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Qualified Individuals

Qualified Individuals Under FDA Human and Animal Food Rules

Qualified individual means a person who has the education, training, or experience (or a combination thereof)
necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned
duties. A qualified individual may be, but is not required to be, an employee of the establishment.

Due to constant efforts by the United States Food and Drug Administration (FDA), Department of Agriculture (USDA), the Centers for Disease Control and Prevention(CDC), the U.S. Public Health Services (PHA) and countless state and local agencies and privates organizations, the food in the United States is the safest in the world. However, despite all these efforts, according to the CDC, millions get sick annually due to food-borne illnesses; thousands die and the cost to the country is billions of dollars.

In preventing food-borne illnesses, food safety directors, managers, and other food safety professionals play a great role by buying food from an approved and reputable supplier that delivers food that has been safe all along the supply chain. In addition, after food is delivered, it is observed that food is safe along the flow of food from receiving, storing, preparing, processing to holding, cooling, reheating and serving. To achieve that, the food safety professionals need the knowledge of food safety principles and personal hygiene.

This section and sections that follow will discuss and summarize food-borne illnesses’ risk factors, various kinds of contaminants, food-borne illness outbreaks, challenges to food safety, and how to keep food safe along the flow of food from purchasing, receiving, storing, and preparing to cooling, reheating, holding and serving. In addition, safe facilities, pest control, cleaning and sanitizing and how to develop an active managerial control will be discussed.

Food-borne Illnesses

A food-borne illness is an illness transmitted to people by food.
 A illness is an outbreak if:
– Two or more people have the same symptoms after eating the same food;
– It is investigated by responsible governmental authorities; and
– It is confirmed by a laboratory analysis.
 Challenges to Food Safety:
– Finding time to train and follow food safety practices, especially when turnover is high.
– Staff who are from different cultural backgrounds and perceive food safety differently.
– Staff with different educational backgrounds.
– Illness-causing microorganisms (pathogens or germs) found on types of food once considered safe.
– Purchasing food from an unapproved and unsafe supplier that can cause a food-borne illness outbreak.
– Increase in the number of high-risk populations.
– Population at High Risk for Food-borne Illnesses:
– Elderly people and pre-school-age children;
– People with compromised immune systems like cancer, HIV/AIDS, transplant recipients; and
– People who are taking certain medications.
– The Cost of Food-borne Illnesses to a Food-service Operation:
– Loss of customers, sales, work, business, and reputation
– Negative media exposure, lawsuits and legal fees;
– Increased insurance premiums and staff training cost;
– Medical costs and long-term disability; and
– Death of Consumers

How Food-borne Illnesses Occur

There are five common risk factors or food- handler mistakes that can cause a food-borne illness:
1. Purchasing food from a supplier that is not reputable and not approved by responsible governmental authorities.
2. Failing to cook food correctly
3. Holding food at incorrect temperature
4. Using contaminated equipment
5. Practicing poor personal hygiene
Assuming the food is purchased from an approved, reputable supplier, there are four factors behind risk factors:
1. Time-Temperature Abuse
– This happens if food stays too long in a temperature that is good for the growth of pathogens
If food is not cooked, held, stored, cooled or reheated correctly.
2. Cross-Contamination
– This happens when pathogens are allowed to be transferred from one surface to another or from one food to other.
– When a ready-to-eat food, such as a sandwich touches a contaminated surface.
– When contaminated ingredients, such as raw chicken, touch a food that receives no further cooking.
– When a food-handler touches contaminated food and then touches ready-to-eat food.
– When contaminated cleaning cloths come in contact with food-contact surfaces.
3. Poor Personal Hygiene
– This causes food-borne illness when food handlers:
– Do not wash their hands correctly after using the bathroom.
– Work while sick.
– Sneeze or cough on food.
– Touch skin, hair, wounds and then touch food.
4. Poor Cleaning and sanitizing
– Pathogens can move from equipment and utensils that are not washed, rinsed, and sanitized between use to food.
– Instead of washing, rinsing and sanitizing food-contact surfaces, the surfaces are only wiped clean.
– Wiping cloths are not stored in a sanitizing solution between use.
– The sanitizing solution is not prepared properly to sanitize items.

– Food Requiring Time(T) and Temperature(T) Control(C) for Safety (S)
(TCS Food) – Ready-to-Eat Food – Food-Contact Surfaces

 TCS foods are food in which pathogens grow well:
– They need time and temperature control to limit their growth and keep them safe.
– Because they require time and temperature control for being safe, they are called TCS food
– It is important to know what they are and examples of them such as:
Milk and dairy products, beef, pork, lamb, poultry, shellfish and crustaceans
– Shell eggs (except those treated to eliminate Salmonella spp.)
– Baked potatoes and cooked rice, beans and vegetables
– Sliced melons, cut tomatoes and leafy greens, sprouts and sprout seeds
– Untreated garlic-and-oil mixtures
– Tofu or other soy proteins, synthetic ingredients, such as textured soy protein in meat alternatives
Ready-to-Eat Food:
– Like TCS food, ready-to-eat food requires careful handling to prevent contamination.
– They are ready to be eaten without any further cooking or preparing and washing, so they must not be contaminated.
– They include cooked food, washed fruits and vegetables, deli meat; and
– sugar, spices, bakery items, and seasonings.
Food-Contact Surfaces:
– Surfaces in a food operation could be food-contact surfaces and non-food-contact surfaces;
– Walls, floors and ceilings are non-food-contact surfaces and need only to be washed and rinsed;
– Food-contact surfaces are surfaces that come in contact with food and must be washed, rinsed and sanitized; and
– Equipment, utensils, knives, forks, plates, saucers, prep tables all come in contact with food

Keeping Food Safe

– To keep food safe we MUST:
– Control time and temperature to deprive pathogens of fast growth environment. Train staff about that.
– Prevent cross-contamination by training staff on how to do that and monitor them.
– Practice personal hygiene by training and monitoring staff and being a role model.
– Buy food from approved and reputable suppliers. Check food upon arrival.
– Clean and sanitize regularly and train and monitor staff about correct methods of doing so.

Governmental Agencies Involved in Food Safety

Many governmental agencies are responsible for the prevention of food-borne illnesses.
The FDA inspects all food except meat, eggs and poultry; it also regulates food transported across state lines.
– The FDA also issues and recommends a Model Food Code for states and local agencies.
– City, county, state, and tribal agencies regulate food service operations such as:
– Restaurants and retail food stores, vending operations,
– Schools, day-care centers, hospitals and nursing homes.
The USDA regulates and inspects meat, poultry and processes eggs.
– It also regulates food that crosses many state boundaries
The CDC and PHS assist FDA and USDA and conduct research to find the causes of food-borne illnesses.
State and Local Regulatory Authorities inspect operations, enforce regulations,
– Investigate complaints and illnesses, issue licenses and permits, approve construction,
– Review and approve Hazard Analysis Critical Control Point (HACCP) plans.