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

Fresh Apples Recalled After Positive Listeria Test in Finished Product

North Bay Produce, Inc. of Traverse City, Michigan is voluntarily recalling 2,297 cases and 2 bulk bins of fresh apples due to the potential to be contaminated with Listeria monocytogenes.   The recall was initiated as a result of a finished product test that indicated the presence of the organism. Upon notification, [the company] immediately ceased the production and distribution product from the identified facility and continue [the] investigation as to what caused the issue, in cooperation with FDA.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/north-bay-produce-voluntarily-recalls-fresh-apples-because-possible-health-risk
North Bay Produce Voluntarily Recalls Fresh Apples Because of Possible Health Risk 
Company Announcement
Summary
Company Announcement Date: October 25, 2019
FDA Publish Date:October 28, 2019 .
Product Type:Food & Beverages
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name:North Bay Produce, Inc.
Brand Name:  Great Lakes, more
Product Description:  Fresh apples varieties:

This Week in Mislabeled Product for Week Ending 10/26/19

Dried Fruit with Sulfites - Shivam Distributors of Longwood, FL is recalling its 7 ounce and 14 ounce packages of PARIVAR brand Dry Dates with batch # 125/BIBT because they contain high sulfite content,  The recall was the result of a surveillance testing done by FL Dept of Agriculture that revealed high sulfite level in the 7 ounce packages of “Dry Dates” with batch # 125/BIBT.

Labels Missing Milk and Soy - MawMaw’s Chicken Pies, a Kernersville, N.C. establishment, is recalling an undetermined amount of chicken pie and meatloaf products due to misbranding and undeclared allergens - the products contain milk and soy, known allergens, which are not declared on the product label.  The problem was discovered by FSIS inspectors during routine label verification activities.

Canada - E. coli Associated Recall of Raw Meat Products Expanded

The Canadian Food Inspection Agency (CFIA) has announced an increase in the amount of beef product being recalled by Ryding-Regency Meat Packers Ltd. and St. Ann's Foods Inc./Ryding-Regency Meat Packers Ltd. due to potential E. coli O157:H7.  Some of this product was shipped into the US.

http://www.inspection.gc.ca/about-the-cfia/accountability/food-safety-investigations/est-99-and-est-639-e-coli-/eng/1570137688624/1570137910930#a1
Food safety investigation: Various beef and veal products may contain E. coli O157:H7

The Canadian Food Inspection Agency (CFIA) is conducting a food safety investigation on E. coli O157:H7 in various beef and veal products sold by Ryding-Regency Meat Packers Ltd. (Establishment 99) and St. Ann's Foods Inc./Ryding-Regency Meat Packers Ltd. (Establishment 639). Should there be a recall of additional products, CFIA will notify the public through additional Food Recall Warnings.
To date, there have been no reported illnesses associated with the consumption of these products.

The complete list can be found here.
http://www.inspection.gc.ca/about-the-cfia/accountability/food-safety-investigations/est-99-and-est-639-e-coli-/eng/1570137688624/1570137910930#a1

FDA Warning Letter - Manufacturer of Vitamin Premix Ingredient with Elevated Vitamin D Levels

FDA issued a warning letter to an ingredient manufacturer responsible for recalls if pet food associated with high Vitamin D levels in finished product. The ingredient made was a vitamin premix and the levels were 3900% higher on the particular lot, and that high level than carried over to another lot that had levels 307% more.

It is interesting in that the company stated in the hazard analysis that although Vitamin D was identified as a hazard in the formulation, it would be controlled through prerequisite programs. This of course failed with high Vitamin D levels getting into their premix and thus their customer's finished product and then finally that product impacting dogs.

Another interesting point to note is that the responses provided by the company to FDA were viewed as inadequate. Although the company stated that they took corrective action after the incident, including making hazardous ingredient addition a preventive control, they did not provide FDA sufficient documentation for the control of their process.    The FDA response states, the company "did not provide sufficient supporting documentation, such as revised standard operating procedures, test results, or other documentation, to show that you have implemented these proposed corrective actions. For example, your supporting documentation for (b)(4) reconciliation includes only the record of a (b)(4) reconciliation on June 21, 2019. We are unable to determine the adequacy of relabeling, (b)(4), and (b)(4) at controlling the hazard because the batches with elevated levels of vitamin D occurred despite a (b)(4) process and (b)(4). With respect to your preventive control, you have identified (b)(4) per lot as the allowable variance for your process control. It is unclear whether that variance would ensure that vitamin levels would result in an animal food for which nutrient toxicity or deficiency is controlled. FDA will verify the adequacy of your corrective actions during the next inspection of your firm."


Warning Letter

DSM Nutritional Products, LLC
MARCS-CMS 578300 — October 11, 2019