Food Safety and

Inspection Service
07/31/2024 Hand Delivered by EIAO on July 31, 2024
Raleigh District Office
Electronically Submitted on July 31, 2024
6020 Six Forks Road
Raleigh, NC. 27609
Voice: Boar's Head Provisions, Co., Inc.,
Fax:
Est. M12612
2230 Wyatts Mill Road P.O. Box 277
Jarratt, 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 to
the 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 416 et 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.

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 , Plant Manager Revised Notice of Suspension
Boar's Head Provisions, Co., Inc., Date: 07/30/2024
Est. M12612

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
withholding 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 in
9 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 (IDs
PNUSAL0022703, 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:

x 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

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 , Plant Manager Revised Notice of Suspension
Boar's Head Provisions, Co., Inc., Date: 07/30/2024
Est. M12612
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/ 1
was 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 noncompliances 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)

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 , Plant Manager Revised Notice of Suspension
Boar's Head Provisions, Co., Inc., Date: 07/30/2024
Est. M12612
NOS Item #1
Your establishment failed to meet the requirements 9 CFR 9 CFR 416.2(b)(1) and (2), 9 CFR
416.2(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 CFR
430.4(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 CFR
416. 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 CFR
416.14.

Summary and Conclusion

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