Resources

Laws, Rules, and Regulations

Code of Federal Regulations

Code of Federal Regulations (CFR) Title 21. Food and Drugs
Subchapter B Food for Human Consumption

• 21 CFR 101 Food Labeling
• 21 CFR 111 Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
• 21 CFR 113 Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
• 21 CFR 114 Acidified Foods
• 21 CFR 115.5 Shell Eggs
• 21 CFR 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
• 21 CFR 118 Production, Storage, and Transportation of Shell Eggs
• 21 CFR 129 Processing and Bottling of Bottled Drinking Water
• 21 CFR 165 Beverages

Indiana Regulations

Indiana Code (IC) Title 16 Article 42. Regulation of Food, Drugs, and Cosmetics

• IC 16-42-1 Regulation of Food, Drugs, and Cosmetics
• IC 16-42-2 Uniform Food, Drug, and Cosmetic Act: Adulteration or Misbranding of Foods
• IC 16-42-2-3 Misbranded Foods
• IC 16-42-5 Food: Sanitary Requirements for Food Establishments
• IC 16-42-10 Food: Manufacture and Sale of Flour, White Bread, and Rolls
• IC 16-42-11 Food:  Eggs Offered for Sale and State Egg Board
• IC 16-42-17 Food:  Regulation of Sodium Saccharin, N.F.
• IC 16-42-18 Food:  Transportation of Food in Trucks Used to Transport Solid Waste

Indiana Administrative Code (IAC) Title 410

• 410 IAC 7-21 Wholesale Food Establishment Sanitation Requirements
• 410 IAC 7-23 Civil Penalty Rule

Guidance Documents

• Food Testing Laboratory List
• Process Authorities List

Allergen Information

Food allergies are abnormal responses of the immune system, especially the production of allergen-specific IgE antibodies to naturally occurring proteins in certain foods that most individuals can eat safely. Frequently, such reactions occur because the presence of an allergenic substance in the food is not declared on the food label.

According to FDA, there is scientific consensus that the following foods can cause serious allergic reactions in some individuals and account for more than 90% of all food allergies:

• Peanuts
• Treenuts
• Soybeans
• Dairy
• Eggs
• Finfish
• Crustacean Shellfish
• Wheat
  Sesame

Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, including potential food allergens, or refuse in the following manner:

• When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in receiving, loading, or shipping areas if that handling could result in contamination.
• Food transported by conveyor shall be protected against contamination as necessary.
• Filling, assembling, packaging, and other operations shall be performed in a way that the food is protected against contamination by utilizing adequate control procedures to prevent allergen cross contact.
• Food products not labeled properly with an allergenic ingredient would be considered misbranded due to an undeclared allergen.
• Food could be considered adulterated if contaminated with an allergen.

It is imperative that critical points in the manufacturing operation be identified and special attention given to areas where allergens may be introduced.

Wholesale Manufactured Foods Forms

• Registration Application for Manufacturer, Processor, Repackager or Wholesale Distributor of Food, Drugs or Cosmetics - State Form 13054
• Operator Response to Inspection - State Form 50047 (2-01)
• Application for Shellfish Dealer Certification - State Form 54654 (3-11)