FSMA Guidance Document - Co-manufacturers Working with Brand Owner's Suppliers

FDA released a guidance document today that allows co-manufacturing companies more time to comply with supplier preventive controls when those co-manufacturing operations are involved in packing products for a brand owner where the suppliers of ingredients for the product are under the control of the brand owner.  The co-manufacturer's food safety plan will state that which activities of the supplier approval and supplier verification are under the brand owner's control.

From the Guidance document:
"If a contract prevents a co-manufacturer from being able to review a brand owner’s documentation of supplier verification activities, the co-manufacturer would not be able to verify suppliers based on its review of that documentation. Consequently, the co-manufacturer would need to conduct supplier verification activities (e.g., on-site audits) that might otherwise not be required."  "To provide time for contracts to be revised to allow co-manufacturers to review all necessary documentation from the brand owner, FDA is announcing that, under certain circumstances and on a temporary basis, we do not intend to take enforcement action against a receiving facility that is a co-manufacturer, and that is not in compliance with certain supply-chain program requirements for food manufactured for the brand owner."

Supplier Approval
FDA does not intend to take enforcement action under the following circumstances: (1) a brand owner conducts supplier approval activities, (2) the co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer conducts any necessary supplier approval activities not conducted by the brand owner. For example, FDA does not intend to take enforcement action when a brand owner (rather than the co-manufacturer) evaluates supplier performance as part of approving a supplier, the co-manufacturer’s food safety plan states that the brand owner will consider supplier performance before a supplier is approved, and the co-manufacturer conducts any other necessary supplier approval activities (e.g., hazard analysis of the food). The co-manufacturer is always responsible for following written procedures for receiving raw materials and other ingredients, and documenting use of the procedures (21 CFR §§ 117.420 and 507.120).

Supplier Verification
FDA does not intend to take enforcement action under the following circumstances: (1) a brand owner determines and/or conducts supplier verification activities for its co-manufacturer, (2) the
co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer conducts any necessary supplier verification activities not conducted by the brand owner. For example, FDA does not intend to take enforcement action when an audit is determined to be the appropriate supplier verification activity but a co-manufacturer does not independently obtain a supplier audit or review the conclusions of a supplier audit obtained and reviewed by the brand owner, the co-manufacturer’s food safety plan states that the brand owner will obtain and review audits of the supplier, and the co-manufacturer conducts any other necessary supplier verification activities (e.g., sampling and testing of the raw material or other ingredient).

We do not intend to take enforcement action regarding the affected provisions until November 6, 2019.


https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM583490.pdf
Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food
Contains Nonbinding Recommendations
November 2017

Outbreak of E. coli Affects Hundreds of Marine Recruits

About 300 marine recruits were stricken with E. coli infection this past week, and of that, 85 are still ill.  The outbreak occurred at Marine Corps Depot San Diego along with some personnel at Camp Pendleton,  The investigation continues as to the cause.

Fox 5 News - San Diego
http://fox5sandiego.com/2017/11/02/dozens-of-marine-recruits-remain-sick-from-e-coli/
Dozens of Marine recruits remain sick from E. coli
Posted 8:51 PM, November 2, 2017, by City News Service

Airline Stops Foodservice Operations After Supplier Found with Listeria on Non-contact Surfaces

American Airlines suspended its food service for flights out of Los Angeles after it food supplier, Gates Gourmet, was found to have 'traces' of Listeria on non-food contact surfaces. including drains and floors.

It is hard to know the real risk with the the little information provided.  We would need to know much more (were food contact surfaces positive, how pervasive was the contamination throughout the operation, what trends were seen, what practices were or were not in place, the accessibility of the non-contact areas to being a risk to food, etc), to opine on the appropriateness of this action.  Just because Listeria is found in a drain, in itself, would not constitute a risk and can really be considered normal.  It seems the supplier was pretty confident in the low risk of the situation.

Business Insider
http://www.businessinsider.com/american-airlines-flights-no-food-after-listeria-outbreak-lax-catering-kitchen-2017-11
American Airlines flights are going without food after listeria found at catering kitchen
Benjamin Zhang

11/1/17

Canada: Breaded Chicken Strips Recalled Due to Staphylococcus Enterotoxin

A Canadian firm is recalling a lot of breaded chicken strips due to the potential presence of Staphylococcus aureus enterotoxin.  The product was recalled after a consumer.  The recall was triggered due to a consumer complaint.

Staphylococcus enterotoxin is a heat stable toxin that is formed as the bacterium Staphylococcus aureus grows in the food when that food is temperature abused.  In this case, it could have grown in the batter as the product was made, or on the breaded strips if those strips were temperature abused.  With one complaint at this point, it is more likely the latter.  This could be a case where the consumer leaves the box of chicken strips on the counter for a long period of time, perhaps when defrosting them, and then cooks them.  In this case, the organism grows on the strips and produces toxin.  Because the strips have been par-fried (to set the coating), there is a little microbial competition present. 

If more cases are reported from a diverse area, this would more likely indicate a production issue.  In this case, the batter temperature was not properly controlled.   For the facility, they would want to demonstrate proper batter temperature throughout the production run, adequate cooling and freezing after the par-cooking step, and then proper temperature control through the shipment of that product.

NET News Ledger.com
http://www.netnewsledger.com/2017/11/02/food-recall-maple-leaf-chicken-breast-strips/
Food Recall – Maple Leaf Chicken Breast Strips
Posted 2 November 2017 by NetNewsLedger in Featured

Recall of Burrito Products After a Sample Tests Positive for Listeria

A Denver, Colo. establishment, is recalling approximately 28,064 pounds of pork and chicken burritos and wrap products that may be adulterated with Listeria monocytogenes. The company notified FSIS on Oct. 30, 2017 that one of its products, Burrito Carnitas Caliente, had tested positive for L. monocytogenes during the firm’s product testing. After a review of the ingredients used in the Burrito Carnitas Caliente, the company determined that four additional products may be affected.

The labels indicate that this is a RTE product based upon the 'heat and serve' directions.

FSIS Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-116-2017-release
Chelsea Food Services Firm Recalls Pork and Chicken Products Due To Possible Listeria Contamination 
Class I Recall 
116-2017 
Health Risk: High
Nov 1, 2017 

Health Alert Issued for Salad Items With Potential Listeria Contamination

A public health alert was issued for chicken meat products produced by Ghiringhelli Specialty Foods, a Vallejo, Calif. establishment.   may be contaminated with Listeria monocytogenes. The Notice comes after receiving notification that the broccoli products used in the chicken salads were included in a U.S. Food & Drug Administration recall due to potential contamination with L. monocytogenes. A recall was not requested because it is believed that all products are no longer in commerce and are past their “Use by” dates.

This recall is related to the other Listeria / vegetable products from Mann packing recalled on October 20, 2017.

FSIS Health Warning Notice
https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2017/pha-103117
FSIS Issues Public Health Alert for Poultry Products Due To Possible Listeria Contamination 

CA Company Recalls Taboule Salad after Sample E. coli STEC Positive

Haig’s Delicacies of Hayward, CA is recalling 342 cases of Taboule Salad because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7).  The potential for contamination was noted after routine testing by the company detected the presence of E. coli O157:H7.  No illnesses have been reported to date.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm583041.htm
Haig’s Delicacies LLC Recalls Lot of Taboule Salad Because of Possible Health Risk
For Immediate Release
October 30, 2017

Supplier Recall of Dark Chocolate for Undeclared Milk Allergen Triggers Customer Recalls

A number of recalls have been issued for dark chocolate products after the supplier, GKI foods, recalled the dark chocolate ingredient because it had undeclared milk.

GKI Foods LLC
Blue Marble, Roundy's Select, and HyVee

Dark Chocolate Products

CVS Gold Emblem, Ocean State Candy, Hannaford Excellent, Market Basket, & Weigels
New American Food Products, LLC
Dark Chocolate Products  

Aurora, AG Supermarkets, Belmont Market, and others
Aurora Products, Inc.
Dark Chocolate Products

Toothsome Chocolate Emporium
Rucker’s Makin’ Batch Candies, Inc.
Dark Chocolate Coffee Beans

Uncle Buck’s and Family Choice
Rucker’s Wholesale and Service Co
Dark Chocolate Peanuts

21st Century Snack Foods
21st Century Snack Foods
Dark Chocolate Almonds

Shoreline Fruit and Cherry Bay Orchards

Shoreline Fruit LLC

Dark Chocolate Covered Cherry Products

Wegmans, Alpine Valley, Circle K and others First Source

Dark Chocolate Products

Meijer
Meijer
Dark Chocolate Products

Figi
Dark Chocolate Gingersnaps


https://www.fda.gov/Safety/Recalls/ucm582769.htm
First Source Issues Allergy Alert for Undeclared Milk in Several Dark Chocolate Products Received from our Supplier GKI Foods LLC
For Immediate Release
October 30, 2017

Camel Milk Seized in Kansas City

US Federal authorities seized 4300 16oz bottles of frozen raw camel milk, camel colostrum, and camel kefir which were stored in a Kansas City warehouse.   One issue was that they were shipped across state lines which was illegal.  Second is that the label and website health claims made are not scientifically supported (see Warning Letter).  One of those claims being that camel milk can help people with autism.   FDA issued an alert earlier this year stating that camel milk is not a treatment for autism.

I see that camel milk is also a 'thing' for putting in your coffee.  According to a Huffington Post article, camel milk is slightly sweet and creamy and slightly salty.  And even more nutritious.  The hard part may be deciding one hump or two.

http://www.kansascity.com/news/local/article179929871.html#storylink=cpy
Feds seize gallons of camel milk they allege was illegally shipped to Kansas
By Tony Rizzo  trizzo@kcstar.com
October 20, 2017 10:07 AM