FDA Releases Information for Companies Wishing to Claim 'Qualified Facility' Status

FDA released information for those facilities wishing to file as a Qualified Facility - very small business who only have to meet modified requirements (do not need to develop a formal Food Safety Plan) as defined within the Preventive Controls for Human (or Animal) Rule. 

Facilities must determine if they meet conditions for a Qualified facility and then must submit as attestation.   Starting October 1, 2018, facilities will be able to submit the qualified facility attestation forms electronically via the Qualified Facility Attestation Module.  Facilities must submit their first attestation to FDA by December 17, 2018, for facilities under Human Food and  December 16, 2019 for Animal Food.

1. Determine if you are a Qualified Facility - see this Guidance Document.
2. Follow instruction for submitting attestation form - See this FDA procedure
• Fill out this form for Human Food - Link to Human Food Attestation Form
• Fill out this form for Animal Food - Link to Animal Food Attestation Form

Or you can take a class and develop a Food Safety Plan like regular food companies.


FDA Releases Information for Qualified Facilities under Preventive Controls Rules
September 14, 2018
Today, the U.S. Food and Drug Administration issued documents designed to help food facilities subject to the preventive controls for human and animal food rules determine if they meet the definition of a “qualified facility” under those rules, and if so, what modified requirements are applicable to such facilities.

FDA and CDC Announce McDonald Salad Mix Linked Cyclospora Outbreak Over

The FDA and CDC announced that the Cyclospora outbreak associated with Fresh Express Salad Mix served at McDonalds is over.   (Note - this case is separate from the Cyclospora Outbreak Associated with Del Monte's Veggie Trays).  In the Fresh Express / McDonalds Salad related Cyclospora outbreak, there were 511 people infected with 24 hospitalizations. The last date for onset of illness was 7/23/18.

https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm613513.htm
FDA Investigation of a Multistate Outbreak of Cyclospora Illnesses Linked to Fresh Express Salad Mix Served at McDonald’s Ends

Pork Sausage Recalled Due to Foreign Material - Clear Hard Plastic

A Xenia, Ohio, establishment, is recalling approximately 46,734 pounds of pork sausage link products that may be contaminated with extraneous materials, specifically pieces of clear hard plastic.  The problem was discovered when the establishment received consumer complaints of extraneous material in the pork sausage products. There have been no confirmed reports of adverse reactions due to consumption of these products.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2018/recall-080-2018-release
Bob Evans Farms Inc. Recalls Pork Sausage Link Products due to Possible Foreign Matter Contamination 
Class II Recall 
080-2018 
Health Risk: Low 
Sep 13, 2018 

'Free From" Foods - The Extra Burden for Manufacturers

An interesting read in Bloomburg on the 'Free-From" foods and the impact on how food is being produced.  The 'Free-From' foods are those that foods that make label claims that include  'antibiotic free', 'gluten free', 'GMO free'.

The sales of these label-claim foods are increasing.  "Products labeled antibiotic free saw growth rates of nearly 20 percent, followed by soyfree at 19 percent and hormone and antibiotic-free at 15 percent."

As food scientists, we recognize that these claims may have little to no impact on health, and where there is a health impact, such as with gluten, there is a very limited number of people affected.  According to one report, 1 in five consumers are avoiding or reducing gluten in their diet, but more than a 1/3 of them have no reason for doing it, while only 8% are gluten sensitive with another 9% claiming inflammation from gluten.  The rest do it because they view it as healthy...more or less.

Regardless of whether we agree on the need for these label-claim items, people are increasingly purchasing them.

For manufacturer's of these types of foods, there are challenges. The first is having transparency.  People know want to know where their food is from, and if they are concerned about GMOs, they want to know the manufacturer is making their food without GMOs...saying so is not enough.

Sourcing is an issue for many of these producing.  Securing a steady source of antibiotic chickens in massive quantities can be difficult.   Chickens will get sick.  Farmers risk loosing a lot of chickens if illness is passed through the flock.  GMO free is difficult.  Grains for example can be hard not to have small amounts of GMO product getting mixed in when you consider the long supply chain from the field to processor with numerous silos and trucks all along the way.

For companies that handle 'free from' and traditional ingredients, managing inventories of numerous ingredients and applying controls to prevent cross contact can be difficult.  Then managing production to make sure there is proper handling of in-process materials, proper clean-out of equipment between production runs, and then labeling.

The positive is the added margin that goes along with these products.   If one is willing to put in  the extra controls, there are people willing to pay a premium.

Bloomburg
https://www.bloomberg.com/news/articles/2018-09-09/-free-from-foods-are-changing-the-way-your-meals-are-produced
‘Free-From’ Foods Are Changing the Way Your Meals Are Produced
By Jen Skerritt, Megan Durisin, and Craig Giammona
September 09, 2018 5:00 AM Updated on September 10, 2018 6:00 AM

RTE Sliced Steak Product Recalled After Samples Test Positive for Listeria

A Kentucky establishment is recalling approximately 6,720 pounds of ready-to-eat (RTE) Philly Beef Steak products that may be adulterated with Listeria monocytogenes.  "The problem was discovered on Sept. 7, 2018, when the establishment received results from their laboratory that four finished product samples from their Aug. 9, 2018 production were potentially positive for Listeria monocytogenes.:

This lot that tested positive had a production day nearly a month after that product was produced.  Not sure of the reason for delay, but it best to test immediately if a company is testing their own product.  Also, if this was the only lot of product tested, there may be additional lots of product that are positive as well.  Unless there is a specific reason how one lot can be positive and the others are not, then it may be expected that contamination may be present in other lots.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2018/recall-078-2018-release
CTI Foods LLC Recalls Ready-To-Eat Philly Steak Products Due To Possible Listeria Contamination
Class I Recall 
078-2018 
Health Risk: High 
Sep 11, 2018 

Spam - Carving Out A Niche for Canned Meat

An interesting read in FoodDive on Spam, a cured canned meat product developed 80 years ago.  At that time, it was claimed to be a miracle meat, and was a protein source for many during the Great Depression.  Over the past half century, it has been endlessly mocked, and used as a moniker for junk email.

But Spam has hung around and is finding a resurgence.   "Spam's sales have been helped by the growth of the Asian American population in the U.S. — they are more likely to consume the product than any other nationality.  Even some McDonald's in Hawaii and high-end restaurants in New York City and Los Angeles incorporate Spam into their dishes."

So could we see Spam-tizers on the menu next to the charcuterie plate?

https://www.fooddive.com/news/spamalot-consumers-cant-get-enough-of-the-mercilessly-mocked-meat/525327/
Spamalot: Consumers can't get enough of the mercilessly mocked meat 

Salmonella Outbreak at San Antonio Mediterranean Grill

A large Salmonella outbreak in San Antonio, TX where over 200 calls with the claim of becoming ill after eating at a Mediterranean grill.  The owner suggested that hummus may be the source.

https://www.mysanantonio.com/food/article/Pasha-Mediterranean-Grill-source-outbreak-13213466.php
Pasha Mediterranean Grill owner says he was told suspected source of outbreak
By S. M. Chavey, mySA.com / San Antonio Express-News and Peggy O'Hare
  Updated  5:50 pm CDT, Friday, September 7, 2018 

NPR on Why Not to Freak on Foodborne Illness

A report on NPR discusses the impact of technology on detecting foodborne illness.  While it may seem like there are more outbreaks, much of it is our ability to detect these illnesses.  

Some insight provided by Penn State's own, Dr. Ed Dudley.  (There are many who wish his name was spelled 'Dudely' instead of Dudley, because then he could be Dr. Dude...or the Dude..just our opinion man)

NPR Salt

https://www.npr.org/sections/thesalt/2018/09/10/645562083/food-safety-scares-are-up-in-2018-heres-why-you-shouldnt-freak-out
Food For Thought
Food Safety Scares Are Up In 2018. Here's Why You Shouldn't Freak Out

This Week in Mislabeled Product - Week Ending 9-8-18

A Sunnyvale, Calif. establishment, is recalling approximately 371 pounds of raw chorizo sausage products due to misbranding, The product contains sesame seed, which is not declared on the product label.  The problem was discovered by FSIS during routine inspection label verification activities.

An Indianapolis, Ind. establishment, is recalling approximately 242 pounds of fully cooked chicken salad product due to misbranding and an undeclared allergen - the contain tree nuts (walnut), a known allergen, which is not declared on the product label.  The problem was discovered after the firm received a consumer complaint

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2018/recall-077-2018-release
New York Style Sausage Co. Recalls Raw Chorizo Sausage Products due to Misbranding and an Undeclared Ingredient 
Class II Recall
077-2018
Health Risk: Low
Sep 5, 2018