If you’re in the food business, you need to know which food laws apply to you. A better understanding of the fundamental laws associated with food production, service, and distribution makes it easier for managers and owners to create and enforce a culture of food safety and quality. Learn about local as well as federal requirements and the pending rules associated with the Food Safety Modernization Act. We’ll also discuss the importance of a documented plan and appropriate records.

1. Food Regulations: Important Information
for Food Businesses
CATHY CRAWFORD
CHARLES GIOGLIO

2. Making Sense of Alphabet Soup
FD&C Act
FMIA
PPIA
EPIA
ORA
MDAR
CDC
USDA
FDA
FSIS
FNS
MDOH
OSHA
EPA
DHS

3. Food, Drug, and Cosmetics Act --
1938
 Provided FDA Jurisdiction to Regulate all Foods
Includes: Bottled Water and Chewing Gum
 Defines Food Standards
 Defines Food Additives
 Defines Dietary (Food) Supplements, e.g., Vitamins, Minerals
 FDA Regulations Codified Under Title 21 (21 Code of Federal
Regulations)
 Establishes Both Civil and Criminal
Responsibility Using Strict Liability

4. Strict Liability
In law, strict liability is a standard for liability which may exist in either a
criminal or civil context. A rule specifying strict liability makes a person
legally responsible for the damage and loss caused by his acts and
omissions regardless of culpability (including fault in criminal law terms,
typically the presence of mens rea). Strict liability is prominent in tort
law especially product liability.
Meaning: Are Liable for Product and Conditions Regardless of State of
Mind, Intentions, or Knowledge.

5. FDA Food Code
 FDA’s Model for the Production and Distribution of Safe,
Unadulterated, Truthfully Presented Foods
 Many State and Local Departments of Health and State and Local
Consumer Protection Agencies have Adopted the Food Code into
Regulations
 Adhering Closely to the Food Code Allows Food Manufactures and
Distributors (big and small) to Maintain Compliance with Food Laws

7. Meat and Poultry
FMIA - Federal Meat Inspection Act:
PPIA – Poultry Products Inspection Act
 Require the Inspection By USDA, FSIS of All Meat and Poultry
Slaughtered and Further Processed into Meat/Poultry Food Products
Produced or Imported into the US
 Products include: Steaks, Burgers, Sausages, Whole Turkeys, Tacos,
Chicken Parmesan, Frozen Entrees, Chocolate Covered Bacon,
Pepperoni Pizza, Canned Chili, etc, etc, etc…….
 Any Meat or Poultry Product Produced for Wholesale Distribution and
Sale (Sale for re-sale).
 Retail Only Facilities and Restaurants Exempted from Inspection, but
meat/poultry Still Under USDA Jurisdiction

8. Inspection Requirements
 Bird by Bird and Carcass by Carcass Inspection (anti-mortem and
post-mortem) by FSIS Inspectors and Veterinarians
 Processing Establishments Inspected Each Shift by FSIS (or State)
Inspector
 Each Package of Product Marked with Inspection Legend
Identifying Manufacturing Establishment
 Establishments Required by Regulation to Operate Under Hazard
Analysis and Critical Control Point (HACCP) Plans for All Products

9. Inspections Enforcement
 FDA - Verify against Food Code and Labeling Requirements
 Contract to States and Locals
 USDA – Daily Inspection, Verify Execution of HACCP and SSOP
 States – Contracted by FDA to verify, Many Codify Food Code
 Locals – Use Food Code to Develop Inspection Standards

10. Pre-Requisite Programs
 Form the Foundation of Food Safety System
 Sanitary Standard Operating Procedures
 Pest and Rodent Control
 Product Temperature Controls
 Environmental Temperature Control
 Employee Personal Hygiene
 Entire Food Safety System Rests
on Solid Management
Commitment

11. HACCP
 Hazard Analysis and Critical Control Point Systems
 Developed by Pillsbury Corp for NASA During Space Race
 Best Known Food Safety System
 Relies on Prevention -- Not Finished Product Testing
 Required by USDA for all Meat and Poultry
 Required by FDA for Juice and Seafood
 FDA will Require for ALL Foods Under FSMA (Food Safety
Modernization Act)
 Implementation Plans for FSMA Currently Underway

12. Product Labeling
Required Label Features
 Statement of Identity (Name of Product)
 Ingredient Statement
 Nutrition Facts
 Allergen declaration
 Net Quantity Statement
 Handling Statement (Keep Refrigerated/Frozen, Etc.)
 Name of the manufacturer, distributor and/or packer
 Inspection Legend (for Meat or Poultry)
 Safe Handling Instructions (Raw Meat or Poultry)

13. Statement of Identity Title 21 CFR 101.3
Title 9 CFR 317
 Federal FDA and USDA regulations
 Common or usual name
 A descriptive or fanciful name
 The statement of identity should be presented in a prominent
manner
 If Standardized Product, Must Meet Standard of Identity, Common
Examples, butter, mayonnaise, peanut butter, hamburger

14. Ingredient Statement Title 21 CFR
101.4
 Ingredient exemptions Title 21 CFR 101.100
 Processing aids
 Incidental additives
 Ingredients shall be listed by order of predominance identified by common or
usual name
 Title 21 CFR 101.22 contains provisions for labeling spices, flavorings, chemical
preservatives and colorings
 Order of predominance is not applicable to ingredients that are present at 2% or
less and are declared with a quantifying statement

15. FOOD INGREDIENT CATEGORIES
Food Additive – 21 U.S.C. 321 (s) & 21 CFR 170.3
 “Unsafe” unless approved for use by FDA
 “… any substance which results or may reasonably be
expected to result (directly or indirectly) in its becoming a
component or otherwise affecting the characteristics of
any food.” 21 U.S.C. 301 (s)

16. Nutrition Facts
Current Proposed

17. Safe Handling Instructions
 Mandatory when meat
and poultry product is raw
or partially cooked
 Specific format for word
size
 Graphics mandated
Safe Handling
Instructions
This product was prepared from inspected and passed
meat and/or poultry. Some food products may contain
bacteria that could cause illness if the product is
mishandled or cooked improperly. For your
protection, follow these safe handling instructions.
Keep refrigerated or frozen. Thaw in
refrigerator or microwave.
Keep raw meat and poultry separate from
other foods. Wash working surfaces
(including cutting boards), utensils, and
hands after touching raw meat or poultry.
Cook thoroughly.
Keep hot foods hot. Refrigerate leftovers
immediately or discard.

18. Traceback/Traceforward Recall
 Whenever Foods in Commerce found Adulterated or Misbranded it
May Require Recall of Products
 Manufacture of Product Responsible to Notify all Consignees with
Recall Instruction
 Recipients of Product Responsibility to Comply with Recall
Instructions (including consumers when necessary)
 Return or Destroy Recalled Product

19. Traceback/Traceforward Recall
 Develop Clear Lot Identification and Tracking Systems for
Manufactured Products
 Track Inventory of Incoming Ingredients and Raw Materials into your
Products
 Maintain Records of Product Distribution
 Including Lot Identity Shipped Where and When

20. Food Defense
 Potential Threat to Food Supply is Real
 Manufactures and Transporters (Big and Small) Have Responsibility
to Protect Food
 Maintain Physical Plant Security
 Ensure Control of Visitors Entering Plant
 Examine Incoming Raw Materials and Ingredients
 Only Authorized Individuals Allowed Access to Products, Raw Materials,
and Ingredients

21. Transportation
 FSMA FDA (States and Local) Will Regulate Transportation of Foods
 Details of Rules / Regulations Being Drafted Now
 Will Require:
 Transporters to Maintain Records
 Ensure Cold-Chain for Foods
 Require Sinks in Shipping / Receiving Areas of Plants
 Food Transportation Vehicles to be Refrigerated (NO Unrefrigerated Vans)

22. QUESTIONS??

23. Thank You