Risk Assessment cannot be considered in the abstract. The activities of the risk assessor and
manager are strongly affected by the relevant legislation and guidelines which have established as
a result of the legislation. One can compare the risk assessment process to a filter system and risk
management to devices to control flow rate. Each layer of filtration material increases product
purity but reduces output. Too few layers allow unwanted contaminants to pass, resulting in
adverse effect on the product. Risk management attempts to insure safety by use of procedural
stratagems without preventing the development of useful products. {protocols for assessment
must be clearly defined and transparent.
Risk assessment and management also must factor in the type of risk and an individual's
acceptance of the particular risk. Thus, one will accept a higher degree of risk to accomplish an
important (to oneself) function. It is acceptable to drive at high speed even though it increases the
risk of accident and greatly increases the risk of serious injury while it may not be acceptable to
inhale second hand smoke even though the inhalation poses a much lower risk of adverse effect
(perhaps one in 10,000 vs one in 1 million). The objective of risk assessment is to produce a
description of the magnitude and likelihood of an adverse effect related to a particular activity.
The credibility and value of the assessment is directly related to the quality and quantity of data
available about the product, the environment in which it will be used and the population involved.
Safe use of biotechnology products can be assured by adherence to risk assessment principles and
development of required data using sound, science based protocols and measurement techniques
Most nations have regulations aimed at protecting citizens from adverse effects of commercial
products. In most countries, these have been judged to be sufficient for providing protection vis a
vie biotechnology products. In most cases, new guidelines or specific provisions to existing have
been added to existing guidelines to assure safety.
The U.S. regulatory scheme for biotechnology products relies on multiple agencies to implement a
mosaic of existing federal statutes. Each statute has a specific goal, e.g. to protect public health
and the environment or to ensure food safety. The mosaic approach was deemed appropriate to
regulate the diversity of new biotechnology products using existing statutes and to provide
credible assessments to form the basis for sound regulatory determinations without unduly
hindering the technology. To succeed, this multi-agency approach requires the responsible federal
agencies (i.e., EPA, USDA, and FDA ) to work in harmony. Only through effective coordination
can the agencies minimize duplication, avoid inconsistent regulatory decisions, address gaps in
oversight, and ensure that regulations evolve with experience and scientific advancements.
The UN has produced a voluntary code for risk assessment and the EC has produced a series of
directives which spell out the process for member states. These documents spell out the
application of risk assessment data in determining the magnitude o risk and the appropriate action.
The basic requirements are: Consistent product definitions and regulatory scope, clearly
established lead and supporting agencies with a mechanism for effective interagency
communication, and consistent statements of information to support reviews. It is of equal
importance to assure that the reviews are of comparable rigor and that the process is transparent.
In all cases the assessor requires identification of the problem: hazard and exposure, in risk
assessment terminology. Hazard is identified as effect in scientific terminology: exposure is seen
as initial establishment and possible transport to new locations for secondary establishment. The
needs of the risk assessor are clear: Ability to enumerate the test organism and to acquire
information about stability and effect of the environment on the organism. Coupled with this need
is the requirement for ability to extrapolate to other environmental situations and to other exposed
populations. These needs generate the requirement for specific methods, some specified by the
reviewing authorities, some available in open literature and some which still require development.
Especially lacking are models which provide the ability to generalize. It is this which limits risk
assessment to a case-by-case level. Only in a few situations (IE Bacillus thuringiensis) is
sufficient background information available to permit generalization and hence relaxation of
information and notification requirements for field testing engineered organisms.
