2 

to 9 CFR 310.1(b)(3). As described in Attachment 2, FSIS SIP Summary and 

IPP Verification, the Public Health Veterinarian (PHV) is to assess 

presentation of carcasses to the online inspector at the carcass inspection 

(CI) station and evaluate the health status of the herd, sanitary dressing

process or other factors that may indicate loss of process control, such as

persistent unattended defects to determine whether these factors are having

any impact on ability of IPP to perform the proper inspection procedures at a

given line speed. The PHV is to reduce the line speed at which the online

carcass inspector can perform proper inspection (9 CFR 310.1(b)(1) and

303.1(h)).

Background: 

The SIP is a voluntary program for meat and poultry slaughter establishments 

that agree to test for Salmonella, Campylobacter (if applicable) and indicator 

organisms and share all sample results and other corresponding process control 

data with FSIS in order to receive waivers of provisions of the regulations (76 FR 

41186, July 13, 2011). Establishments participating in SIP maintain consistent 

process control for Salmonella and use contamination process control verification 

activities to determine control limits along with Salmonella and indicator organism 

test results. 

The protocol submitted includes Pork PREP (Sanitary dressing best practices) 

and an In Process Audit procedure pre-requisite program to gauge process 

capability and performance of carcass dressing procedures in relation to carcass 

cleanliness to consistently monitor changes and control of slaughter hygiene. 

This In Process Contamination (IPC) audit (Attachment 1) serves as a process 

control procedure that targets in-process contamination prevention and 

minimization rather than removal. 

Establishments participating in SIP are to maintain consistent process control for 

Salmonella and use sanitary dressing procedures for preventing visible 

contamination (or ingesta, feces and milk contamination) and include verification 

activities in addition to determining control limits for Salmonella and indicator 

organism test results. 

Waivers granted and Establishment Agreement:

The Food Safety and Inspection Service (FSIS) has completed the review of your 

requests and is hereby granting your establishment a waiver of the regulations 

pending the Agency amendment of 9 CFR 310.1(b)(3), 310.11 and 310.25(a) and 

(b), pursuant to provisions under 9 CFR 303.1(h). 
3 

FSIS has no objection to Est. M244M using alternative procedures to remove 

certain dressing defects in place of 9 CFR 310.11; using alternative 

procedures for line speed in place of 9 CFR 310.1(b)(3); alternative generic E. 

coli testing in place of 9 CFR 310.25(a); and, as described in its SIP Protocol, 

using alternative daily Salmonella sampling and testing procedures in place of 9 

CFR 310.25(b) provided the establishment: 

A. Reassesses, modifies and validates as appropriate, the Hazard Analysis and

Critical Control Point (HACCP) food safety system (HACCP plan, Sanitation-SOP

or other prerequisite program) according to 9 CFR 304.3, 416 and 417.4 for:

1. the SIP protocol;

2. alternative procedures used in place of 9 CFR 310.11 for removing eyelids

and eyelash stubble remaining on carcasses after dehairing and first incision

by a hole-punch device to ensure that the eyelids on the skull, with any hair

present, are removed when the snout is pulled from the head provided; the

Pork Carcass PREP best practices (Attachment 1) and the In-Process

Contamination (IPC) audit program (Attachment 1) continually demonstrate

process control, as per protocols including taking corrective action if control

limits are exceeded;

3. alternative procedures used in place of 9 CFR 310.11 for removing

incidental carcass hair that is not readily visible (does not require frisking or

rubbing the hog to visualize) or exists visually under the dermis layers at

locations after first incision provided the Pork Carcass PREP best practices

(Attachment 1) and IPC (Attachment 2) continually demonstrate process

control, including taking corrective action if control limits are exceeded;

4. Alternative procedures used in place of 9 CFR 310.1(b)(3);

5. Ensures that the post-evisceration, pre-final rail carcass wash at audit step

is turned off if carcasses with visible, incidental fecal or oral ingesta or certain

pathological conditions are found before the wash (at audit 5 step); and

6. Validates in-plant within 90 days of implementing the alternative

procedures for removal of eyelids and eyelash stubble and for removal of not

readily visible incidental hairs.

D. Makes available and discusses with FSIS Inspection Program Personnel (IPP)

at the weekly meeting this SIP Letter and SIP Protocol including:

1. regulations waived (9 CFR 310.11, 310.25(a) and (b)),
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2. alternative procedures the establishment will use in place of each

waived regulation,

3. specified microbiological sampling and testing implemented including

records,

4. the establishment’s agreement to share microbiological sampling and

testing results with FSIS and

5. Attachment 2: FSIS SIP Summary and IPP Verification which

summarizes IPP verification procedures for verifying that the

establishment is operating in a manner that is consistent with the

alternative procedures and SIP Protocol.

E. Conducts microbiological sampling agreed to as condition of receiving the

waiver under SIP as follows:

1. Write sampling collection procedures that identify employees

designated to collect samples and address locations of sampling,

how sampling randomness will be achieved to cover all lines and all

shifts, and handling of the samples to ensure sample integrity for

Salmonella and Enterobacteriaceae (EB).

2. Conduct microbiological sampling according to the written sampling

procedures and at the frequency stated below:

a. Every day of production collect one Salmonella sample per line

per shift at the postchill location after any postchill antimicrobial

intervention applications the establishment has implemented to

reduce microbial contamination of carcasses.

b. Each week collect one pre-evisceration sample to compare

results to a matched1 postchill sample for each of the following

microbes: Salmonella and EB.

3. Record all microbiological test results.

4. Maintain Salmonella process control (currently six2 or less positive

Salmonella test results in a 55 sample set size).

1 Pre evisceration and postchill matched samples—postchill taken after carcass is chilled in cooler 2 Note: The expected level of an establishment’s performance is subject to change if the performance 

standard changes.
5 

5. Evaluate daily Salmonella test results by counting the number of

positives in a moving window of 55 samples.

6. Respond to greater than six Salmonella positive test results in a 55

sample set by:

a. Increasing the frequency of Salmonella testing to two samples

per line per shift (for a total of four samples per day) until 2 consecutive 

discrete sample sets have six or less positive Salmonella test results in 

each sample set.

b. Reviewing the establishment’s total food safety system with

consideration given to whether the waiver of requirements has caused 

the lack of control.

c. Taking corrective and preventive actions to re-gain control and

documenting findings and resulting actions. 

d. Demonstrating restoration of control following any corrective

action by conducting at the increased frequency of testing, 2 

consecutive Salmonella sample sets of 55 with six or less positive test 

results per sample set. After demonstrating control, the frequency of 

testing can then return to 1 Salmonella sample per line per shift

NOTE: At this time, it is not necessary to send Salmonella isolates to the FSIS 

Laboratory at Athens, Georgia.

F. Maintain records in same manner and for the same duration as HACCP

records (9 CFR 417.5).

G. Provide access to the records necessary to document SIP process control,

including microbiological test results when requested by FSIS IPP.

H. Submit microbiological test results to FSIS headquarters monthly

according to the FSIS template and instructions on how to submit which

can be obtained by e-mailing the FSIS “SIP.Mailbox@FSIS.USDA.gov”.

NOTE: Although FSIS expects that an individual establishment submitting data 

through the template and following instructions will not be identified, FSIS cannot 
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guarantee that data may not be obtained through the Freedom of Information Act 

(FOIA). 

I. Provides FSIS 30 days prior written notice if the establishment decides to 

stop participation in the SIP and stop functioning under the waivers.

IPP Verification Responsibilities: 

A. FSIS Attachment 2. FSIS SIP Summary and IPP Verification provides 

specific verification procedures that IPP are to use to verify that the 

establishment is operating in a manner that is consistent with the 

alternative procedures and SIP Protocol. 

B. IPP are to conduct verification tasks based on how the establishment has 

incorporated alternative procedures into its food safety system (HACCP 

plan, Sanitation-SOP or other pre-requisite program) and in accordance 

with FSIS Directive 5000.1 Verifying an Establishment’s Food Safety 

System.

C. Once a week IPP are to verify one or more parts of the alternative 

procedures, SIP sampling and testing and SIP Protocol according to 

instructions in FSIS Directive 5020.1 Verification of SIP. If the SIP protocol

disagrees with the SIP Letter, verify according to the SIP Letter 

requirements and issue non-compliance records (NRs) as appropriate.

D. IPP are to verify that the establishment is conducting and implementing the 

required SIP microbiological sampling and testing according to this SIP 

letter and SIP Protocol. IPP are to verify that the establishment is;

1. Conducting microbiological sampling according to written 

procedures;

2. Recording and evaluating the test results;

3. Responding when the allowable number of positives is exceeded by 

increasing testing frequency until two consecutive sample sets have 

5 or less positive Salmonella results; and

4. Investigating the cause and document any corrective actions.

E. IPP are not to write a noncompliance report (NR) if allowable number of 

salmonella positives is exceeded. IPP are to write NRs when the 

establishment does not follow alternative procedures authorized by the 

waiver, doesn’t maintain records that reflect its use of those procedure or 
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doesn’t follow sampling and testing written procedures required under SIP. 

When noncompliance is found IPP are to take appropriate action and 

follow instructions in FSIS Directive 5000.1, Ch. V. Documentation and 

Enforcement. IPP are to report through their supervisor channels if he or 

she observes a trend of repeated NRs related to the alternative procedures 

or SIP protocol. 

Please be aware that if Tyson Fresh Meats, Inc. (Est. M244M) system conflicts 

with the provisions of the Federal Meat Inspection Act (21 U.S.C. 601, et seq.), or 

has repeated Noncompliance Records (NRs) documenting failure to maintain 

the alternative procedures or to follow the SIP Protocol, then the waivers will be 

revoked. 

If you have questions, please contact, Melanie Abley Risk, Innovations, and 

Management Staff (RIMS), Office of Policy and Program Development (OPPD) at 

(202) 690-5673 or e-mail Melanie.Abley@fsis.usda.gov .

 

Director

Risk, Innovations, and Management Staff

Office of Policy and Program Development

Attachments:

1. SIP Protocol and Attachment 1, 2, 3, 4

2. FSIS SIP Summary and IPP Verification