Applying the Drug Guidance "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection" to Food Operations

FDA recently issued a guidance for drug related companies titled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing to Permit Drug Inspection". Some have suggested that this type of guidance may be extended to food processing facilities that fall under FDA jurisdiction.

It is stated in this guidance:

It is a prohibited act under sections 301(e) and 301(f) of the FD&C Act to refuse to permit entry or inspection or refuse to permit access to or copying of certain specified records.10 New section 501(j) of the FD&C Act, as added by FDASIA section 707, now deems a drug to be adulterated if "…it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection."

 Basically, if they can't see what they want, when they want, that product is adulterated.

The categories defined in the guidance include 1) Delay of inspection (pushing back an inspection, holding up during an inspection, delaying of getting records), 2) Denial of inspection, 3) Limiting an inspection (limiting access, limiting photography, limiting access to records or the copying of those records, and limiting or preventing the collection of samples, and 4) Refusal to permit entry.

It may be worth the time to gain an understanding of this guidance and what constitutes the definitions in preventing access.  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf

Sausage Product Recalled Due to Temperature Abused Rice Ingredient

A Texas company is recalling a Boudin, a sausage product made with cooked rice, after USDA found that the company did not properly handle the cooked rice from a temperature control standpoint.

Boudin is a Cajun type product that is a mixture of cooked rice, pork, and seasonings.  It may contain onions and green peppers.  The mixture is ground and stuffed into a sausage casing.    

One of the primary risks associated with temperature abused rice is Bacillus cereus.  B. cereus can cause illness when people ingest B. cereus cells (diarrheal syndrome) or by the toxin it produces (emetic syndrome).  In this particular case, the concern would be the emetic syndrome.  With this, the spore-forming organism is not destroyed when the rice is cooked, and then grows in the temperature-abused cooked rice.  As it grows to high numbers, it produces the toxin.  When the toxin containing food is eaten, it results in severe vomiting.  This toxin is heat stable..

Industrial Oil Recalled after Being Used in Feed.

An Ohio company is recalling Soyoil containing Lascadoil, industrial processing waste oil, which was intended for non-food product or bio-fuels but may have been used as a feed ingredient.  Use of it in feed may have resulted in the deaths of some turkeys.

Interesting is the fact that this comes as FDA looks to implement preventive control for feed for animals as a part of the FSMA regulation.

Shur-Green Farms is basically a recycler of food waste.  The website (excerpt below) positions itself as a green company taking waste and putting it to best use.  Certainly that is admirable.  But you can imagine that waste streams may be challenging.  While not sure in this case, but if a person inadvertently contaminated a waste product, and then sent it to this company for recycling, and the assumption is made that it can be used in feed...then there can be issues.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm420543.htm
Shur-Green Farms Issues Voluntary Nationwide Recall of Lascadoil/Soyoil Due to Possible Lasalocid Contamination

Contact:
Consumer:
937-459-2768

FOR IMMEDIATE RELEASE — October 23, 2014 — Shur-Green Farms LLC(Ansonia, OH) has voluntarily recalled loads of Soyoil containing Lascadoil, industrial processing waste oil, which was intended for non-food product or bio-fuels but may have been used as a feed ingredient. This voluntary recall is the result of death in turkeys.

The recall includes load sold on or before September 17, 2014.

NJ Company Recalls Cashew Pieces for Potential Salmonella Contamination

A NJ food company is recalling bags of cashew pieces after FDA testing found the potential for Salmonella. There have not yet been any reported illnesses.

It is hard to see from the notice whether the product actually tested positive "The potential for contamination was noted after routine testing conducted by the FDA."   Never comes out to say 'A sample of the product tested positive for Salmonella',

 
FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm420689.htm
Chetak New York L.L.C. Recalls 7 Oz., 14 Oz., & 28 Oz. Packages of "Deep Raw Cashew Pieces" Because of Possible Health Risk

Contact:  Consumer:  1-973-835-1906

FOR IMMEDIATE RELEASE — October 27, 2014 — Edison, NJ — Chetak New York L.L.C. of Edison, NJ is recalling its 5560 packages of 7oz., 3840 packages of 14oz., & 1920 packages of 28oz. "DEEP RAW CASHEW PIECES" because they have 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.

Baby Wipes Recalled Due to Bacterial Contamination

 A PA firm is recalling baby wipes after tests showed that the product contains Burkholderia cepacia. This gram negative bacteria is considered more of a secondary pathogen in that it only causes infection in individuals with underlying health issues, especially those in hospitals. According to the CDC, B. cepacia is a hardy organism in that it is more resistant to common antibiotics. It has also been found to be more resistant to antiseptics. This might be a reason why it was found in this product, and is also a good reason for conducting a recall in that it will have exposure to a high risk group...babies.

FDA Recall Noticehttp://www.fda.gov/Safety/Recalls/ucm420426.htm
Nutek Disposables, Inc. Issues Alert Due to Potential Bacteria in Baby Wipes

Contact:
Consumer: 1-855-646-4351
Media: Sean Wood 1-212-445-8310
swood@webershandwick.com
Hallie Bozzi 1-212-445-8276 hbozzi@webershandwick.com

FOR IMMEDIATE RELEASE — Oct. 25, 2014 — MCELHATTAN, PA — Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria. These wipes were distributed by Nutek prior to October 21, 2014 to the following retail stores: Walgreens, Sam's Club, Family Dollar, Fred's, and Diapers.com.

Breaded Chicken Product Recalled After Linked to Cluster of Salmonella Illnesses

A Chicago based firm is recalling partially prepared breaded chicken breast product - Chicken Kiev after that product was linked to cluster of Salmonella illnesses.

Although this product is partially cooked by the processor (in order to set the breading), it still needs to be further cooked by the consumer as per the cooking instructions.

But it is easy to see where consumer issues can occur regarding undercooking.   For one, the product is frozen, so when the consumer begins with frozen product, they may not cook it long enough in order to achieve the proper internal temperature. Along with this, many people do not use a thermometer in order to ensure that temperature is met. 

Another issue can be related to the fact that breaded products often look like they are fully cooked. This is because the par-cooking that sets the breading gives it a finished cooked appearance.

Salmonella enteritidis is a strain most often associated with eggs, although we can see it in chicken meat as well.
 
 
 
USDA News Release
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2014/recall-073-2014-release
Illinois Firm Recalls Chicken Products Due to Possible Salmonella Enteritidis Contamination
Class I Recall 073-2014
Health Risk: High Oct 24, 2014
Congressional and Public Affairs  Benjamin Bell   (202) 720-9113 

WASHINGTON, October 24, 2014 – Aspen Foods Division of Koch Meats, a Chicago, Il., based establishment, is recalling 28,980 pounds of chicken products that may be contaminated with a particular strain of Salmonella Enteritidis, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. FSIS requested Aspen Foods conduct this recall because this product is known to be associated with a specific illness cluster.

Breaded Chicken Product Recalled Due to Presence of S. aureus Enterotoxin

A Pennsylvania firm is recalling breaded chicken product after the Colorado State Department of Agriculture discovered Staphylococcal enterotoxin present in the product during routine testing.  There have been no reported illnesses.

As you know, when Staphylococcus aureus grows to high levels in food, it can produce an enterotoxin.  A person suffers the illness when they eat the food with the toxin, not the bacteria.  The symptoms. vomiting, nausea, abdominal cramps, and diarrhea, are seen in 1 to 4 hours after consuming, but can be within 30 minutes up to 10 hours after consumption.

The toxin is heat stable, and will survive any cooking done by the consumer.

S. aureus does not grow at refrigeration temperatures, so generally, growth and toxin production is seen in temperature abused products.  The level of S. aureus to get levels of toxin needed for illness is >10E5.

In this particular case, we can assume the product was battered, breaded and then par-fried to set the breading.  Following that thinking, the organism would have either grown in the batter (which is a common issue when batter is not properly temperature controlled), or in the finished product, if that product was temperature abused.  In the first case where it formed in the batter, par-frying would have eliminated the vegetative organism leaving only the toxin.  If it formed on the finished product, again because if that finished product had been temperature abused, we would expect to see the organism as well as the toxin on the frozen product.   We are not able to tell from this report which was more likely the case.

Is Staph enterotoxin a routine test for regulatory laboratories? Not sure.


USDA News Release
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2014/recall-074-2014-release
Pennsylvania Firm Recalls Chicken Products Due to Staphylococcal Enterotoxin Contamination
Class I Recall 074-2014
Health Risk: High Oct 25, 2014

Congressional and Public Affairs  Megan Buckles  (202) 720-9113 

WASHINGTON, Oct. 25, 2014 – Murry’s Inc., a Lebanon, Pa. establishment, is recalling approximately 31,689 pounds of gluten free breaded chicken products that may be contaminated with Staphylococcal enterotoxin, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Is Poor Nutrition Linked to Children's Bad Behavior?

In this month's Food Technology (October, 2014), the feature article A Diet for a Kinder Planet lays out some of the research that indicated a link between poor nutrition and bad behavior. 

It states that omega-3 fatty acids, B vitamins, zinc and tryptophan may be essential for mental balance.  These are often lacking in the diets of children.  Because of this, they suggest that be a cause of antisocial behavior.

The omega-3 fatty acids an important component in brain tissue (considering the 60% of the brain's composition is fat....I guess it is not bad to be called a fat head).   "In particular, the omega-3 fatty acid docasohexaenoic acid (DHA) makes up a significant proportion of nerve-cell membranes and synapse in the central nervous system.."  One of the best sources of omega-3 fatty acids is fish.

The article admits that the studies to this point only demonstrate a positive correlation and do not indicate causation.  This is an interesting read.
 

Food Technology (October, 2014)
http://www.ift.org/food-technology/past-issues/2014/october/features/a_diet_for_a_kinder_planet.aspx?page=viewall
A Diet for a Kinder Planet Toni Tarver | October 2014, Volume 68, No.10

Considered essential for good health, a wholesome diet and good nutrition may also help improve the behavior and mood of society at large.

Good nutrition is a prerequisite for proper development of the human body after conception, and it is considered a crucial factor in the prevention of chronic disease. It is widely accepted that cancer, cardiovascular disease, diabetes, obesity, and other manifestations of chronic inflammation can be controlled or averted with a nutritious diet. Consequently, the food and nutrition policies of the United States, the United Kingdom, Canada, and other wealthy countries have focused almost exclusively on how diet affects physical well-being, recommending proper caloric and nutrient intakes for a healthy heart and healthy teeth, bones, and weight. However, these policies make little or no reference to the human brain, which is the most complex part of the body.

The brain regulates the functioning of vital bodily organs, is the center for intelligence and emotional response, and consumes approximately 20% of the body’s caloric energy. The brain is also responsible for the expression of personality, mood, and behavior—all of which define humanity. Yet wealthy countries with diverse and extensive food and nutrition policies focused on healthy bodily functions and physical well-being have largely ignored the importance of proper brain function and behavioral well-being. As a consequence, Westernized countries such as the United States and the United Kingdom have experienced a precipitous rise in aggression, irritability, impulsivity, and other antisocial behaviors. Are these displays simply a consequence of the extensive free will enjoyed by Americans, Britons, and others, or is something else at play? A fascinating field of research suggests that depression, aggression, impulsivity, and other displays of antisocial behavior may be the result of nutrient deficiencies in the brain and that certain foods and the nutrients they contain may curtail the expression of antisocial behavior.

Serrano Chile Peppers Recalled Due to Potential Salmonella Contamination

 A North Carolina Company is recalling Serrano Chile Peppers after they received notice that the Michigan Department of Agriculture found a positive Salmonella sample in a lot. No illnesses have been reported.

Salmonella on peppers can be an issue because these peppers are often raw when making fresh salsa. Case in point is the 2008 Salmonella Saint Paul Outbreak where the CDC stated "the investigation showed that jalapeño peppers were a major source of contamination and that serrano peppers also were a source".  In this case, it is believed that the diced tomatoes served to support the growth of the Salmonella when that salsa was held at room temperature.


FDA Recall Notice
Bailey Farms Inc. Recalls Fresh Serrano Chile Peppers Because Of Possible Health Riskhttp://www.fda.gov/Safety/Recalls/ucm419894.htm


Contact:  Consumer:  1-888-820-2545

FOR IMMEDIATE RELEASE — October 21, 2014 — Bailey Farms, Inc. of Oxford, NC is voluntarily recalling 6,215 pounds of Fresh Serrano Chile Peppers, 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), endocarditic and arthritis.