Risk and Uncertainty, International Relations/Trade,

Ahl, Alwynelle (Nell) S.

English

Research Papers in Economics

Agricultural Outlook Forum         For Release February 23, 1998
RISK ASSESSMENT PROVISIONS OF IMPORT AND EXPORT REGULATIONS
Alwynelle (Nell) S. Ahl
Director, USDA Office of Risk Assessment and Cost-Benefit Analysis
Risk Assessment for Biological Agents
Risk assessments for human health or environmental health have been carried out by the
Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) for a
number of years.  Historically, most of the hazards were chemicals or toxins; the risk assessment
methods for these agents have been investigated for thirty years.  However, many of the hazards
of interest in agricultural imports are different: they are caused by biological agents which can
replicate.  Thus a commodity with no detectable level of a biological agent (bacterium, fungus,
or virus) could enter an importing country, reproduce itself, establish and spread.  In contrast, for
chemicals and toxins, the “dose makes the poison.”  Risk assessment for these agents is focussed
on understanding exposure and dose-response assessment for humans and the environment.  For
chemicals and toxins, the original amount of material deposited is known.  However, once a
reproducing hazard enters the importing country, it may be impossible to contain.  Therefore the
primary focus of import commodity risk assessment is to avoid bringing an unwanted agent into
the importing country:  prevention is foremost.
The development of the concept for the General Agreement on Tariff and Trade (GATT) in the
1980s provided the stimulus to use science-based risk assessment as one tool for evaluating the
acceptability of an import.  At that time, a specific sub-discipline for biological agent risk
assessment did not exist.  In the early 1990s work was begun in several countries to develop
approaches and methods for biological agent risk assessment.  USDA’s Animal and Plant Health
Inspection Service (APHIS) in 1989 began to evaluate concepts to support risk assessment for
support of sanitary and phytosanitary (SPS) decision-making.  Since that time, variety of
methods, both qualitative and quantitative have been developed.  The ways in which these
methods may be most usefully employed in decision-making is a topic of current discussion in
the fields of crop, livestock and human health (food safety).
Science and Risk Assessment
There is much confusion about the nature and uses of science and of risk assessment.  Science
proceeds by establishing an hypothesis and trying to discredit it.  Following numerous tests of
the hypothesis, if it cannot be disproved, it is accepted as part of the factual body of science. 
Basically science is a very conservative and time-consuming process which demands high level
of proof to establish a fact. The goal is to advance our understanding about phenomena in nature.
Risk assessment is not science.  Risk assessment structures the best available scientific and otherrelevant information to make decisions about hazards.  Hazards are things that can go wrong.   
For example, how likely is the dam to break?  Or if I invest money in a particular stock, how
likely will I achieve a net financial gain.  As a formal discipline, risk assessment has  been
applied in fields such as engineering, finance, and insurance for many years. The General
Agreement on Tariffs and Trade (GATT), now the World Trade Organization (WTO) and other
treaties, from the late 1980s to early 1990s, require that science-based risk assessments be used
to establish appropriate sanitary and phytosanitary protection (S.P.S.) for an importing country.  
World trade restrictions must be based on the findings of risk assessment, not the politics of the
past.
Risk assessment as a formal academic discipline is young enough that the definition of terms in
the field are not standardized.  To complicate matters, risk studies took words from the
vernacular and endowed them with special significance.  The lack of unanimity about the
meaning of the terms adds another layer of complexity in mutual understand.  In 1991, a basic
set of terminologies were established for agricultural use to avoid unnecessary differences about
items on which there is actual agreement.  Risk analysis is the term used to encompass risk
assessment, risk management and risk communication.  Risk assessment is the term used to
define the analytical approaches, processes, models, methods and calculations.  Risk assessment
answers three basic questions about hazard and risk.  The question for hazard identification is
what can go wrong.  Risk is answered by two questions: (1) how likely is it that the hazard will
occur and (2) what is the magnitude of the consequences if the hazard does occur.  This latter
question may be answered in biological or economic terms.  Risk management is the decision
making activity in which results of the risk assessment are incorporated.  It is important,
however, to understand that the results of the risk assessment is only one element which must
enter the thinking of the risk manager.  Risk communication is the open communication
between and  among all interested parties, especially the individuals and groups most affected by
the decisions.
Risk Assessment and Decision-making
Risk assessment as a discipline formalizes some of the most successful strategies used in
decision-making.  For example, one performs an informal, intuitive risk assessment at each
crossing of a busy street.  In planning to arrive on time for a meeting in a distant location, the
same informal and intuitive processes are at work.  In fact, agricultural producers or farmers are
among the most successful risk assessors.  The market dictates that those who are not become
“former farmers. “
Decision making in government for protection of human health, safety or the environment
(including the protection of crop and livestock resources) in the past has been based on
knowledge and science, but the risk assessment has largely been informal and intuitive.  With the
advent of WTO and NAFTA, these methods are no longer acceptable.  Instead,  risk assessments
must be documented in writing, transparent to understanding, well-organized for clarity, flexible
to take into account new information, and consistently applied. 
International standard setting organizations (e.g., Codex Alimentarius, International PlantProtection Commission, and Office of International Epizootics) are currently discussing
standards, methods, procedures for evaluating biological risks associated with trade.  This
includes attempting to define what is an acceptable level of risk (ALR) and an appropriate level
of protection (ALP).  The WTO requires that the ALP be based on “...available scientific
evidence, relevant processes and production methods, relevant inspection, sampling and testing,
relevant ecological or environmental conditions...”   If insufficient scientific information is
available to make a decision, the importing country must “...seek additional information for more
objective assessment of risk...in a reasonable period of time...” The ALP should minimize
negative trade effects. 
The ALP standard may include relevant economic factors.  For example, the lost production and
sales of a commodity in a country in the event of entry of the hazard (biological agent).  The
costs associated with containing the establishment and spread of the pest or disease agent may be
considered, as well as costs of control and eradication should that be necessary.  The cost-
effectiveness of alternative mitigation measures is especially recommended because that assures
that the risk is controlled in the least expensive way, an advantage to both the economy of
exporting and importing countries.
Current Activities in Risk Assessment for Agricultural Trade
Current work in risk assessment focusses on methods for risk assessment (more research is
needed in this area).  There must be scientists trained to perform risk assessments.  Decision-
makers must continue working to understand the meaning and implications of risk assessments. 
And all must work toward the goal of international harmonization.  
Risk assessment based on the best available science along with tools from economics and other
disciplines offers the best opportunity for harmonizing world trade guidelines for reducing and
preventing risks, and maximize benefits to all.
  

RISK ASSESSMENT PROVISIONS OF IMPORT AND EXPORT REGULATIONS

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