FDA to Continue Leniency with Co-packers Supplier Control Where Brands Have Oversight

FDA announced that they will continue to provide 'enforcement discretion' with supply chain controls for co-packers where the brand companies they are packing for have oversight over those suppliers.  In these cases, the co-packer is packing under contract for the brand company, and that brand company has chosen and then manages the suppliers who provide raw materials to the co-packer.

Certainly if the brand companies want the control over the supply chain to the co-packer, then they should be responsible for the supply chain control components and should have the procedures and documentation to support that.  This FDA announcement does not go that far, outside of providing an out for the co-packer.

From the announcement, "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."

From the previously published guidance establishing enforcement discretion:
"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)."

FDA Constituent Update
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-supply-chain-program-requirements-and-co-manufacturer-supplier-approval-and
FDA Continues Enforcement Discretion Policy Relevant to Certain Co-Manufacturers under FSMA
November 6, 2019

Packaged Vegetable Products Recalled for Potential Listeria Contamination

Mann Packing Co., Inc. announced today the voluntary recall of a series of ready-to-eat / ready-to--use packaged vegetable products sold to select retailers in the United States and Canada after they were notified by the Food and Drug Administration and the Canadian Food Inspection Agency of a potential contamination with Listeria monocytogenes. At this point, there have been no reported illnesses.

Wegman's and GHNW, LLC (Clackamas, OR)  also recalled product packed by Mann Packing.

The extensive list of items can be found here:

https://mannpackingproductlist11-2019.us/

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mann-packing-co-inc-voluntarily-recalls-vegetable-products-sold-united-states-and-canada-due
Mann Packing Co., Inc. Voluntarily Recalls Vegetable Products Sold in the United States and Canada Due to Potential Health Risks
Summary
Company Announcement Date: November 03, 2019
FDA Publish Date: November 03, 2019
Product Type: Food & Beverages
Reason for Announcement: Potential contamination with Listeria monocytogenes
Company Name: Mann Packing Co., Inc.
Brand Name: Mann, various private brands
Product Description: Various vegetable products

CDC Investigates a Salmonella Outbreak Associated with Ground Beef

CDC is investigating a Salmonella outbreak associated with ground beef.

• There are 10 cases with 8 hospitalizations and 1 death.  
• Cases occurred in 6 states, all west of the Mississippi.
• Onset of illness is August 8, 2019, to September 22, 2019. 
• Ill people range in age from 48 to 74 years, with a median age of 68. 
• Eighty percent of ill people are male. 
• Of nine ill people with information available, eight (89%) were hospitalized, which is much higher than we would expect for Salmonella infections
• No information was presented as to the source.

Could we say that most cases are older men who probably felt it was okay to eat hamburger on the rarer side...because they always ate it that way?  Or they don't feel they need to use a thermometer.

With the last case starting over a month ago, it may be difficult to find the source at this point, or at least isolate the organism in product. While there may not be more cases if this was a one time contamination event, more cases may pop up if people had frozen the raw ground meat or the undercooked meat.

CDC Investigation Notice

https://www.cdc.gov/salmonella/dublin-11-19/index.html
Outbreak of Salmonella Infections Linked to Ground Beef

Published on November 1, 2019 at 4:00 PM ET

At A Glance
Reported Cases: 10
States: 6
Hospitalizations: 8
Deaths: 1

CDC, public health and regulatory officials in several states, and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) are investigating a multistate outbreak of Salmonella Dublin infections linked to ground beef.

A single, common supplier of ground beef has not been identified. This investigation is ongoing and CDC will update the public as more information becomes available.

This Week in Mislabeled Product for Week Ending November 2, 2019

Natural Casing Not on Label - Taylor’s Sausage Inc., a Cave Junction, Ore. establishment, is recalling approximately 641 pounds of ready-to-eat meat and poultry sausage products because the products may be misbranded and contain a pork casing or a sheep casing that were not declared on the product label. The problem was discovered by FSIS during routine inspection activities.

Cookie Packaging Missing MIlk - Golden Dragon Fortune Cookies Inc.,of Chicago, Illinois is recalling Golden Dragon Inc. Chinese Almond Cookies, because it may contain undeclared Milk. The recall was initiated after it was discovered during an FDA inspection that the Golden Dragon Fortune Cookies Inc. Chinese Almond Cookies were distributed in packaging that did not reveal the presence of Milk.

FDA Proposes Laboratory Accreditation Program for Food Testing - Let the Arms Race Begin

FDA is proposing the establishment of a laboratory accreditation program for those testing food.  Testing by an approved laboratory would then be required in certain circumstances including:

• Testing conducted to comply with specific FDA testing requirements applied to address an identified or suspected food safety problem (including certain tests of shell eggs, bottled water, and sprouts);
• Testing conducted to provide evidence to support the admissibility of imported food into U.S. commerce (e.g., testing conducted for a food that has been detained due to an appearance of adulteration);
• Testing conducted to support the removal of a food from an import alert through successful consecutive testing;
• Testing conducted to address an identified or suspected food safety problem and presented to FDA as part of evidence for an informal hearing before a mandatory recall order, as part of a corrective action plan submitted after an order suspending the registration of a food facility, or as part of evidence submitted for an appeal of an administrative detention order;
• Testing conducted in response to a food testing order, a new procedure proposed by this rule to address an identified or suspected food safety problem.

Basically, FDA will not approve the laboratories, but will  recognize ABs (accreditation bodies), which will, in turn, accredit laboratories to conduct food testing in these circumstances.  "The proposed laboratory accreditation program would incorporate two globally recognized and widely used voluntary consensus standards, ISO/IEC 17011:2017 and ISO/IEC 17025:2017, as foundational requirements for ABs and laboratories, respectively. ABs and laboratories would also be required to meet certain additional requirements."

This always sounds like a good idea, but like so many other similar programs, it becomes a quagmire -  people with the inside track, unevenly applied standards, a scrutinous focus on paperwork, and an overwhelming desire of all laboratories to achieve that recognition.  Although the actual testing may not bring much money to a laboratory, having that accreditation is a great marketing tool....basically a stamp of approval from FDA.  And there will be issues with whether the laboratory has overall approval or approval for a given test(s)?

https://www.fda.gov/food/cfsan-constituent-updates/fda-publishes-proposed-rule-establish-laboratory-accreditation-program-food-testing
FDA Publishes Proposed Rule to Establish Laboratory Accreditation Program for Food Testing
Constituent update
November 1, 2019

King Arthur Adds Additional Lots to Flour to E. coli Recall from Early October

King Arthur is forced to expand it recall of flour again as it supplier, ADM Milling, notified the company that three additional product lot codes of 5lb bags of unbleached all-purpose flour were omitted on the original date provided.  This comes after a month from the expanded recall date of October 3, 2019.  The earlier recall was due to positive E. coli O26 testing in a sample.  There have been no illnesses.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/king-arthur-flour-updates-three-lot-codes-voluntarily-recalled-unbleached-all-purpose-flour-5-lb
King Arthur Flour Updates Three Lot Codes of Voluntarily Recalled Unbleached All-Purpose Flour (5 lb.)
Summary
Company Announcement Date: November 01, 2019 

FDA Publish Date: November 01, 2019

Product Type: Food & Beverages 

Reason for Announcement: E. coli O26
Company Name:King Arthur Flour, Inc.

Brand Name: King Arthur Flour
Product Description:  Unbleached All-Purpose Flour

Frozen Berries Recalled After Sample Tested Positive for Hepatitis A

Wawona Frozen Foods is voluntarily recalling packages of frozen raspberries and frozen berry mixes containing raspberries sold at Aldi Grocery Stores and frozen raspberries sold at Raley's Family of Fine Stores because they have the potential to be contaminated with Hepatitis A.  Wawona Frozen Foods is issuing this voluntary recall out of an abundance of caution due to a positive test result taken as part of a government sampling program.  There have been no reported illnesses

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wawona-frozen-food-voluntarily-recalls-frozen-raspberries-due-possible-health-risk
Wawona Frozen Food Voluntarily Recalls Frozen Raspberries Due to Possible Health Risk
Summary
Company Announcement Date: October 30, 2019
FDA Publish Date: October 31, 2019
Product Type: Food & Beverages Fruit/Fruit Product
Reason for Announcement: Potential to be contaminated with Hepatitis A
Company Name: Wawona Frozen Foods
Brand Name: Season’s Choice, Raley’s
Product Description: Frozen raspberries, frozen berry mixes

Cookie Dough Product Recalled After Complaints of Foreign Material - Rubber Pieces

Nestlé USA is initiating a voluntary recall of ready-to-bake refrigerated Nestlé Toll House Cookie Dough products due to the potential presence of food-grade rubber pieces. Nestlé USA is taking this action out of an abundance of caution after receiving reports of food-grade pieces of rubber in some of these products. We have identified the source of the rubber and have already fixed the issue

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nestle-usa-announces-voluntary-recall-ready-bake-refrigerated-cookie-dough-products-due-potential
Nestlé USA Announces Voluntary Recall of Ready-to-Bake Refrigerated Cookie Dough Products Due to Potential Presence of Foreign Material
Summary
Company Announcement Date: October 31, 2019
FDA Publish Date:  October 31, 2019
Product Type:  Food & Beverages
Reason for Announcement:  Due to the potential presence of food-grade rubber pieces
Company Name:  Nestle USA, Inc.
Brand Name:  Nestle
Product Description:  Ready-to-bake refrigerated cookie dough products

Meat Company Recalls RTE Beef Patties Due to Metal Detected by Down Stream Processor

OSI Industries, LLC, a Fort Atkinson, Wisc. establishment, is recalling approximately 4,218 pounds of ready-to-eat beef patty products that may be contaminated with extraneous materials, specifically metal.  The problem was discovered during further processing activities at another federal establishment.  There have been no confirmed reports of adverse reactions due to consumption of these products.

So they made RTE beef patties for another company, and that customer company found metal in the product as they were using it to make their own product.  So did this RTE beef patty maker have a metal detector in place?  This is how the customer company probably found it.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-104-2019-release
OSI Industries, LLC Recalls Ready-To-Eat Beef Patty Products Due to Possible Foreign Matter Contamination 
Class I Recall
104-2019
Health Risk: High
Oct 28, 2019