Adulteration addresses issues such as additives and sanitation, whereas misbranding addresses issues such as labeling and advertising.

• Adulterated food
  • use safe inputs; assure the ingredients (e.g., ag commodity is not spoiled or diseased); assure the additive is not harmful or poisonous, and that the commodity is not harmful (this last point becomes an issue when genetically-modified commodite (biotechnology) are used in food products);
  • e.g., 9 CFR 301.2 defines adulterated
  • what is being added -- color additives, food additives, dietary supplements (vitamins and minerals)
  • not being contaminated during processing -- sanitation; GMP; HACCP
  • anticipating malicious attack on food supply/food system

• Misbranded food
  • revealing infomation to consumer
  • accruately identified/standards for product
  • no misleading claims/advertising/labels
  • e.g., 9 CFR 301.2 defines misbranded

Overview of Required Actions (corollaries to the prohibited acts)

• Comply with product standards (formulation)
• Sanitation during processing
  • pass inspection
• GMP and HACCP (adopt good practices)
  • HACCP background and implementation
  • Not "command and control," but instead "performance standards"
  • USDA approval of a HACCP plan
  • Monitoring the implementation/execution of a HACCP plan
• Label properly
• Maintain records

Educate

Provide consumers some understanding so they can decide what they want to consume; this education complements laws addressing misbranding and labeling that are intended to assure consumers have accurate information on which to make their decisions.

Alternative Overview of U.S. Response

U.S. food law, whether it was intentional or a consequence of history, has basically divided the food industry into four sectors:

• Production agriculture
• Processing sector
• Retail sector that can be further divided into food that will be consumed at home (e.g., grocery stores) and food that is consumed away from home (e.g., restaurants), and
• Consumers.

Initially, U.S. food law emphasized the regulation of the processing sector wherein both federal and state governments have taken a role.  The federal agencies include the Food Safety and Inspection Service of USDA (for meat and poultry products) and the Food and Drug Administration of the Department of Health and Human Services (for nearly all other foods).  At the state level, a department of health, a department of agriculture, or a similar agency is often given the responsibility of overseeing the food processing sector.  Of course, only food that fits the broad definition of “being in interstate commerce” is within the jurisdiction of the federal agencies.

Congress has not authorized the federal agencies to address the retail sector of the food industry; those businesses are regulated by state government.  However, that has not prevented the FDA from developing suggested standards for the retail food sector, which nearly all states have adopted as statutory or regulatory law.  These suggestions are referred to as the Food Code which is updated by the FDA as that agency deems necessary.

The consumer sector is not regulated and there appears to be no interest in having society regulate the actions of individuals.  However, the law (both federal and state law) emphasizes removing unsafe food from the food chain, educating consumers, and providing them information about food products (i.e., labeling) so consumers can decide what they want to eat.  This is especially true for food sold for home consumption.  Food consumed away from home, at this time, is not subject to the same level of “labeling.”

Historically, the production sector has not been heavily regulated.  Instead, the strategy of federal and state governments has focused on educating producers to reduce the risk of food being rendered unsafe as a consequence of agricultural production practices.  This may be changing.  Federal and state laws are beginning to address production practices, but perhaps more important, the food processing and retail sectors are requiring agricultural producers to verify that the producers’ practices will not adversely impact the safety of the final food product.  At this time, good agricultural practices (GAP) may be mandated more by the marketplace (especially the global marketplace), than by law.

It is perhaps a coincident, rather than by design, that U.S. law has divided the food industry into four sectors and that each sector is being directed by a unique set of legal and market forces to address food safety concerns.  Collectively, however, these strategies strive to minimize the risk of unsafe food “from the farm to the table.”

Last updated February 6, 2010