1. Hazard Analysis and Critical Control Points – A Primer Mark D. Sobsey Envr 890-2 Spring, 2009

2. HACCP H azard A nalysis and (at) C ritical C ontrol P oint(s) Origin: Pioneered in the 1960’s during Apollo space program: safe food for astronauts Adopted by many food processors and the U.S. government Designed to minimize the risk of food safety hazards

3. HACCP is Preventive, not reactive A management tool used to protect the food supply against biological, chemical and physical hazards

4. HACCP Essentials Management commitment HACCP training

5. 7 Principles of HACCP 1.Conduct hazard analysis and identify preventive measures 2.Identify critical control points (CCPs) in the process 3.Establish critical limits 4.Monitor each CCP 5.Establish corrective actions 6.Establish verification procedures 7.Establish record- keeping and documentation procedures

6. Principle 1: Hazard Analysis Hazard identification Hazard evaluation

7. Hazard Identification List potential hazards at each operational step in the process from receipt of raw materials through release of the finished product –SOPs (Standard Operating Procedures) All potentially significant hazards must be considered Hazard: –A biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control

8. Standard Operating Procedures (SOPs) Every procedure and policy for the department needs to be put in writing and distributed to all personnel to ensure food safety –Examples Cooking Potentially Hazardous Foods Personal Hygiene Receiving Deliveries

9. Hazard Evaluation A hazard must be controlled if it is: –Reasonably likely to occur, and –Likely to result in an unacceptable risk to consumers

10. Principle 2: Determine the Critical Control Points Critical Control Point –A point, step or procedure at which control can be applied and is essential to prevent or eliminate a food-safety hazard or reduce it to an acceptable level

11. Principle 3: Establish Critical Limits Critical Limit –A maximum and/or minimum value that must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food-safety hazard

12. Principle 4: Critical Control Point Monitoring To track the operation of the process and enable the identification of trends toward a critical limit that may trigger process adjustments To identify when there is loss of control (a deviation occurs at a CCP), and To provide written documentation of the process control system

13. How Critical Limits and Preventive Measures will be Monitored Examples of monitoring equipment –Thermometers –Clocks –pH meters

14. Who will Monitor? Monitors can be: –Managers –Assistant managers –Line Servers –Cashiers

15. Who will Monitor? Those responsible for monitoring should: –Be trained in CCP monitoring techniques –Fully understand the importance of CCP monitoring –Have ready access to the monitoring activity –Accurately report each monitoring activity –Immediately report critical limit infractions so that immediate corrective actions can be taken

16. Principal 5: Corrective Actions Corrective Action –Procedures to be followed when a deviation occurs

17. Corrective Action Options Include: Isolating and holding product for safety evaluation Diverting the affected product or ingredients to another line where deviation would not be considered critical Reprocessing Destroying product

18. Corrective Action Components To correct and eliminate the cause of the deviation and restore process control –Bring CCP back under control –Determine cause of deviation to prevent future recurrence To identify the product that was produced during the process deviation and determine its disposition

19. Principle 6: Verification Procedures Verification –Those activities, other than monitoring, that determine the validity of the HACCP plan and that verify the system is operating according to the plan

20. Principle 7: Record Keeping Procedures Four Kinds of HACCP Records 1.HACCP plan and support documentation used in developing the plan 2.Records of CCP monitoring 3.Records of Corrective Action 4.Records of Verification activities

21. Other HACCP Applications in WASH Water: Water Safety Plans Water Reuse Agricultural Use of Wastewater and Excreta Shellfish Sanitation Home Hygiene

22. Hygiene IV The Hygiene Hypothesis ENVR 890-2 Mark D. Sobsey Spring 2009

23. “Hygiene Hypothesis” Reduction/lack of in infections and microbial exposures early in life may be associated with increased risk of allergy, asthma and autoimmune diseases Based on observations and speculation on: – Urban/rural differences – Farming/non-farming differences – Birth order / small families / day care – Early exposure to parasites, allergens, viruses, etc.

24. The Hygiene Hypothesis Allergies and asthma and persistent skin conditions diseases have recently become epidemic in some parts of the developed world Studies in the late 1980s and 1990s in the UK and reunified Germany suggested that higher sanitation increased risks of these health conditions The Hygiene Hypothesis: children exposed to other children or animals early in life are exposed to more microbes, and their immune systems develop more tolerance for the agents causing asthma, allergies and skin disorders. The human immune system evolved two types of biological defenses. When one defensive system lacks practice fighting bacteria and viruses, perhaps due to a sanitary lifestyle, the other system becomes too powerful and overreacts to harmless substances like pollen.

25. Hygiene Hypothesis – Proposed Mode of Action/Mechanism Allergic diseases are caused by inappropriate immunological responses to innocuous antigens driven by a TH2 type of immune response. Many bacteria and viruses elicit a TH1 type of immune response which has the ability to down-regulate mediators of TH2 responses. Observations of immune function led to the development of the first proposed mechanism of action of the hygiene hypothesis: –insufficient stimulation of the TH1 arm of the immune system lead to an overactive TH2 arm which in turn led to allergic disease This explanation has been challenged as inconsistent with other evidence that the incidence of inflammatory bowel disease (IBD, multiple sclerosis (MS), and type I diabetes, which are autoimmune diseases linked with an overactive TH1 immune response, is increasing in the same populations with increased allergic disease.

26. Hygiene Hypothesis – Alternative Explanation of Mode of Action If the developing immune system does not receive stimuli from infectious agents, it fails to properly develop cells with a regulatory function. Persons lacking immune regulatory cells are more likely to develop autoimmune diseases due to insufficiently repressed TH1 reactions and allergic diseases due to insufficiently repressed TH2 immune reactions

27. The Old Friends Hypothesis – A Further Refinement T regulator cells become fully effective only if stimulated by exposure to certain microbes, including pathogens of low virulence, with which human have coexisted thru evolutionary history, except until recent times of high sanitation. –Hygienic practices and medical care have diminished or eliminated such traditional fauna from our exposures. E.g., development of T regulator cells may depend on exposure to microbes such as lactobacilli, mycobacteria, and certain helminths. The T regulatory cells learn to respond to harmless or beneficial invaders by damping down the aggressive reaction of the helper T cells and other immune system components to the antigens presented by the harmless symbiotes. As a result, a properly developed immune system is unlikely to aggressively attack harmless allergens or self cells. Both extremes of microbial environments, highly unsanitary and highly sanitized are detrimental to optimal immune system development.