FoodHACCP Newsletter

Food Safety Job Openings

12/30. Auditor - Americas
12/29. Metro Food Safety Specialist – New Orleans, LA
12/29. Dir, Food Safety & Quality – Tigard, OR
12/29. Quality Control Supervisor – Lytton, IA
12/27. Env Specialist - Food Safety Specialist - Iowa
12/27. QA Specialist/Lead – Pittsburg, CA
12/27. QA Lab Technician – Batavia, NY
12/25. Food Safety Specialist – Houston, TX
12/25. QA Coordinator – Columbus, OH
12/25. Food Safety Trainer – Chicago, IL

01/08 2018 ISSUE:790


University of Arizona offering new Food Safety undergrad degree
Source :
By Rebecca D Dumais (Jan 2, 2018)
The Universtiy of Arizona (UA) will begin its new Food Safety Undergraduate Degree program in the fall of 2018. The program will address the need of food safety professionals in the state. Yuma County alone is third largest vegetable supplier in the nation; 90 percent of the USA’s leafy green vegetables are grown in the state between November and March. It produces more than 175 different crops and counts for more than a third of Arizona’s total agricultural revenue; a reported $17.1 billion industry.
Dr. Sadhana Ravishankar, Associate Professor, School of Animal & Comparative Biomedical Sciences at UA, who possesses a food science background, is happy to see the program coming to fruition. “I’ve always felt that food safety is really important and no university in Arizona was offering a food safety degree. It’s definitely a state that has a lot of agricultural significance.” As she points out, most of the produce grown in Arizona is the ‘ready-to-eat’ kind, meaning leafy greens – essentially salad vegetables that will be consumed raw.
10 core courses
With regards to the course itself, students will learn how to handle the evolving safety challenges facing the food industry. Program-specific curriculum includes 10 core courses that make up the basis of food safety education. Students will develop an all-around perspective in food safety, epidemiology, food toxicology and legalities in the food industry as well as an outbreaks investigation course. The program is housed in the School of Animal and Comparative Biomedical Sciences within the College of Agriculture and Life Sciences. Applications for the food safety degree program are currently available.
Contamination is a risky issue that has been more prevalent over the last two decades. Ravishankar notes there was much less incidence 20 – 25 years ago. “In the last while produce has been a big culprit. One of the biggest problems is fecal contamination.” She says even dust from an animal farm can carry bacteria and deposit itself on produce in the field, and irrigation water can also be a source of contamination.
As a career she says it’s an expanding field and there are countless avenues graduates from the program could take. Ravishankar lists a few examples, including: quality assurance manager, food safety manager, product scientist, regulatory affairs specialist, food processing specialist, global trade compliance analyst, food law attorneys, lobbyists, food toxicologist, epidemiologist, public health officers, food inspectors.
Ravishankar has researched on natural ways to prevent contamination and the results look positive, which could aid in natural food safety measures in processing, handling or even at-home preparation. “In our lab one of the main focuses of research is to come up with ways to control bacteria in natural ways,” she says. “We’ve done a lot of research with plant-based anti-microbials. They are good for you, they’re healthy, and don’t have any side effects.”
The recommendation from her lab includes using natural essential oils such as oregano, cinnamon or lemongrass oil as an effective way to wash produce.  “These are very effective at killing food born pathogenic bacteria.” By adding a couple of drops to the wash water Ravishankar says it can kill bacteria that could have occurred anywhere in the food’s production chain.  "We are excited to be the first to offer a major that looks at overall food safety in Arizona."
For more information:
Sadhana Ravishankar
University of Arizona
Animal and Comparative Biomedical Sciences
Tel: 520-626-1499

Trump Administration Indefinitely Delays Key Food Safety Protections
Source :
By Peter Lurie (Jan 4, 2018)
All Americans, regardless of their political affiliation, want safe food.
That’s why the Food Safety Modernization Act passed with broad bipartisan support.  Make no mistake: The Trump administration is today undermining that landmark legislation by indefinitely delaying enforcement of the rules that would put it into effect.  The announcement is a rotten anniversary present, given that FSMA was signed into law on this very day seven long years ago.
FSMA was intended to cover the entire food chain, from farm to fork, and the Trump administration’s new guidance would create a gap in that safety chain by exempting, at least for now, some of those who harvest, package, and hold food produced on farms.  In addition, the guidance would eliminate the written company-to-company food safety assurances required under the final FSMA rules that identify dangerous pathogens that should be addressed by downstream processors.  Undoing those aspects of the rules threatens to expose consumers to hazards like Salmonella and E. coli.
Notably, when these same food safety rules were created, and then delayed for a finite period of time under the Obama administration, the rules were subject to public notice and comment before being published.  During that period, industry had adequate opportunity to raise the very concerns used by FDA today to justify today’s announcement.  But under the Trump Administration, these indefinite delays are being unveiled in a surprise final guidance without public input.

Consumer Reports warns against eating any romaine lettuce
Source :
By NEWS DESK (Jan 4, 2018)
Food safety experts at Consumer Reports are advising people in the U.S. and Canada to stop eating romaine lettuce.
During the past seven weeks, 58 people in the U.S. and Canada have become ill from the strain of E. coli O157: H7. One person in each country has died. In the U.S., the infections have been confirmed in 13 states — California, Connecticut, Illinois, Indiana, Michigan, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Virginia, Vermont and Washington.
Until the cause of the current outbreak is known and the implicated food is removed from the supply chain, CR’s experts say consumers should avoid eating any romaine lettuce. It is a recommendation not yet made by either the U.S. Food and Drug Administration or the federal Centers for Disease Control and Prevention (CDC).
The source of the E. coli food poisoning is being investigated by FDA and CDC, along with public health officials in Canada. Five people in the U.S. received hospital care, and one has died, according to CDC. There has also been one death reported in Canada.
Canadian health authorities identified romaine lettuce as the source of the outbreak in their country, and since Dec. 14 have been advising people in the country’s eastern provinces to consider eating other types of salad greens until further notice. They said sick people reported eating romaine from a variety of locations, including grocery stores, restaurants and private homes.
In the U.S., government health officials are investigating the outbreaks, but have stopped short of recommending people avoid romaine lettuce or any other food.
“Even though we can’t say with 100 percent certainty that romaine lettuce is the cause of the E. coli outbreak in the U.S., a greater degree of caution is appropriate given that romaine lettuce is almost always consumed raw,” according to James Rogers, Ph.D, who is CR’s director of food safety and research.
“While anyone can get sick if they are infected with this strain of E. coli, young children, the elderly, and anyone who has a condition that weakens the immune system, such as cancer or diabetes, are at a greater risk,” Rogers added. He advises that people in these groups should be particularly vigilant about avoiding romaine lettuce.
According to the CDC, the type of E. coli making people sick genetically matches the bacteria involved in the Canadian outbreak. The U.S. investigators say that means the same food source is likely involved. Still, the CDC says it does not have enough information to recommend people in the U.S. avoid any particular food.
Jean Halloran, Director of Food Policy Initiatives at Consumers Union, the policy and mobilization division of Consumer Reports, said, “The FDA should follow the lead of the Canadian government and immediately warn the public about this risk. The available data strongly suggest that romaine lettuce is the source of the U.S. outbreak. If so, and people aren’t warned, more may get sick.”
Neither the U.S. nor Canadian health officials have provided information on where the suspect romaine lettuce was grown or processed. So for now, Consumer Reports says people should assume that any romaine lettuce, even when sold in bags and packages, might be contaminated.
Do not buy romaine lettuce and don’t use any that you may have in your refrigerator until there is more information on the source of contamination, CR says. Consumers should also check salad blends and mixes, and avoid those that contain romaine.
Consumer Reports is the world’s largest independent product-testing organization. Using its more than 60 labs, auto test center, and survey research center, the nonprofit rates thousands of products and services annually. Founded in 1936, Consumer Reports has over 7 million subscribers to its magazine, website, and other publications. Its policy and mobilization division, Consumers Union, works for health reform, food and product safety, financial reform, and other consumer issues in Washington, D.C., the states, and in the marketplace.





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New patents to disinfect avocados and other Mexican produce
Source :
By DAN FLYNN (Jan 4, 2018)
A patent registration is pending at the Mexican Institute of Industrial Property for intervention recipes that might successfully disinfect avocados, mangos, strawberries, chilis, tomatoes and coriander.
If successful, once the intervention mixes reach the market Mexico would be able to keep much of its fresh produce from landing on the Import Alert list maintained by the U.S. Food and Drug Administration.
Mexico frequently finds the food it is exporting to the United States on the Import Alert list once it crosses the international border. Mexico begins 2018 with 71 food products on the FDA Import Alert List, many for produce like cantaloupes, dried peppers and green onions.
Concern over Mexico’s large avocado crop, however, kicked started the new research by the Autonomous University of the State of Hidalgo (UAEH). Mexico growers produce 30 percent of the world’s avocados — more than 1.52 million tons per season — and most are for export.
Javier Castro Rosas and other UAEH researchers have been working on the problem for years, first studying the antimicrobial nature of the hibiscus flower to reduce strains of salmonella, typhoid and E. coli in avocados.
In later research, the UAEH team tried adding commercial solutions of colloidal silver or chlorine. That did reduce some of the bacteria, but not enough. Next they mixed recipes using acetic acids from vinegar, citric acids from lime, and other substances of natural origins that their patent claims eliminate all bacteria on avocados.
Their mixes also control bacteria on other products exported to the U.S.
An FDA Import Alerts with a Detention without Physical Examination order are costly for exporters. Food products that land on that list cannot enter the U.S. until they’ve been sampled and tested by a qualified independent laboratory.
If the independent lab finds an illegal residue or contaminant on the product, FDA will refuse to allow it into the U.S. The product must be sent on to another country or destroyed. And every shipment from exporters who make the Import Alert list must go through the same process.
If new shipments are clean the exporter’s products are allowed to enter the U.S. Getting off the list requires five clean deliveries in a row. The lab protocols are strict.
Fresh Mexican produce often makes Americans sick before an Import Alert is issued.  Last year, maradol papayas from Mexico sickened more than 250 people in four separate outbreaks, resulting in two deaths and 79 hospitalizations. About half of the U.S. states were involved in at least one of the four outbreaks.
Also in 2017, imported fresh produce from Mexico was named as the likely cause of  1,065 laboratory-confirmed cases of cyclosporiasis in the U.S.  Fresh basil, cilantro, mesclun lettuce, raspberries and snow peas transported the parasite caused past outbreaks in the U.S., but the exact cause last season was not found.

Antimicrobial Use in Poultry Processing
Source :
By Dianna V. Bourassa, Ph.D.
Processing aids are used in the production of many foods including poultry. Antimicrobials are a processing aid used to reduce foodborne pathogen contamination, thereby enhancing product food safety. The specific parameters for antimicrobial use in the production of poultry products are described in the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) Directive 7120.1 Rev. 43 (October 5, 2017).
Antimicrobials can be used during multiple steps of poultry processing to create a multi-hurdle approach to minimizing contamination. These steps include prescald brushing, scalding, defeathering, evisceration, on- and off-line reprocessing, carcass washing at multiple steps in the process, chilling and post-chill treatment. While some efficacy has been demonstrated, antimicrobials are generally not applied in the initial steps from slaughter, scalding and defeathering due to added costs and low overall benefit. Most processing plants apply antimicrobials during equipment spraying, carcass washing, reprocessing, immersion chilling and post-chill treatment. To determine efficacy of antimicrobials during each step of the process and to ensure process controls, processing plant biomapping should be conducted regularly. Developing plant biomaps can alert plant managers to any potential process issues and help processors decide which antimicrobials are most effective and at which sites in the process they have the greatest benefit.
A Closer Look at the Process
Following the birds’ arrival at the processing plant and slaughter, an optional brush wash cabinet may be used to remove organic material in combination with a chlorinated water spray. Removing organic material at this stage can help reduce the amount of fecal material entering the scald tank. Feathered carcasses are then scalded in hot water to aid in feather removal. Antimicrobial treatments can be added to scald water, but this poses several challenges. High water temperatures can lead to off-gassing of antimicrobials, and the high organic load may bind and deactivate antimicrobials. The use of sulfuric acid, ammonium sulfate and copper sulfate in scald water has been suggested to decrease aerobic plate counts and Escherichia coli and Salmonella prevalence, as well as minimize cross-contamination.[1] The use of countercurrent water flow between multiple-stage scald tanks can help minimize organic loading and potential cross-contamination in scald tank water.
Microbial contamination has been demonstrated to increase during defeathering.[2,3] When the carcasses enter the picker, rows of disks with spinning rubber picker fingers are used to remove feathers. During this process, the carcasses are massaged and compressed, which has a negative side effect of expressing fecal contents from the lower digestive tract. Steps to minimize contamination include maintenance of picker fingers and adequate feed withdrawal. Generally, antimicrobials are not applied during defeathering due to the large volumes of water being used. However, an antimicrobial rinse following defeathering can decrease contamination. Technologies to prevent expression of fecal contents or the application of antimicrobials during defeathering may be useful in minimizing such cross-contamination. Development of systems for antimicrobial application could provide an additional hurdle against pathogen contamination.
The majority of antimicrobial controls are applied following defeathering. A multi-hurdle approach is used by applying multiple antimicrobial interventions. These antimicrobials are applied during pre-evisceration carcass wash, equipment spraying during venting, opening, evisceration, cropping, inside-outside carcass washing post-evisceration, on-line and off-line reprocessing, prechill dip treatment, carcass chilling, post-chill carcass treatment and parts washing (Table 1).
Commonly Used Antimicrobials in Poultry Processing
The most commonly used antimicrobials are peracetic acid (PAA), cetylpyridinium chloride (CPC), acidified sodium chlorite (ASC), organic acids, bromine and chlorine (Figure 1[4]). Each of these antimicrobials has advantages and disadvantages.
PAA is a mixture of acetic acid and hydrogen peroxide. Application concentration depends on the length of application time. PAA is applied at higher concentrations (200–300 ppm) during short-term treatments (< 1 minute) such as reprocessing, pre- and post-chill carcass treatments and broiler parts treatments. Lower concentrations (20–50 ppm) are used during longer-term (60–120 minutes) immersion carcass chilling. PAA is approved for use up to 2,000 ppm; however, such high concentrations can impact the visual appearance of the carcass, can be unpleasant for plant employees and may have detrimental microbial kill-off impact during plant wastewater treatment. PAA has been demonstrated to be very effective, can be used on products labeled “organic” and is approved for use on exported products.[5] In a 2010 industry survey, PAA was the most frequently used antimicrobial for on-line reprocessing, inside-outside bird washers, carcass chilling and post-chill treatment.4 Disadvantages include high cost, potential yield losses following long-term exposure, increased fat in wastewater and potential product “graying” from chemical reaction with heme in blood.
CPC is typically used as a post-chill treatment with a maximum concentration of 0.8%. CPC has been shown to be effective against Salmonella after short-term treatment. However, USDA-FSIS specifies that carcasses/parts treated with CPC must be rinsed following treatment with potable water. CPC in wastewater may also have detrimental microbial kill-off during wastewater treatment.
ASC is applied as a dip during chilling or during pre- or post-chilling treatments. Chilling levels are generally low (50–150 ppm), while short-term dip treatments can be applied at higher concentrations (1,200 ppm). ASC has been shown to be effective, particularly as a short-term dip treatment, but antimicrobial mixing systems can be expensive.
Acid mixtures can be applied in process water, reprocessing, chilling and as a post-chill treatment. This type of antimicrobial works by decreasing the water pH to 1.0–2.0 and is low cost and effective. However, they require a longer contact time, and there may be some issues with equipment corrosion.
Chlorine (20–50 ppm) is often used for cleaning of equipment to minimize carcass cross-contamination. It is also applied to carcasses during washing. In the past, chlorine was frequently used during immersion chilling, but it is not unusual to see chlorine used in commercial chillers. It is inexpensive as well as very effective when used under certain conditions. However, inactivation due to organic loading and the need to maintain pH below 6.5 make chlorine a less advantageous antimicrobial. Additionally, its use can impact the ability to export products. While chlorine can be used in the U.S., it is not allowed as a processing aid in the European Union.
Regardless of which antimicrobial is used, several additional factors should be considered. Employee safety should be a top priority. These antimicrobials are often applied in an enclosed environment, such as a wash cabinet, but are sometimes applied in a more open environment, such as the chill tanks. Employees should always wear the proper personal protective equipment and have regular training on the use and hazards of the antimicrobials being used. To help ensure safety, airflow should be regulated and monitored, and it is beneficial to have antimicrobials diluted mechanically to avoid contact with the concentrated chemical.   
Dianna V. Bourassa, Ph.D., is an Assistant Professor/Extension Specialist of Poultry Processing in the Department of Poultry Science at Auburn University.
1. Russell, SM. 2011. “Intervention Strategies for Reducing Salmonella Prevalence on Ready-to-Cook Chicken.” Proceeding of the 22nd Latin American Poultry Congress.
2. Berrang, ME et al. 2001. “Broiler Carcass Contamination with Campylobacter from Feces during Defeathering.” J Food Prot 64:2063–2066.
3. Clouser, CS et al. 1995. “Effect of Type of Defeathering System on Salmonella Cross Contamination during Commercial Processing.” Poult Sci 74:732–741.
4. McKee, SR. 2011. “Salmonella and Campylobacter Control during Poultry Processing.” Presented at the 2011 International Poultry Exposition, Atlanta, GA, January 24–25, 2011.
5. Wideman, N et al. 2016. “Evaluating Best Practices for Campylobacter and Salmonella Reduction in Poultry Processing Plants.” Poult Sci 95:306–315.

E. coli victim dies in U.S. but feds can’t discuss investigation
Source :
By CORAL BEACH |(Jan 3, 2018)
Canada says romaine lettuce is cause; no recalls or details on supplier, retailers as threat continues
Editor’s note: A spokeswoman for the CDC confirmed for Food Safety News on Jan. 3 that one person has died in the U.S., five have been admitted to hospitals and two have developed  kidney failure because of HUS as a result of their E. coli infections.
One person in the U.S. has died and two others are gravely ill in an ongoing E. coli outbreak linked to romaine lettuce, but U.S. officials had not made that information public as of Tuesday.
A statement from U.S. Centers for Disease Control and Prevention on Dec. 28 reported that 17 people across 13 states are confirmed in the outbreak, which Canadian officials say is linked to romaine lettuce. The CDC did not report hospitalizations or the death at that time.
Of 41 confirmed victims in Canada, 17 have required hospitalization and one person has died. Canadian officials first reported the outbreak on Dec. 11. In the U.S. and Canada, the first confirmed illnesses began Nov. 16, 2017.
The Toronto Star in Canada reported Tuesday evening that the U.S. CDC had confirmed the death. Additionally, the newspaper’s Alex McKeen reported the CDC said five patients in the U.S. have required hospitalization and two have developed hemolytic uremic syndrome, a type of kidney failure.
No news is not good news
Neither government has released information about the supplier(s), distributor(s) or retailers that handled the implicated romaine lettuce — which is believed to remain in the supply chain.
Neither government has initiated a recall. However, the Canadian grocery chain Sobeys voluntarily pulled romaine lettuce this past week.
“It would certainly seem that with two deaths and 56 other illness in multiple states and Canada, there would be an announcement of where the romaine lettuce was sold and who grew it. This outbreak extends back to November and December of last year,” said Bill Marler, the Seattle food safety attorney who’s been watching foodborne illnesses since the deadly 1993 E. coli outbreak traced to Jack in the Box.
The same variety of the pathogen, O157:H7, which sickened and killed children who ate undercooked fast food hamburgers 25 years ago, is the culprit in the current outbreak in the U.S. and Canada.
Investigators at the U.S. CDC have confirmed through whole genome sequencing that the E. coli O157:H7 sickening people in Canada has the same DNA fingerprint as the pathogen infecting people in the United States. Officials in both countries say that makes it most likely that a common source food is involved.
Cooperation but little candor
The U.S. Food and Drug Administration is working with the CDC on the outbreak investigation, but a spokesman said Tuesday he could not discuss any specific details of the FDA’s ongoing investigation. The CDC’s statement on Dec. 28 cited the Canadian officials’ identification of romaine lettuce as the cause of the outbreak, but added that U.S. officials had not yet made that determination.
“The FDA is supporting the CDC and state and local authorities in an investigation of an outbreak of Shiga toxin-producing E. coli O157:H7 illnesses,” the FDA spokesman said Tuesday.
“CDC informed FDA of this illness cluster in mid-December. As with all outbreak investigations our role is to identify the source of the food(s) the CDC identifies through case interviews and other evidence to identify what was commonly eaten among the people who became ill, and determine whether it is linked to the outbreak through testing or other evidence.”
The FDA will neither confirm nor deny that is has or is testing any samples of romaine or any other foods in connection with the outbreak investigation.
Canada renews warning; says threat is ongoing
North of the border, the Canadian Food Inspection Agency (CFIA) is testing romaine lettuce samples but results are not yet available. In the mean time, the Public Health Agency of Canada (PHAC) continues its warning against consuming romaine lettuce.
“Based on the investigation findings to date, exposure to romaine lettuce has been identified as the source of the outbreak, but the cause of contamination has not been identified,” according to the PHAC update Dec. 28.
The outbreak appears to be ongoing, as illnesses linked to romaine lettuce continue to be reported to the Public Health Agency of Canada. These illnesses indicate that contaminated romaine lettuce may still be on the market  — including in restaurants, grocery stores and any establishments that serve food.”
Since Dec. 14, the Canadian health agency has been urging consumers “to consider consuming other types of lettuce, instead of romaine lettuce, until more is known about the outbreak and the cause of contamination.”
Risks for consumers
Although anyone can get develop an E. coli infection from exposure to the pathogen, pregnant women, people with weakened immune systems, young children and older adults are most at risk for developing serious complications, public health officials warn.
“This is especially true for this outbreak strain of E. coli (O157:H7), which is more likely to cause severe illness than other E. coli strains,” Public Health Agency of Canada reported.
Laboratory testing is necessary to determine whether food is contaminated with E. coli because it can’t be seen, smelled or tasted.
“Romaine lettuce can have a shelf life of up to five weeks; therefore it is possible that contaminated romaine lettuce purchased over the past few weeks may still be in your home,” Canadian officials told consumers.
Advice to consumers
Anyone who has eaten romaine lettuce and developed symptoms of E. coli infection should immediately seek medical attention. Specific lab tests are required to diagnose E. coli infection.
Symptoms can include nausea, vomiting, headache, mild fever, severe stomach cramps, and watery or bloody diarrhea. The onset of symptoms can range from 1 to 10 days after exposure.
“Some do not get sick at all, though they can still spread the infection to others. Others may feel as though they have a bad case of upset stomach. In some cases, individuals become seriously ill and must be hospitalized,” according to the health agency notice.
People who develop hemolytic uremic syndrome (HUS) need intensive medical treatment, usually including dialysis for kidney failure.

Mexico and US strengthen food safety ties
Source :
By  (Jan 3, 2018)
Declaration of intent will identify areas in which the two countries can improve collaboration on key issues
Food safety authorities in Mexico and the US have agreed to boost cooperation between the two countries.
Mexico’s National Service of Health, Safety and Agri-Food Quality (Senasica) and National Association of Self-Service and Departmental Stores (Antad) and the US Food Marketing Institute (FMI) have signed a declaration of intent to build an alliance that will identify key areas where collaboration should be strengthened.
They will draft in producers and marketers of both nations to help consumers obtain greater guarantees on safety by reinforcing preventative practices in the production of fresh and minimally processed fruits and vegetables, according to the Secretary of Agriculture, José Calzada Rovirosa.
The agreement includes training producers on the implementation, certification and continuous verification of the safety schemes promoted by Senasica in order to boost the competitiveness of both sectors.
The agreement will allow suppliers of stores affiliated to the FMI and Antad to improve compliance with standards, guidelines and safety practices, as established by the current regulations on agri-food issues.
Antad has 5,410 affiliated self-service stores, along with 2,307 department stores and 43,992 specialist outlets.

History of Food Poisoning Outbreaks Linked to Lettuce and Other Leafy Greens is Long
Source :
By News Desk (Jan 3, 2018 )
An ongoing E. coli O157:H7 outbreak that may be associated with romaine lettuce has sickened at least 17 people in the United States and 41 people in Canada. Both the CDC and the Public Health Agency of Canada have announced these outbreaks that may be related. In Canada, a link has been made to that type of leafy green, but officials in the United States are still investigating the source.
Public health officials in this country are not releasing much information, beyond the case count by state and the fact that they are investigating the outbreak. In Canada, officials are recommending that people who live in five provinces avoid romaine lettuce, but no such recommendation has been made in the U.S.
This is not the first time lettuce has been linked to a serious food poisoning outbreak. Leafy greens and bacterial pathogens are, unfortunately, a common combination, even though most people do not associate food poisoning with those products.
A 2005 report from the CDC stated that “leafy greens are a significant source of foodborne illness outbreaks.” Another CDC study released in 2014 found that produce accounted for nearly half of all food poisoning illnesses in the United States from 1998 to 2008. Leafy vegetables accounted for the most illnesses. And that has been proven over the years.
People have been sickened by the leafy green-pathogen combination in the past after buying contaminated product at grocery stores, and after eating produce at restaurants. In this current outbreak, patients are scattered across the country, which may indicate a common source early in the production chain, such as produce contaminated in the field or served at a chain restaurant.
In 2016, a Listeria monocytogenes outbreak was linked to recalled Dole packaged salads. At least 33 people in the U.S. and Canada were sickened in that outbreak. That was the first time that a listeriosis outbreak was linked to leafy greens.
In 2013, an E. coli O157:H7 outbreak was linked to ready-to-eat salads sickened 33 people in 4 states. Two ready-to-eat salads sold at Trader Joe’s stores were identified as the likely source of this outbreak. Glass Onion Catering voluntarily recalled many salads and sandwich wrap products after that outbreak was discovered.
In 2012, an E. coli O157:H7 outbreak linked to organic spinach and spring mix blend sickened at least 33 people in 5 states. The pre-packaged leafy greens were produced by State Garden of Chelsea, Massachusetts. Most of the people sickened in that outbreak lived in New York.
In late 2011 and early 2012, an E. coli O157:H7 outbreak linked to romaine lettuce sickened at least 58 people in 9 states. The lettuce was grown and distributed by Amazing Coachella in California.
In 2010, a multistate E. coli O145 outbreak was linked to shredded romaine lettuce. At least 26 confirmed and 7 probable illnesses were linked to that outbreak. Three patients developed HUS and 12 were hospitalized.
An E. coli O157:H7 infection can cause serious illness and death. One person in this outbreak who lived in Canada has died. This pathogen produces Shiga toxins that travel through the body and destroy red blood cells. The damaged cells can destroy the kidneys and cause strokes and seizures.
If you are experiencing the symptoms of this illness, especially if you have recently eaten romaine lettuce, it’s important to see your doctor. If this infection is improperly treated with antibiotics, or if the patient is very young, a complication called hemolytic uremic syndrome (HUS) can develop that can be life-threatening.
The symptoms of an E. coli infection include severe and painful abdominal and stomach cramps, diarrhea that may be bloody and/or watery, and a mild fever. The symptoms of HUS include little or no urine output, easy bruising, a skin rash, lethargy, pale skin, and bleeding from the nose or mouth.

FDA warns supplement makers, seafood and juice processors
Supplement makers from Washington, Maine and Georgia, along with seafood and juice processors from New York and Jamaica, are on notice from the Food and Drug Administration for violations of federal food safety rules.

The FDA sent warning letters to the companies in April, November and December of 2017, and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.

Brain Alert LLC, Lynwood, WA
Source :
By KELSEY M. MACKIN |(Jan  2, 2018)
Supplement makers from Washington, Maine and Georgia, along with seafood and juice processors from New York and Jamaica, are on notice from the Food and Drug Administration for violations of federal food safety rules.
The FDA sent warning letters to the companies in April, November and December of 2017, and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.
In a Dec. 14, 2017, warning letter to distributing agent Jared K. Lykken, the FDA cited serious violations of the Food, Drug, and Cosmetic Act, and determined that the firm’s misbranded dietary supplement do not comply with FDA requirements.
“In addition, FDA reviewed your website at Based on our review, we have concluded that your BrainAlert product is an unapproved new drug and misbranded drug and that, even if it were not a drug, it would be a misbranded dietary supplement.”
According to the warning letter, the firm’s products were prepared, packed, or held under conditions that do not meet Current good manufacturing practice (CGMP) requirements for dietary supplements. During the inspection, the investigator observed the following violations of the FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements:
The firm failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record:
“For example, you stated that you have no knowledge of how your contract manufacturer manufactures or handles your product prior to your receipt of the finished product, or whether your contract manufacturer conducts any testing of the product.”
The firm failed to make and keep written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision:
“To fulfill requirements for quality control operations, quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.”

The firm failed to establish and follow written procedures to fulfill the requirements related to product complaints:
“You have not established written procedures for handling product complaints.”
The firm’s BrainAlert product is misbranded because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient, i.e. Ginseng (Panax), Rhodiola rosea, Ginkgo Biloba, and Gotu Kola, in the product is derived; and
The firm’s BrainAlert product is misbranded in that the presentation of the nutrition information on the labeling is incorrectly listed.
Maine Natural Health Inc., Warren, ME
In an April 12, 2017, warning letter to company owner and CEO Harold J. Leighton, the FDA cited serious violations of the Food, Drug, and Cosmetic Act (the Act), and determined that the firm’s misbranded dietary supplements do not comply with FDA requirements.
“In addition, we have reviewed the labeling for your dietary supplements, including product labels and your website at Based on our review of the labeling and the website, we have concluded that your SO3 + D3 Fish Oil, Fuel Whey Protein, Strong Strength + Muscle, Pure Whey Protein, and Push Pre-Workout products are in violation of the Act and regulations implementing the food labeling requirements of the Act.”
According to the warning letter, the adulterated dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements due to the following violations:
“You failed to establish specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record”
“Your firm failed to collect representative samples of a subset of finished batches of each dietary supplement that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution to verify that the finished batch of dietary supplement meets product specifications”
” When a dietary supplement failed to meet an established specification, your quality control personnel did not reject the component or dietary supplement, nor did they approve a treatment, an in-process adjustment, or reprocessing that would ensure the quality of the finished dietary supplement and that the dietary supplement was packaged and labeled as specified in your master manufacturing record (MMR)”
“The firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch, from batch to batch”
“The firm’s Strong Strength + Muscle, and Push Pre-Workout products are misbranded in that their labeling is false and misleading”
“The firm’s Pure Whey Protein and Fuel Whey Protein  dietary supplement products are misbranded because the labeling bears nutrient content claims, but the products do not meet the requirements to bear the claims”
“The firm’s Peppermint SO3 + D3 Fish Oil, Coconut Fuel Whey Protein, and Coffee Strong Strength + Muscle products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that they are fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name”
“The firm’s Peppermint SO3 + D3 Fish Oil, Coconut Fuel Whey Protein, Chocolate Pure Whey Protein, Fruit Punch Push Pre-Workout, and Coffee Strong Strength + Muscle products are misbranded because of the presentation of the nutrition information on the labels”
“The firm’s Coconut Fuel Whey Protein, Chocolate Pure Whey Protein, Fruit Punch Push Pre-Workout, and Coffee Strong Strength + Muscle products are misbranded because the serving sizes and servings per container are not listed in the Supplement Facts labels in the format” and
The firm’s product labels do not list the name of the manufacturer, packer, or distributor, and lists the net weight in total ounces, rather than pounds and ounces.
Dynamic Technical Formulas, Roswell, GA
In a Dec. 13, 2017, warning letter to company owner and COO William T. Wotiz, the FDA cited serious violations of the Food, Drug, and Cosmetic Act (the Act), and determined that the firm’s misbranded dietary supplements do not comply with FDA requirements.
According to the warning letter,”the products were prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. The inspection also revealed violations of dietary supplement labeling requirements, rendering your DTF, Gym Candy, and Biotech Underground products misbranded.”
The FDA investigator noted the following violations:
The firm’s quality control personnel failed to ensure that their manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record
The firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that they manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch
The firm failed to prepare a batch production record every time they manufactured a batch of a dietary supplement
The firm failed to establish a specification for every point, step, or stage in the manufacturing process where control is necessary to the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record
The firm failed to identify each unique lot within each unique shipment of components that they receive and any lot of components that they produce in a manner that allows them to trace the lot to the supplier, the date received, the name of the component, the status of the component; and to the dietary supplement they manufactured and distributed
The firm failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that they distribute
The firm failed to make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained and
The firm’s OmegaFuel product label declares fish oil, but fails to declare the major food allergen “fish”
According to the warning letter, “We reviewed the labeling of your Lift Candy, Pump Candy, Clafuel, Joint Fuel, DHEA fuel, Pump Fuel, OMEGA fuel, Night fuel, Organ fuel, Purify and Tudca products and found that these dietary supplements are misbranded in that the labels fail to identify a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement.”
Gold Star Smoked Fish Corp., Brooklyn, NY
In an Dec. 15, 2017, warning letter to company president Robert Pincow, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, and determined that the firm’s ready-to-eat (RTE) seafood products are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.
During the inspection, the FDA collected environmental samples consisting of multiple swabs taken from various areas in the facility, “including areas that are near food during processing operations and near food contact surfaces.” According to the warning letter, FDA laboratory analysis of the environmental swabs identified the presence of Listeria monocytogenes in the facility.
The FDA’s laboratory analysis of environmental sample collected on May 12 confirmed that five environmental swabs tested positive for Listeria monocytogenes. The positive swabs were collected from surface areas in locations where Ready-To-Eat (RTE) cold and hot smoked seafood products are manufactured and packaged.
FDA laboratory analysis of the environmental sample “INV987101” collected at the firm’s facility on April 26, 2017, confirmed that 15 of one 110 environmental swabs were positive for L. monocytogenes.
Specifically, “11 of the 15 positive swabs were taken from wheels of stainless steel carts (also referred to as tanks) used to thaw, brine and transport seafood products,” indicating that the facility is not achieving “satisfactory control” against the presence of Listeria monocytogenes within their facility and implementing effective methods and controls to locate niche or harborage points of the organisms within the environment to eliminate and minimize exposure to food and food contact surface during production.
“The presence of a resident strain of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food,” FDA determined.
The FDA acknowledged a June 5 response outlining the corrective actions taken in response to the L. monocytogenes environmental sample findings. “We acknowledge that you have cleaned and sanitized your processing environment, conducted environmental sampling, and that finished product was tested for L. monocytogenes. Your response also describes intensified environmental sampling being conducted after cleaning and sanitizing and before resuming production. At this time, we cannot verify the adequacy of the methods and controls you have used to identify the potential harborage sites for L. monocytogenes in your processing environment or that the methods and controls effectively prevent L. monocytogenes from contaminating finished products you may manufacture in the future. We will verify the adequacy of your corrective actions during any future inspection.”
Naturefield Company, Kingston, Jamaica
Naturefield Company in Kingston, Jamaica is on notice from the FDA because of significant deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation under the Federal Food, Drug, and Cosmetic Act (the Act). The firm ships frozen 100 percent coconut water in retail packaging into the United States.
The warning letter went out after the firm’s response to the FDA’s request for a copy of HACCP documentation associated with the processing of it’s 100 percent coconut water. Staff from the FDA discovered the “serious violations” regarding the firm’s affected products, according to the Nov. 16 warning letter made public by the FDA in recent days.
“You must include in your HACCP plan control measures that will consistently produce, at a minimum, a S­ log reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism,” However, “your HACCP plan for 100% coconut water, a low-acid juice product, does not include control measures that will consistently produce a 5-log reduction of the pertinent microorganism, Clostridium botulinum,” according to the warning letter sent to company contact Patrick Powell.
FDA officials encouraged the firm to review the Act, the juice HACCP regulation, the Juice HACCP Hazards and Controls Guidance, and the Refrigerated Carrot Juice and other Refrigerated Low-Acid Juices Guidance through links in FDA’s homepage.

Watchdog audits fire warning shots at the FDA’s food safety program
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In recent years, the Food and Drug Administration (FDA) has been given the authority to expand food safety inspections. But the agency’s food safety program recently come under close scrutiny by federal watchdogs for failing to protect public health with these much-needed additional inspections mandated by federal law.
The Office of the Inspector General (OIG) at the Department of Health and Human Services and the Government Accountability Office (GAO) have published three highly critical audits revealing shortcomings in the FDA’s enforcement of food safety policies – even though the Food Safety Modernization Act (FSMA) was enacted in 2011 to give the agency new food safety enforcement authorities, and the agency has received substantial increases in its appropriations to implement the new law. Yet, we continue to see the same problems that predated the legislation.
In September 2017, the OIG issued a report that found that while the FDA was on track to meet the inspection mandates of the FSMA for domestic food establishments (every three years for high risk and every five years for low risk plants), the number of inspections actually declined between 2011 and 2015 – from 19,000 to 16,000. In addition, the OIG found that the agency did not always follow up when its inspectors found significant food safety violations to verify that the issues had been addressed. In nearly one in five instances, the agency never followed up, and when it did, it often took over a year.
The FSMA calls for an “integrated food safety system” that uses the resources of state food inspection agencies to supplement the work of the FDA inspectors. In a recent meeting with state food and drug inspection officials, we learned that the agency has not made room for enough state inspection personnel to get trained on the new regulations. Those state officials informed the FDA that their agencies will refuse to conduct required inspections unless their personnel are properly trained by the agency. This stance is justified because in 2000 and in 2011, the OIG found that the FDA provided poor oversight of inspections it had contracted for the states to conduct.
Soon after the OIG report on domestic inspections was released, the GAO published a report in October 2017 on the safety of imported seafood. Seafood safety has been the topic of at least a dozen GAO reports since the 1980s. Over 90 percent of the seafood consumed in the U.S. is now imported, yet the FDA is only able to conduct in-depth inspections of about 2 percent of the imported lines of entry. In 1998, the agency implemented the seafood Hazard Analysis Critical Control Point (HACCP) rule to “modernize” seafood safety. To this day – some two decades later – FDA inspectors still find that some seafood processors, both domestic and foreign, have yet to write effective food safety plans. Aquacultured seafood has become especially problematic since some foreign countries permit the use of fungicides, antibiotics, and other chemicals that are banned in the U.S. because of their human health effects. After years of frustration with the lack of enforcement of food safety standards for imported catfish products, the Catfish Farmers of America successfully lobbied Congress in 2008 to shift the inspection of these products from the FDA to the USDA, even though it meant that their domestic products would be also subject to stricter food safety standards and continuous USDA inspection.
On Dec. 22, 2017 the OIG released a report that revealed major deficiencies in the FDA’s food recall process, even issuing a rare “early alert” in 2016. The agency has traditionally not written its own press releases on food recalls and merely republishes company press releases, sometimes days after a recall was initiated. It is only when the FDA finally sends out the company’s press release that there is widespread media coverage to create any urgency to get the products out of commerce. And the company press releases often contain boilerplate language extolling the virtues of the company instead of focusing on the public health consequences of the recall. To make matters worse, not all food recalls have been publicized by the FDA. Often, food recalls have been buried in the agency’s enforcement reports. When questioned about this, the agency’s response was that there were too many recalls to publicize.
The FDA has also lagged behind other agencies in updating its recall process. In 2004, the USDA began to include photos on its press releases to help consumers identify recalled food products under its jurisdiction. But the FDA did not do so until 2011. When we asked FDA officials in 2004 why it did not follow the USDA’s lead, they claimed that it was too difficult. Lastly, as Thomas Gremillion from the Consumer Federation of America recently argued, the FDA should start publishing the names of the retailers that sell recalled food products, which the USDA has been doing for over a decade. Ironically, in May 2017, Pinnacle Foods announced a recall of Aunt Jemima frozen pancakes, frozen waffles and frozen French toast for listeria monocytogenes contamination. The FDA did not list the retailers who sold these products, but the USDA did when the recalled items contained meat products. If the USDA can provide this information, so should the FDA.
The FDA must start putting people and public health first in its policies and not bend over backwards to protect corporate interests. The agency should also allocate its resources to support its field staff because that is where the rubber meets the road in enforcing food safety regulations. Food & Water Watch worked to shape the FSMA when it was being written and we have been supportive of increasing the appropriations to the agency for food safety. But as both the OIG and GAO have repeatedly pointed out, there are warning signs that the FDA is not moving fast enough to modernize its food safety program. As the FSMA begins to be fully implemented, the agency still has a long way to go to achieve the “preventative food safety system” that the legislation was supposed to deliver.

More Biscuits Recalled over Listeria
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By NEWS DESK (Jan 1, 2018)
Food Lion is voluntarily recalling all code dates of its Food Lion brand Homestyle Buttermilk Biscuits in an abundance of caution after being notified by its manufacturer today the product may contain listeria monocytogenes.
While there have been no reports of illnesses to date, the product is being recalled as a precautionary measure after T. Marzetti Company, the manufacturer of the product, has indicated a possible contamination issue with Listeria monocytogenes at one of its plants.

E. coli – Tainted Romaine Lettuce Likely Source of 57 sick and 1 dead in Canada and US
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By Bill Marler  (Jan 1, 2018)
Illnesses range from November through December, but authorities have yet to publicly identify where grown and by whom, or where lettuce was purchased.
The CDC, FDA and state health officials are investigating a multistate Escherichia coli O157:H7 outbreak that has sickened 17 people in 13 states, and preliminary tests by the US Centers for Disease Control and Prevention (CDC) show that the outbreak strain is closely related to one in Canada that has been associated with romaine lettuce.
The CDC said illness onsets range from Nov 15 through Dec 8, according to a press release today sent to journalists. Affected states include California, Connecticut, Illinois, Indiana, Michigan, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Virginia, Vermont, and Washington.
State and local authorities are interviewing sick people to see what they ate in the week before they became ill. Because a source of the US infections hasn’t been identified, the CDC said it is unable to recommend if US residents should avoid a particular food. “This investigation is ongoing, and more information will be released as it becomes available,” it said.
The Public Health Agency of Canada (PHAC) issued its first announcement about an E coli outbreak linked to romaine lettuce on Dec 11. In a Dec 21 update, it said it is so far investigating 41 cases from five provinces: Ontario, Quebec, New Brunswick, Nova Scotia, and Newfoundland and Labrador. It urged the public to avoid eating romaine lettuce until more is known about the contamination.
Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of E. coli outbreaks and hemolytic uremic syndrome (HUS). The E. coli lawyers of Marler Clark have represented thousands of victims of E. coli and other foodborne illness infections and have recovered over $600 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our E. coli lawyers have litigated E. coli and HUS cases stemming from outbreaks traced to ground beef, raw milk, lettuce, spinach, sprouts, and other food products.  The law firm has brought E. coli lawsuits against such companies as Jack in the Box, Dole, ConAgra, Cargill, and Jimmy John’s.  We have proudly represented such victims as Brianne Kiner, Stephanie Smith and Linda Rivera.
If you or a family member became ill with an E. coli infection or HUS after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark E. coli attorneys for a free case evaluation.

Lack of Effective Pest Exclusion Tops FDA List of 2017 Inspection Violations
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By (Dec 29, 2017)
FDA consulting firm Registrar Corp compiled the most commonly cited food safety violations.
FDA’s inspectional observation data report for fiscal year (FY) 2017 presents an overview of violations cited by FDA during routine food facility inspections from October 2016 through September 2017. FDA consulting firm Registrar Corp compiled the most commonly cited food safety violations:
Lack of Effective Pest Exclusion/Screening – The facility does not take effective measures to protect food against contamination from pests or exclude pests from food production areas.
Sanitation Monitoring – The facility does not monitor sanitation conditions and practices frequently enough to conform to current good manufacturing practices (CGMPs). Some factors that should be monitored include the safety of water coming into contact with food and food contact surfaces, the condition and cleanliness of food contact surfaces, and the measures used to prevent cross-contamination from unsanitary objects.
Plant Cleanliness – The facility fails to maintain cleanliness of the premises, or the facility is not constructed in a way that allows for proper sanitation or maintenance of floors, walls, and ceilings.
HACCP Plan Implementation – A facility manufacturing seafood or juice fails to implement procedures in its HACCP plan. These may include monitoring critical control points of food hazards, verifying the adequacy of the plan's hazard control, or maintaining records as required by 21 CFR Part 123
Reasonable Precautions – The facility does not take precautions to prevent production procedures from contaminating food. Reasonable precautions may include monitoring food processing time and temperature or monitoring manufacturing operations, such as freezing or heat processing.
These violations are nearly identical to the most common violations cited in FY 2016 and FY 2015. Food facilities should use this pattern to anticipate the areas in their daily operations that may require further review before an FDA inspection.
The 2017 list is the first to include violations related to FDA's Preventive Controls and Foreign Supplier Verification Program (FSVP) rules, which had compliance deadlines in 2017. Most food facilities are now required to have implemented HARPC food safety plans, and many importers are required to have FSVPs. Despite the first FSVP compliance deadline passing as recently as May 2017, failure to develop an FSVP was cited 108 times. With the next FSVP deadline landing in March 2018, it is probable that FSMA violations may make their way to the top next year.




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