FDA Issues Warning Letter to RTE Facility with LM Issues

FDA issued a warning letter to a Saranac Foods for an inspection completed in February.  We have seen a number of similar types of Warning letters issued.  In this one, inspectors found LM in a facility making RTE product, and  then conditions that would support the spread of that organism (issues with hose usage, condensation, and airflow).  While the company did respond, the response was lacking in terms of a 'complete' corrective action.

 

Listeria

FDA found 3 of 89 samples positive for Listeria monocytogenes. all non-contact but in the ready-to-eat pasta and deli salad production room.

1. Floor near food carts and the 2-compartment sink;
2. The floor alongside of the interior legs of stand mixer;
3. An area of the floor under the 1-compartment sink where a leak is present.

Although the company took corrective action, the FDA stated: FDA is unable to evaluate the adequacy of your response because it does not provide specific details of your corrective actions and steps taken to prevent contamination of food. 

  

GMP Issues

Hepatitis A in Frozen Strawberries Infects 89 People

CDC reported that 89 people contracted Hepatitis A from frozen strawberries.  The outbreak was initially reported two weeks by the Virginia Department of Health.  In most all cases, the infections were linked to the strawberries being served in smoothie drinks served by Tropical Smoothie Café.

Smoothies, the blending of fruits and vegetables into a nutritious yet tasty beverage, can be an issue if any of the fruit and vegetable ingredients harbor pathogenic bacteria.  The risk can be made worse if the smoothie product is temperature abused.  The hard part when buying from a commercial smoothie producer is knowing where they source their ingredients.  In the past, had been an issue pomegranate sourced from the middle east.  That too was a source of Hepatitis A.
 

CDC Outbreak
http://www.cdc.gov/hepatitis/outbreaks/2016/hav-strawberries.htm
August 2016 - Multistate outbreak of hepatitis A linked to frozen strawberries
Posted September 8, 2016 10:15 AM ET

At a Glance

Case Count: 89

States: 7

Deaths: 0

Hospitalizations: 39

The Rise of the Grocerant and Addressing Food Safety Issues

An article in the Wall Street Journal addresses the food safety issues for grocers that are moving into more sophisticated prepared meals to-go.  These hybrid operations, dubbed 'grocerants' by some, are both grocery store and restaurant.  As consumers demand more of these fresh ready-to-eat or ready-to-heat offerings, store operations will  have to address the food safety challenges that comes with these types of processes.

According to the graphic in the article, sushi and soups are currently the type two types of foods.  But there is an increase in operations making more complex meals.
Here are some of the challenges:

Who Knew This Poop - The Dangers of Raccoon Feces

In this edition of MMWR, we learn that raccoon feces can be a source of a particularly dangerous roundworm - Baylisascaris procyonis.  It can lead to severe neurologic issues, including blindness, or even death if it is not treated rapidly.

The worm's eggs are passed in raccoon feces and can remain infectious for  months.  People, including children, become infected when soil or materials contaminated with raccoon poop containing the eggs are accidently ingested, such as when children stick their fingers in their mouths after playing with little logs in the dirt.

There have not been many cases of this in the US, but this is some serious poop.  Who the heck wants to go blind from raccoon infested poop?    So if you have raccoons scurrying around your yard at night, perhaps they found that special spot to use as a latrine (aka potty), then time to take some corrective action.  A number of websites offer solutions to rid your homestead of that pesky worm-ridden procyonid .  And sure, some of those solutions may work, but this is what you really need - the Black and Tan Coon Hound.

Might just need to get one as a preventive control...an environmental preventive control.  (That's  FSPCA, not SPCA).  So one of the best dogs known to man or blindness?..I think that is an easy choice.

CDC MMWR
http://www.cdc.gov/mmwr/volumes/65/wr/mm6535a2.htm?s_cid=mm6535a2_e
Raccoon Roundworm Infection Associated with Central Nervous System Disease and Ocular Disease — Six States, 2013–2015

Internet Soups Recalled Due to Improper Process

A New York firm is recalling soup packed in jars after FDA found that the company was not using validated processes.  The product were marketed and sold via the internet.

By regulation, companies processing canned soups, which are generally low acid canned foods, must have a validated (or tested) process and that process must be filed with the FDA.  With more companies using non-traditional channels to sell products, such as the internet or farmers' markets,  it is easier for companies to get products into commerce and avoid oversight.  Then we end up with cases like this.

A process must be validated to show it can achieve a 12 log reduction of Clostridium botulinum spores.  If a process has not been validated to accomplish this, then is impossible to know whether the product will be safe.  Validation includes determining where the cold point is on the jar and then determining the processing time needed in order to achieve sufficient amount of heat at that cold spot.

Looking at the Island Soup website and the Team page, there seems to be a lot of chiefs, but no technical person listed as part of the team.  This too is occurring more often.  Entrepreneurs come up with new products, but fail to research them properly.

FDA Website
http://www.fda.gov/Safety/Recalls/ucm519531.htm
Island Soups Company, Inc. Recalls Six Varieties of Island Soups Brand Products Because of Possible Contamination With Clostridium Botulinum
For Immediate Release
September 7, 2016

Wisconsin Dairy Recalls Cottage Cheese Due to Possible Under-Pasteurization

A Wisconsin dairy is recalling cottage cheese after the state tested and found alkaline phosphatase, an enzyme naturally present in raw milk that is used as a measure of pasteurization in that it should be eliminated if processed properly.  Since the enzyme was found to be present, this would mean that the milk used to make the cottage cheese was not properly pasteurized, and because of that, foodborne pathogens such as Salmonella could be present.  It seems the dairy tested the cottage cheese and found no pathogens.

 

In reading the notice posted on the FDA website, it is hard to determine what the issue is.  Going back to the Warning Notice published by WI Dept. of Ag, the issue is better detailed.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm519395.htm
Westby Cooperative Creamery Issues a Voluntary Product Retrieval Notice on a Specific, Single Production Lot of Cottage Cheese Product
For Immediate Release
August 27, 2016

FDA Draft Guidance - Hazard Analysis Risk Based Preventive Controls for Human Foods

On 9/23/16, FDA issued the Draft Guidance for Hazard Analysis and Risk Based Preventive Controls for Human Foods.   The guidance was put together to help people who are developing their FDA mandated Food Safety Plan. It can be found here.

Upon review, this document will serve as a resource for those writing their plans.  For those who took the FSPCA training, you will find that this document pretty much mirrors the FSPCA Participant Manual.  In fact, many of the tables are the same ones found in the FSPCA Participant Manual. 

This is a draft guidance, so FDA will be taking comments and making modifications.  Hard to imagine there will be any major revisions.


FDA Website
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm517412.htm
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food

Cashew Product Recalled Due to Possible Allergen Contamination with Peanuts

 An Ohio Company is recalling 10 ounce stand-up pouches (SUPs) of cashews after it was determined that there could be peanuts present.

While peanuts and cashews are both allergens, they are not the same allergens.  Thus this is an allergen issue and requires corrective action.  There can be some cross-reactivity - people who are allergic to one can  be allergic to the other.  

Cross contact of peanuts and tree nuts can be an issue in facilities that handle both types of nuts.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm519248.htm
Kanan Enterprises Conducts Voluntary Recall of Cashews with Sea Salt
For Immediate Release
September 3, 2016

Ravioli and Brownies Recalled After Complaints of Plastic Pieces

Two different recalls were initiated after consumer complaints were registered about plastic pieces found in the product.  One was for ravioli containing white plastic and the other was for small pieces of plastic in Entenmann’s muffins and brownies.

The recalls are unrelated.  No injuries have been reported.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm519172.htm
Wegmans Announces Voluntary Recall for One Date Code of Wegmans Italian Classics Striped Ricotta & Spinach Ravioli, Which May Contain Pieces of White Plastic
For Immediate Release
September 2, 2016