Processed Food IndustryExpanding Exports to the United States

Carl C Reynolds

U.S. REGULATORY AUTHORITIES

• U.S. Department of Agriculture (USDA)– Domestic and Imported

• Meat

• Poultry

• Eggs

• Establish Ingredient Standards and Approve Recipes and Labels for Processed Meat and Poultry Products

U.S. REGULATORY AUTHORITIES

• Environmental Protection Agency– Water and Air Quality

– Pesticide Approval and Registration

– Establish Tolerances for Pesticides• FDA and USDA Enforces Pesticide Tolerances

• Customs and Border Protection– Collects Duties and Tariffs

U.S. REGULATORY AUTHORITIES

• Food and Drug Administration– Foods – Drugs– Cosmetics– Medical Devices– Veterinary Drugs and Feeds– Biological Products– Radiation Devices

FOOD SAFETY CONTROL

• HACCP• Hazard• Analysis• Critical• Control• Point

• Management Tool Used to Protect Food From Biological, Chemical and Physical Hazards

Traditional inspection methods

versus

The HACCP approach

HACCP

• HACCP is not a stand alone program

• HACCP requires prerequisite programs

• HACCP is not a zero-risk system

• Designed to minimize the risk of food-safety hazards

• Goal is to fix problems before they become hazards

Prerequisite Programs

• Good Manufacturing Practices

• SSOP: Sanitation Standard Operating Procedures

• Product specifications for ingredients and components

• Documented recall program for finished products

HACCP Principles

1. Conduct Hazard Analysis2. Determine the Critical Control Points (CCP’s) in the

Process3. Establish Critical Limits4. Monitor Each CCP5. Establish Corrective Actions6. Establish Verification Procedures7. Establish Record Keeping Requirements and

Documentation Procedures

HAZARD

• A biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

HAZARDS

• True Health Hazard, not just Undesirable Conditions or Contaminants:

• Hair

• Insects

• Filth

• Economic Fraud

• Decomposition or Spoilage

• Other Issues Not Directly Related to Food Safety

SPECIFIC COMMODITY REQUIREMENTS

• SEAFOOD HACCP– Applies to all processors of fish or fishery products in

the U.S. and foreign countries exporting to the U.S.

– Except harvesting, transporting or retail sales

• Processing – a broad definition – Handling, storing, preparing, freezing, changing into

different market forms, heading, shucking, manufacturing, packing, labeling, dockside unloading and holding

IMPORTER REQUIREMENTS

• Fish or fishery product from country with MOU with FDA that documents equivalency of the foreign inspection system with the U.S. system.

• Written verification procedures for ensuring that fish or fishery product offered for import meet the requirements of Seafood HACCP

SPECIFIC COMMODITY REQUIREMENTS

• Juice Sold as Such or Used as an Ingredient in Beverages– Juice means the aqueous liquid, purees, or concentrates

expressed or extracted from one or more fruits or vegetables

• Processing– Commercial, custom, or institutional processing of

juice products• Does not include

– Harvesting, picking, or transporting raw agricultural products

IMPORTER REQUIREMENTS

• Obtain juice from country with MOU with FDA that documents equivalency of the foreign inspection system with the U.S. system.

• Written verification procedures for ensuring that juice offered for import meet the requirements of juice HACCP.

SPECIFIC COMMODITY REQUIREMENTS

• Thermally Processed Low Acid Canned Foods Packaged in Hermetically Sealed Containers– pH greater than 4.6

– Water activity (aw) greater than 0.85

• Acidified Foods– Low acid foods to which acids or acid foods

have been added

IMPORTER REQUIREMENTS

• There are No Specific Importer Requirements for Low Acid or Acidified Foods– Each Manufacturing Facility (Domestic and

Foreign) must Register with FDA.– Must File Scheduled Process with FDA for

Each Product in Each Container Size.– Must Use Specific Forms

PACKAGING

• Any container or wrapping in which any food is enclosed for delivery or display to retail purchasers– Food Additives– Food Contact Surfaces

FOOD LABELING

• Food is misbranded if:– False or misleading in any particular

• Bears false or misleading statement• Fails to bear material fact

– Fails to bear required information– Bears standardized name but does not conform

to compositional standard– Bears nutrient content claim or health claim

that is not authorized

FOOD LABELING

• Label – Any written, printed or graphic matter on the

immediate container or on the food• Labeling

– All written, printed, or graphic matter accompanying the food - includes website

• Advertising– Material that does not “accompany” the food

FOOD LABELING

• Required Label Information– Statement of identity– Net Contents– Ingredients– Name and place of business– Nutrition Labeling

Principal Display Panel

O u i ! O u i !B l u e b e r r y

Y o g u r t

N E T W T . 8 O Z ( 2 2 7 g )

B l u e b e r r yY o g u r t

N e t W t . 8 o z ( 2 2 7 g )

C I T R U SB O Y

O R A N G E J U I C E

N E T C O N T E N T S1 6 F L O Z ( 4 7 3 m l )

N u t r i t i o nl a b e l i n g

i n f o r m a t i o n

I n g r e d i e n ts t a t e m e n t

N a m e &a d d r e s s o f t h e

p l a c e o fb u s i n e s s

N e t 1 G A L . ( 3 . 7 9 L )

M I L K

P D P P D P

P D P

P D P

P D P

J er sey B r a n d

I N T E R N A T I O N A LP A S T E R I Z E D P R O C E S S

C H E E S EN E T W T 1 6 O Z ( 4 5 3 g )

Allergen Labeling

Establishes new definition of misbranding – failure to bear plain language name of major food allergen

Effective date: January 1, 2006Products labeled before date can be sold

MAJOR FOOD ALLERGENS

• Milk

• Eggs

• Fish (specific name)

• Crustacean shellfish (specific name)

• Tree nuts (specific name)

• Wheat

• Peanuts

• Soybeans

FOOD ALLERGENS

• Ingredients: semolina, rice flour, pine nuts, tomato juice, whey, sodium caseinate, and natural flavoring. Contains wheat, milk, pine nuts, and peanuts

• Ingredients: semolina (wheat), rice flour, pine nuts, tomato juice, whey (milk), sodium caseinate, and natural flavoring (peanuts).

COUNTRY OF ORIGIN LABELING

• Under Customs Law:

– All foreign goods must be labeled with the country of origin when they are offered for entry into the United States:

“Product of Turkey”

IMPORTED FOODS

• Meet Same Standards as Domestic Products– Not Adulterated– Labeled Correctly in English– Produced Under Sanitary Conditions– Food and Color Additives Must be Approved

by FDA

IMPORTS: REGULATORY

• FDA does not have statutory authority to conduct inspections of food processing facilities in foreign countries.

• Determine compliance by sampling and examination of shipment at the point of entry.

• FDA refuses entry for those entries that appear to have been manufactured, processed, or packed under insanitary conditions.

BIOTERRORISM ACT REQUIREMENTS

Requires the registration of all food facilities. Requires domestic firms to include the name of an Emergency Contact person and foreign firms to also include the name of a U.S. Agent who can also serve as the emergency contact.

Defines facility as any factory, warehouse, or establishment of an importer that manufactures, processes, packs, or holds food. Failure to register a prohibited act.

BIOTERRORISM ACT REQUIREMENTS

• Prior Notice of Imported Food Shipments

• Time Frames• 2 Hours Before Arrival by Land or Road

• 4 Hours Before Arrival by Air or by Land by Rail

• 8 Hours Before Arrival by Water

• Must be Received and Confirmed Electronically by FDA Before Food is Mailed by International Mail

Thank You