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Overview of US Response

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Introduction
Overview

Government "Players"
Requirements
Producer/Processor/Preparer Liability
Looking Forward/Future Issues

Overview of US Government Response

The current strategy of the US response to food safety centers on several key concepts:

  • food that is known to pose a risk of causing illness will be removed from the supply chain,
  • consumers are responsible for deciding what foods they will consume (based on the assumption that unsafe foods have been removed from the food supply),
  • consumers must be provided accurate information about the food product so they can make informed decisions, and
  • consumers should have educational opportunities to learn how to make good decisions about their food consumption.

Implementing these key concepts has been built upon 3 steps - prohibiting adulterated foods, prohibiting misbranded foods, and offering education. The corollary to the prohibitions is to mandate specific practices that help assure food is unadulterated and not misbranded. Thus the majority of the discussion about food safety addresses

  • what actions are prohibited and what steps are required to assure food is unadulterated,
  • what actions are prohibited and what steps are required to assure food is not misbranded, and
  • providing education about making sound food decisions.

Examples of each include

  • not adding substances that are likely to cause illness,
  • following sanitary procedures during food manufacturing,
  • not using containers that deceive the consumer as to the quantity of the food,
  • providing nutritional information about the food product, and
  • providing information for consumers to learn about safe at-home food preparation practices.

U.S. federal laws dealing with food safety concerns initially addressed the processing sector of the food industry, but other sectors (e.g., final preparation, retail sale, commodity production) have subsequently been subject of government overview. For example, retail sales and final food preparation are subject to state rules (with considerable input from federal agencies), whereas rules for addressing safety concerns in much of the production sector are jsut being devised at this time.

The Function of Food Laws

  • Protect the public health from the adverse consequences of unsafe foods.
    • "Rose Acre [an egg producer] observes that salmonella is not dangerous to the animals; it is contagious among animals but does not injure them. According to Rose Acre, only diseases dangerous to animals fall within the jurisdiction of the Secretary of Agriculture. When the disease is dangerous exclusively to humans, Rose Acre insists, the Food and Drug Administration is the appropriate regulator. The Secretary of Agriculture has neither statutory mandate nor expertise in dealing with human diseases, it submits...

    "The district judge rejected Rose Acre's contention, and properly so... Control of illness among farm animals is for the welfare of humans: to protect our health from diseases animals carry, and to protect our wallets from the costs of sacrificing additional animals should the infection spread. Salmonella spreads from animals to people; it spreads among animals, potentially increasing the financial cost to farmers; and fear of salmonella depresses the demand for dairy and poultry products, again injuring agriculture. Nothing in the text of secs. 111, 114, 114a, or 120 confines the Secretary to addressing diseases fatal to animals."

    Rose Acre Farms, Inc., v. Madigan, U.S. Court of Appeals for the Seventh Circuit, Nos. 91-2358 and 91-2514. February 10, 1992

  • Convey information to the consumers, such as package labeling requirements (labeling strives to provide consumers with information so they can make an informed decision) and education programs.
  • Protect against fraud; e.g., assure that the package contains what the label states.
  • Assure fair trade practices to prevent sellers from misrepresenting what they are selling and from misleading consumers about the quality of the product.
  • Protect the environment; recognizing that food production systems impact air and water qualities.

Consider this site as mandatory reading!

  • A Description Of The U.S. Food Safety System -- a web site prepared by Food Safety and Inspection Service (FSIS) of the USDA. This document, prepared in early 2000, provides an overview of US food safety system; also look at the information/links contained in Annex 1 and Annex 2. 

 

Prohibited Acts

Several Congressional acts prohibit adulterated and misbranded foods; these include the Food, Drug and Comestic Act (21 U.S.C. 331), the Meat Inspection Act (21 U.S.C. 610; 9 CFR 301.2), and the Poultry Product Inspection Act ( 21 U.S.C. 458; 9 CFR 381.1), and the Egg Product Inspection Act (21 U.S.C. 1037; 9 CFR 590.5).

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

   
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