Text: Codex's Billy on Agricultural Biotechnology

(Committee focus is how to make food safety decisions) (2100)



Codex Alimentarius Chairman Thomas Billy says the science of food
biotechnology has advanced so fast that most Codex member countries
have struggled to understand, define and regulate it, underscoring the
need for an adequate, rational international regulatory framework.


"This is particularly trying in the context of ensuring the world a
safe and nutritious food supply while maintaining fair and open
trade," Billy said March 14 at the opening of the Codex Ad Hoc
Intergovernmental Task Force on Food Derived from Biotechnology
meeting in Chiba, Japan. The first Task Force meeting was scheduled
for March 14-17.


"We do not need to decide which foods are safe and nutritious," Billy
said. "Our goal is to provide the framework, not the answers."


Codex Alimentarius is a joint commission of the Food and Agriculture
Organization (FAO) and the World Health Organization (WHO) to ensure
food safety, establish fair practices in food trade and promote the
development of international food standards. The biotechnology task
force was activated with a four-year mandate to examine the risks of
foods derived from the use of genetic engineering and to develop
standards, guidelines or other principles.


Billy, who is also administrator of the Food Safety and Inspection
Service of the U.S. Department of Agriculture, said the international
guidelines developed by Codex for food safety and nutrition should "be
based on the characteristics of the product itself" and not on the
process of its development. One of the major debates surrounding
agricultural biotechnology has been which issue is more important in
developing a regulatory framework, how the product is made -- the
process -- or the actual product, he said.


"In perhaps its simplest formulation, biotechnology is the process of
transferring genes from one organism to another," Billy said. "In this
sense, biotechnology is a new name or label for a process people have
used as long as we have been baking bread, fermenting wine or making
cheese, or cultivating crops and breeding animals."


Following are terms and abbreviations used in the text:



-- FAO: Food and Agriculture Organization.



-- WHO: World Health Organization.



-- OECD: Organization for Economic Cooperation and Development.



-- DNA: Deoxyribonucleic Acid.



Following is a text of Billy's prepared remarks:



(begin text)



Food Safety and Inspection Service

U.S. Department of Agriculture

Washington, D.C.



Prepared remarks for

Thomas J. Billy, Chairperson,

Codex Alimentarius Commission,

For the First Session of the Codex Ad Hoc Intergovernmental Task Force
on Food Derived from Biotechnology
March 14, 2000

Chiba, Japan



I want to begin today by saying thank you to all of you. I appreciate
the chance to speak at the beginning of these important proceedings,
and, perhaps, help set the stage for the tremendous task ahead. We
have a lot of work to do in a relatively short time frame, certainly
by Codex standards. But, I think if we take a few minutes to focus on
why we're here, and determine a strategy for where we want to end up,
we can make the most efficient use of our limited time.


I also want to say that although I shoulder several roles, I stand
before you as the Chairman of Codex, and I want to take this
opportunity to highlight the international focus of why we are all
here.


As we know, the science of food biotechnology has advanced so fast
that most of the 165 countries of Codex and our international
mechanisms have struggled to understand, define and regulate it. This
is particularly trying in the context of ensuring the world a safe and
nutritious food supply while maintaining fair and open trade. While
there are many issues that need to be addressed, we do, however, have
the benefit of building on a strong foundation laid by the joint
FAO/WHO Food Standards Program.


The issue was first raised more than ten years ago, during the 18th
session of the Codex Alimentarius Commission in 1989. The following
year, a Joint FAO/WHO Consultation on the Assessment of Biotechnology
in Food Production and Processing as Related to Food Safety, took
place in Geneva. The Consultation addressed biotechnology as a
continuum, ranging from traditional breeding practices to modern
techniques based on recombinant DNA-technologies. The Consultation
determined that while foods resulting from new methods are not
inherently less safe than traditional products, scientific assessment
is necessary to evaluate their safety and nutrition.


The Codex Alimentarius Commission determined the necessity of
guidelines to evaluate foods produced from biotechnology, and, in
1996, a Joint FAO/WHO Expert Consultation on Biotechnology and Food
Safety met in Rome. This Consultation focused on the process of
substantial equivalence that had been developed by the OECD -- a
process that can provide a useful starting point.


There is, however, still much work for us to do. There are many areas
of concern that must be dealt with and cannot be ignored. In fact, the
issue of biotechnology is so important that Time Magazine in the
United States even named our new century "The Biotech Century." This
importance increases the value and necessity of our efforts today.


Those of us in this room have heard the benefits of biotechnology
being touted: higher yield and more nutritious crops that are more
resistant to perils of pests, drought or less-than-ideal growing
conditions. The promises of super foods and an end to world hunger or
diseases caused by malnutrition, without the need to put more and more
land into agricultural production, are cited as benefits. Crops that
can resist pests on their own, decreasing the need for conventional
pesticides; or crops resistant to weed killer, so farmers can maximize
crop yields while avoiding disturbing the soil and associated erosion
problems, might seem to be the answers to environmentalists' prayers.
There are many who would like to see these benefits realized.


However, there are many concerns that have been raised as well. In
particular, from a Codex perspective, is the question: Are the
national and international risk analysis systems in place adequate for
assessing the safety and nutrition of foods derived by biotechnology,
and communicating the results of risk assessment and risk management
decisions to the public?


There are many legitimate questions that need to be asked and
answered. Our challenge is to take a step back from the often
contentious, sometimes emotional, public debate and to develop a
responsible approach to answering those legitimate questions through a
progressive, science-based exchange of ideas leading to collaboration,
consensus, and perhaps compromise.


There is an expression in English, an admonition: "don't bite off more
than you can chew." I think this expression is particularly
appropriate when considering the charge to this task force. We need to
heed this advice -- especially since biotechnology is a sufficiently
broad topic that we could talk forever.


This task force is specifically charged:



-- To elaborate standards, guidelines or other principles, as
appropriate, for foods derived from biotechnology.


-- To coordinate and closely collaborate, as necessary, with
appropriate Codex Committees within their mandate as relates to foods
derived from biotechnology, and


-- To take full account of existing work carried out by national
authorities, FAO, WHO, and other international organizations and other
relevant international fora.


However, this task force was deliberately limited in time and scope.
That is not to say that other issues are not legitimate, or that other
questions need not be considered; but, fortunately, there are other
committees or institutions to address those areas. We need to be
mindful to stay on topic-and, perhaps, identify areas where it would
be useful to have an exchange of ideas with colleagues addressing the
other areas, such as the Codex labeling committee. We do not need to
decide which foods are safe and nutritious -- our mission is to
determine how Codex and, thus, countries, can establish or perhaps
modify mechanisms to make these decisions in a rational and scientific
way. Our goal is to provide the framework, not the answers.


As we consider our goal here today and in the weeks and months to
come, one very useful starting point is to consider just what is
biotechnology.


In perhaps its simplest formulation, biotechnology is the process of
transferring genes from one organism to another. In this sense,
biotechnology is a new name or label for a process people have used as
long as we have been baking bread, fermenting wine or making cheese,
or cultivating crops and breeding animals.


Through agricultural practices, people have been practicing
biotechnology throughout history. Because of selective breeding, many
domesticated animals and plants common today look little like their
wild counterparts. We have significantly altered the genetic makeup of
many plants and animals.


In recent times, the techniques of biotechnology have become much more
sophisticated and precise; to include what is called "genetic
engineering." Genetic engineering may involve the targeting and
transfer of DNA that produces specific desired traits in one organism,
to another. Genetic engineering is essentially a refinement of the
kinds of genetic modification long used to enhance microorganisms,
plants and animals for food, and it can enable more drastic changes
than can be achieved using more traditional techniques.


One major issue that needs to be considered by this task force is the
question of process vs. product. Is the method by which a product was
created the important issue, or is it the characteristics of the
product itself? I am sure this question alone will inspire debate.


However, let me say that the history of food safety regulation
revolves largely around the "what" and not the "how." If we focus on
the how, we limit ourselves to that which we are familiar and may
overlook important characteristics of our food. Then, there are
techniques that can produce product without a trace of the process by
which the product was created. I would suggest that international
Codex guidelines for food safety and nutrition be based on the
characteristics of the product itself. I suspect we will have much
discussion over this issue as we work on our outputs. And in that
regard, I encourage our thinking about a general text, in the form of
a standard or recommendation, accompanied by sets of guidelines to
amplify key areas of complexity or concern. There are a number of
existing examples of such approaches in Codex to draw from.


There are several key safety issues to keep in mind as our discussions
develop. Among the questions that are relevant to assessing the safety
of any new food derived from biotechnology are the following:


-- Are new substances created or inserted into a new product toxic or
allergens?


-- Is the end product substantially nutritionally altered?



-- Is there a substantial change in food composition?



-- When they are used, are the antibiotic resistance markers
dangerous?


Given the definition of biotechnology and the key issues to keep in
mind, one way of addressing food safety and nutrition is to determine
what, if any, area or areas require more in-depth food safety or
nutritional assessment using the process of substantial equivalence.


To use this process, a determination is made about the degree to which
any aspect of a food is equivalent to a product that is already
accepted as safe. This process is, in itself, based on science and
coming to the "equivalent" conclusion may require some research and
evaluation. But the other side of the question is where the bulk of
the work lies -- in the determination about the degree and
characteristics of the differences. For most discussions about food
safety and nutrition, determining the degree of equivalence is only
the first step, not the conclusion. As appropriate, scientific
studies, evaluations, and risk assessment would then follow to
establish the safety and nutrition of such products, and communication
of the process and results to the public.


By limiting our scope of the work of this task force to food safety
and nutritional issues only, and by building on the work done by the
FAO/WHO consultations that have met before us, we stand a good chance
of achieving our important goal. We certainly have a difficult and
important task: to elaborate a standard or set of principles and
guidelines for the safety and nutrition of foods derived from
biotechnology. Even though we do not have to come up with all the
answers, if we do our jobs well, we will enable the international
community and our individual countries to better come to terms with,
and perhaps hasten, any benefits from this exciting new technology,
while continuing to protect human health.


(end text)



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