Processed Food Industry

1

• Processed Food Industry
• Expanding Exports to the United States
• Carl C Reynolds

2
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

3
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

4
U.S. REGULATORY AUTHORITIES

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

5
FOOD SAFETY CONTROL

• HACCP
• Hazard
• Analysis
• Critical
• Control
• Point
• Management Tool Used to Protect Food From
  Biological, Chemical and Physical Hazards

6

• Traditional inspection methods
• versus
• The HACCP approach

7
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

8
Prerequisite Programs

• Good Manufacturing Practices
• SSOP Sanitation Standard Operating Procedures
• Product specifications for ingredients and
  components
• Documented recall program for finished products

9
HACCP Principles

1. Conduct Hazard Analysis
2. Determine the 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 Requirements and
   Documentation Procedures

10
HAZARD

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

11
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

12
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

13
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

14
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

15
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.

16
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

17
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

18
PACKAGING

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

19
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

20
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

21
FOOD LABELING

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

22
Principal Display Panel
23
Allergen Labeling

• Establishes new definition of misbranding
  failure to bear plain language name of major food
  allergen
• Effective date January 1, 2006
• Products labeled before date can be sold

24
MAJOR FOOD ALLERGENS

• Milk
• Eggs
• Fish (specific name)
• Crustacean shellfish (specific name)
• Tree nuts (specific name)
• Wheat
• Peanuts
• Soybeans

25
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).

26
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

27
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

28
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.

29
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.

30
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

31
(No Transcript)