Compliance and regulatory requirements for the meat and poultry ...

Listeria - compliance and
regulatory requirements for the
meat and poultry industries
David Miles
Senior Technical Officer
Dealing with Listeria
in the processed meat
& poultry industries
8 July 2010

Regulatory approach to control of
Listeria monocytogenes
• Risk assessment – basing regulation on science
– FDA/USDA
– FAO/WHO
• Risk management - Australian regulations
– Food Standards Code
– Guidelines
• Risk management – meat industry specific requirements
– Listeria management program
• Risk communication
– Advice to pregnant women
• Codex – microbiological criteria in RTE foods

Science-based regulation
• International risk assessments have examined the public
health risk from Listeria monocytogenes in great depth
• FDA/USDA risk assessment (2003)
– examined 23 ready-to-eat (RTE) foods
– consumption data and prevalence data were combined
with the potential for the food to support the growth of the
organism
– foods were ranked according to:
• risk per serving
• risk per annum

Deli meats were ranked
as the highest risk food,
estimated to cause over
1500 (90% of total)
listeriosis cases in the
USA each year
Dry/semi dry fermented
sausages were ranked
as one of the lowest risk
food - estimated to
cause less than one
case of listeriosis every
10 years

International risk assessments
• FAO/WHO (2004) - Risk assessment of Listeria
monocytogenes in ready-to-eat (RTE) foods was developed to
answer three specific questions:
1. Estimate the risk of illness in food when the number of
organisms ranges from ND - 1000 cfu/g, or does not exceed
specified levels at the point of consumption
2. Estimate the risk of illness in different susceptible population
groups (elderly, infants, pregnant women and
immunocompromised patients) relative to the general
population
3. Estimate the risk of illness in foods that support its growth and
foods that do not support its growth at specific storage and
shelf-life conditions.

Q3 - Estimate the risk of illness in foods that support its growth
and foods that do not support its growth at specific
storage and shelf-life conditions.
Risk estimates of the risk per serving for 4 RTE foods and estimated number of
illness per 100 million people per year
Food
Milk
Cases of listeriosis per
1 million serves
0.005
Cases of listeriosis per
10 million people per year
9.1
Ice cream
0.000014
0.012
Smoked fish
0.021
0.46
Fermented meats
0.0000025
0.00066

Q2 - Estimate the risk of illness for consumers in
different susceptible population groups
Relative susceptibilities for different sub-population groups (based on French data)
Condition
Relative susceptibility
Transplant
2584
Cancer-blood
1364
AIDS
865
Dialysis
476
Cancer-pulmonary
229
Cancer-gastrointestinal and liver
211
Non-cancer liver disease
143
Cancer-bladder and prostrate
112
Cancer-gynaecological
66
Diabetes, insulin dependent
30
Diabetes, non-insulin dependent
25
Alcoholism
18
Over 65 years old
7.5
Less than 65 years old, no other condition
1

Q1 - Estimate the risk of illness in food when the number of
organisms ranges from ND - 1000 cfu/g, or does not exceed
specified levels at the point of consumption
• Nearly all cases of listeriosis result from the consumption of high
numbers of the pathogen
• Vast majority of listeriosis cases associated with the consumption of
foods not meeting current standards for Listeria monocytogenes in
foods, whether that standard is zero tolerance or 100 cfu/g
• Control measures that reduce the frequency and levels of
contamination will have a proportional reduction in the rates of illness

Food Standards Code
• Standard 4.2.2 - Primary Production and Processing Standard for
Poultry Meat (to commence on 20 May 2012)
A poultry processor must
1. systematically examine all of its processing operations to identify
potential hazards and implement control measures to address those
hazards.
2. have evidence to show that a systematic examination has been
undertaken and that control measures for those identified hazards
have been implemented.
3. must verify the effectiveness of the control measures.
4. operate according to a food safety management statement that sets
out how the requirements are being complied with.
Standard 4.2.3 – Primary Production and Processing Standard for Meat and meat
products currently under development

Australia New Zealand Food Standards Code
Standard 1.6.1 - Microbiological Limits for Foods
• Lists the maximum permissible levels of microorganisms
in certain foods at any stage of their manufacture or sale
• Mandatory microbiological standards set where:
– risk assessment has shown that the risk of foodborne
illness associated with the consumption of certain foods
is relatively high; and
– that a standard could contribute to the management of
the identified risk.

Standard 1.6.1 – limits for Listeria
Meat products
Food
Microorganism
n
c
m
M
Packaged cooked cured/salted meat
Listeria monocytogenes/25g
5
0
0
Packaged heat treated meat paste and
Listeria monocytogenes/25g
5
0
0
packaged heat treated meat pâté
n = minimum number of sample units to be tested
m = the acceptable microbiological level in a sample unit
c = maximum allowable number of defective units
M = is the level, if exceeded, that would cause the
lot to be rejected

Packaged cooked cured/salted meat
• FSANZ user guide states “Cooked cured and cooked
salted meat products include meats such as ham, bacon
and emulsion-style sausages (e.g. frankfurters)”
• Some products may have natural or liquid smoke applied
to them.
• The standards apply to packaged product as
contamination of unpackaged product can occur as a
result of poor handling and this should not be mistakenly
attributed to the manufacturing process.

Standard 1.6.1 – limits for Listeria
Food
Microorganism
n
c
m
M
Packaged cooked cured/salted meat
Listeria monocytogenes/25g
5
0
0
Packaged heat treated meat paste and
Listeria monocytogenes/25g
5
0
0
packaged heat treated meat pâté
n = minimum number of sample units to be tested
m = the acceptable microbiological level in a sample unit
c = maximum allowable number of defective units
M = is the level, if exceeded, that would cause the
lot to be rejected

Packaged heat-treated meat paste and
packaged heat-treated pâté
• Meat paste and pâté (including terrine) include all spreads
made from a variety of meats and poultry, which may be
flavoured with herbs, spices, nuts, fruits or alcohol. Fishbased
paste or pâté is not covered by this standard.
• The standards apply to packaged product, as
contamination of unpackaged product can occur as a
result of poor handling. This should not be mistakenly
attributed to the manufacturing process.

What about foods not listed in Standard 1.6.1?
• The absence of microbiological standards for other foods has been a
problem for State and Territory food regulators when confronted with the
isolation of Listeria monocytogenes……
what is the risk to the consumer??
• FSANZ has also developed advisory microbiological guidelines for various
foods that are additional to the standard:
• User guide to Standard 1.6.1 – Microbiological limits for foods with
additional guideline criteria
• Guidelines for the microbiological examination of ready-to-eat foods
• Recall guidelines for packaged ready-to-eat food found to contain
Listeria monocytogenes at point of sale

Microbiological guidelines
• Listeria monocytogenes may on occasion be found in a wide variety of
packaged foods sampled at the retail level for which there are no standards
or guidelines in Standard 1.6.1.
• Additional microbiological guideline criteria
• Applicable where a standard is not justified based on risk and
occurrence
• These guideline criteria are intended to complement other riskmanagement
strategies undertaken by government and industry
– (e.g. Food Safety Program, GMP, GHP)
• Exceedance of the guideline levels generally indicates a failure in the food
production process or hygiene procedures.
• Action should be taken to identify and remedy the problem.

Microbiological guidelines
• Provide industry and government with information on
benchmark levels to assist with interpreting results
• The maximum levels of microorganisms specified apply at
any point in the shelf life of a product, from manufacture to
retail.
• If exceeded, investigation recommended and action take to
remedy the problem
• While guidelines are not legally enforceable the Food Act
requires all food to be safe and suitable for human
consumption.

Guidelines for the microbiological examination of ready-to-eat foods
Listeria monocytogenes
Standard Plate Count
Test Satisfactory Marginal Unsatisfactory
not detected in 25g
detected but

Recall guidelines for packaged RTE foods found
to contain L.monocytogenes at point of sale
• Recall guidelines prepared by FSANZ in 2001 to assist State and
Territory food regulatory authorities determine when the
presence/level of Listeria monocytogenes in packaged RTE foods
presents a risk to public health.
• In the past, the detection of L. monocytogenes in any food product
would often lead to a recall without any evaluation of the actual risk
• Similar guidelines exist in the UK, Canada, Denmark and the EU.
• These guidelines have been developed specifically for use for
packaged product at retail level.

Recall guidelines for packaged RTE foods
• A concentration of L. monocytogenes

Recall guidelines for packaged RTE foods
• Food processed correctly and protected from contamination after
processing should normally be able to comply with a not detected in 25g
criterion.
• The presence of L. monocytogenes in products produced by a process
which is capable of achieving a Listeria-free product may indicate that
the process is not totally under control (i.e. an indication of either
inadequate processing or post-process contamination that should be
investigated by the manufacturer)
• Manufacturers must still strive for nil tolerance in their packaged
ready-to-eat products.

Foods where a Listeria tolerance may apply
• For a food to be truly considered as not allowing the
growth of Listeria monocytogenes, it would have to be:
• held below -1°C; or
• have a pH less than 4.5; or
• a water activity of 0.92; or
• be demonstrated through reliable scientific evidence:
– challenge tests
– changed formulations to inhibit growth
– organic acids or other chemicals that exhibit inhibitory activity
(e.g. nisin)
– predictive modelling

Specific industry requirements
• The NSW Food Authority may require additional testing to
that specified in the Food Standards Code, as a condition
of licence
• This normally applies to those foods that have been
identified as “high risk”

Testing and notification of results
Analysis of samples
• Must be carried out in a laboratory approved by:
– the National Association of Testing Authorities (NATA - www.nata.asn.au) or
– the NSW Food Authority (www.foodauthority.nsw.gov.au )
Reporting of failures
• The Authority must be notified if any sample analysed
fails to meet the standard
– orally within 24 hours after the licence holder becomes aware of the results
of the analysis (eg by phone), and
– in writing within 7 days after becoming aware of the result of analysis (eg by
fax, email, letter).

Food Safety Schemes Manual testing
requirements
Licensed meat businesses must comply with the sampling and analyses provisions of
the Meat food safety scheme of Food Regulation 2010
Product to be tested
Test
Limit
Frequency
RTE meat and poultry
Listeria monocytogenes
Not detected
/25g
Every 10 batches
Sliced or whole packaged
RTE meat products
Listeria monocytogenes
Not detected
/25g
Every 10 batches
Environmental and work surfaces
testing for Listeria spp.
No detection
Every month
(5 samples collected pre and post
operations)
Whole packaged RTE
meat product that
receives a post pack
pasteurisation step
Listeria monocytogenes
Not detected
/25g
Every 10 batches

Moving to a preventative approach
Zone 1 sites are those that are typically contaminated with L. monocytogenes
contamination
Zone 2 sites are those that can harbour Listeria in a RTE processing environment.
Samples shall be taken from Zone 1 and Zone 2 surfaces.

Zero tolerance vs 100 cfu/g as a safe level
• Dose response still not clearly defined - Infectious dose remains
problematic
• susceptibility of individuals
• variation in strain virulence
• Current data suggest that greater than 1000 cfu/g may be needed to
cause listeriosis
• Epidemiology of disease is changing
• > numbers elderly with underlying medical conditions
• more sporadic cases, not large outbreaks

Risk communication

Codex - – microbiological criteria in RTE foods
• In 2007 Codex published the:
• Guidelines on the application of general principles of food hygiene to the
control of Listeria monocytogenes in ready-to-eat foods (CAC/GL 61-
2007)
• Since then, in 2009 an annex was released on Microbiological criteria for
Listeria monocytogenes in ready-to-eat foods

Codex …
• Because different types of food present different risks from
Listeria monocytogenes, different microbiological criteria can
be applied for the following categories of foods:
(a) ready-to-eat foods in which growth of L. monocytogenes will not
occur, and
(b) ready-to-eat foods in which growth of L. monocytogenes can occur.
• Align with existing policies around the world.

When is growth….not growth?
• To define a product in which growth of L. monocytogenes
can occur.
• “A ready-to-eat food in which there is greater than an
average of 0.5 log cfu/g increase in L. monocytogenes
levels for at least the expected shelf life under reasonably
foreseeable conditions of distribution, storage and use”
Practical issues to resolve
• “Plus a safety margin” – what is a realistic safety margin?
• Is the cold chain always at 5°C ?
• How do we evaluate if L. monocytogenes can grow or not?

How to demonstrate?
• Ready-to-eat foods in which growth of L. monocytogenes will not occur
would be determined based on scientific justification , including the
inherent variability of factors controlling L. monocytogenes in the
product. Factors such as pH, aw, are useful in preventing growth.
• For example, L. monocytogenes growth can be controlled in foods that
have:
– a pH below 4.4,
– a water activity < 0.92,
– a combination of factors (pH, aw ,), e.g. the combination of pH < 5.0
with aw < 0.94,
– are stored frozen,
– or other interactive factors (preservatives etc.)

Codex standards
Point of application
Microorganism
n
c
m
M
Microbiological criterion for ready-to-eat foods in which growth of L. monocytogenes will not occur
Ready-to-eat foods from the end of
manufacture or port of entry (for
imported products), to the point of
sale
Listeria
monocytogenes
5
0
100 cfu/g
Microbiological criterion for ready-to-eat foods in which growth of L. monocytogenes can occur
Ready-to-eat foods from the end of
manufacture or port of entry (for
imported products), to the point of
sale
Listeria
monocytogenes
5
0
Absence in
25g (

In summary – Australian requirements
• Food Standards Code
– Primary production and processing standards
– Nil tolerance in product
• Recall guidelines
– Up to 100 cfu/g in product that does not support the growth
– Not detected in product prepared for ‘at risk’ groups
• Listeria management plan
– Product / environmental testing
– Food service to vulnerable persons