Transcript Document

Processed Food Industry
Expanding Exports to the United States
Carl C Reynolds
U.S. REGULATORY AUTHORITIES
• U.S. Department of Agriculture (USDA)
– Domestic and Imported
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Meat
Poultry
Eggs
Establish Ingredient Standards and Approve Recipes and
Labels for Processed Meat and Poultry Products
U.S. REGULATORY AUTHORITIES
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Environmental Protection Agency
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Water and Air Quality
Pesticide Approval and Registration
Establish Tolerances for Pesticides
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FDA and USDA Enforces Pesticide Tolerances
Customs and Border Protection
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Collects Duties and Tariffs
U.S. REGULATORY AUTHORITIES
• Food and Drug Administration
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Foods
Drugs
Cosmetics
Medical Devices
Veterinary Drugs and Feeds
Biological Products
Radiation Devices
FOOD SAFETY CONTROL
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HACCP
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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
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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 Analysis
2. Determine the Critical Control Points (CCP’s) 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
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:
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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
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Statement of identity
Net Contents
Ingredients
Name and place of business
Nutrition Labeling
Principal Display Panel
Jersey Brand
PDP
Nutrition
labeling
information
MILK
PDP
PDP
Ingredient
statement
Blueberry
Yogurt
Net Wt. 8 oz (227g)
Oui! Oui!
Blueberry
Yogurt
NET WT. 8 OZ (227g)
Name &
address of the
place of
business
Net 1 GAL. (3.79 L)
CITRUS
BOY
ORANGE JUICE
PDP
PDP
INTERNATIONAL
PASTERIZED PROCESS
CHEESE
g
lin
t
be
la on
en e
n ati
m
itio rm tate of ths
s s
utr fo nt s
N in
es e
ie
dr sin
ed ad bu
gr
& of
In
e ce
am pla
N
NET WT 16 OZ (453 g)
NET CONTENTS
16 FL OZ (473 ml)
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
MAJOR FOOD ALLERGENS
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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
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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
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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