Food Regulations

1
Food Regulations

• Dr. Joe OLeary
• Introduction to Animal and Food Sciences Agent
  In-Service

2
U.S. Food Regulations

• 12 different Federal Agencies
• 35 different separate federal statutes
• Having the intent to protect the publics health
  and prevent economic fraud
• State and local regulations
• Federal preemption for
• labeling

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4 Major U.S. Regulatory Agencies

• Food and Drug Administration (FDA)
• US Department of Agriculture (USDA)
• Environmental Protection Agency (EPA)
• National Oceanic and Atmospheric Administration
  (NOAA)

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Milestones in U.S. Food and Drug Law History

• Food Drug Cosmetic Act 1938
• Food Additives amendment - 1958
• Nutrition Labeling Education Act 1990
• Food Quality Protection Act amends the Food,
  Drug, and Cosmetic Act, eliminating application
  of the Delaney proviso to pesticides - 1996

5
Recent Changes

• Public Health, Security and Bioterrorism
  Preparedness and Response Act 2002 (effective
  Dec.12, 2003)
• Country of Origin Labeling (effective Sept. 30,
  2006)
• Trans-fat as part of nutrition facts (required by
  January 1, 2006),

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Code of Federal Regulations (CFR)

• Codification of the general and permanent rules
  published in the Federal Register by the
  executive departments and agencies of the Federal
  Government
• Divided into 50 titles updated annually
• Title 9 Animals and animal products
• Title 21 Food and drugs

7
State Regulation

• Kentucky Food Drug and Cosmetic Act - KRS 217.005
  to 217.215, 217.992Kentucky Food Establishment
  Act and State Retail Food Code - 902 KAR 45005
• Kentucky's Food, Drug, and Cosmetic Act mimics
  the Federal Food, Drug and Cosmetic Act very
  closely.

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Kentucky Exceptions

• Filled Milk is considered an adulterated
  product
• With a prescription from a physician the sale of
  unpasteurized goat milk is allowed

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KY Cabinet for Health ServicesDepartment for
Public Health

• Food Safety Branch275 East Main
  StreetFrankfort, KY  40621(502)
  564-7181guy.delius_at_ky.gov  
• http//chs.ky.gov/
• publichealth/Food-Program.htm

• Milk Safety Branch275 East Main
  StreetFrankfort, KY  40621(502) 564-3340
• ext. 3708 lewis.ramsey_at_ky.gov
• http//chs.ky.gov/
• publichealth/milk.htm

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Food Safety Branch

• KY Food Manufacturing Program
• Home-Based Processing/ "Farmers' Market
  Regulation"
• Temporary Food Operations
• Statewide Mobile Food Unit Operations
• How to Process/Manufacture Food for Sale
• Establishment Fixture Requirements

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How To Process Or Manufacture Food For Sale

• Facility new or existing
• Permit to operate
• Product information
• Inspection

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Establishment Fixture Requirements

• Must meet minimum fixture requirements in order
  to receive a permit to operate
• Retail Food Establishments
• Retail Food Stores
• Food Processing Establishments
• Bed and Breakfasts
• Boarding Homes
• Tattoo Studios

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Processing Requirements

• Not a home kitchen
• A 3 compartment sink with drainboards
• Handwash basin in food preparation and utensil
  washing areas
• Service (mop) sink
• Restroom for employee use
• Hot and cold running water

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Milk Safety Branch

• The responsibility of the Milk Safety Branch
  both at present and in the future is and should
  be to protect the health and well being of the
  citizens of the Commonwealth of Kentucky. 
• Sale of raw milk not permitted

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Kentucky Milk Program Policies

• Bacteria
• Somatic cell  
• Accelerated sampling program
• Drug residue
• Adulteration  
• Sediment

• Water supply    
• Inspection 
• Conference/Hearing
• Twenty one day notice/Suspension

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Food Labeling Requirements

• The intent of the labeling requirement is to
  fully inform the consumer of food contents,
  nutritional value, identify the manufacturer, and
  help regulatory agencies track food back to the
  source if problems or a product recall arise.

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Basic Label Requirements

• Common Name of the Commodity
• Name of Manufacturer, Packer or Distributor
• Place of Business
• Ingredient Declaration
• Net Quantity of Contents
• Nutritional information

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Labeling Meat in Kentucky

• A farmers guide to labeling USDA inspected meat
  products for direct sale.
• Kenneth H. Burdine, University of Kentucky,
  Department of Agricultural Economics
• Tess Caudill, Kentucky Department of Agriculture,
  Division of Value-Added Livestock, Poultry and
  Forage Promotion

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A Food Labeling GuideFood Labeling Guide CFR
References
CFR 101.7721 CFR 101.7821 CFR 101.7921 CFR
101.8021 CFR 101.8121 CFR 101.9521 CFR
101.10021 CFR 101.10521 CFR 102.33 21 CFR
104.20 21 CFR 179.26

• CFR 101.5421
• CFR 101.5621
• CFR 101.6021
• CFR 101.6121
• CFR 101.6221
• CFR 101.6521
• CFR 101.7021
• CFR 101.7221
• CFR 101.7321
• CFR 101.7421
• CFR 101.7521
• CFR 101.7621

• 21 CFR 1.21
• 21 CFR 74.70, 5
• 21 CFR 101.2
• 21 CFR 101.3
• 21 CFR 101.4
• 21 CFR 101.921
• CFR 102.521
• CFR 101.1221
• CFR 101.1321
• CFR 101.1421
• CFR 101.1521
• CFR 101.1721
• CFR 101.2221
• CFR 101.3021

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FSIS Regulated Products

• Establishment Labeling Responsibilities
• Meat, Poultry, and Egg Product establishments are
  responsible for accurately labeling their product
  for human consumption. All labels must be
  approved by the FSIS Labeling and Consumer
  Protection Staff.

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Meat and Poultry

• USDA Technical Service Center
• HACCP Hotline
• Omaha, NE
• 1 800 233 3935

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The National Organic ProgramAMS - USDA

• Labeling standards are based on the percentage
  of organic ingredients in a product. 
• Products labeled "100 percent organic" must
  contain only organically produced ingredients.
• Products labeled "organic" must consist of at
  least 95 percent organically produced
  ingredients.
• Products meeting the requirements for "100
  percent organic" and "organic" may display the
  USDA Organic seal.  

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Organic Labeling Requirements

• Processed products that contain at least 70
  percent organic ingredients can use the phrase
  "made with organic ingredients" and list up to
  three of the organic ingredients or food groups
  on the principal display panel. 

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Organic Labeling Requirements

• Processed products that contain less than 70
  percent organic ingredients cannot use the term
  organic other than to identify the specific
  ingredients that are organically produced in the
  ingredients statement.  

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What is Fresh?

• 21 CFR 101 part 95
• Fresh suggests or implies that the food is
  unprocessed, means that the foods is in the raw
  state and has not been frozen or subjected to any
  form of thermal processing or other form of
  preservation except for waxing, washing,
  post-harvest pesticides and low levels radiation
  treatment of raw agricultural commodities.

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Other Label Concerns

• Allergenic ingredients
• Food Allergen Labeling and Consumer Protection
  Act July 2004
• Will require allergenic ingredients to be listed
  in plain English
• Biotech foods
• UPC bar code

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Other Regulations May Apply

• Good Agricultural Practices (GAPs)
• Good Manufacturing Practices (GMPs)
• Sanitation Standard Operating Procedures (SSOP)
• Hazard Analysis Critical Control Point (HACCP)

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• 217.350 Spitting in food establishment --
  Employees to wash hands.
• No person shall expectorate on the food or
  utensils in, or on the floor or wall of, any
  place of the kind mentioned in KRS 217.280. All
  persons who handle the food shall, before
  beginning work and after visiting the toilet,
  wash their hands thoroughly in clean water.
• Effective October 1, 1942

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What is Pasteurization?

• There is not a clear quantitative definition to
  the word pasteurization FDC Act (403(h))
  describes pasteurization as a safe process or
  treatment able to protect the public health
• National Advisory Committee on Microbiological
  Criteria for Foods (NACMCF) has a subcommittee to
  identify a new definition for Pasteurization

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What is Pasteurization?

• Prior to 2002 FDA considered pasteurization to be
  a thermal treatment
• Prior to 2002 FDA would not allow a nonthermal
  processing technology to promote its treatment as
  a pasteurization process
• In 2002 U.S. Congress passes a law requiring FDA
  to allow the use of the word pasteurization for
  technologies including both thermal and nonthermal

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Heat Processed Foods in Hermetically Sealed
Containers

• 1. Low acid foods (pH gt 4.6)
• 2. Acidified foods (pH lt 4.6)
• 3. Acid Foods pH lt 4.6 naturally or due to
  formulation
• Both 1 2 very strictly regulated

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Low Acid Acidified Regulations

• CFR Title 21 PART 113 -THERMALLY PROCESSED
  LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED
  CONTAINERS
• CFR Title 21 PART 114--ACIDIFIED FOODS