raw milk cheese - Dairy Australia

Understanding the regulatory requirements
for manufacturing raw milk cheese in
Australia
Deon Mahoney
NCDE Webinar
16 June 2015
2
3
Raw milk cheese
Food Standards Australia New
Zealand (FSANZ) has reviewed
permissions in the Food
Standards Code to allow the
production and sale of raw milk
cheese
An amendment to Standard 4.2.4
was gazetted in February 2015
SLIDE 4
Standard 4.2.4: Definitions
raw milk means milk that has not been
processed in accordance with subclause
16(1), subclause 16(2) or paragraph
16(3)(a) of this Standard
raw milk cheese means a cheese or cheese
product made with raw milk
________
SLIDE 5
6
Where did this journey begin?
•
•
•
Uniform laws and standards applicable to food in
Australia came about through the National Food
Authority Act (1991)
The Act established the Authority with the purpose of
providing an Australia-wide system for setting national
food standards
The Food Standards Code (1987) was adopted as the
regulatory framework under each state and territory
Food Act
SLIDE 7
Regulation H9
The regulation resulted in some
imported cheeses unexpectedly
being excluded from the market
SLIDE 8
Swiss cheese
•
•
•
Swiss hard and semi-hard cheeses had been imported for
30+ years - no evidence of adverse public health impact
1994 - the National Food Authority advised AQIS (Australian
Quarantine and Inspection Service) that Swiss cheeses made
from raw milk did not represent a risk to public health and
safety by virtue of the heat treatment and long maturation
In October 1997, imports of Swiss cheeses were suspended
by AQIS following a review of quarantine requirements these cheeses were made from raw milk and did not comply
with the technical requirements of the Code
SLIDE 9
Application A357
•
•
Australia New Zealand Food Authority received an
application (A357) from the Swiss Federal Veterinary
Office on 24 March 1998 requesting a variation to
Standard H9 - Cheese and Cheese Products
The variation sought permission to use fresh milk that
has not been pasteurised or thermised in the making of
cheeses: Swiss Gruyère, Swiss Emmental, Swiss
Sbrinz, Swiss Appenzeller, Swiss Tilsiter, Vacherin
Fribourgeois, and Tete de Moine
SLIDE 10
Very hard cooked-curd cheese
•
•
•
Proposal P263 assessed the safety of very hard cheeses
(<36% moisture) made from raw milk to determine whether
the Code should be amended to allow their continued sale
Scientific evidence demonstrated that raw milk very hard
cheeses (<36% moisture, stored for 6+ months at no less
than 10 ºC and which have undergone a curd heat treatment
of no less than 48ºC) can achieve an equivalent level of
safety as cheeses using heat treated milk and do not pose
any significant public health and safety risk
The Code was amended to support the continued importation
of cheeses such as Grana Padano and Parmigiano
Reggiano, which have been imported into Australia for years
SLIDE 11
Proposal P499 – Roquefort cheese
•
•
•
•
2004 – Application received from French
Government to amend Standard 2.5.4 to
permit sale of Roquefort cheese
Scientific evaluation concluded Roquefort
manufactured according to submitted
regulatory and industry processes poses
a low risk to public health and safety
Verified by on-site verification
Standard 4.2.4a - Primary production and
processing standard for specific cheeses
was amended
SLIDE 12
PPP standard for dairy products
•
Proposal P296 (2004)
Primary production and processing standard for dairy
•
Proposal P1007 (2009)
Address issues in relation to production and sale of raw milk
products in Australia arising from inconsistent legislation currently
applying to domestic and imported dairy products, applications to
FSANZ to permit raw milk products, and any public health and
safety issues from consumption of raw milk products
•
Proposal P1022 (2012)
To consider permissions for the production and sale of approved
raw milk products
SLIDE 13
Other applications - 2004
•
•
Proposal P530
Proposal P531
Both applications are
still on the FSANZ
work plan
SLIDE 14
Food safety – why?
•
•
•
Assuring the safety and integrity of the food
supply is an important function in society –
community belief that government is
responsible for regulating food safety
Food standards place obligations on
Australian businesses to produce safe and
suitable food (including imports)
Regulation must be carefully designed so
as to not have unintended or distortionary
effects e.g. imposing unnecessary costs,
restricting consumer choice, or restricting
competition
SLIDE 15
Food Standards Code
15 Processing of milk and dairy products
(1) Milk must be pasteurised by –
(a) heating to a temperature of no less than
72°C and retaining at such temperature for
no less than 15 seconds; or
(b) heating, using any other time and
temperature combination of equivalent or
greater lethal effect on any pathogenic
microorganisms in the milk; or
(c) using any other process that provides an
equivalent or greater lethal effect on any
pathogenic microorganisms;
unless an applicable law of a State or Territory
otherwise expressly provides.
The sale of raw cow’s milk
for human consumption is
not permitted in Australia
SLIDE 16
Standard 4.2.4: Raw milk cheese
•
The amendment of Standard 4.2.4 has introduced
enhanced food safety requirements across:
• Primary production of milk
• Transport of milk
• Processing of milk
These requirements will need to be
addressed by improvements to licensees’
food safety programs, and will be the
subject of increased regulatory oversight
SLIDE 17
Safety of cheese
•
•
Pathogens most frequently associated with human
illness linked to the consumption of raw milk cheese:
•
Campylobacter spp.
•
Pathogenic Escherichia coli (STEC)
•
Listeria monocytogenes
•
Salmonella spp.
•
Staphylococcus aureus
Various extrinsic and intrinsic parameters affect their
growth and survival e.g. temperature, pH, water activity,
salt concentration, antimicrobial substances
SLIDE 18
Supporting documents
•
SD1 – Guide to the
requirements for raw milk
products in Standard 4.2.4
•
SD2 – Guide to the validation of
raw milk products
•
SD3 – Scientific information for
the assessment of raw milk
products – Cheeses
Provides explanation and information
on the additional requirements for raw
milk cheese in Standard 4.2.4
Available on
FSANZ website
SLIDE 19
Standard 4.2.4
Division 5 – Additional requirements for raw milk cheese
Subdivision 1 – General
17
Application of Divisions 1 to 4
Subdivision 2 – Primary production of milk for raw milk cheese
18
Application
19
Requirement for additional and specific control measures
20
Animal health requirements
21
Requirements for animal identification and tracing
22
Requirement to control specific inputs
23
Health and hygiene requirements
24
Requirement for milking practices
25
Requirements for cooling and storage
26
Requirements relating to non-conforming milk
Subdivision 3 – Transport of milk for raw milk cheese
27
Application
28
Requirement for additional and specific control measures
29
Requirements for temperature control
30
Handling requirements
Subdivision 4 – Processing of milk for raw milk cheese
31
Application
32
Requirement for additional and specific control measures
33
Requirements relating to milk receipt and storage
34
Requirements to control specific food safety hazards
35
Requirements relating to non-conforming milk
SLIDE 20
Standard 4.2.4: Requirements
Subdivision 2 – Primary production
of milk for raw milk cheese
18 Application
19 Requirement for additional and specific control
measures
20 Animal health requirements
21 Requirements for animal identification and
tracing
22 Requirement to control specific inputs
23 Health and hygiene requirements
24 Requirement for milking practices
25 Requirements for cooling and storage
20 Animal health requirements
(1) Milk for raw milk cheese must not be
obtained from a diseased animal.
(2) A diseased animal must not be
introduced into a raw milk herd.
(3) A diseased animal in a raw milk herd
must be –
(a) separated immediately from the
herd; and
(b) kept separate from any other
animal that will be milked for milk
for raw milk cheese.
24 Milking practices
(1) The teats of an animal milked for milk
for raw milk products must be clean and
dry before the animal is milked.
26 Requirements relating to non-conforming milk
SLIDE 21
Standard 4.2.4: Guidance
20 Animal health requirements
(1)
(2)
(3)
Milk for raw milk cheese must not be obtained from a diseased animal.
A diseased animal must not be introduced into a raw milk herd.
A diseased animal in a raw milk herd must be –
(a)
separated immediately from the herd; and
(b)
kept separate from any other animal that will be milked for milk for raw milk
cheese.
•
•
•
Significant animal health issues should be
advised to the enforcement agency and the
business to which the milk is being supplied
Written records of animal health issues,
veterinary visits (e.g. diary, computer, cow
records) and veterinary reports should be
filed as part of the food safety program
records. It would be expected that animals in
the milking herd would be subjected to a
veterinary inspection at least annually
Recommended monitoring criteria
SLIDE 22
Monitoring raw milk
Test
Acceptable limit
General health and quality: Weekly
Somatic cell count* 200,000 cells/ml for bovines
TPC (30°C/72 hr)
E. coli
1,000,000 cells/ml other species
25,000 cfu/ml
<10 cfu/ml
Pathogen monitoring: Routine testing
S. aureus
<100 cfu/ml
Salmonella spp.
Not detected in 25ml
L. monocytogenes
Not detected in 25ml
Corrective actions
Exceed limit – need
investigation to verify
hygiene measures.
Cessation may result if limit
routinely exceeded
Any test failure for
pathogens should result in
cessation of supply for raw
milk product manufacture.
SLIDE 23
Moving window – raw milk quality
BMCC:
TPC:
E. coli count:
S. aureus count:
TPC/ml
n=5, c=1, m=200,000, M=400,000
n=5, c=1, m=25,000, M=50,000
n=5, c=1, m=10,
M=100
n=5, c=1, m=100,
M=1,000
MOVING WINDOW FOR TOTAL
PLATE COUNT
35,000
Five consecutive TPC compared.
No sample may exceed 50,000;
one sample between 25,000-50,000.
At any point along the moving
window, four or more samples must
be less than 25,000 cells/ml.
30,000
30,000
28,000
25,000
23,000
20,000
20,000
18,000
3rd moving window - fail criteria
15,000
11,000
10,000
8,000
2nd moving window – achieve criteria
5,000
1st moving window – achieve criteria
0
1
2
3
4
5
6
7
8
9
10
Testing period
SLIDE 24
Standard 4.2.4
Division 5 – Additional requirements for raw milk cheese
Subdivision 1 – General
17
Application of Divisions 1 to 4
Subdivision 2 – Primary production of milk for raw milk cheese
18
Application
19
Requirement for additional and specific control measures
20
Animal health requirements
21
Requirements for animal identification and tracing
22
Requirement to control specific inputs
23
Health and hygiene requirements
24
Requirement for milking practices
25
Requirements for cooling and storage
26
Requirements relating to non-conforming milk
Subdivision 3 – Transport of milk for raw milk cheese
27
Application
28
Requirement for additional and specific control measures
29
Requirements for temperature control
30
Handling requirements
Subdivision 4 – Processing of milk for raw milk cheese
31
Application
32
Requirement for additional and specific control measures
33
Requirements relating to milk receipt and storage
34
Requirements to control specific food safety hazards
35
Requirements relating to non-conforming milk
SLIDE 25
Standard 4.2.4: Raw milk cheese
•
Cheese must be produced using a process
where the combination of control measures
ensures:
•
there is no net increase in pathogenic
microorganisms that may have been present in
the raw milk
and
•
•
Referred to
as qualifying
criteria
the final product cannot support the growth of
pathogenic microorganism (no growth)
Specific control measures must be outlined
in the Food Safety Program
SLIDE 26
Requirements for manufacturers
32
Requirement for additional and specific control
measures
The documented food safety program required by clause
13 must include control measures that –
(a) ensure that the requirements of this subdivision are met; and
(b) address each of the following in relation to processing –
(i)
starter culture activity;
(ii) pH reduction;
(iii) salt concentration and moisture content;
(iv) storage time; and
(v) storage temperature.
SLIDE 27
State dairy regulators
•
Implementation arrangements:
• farmers supplying milk for raw milk cheese manufacture become
a high-risk part of the supply chain
• need for enhanced food safety programs – raw milk producer,
transporter, and cheese manufacturer
• potential for higher frequency of audits and more stringent
regulatory oversight – especially during start-up phase
• achieving consistency when evaluating qualifying criteria
•
•
Developing checklists
Drafting decision trees to assess qualifying criteria
SLIDE 28
Decision tree – no growth criteria



Two separate decision trees
have been developed:
1. No growth criteria
2. No net increase in pathogens
during cheese making
SLIDE 29
Augustin model – no growth criteria
Probability of growth of Listeria
monocytogenes at 10C
Cheese water
activity (aw)
Cheese pH
High probability of growth
Low probability of growth
SLIDE 30
Augustin model – no growth criteria
At 10C
pH
aw
Cheese with pH 5.9 and water
activity of 0.96 has a 90%
probability of supporting the
growth of L. monocytogenes
SLIDE 31
Augustin model – no growth criteria
Cottage cheese:
pH 4.6-4.7
aw 0.99
At 10C
pH
aw
Cheddar cheese:
pH 5.1-5.3
aw 0.95
Camembert cheese:
pH 6.0-7.0
aw 0.97
SLIDE 32
Augustin model – no growth criteria
At 10C
Currently undertaking a project with the Food Safety Centre
(University of Tasmania) to develop a more comprehensive
decision support tool.
It will be completed within 6 months and made available on the
web for use by regulators and the dairy industry.
SLIDE 33
Decision tree – no net increase


Challenge of being able to control
cheese making conditions to
produce a cheese of consistent
quality
SLIDE 34
No net increase in pathogens
•
∑ Reduction + ∑ Increase ≤ 0
Incoming raw milk quality
•
Validation needs to consider:
•
the initial level of the hazard;
•
potential increases due to growth or
entrapment of pathogens during curd
formation;
•
reductions during acidification and
maturation/ripening; and
•
Opportunity for growth
during fermentation and
concentration at wheying-off
Understanding factors
affecting pathogen die off
the impact of the physico-chemical
characteristics of the cheese
SLIDE 35
Decision support tool
•
•
•
Purpose: determine if a defined cheese meets the
qualifying criteria
Structure: series of models
Users able to tap into different interfaces and input
data e.g. pH, time, temperature, lactate, etc.
Type of cheese
Family
Milk
BMCC, TPC, E.coli, L.
monocytogenes,
Salmonella, S.aureus
Storage and
transport
Time and temperature
Hold time
Heating for
fermentation
Time and temperature
(including curd cook)
Time at ~32C
Addition of starter
 temperature
Start and finish (rate)
Time before
moulding
Maturation time
Final cheese
characteristics
Fermentation
conditions
Time, pH, lactate
levels, temperature,
weight loss, [salt]
Time, temperature,
relative humidity
pH, water activity,
lactate level, other
SLIDE 36
Training and development
•
•
The challenge of manufacturing a safe raw milk
cheeses raises questions about how we train and
develop competent professionals in our industry
Do we have sufficient expertise and savvy in how to
safely make specialty cheeses using raw milk?
•
•
•
Opportunity to tap into international expertise and undertake
study tours
Access to formal/informal training programs
What more can we do to support our professionals
SLIDE 37
When is it a raw milk cheese?
raw milk means milk that has not been processed in accordance with
subclause 16(1), subclause 16(2) or paragraph 16(3)(a) of this
Standard.
raw milk cheese means a cheese or cheese product made with raw milk.
________
16 (3)
However, milk or dairy products used to make cheese or cheese products do not
need to be processed in accordance with subclauses 16(1) and 16(2) if the
cheese or cheese product is processed –
(a)
such that –
(i) the curd is heated to a temperature of no less than 48°C; and
(ii) the cheese or cheese product has a moisture content of less than
39%, after being stored at a temperature of no less than 10°C for a
period of no less than 120 days from the date of processing
SLIDE 38
What next?
•
•
DFSV will continue to develop information
and provide guidance for manufacturers
interested in making raw milk cheese
The challenge for manufacturers is to:
• understand the risks
• source raw milk of suitable safety/quality
• recognize and meet qualifying criteria
• consistently make cheese of the physicochemical properties that meet qualifying criteria
SLIDE 39
Links
•
•
•
DFSV statement
Food Standards Australia New Zealand (2015) –
Proposal P1022: Primary Production and Processing
Requirements for Raw Milk Products
Food Standards Australia New Zealand (2015) –
Standard 4.2.4
SLIDE 40
•Questions?
SLIDE 41