Laws, Rules, and 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 112     Standards for the Growing, Harvesting, Packing, and  Holding of Produce for Human Consumption
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 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 16-42-5.2   Food Handlers
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 Article 7. Food and Drugs

410 IAC 7-21  Wholesale Food Establishment Sanitation Requirements
410 IAC 7-22  Certification of Food Handler Requirements
410 IAC 7-23  Civil Penalty Rule
410 IAC 7-24  Retail Food Establishment Sanitation Requirements

Public Health Reasons for the Retail Food Establishment Sanitation Requirements Title 410 IAC 7-24

Letter to Chief Food Specialists in All Local Health Departments Regarding Public Health Reasons

Process Authority List

Bed and Breakfast Rule

Indiana Codes Specific to Produce Safety

Directions for locating online, the sections list below.

Go to: http://iga.in.gov/
Next to “Search” in the upper right corner; select “Code”; for T, enter 16; for A, enter 18 or 42;
for C, enter a section or leave blank

Article 18. General Provisions and Definitions

IC 16-18-2-124  "Federal act"

Sec. 124. "Federal act", for purposes of IC 16-42-1 through IC 16-42-4, refers to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.; 52 Stat. 1040 et seq.), as amended by the FDA Food Safety Modernization Act (Public Law 111-353), and amendments to those statutes. [Pre-1993 Recodification Citation: 16-1-28-3(a).]As added by P.L.2-1993, SEC.1. Amended by P.L.101-2018, SEC.1

IC 16-18-2-294.1  "Produce farm"

Sec. 294.1. "Produce farm", for purposes of IC 16-42-1 through IC 16-42-4, means a person that: (1) grows, harvests, packs, or holds covered produce (as defined by 21 CFR 112) that is intended for human consumption; and (2) is subject to 21 CFR 112. The term does not include a person that is exempt under 21 CFR 112. As added by P.L.101-2018, SEC.2

Article 42. Regulation of Food, Drugs, and Cosmetics

IC 16-42-1-1  Purpose of act

Sec. 1. (a) IC 16-42-1 through IC 16-42-4 are intended to safeguard the public health and promote the public welfare by protecting the: (1) consuming public from injury by product use; and (2) purchasing public from injury by merchandising deceit; flowing from intrastate commerce in food, drugs, devices, and cosmetics. (b) IC 16-42-1 through IC 16-42-4 are intended to be uniform with the: (1) Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), as amended by the FDA Food Safety Modernization Act (Public Law 111-353); and (2) Federal Trade Commission Act (15 U.S.C. 41 et seq.); including amendments to those statutes, to the extent they expressly outlaw the false advertisement of food, drugs, devices, and cosmetics. (c) IC 16-42-1 through IC 16-42-4 thus promote uniformity of such statutes and their administration and enforcement throughout the United States. [Pre-1993 Recodification Citation: 16-1-28-2(a), (b).] As added by P.L.2-1993, SEC.25. Amended by P.L.101-2018, SEC.3

IC 16-42-1-13   Entry and inspections

Sec. 13. For the purpose of enforcing IC 16-42-1 through IC 16-42-4, the state health commissioner or the commissioner's authorized representative may do the following: (1) Enter, at reasonable times any produce farm, factory, warehouse, place of production, or establishment subject to IC 16-42-1 through IC 16-42-4 or enter any vehicle being used to transport or hold food, drugs, devices, or cosmetics. (2) Inspect, at reasonable times, the produce farm, factory, warehouse, place of production, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, labeling, and advertisements. [Pre-1993 Recodification Citation: 16-1-28-13.] As added by P.L.2-1993, SEC.25. Amended by P.L.101-2018, SEC.4

IC 16-42-3.5-1  Produce farm requirements; suspension of requirements

Sec. 1. (a) Subject to subsection (b), a produce farm shall comply with the requirements in 21 CFR 112. However, a produce farm that has a qualified exemption under 21 CFR 112 is required only to comply with the requirements specified for the qualified exemption under 21 CFR 112.6. (b) The state department may suspend the requirements under subsection (a) if the federal government does not provide sufficient funds for the state department to administer and enforce the requirements in 21 CFR 112. However, if the federal government does not provide any funds for the state department to administer and enforce the requirements in 21 CFR 112, the state department shall suspend the requirements under subsection (a). As added by P.L.101-2018, SEC.5

IC 16-42-3.5-2  Implementation; rules

Sec. 2. (a) The state department shall implement this chapter. (b) The state department may adopt rules under IC 4-22-2 that are necessary to implement this chapter. However, the rules may not provide for requirements that are more stringent than required under 21 CFR 112.  As added by P.L.101-2018, SEC.5

 FDA Food Code  2017 FDA Model Food Code

FDA Guidance

Guidance for Industry: Evaluating the Safety of Flood-affected Food Crops for Human Consumption

Shell Eggs
FDA Egg Safety Rule   Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation

Also see 21 CFR 115.5 and CFR 118

The National Shellfish Sanitation Program (NSSP) is the federal/state cooperative program recognized by the U. S. Food and Drug Administration (FDA) and the Interstate Shellfish Sanitation Conference (ISSC) for the sanitary control of shellfish produced and sold for human consumption. The purpose of the NSSP is to promote and improve the sanitation of shellfish (oysters, clams, mussels and scallops) moving in interstate commerce through federal/state cooperation and uniformity of State shellfish programs. Participants in the NSSP include agencies from shellfish producing and non-producing States, FDA, EPA, NOAA, and the shellfish industry. Under international agreements with FDA, foreign governments also participate in the NSSP. Other components of the NSSP include program guidelines, State growing area classification and dealer certification programs, and FDA evaluation of State program elements.
Gluten-Free Final Rule - Federal Register (FR) 8/5/13
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