Best if printed in landscape.

How US law is created

Process of creating and enforcing food law

We, the people of the United States, -- opening phrase of the Preamble to the US Constitution.

The U.S. government can do no more than the people allow it to do and the grant of power from the people to the government is delineated in the Constitution. This arrangement implies that unless an action is prohibited, the people are free to take that action.

Another key point is that government does not empower people, but instead, people grant power to government.

Other nations may follow a thought process that the power lies with government and that people are allowed to do only what government has granted them the authority to do.

U.S. Government is Reactive?

This value that power flows from the people to government can significantly impact how laws, such as food safety laws, are updated and revised. Under the U.S. system of government, regulatory agencies can take no action unless Congress authorizes them to do so, and Congress may not grant that authorization until there is strong support among the people that such government action is necessary - even though informed persons such as agency experts feel such government action would be beneficial.

Other forms of government may be able to respond more quickly to a problem if the responsible agency does not have to wait for the political process to convince Congress to extend such authority to the regulatory body. This fundamental difference in who holds the authority has practical, as well as major long-term implications. It can also lead to differences in how and when the United States responds to an emerging or new food safety issue and how another nation responds to the same food safety concern.

Overview of U.S. Legal System

Also see Overview of Legal System (mandatory reading!)

To understand food law, it is helpful to generally understand the U.S. legal system and government structure.

Statutes

• Congressional action is necessary for any federal statute to be enacted; Congress is unlikely to enact a statute unless there is political pressure/support to do so.
• General principles are set forth by Congress in the statutes; Congress relies on agencies (in the executive branch of the federal government) to specify the details of the program (these are set forth in regulations), implement and enforce/assure compliance.

• Clarification of authority -- Congress specifies which agency is to implement a program, but one statute may impose the responsibility on one agency and the next statute with a related program may impose that responsibility on another agenc. This can sometimes lead to confusion and complexity for agenices responsible for implementing the programs and for businesses that need to comply with several programs. For example:
  • FDA regulates macaroni and noodle products (21 CFR Part 139) while USDA regulates spaghetti products that contain meatballs and sauce (9 CFR 319.306);
  • FDA regulates Grade A (fluid) milk (21 CFR 131); USDA regulates dairy products such as butter and cheese (7 CFR Part 58); but state governments also are often involved (e.g., ND Dept of Ag, Dairy Division);
  • An open-face sandwich with meat or poultry is regulated by USDA; a closed sandwich with meat or poultry is regulated by FDA;
  • Soup with more than 2% meat is regulated by USDA; other soup is regulated by FDA;
  • Pizza with cheese is regulated by FDA; pizza with meat and cheese is regulated by USDA; but USDA regulates cheese (see previous point), so why would FDA regulate cheese pizza?  Explanation -- cheese is only an ingredient in cheese pizza; cheese is not the ultimate product in this case (it is pizza); thus FDA regulates pizza where cheese is an ingredient;
  • Canned beans with more than 2% meat/pork is regulated by USDA; other beans are regulated by FDA;
  • Beef broth is regulated by USDA; dehydrated beef broth is regulated by FDA; dehydrated chicken broth is regulated by USDA; chicken broth is regulated by FDA.
    • review FDA/USDA Jurisdiction Chart

• Continual updating -- due to changing conditions and needs, laws also continue to evolve. This ongoing change often clarifies issues by addressing unanswered questions, but it also raises new issues such as interpreting the new laws and reconciling new laws with existing laws.

• It can be argued that when the government limits an individual's activity, the government is "taking" a property right, and the US. Constitution, Amendment V requires that an individual be compensated if the government takes a property right. Based on this thinking, one might further argue that a food busienss is entitled to government compensation when a regulation is imposed that limits how the business can be operated.
• However if the limitation is imposed in order "to promote the general safety, health, and well-being of society," the government can "take" or limit that right without compensating the owner. In such a situation, the government action is considered to be an exercise of the government's police power. Restated, police power generally defines the limit of action government can take without compensating the individuals affected by the government action.
• In summary, all regulations imposed on the food industry must fit within the scope of an exercise of police power in order to be valid.

• Another key point is that Congress can do no more than it is authorized to do in the Constitution. Thus a statute is valid only if it does not conflict with the Constitution. A statute that conflicts with the Constitution is invalid and unenforceable.

Regulations

• Agencies of the Executive Branch are given responsibility by Congress to implement the programs (execute the statutes) that Congress enacts.
• Details about application and enforcement of the programs are set forth (promlugated) by the responsible agency in the form of regulations.
• Agencies must follow a process when promulgating regulations, that is, the Rule-making Process:

• Proposed rules are published in the Federal Register

• Advanced notice of plans to issue proposed rules is sometimes given as a way for the agency to gather public input before drafting the proposed rules.

• Comments are received from the public in response to the proposed rules; the agency is required to consider and respond to each comment (sometimes 1000s of comments); a public hearing also is often held as part of the comment process

• The final rule is subsequently published as a regulation in the Federal Register after the agency has reviewed the comments and revised the proposed rule.

  Example of interaction between a Congressional statute and an agency regulation (mandatory reading!)

• The purpose of the process used to promulgate a regulation is to assure there is an opportunity for public awareness and input into the new regulation.

• Force of Law -- a regulation has the force of law (it is enforceable) after the rule making process has been completed.

• Code of Federal Regulations (CFR) -- regulations are then compiled and published in the Code of Federal Regulations.

• Example, FDA regulations are found in Title 21 of CFR; parts 1-199 address food issues.

• USDA regulations for animals and animal products are found in Title 9 of CFR.

• The CFR also can be searched at http://www.gpoaccess.gov/cfr/index.html.

• An agency can do no more than what Congress has authorized it to do; likewise, agencies are required to do everything that Congress mandates they must do.  Conflicts between Congressional direction (the federal statute) and the agency action are often resolved with litigation in court.

• The issue in these legal cases is not whether the statute or the regulations prevails -- the statute always prevail; instead, the issue is whether the regulation is in compliance with the statute.

Court Decisions

In addition to statutes and regulations, court decisions interpreting the statutes, regulations and Constitution influence government oversight of the food industry. The brief excerptions that follow illustrate how court decisions influence (determine) the interpretation and administration of our laws.

• Shamrock Farms v. Venman, 9th Circuit Court of Appeals, case number 97-15428, July 2, 1998

• "Shamrock asserted that California processors received a competitive advantage against out-of-state processors because California only gave the fortification allowance to in-state processors.

• "CONCLUSION Congress has insulated California's milk laws against Commerce Clause challenges, and the district court therefore properly dismissed Shamrock's claims..."

 

• In this court case, dairy processors from outside California argued that the state statute was invalid because it conflicted with the U.S. Constitution which prohibits statutes that favor the citizens of one state over the citizens of another state. The court, however, interpreted the statute and the Constitution and decided that the statute did not conflict with Constitution and therefore was a valid statute. This case illustrates that the judicial branch of government, i.e., the courts, are responsible for interpreting the Constitution and statutes, and determining whether a statute conflicts with the Constitution.

 

• Hillside Dairy Inc. v. Lyons, U.S. Supreme Court (01-950), June 9, 2003.

• "The text of the federal statute plainly covers California laws regulating the composition and labeling of fluid milk products, but does not mention laws regulating pricing. Congress certainly has the power to authorize state regulations that burden or discriminate against interstate commerce ... but we will not assume that it has done so unless such an intent is clearly expressed... While §144 unambiguously expresses such an intent with respect to California's compositional and labeling laws, that expression does not encompass the pricing and pooling laws ... Because §144 does not clearly express an intent to insulate California's pricing and pooling laws from a Commerce Clause challenge, the Court of Appeals erred in relying on §144 to dismiss the challenge."

 

• In this court case, the justices decided that the statute was invalid because it did conflict with the Constitution. This case again illustrates the role of the judicial branch of government, that is, to resolve disputes, which includes interpreting the Constitution and statutes, if necessary to resolve a dispute.

Enforcing the food safety law

• To enforce food laws, agencies have the authority to seek injunctions, seize unsafe food products, impose penalties, mandate product recalls, encourage voluntary product recalls, and stop inspections of food businesses.  Each of these is discussed on another web page.

• In the past, the basic government strategy for implementing legal requirements has been "command and control;" that is, the government set standards that were applied to all businesses and responded when it became aware of a violation. More recently, the approach has been for government to set more general standards and require the businesses to provide individual plans as to how it would operate to meet those standards. The government then holds the business accountable to the plan the business developed. This change in practice allows business to develop ideas as to how it will operate and has led to practices such as HACCP, as discussed on another web page.

Example of Interaction among Agencies and Enforcement

The following excerpt is from Rose Acre Farms, Inc., v. United States, United States Court of Appeals for the Federal Circuit, No. 03-5103, June 30, 2004. The case illustrates how agencies attempt to administer the law. It also illustrates that there is not always total agreement on the process being followed.

In the late 1980s, the Centers for Disease Control ("CDC") determined that the incidence and geographic spread of human illness resulting from exposure to Salmonella enteritidis serotype enteritidis ("SE") bacteria was increasing. In response to the increase, the Animal Plant Health and Inspection Service ("APHIS"), a USDA division responsible for preventing the spread of communicable diseases, determined that emergency regulations were necessary to control the spread of SE in poultry flocks. On February 16, 1990, USDA published interim regulations that restricted the interstate sale and transportation of eggs and poultry from flocks determined under the regulations to be SE-contaminated. Poultry Affected by Salmonella Enteritidis ... (codified at 9 C.F.R. §§ 82.30-82.36 (1991)). The interim regulations were effective immediately upon publication, USDA having "determined that there is good cause for publishing this rule without prior opportunity for public comment," namely, the need for "[i]mmediate action . . . to prevent harm to the egg-type chicken industry and the public."

The interim regulations applied to "flocks," defined as "[a]ll the poultry on one premises," ... and operated as follows. If "a Federal or State representative determine[d] through epidemiologic investigation that [a] flock [was] the probable source of disease in an outbreak of [SE-caused] disease in humans or poultry," USDA designated the flock as a "study flock." ... A study flock was subsequently designated a "test flock" if either (1) "one or more" environmental test samples, i.e., "manure samples and egg transport machinery samples . . . collected and tested in accordance with" procedures set forth in the interim regulations tested positive for SE, or (2) "the person in control of the flock" refused to allow or interfered with the collection of such samples. Id. § 82.32(b). At the time the interim regulations were published, USDA believed that evidence of SE in layer hens' environment meant that the hens were infected and would, therefore, be more likely to produce SE-contaminated eggs. See 55 Fed. Reg. at 5576 (describing the "vertical" (hen to egg) and "horizontal" (environment to hen) modes of SE transmission).

"Test flock" status triggered restrictions on the interstate movement of eggs. Specifically, eggs from a test flock could be moved interstate only for uses requiring pasteurization, and then only if the shipper obtained a permit and met other conditions. 9 C.F.R. § 82.33(a) (1991). Thus, the interim regulations prohibited the interstate shipment of test flock eggs for sale as table eggs.

Specified numbers of the hens in test flocks were also required to undergo blood and internal-organ testing ... A test flock was designated an "infected flock" if the organs of one or more hens tested positive for SE. Id. Infected flocks were subject to the same interstate transportation restrictions as test flocks ... An infected flock retained its "infected" designation until either (1) the flock was retested in accordance with the regulations and no internal organ tested positive for SE or (2) the houses that contained the infected flock were depopulated, subjected to specified wet cleaning and disinfecting procedures, and repopulated with a new flock ...

After USDA reviewed comments received from interested parties following the publication of the interim regulations, it published final SE regulations on January 30, 1991 ... The final regulations incorporated all of the above requirements, but authorized the imposition of restrictions on individual layer houses as opposed to whole flocks ... A provision conditioning release from "infected" status on a successful post-cleaning inspection of a depopulated infected house by a federal or state official was added ... Additional testing and retesting requirements were imposed on all houses on the same premises as any infected house ...

APHIS administered these SE regulations until mid-1995. A total of thirty-eight flocks were restricted between 1990 and 1994, resulting in over 1.3 billion eggs being diverted from the United States table egg market to breaker plants.

In 1990, after the interim regulations took effect, SE illness outbreaks were traced to each of [several Rose Acre farms]. As a result of testing carried out in accordance with the interim regulations, USDA first restricted the interstate transportation of eggs from these three farms on October 5, 1990, November 27, 1990, and January 15, 1991, respectively. In each case, Indiana officials similarly restricted the intrastate transportation of eggs (except for uses requiring pasteurization) shortly after receiving notice of the federal restrictions.

After "test flock" restrictions were imposed as a result of environmental testing at each affected Rose Acre farm, USDA conducted blood and organ testing as set forth in the regulations. For organ testing, USDA employees physically removed 60 hens (whose blood had tested positive) from each house, killed them, and transported their carcasses to a USDA laboratory in Ames, Iowa. As described above, a single positive organ result in a given house resulted in an "infected house" designation. No additional transportation restrictions were imposed as a result of an "infected" designation; obtaining release from restricted status, however, became more difficult. At first, Rose Acre tried to obtain release through continued organ testing of the hens in infected houses. For the most part, however, Rose Acre had to depopulate, clean, and disinfect infected houses, and then have those houses pass USDA inspection. The trial court noted that in some cases, houses were empty for long periods while awaiting inspection ... It also noted that USDA inspection officials did no more than visually examine the interior of depopulated houses (after cleaning) with the aid of flashlights. Id.

Rose Acre finally succeeded in obtaining release from the restrictions imposed on [the three farms] on July 16, 1992, May 8, 1992, and October 30, 1992, respectively. Thus, for a period of twenty-five months, Rose Acre was unable to sell eggs as table eggs from one or more of the three farms.

[The court goes on to discuss whether Rose Acre Farms is entitled to be compensated for this interruption of its normal business operations.]

• This case illustrates how the agencies needed to first develop regulations that had the "force of law" before the agency could apply those regulations against a business. In this situation, the agency expedited the process of promulgating the regulations in an effort to shorten its response time to an existing problem.
• Also note the detailed process described in the regulations. Again, the underlying statute enacted by Congress often sets a general policy direction with the expectation that the agencies of the executive branch will promulgate detailed regulations before implementing the law.

How is international law created?

The extensive and expanding global trade of food (and many other products) necessitates that nations and businesses understand the rules that guide their transactions. There is no global supreme legal authority, but there needs to be a set of rules for trading partners. Therefore, the current process for establishing such rules is negotiations among nations.

• Voluntary negotiations that culminate in treaties;
• Cannot "force" compliance but can motivate compliance through economic impacts, such as no one is willing to transact business with a nation that does not agree to the standards.
  • This is different than the laws of a nation; for example in the U.S., once a majority supports and enacts a law, everyone is required to comply with it, even if they did not support its enactment.
• Treaties often provide a dispute resolution process for nations that have ratified the treaty.

If these agreements are bilateral (that is, between two nations), a nation wanting to trade with most other nations in the world would need to negotiate and maintain more than 140 trade agreements -- one for each other nation in the world. If most nations in the world would want to trade with most other nations in the world, and the trade agreements were primarily bilateral, there would be thousands of agreements. In addition, any variation of standards among those agreements would force businesses to have to produce products with slight variations based on which nation is buying the product. It is apparent that a system of international trade this is based primarily on bilateral agreements would be cumbersome.

The alternative is multi-lateral agreements wherein a group of nations agree to one set of standards/rules for trade among any members of the group. One challenge, though, is negotiating one agreement that numerous nations would agree to and support. The process of negotiating multi-lateral trade agreements is ongoing and will likely be a challenge for many years into the future. However, the desire of consumers and sellers to do business with people in other nations will continue to push the need for an understandable and functional set of international rules.

Bottom line -- ongoing advances in communication, transportation, and production technologies will continue to fuel the desire of consumers and sellers to transact business regardless of where each party is located, and this desire will continue to fuel the need for rules for international trade. The challenge of establishing these rules is not likely to diminish. Our challenge, then, is how do we accomplish the task of establishing the rules for international trade through multi-lateral negotiations.

Locating U.S. Laws

The next page introduces how to find statutes, regulations, and court decisions (that is, the laws) that direct the activities of the food industry.

Summary

• U.S. legal authority arises from the people who have empowered government as specified in the Constitution.
• Congress (the legislative branch) sets policy directions by enacting statutes. These statutes must be consistent with the Constitution.
• The Executive branch of government (i.e., the President and the agencies of the Executive branch) is responsible for implementing and enforcing the statutory laws. The Executive branch also sets forth detailed legal standards in the form of regulations that must be consistent with the underlying statute and the Constitution.
• The Judicial branch of government (i.e., trial and appellate courts) is responsible for resolving disputes, including issues relating to whether a statute is consistent with the Constitution, whether a regulation is consistent with its underlying statute and the Constitution, and whether an agency's enforcement activities are consistent with its regulation, the underlying statute, and the Constitution.
• The authority of the Executive agencies are specified by Congress in statutory law.
• Executive agencies must follow a specific process when promulgating regulations, including pulbic notice of a proposed regulation and an opportunity for public comment on the proposed regulation.

Last updated April 7, 2009

E-Mail agecinf@ndsuext.nodak.edu
Published by Agribusiness and Applied Economics
Morrill Room 217, P.O. Box 5636
North Dakota State University, Fargo, ND 58105-5636
Phone: (701) 231-7441
Fax: (701) 231-7400