09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
PS787 Pilgrim's Pride | DEBOSO 09/21/2018 | 04CO5 | 381.65(b) #210 On September 22, 2018 at approximately
Corporation 409422 0310 hours, | observed 9 cadavers in a yellow
2N-1 condemn can by the Meyn line 1 rehang table in

the picking room. All of the cadavers had the
heads on the carcasses with no evidence of any
cut having been made. The carcasses were bright
red to purple in color. All of these cadavers were
removed from the top part of the barrel and were
still warm to the touch. The plant had just
returned from break and had resumed operations
at approximately 0305. The appearance of such
birds is indicative that they had entered the scald
vat and drowned. (ye)

(6) was notified and shown these
cadavers on Meyn line 1. The presence of these 9
cadavers that entered the scald tank alive
indicated a loss of process control at that time.
Poultry must be slaughtered in a manner that will
result in thorough bleeding of the carcasses and
ensure that breathing has stopped prior to
scalding. Carcasses of poultry that die from
drowning in the scald vat result in an
unwholesome/adulterated carcass. Birds that die
by means other than slaughter represent a failure
of the establishment to comply with 9 CFR 381.90
and 381.65(b). Please refer to NR issued on
7/26/18 #DEB1908072027N/1 for a similar

noncompliance. (by(6)



the selection and development of the CCPs and critical limits would result in safe and
wholesome products.

Poorly maintained facilities and equipment can and do harbor foodborne pathogens,
which can then multiply and be dispersed throughout the food processing environment
increasing the chances of product contamination rendering the product unsafe.
Furthermore, dripping condensation can be a source of direct product contamination
which can render product adulterated.

The Poultry Products Inspection Act, 21 U.S.C. 456, states “the Secretary shall refuse to
render inspection to any establishment whose premises, facilities, or equipment, or the
operation thereof, fail to meet the requirements of this section.” Perdue Foods, LLC, Est.
2882, failed to maintain sanitary conditions at your establishment, creating insanitary
conditions that could result in the production of products, which may have been rendered
injurious to health.

The Poultry Products Inspection Act, 21 U.S.C. 463 states that “the Secretary shall
pronutgate such other rules and regulations as are necessary to carry out the provisions of
this Act.” Perdue Foods, LLC, Est. 2882, failed to abide by the rules and regulations of the
Poultry Products Inspection Act.

Establishment process controls are essential to product safety and wholesomeness and all
meat and poultry producing establishments must have written HACCP and SSOP programs
that address all food safety hazards that are reasonably likely to occur in the process. FSIS
affirms that proper process controls are an important and integral part of every food process
and fundamental requirement of the inspections laws that FSIS administers and enforces.

In accordance with FSIS’ Rules of Practice, Title 9 CFR Part 500, we are notifying you of
our intent to withhold the marks of inspection and suspend the assignment of inspectors at
your facility. Please provide this office with a written response within three (3) business
days from the date of your receipt of this letter. We will determine if we will take any
further administrative enforcement action based on your response. You may submit your
response by facsimile to (844) 622-0081, or by electronic mail (e-mail).

In accordance with Title 9 CFR 500.5(b)(4), you may contest the basis for the proposed
action by contacting:

Dr. Keith Gilmore

Executive Associate for Regulatory Operations
210 Walnut St

Room 923

Des Moines, IA 50309

Phone: 515-727-8970

An Equal Opportunity Provider and Employer Page 14 of 15


09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
P206+V206 | Pilgrim's Pride | KCCO70 06/14/2018 | 04CO5 | 381.65(b) At approximately 0630 hours, | observed a
Corporation 906461 cadaver at the Pinner/Sorting station on the East
AN-1 line. The carcass was bright cherry red with no

bleeding cut on the neck. Within 2 minutes, |
observed another cadaver arrive at the
Pinner/Sorting station, also with no bleeding cut
ontheneck. Atthattime,|saw[__ ea _—ids
Cie and showed him the
2 cadavers. He informed his Back Dock
Supervisor. On her way to the Pinner/Sorting
area, the Back Dock Supervisor removed another
cadaver from the line. | then took regulatory
control action and |instructed[ 6) to
decrease the line speed from} irds per

m. The plant had increased the
linespeed on the East line because the West line
was having mechanical issues and was not
operating at the time. | went to the Kill Machine
and observed that there were 2 employees
backing up the Kill Machine. These 2 employees
were not effective in backing up the machine to
prevent live birds from entering the scalder.
While at the Kill Machine area, | also observed
that paws that were not being unloaded properly
at the Paw equipment were not being removed
before hanging chickens on the same shackle,
possibly causing stunning issues. | pointed this
out tol) | then proceeded back to
the Pinner/ Sorting area where 2 more cadavers
were removed from the East line. | then notified
Tonya Byers, Plant Manager of the numerous
cadavers found at sorting (8 total in an
approximately 20 minute period) and that the
finding would be documented on a
noncompliance record. The establishment did not
meet 9 CFR 381.65(b) which states: “Poultry must
be slaughtered in accordance with good
commercial practices in a manner that will result
in thorough bleeding of the carcasses and ensure
that breathing has stopped prior to scalding.” The
PPIA (21 U.S.C, 453(g)(5)) and 9 CFR 381.90
provide that poultry carcasses showing evidence
of having died from causes other than slaughter
are considered adulterated and must be
condemned.

9


Title 9 CFR 416.13(c) and 416.4(d).

c. On August 23, 2018, at approximately 0940 hours, in the Cut-up
Department, the EIAO observed establishment’s employee reconditioning
a whole body carcass using the ozone line hose. However, your

establishment's written reconditioning procedure states, “[__ |

oe) |
(oy) Your establishment failed to implement the

reconditioning procedures in your SSOP as written. This is a regulatory

noncompliance with Title 9 CFR 416.13(c) and 416.4(d).

Throughout the FSA, EIAOs observed product on the floor near drains in second
processing and on standing platforms and rubber mats, and that the product were
there for more than 15 minutes. Your plant management indicated that this
product would be condemned. However, it is unclear how your establishment
distinguishes between product for reconditioning and product to be condemned.
Furthermore, ETAOs observed that your establishment did not pick up product to
be condemned in a “timely manner”’, to ensure that product would not be picked
up and reconditioned. In addition, your Salvage procedures do not include any
procedures for when products have not been picked up within 15 minutes. Your
establishment failed to prevent the creation of insanitary conditions. This is a
regulatory noncompliance with Title 9 CFR 416.4(d).

Since February 1, 2018, FSIS Inspection Personnel have issued eight (8) NRs for
your establishment's failure to effectively implement your salvage and
reconditioning procedures to prevent insanitary conditions. These multiple
regulatory noncompliances documented by FSIS personnel and observed during
the FSA demonstrate that your establishment has not taken effective corrective
actions to prevent insanitary conditions.

5. Your establishment failed to operate in such a way to prevent the creation of
insanitary conditions, as required by the Sanitation Performance Standard (SPS)
regulations of Title 9 CFR 416. During the FSA, the EIAOs identified the
following regulatory noncompliances:

a, On August 21, 2018, at approximately 0845 hours, in the tub washroom,
EIAO observed your establishment employee putting FCS hand tools, such
as knives with white handles and knife sharpeners. on the floor. Your
employee used his boot to hold down those hand tools, and sprayed the
utensils laying on the floor with chlorinated water. The EIAO notified
(ord) | of these findings.

bX6) indicated that the cleaning method was not “idea/” and that your
establishment stores these hand utensils overnight in peroxyacetic acid
(PAA) sanitizer. There was no follow-up or corrective action taken to restore
sanitary conditions. ELAO reviewed your establishment’s cleaning
procedures, which do not cover the cleaning of hand tools. Procedures in the
SSOP that are to be conducted prior to operations shall be identified as such,
and shall address, at a minimum, the cleaning of FCS of facilities, equipment,
and utensils. Your establishment failed to provide a cleaning procedure for
the FCS hand tools to demonstrate that your establishment is maintaining

An Equal Opportunity Provider and Employer Page 5 of 15


09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
fi
P7156+V71 | Tyson Foods, JTFS81 08/17/2018 | 04COS | 381.65(b) On 08/17/2018 at approximately 1540 hours SCS!
56 Inc. 808361 was notified by who-wa
7N-1 performing postmortem -inspéction in linea]

statior[_—]that she identified 12 cadavers. Five of
them were hung on the rack behind the inspector
station. When verified the hung carcasses, their

necks were red uncut, and their heads were rie
engorged. The viscera parts related to the

carcasses appeared congested more than t

other passed carcasses. SCSI asked food inspectors
[ 6) Jon station{ nd [Bx]

Young on station 1 and found that they identified
a total of 3 cadavers. The line was stopped for 3
minutes to notify[_ x)

[&6)_Jof the noncompliance.
WG) hotified SCSI that they experienced

equipment default in the kill area. While was

oye
walking toward the kill machine SCSI observed,

that other carcasses that had red, uncut necks,
engorged red heads whic! Coming down
stream in space feu ven machine was
not operating and 2 back up team members were
bleeding birds. Two birds were passed back up kill
persons without being properly bled, SCS! applied

control action and ensured birds were properly
bled before the line allowed to operate back. SCSI

was notified by Maintenance personnel that bird: the
hanging was stopped to fix the kill machine. SCSI

verified no birds were hung until Kill machine-was
fixed. Total of 25 cadaver were reported.on tally
sheets on inspection stations of lint efore kill
machine back to operation. FSIS Directive
6110.1 states that repeated occurrence of birds
that dying otherwise than by slaughter or not
being appropriately bled represents a
noncompliance of Good Commercial Practices.
Kill machine was verified at 2018 hours and was
found working properly.



09:42 Friday, October 26,2018 12

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
} fa)
P7044 Tyson Foods, GJJ172 05/22/2018 | 04COS | 381.65(b) At approximately 2150-2200 hours, while leaving
Inc. 005262 the chiller areal 16) __ observed a On
2N-1 cadaver on the floor under t isceration

equipment for Line|
rehang line for Line 1.

cadaver to] ie) and proceededjtojiy4)

the Live Hang area to conduct a GCP task. On

approach to the Live Hang area she a
live chicken eatinepiecee ia land
Line{ -Fcatd tanks in the Picker Room. On entry to
the Live Hang area, the Live Hang Supervisor was
observed to be leaning on a fan watching the
hangers. [©®}notioned for him to come over and
showed him a pile of paws/litter at the door, the
live birds on the floor and the live bird in the
btated that someone was
coming to clean the area.___©)@___ went to
find|_ ©) to notifyoiwyp ‘oncerns.
During conduction of the GCP task, other
conditions were observed that describe failure of
the establishment to comply with Good
Commercial Practices. These items were shown

to establishment management: (by)

| HG) J
| 6) |
(by) proceeded to complete

the remainder of the GCP task. At 2210 hours,
(iG pbserved two additional head-on
cadavers on Line 1 in the Picker Room
followed the cadavers to the evisceration rehang
table and had them removed. At that tim
notified the Evisceration lead to slow the line
speed on Line 1 to 126 BPM to allow the Live
Hang/Picker Room Supervisor to regain process
control in his area. The establishment stated that
the root cause of the cadavers was due to the Line
1 kill machine lowering when the line was
stopped; the establishment did not state at what
time it lowered. The backup cutter was unable to
catch all of the birds before they entered the scald
tanks.[___(616)__ asked that the establishment
encourage the backup cutters to stop the line or
notify management before birds are allowed to
enter the scalders breathing. Establishment
management stated the employee issue would be
addressed at the end of the shift. The backup
cutter was observed to be ensuring all birds
missed by the autoknife had a cut applied to
severe the major arteries of the neck before they
entered the scald tanks. No additional cadavers
were observed after monitoring the line (in the
Picker Room) for approximately 5 minutes.
Regulatory control action was released to the
establishment at 2138 hours, when sanitary
operations were regained in the Live Hang and



09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
P206+V206 | Pilgrim's Pride | KCC491 | 06/06/2018 | 04C05 | 381.65(b) On June 6, 201 (b\6) bserved the
Corporation 306460 following GCP noncompliance. At approximately
6N-1 1400 hours the east evisceration line was stopped

due to a maintenance issue. At 1435

went to the live hang room to verify live birds
were being handled appropriately. The employees
in the live hang room had stopped hanging birds
and the birds prior to the stunner had been
removed from the line. Upon inspection of the
stunning and kill equipment there were
approximately 20 dead birds inside of the stunner.
[ OO Mas called to
the area and shown the noncompliance. The dead
birds had drowned in the stunner and
) — |was instructed to remove the dead
birds from the line to be properly disposed of.
Failure to implement procedures for preventing
accidental injury and/or death inconsistent with
SCFR 381.65(b) in regards to birds presented for
slaughter, resulted ina lack of response to a
known GCP failure, and birds were allowed to die
by a means other than slaughter. The
establishment was notified that the USDA expects
the establishment to employ handling methods
consistent with Good Commercial Practices. Plant
Management is asked to consider these USDA
concerns and prevent future occurrences.

Copies of this noncompliance will be distributed
to the establishment, inspection file and District
Veterinary Medical Specialist per FSIS Directive
6100.3. The establishment is also reminded that
NRs and MOls documented for GCP issues can be
FOIA requested and made available for viewing by

FSIS. Documented by



09:42 Friday, October 26,2018 3
Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
P7669 Turkey Valley RZB171 07/04/2018 | 04COS | 381.65(b) At approximately 1240 hours while performing a
Farms LLC 407540 routine Good Commercial Practices task on heavy
5N-1 toms the following noncompliance was observed.

When entering the picking room, | observed 13
cadaver carcasses, with a cherry-red appearance
of the skin, no cut present on the neck, and
significant blood pooling in the neck region, lying
on the floor of the picking room, near the hock
cutter. | then proceeded to observe birds entering
the scalder and observed 1 bird showing signs of
consciousness (blinking eyes, open mouth
breathing, and raised head) proceed into the
scalder. During this time | also observed 3 out of
100 birds hanging by one leg in the shackle, |
immediately notified

of my findings. He

informed me that he was aware that there wag aninyay
issue with too many cadavers and that he would

replace the back-up cutter immediately a
regulatory control acti reduce the lirie speed
from [=Jpirds per minute down to [birds per
minute. At approximately 1300 hours | performed
a recheck and | observed 4 additional cadaver
carcasses that had a cherry-red appearance of the
skin, no cut present on the neck, and significant
blood pooling in the neck region lying on the floor
of the picking room, near the hock cutter. | also
observed 3 out of 100 birds hanging by one leg in

the shackle. Again, | immediately notified®® | — anh

{_@@__Jof my findings and he informed me that aq)

he had not removed the back-up cutter as

previously stated. | took a regulator
action to reduce the line s1 ise]
minute down td birds per minute. At
approximately 1315 hours | went to perform a
recheck but the establishment had changed lots
toa different class of birds (breeder toms).

e)_|and| we) ] were
notified of the noncompliance. The
establishment's corrective actions taken to ensure
carcasses were slaughtered in accordance with
good commercial practices in a manner that will
result in thorough bleeding of the carcasses and
ensure that breathing has stopped prior to
scalding were either ineffective or not
implemented. Therefore, the establishment is not
in compliance with 9 CFR 381.65(b).

irds per



chilling requirements by implementing former regulatory time and temperature
provisions that the final rule on modernization of poultry inspection removed
from 9 CFR 381.66 (b) or by following the time and temperature chilling
procedures that FSIS approved under the Salmonella Initiative Program (SIP).”’
Your establishment was unable to provide a SIP waiver with time and temperature
chilling procedures to support the [©@ F temperature parameter. Your
establishment failed to provide adequate supporting documentation for your
critical limit stated in your CCP 2B chilling HACCP plan. This is a regulatory
noncompliance with Title 9 CFR 417.5(a)(2) and 417.2(c)(3).

8. Your establishment failed to document a direct observation for an actual
monitoring activity. On HACCP record dated June 28, 2018, for CCP 2B Giblet
Chilling, your establishment documented from 8:27am to 2:30pm entries
indicating that that there was no product available. An establishment employee
documented a direct observation at 3:21pm on June 28, 2018, on that HACCP
record with the result of “compliant.” Your establishment documented a direct
observation for a monitoring event that never occurred. This is a regulatory
noncompliance with Title 9 CFR 417.5(a)(3) and 417.4(a)(2)(ii).

9. Your establishment failed to support the selection of your verification procedure
“physical verification” listed in the HACCP plan slaughter CCP 1B for zero
tolerance for whole body carcasses, salvage parts, and feet. The HACCP plan for
the slaughter CCP 1B lists “physical verification” as a verification proce
the HACCP plan. The HACCP plan lists the following description for
2)

we) [In review of
your HACCP records, EIAOs observed that your establishment did not document
the implementation of this verification procedure. In addition, EIAO’s review of
your establishment’s supporting documentation for your HACCP plan, including
decision-making documents, indicate that your establishment did not provide any
documentation to support the adequacy of this verification procedure and
frequency, including any explanation or definition of “physical verification.”
This is a regulatory noncompliance with Title 9 CFR 417.5(a)(2), 417.2(b)(1),
417.5(a)(3), and 417.2(c)(7).

10. Your establishment failed to support the decisions in your hazard analyses and failed
to consider potential food safety hazards at multiple steps in the Slaughter, Raw
Intact, and Raw Non-Intact hazard analyses that can occur before, during, and after
entry into the establishment and that can potentially occur in raw poultry products in
the absence of any controls. This is a regulatory noncompliance with Title 9 CFR
417.2(a)(1) and 417.5(a)(1).

a. Your establishment failed to support the decisions in your Slaughter and
Raw Intact hazard analyses. At multiple process steps, your establishment
refers to a prerequisite program and/or procedure: however, your
establishment failed to identify the hazard you are addressing with the
prerequisite program referenced. For example, at the “/nside/Outside Bird
Washers (IOBW’s)” step in the “Slaughter” hazard analysis. At this step
in the hazard analysis, your establishment identifies no hazards and

An Equal Opportunity Provider and Employer Page 10 of 15


09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
P46869 Carrol Poultry, | DLA161 05/29/2018 | 04C05 | 381.65(b) On 5/29/2018 approximately 17:23 while
LLC 805252 performing a Good Commercial Practice task |
QN-1 observed an alive (controlled movements, blinking

eye and rhythmic breathing) at the entrance to
the scalder and proceeded into the scalder. |
noticed a second alive bird on the line and the
bird was removed from the line. Six more alive
birds were observed and removed from the line
before entering the scalder. | also observed seven
more alive birds piled in the sink adjacent to the
blood tank. In less than a minute three more live
birds were observed on the line just prior to
entering the scalder. Regulatory action was taken
by stopping the line to prevent live birds from

goinginto the scalder.|notified| ye)

(by6) pf the

systematic failure of the plant’s Good Commercial
Practice 381.65 (b) and the regulatory action
taken. 9 CFR 381.65(b) states the regulations also
required that poultry be slaughtered in
accordance with Good Commercial Practices, ina
manner that results in thorough bleeding of the
poultry carcass and ensures that breathing has
stopped before scalding so that the birds do not
drown. . Further investigation | observed a full
barrel of cadaver birds at the rehang table exit,
two on the rehang hang table, and one on the line
after the pickers on the same production day. The
preventive measure is to conduct training prior to
the start of production on May 30, 2018. The
establishment reviewed their procedure and
found it to be not detailed on specific on the knife
cut. The procedure will be updated to be more
detailed. Training will be signed off on and QA will
verify and audit against the effectiveness. Any
employee found not following the procedures will
be disqualified and not allowed to perform the job
until they can requalify and retested. Employees
will be trained on the new updated procedure
prior to start of shift on May 30th. Operations
resumed once the plant had given and
implemented their preventative measures.

18


09:42 Friday, October 26,2018 15
Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
O44)
P1307 Mar-Jac KILO215 | 09/14/2018 | 04CO5 | 381.65(b) At approximately 13:45 while monitoring
Poultry-AL 090914 operations in the rehang area of the evi: ion
N-1 department, | observed 8-1 vers in the drip
pan near the lin juto-rehanger. As |

continued to observe, | saw the back-up employee
remove 6 more cadavers from the line

and dispose of them in the condemn barrel within
a short time span. At 13:47, | proceeded to the
scalding area to observe birds entering the
scalders. | observed for one minute, and within
that time, | observed four birds enter the scalder
with their eyes blinking and their necks arched,
which is an indication that the birds were alive. |

concluded that the establishment's process waS—j5j4)
out of control. At 13:49, | immediately went tq

the live hang room, and took regulatory control
action by instructing the emplo\ 0 stop
hanging chickens on lint As | looked around
in the live hang area, | observed approximately
20-25 live chickens which were loose on the floor
of the hanging pen. There were piles of chicken
litter, feathers and fecal material mixed with piles
of dead and dying birds at the end of each of the
live conveyor belts. The piles were approximately
2 feet in diameter and approximately 2 feet high
on each line. As the plant employees dug through
the piles of debris, there were 2 or 3 live

chickens found on each line. The live chickens
were euthanized by cervical dislocation.



contact with the FCS shackles (prior to the Inside-Outside Bird Wash
(IOBW)). This is a regulatory noncompliance with Title 9 CFR 416.4(a).

f, FSIS inspection personnel have documented multiple NRs for your
establishment's failure to maintain sanitary conditions of equipment used
during production. Since February 1, 2018, FSIS inspection personnel have
documented nine (9) NRs, for observations of your establishment employees
grabbing unclean totes for use in production.

Furthermore, on August 20, 2018, at approximately 1050 hours, ELAO
observed FCS tubs turned over on a wooden pallet. indicated
that those tubs were designated to go to the tub wash room. On that same
day, at approximately 1100 hours, in the dark meat deboning room, the
EIAO observed upright FCS tubs on a cardboard slip on a wooden pallet.
As there was no label or identification indicating whether the tubs were
clean, EIAO asked if the tubs were clean, and
indicated that tl usually clean if the tubs are standing upright and
not flipped ov: dicated that the “assumption” can be made that
these tubs are clean since they are right-side-up and that the employees
would know if they are clean or dirty. As evidenced by the multiple NRs
documented by FSIS personnel, your establishment employees have
repeatedly pulled unclean totes for use in production, demonstrating that
your establishment does not have effective procedures in place to ensure
equipment is maintained in a sanitary condition so as not to adulterate
product. This is a regulatory noncompliance with Title 9 CFR 416.3(a).

Since February 1, 2018, FSIS inspection personnel have issued 93 NRs for failure
to maintain sanitary conditions. Your establishment has received multiple NRs
for unidentified foreign material (UFM) including black specks on product and
FCS, product residue on non-FCS, and poor employee hygiene practices that led
to direct product contamination. Additionally, FSIS has documented your
establishment's failure to maintain your facility in good repair, including findings
of mold in the facility and failure to maintain an adequate pest management
program to prevent pests in your establishment. These observations indicate your
failure to implement your SSOPs to prevent direct contamination or adulteration
of products, and your failure to implement the SPS to maintain sanitary conditions
in your facility. Your SSOP program and associated records indicate that your
establishment has not re-evaluated and revised your SSOP program as needed
since 2016, even after your establishment received multiple, repetitive, and
recurring sanitation noncompliance records. These findings are regulatory
noncompliance with Title 9 CFR 416.14.

Hazard Analysis and Critical Control Points (HACCP) - Title 9 CFR 417

6. Your establishment failed to support the decisions in the Raw Intact hazard
analyses that Salmonella and Campylobacter are not reasonably likely to occur.

An Equal Opportunity Provider and Employer Page 7 of 15


sanitary conditions to prevent the contamination of product. This is a
regulatory noncompliance with Title 9 CFR 416.12(c), 416.3(a) and 416.4(d).

b. On August 16, 2018, at approximately 0930 hours, EIAO observed beaded.
condensation on the ceiling above the transfer conveyor of the front-halves,
which transfers chicken front-halves from the cut-up department to the
boneless/skinless breast department. Your establishment failed to maintain
adequate ventilation to control condensation and prevent insanitary
conditions. This is a regulatory noncompliance with Title 9 CFR 416.2(d).

Since February 1, 2018, FSIS Inspection Personnel have issued 10 NRs for
similar findings of condensation in your establishment. Your establishment
has failed to implement adequate controls to prevent condensation in your
facility.

ec. On August 15, 2018, at approximately 0315 hours, the EIAO observed
chicken residue and blood on the hand dryer and on the soap dispenser at the
hand wash station entering the slaughter floor. Your establishment employees
use this hand wash station to wash their hands prior to returning to the
slaughter and production floor. EIAO notified plant management of these
findings on August 15, 2018. On August 16, 2018, at approximately 1125
hours, the EIAO observed that the hand dryer and soap dispenser still had
residue and blood that was observed from the previous day. Your
establishment failed to maintain sanitary conditions. This is a regulatory
noncompliance with Title 9 CFR 416.4(b).

d. On August 20, 2018, at approximately 1110 hours, the EIAO observed that
your establishment employee was hanging a clear plastic bag near the
conveyor where your establishment is packaging product in the cone line
department. EIAO observed an establishment employee putting pieces of
chicken fat and trim in the plastic bag. Because the plastic bag had no
identification or label, the EIAO asked Plant Manager, Daniel Morales, what
the raw chicken material in the plastic bag was for. Mr. Morales indicated
that the employee was removing trim that would be thrown away. Similarly,
on August 21, 2018, at approximately 0732 hours, the ELAO observed that
your establishment was hanging a clear plastic bag with no identification on a
hook where your establishment employee was standing on the evisceration
line. EIAO observed that the plastic bag contained other plastic bags and
paper towels. Your establishment indicated that it was trash and that it would
go into the trash can after the shift change/break. For both of these instances,
your establishment failed to identify the bag with conspicuous and distinctive
marking to identify the contents. This is a regulatory noncompliance with
Title 9 CFR 416.3(c).

e. On August 15, 2018, at approximately 0330 hours, while your establishment
employees had gone on lunch break during Shift A (Night Shift) and no birds
were on the shackles, the EIAO observed a dirty yellow hose, with black
unidentifiable foreign material (UFM) hanging above, coming into direct

An Equal Opportunity Provider and Employer Page 6 of 15


09:42 Friday, October 26, 2018,

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
PS787 Pilgrim's Pride | DEB190 07/26/2018 | 04COS5 | 381.65(b) #154 On July 26, 2018 at approximately 0950
Corporation 807202 hours, | observed 5 cadavers ina yellow condemn
7N-1 can by the Meyn line 1 rehang table in the picking

room. All of the cadavers had the heads on the
carcasses with no evidence of any cut having been
made. All the carcasses were bright red to purple
in color. The appearance of such birds is
indicative that they had entered the scald vat and
drowned. was
notified of the presence of these cadavers on
Meyn line 1. The previous week on July 19, 2018
while performing a Poultry Good Commercial
Practices task during observation of the steps of
stunning, kill blade and back up on Meyn line 1, |
noted that the back-up missed a bird as it went
past him. | alerted
and he was able to remove the bird from the line
before it entered the scald tank. The presence of
the 5 carcasses that entered the scald tank alive
indicated a loss of process control at that time.
Poultry must be slaughtered in a manner that will
result in thorough bleeding of the carcasses and
ensure that breathing has stopped prior to
scalding. Carcasses of poultry that die from
drowning in the scald vat result in an
unwholesome/adulterated carcass. Birds that die
by means other than slaughter represent a failure
of the establishment to comply with 9 CFR 381.90

and 381,656)

4


417.2(c)(4).

Your establishment failed to support the critical limit in your HACCP plan for
CCP 2B. Your establishment’s "CCP 2B Master Plan” for “Carcass, Salvage
Parts and Feet Water Chilling, Air Chilling, WB Tank Chilling” lists the
following critical limit for the “Water Chill Process”: “Poultry carcasses,
salvage parts and feet shall be chilled to or below within the time allotted
by safe harbor rule.” The “CCP 2B Master Plan” for the “Air Chill Process”

lists the following critical limit: “ (b)(4)
(b)(4) ’ Your establismmentimanagement proviaea F STS

Compliance Guide: Modernization of Poultry Slaughter Inspection: Chilling
Requirements, 2014,” which indicates that FSIS considers “the former regulatory
time and temperature provisions” to be “safe harbors” (page 4) to meet the new
chilling regulatory requirement of 9 CFR 381.66(b). Your plant management
indicated that your establishment is using the former regulations Title 9 CFR
381.65(a) and 381.65(h) to support these critical limits. However, the temperature
parameter (44.6F) of the critical limit of CCP 2B does not match the temperature
parameter described in the former provisions, which state:

« “All poultry that is slaughtered and eviscerated in the official establishment shall
be chilled immediately after processing so that the internal temperature of
poultry carcasses and major portions weighing under 4 pounds was reduced to
40 °F or below within 4 hours of processing; carcasses weighing 4 to 8 pounds,
within 6 hours of processing; and those weighing over 8 pounds, within 8 hours
of processing unless such poultry is to be frozen or cooked immediately at the
official establishment. Once chilled, poultry to be packaged and shipped is to be
stored at 40 °F or less.”

e “Giblets should be chilled to 40° F or lower within two hours of the time that they
are removed from the inedible viscera, except that when the giblets are cooled
with the carcass from which they were drawn, the giblets should be subject to the
same time and temperatures for carcasses above in paragraphs A and B. Any of
the acceptable methods of chilling the poultry carcass may be followed in cooling
giblets.”

© ‘“Inair chilled, ready-to-cook poultry, the internal temperature of the carcasses
shall be reduced to 40° F or less within 16 hours.”

Your establishment indicated you are using the (b)\(4) which states that
the minimum growth temperature of Salmonella is 44.6F. Therefore, it is unclear
what your establishment is using to support both the product temperature and time
parameters of your CCP 2B critical limit.

The FSIS compliance guideline you provided as support indicates that
“establishments producing ready-to-cook (RTC) poultry can meet the new

An Equal Opportunity Provider and Employer Page 9 of 15


09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr

EstName NR# Date

Task

Regs

Description

P206+V206

Pilgrim's Pride | KCCO71 06/22/2018
Corporation 306182
2N-1

04c05

381.65(b)

On une22, 2018, 5]

observed the following GCP noncompliance. At
approximately 0816 hours, | was going to live
hang just before break and noticed that the West
line had stopped. | arrived at the stunner about
0819 hours and the stunner was full of birds with
about 10 birds in shackles behind the stunner.
The East line continued to run and the back-up
killer left the East line. The West line back-up
killer finally cut the necks of the birds between
the stunner and kill equipment about the time the
line restarted. The line stopped again with one
bird still in the stunner. | walked to the back of
the stunner and the bird was struggling to get its
head out of the water. (bis)

we walked by me
and | told him he had a bird drowning in the
stunner. | watched the bird drown from behind
the stunner before the line started back up. |
went to the back-up killer and had him remove
the bird from the line and watched him dispose of
the cadaver carcass. Failure to implement
procedures to prevent the accidental drowning of
birds in the stunner is a violation of 9 CFR
381,65(b) and a GCP failure. On Tuesday, there
were multiple stoppages due to equipment
problems and! mentioned to[__@)_jand
Plant Manager Tonya Byers that plant employees
were not taking care of birds in the stunner when
the lines were stopped. Corrective actions and
preventative measures given for a similar incident
on June 6, 2018, states that the plants standard
procedure is to turn off the stunner and lower the
stunner water to allow the birds to breathe when
the line stops for more than two minutes. On
Tuesday | was monitoring multiple stoppages of
one or both lines and the lines might be stopped
for more than two minutes, including several
close to three minutes. There was not any plant
employee activity to turn off the stunner and
lower the stunner water. Plus the back-up killers
did not always cut the necks of the birds between
the stunner and kill equipment after the two
minutes. USDA expects the establishment to
implement handling procedures consistent with
Good Commercial Practices. | urge the
establishment to consider a program that
prevents birds from drowning in the stunner
before slaughter. Copies of this noncompliance
will be distributed to the establishment,
inspection file and the District Veterinary Medical
Specialist per FSIS Directive 6100.3. The
establishment is also reminded that NRs and MOls
documenting GCP issues can be FOIA requested

10


Food Safety and
Inspection Service

Alameda District
800 Buchanan St
Albany. CA 94710

Phone: (510) 769-57
Fax: (510) 337-5081

SDA

pelt
ME nite states Department of Agriculture

August 31, 2018

| Vis)
Perdue Foods, LLC
2 Establishment 2882P Hand Delivered
2700 Lakeview Highway
Petaluma, CA 94955

NOTICE OF INTENDED ENFORCEMENT

Dear

This serves as an official notification by the Food Safety and Inspection Service (FSIS) of
our intent to withhold the marks of inspection and suspend the assignment of inspectors for
the Slaughter and Raw Intact processes at your establishment, in accordance with Title 9
Code of Federal Regulations (CFR) Parts 500.4(a), 500.4 (b), and 500.4 (c). This action is
based on your establishment's failure to effectively implement and appropriately maintain
the required Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and
Critical Control Points (HACCP) programs, in accordance with Title 9 CFR Parts 416 and
417. Furthermore, your establishment failed to implement and maintain the required
Sanitation Performance Standards (SPS) in accordance with Title 9 CFR Part 416.

You are required to respond to this notice adequately, in writing, addressing all
regulatory noncompliances in this notice. Failure to respond adequately within three (3)
business days from the day of receipt of this notice may result in the suspension of the
assignment of inspectors at your establishment. FSIS will evaluate your response and will
determine if any further administrative enforcement action will be necessary.

Background/Authority

The Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) provides that it is
essential in the public interest that the health and welfare of consumers be protected, by
assuring that poultry and poultry products distributed to them are wholesome, not
adulterated, properly marked, labeled and packaged. This Act gives FSIS the authority, as
designated by the Secretary of the Department of Agriculture, to issue rules and regulations
describing sanitation requirements for inspected establishments. This Act also provides
FSIS program personnel the authority to refuse to allow poultry or poultry products to be
labeled, marked, stamped, or tagged as “inspected and passed” and to prevent the entry of
products into commerce when the sanitary conditions of any such establishment are such
that products are adulterated and provides definitions for the term “adulterated.”
Furthermore, this Act provides FSIS the authority to appoint inspectors from time to time to
examine and inspect products, including the sanitary conditions of facilities. This Act also
gives FSIS program personnel the right to examine and inspect all carcasses and parts of
carcasses that are further treated and prepared and the right to access and examine

An Equal Opportunity Provider and Employer Page 1 of 15


Your establishment failed to identify all applicable food safety hazards and did not
provide documentation to support the decisions in your hazard analysis. This is a
regulatory noncompliance with Title 9 CFR 417,2(a)(1) and 417.5(a)(1).

11. Your establishment failed to support the design of your Control Point (CP) 1B for
Venter, CP 2B for Body Opener, CP 3B for Eviscerator, and CP 4B for IOBW
performance monitoring evaluations. Your establishment references these
performance monitoring evaluations to support the decisions at the “Venter,” “Body
Opener, ” “Backup Venter/Body Opener,” and “Eviscerator” steps in the
“Slaughter” hazard analysis that the biological hazard “Fecal Contamination” is not
reasonably likely to occur. Your establishment does not maintain a written program
for these control points. Mr. Evans indicated that the columns in the records
identifying CP 1B, CP 2B, and CP 3B are what demonstrate that your establishment
is implementing these CPs. EIAO identified that there is no column for CP 4B, but
that your establishment is documenting the monitoring of the IOBW. In your CP
records, your establishment documents a checkmark. However, it is unclear what
you are checking and what the checkmark indicates. Your plant management
indicated that these columns for CP 1B, 2B, and 3B are for documenting whether
“bird presentation [is] good.” Your establishment provided no documentation to
indicate what “bird presentation good” means and how this monitoring check is
addressing fecal contamination to support the decision that fecal contamination is
not reasonably likely to occur at the “Venter,” “Body Opener,” “Backup
Venter/Body Opener,” and “Eviscerator” steps in the “Slaughter” hazard analysis.
This is a regulatory noncompliance with Title 9 CFR 417.5(a)(1).

12. Your establishment failed to implement the test kit instructions for the “‘Anti-
microbial Interventions Prerequisite Program” as written to demonstrate that the
results of the PAA titration are accurate and valid and to support the hazard
analysis decisions in the Slaughter and Raw Intact hazard analyses where this
antimicrobial interventions (AMD) prerequisite program is referenced. On August
15, 2018, at approximately 0545 hours, EIAO observed your QA Technician
conduct the monitoring of the antimicrobial, which includes titration of PAA to
ensure that the chemical is at the target concentration. EIAO reviewed the
“Peracetic Acid Test Kit,” which instructs to ‘swirl 5 seconds to mix” after a new
chemical is added. EIAO observed that your QA Technician did not “swirl” for 5
seconds to mix. Your establishment personnel failed to follow your titration
procedures as written. Without adequate implementation of your monitoring
procedures, your establishment is unable to support the decisions in your hazard
analysis. This is a regulatory noncompliance with Title 9 CFR 417.5(a)(1).

13. Your establishment failed to provide an accurate product flow diagram and failed to
conduct a hazard analysis on all process steps. In reviewing your establishment’s
flow chart, and hazard analyses, EIAOs identified the following noncompliances.

a. Your establishment’s flow chart for “Reprocessing: Off-Line
Reprocessing: Whole Body’s with gross contamination, ingesta, kidney
pathology and/or broken viscera (feet remain attached)” includes a
“Hang Back on Evisceration Line After IOBW” step that is not addressed
in the “Reprocessing: On-Line, Carcass — Off-Line, Salvage Parts”
hazard analysis. This is a regulatory noncompliance with Title 9 CFR

An Equal Opportunity Provider and Employer Page 12 of 15


references “CP 4B; Downstream control point for Sanitary Dressing” as a
“Control Point.” Your establishment also references “Monitor and
Control IOBW Pressures (a, b, ¢) and Spray Nozzles” as a measure “to
prevent, reduce, or eliminate hazard to an acceptable level.”’ However,
you have not identified the hazard you are addressing at this step.

This same “CP 4B" is referenced at process steps where the hazard
analysis does identify fecal contamination as a biological hazard not
reasonably likely to occur, such as the “Venter” step, “Body Opener” step,
“Backup Venter/Body Opener’ step, and “Eviscerator” step. During the
FSA, Mr, Evans indicated that there are no hazards at the IOBW step
because the IOBW equipment does not contain any hazards “in and of
itself.’ However, your establishment was unable to provide any
documentation to support there are no hazards associated with this step
when you have a prerequisite program referenced, This similar
observation is identified at multiple steps throughout your Slaughter and
Raw Intact hazard analyses.

b. Similarly, at multiple process steps, your establishment references “PR: AMI
Step 4”; however, there are no hazards identified to demonstrate what the
prerequisite program is addressing. For example, at the “Post-Chiller
SANOVA Cabinet” step in the “Slaughter” hazard analysis and at the
“SANOVA OLR” step in the “Reprocessing: On-Line, Carcass — Off-Line,
Salvage Parts” hazard analysis, your establishment identifies no hazards at
these steps and references ‘PR: AMI Step 4." However, your establishment
references this same “Antimicrobial Intervention System Prerequisite” at the
“Receiving Live Poultry” step in the hazard analysis where your
establishment identifies Salmonella and Campylobacter as biological hazards
not reasonably likely to occur on the “basis” that “inherent pathogen risk
associated with processing poultry mitigated to acceptable level via
Antimicrobial Intervention System Prerequisite.’ Your establishment is
referencing this same prerequisite program at the “Post-Chiller SANOVA
Cabinet” and “SANOVA OLR” steps. However, your establishment was
unable to provide any documentation to support there are no hazards
associated with this step when you have a prerequisite program referenced.
This similar observation is identified at multiple steps throughout your
Slaughter and Raw Intact hazard analyses.

c. Similarly, at the “Refrigeration” and “Cut-up Parts from Rework/ Outside
Product” steps in this hazard analysis, your establishment identified no
h ‘ds and referenced “PR: Temp Control Maintain WIP temperatures <
and product stored overnight temperatures < and “PR:
Incoming Mayeriqls Prerequisite Program for Outside Product - CCP 3B -
WIP temps <{©|? as a “Control Point.” However, your establishment was
unable to provide any documentation to support why there are no potential
biological hazards of concern at these steps in the “Cut-Up Bulk” hazard
analysis. This similar observation is identified at multiple steps throughout
your Slaughter and Raw Intact hazard analyses.

An Equal Opportunity Provider and Employer Page 11 of 15


09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr

EstName

NR#

Date

Task

Regs

Description

p44947

Two Brothers
for Wholesale
Chicken, Inc.

TRR360
807461
7N-1

07/17/2018

04c05

381.65(b)

While performing a routine GCP task at 920 on
7-17-18, and walking over the kill floor, | saw that
one of the barrels used to wheel the bled-out
birds from the killing area to the scalder was
covered by an empty chicken crate. | removed the
crate, and then observed that several chickens
were breathing and flapping their wings inside the
barrel, and were trying to escape. | pointed this
out to one of the kill floor employees, who
immediately removed the live birds from

the barrel and dropped them back into the cones
so that they could be thoroughly and

properly bled out. Production was not halted,
because the est. had already finished killing
before its 930 break. Because the floor manager
was not in the building, | notified one of the kill
floor employees that, because this was the third
instance in the last month in which | had observed
birds being dropped inside the barrels before they
had been thoroughly bled, and then left in the
barrels either to finish bleeding out or to die by
suffocation, | would be writing a noncompliance
report. The est. is noncompliant with 9 CFR
381.65(b), which states that poultry must be
slaughtered 'in a manner that will result in
thorough bleeding of the carcasses and that

will ensure that breathing has stopped prior to
scalding.’

P45045,

Bee Bee Farms,
LLC

BGI501
306072
2N-1

06/20/2018

04CO5

381.65(b)

On 6/20/2018 at approximately 1020 hours, |,
| x6)__} conducted an Poultry Good
Commercial Practice task. While observing birds
hanging on the chill rack, several birds had fecal
material on them. |,
immediately notified of

the deficiency.
inquired about the issue. |,

explained that there is fecal on the birds. Upon
further inspection of the chill rack, me _|
(x6) [observed fecal material
on the birds. The chiller was washed out and
refilled. All birds since the beginning of production
were reworked oro
lowered the line speed to 25. | informed
(6x6) ]

(x6) that an noncompliance report
would be generated for violation of 9 CFR
381.65(B).

7


09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
P6164A Foster Poultry | OWU1815 | 09/13/2018 | 04COS | 381.65(b) On September 13, 2018, at approximately 0950
Farms 094313 hrs, ©) pf P6164A, was
N-1 performing inspections of the scalding tank areas

as part of a routine Good Commercial Practices
(GCP) verification task. When | approached the
pre-re-hang sorter station, | observed the
establishment sorter remove a bird from the line
and toss it into ared establishment condemn
barrel without logging the disposition. Noticing
that the condemned bird was brightly red-tinged
with a purple-colored head, | searched the
condemn barrel. Inside the barrel on top of
approximately fifteen birds, | found the bird and
observed its head fully intact without cuts.
Examining the remaining birds, | found three
other birds similarly with head and necks
engorged with blood and no sign of slaughter.
Two of the four birds had two minor nicks about
the head which, in addition to the eyes and
mouth were congealed with blood, but
nevertheless were also insufficiently bled out. The
signs of death by means other than slaughter
defined the four birds as cadavers. |
notified[ (6x6) Jof
the finding who promptly segregated the birds for
examination and began to attend the issue. [(©
[x6 ftated tof HG) that the barrel was
last emptied at the 1st break at approximately
0820; therefore, the period over which the four
cadaver birds had occurred was bracketed
between approximately 0820 hrs and my
inspection at 0950 hrs. That resulted ina rate of a
cadaver occurring approximately every twenty
two minutes for at least an hour and a half.
Additionally, an ongoing pattern of birds dying
otherwise than slaughter had been
documented by five recent GCP MOls (9/11/18,
8/3/18, 5/3/18, 4/23/18, 4/20/18) written by
four different inspection personnel each observing
live birds approaching or entering the scalding
tanks. | informed! Ghat
that current rate of cadavers coupled with the
history of ongoing pattern of live birds entering
the scalders indicated that the process was out of
control anda noncompliance would be
documented. No indication of deliberate
mistreatment of poultry by establishment
personnel was observed. As all the adulterated
product was appropriately removed from the
process, no product was tagged/retained, and
therefore no adulterated product entered

commerce.

16


ey)

yay

Your establishment added PAA sprays as part of your establishment’s corrective
actions in response to the Performance Standard failure for Salmonella. Your
establishment provided two studies to support this antimicrobial intervention in
second processing. The first study, “DATA SUMMARY For Beef and Chicken
Exposed To PAA Under Various Use Conditions,” dated October 13, 2015, only
provides a summary of the results and does not provide details on how the study
was conducted, Furthermore, the document indicates “Average ‘% Reduction.”
However, it is unclear what is being reduced. Therefore, it is unclear how your
establishment is using this document to demonstrate that the PAA spray
application in your poultry process is effective to address Salmonella and
Campylobacter.

The second study provided is titled “A study to determine strategies for
increasing the antimicrobial efficacy of Peroxyacetic Acid (PAA) and Acidified
Sodium Chlorite (ASC) against Salmonella Infantis on chicken,” dated December
13, 2017. This study was conducted using a PAA dip at various contact times;
however, your establishment is using a PAA spray in [@@_|processing. Your
establishment was unable to provide any decision-making document or other
support to demonstrate how this study on a PAA dip will support the PAA spray
application in your process, In addition, your establishment does not have a
designated contact time for your PAA application. During the FSA, the EIAOs
observed that your PAA spray does not provide complete coverage of parts as it
only sprays the top of the products on the Raw Intact lines of Tray Pack, Repack,
and Dark Meat Deboning. Without adequate application of your antimicrobial
intervention, it is unclear if your PAA application is effective to address the
pathogens of concern. Your establishment failed to provide supporting
documentation for your ‘‘Anti-microbial Interventions Prerequisite Program” to
demonstrate that your PAA antimicrobial intervention in second processing is
effective and to support the decisions in the Raw Intact hazard analyses that
Salmonella and Campylobacter are not reasonably likely to occur. This is a
regulatory noncompliance with Title 9 CFR 417.5(a)(1).

7. Your establishment failed to maintain and implement a HACCP Plan that meets
regulatory requirements set forth by Title 9 CFR 417. Your establishment failed to
implement CCP 3B for necks at the “Bulk Packing: Necks and Giblets” step. Your
establishment's “Slaughter, Giblets & Necks” hazard analysis references “CCP 3B:
Giblet and Neck Temps < 55F” at the “Giblet & Neck Wrapping,” "

‘iblet Cups or wa)
a Trays,” “Bulk Packaging: Necks and Giblets,” and “Weigh & Price.” The HACCP
- itan-for, CP 3B states that your establishment will monitor the pr =

‘oduct internal zs
7s eRAUEES Off: randomly selected carcasses or parts on| ckagi ith~
the “Jiighes nitoring temperature is documented” “random x
shift ingore * During the FSA, your plant management
indicated that your establishment is only monitoring the product temperatures when
the necks are used for your Mechanically Separated Chicken (MSC) process and
when the necks are packed in whole body birds. Your establishment is currently not
monitoring the work in progress (WIP) temperatures of necks at the bulk packaging
step, Your establishment therefore failed to monitor necks under the CCP 3B at bulk
packaging and failed to monitor each packaging line as indicated in your HACCP
plan. This is a regulatory noncompliance with Title 9 CFR 417.2(b)(1) and

An Equal Opportunity Provider and Employer Page 8 of 15


09:42 Friday, October 26,2018 7
Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
wai
P7156+V71 | Tyson Foods, JTF581 08/17/2018 | 04Cc05 On 08/17/2018 at approximately 1540hours SCSI
56 Inc. 808361 wasnotifiedby[ HG)

7N-2 performing postmo!
station|_} that she identified 12 cadavers. Five of
them were hung on the rack behind the inspector
station. When verified the hung carcasses were

their necks uncut, red very engorged heads. ve
Viscera parts related to the carcasses appearet

congested more than the other passe eS,
SCSI asked bas We) on
station| + (b)6} on station 1 and
found that they identified a total of 3 cadavers.
The line was stopped for 3 minutes to notify | (6)

[ CHO) Jof the -—HGy
noncompliance. While was walking toward the kill

machine SCSI observed that other carcass iat
were with red, uncut necks, engorgedfed heads
coming down stream in lint CSI found that kill
machine was not operating and 2 back up team
members were bleeding birds. Two birds were
passed back up kill persons without being
properly bled, and SCSI applied control action and
ensured birds were properly bled before the line
allowed to operate back. SCSI was notified by
Maintenance personnel that birds hanging was
stopped to fix the kill machine. SCSI verified no
birds were hung until Kill machine was fixed.
Total of 25 cadaver were reported on tally sheets
on inspection stations of line 2 before kill machine
back to operation. FSIS Directive 6110.1 states
that repeated occurrence of birds that dying
otherwise than by slaughter or not being
appropriately bled represents a noncompliance of
Good Commercial Practices. Kill machine was
verified at 2018 hours and was found working
properly.



09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr

EstName

NR#

Date

Task

Regs

Description

Picker Room areas. A similar noncompliance was
documented on May 9, 2018 (NR
GJJ5208055209N-1). The root cause of that
incident was also determined to be failure to
maintain equipment in a manner that resulted in
the proper bleed out of poultry slaughtered at the
establishment, as well as failure of supervision to
maintain control of the area. The requirements
of SCFR 381.65(a) and 9CFR 381.65(b) were not
met. Documentedby(

Nacogdoches Circuit 4029

PS517

Mar-Jac
Poultry-MS

Q0032
160815
21N-1

06/22/2018

04c05

381.65(b)

approximately 0906 hours on June 22, 2018,
while verifying Good Commercial Practices in
Poultry (GCPIP) verification task at 00517P (Mar
Jac), in Hattiesburg, MS, the following less than
GCPIP incident was observed at the cage dumper
for live birds. An employee was observed grabbing
several (approximately three in each hand) birds,
that had not fallen onto the conveyor, out of the
cages and throwing them onto both the North
and South conveyors leading to the hanging pens.
Asimilar incident was written
(Q0042090505246) on May 24, 2018 with the
respect of mishandling live birds at the dumper.
Throwing birds is not consistent with GCPIP.
Establishments are responsible for birds entering
the official premises and must employ GCPIP to
prevent unnecessary suffering, injury or death,
This issue was discussed with
[ (by6) Jon
June 22, 2018 at 0920. As per Federal Register
Notice Docket 04-037N, dated September 28,
2005, “Treatment of Live poultry Prior to
Slaughter”, the4 Food Safety Inspection Service
(FSIS) strongly encourages all establishments
engaged in the slaughter of poultry to abide by
Good Commercial Practices (GCP’s) as described
in industry guidelines.

13


Title 9 CFR 416.13(a), 416.13(c), and 416.16(a).

3. Your establishment failed to develop and implement SSOP procedures that your
establishment will conduct daily, before and during operations to prevent direct
contamination. On August 15, 2018, at approximately 0530 hours, the EIAO
observed a combo bin of salvage product near the salvage stations. The EIAO
observed yellow hoses touching the inside of the FCS plastic liner of the combo
bin. The EIAO notified Director of Food Safety and Quality Assurance, Terry
Evans, who indicated that the yellow hoses are considered FCS. However, your
establishment is not documenting in pre-operational SSOP records that the yellow
hoses are being cleaned and being monitored as a FCS. Furthermore, your SSOP
program does not include any procedures for the cleaning of the yellow hoses.
Your SSOP do not describe all procedures your establishment is conducting daily,
before and during operations, to prevent direct contamination. This is a regulatory
noncompliance with Title 9 CFR 416.4(a), 416.11, 416.12(a), 416.13(c), and
416.16(a).

4. Your establishment failed to implement your SSOP “Salvage Procedure for
Carcasses, Parts on the Floor or in Drip Pans” as written.

a. Your establishment’s SSOP “Salvage Procedure for Carcasses, Parts on
the Floor or in Drip Pans” states the following: * we)

(b)(4)

(bys) i

On August 20, 2018, at approximately 1130 hours, the EIAO observed
half carcass in a drip pan under the “elevator” front-half conveyor in the
cone line/white deboning department. The EIAO notified, OO]
[ we) |, of this finding. However.
subsequently, on August 20, 2018, at approximately 1400 hours, after
was finished conducting his operational SSOP
monitoring check, the E[AO observed that the same product was still in
the drip pan under the “e/evator” front-half conveyor in the cone

line/white deboning department. Your establishment failed to pick up
roduct in the drip pan in a timely manner —— |
ie), in accordance with your establishment’s written SSOP “Salvage

Procedure for Carcasses, Parts on the Floor or in Drip Pans”’. This is a
regulatory noncompliance with Title 9 CFR 416,.13(c) and 416.4(d).

b. On August 23, 2018, at approximately 0900 hours, the EIAO observed a
front-half chicken on the motor, which is not a product contact surface,
behind the front-halves rehang table in the cone line room. Your
establishment employees picked up this front-half for reconditioning at
0918 hours. Your establishment failed to pick up product in a timely
manner (‘ yA) |), in accordance with your
establishment’s written SSOP “Salvage Procedure for Carcasses, Parts
on the Floor or in Drip Pans.” This is a regulatory noncompliance with

An Equal Opportunity Provider and Employer Page 4 of 15


If you have any questions, please call the Alameda District Office at (510) 769-5712.
Sincerely,

SY Virginia Felix, DDM
(for)

Yudhbir Sharma, DVM
District Manager

ce:

V. Felix, DDM
S. Beckett, DDM
A. Amin, DDM
F. Gillis, DDM
L. Wang, DCS

(b)(6)

(b)(6)

K. Gilmore, EARO
(b)(6)

An Equal Opportunity Provider and Employer Page 15 of 15


09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
P18414 MB Jyl0S13 06/26/2018 | 04CO5 | 381.65(b) At approximately 1345, while inspecting the live
Consultants 063426 poultry hang area, | observed the following
LID N-1 noncompliance. The turntable past the shackling

station where the empty crates enter the water
bath had a crate with live birds in it still. The
employee who pushes the crates into the water
bath removed three chickens and threw them
over to the shackler employees. One of the
chickens that he threw hit a crate before falling
onto the floor and the other two landed in the
shacking area. It is about seven feet in distance
from where the chickens were thrown. Throwing
chickens as | observed is inhumane and contrary
to good commercial practices. | notified|_(6X6)

(6) of the noncompliance.



Sanitation Standard Operating Procedures and Sanitation Performance Standards —
Title 9 CFR 416

L.

Your establishment failed to implement pre-operational sanitation procedures to
prevent insanitary conditions. Your SSOP pre-operational sanitation procedures
state, | we) |

[ De ]
[ EH ]On August 17, 2018, at
approximately 0050 hours, in the dark meat room after your establishment Quality
Assurance (QA) personnel completed his pre-operational inspection, the EIAO
observed product residues in multiple locations inside the thigh hopper. The
inside of the hopper is a food contact surface (FCS). Residues such as this can
provide an excellent growth medium for many micro-organisms, including
pathogens, Your establishment is not implementing your pre-operational
sanitation procedures as written to ensure sanitary conditions are maintained. This
is a regulatory noncompliance with Title 9 CFR 416.13(a).

In addition, on August 16, 2018, at approximately 2150 hours, in the air chill
room, the EIAO observed your establishment employee conduct pre-operational
inspection. After your QA personnel completed his pre-operational inspection, the
EIAO observed product residue on the floor. Your establishment failed to ensure
sanitary conditions prior to the start of operations.

Since February 1, 2018, FSIS Inspection Personnel have issued 14 NRs for your
establishment’s failure to implement pre-operational sanitation procedures to
prevent insanitary conditions as required by Title 9 CFR 416.13(a). FSIS has
concerns regarding your establishment's ability to maintain sanitary conditions as
evidenced by the ongoing and recurring noncompliance records issued to your
establishment.

Your establishment failed to implement your written SSOP procedures for your
air chill room. Your establishment management indicated that the ceiling in the
air chill room is considered a FCS in case condensation occurs and that the air
chill room ceiling is cleaned nightly. However, your establishment is not
documenting in the “Preoperational Sanitation Inspection Report” records that
the ceilings are being cleaned and monitored. Furthermore, your SSOP program
does not include any procedures for the cleaning of the ceiling, which you have
identified as a FCS. Your SSOP do not describe all procedures your establishment
is conducting daily, before and during operations, to prevent direct contamination,
This is a regulatory noncompliance with Title 9 CFR 416.12(a).

Furthermore, your establishment’s SSOP indicate your QA
oe |
oe |

©@_|In review of the Adenosine Triphosphate (ATP) testing results provided,
your establishment was unable to demonstrate that you are performing any ATP
swab tests on the air chill room ceiling, This is a regulatory noncompliance with

An Equal Opportunity Provider and Employer Page 3 of 15


09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr

EstName

NR#

Date

Task

Regs

Description

and made available for viewing by FSIS.

Documented by

aul


establishment records. When the sanitary conditions of a facility are not properly
maintained, FSIS can refuse inspection and indefinitely withdraw inspection from an
establishment, provided the establishment is afforded the right to an administrative hearing.

Under the authorities of this Act, FSIS has prescribed rules and regulations required for
establishments producing meat and poultry products including the requirements
pertaining to Sanitation Standard Operating Procedures (SSOP) and Sanitation
Performance Standards (SPS) (Title 9 CFR Part 416) and other matters. FSIS has also
developed Rules of Practice regarding enforcement (Title 9 CFR Part 500). The Rules of
Practice describe the types of enforcement action that FSIS may take and include
procedures for taking a withholding action and suspension, with or without prior
notification, and for filing a complaint to withdraw a grant of Federal Inspection.

Findings/Basis for Action

From August 14, 2018, through August 23, 2018, Enforcement Investigations and
Analysis Officers (EIAOs) conducted a Food Safety Assessment (FSA) at your
establishment. The purpose and scope of this assessment was to review the food safety
systems for regulatory compliance and to determine if the systems were scientifically
sound and supported. During the FSA, the E[AOs reviewed your establishment's HACCP.
plans, SSOP program, prerequisite programs supporting your hazard analyses, supporting
documentation, as well as corresponding records. In review of your establishment’s
documentation, the EI[AOs found your HACCP system to be inadequate. In addition, you
failed to maintain sanitary conditions in accordance with the SSOP and SPS regulatory
requirements.

On March 30, 2018, FSIS personnel notified your establishment that you failed to meet
the Salmonella performance standards for Chicken Parts for the sampling period of
February 26, 2018, to May 19, 2018. Your establishment exceeded the maximum
acceptable percent positive of 15.4%, as defined in the Federal Register Vol. 81 No. 28
"New Performance Standards for Salmonella and Campylobacter in Not-Ready-to-Eat
Comminuted Chicken and Turkey Products and Raw Chicken Parts and Changes to
Related Agency Verification Procedures.”

From February 1, 2018, through August 13, 2018, FSIS Inspection Program Personnel
have issued 126 Noncompliance Records (NRs) for your establishment's continued
failure to effectively maintain and implement the required SSOP, SPS, and HACCP
programs, in accordance with Title 9 CFR Parts 416 and 417. These recurring NRs
indicate your failure to operate and maintain your establishment in a manner to prevent
the creation of insanitary conditions and to ensure product is not contaminated or
adulterated.

The following are the regulatory noncompliances documented by FSIS Enforcement,
Investigation, and Analysis Officers (EIAOs) during the Food Safety Assessment (FSA)
at your establishment for the period from August 14, 2018, through August 23, 2018.

An Equal Opportunity Provider and Employer Page 2 of 15


09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
P46869 Carrol Poultry, | DLAOQ21 06/07/2018 | 04C05 | 381.65(b) On 6/07/18 while performing a GCP, | observed at
LLC 706390 the end of the blood tunnel before the scalder a
7N-1 live bird (controlled movements, blinking eye and

rhythmic breathing). The bird was removed from
the line. | also observed seven more alive birds
removed from the line. There was a large gap in
the line (no birds were on shackles), line was not
stopped no birds were hung. | notified
[- x6) of the non-compliance 9 CFR
381.65(b). | observed the preventive measure
described in the GCP noncompliance on
5/28/2018 was not being implemented. Further
investigation | observed a half full barrel of
cadaver birds at the rehang table in EVIS. All the
birds in the barrel did not have a cut on the throat
to allow proper bleeding before entering the
scalder . | observed, while giving breaks, a cadaver
bird at the inspection stand and 3 more cadaver
birds were documented on the USDA lot sheet. |
also observed eight cadavers being removed from
the line after pickers before the hock cutters.

The establishment’s preventive measure is to
enforce the preventive measure described in the
last noncompliance on 5/28/2018 and to monitor
the cutters throughout the shift. They also placed
skilled cutters toward the beginning to decrease
the amount of birds needing a backup cut from
the back up killers. Establishment preventive
measure was given before hanging more birds on
to the line.

19



09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr EstName NR# Date Task Regs Description
P509 Koch Foods |PG230 08/29/2018 | 04CO5 | 381.65(b) The following occurred on the shift beginning
LLC 208173 08/29/2018 while performing Good Commercial
ON-1 Practices. At approximately 0132 hours, |

observed less than good commercial practices.
While | was performing a 500 bird count after the
back-up killer, | had observed eight (8) birds
travelling to the first scalder, each one
unwounded and retaining consciousness (blinking,
attempting to right themselves), some of which
were hung overlapping another bird or with two
legs in one half of the shackle. Birds that drown in
the scalder have not been slaughtered in
accordance to the GCP, per 9 CFR 381.65(b).
Before performing the count, | had observed the
picking line speed atf@pirds per
minute. During the count, | observed the back-up
killer trying to keep up with the number of birds
that the kill machine had missed. No one else
was present, as it was later told to me that the
maintenance personnel assigned to the Kill
Room/Picking Area was at lunch. Production was
halted, and
(x6) ]
a) i
eo) were immediately summoned to

the Kill Room. The Halal representative also came
to the Kill Room. Adjustments were made to the
kill machine, and the picking line was slowed to
[bic pirds per minute. Another 500 bird count
was performed, with no live birds entering the
scalder, The area was back in compliance at
approximately 0146 hours. A copy of Federal
Register / Vol. 70, No. 187 Docket No. 04-037N
titled "Treatment of Live Poultry Before Slaughter"
can be made available to the Establishment.

4


417.2(a)(1).

b. Your establishment’s flow chart for the “Slaughter Process: Evisceration,
OLR And Chilling” and “On-Line Reprocessing: Minor contamination,
ingesta, digestive tract remnant, etc.” indicate that the product goes from
“SANOVA OLR Cabinet” to “NELS Inspection Station.” Your plant
management indicated that the “NELS Inspection Station” is the area
where your establishment conducts your CCP 1B zero tolerance checks.
However, the EIAO observed that your establishment collects the carcass
samples for the zero tolerance checks after the birds go through IOBW and
before the birds enter the OLR Sanova pre-chill dip tank antimicrobial
intervention. The flow charts your establishment provided are not up-to-
date and do not accurately reflect the product flow. This is a regulatory
noncompliance with Title 9 CFR 417.2(a)(2).

c. Your “Whole Body” flow chart includes the step “To Cut-Up Process”
that is not addressed in the “Whole Body” hazard analysis. This is a
regulatory noncompliance with Title 9 CFR 417.2(a)(1).

d. Your “Tray Pack” flow chart includes the step “Condemn” that is not
addressed in the in the “Tray Packs” hazard analysis. This is a regulatory
noncompliance with Title 9 CFR 417.2(a)(1).

Your HACCP plans in operation do not meet the regulatory requirements of Title 9 CFR
417.2(a)(1), 417.2(a)(2), 417.2(b)(1), 417.2(c)(3), 417.2(c)(4), 417.2(€)(7),
417.4(a)(2)(ii), 417.5(a)(1), 417.5(a)(2), and 417.5(a)(3). You also failed to meet the
sanitation regulatory requirements of Title 9 CFR 416.2(d), 416.3(a), 416.3(c), 416.4(a),
416.4(b), 416.4(d), 416.11, 416.12(a), 416.12(c), 416.13(a), 416.13(c), 416.14, and
416.16(a).

For the reasons stated above and in accordance with Title 9 CFR 417.6(a), 417.6(b), and
417.6(d), FSIS has determined your HACCP system is inadequate. Your establishment
failed to support the decisions in your hazard analyses and you failed to adequately
implement your HACCP plans and maintain adequate records. FSIS is unable to
determine that your establishment’s HACCP system is safe, scientifically supported and
sound.

Pathogens such as Salmonella and Campylobacter are of serious public health concern
that can cause a variety of serious illnesses. The organisms can cause a serious infection
which can lead to illnesses, including death. Without adequate implementation and
supportable design of your HACCP program that would support the control of
Salmonella and Campylobacter in your process, FSIS cannot determine that you have
adequately addressed the hazards of concern to ensure you are producing safe and
wholesome product.

Supporting documentation is an important recordkeeping component necessary to show
that the implemented HACCP plan will ensure the production of safe food. Without
documentation that adequately supports the HACCP plans, FSIS cannot determine that

An Equal Opportunity Provider and Employer Page 13 of 15


09:42 Friday, October 26, 2018

Table: Noncompliance Reports in Response to FOIA_2019_18

EstNbr

EstName

NR#

Date

Task

Regs

Description

P1480

P4734

Tip Top
Poultry, Inc.

New Lee's Live
Poultry Market
Inc.

JBA362
109060
4N-1

XKD360
909230
5N-1

09/04/2018

04c05

381.65(b)

08/28/2018

04C05.

381.65(b)

On 08/17/2018 after a review of trailers on the
yard it was found that a trailer and a half would
be left over the weekend to be slaughtered on
Monday 08/20/2018. One trailer had a total of
approximately birds and the second trail
contained approximately|
conducted a GCP Saturday 08/18/2018
to assess the condition of the birds that had been
left over the weekend. | observed 4-5 coops at the
top of the rigs where birds in each coop were
dead. | observed other coops where some of the
birds were dead, not moving around or making
any noise. | observed other coops with the birds
hunkered down and heads hanging low. |
observed other birds making noises. On Monday
Morning 08/20/2018 there was a 21.5% death
rate on the load of 3,456 which is approximately
743 birds. Based on the DOA’s rate, the
establishment lost process control and the birds
died by other means rather than slaughter. This is
a failure to meet the requirements of 381.65 (b).
Continued failure to meet the requirements of
381.65 (b) may lead to further regulatory
requirements.

On Tuesday 08/28/2018, at approximately
11:15am, while performing an unscheduled Good
Commercial Practice PHIS task in order to verify
the establishment was conducting daily
inspections and meeting with regulatory
requirements of CFR 9(416), the following
incompliance was observed. In the live holding
/killing floor area, six geese slaughter and
bleeding out inside shipping crate, twenty geese
bleeding out in required designated equipment.
[_ ©) _]the establishment’s Person in
charge was notified of these incompliance both
verbally and in writing with this NR the
establishment was in violation of regulations
indicated on section (#6) of this document , and
reoccurrences of this malpractice can lead to
agency disciplinary action.