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Introduction to Several Legal Concepts
Legislative, Executive and Judicial Branches of Government;
Statutes and Regulations; and
Preemption of Federal Law over State Law
Throughout SAFE 408/608, the materials reference Congress and government agencies, statutes and regulations, and the relationship between federal and state agencies. This web page briefly explains each of these concepts to enhance the student’s understanding of the overall materials.
The U.S. government is organized into three branches:
- The legislative branch (referred to as Congress at the federal or national level of government) which is comprised of elected officials (e.g., senators and representatives) who debate and resolve policy issues by enacting statutory law;
- The executive branch which consists of the president at the federal or national level (governors at the state level) and the numerous government agencies (e.g., FDA and FSIS) which are responsible for implementing (executing) the laws and government programs established in statutory law by the legislative branch; and
- The judicial branch (the court system) which resolves disputes among conflicting parties (such as persons, agencies, and other entities) and interprets the law (e.g., Constitution, statutes, and regulations) when the meaning or application is uncertain.
Note – the executive branch (e.g., president and agencies at the federal level of government) can do no more than they are authorized to do in the statutes enacted by the legislative branch of government.
Each branch of government creates is own type of law:
- The legislative branch enacts statutes. At the national or federal level of government, these statutes are organized into the United States Code (U.S.C.). A citation in the materials to the U.S.C. (e.g., 21 U.S.C. §343) indicates that the referenced material is a statute that Congress enacted;
- The executive branch promulgates regulations that provide details on how the agency will execute the mandates set forth in the statute. At the federal level of government, these regulations are organized into the Code of Federal Regulations (C.F.R.). A citation in the materials to the C.F.R. (e.g., 21 C.F.R. 300) indicates that the referenced material is a regulation promulgated by a federal agency.
- The judicial branch (especially the appellate courts within the judicial system) creates “common law” by explaining its decisions or interpretations in court opinions. The common law is not emphasized in these materials.
Note – a regulation cannot conflict with its authorizing statute.
Note – state governments are organized similarly to the U.S. federal government.
There are situations where state government and federal government have addressed the same issue; for example, a state legislature has enacted a statute to regulate food processing businesses in the state even though Congress has enacted a statute to regulate all food processing businesses in the United States. A question that arises is which statute must the food business comply with. The U.S. Constitution clearly states that the federal law will prevail over or preempt the state law.
Visit Interaction Between a Statute and a Regulation for an example of the relationship between the legislative and executive branches of government.
Also visit Overview of Legal System for additional explanation of the U.S. legal system.
The following points review the introductory comments.
- Congressional action is necessary for any federal statute to be enacted
- 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 the responsibility on another agency, this can sometimes lead to confusion and complexity in implementing the programs and in complying with several programs that apply to a business operation.
- For the purposes of Federal Food, Drug, and Cosmetic Act, “Secretary” means the Secretary of Health and Human Services (excerpts from 21 USC §301 and §321).
- As used in the Meat Inspection chapter, the term “Secretary” means the Secretary of Agriculture (excerpt from 21 USC §601).
- For purposes of the Poultry and Poultry Products Inspection chapter, “Secretary” means the Secretary of Agriculture (excerpt from 21 USC §453).
- For purposes of the Egg Products Inspection chapter, Secretary” means the Secretary of Agriculture (excerpt from 21 USC §1033).
- Continual updating -- due to changing conditions and needs, laws also continue to evolve; this ongoing change often clarifies issues by addressing unanswered questions, but also raises new issues such as interpreting the new laws and reconciling the new laws with existing laws.
- Congress controls what the agencies can do; politics influence Congressional decisions, despite statements that issues such as food safety should be based on science, and not economics or political clout.
- Agencies of the Executive Branch are given responsibility by Congress to implement the programs (execute the laws) that Congress sets forth.
- Details about application and enforcement of the programs are set forth (promlugated) by the responsible agency in the form of regulations.
- Develop regulations (frequently referred to as rules)
- 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
- Final rule is 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.
- Force of Law -- the 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; parts 300 et seq.
- Agency can do no more than 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.
In addition to statutes and regulations, court decisions interpreting the statutes, regulations and Constitution influence government oversight of the food industry. These brief excerpts from two court decisions illustrate the interaction between federal and state law.
- 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..."
- 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."
Example of Interaction among Agencies and Enforcement
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. It is an example of the interaction among federal agencies as the fulfill their respective responsibilities. Note the critical role of agency regulations in implementing the programs. Also note the role of the court in assessing whether the agency's action aligned with the agency's authorities.
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.]
Return to section 3 --
Relevant Agencies and Organizations
November 15, 2010