February 24, 2000

i submitted the comments below to U.S. Codex, before the Codex
Committee on General Principles met to address the Precautionary
Principle.  They are even farther along this year, as is the Food
Labeling Committee.

Regards,

Mark Mansour

___________________________________________________________


We are writing to offer our comments regarding the precautionary
principle which, largely as a result of sustained EU pressure,
continues to be a subject of discussion within the Codex Committee on
General Principles.  It is our view, and we believe it is shared by
many in the food industry, that the ultimate disposition of this
signal issue will determine in large measure whether Codex fulfills
its mission of developing an effective mechanism, based on recognized
scientific principles, by which the nations of the world can guarantee
a safe and efficient food supply for the coming century, or whether it
will instead allow parochial interests to reduce nearly forty years of
labor to what would essentially become a network of technical and
non-tariff barriers to trade.

It is ironic, given that one of Codex's central missions is to create
a framework by which the World Trade Organization (WTO) can
effectively and expeditiously resolve disputes over trade in food,
that such concepts as the precautionary principle may result in
Codex's own work leading to the erection of  barriers to the free flow
of goods.

A threshold concern regarding the precautionary principle is that is
imperfectly defined, making it subject to a variety of
interpretations, some of them inconsistent with the scientific
principles which form the basis for Codex's work.  In addition, there
is a growing tendency by some parties to view the principle as
grounded in international law, when it is not.  Although the EU
portrayed the principle in this light, neither the U.S. nor the WTO
Panel and Appellate Body agreed.  The precautionary principle is, and
has been, more appropriately applied to environmen tal law.  There is
no basis for extrapolating from its use as an environmental doctrine
to other international spheres, let alone as the basis for risk
analysis in the area of food regulation.

The presumption that supports the precautionary principle is that
hazards and risks are somehow synonymous.  The appropriate analytical
framework for Codex purposes would recognize the distinction.   Unless
there exists a clear, demonstrable, scientific justification,
including the presence of empirical information and credible,
objective data that demonstrate harm, or the likelihood of harm, to
human, animal or plant health or the environment, the presumption must
be against prohibitive or restrictive recommendations that might lead
to burdensome and unjustified regulations.  Each and every uncertainty
should not be cause for another Codex guideline and subsequent
regulation at the individual country level of products and their
labeling.

The resulting disparity in individual country laws, inevitable
because some countries would oppose regulation based on such a
principle, would have a cumulative and damaging effect on
international trade and on the ability of manufacturers to communicate
with consumers, without a corresponding benefit to public health and
welfare.  Taken to the extreme, exercise of the precautionary
principle would facilitate the imposition of various use and labeling
restrictions even when conventionally accepted methods of risk
assessment, such as JECFA's, are employed.

The current EU position, which is derived in part from a DG XXIV
working paper addressing the precautionary principle among other
issues, reflects an inaccurate interpretation of the EC Green Paper,
which states that, "Where a full risk assessment is not possible,
measures should be based on the precautionary principle."  It goes on
to describe the precautionary principle, stressing the concept of
incompleteness, rather than uncertainty: "a precautionary approach is
the rule in case scientific evidence is incomplete or unconvincing one
way or the other, which makes a full risk assessment impossible."

The general thrust of this statement is that a full risk assessment
should be employed, if at all possible.  Although the DG XXIV working
paper is not a final document, to the extent it reflects an evolving
EU position, it remains a cause for legitimate concern.  (NOTE:  OF
COURSE, IT IS NOW A FINAL DOCUMENT.)

Based on the analysis set forth in the DG XXIV document, the EU would
apply the precautionary principle whenever "there is a potential
(emphasis added) for adverse effects," taking the position that, if
such a potential exists, no matter how minuscule the potential may be,
then a risk exists which must be ameliorated.

Such application of a certainty-based standard flies in the face of
scientific principles.  By demanding certainty, adherents to the EU
interpretation of the precautionary principle ignore the fact that,
very often, the level of data and information about potential risks is
sufficiently complete as to allow for a decision that both protects
the public welfare and permits the free movement of goods and
commercial communication.

As noted earlier, another concern revolves around the misapplication
of the precautionary principle to food and food ingredients, when its
primary use is, and has been, as a standard for managing environmental
risks.  Unlike many environmental risks, the risks associated with
food products and food ingredients are well-known, and are usually
minimal in nature and scope,  and not of persistent duration.  The
focus should be on severe and quantifiable adverse conditions and
effects, and such decisions should be made on the basis of proper
scientific evaluation, rather than on unsubstantiated fears or biases.
 It is wholly unjustifiable to predicate the integrity of
international trade agreements on any standard that is based on less
than sound scientific principles.

As a first step toward achieving a needed refocusing of the
discussion regarding this issue, the precautionary principle should be
properly and clearly defined, and given a concise scope.  The
definition process should take into consideration the following:

Codex guidelines, principles and conclusions have a profound impact
on international trade.  The precautionary principle should be
consistent with, and not take precedence over, proper scientific risk
assessment, recognizing that science does not provide certainty.   To
do otherwise would subvert the intent of the WTO's Sanitary and
Phytosanitary (SPS) and Technical Barriers to Trade (TBT) Agreements.

Any guiding principle employed by Codex for such purposes should
focus on serious adverse effects of a persistent, rather than a
transitory nature.  The precautionary principle views all hazards as
entailing potential risks, which is inaccurate.

There is much that industry, with its valuable experience and
expertise in risk assessment and management, can do to assist in
reframing the debate and arriving at a standard that meets the needs
of government, business and consumers.  It would benefit Codex and,
ultimately all of the parties involved, to draw on that expertise and
experience for the greater good, rather than to adopt independent
methods that advantage none.

A welcome first step would entail the adoption of transparent
procedures governing hazard identification, risk assessment, risk
management and risk communication, coupled with an open exchange of
information and views between Codex and all of the stakeholders in the
process, so that consumers, industry, regulators and policy makers all
have access to data and the rationale on which initiatives and
decisions of such long-term consequence are based.

We again emphasize our deep concern that the precautionary principle
not be simply accepted as a guiding principle, but instead that it be
subjected to a vigorous debate and questioning.  Otherwise, Codex will
take a step back from meeting the challenge set for it by the WTO,
that it serve as a basis for expeditiously and fairly resolving
questions that impede the free and safe flow of food products between
nations.

Thank you for providing us the opportunity to present comment. 
Please contact us if we can answer questions or provide further
assistance.