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FSPCA - Food Safety Preventive Controls Alliance

Friday, September 13, 2024

Deli Meat Plant Responsible for Listeria Outbreak to Close, FSIS Notice of Suspension

Boar's Head Provisions has decided to shut down their Jarrett, VA facility in light of the Listeria outbreak that was linked to product produced at that facility.  There have been at least 57 cases with 9 deaths.

The closure affects 500 union workers as well as management.

The FSIS USDA Notice of Suspension is posted below.  It is interesting that the FSIS intensive sampling only found one positive in the environment...and that was on a pallet jack.  It is important to point out that this intensive sampling occurred as the company found out that product was involved in an outbreak, so did the plant get an opportunity to do a more intensive cleaning, was the plant operational at the time of sampling, was sampling done during operations and with that, was it done after production was going for 2 to 4 hours?  What did the company's internal sampling regiment results indicate, and how intensive of a program was it?

USA Todayhttps://www.newsbreak.com/share/3595027287273-boar-s-head-to-close-virginia-plant-linked-to-listeria-outbreak-500-people-out-of-work
Boar's Head to close Virginia plant linked to listeria outbreak, 500 people out of work
By Mary Walrath-Holdridge and Mike Snider, 
USA TODAY,
9/13/24

The Jarratt, Virginia Boar's Head plant linked to the ongoing multistate listeria outbreak is closing permanently, the company announced on Friday.

The deadly outbreak was first reported on July 19 by the Centers for Disease Control and Prevention and was followed by a recall of 207,528 pounds of liverwurst by the company on July 26. Boar's Head issued an expanded recall on July 30 to include every product made at the same Jarratt, Virginia facility where its liverwurst was produced, equating to about 7.2 million pounds.

At least 57 have been hospitalized as a result of the outbreak across 18 states, including nine deaths as of Aug. 28, according to the CDC investigation.

Inspection records showed issues in the plant dating back to at least 2021, including reports of mold and mildew, insects, water leaks and other unsanitary conditions.

About 500 union workers are impacted by the closing, United Food and Commercial Workers Local 400 Union spokesman Jonathan Williams told USA TODAY. Additional employees in management were likely affected, too, but he was unsure how many were impacted, he said.

"Given the seriousness of the outbreak, and the fact that it originated at Jarratt, we have made the difficult decision to indefinitely close this location, which has not been operational since late July 2024," Boar's Head said in an email statement.

The company also shared the U.S. Department of Agriculture (USDA) Notice of Suspension issued to the facility in July. The agency told Boar's Head the plant was to be closed "based on the determination that your establishment failed to maintain sanitary conditions" and that "your establishment produced product adulterated with (Listeria monocytogenes) linked to an ongoing outbreak."




USDA FSIS Notice of Suspension

07/31/2024 Hand Delivered by EIAO on July 31, 2024
Electronically Submitted on July 31, 2024
Boar's Head Provisions, Co., Inc.,
Est. M126122230
Wyatts Mill Road P.O. Box
277Jarratt, Virginia 23867

Revision of the NOTICE of SUSPENSION
Attention: , Plant Manager
This letter serves as written notification by the Food Safety and Inspection Service(FSIS) of our decision to withhold the federal marks of inspection and suspend the operations of Ready-to-Eat (RTE) products at Boar's Head Provisions, Co., Inc., Est.M12612, located at 2230 Wyatts Mill Road P.O. Box 277 Jarratt, Virginia 23867.This letter follows verbal notification of the suspension action, provided by me tot he establishment representatives at approximately 3:10 pm on Monday, July 29,2024.

The decision to institute this enforcement action is in accordance with Title 9 of the Code Federal Regulations (CFR), Rules of Practice 500.3(a)(4), based on the determination that your establishment failed to maintain sanitary conditions, as required by 9 CFR 416et seq., and 500.3(a)(1), based on the determination that your establishment produced and shipped adulterated product.

Background/Authority

The Federal Meat Inspection Act (FMIA) (21 USC 601 et. seq) provides it is essential to the public interest that the health and welfare of consumers be protected, by assuring meat and poultry products distributed to them are wholesome, not adulterated, and properly marked, and labeled. The Act gives FSIS the authority, as designated by the Secretary of Agriculture, to prescribe rules and regulations describing sanitation requirements for inspected establishments and provide FSIS program personnel the authority to refuse to allow meat/meat food products or poultry/poultry food products to be marked, labeled, stamped, or tagged as inspected and passed, to prevent the entry of products into commerce. This Act provides definitions for the term adulterated and further provide FSIS the authority to appoint inspectors to examine and inspect all carcasses, parts of carcasses and products as well as the sanitary conditions of facilities

Under the delegated authorities of this Act, FSIS has prescribed rules and regulations required for establishments producing meat/meat food products and poultry/poultry food products, including the requirements pertaining to Sanitation Standard Operating Procedures (SSOP) and Sanitation Performance Standards (SPS) (9 CFR 416) and other matters. FSIS has also developed the Rules of Practice regarding enforcement (9 CFR 500). The Rules of Practice describe the types of enforcement action that FSIS may take and include procedures for taking a with holding action and/or suspension, with or without prior notification, and for filing a complaint to withdraw a Federal Grant of Inspection. FSIS can refuse to render inspection and indefinitely withdraw inspection from an establishment, provided the establishment is afforded the right to an administrative hearing.

Findings/Basis for Action

This revised notice of suspension retains all the contents of the original notice of suspension that was issued on July 26, 2024, with the addition of the findings detailed below. Your establishment defines Listeria monocytogenes ( Lm) as low risk in the ready to eat (RTE) post-lethality exposed processing environment that includes post-chill, peeling (if applicable),refrigerated, splitting (if applicable) environment due to employee practices in the GMP Plan which reduce the likelihood of product recontamination, along with monitoring employees and environment through the SSOP plan. Your program further states that “The risk is further reduced through an SSOP Plan conforming to Alternative 3 and Listeria sampling as required in9 CFR 430 and Directive 10,240.4. Packaging Step.”

Your establishment produced product adulterated with Lm linked to an ongoing outbreak of Lm. As of July 30, 2024, this outbreak of Lm includes 34 ill people from 13 states; 33/33 (100%) of ill people with information available have been hospitalized and there are 2 reported deaths attributed to listeriosis. The Maryland Department of Health tested an unopened liverwurst product (Boar’s Head Strassburger Brand Liverwurst, Sell By date 8/10/24, lot code J3 09:54) and the sample tested positive for Lm. On July 29, 2024, whole genome sequencing (WGS) was completed (IDsPNUSAL0022703, PNUSAL0022704, and PNUSAL0022702) and WGS data showed that the Lm isolated from the liverwurst sample is highly related to the Lm making people sick in this outbreak.   

On July 24 and 25, 2024, Intensified Verification Testing (IVT) sampling was conducted, and one (1) sample, identified as non-food contact surface/environmental, tested positive for Lm. This sample was collected from the following location:

-  Line 2: Non- Product Contact Surface Sponge, form # 103433961 confirmed positive for Lm, site description: Pallet Jack SH3 during the production of Beechwood Ham lot #9624.

Pallet Jack SH3 is used to move racks of product out of blast coolers to production lines in the processing room, as well as move product racks around the processing room. The processing room consists of one large open room. Processing lines 1 through 4 are located on the left side when standing with back to the coolers and Processing Lines 5 through 8 are located on the right side and used to process hot dogs and other small sausages. There are no barriers or walls that separate the processing lines. Pallet jacks and product racks move between all processing lines and all blast coolers. 

This positive Lm result on the pallet jack demonstrates Lm is present in the RTE post lethality processing environment and there are inadequate controls to prevent its spread throughout the RTE post lethality processing environment. 

In addition, there is a risk of employees spreading Lm through the RTE post lethality processing environment. Although employees typically work on one line, when needed they may move between lines to help. Your establishment does not have a written plan to describe employee practices and use of personal protective equipment (PPE) when moving between lines. When EIAO discussed this with , the QA Manager, she stated verbally that if employees are moving to a different line, producing a different product, they must change their disposable apron, gloves, and arm covers. If they are moving to a different line that is producing the same product, they do not have to change those items. However, this is not stated in the written program. During IVT collection, EIAOs observed employees moving racks out of coolers and between lines without changing PPE, even when interacting with different product types. They also observed employees who freely move between all lines without directly interacting with product such as those removing garbage, removing product debris from the floors, removing condensation from overhead structures, or performing maintenance. 

Further insanitary conditions observed in the establishment that have the potential to spread contamination and Lm are as follows. On July 26, 2024, a noncompliance IDG3616071628N/ 1was issued by In-Plant-Personnel (IPP) describing beaded condensation on the door opening and inside of the Blast Cell #12 dripping over the product. U.S. Retained tags B37563411,B37563412, B37563413, B36563414, B37563415, B37563416, B37563417, B37563419,B37563420 were applied to nine trees of Beechwood Hams (approximately 10,418lbs.). This noncompliance indicates your establishment’s failure to maintain sanitary conditions during processing, handling, and storing of the RTE post-lethality exposed products.

On July 27, 2024, a noncompliance IDG3520074727N / 1 was issued by IPP on the RTE side of the plant, in the Blast Cell Hallway, next to Blast Cell #9, when clear liquid was observed falling from a square patch in the ceiling. Ten feet from the patches, a black fan was mounted to the ceiling and was blowing the leaking clear liquid into the Blast Cell Hallway, where 9 trees of uncovered Assorted Hams were stored. These 9 trees were retained by inspection personnel. This indicates your establishment’s failure to maintain sanitary conditions.

In summary, the WGS IDs for these isolates from the liverwurst sample are highly related to the clinical outbreak strains, the IVT sample confirmed Lm positive for Pallet Jack SH3, combined with no written plans to prevent cross contamination by employees between processing lines, and the noncompliance documented on July 26 and 27, 2024 by IPP for insanitary conditions is evidence that your current SSOP programs, and Listeria Control Program are ineffective in supporting that Lm is Not Reasonably Likely to Occur (NRLTO) within your Hazard Analysis. 

Sanitation Performance Standards (SPS)

NOS Item #1

Your establishment failed to meet the requirements 9 CFR 9 CFR 416.2(b)(1) and (2), 9 CFR416.2(d), 9 CFR 416.4(a), 9 CFR 416.4(d) and 9 CFR 416.4(b). The Maryland Department of Health Liverwurst product sample that tested positive for Lm and the positive Lm IVT environmental sample from Pallet Jack SH3 demonstrate that your establishment’s current sanitation is inadequate to prevent the creation of insanitary conditions and the adulteration of products.

Sanitation Standard Operating Procedures (SSOP)
NOS Item #2

Your establishment failed to meet the requirements of 9 CFR 416.14.Your establishment uses Alternative 3 to control Lm in post lethality exposed RTE products through the use of sanitation measures only. The positive Lm test results from liverwurst product in retail and the IVT environmental swab of Pallet Jack SH3 demonstrate your establishment has been operating under insanitary conditions. Therefore, you cannot support the use of sanitation alone to control Lm, and determine Lm is a hazard not reasonably likely to occur.

HACCP
NOS Item #3

Your establishment failed to meet the requirements of 9 CFR 417.5(a)(1).Your establishment’s Hazard Analysis has identified Lm as a hazard that is not reasonably likely to occur because it is controlled through SSOPs and sanitation. Positive Lm test results from liverwurst product in retail and the IVT environmental swab of Pallet Jack SH3 demonstrate this decision making is not supported and therefore, your Fully Cooked Not Shelf Stable HACCP plan is inadequate. Control of Listeria monocytogenes in post-lethality exposed ready-to-eat products

NOS Item #4

Your establishment failed to meet the requirements of 9 CFR 430.4(c)(3) and 9 CFR430.4(c)(5).Your establishment has identified it will control exposure of post lethality exposed RTE product to Lm though Alternative 3, which relies on the use of sanitation measures only. Result of IVT sampling collected on July 24, 2024, form # 103433961 shows the use of Alternative 3 has been inadequate to control and prevent exposure of RTE product to Lm. Your establishment has failed to maintain sanitation in the post-lethality processing environment in accordance with 9 CFR416. Your establishment uses SSOPs to designate Lm control measures. Your establishment has failed to adequately evaluate the effectiveness of these measures in accordance with 9 CFR416.14.

Summary and Conclusion



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