Hazard Analysis and Critical Control Points – A Primer

Mark D. Sobsey

Envr 890-2

Spring, 2009

HACCPHazard Analysis and (at) Critical Control Point(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

HACCP is

• Preventive, not reactive

• A management tool used to protect the food supply against biological, chemical and physical hazards

HACCP Essentials

• Management commitment

• HACCP training

7 Principles of HACCP

1. Conduct hazard analysis and identify preventive measures

2. Identify critical control points (CCPs) in the process

3. Establish critical limits4. Monitor each CCP5. Establish corrective

actions 6. Establish verification

procedures7. Establish record-keeping

and documentation procedures

Principle 1: Hazard Analysis

• Hazard identification

• Hazard evaluation

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

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

Hazard Evaluation

• A hazard must be controlled if it is:– Reasonably likely to occur, and– Likely to result in an unacceptable risk to

consumers

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

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

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

How Critical Limits and Preventive Measures will be Monitored

• Examples of monitoring equipment– Thermometers– Clocks– pH meters

Who will Monitor?

• Monitors can be:– Managers– Assistant managers– Line Servers– Cashiers

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

Principal 5: Corrective Actions

• Corrective Action– Procedures to be followed when a deviation

occurs

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

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

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

Principle 7: Record Keeping Procedures

• Four Kinds of HACCP Records1. 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

Other HACCP Applications in WASH

• Water: Water Safety Plans

• Water Reuse

• Agricultural Use of Wastewater and Excreta

• Shellfish Sanitation

• Home Hygiene

Hygiene IVThe Hygiene Hypothesis

ENVR 890-2

Mark D. Sobsey

Spring 2009

“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.

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.

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.

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

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.