Wednesday, May 31, 2017

Preparing for a FSMA Audit from FoodOnline

A recent article in FoodOnline (an informative online journal you should subscribe to if you haven't already) discusses how Kraft Heinz prepares for FDA FSMA inspections. A few key points brought up in this article are similar to what we have been hearing about from our industry friends about their recent audits.

A summary of what this company's regulatory affairs manager discussed about their company's experiences:
  • 'Inspectors are calling these ‘routine FSMA inspections' and are not distinguishing between Preventive Controls and modernized GMP inspections' 
  • These audits are generally more focused on high-risk products.
  • Auditors had visited 7 of these audits - one full Preventive Controls inspection and six modernized GMP audits.
  • Generally there are three inspectors.
  • Audits have lasted 1 to 5 days, mostly 4 to 5 days.
  • Four of the seven audits included swabathons (100 to 150 swabs), which included Zone 1 (30%), Zone 2 (20%) and Zone 3 (50%).  No zone 4.
  • There is a focus on the company's environmental monitoring program including the records and corrective actions on positvie results.
  • With regard to verification activities, they are focusing on records including corrective action logs, production schedules, sanitation records, and calibrating inspection equipment records.
  • With regard to the Preventive Control plan, inspectors are reviewing the hazard analysis with questions on the justification behind each of the identified hazards.
  • There is also a review of the written recall plan.
  • Recently there is attention on the supply chain program.
  • Review of handling of byproducts used for animal feed, consumer complaint handling, and FSPCA training looking for certificates of completion.
An interesting item in the article is that FDA will want to take photos in the facility, so a company needs to have a policy to address this.  The same goes with photocopying records.

Source: Food Online 
Inside Kraft Heinz's FSMA Inspection Readiness 
By Sam Lewis, associate editor
Follow Me On Twitter @SamIAmOnFood

Thursday, May 25, 2017

Breakfast Sausage Recalled Due to the Potential for Metal Foreign Material

A Kansas establishment is recalling 90,000 lbs of RTE breakfast sausage for metal pieces after "another FSIS-regulated establishment that pieces of metal were embedded in a fully cooked sausage product".

Over the past year, there has been an increasing amount of recalls due to foreign objects.  While these foreign objects may not result in any major injuries, the cost of conducting a recall warrants companies putting in more effort in foreign object control.  This goes beyond just having a metal detector installed into the process.

First, many metal detectors do not get the attention they need.  A really nice guide for metal detectors is "The Guide to Reducing Metal Contamination in the Food Processing Industry" published by Safeline.  

X-ray equipment is much more affordable than it once was, and it can pick-up items metal detectors can't, such as glass, hard plastic, stones, etc.  They are even suitable for metal and foil containers.

But detection is just one part of a foreign object control program.  Other important elements include raw material inspection, preventive maintenance, employee training to prevent accidental drops, and controls at ingredient addition steps to prevent foreign material from packaging and inline preventive devices such as magnets and sifters.

All of these systems need to be properly maintained and verified for performance.  Additionally, consumer complaints must be reviewed with an investigation and appropriate corrective action for any foreign material issues.

USDA / FSIS Recall Notice
Armour Eckrich Meats, LLC Recalls Ready-To-Eat Sausage Products Due to Possible Foreign Matter Contamination
Class II Recall 054-2017
Health Risk: Low 
May 24, 2017

Monday, May 22, 2017

Packaged Salad Items Recalled Due to Metal Pieces from Construction

A NY based produce company is recalling salad products due to the potential for metal pieces.  The metal was said to be generated from construction activities. 

Many facilities carryout construction activities while they are producing products.  However, it is critical to protect product from contamination.  Metal pieces can easily be shot over wide areas during construction activities such as grinding and wielding.

BrightFarms is an interesting company.   Based in NY, the company is building huge hydroponic greenhouses in various market areas in order to grow produce locally to supply those markets.  [Story below].

FDA Recall Notice
Brightfarms Announces Voluntary Regional Recall of Produce Due to Potential Presence of Metal Pieces From Construction
For Immediate Release
May 18, 2017

One Man Dead, A Mom Still Hospitalized after Three Weeks, Both Consumed Contaminated Nacho Cheese Sauce

One woman's story, associated with the botulism in gas station nacho sauce case, highlights the issues for someone with botulism poisoning.  A few hours after eating Doritos drizzled with nacho cheese sauce, she felt fatigue and by the next day, she had blurred vision followed by vomiting and difficulty in breathing.  These symptoms are caused by the  neurotoxin produced by Clostridium botulinum as it grew in the nacho cheese sauce. Once the toxin contaminated food is consumed, "Botulinum toxin causes flaccid paralysis by blocking motor nerve terminals at the neuromuscular junction. The flaccid paralysis progresses symmetrically downward, usually starting with the eyes and face, to the throat, chest, and extremities. When the diaphragm and chest muscles become fully involved, respiration is inhibited and, without intervention, death from asphyxia results". (FDA Bad Bug Book)

There has also been one death being associated with the tainted nacho cheese.  A man had been on life support.  This has not yet been confirmed by State officials.

There are now 10 people that have been affected from eating at this establishment.

Sacramento Bee
Mom put nacho cheese on her Doritos. Three weeks later, she’s still in the hospital.
By Sammy Caiola
May 16, 2017

Meat Processor Recalls Hot Dogs After Receiving Three Complaints for Metal

An Ohio meat processor is recalling 210,000 lbs of  hot dogs after 'the establishment received three complaints of metal objects in the beef frank product package'.

USDA / FSIS Recall Notice
John Morrell and Co. Recalls Beef Frank Products Due to Possible Foreign Matter Contamination
Class II Recall 052-2017
Health Risk: Low May 19, 2017

WA Institutional Food Processor Recalls Food After Learning of Water Contamination Issue

A Washington state establishment which manufacturers food for correctional facilities, senior centers, and county jails, is recalling 319, 000 lbs of food after being notified by the local water authority that the well water used to manufacture their products may be contaminated with hazardous chemicals. This contamination issue also affects the local city's drinking water.

The chemicals, Perfluorooctanesulfonic acid (PFOS) and Perfluorooctanoic acid (PFOA), originated from the local Air Force base where they were used in fire fighting spray.  While these chemicals are above EPA standards, there are no food safety regulations. The EPA classifies these as emerging contaminants.with a limit of 70 parts per trillion.  The wells were found to have 1100 parts per trillion.  The chemicals do not have an acute affect at this level, but the concern is for cumulative exposure where they can cause liver damage, cancer, among other negative health affects.  

It is important to understand where a facility's water comes from and potential contamination issues, even if it is municipal water and/or well water.  Are the wells in areas where there has been past contamination issues?  What is the depth of the well?  How often is the water monitored and what is it monitored for?

UDSA /FSIS Recall Notice
Correctional Industries Airway Heights Food Operations Recalls Frozen Meat and Poultry Products Due to Water Contamination
Class II Recall 053-2017
Health Risk: Low May 20, 2017

Monday, May 15, 2017

Nacho Cheese Sauce Probable Source of Gas Station Botulism Cases

Public Health officials in CA believe the source of the botulism cases that occurred from eating at a gas station to be the nacho cheese sauce product.  Most cheese sauce products are made to be shelf-stable for distribution, but once opened, most products may need to be stored at the proper temperatures (outside of the temperature danger zone) to prevent growth. Much of this depends on the formulation (pH, Aw, preservatives).  They also have to be protected against cross contamination.

It difficult to tell whether these product were not properly formulated or were improperly held,  One could guess that the cheese sauce was not properly stored or handled after opening, allowing for a small amount of contamination to grow.  It may have been transferred from a pouch to a canister or serving trey.  For Clostridium botulinun, intoxication to occur, the organism would need to grow in number to produce sufficient toxin.  The product itself would need to be formulated to allow growth and that product would also need to be held at improper temperatures, most likely in the upper part of the temperature danger zone (70F to 125F).

With a thick product like this, people may assume it is like ketchup or mustard that can be left at room temperature after opening....not unless it was formulated that way.  Generally cheese sauce have a higher pH and Aw.   Another potential issue can occur if these products are modified in any way.  Adding peppers or other raw ingredients can be an issue.  Adding water to the product can also be an issue....such as might be the case if the product thickened up after sitting on the hot bar all day.

Sacramento Bee
Nacho cheese to blame for rare botulism outbreak at Sacramento area gas station
By Sammy Caiola
May 10, 2017

Canadian Firm Recalls Frozen Breaded Chicken Products for Potential Staph Aureus Enterotoxin

A Canadian firm is recalling breaded chicken products for Staphylococcus aureus enterotoxin.  Product was distributed in Ontario.  No illnesses have been reported.

The issue with Staphylococcus is that the organism  can grow in the batter if that batter is temperature abused.  As the organism grows to high numbers, it produced a heat stable toxin.  So once there, the fryer used to set the coasting at the manufacturing facility as well as any cooking done in the home by the consumer will not eliminate that toxin.. It is critical (thus a CCP / Process Preventive Control) for facilities to control batter temperature throughout the day.

Food Recall Warning - Various breaded chicken products recalled by Maple Leaf Foods due to a toxin produced by Staphylococcus bacteria
Recall date:May 9, 2017 
Reason for recall:Microbiological - Staphylococcus aureus .

Fresh Bagged Spinach Recalled for Listeria Contamination

A KY company is recalling bags of fresh spinach after being notified by their supplier partner that the spinach may have Listeria contamination.  According to the report, "The products were distributed in North Carolina, Illinois, Kentucky and West Virginia and distributed through retail stores, wholesale and foodservice distributors."

FDA Recall notice
The Horton Fruit Company, Inc. Issues Voluntary Recall of Fresh Spinach Because of Possible Health Risk
For Immediate Release
May 12, 2017

Frozen Peas Recalled After Sample Tests Positive for Listeria

A Wisconsin frozen food company is recalling frozen peas after product was tested by the State of Florida and found to contain Listeria.

While we would expect that someone would cook frozen peas, which if done according to instructions, would eliminate Listeria, people may not always do that.  Or they may use them as raw in specific applications such as pea salad or in a smoothie.

FDA Recall Notice
Lakeside Foods, Inc. Recalls Season's Choice Frozen Sweet Peas Because of Possible Health RiskFor Immediate Release
April 11, 2017

RTE Burrito Products Recalled for Listeria Contamination.

A New Mexico food company is recalling 252,000 lbs of frozen burrito products after FSIS testing found a Listeria positive product sample.  The product is classified as a ready-to-eat product, and as a ready-to-eat product, the company would need to have an active Listeria control program.   With this much product recalled, it probably was not that 'active'.

The directions are heat-and-serve for both frozen and thawed product.

USDA / FSIS Recall Notice
Green Chile Food Company Recalls Meat and Poultry Burrito Products Due to Possible Listeria Contamination
Class I Recall 050-2017
Health Risk: High 
May 13, 2017

Thursday, May 11, 2017

Home Delivered Meat - Buyer Beware

A recent study conducted by RU and TSU looks at issues involving meat shipped to homes via home delivery systems such as meal kits.   These issues include:
  • A wide range of temperatures upon receipt, ranging from (-)23F to 75F.  Much of the issue was related to the type of coolant (dry ice best, gel packs worst) and the amount of insulating packaging material surrounding the product.
  • Most home delivery companies did not require receipt upon delivery, which means that product can sit on the front porch until the home owner realizes it is there.  This can be an issue when the product is shipped as a surprise gift, so the recipient is not expecting it.
  • Home delivery companies did not have food safety information on their website
  • Products were not properly labeled to indicate the type of meat.
  • Microbial loads varied greatly. Pathogen loads varied greatly.
The authors stated that the bigger, better known companies did a better job, but with many companies entering the business channel, there may be more concern.

In the end, buyer beware.

Study of meat from home delivery services shows disturbing results
By Rita Jane Gabbett on 5/11/2017

Spinach Dip Recalled after Complaints of Small Glass Fragments

Publix Super Markets is recalling deli packs of artichoke and spinach dip after receiving complaints of small glass fragments in the product.  Product was distributed to 6 states in the Southeast US.

We have not seen many glass related outbreaks recently outside of product packed in glass containers.

FDA Recall Notice
Publix Recalls Private Label Brand of Deli Artichoke and Spinach Dip Due to Possible Health Risk

May 8, 2017

CDC Report - 2016 E.coli (STEC) Outbreak Linked to Stream Water Contaminated with Deer Feces

In May of 2016, 4 children became infected with Shiga toxin-producing E. coli (STEC) after playing in a stream in a city park.  After an investigation, the likely source was determined to be deer poop (aka scat).  According to the report, "MLVA profiles were identical for the case-patient, water, and deer scat isolates".

The presence of E. coli in the water varied over time. Coyote scat also had E. coli of similar makeup..but this may be related to the fact the coyote is drinking that same water.  What this does show is that surface water is prone to contamination from animal feces and this contamination can be passed to humans directly through intake of that water or potentially through food irrigated with that water.

CDC - Emerging and Infectious Disease
Contaminated Stream Water as Source for Escherichia coli O157 Illness in Children


In May 2016, an outbreak of Shiga toxin–producing Escherichia coli O157 infections occurred among children who had played in a stream flowing through a park. Analysis of E. coli isolates from the patients, stream water, and deer and coyote scat showed that feces from deer were the most likely source of contamination.

Monday, May 8, 2017

Cases of Botulism Linked to Food Sold at CA Gas Station

In Sacramento CA, there have been 5 cases of botulism that seem to be linked to food sold at a gas station.

Sacramento Bee
Botulism outbreak suspected to have started at Sacramento region gas station
May 07, 2017 10:38 AM
By Ellen Garrison

Chicken Sausage Products Recalled Due to Plastic Foreign Material

Perdue Foods LLC of Gainesville, GA is recalling chicken sausage products due to the potential for plastic pieces.  According tot the report, "The problem was discovered on May 5, 2017, when FSIS was notified by the firm that they had received three consumer complaints of blue plastic materials in the sausage."  No injuries have been reported.

USDA / FSIS Recall Notice
Perdue Foods LLC. Recalls Poultry Products Due to Possible Foreign Matter Contamination
Class I Recall 045-2017

Health Risk: High
May 6, 2017

Frozen Waffles, Pancakes, and French Bread Slices Recalled Due to Listeria Positive Environmental Test Results

Aunt Jemima frozen pancakes, waffles, and French Toast Slices are being recalled due to potential Listeria contamination.  According to the announcement, "Pinnacle Foods initiated the recall after testing indicated the presence of Listeria monocytogenes in the plant environment".

This is probably a low risk situation.  For one, the consumer is likely to hat the product according to the instructions.  Bu while these products would likely be heated and that heating would likely eliminate the Listeria from the surface, where it would likely be located, one couldn't guarantee the consumer is going to do that.  Another factor indicating low risk is the fact that the product is not likely to support the growth of Listeria....Partially due to product properties - perhaps with the exception of the product where meat is included, and maybe the french bread, depending upon the impact of the egg batter on the bread.  Also the fact the consumer is likely to keep frozen until they are ready to be heated.

FDA Recall Notice
Pinnacle Foods Inc. Voluntarily Recalls Aunt Jemima Frozen Pancakes, Frozen Waffles & Frozen French Toast Slices Due to Possible Listeria Contamination
For Immediate Release
May 5, 2017

Thursday, May 4, 2017

Cashew Butter Recalled Due to Potential for Listeria

An Illinois firm is recalling its Nutty Infusions Cashew Butter products for Listeria after "Evidence of contamination was noted after a routine FDA inspection of the Nutty Infusions supplier".

From the labels, the only ingredients in common to both products are the roasted cashews.

FDA Recall Notice
Now Health Group Inc. Voluntarily Recalls Select Ellyndale® Nutty Infusions™
For Immediate Release
May 4, 2017

Frozen Meals Recalled After Wrong Pre-labeled Product Carton Used

A TX firm is recalling frozen meals after a mix up or pre-labeled product cartons. It appears that this cheese enchiladas or similar product,

got this carton.

So of course, the beef chile label does not declare dairy/milk listed as an allergen.  Hopefully the consumer with allergies to milk would quickly realize that they have cheese enchiladas when they were hoping for some meat.

USDA Recall Notice
Blount Fine Foods, Corp. Recalls Beef Chile Colorado Frozen Meals Due to Misbranding and an Undeclared Allergen
Class I Recall 043-2017
Health Risk: High 
May 3, 2017

Monday, May 1, 2017

Deer Antler Tea Source of Botulinum Illnesses

A deer antler tea product may be responsible for two cases of botulism in Los Angeles.  Botulism is deadly disease caused by the toxin produced by Clostridium botulinum.   This neurotoxin stops neural signals resulting in double vision, slurred speech and difficulty swallowing.  If not treated, it can lead to death by suffocation.  
 How did the botulinum toxin get into this antler tea product? If one had to make a guess, it was after the extraction process.  To make the antler tea, antlers would be heated to pull out the marrow creating a broth and then this would be cooled to make a gelatinous material that would be packaged.  As in a typical C. botulinum growth scenario, when the product is heated to create the marrow broth, the high temperatures kills the competing spoilage organisms and creates an anaerobic environment in the marrow broth.  When the product is cooled, but held above refrigeration temperatures, C. botulinum grows and produces its toxin.  Generally an item like this would either need to be refrigerated or acidified.  A preservative can also be added to prevent growth.
The benefits of drinking antler tea are said to include helping with arthritis, preventing osteoporosis, promoting the health of the joints and repairing connective tissues, nourishing the spleen and the kidney, a defense against cancer cells, boosting the HB count in the blood, treating sexual disorders, increasing stamina and actual physical strength while also improving mental capacity, helping women who have vaginal discharge problems, flooding and spotting and it also helps in stanching excessive uterine bleeding.  Who knew.
LA Times
Tea made from deer antlers may cause botulism; health officials issue alert 
Rong-Gong Lin IIBy Rong-Gong Lin II•Contact Reporter
April 29, 2017, 3:00 AM