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Page 1: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

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Food Allergen Labeling

Page 2: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

2

Regulations

Revised January 2006 Food and Drug Administration (FDA)

requires food manufacturers to: List common allergens on labels in simple

terms that adults and older children can understand

Listed in: Ingredients list After the list Right next to it

Page 3: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

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Food Allergens List top eight, which account for 90% of all

documented food allergies: Milk Eggs Peanuts Tree nuts (such as almonds, cashews, walnuts Fish (such as bass, cod, flounder) Shellfish (such as crab, lobster, shrimp) Soy Wheat

Represent allergens most likely to cause a severe or life-threatening allergic reaction (anaphylaxis).

Page 4: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

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Food Label Questions What foods are labeled?

Any domestic or imported packaged food regulated by FDA.

What’s included on label? Lists type of allergens as well as any ingredient that

contains a protein from the eight major food allergens What foods aren’t labeled?

Fresh produce, fresh meat, and certain highly refined oils.

Foods that might inadvertently come into contact with a food allergen during growing, harvesting, or manufacturing.

Page 5: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

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Allergen Label: Information

Page 6: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

Non-Microbial Hazards

Biological, Chemical, Physical Hazards and Allergens

Page 7: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.01 -- Non-Microbial Hazards

Biological HazardsSeafood Toxins Ciguatera toxin Scombroid toxin Shellfish toxins Systemic fish toxins

Plant Toxins Poisonous plants

Fungal Toxins Poisonous mushrooms

Page 8: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.01 -- Non-Microbial Hazards

Chemical Hazards

Toxic Metals Lead, copper, brass, zinc, antimony, cadmium

Cleaning Agents Detergents, sanitizers, polishers, abrasive

cleaners, lubricants

Pesticides and insecticidesFood additives Preservatives (nitrite and sulfites), flavor

enhancers (MSG), nutritional additives (niacin)

Page 9: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.01 -- Non-Microbial Hazards

Physical Hazards Band-aids Fingernails and nail polish Jewelry Broken light bulbs Hair Metal and wood Chipped glass Broken dinnerware

Page 10: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.01 -- Non-Microbial Hazards

Allergens 6 to 7 million Americans have food

allergies. Most common food allergens:

Milk Eggs Fish Shellfish Wheat Soy Peanuts and tree nuts

Page 11: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

Government Regulations

Page 12: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- Regulations

Who is responsible for our food?

Primary responsibility for enforcing federal regulations is USDA and FDA.

USDA is responsible for overseeing approximately 20% of the food supply.

FDA is responsible for 80%. Other agencies also

oversee various aspects of food safety.

Page 13: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C 6.02 -- Regulations

USDA Responsible for regulating:

Red meat, poultry, and certain egg products

Key legislation that USDA enforces: Federal Meat Inspection Act Poultry Products Inspection

Act Egg Products Inspection Act Voluntary Inspection Program

Page 14: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C 6.02 -- Regulations

Food and Drug Administration

Responsible for regulating: All other foods not regulated by

USDA. Food is – food or drink for man or

animal, chewing gum, and any food component.

Key legislation: Federal Food Drug and Cosmetic

Act Food Code Low Acid Foods Registration and

Process Filing

Page 15: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C 6.02 -- Regulations

Environmental Protection Agency

Set pesticide residue tolerances or legal limits on how much residue that can be on particular foods.

FDA and USDA enforce those tolerances on their portions of the food supply.

Tolerance levels set for over 9,000 pesticides.

Page 16: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C 6.02 -- Regulations

Department of Commerce Oversee management

of fisheries in the United States.

Responsible for seafood quality and grading.

Operate a voluntary inspection program for fish in conjunction with FDA.

Page 17: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C 6.02 -- Regulations

Department of Treasury

Two divisions address food safety: Bureau of Alcohol,

Tobacco, and Firearms

U.S. Customs

Page 18: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C 6.02 -- Regulations

Federal Trade Commission (FTC )

Works with FDA and USA over claims made by food manufacturers. FTC oversees food

advertising FDA oversees food labeling

FTC requires that any objective claim made in advertising must be substantiated.

Page 19: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

HACCP

Food Safety Plan

Page 20: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- HACCP

What is HACCP? HACCP (Hazard Analysis Critical Control

Point) is a systematic way to identify, evaluate, and control food safety hazards.

Hazards are biological, chemical, or physical agents likely to cause illness or injury if they are not controlled.

HACCP prevents food safety hazards rather than reacts to food safety hazards.

To develop a HACCP plan, one follows the seven principles.

Page 21: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- HACCP

Prerequisite Programs

Focus on employees, facilities, and equipment. Examples of prerequisite programs include:

Illness policy Cleaning and sanitizing procedures Garbage removal Pest control Equipment selection Employee hygiene

Page 22: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- HACCP

1: Conduct a hazard analysis

Identify hazards associated with a specific menu item. Prepare flow diagram from receiving to service. List likely hazards associated with each step. Identify how to prevent the hazards at each step.

Hazards can be biological, chemical, or physical.

List hazards likely to occur and that will cause severe consequences if not controlled.

Hazards that are low risk and that are not likely do not need to be considered.

Page 23: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- HACCP

2: Determine CCPs A control point is any point, step, or

procedure where biological, physical, or chemical factors can be controlled.

A critical control point (CCP) is a point, step, or procedure where an identified hazard can be prevented, eliminated, or reduced to acceptable levels.

Critical control points are monitored much more frequently than are control points.

Page 24: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- HACCP

3: Establish critical limits

Establish criteria that must be met to prevent, eliminate, or the reduce the identified hazard at the CCP so that the food is safe to eat.

Examples of critical limits are: temperature, time, physical dimensions, water

activity, pH, and available chlorine Critical limits can come from regulatory

standards and guidelines, scientific literature, experimental studies, and consultation with experts.

Page 25: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- HACCP

4: Establish monitoring procedures

Monitoring is a planned observation or measurement: to determine if a CCP is under control and

Examples of monitoring include: Visual observations Temperature measurements Time assessment pH measurements Water activity measurements

Page 26: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- HACCP

5: Establish corrective actions

Corrective actions focus on: what do when a food does not meet the critical limit.

Example of a corrective action: A hamburger is 140oF (50oC) Critical limit -- Cook hamburger to 155oF (68oC) or

hotter. Continue cooking until hamburger is 155oF (68oC) or

hotter. Throwing out food might be a corrective action. Maintain records of all corrective actions taken.

Page 27: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- HACCP

6: Verification proceduresFour phases needed for a HACCP plan:1. Determine that critical limits for all CCPS

are sound.2. Make sure that the establishment’s HACCP

plan is being properly implemented.3. Have regulatory personnel review the plan

to make sure that it is being properly implemented.

4. Check the accuracy of all monitoring equipment.

Page 28: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- HACCP

7: Establish record keeping

The following make up the records of a HACCP Plan

– List of HACCP team and their assigned responsibilities– Description of each menu item– Flow diagram for each menu item indicating CCPs– Hazards associated with each CCP and preventive

measures– Critical limits– Monitoring procedures– Corrective actions plans– Record keeping procedures– Procedures for verification of the HACCP plan

Page 29: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

Farm to Table

Food Safety Interventions

Page 30: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- Farm to Table

Farm

Good Agricultural Practices (GAPS)1. Water2. Manure and municipal biosolids3. Worker health and hygiene4. Sanitary facilities5. Field sanitation6. Packing facility sanitation7. Transportation8. Traceback

Page 31: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- Farm to Table

Food Processing

Good Manufacturing Practices -- procedures for processing and packing under sanitary conditions.

Standard Sanitary Operating Procedures -- ensure a clean and sanitary environment

HACCP -- Systematic approach to identify, assess and control the risks of identified hazards.

Page 32: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- Farm to Table

Foodservice -- HACCP HACCP – seven steps to systematically identify,

assess, and control identified hazards. Not all foodservice establishments must have a

HACCP plan. If do the following, a HACCP plan is needed:

– Vacuum package food– Service of raw meats– Package fresh squeezed orange juice– Serve shellfish directly from a tank– Curing or smoking food for preservation

Page 33: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

C-6.02 -- Farm to Table

Home – Four Steps to Fight BAC!

CLEAN: Wash hands and surfaces often

SEPARATE:  Don't cross-contaminate!  

COOK:  Cook to proper temperature 

CHILL:  Refrigerate promptly Fight BAC! -- national food

safety campaign targeting consumers.

Page 34: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

OBJECTIVE 7.01 -- Distribution 34

Distribution

Food Product

Page 35: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

OBJECTIVE 7.01 -- Distribution 35

Distribution

Target Market -- define demographics. State the needs or wants of that target

market. State how your product will satisfy the

needs or wants of your target market.

Page 36: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

OBJECTIVE 7.01 -- Distribution 36

Market

State where your product will be produced.

State where your target market will expect to receive your product.

State how you will be distributing your product in a timely manner.

Page 37: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

OBJECTIVE 7.01 -- Distribution 37

Survey of sales

State how you will survey customers to evaluate the reception of your product.

Page 38: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

OBJECTIVE 7.01 -- Distribution 38

Payment for product

State how much you will be profiting on the sale of each item.

Estimate the profit you will be making on each production run.

State how payment will be received.

Page 39: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

Differences

Organic vs. Conventional Production

Page 40: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 7.02 -- Differences

Conventional Production

Most farmers in the U.S. use conventional production practices.

Use synthetic chemicals, such as: Fertilizers Pesticides Herbicides Antibiotics

Page 41: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 7.02 -- Differences

Organic Food Production Focus on management

practices that promote and enhance ecological harmony

Practices encourage soil and water conservation and to reduce pollution.

To be labeled organic, must meet specific standards.

Page 42: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 7.02 -- Differences

Organic Food Trends Grown at nearly 20% per year for the last seven

years. Americans spent more than $51 billion on

natural and organic products in 2005. Consumers in the U.S. and the European Union

(EU) make up 95% of the world’s retail sales of organic food products -- estimated at more than $25 billion worldwide.

Research is currently being done to explore the differences in conventionally and organic produced food.

Page 43: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 7.02 -- Differences

Differences in Practices

CONVENTIONAL ORGANICFertilizers Apply chemical

fertilizers to promote plant growth.

Apply natural fertilizers, such as manure or compost, to feed soil and plants.

Insecticides Spray insecticides to reduce pests and disease.

Use beneficial insects and birds, mating disruption or traps to reduce pests and disease.

Page 44: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 7.02 -- Differences

Differences in Practices

CONVENTIONAL ORGANIC

Herbicides

Use chemical herbicides to manage weeds.

Rotate crops, till, hand weed or mulch to manage weeds.

Antibiotics

Give animals antibiotics, growth hormones and medications to prevent disease and spur growth.

Give animals organic feed and allow access to outdoors. Use preventive measures —rotational grazing, a balanced diet and clean housing — to minimize disease.

Page 45: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 7.02 -- Differences

Differences in Product

STANDARD ORGANIC CONVENTIONAL

Nutrition No difference No difference

Quality Spoil faster Spoil more slowly

Appearance Less perfect More uniform

Safety No difference No difference

Taste No difference No difference

Page 46: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

Biotechnology

Page 47: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 8.01 --Biotechnology 47

Definition

• Techniques used to modify deoxyribonucleic acid (DNA) or the genetic material of a microorganism, plant, or animal to achieve a desired trait.

Page 48: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 8.01 --Biotechnology 48

Biotech-produced foods

Also known as: Genetically engineered Bioengineered Genetically modified, although

"genetically modified" can also refer to foods from plants altered through methods such as conventional breeding

Page 49: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

Uses of Biotechnology

Page 50: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 8.01 -- Uses of Biotechnology

General Uses

New products that are higher quality, safer, and/or more nutritious.

Lower production and processing costs.

Improve microbial processes upon which processors rely. Fermentation Enzymes

Page 51: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 8.01 -- Uses of Biotechnology

Two Uses – Quality and Safety

Quality Food additives – natural flavors and colors Processing aids – enzymes, emulsifiers, and starter cultures Environment – more waste treatment options, greener manufacturing options, biodegradable plastic wrap that kills bacteria.

Food safety rapid detection tools to detect microorganisms and the toxins they produce.

Page 52: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

Ethical vs. Empirical

Page 53: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 8.02 -- Claims

Empirical vs. Ethical

Empirical – statements of fact Statements about risks and benefits are

empirical claims. Statements about what something is made of

or how something functions are empirical claims.

Ethical – values “It is good to care for the environment and

promote human health.” Ethical claims set forth what is good to do

and what is bad to do in general.

Page 54: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 8.02 -- Claims

What are ethics?

Ethics is critical thinking about right and wrong action.

Ethics involve the study of values, not just reliance on intuition or what our friends think.

The ethical conclusion is the specific course of action that one should follow, if the empirical claims (facts) and ethical claims (values and beliefs) are accepted as true.

Page 55: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 8.02 -- Claims

Ethical Concerns of Biotechnology

Environmental impact Health and allergens Allergens Labeling Unknown effects Gene source and religion

Page 56: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

Labeling

Page 57: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 8.02 -- Labeling

Labeling Laws for Biotech Foods

Designed to help consumers make informed buying decisions.

The European Union and Japan require some foods derived from biotechnology be labeled.

The U.S. does NOT require labeling.

Page 58: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 8.02 -- Labeling

Why U.S. opposed to labeling?

Labeling required in the U.S. for health reasons.

Safety should be addressed through non-regulatory means -- outreach or education programs.

Labeling of biotech foods might send a negative signal to consumers about the safety of these products which the FDA has deemed to be safe.

Page 59: 1 Food Allergen Labeling. 2 Regulations Revised January 2006 Food and Drug Administration (FDA) requires food manufacturers to: List common allergens

D 8.02 -- Labeling

Suggestions for Labeling

The U.S. has supported the idea of voluntary labeling.

Allow the market to address consumer choice rather than the government regulating choice.


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