BrackettPresentation11 25 05

The Role of Microbiological Testing and Microbiological Criteria in an Evolving Regulatory Environment
International Commission on Microbiological Standards for Foods Washington, D.C.

October October 31, 31, 2005 2005
Robert Robert E. E. Brackett, Brackett, Ph.D. Ph.D. Director, Director, Center Center for for Food Food Safety Safety and and Applied Applied Nutrition Nutrition Food Food and and Drug Drug Administration Administration
Microbial Testing
Why test? Safety of batches Investigational sampling Surveillance Process control Quality control/assurance
Microbial Testing
Why test? Safety of batches Investigational sampling Surveillance Process control Quality control/assurance
The Poison Squad
Microbial Testing
Microbiological testing is almost always an important component of any integrated program to assure the safety of foods
Testing for Safety

Detection and identification
Testing for Safety

Traditional Plating
Traditional Microbiological Plating
Plating on Sorbitol-MacConkey
K-12
Strain 868
Traditional Microbiological Plating
Plating on MUG for -glucuronidase
Testing for Safety

Traditional Plating Rapid Tests
Miniaturized tests Gene probes Enzyme-linked immunosorbant assays (ELISA) Polymerase Chain Reaction (PCR) Biosensors
Sample
Biologically sensitive coating
Sensor
Transducer
Output
Testing for Safety

Detection and identification Enumeration
Most probable number (MPN) Plate counts Instrumental methods
Flow cytometry
RT-Polymerized Chain Reaction (RTPCR)
What does the count mean?
Probability density
0.5 0.4 0.3 0.2 0.1 0.0 1 2 3 4 5 6 7
Mean Log cfu/g
Testing for Safety

Detection and identification Enumeration Attribution
Gram stain Morphology Biochemical tests Immunological
Serotyping Serotyping ELISA ELISA
Molecular
Pulse Pulse field field gel gel electrophoresis electrophoresis Multilocus Multilocus sequence sequence typing typing Cladistic Cladistic analysis analysis
Outbreak Response:
S. Agona in Cereal
Bacteria from the food and patients were the same Matched using DNA finger print, which is read like a bar code (PulseNet)
Patient Food Different Salmonella
Microbiological Criteria
What are Criteria?

Criterion
Standard: Must meet, regulatory requirement Guideline: Should meet, GHP Specification: Expected to meet, generally used to describe an agreement between a supplier and a purchaser
Indicator organisms
Examples of Microbiological Criteria

Presence or populations of organism statistically associated with a pathogen
Coliforms, fecal coliforms, E. coli
Indicator organisms Target pathogens

None detected
Zero Tolerance
Examples of Microbiological Criteria
Attribute estimate (e.g. X positive samples in Y total samples) Point value limit (e.g. 100 cfu/g)
Bright Shining Line
10
Do the criteria have ANY theoretical or demonstrable relationship to public health?
Do the criteria have ANY theoretical or demonstrable relationship to public health? What qualitative or quantitative values best assure the safety of foods?
11
What does the count mean?
Probability density
0.5 0.4 0.3 0.2 0.1 0.0 1 2 3 4 5 6 7
Mean Log cfu/g
Perceived Prediction of Safety
UNSAFE
SAFE
12
Realistic Estimation of Safety UNSAFE Less Safe Safer SAFE
Defining Question
How Does One Choose the Right Value?
13
Changes in Philosophy to Assure Safe Foods

Microbiological Testing for Safety
Changes in Philosophy to Assure Safe Foods

Microbiological Testing for Safety Preventative Controls
14
Preventative Controls
Good Manufacturing/Agricultural Practices
Minimum practices to reasonably assure sanitation, etc. Foundation for HACCP
Preventative Controls
Good Manufacturing Principals Hazard Analysis Critical Control Points (HACCP)
Focuses on identifying and preventing hazards from contaminating food Based on sound science Permits more efficient and effective government oversight, Places responsibility for ensuring food safety appropriately on the food manufacturer or distributor Reduces barriers to international trade.
15
Changes in Philosophy
Microbiological Testing for Safety Preventative Controls Outcome Based Food Safety
National Public Health Goals
16
National Public Health Goals Risk Management Framework
Risk Management
It is all about making decisions
Have to establish the level of protection deemed appropriate to safeguard the public That level is both a scientific and a societal decision Risk assessment is making it possible to link control measure to pubic health impact
17
Risk Management Concept

The degree of regulatory control placed on a pathogenfood pair should be a function of the risk to public health
Outcome Based Food Safety

Quantitative Risk Assessments
Salmonella Enteritidis in Shell Eggs (USDA/FDA) Listeria monocytogenes in Ready-toEat Foods (FDA/USDA, WHO) Vibrio vulnificus in molluscan shellfish (FDA) Vibrio parahaemolyticus in seafood (FDA)
18
Impact of Risk Analysis Framework

Being able to better link food safety activities to public health outcomes via risk assessments has allowed:
New concepts to be considered
Food Safety Objective (FSO) Appropriate Level of Protection (ALOP) Performance Objective (PO)
Food Safety Objective

An FSO can be viewed an a bright shining line By definition Below is safe Above is not safe PO is the equivalent at a specified point earlier in the food chain
19
Impact of Risk Analysis Framework

Being able to better link food safety activities to public health outcomes via risk assessments has allowed:
New concepts to be considered Old concepts to be put on a more scientific basis
Performance criteria Process criteria Product criteria Microbiological criteria
The Evolving Regulatory Environment
20
The Evolving Regulatory Environment

Massive and Revolutionary changes are occurring which affect Regulatory Policy
Change #1
21
Past Philosophy
Command and control
Pasteurized Milk Ordinance (PMO) 1924 Low-Acid Canned Foods 1973, 1979 Acidified Foods 1979 Infant Formula Quality Control Procedures - 1982 Current Good Manufacturing Practice - 1986
New Philosophy
End results
Preventative technologies Food Safety Objectives
22
New Philosophy
Performance standards
Focusing less on how outcomes are achieve Focusing more on IS the outcome achieved
If the food safe?
New Philosophy
Creativity on the part of the industry
Take risks in developing new technologies Providing the scientific rationale and data for new processes
Importance of microbiological testing
23
Change #2
Changes in Knowledge
Genetics
24
Reference Strain Collection
History of Microbial Identification

Detection at Genus Level
25

Detection at Genus Level Detection at Species Level

Detection at Genus Level Detection at Species Level Detection at Subspecies Level
26

Detection at Genus Level Detection at Species Level Detection at Subspecies Level Detection at Serotype or Serovar Level

Detection at Genus Level Detection at Species Level Detection at Subspecies Level Detection at Serotype or Serovar Level Detection at Molecular Level
27
Genetics Pathogenicity/Virulence
Identification of virulence factors Role of extrachromosomal elements
Plasmids
What turns virulence genes off or on

Quorum sensing
Genetics Pathogenicity/Virulence Ecology
28
Attachment and Survival of E. coli O157:H7 on Cut Lettuce
Internalization of Pathogens
29
30
Genetics Pathogenicity/Virulence Ecology
Growth and Survival in Extreme Environments

Microbial adaptation and change
Unrestricted use of antibiotics Resistance to food processing technologies Acid, redox potential, sanitizer, preservative adaptation
Genetics Pathogenicity/Virulence Ecology Growth and Survival in Extreme Environments
New Foodborne Pathogens

New, more virulent strains
E. coli O157:H7, S. Typhimurium DT104, S. Enteritidis PT2
31
Emergence of Foodborne Pathogens
1942
Staphylococcus aureus Salmonella Clostridium botulinum Streptococci
32
Emergence of Foodborne Pathogens

Campylobacter jejuni Clostridium botulinum (infant) E. coli 0157:H7 Listeria monocytogenes Salmonella Enteritidis Vibrio cholerae (Latin America) Vibrio vulnificus Yersinia enterocolita Enterobacter sakazakii Norwalk and Norwalklike viruses Rotavirus Cryptosporidium parvum Giardia lamblia Toxoplasma gondii Bovine spongiform encephalopathy prion
New or Non-traditional Foods Associated With Recent Outbreaks

Mangos Puffer fish Almonds Potatoes Soft cheese Mamey Infant formula Dry Cereal Seed/bean sprouts Eggs Salsa Bean dip Cantaloupe Fruit juices Berries
33
Change #3
Changes in Society
Changes in Society
Technology
34
Changes in Society
Technology
Processing technology
Aseptic High pressure
Transportation
Air freight Refrigerated/MA trucking
Packaging
Extended shelf-life
Changes in Society
Technology Human Demographics and Behavior
35
Changes in Society
Technology Human Demographics and Behavior
Age Increased reliance on medicines Purchasing and eating habits Migrations to urban centers
Changes in Society
Consumers are eating different foods
36
Changes in Society
20%-25% of the Population is At Risk
Changes in Society
More Food Prepared Outside the Home
37
Changes in the U.S. Population

17% of population is 60 or older
4% of the population is 80 or older
64% of the adult population is overweight 5% of infants and young children and 2% of adults have food allergies 44% of the non-institutionalized population reports taking one or more prescription medications during the last month
Changes in Society
Technology Demographics Travel and Tourism
38
Global Travel
International travel is a at an all time high and is expected to increase
Business Tourism
Travelers will be exposed to new types of organisms

E.g. Cyclosporiasis
Once rare illnesses could become endemic in home country
Forecast of Inbound Travel to U.S.

48 48 46 46
Arrivals (millions)
44 44 42 42 40 40 38 38 36 36
2003 2003
2004 2004
2005 2005
2006 2006
Travel Year
39
Changes in Society
Technology Demographics Travel Business
International trade Economic development and land use
Consolidation of production and processing facilities
Changes in Society
More Food Now Comes From Distant Places
40
Imported Food Line Entries

Food Import Line Entries
14,000,000 12,000,000 10,000,000 8,000,000 6,000,000 4,000,000 2,000,000 0
20 04 20 06 * 19 90 19 96 19 98 19 92 19 94 20 00 20 02
*Estimates (2005 and 2006)
Year
Changes in Society
Technology Demographics Travel Business
International trade Economic development and land use
Consolidation of production and processing facilities
41
Future Trends Affecting the Regulatory Environment?
Future Trends
Enhanced role of epidemiology
Role of traditional microbiological testing?
42
Future Trends
Enhanced role of epidemiology Better attribution
Use of molecular biology to match outbreak strains to facility/line Identification of hot strains
Future Trends
Enhanced role of epidemiology Better attribution
Importance of International Agreements
NAFTA-North America Free Trade Agreement GATT-General Agreements on Tariffs and Trade
SPS-Sanitary and Phytosanitary Measures Provisions
43
Global Trade
Harmonization
International Standards and Regulations Methods of Analysis Codex Alimentarius Commission
Standardizing body
Global Trade
Harmonization Increased importance of International Scientific Bodies Joint Expert Committee on Food Additives (JECFA) Joint Expert Meetings on Microbiological Risk Assessment (JEMRA)
44
Summary
Microbiological Testing will Continue to be a Fundamental Regulatory Tool Scientific and Social Changes will Impact the Role of Microbiological Testing
Changes in philosophy Changes in knowledge Changes in society
Both Technology and the Regulatory Environment will change in response
45

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The Role of Microbiological Testing and Microbiological Criteria in an Evolving Regulatory Environment

International Commission on Microbiological Standards for Foods Washington, D.C.

The Poison Squad

Testing for Safety

Testing for Safety

Traditional Microbiological Plating

Traditional Microbiological Plating

Plating on MUG for -glucuronidase

Testing for Safety

Testing for Safety

RT-Polymerized Chain Reaction (RTPCR)

What does the count mean?

0.5 0.4 0.3 0.2 0.1 0.0 1 2 3 4 5 6 7

Mean Log cfu/g

Testing for Safety

Patient Food Different Salmonella

What are Criteria?

Examples of Microbiological Criteria

Indicator organisms Target pathogens

Examples of Microbiological Criteria

What does the count mean?

0.5 0.4 0.3 0.2 0.1 0.0 1 2 3 4 5 6 7

Mean Log cfu/g

Perceived Prediction of Safety

Realistic Estimation of Safety UNSAFE Less Safe Safer SAFE

Changes in Philosophy to Assure Safe Foods

Changes in Philosophy to Assure Safe Foods

Risk Management Concept

Outcome Based Food Safety

Impact of Risk Analysis Framework

Food Safety Objective

Impact of Risk Analysis Framework

The Evolving Regulatory Environment

The Evolving Regulatory Environment

Reference Strain Collection

History of Microbial Identification

History of Microbial Identification

History of Microbial Identification

History of Microbial Identification

History of Microbial Identification

What turns virulence genes off or on

Attachment and Survival of E. coli O157:H7 on Cut Lettuce

Growth and Survival in Extreme Environments

New Foodborne Pathogens

Emergence of Foodborne Pathogens

Emergence of Foodborne Pathogens

New or Non-traditional Foods Associated With Recent Outbreaks

Changes in the U.S. Population

Travelers will be exposed to new types of organisms

Once rare illnesses could become endemic in home country

Forecast of Inbound Travel to U.S.

Imported Food Line Entries

*Estimates (2005 and 2006)

Future Trends Affecting the Regulatory Environment?

Importance of International Agreements

Both Technology and the Regulatory Environment will change in response

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