Botulism Blog

Botulism Outbreak Now Underway In Uganda

bmarler@marlerclark.com (Botulism Attorney) — Tue, 18 Nov 2008 14:02:24 -0800

The U.S. Centers for Disease Control and Prevention in Atlanta have confirmed the conclusion of the in-country Minister of Health: Uganda has an outbreak of botulism to deal with.

According to The New Vision, which claims to be Uganda's top website, the health ministry has issued a public warning about the botulism outbreak. Here is what is being reported:

"THE health ministry has warned the public of a possible outbreak of botulism, a condition caused by consuming toxic canned foodstuffs.

In a statement released on Monday, the ministry cautioned students, parents and school administrators to “exercise care while preparing foodstuffs expected to be stored for long at room temperature.”

“Care should be taken in handling foods, including proper refrigeration of perishable foods,” a ministry statement signed by Dr. Sam Zaramba, the director general of health services, said.

“Avoid the purchase of canned foods that are expired, damaged, bulging or in perforated containers,” the statement adds.
The warning follows the death in October, of Sarah Akoo, a student of Seeta High School in Mukono.

Test results from Centres for Disease Control (CDC) in Atlanta USA, confirmed that the deceased and her two friends, who have since been admitted to Mulago Hospital, suffered from botulism.

The New Vision has established from Alice Akoo, the mother of the late Sarah Akoo, that her daughter died at Kololo Hospital and the body was taken to International Hospital Kampala for a postmortem examination. Sarah, she clarified, died a week before the school’s gazetted visiting day. "

More can be found here and here.

Augusta Canning Factory Closes Its Doors Forever

bmarler@marlerclark.com (Botulism Attorney) — Fri, 14 Nov 2008 13:34:12 -0800

The canning factory responsible for giving botulism poisoning to at least eight people closes forever today.

Castleberry's in Augusta, GA closes today, putting 327 people out of work.

Connor Brothers, which owns Castleberry's is selling the company to Hanover foods.

Hanover currently operates its own factory in New Jersey.

Executives with Conner Brothers say Castleberry's sales never recovered from the 2007 botulism outbreak that temporarily closed the plant.

Botulism Victim Settles With Castleberry After Difficult Recovery

bmarler@marlerclark.com (Botulism Attorney) — Wed, 12 Nov 2008 13:43:37 -0800

Myself, along with Charles Murray, Esq., represented Carl Ours, a man with the tragically bad luck to be one of the eight cases of botulism associated with contaminated Castleberry’s Austex Hot Dog Chili Sauce. As a result of the botulism, Carl spent almost a month in the hospital, with sixteen days of it on a ventilator. He then spent weeks in a nursing home and a year latter he is still suffering from the impacts. We were able to secure a settlement for Carl after mediation. For the full detail on the outbreak click here.

Botulism is a rare, life-threatening paralytic illness caused by neurotoxins produced by an anaerobic, gram-positive, spore-forming bacterium, Clostridium botulinum. The incidence of foodborne botulism is extremely low. 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.” This danger includes a mortality rate of up to 65% when victims are not treated immediately and properly. Most of the botulism events that are reported annually in the United States are associated with home-canned foods that have not been safely processed. Very occasionally, however, commercially- processed foods are implicated as the source of a botulism events, including sausages, beef stew, canned vegetables, and seafood products.

Mexican Black Tar Heroin Blamed For "Wound" Botulism Cases

bmarler@marlerclark.com (Botulism Attorney) — Sun, 02 Nov 2008 11:16:31 -0800

Two Mendocino County, CA cases of wound botulism are being blamed on Mexican black tar heroin use. Wound botulism is caused by the same bacteria that causes foodborne and infant botulism.

According to The Willits News:

The two residents infected with the rare but extremely virulent disease are breathing on mechanical ventilators and were transferred to Bay Area hospitals for treatment.

These two cases are believed related to contaminated black tar heroin recently brought to the county from a Bay Area source.

Last year there were no wound botulism cases reported in Mendocino County and only 10 reported in California, according to California Department of Public Health. They are usually caused by intravenous drug use.

More can be found here.

Gopher U Does Case Study On 2007 Castleberry's Botulism Outbreak

bmarler@marlerclark.com (Botulism Attorney) — Wed, 22 Oct 2008 11:30:29 -0800

The Food Industry Center at the University of Minnesota has published a case study of last year's botulism recall. The Castleberry's: 2007 Botulism Recall publication examines this nationwide recall in a case study that "illustrates the complexity of the food industry." The case study was funded by the National Center for Food Protection and Defense is available as a free Adobe Acrobat download here.

Recalling The Big Botulism Outbreak of 1978 in Clovis, New Mexico

bmarler@marlerclark.com (Botulism Attorney) — Mon, 20 Oct 2008 13:13:22 -0800

Clovis, New Mexico is usually known for Cannon Air Force Base and the Norman Petty Recording Studios. Cannon is home of the Air Force's Special Operations Command. Petty's studio recorded Buddy Holly's first chart-topping hits. Clovis, however, is known for something else. Something that happened 30 years ago---a botulism outbreak that killed two and made 30 others sick, some very seriously.

Don McAlavy, Clovis News Journal columnist, recalled what happened:

One of the most dreaded food-borne poisons known to man struck Curry County on Friday night, April 4, 1978. A group of people were at a banquet in the old Colonial Park Country Club that night. Some 30 members of that group became slightly ill to very ill. It was the dreaded botulism that killed two people in that group. One of them was John Garrett Jr., a noted farmer at Claud.

Dr. Jonathan Mann, state health officer, said the area is extremely fortunate that help for the victims were able to mobilize to assist victims in this tragic case. Cannon AFB Hospital had air-evacuation aircraft to fly patients to Albuquerque when first alerted.

All day Saturday and Sunday, volunteers from all walks of life called the hundreds of people that were known to have eaten at the club in the past week.

As patients were hospitalized in Clovis, Albuquerque, Lubbock, Amarillo, El Paso and Santa Fe, Dr. Mann arranged for anti-toxin to be flown in from all over the country.

For the rest of McAlavy's look-back, go here.

Oregon Infant Recovering From Infant Botulism

bmarler@marlerclark.com (Botulism Attorney) — Tue, 14 Oct 2008 18:33:19 -0800

Oregon sees just two such cases a year. The whole country records just 100. We are talking about infant botulism.

One victim is being treated now at Doernbecher Children's Hospital in Portland.

The month-old infant is beginning to recover. Its mother, Jennifer Perez says tiny Aracelis Mora went limp the day after they passed a construction site while on a walk.

Infant botulism causes muscles and respiratory systems to experience paralyzing symptoms.

The bacteria that causes botulism is often associated with food but can also pass through the air to babies who breathe in or swallow infectious spores sometimes found in dirt or dust.

Here Is An Update On the Ohio Family Fighting Botulism

bmarler@marlerclark.com (Botulism Attorney) — Wed, 08 Oct 2008 19:39:32 -0800

Bucyrus City Auditor Joyce Schifer gave this update on the Ohio family stricken by botulism poisoning from home-canning gone bad:

"Joann Palm's family is still very sick from botulism poisoning. Her 15-year-old son is still in Akron's Children's Hospital and she is staying at the Ronald McDonald House there," Schifer said. "Her parents are still in Mansfield General Hospital but are doing better. One of her twin daughters was also affected and while she is back in school, she still gets worn out easily and is in speech therapy from the problems caused by the botulism.

"Her son will soon be moved to Children's Hospital in Columbus, but it will be a long process for him to get well. Many city employees have donated their sick time to Joann and that is very much appreciated."

The Palm family was affected by the botulism after eating home-canned green beans.

Ohio Family Gets Botulism From Home Canned Beans

bmarler@marlerclark.com (Botulism Attorney) — Sat, 20 Sep 2008 12:55:17 -0800

We've been passing along information on how to safely can at home, and here comes a story on why you really do have to be careful. The Mansfield News Journal reported this week that:

A Crestline man and his grandson remain in the hospital after coming down with food-bourne botulism last weekend.

Nortbert Reinhard is listed in critical condition at MedCentral/Mansfield Hospital and grandson Lucas Palm is in serious condition at Akron Children’s Hospital after eating home-canned green beans. Lucas’ sisters Jessica and Samantha Palm also were treated for botulism and have been released from Akron Children’s.

Stephanie Zmuda, Environmental Health Director at the Galion City Health Department, said after 10 years in the field, this is the first time she’s dealt with such cases of contamination.

“Botulism is a type of food poisoning and is the most dangerous,” she said. “Six organisms is the infectious dose, so just a little bit of this germ can get you sick. You do not have to have a whole serving of the food to get sick.”

For more, go here.

Final Victim of Botulism Outbreak: All 327 Castleberry Workers

bmarler@marlerclark.com (Botulism Attorney) — Wed, 17 Sep 2008 06:47:52 -0800

The Connors Brothers Income Fund has dumped (oh, sold) its Castleberry brands to Hanover Foods Corp. It means the 82-year old Castleberry canning factory in Augusta, GA will be closed with the next 60 days.

The troubled canning factory was responsible for a botulism outbreak in late 2007. The 20-acre factory site is also on the block. The sale to Hanover will shift production of any Castleberry brands to the company's Aunt Kitty's Foods plant in scenic New Jersey.

Closure of the Castleberry's canning factory will put 327 people out of work, according to the Augusta Chronicle. And its not a good time to be hitting the bricks. The newspaper said:

As Donte Jones walked through the Augusta plant's gates after completing his shift Tuesday, the 21-year-old temporary worker said he was told of the closing just before 7 p.m.

"I'm just hoping they'll call me back tomorrow," said Mr. Jones, a loader for the company.

Having lived across the street from the plant since 1959, Mary Clayton said the closing would be catastrophic for the entire community.

"These are not good times for people to be out of work," the retired Fort Gordon employee said. "I really hate for this to happen."

Castleberry's Toronto-based owner spent the past seven months investigating a sale of its meat division, prompted by a loss of $38 million when the plant shut down for two months in 2007 when botulism toxin was found in its chili sauce.

For more, go here.

Avoid Botulism, Do Not Make Mistakes While Canning

bmarler@marlerclark.com (Botulism Attorney) — Thu, 11 Sep 2008 13:26:42 -0800

Mistakes commonly made when pressure canning include:

Taking “short cuts.” Recommended preparation and processing instructions should always be followed.
Using jars not specifically designed for home canning. Commercial glass jars with screw-on lids should not be used when canning.
Using outdated canning books or instructions. Updated (within the past 10 years) canning books and instructions should be used.
Using untested recipes. Canning recipes should always be sought from a reliable source such as your local extension office

For more, go here. Thanks to Extension Service, USDA.

Irradiating Won't Eliminate The Botulism, But Will Get the Vitamin A!

bmarler@marlerclark.com (Botulism Attorney) — Tue, 26 Aug 2008 15:49:18 -0800

Tim Darragh of The Morning Call ponders the federal government decision to allow irradiation of some fresh produce, but points out one problem with the policy. Go here for the complete column. Darragh writes:

Three years ago, the FDA sent a letter to lettuce growers, packers, processors and shippers noting its ''serious concern'' about 19 E. coli outbreaks involving lettuce and spinach since 1995, resulting in 409 illnesses and two deaths.

Irradiating lettuce and spinach, the FDA said, is important because consumers almost always eat lettuce and often eat spinach uncooked.

But even the FDA acknowledges that irradiating spinach and lettuce will reduce their vitamin content somewhat, particularly Vitamin A. However, since spinach is not a major source of vitamins in Americans' nutritional intake, FDA concluded that irradiation will not hurt their overall diet.

Irradiating food creates a ''disincentive'' for farms to adopt cleaner farming methods, added Bill Freese of the Center for Food Safety in Washington, D.C. ''The way to get safe food is to clean up the filthy conditions at our factory farms,'' he said.

In addition, irradiation doesn't eliminate all bugs, including the bacterium that causes botulism, he noted.

New Investors May Bring Hope To New Era

bmarler@marlerclark.com (Botulism Attorney) — Tue, 19 Aug 2008 08:52:12 -0800

The Muskegon Chronicle today has a story about Michigan's New Era Canning Company's attempt to get back in business after botulism-related recalls forced its shut-down.

Family-owned since it began in 1910, New Era wants to resume production. Rick Ray, New Era's president and chief executive officer, told the Chronicle the outlook for the company can be described this way:

The positive: The FDA recently provided a permit to the company, with a couple requirements, that allows for certain cans of produce in the warehouses to be sold and the canning process to begin.
The frustration: Company officials contend that the FDA was slow to respond during the shutdown, causing operations to be ceased longer than New Era Canning management figured it should.
The hope: Interest seems to be high for potential investors in the cannery. "The process is going well," Rick Ray said. "There are a lot of people interested."

The family is even willing to give up control of New Era to new investors if it helps in getting the canning factory back in business. Up to 260 seasonal and 50 full-time jobs would result.

In reading the story, found here, we find it interesting or perhaps telling that there is no mention of help for New Era from the State of Michigan. The state is mess and maybe this is an example of why. We wonder if Connors Brothers might look at New Era if they dump Castleberry's. That would be ironic.

Connors Looks At Whether Or Not To Keep Castleberry's

bmarler@marlerclark.com (Botulism Attorney) — Mon, 18 Aug 2008 14:57:10 -0800

The Connors Brothers Income Fund, based in Canada, was not ready to say last week if it would keep its Augusta, GA canning factory for Castleberry's brands.

Botulism poisoning in its chili cause forced the plant to shut down a year ago. Since its been back up and running, Connors said its was "stable and performing to expectations"

The recall cost the income fund more than $35 million with litigation remaining on behalf of some of the victims.

Wal-Mart is still shying away from the Castleberry's brand, which has prevented recovery of sales, according to chief executive Chris Lischewski.

“We still have not regained distribution at our largest customer, which is Wal-Mart,” Mr. Lischewski said.

More can be found here.

Washington State University Offers Helpful Advice To Home Canners

bmarler@marlerclark.com (Botulism Attorney) — Thu, 14 Aug 2008 14:13:35 -0800

Rebekah Denn writes a blog called Devouring sEATtle as part of her duties as a food writer at the Seattle Post Intelligencer. She is out today with Free canning class - no botulism allowed.

In addition to telling her readers about the canning class offered by the Washington State University Extension Service, Denn gives readers some advice about canning and avoiding botulism at the same time. She credits WSU's Jessica Dally for these words of wisdom:

1. Don't assume a recipe or canning process is safe because it was handed down from your grandparents. "Your grandmother or grandfather or whoever was canning might have gotten away with a lot of things, but that doesn't mean you're going to." (This makes me feel better about not having learned canning at my grandmother's knee. At least I learned applesauce.)
2. Don't use old recipe books or ancient canners; invest in newer ones. Canners have been redesigned, our understanding of food safety has improved; even the way we grow some produce has changed. Dally recommends this book and this one.
3, If your pressure canner uses a dial gauge, it needs to be checked annually for accuracy. And there are very, very few places anymore that check gauges. Use a canner with a weighted gauge to make your life easier.
4. After your goods are canned, store them without the rings around the jar lids. If the seal should break, you want to know about it; you don't want the ring holding the lid in place. Besides, that lets you re-use the rings instead of buying a new batch each time you can. For the same reasons, don't stack your canned goods; store them in a single layer.
5. Do not alter recipes. Even a tweak like adding extra garlic can change the food's acidity and the recommended processing time. "You are playing around with something you don't want to play around with."
6. A jar lifter can be your best friend in the canning kitchen.

Faulty home canning has long been a source of botulism. Commercial canning had a long track record of going botulism-free, but sadly as Castleberry's and New Era has shown, that is no longer the case.

One Woman's Opinion; Funny But Not True

bmarler@marlerclark.com (Botulism Attorney) — Mon, 04 Aug 2008 16:41:56 -0800

Joan Rivers, age 75, says everybody should have Botox, the wrinkle-free injection for maintaining a youthful appearance.

"Age has freed me to say whatever I want. Everyone should do Botox. Botulism is everywhere - in the air we breathe. I always say a little botulism never hurt anyone."

Ms. Rivers probably has not met the victims of Castleberry's Chili, but she is funny.

About Clostridium Botulinum - Botulism

bmarler@marlerclark.com (Bill Marler) — Wed, 30 Jul 2008 17:38:05 -0800

Botulism is a rare, life-threatening paralytic illness caused by neurotoxins produced by an anaerobic, gram-positive, spore-forming bacterium, Clostridium botulinum. 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.

Overview

These rod-shaped bacteria grow best under anaerobic (or, low oxygen), low-salt, and low-acid conditions. Bacterial growth is inhibited by refrigeration below 4° C., heating above 121° C, and high water-activity or acidity. 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.

The incidence of foodborne botulism is extremely low. 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.” This danger includes a mortality rate of up to 65% when victims are not treated immediately and properly. Most of the botulism events that are reported annually in the United States are associated with home-canned foods that have not been safely processed. Very occasionally, however, commercially- processed foods are implicated as the source of a botulism events, including sausages, beef stew, canned vegetables, and seafood products.

Symptoms

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. There, the neurotoxins cause flaccid paralysis by preventing the release of acetylcholine, a neurotransmitter, at neuromuscular junctions, thereby preventing motor-fiber stimulation. The flaccid paralysis progresses symmetrically downward, usually starting with the eyes and face, then moving to the throat, chest, and extremities. When the diaphragm and chest muscles become fully involved, respiration is inhibited and, unless the patient is ventilated, death from asphyxia results. 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. Infants with botulism appear lethargic, feed poorly, are constipated, and have a weak cry and poor muscle tone. Throughout all such symptoms, the victims are fully alert and the results of sensory examination are normal.

In foodborne botulism cases, symptoms usually begin anywhere between 12 and 72 hours after the ingestion of toxin-containing food. 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. Full recovery often takes from weeks to months. And, as earlier indicated, mortality rate can be from 30% to 65% , with rates generally lower in European countries than in the United States.

Detection and treatment

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. 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. The food consumed by the patient can also be tested for the presence of toxins. 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. This test typically takes 48 hours, while the direct culturing of specimens takes 5-7 days. Some cases of botulism may go undiagnosed because symptoms are transient or mild, or are misdiagnosed as Guillain-Barre Syndrome.

If diagnosed early, foodborne botulism can be treated with an antitoxin that blocks the action of toxin circulating in the blood. This can prevent patients from worsening, but recovery still takes many weeks. The mainstay of therapy is supportive treatment in intensive care, and mechanical ventilation in case of respiratory failure, which is common.

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. The outside limit for such improvement appears, however, to be one year. 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.

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.” 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.

There is, as a result, no question that the damaging effects of botulism are life-long.

Some background information on canning

The canning process dates back to the late 18th century in France when the Emperor Napoleon Bonaparte, concerned about keeping his armies fed, offered a cash prize to whoever could develop a reliable method of food preservation. Nicholas Appert conceived the idea of preserving food in bottles, like wine. After fifteen years of experimentation, he realized if food is sufficiently heated and sealed in an airtight container, it will not spoil. More than fifty years later, Louis Pasteur provided the explanation for effectiveness of canning when he was able to demonstrate that the growth of microorganisms is the cause of food spoilage.

An Englishman, Peter Durand, took the idea one step further and replaced the breakable glass bottles with cylindrical tinplate canisters (later shortened to “cans”). Durand did not can foods himself, but sold his patent to two other Englishmen, Bryan Donkin and John Hall, who set up a commercial canning factory. By 1813, Donkin and Hall were busily producing their first canned goods for the British army, thus continuing the connection of canning to the military.

The basic principles of canning have not changed dramatically since Nicholas Appert and Peter Durand developed the process. Heat sufficient to destroy microorganisms is applied to foods packed into sealed, or "airtight" containers. The canned foods are then heated under steam pressure at temperatures of 240-250°F (116-121°C). The amount of time needed for processing is different for each food, depending on the food's acidity, density and ability to transfer heat.

Processing conditions are chosen and designed to be the minimum needed to ensure that the foods are made “commercially sterile,” while still retaining the greatest flavor and nutrition. All canning-processes must first be approved by the U.S. Food and Drug Administration. Once the cans are sealed and heat processed, the resulting canned food must maintain its high eating quality for more than two years and be safe to eat as long as the can is not damaged in any way. Historically, commercially-canned food has a near-perfect track record, having caused only four outbreaks in over forty years. The last outbreak occurred in 1974 and involving beef stew.

Botulism Associated with Commercial Carrot Juice—Georgia and Florida, September 2006

On September 8, 2006, the Georgia Division of Public Health (GDPH) and CDC were notified of three suspected cases of foodborne botulism in Washington County, Georgia. On September 25, the Florida Department of Health and CDC were notified of an additional suspected case in Tampa, Florida. This report describes the joint effort.

On September 8, the three patients from Washington County, Georgia, went to a local hospital with cranial nerve palsies and progressive descending flaccid paralysis resulting in respiratory failure; the patients had shared meals on September 7. On the evening of September 8, physicians suspected foodborne botulism, notified the state health department, and collected clinical specimens for testing at CDC. On the same evening, CDC provided clinical consultation and dispatched botulinum antitoxin, which was administered to each of the patients the following morning. After receiving antitoxin, the patients had no progression of neurologic symptoms, but they remain hospitalized and on ventilators.

On September 9, the Washington County Health Department, Richmond County Health Department, and GDPH launched an investigation. The three patients had consumed several food items during their two meals together on September 7, including juice from a single 1-liter bottle of Bolthouse Farms carrot juice. The bottle had a "best if used by" date of September 18, 2006. Clinical specimens and leftover food and juice were collected and sent to CDC for testing. On September 13, botulinum toxin type A was identified in the serum and stool of all three patients. On September 15, leftover carrot juice recovered from the home of one of the patients also tested positive for botulinum toxin type A.

During September 8-15, FDA, the Georgia Department of Agriculture, the Georgia Hospital Association, and public health officials in all 50 states were notified of the outbreak and the implicated product as information became available. After these notifications, no additional cases of botulism in Georgia were reported to the state and local health departments or to CDC. During this time, FDA launched an investigation of the Bolthouse Farms, Inc., manufacturing plant in Bakersfield, California. FDA and CDC tested other bottles of the implicated brand of carrot juice, including bottles from different lots, and all were negative for botulinum toxin. Because botulinum toxin was found only in the bottle of carrot juice consumed by the three patients, a lapse in refrigeration of the carrot-juice bottle during transport or storage was suspected, which would have allowed for growth of Clostridium botulinum and subsequent production of botulinum toxin. Based on the CDC test results, on September 17, FDA issued a consumer advisory on the importance of keeping carrot juice refrigerated. However, information obtained from patient interviews regarding storage and transport of the carrot juice did not confirm mishandling by the patients.

On September 25, officials at the Florida Department of Health, the Hillsborough County Health Department, and CDC were notified that a patient had been hospitalized in Tampa, Florida, on September 16, with respiratory failure and descending paralysis. On September 28, botulinum toxin type A was identified in the patient's serum. Circulating toxin persisted more than 10 days after illness onset in this completely paralyzed patient, indicating ingestion of a massive toxin dose. Accordingly, the patient was treated with antitoxin, which prevents binding of circulating botulinum toxin to nerve endings. The patient remains hospitalized, paralyzed, and on a ventilator. The Hillsborough County Health Department collected an open, 450-milliliter bottle of Bolthouse Farms carrot juice, which had been found by a family member in the hotel room where the patient had been staying during the month before being hospitalized. The hotel room had no refrigerator. The bottle, which had a "best if used by" date of September 19, 2006, had a different lot number than the bottle associated with the Georgia cases. On September 29, botulinum toxin was identified in carrot juice from the bottle found in the patient's hotel room; the toxin was subsequently identified as botulinum toxin type A. The Hillsborough County Health Department and CDC notified FDA, public health officials in all 50 states, and infection-control practitioners in Hillsborough County about the botulism case and implicated product.

The carrot juice consumed by these four patients was manufactured by Bolthouse Farms, Inc., and distributed in all 50 states, Mexico, Canada, and Hong Kong with the labels "Bolthouse Farms 100% Carrot Juice," "Earthbound Farm Organic Carrot Juice," and "President's Choice Organics 100% Pure Carrot Juice." Investigations of these cases by state and local health departments and investigations of the manufacturer by FDA are ongoing. On September 29, GDPH and the Georgia Department of Agriculture recommended that Georgia residents not purchase or consume Bolthouse Farms carrot juice. The same day, the FDA warned consumers not to drink Bolthouse Farms carrot juice with "best if used by" dates of November 11, 2006 or earlier (i.e., all bottles produced before the date the warning was issued), and Bolthouse Farms issued a voluntary recall of these products.

The 2007 Castleberry Botulism Outbreak

On July 7, 2007, the Centers for Disease Control and Prevention (“CDC”) learned that two siblings in Texas were critically ill with botulism and that their illnesses were likely acquired by eating contaminated food. The two children were admitted to pediatric intensive care, and there required mechanical ventilation. The CDC released doses of botulinum antitoxin, which was administered to the children the next morning.

Four days later on July 11, public health officials in Indiana reported to the CDC that a married couple in Indiana were suspected of having foodborne botulism. Serum samples were collected from each of them on July 10 and then sent to the Botulism Reference Laboratory at the CDC. On July 16, one day after the lab received the serum samples, botulinum toxin type A was detected by mouse bioassay in the man’s serum sample. Botulinum toxin was also detected by mouse bioassay in serum submitted by the wife, but the sample volume was insufficient to determine the toxin type. Investigations conducted by state and local health departments in both Texas and Indiana revealed that all four patients had eaten types of Castleberry’s hot dog chili before symptom onset.

Texas investigators found an unopened can of Castleberry’s Austex Hot dog Chili Sauce Original date stamped with a manufacture date and time of May 7 at 9:41 p.m. at the children’s home and tested it for botulism. The Texas Department of Health Services laboratory tested an aliquot from this can using an enzyme-linked immunosorbent assay (ELISA) for botulinum toxin and did not detect the toxin.

The Indiana couple had an unlabeled, sealed plastic bag of leftover chili mixture in their refrigerator that local health officials collected and sent to the CDC for C. botulinum toxin testing. On July 16 the CDC detected botulinum toxin type A by mouse bioassay in the chili mixture. Empty, well-rinsed cans of Castleberry’s Hot Dog Chili Sauce Original and chili made by another company were found in the couple’s recycling bin. CDC re-rinsed the two cans and tested the rinse water for botulinum toxin by mouse bioassay; both were negative. The label on the can of Castleberry’s Hot Dog Chili Sauce Original indicated a production-date of May 8, and a time of 2:23 AM—less than five hours after the production-time indicated on the can collected from the Texas home.

On July 17, CDC staff provided information regarding the production-dates and times to the FDA. The evidence strongly suggested that brands of Castleberry’s hot dog chili sauce were the common source of the four ill persons with botulism. On July 18, FDA issued a consumer advisory. On that same day, after being informed about the outbreak, and findings from the FDA investigation of the canning facility, Castleberry’s Food Company issued a voluntary recall that included a limited number of production dates of Castleberry’s Hot Dog Chili Sauce Original, Castleberry’s Austex Hot Dog Chili Sauce Original, and Kroger Hot Dog Chili Sauce. The recall was expanded on July 21 to include all production dates for 91 types of canned chili sauce, chili, other meat products, chicken products, and dog food that were manufactured in the same set of cookers, or “retorts” as the hot dog chili sauce at the Castleberry’s facility in Augusta, Georgia.

By August 24, eight cases of botulism had been reported to the CDC. In addition to the Indiana couple, the mother of the children in Texas had developed symptoms of botulism, which brought the total number of Castleberry-associated cases in Texas to three. There was also three unrelated residents of Ohio who had developed botulism consuming Castleberry’s hot dog chili sauce in the week before symptom onsets. Botulinum toxin was identified in leftover chili sauce collected from the refrigerator belonging to one of the Ohio cases.

The Castleberry’s manufacturing facility in Georgia produces products regulated both by the FDA and USDA-FSIS. Initial reports of illnesses were linked to meatless hot dog chili sauce and thus, fell under the jurisdiction of the FDA. The agency’s Atlanta District Office took the lead in the investigation of facilities.

The inspection started on the evening of July 17. FDA investigators requested company maintenance records, which were not immediately available because they were stored on a laptop of a vacationing employee. Finally, three days later, under threat of severe penalty, the company produced some of the requested records. Included in records provided to federal investigators was a 42-page report written by a consultant hired by Castleberry’s to investigate swollen cans of stew, chili, and hash produced in April and May 2007. The consultant had attributed spoilage to post-process handling operations in one of the plant’s cooking equipment. Reports by two other company-hired consultants would also implicate post processing as the reason for swollen cans. Unfortunately, Castleberry’s had not investigated the issues further.

On July 18 and 19, a team of federal investigators were sent to the firm’s warehouse. Samples of Castleberry’s Austex and Castleberry’s brand Hot Dog Chili Sauce with the “best by May 7, 2009” and “best by May 8, 2009” lot codes were collected and sent to FDA laboratories for testing.[42] FDA testing of sample 428113, consisting of 17 swollen cans, found C. Botulinum toxin in 16 of the cans. This sample included the same time-stamp and lot code from the May 8, 2007 production as the can found in the Indiana home. FDA testing of sample 420352, consisting of six swollen cans, found C. Botulinum in four cans. FDA sample 420353 included one swollen can, and its contents tested positive for C. Botulinum toxin.

Federal investigators conducted extensive tests on Castleberry equipment. The findings are presented in an FDA report issued on August 10, 2007, Attachment No. 1, FDA Inspectional Observations dated 08/10/2007, (Summary pages only). Noted observations include:

The system, equipment, and procedures used for thermal processing of foods in hermetically sealed containers were not operated and administered in a manner that ensures commercial sterility is achieved.

Each retort did not have an accurate temperature records device.

Failure to supply a suitable water valve used for water cooling to prevent leakage of water into the retort during processing.

The condensate bleeder was not checked with sufficient frequency to ensure removal of condensate or equipped with an automatic alarm system for the continuous monitoring of condensate bleeder functioning.

Required information was not entered on designated forms at the time the observation was made by the retort or processing system operator or designated person.

Failure to maintain fixtures in repair sufficient to prevent food from becoming adulterated.

Failure to properly adjust the temperature-recording device. The temperature recorded on the temperature-recording device chart was higher than the mercury-in-glass thermometer during processing.

The report ultimately placed blame on Castleberry management saying there was no commitment from employees in making the products and there was not adequate management oversight. As one Castleberry employee noted: “Two years ago the [implicated retorts] were maintained very well, but they are maintained poorly now.” The FDA plainly agreed, citing Castleberry’s for the “failure to maintain fixtures in repair sufficient to prevent food from becoming adulterated.”

Castleberry made substantial fixes at its plant and then reopened in the fall of 2007. The company re-branded its line to American Originals, and redesigned product labels. But in March, 2008, the plant was forced to close again after a February 27 joint-inspection by the FDA and USDA revealed deviations in some equipment operations on the processing line. The line was not related to deficiencies noted in the summer of 2007 but because under-processing caused the botulism outbreak, the plant’s operating permit was suspended.

References

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).

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)

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&).

St Louis ME, Peck SH, Bowering D, et al. Botulism from chopped garlic: delayed recognition of a major outbreak. Ann Intern Med 1998;108:363

Morse DL, Pickard LK, Guzewich JJ, et al. Garlic-in-oil associated botulism: episode leads to product modification. Am J Public Health 1990;80:1372

See J. Sobel, et al., Foodborne Botulism in the United States, 1990-2000, Emerging Infectious Diseases, Vol. 10, No. 9, at 1606 (Sept. 2004).

James M. Jay, MODERN FOOD MICROBIOLOGY, 466 (6th Ed. 2000).
Id. at 469-71; see also Sobel, supra note 2, at 1606.

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). 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.

Thomas P. Bleck, Clostridium botulinum (Botulism), in MANDELL, DOUGLAS AND BENNETT’S PRINCIPLES AND PRACTICE OF INFECTIOUS DISEASE 2543, 2544 (5th ed. 2000). see also BOTULISM FACT SHEET, National Agricultural Bio-Security Center, Kansas State University, online at http://nabc.ksu.edu/content/factsheets/category/Botulism#f26

R. Shapiro, et al., Botulism in the United States: A Clinical and Epidemiologic Review, Ann. Intern. Med. 1998; 129:221-28.

FDA/CFSAN Bad Bug Book, Clostridium Botulinum, available at http://vm.cfsan.fda.gov/~mow/chap2.html

The following introductory material is based on information from the Wikipedia entry on canning, online at http://en.wikipedia.org/wiki/Canning, and the sources there cited.

Tony Baird-Packer, The Production of Microbiologically Safe and Stable Foods, in Volume 1 of THE MICROBIOLOGICAL SAFETY AND QUALITY OF FOOD, 4 (B. Lund, et al. Eds. 2000).

See, e.g. MMWWR, supra note 1, at 3 (citing P. Blake, et al., Type A Botulism from Commercially-Canned Beef Stew, South. Med. J. 1977; 70:5-7).

The information about the outbreak comes primarily from the CDC-published report issued July 30, 2007. See MMWR, supra note 1, at 1-2.

Home canning? Be Careful!

bmarler@marlerclark.com (Botulism Attorney) — Sat, 26 Jul 2008 19:26:01 -0800

We thought we'd pass along some advice we read in the Springfield News Leader about home canning. This newspaper had readers who proudly call themselves "Ozarkers." But those folks are not the only ones these days who are trying to be more self-sufficient and thrifty, so listen up!

Canning fresh foods at home can be a safe and affordable way to preserve bounty from your garden, but it can also pose a health risk if done improperly, said Jaci McReynolds, with the Springfield-Greene County Health Department.

“The most serious health risks with home canning are caused by improper preparation of the food during the canning process,” she said.

“In fact, about 90 percent of the foodborne illness outbreaks and death related to botulism can be traced to improperly home canned low-acid foods,” she said.

Botulism is a deadly toxin produced by the bacteria Clostridium botulinum, McReynolds said.

For more, go here.

New Era Getting Ready To Re-Open The Canning Factory

bmarler@marlerclark.com (Botulism Attorney) — Mon, 07 Jul 2008 14:37:34 -0800

Michigan's New Era Canning Co., closed for the past 7 months, is going to resume production. It's been granted a temporary permit that will allow it to begin sales, bring back employees and resume processing.

The Muskegon Chronicle reports:

Rick Ray, the company's president and chief executive officer, is optimistic that his family owned business will be back processing beans and other produce later this summer.

However, he said he is frustrated by the length of time the U.S. Food and Drug Administration has kept the company from returning to full operation.

"We certainly don't feel this should have taken so long," said Ray, the fourth generation of his family to lead the company. "It's hard to imagine that our government can shut us down without telling us what their case is."

He criticized the FDA for not returning phone calls or answering questions in a timely matter, and for not allowing the company's hired technical consultants to review the test results. The recalls involving cans of beans, peas and asparagus in December, January and February were the first in the company's long history.

FDA forced New Era to recall about 1.5 million cans due to concerns about potential botulism contamination in late 2007. It was closed in December. For more, go here.

Another Story With A Happy Ending!

bmarler@marlerclark.com (Botulism Attorney) — Mon, 07 Jul 2008 14:08:11 -0800

BOTULISM FUN FACTS:

1. Botulism is the single most acutely toxic substance (natural or manmade) known to science, with a median lethal dose of about 1 ng/kg, meaning that a few hundred grams could theoretically kill every human on earth. (For perspective, the rat poison strychnine, which is also considered to be highly toxic, has a median lethal dose of about 1,000,000 ng/kg, and it would take four hundred tons to kill every human).

2. It is also remarkably easy to come by: Clostridium spores (which form the botulinium toxin in the human intestine if inhaled) are found in soil practically all over the earth... particularly in the state of California.

3. Since botulism is so toxic, many (including the US government) have researched it's application as a biological weapon. Although it hasn't been used in overt warfare, it was used in "Operation Mongoose" where in 1961, the CIA saturated some cigars, of Fidel Castro's favorite brand, with botulinum toxin for a possible assassination attempt. The cigars were never used, but when tested years later were found still effective.

4. And it sucks.

Botulism Fun Facts was first appeared last May 31 on Vita Hardy's Blog.

Vita, who hails from Santa Cruz, CA, was 7 months old on July 4th and she is a botulism survivor.
According to her mother, a little over six weeks ago Vita was diagnosed with botulism. What followed was not pleasant, but the infant is making an excellent recovery. Both her encounter with Infant Botulism(IB) and her great recovery can be followed by looking at her blog entries for May and June.

Thanks to her Mom Jennifer for sharing it with us!