Food Law

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Organization of U.S. Government

This page provides an overview of the structure of U.S. government and links to food safety information available from agencies responsible for overseeing the U.S. food industry.

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To better understand U.S. food law, it is helpful to understand the basic structure of U.S. government.

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Structure of U.S. Government

From the perspective of persons in the United States, there are four levels of government:  local, state, federal and international (but the international level is NOT a government, it is primarily voluntary arrangements or agreements among national governments).

  • Local governments (cities) were perhaps the first governments to address food safety, especially concerns about milk and flour/bread.

  • Local government oversight was supplanted by state and federal regulations, but cities still have authority to regulate food businesses within their jurisdiction, such as dairy processing and food service businesses (e.g. restaurants).

  • State governments have authority to regulate food businesses within their jurisdiction and primarily regulate food processing (even though much of that oversight has been supplanted by federal law) and the retail sector, such as, restaurants (food services) and grocery stores.

  • U.S. federal law primarily focuses on regulating the food processing sector.

  • Of course, most other nations also have national food laws to address food safety concerns in their country.

  • There is no international government; there are non-government organizations (NGOs) that suggest standards for national governments to adopt in an effort to harmonize food standards and thereby reduce political hurdles to international food trade.  There also are trade agreements negotiated among national governments and some of these agreements may address food safety issues that arise from import and export of food products.  Disputes among nations are resolved by either negotiating resolutions among the disputing nations, or severing their interactions and other economic ties.  Hopefully the disputing nations will not resort to military conflict to resolve a dispute.

As a general rule, if there is a conflict between state law and federal law in the United States, federal law prevails over (preempts) state law (U.S. Const. Art. VI).

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Source of Legal Authority in the United States

The people are the ultimate source of legal authority in the United States.  For example,

  • "We the people of the United States ... ordain and establish this Constitution for the United States of America."  U.S. Const. Preamble
  • "All political power is inherent in the people. Government is instituted for the protection, security and benefit of the people, and they (the people) have a right to alter or reform the same (the government) whenever the public good may require."  N.D. Const. Art. 1, Sec. 2.

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Role of Constitutions

The United States uses constitutions to establish government; that is, the U.S. Constitution establishes the federal government and state constitutions establish state governments.  The U.S. Constitution (as well as the state constitutions) define the authority of government (the authority of local government is based on its state's constitution).  Government, whether the federal government, state government, or local government, can only do what it is authorized to do in its respective constitution, and cannot do what it is prohibited from doing in the constitution.

The following examples illustrate authorities and prohibitions in the U.S. and North Dakota Constitutions.

  • Example of an authority granted to the federal government in the U.S. Constitution:  "The Congress shall have power to ... To regulate commerce with foreign nations, and among the several states, and with the Indian tribes."  U.S. Const. Art. II, Sec. 8. This example was chosen because this statement in the U.S. Constitution is the basis for the federal government to regulate the food industry in the United States, based on the understanding that most food in the United States fits the definition of interstate commerce (that is, "commerce ... among the several states...").

  • Example of an action that the U.S. Constitution prohibits the federal government from doing:  "No tax or duty shall be laid on articles exported from any state."  U.S. Const. Art. II, Sec. 9.  This example was chosen to clarify that no tax will be imposed on food (or any other product) as it is moved from one state to another.  This prohibition was included in the U.S. Constitution in the late 1700s as a way to prevent tax from interfering with interstate commerce -- an idea based on the assumption that interstate commerce is important to the economic growth of the nation.  This assumption continues to be held today; many people believe that commerce among nations also stimulates global economic growth.

  • Example of an authority granted to the North Dakota state government by the North Dakota Constitution:  "The legislative assembly shall enact all laws necessary to carry into effect the provisions of this constitution." N.D. Const. Art. IV, Sec. 13.

  • Example of an action that the North Dakota Constitution prohibits North Dakota state government from doing:  "The free exercise and enjoyment of religious profession and worship, without discrimination or preference shall be forever guaranteed in this state..."   N.D. Const. Art. I, Sec. 3. This constitutional right for individuals prohibits state government from taking any action that infringes on an individual's religious beliefs and practices.  This prohibition, however, does not forbid people from relying on their religious values when deciding how to vote for government officials.

  • Example of an action that the U.S. Constitution prohibits for all levels of government in the United States:  "No person shall be ... deprived of life, liberty, or property, without due process of law; nor shall private property be taken for public use, without just compensation."  U.S. Const. Amend. V.  This example was chosen because it begins to define a limit to the regulatory authority of the government in the United States, including the authority of government to regulate the food industry.

Constitutions are intended to reflect the thinking of the voters.  To preserve this idea, only voters in the state can amend the North Dakota Constitution (not the state legislature) and only a majority of the states can amend the U.S. Constitution (not the Congress); see U.S. Const. Art. V and N.D. Const. Art. IV, Sec. 16 and Art. III, Sec. 9.  In summary, the government has no more authority than what the people have granted to the government.

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Branches of Government

The U.S. Constitution and the state constitutions establish three branches of government:  legislative, executive and judicial.  The following sections focus on the role of each branch of U.S. government and the type of law each branch creates.

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The Role of Each Branch of Government

Each branch of U.S. government has a distinctive role.

  • Legislative branch:  the elected officials who comprise the legislative branch set public policy by enacting statutes. The federal legislative branch is Congress; state legislative branches are usually referred to as legislatures.

    • Suggestions or ideas for proposed policies come from many sources, including citizens, government agencies, and the president (or governor).

    • Sometimes the proposal addresses novel policy issues; other times, the proposal revisits issues that have been previously addressed by a court or the legislature. The reason to revisit an issue is because the current legislature wants to reinforce, clarify, or change the current law.

      • The following statement by the North Dakota Supreme Court clearly indicates the respective responsibilities of the legislative and judicial branches of government:  "The legislature, not this Court, should weigh the competing policy concerns and decide whether to change the clear statutory language." Treiber v. Elmer, 1999 ND 130, ¶ 17, 598 N.W.2d 96.

    • Statutes cannot conflict with the Constitution. The following statements are excerpts from two court decisions in which the courts determined that an amendment to a state constitution and a local ordinance were invalid because they conflicted with the U.S. Constitution.

      • "states may not enact laws that discriminate against or unduly burden interstate commerce... Because we conclude that Amendment E was motivated by a discriminatory purpose, we must strike it down as unconstitutional ..." S.D. Farm Bureau v. Hazeltine (2003) striking down Amendment E of the South Dakota Constitution, which limited corporate farming, because it conflicted with the U.S. Constitution.

      • "The ordinance discriminates against interstate commerce [clause of the U.S. Constitution], and thus is invalid." C & A Carbone, Inc. v. Town of Clarkstown, New York

    • Federal statutes are compiled in the United States Code (U.S.C.); state statutes are compiled in the states' code, such as the North Dakota Century Code (N.D.C.C.).

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  • Executive branch:  executes or implements the statutes enacted by the legislative branch.  The executive branch consists of some elected officials and numerous government agency employees.  For example, the only person elected in the U.S. federal executive branch is the president/vice president team.  All other members of the federal executive branch are agency employees who have been appointed or hired (directly or indirectly) by the president.

    • At the state level, the governor leads the executive branch.  In some states, such as North Dakota, several members of the executive branch are elected, for example, the Governor, Agriculture Commissioner, Tax Commissioner, Commerce Commissioner, and the Attorney General.  In other states, fewer state officials are elected; in those states, the governor appoints these executive heads.

    • Executive agencies (whether at the federal level or state level) promulgate regulations to set forth details about implementing the statutes.

    • Regulations cannot conflict with the Constitution nor the underlying statute that serves as the foundation for the regulation.  Restated, the executive branch can do no more than it is authorized to do in the statutes enacted by the legislative branch; nor can the executive branch ignore the mandates that the legislative branch imposes on the executive branch.  The following examples illustrate a statute in which the legislative branch mandates action by the executive branch as well as a statute wherein the legislative branch grants the executive agency a discretionary authority.
      • N.D.C.C. 23-09-11. "Every ... food establishment ... must be inspected at least once every two years by the [North Dakota state] department [of health]."  Note the mandatory language in this statute.

      • N.D.C.C. 23-09-16.  "The [North Dakota state] department [of health] may adopt rules [regulations] establishing the amount and the procedures for the collection of annual license fees [from food establishments]."  Note the discretionary nature of this legislative authorization.

    • Federal regulations are compiled in the Code of Federal Regulations (CFR); state regulations are compiled in the states' regulatory code, such as the North Dakota Administrative Code (N.D.A.C.).

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  • Judicial branch:  resolves disputes and interprets the law.

    • The judicial branch of government is the court system. It is comprised of trial courts (to determine the facts) and appellate courts (to interpret or clarify the Constitution, statutes, regulations and common law).
    • The court system is our society's mechanism for resolving disputes (it is better than using force or resorting to violence to resolve disputes).
      • "Litigation is civilized war." Doug Nill, attorney and '81 NDSU graduate, BS Ag Economics, quoted in AGWEEK , May 10, 2004, page 30.
    • Types of Court Cases
      • Criminal court case -- state government charges a person with a crime; the penalty for committing a crime will be either imprisonment or a fine. This web site does NOT address criminal law.

        • "A criminal action is one prosecuted by the state as a party against a person charged with a public offense..." N.D.C.C. §32-01-05 .
        • In food law, the regulatory government agency (such as the Food & Drug Administration) may initiate the process for having a food company charged with a crime, especially if the food company is not cooperating in resolving a food safety problem.  If the company is found guilty of the crime, the company may be punished with a fine.
        • See U.S. Department of Justice.  Bringing Criminal Charges Against Corporations. Memorandum dated June 16, 1999 at http://www.justice.gov/criminal/fraud/documents/reports/1999/charging-corps.PDF ; viewed November 18, 2012.
        • September 26, 2013: Eric and Ryan Jensen Charged with Introducing Tainted Cantaloupe into Interstate Commerce at http://www.fda.gov/ICECI/CriminalInvestigations/ucm374349.htm.  "The defendants were aware that their cantaloupes could be contaminated with harmful bacteria if not sufficiently washed."  It is the awareness of the problem, coupled with failure to remedy a known problem, that led to criminal charges against the producers when their product caused the death and illness of consumers.
        • September 21, 2015:  "the Parnells, Lightsey and Kilgore participated in a scheme to fabricate COAs that stated that the food at issue was free of pathogens when in fact there had been no testing of the food or tests had revealed the presence of pathogens."  See http://www.justice.gov/opa/pr/former-peanut-company-president-receives-largest-criminal-sentence-food-safety-case-two  .  Evidence presented in court established that the executives of the food business knew the contaminated condition of their product but took steps to mislead the buyers of their product.  Their knowledge of the problem and their subsequent actions to disguise the problem underpinned the decision to charge them with criminal offenses.
          • COA is a certificate of analysis, that is, a document summarizing laboratory results, such as test results concerning the presence or absence of pathogens in food.
      • Civil court case -- dispute between two parties (e.g., an ill consumer and the food company that the consumer believes caused the food to be unsafe).  A civil court case is not a crime. The solution generally will be a court ordering one party to compensate the injured party and/or to stop their illegal activities.
        • In food law, a civil case may arise when an ill consumer (the plaintiff) initiates a lawsuit (litigation) against a food company (defendant) that the consumer thinks caused the food to be unsafe.  A payment to an ill consumer from a food company that caused the food to be unsafe is intended to resolve the dispute by compensating the ill consumer.
          • "As a general rule compensation is the relief or remedy provided by the law ... for the violation of private rights ..." N.D.C.C. §32-01-11.
        • The FDA also may initiate a civil action to request the court order a food company to not move or sell a food that is found to be in violation of the law; that is, food that is adulterated or misbranded.
        • Courts also decide whether there is a conflict among a regulation, statute, and Constitution.  If there is a conflict, the Constitution prevails and the conflicting portion of the statute or regulations will not be enforced.  If the (administrative agency) regulation is not consistent with the (Congressional/legislative) statute, the regulation will not be enforced.
        • Civil lawsuits are initiated in a trial court. The task for the jury (or in some cases, the judge) is to listen to the evidence presented by the litigants, decide what happened, and determine a solution to the dispute. The judge oversees the trial process to assure all litigants are given an opportunity to present their information and to assure the jury appropriately applies the law to the facts of the case.
        • An appellate court reviews the action of the trial court.  A litigant will initiate an appeal if the litigant feels the trial judge made a mistake in overseeing the trial process or in interpreting and applying the law. The appellate court does not determine the facts of the case (that has already been done by the trial court); the appellate court focuses on whether the law was correctly interpreted and applied during the trial process.
        • Appellate court decisions/opinions serve as precedence for later disputes with similar facts and questions.  These decisions are referred to as the common law. These decisions often are clarifications or interpretations of the law, including interpretations of the Constitution, a statute, a regulation, a previous court decision, or a combination of these.
        • Although appellate court decisions are primarily intended to interpret current law, there are times when court decisions serve as an indicator of society's concept of right and wrong, especially if the legislature has not clearly stated a policy or direction. Thus judicial decisions can influence legislators (policy).

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The Type of Law Created by Each Branch of Government

Each branch of government creates its own type of law.  The legislative branch enacts statutes; the executive branch promulgates regulations, and the judicial branch renders court decisions or opinions.  The purpose of each type of law reflects the role or purpose of the branches of government; that is, (legislative) statutes set forth public policy, (administrative) regulations add details as to how statutes will be executed, and court decisions (court opinions) explain, interpret or clarify the Constitution, statutes, regulations, and previous court decisions.

The processes by which a legislature enacts a statute, an agency promulgates a regulation, or an appellate court renders a decision are not the same.  This paragraph focuses on the process by which a federal agency promulgates a regulation because this process appears to be least understood.  It also is important to understand the process because regulatory law (i.e., regulations) are created by government employees, not elected officials.  Accordingly, it is important to understand the process of promulgating a regulation so people recognize their opportunity to provide input into regulatory/administrative law.

The general procedure a federal agency will follow when promulgating a regulation is:

  • The agency intending to promulgate a regulation may publish an "Advance notice of proposed rulemaking; invitation to comment" (optional) in Federal Register. This notice informs interested persons, businesses, and others that a regulation will soon be proposed.
  • The agency publishes the proposed regulation in the Federal Register.
  • A period of time is specified for comment and public hearing; it is an opportunity for concerned or interested persons or groups to comment on the proposed regulation.  The time often is 30-, 60-, 90-days, as deemed appropriate for the proposed regulation.
  • The agency will consider the public comments, decide whether to revise the proposed regulation, and then publish the final regulation in Federal Register.  At that point, the regulation takes effect as a standard that the food industry must meet.

Visit Interaction Between a Statute and a Regulation for an example of the interaction between a statute and a regulation.

Of course as suggested above, a person can initiate a lawsuit if the person believes a regulation is not consistent with its underlying statute or the Constitution.

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Locating Food Laws

U.S. law is accessible, whether it is a statute, regulation or court decision; and whether it is federal, state or local laws.  With internet capabilities, these laws are "at the fingertips" of most people.  The following list provides internet connections to some U.S. food law.

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Sources of Information about U.S. Food Law

Despite the availability of U.S. law, they are not always easy to understand.  Another source of information about U.S. food law may be explanations provided by the agencies responsible for executing the laws, such as the Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) of the USDA.

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Summary

U.S. law reflects the structure of government.  Perhaps most important to understand is 1) the legislative branch of government sets public policy by enacting statutory laws, 2) the executive branch of government implements the statutory laws and adds details by promulgating regulations, and 3) the judiciary branch of government resolves disputes, including the interpretation of constitutions, statutes, regulations, and prior court decisions (i.e., the common law).

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Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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