regulations and schemes Overview

U.S. Federal law divides the food processing sector into two broad categories: meat and poultry which is overseen by the Food Safety Inspection Service (FSIS) of the USDA and all other food processors as overseen by the FDA. The food processing sector includes the processing, warehousing and transportation of food.  Pet food, animal, livestock feed are also subject to sanitary regulations.  Within the FDA The Center for Food Safety and Applied Nutrition (CFSAN) focuses on human food and The center for Veterinary Medicine (CVM) is responsible for animals.  Within Canada the Canadian Food Inspection Agency is dedicated to the safeguarding of food, plants, and animals.  Mexico’s equivalent of the FDA is COFEPRIS.

There have been a variety of congressional acts, including the Food Safety Modernization Act (FSMA), that regulate the United States Food Chain. These acts are codified into law in the Federal Register which contains the Code of Federal Regulations (CFR). There are three titles relevant to the Food Chain safety. Title 7 – Agriculture, Title 9 – Animals and Animal Products, and Title 21 – Food and Drugs. These titles are divided into parts. So for example if you see 21 CFR part 110 you can see that it relates to Food and Drugs and can go into the Federal Regulations to see that it describes “Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.”

Independent of Government a global food safety standard (or scheme) emerged called the Global Food Safety Initiative (GFSI). GFSI is a non-profit making foundation sponsored by Belgium that benchmarks existing food standards against food safety criteria, and also looks to develop mechanisms to exchange information in the supply chain, to raise consumer awareness and to review existing good retail practices. GFSI does not provide food safety certifications but instead recognizes a number of certification programs that meet the GFSI requirements.

These certification programs (or schemes) include:

  • SQF
  • FSSC 22000
  • IFS International Featured Standards
  • primusGFS

It is not realistic for a typical food processor to read the vast number of pages in the Federal Register and then independently take the steps necessary to be in compliance.  There are a variety of schemes including SQF and FSSC 22000 that when implemented ensure that you are in compliance with the FSMA and GFSI. So if the scheme is implemented you and your customers can be sure you are in compliance with laws and the GFSI standard.

The FDA, USDA, and CFIA require registration of all food processors, etc and under their jurisdiction conduct food safety audits. These audits are both announced and unannounced. When they find practices or conditions that are not in compliance with the regulations they issue “non-compliance” findings.  Depending upon the severity of the non-compliance findings penalties up to criminal prosecution can occur. Because inspections may occur at any time the food processors need to have an ongoing food safety program. The food safety schemes like SQF provide the guidelines on how to do that.

The schemes ensure compliance in the following areas required under FSMA:

  • Federal Registration
  • Hazard Analysis and Critical Control Point (HACCP) Food Safety Plan
  • Food Defense Plan to prevent intentional attacks
  • Good Manufacturing Practices (GMPs/SSOPs)
  • Standard of Identity reflected properly on labels
  • Food Additives and GRAS (Generally Recognized as Safe)
  • Color Additives
  • Supplier Verification
  • Contact Surfaces, Water and Air
  • Packaging
  • Labeling
  • Nutrient Content and Health Claims
  • Product Recall and Recall Plan
  • Record Keeping
  • Employee Training
  • Food Imports and Exports
  • Reportable Food Registry
  • The National Outbreak Reporting System (NORS)
  • Enforcement

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