FDA Release Guidance on Food Defense - Mitigation Strategies to Protect Food Against Intentional Adulteration

The FDA published a draft guidance for food defense titled Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry in support of the Prevention of Intentional Adulteration rule. The draft guidance provides ways to meet the requirements in the rule specifically conducting the vulnerability assessment and putting mitigation strategies in place for ‘actionable process steps’ or APS. These APS are defined as “a point, step, or procedure in a food process where a significant vulnerability exists and at which mitigation strategies can be applied and are essential to significantly minimize or prevent the significant vulnerability”.

To summarize the 159 page document - a Food Defense Plan is essentially conducting a HACCP type of analysis where the goal is to find steps in the process where significant vulnerability exists and to put in measures, or the mitigation strategies’ to reduce the vulnerabilities. These vulnerable points are points where there is access to product where the product can then be contaminated.

There is flexibility in how one conducts a vulnerability assessment, but the guidance provides some basic ways. The elements that must be considered include 1) the potential public health impact (e.g., severity and scale) if a contaminant were added, 2) the degree of physical access to the product; and 3) the ability of an attacker to successfully contaminate the product. The analysis must consider an attack by an insider, a person working in the company. The written assessment must document why each step was considered, or not considered, an APS.

For steps designated as an APS, mitigation strategies are put in place. These strategies may limit access to the step, or may reduce the likelihood that someone can contaminate product at that step. Like critical controls points, each mitigation strategy must have monitoring, verification, and corrective action.

While many may ask about facility wide measures – items such as exterior fencing, employee access to the facility and such – these are not included within the plan unless they can be tailored to impact a specific Actionable Process Step. Sure, they are important, but many have these in place already for other purposes and in reality, they are harder for regulators to regulate.

USDA Issuing Guidelines to Increase Attention to Foreign Material Complaints

Over the past few years, food companies, specifically meat and poultry processors, have issued a large number of recalls related to foreign objects.  Now USDA is issuing guidelines for food companies to respond more aggressively with foreign material complaints.  The USDA wants "food makers to start internal investigations when they receive customer complaints and to notify the government within 24 hours if contaminated products are in the marketplace".

Are foreign material issues an increasing issue?  I would argue that it is not.   Certainly the visibility of these issues is new.  Within the past few years, the Reportable Food Registry and Consumer Complaint portals were introduced and the use has increased.  So while in the past, consumer complaints for foreign materials were received by companies and handled internally without  much federal intervention.  Recalls were issued for serious foreign material issues.  What has changed isn't as much there are more foreign material issues, but USDA is paying close attention.  And much of this started as consumers were able to complain directly to USDA, and with that, inspectors began paying more attention to foreign material issues.  As issues were seen within the complaint records, more recalls were issued.

 Is a more aggressive response prudent? Not being involved directly in these investigations, it is difficult to know exactly.  From the recall notices, it appears that many recalls are issued after one complaint.  But what did the investigation show?   It is important that complaints are well investigated before wasting resources on a recall.  I have seen where complaints were made by consumers in order to get a replacement product (free product).  There were other cases where the consumer improperly cut the package with a part of that package unknowingly falling into the product only to be viewed by the consumer as a foreign object.  People have assumed the food was a source of a foreign object when that food was used in a recipe. 

Perhaps some of us come from a different era that when we found a piece of plastic in a food item, we accepted that as 'something that can happen', and threw the piece of plastic out.  Not saying that is right and that food companies should do a better job, but if no injury than no foul.

We are already seeing people pay less heed to recalls.  As we add more and more recalls to the weekly list, it is bound to increase the consumer ambivalence.  So at the very least, time should be allowed for an investigation and companies should be allowed input on the determination of whether the recall is necessitated.  In the end, they will pay for the real issues.

https://www.nbcnews.com/health/health-news/new-food-safety-guidelines-expected-after-spike-meat-poultry-recalls-n979161
New food safety guidelines expected after spike in meat and poultry recalls
More food prepared by machines contributes to more parts breaking off and contaminating food, consumer advocates say.
March 4, 2019, 5:53 PM EST
By Reuters

Washington State Firm Recalls Ground Beef Chubs After Complaint of Hard Plastic

WASHINGTON, March 2, 2019 – Washington Beef, LLC, a Toppenish, Wash. establishment, is recalling approximately 30,260 pounds of ground beef chubs products that may be contaminated with extraneous materials, specifically hard plastic and metal.  The problem was discovered by a consumer complaint to the company on February 28, 2019.  There have been no confirmed reports of adverse reactions due to consumption of these products.

https://origin-www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-024-2019-release
Washington Beef, LLC Recalls Ground Beef Products due to Possible Foreign Matter Contamination 
Class I Recall 
024-2019 
Health Risk:High 
Mar 2, 2019 

Salmonella Outbreak Associated with Tahini Appears to Be Over

As of February 27, 2019, FDA and CDC are saying that the multistate outbreak of Salmonella Concord illnesses linked to tahini imported from an Israeli manufacturer, Achdut Ltd., located in Ari’el, Israel appears to be over.  In all, there were 8 cases of salmonellosis. 

February 8 Update
https://pennstatefoodsafety.blogspot.com/2019/02/fda-investigating-multistate-salmonella.html

FDA Investigated a Multistate Outbreak of Salmonella Concord Linked to Tahini Produced by Achdut Ltd.
Update: February 27, 2019

Case Counts
Total Illnesses: 8
Hospitalizations: 0
Deaths: 0
Last illness onset: April 21, 2018 to January 3, 2019
States with Cases: HI (1), MA (1), MI (1), NY (5)

This Week in Mislabeled Products for Week Ending March 2, 2019

Sulfites Missing from Label - Joy Gourmet Foods Inc. of Maspeth, NY is recalling its Joy Brand Chutneys and Pastes products because they contain undeclared sulfites.  The recall was initiated after a routine inspection by a United States of America Food and Drug Administration(FDA) Food Inspector, which revealed that the sulfites containing product was distributed in packages that did not declare their presence.  [Label design issue - failure to recognize sulfites, used to protect against fruit oxidation/discoloration, need to be on the label...may have been using more a processing aid).

Ingredients Listed for Wrong Salad Dressing - Russ Davis Wholesale – Crazy-Fresh, an Eagan, Minn. establishment, is recalling approximately 702 pounds of chicken Caesar salad products due to misbranding and undeclared allergens, the product contains milk and anchovies, known allergens, which are not declared on the product label. The problem was discovered on February 24, 2019, when FSIS was notified that the establishment discovered the misbranding of product while performing a label review.  [Clearly a design issue...this one gets chalked up as a marketing department error or the nutritionist]

Cashews in Marinara Sauce - B&G Foods announced today it is voluntarily recalling 1,280 cases of a single date code of 40 oz. Victoria Marinara Sauce, with a “best by” date of 03/06/2022, after learning that the product may contain cashew allergens that are not declared on the product’s ingredient statement. B&G Foods discovered this issue when it received one consumer complaint alleging a cashew allergic reaction. B&G Foods initiated the recall of this product based on the results of its investigation and testing that indicated the possible presence of cashew allergens in up to 1,280 cases of this product with this particular “best by” date. [Looks to be an improper line clean-out]

Wrong Bag for Pretzels - Utz Quality Foods, LLC., is voluntarily recalling a specific expiration date code of Bachman® 10 oz Twist Pretzel packages due to undeclared milk. This recall was initiated after reviewing production records which identified a small number of packages were mislabeled.


https://www.fda.gov/Safety/Recalls/ucm632223.htm
Joy Gourmet Foods LLC Issues Allergy Alert on Undeclared Sulfites
For Immediate Release
February 27, 2019

FDA Issues Warning Letters to Two Egg Facilities - NY and AL

FDA issued Warning Letters to two different egg production facilities with a focus on inadequate controls for Salmonella enteriditis.  For one of the facilities, the investigation came after a Salmonella outbreak.

Our handling and cooking of eggs has become dependent on egg farmers controlling Salmonella in their flocks.  We generally eat eggs with minimal cooking (over easy, poached, or we go Rocky), but there is a risk.  For facilities with good controls in place, the Salmonella risk is minimal, but for those farms that don't have good controls, Salmonella can be present in the eggs.

Gravel Ridge Farms, Alabama - Because of a Salmonella outbreak associated with eggs in September, FDA conducted an inspection of egg facility in Alabama.  The issues were:

• There was not control program for Salmonella Enteritidis (SE).
• Inadequate cleaning to prevent cross contamination.
• There were no biosecurity measures in place
• There was no pest control program
• They did not clean the facility to remove pest harborage sites.

In the Notice it was noted that the facility was shut down by owners with no plans on reopening.

FDA issued a warning letter to  Pitcher Road Farm of Ovid, NY, 14521 after an inspection that took place from August 1 through August 2, 2018.  The farm had failed to implement thier SE plan including not testing the environment for SE or implementing measures for preventing cross contamination.

Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772

February 12, 2019

WARNING LETTER 566836

Bagged RTE Green Beans and Squash Recalled After Supplier Test Reveals Listeria

Southern Specialties Inc. of Pompano Beach, Florida is voluntarily recalling select bags of Marketside brand green beans and butternut squash because they have the potential to be contaminated with Listeria monocytogenes.  This recall was voluntarily issued after a raw material supplier notified the company that it was issuing a recall after a routine test of a food contact surface tested positive for the bacterium. As a precautionary measure, Southern Specialties is recalling all products that were repacked at its facility on the same repacking line as the supplier’s product.

The bagged product is labeled as a fresh ready-to-eat product.  It would be sold refrigerated.

The statement said that "Although most of the product was retrieved before distribution to retail stores, some product shipped on February 17th may have reached select stores in Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee and Virginia."

Southern Specialties is a vertically integrated produce company with operations in North, South, and Central America.  They have a network that can supply fresh bagged produce year round.  Produce would be washed prior to packaging in bags to be labeled as RTE.

https://www.fda.gov/Safety/Recalls/ucm632027.htm
Southern Specialties Voluntarily Recalls Bagged Green Beans and Butternut Squash Distributed in Southeast because of Possible Health Risk
For Immediate Release
February 25, 2019

FDA Releases Report on Strategy for Imported Food

FDA released a report on their strategy for ensuring the safety of food imported into this country.  Full report can be found here.

First, a few facts

• There is a continued 15 year trend of increasing importation of food 
• Annually, the US imports:
• 32 percent of the fresh vegetables, 
• 55 percent of the fresh fruit, and 
• 94 percent of the seafood 
• US imports food from more than 200 countries or territories and approximately 125,000 exporting food facilities plus farms
• In 2019, between 14 and 15 million shipments of imported food are expected to enter the United States
• Mexico accounts for the largest percentage of shipments followed by Asia.

FDA applies the same U.S. food safety requirements to all food consumed in the United States, regardless of whether the facility or farm that produces the food is located within the United States or half way across the globe.  But the strategy for overseeing this is different than for domestic product.  Much of this is based upon a risk based approach with focus on highest risk items with a continued optimization of the process.  It also utilizes partnerships as well as pre-approvals.

GOAL 1: Food Offered for Import Meets U.S. Food Safety Requirements

Objectives

1. Optimize use of foreign inspections
2. Ensure importer use of verified foreign suppliers through effective implementation of the Foreign Supplier Verification Programs final rule
3. Take into account the public health assurances of reliable audits such as those issued under FDA’s Accredited Third-Party Certification Program or pursuant to other assurance programs aligned with FDA food safety requirements
4. Incentivize importers to use verified suppliers of safe food through the Voluntary Qualified Importer Program
5. Leverage the oversight efforts of regulatory counterparts with strong food safety systems
6. Increase awareness of and training on food safety requirements and strengthen the capacity of foreign suppliers to produce safe food

GOAL 2: FDA Border Surveillance Prevents Entry of Unsafe Foods

Objectives

1. Continue to enhance and refine FDA’s import screening and entry review processes
2. Optimize use of physical examination and sampling of imported food
3. Strategically utilize import alerts and import certifications
4. Improve testing methodologies and tools used to determine admissibility of food offered for import
5. Maximize the benefit to border surveillance from state and other partnerships

GOAL 3: Rapid and Effective Response to Unsafe Imported Food

1. Maximize effectiveness of FDA response to an event involving an imported food
2. Enhance the efficiency and effectiveness of imported food safety recalls
3. Use information-sharing opportunities to prepare for and respond to the entry of unsafe imported food

GOAL 4: Effective and Efficient Food Import Program

1. Optimize resource allocation by developing a comprehensive global inventory of food facilities and farms and assessing the cumulative oversight applied to the global inventory
2. Ensure effectiveness of import activities through performance assessment and continuous improvement

Frozen Meat Entrees Recalled After Complaints Received for Foreign Material - Glass or Hard Plastic

Bellisio Foods, a Jackson, Ohio establishment, is recalling approximately 173,376 pounds of frozen pork entrée products that may be contaminated with extraneous materials, specifically pieces of glass or hard plastic.   The problem was discovered when the establishment received consumer complaints of glass or hard plastic extraneous material in the rib shaped patty.

The frozen, not ready-to-eat (NRTE) boneless pork rib patties being recalled were produced over a variety of dates ranging from Dec. 7, 2018 to Feb. 15, 2019, which may indicate that complaints were made for more than one production date.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-020-2019-release
Bellisio Foods Recalls Boneless Pork Rib Frozen Entrée Products Due to Possible Foreign Matter Contamination 
Class IRecall 
020-2019 
Health Risk:High 
Feb 23, 2019