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FoodHACCP Newsletter
10/26 2015 ISSUE:675

FDA Weighs In on Karoun Dairies Listeria Outbreak
Source :
By Carla Gillespie (Oct 25, 2015)
The U.S. Food and Drug Administration (FDA) has issued its final update on the Karoun Dairies Listeria outbreak. The cheeses distributed by Karoun and sold under a variety of brand names sickened 30 people in 10 states over the course of five years.  Three people died and one woman had a miscarriage.
The FDA and the Centers for Disease Control and Prevention (CDC) collaborated on the investigation of the outbreak. Together they identified five rare outbreak strains that had been causing illness since August 8, 2010. The most recent illnesses were reported this summer.
By state, the illnesses totals were as follows: California (18), Colorado (1), Illinois (2), Massachusetts (2), Michigan (1), New York (2), Ohio (1), Tennessee (1), Virginia (1), and Washington (1). Twenty eight people were hospitalized. Six of the illnesses were pregnancy-related, with one resulting in a miscarriage.  There were three deaths reported, one in California in 2012, one in Ohio in 2012 and one in California in 2015.
The case patients in this outbreak range in age from less than 1 year to 92. The median age is 73. Seventy percent of ill people were female. Twenty of 30 people with available information were of Middle Eastern or Eastern European descent or shopped at Middle Eastern or Eastern European-style markets.
Most reported eating Middle Eastern, Eastern European, Mediterranean, or Mexican-style cheeses, including ani, paneer, feta, Middle Eastern-style string cheese, nabulsi or village cheese before they became ill. Brands distributed by Karoun were mentioned specifically.
A recall was issued on September 16 for the cheeses sold under the brand names: Karoun, Arz, Gopi, Queso Del Valle, Central Valley Creamery, Gopi, and Yanni. They were vacuum packed, in jars or in pails in weights varying from 5 ounces to 30 pounds and distributed to grocery stores and food service accounts. Click the preceding link for a complete list of recalled cheeses. A complete list of retailers that sold the cheeses was not made available but two stores that carried them were Publix and Sam’s Club.
The cheeses were made for Karoun Dairies at Central Valley Cheese, Inc. manufacturing facility in Turlock, California. FDA investigators found Listeria closely related to the outbreak strains at the Central Valley Cheese, establishing an epidemiologic link between the cheeses and ill consumers.
Consumers who still have this cheese at home should not eat it as Listeria causes serious illness and death. Symptoms of a Listeria infection include high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Those at high risk of Listeria infections are young children, seniors, those with compromised immune systems and pregnant women. Among pregnant women, Listeria can cause miscarriage, stillbirth, premature delivery and infections in newborns.

Mariscos San Juan Shigella Outbreak Sickens 141
Source :
By Carla Gillespie (Oct 25, 2015)
A Shigella outbreak at the San Jose restaurant has sickened 141 people and reports of additional illness are still coming in, according to public health department. Many people were hospitalized; 12 were admitted to intensive care.
Almost all of those who became ill ate at the San Jose restaurant located at 205 N. 4th Street  in San Jose on Friday, October 16 or Saturday, October 17. The origin of the outbreak has not yet been determined. Health officials are expecting results of tests on all food handlers this week.
 Most of cases, 118, are from Santa Clara County, the other 23 cases are from Alameda, Santa Cruz and San Mateo counties. Forty nine of the case are lab-confirmed, 35 of those are Santa Clara County residents. All of the cultures have come back as Shigella sonnei, the most common of four species of Shigella.
Ingesting only a few Shigella bacteria can causes an infection called shigellosis which is extremely contagious. It is transmitted vis the fecal-oral route meaning food contaminated with microscopic amounts of fecal matter containing Shigella bacteria is ingested.
Shigella can be transmitted by those who are sick. Someone infected with shigellosis will have Shigella bacteria in their stools for up to two weeks after their diarrhea has ended. If their hands are not washed properly after using the restroom, anything they touch can become contaminated. When other people touch these items or surfaces, their hands can become contaminated and they can become sick if they touch their food or their mouths.
Food can become contaminated if it is handled by someone who has Shigella bacteria on their hands – for example, a food worker who has shigellosis. Flies that breed in infected feces can contaminate food when they land on it. Sometimes, produce becomes contaminated when there is human sewage in growing fields or contaminated irrigation water.
Nationwide, about 500,000 cases of shigellosis are reported each year. It does not have a “season.” Although Shigella can affect people of all ages, young children are at greatest risk. Outbreaks are most often associated with daycare or child care centers
Symptoms of shigellosis usually begin between 24 and 48 hours after exposure. They include diarrhea that can sometimes be bloody, fever, abdominal pain, vomiting and tenesmus, or the painful sensation of needing to pass stools even when bowels are empty.
Symptoms usually last about a week, but it could takes several months before bowel habits return to normal. Shigellosis can cause serious illness and death. Patients with severe diarrhea or vomiting can become dehydrated and require immediate medical attention to prevent shock.
Health officials urge anyone who ate at Mariscos San Juan restaurant #3 on 205 N. 4th Street in San Jose on Friday October 16th or Saturday, October 17th, who developed sudden onset of diarrhea and fever within two days of the meal to see a doctor. Mention that you may have been exposed to Shigella. A stool sample can confirm the infection and determine if it is part of the outbreak.

Letter From the Editor: It’s Antibiotic Resistance That’s Hard
Source :
By Dan Flynn (Oct 25, 2015)
Chick-fil-A, McDonald’s, Chipotle, Panera and, most recently, Subway have made public pronouncements indicating their intentions to source their poultry and meat from producers who don’t use antibiotics. The promises usually involve some time in the future, or an extended phase-in period.
These announcements usually follow some noise by activists, who are guilty of greatly simplifying the complex and multifaceted problem of antibiotic resistance. And when consumers hear about restaurant chains switching to only using poultry and meat raised without antibiotics, they might assume it means that antibiotics are contained in the poultry and meat being sold today by Chick-fil-A, McDonald’s, Chipotle, Panera and Subway.
I usually hit the delete button as soon as I read about a corporation promising to do something in the future. After all, I am still waiting for those afternoon wine bars that Howard Shultz promised way back when would show up at my local Starbucks. My mode of operation finds it hard enough to cover what businesses are actually doing to have any time left over for their pie-in-the-sky talk. However, the plot does thicken every time one of these outfits makes some sort of an antibiotics-free pledge. Even if they could be held to their recent announcements in the future, what is that going to really mean?
The activists contribute to the disinformation with their over-heated rhetoric, such as charging that “the current system breeds antibiotic-resistant bacteria.” A couple of observations on that one: If we knew how to “breed antibiotic resistance,” would it not follow that we’d know how to stop it by now? And, second, unless the activists are totally ignorant — and we know they are not — it is no secret that the current system delivers meat and poultry that is antibiotic-free today. The current system recognizes the difference between animals being treated with antibiotics just as people are, at some point during their lifetime, and still managing to produce antibiotic-free meat and poultry.
The chicken sandwich outlets now demanding antibiotic-free flocks are not being honest about their motives, or at least not very specific. They are making the change based on a perceived marketing need to keep up with their competition, not because they will be doing anything for food safety. That’s regrettable but par for the course. Forcing suppliers to change is one thing, but what share of the responsibility are these retail chicken shops going to take if diseases burn through poultry barns for want of antibiotics? FDA is tamping down on the use of antibiotics, especially those shared by humans and animals, but not advocating wholesale withdrawals.
But are the other chicken shacks saying — like McDonalds — that they will purchase only chickens raised without antibiotics important to human medicine? Are any of these companies saying that they will ban their chicken producers from all antibiotics including ionophores, which are the go-to solution when parasitic diseases threaten to wipe out a poultry barn? Oh, and I like this little detail — ionophores are defined by the U.S. Food and Drug Administration as an antibiotic. However, in the European Union, ionophores are defined as anticoccidials. The devil is always in the details.
I am often asked if antibiotic resistance is a serious problem. I always say that when the U.S. Centers for Disease Control and Prevention (CDC) announced that 2 million Americans are sickened and 23,000 die annually, damn right it is serious. But when asked what people should do, I say if at all possible, stay out of hospitals. We probably all have a relative who checked into hospital for something else and ended up with C. diff. But be sorry about eating a chicken sandwich? No reason to.
Retail chicken businesses are easy targets for the activists in these times when digital petitioning has taken its place alongside the pen-and-paper kind. We are in a new petition era because of the Internet. If you don’t have your own, you can go to online petition sites such as and Care2 Petitions. The White House has its “We the People” site to create the illusion that it cares what the public thinks. The White House even offers a response for petitions that reach a certain signature threshold.
It’s become apparent to me that government and businesses have set far different thresholds for determining what numbers are important when it comes to petitions. By their very nature, businesses in a free economy are constantly reacting to market demands. So, it should come as no surprise that businesses are susceptible to organized pressure. The reason I say that businesses are an easy target is because they frequently give in to their critics over a number so low that your typical Washington, D.C., pol would consider it laughable.
In last week’s Subway story, the activists were proudly claiming that they had 300,000 signatures on petitions. Can anyone imagine Nancy Pelosi or Mitch McConnell moving a single hair on their head if provided with a such a petition against one of their policies? You need far more serious numbers and a boatload of money to move the average member of Congress. That’s because when politicians look at the numbers, they first check the U.S. population, which is currently 326 million. Then they recall that after redistricting in 2010, congressional districts were redrawn so that each would accommodate 700,000 people. And they know they can safely ignore about half of those 425 districts, or around 140 million people.
Meanwhile, the typical marketing vice president at Subway worries anytime they hear from any consumer who has a negative opinion about one of their franchises. Present that VP with petitions bearing 300,000 signatures of people wanting just one thing, and his or her resistance will prove futile.




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Karoun Cheese Listeria Outbreak Ends After Killing Three
Soruce :
By Carla Gillespie (Oct 23, 2015)
karoun-cheese-listeria outbreak
The Listeria outbreak linked to soft cheeses produced by Karoun Dairies Inc. of San Fernando, California has ended after killing three people, sickening 27 others and causing one miscarriage. However, because some consumers may still have the recalled cheese in their refrigerators, health officials are worried that others may become sick.
The Centers for Disease Control and Prevention (CDC) and the U. S. Food and Drug Administration worked together on the investigation of the outbreak. Together they used DNA testing to identify five rare outbreak strains that sickened 30 people in 10 states over the course of five years.  The most recent illnesses were reported this summer.
By state the case count was as follows: California (18), Colorado (1), Illinois (2), Massachusetts (2), Michigan (1), New York (2), Ohio (1), Tennessee (1), Virginia (1), and Washington (1). There were two fatalities in California and one in Ohio.
Twenty eight of the case patients were hospitalized. Six of the illnesses were pregnancy related. There was one miscarriage.
The case patients in this outbreak range in age from less than 1 year to 92. The median age is 73. Seventy percent of ill people were female. Twenty of 30 people with available information were of Middle Eastern or Eastern European descent or shopped at Middle Eastern or Eastern European-style markets.
Most of them reported eating Middle Eastern, Eastern European, Mediterranean, or Mexican-style cheeses, including ani, feta Middle Eastern-style string cheese, nabulsi or village cheese before they became ill. Brands distributed by Karoun were mentioned specifically.
A recall was issued on September 16 for the cheeses which were vacuum packed, in jars or in pails under the brands: Karoun, Arz, Gopi, Queso Del Valle, Central Valley Creamery, Gopi, and Yanni. They were sold in varying weights vary from 5 ounces to 30 pounds. They were distributed to nationwide to grocery stores and food service accounts. A complete list of retailers that sold the cheeses was not made available but two stores that carried them were Publix and Sam’s Club.
The cheeses were made for Karoun Dairies at Central Valley Cheese, Inc. manufacturing facility in Turlock, California. FDA investigators found Listeria closely related to the outbreak strains at the Central Valley Cheese, establishing an epidemiologic link.
Consumers who still have this cheese at home should not eat it as Listeria causes serious illness and death. Symptoms of a Listeria infection include high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Those at high risk of Listeria infections are young children, seniors, those with compromised immune systems and pregnant women. Among pregnant women, Listeria can cause miscarriage, stillbirth, premature delivery and infections in newborns.

If you grill, don’t chill on meat thermometer use
Source :
By Ben Chapman (Oct 23, 2015)
The STEC beef safety #Grill160toKill tailgate project hits Virginia Tech:
Grilling burgers in your backyard or at a late afternoon tailgate doesn’t seem like a scenario set for danger, but your burger can bite back if bacteria is allowed to remain in the meat, Virginia Tech researchers say.
Daniel Gallagher, an associate professor in the Via Department of Civil and Environmental Engineering, is the principal investigator on a collaborative project to track thermometer use in cooking hamburger meat. Renee Boyer, associate professor of food science and technology, and Virginia Cooperative Extension specialist in the College of Agriculture and Life Sciences is collaborating on the project, a joint effort with North Carolina State University, Kansas State University, University of Nebraska, and Texas A&M.Screen Shot 2015-10-09 at 10.02.37 PM
Boyer and her lab have been distributing kits at Virginia Tech football tailgates that contain a digital read out thermometer, an apron, and a beverage koozy with temperature guidelines. The goal is to prompt people to monitor the temperature of their ground beef.
The team will be handing out supplies around campus parking lots again at a future football game. They will also be checking in with people who have already received kits to see if they are using proper cooking techniques.
The group has launched a social media campaign on Instagram and Twitter. Users who post photos with the thermometer reading 160 degrees with meat using the hashtag #Grill160toKill will be entered to win an iPad.
“We are trying to create an awareness of the importance of grilling meats to 160 degrees to avoid E.coli illnesses by using a thermometer and seeing if we can shift the public’s attitude about monitoring cooking temperatures,” said Boyer.
The bacteria — Shiga-toxin producing Escherichia coli, or STEC — are associated with at least 265,000 illnesses per year.
Cooking meat to 160 degrees kills E. coli bacteria.
“You go to the doctor to monitor your sodium and cholesterol; using a thermometer to cook meat is the same principle,” said Lily Yang, a doctoral student from San Francisco. “It’s a preventative measure.”
Hamburger, as opposed to steak which has only the surface area exposed, can potentially have contaminants distributed throughout the patty because the meat is ground and mixed.
“As a consumer you are the last line of defense against getting sick from consuming E. coli bacteria,” said John di Stefano, a master’s student from Midlothian, Virginia. “Using a thermometer to monitor your cooking temperature is the best way to do that.”
The outreach effort is funded by a $25 million grant from the U.S. Department of Agriculture.

No Product Found to Compare to VT Outbreak Strain — or to Recall
Source :
By Dan Flynn (Oct 23, 2015)
An all-too-common problem for foodborne illness investigations is that the only real evidence gets eaten. That appears to be what happened with the E. coli illnesses in Vermont last month, where 11 people had E. coli O157:H7 infections that state health officials blamed on likely contamination from undercooked hamburgers.

Food Safety News last reported on the outbreak associated with the popular Worthy Burger restaurant and brew pub in South Royalton, VT, on Oct. 20, when it was still widely believed that Shiga toxin-producing bacteria had been found in an unopened package of beef on the shelf of Worthy Burger’s walk-in cooler. That in turn raised the question of why — after a month — there had not been any recall.
After that story was published, USDA’s Food Safety and Inspection Service (FSIS) responded to our inquiries, and an update was included in the original story to state that there was no recall because the ground beef sample, which we thought had tested positive for E. coli O157:H7, did not contain the illness-causing H7 antigen, nor did it contain Shiga toxin-producing bacteria.
Therefore, the product “is not adulterated and subject to recall,” said Gabrielle Johnston, FSIS public affairs specialist, adding, “FSIS continues to work closely with our public health partners on finding the source of this outbreak.”
FSIS spokesman Adam Tarr then underscored the dilemma by telling Food Safety News that “Shiga toxin-producing bacteria were not found at the restaurant — or at all, for that matter.”
However, no product to compare to the outbreak strain does not let Worthy Burger off the hook. It means that the final report likely will have the benefit of pulsed-field gel electrophoresis (PFGE) patterns, also known as DNA fingerprints, but will also have to rely on good, old-fashioned epidemiology.

What Caused the Shigella Outbreak at Mariscos San Juan Restaurant in California?
Source :
By Linda Larsen (Oct 22, 2015)
A Shigella outbreak at the Mariscos San Juan No. 3 restaurant in San Jose, California has sickened at least 98 people, according to the Santa Clara County Public Health Department. Twenty-four people have been diagnosed with shigellosis, the illness caused by this bacteria. And 12 people are in intensive care units at hospitals as a result of their illness.
The numbers were updated October 21, 2015 by the Health Department. Public health officials are interviewing and testing all food handlers at the restaurant. The owner and employees of the restaurant are cooperating with the investigation.
Health officials in Santa Cruz county are currently investigating five more “suspect cases” that may be linked to the restaurant. What caused this outbreak, and why are people so sick?
First, shigella bacteria are very contagious. It only takes a few bacteria to make someone extremely sick. And the amount of feces needed to cause illness is too small to see with the naked eye. This bacteria causes about 500,000 cases of diarrheal illness in the U.S. every year.
Second, some people can carry the bacteria without having any symptoms. The bacteria are in she stools of infected people. If someone goes to the bathroom, then doesn’t wash their hands properly and then prepares or serves food to others, or touches surfaces that other people touch, the bacteria can be spread. Hands can also be contaminated while changing diapers or caring for a person who has diarrhea.
Third, many food workers work while they are sick. The restaurant industry is notorious for not allowing time off when an employee is sick. And many restaurant workers are paid hourly. If they don’t work, they aren’t paid. Hiding an illness and going to work is common in this industry.
And fourth, the shigella bacteria in this outbreak may be antibiotic-resistant. That can make the illness more difficult to treat, and symptoms may be more serious and longer-lasting.
Quite a few people have been hospitalized in this outbreak. Shigellosis can be a very serious infection. It can cause hemolytic uremic syndrome (HUS), which can cause kidney failure and death. This complication, which is also caused by E. coli O157:H7 infections, is caused by toxins produced by Shigella dysenteriae bacteria. Shigella bacteria can also cause bloodstream infections, and can develop into Reiter’s syndrome, which can cause arthritis.
The seriousness of the outbreak also depends on the health status of people who got sick. Young children are more likely to become seriously ill with this infection. People who have compromised immune systems and chronic illnesses are also more likely to experienced serious complications from shigellosis.
The symptoms of shigellosis appear suddenly and without warning. They include diarrhea that may be bloody, fever, abdominal pain, and tenesmus, a painful sensation of needing to pass stools when the bowels are empty. Symptoms usually appear within 1 to 2 days after exposure. Most people get better within a week, although it may take months before some patient’s GI tracts return to normal.
If you have been treated for shigellosis and don’t feel better within a few days, tell your doctor. The bacteria may be antibiotic-resistant and your doctor will order more tests to see if other antibiotics could treat the infection.
Public health officials are urging anyone who ate at the Mariscos San Juan No. 3 restaurant on October 16 and 17, 2015, and experienced the symptoms of shigellosis, to see a doctor. Identification of patients and proper treatment is necessary to prevent the growth of this outbreak.

Raw Milk E. coli and Campylobacter Outbreak in Idaho
Source :
By Denis Stearns (Oct 21, 2015)
Public Health officials are investigating eight illnesses in southwest Idaho likely associated with drinking unpasteurized (raw) milk. To date, four Campylobacter and four E. coli 0157:H7 cases have reported drinking raw milk produced by the Natural Farm Fresh Dairy of Kuna in the week prior to getting sick. The investigation is ongoing with Southwest and Central District Health departments, working in association with the Idaho State Department of Agriculture.
“If people have recently purchased raw milk from this dairy, we advise them not to drink it and to discard it,” says Dr. Leslie Tengelsen, State Public Health Veterinarian with the Idaho Department of Health and Welfare.
The Idaho State Department of Agriculture is working with Natural Farm Fresh Dairy to confirm if the raw milk from that facility was the source of the reported illnesses. The dairy is fully cooperating with the investigation and issued the following statement: “Natural Farm Fresh is committed to providing a safe and wholesome product to its customers. Effective immediately, we are voluntarily removing all raw milk products currently on the shelves in retail stores and we will discontinue further distribution of our raw milk until additional product testing is completed.”
People should inform themselves of possible health risks before consuming raw, unpasteurized dairy products or providing these products to family members, particularly those considered members of high risk groups. Those at higher risk of illness after consuming raw, unpasteurized milk include young children, pregnant women, the elderly, and those with compromised immune systems.
Common symptoms of acute Campylobacter infection include fever, diarrhea (sometimes bloody), abdominal pain, general discomfort, and vomiting. Symptoms often begin 2-5 days after consumption of contaminated foods and last for about a week in most people; in 20 percent of cases symptoms can last for up to three weeks. Symptoms of E. coli O157:H7 infection typically include stomach cramps and diarrhea, including bloody diarrhea. Symptoms often occur 3-4 days after exposure, but can be as short as 1 day and as long as 10 days. E. coli O157:H7 infections sometimes lead to a serious complication called hemolytic uremic syndrome (HUS), which can cause kidney failure and can occur a week or more after the onset of diarrhea. People with any symptoms of illness after consuming unpasteurized milk from Natural Farm Fresh of Kuna should seek medical attention.

New regulations for producers will benefit consumers, say food safety experts
Source :
By (Oct 21, 2015)
Food safety experts at Iowa State University are taking a lead role to help producers in Iowa and the Midwest comply with new federal regulations to guarantee the food we eat is safe.
The Centers for Disease Control and Prevention estimates that 48 million Americans – or one in six – get sick every year from foodborne illnesses. That's why the Food and Drug Administration is implementing new rules to make food producers, manufacturers and processors more accountable in preventing an outbreak.
"It's really making food industries think about their product holistically and what measures they can take to ensure when the product goes out the door and touches the consumer's plate, it is safe," said Angela Shaw, an assistant professor of food science and human nutrition at Iowa State.
The new rules require companies to identify and address potential risks at all points of the food supply chain. That includes suppliers providing ingredients for the final product as well as the transportation system used to get the product to market. Shaw says the emphasis on risk-based prevention is intended to reduce the number of foodborne illnesses and recalls. The rules also allow for stronger enforcement when there is a problem.
"Prior to this rule, FDA could not require a recall to occur, it was all voluntary," Shaw said. "Now with this rule, they can force a mandatory recall."
The FDA's case against Stewart Parnell, the former CEO of Peanut Corporation of America, is an example of why mandatory recalls are needed. Parnell was recently sentenced to prison for failing to take action in a salmonella outbreak linked to nine deaths and hundreds of illnesses. Shaw says this is an extremely rare case, but it underscores the importance of mandatory recalls so that the FDA does not have to resort to legal action.
Produce is a primary target
Iowa State food safety teams are creating training programs, based on the FDA mandate, for producers ranging from food hubs that serve restaurants and grocery stores to companies that make barbecue spices and sauces. Shaw says there are three main preventative controls – fresh produce, food for humans and animal food – that will impact most Iowa producers and processors. Farmer's markets are exempt.
Unprocessed fruits and vegetables, a common source of foodborne illnesses, were previously unregulated by the FDA in the U.S. Catherine Strohbehn, an adjunct professor of hospitality management at Iowa State, works specifically with growers of fresh produce. The majority of those growers have already identified changes for their farms, Strohbehn said.
However, much of the produce we consume is imported. The new FDA rules also increase surveillance of fruits, vegetables and other ingredients from foreign producers. Strohbehn says this will limit the risk associated with a global food supply.
"A global food supply does provide us with wider variety of choices and enables us to enjoy fresh produce when not in season in the U.S.," Strohbehn said. "However, each link of the food chain presents opportunity for risk, and mishandling at any step in the farm-to-fork flow can cause an illness. With global transportation, traceability is paramount."
Food producers, processors and manufacturers have two to four years, depending on the size of their operation, to comply with the rules. Shaw is hopeful that the regulations will not create a hardship for smaller producers and force them out of business. She says the process is similar to changes the meat industry faced in the late '90s. While there were challenges, most companies survived the transition.
"FDA is really making an effort to ensure that farmers, growers and manufacturers are equipped to handle this rule," Shaw said. "If we want to have a healthier America, we need to focus on making our food supply safer. We have seen an increased commitment from Iowa-based food and feed companies to ensure their procedures are safer and their employees are trained on safe food handling."

US Marshals seize adulterated crab products for food safety violations
Source :
By FDA (Oct 21, 2015)
At the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of Massachusetts, U.S. Marshals have seized about 5,000 cases of ready-to-eat frozen Jonah crab products processed by Rome Packing Company Inc. (Rome Packing). FDA investigators determined the products have been prepared, packed and held under unsanitary conditions and may present a risk to human health.
During an FDA inspection of Rome Packing in Lakeville, Massachusetts, from November 2014 through January 2015, investigators observed poor sanitary practices and found that the company’s cooking process for crabs did not maintain adequate temperatures to prevent the growth of pathogens such as Listeria monocytogenes (L. mono). FDA investigators collected environmental swabs during the inspection and confirmed the presence of L. mono in the manufacturing area. The presence of L. mono in the processing environment may indicate colonization in other areas of the facility.
“The FDA made several efforts to help Rome Packing correct processes, but the company failed to take adequate corrective measures,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “In this case, we had to intervene and seize this adulterated food to prevent it from reaching consumers.”
The FDA used a bacterial typing tool called whole genome sequencing (WGS) to link the samples collected in the facility. WGS technology can show the relationship among isolates of bacterial pathogens found in the environment, a food source, or a person who became ill from consuming contaminated food.
L. mono is a pathogenic bacterium that can contaminate foods, which may result in a sometimes life-threatening illness called listeriosis. People with compromised immune systems, the elderly, pregnant women and developing fetuses are particularly susceptible to listeriosis. L. mono grows under refrigeration and wet conditions, resists diverse environmental conditions, and can survive for prolonged periods of time.
Rome Packing is currently not operating or producing food. No illnesses have been reported to date.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

How Much Do You Know about Wine Safety?
Source :
By Jörn Kleinhans (Oct 20, 2105)
How Much Do You Know about Wine Safety?
Wine is among the oldest of beverages. Today, millions of consumers around the world drink wine to enjoy its beautiful aromatic bouquet, its complex flavors or its ability to complement fine cuisine. However, wine’s original appeal was its safety.
We began producing and drinking wine because it was easy to keep free of bacteria (killed by the high levels of alcohol) and the contaminants, natural and manmade, found in every premodern source of water.
Most people today are well aware of the health and safety issues that come along with drinking too much wine, or drinking it irresponsibly—accidents and poor choices from intoxication, and diseases of the liver, to name a few. However, most of us never hear much about the safety issues that are not related to intoxication or unhealthy over-drinking, but which have resulted in great injury to many consumers.
As a professional sommelier, I’ve seen (or heard stories of) it all. Here are five mostly unknown safety issues to be aware of when storing, serving and consuming wine, just as applicable to the restaurant wait staff as to the home wine enthusiast:
1)    Flying Champagne corks can cause serious harm. Knowing that the pressure inside a bottle of Champagne is between 70 to 90 psi, it’s no surprise that many people suffer from eye and other injuries each year from improperly removed corks. When you open any bottle of sparkling wine, keep your thumb firmly planted over the cork, and place a serviette over your hand. Then, pointing the bottle away from every person in the room (or anything that could be knocked over), twist the cork gently until it begins lifting out of the bottle. Hold tight until the cork is all the way out of the bottle.
2)    Storing wine in an unsecured high place can result in serious injury. A bottle of wine weights about two pounds, and the glass is surprisingly easy to shatter. Where I live in California and in many other places that are prone to earthquakes, this can be a serious issue. Many people store wine for years at a time, and don’t think about the bottles that could have rolled around during a small earthquake. Be sure to secure any top-shelf bottles in your wine cellar or cabinet. Of course, this principle applies to any wine storage space that might be shifted or moved across time. Keep your bottles secure in boxes, specialized shelving, or in crates to ensure against the danger of falling bottles when you next retrieve a wine.
3)    Capsules of screw-top wine bottles are very sharp, if you attempt to remove them. If you’re used to removing a cork from a bottle of wine, you might expect the capsule that goes around the neck of the bottle (usually made from a non-heavy foil) to be easy and safe to remove. However, attempting to remove the metal capsule from a bottle of wine with a screw-top can be dangerous. The metal is several times thicker than a normal capsule and can create extremely sharp if you attempt to remove it from the bottle.
4)     Wine is an extremely sensitive fluid that is easily damages by temperate fluctuations. While temperatures that are too low (below 40 °F) can slow down the aging process and possibly create freeze burn, the biggest problem will be high temperatures. Storing or transporting wine above 90 °F can spoil the wine quickly. Since most of the temperature damage occurs during transport, foodservice operators and wine collectors often don’t find out about a contaminated wine until years later. The damage is not visible from outside the bottle. Gladly, most spoilage is not directly harmful to human health, and a spoiled collection is easily identified by an experienced wine expert. The optimal storage condition for wine is 55 °F, without light and vibrations.
There are just a few of the common wine-related injuries reported each year, which we would all do well to be more vigilant about.

Ready, Set, Go—The Food Safety Regs Are Final!
Source :
By Kathy Hardee, Esq.(Oct 20, 2015)
Ready, Set, Go—The Food Safety Regs Are Final!
After a wait of nearly 5 years, multiple drafts, public comments and even a court order, the U.S. Food and Drug Administration (FDA) has published final versions of two of the cornerstone regulations its implementation of the Food Safety Management Act (FSMA). Described as the largest overhaul of this country’s food safety laws in more than 70 years, FSMA was intended change the focus of food safety in this country from being reactive to preventive. It also sought to look at food safety from a more global perspective, coordinating with other countries that also enforce stringent food safety practices and prevent products from entering this country that do not meet the same safety criteria as those manufactured here.
Overall, FSMA is built around what FDA refers to as its 7 Pillars. These Pillars include Preventive Controls for Human Food, Preventive Controls for Animal Food, Produce Safety, Sanitary Transportation, Food Defense, Foreign Supplier Verification and Third-Party Auditor Rules. The preventive control rules for both human and animal food were released by FDA and published in the Federal Register on September 17, 2015. The final regulations reflect FDA’s responsiveness to comments raised by industry participants and consumers. A high level overview of the primary components of the rule relating to preventive controls for human food is discussed here.
I.    Written Food Safety Plan
Covered facilities, those required to register with FDA as a food “facility,” will now be required to create a very particularized written food safety plan and continually insure its enforcement and effectiveness. Every step in the process must be documented, including the reasons behind each decision to act or to not act.
A.    Creation of the Plan
The primary component steps in creating a food safety plan include conducting a Hazard Analysis and designing preventive controls. In an effort to allow flexibility for a manufacturer to design a safety plan that meets the unique needs of both its food product and its facility, the rule is in places left intentionally vague. In fact, FDA has declined to provide even a sample plan. It is clear that a manufacturer must analyze each of its facilities and create separate written safety plans for each.
The first necessary step is to perform a Hazard Analysis. Hazards must be identified that are either known or reasonably foreseeable, including biological, chemical and physical hazards. Hazards might be present in or around food because they occur naturally, are unintentionally introduced or are intentionally introduced for purposes of adulterating the food for an economic gain.
Once hazards are identified, preventive controls must be designed and implemented to provide assurance that the risk of that hazard will be significantly minimized or prevented so that food adulteration can be avoided. A preventive control could include a change to a manufacturing process such as food allergen and sanitation controls. If a hazard is identified that can only be preventively controlled by another participant in the food chain, a supply-chain program can be developed that will verify that the participant with the ability to prevent the hazard does so. Preventive controls will also include a mandated written recall plan for any food presenting a potential significant hazard. In more simple terms, a written recall plan is always a good idea.
Many manufacturers and safety analysts are operating under the misunderstanding that a Hazard Analysis and Critical Control Points (HACCP) analysis or HACCP plan will satisfy the requirements of the new FSMA requirements. That is not necessarily the case. The requirements under FSMA and HACCP are distinguishable. While overlap may exist, simply following an existing HACCP plan will run afoul of the requirements of the FSMA safety plan.
B.    Management of the Food Safety Plan and Its Components
To insure that the Hazard Analysis is and remains an accurate assessment of risk and that the preventive controls remain effective, ongoing management of the food safety plan is required. Management of that plan includes monitoring activities, corrective actions and verifications.
Monitoring activities can be as varied as the preventive controls themselves. The underlying goal is to simply confirm that the preventive controls are properly implemented and are consistently performed. Corrections or corrective actions must be taken whenever it is determined that the preventive controls are not being consistently performed or that there is some problem that has occurred in implementing the preventive control. Effective monitoring will identify when corrective action needs to be taken. A facility must then take appropriate action to reduce the likelihood that the problem will recur, make sure that all affected food is evaluated and, if adulterated, is not permitted to enter into commerce.
The last component of managing a food safety plan is referred to as verification. Verification can be viewed as an oversight audit. It is a review process which insures that every step of the food safety plan and its management are performed, appropriate and documented. Unlike monitoring, which makes sure that the designed preventive control is performed, verification confirms that the preventive control is effective in controlling the hazard it was designed to address. Verification of the preventive controls may include environmental testing, end product testing or other scientific confirmation. Verification must confirm that monitoring activities are occurring, that corrective actions are taken and that the entire plan and its procedures are re-evaluated as appropriate. Even when working well, a facility’s written safety plan must be re-evaluated every 3 years.
C.    Persons Qualified to Design and Manage Safety Plans
Every step from the identification of hazards through the creation and implementation of the written safety plan must be performed or overseen by a preventive controls qualified individual. To meet the definition of a preventive controls qualified individual, one must either successfully complete an FDA-approved standardized curriculum or have equivalent experience. Unfortunately, because the standardized curriculum has not yet been completed, equivalent experience also can’t be measured. It is the stated intent that following publication of these rules that curriculum will be finalized and training programs developed by FDA in partnership with particular industry alliances: The Produce Safety Alliance; Food Safety Preventive Controls Alliance and Sprout Safety Alliance.
II.    Current Good Manufacturing Practices
Manufacturers of human food have long been subject to industry standards referred to as Current Good Manufacturing Practices (cGMPs). While changes in science and technology have evolved, the cGMP standards had not been formally updated since 1986. While the revisions to cGMP provisions are not significant, there are a few changes to note. Individuals involved in manufacturing, processing, packing or holding food now have mandated requirements for the education and training of their employees in the area of food hygiene, food protection, employee health and personal hygiene, as those may impact the safety of food products. Specific record keeping is required to document the training.
FDA has for some time taken the position that GMPs should address allergen cross-contact. That position is now made specific in the revisions to cGMPs. Finally, the much-publicized debate relating to human food by-products being used in animal food will now be addressed, but are specifically contained in preventive controls for animal foods.
III.    Compliance Deadlines
The deadlines for facilities handling human food to become FSMA compliant are staggered over several years:
• Very small businesses (averaging less than less than $1 million per year in both annual sales of human food plus the market value of human food manufactured, processed, packed and held without sale) – 3 years.
• Businesses subject to the Pasteurized Milk Ordinance – 3 years.
• Small businesses (fewer than 500 full-time equivalent employees) – 2 years
• All other businesses – 1 year
FDA will be issuing guidance documents in the near future. On October 20, 2015, a public meeting will be held during which FDA will discuss its plans for the implementation of these preventive controls. Attendance at the public meeting is also available online at

Crab Meat Seized Over Listeria Fears
Source :
By Drew Falkenstein (Oct 20, 2015)
The United States seized approximately 5,000 cases of frozen, processed crab products manufactured by Rome Packing Company, Inc. (Rome), because the crab meat is suspected to be contaminated with harmful bacteria.
In a complaint unsealed today, the government alleged that Rome, formerly based in East Providence, R.I., prepared, packed, and processed Jonah crab products in a facility contaminated with Listeria monocytogenes, a pathogenic bacterium that, once it contaminates foods, can cause serious, sometimes life-threatening, illness.  According to court documents, the Food and Drug Administration (FDA) inspected Rome’s facility on six occasions and observed that Rome’s cooking process for crabs did not adequately control temperatures to prevent the growth of pathogens.  Environmental swab samples collected from three areas of Rome’s facility allegedly tested positive for Listeria monocytogenes.  The inspection also allegedly revealed poor sanitary practices and conditions in Rome’s facility that may cause cross-contamination between finished and raw food products.
The U.S. Marshal’s Service seized the crab products today from cold storage warehouses in Lakeville, Mass., which were being monitored by FDA officials.  Rome is now in receivership, according to the court documents.
The Food, Drug, and Cosmetic Act authorizes the government to seize and condemn food products if they are prepared, packed, or held under insanitary conditions that may have caused the products to become contaminated with filth or to pose a threat to consumer health.
“In partnership with the FDA, we are working to ensure food safety,” said United States Attorney Carmen M. Ortiz.  “Lax sanitary practices in the preparation and storage of food products endanger public health.  Where necessary we will intervene to prevent contaminated food from reaching consumers.”
“The FDA is committed to working with its federal partners to prevent contaminated food from reaching consumers.  Thanks to the collaboration between the FDA and the Department of Justice, we have ensured that the adulterated crab produced by Rome Packing doesn’t make its way to consumers,” said Melinda K. Plaisier, the FDA’s Associate Commissioner for Regulatory Affairs. “We will continue to work together to protect the public health.”
“The ‎duties of the United States Marshals Service vary in scope and nature and include enforcing all federal court orders such as the one executed today with our partners from the Food and Drug Administration and the U.S. Attorney’s Office” said United States Marshal John Gibbons of the District of Massachusetts.  “Preparing and processing tainted food products for sale to consumers is unacceptable and the United States Marshals Service will do its part in protecting our nation’s consumers.  I would like to thank the USAO and the FDA for our close partnership‎ on this case.”

Crackdown on food safety in Iran
Source :
By Doug Powell (Oct 20, 2015)
Hassan Qazizadeh Hashemi, who was speaking on the sidelines of a conference to mark World Food Day, said that no serious reform has taken place in the food sector over the last year, Tasnim reported.
World Food Day is observed globally on October 16.
“What embarrasses us is that why we cannot spot all food safety violators. Or when we ban some unhealthy products, why do they return into market?” Qazizadeh Hashemi said, adding that the problem is in the type of the punishment which has failed so far.
“We are determined not to allow [anybody] to play with people’s health at all and we take measure against [law violators] but we need judicial system as well as executive power to support us,” he stressed.

Food Outbreak Scan for Oct 19, 2015
Source :
Salmonella outbreak investigations tied to frozen chicken declared over
The Centers for Disease Control and Prevention (CDC) on Oct 16 released final reports on two separate Salmonella outbreaks linked to frozen chicken entrees.
The first Salmonella Enteritidis outbreak sickened 15 people, 4 of whom were hospitalized, in 7 states. Illness onset occurred from Apr 5 to Jul 27, and four Salmonella isolates tested were found to be resistant to the antibiotics ampicillin and tetracycline.
States affected included Connecticut (1 case), Illinois (2), Minnesota (8), New Hampshire (1), New York (1), Oklahoma (1), and Wisconsin (1). Six of the cases are new since the CDC's previous update on Jul 29.
Investigators identified the source of the outbreak as raw, frozen, stuffed chicken entrees produced by Barber Foods and sold under multiple brands, including Omaha Steaks. A Jul 12 expanded recall of approximately 1.7 pounds of frozen chicken entrees followed a Jul 2 recall of 58,320 pounds of frozen chicken Kiev entrees.
Though CDC said the outbreak is now over, it cautioned that affected products may still be in consumers' freezers and should not be eaten.
Oct 16 CDC Barber Foods update
Jul 30 CIDRAP News scan on previous update
The CDC also declared that a separate outbreak of Salmonella Enteritidis due to raw, frozen, stuffed, breaded chicken entrees is now over. The outbreak, attributed to products distributed by Aspen Foods, is not related to the Barber Foods outbreak.
The outbreak sickened five people, two of whom were hospitalized, all in Minnesota. Illness onset occurred from May 9 to Jul 22, and all three isolates tested were susceptible to antibiotics.
Investigators determined that the source of the outbreak was raw, frozen, stuffed, breaded chicken entrees sold by Aspen Foods under multiple brand names, including Antioch Farms. On Oct 2, Aspen Foods expanded its Jul 15 recall of 1.9 million pounds of frozen chicken entrees to include an additional 561,000 pounds of chicken.
The US Department of Agriculture (USDA) Food Safety and Inspection Service cautioned that it cannot guarantee the safety of any Aspen Foods raw frozen chicken products produced between Jul 30 and Sep 17.
Though the outbreak is now over, the CDC said that affected products may still be in consumers' freezers and should not be eaten.
Oct 16 CDC Aspen Foods update
Jul 16 CIDRAP News scan on outbreak
USDA awards more than $2 million to new local food safety centers
Regional training and technical assistance centers in Florida and Oregon each received more than $1 million to create programs that would enhance food safety compliance among small farms and produce wholesalers, according to an Oct 14 USDA press release.
The USDA's National Institute of Food and Agriculture (NIFA) distributed the grants as part of a collaboration with the Food and Drug Administration to create a national coordination center and four regional centers focused on food safety training. Funding aims to assist small and medium-sized farms, beginning farmers, socially disadvantaged farmers, and small produce wholesalers to become compliant with the Food Safety Modernization Act.
As part of the collaboration, NIFA's National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Grant Program funded two regional centers to provide food safety programs. The national coordinating center will be located at the International Food Protection Training Institute in Battle Creek, Mich.
The Southern Training, Education, Extension, Outreach, and Technical Assistance Center to Enhance Produce Safety at the University of Florida in Gainesville received $1,197,751 to develop cross-sector partnerships and training programs aimed at strengthening the southern produce industry.
The Western Training, Education, Extension, Outreach, and Technical Assistance Center to Enhance Food Safety at Oregon State University in Corvallis received $1,197,606 to provide training and outreach to small or disadvantaged farmers and wholesalers.
Training and outreach programs funded by NIFA will address food safety compliance issues faced by conventional and organic farmers and help small producers gain access into wider markets, the USDA said.

Report Suggests Taking a Second Look at Safety of Animal Drugs
Source :
By News Desk (Oct 19, 2015)
There might be more animal drugs to worry about than just antibiotics. That’s according to a report released by the Center for Food Safety (CFS) this past week.
“America’s Secret Animal Drug Problem” is an overview of safety information currently available for commonly used animal drugs. In addition to the antibiotics, CFS also addressed beta-agonists, steroid hormones, antioxidants, antibiotics arsenicals, and cocciodiostats.
“[T]he animal agriculture industry uses over 450 animal drugs, drug combinations, and other feed additives to promote growth of the animals and to suppress the negative effects that heavily-concentrated confinement has on farm animals,” report states.
The report described the uses of each type of drug and the possible threats they pose to animal, human or environmental health. For many of these drugs, a big issue is the lack of information regarding their effects.
A significant portion of the report was dedicated to antibiotics, reiterating concerns that the Food and Drug Administration’s (FDA) guidance to industry for removing growth promotion claims from animal antibiotics labels doesn’t address the other non-therapeutic use of disease prevention.
The CFS report also raises the idea that a ban on non-therapeutic uses could result in an increase of other non-antimicrobial drugs used for growth promotion.
Two beta-agonist drugs – ractopamine and zilpaterol – are widely used for last-minute weight gain in animals before slaughter. CFS states that these drugs lack “adequate rigorous assessment,” despite the fact that ractopamine increases the number of “downer” or lame animals and that residues have been detected on meat products.
There are six hormones approved for use in U.S. cattle production, and concerns have been raised that exposure to certain hormones can affect the human reproductive system, particularly in fetuses and adolescent girls. FDA says that any hormone residues in meat are below natural hormone levels, but CFS is skeptical of this claim.
Ethoxyquin is a synthetic antioxidant approved as a feed additive. The report states that FDA has raised concerns about “deleterious and poisonous” effects of the antioxidant, but the agency has “failed to take meaningful action to reevaluate or restrict” its use.
Coccidiostats are a class of anti-parasitic drugs, and residues have been found in food, but again, the CFS report states that there is a lack of studies dedicated to the potential health effects.
CFS and the Institute for Agriculture and Trade Policy petitioned FDA in 2009 to remove all arsenic-based compounds, or arsenicals, from animal feed. The agency ultimately decided to withdraw approval for 98 out of 101 arsenic-based feed additives and later announced that it would take the remaining arsenicals off the market by 2016.
“While this is a significant victory, FDA should have acted sooner to protect public health,” according to the CFS report.
CFS is critical of FDA not just for a lack of transparency about drug information, but also for “not routinely monitor emerging data on approved drugs but [relying] on others to bring the data to its attention.”
“FDA should use its existing authority under the Federal Food, Drug, and Cosmetic Act (FFDCA) to conduct regular, systematic reviews of the safety of animal drugs to ensure that they are still safe to be marketed,” the report recommends.

Poll: Sick Employees Insist on Serving Up Food
Soruce :
By Staff (Oct 19, 2015)
Poll: Sick Employees Insist on Serving Up Food
More than half of food industry workers go to work sick, according to the annual Mind of the Food Worker study conducted by the Center for Research and Public Policy and commissioned by Alchemy Systems.
A few highlights from the poll:
•51 percent of workers say they “always or frequently” go to work when sick.
•More than 45 percent say they go to work because they can’t afford not to.
•More than 46 percent said they don’t want to let their fellow coworkers down by not showing up for their scheduled shift.
•Oddly, when managers were asked how many of their employees show up to work sick, most replied with a mere 18 percent.
•Another odd finding is that despite their habit of going to work sick, 87 percent of frontline workers said they would still serve the food they make to their families and children.
“The vast majority of frontline food workers and their employers are committed to providing safe foods for their customers,” says Alchemy CEO Jeff Eastman. “The survey shows that over 90 percent of food workers feel responsible for the safety and well-being of their customers. So managers and supervisors need to better communicate why it’s okay to stay home when sick.”
The Mind of the Food Worker study’s purpose is to “increase the food industry’s understanding of frontline worker attitudes and behaviors.” In order to garner feedback from across the entire food supply chain, more than 1,200 food workers at farms, dairies, slaughter houses, meat facilities processing plants, cafeterias, commercial bakeries, restaurants and grocery stores were polled. The data was collected between July 3 through 16, 2015.

Ciguatera Outbreak in 2014 Revealed by CDC’s MMWR Report
Source :
By Linda Larsen (Oct 18, 2015)
An outbreak of Ciguatera fish poisoning (CFP) that took place in 2014 in Florida has been revealed by a report in the CDC’s Morbidity and Mortality Weekly Report (MMWR). This illness is caused by eating predatory reef fish that have the toxin in their systems. This toxin cannot be destroyed by cooking or freezing and there is no antidote for it.
On November 3, 2014, the Florida Department of health in Orange County received a report from their online foodborne illness complaint system that a patient describing paresthesias (tingling or burning sensation) and numbness had seen a doctor. That person got sick on October 31, 2014, one day after eating two meals of fish. A single case of ciguatera fish poisoning in Florida is considered an outbreak.
Data sources identified five additional CFP cases. Government officials collaborated to conduct investigations at two restaurants, one grocery store, two fish distributors, and one fish supplier to identify the outbreak food source. The six ill persons ate black grouper either at a local restaurant or purchased at a grocery store. The fish was traced back to a common international distributor. None of the patients, the restaurants, the grocery stores, or the distributor were identified in the report.
The initial investigation identified the first patient as an adult female who did not live in Florida who ate mahimahi at restaurant A on October 30, then a black grouper filet at restaurant B the same day. The woman experienced paradoxical temperature perception, where hot things feel cold and cold things feel hot, tingling, extremity numbness, a metallic taste, nausea, vomiting, abdominal pain, diarrhea, fever, and dizziness.
The Florida Department of Orange County Health queried surveillance systems to try to find other patients. They found an email alert from ESSENCE-FL (Early Notification of Community-Based Epidemics-Florida0 that on November 5, 2014, within a period of 22 minutes, four people went to one Orange County emergency department for “food poisoning.” A report that the patients ate “bad fish” was found in all four medical records. the patients were discharged with diagnosis of gastroenteritis.
All four of those patients, who belonged to the same family, and a fifth person from that same family shared a meal of black grouper fish heads on November 3, 2014. They were purchased from grocery store A on the same day that they were eaten. Symptoms began 3 hours after the meal and included symptoms typical of CFP, including flawed temperature perception, numbness, and tingling.
Patients in this outbreak ranged in age from 36 to 64 years, with a median age of 47. Four were male. The interval between eating the fish and getting sick ranged form three to 7.25 hours. All patients experienced paradoxical temperature perception, nausea, tingling, numbness, abdominal pain, diarrhea, joint pain, and muscle pain.
Supportive care was provided to the five patients, but none of them received intravenous mannitol (a sugar solution), which can be effective in reversing the symptoms of CFP.
Restaurant B and grocery store A both received the grouper from supplier A. Supplier A facilities were inspected and inspectors found that the implicated lot of black grouper was received whole, then divided into filets sold to restaurant B and fish heads sold to grocery store A. The black grouper was caught in Mexico. No leftover fish from the meals that caused that illness was available for lab analysis.
If you have eaten fish, particularly large predatory reef fish such as grouper, barracuda, parrot fish, amberjack, coral trout, Spanish mackerel, wrasses, king mackerel, snapper, or moray eel, and have experienced the symptoms of CFP, see a doctor as soon as possible. Symptoms can be alleviated with medical treatment, although there is no antidote, or cure, for the toxin.
This toxin is produced by marine algae that live in warm waters. Smaller fish eat the algae, and those fish are eaten in turn by larger fish. The toxin accumulates in the fish’s flesh. When someone eats a fish containing that toxin, they get sick.
To protect yourself against this type of food poisoning, always look for warnings about ciguatera if you fish to eat. Don’t eat fish that weigh more than six pounds. And avoid eating the guts of fish, where the toxin is most likely to accumulate.

FDA’s Multiple “Conditions of Use”
Source :
By George G. Misko, Esq.
FDA’s Multiple  “Conditions of Use”
The U.S. Food and Drug Administration (FDA)’s use of the term “Conditions of Use” can be confusing. FDA employs the term in its food additive regulations to describe the typical temperature conditions under which food products may be used in contact with packaging materials intended to process or hold food. However, in its guidance documents, “Conditions of Use” describe the temperature and duration at which a material should be tested to simulate the manner in which the material is intended to be used. To add to the confusion, FDA also references the term “Conditions of Use” when describing the extractive testing required to establish compliance for many food packaging materials under the food additive regulations.
To make matters even worse, the Conditions of Use employed in the food additive regulations for food contact substances were modified by FDA in the context of the Food Contact Notification (FCN) program so that there is now an incongruity as to the conditions described in the regulations versus the FCNs. The purpose of this article is to attempt to explain the various ways in which FDA talks about Conditions of Use for placing regulatory limits on the use of some food contact materials, for extractive testing compliance purposes and for migration testing needed to support an FCN.
“Conditions of Use” Defined in the Regulations
For food contact substances (FCSs) cleared by the food additive regulations, any temperature restriction on intended use is generally specified by reference to the Conditions of Use as defined in Title 21 Code of Federal Regulations (C.F.R.) Section 176.170(c), Table 2, which are as follows:
•    Condition of Use A, High temperature heat-sterilized (e.g., > 212 °F)
•    Condition of Use B, Boiling water sterilized
•    Condition of Use C, Hot filled or pasteurized above 150 °F
•    Condition of Use D, Hot filled or pasteurized below 150 °F
•    Condition of Use E, Room temperature filled and stored (no thermal treatment in the container)
•    Condition of Use F, Refrigerated storage (no thermal treatment in the container)
•    Condition of Use G, Frozen storage (no thermal treatment in the container)
•    Condition of Use H, Frozen or refrigerated storage: Ready-prepared foods intended to be reheated in container at time of use
Even though Section 176.170 is a regulation pertaining only to paper and paperboard food packaging, the first column of Table 2 (set forth above) has been used as a convenient reference in many other regulations and, until April 2006, in FCNs for all types of FCSs. Conditions of Use A–H are also set out in Section 175.300 (“Resinous and polymeric coatings”) and Section 177.1210 (“Closures for sealing gaskets”). In addition to defining Conditions of Use, each of the noted regulations also includes an extractive test that tracks the relevant Condition of Use under which the additive is permitted to be used along with identification of the appropriate food simulants that should be used to conduct the testing and the duration of the test.
It is important to note that while the times and temperatures specified for testing in these regulations are more or less severe according to the intended Condition of Use, these testing conditions are applicable only for the purpose of demonstrating that materials or articles that consist of substances explicitly cleared in a particular regulation comply with the requirements of that regulation; these conditions do not necessarily reflect actual use conditions. Accordingly, when another regulation lists an FCS as permitted for use under Conditions of Use A–H, as defined in 21 C.F.R. Section 176.170(c), Table 2, this cross-reference does not in any way suggest that extraction testing in accordance with Section 176.170 is required, or that such testing would be sufficient to determine whether, or to what extent, substances may reasonably be expected to migrate to food when used as intended.
The Expanded Conditions of Use
Many FCNs and regulatory clearances include a reference to a Condition of Use. Prior to April 2006, all of the referenced Conditions of Use were found in 21 C.F.R. Section 176.170(c), Table 2. Then in April 2006, FDA expanded its list of Conditions of Use to include Conditions I (Irradiation) and J (Cooking at temperatures exceeding 250 °F), but it did not do so by proposing to amend Table 2 in 21 C.F.R. Section 176.170 or otherwise modifying the food additive regulations. Instead, the revised list of Conditions of Use was simply published on FDA’s website.[1] Shortly thereafter, this expanded list was used by the agency as the reference for permitted Conditions of Use relative to new FCNs, instead of the FDA continuing to reference Section 176.170, Table 2.
Migration Testing Requirements of FDA’s Chemistry Guidance
In December 2007, FDA issued an updated guidance document on chemistry issues related to preparing FCN submissions, Guidance for Industry, Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations.[2] The purpose of the guidance document is to explain the migration testing needed to clear a food contact substance for a particular intended use. The update addressed the new Conditions of Use I and J. With respect to the use of packaging materials with food that is subject to cooking, the previous Chemistry Guidance, published in 2002, had merely recommended that migration testing be conducted “under the most severe conditions of temperature and time anticipated for the proposed use.” The 2007 edition of the Chemistry Guidance specifically recommends conducting migration testing at the maximum intended cooking temperature for the longest intended cooking time, using a food oil or a fatty food simulant, that is, the update spelled out more clearly what is meant by the “most severe conditions.”
A table describing all of FDA’s Conditions of Use categories is included in Appendix V of the 2007 Chemistry Guidance. Notably, whereas Condition of Use A is defined in Section 176.170(c) of the food additive regulations as “High temperature heat-sterilized (e.g., > 212 °F),” in Appendix V of the 2007 Chemistry Guidance, Condition of Use A is described as “High temperature, heat sterilized or retorted [~121 °C (250 °F)].” Condition of Use A is the category applicable to retorting food in a container. Thus, because retorting is normally done at 250 °F and above, it makes sense that FDA would reference the more precise temperature of 250 °F in the guidance document, rather than referencing temperatures “over 212 °F,” which is the boiling point of water (i.e., the temperature applicable to Condition of Use B).
The 2007 Chemistry Guidance also contains updated migration testing information for microwave-only containers. FDA confirmed that tests performed for broad coverage under the protocol for Condition of Use H (reheating ready-to-eat prepared foods) are adequate to cover microwave-only containers in addition to conventional oven reheating of ready-to-eat prepared foods. However, where such containers are intended to cook food in a microwave, the agency expects the testing to be conducted in accordance with the admonition noted above, which in this case is use of a food oil or fatty food simulant at 266 °F for 15 minutes and an aqueous food simulant at 212 °F for 15 minutes. The guidance also includes specific protocols on testing for dual ovenable and microwave heat susceptor packaging.
Condition of Use I – Irradiation of Packaged Food
FDA’s Good Manufacturing Practice (GMP) requirements for the irradiation of prepackaged food mandate that the packaging materials be cleared for such use under Section 179.45 of the regulations, be the subject of an exemption from the need for regulation under the Threshold of Regulation (TOR) or be the subject of an effective FCN.
Condition of Use I applies only to materials used during irradiation of prepackaged food and not to packaging materials that are irradiated as part of their manufacturing process to promote cross-linking or some other physical attribute. The latter use of irradiation may be considered acceptable without FDA preclearance or authorization, provided that no chemical compounds are created during irradiation that could affect the suitable purity of the materials for use with food.

nterestingly enough, although FDA created Condition of Use I, the Chemistry Guidance does not describe the kinds of migration tests that must be done. Rather, FDA states, “We do not have protocols for studies on FCSs that are intended to be irradiated with ionizing radiation. Please consult with FDA to discuss recommended protocols for this use.”
To date, there are no effective FCNs covering the use of irradiation, although there are several TOR exemptions. Of particular interest, the agency determined that no regulations are necessary for the irradiation of otherwise compliant food packaging materials, provided that the radiation processing is done in compliance with 21 C.F.R. Section 179; the packaging materials are subjected to radiation not exceeding 4.5 kGy; and the packaged food is irradiated either in a verifiably oxygen-free environment or while frozen and contained under vacuum. This exemption is applicable to food contact materials listed in 21 C.F.R. Sections 174 through 186, as well as those listed in FDA’s Inventory of Effective FCS Notifications and Inventory of TOR Exemptions.[3,4]
Temperature Restrictions on Cleared FCSs
The adoption of Condition of Use J raised some concerns about temperature restrictions on FCSs previously cleared by FDA, especially those used in microwaveable food packaging. With respect to FCSs cleared through a food additive regulation, FDA has not promulgated an overarching regulation establishing a temperature limitation on any specific food additive regulation. Thus, unless a specific food additive regulation sets out a temperature limit with respect to the substance that is the subject of the regulation, that substance may be used in cooking applications, provided that such use conforms to GMP requirements in 21 C.F.R. Section 174.5 (i.e., used in a manner that does not affect the suitable purity of the finished product for its intended use). Establishing the suitable purity of the finished product with respect to certain FCSs may require additional testing to establish that no significant migration to food results from the actual intended use.
In FCN submissions, even prior to the 2007 revision of the Chemistry Guidance, FDA typically required migration testing at temperatures higher than 250 °F for FCSs intended for use in applications where they would be subjected to higher temperatures. The purpose of this requirement was to establish that there was not a significant change in the nature or amount of potential migrants, as opposed to the migrants obtained by extraction at 250 °F, the phase of migration testing recommended for establishing a clearance for Condition of Use A.
For substances cleared through the FCN process prior to the adoption of Condition of Use J, the submitters of the notifications should be able, at a minimum, to interpret the notifications as covering the temperatures of use supported by the highest temperature of the migration testing. Companies that have effective notifications may want to consider having FDA add a reference to Condition of Use J if the previously submitted migration data or new data support the higher temperature use. If there are no additional data, then there may be some risk that the clearance will be considered not to include Condition of Use J.
Discussions and presentations made by FDA staff provide further direction. For aqueous foods, no further testing should be required if the substance is cleared for use under Conditions of Use A, B or H. For single-service packaging for fatty foods intended to be cooked in a conventional oven at temperatures exceeding 250 °F, the packaging material should be exposed at the maximum temperature and time at which it is expected to be used, or it should be tested at 350 °F for 2 hours using a fatty food simulant, such as corn oil or Miglyol 812. Testing at 350 °F for 2 hours covers use of the FCS at higher temperatures (i.e., not limited to use at 350 °F).
FDA’s recommended test procedure for repeated-use food contact articles generally is to extract the samples at the highest-use temperature for 240 hours (10 days) and divide the amount extracted by the amount of food that will contact the article over its useful life to determine exposure to the FCS.
Identifying the correct Conditions of Use for testing purposes is critical to obtaining the desired clearance from FDA and establishing compliance with extractive testing requirements in the regulations. Unfortunately, FDA has not made this easy to understand with the overlapping and sometimes inconsistent use of similar terminology. 




Internet Journal of Food Safety (Operated by FoodHACCP)
[2015] Current Issues

Vol 17.64-74
Sanitation and Hygiene Meat Handling Practices in Small and Medium Enterprise butcheries in Kenya - Case Study of Nairobi and Isiolo Counties
Sharon Chepkemoi, Peter Obimbo Lamuka, George Ooko Abong’ and Joseph Matofari

Vol 17.25-31
Combined Effect Of Disinfectant And Phage On The Survivality Of S. Typhimurium And Its Biofilm Phenotype
Mudit Chandra, Sunita Thakur, Satish S Chougule, Deepti Narang, Gurpreet Kaur and N S Sharma

Vol 17.21-24
Quality analysis of milk and milk products collected from Jalandhar, Punjab, India
Shalini Singh, Vinay Chandel, Pranav Soni

Vol 17.10-20
Functional and Nutraceutical Bread prepared by using Aqueous Garlic Extract
H.A.R. Suleria, N. Khalid, S. Sultan, A. Raza, A. Muhammad and M. Abbas

Vol 17.6-9
Microbiological Assessment of Street Foods of Gangtok And Nainital, Popular Hill Resorts of India
Niki Kharel, Uma Palni and Jyoti Prakash Tamang

Vol 17.1-5
Assessment of the Microbial Quality of Locally Produced Meat (Beef and Pork) in Bolgatanga Municipal of Ghana
Innocent Allan Anachinaba, Frederick Adzitey and Gabriel Ayum Teye

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