The Park Doctrine and Jensen Farms

Many were surprised by the recent arrest of the Jensen Farm’s owners for selling Listeria contaminated cantaloupes that caused 33 deaths (http://pennstatefoodsafety.blogspot.com/2013/09/jenson-brothers-growers-of-tainted.html). Introducing the Park Doctrine. All responsible company officials, whether their company is manufacturing food items OR distributing food items manufactured by someone else, should be aware of the implications. 

 From the FDA Law Blog – Feb 2, 2011 (reference below):

“… a corporate official can be convicted of a misdemeanor based solely on his position of responsibility and control to prevent the underlying violation of the FDCA. There is no requirement that the official acted personally in the wrongdoing, or that he even had knowledge of it. The Supreme Court determined that the FDCA “imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur.” Park, 421 U.S. at 672.”

 This is not limited to the processors, but to those who utilize contract manufacturers. From the FDA Law Blog – May 28, 2013 (reference below):

“The letters cite Park and Dotterweich to support the legal theory that a distributor that uses contract manufacturers or labelers may be liable (or convictable) for Current Good Manufacturing Practice ("CGMP") violations by its contractors.”

This is different than the PCA Peanut Butter cases, where officials knew they were shipping contaminated product. As seen in the Jensen case, it is more of a point that they should have known and taken preventive actions.


FDA Law Blog

February 06, 2011

FDA Finally Releases “Non-binding” Park Doctrine Criteria

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/02/fda-finally-releases-non-binding-park-doctrine-criteria.html

By Anne K. Walsh –

Eleven months after telling Senator Grassley (in a letter available here) that “[c]riteria now have been developed for consideration in selection of misdemeanor prosecution cases and will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor prosecutions,” FDA just last week finally released those criteria. The idea behind such criteria is to increase misdemeanor prosecutions against corporate officials under the Park doctrine. 

Jenson Brothers, Growers of Tainted Canteloupes, Arrested

The Jensen brothers, owners of the farm that grew and packed the Listeria tainted cantaloupes which were responsible for killing 33, have been arrested and now face jail time for the incident. This is in addition to having their farm go bankrupt, one owned by the family for generations. 

This case is a huge deal for all food operations in that owners/managers are facing prison for a foodborne outbreak. While all basically agree that there was no intent by the Jensen brothers, it is the fact that the shipped contaminated product from an operation with food safety lapses that have led to the misdemeanor charges, where intent is not a factor. The food safety lapses can be summed up”

1) They installed a potato washer to wash cantaloupes. It did not wash cantaloupes well, it did not cool them, and the equipment was not easy to clean. Because it was not easy to clean, it actually served as a source of contamination. By not cooling, the warmer temperatures provided better growing conditions for Listeria on the outside of the cantaloupe.

2) The chlorine sanitizer spray system was not operational.

The later point is worth noting. In certain applications, it is easy to overlook these microbial reduction interventions. Who knows, perhaps the location of the spray nozzles were located at a point where the chlorine would be quickly inactivated because of the solids on the cantaloupes, so they decided not to hook them up. 

It can be easy to look at a number of bacterial reduction interventions and wonder if there is a significant impact versus the cost of operating that intervention, or operating it at the level it should be operated. Or even maintaining the appropriate verification steps (checking concentration, conducing bacterial counts before and after) to ensure that the intervention is operating at that level it is supposed to be operating. 

So when the unfortunate event occurs, in this case one of the most deadly foodborne outbreaks in US history, investigators are going to look at everything - Is the process right for the products it is processing? Are the appropriate antimicrobial systems in place that are standard in the industry? Are the antimicrobials systems that are in place working, and are they operating at the right parameters? 

Companies need to use this case as a reason to review all processes, with specific attention to these antimicrobial interventions. If a system is in place, make sure it is working as it designed. If these systems are not operating, then either fix it. If they have been abandoned, then move it, replace it or remove it.

Note that these brothers are just farmers, one 37 years old, and the other 33. While the thought of jail time probably pales in comparison to the responsibility for 33 deaths, they probably wonder how some poor decisions led to where they are now.


United States Attorney’s Office – District of Colorado
New Release
http://www.justice.gov/usao/co/index.html

Eric and Ryan Jensen charged with introducing tainted cantaloupe into interstate commerceFOR IMMEDIATE RELEASE

September 26, 2013

DENVER – Eric Jensen, age 37, and Ryan Jensen, age 33, brothers who owned and operated Jensen Farms, located in Granada, Colorado, presented themselves to U.S. Marshals in Denver today, where taken into custody on federal charges brought by the U.S. Attorney’s Office with the Food and Drug Administration – Office of Criminal Investigation, United States Attorney John Walsh and Food and Drug Administration (FDA) Office of Criminal Investigations Special Agent in Charge Patrick Holland announced. The Information charges the brothers with introducing adulterated food into interstate commerce. The defendants are scheduled to make their initial appearance this afternoon at 2:00 p.m. before U.S. Magistrate Judge Michael E. Hegarty. At that hearing they will be advised of their rights as well as the charges pending against them.

According to the six-count Information filed under restriction on September 24, 2013, as well as other court records, Eric and Ryan Jensen allegedly introduced adulterated cantaloupe into interstate commerce. Specifically, the cantaloupe bore a poisonous bacteria, Listeria monocytogenes. The Information further states that the cantaloupe was prepared, packed and held under conditions which rendered it injurious to health.

Salad Items Recalled due to Potenial Listeria Contamination

Update 10/25/13 - Garden Fresh is expanding its recall http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2013/recall-055-2013-expansion

Garden Fresh Foods of Wisconsin is recalling various salad, slaw and dip items due to the potential for Listeria monocytogenes. The problem was discovered through product testing conducted by FDA.  To date, there have not been any reported illnesses.

Product was shipped nationally under various brand names: Market Pantry, Archer Farms (both Target brands), D’Amico and Sons, Finest Traditions, Garden Fresh and Weis.

This same company issued a recall back at the beginning of the month. This was a smaller recall, that for potato salad, but for the same reason – the potential for Listeria as well (link below). That was discovered through routine sampling. Being that occurred over three weeks ago, it would probably indicate the company was under increased scrutiny. And this may be why the latest recall notice indicated that the pathogen was discovered through testing done by FDA.

As we discuss many times, this is a reason for companies using co-packing operations to watch recall notices and consider strong action when their co-packer has an issue. It may not be your brand initially impacted or even the product you purchase, but in too many cases, we see these contamination events rapidly expand when FDA or USDA investigate smaller issues and find the troubled manufacturer has bigger issues that impact a broader set of products.


USDA Recall Alert
Wisconsin Firm Recalls Ready-To-Eat Chicken And Ham Products Due To Potential Listeria Monocytogenes Contamination
Class I Recall 055-2013

Health Risk: High Sep 25, 2013

Congressional and Public Affairs
Catherine Cochran
(202) 720-9113

WASHINGTON, Sept. 25, 2013 – Garden Fresh Foods, a Milwaukee, Wisc.establishment, is recalling approximately 19,054 pounds of ready-to-eat chicken and ham products due to possible contamination with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Overstating the Link of Antibiotic Resitant Bacteria in Animals to Humans

There has been a huge concern on the importance of antibiotic resistant strains of Salmonella in domestic animals and their impact on humans.  In a comprehensive study conducted over a 22 year period that evaluated DNA variation, researchers have found that there is little cross-over from animals to humans and therefore domestic animals are unlikely to be a major source of antibiotic resistant Salmonella strains in humans.

“The team discovered that, contrary to much current thinking, the populations of Salmonella in humans and animals were distinguishable. They also found that the estimated number of times that the bacteria had jumped from animals to humans (and vice versa) was remarkably low. In addition, there was greater diversity in antibiotic resistance genes in salmonellae isolated from humans. Taken together, these findings suggest that the contribution of local animal populations to human infections with S. Typhimurium DT104 may previously have been overstated.”

The author of the study goes on to say “"This finding in no way undermines the importance of prudent antimicrobial use in all species. But our study does demonstrate that greater effort needs to be focused on understanding the natural history of the pathogens and on identifying the major sources of resistance in our global ecosystems."

With regard to our inability to completely comprehend why and where bacteria do what they do, Dr. Steve Goodfellow, a seasoned food microbiologist, liked to say that ‘bacteria don’t read the textbooks’.   I think we can also say that bacteria don’t follow stories put out by the news media either.

 

Contribution of Local Animal Populations to Human Salmonella Infections Overstated

Science Daily
http://www.sciencedaily.com/releases/2013/09/130912143421.htm

Sep. 12, 2013 — A new study has shown that, contrary to popular belief, local domestic animals are unlikely to be the major source of antibiotic resistant Salmonella in humans. The result comes from a detailed study of DNA from more than 370 Salmonella samples collected over a 22-year period.

By studying the genetic variation in the Salmonella bacteria and their drug resistance genes, researchers found that distinguishable bacterial populations exist in human and animal populations living side by side. Antibiotic resistance is considered to be one of the most important dangers to human health, threatening to make many treatments to common infections ineffective. By comparing the genomes of Salmonella in humans and animals the researchers have provided important new insights into the likely sources and spread of antibiotic resistant infections. First, the Salmonella bacteria largely remained within their original host populations and second, there were more varied combinations of drug resistance in the human-infecting bacteria.

Salmonella infection is a global issue, with approximately 94 million people contracting gastroenteritis or food poisoning each year. The combined annual cost in the United States and European Union is estimated to be more than £4 billion ($6 billion). This public health issue is exacerbated further by antibiotic resistance, which can lead to more complicated and protracted illness in patients and increased treatment costs.

"For the first time we've determined in detail and on a large scale how Salmonella strains taken from humans and animals in the same setting and over the same time period relate to each other," says Dr Alison Mather, first author on the study, from the Wellcome Trust Sanger Institute. "Our genomic data reveal how the Salmonella bacteria spread during the course of a long-term epidemic. We found that people have a more diverse source of infection and antibiotic resistance than just the local animals, pointing towards alternative sources."

The team sequenced DNA from 373 samples from humans and animals infected with Salmonella Typhimurium DT104 over a 22-year period, mainly from Scotland, but also from other countries. This is the largest study of its type; whole genome DNA sequencing delivers the highest level of resolution possible to examine how closely related the bacteria are, enabling the team to unravel the details of this epidemic.

The team discovered that, contrary to much current thinking, the populations of Salmonella in humans and animals were distinguishable. They also found that the estimated number of times that the bacteria had jumped from animals to humans (and vice versa) was remarkably low. In addition, there was greater diversity in antibiotic resistance genes in salmonellae isolated from humans. Taken together, these findings suggest that the contribution of local animal populations to human infections with S. Typhimurium DT104 may previously have been overstated.

Chobani Recalls Greek Yogurt Due to Quality Issues

Chobani is recalling its Greek Yogurt due to issues encountered by consumers, namely product bloating / swelling. News reports suggest the issue may be related to mold and that there may be some related illnesses.

Initially the company cited this as a quality issue and did not recall the product. But after public outcry and a solid media beat-down, the company issued a recall and ceased distribution of the product (Guardian article below).

Chobani pioneered Greek yogurt, and now controls 35% of the Greek yogurt market. And this market has taken a serious bite out of the traditional yogurt markets, now accounting for about 1/3 of the US yogurt market. Much of this is due to the products higher protein content compared to traditional yogurt (see the nice NY Times article below).

This issue and the lack of a firm response will certainly give the competitors a leg up. Especially when this company had such a ‘consumer oriented’ brand. We’ll need to watch how market share changes after this incident. This case is one of those hard lessons all food companies can learn from.


FDA News Release
Chobani, Inc. Voluntarily Recalls Greek Yogurt Because of Product Concerns
FOR IMMEDIATE RELEASE - September 5, 2013 - Chobani, Inc., of Twin Falls, Idaho is voluntarily recalling Greek Yogurt.
http://www.fda.gov/Safety/Recalls/ucm367298.htm

The company has ceased the distribution of the product due to reports of product bloating and swelling and some claims of illness as the company continues its investigation to identify the root cause.

Let the Alarmism Begin on The Safety of Spices

Earlier this week, we commented on the New York Times report regarding an FDA study on the safety of spices (http://pennstatefoodsafety.blogspot.com/2013/08/safety-of-imported-foods-spices-and-fsma.html) . We indicated that there is essentially no risk for consumers when buying spices from the grocery store. Brand label spices are produced by reputable companies, such as McCormick, have extensive food safety systems in place that minimize the risk.

But unfortunately, major media outlets can’t help themselves from jumping on this study and spreading some fear. At least, the NY Times article’s title ‘Spices’ Link to Food Ills Prompts Changes in Farming’ wasn’t overly misleading. But from that article, other news outlets had their own spin in order to ‘one-up’ the other. Let’s take a look at these titles. 

From NPR, we have ‘ Your Kitchen Spices Can Often Harbor Salmonella’. The title suggests something that is completely inaccurate. Even the reader’s comments at the bottom of the article (you can connect to the link on the article below to read) indicate that these readers know that this is over-the-top fear mongering.

NPR is not the only one. LA Weekly has an article “Spices a Potent Source of Food Poisoning”. Not to be outdone MSN News has - Rumor: Common kitchen spices contain salmonella’ and goes on to state that this rumor is true. No it is not.

Certainly there have been a few incidents that contaminated spices have resulted in illnesses, but these were extremely isolated and due to unique circumstances. Going back to look at the original study, there are few things we can see in this FDA study which was published in Food Microbiology that warrant comment :

• The sampling in the study primarily evaluated untreated spices which had a higher level of contamination…as we would expect. Will those spices be treated at some point during further processing….probably yes?
• We don’t know the type of importer for the spices that were found positive. Were the major spice companies, or smaller importers? Companies with familiar brands names must protect those brands, and thus will have solid quality and safety programs including preventive control measures. But unfortunately, this study does not indicate they type of company. And the news articles then lump all spice companies together.

This is not to say that these companies representing major brands will not have the occasional issue, but they are few and far between. So as I put pepper on my pizza tonight, I will not worry about Salmonella contamination. Will you worry about the spices in your cabinet? Probably not.

The real take home from the FDA study is that companies who import spices need to have preventive controls in place to ensure the safety of those items.



Your Kitchen Spices Can Often Harbor Salmonella
by Nancy Shute
August 29, 2013 3:16 PM
NPR – The Salt
http://www.npr.org/blogs/thesalt/2013/08/28/216550862/your-kitchen-spices-can-often-harbor-salmonella

 Spice may be nice, but spices also can carry very bad bugs. About 7 percent of spices tested by Food and Drug Administration researchers were contaminated with salmonella, which can cause serious illness and death. Because of this finding and others, the FDA and international food safety organizations are putting more effort into how to reduce the risk.

 

A New York Times

article this week really brought the issue to everyone's attention. Here are some of the questions we've been asking about spices and salmonella here at The Salt:

Safety of Imported Foods - Spices and FSMA

A NY Times article released today (below with link) details the high contamination Salmonella rate of spices and the challenges that exist in importing products. Primarily, these spices are produced in tropical zones in ‘rustic’ conditions. Because of this, these items have a high risk of becoming contaminated with Salmonella (from birds, animal manure, reptiles, etc) and then, that organism can survive in these dried spices for months or longer.

Spices have been processed this way it has been since the time of the spice trade, thousands of years ago. But as consumers, do we generally worry about the safety of spices? Generally not. Companies that have been involved in buying and selling spices have secured their supply chains and where needed, have added interventions such as irradiation to eliminate these bacterial hazards. So there is no risk to the consumer, when you look at the vast quantities of spice consumed each day in this country.

This is not to say there have not been issues, but primarily those issues were linked to food companies using less than reliable sources for their spices. In the small number of cases where there have been issues, importers of spice did not have adequate control measures in place.

So what is the point of the NY Times article? It is directed at the Foreign Supplier Verification Program (FSVP) component of FSMA. In this proposed regulation, emphasis is put on the companies who import food to ensure the safety of those foods. It defines the importer as the person in the US who has purchased the item, and in many cases, this can be the retailer or the distributor. 

The NY Times piece provides ammunition for those who feel that the federal government should have a heavier hand in determining the safety of those imported food items. This would necessitate a heavy testing program conducted by the government agencies at the border for incoming foods and having FDA inspectors inspect foreign companies.

With about 15% of the food consumed in this country being imported, it is not financially feasible to have FDA take on that responsibility. The concept proposed in FSVP is better…making companies responsible for the foods they import. We just have to look at companies like McCormick who have practiced the safe importation and processing of spices for more than a century.  

For those identified as importers, FSVP provides the elements of a supplier verification program that these companies will need to establish for each suppler, including verifying that he supplier has a HACCP type system in place and conducting verification, corrective action, and record keeping activities.

In the long run, FSVP will create a stronger food supply system. Companies who sell imported foods will either be forced out of selling if they are not willing or capable of implementing such an adequate supplier contol system, or will need to align with an importer who does have the necessary capabilities.


NY Times
Spices’ Link to Food Ills Prompts Changes in Farming
By GARDINER HARRIS
Published: August 27, 2013
http://www.nytimes.com/2013/08/28/world/asia/farmers-change-over-spices-link-to-food-ills.html?pagewanted=1&_r=0

IDUKKI, India — Spices grown in the mist-shrouded Western Ghats here have fueled wars, fortunes and even the discovery of continents, and for thousands of years farmers harvested them in the same traditional ways. Until now.

Science has revealed what ancient kings and sultans never knew: instead of improving health, spices sometimes make people very sick, so Indian government officials are quietly pushing some of the most far-reaching changes ever in the way farmers here pick, dry and thresh their rich bounty.

The United States Food and Drug Administration will soon release a comprehensive analysis that pinpoints imported spices, found in just about every kitchen in the Western world, as a surprisingly potent source of salmonella poisoning.

Cyclospora cases now over 600, Texas cases not linked to Taylor bagged salad

As of August 26th, CDC is reporting that there are 610 cases of Cyclospora infection in 22 states. While many of the illnesses in IA and NB were linked to bagged salad mix produced by Taylor Farms de Mexico, CDC indicates that a number of cases in Texas are unrelated to the cases in IA and NB, but rather originated with people eating at the same restaurant..

CDC is investigating the Texas cases as well as the cases seen in other states to see how any of them might be related and what might be the source (CDC release below).

The Taylor Farms facility in Mexico that was linked to the IA and NB cases has resumed production after undergoing an extensive FDA audit. (story and link below).


CDC News
Investigation of an Outbreak of Cyclosporiasis in the United Stateshttp://www.cdc.gov/parasites/cyclosporiasis/outbreaks/investigation-2013.html

LAST UPDATED AUGUST 26, 2013 7:00 PM EDT
Case counts are updated Mondays, Wednesdays, and Fridays
On June 28, 2013, CDC was notified of 2 laboratory-confirmed cases of Cyclospora infection in Iowa residents who had become ill in June and did not have a history of international travel during the 14 days before the onset of illness. Since that date, CDC has been collaborating with public health officials in multiple states and the U.S. Food and Drug Administration (FDA) to investigate an outbreak of cyclosporiasis.

Highlights
Read the Advice to Consumers
Read the Guidance for Laboratories
Cyclospora cayetanensis is a single-celled parasite that causes an intestinal infection called cyclosporiasis.
As of August 23, 2013 (5pm EDT), CDC has been notified of 610 ill persons with Cyclospora infection from 22 states: Arkansas, California, Connecticut, Florida, Georgia, Illinois, Iowa, Kansas, Louisiana, Minnesota, Missouri, Nebraska, New Jersey, New Hampshire, New York (including New York City), Ohio, South Dakota, Tennessee, Texas, Virginia, Wisconsin, and Wyoming.
Most of the illness onset dates have ranged from mid-June through mid-July.
Among 581 ill persons with available information, 43 (7%) have reported being hospitalized. No deaths have been reported.
Public health officials in Iowa and Nebraska performed investigations within their states and concluded that restaurant-associated cases of Cyclospora infection in their states were linked to a salad mix produced by Taylor Farms de Mexico.
On August 12, 2013, Taylor Farms de Mexico informed FDA that the company had voluntarily suspended production and shipment of any salad mix, leafy green, or salad mix components from its operations in Mexico to the United States.
On August 25, 2013, Taylor Farms de Mexico, with FDA concurrence , resumed production and shipment of salad mix, leafy greens, and salad mix components to the United States.
Currently, CDC is collaborating with the Texas Department of Health and Human Services and local public health departments to investigate cases of cyclosporiasis reported among people in Texas.
The preliminary analysis of results from an investigation into a cluster of cases that ate at a Texas restaurant does not show a connection to Taylor Farms de Mexico. This investigation is ongoing.
Although the investigation of cases continues, available evidence suggests that not all of the cases of cyclosporiasis in the various states are directly related to each other.

What is Gluten Free - FDA sets a standard

FDA established a standard that defines “Gluten Free”. Gluten free is a food that does not contain an a gluten containing grain such as wheat, does not contain an ingredient that is derived from a gluten containing grain, and does not contain an ingredient derived from a gluten containing grain that has been processed to remove the protein (such as wheat starch) where that ingredient has more than 20 ppm of gluten. And is produced so that the food will not be contaminated with the unavoidable presence of gluten to a level of no more than 20 ppm.

Foods that are free of gluten by their nature can be labeled as gluten free, however they do not have to be labeled as such if they are gluten free. It is voluntary. Manufacturers are not required to test for the presence of gluten, but are required to meet the requirements of the law, so manufacturers can use a number of tools to meet the standard.

Establishing this set standard allows uniform labeling thus making it easier for those with the celiac disease to make informed decisions regarding food items.

Gluten is protein that is found in wheat, rye, barley. In people with celiac disease, gluten triggers an immune reaction that results in antibodies attacking the intestinal lining. It can be painful for those individuals who inadvertently ingest gluten. It can also impact absorption of nutrients from the intestines. This condition is especially problematic in children where it can lead to growth problems, and weight loss. For adults, in addition to the stomach issues, it can lead to long term effects such as malnutrition, liver disease, and cancer of the intestines. It is estimated that roughly 1 in 100 people have the disease (whether they know it or not). http://www.celiac.com/articles/23024/1/Just-How-Common-are-Celiac-Disease-and-Gluten-Sensitivity/Page1.html

It is important to remember that gluten is an important part of the diet and a gluten free diet is not recommended for the general public



FDA NEWS RELEASE
 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm363474.htm
For Immediate Release: August 2, 2013

Media Inquiries: Shelly Burgess 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
En Español1

FDA defines “gluten-free” for food labeling
New rule provides standard definition to protect the health of Americans with celiac disease

The U.S. Food and Drug Administration today published a new regulation defining the term "gluten-free" for voluntary food labeling. This will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten free diet.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.”

This new federal definition standardizes the meaning of “gluten-free” claims across the food industry. It requires that, in order to use the term "gluten-free" on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.” 

The FDA recognizes that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have a year after the rule is published to bring their labels into compliance with the new requirements.

“We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with celiac disease to identify foods that meet the federal definition of ‘gluten-free’” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

The term "gluten" refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.

The FDA was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which directed FDA to set guidelines for the use of the term “gluten-free” to help people with celiac disease maintain a gluten-free diet.

The regulation was published today in the Federal Register2.

For more information:
FDA: Gluten-Free Labeling3
FDA: Gluten-Free Labeling Final Rule Q&A4
Consumer Update5 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Iams and Eukanuba dry pet food recalled due to the potential for Salmonella contamination

Proctor and Gamble is issuing a recall for Iams and Eukanuba dry dog food and dry cat food due to the potential to be contaminated with Salmonella. The issue was discovered during product testing. No illnesses have been reported.  

A wide variety of the products are being recalled, but is limited to a 10 day production window. Products were distributed across the US.

Salmonella in pet food can cause infection in pets as well as owners who do not wash their hands after handling contaminated product. Of course there are those people who either let the dog lick their face, or may try a kibble or two.

Dry pet food becomes contaminated with Salmonella through cross contamination in the post-process environment (after extrusion) when either the plant environment is contaminated or when one of the post-process additions (fat or flavoring) is contaminated. The way to prevent this is to prevent Salmonella in plant, specifically in the finished product areas. This is done through good sanitation, air control, as well as the movement of people and materials. Salmonella must also be eliminated from the post-process additions of fat and flavoring through proper processing and handling of those ingredients. Once either the post-process environment becomes contaminated with Salmonella, or one of the post-process addition becomes contaminated, then it can contaminate pet food. Salmonella can survive in the plant and on the dry pet food for months.


FDA Recall Notice
P&G Voluntarily Recalls Limited Quantity of Dry Pet Food Due to Possible Health Risk
http://www.fda.gov/Safety/Recalls/ucm365154.htm

Contact
Consumer:
800-208-0172

Media:
Jason Taylor
513-622-1111

FOR IMMEDIATE RELEASE - August 14, 2013 - The Procter & Gamble Company (P&G) has voluntarily recalled specific lots of dry pet food because they have the potential to be contaminated with Salmonella. These lots were distributed in the United States and represent roughly one-tenth of one percent (0.1%) of annual production. No Salmonella-related illnesses have been reported to date in association with these product lots.

What is the Risk? - Household Germ Study

A newly released “study”, the 2013 NSF International Household Germ Study, has sparked some media attention. http://www.nsf.org/business/newsroom/pdf/2013_germ_study_FOR-WEB-ONLY.pdf

The summary report discusses the analysis of 14 common kitchen items for the presence of E. coli, Salmonella, yeast and mold, and Listeria. In they identify:

The six “germiest” items contained the following microorganisms that can cause sickness:
1.) Refrigerator vegetable compartment: Salmonella, Listeria, yeast and mold
2.) Refrigerator meat compartment: Salmonella, E.coli, yeast and mold
3.) Blender gasket: Salmonella, E.coli, yeast and mold
4.) Can opener: Salmonella, E.coli, yeast and mold
5.) Rubber spatula: E. coli, yeast and mold
6.) Food storage container with rubber seal: Salmonella, yeast and mold 

And share their analysis on organisms found.

• E. coli – 36 percent of items contained E. coli. Items with E. coli included the refrigerator meat compartment, rubber spatula, blender gasket, can opener and pizza cutter.
• Salmonella – 36 percent of items had Salmonella including the refrigerator vegetable and meat compartments, can opener, blender gasket and the rubber seal on a food storage container.
• Yeast and mold – All 14 items (100 percent) tested positive for yeast and mold, and six items (43 percent) tested positive at concerning levels. The six items with concerning levels of yeast and mold were the refrigerator vegetable compartment, rubber spatula, blender gasket, refrigerator ice and water dispensers, and the rubber seal on a food storage container.
• Listeria – 14 percent of items tested positive for Listeria. The refrigerator vegetable compartment contained Listeria, as did the refrigerator door seal.

While the summary of the “study” highlights the need for cleaning in the kitchen, it is unknown to what degree this is actually a scientifically based study (statistically sound, peer reviewed, etc). The results are also questionable - the percent of samples found to be positive for Salmonella and E. coli is very high compared to previously published studies. (It is also important to note that this is generic E. coli, not necessarily pathogen E. coli). It would have been nice if they published the actual results so we could see the number of kitchens sampled (was it one kitchen?), percent positive for each item, etc.

Another item missed in this report is the impact of cross contamination during handling of raw foods and subsequent cleaning. This is when there is most likely to be transfer of pathogens to food contact surfaces, including appliance, as well as other foods. Along with this, there is the need for cleaning practices immediately after handling and processing (proper use of cleaning cloths and the use of cleaning/sanitizing agents). 

So yes, proper, routine cleaning of kitchen appliances and utensils is very important, and NSP does provide nice links for cleaning various kitchen appliances, but they miss what many consider a bigger risk for pathogen cross contamination in the kitchen – the potential for cross contamination during handling, processing, and subsequent cleaning. And there will be many who read this and overreact, thinking that their kitchen is full of Salmonella. Unfortunately, too others will carry this story not making any qualifying comments, but rather will probably further embellish upon the results.

Cyclospora outbreak in salad linked to Mexican farm

The cyclospora outbreak has been linked to foodservice bagged salad served at Olive Garden and Red Lobster. The source of the salad was a Mexican farm. The farm, run as a subsidiary of the US produce company Taylor Farms, was said to be a state-of-the-art facility with an exception food safety record. It had been recently inspected by FDA in 2011 and they found no notable issues.

To date, over 400 individuals in 16 states have become ill from salad contaminated with cyclospora. Taylor Farms reports that none of the salad is still on the market.

 

FDA Links Bagged Salad Mix Stomach Bug In 2 States To Mexican Farm
By MARY CLARE JALONICK 08/02/13 11:16 PM ET EDT
http://www.huffingtonpost.com/2013/08/02/cyclospora-stomach-bug-mexican-farm-fda_n_3698075.html


WASHINGTON — The Food and Drug Administration says an outbreak of stomach illnesses in Iowa and Nebraska is linked to salad mix served at local Olive Garden and Red Lobster restaurants and supplied by a Mexican farm.

The outbreak of cyclospora infections has sickened more than 400 people in 16 states in all. The agency says it is still working to determine whether the salad mix is the source of illnesses in the other 14 states.

Local Farmers Worry About New Food Safety Guidelines

WPSU’s Emily Reddy talked with Dr. Luke LaBorde of Penn State and  Kim Tait, a small scale processor, on the FSMA bill and the impact on smaller farms and processors,   [Link to radio report]

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.

Cheese recalled after it was linked to illness

UPDATE - April 4, 2014, CDC issued Notes from Field report.


Whole Foods is recalling Crave Brothers Les Frères cheese in response to a recall issued by the manufacturer, Crave Brothers, when their cheese was linked with 5 illnesses and one death.

 According to the company website, the type of cheese, Les Freres, is a semi-soft cheese.  

(http://www.cravecheese.com/our-cheese.php?Cheesecyclopedia-5)

Description
This European style farmstead cheese was developed with great care to reflect the Crave Brothers' Irish-French heritage. This one-of-a-kind washed-rind cheese has an earthy, mushroomy, fruity flavor and a creamy texture that is softer than Brie and has a nutty aftertaste. It is available in a small version-- Le Petit Frère®.

Appearance
It has a light-colored paste that does not become too runny, and holds its shape well.

Texture
Semi-soft.

Flavor
It is a rich, rind washed cheese with an earthy, fruity flavor. It has just a mildly mushroomy appeal.

The product sold at Whole Foods was packaged pre-cut wedges. Crave Brothers is also recalling - Les Frères (LF225 2/2.5#) with a make date of 7-1-13 or prior, packaged in white plastic with a green and gold label; Petit Frère (PF88 8/8 oz) with a make date of 7-1-13 or prior, packaged in small round wooden boxes; and Petit Frère with Truffles (PF88T 8/8 oz) with a make date of 7-1-13 or prior, packaged in small round wooden boxes.

FDA News Release
Whole Foods Market Recalls Cheese Because of Possible Health Riskhttp://www.fda.gov/Safety/Recalls/ucm359697.htm
FOR IMMEDIATE RELEASE - July 5, 2013 -Whole Foods Market announces that it is recalling Crave Brothers Les Frères cheese in response to a recall by the Crave Brothers Farmstead Cheese Company of Waterloo, Wisconsin. The cheese is being recalled because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, one illness and one death have been reported. Crave Brothers was informed by regulatory agencies of an ongoing investigation related to potential health risks associated with Listeria monocytogenes. The company immediately ceased the production and distribution of the products.

Handwashing - How many are actually improperly washing?

In a recently released study, researchers found that only 5 percent of people wash their hands correctly. While the study does point out that many people do not wash their hands correctly, the reported 5% seems lower than what we would expect. There may be a few issues with the study.

1) The US Food Code states that proper scrubbing of hands is 10 to 15 seconds (total handwashing time is 20 seconds), while the study uses 15 to 20 seconds. (http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm181242.htm)

2) All observations were conducted on a college town. Perhaps not a great cross-section of the general public.

3) The study was conducted by visual observation – someone standing around in the restroom watching others….now, if  some creeper is hanging out in a bathroom and staring at you, are you going to move on a little quicker than normal and rewash later?

Only 5 Percent of Restroom Patrons Wash Hands Properly, Study Finds

And 1 in 10 don't scrub up at all after flushinghttp://health.usnews.com/health-news/news/articles/2013/06/11/only-5-percent-of-restroom-patrons-wash-hands-properly-study-finds

USNews Health June 11, 2013 RSS Feed Print

TUESDAY, June 11 (HealthDay News) -- The next time you reach out to shake someone's hand, consider this finding: A recent study of hand-washing habits found only 5 percent of people who used the restroom scrubbed long enough to kill germs that can cause infections.
Thirty-three percent didn't use soap, and 10 percent didn't wash their hands at all, according to the study, based on Michigan State University researchers' observations of more than 3,700 people in a college town's public restrooms.

"These findings were surprising to us because past research suggested that proper hand washing is occurring at a much higher rate," lead investigator Carl Borchgrevink, an associate professor of hospitality business, said in a university news release.

Among the other findings:

Men were less likely than women to clean their hands. Fifteen percent of men and 7 percent of women didn't wash their hands at all. When they did wash their hands, only 50 percent of men used soap, compared with 78 percent of women.
People were less likely to wash their hands if the sink was dirty.
People were more likely to wash their hands earlier in the day. This may be because when people are out at night for a meal or drinks, they are relaxed and hand washing becomes less important, the researchers suggested.
People were more likely to wash their hands if they saw a sign encouraging them to do so. 

Linkage of the level of pathogens at farm level to the level at processing

In a recent study, researchers found that pathogen level at the farm level impacted the level of pathogens found in the processing plant, that is, the more pathogens at the farm, the more that were found in the plant. While this is not surprising, it points to the need for added control at the farm level. Unfortunately, there is still a disconnect for some on the impact of farms on downstream contamination issues. While total elimination of pathogens at the farm would unfeasible, a reduction of the level may be achieved through the adoption of improved practices.

Investigators Link Poultry Contamination on Farm and at Processing Plant

CONTACT: Jim Sliwa ASM Newsroom
http://www.asm.org/index.php/asm-newsroom2/88-news-room/journal-tipsheets/91694-investigators-link-poultry-contamination-on-farm-and-at-processing-plant

WASHINGTON, DC – May 31, 2013 -- Researchers at the University of Georgia, Athens, have identified a strong link between the prevalence and load of certain food-borne pathogens on poultry farms, and later downstream at the processing plant. They report their findings in a manuscript published ahead of print in the journal Applied and Environmental Microbiology.

“This study suggests that reducing foodborne pathogen loads on broiler chicken farms would help to reduce pathogen loads at processing, and may ultimately help to reduce the risk of foodborne illness,” says Roy Berghaus, an author on the study. “This is important because most of our efforts towards reducing foodborne pathogens are currently focused on what happens during processing. Processing interventions are effective but they can only do so much.”

Salmonella and Campylobacter bacteria cause an estimated 1.9 million food-borne illnesses in the US annually, and poultry is a major source of both. Earlier studies have linked pathogen prevalence on the farm and at processing, but none has measured the strength of the associations between pathogen loads, according to the report. In the current study, Salmonella and Campylobacter detected at the processing plant were found in farm samples 96 and 71 percent of the time, respectively.

The prevalence of both pathogens dropped during processing, Salmonella from 45.9 percent to 2.4 percent, and Campylobacter from 68.7 to 43.6 percent, according to the report.

The two pathogens are major contributors to human misery in the US. Among 104 different pathogen-food combinations, Campylobacter and Salmonella infections from poultry were recently ranked first and fourth, respectively in terms of “combined impact on the total cost of illness and loss of quality-adjusted life years,” according to the report.

The team suggests that fewer pathogens on the farm would reduce contamination levels at the processing plant, and notes that “vaccination of breeder hens, competitive exclusion products and the use of acidified water during feed withdrawal” have all reduced Salmonella in commercial broiler flocks. However “reliable approaches to reduce Campylobacter colonization are currently unavailable,” although post-processing freezing has reduced Campylobacter loads on carcasses.

A copy of the manuscript can be found online at http://bit.ly/asmtip0513a. The paper is scheduled to be formally published in the June 2013 issue of Applied and Environmental Microbiology.

(R.D. Berghaus, S.G. Thayer, B.F. Law, R.M. Mild, C.L. Hofacre, and R.S. Singer, 2013. Enumeration of Salmonella and Campylobacter spp. in environmental farm samples and processing plant carcass rinses from commercial broiler chicken flocks. Appl. Environ. Microbiol. published ahead of print 26 April 2013 ,doi:10.1128/AEM.00836-13.)

Proposed rule for labeling of injected meat

USDA has issued a proposed rule that would require the label ‘mechanically tenderized” on labels of raw or partially cooked needle or blade tenderized beef. http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2008-0017.pdf

The Food Safety and Inspection Service (FSIS) is proposing to require the use of the descriptive designation ‘‘mechanically tenderized’’ on the labels of raw or partially cooked needle- or blade-tenderized beef products, including beef products injected with marinade or solution, unless such products are destined to be fully cooked at an official establishment. Beef products that have been needle- or blade-tenderized are referred to as ‘‘mechanically tenderized’’ products.

Meat products that are needle injected or blade tenderized should be cooked to a higher temperature than intact beef because in the process of injecting or blade tenderizing (as in chopped steak), the needles or blades can push pathogenic bacteria deep into the meat. So like ground beef, the heat has to penetrate further into the meat to kill the bacteria.

Processors inject meat in some cases when they want to marinade the product, or in other cases when they have a cheaper cut of meat that they want to inject solution to help the meat retain more moisture during cooking. Blade tenderizing is done to help break the connective tissue in the meat to make it easier to chew. Unfortunately, too many people cook this meat rare or medium rare, just like regular cuts of steak. But for safety, consumers should cook this type of meat to an internal temperature of 160 F.*(155 F for foodservice.) By requiring meat to be labeled as mechanically tenderized, and by having validated cooking instructions, it is more likely that this meat will be identified as meat that should be cooked to a higher temperature.

*or other temperature that is scientifically validated by the processor.

USDA and EPA Launch U.S. Food Waste Challenge

USDA in conjunction with EPA is launching a new initiative to reduce food waste. They estimate that food waste is roughly 30 to 40 percent of the US Food Supply. Wasted food happens at every part of the food chain, including retail, foodservice, and the consumer. According to the release – “USDA will also work with industry to increase donations from imported produce that does not meet quality standards, streamline procedures for donating wholesome misbranded meat and poultry products, update U.S. food loss estimates at the retail level, and pilot-test a meat-composting program to reduce the amount of meat being sent to landfills from food safety inspection labs.”

http://www.usda.gov/wps/portal/usda/usdahome?contentid=2013/06/0112.xml&contentidonly=true

FDA issues the Reportable Food Registry Annual Report

The Reportable Food Registry (RFR) is a portal established by FDA for parties to report food safety issues. “A reportable food is an article of food/feed for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.” This past year, there were 1095 submissions, slightly higher than last year. Of notable items resulting in recalls were Listeria detected in sliced onions, Salmonella in Mangoes, and undeclared milk in a snack bar. Looking at Table 5 Distribution of Primary RFR Entries by Commodity and Hazard- Year 3m, there are a few categories that are worth noting:

Bakery – Undeclared allergens (18)
Animal Feed – Nutrient unbalance (8), Salmonella (5), and drug contamination (4)
Confections – Undeclared allergens (11)
Dairy - Listeria (11) and Allergens (7)
Dressings – Undeclared allergens (5)
Nuts – Salmonella (8)
Fresh Cut Produce – Listeria (15) and Salmonella (6)
Produce RAC – Listeria (10) and Salmonella (22)
Snack foods – Undeclared Allergens (7)
Spices and Seasonings – Salmonella (5) and Allergens (3)

http://www.fda.gov/Food/ComplianceEnforcement/RFR/ucm200958.htm

FDA / USDA release Food Defense Plan Builder

FDA / USDA released a Food Defense Plan Builder – This is a downloadable program for developing a Food Defense Plan. It was  found to be very easy to use. Once you enter in your data, it prints off a nice little food defense plan.   It is actually worth giving it a shot.

http://www.fda.gov/Food/FoodDefense/ToolsEducationalMaterials/ucm349888.htm

General Mills recalls Cinnamon Toast Crunch Bowlpak

General mills is recalling 168 cases of single serve reduced Cinnamon Toast Crunch after one of their ingredient suppliers reported the possible presence of Salmonella in the ingredient. This is a great reminder of the impact of a supplier (and the lab of that supplier) can have on a major company. Although only a small number of cases were recalled, this news release was picked up by every news outlet.

http://www.fda.gov/Safety/Recalls/ucm355309.htm

CDC Report: Listeria Illnesses, Deaths, and Outbreaks — United States, 2009–2011

CDC just released a report detailing Listeria outbreaks in the United States, 2009-2011. In this time frame, ,1651 cases were reported nationally. 

In summary, Listeria monocytogenes is a foodborne pathogen that primarily impacts those in high risk groups – elderly, immunocompromised, and pregnant women. Listeria infection in these individuals leads to bacteremia (bacterial blood infection), meningitis, and death (mortality rate of 21%).

Soft cheeses and cheeses made from unpasteurized milk are the primary vehicles, although there have been cases related to produce (cut celery and cantaloupe). So for high risk groups, individuals in these high risk groups may want to forgo the soft cheeses, cheeses made from unpasteurized milk, and unpasteurized milk.

I think it is important to note what is not on list of responsible food items in this reporting period – deli meats. The meat industry has done a good job in reducing the risk associated with those ready-to-eat meat items. But work needs to continue with all refrigerated RTE items that can support the growth of Listeria. Recently, an interagency report on the risk of Listeria in Retail Delicatessens (http://pennstatefoodsafety.blogspot.com/2013/05/risk-assessment-of-listeria-in-retail.html) highlighted the practices retail stores can take to reduce the risk of Listeria contamination.


CDC MMWR Repot  http://www.cdc.gov/mmwr/preview/mmwrhtml/mm62e0604a1.htm?s_cid=mm62e0604a1_w

Vital Signs: Listeria Illnesses, Deaths, and Outbreaks — United States, 2009–2011

Early Release
June 4, 2013 / 62(Early Release);1-5

Abstract

Background: Older adults, pregnant women, and persons with immunocompromising conditions are at higher risk than others for invasive Listeria monocytogenes infection (listeriosis), a rare and preventable foodborne illness that can cause bacteremia, meningitis, fetal loss, and death.

Methods: This report summarizes data on 2009–2011 listeriosis cases and outbreaks reported to U.S. surveillance systems. The Listeria Initiative and PulseNet conduct nationwide surveillance to rapidly detect and respond to outbreaks, the Foodborne Diseases Active Surveillance Network (FoodNet) conducts active, sentinel population–based surveillance to track incidence trends, and the Foodborne Disease Outbreak Surveillance System (FDOSS) receives reports of investigated outbreaks to track foods and settings associated with outbreaks.

Results: Nationwide, 1,651 cases of listeriosis occurring during 2009–2011 were reported. The case-fatality rate was 21%. Most cases occurred among adults aged ≥65 years (950 [58%]), and 14% (227) were pregnancy-associated. At least 74% of nonpregnant patients aged <65 years had an immunocompromising condition, most commonly immunosuppressive therapy or malignancy. The average annual incidence was 0.29 cases per 100,000 population. Compared with the overall population, incidence was markedly higher among adults aged ≥65 years (1.3; relative rate [RR]: 4.4) and pregnant women (3.0; RR: 10.1). Twelve reported outbreaks affected 224 patients in 38 states. Five outbreak investigations implicated soft cheeses made from pasteurized milk that were likely contaminated during cheese-making (four implicated Mexican-style cheese, and one implicated two other types of cheese). Two outbreaks were linked to raw produce.
Conclusions: Almost all listeriosis occurs in persons in higher-risk groups. Soft cheeses were prominent vehicles, but other foods also caused recent outbreaks. Prevention targeting higher-risk groups and control of Listeria monocytogenes contamination in foods implicated by outbreak investigations will have the greatest impact on reducing the burden of listeriosis.

Implications for Public Health Practice: Careful attention to food safety is especially important to protect vulnerable populations. Surveillance for foodborne infections like listeriosis identifies food safety gaps that can be addressed by industry, regulatory authorities, food preparers, and consumers.