FoodHACCP Newsletter

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05/26. Food Safety Specialist – Beltsville, MD
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05/22. Director Enterprise Food Safety – Green Bay, WI


05/29 2017 ISSUE:758


E coli outbreak in Germany sickens 30, half confirmed, 1 dead
Source :
By NEWS DESK (May 31, 2017)
An E. coli O157 outbreak, dating back to December and believed to be linked to minced — or ground — meat has taken a life in Germany.
The outbreak has sickened about 30 people since it began. The cause is Shiga toxin-producing E. coli O157 with the onset date for the most recent confirmed case being April 13.
Molecular typing shows close relationship among the isolates from 14 cases that have been confirmed for E. coli O157. A 15th case is suspected. That probable case had a positive stool sample, but the culturing was not successful. The confirmed cases involve residents of Berlin and Northwest Germany. The cases are split between males and females and ages range from 1 to 36.
Among the confirmed cases, 13 developed hemolytic uremic syndrome or HUS, including one German who died. All individuals who had no pre-existing conditions required intensive care in hospitals.
This current O157 strain in German has not been detected in any other European countries. The University of Munster and the Robert Koch Institute are both involved in the outbreak investigation. The ill people who’ve responded say minced meat, including both beef and pork mixed, Vienna style hot dog sausages and commercially available yogerts and puddings were among their common foods lists.
Minced meats came up more frequently among the sick people than it did in questionnaires filled out by people in the control group, who did not get sick.
“Based on the investigations to date, we suspect packaged meat — beef and pork mixed — sold at one or several supermarket chains, as the most like source,” investigators said. They cannot yet rule out Vienna sausages, but consider them to be less plausible. Sausages would explain fewer cases and also the product is typically heated before its eaten.
The outbreak is the largest of this strain since 2002 and because it has lasted four months it is still considered active and additional cases may occur. In several previous sorbitol-fermenting STEC O157 outbreaks, Germany was not able to find the source “despite efforts of health and food safety authorities.”

Trump’s budget — Does FDA get a 9% increase or 31% cut?
Source :
By STEVEN GROSSMAN (May 28, 2017)
Editor’s note: This was originally published May 26, 2017, on the website of the Alliance for a Stronger FDA. The alliance is committed to an ongoing, multi-year effort with two specific goals — to assure that the U.S. Food and Drug Administration has sufficient resources to protect patients and consumers, and to maintain public confidence and trust in the FDA.
The good news is that the new Administration proposed a significant increase in aggregate funding for the FDA. In a budget in which almost all agencies faced large cuts, the strength of FDA’s mission and responsibilities led the new Administration to request a 9 percent — $452 million — increase. We think that’s exactly right and we love the message “FDA needs more resources!”  We applaud the Administration’s intent.
However, there is definitely bad news that might well overwhelm the good. The OMB proposal would cut $871 million from the agency’s budget authority (BA) appropriations, which is a 31 percent cut. This includes a $108 million cut in food funding, or 8 percent, a $705 million cut in medical product funding, or 52%, and a cut of about $50 million in activities that as far as we can tell are not characterized as food or medical product programs.
To lessen the blow on the food side, the Administration proposed a $54 million increase in animal drug and animal generic drug user fees. It is extremely unlikely that Congress will authorize these additional funds. To lessen the blow on the medical product side, the Administration is proposing a $1.2 billion dollar expansion of PDUFA, GDUFA, MDUFA, and BsUFA. That would roughly double the size of those programs. Congress has already made clear that they will not re-open the current re-authorization process to consider the proposed additional fees.
Apart from these practical reasons why expanded user fees won’t happen, there is also our concern that user fee funds should not be a substitute for budget authority funds. They serve different purposes. BA appropriations pay for fulfilling FDA’s mission and responsibilities. This includes safe and effective medical products and safe foods, and also a myriad of other Congressionally-mandated public health and consumer protection programs. The primary beneficiary is the public.
In contrast, user fees supplement the agency’s BA appropriation and pay for improvements; they were never intended to replace the agency’s BA appropriation. They result from carefully balanced negotiations in which FDA commits to undertake certain programs and meet certain metrics in exchange for the user fees that medical product industries have agreed to pay.
In sum, the pieces of the Administration proposal do not really fit together. As Ladd Wiley, our Executive Director, has been widely quoted as saying:
“The real practical problem here is that [the Administration proposal] is taking appropriations away and replacing it with something that’s not going to happen, and what we’re left with, is the taking away and a significant hole in the agency’s budget.”
What happens next? The House held its FDA appropriations hearing this week and we assume the Senate will do the same within the next month. In each subcommittee, staff will be discussing tentative funding levels for major agencies and programs.
However, the process can’t be completed until the Budget Committees determine the size of the federal budget in FY 18 and the full appropriations committees allocate that total amount among their 12 subcommittees. Subcommittee and committee mark-ups follow. This all will take some time, but can move remarkably quickly if a consensus forms. On the other hand, if it grows too contentious, there is the possibility that the process will grind to a halt.
So, the Alliance will be proceeding with urgency, working with Congress to find ways to support the agency in the new fiscal year. Expect additional action alerts and Hill meetings as we ask you to help spread the word.

Food safety for outdoor cookouts
Source :
Do you know the difference between grilling and smoking foods? Grilling is cooking food over direct heat. Its intensity is similar to broiling, so tender meats and poultry are best for grilling. A grill is a utensil made of parallel bars on which food is cooked over charcoal, wood or special rocks heated by gas or electricity.
Smoking is cooking food indirectly in the presence of a fire. It can be done in a covered grill if a pan of water is placed beneath the meat on the grill; or meats can be smoked in a “smoker,” which is an outdoor cooker especially designed for smoking foods. Smoking is done much more slowly than grilling, so less-tender meats benefit from this method, and a natural smoke flavoring permeates the meat. The temperature in the smoker should be maintained at 250 to 300 ºF for safety.
Safe Handling: Some recipes state to marinate meat and poultry for several hours or days, either to tenderize or add flavor. Acid in the marinade breaks down connective tissue in meats. This is especially beneficial in lean meats, such as “Select” grade, which do not have a lot of fat marbling to enhance tenderness. Always marinate food in the refrigerator, not on the counter. If some of the marinade is to be used for basting during cooking or as a sauce on the cooked food, reserve a portion of the marinade. Do not reuse the marinade from raw meat or poultry on cooked food unless it is boiled first to destroy any bacteria.
If you choose to pre-cook meat or poultry, do so immediately before grilling. Once food is on the grill, cook until it reaches a safe temperature as determined with a meat thermometer.
When carrying food to a picnic site, keep it cold to minimize bacterial growth. If take-out foods such as fried chicken or barbecued beef will be reheated on the grill, and the food will not be eaten within two hours of pickup, buy them ahead of time and chill thoroughly.
Place raw meat packages in plastic bags and pack separately from canned drinks and ready-to-eat foods that might otherwise become contaminated. Use an insulated cooler with sufficient ice or ice packs to keep the food at 40 degrees. Pack food right from the refrigerator into the cooler immediately before leaving home.
• In the car, keep the cooler in the air-conditioned passenger compartment; at the picnic, in the shade or shelter.
• Avoid opening the cooler’s lid, which lets cold air out and warm air in. Pack beverages in one cooler and perishables in another cooler.
• When handling raw meat, remove from the cooler only the amount that will fit on the grill.
Handling: Pack clean, soapy sponges, cloths and wet towelettes for cleaning surfaces and hands. Be sure there are plenty of clean utensils and platters for separately handling the raw foods and the cooked foods. Never use the same platter and utensils for raw and cooked meat and poultry. Any bacteria present in raw meat or juices can contaminate the safely cooked meat.
Cooking Equipment: For grilling and smoking, buy good-quality charcoal, briquettes or aromatic wood chips. Set the grill or smoker in a well-lit, well-ventilated area away from trees, shrubbery and buildings. Only use approved fire starter, never gasoline or paint thinner, for example.
Building a Fire: Keep children and pets away from the fire. Have a squirt bottle of water nearby to control flare-ups. Do not wear baggy clothes. Use flame-resistant mitts, hot pads and cooking utensils with long handles.
Let charcoal get red-hot with gray ash, about 10 to 20 minutes depending upon the quantity. Spread out the charcoal under the grilling surface or bank it around the drip pan for smoking. Replenish charcoal if necessary for grilling. Add about 15 briquettes every hour to maintain temperatures between 250 and 300 °F in a smoker. For hickory-smoked flavor, add a half-cup water-soaked wood chips or flakes during the last 30 minutes of smoking.
Use long-handled tongs when placing or turning meat on the grill to avoid the loss of juices that keep meat moist and tender. Piercing meat with a fork or knife can also affect food safety. Bacteria are normally found only on the external surface, so roasts and steaks cooked to an internal temperature of 145 °F will be safe because the outside will reach a temperature high enough to kill the surface bacteria. However, if a steak is poked or stabbed, these bacteria can be pushed inside, and then the meat must be cooked to 155 °F, the same as hamburger.
Cooking Times: Cooking time depends on many factors: type of meat; its size and shape; distance of food from the heat; the temperature of the coals; and the weather. Use a thermometer to be sure foods reach proper temperatures to destroy any bacteria present. Cook beef, lamb and veal steaks, roasts and chops to 145 °F for medium rare or 160 °F for medium. Cook ground meats and all cuts of pork to 155 °F. Cook poultry to 165 °F or hotter. These temperatures ensure that foodborne bacteria have been destroyed.
When using a sauce, apply during the last 15 to 30 minutes of grilling to prevent excess browning or burning.




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Food Safety During Picnic Season
Source :
By (May 25, 2017)
Memorial Day is fast approaching – and with it, patriotic picnics and cookouts.  As you plan your next outing, the U.S. Food and Drug Administration reminds you that foodborne bacteria multiply faster in warm weather and this can lead to food poisoning (also known as foodborne illness).
Follow these tips to help ensure that your picnic basket is packed with food safety in mind!
Basic Warm-Weather Precautions To Prevent Food Poisoning
Prior to picnic time
Defrost meat, poultry, and seafood in the refrigerator or by submerging sealed packages in cold water. You can also microwave-defrost, but only if the food will be grilled immediately afterward. If marinating, use the fridge not the countertop.  Never reuse marinade that contacted raw foods unless you boil it first or set some of the marinade aside before marinating food to use for sauce later.
Thoroughly wash all produce before eating even if you plan to peel it.  Fruits and vegetables that are pre-cut or peeled should be refrigerated or kept on ice to maintain quality and safety.
If your picnic site doesn't offer clean water access, bring water or pack moist towels for cleaning surfaces and hands. Don't forget to pack a food thermometer!
When packing coolers
Place food from the refrigerator directly into an insulated cooler immediately before leaving home and use lots of ice or ice packs to keep it at 40 °F or below.
Pack raw meat, poultry, and seafood in a separate cooler if possible, or wrap it securely and store at the bottom of the cooler where the juices can't drip onto other foods. Place beverages in a separate cooler; this will offer easy drink access while keeping perishable food coolers closed.
Load coolers into the passenger compartment of the car– it's cooler than the trunk. Once at the picnic site, keep food in coolers until serving time (out of direct sun) and avoid opening the lids often.
When grilling
Have clean utensils and platters available. Cook meat, poultry, and seafood to the right temperatures– use a food thermometer to be sure (see Safe Minimum Cooking Temperatures Chart). Keep cooked meats hot at 140 °F or warmer until serving time and set them to the side of the grill rack to keep them hot.
When removing foods from the grill, place them on a clean platter – never use the same platter and utensils you used for raw meat, poultry, or seafood.
Watch the time and outside temperature
Don't let hot or cold food sit out in the "Danger Zone" (between 40 °F and 140 °F) for more than 2 hours – or 1 hour if the outdoor temperature is above 90 °F. If they do, discard them.

Maybe, don’t know: Do hand sanitizers cut down on illness?
Source :
By Doug Powell (May 25, 2017)
My first reaction to any food safety claim, policy or recommendation is, are fewer people going to barf?
I usually don’t get an answer.
Because it’s really hard to associate policy with rates of barfing.
A couple of weeks ago, Karen Weintraub of The New York Times wrote: With the recent increase in use of sanitizers (hand lotions, wipes for supermarket carts, etc.) has there been any real impact on transmission of colds, flu or other diseases?
The short answer is no one knows, because no one has studied whether hand sanitizers have cut down on the number of infectious diseases among the public at large.
On a personal level, good hand hygiene clearly can make a difference in health. A 2008 study in The American Journal of Public Health concluded that improvements in hand hygiene, regardless of how the participants cleaned their hands, cut gastrointestinal diseases by 31 percent, and respiratory infections by 21 percent.
The key to stopping disease is breaking the chain that allows pathogens to be transmitted from person to person. Either hand washing or sanitizing can do that.
Sally Bloomfield, an expert in hand hygiene and an honorary professor at the London School of Hygiene and Tropical Medicine, said she always carries hand sanitizer with her when she travels. “London airport bathrooms are usually fine because they are well designed to make sure we wash our hands properly — and dry them properly,” she said, but some train “loos” leave something to be desired.
Grocery carts can be particularly risky points of transmission. Someone grabbing chicken or meat can leak the juices onto a cart and their hands, and then continue to push the cart around, transmitting pathogens like Salmonella and E. coli onto the handle. The next person who handles the cart, or the next child who sits in the top of the wagon, can then pick up the bugs.
“If you can wipe down the handle bars on the shopping cart with an alcohol-containing preparation, that’s probably a good idea,” said Dr. Cody Meissner, chief of the division of pediatric infectious disease at Floating Hospital for Children at Tufts Medical Center in Boston.
That said, Dr. Meissner and others cautioned against germaphobia. Every surface around us is coated in bacteria and other microbes, the vast majority of which are neutral or beneficial, said Liz Scott, chairwoman of the department of public health at Simmons College in Boston.
“We really need to target our hygiene practices,” she said, focusing on likely chains of transmission. That means washing your hands when you get back from the grocery store, public transit or any other public place, said Dr. Scott, who also admits to avoiding handshakes whenever possible, especially during flu season.
Fist bump.
(The pic, above left, is from a TV commercial Dettol shot at Sorenne’s school – she’s one of the blurred out kids, second row, far right).

Salmonella Outbreak at Boston Back Bay Sandwich and Cafe Med
Source :
By Linda Larsen (May 25, 2017)
Two Boston restaurants have had their permits to operate temporarily suspended after an apparent Salmonella outbreak. Ana Karina Vivas, Media Relations Manager at the Boston Public Health Commission, told Food Poisoning Bulletin that there are eight confirmed cases of Salmonella and no known hospitalizations. Four of the patients ate at Cafe Med, two at Back Bay Sandwich, and two people ate at both facilities. She said that they are working on testing employees to identify the source of the outbreak.
Boston public health officials found violations in the way those facilities prepare, handle, and hold food. Back Bay Sandwich at 31 Saint James Avenue had its permit pulled on May 17 and May 18, 2017 for “multiple risk factors.” And Cafe Med, also at 31 Saint James Avenue was temporarily closed on May 18, 2017.
The Boston Inspectional Services Department issued this statement: “ISD and the Boston Public Health Commission are working with Cafe Med and Backbay [sic] Sandwich to ensure compliance of all applicable codes. This is an ongoing investigation into the cause of the illness and the health permits for both establishments will be suspended until further notice.”
Attorney Ryan Osterholm, who has representing many people sickened with Salmonella infections, said, “Restaurants are heavily regulated to prevent outbreaks such as this one. Owners should understand every facet of the law. And employees must understand and practice basic food safety principles.”
At Back Bay Sandwich, some of the violations included employees wrapping products in waxed paper and plastic before the food is cooled to 41°F or below. Whole turkey breast was at 50°F, sliced roast beef at 56°F, mayonnaise at 55°F, and sliced turkey at 52°F. The danger zone for the risk of bacterial growth is between 40°F and 140°F. Cold holding was also an issue. The salad unit was at 57°F, and cheeses were held at 55°F.
In addition, employees were multitasking while wearing disposable gloves. They were touching ready to eat food and non food contacts without removing their gloves and properly washing their hands. There was evidence of rodent activity and droppings in the basement storage. The report also states that “employees are not adequately trained in food safety and sanitation.”
At Cafe Med, foods were held at unsafe temperatures. The cheese turnovers were at 117°F, chicken at 88°F, and spanakopitas at 87°F. Foods that should be held at temperatures below 40°F were too warm. Feta cheese was at 74°F for about 3 hours, raw chicken was at 48°F, and ground beef was at 62°F for an “unknown time.”  Raw waste was backing up into prep sinks and refrigerators were dirty.
Also, raw eggs and raw chicken were stored above and with ready to eat items. Packaged spinach and raw chicken were stored in “green liquid.” Raw ground beef stored on the sandwich unit next to ready to eat products. The inspector also found that multiple food items were missing proper covers and wrapping. And food handlers were multitasking wearing glove and not properly washing their hands. Two hand wash sinks were blocked with equipment and paper towels were missing from hand wash areas.
Salmonella outbreaks in the past have been linked to improperly cooked food, food held at dangerous temperatures, and cross-contamination. The symptoms of a Salmonella infection include nausea, vomiting, abdominal pain, and diarrhea. Symptoms usually begin a few hours to a few days after exposure to the bacteria. If you ate at those restaurants and have been experiencing these symptoms, see your doctor.

What to know about Botulism
Source :
By BILL MARLER (May 24, 2017)
What is Botulism
Botulism is a rare, life-threatening paralytic illness caused by neurotoxins produced by an anaerobic, gram-positive, spore-forming bacterium, Clostridium botulinum.[1]  Unlike Clostridium perfringens, which requires the ingestion of large numbers of viable cells to cause symptoms, the symptoms of botulism are caused by the ingestion of highly toxic, soluble exotoxins produced by C. botulinum while growing in foods.[2]  These rod-shaped bacteria grow best under anaerobic (or, low oxygen), low-salt, and low-acid conditions.[3] Bacterial growth is inhibited by refrigeration below 4° C., heating above 121° C, and high water-activity or acidity.[4]  And although the toxin is destroyed by heating to 85° C. for at least five minutes, the spores formed by the bacteria are not inactivated unless the food is heated under high pressure to 121° C. for at least twenty minutes.[5] Clostridium botulinum bacteria and spores are widely distributed in nature, because they are indigenous to soils and waters.[6]They occur in both cultivated and forest soils, bottom sediment of streams, lakes, and coastal waters, in the intestinal tracts of fish and mammals, and in the gills and viscera of crabs and other shellfish.[7]
The incidence of foodborne botulism is extremely low.[8]  Nonetheless, the extreme danger posed by the bacteria has required that “intensive surveillance is maintained for botulism cases in the United States, and every case is treated as a public health emergency.”[9] This danger includes a mortality rate of up to 65% when victims are not treated immediately and properly.[10] Most of the botulism events[11] that are reported annually in the United States are associated with home-canned foods that have not been safely processed.[12]  Very occasionally, however, commercially- processed foods are implicated as the source of a botulism events, including sausages, beef stew, canned vegetables, and seafood products.[13]
Symptoms of Botulism
After their ingestion, botulinum neurotoxins are absorbed primarily in the duodenum and jejunum, and pass into the bloodstream and travel to synapses in the nervous system.[14] There, the neurotoxins cause flaccid paralysis by preventing the release of acetylcholine, a neurotransmitter, at neuromuscular junctions, thereby preventing motor-fiber stimulation.[15]The flaccid paralysis progresses symmetrically downward, usually starting with the eyes and face, then moving to the throat, chest, and extremities.[16] When the diaphragm and chest muscles become fully involved, respiration is inhibited and, unless the patient is ventilated, death from asphyxia results.[17]
Classic symptoms of botulism include nausea, vomiting, fatigue, dizziness, double vision, drooping eyelids, slurred speech, difficulty swallowing, dryness of skin, mouth, and throat, lack of fever, muscle weakness, and paralysis.[18]  Infants with botulism appear lethargic, feed poorly, are constipated, and have a weak cry and poor muscle tone.[19] Throughout all such symptoms, the victims are fully alert and the results of sensory examination are normal.[20]
In foodborne botulism cases, symptoms usually begin anywhere between 12 and 72 hours after the ingestion of toxin-containing food.[21]  Longer incubation periods—up to 10 days—are not unknown, however.  The duration of the illness is from 1 to 10 (or more) days, depending on host-resistance, the amount of toxin ingested, and other factors.[22]  Full recovery often takes from weeks to months.[23] And, as earlier indicated, mortality rate can be from 30% to 65%, with rates generally lower in European countries than in the United States.[24]
Detection and Treatment of Botulism
Although botulism can be diagnosed based on clinical symptoms, its differentiation from other diseases is often difficult—especially in the absence of other known persons affected by the condition.[25] Once suspected, the most direct and effective way to confirm the diagnosis of botulism in the laboratory is testing for the presence of the botulinum toxin in the serum, stool, or gastric secretions of the patient.[26]  The food consumed by the patient can also be tested for the presence of toxins.[27]  Currently, the most sensitive and widely used method for the detection of the toxins is the mouse neutralization test, which involves injecting serum into mice and looking for signs of botulism.[28]  This test typically takes 48 hours, while the direct culturing of specimens takes 5-7 days.[29] Some cases of botulism may go undiagnosed because symptoms are transient or mild, or are misdiagnosed as Guillain-Barre Syndrome.[30]
If diagnosed early, foodborne botulism can be treated with an antitoxin that blocks the action of toxin circulating in the blood.[31] This can prevent patients from worsening, but recovery still takes many weeks.[32] The mainstay of therapy is supportive treatment in intensive care, and mechanical ventilation in case of respiratory failure, which is common.[33]
Long-Term and Permanent Injury
Although a minority of botulism patients eventually recover their pre-infection health, the majority do not. For those who fully recover, the greatest improvement in muscle strength occurs in the first three months after the acute phase of illness.[34]  The outside limit for such improvement appears, however, to be one year.[35]  Consequently, physical limitations that still exist beyond the one-year mark are more probably than not permanent.  Recovery from acute botulism symptoms may also be followed by persistent psychological dysfunction that may require intervention.[36]
According to a recently-published study that tracked the long-term outcomes of 217 cases of botulism, a large majority of patients reported “significant health, functional, and psychosocial limitations that are likely the consequences of the illness.”[37]  These limitations included: fatigue, weakness, dizziness, dry mouth, and difficulty lifting things.  The victims also reported difficulty breathing caused by moderate exertions, such as walking or lifting heavy items.  They were also more likely to have limitations in vigorous activities, like running or playing sports, climbing up three flights of stairs, or carrying groceries. Summarizing its finding, the study concluded that:
Even several years after acute illness, patients who had botulism were more likely than control subjects to experience fatigue, generalized weakness, dizziness, dry mouth, difficulty lifting things, and difficulty breathing caused by moderate exertion….In addition, patients…reported worse overall psycho-social status than did control subjects, with patients being significantly less likely to report feeling happy, calm and peaceful, or full of pep.[38]
There is, as a result, no question that the damaging effects of botulism are life-long.
[1]           See J. Sobel, et al., Foodborne Botulism in the United States, 1990-2000, Emerging Infectious Diseases, Vol. 10, No. 9, at 1606 (Sept. 2004).
[2]           James M. Jay, MODERN FOOD MICROBIOLOGY, 466 (6th Ed. 2000)
[3]           Id. at 469-71; see also Sobel, supra note 2, at 1606.
[4]           Sobel, supra note 2, at 1606.
[5]           Id.
[6]           Jay, supra note 3, at 467-69.  See also, generally H. Houschild, Clostridium Botulinum, in FOODBORNE BACTERIAL PATHOGENS, at 112-89  (M. Doyle Ed. 1989)
[7]           Jay, supra note 3, at 467-69.
[8]           Sobel, supra note 2, at 1607-09; Jay, supra note 3, at 472-76.
[9]           Sobel, supra note 2, at 1606-07 (also noting that the CDC maintains a 24-hour clinical consultation and emergency antitoxin release service).
[10]          Jay, supra note 3, at 474.
[11]          With botulism, the broader term “event” is used to encompass both outbreaks—i.e., two or more cases of botulism caused by a common-source, as well as individual (or sporadic) cases.
[12]          Sobel, supra note 2, at 1610; Jay, supra note 3, at 474.
[13]          Id.
[14]          Thomas P. Bleck, Clostridium botulinum (Botulism), in MANDELL, DOUGLAS AND BENNETT’S PRINCIPLES AND PRACTICE OF INFECTIOUS DISEASE 2543, 2544 (5th ed. 2000).
[15]          Id.; Sobel, supra note 2, at 1606.
[16]          Bleck, supra note 15, at 2545; see also BOTULISM FACT SHEET, National Agricultural Bio-Security Center, Kansas State University, online at
[17]          Bleck, supra note 15, at 2545; Sobel, supra note 2, at 1606.
[18]          Sobel, supra note 2, at 1606; Jay, supra note 3, at 474.
[19]          Jay, supra note 3, at 476-77.
[20]          Sobel, supra note 2, at 1606.
[21]          Jay, supra note 3, at 474.
[22]          Id.
[23]          R. Shapiro, et al., Botulism in the United States: A Clinical and Epidemiologic Review, Ann. Intern. Med. 1998; 129:221-28.
[24]          Jay, supra note 3, at 474.
[25]          Bleck, supra note 15, at 2546 (noting that “botulism has a limited differential diagnosis”).
[26]          Sobel, supra note 2, at 1607; see also FDA/CFSAN Bad Bug Book, Clostridium Botulinum, available at
[27]          Id.
[28]          Bleck, supra note 15, at 2546.  See also, e.g. MMWWR, supra note 1, at 2 (“CDC detected botulinum toxin Type A by mouse bioassay in the man’s serum sample”).
[29]          Bad Bug Book, supra note at 25.
[30]          Sobel, supra note 2, at 1606; Shapiro, supra note 23, at 223.
[31]          Jay, supra note 3, at 474; Sobel, supra note 2, at 1606.
[32]          Id.; Bleck, supra note 15, at 2546-67.
 [33]          Sobel, supra note 2, at 1606.
[34]          Bleck, supra note 15, at 2547. See also P. Wilcox, et al., Recovery of Ventilatory and Upper Airway Muscles and Exercise Performance After Type-A Botulism, Chest, 98:620-26 (1990); J. Mann, et al., Patient Recovery From Type-A Botulism: Morbidity Assessment Following a Large Outbreak, Am. J. Public Health, 71 (3):266-69 (Mar. 1981).
[35]          Id.
[36]          Bleck, supra note 15, at 2547. See also F. Cohen, et al., Physical and Psychosocial Health Status 3 Years After Catastrophic Illness—Botulism, Issues Mental Health Nurs., 9:387098 (1988)
[37]          S. Gottlieb, et al., Long-Term Outcomes of 217 Botulism Cases in the Republic of Georgia, Clin. Infectious Disease, 45: 174-80, at 180 (220&).
[38]          Id. at 179.

Botulism toxin confirmed in Gehl’s cheese sauce; no recall
Source :
By CORAL BEACH (May 23, 2017)
Health officials have confirmed that cheese sauce sold at a gas station in California was contaminated with the same type of botulism toxin as victims of a deadly outbreak, but there are no plans for a recall.
Although the California Department of Public Health did not name the brand of the cheese sauce, an inspector from the Sacramento County Health Department reported impounding “four bags of Gehls (sic) cheese sauce” from the Valley Oak Food & Fuel gas station in Walnut Grove, CA, on May 8.
Ten people have been confirmed in the outbreak of botulism poisoning, including Martin Galindo-Larios Jr., 37, of Antioch, CA, who died Thursday, according to the San Francisco Medical Examiner’s office. All nine of the other victims remain hospitalized.
“We are representing six of the victims, including a 16-year old and a 17-year old, and all of them are still hospitalized and on ventilators,” said Seattle food safety attorney Bill Marler.
Botulism poisoning causes paralysis that often includes muscles necessary for breathing, requiring patients to be placed on ventilators.
Marler said there is concern that the bacterium Clostridium botulinum, which produces the toxin that causes botulism poisoning, was present in the cheese sauce when the gas station received it. If that is the case, other foodservice operators could have received contaminated cheese.
Officials with Gehl Foods LLC of Germantown, WI, did not immediately respond to requests for comment from Food Safety News. In a statement provided to the Sacramento Bee newspaper, Gehl officials said the Food and Drug Administration had notified them of the situation.
“We immediately retested samples from the relevant lot of cheese, and it remains clear of any contamination,” the Gehl’s officials said, according to the Sacramento newspaper.
“To ensure the integrity of those test results, we also sent multiple samples to an independent lab, which confirmed our findings. Gehl’s facilities remain safe for food production and all of our food samples continue to test negative for any contaminants. There is no recall of Gehl’s nacho cheese product.”
The investigation
An FDA spokeswoman confirmed Monday that the agency is assisting public health officials at the state and local levels in California with the outbreak investigation, but she did not provide any details.
California’s Department of Public Health (CDPH) reported state officials don’t think there is an ongoing risk to the public.
“The nacho cheese sauce was removed from sale on May 5. CDPH believes there is no continuing risk to the public,” according to the department’s Monday afternoon statement on the outbreak.
“To protect patient privacy, CDPH is not sharing information about the patients affected in this botulism outbreak, their conditions or the four counties that have reported cases.”
California public health officials requested botulism antitoxin for all 10 outbreak victims through the CDC’s quarantine stations in California, according to a spokeswoman with the Centers for Disease Control and Prevention.
“We are not aware of any botulism cases linked to this outbreak outside of California,” the CDC spokeswoman said Monday afternoon.
Advice for the public
Anyone who ate cheese sauce from the Valley Oak Food & Fuel gas station in Walnut Grove, CA, in recent weeks and developed symptoms of botulism poisoning should immediately seek medical attention, according to the California health department.
State officials are also urging health care providers to be on the lookout for people with symptoms, which include:
Double or blurred vision;
Drooping eyelids;
Slurred speech;
Difficulty swallowing’
Dry mouth; and
Muscle weakness.
“Foodborne botulism is a rare but serious paralytic illness caused by a nerve toxin produced by the bacterium Clostridium botulinum,” according to the California health department.
“The toxin that causes botulism can be found in foods that are not properly processed or stored. It is odorless and colorless, so it is not possible to tell if a product is contaminated just by looking at it.”
‘Served more than a million times a day’
Promoted on the Gehl Foods LLC website as being “served more than a million times a day,” Gehl’s brand cheese sauce is available in a variety of packaging styles for foodservice and other customers.
The cheese sauce available in “pouches” are designed for use in dispensers and in trays on steam tables, according to the company’s website.
The bags for dispensers take four to six hours to reach the serving temperature of 140 degrees F, and can be used for up to five days as long as the dispenser heat is on continuously “for food safety.” The bags of cheese sauce for steam tables can be used for up to six hours, if held at a safe temperature. The shelf life of both package styles is 12 months from the date of manufacture.
“Aseptic processing allows us to protect product quality without preservatives,” according to the Gehl’s website. “Our secret is an advanced ‘aseptic’ process that locks in freshness without refrigeration.
“Gehl Foods’ Aseptic processing means food and beverages achieve sterility through a rapid process of heating and cooling, producing a commercially sterile product that won’t spoil. Packaging materials are pre-sterilized, then filled with sterile ingredients and sealed, all in an airtight sterile environment and allow a 12- to 18-month ambient shelf life without compromising taste.”

US groups sue FDA over alleged food safety failures
Source :
By Undercurrent News (May 23, 2017)
US consumer, health, and food safety groups have filed suit against the Food and Drug Administration (FDA), challenging a rule they argue undermines the integrity of the nation's food safety system, according to a release from the Center for Science and the Public Interest (CSPI).
Chemical and food manufacturers often seek to add chemicals to food, typically to enhance flavor, add nutrients, or prevent spoilage, the CSPI said, adding that chemicals often leach into foods from processing equipment and packaging.
While Congress has required FDA determine that chemical additives are safe before they can be used on food, the FDA rule allows manufacturers to decide for and by themselves—in secret—what can be added to foods. The groups assert this rule is unconstitutional and illegal.
"The public expects, and the law demands, that FDA ensure the safety of Americans’ food," CSPI said.
The groups suing the FDA for allegedly illegally delegating that authority to self-interested food and chemical manufacturers include the Center for Food Safety (CFS), Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund and Environmental Working Group, represented by legal counsel from CFS and the environmental law firm Earthjustice.
They also allege that while Congress mandates an open and public process, the FDA allows manufacturers to make these decisions about food ingredients without any disclosure to either the FDA or the public. The lawsuit was filed in the US District Court for the Southern District of New York.
Federal law requires the FDA to ensure that substances used in food are safe, taking into account consumers’ entire diet and all exposure to the chemical and similar chemicals, CSPI said.
But any substance designated as “generally recognized as safe” (GRAS) by FDA or by a food or chemical company can bypass the rigorous pre-market review and approval process applied to food additives. This exemption was initially created to cover ingredients that are widely known to be safe, such as vegetable oil, but has been applied in recent practice to novel chemicals and is now a loophole that has swallowed the law, the CSPI said.
Under pressure from industry, in 1997 and again in 2016, FDA adopted a practice that allows food and chemical manufacturers to decide for themselves, without notice to FDA or the public, that food chemicals are safe—even if the chemicals are new, not widely studied, and not widely accepted as safe, CSPI said.
CFS filed suit in 2014 to challenge FDA’s use of an interim rule that initially put this practice into place; and that successful challenge forced FDA to stop using the interim rule and instead finalize the GRAS rule, CSPI said. Today’s lawsuit challenges the final rule that formalizes this practice.
“FDA has a duty to ensure the products we buy and feed our families are safe,” said Cristina Stella, staff attorney for the Center for Food Safety and co-counsel in the case. “The secretive GRAS system makes it impossible for FDA to carry out its core responsibility to the public.”

USDA’s Food Safety and Inspection Service New Directive Indicates Expanded Testing of Brazilian Beef
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By (May 23, 2017)
As previously covered on this blog, Brazilian federal police raided several meat producers earlier this year for allegedly doling out bribes to inspectors to certify meat that was either rotten or tainted with Salmonella. Following the bribery scandal, USDA’s Food Safety and Inspection Service (FSIS) instituted 100% point-of-entry reinspection of all Brazilian meat products imported into the United States.
On May 12, 2017, FSIS issued Directive 26-17 which appears to formally expand the scope of pathogen testing for Brazilian beef.  In particular, Directive 26-17 provides that the increased “Level of Reinspection” at the U.S. border includes conducting product examination on 100% of the lots, condition of container examination of 100% of thermally processed products, and 100% testing of ready-to-eat products for Salmonella and Listeria monocytogenes.  The ramped up inspection also includes testing 100% of beef trimmings from Brazil for Salmonella, Escherichia coli (E. coli) O157:H7 and non-O157 Shiga toxin-producing E. coli (STEC).
In light of lingering concerns stemming from the recent bribery scandal, FSIS’ ramped up inspection will likely continue until the Agency is satisfied that Brazil’s raw and processed beef inspection systems are adequately addressing foodborne pathogens.

Food-Safety Shopping Tips
Source :
By Sally Wadyka (May 23, 2017)
Many of us just want to get into and out of the supermarket quickly. But in our rush, "some of us handle the food we buy in a way that poses safety risks, like spoilage and cross-contamination, that can result in illness," says James E. Rogers, Ph.D., director of food safety and research at Consumer Reports. To avoid spreading harmful germs, "you need to practice the fundamentals of food handling, just as when you're cooking at home," says Shelley Feist, executive director of the Partnership for Food Safety Education. To stay truly safe, you may need to risk looking slightly germophobic in public, but it's well worth it.
Food Shopping Safety Tips
Clean your shopping cart. Wipe down the child seat, as well as the cart handle, with a disinfecting wipe. A study from the journal Food Protection Trends found E. coli on 50 percent of shopping cart handles. If your store doesn't provide hand sanitizer and wipes, take your own.
Use hand sanitizer. It's a must after handling raw and packaged poultry at the meat counter if soap and water aren't available.
Take care of your reusable bags. They may be great for the environment, but if you don't keep them clean, they could be hazardous to your health. Store bags in the cleanest area of the car and launder or wipe them down with hot, soapy water at least once per month. "Meat, poultry, and even produce can leave behind bacteria that can linger in the bag and contaminate other food," says Marianne Gravely, M.S., a food safety specialist with the Department of Agriculture's Office of Public Affairs and Consumer Education.
Check your eggs. Open the carton and make sure none are cracked. "If one cracks on the way home, just make sure to cook it within 24 hours," Gravely says.
Bag meat of any kind separately. Juices from meat and poultry can drip onto other food, spreading bacteria, Feist says. "At home, keep it in that same bag in the refrigerator until ready to use."
Organize your cart. A Journal of Food Protection study observed shoppers putting poultry in their cart's main basket, with other foods around it, 84 percent of the time. "Keep meat and produce separated," Gravely says. "And keep cold and frozen foods together in your cart and grocery bag, so they help keep each other cooler longer."
Shop the perimeter last. The store is arranged for you to pick up produce, meat, and dairy before shopping the main aisles, but it's safer to put products requiring refrigeration into your cart last. "That way they'll spend the least time possible out of the cold," Gravely says.
Get food home quickly. Make grocery shopping your last errand before heading home. Perishable food should not be out of refrigeration for more than 2 hours, or 1 hour in hot weather. Buy some extra time by keeping a cooler in your car for stowing perishables.
Editor's Note: This article also appeared in the July 2017 issue of Consumer Reports magazine.

Lawsuit: FDA GRAS Rule Undermines Food Safety
Source :
By Josh Long (May 22, 2017)
An FDA rule is unconstitutional and weakens the integrity of America’s food safety system,  according to several groups in a lawsuit filed Monday in New York.
Adopted in August 2016, the final rule clarifies criteria in FDA regulations for when the use of a substance in food is not subject to premarket approval because it is generally recognized as safe (GRAS). In 1997 and again last year, FDA adopted a practice that allows chemical and food manufacturers to determine for themselves without notifying FDA that food chemicals are safe, according to a news release announcing the groups’ lawsuit.
The complaint for declaratory and injunctive relief was filed by the Center for Food Safety, Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund and Environmental Working Group. The lawsuit names as defendants Health and Human Services Secretary Tom Price, M.D., FDA Commissioner Scott Gottlieb, M.D., and FDA.
“Most Americans would be shocked to learn that FDA allows novel chemicals onto the market without a safety review," said Tom Neltner, chemicals policy director at Environmental Defense Fund, in a statement. “Yet, FDA’s practice on GRAS additives flouts the law and leaves the agency unaware of what chemicals are being added to our food and with no way to ensure that these additives—and the food that contains them—are safe."
Marianna Naum, an FDA spokesperson, said the agency does not comment on pending litigation.
In announcing the final rule in a constituent update, FDA encouraged companies to notify the agency of its GRAS conclusions, and FDA said it could question the basis for an independent GRAS conclusion regardless of whether it was notified and take appropriate action. FDA explained “the notification procedure yields important information that aids the agency’s food safety monitoring efforts."
Under the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FDCA), any substance intentionally added to food is a food additive subject to premarket approval by FDA unless the use of the substance is GRAS or otherwise exempt from the food additive definition.
“General recognition of safety requires common knowledge, throughout the expert scientific community knowledgeable about the safety of substances directly or indirectly added to food, that there is a reasonable certainty that the substance is not harmful under the conditions of its intended use," FDA explained in its final GRAS rule.
FDA’s critics, however, lamented that GRAS determinations function as a major loophole swallowing the normal requirement for premarket approval of food additives and are riddled with conflicts of interest because manufacturers or their consultants make most GRAS determinations.
“The GRAS rule allows FDA to abdicate its core duty under the FDCA: to be responsible for the safety of the food supply," the lawsuit alleged.
While the GRAS exemption was created to cover ingredients that are widely known to be safe, such as vegetable oil, an estimated 3,000 chemicals are in use that have never been examined by FDA, the plaintiffs proclaimed in the news release.
“FDA has a duty to ensure the products we buy and feed our families are safe," said Cristina Stella, staff attorney for the Center for Food Safety and co-counsel in the lawsuit, in a statement. “The secretive GRAS system makes it impossible for FDA to carry out its core responsibility to the public."
The lawsuit was filed in the U.S. District Court for the Southern District of New York. The consumer, health and food safety groups requested a declaration that the final rule violates the FDCA, Administrative Procedure Act and the U.S. Constitution. The lawsuit also requested a declaration that the GRAS rule is unlawful because, among other reasons, it does not require FDA to independently review GRAS determinations.
Finally, the groups requested the court vacate the GRAS rule with directions to FDA to correct any legal deficiencies, award plaintiffs’ attorneys’ fees and reasonable expenses, and grant other injunctive and declaratory relief as the court deems appropriate.




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