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
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm570807.htm
July 5, 2017
WARNING LETTER
Brent A. Bischoff
President
K & B Company Inc.
109 Arnold St.
Gallup, NM 87301

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 (http://www.epeanuts.com/), 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
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm569815.htm
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

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
http://www.toledoblade.com/Medical/2017/08/10/Number-of-norovirus-cases-linked-to-Mama-C-s-Donuts-rises-to-nearly-240.html
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
http://www.bbc.com/news/world-europe-40896899
Eggs containing fipronil found in 15 EU countries and Hong Kong
8/11/17

Salmonella Outbreak Associated with Papayas Increase to 141 Cases

The case count for those impacted by the Salmonella outbreak associated with Maradol papayas continues to increase.  As of 8/11/17, infections have been reported in 19 states with a total of 141 cases with 45 hospitalizations and 1 death.

The Maradol papayas originated from the Carica de Campeche farm in Mexico.  FDA has issued warning for 3 brands - Caribeña, Cavi and Valery brands of Maradol papayas.  Recalls were issued for each of the brands ( Caribeña, Cavi, and Valery ).

FDA has issued an import alert.  (Import Alert 99-35)

Several types of Salmonella bacteria have been isolated, including Salmonella Agona, Salmonella Kiambu, Salmonella Gaminara, Salmonella Thompson, and Salmonella Senftenberg.

Posted 8/11/17

CDC Outbreak Notice
https://www.cdc.gov/salmonella/kiambu-07-17/index.html
Multistate Outbreak of Salmonella Kiambu and Salmonella Thompson Infections Linked to Imported Maradol Papayas

This Week in Mislabeled Product

Each week, we normally see numerous recalls issued that involve mislabeling of product.    In most cases, theses calls involve allergen risks.  This past week was no exception.  The scope of these recalls vary as well as the way in which the mislabeling issue was identified. 

A Wisconsin firm is recalling hamburger patties after receiving complaints that hamburger patties with cheese, a dairy allergen, and bacon were mislabeled as plain patties.

A St. Louis, Mo. establishment, is issuing an allergy alert on 13 German Chocolate Cakes labeled as regular chocolate cake because the product contains pecans that are not listed on the ingredient label.  The issue was discovered by an employee

A Calif. establishment, is recalling approximately 2,133 pounds of ready-to-eat (RTE) beef products due to misbranding. The products contain monosodium glutamate (MSG) that was not declared on the product labels.  The issue was discovered during a USDA / FSIS inspection.

Taylor Farms Retail, Inc. in Salinas is conducting a limited recall of 293 cases of Taylor Farms Creamy Homestyle Coleslaw Kits due to an undeclared milk allergen.  Milk is an ingredient in the dressing packet included in the salad kit. The undeclared allergen was discovered through a quality check.

USDA / FSIS Recall Notice
https://www.fsis.usda.gov/wps/wcm/connect/FSIS-Content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-091-2017-release
Kenosha Beef International, LTD. Recalls Beef Products Due To Misbranding and Undeclared Allergens
Class I Recall091-2017
Health Risk: HighAug 9, 2017

Black Forest Ham Recalled for Not Declaring Malted Barley on Label

A Maryland Company is recalling close to 120,000 lbs of RTE Black Forest Ham because the product label did not have an ingredient - Malted Barley.  The recall came after a complaint was made.

The recall notice states that the absence of malted barley as an undeclared allergen.  And while barley is allergenic, it is not included within FALCPA.   It does contain gluten however.

USDA / FSIS Recall Notice
https://www.fsis.usda.gov/wps/wcm/connect/FSIS-Content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-088-2017-release
Hahn Brothers, Inc. Recalls Ready-To-Eat Ham Products Due To Misbranding and Undeclared Allergens
Class II Recall 088-2017
Health Risk: Low 

Aug 5, 2017