Food Safety And Plant Sanitation

1
Food Safety And Plant Sanitation

• Must have a risk based food safety system in
  place
  
• Programs should be aimed at anticipating and
  preventing issues
  

2
Key Messages

• The U.S. food supply is one of the safest in the
  world
  
• Recent outbreaks have caused loss of consumer
  confidence in food safety
  
• Legislative interest in food safety is high
• Increasing amount of imported foods adds
  complexity
  
• Changes in agencies, consumers and media
  highlight the need for a new approach to food
  protection
  
• Industry must place greater emphasis on prevention

3
New Challenges

• FDA faces increasing challenges and risks the
  nations food system
  
• Changes in consumer expectations
• Changes in farming, manufacturing and processing
• Shifting demographics
• Increased globalization
• Terrorism

4
Regulatory ChangesWhat has/is Changing ?

• Decade of significant regulatory change
• New Authorities
• New Regulations
• New collaboration between Agencies,
• States and between governments
• IT upgrade amplifying communication speed

5
Priorities of the FDA

• Modernization of the Food Safety Systems
• Imports
• Food Defense
• Enhancing and Up-grading Information Technology

6
Recent/Future FDA Modernization Changes

• FALCPA Implementation
• Revising GMPs first comment round completed
• Food Protection Plan
• Focus on best practice for fruits and vegetables
• Animal Feed Registration

7
Imports

• Melamine Issue
• Rising number of imports

8
Complexity of the Supply Chain
106 U.S. Hatcheries
Feed
Canadian Fish Feed Manufacturer
2 China Suppliers
Aquaculture Farms (2)
Poultry Farms
Slaughter House
Ingredients Meals
Feed Mill
Feed
3 Feed Ingredient Manufacturers
Hog Farms
Scraps
Scraps
5 U.S. Importers
Offal/Meat/Bone Meal
Ingredients Meals
14 Pet Food Manufacturers
5 Rendering Plants
Scraps
Pet Food
9
New Food Protection Plan

• Introduced November 2007
• Combines
• Information Technology
• Science
• Identify potential hazards before they have
  an impact

10
Current Regulatory/Legislative

• Increased emphasis on security and focus on food
  safety
  
• Detection of food safety is increasing in
  sophistication IT is facilitating rapid
  communication and actions
  
• Food safety has become a political issue with
  continuous media attention

11
Food Security/Defense vs. Food Safety

• Not synonymous with food safety
• Food security/defense serves as the umbrella
  under which food safety operates
  
• Food Security
• protection of food products from
  intentional
  
• adulteration
• Food Safety
• protection of food products from
  unintentional
  
• contamination

12
Food Security/Defense vs.. Food Safety

• Differentiation based upon
• the intentional vs.. the accidental
• the diabolical intent vs.. the chance
  occurrence
  
• the deliberate vs.. the unplanned
• the sporadic vs.. the on-going

13
IT Infrastructure Enhancements

• More and better detection capability and expanded
  use of epidemiology data for decision making
  
• Lab Response Networks
• FERN Food Emergency Response
  
  
• Network
• Pulse Net Laboratory based system
• Food Net Agency based system for data
  capture
  
• Border Front
• ACE .
• Automated Commercial Environment
• OASIS Operational Administrative System
  for Import
  
• Support
• LRN

14
Government Conclusions

• Profile on Food Safety is Increasing
• Ag and Food Supply Chain more complex with an
  Increased Focus on Food Defense and Food Safety
  
• More and Faster Pace of Food Legislation and
  Regulations
  
• Detection of Food Safety Failure is Increasing in
  Sophistication IT is Facilitating Rapid
  Communication and Actions
  
• Science-based subordinated to precautionary,
  emotion-based decisions
  

15
IndustryWhats Changed/Changing

• New legislation and regulations have been or are
  being enacted
  
• Enhanced information technology tools directly
  impact industry
  
• Product life cycle increasingly important
• Not all risk are created equal
• Domestic and Imported products
• Effective partnerships are essential

16
Current Industry Needs

• Prerequisite programs that are foundationally
  sound
  
• Use of a Risk based Approach to Food Safety
• Be proactive. Prevent what we can, minimize the
  impact of what occurs
  
• Anticipate and integrate new requirements

17
Prerequisite Programs

• Good Agricultural Practices
• Good Manufacturing Practices
• Standard Operating Procedures
• Standard Sanitation Operating Procedures
• Training
• Documentation
• Quality Programs
• Allergens
• Labeling
• Microbiological
• Crisis Management/Recall
• HACCP

18
Prerequisite Programs

• Say what you do
• Do what you say
• Validate
• Verify
• Document

19
Good Agricultural Practices

• Food Safety Starts Here
• Work with Growers
• External Agencies

20
Standard Operating Procedures

• Written and Documented
• Proper training is essential
• Responsibility and Accountability

21
Standard Sanitation Operating Procedures

• Must be comprehensive and written
• Sanitation by design for the plant and equipment
• Pre operational controls
• Hygiene practices
• Documentation and Recordkeeping
• Trust but Verify

22
Good Manufacturing Practices

• Code of Federal Regulations 21 CFR 110
• Provide the MINIMUM requirements
• Review and Enforce/Upgrade where possible

23
Training

• Management Commitment
• Managers, Supervisors, Employees
• Refresher Training

24
Documentation

• Substantiates Quality Programs
• Written procedures to control all documents
• Review

25
Quality Programs Allergens

• Update company Policies/Procedures
• Dedicated Product Systems
• Scheduling, Separation, Sanitation
• Training/Education
• Documentation
• Labeling

26
Prevalence and severity of Tree Nuts
27
Industry Initiatives

• Use of test kits to verify cleaning
  effectiveness
  
• Voluntary recalls when mistakes are made
• Food Allergy network Special alert Mailing
• Allied Trade and Regulatory Associations

28
Quality Programs Labeling

• Consumer Concerns
• Industry Quandary
• FDA

29
Advisory Label Examples

• May contain nuts
• Contains nuts
• Contains traces of nuts
• May contain the occasional nut
• Manufactured on equipment that processes nuts
• Manufactured in a facility that processes nuts
• May contain soy flour, whey, peanuts, and tree
  nuts
  
• May contain (Listings of Nuts)

30
Impact of Over Labeling

• Food Allergic Consumers
• Angry, frustrated, and scared
• Restricted food choices become more restricted
• Their lives will be controlled by our ability to
  get closer and closer to zero
  

31
Quality Programs Microbiological

• Recent findings have necessitated re-evaluation
  of programs
  
• Emphasis placed on Environmental Monitoring
• SSOPs
• GMPs

32
Background - Salmonella in RTE foods
Notable cases of food-borne salmonellosis
linked to low moisture products
Cross contamination from environment
Ingredient contamination
33
Most Recently

• 3 outbreaks of Salmonella in past year
• Low moisture ready-to-eat (RTE) foods
  contaminated by either the environment or
  ingredient
  
• Cadburys Chocolate
• Leaky waste water pipe above product zone
• Peter Pan Peanut Butter
• Leaky roof and/or faulty sprinkler were sources
  of water
  
• Dormant transient pathogen now able to grow and
  become an established pathogen site and
  contaminate product
  
• Roberts American Gourmet Veggie Bootie Snack Mix
• Source of Salmonella appears to be seasoning blend

34
Industry Need

• Re-assess your hazard assumptions
• Re-assess your risk exposure
• Do you have all the right programs in
  place?
  
• Do you have to do more of anything?
• Do you have to do anything differently?

35
Crisis Management

• Comprehensive Program
• Accountabilities
• Action
• Communication
• Decision Making
• Recalls
• Traceability
• Documentation

36
Traceability

• Lot Coding
• Rework/Work In Progress
• Records
• Mock Recalls

37
HACCP

• Risk based systematic approach to hazard
  identification, assessment and control
  
• Biological
• Pathogens
• Chemical
• Poisons, Pesticides, Toxic cleaning
  chemicals or
  
• any other compounds that could cause
  injury or death
  
• Physical
• Magnets, Sifters, Screens, Metal
  Detectors
  

38
Sanitation

• Organizational Effectiveness
• Measurement
• Planning
• Preventative Predictive Sanitation
• Training

39
Industry Conclusions

• Review Prerequisite Quality Programs
• Industry will place more emphasis on Programs and
  Documentation
  
• Train
• Share Best Practices There is no competition
• when it comes to food safety!
• Be proactive. Prevent what you can, minimize the
  impact of what occurs
  

40
Concluding Remarks

• New century of interconnectedness and
  collaboration
  
• Globalization will present new issues and
  increase exposure to old
  
• Prevention, early detection and communication
  will serve us all well
  
• Train
• Be Proactive

41
Thanks

• Sara Geisert, General Mills Regulatory
• Dr. Tom Trautman, General Mills Toxicology
• Kevin Farnum, General Mills Sanitation/Food Safety