7 in domestic ruminants, meat products, and fruit and vegetables
Foodborne Pathogens and Disease, June 2017, ahead of print, Wang Lili, Qu Kunli, Li Xiaoyu, Cao Zhenhui, Wang Xitao, Li Zhen, Song Yaxiong, and Xu Yongping, https://doi.org/10.1089/fpd.2016.2266
Although aquaponics is still in its infancy, Fort Langley–based West Creek Aquaculture and others see potential for this alternative to conventional agriculture
Felicity Stone of BC Business reports the fish from B.C.’s handful of land-based aquaculture farms are considered sustainable, with Ocean Wise certification from the Vancouver Aquarium. The farms use no antibiotics, hormones or chemicals, and they compost the fish waste.
Instead of composting the waste, West Creek has experimented with aquaponics, growing vegetables in the same water as the fish so the effluent nourishes the plants, which in turn clean the water. Although plant yield increased, Read found that he couldn’t compete with traditional vegetable growers. He’s still looking for a way to monetize fish effluent as plant fertilizer, but he thinks aquaponics is best suited for farmers in the business of plant, not fish, production.
Crops raised using aquaponics actually tend to be more profitable than the fish, according to U.S. studies. The key is marketing them to compete with other local and organic greens. Andrew Riseman, an associate professor of applied biology and plant breeding at UBC, believes aquaponic produce is superior to both conventionally grown and organic. “But until there’s product differentiation in the marketplace where they can get a premium for that specific product, they’re just lumped in with organics or chemical-free or pesticide-free or whatever other generic grouping they fit into,” he says. “Much like the land-based fish production—they’re grouped in with farmed salmon.”
The key is proving the produce is microbiologically safer?
Guess the aquaponics folks wouldn’t want to market that.
I was wearing one of our 2006 don’t eat poop T-shirts today as I walked Sorenne to school with Ted the wonderdog.
Clearly someone I could chat with.
He knew all the Australian outbreaks, and said he was in California when spinach happened in 2006, so was a good chat.
But maybe we talk about poop too much. From our artistic (and spelling-challenged) daughter:
This is why avant-garde jazz saxophonists shouldn’t be responsible for food safety
And that’s nothing against avant-garde jazz saxophonists, although I hate jazz.
In late Oct. 1996, an outbreak of Escherichia coli O157:H7 was traced to juice containing unpasteurized apple cider manufactured by Odwalla in the northwest U.S. Sixty-four people were sickened and a 16-month-old died from E. coli O157:H7. During subsequent grand jury testimony, it was revealed that while Odwalla had written contracts with suppliers to only provide apples picked from trees rather than drops – those that had fallen to the ground and would be more likely to be contaminated with feces, in this case, deer feces — the company never verified if suppliers were actually doing what they said they were doing. Earlier in 1996, Odwalla had sought to supply the U.S. Army with juice. An Aug. 6, 1996 letter from the Army to Odwalla stated, “we determined that your plant sanitation program does not adequately assure product wholesomeness for military consumers. This lack of assurance prevents approval of your establishment as a source of supply for the Armed Forces at this time.”
Once a huckster, always a huckster.
Stephanie Strom of the N.Y. Times reports for the past 20 years, Greg Steltenpohl, an avant-garde jazz saxophonist turned beverage entrepreneur, has worked to rekindle the magic behind his greatest hit — and make peace with a nightmare that led to an abrupt fall.
Food safety issue: Mr. Steltenpohl started the juice company Odwalla in 1980, selling drinks out of his band’s Volkswagen van in and around San Francisco. Within a few years, the company was a multimillion-dollar business, flying high as one of the first breakout healthy drinks now commonplace in grocery aisles.
Then, in 1996, a child died and dozens were sickened because of contaminated apple juice produced by Odwalla, changing everything. About 90 percent of the company’s revenue evaporated almost overnight in the wake of the outbreak. With the company on the brink of bankruptcy, Mr. Steltenpohl and his partners were forced to sell a controlling interest in Odwalla to private equity firms, the equivalent — to him — of selling out to the devil. Not long after, the company was sold to Coca-Cola.
Quite a fairytale he spins.
“Odwalla took him to the top of the world and then to the bottom,” said Berne Evans, his business partner today. “I don’t think he’s ever gotten over it.”
But now Mr. Steltenpohl, a gentle and avuncular 62, is once again near the center of beverage industry buzz as the head of Califia Farms, a nut milk business that is fast expanding into bottled coffees and other drinks. This time, he is taking advantage of a new trend sweeping the industry, as young beverage companies — empowered by changes in distribution and consumer tastes — are rising and competing successfully with titans like Coca-Cola and PepsiCo.
Only a few years after its founding, in 2012, Califia is on track to ring up $100 million in sales and is adding products at a fast clip. The company is considered one of the hottest young brands in the beverage world, leading to whispers about whether one of the big competitors will soon swoop in with a buyout offer that Mr. Steltenpohl and his partners can’t refuse.
Not this time, he insists. “I’ve had to sell out once,” Mr. Steltenpohl said. “That was enough.”
The story has lots of financial stuff, and how people who know shit about food safety market and sell shit to people who don’t know better, and the people who know shit make billions.
With Trump as President, the time is ripe for a comeback, I guess.
Duane Stanford, the editor of Beverage Digest, said a young beverage company today can buy its flavors from a flavor house, branding expertise from a branding expert and manufacturing from a producer on contract.
“You have this situation where these companies can become viable, robust, cash-generating businesses without the help of a big company,” he said. “They’re even getting creative at building independent distribution networks.”
Odwalla came together out of a necessity to eat. After graduating from Stanford with a degree in environmental sciences, Mr. Steltenpohl joined with some friends to start a band called the Stance. He also got hooked on the taste of fresh-squeezed orange juice, which his father made for him.
“We were a band of musicians who weren’t really that accomplished — or popular,” Mr. Steltenpohl said of himself and the band members, who became his partners in Odwalla. “We were broke and starving, and we figured if we started a juice business, we could live off the juice and maybe make a little extra.”
He read a book, “100 Businesses You Can Start For $100,” and the partners invested in a juicer and started making juice. They didn’t even try to break into groceries and convenience stores, instead stocking refrigerators in video stores and laundromats with Odwalla fresh juice each day. “Everyone who was a musician back then was basically living out of a VW bus,” Mr. Steltenpohl said. “We quit living in ours and began selling juice out of the back.”
For most of its early years, the Santa Cruz Community Credit Union financed the company. But as consumers cottoned on to its intensely flavored, wacky mixes of unpasteurized juice, it needed something more.
In October, 1996, a 16-month-old Denver girl drank Smoothie juice manufactured by Odwalla Inc. of Half Moon Bay, California. She died several weeks later; 64 others became ill in several western U.S. states and British Columbia after drinking the same juices, which contained unpasteurized apple cider — and E. coli O157:H7. Investigators believed that some of the apples used to make the cider might have been ins
The brand’s claims about the healthiness came back to haunt it as reporters dug into its failure to heed warnings about food-safety lapses.
Those failures are legendary in the food safety world, and a similar failure for Steltenpohl to say, “(Coke) never saw the enormous potential of the Odwalla brand and instead saw it as just another product in the juice portfolio.”
It’s also a failure for the N.Y Times to not report how those Odwalla failures went straight to the top..
Odwalla’s brand is nothing more than a cautionary food safety fairytale.
I have many.
Maybe Cafia will become one.
The story notes that Steltenpohl is also trying to avoid past mistakes. The plant is equipped with cutting-edge food-safety monitors that share alerts about problems as they happen with the entire senior management team. Josh Butt, who previously oversaw food safety systems at Danone, the big French dairy company, presides over the plant’s operations.
Cutting-edge is a phrase that appeals to investors but means shit to any food safety type.
Cutting corners is this guy’s calling card.
And making a buck.
This is what I wrote at the time:
Sometime in late September 1996, 16-month-old Anna Gimmestad of Denver has a glass of Smoothie juice manufactured by Odwalla Inc. After her parents noticed bloody diarrhea, Anna was admitted to Children’s Hospital on Oct. 16. On 8 November 1996 she died after going into cardiac and respiratory arrest. Anna had severe kidney problems, related to hemolytic uremic syndrome and her heart had stopped several times in previous days.
The juice Anna — and 65 others who got sick — drank was contaminated with E. coli O157:H7, linked to fresh, unpasteurized apple cider used as a base in the juices manufactured by Odwalla. Because they were unpasteurized, Odwalla’s drinks were shipped in cold storage and had only a two-week shelf life. Odwalla was founded 16 years ago on the premise that fresh, natural fruit juices nourish the spirit. And the bank balance: in fiscal 1996, Odwalla sales jumped 65 per cent to $60 million (U.S.). Company chairman Greg Steltenpohl told reporters that the company did not routinely test for E. coli because it was advised by industry experts that the acid level in the apple juice was sufficient to kill the bug.
Who these industry experts are remains a mystery. Odwalla insists the experts were the U.S. Food and Drug Administration. The FDA isn’t sure who was warned and when. In addition to all the academic research and media coverage concerning verotoxigenic E. coli cited above, Odwalla claimed ignorance.
In terms of crisis management — and outbreaks of foodborne illness are increasingly contributing to the case study literature on crisis management — Odwalla responded appropriately. Company officials responded in a timely and compassionate fashion, initiating a complete recall and co-operating with authorities after a link was first made on Oct. 30 between their juice and illness. They issued timely and comprehensive press statements, and even opened a web site containing background information on both the company and E. coli O157:H7. Upon learning of Anna’s death, Steltenpohl issued a statement which said, “On behalf of myself and the people at Odwalla, I want to say how deeply saddened and sorry we are to learn of the loss of this child. Our hearts go out to the family and our primary concern at this moment is to see that we are doing everything we can to help them.”
For Odwalla, or any food firm to say it had no knowledge that E. coli O157 could survive in an acid environment is unacceptable. When one of us called this $60-million-a-year-company with the great public relations, to ask why they didn’t know that E. coli O157 was a risk in cider, it took over a day to return the call. That’s a long time in crisis-management time. More galling was that the company spokeswoman said she had received my message, but that her phone mysteriously couldn’t call Canada that day.
Great public relations; lousy management. What this outbreak, along with cyclospora in fresh fruit in the spring of 1996 and dozens of others, demonstrates is that, vigilance, from farm to fork, is a mandatory requirement in a global food system. Risk assessment, management and communication must be interlinked to accommodate new scientific and public information. And that includes those funky and natural fruit juices.
Internalin A is an essential virulence gene involved in the uptake of the foodborne pathogen Listeria monocytogenes into host cells. It is intact in clinical strains and often truncated due to Premature Stop Codons (PMSCs) in isolates from processed foods and processing facilities. Less information is known about environmental isolates.
We sequenced the inlA alleles and did Multi Locus Variable Number Tandem Repeat Analysis (MLVA) on 112 L. monocytogenes isolates from a 3-year period from naturally contaminated watersheds near a leafy green growing area in Central California. The collection contained 14 serotype 1/2a, 12 serotype 1/2b, and 86 serotype 4b strains. Twenty-seven different inlA alleles were found. Twenty-three of the alleles are predicted to encode intact copies of InlA, while three contain PMSCs. Another allele has a 9-nucleotide deletion, previously described for a clinical strain, indicating that it is still functional. Intact inlA genes were found in 101 isolates, and 8 isolates contained the allele predicted to contain the 3-amino acid deletion. Both allele types were found throughout the 3-year sampling period. Three strains contained inlA alleles with PMSCs, and these were found only during the first 3 months of the study. SNP analysis of the intact alleles indicated clustering of alleles based on serotype and lineage with serotypes 1/2b and 4b (lineage I strains) clustering together, and serotype 1/2a (lineage II strains) clustering separately. The combination of serotype, MLVA types, and inlA allele types indicate that the 112 isolates reflect at least 49 different strains of L. monocytogenes. The finding that 90% of environmental L. monocytogenes isolates contain intact inlA alleles varies significantly from isolates found in processing plants.
This information is important to public health labs and growers as to the varieties of L. monocytogenes that could potentially contaminate fresh produce in the field by various means.
The majority of genotypes of the virulence gene inlA are intact among natural watershed isolates of Listeria monocytogenes from Central California Coast
PLoS ONE 11(12): e0167566. doi:10.1371/journal.pone.0167566
From the U.S. Government Accountability Office:
Although the United States has one of the safest food supplies in the world, foodborne illness is a common public health problem. Some of this illness can be linked to produce. In 2006, for example, an E. coli outbreak associated with baby spinach sickened 205 people and killed 3; in 2011, 147 people fell ill and 33 died as a result of eating melons contaminated with Listeria. Other produce-related outbreaks in recent years have involved cucumbers, alfalfa sprouts, bean sprouts, and packaged salads.
The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), has responsibility for ensuring the safety of produce, along with many other foods. Overall, FDA is responsible for ensuring the safety of more than 80 percent of the U.S. food supply.
Because produce is often consumed raw without processing to reduce or eliminate contaminants, preventing contamination is key to ensuring safe consumption. In January 2011, the FDA Food Safety Modernization Act (FSMA) was signed into law, representing the largest expansion and overhaul of U.S. food safety law since the 1930s.1 FSMA, according to FDA, marked a historic turning point by focusing on preventing rather than reacting to foodborne illnesses. FSMA did so, in part, by requiring FDA to promulgate new rules that together provide a framework for industry to implement preventive measures and for FDA to oversee implementation. In response to FSMA, FDA developed seven foundational rules; among them was the rule entitled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption—widely referred to as the produce safety rule.2 This rule, which FDA promulgated in November 2015, established the first enforceable national standards for on-farm growing, harvesting, packing, and holding of domestic and imported produce.3 Among other things, the rule established standards related to agricultural water quality; the use of soil amendments, such as raw manure; the presence of domesticated and wild animals; worker training, health, and hygiene; and sanitation of equipment, tools, and buildings. The rule includes staggered compliance dates depending on average annual produce sales of a business and other factors. For example, compliance for some of the largest businesses comes due beginning in 2017 and 2018, while compliance for certain smaller businesses is not due until 2020. FDA has been developing guidance and training for those affected by the new standards under the produce rule; the agency has also set aside funding for states to help them support implementation of the rule. In addition, the agency is hiring experts with backgrounds in science and policy to work in different regions of the country assisting state officials with implementation of the rule, according to FDA officials.
Some in the produce industry have expressed concerns about the new produce rule standards, including concerns about the scientific basis for standards in such areas as water quality. Some have also expressed concerns about the costs associated with meeting the new standards, particularly for smaller businesses. The Agricultural Act of 2014, also referred to as the 2014 Farm Bill, required that FDA ensure the final produce rule include “a plan to systematically…develop an ongoing process to evaluate and respond to business concerns.”4
The act included a provision for GAO to report, 1 year after the promulgation of the final produce rule and again the next year, on the ongoing evaluation and response process. This first report examines (1) how FDA evaluates and responds to business concerns regarding the produce rule and (2) how FDA plans to assess the effectiveness of its efforts to evaluate and respond to business concerns regarding the rule.5
To examine how FDA evaluates and responds to business concerns regarding the produce rule, we reviewed the final rule, including FDA’s responses to public comments on the rule; reviewed relevant information on FSMA and the produce rule on FDA’s website; interviewed FDA officials involved in implementation of the rule; and interviewed representatives from two organizations assisting FDA with implementation of the rule.6 We also interviewed representatives from six produce industry associations and one large retailer for their views on any FDA efforts to respond to business concerns.7 We selected industry associations with large memberships, those representing both large and small businesses, and those representing differing types of produce. These interviews provided a sampling of views and are not generalizable to all produce industry associations, businesses, or others affected by the produce rule. To determine how FDA plans to assess the effectiveness of its efforts to evaluate and respond to business concerns, we interviewed FDA officials to learn about any ongoing or planned efforts.
We conducted this performance audit from August 2016 to November 2016 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.
FDA has developed an information clearinghouse to evaluate and respond to concerns from businesses and other stakeholders regarding any of the FSMA rules, including the produce rule. Operational since September 2015, this clearinghouse, called the Technical Assistance Network (TAN), serves as a central source of information to support understanding and implementation of the FSMA rules. Businesses and other stakeholders—such as industry associations, academia, and consumers—can submit questions online or by phone or traditional mail. Phase 1 of the TAN, which is currently operational, evaluates and responds to questions related to the publication of FSMA rules. Phase 2, which FDA expects to begin in 2017, will evaluate and respond to questions from FDA and state inspectors working to ensure industry compliance with FSMA rules. FDA officials we interviewed told us the agency intends to maintain the TAN as a mechanism to respond to stakeholder questions and concerns even after the produce rule and other FSMA rules are fully implemented.8
We examined FDA data on TAN questions received by the agency from early September 2015 through early September 2016.9 During that period, FDA received 2,626 TAN questions, most of which had been submitted online.10 About 14 percent of questions (363) pertained to the produce rule, and about 60 percent of questions (218) pertaining to the produce rule came from those who identified as belonging to “industry/business.”11 According to FDA, the agency tracks TAN questions to help inform FSMA policy, guidance, and training. For example, officials at FDA told us that many of the questions it received related to the produce safety rule sought clarification regarding uses of water that meet the definition of “agricultural water.” FDA also received many questions seeking clarification on the requirements for collecting samples of agricultural water. Because of the large number of questions on both of these topics, FDA considers them high-priority areas to address in developing guidance. Specifically, FDA identified these topics as those most important to include in the first phase of its general compliance and implementation guidance for the produce rule, whereas other topics will be addressed in the second phase of the guidance.
In addition to addressing business concerns through the TAN, FDA officials told us they will continue to reach out to industry during produce rule implementation, just as they did while developing the rule. For example, FDA officials plan to meet with industry as they develop guidance documents, which provide direction on complying with produce rule standards. According to these officials, the guidance development process will provide another opportunity to hear and respond to business concerns. FDA may incorporate industry suggestions into the final guidance, as appropriate. Representatives from industry associations we interviewed generally praised FDA’s level of collaboration during the rulemaking process, noting that FDA had been willing to engage with them and address their concerns.12
FDA Is Developing a Survey and Other Metrics to Assess Its Information Clearinghouse
FDA officials we interviewed said the agency is developing a stakeholder survey to assess the effectiveness of its information clearinghouse, the TAN. FDA will send a copy of the survey to businesses and other stakeholders when providing responses to TAN questions submitted online. Most TAN questions are submitted online. Officials told us surveys will be sent starting in fiscal year 2017, after the required Office of Management and Budget (OMB) review is complete.13 FDA plans to implement the survey in two parts, according to officials. The first part will begin in early fiscal year 2017 and will solicit feedback from stakeholders about the web page FDA provides for submitting questions online. In late fiscal year 2017, FDA will begin soliciting feedback about the quality of information the agency provided in its responses to TAN questions. In addition, officials said the agency is developing metrics to measure overall success in implementing the produce rule and plans to begin using these metrics in January 2018, when compliance with most of the produce rule standards comes due for most large businesses. These metrics will be used to examine how effective the TAN is in responding to questions and will ultimately be used to assess whether additional training and outreach to business are needed to help implement the produce rule.
We asked representatives from industry associations and other organizations we interviewed about their experiences submitting questions to the TAN. These representatives generally told us that wait times for answers from the TAN can be long, and some had not yet received answers to their questions. For example, representatives from one industry association told us it took 4 months to get an answer through the TAN.
FDA officials told us that, as of early October 2016, the agency had responded to about 72 percent of all TAN questions received. Officials said FDA is currently studying how long it takes, on average, to respond to questions submitted to the TAN, and the agency is working to decrease its response time. Also, according to FDA officials, response times to TAN questions may be longer in some cases because agency guidance on the produce rule and other FSMA rules is still under development, and the agency does not want to provide information through the TAN that might conflict with the subsequent guidance. In addition, officials said that while simpler questions can often be addressed immediately by FDA staff that monitor the TAN, about 95 percent of the questions are more complex. These questions are forwarded to subject matter experts within the agency and, consequently, require more time for a response. According to FDA, median response time for questions forwarded to subject matter experts is 22 business days. FDA officials told us that if a question is still unaddressed after 30 days, FDA will send an automated message saying the agency is working on a response; a second automated message is sent after 60 days if the question is still unresolved.
The Packer writs in an editorial that the produce industry is justified in being upset about the latest accusation of lax food safety practices, but also acknowledges the industry has a strong food safety message and should be eager to share it.
It’s important that retailers and foodservice providers know the industry’s response to the most recent attack, this time from a United Kingdom study that raises concerns about salmonella in bagged salads.
How to do that?
Because at retail, the person consumers are going to ask is some minimum-wage kid who is stocking produce when a shopper walks by.
Most people want to go shopping, not do homework.
They are an abundance of tools that have been developed to help support risk communication at retail.
On the front lines.
Where sales are won and lost.
Market microbial food safety at retail rather than offering boilerplates.
In a time when facts don’t matter and Donald Trump is President-elect, there is scrutiny of any new study, and rhetoric is increasingly common.
Socrates, via Plato, had some thought on rhetoric (yes I dabbled in philosophy many decades ago, didn’t everyone experiment in university?).
Still no comment from the Leafy Greens Marketing Agreement but they sent a few of their spokesthingies out to counter a study that says Salmonella grows in cut leafy greens, even at refrigerator temperatures..
Ashley Nickle of The Packer reports that Bruce Taylor, CEO and founder of Salinas, Calif.-based Taylor Farms, emphatically denounced the study.
“We find the artificial conditions created by this study to be ridiculous,” Taylor said in an e-mail. “Producers of bagged salads do not have ‘juice’ in the salad bag, and producers take painstaking steps to avoid the introduction of salmonella or any other pathogen.”
The conclusion regarding refrigeration was the only notable one in the study, said Trevor Suslow, a member of the technical committee of the Center for Produce Safety. Scientists would expect salmonella to be able to survive at the temperature recorded in the study but would not expect it to grow, he said.
“People will definitely be trying to reproduce their results as far as growth under refrigeration temperature for salmonella,” Suslow said. “That’s, for me, the key issue.”
Suslow, an extension research specialist at the University of California-Davis, said it is already known that a bagged salad is an environment in which salmonella can have the nutrients it needs to grow, which is why the industry has focused so intently on ensuring no pathogens make it into bags into the first place.
Drew McDonald, vice president of quality, food safety and regulatory affairs at Salinas-based Church Brothers Farms, said in an e-mail that, although the researchers did some things well, he also had some issues with the study.
“From my read, the study essentially grew salmonella in juices extracted from actual bagged salads in a mixture of sterile water,” McDonald said. “The issue is that in the ‘real’ world the salmonella has to come from somewhere (the surface of the leaf for example) but along with this would be many other microorganisms. That they were able to grow salmonella under these forced, artificial conditions without any competition from other organisms is not surprising.”
“From my understanding, (the) project used ‘bagged salad,’” McDonald said. “I am assuming this means it was already washed. The fact that they added salad juice and salmonella after it had already been bagged and washed really just shows how important it is to not cross-contaminate cleaned product.”
The researchers, as a result of their findings, suggested people eat bagged salads as soon as possible after purchase to minimize risk. They wrote in a question-and-answer supplement to the release that they no longer keep their bagged salads in the refrigerator longer than one day.
“Ridiculous recommendation,” Taylor said in his e-mail. “For 30 years consumers have enjoyed hundreds of millions of bagged salads weekly with great benefit to their health and wellbeing.”
Jennifer McEntire, vice president of food safety and technology at United Fresh Produce Association, also disagreed with the recommendation.
“People should always follow the instructions, including best-by dates, on packages, mainly so that they experience the best quality product,” McEntire said in an e-mail. “People shouldn’t be afraid to keep salad in their refrigerators for the full duration of the shelf life.”
She may mean use-by dates.
Suslow described the study as another piece of the puzzle in trying to find long-term solutions for food safety issues, but he was not impressed by it.
“Sort of generating a lot of additional concern and fear without any real basis for changing what (is) sort of standard practice isn’t necessarily helpful,” Suslow said. “Could hurt the category, but probably no more so than other things such as those instances when there are outbreaks or recalls.
“I think consumers understand that there’s no such thing as zero risk,” Suslow said (smartest thing anyone said in this story). “They understand and appreciate the convenience of packaged salads with multiple ingredients with very healthy mixed leafy greens, and that’s how the category has grown.”
This import alert represents the Agency’s current guidance to the Food and Drug Administration (FDA) field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer any rights for or any person, and does not operate to bind FDA or the public.
Produce is vulnerable to contamination with pathogenic microorganisms if exposed to insanitary conditions during growing, harvesting, packing, holding, or manufacturing, processing, or transportation. Multiple foodborne illness outbreaks have been linked to produce items that were likely contaminated as a result of insanitary conditions during growing, harvesting, packing, holding, manufacturing, processing, or transportation. Produce is of special concern because in many instances it is consumed without further treatment to adequately destroy or remove pathogenic microorganisms.
FDA may document insanitary conditions during an inspection of an establishment that grows, harvests, packs, holds, manufactures, processes, or transports produce. FDA may also use analytical evidence or epidemiological and traceback evidence to establish that a produce item was manufactured, processed, prepared, packed, or held under insanitary conditions.
Districts may detain, without physical examination, produce items from manufacturers, shippers, farms, packers and/or other entities (firms) identified on the Red List of this import alert.
Examples of evidence FDA may use to place a firm on the Red List include:
- Inspectional evidence.
- Epidemiological evidence and traceback evidence. This should include evidence implicating the particular produce item as a vehicle in a foodborne illness outbreak (including positive test results), traceback evidence demonstrating that the firm grows, harvests, packs, holds, manufactures, processes, or transports the implicated vehicle, and expert opinion that the outbreak was likely a result of insanitary conditions at the foreign firm (e.g., contamination likely resulted from insanitary conditions due to the typical modes of transmission of the pathogen implicated in the outbreak) or was related to a resident pathogen or systemic contamination at the foreign firm, or both.
- Analytical evidence. This should include evidence of a resident organism at the foreign firm and/or systemic contamination at the foreign firm, such as an expert opinion that the analytical evidence indicates insanitary conditions at the foreign firm or indicates a resident pathogen or systemic contamination at the foreign firm, or both. Examples include:
* A pathogen that matches an outbreak strain is isolated from an imported produce item;
* Microbial pathogens that are indistinguishable by one or more genetic tests are isolated from two or more lots of imported produce originating from the same foreign firm.
INFORMATION FOR FIRMS REQUESTING REMOVAL FROM THE RED LIST:
In order to be removed from the red list, the firm should submit documentation to FDA demonstrating that the firm has made all relevant corrections to overcome the appearance of adulteration, so that the agency will have confidence that future entries will be in compliance with the Act. Examples of such documentation may include:
- Documentation to show that inspectional observations or violations identified by FDA have been corrected. Firms whose produce items appear to be adulterated based on inspectional evidence should submit detailed descriptions of the specific steps taken to correct the violations along with documentation such as (as applicable) written plans, field records, packinghouse or facility records, training records, and photographs.
- Root cause analysis to identify potential sources and routes of contamination. Firms whose produce items appear to be adulterated based on analytical or epidemiological and traceback evidence should include a detailed root cause analysis to evaluate all aspects of their operations in order to identify potential sources and routes of contamination. The firm should also provide documentation to demonstrate that corrective actions to adequately control the sources and routes of contamination identified in the root cause analysis have been implemented.
– Water adequacy for irrigation, agricultural sprays, cooling, and other uses;
– Soil amendment and biosolids;
– Animal management;
– Worker health and hygiene;
– Sanitary facilities, disposal of sewage and silage;
– Equipment cleaning and sanitation;
– Farm or facility sanitation;
– Transportation; and
– Programs to monitor produce safety practices, processes and procedures and to take corrective actions when measures fail or are not fully implemented.
The firm may wish to refer to FDA’s Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, or similar guidance, to assist them in their root cause analysis and corrective action. Additional guidance for produce, including commodity specific guidance, may be found the FDA website at www.FDA.gov.