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Food Safety Regulatory Issues (SAFE 408/608)

Introduction to Food Safety Regulatory Issues
History of US Food Law (sec 1)
Purpose of Food Law (sec 2)
Relevant Agencies and Organizations (sec 3)
Regulatory Strategies (sec 4)
Regulating the Food Processing Sector (sec 5)
Directing Other Sectors of the Industry (sec 6)
Concluding Thoughts (sec 7)
Summary (sec 8)

Directing Other Sectors of the Food Industry (sec 6)

Overview of the Regulation of Retail Stores and Businesses that Prepare Food Away from Home and Education of Agricultural Producers and Consumers

Section 5 addressed the regulation of the food processing sector of the industry. This section briefly overviews the extent to which other sectors of the industry (such as producers, food preparers, and consumers) are regulated.

Retail Stores and Food Preparation Away from Home

  • Regulating grocery stores, restaurants, and other entities that prepare food for consumers is primarily the responsibility of state and local government.
  • This sector of the industry includes a wide variety of activities, such as retail food stores with a delicatessen, vending machines, and mobile food carts.
    • For example, see North Dakota regulations (N.D.A.C. § 33-33-04-01(29)) which defines food establishment as "an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption: (1) Such as a restaurant, satellite or catered feeding location, catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people, market, vending location, conveyance used to transport people, institution, or food bank; and (2) That relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers."
  • To assist state and local governments develop appropriate requirements, FDA developed a model Food Code that state and local governments can adopt as their law. By providing a model code, FDA significantly reduced the effort that state and local governments would have to expend in developing detailed expectations. The model code also promotes a standardized set of requirements for these businesses even though primary regulatory responsibility lies with state and local governments.
    • FDA 2009 Food Code -- is not direct federal law; it is FDA's suggestions/recommendations to the states; the suggestions, however, are based on a variety of federal statutes and regulations. North Dakota and Minnesota have promulgated a food code as state regulations. These state regulations are heavily based on the FDA's model Food Code.
  • Enforced by either the state health and agriculture departments, depending on how the state government is organized.
  • The model Food Code was first available in September 1998; states began adopting the code thereafter.
  • The model Food Code is intended to provide a uniform approach to food safety regulation; this is a benefit to interstate commerce.
  • The Food Code does not address food-processing facilities; e.g., see N.D.A.C. 33-33-04-01(29)(c)(3).

Provisions of the Food Code

  • The Code addresses concerns about storing food, cooking food, and other practices.
  • The Code also addresses concerns about facilities, equipment, utensils and materials
  • The Code requires firms to have an employee who has Food Manager Certification, that is, specific training to promote the appropriate practices by the business.
    • This requirement was included in the Food Code in 2000.
    • All establishments preparing and/or serving food need a certified food manager.
    • The food manager must take an approved training course and pass the qualification exam.
    • Food manager must apply for certification, e.g., to the MN Dept. of Health.
  • The Food Code also incorporates elements of HACCP; that is, it imposes responsibility for developing a plan for safety analysis on the business and requires firms to develop individual HACCP plans.

FDA also assists states in their regulatory role by offering a FDA Food Establishment Inspection Report Form 3-A.

  • Note the checklist the state or local government inspector will follow.
    • Also note that the emphasis is on microbial contamination.
  • Finally, note the form the inspector will use to inform the business of the results of the inspection.

Production Agriculture

These materials have addressed the processing and preparation sectors of the food industry. Now let’s shift back to earlier stages in the food industry; that is production agriculture.  What steps are being taken the production agriculture minimizes the risk of unsafe food?

  • In the past, the major strategy has been to encourage producers to voluntarily pursue education, but generally the education focused on production and quality; there was limited direct discussion about the safety of the final food product.
  • Today, the strategy is still voluntary education, but the education is more explicit on how production practices impact the final food product.  Producers are much more aware of their role in assuring their practices do not detract from the safety of the food product.
  • Some market incentives are arising wherein the buyer of ag commodity wants products produced with practices that assure buyer is acquiring commodity that will not render the final product unsafe.  It is suggested that HACCP practices may be adopted by producers because their buyers are demanding assurances that are best made if the producer has adopted HACCP-like practices.

Major topics for the Production Sector

  • Livestock medications and crop pesticides residues: food processors generally are the primary target of regulations addressing residues (see ??? ); that is, processors must assure their food products do not contain an unacceptable type or level of residue. To achieve this, processors expect the commodities they are using do not have unacceptable level of residues. The implication is that producers must adopt practices to assure the commodities they produce align with the expectations of the final food product. This expectations of producers are not being imposed by direct government regulation, but by the processors whose food product is directly regulated.
  • Organic production practices -- primary efforts at the producer level are 1) education about organic production practices and 2) certification of organic production practices.
  • Production of GMO ag commodities (e.g., soybeans and corn); primary regulatory focus is on firms develoing the GMO, not the producers who are using the GMO. Educational efforts is the primary strategy for producers involved in producing GMO commodities.
  • Education – GAPs (and the influence of HACCP)
  • Protection against intentional attack – is this an emerging concern?
  • Traceability and product liability – emerging concerns for producers; again not direct regulation (e.g., 2002 Bio-terrorism Act taht exempts recordkeeping for producers) but is arising as a result of industry pressure.
  • Import and export of live animals and plants
  • There is some regulation at the production level, such as dairy farms required to be inspected; see N.D.C.C. §4-30-36 and FDA's recommended Grade "A" Pasteurized Milk Ordinance; see Section 5 and Standards for Grade A Raw Milk. Note FDA's strategy of recommending standards for state and local governments to adopt and implement.

Consumer education

  • Consumer still makes their own decisions about what they will eat – see comment from 1962 in section 1. Government does not intend to regulate consumers, but instead to offer them education and product information so they are able to make decisions for themselves.
  • Likewise, government does not intend to regulate what occurs in the home.
  • The emphasis is on offering education so consumers are able to make decisions and follow practices that are appropriate for themselves.
  • Thus the importance of preventing misbranded product is re-emphasized; consumers need accurate information about the product so they can make informed decisions.


The next section provides some Concluding Thoughts.

Last Updated November 17, 2010

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