Wednesday, October 18, 2017

Canada - Company Recalls Chicken Burgers After being Linked to Salmonella Outbreak

In Canada, breaded chicken patties and cutlets are being recalled after being linked to an outbreak of Salmonella.  The product is uncooked, and that is clearly stated on the label.  BUT there is nothing stated about checking the internal temperature of the product.

The cooking instructions (taken from the company's website) state"
Cook from frozen.
OVEN: Bake in a preheated oven at 425°F (218°C) oven for 10 minutes, flip, then cook for 10 to 12 more minutes.
Considering this is a raw product, we know that consumers can screw this up.  Is the oven temperature correct?  Did they start timing when the over was actually at 425F?  Did they cut the time off a little?

Now Tyson Chicken Patties also have the cooking instructions that are similar,  BUT, these products are stated as being fully cooked.
Conventional Oven
1.  Preheat oven to 400°F.
2.  Place frozen chicken patties on baking sheet.
3.  Heat 17 to 20 minutes.
The other issue is calling these things chicken burgers rather than chicken patties considering that they are breaded.

CBC News - Canada
2 Janes chicken products recalled due to salmonella
Investigation linked to 13 cases of illness

By Kevin Yarr, CBC News
Posted: Oct 18, 2017 6:58 AM AT| Last Updated: Oct 18, 2017 2:41 PM AT

Canada - Mechanically Tenderized Beef Recalled Due to E. coli STEC Contamination

A Canadian firm is recalling mechanically tenderized beef due to E. coli O157:H7.  The contamination was found by the company.

It is interesting to note that the safe cooking instructions posted on the Canadian product only requests that the consumer cook the product to 145F (CFIA).   In the United States, USDA requires safe handling instructions for mechanically tenderized beef that state the product be cooked to 145F with a 3 minute rest (USDA) while the US Food Code requires 155F for 15 seconds for food service.

Canadian Food Inspection Agency
Food Recall Warning - Mechanically Tenderized Steak recalled due to E. coli O157:H7
 Recall date:October 17, 2017 
Reason for recall:Microbiological - E. coli O157:H7 
Hazard classification:Class 1 
Company / Firm:Vantage Foods (ON) Inc. 
Extent of the distribution:Retail   

Supermarket Chain Recalls Chili and Soup Items due to the Potential for Foreign Material Contamination - Hard Plastic

A Wisconsin retailer is recalling over 16,000 lbs of ready-to-eat (RTE) chili and soup items due to potential foreign material contamination, specifically hard plastic.  The issue was discovered by the company's food safety team

USDA / FSIS News Release
Roundy's Supermarkets, Inc., Recalls Chili and Soup Products Due To Possible Foreign Matter Contamination
Class I Recall 
Health Risk: High 
Oct 17, 2017

Tuesday, October 17, 2017

Man Arrested for Intentional Contamination of Grocery Store Produce with Feces-Smelling Substance

In North Carolina, a man was arrested after he sprayed a feces-smelling brown liquid on grocery store produce.  "According to Harris Teeter officials, the suspect attempted to contaminate food in the produce department and the fresh foods department. Store officials say associates immediately took action and closed down the affected departments and notified supervisors."  The man is said to be a disgruntled contractor who was saying that the store owed him money.

CBS 5 Charleston
Bond set for contractor accused of contaminating produce at W. Ashley Harris Teeter
Published:Sunday, October 15th 2017, 3:59 pm EDT
Updated:Monday, October 16th 2017, 7:44 pm EDT
By Ray Rivera, Digital Producer
By Harve Jacobs, Reporter

Monday, October 16, 2017

Jars of Tarragon Spice Recalled After Positive Salmonella Test

A California spice company is recalling 0.4oz jars of tarragon spice after testing found the raw material was positive for Salmonella. 

FDA Recall Notice
Spicely Organics Recalls Organic Tarragon Because Of Possible Health Risk
For Immediate Release
October 16, 2017

Nut Butter Recalled in March for E. coli Contamination Still in Marketplace

FDA issued a news release to remind the public and retailers that the I.M. Healthy Soy Nut Butter Products have been recalled and must not be available for sale.  These products were recalled back in March after being linked to a dozen cases of E. coli O157:H7 infection.  The problem is that these products are still being sold, both online and in retail stores.  The packer was suspended.

The occurrence of recalled product, and dangerous product at that, still being in the marketplace shows the difficulty of recall compliance in smaller retailers and online venues where niche product like this is likely to sell.

FDA Outbreak Notice
FDA Reminds Public that All I.M. Healthy Soy Nut Butter Products Are Recalled
October 13, 2017

Vermont Meat Processor Recalls Ground Beef After 2 Cases of E. coli Infection

A Vermont meat processing facility is recalling ground beef product after 2 people became ill with E. coli O157:H7.

From the Recall Notice:
"On September 30, 2017, FSIS was notified of an investigation of E. coli O157:H7 illnesses. Working in conjunction with the Vermont Department of Health and the Centers for Disease Control and Prevention, FSIS determined the cooked beef burgers that were served at an event at Bread & Butter Farm was the probable source of the reported illnesses. Based on the epidemiological investigation, two case-patients were identified in Vermont with illness onset dates ranging from September 18, 2017, to September 23, 2017. Traceback information indicated that both case-patients consumed ground beef products at Bread & Butter Farm which was supplied by Vermont Livestock Slaughter & Processing"

Vermont Livestock Slaughter And Processing LLC, Recalls Ground Beef Due To Possible E. Coli O157:H7 Contamination
Class I Recall 
Health Risk: High 
Oct 13, 2017

NY Establishment Recalling Luncheon Meats Due to Foreign Material - Aluminum

A NY establishment is "recalling approximately 22,630 pounds of ready-to-eat (RTE) Genoa Salami and Capocollo products that may have been contaminated with foreign matter, specifically aluminum.   The problem was discovered when the company notified FSIS of an incident where an aluminum clip was found in the product shipped to a retailer. The issues were found during preparation and slicing of product at the retail level."
Battistoni Italian Specialty Meats, LLC, Recalls Salami and Capocollo Products Due To Possible Foreign Matter Contamination
Class II Recall 
Health Risk: Low 
Oct 13, 2017

Warning Letter Issued to Bean Manufacturer for Inadequately Handling Can Seam Issue

Bush Beans was issued a warning letter related to how they handled a can seam issue this past summer.  Although a recall was conducted, FDA cited the plant for not notifying FDA of the issue, minimizing the issue even though a container failure issue could be danger to the public, and failing to take appropriate action regarding in-process rejects.  The issue was that the firm did not take appropriate action to a supplier related can seam issue. Can seam issues for low acid canned foods can result in serious issues such as the potential for Clostridium botulinum.

The warning letter specified two major items:
1.  Failed to promptly report to FDA any instance of spoilage or potential public health significance where any such lot of food had in whole or in part entered distribution, by distributing bean products after a side seam defect was identified by plant personnel and confirmed by the can manufacturer.  The issue was identified as a weld adhesion failure on the side seams.  The company only considered a market withdrawal for cans manufactured on one day identified as having the most can seam defects, but other dates were involved. "The explanation provided to the FDA Investigators was that your Quality Assurance Department identified this as a food quality issue and not a food safety issue."  Additionally, the firm did not conduct any microbiological tests on the questionable lots at the time of the inspection, and, was not able to give assurance that those products would pose no significant health risks to consumers due to potential post-process contamination based on the observed side seam defect.  The firm did not routinely do microbiological analysis of the cooling water, which while not expressly required, it is important to show control.

2.  Failed to perform and record defects of containers, and perform a corrective action when cans were identified as losing their hermetic seal.  Basically, the firm had an inline dud detector to determine which cans had lost vacuum, but the record keeping was poor and there was no follow-up to cans that were rejected.

The Low Acid Canned Food regulations (LACF) are in place for all those who package low acid canned foods where Clostridium botulinum can be an issue.
September 29, 2017
Warning letter 535494

Friday, October 13, 2017

Port Wine Cheese Spread Recalled After Complaints for Foreign Material

BelBrands is recalling Merkts Port Wine Cheese Spread after the company received complaints from consumers about finding small pieces of plastic in the product.  It appears to be limited to one production date.

FDA Recall Notice
Bel Brands USA, Inc. Issues a Nationwide Voluntary Recall Of Merkts Port Wine Cheese Spread Because Of Possible Foreign Bodies Found In a Limited Batch Of Products
October 13, 2017
Consumers 1-888-840-0096
View Product Photos 

Three Hepatitis A Issues from Across Country

There are some Hepatitis A outbreak events worth noting.
  • First is a case in Alabama where a pizza delivery person has been diagnosed.  People who have purchased pizza from this establishment have been asked to get a vaccine.
  • In San Diego, CA, a huge outbreak of Hepatitis A has close to 500 infected but has had a huge impact among the homeless population.  Vaccines have been given at local parks, a place where the homeless my frequent.
  • In SE Michigan, more than 300 have become infected, including at least one food worker.

ABC 33 Alabama
Vaccines recommended after Anniston restaurant worker tests positive for Hepatitis A
by James Franklin| [not the football coach]
Wednesday, October 11th 2017

Ben and Jerry's Changing Sourcing to Eliminate Glyphosate from Ingredients

Ben and Jerry's  announced that they are making changes to their sourcing to eliminate the chemical glyphosate from ingredients they 2020.  Glyphosate, a main ingredient in the herbicide Roundup, was found to be present in their product (as well as other food products) at very low levels - far below what EPA would cause adverse effects (EPA has a limit of 2 mg/kg/day vs 1.75 ppb found) and EPA says that the chemical is not likely to be carcinogenic.  In 40CFR180, lists the tolerances for pesticide residues in food including glyphosate (180.364 - table below).   EPA's established tolerance for glyphosate in drinking water is 700 parts per billion (ppb).

So 1.75 ppb is pretty darn low, and based upon this EPA limit, a news article (below) determined that a kid would have to eat over 100,000 servings per day to get to this level.  And glypshate is common in the environment and as well other foods.  A study found that many cereal grain products had levels ranging from 25 to 1000 ppb - again, all well below EPA limits.  It is even in wine (in a 2016 report, the highest level found was 18.74 ppb).

But people get excited, especially once you link a herbicide to thier food.  I think the controversy is good.  It forces the science to prove its safety and for the agricultural industry to manage its use.  Where we fail is communicating to consumers the minimal risk associated with the amount that was found.

Ben & Jerry’s to Change Ingredients After Weed Killer Discovery
By Jack Thurston

Another Recall for Foreign Material in Meat Products

A Texas establishment, is recalling approximately 12,816 pounds of fully cooked shredded beef products that may be contaminated with extraneous materials, specifically plastic.  The problem was discovered on October 11, 2017, when the company received notification from their consignee that a consumer complaint had been received regarding foreign material, specifically plastic, in the product.

Here is another recall for foreign material in the form of plastic.  It appears from this notice there was one complaint, but hard to tell the extent of the issue.  Still, probably a small error that will be costly for a small private company.

USDA / FSIS Recall Notice
J & B Sausage Company, Inc. Recalls Fully Cooked Shredded Beef Products Due To Possible Foreign Matter Contamination
Class II Recall 
Health Risk: Low 
Oct 12, 2017

Wednesday, October 11, 2017

This Week in Mislabeled Product - Ending 10/13/17

Whole Foods Market stores is voluntarily recalling 365 Everyday Value Organic Raisin Bran because the product contains undeclared peanuts that were not listed on the product label.  The issue was discovered after Whole Foods Market determined the packaging contained Peanut Butter Cocoa Balls instead of Organic Raisin Bran.

A Tennessee firm is recalling 816 Premium Chicken Salad Wheatberry Sandwich Lot Number 17 198 because they have the wrong ingredient statement and contain undeclared eggs and soy.  The recall was initiated after Quality Assurance discovered that product containing the allergens was distributed in packaging that did not reveal the presence of the allergen. The ingredient statement on the affected product is for a different sandwich.

General Mills is voluntarily recalling two days of production of Cascadian Farm Organic Cinnamon Raisin Granola cereal produced on July 15 and 16, 2017 because the product may contain almonds, an undeclared nut allergen. 

La Terra Fina is voluntarily recalling its 10 oz. containers of Spinach Artichoke & Parmesan Dip & Spread with the date of BEST BY NOV-01-2017 due to undeclared egg.  The issue was discovered after receiving notification from a retailer that the ingredient statement and UPC code were for a different dip.

A PA firm is recalling Pennsylvania is voluntarily recalling one lot of Hannaford Supermarkets’ potato salad because it may contain undeclared egg.  "The recall was initiated after it was discovered that certain packages of the recalled product contained an ingredient and nutrition label from another product [Taste of Inspirations Rotini Salad] that did not reveal the presence of egg."
Whole Foods Market Issues Nationwide Allergy Alert on Undeclared Peanuts in 365 Everyday Value Organic Raisin Bran
For Immediate Release
October 6, 2017

FDA Reminder - Choose Legitimate Source When Purchasing Pet Meds Online

The FDA reminds us that it is important then when purchasing pet medications online, ensure they are from a legitimate source.  They suggest that you should look for pharmacy websites ending in “.Pharmacy.”  It is also advisable to work in conjunction with your veterinarian.
Buying Pet Medicines Online: Ensuring Products are Safe

In Virginia, Chili Cook-off is Site for Salmonella Outbreak

In Virginia, a Volunteer Fire Company's Chili Cook-off is being blamed for dozens of people becoming ill from Salmonella.  The exact food source responsible for the Salmonella contamination has not yet been identified.

You always wonder about eating food at these events - 1) do these cooks, the people making the food, really understand food safety principles, have they been trained in any way, 2) are they implementing those principles - have they taken the necessary precautions to transport and prepare the food for an onsite event such as this, 3) do their normal kitchen handling and preparation procedures adapt in order to make the larger quantities needed for this event, and 4) is the food protected at the event from cross contamination.

While regulations do not require training for these events, training is available.  Penn State offers the Volunteer Food Safety - Cooking for Crowds training.

Virginia Pilot - Local News
Salmonella found in food from Chincoteague Chili and Chowder Cook-off
By Ryan Murphy
The Virginian-Pilot
Oct 10, 2017 Updated 10 hrs ago

Tuesday, October 10, 2017

Ohio Firm Recalls Raw Meat Products After Processing Water Found to Be Non-Potable

An Ohio establishment is recalling raw meat products after thier water tested positive for coliforms (not E. coli). "Therefore, the non-potable water supply resulted in the potential creation of insanitary conditions and potential direct product contamination leading to adulteration of the products processed in the facility during this time period."

 Using non-potable water is an issue...whether pathogens are detected in teh sample or not.  With coliforms, all one can tell is that water source has been compromised, so there is an uncertainty what else can be there including chemicals.

It is important to know the ultimate source of your facility's water.  It is also important to know what to do in the event of a water emergency whent that water becomes contaminated.  It would be interesting to know in this case whether the facility had warning or was the testing done afterwards.
Shiloh's Newswanger Meats recalls more than one ton of meat

Monday, October 9, 2017

FSMA Compliance Date Reference Sheet from FSPCA

FSPCA has published a nice reference sheet that lists the FSMA compliance dates for the various rules.    That sheet can be found here LINK.

Friday, October 6, 2017

Frozen Peas Recalled for Possible Listeria Contamination

Pinnacle Foods is recalling frozen peas for potential Listeria contamination after "testing indicted the presence of Listeria in the retail environment".   Recalls were issued by the Department of Defense, Publix, and possibly other retailers, but nothing has yet been posted on the FDA website.

The fact the contamination was found at retail would indicate that it was not found by the company.  This may be the reason for the delay as the company tries to understand the scope of the recall.  Perhaps their own internal testing has not found anything, which can be certainly possible if the contamination level is low.

More will come on this issue.

Department of Defense News Room
Birdseye Peas recalled due to possible Listeria contamination
October 2, 2017

This Week in Mislabeled Product - 10/6/17

Dean Dairy is voluntarily recalling one-gallon size Tampico® Tropical Punch sold in Illinois, Indiana and Wisconsin and bottled and distributed by Dean Dairy that has the “Best By” code date of 12-27-17 because this product may contain milk, an undeclared allergen. "Due to a manufacturing error, milk became mixed with the Tropical Punch with the “Best By” date of 12-27-17. To date, no complaints or reactions have been reported."

A WA establishment is recalling Royal Asia Shrimp Wonton Noodle Soup, because it may contain undeclared egg. "One allergic reaction complaint has been CONFIRMED to date. The recall was initiated after the product was tested for presence of egg, and was confirmed. Because the packaging does not reveal the presence of Egg..."

A MA company is voluntarily recalling Dried Chili De Arbol Peppers because it does not have the proper allergens identified, being peanuts.  "During repacking, the peanut contamination was discovered in the sealed bulk containers of the product."

A San Antonio, Tex. establishment, is recalling approximately 1,150 pounds of diced chicken thighs due to misbranding and undeclared allergens, the product contains wheat, a known allergen which is not declared on the product label.  "The problem was discovered on Oct. 2, 2017 when a consumer noticed an incorrect label and notified the company, which then notified FSIS."

An Ill. establishment, is recalling approximately 1,222 pounds of ready-to-eat beef products due to misbranding and undeclared allergens - the products are mislabeled as beef pot roast but the package actually contains beef meatloaf....whichh contains wheat and soybean oil, known allergens, which are not declared on the product label. The problem was discovered on October 4, 2017, when a consumer reported that they purchased a product labeled as beef pot roast but actually contained beef meatloaf.

FDA Recall Notice
Dean Dairy Conducts Voluntary Recall of Tampico® Brand Tropical Punch in Illinois, Indiana and Wisconsin Because It May Contain Undeclared Allergen (Milk)
For Immediate Release
October 2, 2017

Thursday, October 5, 2017

FDA Warning Letter - Bakery with 'Love' Listed in Ingredient Statement - Nasty Food Operations Exposed

A MA bakery received a Warning Letter from FDA.  While the bakery violated most all basic GMPs, the one item that has caught the eye of the press is the fact the the company listed 'love' as an ingredient.  "Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name [21 CFR 101.4(a)(1). "Love" is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient."  But this was just a minor issue compared to the vast array of GMP violations.  That is, unless they refer to nastiness as 'love',..,..then there was plenty.

Now, if I am overseeing a bread operation, and seeing this as well as this Warning Letter in August for a NM bakery, I am getting a sense that FDA will probably be looking at bakeries a little more critically than they have in the past, and thus, it may be time to tighten up the ship a bit more.

There were a ton of issues, but as a sampling:

  • Food residue on equipment that was stated as being clean and sanitized including "empty color-coded barrels designated for use with different allergens including tree nuts and cheese with apparent dough residue inside and out, and stacked inside one another."  It was stated that the "firm does not have a procedure or production schedule to ensure cleaning and sanitation is done before production or in between changes to prevent cross-contamination of different allergen products."
  • Failed to maintain equipment and utensils and finished product containers in an acceptable condition through appropriate cleaning and sanitizing  - bread residues on screens, totes, etc.
  • failed to maintain buildings, fixtures, and other physical facilities in a sanitary condition - ceilings, air intakes etc coated with stuff.
  • Failed to ensure equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination
  • failed to provide, where necessary, adequate screening or other protection against pests - flies and crawing bug in processing area.
  • Personnel not following basic GMPs. - wearing jewelry, eating in operational areas.

FDA Warning Letter
Office of Human and Animal Food Operations East
Division 1

CMS# 532236

Nashoba Brook Bakery, LLC 9/22/17
September 22, 2017

Auditor General - FDA Follow-up to Inspections Found to Be Slow and Lacking

In a report by the Auditor General to the FDA, there was criticism that FDA was not taking enough action fast enough.  "Auditors examined data from 2011 to 2015 and determined the agency was on pace to conduct the required inspections, but hadn’t made sure that all problems were corrected."  In defense, many of the inspections that were longer in response were for dietary supplements - the wild west of FDA's regulatory world.  And with new regulations just coming upon implementation date, there is a huge gap in knowledge for both the firms and the inspectors.
  • In the time frame analyzed, inspectors found significant dificiences in 1245 establishments.
  • While some type of actions was taken in 78% of the inspctions, in 22% nothing was done.
  • "Almost half of the warning letters were sent after the agency’s goal of four months [which is still a long time]. Twenty percent were sent after more than six months, and 2 percent were sent more than a year after the inspection."
  • "The agency took an average of 6.7 months to initiate judicial action, the audit said. In one case, a seizure didn’t occur for more than a year, and an injunction didn’t occur for nearly two years."
  • "Of 766 facilities that received “advisory” actions, about 1 in 5 were found to have significant violations on follow-up inspections. In about three-quarters of them, the violations were identical to those previously discovered."

The Morning Call (Allentown, PA)
Food safety oversight not well done
by Paul Muschick•Contact Reporter
The Watchdog
October 4, 2017, 8:55 PM

FDA - Impact of Gluten Free Labeling Standard

From the FDA website, a conversation about the impact of the gluten free labeling standard.  Three years ago, FDA rolled out what it means for a label to say "Gluten Free".  In short, it must have less than 20 PPM of gluten.  Overall, it has been successful in helping people with celiac disease - a serious ailment that damages the lining of the small intestine gut that prevents the body from absorbing nutrients.

FDA has been conducting testing on products labeled "Gluten Free".  "Earlier this year we released the results of a sampling assignment in which 702 samples from more than 250 products labeled “gluten-free” were analyzed. Only one of those products did not comply with our labeling requirements."  FDA plans to continue testing.

FDA Website
Updated 10/04/17
Three Years Later, What is the Impact of the Gluten-Free Labeling Standard?

A NC Establishment Recalls Ground Turkey for Foreign Material - Metal Fragments

A N.C. establishment, is recalling approximately 38,475 pounds of ground turkey that may be contaminated with extraneous materials.  The problem was discovered on September 27, 2017, when FSIS was notified by plant employees performing sanitation on processing equipment. On the same day, one of the retail locations involved noticed metal shaving in a package of ground turkey from the recalling firm, and notified the company.  Good job to these sanitation guys for catching this!

USDA Recall Notice
Prestage Foods, Inc. Recalls Turkey Products Due To Possible Extraneous Material Contamination
Class II Recall 104-2017
Health Risk: Low 
Oct 2, 2017

PA Establishment Recalls Ground Beef for E. coli O157:H7

A PA establishment is recalling approximately 700 pounds of ground beef products that may be contaminated with E. coli O157:H7.  "The problem was discovered on Oct. 2, 2017 when the firm notified FSIS that the firm’s sample of ground beef had tested positive for E. coli O157:H7 by a third party lab. There have been no confirmed reports of adverse reactions due to consumption of these products."

Yes, this organism is still a risk in ground beef with dire consequences for those who become infected from eating undercooked contaminated hamburgers.  A reminder to use those thermometers.

USDA Recall Notice
Clair D. Thompson & Sons, Inc. Recalls Ground Beef Products Due To Possible E. Coli O157:H7 Contamination
Class I Recall 106-2017
Health Risk: High Oct 4, 2017

Wednesday, October 4, 2017

Puppy Related Campylobacter Outbreak Now Reaches 55 Cases

There are now 55 cases of Campylobacter linked to puppies sold through a Ohio pet store.  The recall was first announced by CDC on September 11th. .  Isolates were taken from stool samples from ill puppies closely matched those of ill individuals.  Isolates were also tested for antibiotic resistance and all 13 of Campylobacter isolates tested were shown to be antibiotic resistant to first line antibiotics.
Multistate Outbreak of Human Campylobacter Infections Linked to Pet Store Puppies
Posted October 3, 2017 2:00 PM ET

Monday, October 2, 2017

Egg and Ham Salad Sandwiches Recalled for Potential Listeria Contamination

The US affiliate of Greencore, an international company specializing in making ready made sandwiches, is recalling Egg Salad and Ham Salad sandwiches and Seafood Stuffing after FDA samples and found Listeria in the food processing environment.    The product was distributed in Northeast US

It was not stated where in the facility the samples were found, but one would expect that it was in an area that implicated the potential for product contamination.
Greencore USA, LLC Recalls Egg Salad Sandwiches, Ham Salad Sandwiches, and Seafood Stuffing Because of Possible Health Risk
For Immediate Release
September 29, 2017

This Week in Mislabeled Product - ending 9/29/17

A WI firm is voluntarily recalling Waterfront Bistro Tartar Sauce because there is a chance an incorrect back label was attached to the product, which does not correctly identify ingredients that could pose an allergen risk; specifically egg.  From the notice - "The recall was initiated after production checks at our manufacturing facility found the incorrect back label for Hot Cocktail Sauce instead of Tartar Sauce.  ....... The defect identified was caused by a temporary breakdown in our label supplier’s production and quality control processes."

An Illinois establishment is recalling an undetermined amount of smoked turkey products due to misbranding and undeclared allergens - the products contain milk, a known allergen, which is not declared on the product label. The problem was discovered by FSIS Inspection Program Personnel while performing routine label verification checks.

A NY firm is recalling its VINA CAFÉ WAKE-UP INSTANT COFFEE MIX in 18 PACK CARDBOARD BOXES (.6 oz packs), with lot “EXP:17.MAR.2019 1T13.” because they contain undeclared milk allergens.  The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk allergens in the 0.6 ounce plastic package, with 18 packets per cardboard box of VINA CAFÉ WAKE-UP INSTANT COFFEE MIX which did not declare a milk ingredient on the label.

FDA Recall Notice
Silver Spring Foods, Inc. Voluntarily Recalling Waterfront Bistro Tartar Sauce Due To Possible Mislabeling and Undeclared Allergen
For Immediate Release
September 26, 2017

Friday, September 29, 2017

CDC MMWR - 2016 Outbreak of Campylobacter Linked to Undercooked Chicken Liver Mousse

In a 2016 case, 4 people became ill from Campylobacter after eating undercooked chicken liver mousse.  From the report, "During an inspection on July 15, the sous-chef solely responsible for preparing the chicken liver mousse demonstrated preparation to the CCPH food safety inspector, who observed that the sous-chef used the appearance of the livers alone to determine whether they were fully cooked. Final internal cook temperature of the largest liver measured by the inspector was <130°F (54°C), below the minimum 165°F (74°C) internal temperature deemed necessary by the Food and Drug Administration to eliminate food safety hazards"

Campylobacter is naturally found in chickens and is a risk for causing foodborne illness when there are cross contamination issues or undercooking.
Notes from the Field: Outbreak of Campylobacter jejuni Associated with Consuming Undercooked Chicken Liver Mousse — Clark County, Washington, 2016
Weekly / September 29, 2017 / 66(38);1027
Derel Glashower, MPH1; Jennifer Snyder1; Diane Welch, MS1; Shannon McCarthy1 (View author affiliations)
View suggested citation

Deli Chicken Salad Recalled for Potential Listeria Contamination

King Soopers retail chain is recalling deli chicken salad after the supplier indicated that the product may be contaminated with Listeria monocytogenes.  The product is a deli pack with the clear plastic tortoise shell packaging.

Listeria is a risk in premade salad items like this.  From the retailer's perspective, it is critical to ensure the supplier has tight controls and a solid enviromental monitoring system.

It is interesting to note that the recall was posted on 9/27, but the retailer was notified on 9/21.  This seems to be a pretty long delay.  Hopefully the recall began immediately at store level.

FDA Recall Notice
King Soopers Recalls Deli Chicken Salad Sandwich (6.8oz) Because of Possible Health Risk
For Immediate Release
September 27, 2017

Monday, September 25, 2017

This Week in Mislabeled Product - 9/22/17

A CA company is recalling Tasty Treats Nonpareils Milk Chocolate because it contains undeclared milk.  Yep, a milk chocolate product and forgot the milk on the label as an ingredient and as an allergen.  Note though, the label did have a precautionary statement that says processed in a facility that processes milk products, but it need to claim milk as an ingredient.  The problem was caused by a temporary breakdown in the company's label review process.

A NY firm is recalling the following products because an allergenic ingredient, milk, was not declared in labeling. CFIA detection initially found this issue, and we are voluntarily recall the similar ingredients of other products

FDA Recall Notice
First Source Issues Allergy Alert On Undeclared Milk In Tasty Treats Nonpareils Milk Chocolate
For Immediate Release
September 20, 2017

Nacho Cheese Sauce and Botulism - Case Findings and Recommendations

In May of 2017, there was a botulism outbreak involving nacho cheese sauce served at a California gas station.  It is easy to see from this that the gas station did not monitor temperature, so likely that the units were possibly shut off.  This is a TCS food item, and with that, strict temperature control is required.   Unfortunately, this type of nacho cheese sauce if often treated as a shelf-stable item.   In the recommendations below, it states that the cheese can be hot held for up to 6 much for me eating nacho cheese on anything served on a food bar...not that I have eaten it ever in the past.

The California Department of Public Health released a memo regarding their findings and recommendations (abridged here, in full below).

Chicken Sashimi - Eating Raw Chicken is a Risk

Chicken sashimi is a raw chicken item being prepared by a few restaurants here and in Japan.  With chicken having a high prevalence of  Salmonella and Campylobacter, this product poses a high risk for foodborne illness, even if the surface is quickly heated.  

Buzz Feed
Chicken Sashimi Exists, And Americans Are Freaking Out
Literally everyone on Twitter: "No."
Michelle No
BuzzFeed Staff

Sunday, September 24, 2017

Mexico - Meth Contamination Reported in 7Up

In Mexico, there has been one reported death and several illness from Methamphetamine, or meth, adulteration in bottles of 7Up soft drink.  This product tampering issue occurred in the Mexicali area, which is south of the Mexican border with California.

Washington Post
WorldViews Analysis
Travelers beware: Meth-laced 7Up reportedly causes death in Mexico
By Rachel Chason September 23

Friday, September 22, 2017

Cyber Security for Automated Food Processing Equipment

A recent article in Food Safety Magazine discusses the concern of cyber attacks on the supply chain.  Basically, the issue would be when somebody gains control over your automated processing equipment.  This could result in processing changes or formulation changes that can lead to contamination issues.

A division of Homeland Security, ICS-CERT (Industrial Control Systems Cyber Emergency Response Team), monitors and reports such attacks.  In April, they reported such an attack on a food processing system.  In 2016, this group reported 3 incidents on the food and agriculture sector.

As a food safety professional, this is just another concern to keep you awake at night.
Of course, the big concern is that somebody turns your automatic palletizer into this:

Damn, that Skynet software package.

Food Safety Magazine
Signature Series | September 14, 2017
When Food Safety Meets Cyber Risk

Thursday, September 21, 2017

Cold Brew Coffee Recalled for Botulism Concerns

A NY company is recalling its canned cold brewed coffee after it was determined that the product may be conducive to the growth of Clostridium botulinum, the causative agent of  botulism.  The product's name, interesting enough, is Death Wish.  Probably appropriate.

In canned beverages such as juices and teas, pH is often used as a control for preventing Clostridium botulinum growth.  For this, the pH is kept below 4.6.  The pH of coffee can vary widely from 4.2 to 5.2 or higher depending upon the type of coffee.  In making a canned product such as this, it would be important to adjust pH to a value below 4.6, if pH is used as a control.  Other controls may be used.

FDA Recall Notice
Death Wish Coffee Co. Announces Recall of Nitro Cold Brew Cans From Retailers, Online Sales
For Immediate Release
September 19, 2017

Wednesday, September 20, 2017

Dirty Deeds: Recent Food Safety Crimes from Modern Farmer

This is reprinted from Modern Farmer and thought it a nice summary of recent cases where company owners received prison sentences for shipping tainted product.  The reasons listed below are a little short in terms of the details, but it is a nice review.

Modern Farmer
Dirty Deeds: Recent Food Safety Crimes
By Brian Barth on September 20, 2017

Early Exposure to Allergens is a Good Thing - Let Those Babies Play in the Dirt, Eat Peanuts

A study released by NIH (National Institutes of Health) shows that infants that lived in dirtier conditions had a lower risk of asthma. From the release, "Higher concentrations of cockroach, mouse and cat allergens present in dust samples collected from the children’s homes during the first three years of life (at age 3 months, 2 years and 3 years) were linked to a lower risk of asthma by age 7 years." This is not surprising. Also recently, FDA recognized that the introduction of peanut allergies before the age of three reduced peanut allergies later in life.  So FDA "announced they would allow updated labels on some peanut-containing foods that they may reduce the risk of allergens.

So it is a delicate balance.  Introducing children to allergens early, but not particularly harmful agents such as the bacterial pathogens Listeria or Salmonella.  As parents, there is a tendency to keep infants from playing in dirty conditions, but the exposure to allergens in those dirty conditions is important for exposure.  Not exposing kids to allergens early means that when they are exposed to them later in life, they are more likely to have abnormal reactions to them in the form of allergies.

So let those little kids play in the dirt.  Buy them a puppy.  Visit a friend who has a cat, is less tidy and has roaches(ewww).  Have you ever considered the reason why there is an increasing percentage of children with allergies is nothing more than the fact that we are too risk averse to giving them certain foods or that we are too clean?

As the adage goes - The key to a healthy immune system is a constant challenge. But perhaps better stated - The key to a healthy immune system is an early challenge.

NIH Release
Tuesday, September 19, 2017
Exposure to pet and pest allergens during infancy linked to reduced asthma risk
NIH-funded study may aid development of asthma prevention strategies

Monday, September 18, 2017

WA Establishment Recalls Cooked Meat Products Due to Process Deviation with Potential for Staph Toxin

A WA establishment is recalling sausage and other cooked meat products due to "a possible processing deviation that may have led to staphylococcal enterotoxin contamination."  "The problem was discovered on Sept. 14, 2017, by FSIS Inspection Program Personnel (IPP) when they observed a possible processing deviation while reviewing records."  If one would guess, during the smoking cooking process, product remained in the temperature danger zone for an extended period, probably before reaching lethality. If Staphylococcus aureus was present at this time, there would be the potential for growth and toxin formation.  Further heating would not remove the toxin.

USDA FSIS Recall Notice
German Sausage Haus, LLC, Recalls Meat Products Due To Possible Processing Deviation and Staphylococcal Enterotoxin Contamination
Class I Recall 102-2017
Health Risk: High
Sep 17, 2017

Friday, September 15, 2017

This Week in Mislabeled Product - ending 9-15-17

A CA company is recalling "272 cases of one specific lot of its 4-4 ounce packages of "San Francisco Seafood Salad Made with Greek Yogurt" bearing a UPC bar code of 47502 19701 because the individual cups inside the carton may be mislabeled as Seafood Salad with Real Mayonnaise and does not declare "milk"........The recall was initiated as a result of a consumer inquiry into a label inconsistency; the cups within the 4-pack sleeve were labeled as Seafood Salad made with Real Mayonnaise while the outer carton was Seafood Salad with Greek Yogurt."

A Michigan company is recalling approximately 123 pounds of meatball products due to misbranding and undeclared allergens,  The product contains soy which is not declared on the product label.  The problem was discovered during routine label verification checks

A retail operation in the upper Midwest US is recalling packages of its American Rye Bread and Caraway Bread, which contain undeclared allergens (milk, soy and egg) as a result of an update to the ingredient profile from the manufacturer of the base.  This appears to be one of those supplier related issues where the supplier makes a change in an ingredient.

A Colorado-based natural grocery chain, is recalling Natural Grocers brand Organic Deglet Noor Dates Pitted because it may contain undeclared coconut, an allergen.  The recall was initiated after it was discovered that product containing coconut was distributed in packaging that did not reveal the presence of coconut.

 A NY firm is recalling its 12-ounce packages of CHERRY VALLEY VANILLA CUPCAKES and CHERRY VALLEY CHOCOLATE CUPCAKES because they may contain undeclared milk allergens. The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk allergens in the 12-ounce packages of CHERRY VALLEY VANILLA CUPCAKES which did not declare a milk ingredient on the label.

Simply Fresh Foods, Inc. Issues Allergy Alert on Undeclared Milk in Single Serve Cups of San Francisco Seafood Salad Made with Greek Yogurt
For Immediate Release
September 8, 2017
Consumers 1-855-207-2758  Media Dale Jabour  1-800-807-7335

Hurricane Irma - Impact on Food Safety

Hurricane Irma has posed a number of challenges to the food supply chain - from growers to restaurants, to consumers.

Millions of people are still without power 5 days after the hurricane. At this point, perishable refrigerated and frozen foods are certainly lost. This not only impacts products at home, but also those in restaurants and retail.

Flooding, especially in coastal areas impacted by storm surges, has impacted homes and businesses.  Any food contacting flood waters should be thrown out.

There has been a huge impact on the agricultural sector from both flooding and from wind. It is estimated that 50% of the fruit came off the region's citrus trees. Vegetable crops have also been lost in areas prone to flooding.

Orlando Sentinel
Hurricane Irma challenges Florida grocery pipeline
September 19, 2017

Hair as a Hazard - An Extreme Case - Hairball Formation

When evaluating food for hazards, hair is not normally considered a risk  It can be considered a sign of insanitary handling and preparation, or it can be the source of hazards such as the bacterium Staphylococcus aureus (an organism found on human skin), but in itself, is not a hazard.  However, here is a case where hair became a hazard.  A young woman ate enough hair overtime, that it formed a hairball in her stomach which led to deadly condition.

NY Post
‘Rapunzel syndrome’ teen dies from eating her own hair
By Fox News
September 14, 2017 | 1:21pm

Tuesday, September 12, 2017

Pet Store Puppies Linked to Outbreak of Campylobacter

Puppies sold through Petland pet stores have been linked to an outbreak of Campylobacter.  There have been 39 cases (12 of those are store employees) in 7 states.  Age of those who became ill ranged from one year old to 77.

Petland doesn't necessarily agree with the assessment “The CDC has not identified any failures of Petland’s operating system that would lead to any Campylobacter infection. Petland reinforces proper hand sanitization before and after playing with any of our puppies with the many sanitation stations in each store and has strict kennel sanitation procedures and protocols put in place by consulting veterinarians.   “… we again stress the importance of proper hand sanitizing when handling pets and when handling their food or waste. It is also important not to let any dog lick your mouth.”

Campylobacter would be spread through the fecal material that can be left on the fur of the dog or even on the carpet.

Multistate Outbreak of Human Campylobacter Infections Linked to Pet Store Puppies
Posted September 11, 2017 9:00 AM ET
Outbreak Advisory
  • Cases 39
  • States 7
  • Hospitalizations 9
  • Death 0

Monday, September 11, 2017

Papayas Recalled After Tests Positive for Salmonella and New Outbreak

A California produce company is recalling Maradol Papaya after product tested positive for Salmonella.  Testing appears to have been done by FDA. 

This recall comes after a large Salmonella outbreak linked to papaya occurred in August.  This recent recall however, is an example of why it is important to track issues of the same or related product.  it only makes sense that when an outbreak occurs in product, in this case papaya, then the regulatory agencies will be focused on that and similar products.

FDA Recall Notice
Bravo Produce Inc. Recalls Maradol Papaya from Productores Y Exportadores De Carica Papaya De Tecomán Y Costa Alegre SPR of RL and Packed by Frutas Selectas De Tijuana, S. De R.L. De C.V. Because of Possible Health Risk
For Immediate Release
September 10, 2017

Friday, September 8, 2017

British Online News Report on Fear of Terrorist Attacks Using Food

A British online news report raises concern of an ISIS fueled terror attack through the contamination of food in grocery store.

Mail OnLine
ISIS tells its fanatics to poison food in Western supermarkets after testing the method on its prisoners in Iraq

  • ISIS leaders are reportedly planning on poisoning food in UK and U.S. shops 
  • Used prisoners in Mosul, Iraq as guinea pigs to test poisons in foodI
  • Details of their 'tests' uncovered when Mosul was liberated this year 

By Sara Malm for MailOnline
Published: 15:30 BST, 6 September 2017  | Updated: 18:31 BST, 6 September 2017

This Week in Mislabeled Product - Sept 8, 2017

A grocery chain is recalling semi-sweet chocolate chips because the bags may contain milk chocolate chips and milk is not declared on the label.  While the statement does not tell how the issue was discovered, one could imagine either a some left-over milk chocolate chips left on the packaging line, or someone dumped the wrong chips during packaging operations.

A grocery store chain is recalling assorted muffin four packs that may include a banana nut muffin containing walnuts where that nut allergen not listed on the label.

FDA Recall Notice
Wakefern Food Corp. Voluntarily Recalls ShopRite Semi-Sweet Real Chocolate Chips
September 1, 2017

Plant-based Hamburger With Bioengineered Soy Meat Protein Questioned on Allergen Issue

The primary ingredient in the plant based hamburger (yeah, a fake burger) is being questioned due to the fact that it may be an allergen.  According to this article, the company had tested the bioengineered soy leghemoglobin for safety, but the FDA may still have concerns.

My concerns are a little different.....

Food Business News{5C9956A8-4832-4A78-A853-05ECE1FF3D41}&
Impossible Burger, environmentalists clash over key ingredient
 Sept. 5, 2017 - 
by Erica Shaffer

Infant Probiotic Solution Recalled Due to Potential Choking Concern

Garden of Life is recalling their Baby Organic Liquid Formula because there is inadequate instructions for delivering the product to infants.  Evidently, the product is too thick.  Directions for using syringe are not adequate.

This is a probiotic solution.

FDA Recall Notice
Garden of Life LLC Issues Recall of Baby Organic Liquid Formula
For Immediate Release
September 7, 2017

Wednesday, September 6, 2017

FSIS Issues Updated Compliance Guideline for Control of Pathogenic E. coli (STEC) in Non-intact Beef

FSIS released an updated 2017 Compliance Guidance on Minimizing the Risk of Shiga Toxin-Producing Escherichia coli (STEC) in Raw Beef (including Veal) Processing Operations.  This guideline updates and combines information from both the 2008 Sampling Beef Products forEscherichia coli O157:H7 (August 12, 2008) and •Sanitation Guidance for Beef Grinders (January 2012).  "This guideline incorporates current Agency thinking on the use of antimicrobial treatments, establishment sampling programs, and other measures in the establishment’s HACCP system."

This guidance states "FSIS is revising [the previous guidance documents] because it has seen that many small and very small establishments have had difficulty in designing and supporting their HACCP system (e.g., HACCP plan, Sanitation Standard Operating Procedure, or other prerequisite program) in a manner to prevent, eliminate, or reduce STEC to an acceptable level."

The guidance applies to non-intact beef products including: "ground beef; beef that an establishment has injected with solutions; beef that is vacuum tumbled with solutions; beef that an establishment has mechanically tenderized by needling, cubing, pounding devices (with or without marinade); beef that an establishment has reconstructed into formed entrees; and diced beef less than ¾ inch in any one dimension."

Sliced Produce Recalled Due to Listeria

A Florida produce operation is recalling diced produce due to the potential for Listeria.  The product, packed in clear plastic container or in Styrofoam trays overwrapped with clear plastic film, is being recalled as the result of a single routine sample taken at a retail store in Georgia which revealed that the finished product tested contained the bacteria.

The product has already passed its expiration date.  The delay was probably related to sampling / testing / reporting.

In cases like this, the source of contamination often originates in the environment of the slicing and packaging operation.  Slicing/dicing equipment is a primary culprit because of the difficulty cleaning. Packaging machinery is another potential source.

FDA Recall Notice
Country Fresh Orlando LLC, Recalls Product Because of Possible Health Risk
For Immediate Release
September 2, 2017

Friday, September 1, 2017

Bad Pet Ideas for Little Kids - The Turtle Edition

CDC is reporting a large Salmonella outbreak linked to little turtles - 37 cases with 16 hospitalizations.  While FDA has banned the sale of little turtles (less than 4 inches) back in the 1970's for this reason, we have continued to have outbreaks.  Turtles and other reptiles can carry Salmonella and this is an issue with little kids in that they may be less likely to wash their hands afterwards, or may stick the animal in or around their mouth.  Other pets that have been problematic - baby chicks, frogs, and hedgehogs.  

CDC Outbreak Report
Multistate Outbreak of Salmonella Agbeni Infections Linked to Pet Turtles, 2017
Posted August 29, 2017 1:00 PM ET

FDA Enforcement Report - Week of August 30, 2017 - Summary

FDA's Weekly Enforcement Reports - Whereas not all recalls are announced in the media or on FDA's Recalls press release page, all recalls go into FDA's Enforcement Report once they are classified according to the level of hazard involved.

As a way to see more fully issues occurring, we thought we might summarize the food related items (allergen issues are posted on This Week in Mislabeled Product).
  • Go-Fresh of MN and Fresh Venture of CA Mary's Harvest Fresh Foods, Inc. of OR were impacted when firm test results found potential E-coli O26 contamination in Broccoli Florets. This has impacted a number of brands. - Class 2
  • Lakeside Foods of WI is recalling french style green beans for potential Listeria contamination.  This company has has Listeria contamination issues in the past.  Class 2
  • Koogee-Queen Anne, of KY is recalling ice bream products due to E. coli and high coliform counts. - Class 2
It is interesting to note how these recalls were classified.  The recalls for broccoli due to E. coli O26 and for green beans due to Listeria were classified as Class 2 recalls even though these are serious pathogen.  This is because the packages had validated cooking instructions, with the thought that proper cooking would minimize the risk of these pathogens.   Now if these pathogens had genetic matches to a serious outbreak as determined by WGS, then this would be a different story.

This Week in Mislabeled Product - August 25 to September 1, 2017

A list of recalls related to mislabeling / allergens.

  • A Calif. establishment, is recalling approximately 15,092 pounds of beef, chicken and pork products due to misbranding and undeclared allergens The problem was discovered on Aug. 22, 2017 when FSIS Inspection Program Personnel observed that the establishment utilizes a soy protein concentrate in the production of several products, but the finished product labels do not declare soy. In addition, some of the same products contain wheat flour and wheat is also not declared on the finished product labels.
  • A Mass. established reissued a recall notice to include the states in which the product was distributed. The establishment is recalling approximately 3,448 pounds of chicken breakfast sausage products due to misbranding and undeclared allergens. The product contains soy lecithin, a known allergen, which is not declared on the product label. The problem was discovered during routine FSIS label verification activities
  • A Mass. establishment, is recalling approximately 32,228 pounds of fully cooked chicken sausage product due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains milk, a known allergen, which is not declared on the product label. The problem was discovered by FSIS Inspection Program Personnel during routine label verification activities. There have been no confirmed reports of adverse reactions due to consumption of this product
  • A firm in MI, is recalling several brands of butter flavored popcorn because they may contain undeclared milk.  The recall was initiated after a non-illness consumer complaint in relation to flavor.
  • A distributors in GA is recalling 1467 packets of Jalebi because it may contain undeclared Almond pcs "This problem was highlighted by FDA inspectors while inspecting our food distribution facility. The problem was caused due to recent change in the packing of the product to enhance the appearance of the product."  (So what, now we could see the almonds that should not have been there?).

And from the FDA Weekly Enforcement Reports

  • Shatto Milk Co of Osborn, MO, labels on butter products failed to mention the milk allergen.
  • D&D Foods missed soy lecithin on the label for co-packed pizza products.
  • Penobscot McCrum missed milk on labels for Jo-Jo wedges (potato wedges)
  • The Best Bar Ever initiated a voluntary recall of the Peanut Butter Crunch flavor (40g size) because the individual wrapper mistakenly has a gluten-free logo on the label. The wrapper for Peanut Butter Crunch flavor (40g size), had a gluten-free logo on the individual wrapper label. The ingredient listing and allergen statements are correct. The only issue is the gluten-free icon was not supposed to be on that flavor

Blossom Foods, LLC Recalls Frozen Meat Products Due to Misbranding and Undeclared Allergens

FDA Updates Preventive Controls Guidance With Chapter on Heat Processing PC

FDA updated their Preventive Controls Guidance document with a chapter on addressing the use of heat treatments as process controls.  To this point, the guidance provided somewhat similar information to that in the FSPCA manual, although the information is split differently among the chapters. However, the information covered in Chapter 6 goes into more detail, providing more information on heating, including examples for baking cookies, heating soup, and processing salsa.  This information covers how one would validate that information, and then implement and manage the process - monitoring, corrective actions, verification, and records.

Currently, the Guidance has 5 previous chapters, while Chapters 7 to 14 are yet to be released.

  • Chapter 1 is an introduction
  • Chapter 2 discusses how to conduct a hazard analysis.
  • Chapter 3 provides additional information on hazards in foods. For example, it discusses pesticides, animal drugs, and mycotoxins as chemical hazards and when you may want to consider those hazards.  While it does not provide complete information on each of the hazards, it does provide some additional information.
  • Chapter 4 overviews the preventive controls - Process, Sanitation, Allergen, and Supply Chain controls - highlighting primary types for each.  Under Process Controls, the chapter covers leathality treatments (heat, HPP, irradiation, fumigation), cold holding, formulation control, etc.  Again, not a complete listing of types, but give information on the major types.
  • Chapter 5 is the application and management of preventive controls...provides some additional information to the preventive controls discussed in chapter 4.
Each of the coming chapters will expand upon the preventive controls as was done in Chapter 6 for heat processing.

This will become more of a companion reference document as examples of the process controls are expanded upon.  This guidance will give information on the types of things an FDA inspector will be looking for as they conduct inspections.  Certainly a document worth printing or bookmarking.  Be sure to watch for updated sections as they are released.

Friday, August 25, 2017

FDA Releases Food Defense Plan Guidance

FDA released a guidance document on developing and implementing a Food Defense Plan for mitigating against intentional contamination.  LINK.

The Food Defense Plan is required as part of FSMA.
The rule requires a written food defense plan for all covered facilities unless an exemption applies (21 CFR 121.5). The written plan must include (21 CFR 121.126):

  1. 1. A vulnerability assessment to identify significant vulnerabilities and actionable process steps, and associated explanations
    • Mitigation strategies and associated explanations
    • Procedures for food defense monitoring
    • Procedures for food defense corrective actions
    • Procedures for food defense verification
  2. The rule requires training for certain personnel. See “EDUCATION, TRAINING, AND QUALIFICATIONS” section (21 CFR 121.4)
  3. The rule requires covered facilities to maintain the food defense plan as a record as well as records for training, food defense monitoring, food defense corrective actions, and food defense verification. (21 CFR 121.126(c), 121.140(c), 121.145(b), and 121.150(c))
  4. The rule requires reanalysis of the food defense plan. (21 CFR 121.157)
For most companies, the compliance date is July of 2019. Smaller companies have more time.

FDA Conducts Pathogen survey on Sprouts

FDA conducted a sampling of sprouts for pathogens in order to determine the prevalences of Salmonella, Listeria monocytogenes and E. coli O157:H7 in sprouts. Seeds, finished product and spent irrigation water were tested.

The summary of the findings:
  • Prevalence of Salmonella in the finished product sprouts to be 0.21 percent. 
  • Prevalence of Salmonella in seeds (2.35%) and in spent irrigation water (0.54%)
  • Prevalence of Listeria monocytogenes in the finished product to be 1.28 percent. 
  • There was no significant difference in the prevalence of Listeria monocytogenes based on point in the production process. 
  • None of the samples tested positive for E. coli O157:H7
  • Most of the positive samples at a small number of sprouting operations
From 1996 to July 2016, there were 46 reported outbreaks of foodborne illness in the United States associated with sprouts. So while the prevalence is not high, because the fact that sprouts are especially vulnerable to pathogen contamination and growth "given the warm, moist and nutrient-rich conditions needed to grow them", sprouts are a risk for foodborne illness.......especially for high risk populations.  Salmonella and E.coli are more of an issue on incoming seeds, while Listeria would be more of a concern within the processing environment.

Going forward, FDA "intends to conduct a study at establishments that grow, harvest, condition, pack/re-pack, and/or supply seeds and beans for sprouting to gain insights on production practices, sanitation methods and manufacturing processes and to help the establishments achieve compliance in the event that insanitary conditions are observed".  "FDA also intends to inspect sprouting operations to ensure they are complying with the Produce Safety Rule and may continue to sample sprouts and the production environment"

FDA Release
FY 2014 – 2016 Microbiological Sampling Assignment
Summary Report: Sprouts

Office of Compliance
Center for Food Safety and Applied Nutrition
August, 2017

Thursday, August 24, 2017

Warning Letter - Oregon Canned Food Manufacturer

An Oregon canned food manufacturing company was issued a Warning Letter from FDA for inadequate responses to the FDA inspection report (483) that they were issued regarding low acid canning procedures.  With low acid canned food, there are specific regulatory requirements that must be met including having approved processes, filing those processors, controlling the process, and collecting the appropriate documentation.  (LACF Regulations).
  • Non-validated venting process for the retort.
  • Failure to record critical data including potato dimensions, cooling overpressure time and temperature, and headspace.
  • Failure to identify deviations from the filed schedule
  • Failure to record the results of visual examination of the container closures at intervals of sufficient frequency to ensure proper closure
The primary issue of not following strict procedures is the risk of Clostridium botulinum growth and toxin production.

FDA Warning Letter
Oregon Wild Berries, Inc. 8/9/17

FDA Releases Food Safety Plan Builder

FDA has provided a Food Safety Plan Builder which is an input driven tool that helps one to document and organize their company's Food Safety Plan.

While some may like having such a tool, I find it more difficult in some ways.  For one, you have to have all of your information ready as you input the data.  It is almost better to have your plan written before inputting for ease.  Second, it is hard to keep an overview of what you have written since with this, you are going step by step.  Lastly, it put the document into a format that is not as easy to change as if you used Word or Excel.

So this is not going to be something I recommend. I find it much easier to use open forms that are easy to add information, modify that information, or visual your plan when working on it.  I also prefer having my documentation in a format that will always be available, and for me, I prefer working in Excel for tables and Word for policies and procedures.

But take a look and let us know what you think.
Download the Food Safety Plan Builder Tool

Food Safety Plan Builder

Canadian Firm Recalls Fully Cooked Chicken Skewers for Listeria Contamination

A Canadian firm is recalling fully cooked chicken skewers for Listeria.  The Listeria was discovered during FSIS import inspection.  Product had been shipped to retail locations in Arizona, Connecticut, Florida, Illinois, Maryland, Michigan and Texas.

USDA FSIS Recall Notice
Expresco Foods Inc. Recalls Chicken Skewer Products Due to Possible Listeria Contamination
Class I Recall 095-2017
Health Risk: High Aug 23, 2017
En Español
Congressional and Public Affairs Mitch Adams (202) 720-9113 

Packaged Frozen Cherries from Turkey Recalled for Listeria

Sunrise Growers Inc. a subsidiary of SunOpta Inc’s subsidiary, is recalling frozen organic dark sweet pitted cherry products due to the potential to be contaminated with Listeria monocytogenes.  The issue was discovered during routine testing by Sunrise Growers.

Not directly stated in the announcement is that the product is imported from Turkey (printed on package) and distributed within the US.  So this is a supplier control issue, and knowing how well the packer of this product controls Listeria in the processing environment.  The distributor did testing, but it appears that product had already been distributed.  So was a sample and hold procedure in place?

While Listeria will not grow on the frozen cherries, the concerns would be related to the level of Listeria on the cherries and how the application for using cherries. The risk increases with a higher level of Listeria present and if the cherries will be used in 1) RTE applications such as a fruit smoothie and 2) in a matrix that will allow for growth, (if the blended smooth has a sufficient PH and 3) that product will be held for a sufficient time to allow for growth...someone leaves that smoothie on their desk all day.

FDA Recall Notice
Recall of Certain Frozen Organic Dark Sweet Pitted Cherry Products Due to Possible Contamination by Listeria Monocytogenes
For Immediate Release
August 23, 2017

Wednesday, August 23, 2017

Salmonella Cases Linked to Backyard Chickens Continues to Increase

Chickens can carry Salmonella, and if you raise chickens, you need to be aware of that you have an increased risk of Salmonella infection.  But as the backyard chicken craze continues, more people are becoming infected with Salmonella.

CDC has a nice publication regarding backyard flocks -
Follow these guidelines - including washing your hands after handling birds -  and you will reduce your risk.

CDC Outbreak Notice
Multistate Outbreaks of Human Salmonella Infections Linked to Live Poultry in Backyard Flocks, 2017
Posted August 21, 2017 11:00 AM ET

Outbreak Advisory
961  Cases
48 States
215 Hospitalizations
1 Death

Firm Recalls RTE Sausage After Accidentally Shipping Product on Hold for Listeria

A Wisconsin firm is recalling fully cooked sausage patties after product being held for potential listeria contamination was accidentally shipped.  "The problem was discovered when firm’s routine testing indicated positive results for Listeria monocytogenes. The products were on hold at a distribution center, however, the products were inadvertently shipped. There have been no confirmed reports of adverse reactions due to consumption of these products."

USDA Recall Notice
News Release
Fair Oaks Farms, LLC Recalls Pork Sausage Patties Due to Possible Listeria Contamination 
Class I Recall  094-2017
Health Risk: High
Aug 22, 2017
En Español
Congressional and Public Affairs  Mitch Adams  (202) 720-9113

FDA Warning Letter - King of Pops - Nasty Food Operations Exposed

FDA issued a warning letter to a GA firm after that firm inadequately responded to the findings of an FDA inspection.

The findings - pretty nasty especially considering this company is producing ready-to-eat foods, and if we had to guess because they are ice pops, will be eaten by children.

  • Rodent droppings throughout the facility.
  • Food residues on equipment
  • Untreated and unsanitary floors
  • Improper glove usage - not changing gloves after touching unsanitary surfaces.
  • Inadequate floor drainage leading to standing water
  • Table top surfaces not of sanitary construction - not cleanable.
  • Not removing debris from production area in a timely manner.
  • Large gaps in facility capable of allowing pests in.
  • Exposed glass light bulbs in production areas.

Looking at the facility, it appears to be just a bad looking retail location.

But looking at the website, you can see it is a much larger operation.  Started by some young corporate-dropout types, it looks as though they never took the time to learn about safe food processing, or the need to implement food safety systems.

FDA Warning Letter
August  3, 2017

Friday, August 18, 2017

This Week in Mislabeled Products - 8/12/17 - 8/18/17

A very solid week of mislabeled items with 8 different entries.  Each has its own reason for error.

A MN company is recalling their Vanilla Cherry Pecan Muesli 12 oz. pouches because it may contain undeclared almonds. "The recall was initiated after it was discovered that the product containing almonds was distributed in packaging that did not reveal the presence of almonds. Subsequent investigation indicates the problem was caused by a temporary breakdown in their manufacturing partner’s production and packaging processes."  So, the co-packer screwed up.

A NJ establishment, is recalling approximately 1,719 pounds of chicken caesar salad products due to misbranding and an undeclared allergen - the product contains wheat which is not declared on the product label.  "The problem was discovered when the establishment received notification from the sole retailer of the chicken products that the incorrect ingredient label was applied to the chicken caesar salad products.  The ingredient label has a statement that the products were made without gluten containing ingredients, however, the Chicken Caesar Salad contains croutons made with wheat, and thus the wheat allergen was not declared on the label"  Ah...those darn croutons.

A NY company is recalling its 14 ounce packages of "CALIFORNIA ALOHA MIX" because they may contain undeclared tree nuts (Almonds, Walnuts and Cashews).  "The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed that the tree nut containing product was distributed in packages that did not reveal the presence of tree nuts (Almonds, Walnuts and Cashews)."  This looks to be a case of cross contact, probably in the packaging process.  NOTE - this product does have the precautionary label - "Manufactured in a facility that processes/packages products that contain peanuts, tree nuts, milk, soy, and wheat."  (picture of label below).

An IL based distributor, is recalling its 7 ounce and 14 ounce packages of “Gazab Green Raisins (Chinese)”, because it may contain undeclared sulfites. "The recall was initiated after it was discovered that the sulfite-containing product was distributed in packaging that did not reveal the presence of sulfites. Subsequent investigation indicates the problem was caused by a product packaging process when creating labels."  So the company was using generic packaging with print-on-demand labels.  Easy for these labels to not be checked well enough when being input into the machine and when selecting the right label code when printing.

A St. Louis supermarket chain is recalling two deli items due to the presence of undeclared fish (bonito, cod), undeclared lobster, crab, and shrimp in scampi butter and undeclared soy and wheat in cabernet grille butter. The recall was initiated after it was discovered by store personnel during an internal audit. "Subsequent investigation indicated the omissions were the result of ingredient changes in the products".

Litehouse Inc.. a WA based company, is voluntarily recalling a limited quantity of its OPA by Litehouse Ranch because it may contain undeclared eggs.  "The recall was initiated after it was discovered that product containing egg was distributed in packaging that did not reveal the presence of eggs. Subsequent investigation indicates the problem was caused by a packaging error."

Another WA establishment, is recalling approximately 4,805 pounds of poultry products due to misbranding and undeclared allergens. The products are mislabeled as Chicken Chile Verde that contain milk and soy, but contain Turkey Meatloaf, which has additional allergens, eggs and fish (anchovies), that are not declared on the product label.  The problem was discovered after the firm received consumer complaints of the wrong meal inside the retail boxes.

A Colorado company is recalling boxes of Chocolate Chip Cookie Mix because it may contain undeclared milk .  "The recall was initiated by Madhava Natural Sweeteners after it was discovered that one ingredient in the chocolate chips may include a milk product."

FDA Recall Notice
Dierbergs Markets Issues Allergy Alert on Undeclared Fish (Bonito and Cod), Lobster, Crab, Shrimp, Soy and Wheat in Product
For Immediate Release
August 14, 2017

Thursday, August 17, 2017

Canada - Norovirus in Raspberry Mousse Cake

In Canada,  a norovirus outbreak associated with Raspberry Mousse cakes has been reported.  The suspect product had been shipped throughout Canada.  There is not much more information available including how the product came to be contaminated.

While the raw materials may have been contaminated, it seems much more likely that this situation is the result of a norovirus-infected employee handling the finished product.  People who become infected with norovirus illness can develop symptoms as fast as 12 hours after exposure and those symptoms can last 24 hours or longer.  These symptoms include vomiting, diarrhea, nausea and stomach cramps. As they shed the virus through either portal, (and even after they are feeling better), the virus can get on hands or other surfaces, where it can makes its way to the food.   On surfaces, it can last for weeks, unless that surface is properly cleaned.  This is why it is critical to have sick employees (especially those who are vomiting, have diarrhea or jaundice), stay away from food.

CFIA Release
Updated Food Recall Warning - Raspberry mousse cakes recalled due to norovirus 
Recall date: August 16, 2017 
Reason for recall:  Microbiological - Other Hazard classification:
Class 3 Company / Firm:
Industry Distribution:
Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Possibly National, Quebec, Saskatchewan Extent of the distribution:

FDA Guidances for Bridging FSMA with Seafood HACCP, Juice HACCP, and LACF

The biggest impact with FSMA on juice, seafood, and LACF processors is the requirement for employees and supervisor personnel (1) be a qualified individual as defined in 21 CFR 117.3, i.e., have the combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties (21 CFR 117.4(b)(1)); and (2) receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility, and the individual’s assigned duties (21 CFR 117.4(b)(2)).  So training of employees and managers is required, with the appropriate documentation to demonstrate that.

A NM Bakery Issued a Warning Letter - Issues with Sanitation and Lack of Management Training

A New Mexico bakery was issued a warning letter from the FDA.  Most of the issues cited involved basic sanitation, and they were issues that were also noted in a 2014 inspection...thus the issuance of the Warning Letter.  To look at the facility from Google Street view (below), it looks like a legit operation (compared to this)

Many bakeries may be new to FDA inspections, although it was noted that this firm had a previous FDA inspection in 2014 (and unfortunately, didn't make much progress from that time...or so it seems).  But one of the items that is most interesting involves training, or the lack of training, specifically of management (see further down).

  • Unsanitary condition noted on 1) walls, overhead door, and cooling fan in areas used to cool baked bread., 2) condenser fans and support pole in walk-in refrigerator used to store uncovered apple pies, and 3)  3-Compartment sink used to clean in process equipment.
  • Peeling paint in the incoming supply room above ingredient containers which had broken lids, no lids, lids not fully covering materials. Additionally, peeling paint was observed on the ceiling of the walk-in refrigerator used to store uncovered apple pies.  
  • Fresh and dried dough on the ceiling above an uncovered mixer and along the rim of the (b)(4) bucket. (b)(4) is used as a processing aid in the production. 
  • Condensation issues  with buildup inside the proofing  along the ceiling, sides of walls, and along the door frame. As the uncovered dough enters the  proofing (b)(4), condensation drips directly onto uncovered dough.  Dark brown condensation buildup was observed in the production area on the ceiling above the proofing  and the final bread rolling area.  Condensation buildup was observed in the walk-in freezer fans located above finished product.
  • Inadequate screening or other protection against pests - the outer door and warehouse garage doors were open during food production activities without adequate protection to prevent entry of pests into the production facility.
  • The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment - the 3-compartrnent sink was set up in the following incorrect order: wash, sanitize, and rinse. Utensils were then immediately used without allowing them to air dry. At the final dough, recently used trays covered with residue were slammed on the floor to remove particles and then placed onto the cart, without washing, to be reused. Our investigator observed fresh dough immediately placed on these trays and sent to proofing .   In the proof , there is no evidence that the conveyor trays used to transport the dough from the extruder to the are sanitized.  The firm’s water filters have not been changed since 2013. There was dark brown and slimy residue in the filter. The filtered water is used in the production of dough, to clean large pieces of equipment, and used in the 3-compartment sink.

But this is the item to note - "Personnel responsible for identifying sanitation failures and food contamination lack a background of education and experience to provide a needed level of competency as required by 21 CFR 110.10(c). Specifically:
  •  The production manager did not know the correct order of operation to properly clean and sanitize utensils at the 3-compartment sink. The 3-compartrnent sink was set up in the following incorrect order: wash, sanitize, and rinse. During the inspection, the rinse water was observed to be cloudy and dirty, providing a possible source of cross-contamination.
  • The production manager did not know what the adequate sanitizer concentration should be; there were no test strips available to verify the concentration, and he relied solely on placing one capful of bleach into water
  • The president of the company lacks basic sanitation knowledge. For example, when asked about the sanitation procedures, he commented on cleaning the floors and was not aware of equipment cleaning and maintenance schedules. He also did not know the required sanitizer concentration and did not provide test strips to employees for verification."
As we know, as part of 21CFR117, it is required that management be adequately trained in food safety.

Finally - the firm failed to provide appropriate training in food handling techniques and food protection principles have not been provided to food handlers 1) an employee touching ready to eat bread rolls with bare hands to determine if they were cool enough for packaging. 2) an employee in the packaging area wearing only one glove, on the right hand. The employee was manually sorting bread into final packaging with both the gloved and bare hands.

FDA Recall Notice
July 5, 2017
Brent A. Bischoff
K & B Company Inc.
109 Arnold St.
Gallup, NM 87301

Monday, August 14, 2017

Virginia Peanut Company Issued Warning Letter - A Cat for Pest Control? The Risks of Ordering Food Online

FDA issued a warning letter to a Virginia peanut products company.    A summary of the key findings:

  • A cat as pest control.  And cat feces in the facility.
  • Sliding doors not sealed providing an opening to the outside
  • Employees not properly washing hands
  • Employees using tobacco in food contact areas
  • Food residues left on equipment
  • Old, unused equipment stored throughout facility
  • Air flow blowing peanut dust around.
  • Employees not wearing hair restraints.
  • Labeling issues involving nutrient claims, ingredient statements, and company listing.

It seems that they sell products online, and looking at their website (, it seems like a legitimate company.   However, entering the address into google street view, this is the picture that comes up..
While I am not sure if this is the processing facility or facilities, it does seem to match the description painted by the warning letter.

Really makes you think twice about ordering food online, doesn't it?

FDA Warning Letters
Coleman Peanut Company 8/2/17
August 2, 2017

Peas at Farmers' Market Responsible for Salmonella Infections - Wisconsin

Loose, shelled peas sold at a Wisconsin farmers' market are responsible for causing 7 cases of Salmonella infection, according to the Wisconsin Department of Health.

As a raw agricultural commodity, the peas fall outside of regulatory oversight.  

The name of the vendor has not been released, so this impacts all vendors selling peas at the Green Bay Farmers' Market, as well peas sold by vendors at another nearby farmers' market.

Peas are often cooked before heating, and this would have most likely eliminated the pathogen, but we know that many people use them raw without cooking. Certainly they should have been first washed, but this may not have removed the pathogen especially if present in high numbers. but it would have helped.

ABC News 2 - Wisconsin
Salmonella outbreak linked to peas sold at Farmers Markets
By Brittany Schmidt |
Posted: Fri 1:44 PM, Aug 11, 2017 |
Updated: Fri 10:43 PM, Aug 11, 2017

Friday, August 11, 2017

Doughnuts Gone Bad - Norovirus Outbreak Linked to Ohio Doughnut Shop

In Ohio, over 250 have become infected with norovirus linked to a doughnut shop - Mama C's Donuts.  Symptoms of norovirus, which include vomiting, diarrhea, stomach pain, fever, and body aches can last as long as 24 hours.  The highly contagious virus spreads easily, so the health department is concerned about secondary infections.

So instead of a cruller, you get a crueler.   Hey, a new way to make coconut glaze.

The Blade
266 norovirus cases linked to Maumee doughnut shop 
By Lauren Lindstrom  | BLADE STAFF WRITER

Europe - Eggs Contaminated with Pesticide Removed from Shelves

In Europe, eggs (and products made from eggs) from farms in the Netherlands and Belgium are being pulled from store shelves after it was found that those farms used a banned pesticide, Fiponil, a substance used to kill lice and ticks in chickens.  Product was shipped to  countries that have received the eggs are the UK, Sweden, Austria, Ireland, Italy, Luxembourg, Poland, Romania, Slovenia, Slovakia, Denmark and Switzerland.

Brittan’s Food Standards Agency says it is "very unlikely" there is any health risk.  However it is caused quite a stir throughout the EU.

BBC News
Eggs containing fipronil found in 15 EU countries and Hong Kong