Alternatives 1 & 2 for Control for Listeria monocytogenes
Components of the
Individual Alternatives
Alternative 2
Ø
Establishments that choose
Alternative 2 will likely be subject to less agency sampling than establishments
that choose Alternative 3.
Ø
Alternative 2 would likely be
subject to less testing because the risk of contamination in the finished
product by Lm decreases from Alternative 3 to 2, based on the control
methods used by the establishment.
Alternative 2
Ø
An establishment that chooses to utilize Alternative 2 in
processing its product must apply either:
l
A post-lethality treatment; OR
l
An antimicrobial agent or process that controls the growth of
Lm
Alternative 2
Ø
When using a post-lethality treatment, the establishment must:
l
Include the treatment in the HACCP plan
l
Validate the effectiveness of the treatment per 417.4 of the
regulations
Alternative 2
Ø
When using an antimicrobial agent or process, the establishment
must:
l
Include the treatment in either the HACCP plan or Sanitation
SOP (SSOP), or other prerequisite program
l
Document in the HACCP plan, SSOP, or other prerequisite program
that the antimicrobial agent or process is effective in suppressing or limiting
the growth of Lm
Alternative 2
Ø
Using only an antimicrobial
agent or process, the establishment must:
l
Maintain sanitation in the
post-lethality environment according to Part 416 (SSOP)
l
Include, in the sanitation
program, testing for food contact surfaces in the post-lethality environment to
ensure that the surfaces are sanitary and free of Lm or its indicator
organism (Listeria species)
–
An effective sanitation program
is important because antimicrobials are not effective at high levels of
contamination
Alternative 2
Sanitation Program
Workshop Discussion
Alternative 2
Ø
What do the regulations require to be in the sanitation program
to prevent Lm contamination on food contact surfaces when using the
antimicrobial treatment or process?
Alternative 2
Ø
The sanitation program must:
l
Test food contact surfaces in
the post-lethality processing environment
l
Indicate the frequency of
testing
l
Identify the size and location
of the sites to be sampled
l
Include an explanation of why
the testing frequency is sufficient to ensure the effective control of Lm
or its indicator organisms
l
An establishment must implement
a hold-and-test procedure for a positive test for Lm or its indicator
organism
Alternative 1
Ø
Establishments that choose
Alternative 1 will likely be subject to less agency sampling than establishments
that choose either Alternative 2 or 3.
Ø
Alternative 1 would likely be
subject to less testing because the risk of contamination in the finished
product by Lm decreases from Alternative 2 to 1, based on the control
methods used by the establishment.
Alternative 1
Ø
An establishment that chooses to utilize Alternative 1 in
processing its product must apply both:
l
A post-lethality treatment; AND
l
An antimicrobial agent or process that controls the growth of
Lm
Alternative 1
Ø
For the post-lethality treatment, the establishment must:
l
Include a CCP for the treatment in its HACCP plan that has been
validated for effectiveness per 417.4 of the regulations
Ø
For the antimicrobial agent or process, the establishment must:
l
Include the treatment in its HACCP plan, SSOP, or other
prerequisite program
Alternatives 1 & 2
Ø
Examples of post-lethality treatments
l
Steam/Hot water Pasteurization
l
Pre-Package/Post-Package Surface Pasteurization
l
High Hydrostatic Pressure Processing
l
Ozone
l
Pulse electrical field
l
Organic acids
Post-Lethality Treatment
Workshop Discussion
Post-Lethality Treatment
Ø
Post-lethality treatment that may be used by small/very small
plants.
l
Can anyone provide an example that may be used or that you are
using in your establishment?
(e.g., Hot water pasteurization)
Post-Lethality Treatment
Ø
Example, when evaluating a post package product pasteurization
process using hot water in a product heating vat
l
What are the important factors to control and monitor for this
treatment?
(e.g., product surface time/temperature profile)
Alternatives 1 & 2
Ø
Validation of the
post-lethality treatment
l
Specifying and confirming the reduction level achieved by the
treatment should be a part of the validation.
l
Points to consider during validation:
–
The post-lethality treatment
must be sufficient to eliminate the levels of Lm contamination that may
occur.
–
Products, treatments, or other
variables that are used in the establishments’
process should be the same as those used in the published literature, or the
treatment should be validated for the plant’s
specific conditions and product characteristics.
Alternatives 1 & 2
Ø
Examples of Outreach Contacts
and Resources:
l
University professors
l
University/USDA Extension
Service
l
Meat and Poultry Associations
l
University/Public Libraries
l
Agricultural Research Service (ARS)
Scientists
l
International HACCP Alliance
l
Equipment Manufacturers
l
Enforcement Regulatory &
Analysis Officers (ERAO) (CSO’s)
l
Company supplying antimicrobial
agents/processes
l
Strategic Initiatives,
Partnerships and Outreach (SIPO) Staff (FSIS)
l
FSIS Compliance Guidelines
Alternative 1 & 2
Ø
The effectiveness of the post-lethality treatment should be
verified by testing for Lm
l
Points to consider:
– Plant data
must verify the elimination or reduction of Lm
–
Establishment documentation must support the verification procedures selected
and the frequency of those procedures
Alternatives 1 & 2
Ø
Examples of antimicrobial agents and processes
l
Addition of lactates and diacetates to meat formulations
l
Growth inhibitor packaging
l
Lethality treatment and antimicrobial process that renders RTE
product shelf stable (e.g., beef jerky)
l
Freezing during shelf life of RTE product
Antimicrobial Agents and Processes
Workshop Discussion
Antimicrobial Agent or Process
Ø
Antimicrobial agents or processes that may be used by
small/very small plants
l
Can anyone provide an example, other than sodium lactate or
freezing, that may be used or that you are using in your establishment?
Antimicrobial Agent or Process
Ø
For example, when evaluating a process that renders a RTE
product shelf stable
l
The important factors to control and monitor this treatment.
– Water
activity
– pH
Alternatives 1 & 2
Ø
Validation of the antimicrobial
agent or process
l
As a part of their validation,
the plant should have documentation to demonstrate that the antimicrobial agent
or process, as used, is effective in suppressing or limiting the growth of Lm
–
For example, the plant should
be able to support the reduction levels of the pathogen that the antimicrobial
agent or process can achieve, or to what growth suppression level, and length
of time in days that the antimicrobial agent or process is effective
l
Points to consider during
validation:
–
Documentation must support the
use of the particular antimicrobial agent or process
Alternatives 1 & 2
Ø
The effectiveness of the antimicrobial agent or process should
be verified by testing for Lm
l
Points to consider:
– Plant data
must show that the growth of Lm is either suppressed or limited
–
Establishment documentation must support the verification procedures selected
and the frequency of those procedures
CONCLUSION
A General Session For Questions and
Answers Will Convene In 15 Minutes