RS20310: Science Behind the Regulation of
Food Safety:
Risk Assessment and the Precautionary Principle
Mickey Parish1
Congressional Science Fellow
Domestic Social Policy Division
Updated August 27, 1999
Summary
Although Congress, the President and agency
administrators support the use of science as a basis for food safety regulatory
activities, there are controversies about how science can best be used for this purpose.
Supporters of science-based regulations regard conclusions from well-designed scientific
studies as largely impartial and fair; however, basing regulations on scientific data is
not always clear-cut since it may take years before scientists generally agree about
results of controversial studies. Meanwhile, it is up to regulators to decide on the best
means of applying scientific data as it becomes available. Some advocates of science-based
regulatory activity support risk assessment for the rule-making process. Others voice
concerns about lengthy time periods needed to conduct authoritative risk assessments. They
sometimes favor the "precautionary principle" as a mitigation strategy. This
principle allows for the eliniination of industrial activities or products if evidence
indicates possible harm to humans or the environment, even without conclusive scientific
proof that such activities or products are unsafe. Since the precautionary principle is a
basis for the European Union (EU) ban on imports of U.S. beef from hormone-treated cattle,
and since it is being adopted by other international bodies, Congress may consider what
the effects these two competing philosophies will have on regulatory activity and on
trade. This report will not be updated.
U.S. agencies principally
involved in assuring food safety are the Food and Drug Administration (FDA) of the
Department of Health and Human Services (HHS) and the Food Safety and Inspection Service
(FSIS) of the Department of Agriculture (USDA). At the core of these agencies' approaches
to assuring food safety is the scientific method. When developing regulations related to
food safety, these agencies have been required by Congress to conduct risk assessments
using the best available scientific infoimation in a transparent, rule-making process open
to public comment.2
While agencies assert that they
meet the congressional mandate to base regulatory activity on science, development of
specific science-based food safety regulations is usually conducted on a case-by-case
basis without use of a standardized procedure. For example, FDA uses a combination of
various approaches for incorporating scientific data into the development of food safety
regulations. The agency consults with two expert panels, the Food Advisory Committee and
the National Advisory Committee on Microbiological Criteria of Foods, to provide outside
input into issues that might require proposed regulations. These panels ineet regularly
and write science-based reports on specific food-related issues brought by the agency. In
addition, internal FDA scientists address the useflilness of scientific studies for
regulation development on a case-by-case basis. FDA also contracts with outside,
independent, science-based organizations, such as the Institute of Food Technologists, to
provide expert scientific opinion on specific issues that may eventually be addressed with
proposed regulations.
Risk assessment is one method by which science can
be used to address food safety. It is broadly defined as the use of scientific data to
rank or measure hazards, assess exposure, and characterize risks involved with a
food-related activity or product;3 however, risk assessments do not specifically determine whether a product
is "safe" or "unsafe." The use of risk assessments in regulation
development is related to the expected impact of a particular food safety problem, the
expected impact of protective mitigation measures, and the levels of urgency and
controversy surrounding an issue.4
Critics of risk assessment often
advocate a different approach to regulatory activity known as the "precautionary
principle." The precautionary principle generally would require banning products or
activities when evidence suggests they are harmful even if there is no definitive
scientific proof of harm This principle is not mandated for regulatory activities related
to food safety in the United States; however, agencies occasionally engage in rule-making
efforts that appear similar in concept to the precautionary principle. Since the European
Union (EU) uses the precautionary principle more often than the United States to address
environmental and food safety regulation, the EU-U.S. relationship on food safety issues
is occasionally strained. This report describes how the use of science in food safety
regulation is irifluenced by the two different regulatory philosophies of risk assessment
and the precautionary principle.
Issues Regarding Science
in Regulations. In risk assessment analysis, the use of science is not as
clear-cut and simple as it may appear initially. First, since scientific knowledge
constantly changes and evolves; the best available science about food issues may be
different from one year to the next. For example, application of the scientific method of
investigation to food-borne disease outbreaks changed fundamental knowledge about the
bacterium, Escherichia coli (E. coli). Prior to 1982, E. coli was
considered to be a harmless and helpful bacterium in the intestines of all animals,
including humans. Because of scientific investigations stemming from many outbreaks of
food-borne illnesses since 1982, scientists now understand that a small number of strains
of E. coli are pathogenic and can cause serious disease.5 This knowledge led to a change in U.S. regulatory activity related to E.
coli.
Another complicating factor in
the application of science to risk assessment analysis is disagreement among scientists
about conclusions from key influential studies. Ideally, scientists conduct research in a
manner that produces precise and accurate results so that study conclusions are
authoritative and nonbiased; however, it is not unusual for scientists to disagree about
an experiment's design and conclusions, especially if the results alter the conventional
knowledge about a subject. These disagreements may require years of debate and further
experimentation in other laboratories before results are accepted by most scientists.
Regulations based on professionally disputed scientific studies may not be scientifically
defensible once the controversy is resolved through additional data gathering and
analysis.
Risk Assessment.
Although the concept of assessing risks associated with chemicals, such as pesticide
residues on foods, is not new, only in recent years has it been formally applied by U.S.
regulatory agencies to address food-borne pathogenic microorganisms.6 Therefore, the specific manner in which a formal risk assessment of
food-borne pathogens is conducted is not yet firmly established and may vary depending
upon the scope and objective of the assessment. In general, a food safety risk assessment
begins with consultations among assessors, risk managers, and other professionals to
define the scope of the proposed assessment. Once the scope is defined with specific
boundaries, a flow diagram is developed that identifies each step in the process.
Scientists then conduct an extensive search for relevant data, published in scientific
joumals and for unpublished data produced in academic, government, or industry
laboratories, that is applicable to each step in the flow diagrarm Data may be weighted
based upon their perceived quality, placed into a database, then used in mathematical
models that are part of the risk assessment. The models then are used to produce
information necessary to evaluate the risk associated with food products or processing
activities.
Risk assessments are usually
categorized as either quantitative or qualitative. If a substantive amount of scientific
data is available for analysis, a quantitative risk assessment is conducted to yield a
numerical expression of risk. When insufficient data exist to produce a quantitative
analysis, a qualitative risk assessment may be produced to identify, describe, and rank
hazards associated with a food. The extent of data available for food safety risk
assessments may be limited by the resistance of food companies to sharing their internal
data They are concerned that any data they share with risk assessors could serve as a
basis for lawsuits or increased regulatory action, or could end up in the hands of
competitors. In addition, scientific journals generally do not publish raw data in
articles due to space and cost limitations thereby limiting data available for a risk
assessment.
There appears to be general
agreement among stakeholders that qualitative risk assessment is valuable as a method to
determine which hazards are associated with a food. Quantitative analysis, on the other
hand, seems to be controversial for two reasons. First, risk assessors may disagree about
the quantity and quality of data necessary to conduct a particular quantitative analysis.
Secondly, proponents of the precautionary principle contend that quantitative risk
assessments are unnecessary since a product or activity having any potential risk
associated with its use should be eliminated or banned.
Since quantitative risk
assessments are often very time-consuming, precautionary principle advocates sometimes
view them as a way for industry to postpone or avoid implementation of regulations that
should be finalized sooner rather than later in order to deal with a perceived food safety
risk.7 Supporters of risk
assessment see it as a method to provide nonbiased information for regulation development.
They assert that risk assessments help to determine those steps in the food production
chain where hazards can be reduced or eliminated, and that a valid risk assessment clearly
identifies where data gaps exist and how those gaps influence the results. Additionally,
they state that properly conducted risk assessments are not static entities and are
capable of utilizing knowledge gained from new research studies to yield different
results.
The Precautionaty Principle. Some
have advanced the precautionary principle, also known as the precautionary approach, as an
intermediate step that can be used for regulation when authoritative, definitive
scientific evidence is not available. They support it as an alternative to quantitative
risk assessment. At the international level, the precautionary principle usually focuses
on environmental issues but has been used recently to address food safety. As its
influence with other governments increases, the precautionary principle has had an impact
on trade negotiations important to U.S. interests. Since it is a part of the Maastricht
Treaty that established the EU,8 the precautionary principle has considerable backing among organizations
within Europe, especially environmental and "green" political groups.
There is no single definition of
the precautionary principle that is universally accepted; however, the basic concept is
that an industrial activity or product that is thought to cause harm should be banned even
if only limited scientific evidence exists that it may be harmful. The precautionary
principle is described in the 1992 Rio Declaration on Environment and Development as:
"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 degradation." The International Joint Commission (IJC), an organization
that prevents and resolves disputes between the U.S. and Canada under the 1909 Boundary
Waters Treaty, uses a precautionary approach, among other approaches, to work toward the
goal of virtual elimination of persistent toxic substances from the water and air within
its purview. According to the IJC, the precautionary approach "requires
manufacturers, importers and users to prove that suspected substances are not and will not
be harmful before they can generate, use or acquire them."9 The IJC uses a "weight-of-evidence" approach to determine if a
product or activity should be considered hazardous.
A group of academic scientists,
lawyers, and grass-roots environmental met in Racine, Wisconsin, January 23-25, 1998,
to discuss the precautionary principle.10 The consensus opinion of this meeting describes the precautionary
principle as: "When an activity raises threats of harm to human health or the
environment, precautionary measures should be taken even if some cause and effect
relationships are not fully established scientifically." Some European industrial
organizations interpret the precautionary principle more broadly and support it as
guidance, not law.
Critics of the precautionary
principle state that it is poorly defined, not sufficiently grounded in science, stifles
development of technology, and hinders trade. For example, two medical researchers in the
United Kingdom (UK) recently stated that the precautionary principle is not a valid
principle for evaluating scientific evidence, and will distort reality and lead to
acceptance of false beliefs.11 Opponents are also concerned that the precautionary principle's focus on
hypothetical risks will distract consumers and policy makers from policies needed to
address known food-borne threats to human health.12 Others suggest that the current EU ban on imports of U.S. beef from
hormone-treated cattle, in effect since 1985, is an example of how the precautionary
principle can be used as a trade barrier. Scientific data have been collected and analyzed
by FDA since the 1950s on the use of hormones to promote growth of beef cattle, and no ill
effects on human health from consumption of the beef have been observed. In addition,
several international bodies studied the issue since the early 1980s and have concluded
that beef from cattle treated with hormones to promote growth is safe for human
consumption.13 The EU,
on the other hand, reflecting a position held since the 1980s, argues in a May 1999 report
by its Scientific Committee on Veterinary Measures Relating to Public Health that there
are not enough data to conduct a valid quantitative risk assessment on the long term
health effects from consumption of this beef, especially for prepubescent children. Based
on this report, the European Parliament passed a resolution that specifically links the
precautionary principle with its ban on U.S. beef from hormone-treated cattle.14
In some cases, it has been
argued, U.S. law employs the precautionary principle, as in the Federal Food, Drug, and
Cosmetic Act (FFDCA) as amended by the Food Quality Protection Act of 1996; it mandates a
precautionary safety factor in addition to an ample margin of safety. An example of a
precautionary approach by U.S. agencies is the establishment of
"zero-tolerances" for ceriain bacteria in ready-to-eat foods. For example, when
the bacterium E. coli O157:H7 was determined in the early 1980s to cause
potentially serious illness, U.S. regulators required that it not be present in
ready-to-eat foods even though a risk assessment had not been conducted and there was not
a complete scientific understanding about its pathogenicity and whether certain levels in
food might be tolerable. Congress also has used a precautionary, zero-tolerance approach
to food safety with the implementation of the Delaney Clause,15 which states, "no additive shall be deemed safe if it is found to
induce cancer when ingested by man or animal, or if it is found, after tests which are
appropriate for the evaluation of the safety of food additives, to induce cancer in man or
animal." The zero tolerance aspect of this clause for pesticide residues was repealed
by the Food Quality Protection Act of 1996. The Delaney Clause remains in effect for food
and color additives.
Concluding Remarks.
While most stakeholders agree that science should serve as a basis for food safety
regulatory activities, there is no single clear-cut method to achieve science-based
regulations. The use of risk assessments is mandated by U.S. law for some aspects of the
food safety rule-making process although agencies occasionally utilize an approach similar
to the precautionary principle. Growing international influence of the precautionary
principle on trade is likely to become a subject of congressional discussion.
Footnotes:
1 [back] For
questions and additional information on this issue, contact Donna Vogt.
2 [back] Relevant
laws include the Federal Food, Drug and Cosmetic Act; Poultry Products Inspection Act;
Meat Products Inspection Act; FDA Modernization Act of 1997; and The Federal Crop
Insurance Reform and USDA Reorganization Act of 1994. Additionally, Executive Order 12866
of September 30, 1993, states that agencies must use scientific data to assess nsks,
costs, and benefits before proposing regulatioris.
3 [back] For
further details on risk assessment, see CRS Issue Brief 94036, The
Role of Risk Analysis and Risk Management in Environmental Protection, by Linda-Jo
Schierow; CRS Issue Brief 95035, Federal Regulatorv Reform;
An Overview, by Rogeho Garcia; and CR5 Report RL30043, Environmental,
Health, and Safety Tradeoffs: A Discussion of Policymaking Opportunities and Constraints,
by Jolin E. Blodgett.
4 [back] Report of
the Presidential/Congressional Commission on Risk Assessment and Risk Management, Framework
for Environmental Health Risk Management; v.1, 1997. p.25.
5 [back] Centers
for Disease Control and Prevenfion. Isolation of E. coli O157:H7 from Sporadic
Cases of Hemorrhagic Colitis-United States. Morbidity and Mortality Weekly Report, November
5, 1982; U.S. Food and Drug Administration. Center for Food Safety & Applied
Nutrition. Foodborne Pathogenic Microorganisms and Natural Toxins Handbook
6 [back] The first
government sponsored risk assessment on a food safety issue, Salmonella Enteritidis
in shell eggs and egg products, was prepared by an interagency collaborative team. The
final report was submitted to the FSIS on June 12, 1998. Currently, FDA and USDA are
conducting other food safety risk assessments for specific food-borne bacterial pathogens
in certain foods.
7 [back] Phone
conversation with Rick Hind, Greenpeace, Washington, D.C. office, June 9, 1999.
8 [back]
The text of the Final Act of the Treaty on European Union was signed at Maastricht, the
Netherlands on February 7, 1992. Text from the treaty states that EU environmental policy
"shall be based on the precautionary principle and on the principles that preventive
action should be taken, that environmental damage should as a priority be rectified at
source and that the polluter should pay."
9 [back] From the
International Joint Commission's Ninth Biennial Report on Great Lakes Water Quality
presented at the Great Lakes Water Quality Agreement Public Forum, Niagara Falls, Ontario,
November 1-2, 1997.
10 [back]
Participants of this meeting produced the "Wingspread Statement on the Precautionary
Principle" published online in Rachel's Environment & Health Weekly #586 [http://www.monitor.net/rachel/r586.html].
11 [back] Letter
published in Nature, July 29, 1999. Soren HoIm and John Harris, Institute of
Medicine, University of Manchester, UK.
12 [back]
Remarks from Dr. Elizabeth Whelan, president of the American Council on Science and Health
[http://www.acsh.org/publications/priorities/0803/future.html].
13 [back]
Organizations that assert the safety of beef from hormone-treated cattle include the World
Trade Organization; the Lamming Committee of the European Community (the European
Community became the EU in 1993); the Joint Expert Committee on Food Additives of the
World Health Organiaation and the Food and Agriculture Organization of the United Nations;
the Committee on Veterinary Drugs of the Codex Alimentarius Commission; FDA; USDA; and a
1995 Scientific Conference convened by the European Commission.
14 [back]
Items 16 and 17 of a May 3, 1999 EU resolution on the EU/US trade disputes links the
precautionary principle with the European Commission "ban on hormone-treated
meat."
15 [back] 1958
Food Additives Amendment to the Federal Food, Drug and Cosmetic Act. Saccharin, a sugar
substitute shown to cause bladder cancer in rats, exempted from the Delaney Clause by the
Saccharin Study and Labeling Act of 1977 (P.L. 95-203).
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