Best if printed in landscape.
US law is created
of creating and enforcing food law
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.
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?
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.
of U.S. Legal System
Overview of Legal System (mandatory reading!)
understand food law, it is helpful to generally understand the U.S. legal system
and government structure.
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
FDA regulates Grade A (fluid) milk (21
CFR 131); USDA regulates dairy products such as butter and cheese
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.
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.
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:
rules are published in the Federal
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
rule is subsequently published as a regulation in the Federal Register after
the agency has reviewed the comments and revised the proposed rule.
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.
- 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.
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.
Farms v. Venman, 9th Circuit Court of Appeals, case number 97-15428,
July 2, 1998
- 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.
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.
of Interaction among Agencies and Enforcement
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.
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."
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).
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.
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 ...
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 ...
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.
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.
"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.
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
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
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.
negotiations that culminate in treaties;
"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.
often provide a dispute resolution process for nations that have ratified
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.
- 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.
April 7, 2009