J Agric Environ Ethics (2010) 23:267–278

DOI 10.1007/s10806-009-9194-1

ARTICLES

Food Law, Ethics, and Food Safety Regulation: Roles,

Justifications, and Expected Limits

Daniel Sperling

Accepted: 22 June 2009 / Published online: 14 July 2009

Ó Springer Science+Business Media B.V. 2009

Abstract Recent food emergencies throughout the world have raised some serious
ethical and legal concerns for nations and health organizations. While the legal
regulations addressing food risks and foodborne illnesses are considerably varied
and variously effective, less is known about the ethical treatment of the subject. The
purpose of this article is to discuss the roles, justifications, and limits of ethics of
food safety as part of public health ethics and to argue for the development of this
timely and emergent field of ethics. The article is divided into three parts. After a
short introduction on public health ethics, all levels of food safety processes are
described and the role that ethics play in each of these levels is then analyzed. In the
second part, different models describing the function of food law are examined. The
relationship between these models and the role of ethics of food safety is assessed
and discussed in the final part, leading to some relevant comments on the limits of
the role and effect of ethics of food safety.

Keywords Ethics of food safety
Food policy
Food law
Medical ethics

Public health ethics

Introduction

As methods of food production and processing have developed over the last few
decades, and foodborne illness and environmental degradation related to food
production have dramatically increased (Coveney 2003), the issue of food safety has
recently provoked much interest, presenting challenges for those in charge of
controlling the safety in the food sector. Moreover, recent food emergencies in

D. Sperling (&)
The Federmann School of Public Policy and Government, Braun School of Public Health &
Community Medicine, The Hebrew University of Jerusalem, Mount Scopus, 91905 Jerusalem, Israel
e-mail: [email protected]

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Israel and throughout the world have raised some serious ethical and legal concerns
for nations and health organizations. Between 1993 and 1995 one of the largest milk
producer in Israel, Tnuva, manufactured and marketed around 13 million liters of
ultra-high temperature milk consisting of DMPS, or in its common name silicon.
The silicon was added to the milk to overcome a technical problem in the
production process and saved Tnuva around 400,000$ by not having to replace its
equipment. Tnuva did not mark on the milk box that it contained DMPS, and did not
report to the Ministry of Health about this, and even after it was discovered by the
Ministry, it continued to deny this.
Tnuva and its managers were prosecuted and convicted in a criminal trial (T.P
3031/95 1996) and recently they were also sued in a class action for the breach of
consumers’ autonomy. Although no concrete damage from the silicon was found,
the Ministry of Health testified that possible health hazards might be caused in the
long run, especially among children consuming the milk. Tnuva was therefore found
liable and obligated to compensate claimants 55 millions of NIS. In a very original
way, the court decided to divide compensation to three purposes: benefiting
consumers by making the milk cheaper; donating money for research and
scholarship in the area of food and nutrition; and providing free milk by public
organizations for those in need (T.A 1372/95 2008).
Another recent food scandal in Israel involved baby milk produced by a German
company Humana and exported to Israel by a food corporation named Remedia. An
investigation carried out by the Ministry of Health explored three case fatalities and
17 more suffering from developmental diseases as a result of consuming the milk
(YNET’s Reporters 2003). The investigation showed that the milk contained 10
times less vitamin B1 than reported on the milk label. A police investigation found
that Remedia knew that the producer stopped including vitamin B1 in the milk but
did not report on this. Almost 5 years later, the state attorney prosecuted the owner
and managers of Remedia, the former head of the national food services in Israel
and four import inspectors. The defendants are accused of negligent breach of
responsibility leading to the deaths of three children, the spread of disease, and
misleading the public. The first hearing of the court will take place in October 2009
(Lubitz 2006).
Other food scandals outside Israel also raised considerable attention. Most notably,
milk contaminated with melamine (as a means of increasing ‘‘protein’’/nitrogen
content) in infant formula produced in China, resulting in four deaths and 53,000
children made ill by it (mainly with kidney stones and kidney failure), followed by
deaths and illnesses of thousands of pets in the US that ate pet food linked with the
same toxin, presented a serious health threat not only to Chinese consuming the foods
but also to many other countries importing it (CNN 2008; Maureen 2008). These and
other disturbing events have prompted the creation of a food safety working group and
the call for a tighter food inspection following President Obama’s recent announce-
ment (http://www.msnbc.msn.com/id/29691788/).1

1
For a commentary see Marion Nestle, What President Obama can do in the USA? (2009) Public Health
Nutrition 433–435.

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Food Law, Ethics, and Food Safety Regulation 269

Although controlling foodborne diseases ranks among the greatest achievements

of public health during the last 100 years, foodborne diseases continue to impose
serious burdens on health systems. Approximately 76 million cases of foodborne
illness occur each year in the US, resulting in 323,000 hospitalizations and 5,200
deaths (Kux et al. 2007). While legal regulations addressing food risks and
foodborne illnesses are considerably varied and variously effective, less is known
about the ethical treatment of the subject. A recent attempt to provide and apply a
principled approach to employment of biotechnology in the food industry raised the
need to develop more the area of ethics of food safety (Mepham 2002). Such ethics
would be part of a larger endeavor to guide people working in the private and public
sectors whose actions and behaviors affect the public health and direct their, and the
public’s, performances concerning health toward a more ethical and fair practice.
The article calls for the establishment and the development of this new field of
ethics that appears necessary in light of recent emergencies.

Public Health Ethics and Food Safety

Public health policy requires that the majority, or a powerful minority, accept their
fair share of the burden of protecting a relative minority threatened with death or
disability (Beauchamp 1999). Public health activities aim at longer lives with fewer
diseases and can be justified by consequentialist, deontological, and virtue ethics
(Hayry 2006). While bioethics in general, and codes of medical and research ethics
specifically, give high priority to individual autonomy, public health ethics address
the social justice functions of public health, most notably its affirmative obligations
to improve the public health and reduce certain social inequities (Kass 2001),
thereby advancing an idea of autonomy for communities (Hall 1992). Hence, it is
not surprising that critical elements in the practice of public health include limits of
privacy, liberty, and autonomy (Bayer and Fairchild 2004).
Food safety policy is part of this larger effort to protect and enhance the public
health. Such a policy is usually based on risk analysis consisting of three
components (Jensen and Sandoe 2002). First is risk assessment. This component
includes the scientific evaluation of known or potential adverse health effects
resulting from human exposure to foodborne hazards. This is an allegedly purely
scientific process and apparently involves no value judgments.
The second constituent of risk analysis is risk management involving the process
of weighing policy and technological alternatives to accept, minimize, or reduce
assessed risks and to select and implement options. This is a political/administrative
process. The final stage of risk analysis is risk communication. This stage involves
exchange of information and option on risk among risk assessors, risk managers,
and other interested parties, including the public.
It will be argued that ethics should play an important role in all three levels of
risk analysis of food safety. As to the first level, ethics will help reflect on and make
value judgments in the process of risk assessment. There are several ways in which
such a role may be carried out. To be exposed to risks means to be in a situation
with unwanted consequences. However, to determine and declare which

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consequences are unwanted is a value judgment.2 In addition, risk assessments are

determined by the exact choice of a supposedly particular hazard, e.g., particular
agent (human being or pets) or a specific property (food-borne) to be assessed for
possible unwanted consequences. This choice serves as a precondition for the
application of scientific methods and is a value judgment as well. Likewise, risk
assessment is based on a number of methodological choices, each of which has
normative implications, especially when risk assessment leads to uncertainty
(Jensen and Sandoe 2002). No doubt, in all these aspects the normative
characteristic of ethics will help make risk assessment a more comprehensive and
justifiable process.
Ethics will have important contributions to make to the second level of risk
analysis as well. Ethics will facilitate decision making by risk managers. This is a
very important role, which has a few aspects. First, principles of ethics may help
weigh up the risks (in terms of adverse health effects) against the expected benefits
of food consumption and the liberal conception advocating for avoidance of
excessive regulatory burden on individuals. These principles may reflect what Paul
Thompson argues, an optimization approach (Thompson 2001).
A starting point for the ethics of risk management is provided by the
precautionary principle. One of the more accepted interpretations for such a
principle is that it stipulates an obligation to protect populations against reasonable
foreseeable threats, by putting a burden of proof on those who would initiate risk to
demonstrate that the benefits outweigh the dangers and that the risk is rationally
worth taking (Callahan and Jennings 2002), or as put forward in principle 15 of the
1992 Rio Declaration on Environment and Development: ‘‘Where there are threats
of serious or irreversible damage, lack of full scientific certainty shall not be used as
a reason for postponing cost-effective measures to prevent environmental degra-
dation’’ (United Nations 1992). The precautionary principle may be highly efficient
in the food context where the food sector can meet the burden of proof with
considerable ease, and indeed this principle has been recently adopted by the
American Academy of Environmental Medicine in its guidelines on genetically
modified foods (American Academy of Environmental Medicine 2009).
Applying the 6-steps framework for public health ethics developed in the
literature (Kass 2001; Kass and Gielen 1998; Gostin and Lazzarini 1997) will
further help risk managers consider the ethical implications of any food regulation
or policy based on previous scientific assessments. Such ethical framework will
address the following questions: What are the goals of the proposed food regulation
or policy? How effective are the suggested food policy/regulation in achieving their
goals? What are the known or potential burdens of the suggested food policy/
regulation? Can these burdens be minimized and are there any alternative
approaches? Do the suggested food policy/regulation promote equality and are
they implemented fairly? Are the expected benefits of the proposed food policy/
regulation justifying the identified burdens?
A very important contribution of ethics in the risk management level also
involves queries relating to risk reduction. Most notably, ethical concerns in this

2
For a different approach see Thompson (2001).

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regard will address the questions of what level or degree of risk is socially
acceptable to individuals and communities, who should decide about this and how
should exposure to risks be distributed across the affected population (Callahan and
Jennings 2002).
Finally, consideration of the major guiding principles and values of public health
ethics will also help balance various proposals to deal with the scientific food risk
and determine the best (or least harmful) solution. These principles and values
include the salience of population health, safety, and welfare; fairness and equity in
the distribution of services; and respect for the human rights of individuals and
groups (Gostin 2003).
One of the most influential aspects where ethics can contribute to risk
management process concerns the many perspectives within which it interacts.
Ethical considerations may expand and complete our understanding of risk
assessment by referring to broader social concerns that scientific advice may not
(justifiably) take into account. Take, for example the case of genetically modified
organisms used in food (GMO).
With the help of genetic engineering, it is possible today to add new genetic
material into an organism’s genome to generate new traits. Use of GMO can be
observed in the food industry where genetically engineered bacteria protect plants
from frost damage and transgenic plants are developed to resist pests and harsh
environmental conditions. GMO also improves product shelf life, increases
nutritional value (by improving the quantity and quality of protein), and diversifies
food products (by adding new tastes, colors and textures). Use of GMO is very
widespread, for example in the US, where around 50% of corn and soybean are
GMOs.
While in the strict sense, GMO in food may apparently not cause any adverse
health hazards (although some argue that this has not been conclusively proved),
many people oppose consuming such a food. This is because society has conflicting
values or ethical perspectives on GM foods as a result of many non health-related
concerns (James 2003). Some of these concerns are environmental, deriving from
the fact that when genetically modified or engineered plants are grown on open
fields without containment, there are risks that modification will escape into the
general environment.
Other concerns that are more unique to the Israeli context relate to issues of
religious requirements of Kashrut, and more generally to vegetarianism or veganism.
From these perspectives, one can argue that, for example the consumption of a
genetically engineered tomatos supplemented by a gene of an organism violates
personal values of people holding such beliefs. In addition, it may be questionable
whether society should tolerate interfering with biological states or processes that
have naturally evolved over the years, and whether modern science can fully
comprehend all the potential negative ramifications of genetic manipulations. Lastly,
it may be assumed that patenting plant varieties will raise the price of seeds so much
that small farmers and third world countries will not be able to afford seeds for GM
crops, thereby widening the gaps between the rich and the poor (Whitman 2000).
These broader concerns, which—as one can see—are not based on health effects,
raise a series of difficult questions: do consumers have the right to know—or, rather

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have access to—the sources and production processes of the food they consume?
(Hansen 2004) Do they have the right to choose between GM and non GM foods?
What information should consumers be given with regard to GM food? Should
society ban consumption of GM food, inform citizens of potential risks to society, or
merely label such a food and leave consumers make their own decisions? These are
very difficult questions that ethics will help articulate and better explore.
Ethics will also have important roles to play in the third level of risk analysis,
namely risk communication by improving risk communication between risk
assessors, risk managers, and the public. These roles may be performed in varied
ways. One important mechanism for reducing risks through better communication
and respect for consumer autonomy is food labeling.
Ethics of food labeling may provide core principles to decide not only what food
ought to be labeled, the exact label format, size, information, impact, etc., but also
the degree under which food labeling should be carried out, for example, whether it
should include ingredients and, if so, whether it is sufficient to present these in a list
or also describe them by weight. In this context, ethics may also offer other
principles to be balanced with the principle of respect for consumer autonomy
resulting from food labeling, such as the protection of food technology from being
stigmatized, the manipulation of consumers (Thompson 1997), and the possible
negative effects of information associated with confusion and misinterpretation of
information (Grill and Hansson 2005).
Another means by which ethics may help improve risk communication is by
providing a new and more open atmosphere within which individuals will make
choices about food. Studies show that food choices of consumers are more
influenced by concerns about the health impact of the food system and less by the
impact on and the relationship between food production and the environment
(Kriflik and Yeatman 2005). Addressing the latter issues will broaden consumers’
perspectives and choices regarding food, thereby better protecting the public health.
A third possible contribution of ethics to risk communication concerns the
challenge of food disparagement laws, enacted in a few states in the US, which
make persons legally liable for asserting that certain foods are unsafe for
consumption unless good faith and a high standard of proof are demonstrated by
critics (Kux et al. 2007; Texas Beef Group 1998). Besides the limitation of free
speech, these laws inhibit members of the society, who mainly for financial reasons
cannot meet the legal burden, from engaging in the public debate on food. Ethical
considerations will help reflect on these laws making the broader implications of
them become more visible and subject to public criticism.
In addition to the contribution of ethics to all three levels of risk analysis of food,
ethics is important for the mechanism of risk analysis in encouraging transparency
and minimizing conflict of interests. In order for risk managers to assess the
soundness of scientific advice it is important to make sure what the normative
assumptions of risk assessors are as well as the goals they wish to promote with their
recommendations. Hence, ethics will be important to uncover and make transparent
the foundations of scientific advice so that these will be properly understood and
treated by risk managers. Furthermore, to ensure scientific integrity of the risk
assessment process and reduce any conflict of interest between risk assessment and

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risk management, it is imperative to make sure that different institutions carry out
these processes. Ethical guidelines addressing the issue of conflict of interests
should be applied to the scientific bodies functioning in the risk analysis so that they
should remain independent of the political system and be able to freely provide
scientific advice.

Models of Food Regulation

Regardless of the great importance of ethics to food safety evidenced in all three
levels of risk analysis of food discussed above, it is asserted that the contribution of
ethics to risk analysis of food will be dependent on the exact role the law will play in
food safety and on the perceived relationship between law and ethics in each
society.3
Like any other concern for the public health, law of food safety may coerce food
companies or citizens to behave or act in some healthy ways and secure the food
supply from international acts of contamination so that ‘‘food shall be of the nature,
substance and quality demanded’’ (Lang 2006 p. 34). Public health is one of the few
areas that have legal power, ensuring the fulfillment of obligations toward the
government that controls it and the public that it serves (Callahan and Jennings
2002). Along with the establishment of a set of global legal standards that will be
applied throughout the World (Millstone 1996), local Laws concerning food safety
are part of public health law, the latter being defined as ‘‘the study of the legal
powers and duties of the state to assure the conditions for people to be healthy (e.g.,
to identify, prevent, and ameliorate risks to health in the population), and the
limitations on the power of the state to constrain the autonomy, privacy, liberty,
proprietary or other legally protected interests of individuals for protection or
promotion of community health’’ (Gostin 2000). In this sense, public health law is
different from public health ethics due to the controlling authority by which the first
is prescribed and the binding force it enjoys (Gostin 2003). Hence, law is central to
public health and has more powerful effect on the scope and goals of public health
than ethics. However, when the contribution of law is less evident and when public
accountability requires visibility and justification for actions, policies, or regula-
tions, ethics have important roles to play.
There are three models to describe the function and contribution of law to food
safety (Lang 2006). The first is the traditional model, according to which the state or
any other authorized world health organization, e.g., Codex sets laws and
regulations that frame what the food supply chain can and cannot do. This model
implies a ‘‘top-down’’ Hobessian or otherwise conservative state exercising its
power over individuals and private businesses. Under such a model, public health is
protected by the creation and maintenance of food standards while the role of the
government is to set and deliver compositional and hygiene standards. It follows
that as long as food corporations and retailers adhere to the law and satisfy their
customers or shareholders, they discharge their duties.

3
For the relationship between law and ethics in the context of bioethics see Sperling (2008).

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A second model upholds duality in food governance. According to this model,

state and food corporations compete for regulatory influence through, e.g.,
advertising, marketing, etc. This model is efficient in combating non-communicable
diseases requiring collaborative action and change in the market, such as tackling
obesity or diabetes. Under such a model, while the state incorporates the compliance
of the private sector in its implementation of policy goals and seeks to gain control
of this sector’s led initiative, (Barling 2007) food businesses and corporations are
equal actors in the public sphere—both at national and international levels—setting
the terms and conditions for food production and also holding social responsibilities
and duties toward members of the society (Nuffield Council on Bioethics 2007).
Under the duality model, both the state and food corporations are motivated in
encouraging healthy food whether they see it as a public health or an economic
issue, although the success of the latter greatly depends on the extent to which they
follow health risk evidence and their ability to make substantial shifts in entire food
culture or consumer behavior like in the case of obesity. In contrast to the statist
traditional model that is policed by state bodies, the duality model is characterized
by market and industry self-regulation, usually set by company contracts and
specifications, and is policed by company buyers and inspectors working together to
apply principles of traceability and due diligence beyond the requirements set by the
state (Lang 2006). An example of this dual system of setting of food standards,
which may lead to mixed messages that all are competing for ‘‘policy space,’’ can be
seen in the context of pesticides in food where in addition to the state setting a
baseline, different company systems and retailers—whether individual or consor-
tia—share their focus to deliver residue-free foods (Lang 2007).
The third model is the triangular dynamic model. This is a multi-faceted model
whereby, in addition to the state and food companies, civil society-based non
governmental organizations and popular pressure, especially from consumer
movement, also frame food governance and law. This model is characterized by
very little regulation and the passing of responsibility onto consumers, who defend
their rights to health using civil law, and apply their own definitions and values to
which foods are safe. Examples of these new forms of food control include the
setting and grading of standards of foods assurance schemes or the contracting of
various food specifications and demands by manufacturers and retailers to farmers
and growers or by retailers (as gatekeepers to consumers) to manufacturers through
labeled food (Barling 2008). Other examples involve the battles of NGOs during the
1980s and 1990s over the nature and extent of food labeling and the location of
nutrition labels (Lang 2006). Under such a model, the law may still retain an
important role in instigating change to the physical and socioeconomic environ-
ments that shape individuals’ choices and health behaviors, but is only a partial
mechanism to achieve these goals (Martin 2008).
With increasing internationalization of food, the growth of cross-border food
trade and the growing influence of food companies on what food is grown and on
what food is provided to consumers (depending, inter alia on its price), food
corporations have exercised regulatory powers that are policed by company buyers
and inspectors and that at times may be more stringent than those required by the
state. Under this self-regulatory model in which food corporations exercise power

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through, for example, massive marketing, the concept of food governance is

replaced by consumer choices, or more accurately, as put by Tim Lang, consumer
selections (Lang 2007).
At the same time, active civil society processes and, more generally successful
notions of the consumer movement, create public pressures leading to food law
reforms and to the acknowledgment of legal rights to consume better food. New
conceptions of public health, e.g., those offered by the Institute of Medicine
(Institute of Medicine 1988) and by scholars like Lawrence Gostin (Gostin 2003)
also put emphasis on cooperative and mutually shared obligations to safeguard
population health, thereby advancing and justifying a shift toward the triangular
dynamic model. These recent trends have led to the gradual shift from governing to
governance, namely from centralized legally focused public ruling to diverse,
pluralistic, and multilevel policy and authority networks (Barling 2008).

Limits of Ethics of Food Safety

With this specific understanding of food law, and given the assumption that the
greatest success of ethics will be determined by the relatively poor accomplishment
of food law along with the satisfactory function of food culture, consisting of public
institutions, movements, and policies, it is sound to argue that the role ethics will
play in food safety depends not only on the effective role of food law in a given
system, but also and more specifically on the exact model by which food is legally
regulated and the most powerful effect that each model has on various levels of risk
analysis of food.
Hence, in systems where the traditional model still prevails, it may be assumed
that the law will have much effect on the 2nd and 3rd levels of risk analysis, namely
risk management and risk communication, and less influence on risk assessment.
According to the general argument argued in this article that ethics will have its
most effect when it will complete deficiencies in public health law, it is anticipated
that ethics will have its most powerful effect on risk assessment and less on risk
management and risk communication.
In contrast, in systems upholding the duality model, the law will have only partial
effect on risk management and food decision-making since these will also be shared
with, and shaped by food corporations, private businesses, and the like. Under such
systems, the government (through its law and legal system) will probably have
advantage over food corporations in terms of their reliability and credence of
transmitting and communicating risks in food. However, even under the duality
model, the public will still need to be warned from and communicated about risk
assessments and so ethics will still play an important role to address the 3rd level of
risk analysis. Yet, the most significant contribution that ethics will have (derived
from law’s relative advantage under the duality model) will be on the 2nd level of
risk analysis, namely on food decision-making and risk management. Less effect
and contribution of ethics to risk assessment will be evidenced in such a context.
Finally, in systems where the triangular dynamic model is most dominant,
communication of risks will be less influenced by the law, since the public will

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actively participate in the debate over what counts as good or bad food to consume
and there will exist various food assurance schemes aimed at identifying and
informing the public and food corporations of the provenance of food. These
schemes will directly communicate on the whole length of the food chain from
producer to consumer and the safety of its discrete stages [see e.g., Barling’s
description of public and NGOs’ campaigns against the introduction of GM foods in
the UK and other European countries (Barling 2008)]. Hence, it is reasonable to
argue that within such systems, ethics will have the most influential contribution to
the area of risk communication and to other relevant considerations raised by the
public or NGOs relating, e.g., to animal welfare, environmental impact, fair trade, or
labor practice. In this context, ethics will enable a more open and democratic
participation of consumers in the food marketplace having their choices and
decisions respected. Other contributions of ethics, but with less degree of
importance, will be seen in the 1st and 2nd levels of risk analysis of food. With
regard to these levels, it may be assumed that food culture, public institutions,
public movements, policies, and the law will also have important contribution to
make.

Conclusion

Ethics of food safety is a dynamic area that continues challenging our perceptions of
food consumption, health risks, and public responsibility for food borne illness. As
argued in this article, ethics will have a great contribution to food safety in all three
levels of risk analysis of food: risk assessment, risk management, and risk
communication. The exact role that ethics will play in safeguarding food safety will
depend on the centrality and effect of public health law, the satisfactory function of
public institutions, public movements and policies, and the extent to which law
promotes each of these levels in analyzing food risks.

Acknowledgments Special thanks are deserved to Bernard Dickens and Elliot Berry who commented
on early drafts.

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