FDA proposes fee structure for re-inspections and recalls as part of FSMA

As part of the provisions in FSMA, FDA is setting a fee schedule for re-inspections of a facility when that facility had non-compliance/food safety issues during the initial inspection and for conducting a recall when the company fails to comply with a recall order.

For 2014 (which begins Oct 1, 2013), the fee rate is $237 an hour ($302 when foreign travel is required).

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm257982.htm?source=govdelivery

So for an all day visit (8 hours - arriving at 8 am and leaving at 4 am, no lunch), a facility is looking at a roughly a $1900 bill from Uncle Sam. Their goal will be to determine that corrective action was aken to resolve the noncompliance issue. Hopefully they can be convinced actions in 30 minutes the the corrective action was successful.

Industry Guidelines for Handling Foodborne Illness Investigation

CIFOR (The Council to Improve Foodborne Outbreak Response) released guidelines for industry to follow in the event of a foodborne illness outbreak investigation. This is very nice resource that warrants a review by every food company.  It provides a thorough review of the steps that occur when there is a foodborne illness that may be associated with an establishment.

The 78 page document lists procedures as well as forms that should be incorporated into a company’s crisis management plan. It details the roles of government and the food establishment in the event of a food emergency.

It was developed through a collaboration of food industry professionals and government authorities including FDA, USDA, and CDC.

Food industry owners or managers, need to print, review, and implement this document as part of the crisis management planning. Then keep it along with the required documentation as part of the company’s proactive action plan in the unfortunate event of the establishment may be involved in food illness outbreak. 

Print it today! 

CIFOR Industry Guidelines

 

HHS News Release 7/30/13

HHS, USDA and the food industry welcome new guidelines promoting industry

Guidelines provide tools for companies aiding government outbreak responders

http://www.hhs.gov/news/press/2013pres/07/20130730b.html

Health and Human Services Secretary Kathleen Sebelius and Agriculture Secretary Tom Vilsack today commended the Council to Improve Foodborne Outbreak Response (CIFOR) for the new CIFOR Foodborne Illness Response Guidelines for Owners, Operators and Managers of Food Establishments.

155 ill from Hepatitis A in pomegranate used in frozen berry mix

The CDC reports that 155 people in 9 states have become ill from hepatitis A after eating frozen mixed berries with 67 people that had been hospitalized. The source of the Hepatitis A was the pomegranate seeds which were imported from Turkey. 

The outbreak was first reported at the end of May, with cases beginning in April and extending into July. The reason is that symptoms do not occur for 2 to 6 weeks after exposure, and then those symptoms can last 2 to 6 months. Symptoms include fever, fatigue, nausea, vomiting, dark urine, and of course, jaundice . Although most people recover, it can cause liver failure in more susceptible individuals (elderly, people with liver disease) .

The organic frozen berry mix was sold by an Oregon company, Townsend Farms, and distributed through Costco. The blend is produced using fresh fruit and then is bought and used fresh by customers to make smoothies and other fruit drinks. So if Hepatitis A is present on the incoming ingredients, it will not be eliminated by processing (viruses will easily survive freezing), and then end up in product the consumer eats. With the long delay in seeing symptoms, it is easy to see why so many may have become infected.

The strain of Hepatitis A is found primarily in North Africa and the Middle East, and one of the ingredients, pomegranate seeds, is said to come from Turkey.

Food safety is important for ingredients used in products that will be used in RTE (ready-to-eat) applications, This is especially difficult when those ingredients are purchased in international markets. If this company lives up to the promise posted on their website, they should have no problems working back to the source of the issue. Unfortunately, this is not the first time berries have been involved in outbreaks. Earlier this year, there was an outbreak in Europe (71) and another in Canada (8). The Canadian product contained pomegranate. So at this point, if a company is using pomegranate, it may be good to stop using it until the safety can be verified. As a consumer, I would forgo my pomegranate-containing smoothie.



Multistate outbreak of hepatitis A virus infections linked to pomegranate seeds from Turkey
Posted July 30, 2013 9:15 AM ET
http://www.cdc.gov/hepatitis/Outbreaks/2013/A1b-03-31/


CDC is collaborating with public health officials in several states and the US Food and Drug Administration (FDA) to investigate a multistate outbreak of hepatitis A virus infections. Results from the ongoing investigation are highlighted below.

Epidemiologic Investigation:

· As of July 29, 2013, 155 people have been confirmed to have become ill from hepatitis A after eating ‘Townsend Farms Organic Antioxidant Blend’ in 9 states: Arizona (23), California (76), Colorado (27), Hawaii (8), New Hampshire (1), New Mexico (9), Nevada (6), Utah (3), and Wisconsin (2). [Note: The cases reported from Wisconsin resulted from exposure to the product in California, and the cases reported from New Hampshire reported fruit exposure during travel to Nevada.]

o 86 (55%) ill people are women
o Ages range from 1 – 84 years;
  -  87 (56%) of those ill were between 40 – 64 years of age.
  -  11 children age 18 or under were also ill. None were previously vaccinated.
o Illness onset dates range from 3/31/2013 – 7/14/2013
o 67 (43%) ill people (all over 18 years of age) have been hospitalized, and no deaths have been reported
o All ill people who reported eating this product purchased it from Costco markets; however, the product was also sold at Harris Teeter stores. No ill people have been identified that bought the product at Harris Teeter at this time.
 o CDC continues to track hepatitis A cases in all states and test specimens in order to determine if any other cases are related to this outbreak.

Cyclospora outbreak linked to bagged salad

The cyclospora outbreak centered in Iowa has been linked to bagged spinach. The brand has not yet been identified. At this point, there is a reported 378 cases in 15 states.

 Cyclospora is a parasite, most often seen in tropical and subtropical regions, results in watery diarrhea, stomach pain, etc (http://pennstatefoodsafety.blogspot.com/2013/07/cyclospora-outbreak-in-ia-and-ne-may-be.html ). If one had to guess, cyclospora oocysts would have contaminated the produce in the field probably from contaminated irrigation water and then it would be unlikely that washing would be sufficient to destroy the oocysts, perhaps even spreading it to more more product and thus more bags in the washing system. Although it could also be that the wash water used was contaminated. Hopefully the investigation will provide that information.

CDC has a listing of organisms and their inactivation by chlorine. (Bottom of this and http://www.cdc.gov/safewater/effectiveness-on-pathogens.html. ) As can be seen, parasites are much more resistant, especially cyclospora (listed in the footnote on the CDC table).

At this point, they have not yet released the information surrounding the brand name. This is interesting in that they know the product is no longer on the shelf. As a consumer, I would be interested in knowing that information so that I could avoid that brand, and then would also have more confidence in buying other brands. Therefore, I think delaying the release of this information, it has the potential to negatively impact sales of other brands of bagged salad.


Salad Mix Behind Food Poisoning Outbreak, Health Officials Say 
By GRANT SCHULTE and MARY CLARE JALONICK 07/30/13 08:02 PM ET EDT  http://www.huffingtonpost.com/2013/07/30/salad-mix-food-poisoning_n_3679072.html

 LINCOLN, Neb. — Health officials in Iowa and Nebraska on Tuesday identified prepackaged salad mix as the source of a severe stomach bug that sickened hundreds of people in both states, but federal authorities said it's not clear whether cyclospora outbreaks elsewhere in the U.S. are also linked to that produce.

Cyclospora is a rare parasite that causes a lengthy gastrointestinal illness, and outbreaks of the illness have been reported in 15 states. The U.S. Centers for Disease Control and Prevention said Tuesday that it's not clear whether all of the illnesses are linked to a single source. The outbreak has sickened at least 145 residents in Iowa and 78 in Nebraska.

Botulism and Home Canned Elk Meat

Each year, those one or two cases of botulism that show up in the news serve as reminders of the importance of following proper processing (and using common sense). In summary, Mr. O’Connell thought he would short cut the canning processing by not going through the full heat process so that he could get more jars of elk meat. Rather, he just got the cans to form a vacuum seal and then moved on to the next batch. And when he heard one of the jars pop (lose vacuum) a week later, he threw it in the refrigerator. A few days later, he ate it for supper. Being a learned man, actually a lawyer, he knew something was wrong when his vision got blurry and his legs become wobbly. It progressed to a point where he lost all strength and had shallow breaths. His doctors were able to figure it out in time to save him.

He did use a pressure canner, but failed to follow process. Then instead of tossing the jar with the popped lid, he ate it.

Here are the links to Penn State’s publications.

Let’s Preserve: Basics of Home Canning

http://pubs.cas.psu.edu/FreePubs/PDFs/ee0066.pdf
 
Let's Preserve Meat and Poultry
http://pubs.cas.psu.edu/FreePubs/PDFs/ee0058.pdf

 

Home Canning Hobby Leads to Near-Fatal Medical Emergency
By Austin Jenkins July 20, 2013 KPLU
http://www.kplu.org/post/home-canning-hobby-leads-near-fatal-medical-emergency

Home canning is regaining popularity as part of the local food movement. If done right, families can enjoy home grown fruits, vegetables and even meat all through the winter. But if done wrong, it can be devastating, if not deadly.

A lawyer for the state of Washington recently learned that lesson the hard way.

On the Friday before Mother’s Day this year, Mike O’Connell was looking forward to spending the weekend with his wife at their home in the Seattle area. During the week, he lives alone in Olympia where he works. But he woke that morning with the strangest affliction: double vision.

“There were two of everything and I had an awful time just shaving and getting ready for work,” O’Connell said.



O’Connell, 67, is chief counsel to Washington’s Legislative Ethics Board. He suspected the double vision was related to some laser eye surgery he recently had. He managed to make it into work, but soon went home. That evening, he experienced more strange symptoms.

“My legs felt rubbery,” he said.

The next morning, he felt even worse. He was bumping into walls. He called his wife.

“I told her, ‘You know, I’m going to stop by the ER on the way up just so somebody can tell me I’m okay and I’m not having a stroke,”’ he said.

At the hospital, that’s exactly what they thought he was having. He heard “stroke in progress” called over the intercom. Suddenly he was surrounded by nurses and doctors. O’Connell’s wife arrived. Test results started coming back. There was no evidence of stroke.

“I didn’t know enough to bring up the fact that I had eaten canned meat,” said O’Connell.

Canned meat. You see, the night before O’Connell woke up with double vision, he had eaten some elk meat from a hunting trip. He canned it himself about a week earlier.

“Borrowed a pressure cooker, used an old family recipe for canning,” O’Connell said.

O’Connell’s mother had canned everything when he was a kid. He wanted to recapture a bit of his childhood. But things started going wrong from the start.

I had way too much meat to deal with,” said O’Connell.

The pressure cooker was too small. O’Connell had already browned the meat in a cast iron pan. So he decided to shortcut the process. Once the jars sealed airtight he would take them out of the pressure cooker and start a new batch. The next day, he heard a pop in the pantry.

“Which I remember as a child was the signal for you’ve lost the seal,” said O’Connell.

O’Connell found the jar with the popped seal, put it in the fridge and ate it the next day. He says it was delicious. The following week he heard another lid pop. Just as he had before, O’Connell found the jar and stuck it in the fridge. And a few days later he ate it for supper.

“This time, it didn’t work out,” O’Connell said.

O’Connell had an upset stomach in the night, but he didn’t connect it to having eaten the meat. He says growing up, he didn’t know anyone who got food poisoning from home canned foods.

At the hospital, once doctors ruled out a stroke, O’Connell was sent home. But he was back in the hospital a few hours later. Now he was having difficulty swallowing. The next morning, Mother’s Day, O’Connell’s daughter, Kelly Weisfield, drove to Olympia to see her dad.

“His voice was very slurred and his eyelids were droopy, but he was sitting up in bed and he was communicative,” Weisfield said.

As the day progressed though, O’Connell’s condition got markedly worse.

“By now, my eyes were closed. My strength—it was just amazing how quickly that went,” O’Connell said.

His breathing was getting shallow. Daughter Weisfield was frustrated with the lack of answers and scared. She called a doctor she knew, a neurosurgeon. He ran through a short checklist of things to rule out. That list included a disease first identified in the 18th century: botulism. Weisfield looked it up online.

“It just made the hair on the back of my neck stand up because it was every single symptom just laid out exactly what my dad was experiencing,” she said.

Botulism is a paralyzing illness caused by what Centers for Disease Control calls the most potent toxin known to science. It’s rare; there were only 20 foodborne cases nationwide in 2011, just one in Washington state last year.

Improperly home canned foods are the leading culprit, especially those low in acid like green beans and, yes, meats. Weisfield called her mom who had just left the hospital.

“And I said, ‘Mom, turn around. You got to go back and tell them to look into this,’” Weisfield said.

Weisfield was relieved, but also terrified that it was too late. Her father could hardly move now. He was having more and more difficulty breathing. The hospital had parked a ventilator outside his room. Weisfield didn’t know what to tell her 10-year-old son, who is very close to his grandfather.

“First thing Connor said was, ‘Are we still going to go on our fishing trip?’ And I could never answer him, because I didn’t know,” she said.

The doctors didn’t even wait to confirm botulism. They ordered a dose of anti-toxin from the CDC. Now the medical mystery was solved. But how did O’Connell get botulism?

Remember he stopped cooking the jars of elk meat when he heard the seals lock in place. Washington State University food safety expert Zena Edwards says that was O’Connell’s nearly fatal mistake.

“All that indicated was it had now become an anaerobic environment, an oxygen-free environment,” Edwards said.

And that’s the strange thing about the bacteria that causes botulism. It thrives when deprived of oxygen. By shortcutting the cooking time, O’Connell failed to kill the bacteria. Instead, he sealed it into the perfect environment for it to produce the poisonous toxin.

Edwards says what happened to O’Connell reaffirms two cardinal rules of home canning: “plan before you can” and “when it doubt, throw it out.”

After receiving the anti-toxin, O’Connell transferred to Swedish Hospital in Seattle for rehab. It took just days for the Botulism to paralyze O’Connell. The recovery would be painfully slow.

“My eyes were the first thing to come back. I still walk with difficulty and use a cane. I have no taste with the exception of chocolate, so I buy chocolate ensure, chocolate mints and night before last, I found where they sell chocolate wine so I had some of that, too,” O’Connell said.

O’Connell doesn’t know if or when he’ll get his taste back. Before the botulism, he was fit and active—a hunter and avid hiker. His daughter says it’s hard to see her dad like this.

“I’m so grateful that he’s made it through. And I’m so sad that he’s gone through all this, and he’s not the same,” Weisfield said.

O’Connell was able to keep that promise he’d made months ago to his grandson to go fishing together on the upper Columbia River. As for future home canning projects, his family has made it clear that’s not going to happen.

Cyclospora outbreak In IA and NE may be due to contaminated vegetables

Approximately 100 people have become ill from Cyclospora in Iowa and Nebraska.  Fresh vegetables are considered the likely source.

Cyclospora is a single cell parasite that infects the intestinal tract when oocysts are ingested.  According to the CDC website (http://www.cdc.gov/parasites/cyclosporiasis/gen_info/faqs.html), the symptoms are watery diarrhea (sometimes  explosive), loss of appetite, weight loss, stomach pain and bloating, increased gas and nausea.  If not treated, symptoms can last several days to over a month.  Patients will often have one or more relapses.  For immunocompromised individuals, symptoms can last much longer.

 


This parasite is more common in tropical and subtropical areas, but has been involved in outbreaks in the US, primarily through contaminated produce.  The last large outbreak was in 1996, when more than 850 become ill from eating contaminated raspberries.





Officials say vegetables likely cause of cyclospora outbreak -

See more at: http://www.thepacker.com/fruit-vegetable-news/Officials-think-fresh-veggies-likely-cause-of-cyclospora-outbreak-215584211.html#sthash.tkfOmaJX.dpuf
The Packer
07/15/2013 04:42:00 PMCoral Beach   

With more than 100 people in at least two states confirmed to have infections from the cyclospora parasite, public health officials investigating the outbreak suspect the culprit is some kind of fresh vegetable.

We are pretty sure it’s not fruit but a vegetable,” said Dr. Patricia Quinlisk, head epidemiologist and medical director for the Iowa Department of Health. “We are trying to correlate what the common source might be.”

FDA Proposes Action Level for Arsenic in Apple Juice

FDA proposed a limit of 10ppb for inorganic arsenic in apple juice.  This is the same level that is in place for drinking water.

This issue garnered attention when that crusader for scaring the heck out of people in the name of public health, Dr. Oz, put a beat down on apple juice claiming that samples had high levels of aresenic.  However, FDA countered with scientific facts -  that they had monitored juice samples for years and had not found such levels AND the methodology used by the Oz quoted study looked at total arsenic and not inorganic aresenic, the harmful form.

If anything, it shows how mass-media-generated misinfomation can be used to force regulation.

FDA NEWS RELEASE
 FDA proposes “action level” for arsenic in apple juice

For Immediate Release: July 12, 2013
Media Inquiries: Theresa Eisenman, 301-796-2805, theresa.eisenman@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDAhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm360466.htm

Agency testing and analysis confirm overall safety of apple juice

The U.S. Food and Drug Administration today proposed an “action level” of 10 parts per billion (ppb) for inorganic arsenic in apple juice. This is the same level set by the U.S. Environmental Protection Agency (EPA) for arsenic in drinking water.

“The FDA is committed to ensuring the safety of the American food supply and to doing what is necessary to protect public health,” said FDA Commissioner Margaret A. Hamburg, M.D. “We have been studying this issue comprehensively, and based on the agency’s data and analytical work, the FDA is confident in the overall safety of apple juice for children and adults.”

“While the levels of arsenic in apple juice are very low, the FDA is proposing an action level to help prevent public exposure to the occasional lots of apple juice with arsenic levels above those permitted in drinking water,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.


The FDA is establishing this threshold to provide guidance to industry. The agency takes the action level into account when considering an enforcement action, if it finds a food product exceeds the threshold.

The FDA has been monitoring the presence of arsenic in apple juice for the past 20 years and has consistently found that samples contain levels of arsenic that are low, with few exceptions. New tools, however, have allowed the agency to better understand the breakdown between organic and inorganic arsenic levels. Last year the FDA released findings from its latest data collection and analysis of 94 samples of arsenic in apple juice. The analysis showed that 95 percent of the apple juice samples tested were below 10 ppb total arsenic; 100 percent of the samples were below 10 ppb for inorganic arsenic, the carcinogenic form of arsenic.

The proposed level of 10 ppb takes into account this sampling data plus a recently completed, peer-reviewed risk assessment of inorganic arsenic in apple juice conducted by FDA scientists. The assessment is based on lifetime exposure.

Inorganic arsenic may be found in foods because it is present in the environment, both as a naturally occurring mineral and because of activity such as past use of arsenic-containing pesticides. A known carcinogen, inorganic arsenic also has been associated with skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes.

In conducting its new assessment on apple juice, the FDA was able to use data from two studies published in 2010, as well as a 2011 evaluation by the Joint Expert Committee on Food Additives and Contaminants of the Food and Agriculture Organization, part of the United Nations and the World Health Organization.

The agency will accept public comments on the proposed action level and the risk assessment for 60 days.


It's Dr. Oz versus the FDA on apple juice and arsenic
September 16, 2011|By Jeannine Stein, Los Angeles Times / For the Booster Shots blog http://articles.latimes.com/2011/sep/16/news/la-heb-apples-arsenic-oz-20110916

An apple a day may keep the doctor away, but apple juice? That's asking for trouble.

Witness the white-hot flames of controversy this week over Dr. Mehmet Oz's claims that apple juice contains unhealthful levels of arsenic. Here's the background in a nutshell: On his syndicated television show, Oz made the claims about apple juice containing arsenic, which prompted the Food and Drug Administration and others to fire back, saying that Oz's claims were unfounded and that the juice was safe to drink.

Pistachios Recalled Due to Potential Salmonella Contamination

 A California company, Western Mixers Produce and Nut Company, is recalling pistachios due to the potential for the presence of Salmonella.    No illnesses have been reported.


FDA News Release
Western Mixers Produce & Nuts, Inc. Recalls Pistachios Because of Possible Health Risk

http://www.fda.gov/Safety/Recalls/ucm360343.htm

FOR IMMEDIATE RELEASE - July 10, 2013 - Western Mixers Produce & Nut Company of Los Angeles, California is recalling ARO and/or Treasured Harvest Pistachios, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Organic Oregano Recalled Due to Potential for Salmonella

Organic oregano, packed in 2.2 oz jars, is being recalled after Salmonella was discovered during raw material testing.  This product was sold exclusively at BJ Wholesale Club in 15 different states..  No illnesses have been reported.



FDA News Release
Olde Thompson Inc. Issues a Voluntary Recall of Earth’s Pride Organics: Organic Oregano 2.2 Oz Glass Jars With Cork Closure Due to Possible Salmonella Riskhttp://www.fda.gov/Safety/Recalls/ucm360719.htm

FOR IMMEDIATE RELEASE July 12, 2013 - Olde Thompson Inc. Oxnard, CA in cooperation with the FDA is recalling Earth’s Pride Organics: Organic Oregano packaged in a 2.2 oz. glass jar with cork closure, Lot #: 060367, 060692, 061252 and 061864 due to possible contamination by Salmonella. If you have the recalled product, please do not consume it. Please dispose of the recalled product and its container.

Salmonella is known to cause salmonellosis in humans and animals. Symptoms of salmonellosis include diarrhea, abdominal cramps and fever and are known in some cases to be severe enough to require hospitalization and can cause serious complications or death in young children, the elderly, or a person with a compromised immune system. If you have already consumed the product and have concerns about your health, please consult your healthcare provider.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers immediately.

The recalled product is identified and distributed as follows:
Earth’s Pride Organics: Organic Oregano 2.2 oz. in glass jar
UPC code: 400000290942
Sold exclusively at BJ’s Wholesale Club in CT, DE, FL, GA, ME, MD, MA, NH, NJ, NY, NC, OH, PA, RI, and VA, between January 1, 2013 and July 10, 2013
The recall affects 1,075 cases Earth’s Pride Organics: Organic Oregano 2.2 oz in glass jar.
Lot # (s): 060367, 060692, 061252 and 061864 located on the bottom of the jar.

No illnesses have been reported.
The bacterium was discovered during routine sampling of raw materials.


Customers who have purchased these products and have any questions should contact a BJ’s Wholesale Club Member Care Representative at 1-800-BJS-CLUB (800-257-2582) available Monday – Friday, 9AM – 7PM E.D.T., Saturday, 9AM – 6PM E.D.T. and Sunday, NOON – 6PM E.D.T.