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Date:

July 20, 2000

Subject:

Science and testing in GMO risk/safety assessment

 

AgBioView - http://www.agbioworld.org, http://agbioview.listbot.com

Date: Jul 20 2000 20:06:59 EDT
From: Marcus Williamson
Subject: Re: precautions

Malcolm

I've been asking GM companies and government agencies for the last two
years for reports showing testing GM food safety and not one has been able
to provide them.

Can you provide an example (perhaps just one) showing conclusive safety
testing for GM corn or soya?

Thanks & regards
Marcus Williamson
Editor, "Genetically Modified Food - UK and World News"
http://www.gmfoodnews.com/

On Fri, 21 Jul 2000 09:52:03 +1000, you wrote:

>Marcus,
>
>Testing of GM foods is done by the scientists who make them. So many
>references that I can't give you all of them (thousands). Check out any
>publication eg Plant Cell Reports, Plant Journal etc. Testing for
allergens
>is often done by FDA, USDA or companies like Monsanto. These are not peer
>reviewed but I'm sure you can get information from these public
authorities.
>
>Malcolm
=========================================================

Subj:Science and testing in GMO risk/safety assessment
Date:Fri, 21 Jul 2000 5:53:56 AM Eastern Daylight Time
From:Horst Backhaus

I found myself stimulated to engage in the discussion of this forum by
some contributions about the role of science and testing in assessing risk
and in modifying public confidence. Being engaged in regulation of GMO
releases and marketing, as well as in some areas of so called "safety"
research, I want to present my perception to this forum. Extracts of
argumentation by Robert Vint, David Lineback, Rick Roush, and Andrew Apel
are cited first. Then I give my comments in four chapters.
--------------------
Robert Vint (RV):
1. existing unpublished corporately sponsored research satisfies
governments // no chance to satisfy consumers (or insurance industry)
2. What is needed to resolve the crisis /.../ an independent and open
research program, designed in consultation with NGO?s ... /publication
/peer review of results.
3. ... reassurance that is now clearly needed.
4. ...end the deadlock by trying to get the two sides in this debate to
agree on the kind of research that is needed to restore public confidence
5. what research ... the public will see as reasonable before they eat...
6. what practical alternative (to testing in response to consumer fears
(response to R.Roush))?
7. Regulatory confidence in results: What is there to loose? ...research
would /.../ be sensible PR

David Lineback (DL):
1. approach requested (by R.Vint) has little basis in reality
2. distinguishing between a research program and a testing program.
3. testing programs do not contribute new knowledge in the sense of ...
research programs
4. genetically improved foods have undergone /.../ a testing program
/.../ not a research program
5. testing programs ... not subjected to peer review and
publication....reviewed by regulatory authorities.
6. (testing programs are) part of a sound, justifiable risk analysis
approach...
7. testing of all foods? /.../ only those with which consumers are not
satisfied?
8. Most of the foods ... have never undergone such testing

Rick Roush (RR):
1. What research adequate?
2. Every offer ... would require a level of testing never before
applied... (e.g. kiwis, ...resistant cultivars)

Andrew Apel (AA):
1. Strongly disagree with ... assertion of a distinction between
research and testing
2. Results of testing are of interest to many
3. Lack of transparency ... Publicised testing would "tip off" competing
companies
4. How to solve the issue (of transparency)?
en by curiosity, much less by
altruistic motivation - investigates (and expands) the area of incomplete
knowledge to improve explanations of phenomena and to gain control.
Hypotheses formulate rules and mechanisms; their power determines the
potential of inferences and extrapolation (for explaining divergent
phenomena, and to predict the outcome of varied combinations under a set
of parameter conditions). Science may be characterised by its dynamics of
changing knowledge: putting forward novel hypotheses or expanding the
range of their applicability.
Testing and applied science, depending on a state of science, are using
knowledge to manipulate materials and nature or to generate empirical data
for the sake of our objectives (e.g. dose response, mobility, partition
coefficients, etc. of a toxicant for predicting the degree of interaction
with a sensitive organism; meteorological data for whether forecasting).

Testing, in the narrow sense of producing data with a set of standardised
protocols, relies on the applicability of theory. Its quality may be
characterised by the precision of data generation. Adapted to their
particular objectives, testing systems must be modified or exchanged with
time, in order to efficiently transform the progress of science.

ii. Thus, - "testing", to become a "part of sound, justifiable risk
analysis programme" (DL 6.), needs some consensus among regulators (e.g.,
about the state of the art in representing science by the methodology of
data generation and interpretation), the adjustment to political claims of
risk management objectives and last but not least some degree of
confidence in the process in the general public.
A prerequisite to the use of a testing regime to obtain data about risks,
is the knowledge (or the consensus about) the relation of test data of the
degree of a particular risk under investigation.
Furthermore limits of precision as well as levels of risk have to be
defined explicitly with respect to acceptability - or must have been
implemented in the procedure as a result of some convention or tradition.
Also, the concepts of "protected goods" must be defined, and finally a
consensus must exist about an adequate choice of management tools to
mitigate not acceptable levels of risk.
Internationally, particularly in Europe, such prerequisites quite
apparently do not exist. So far, I do not observe an approach to some
consensus shaped by "state of science" with respect to testing
procedures, endpoints or data quality. One reason - somehow in common to
any approaches to GMO risk assessment, however, to a widely divergent
degree internationally - is the intention to investigate risk hypotheses,
irrespective of a primary estimation of their probability according to
state of science. Usually this is combined with ambitious objectives to
control the unpredictable (unintended effects of genetic modifications,
ecological long term effects, evolutionary processes, the development of
agricultural practices). Divergent protection objectives and risk
balancing perspectives appear to be the main reason, shaping these
perspectives to a
large extent. Whereas the effects of other human interventions (e.g.,
conventional agriculture) sometimes (in a minority of cases) are
proclaimed to be used as a measure of relative risk, such comparison is
rarely used to balance the degree of investment into the exploration of
hypothetical risk scenarios. Using the reference to the "precautionary
principle", there is a tendency to put the burden of proving zero risk
onto applications of genetechnology in agriculture and food/feed
production. Public (or group specific) perception may deliberately stress
any risk scenario among the
multitude which can be constructed without generally conflicting with
present scientific knowledge. The political agenda, somehow supported by
ambiguous lists of criteria in the directive, is taking care for the
transmission of (public/scientific) perceptions into the regulatory
regimes. Nationally divergent viewpoints may further shape data
requirements and their acceptability rather easily. The emerging conflicts
with the ideas of a common market and a promotion of international trade
are very obvious.

Clearly, "testing" - in the sense of analysing a particular degree of
risk against a background of common understanding of acceptable
uncertainties and protection objectives - does not serve to promote the
marketing of GMOs internationally by now and for some time to come. The
challenge on science related to "biosafety" in a broad sense is to
elaborate on a variety of hypotheses and to explore the relevance of a
multitude of hypothetical risk scenarios, including their testability
(potential for prediction):
unfavourable health effects induced by non predicted variations in GM
food, enhanced "fitness" of crop and wild plant hybrids with modified
genes, negative (long term -)effects connected with gene establishment
after gene transfer, generation of pathogen populations with novel
virulence or host specificity by interaction with (virus-resistant) GM
plants, ...
Much of this research surpasses a borderline between applied and basic
science and challenges the potential of inference from present knowledge
in biology, genetics, evolutionary theory, and ecology. It is totally
unclear whether most of the risk scenarios will ever become testable for
the purpose of determining (predicting) a degree of risk with any
precision.
With an obligation of "monitoring" (for uncertain parameter values of
predicted risk scenarios, but including unexpected effects) in connection
with any GM plant or product after eventual marketing, as envisaged for
the redrafting of the European regulation, politics tries to cope with
this perspective. It is questionable whether such monitoring can improve
future approaches to risk assessment. Obviously it does not satisfy the
definition of "testing" as given in the intro to this paragraph (ii.).
OECD reports issued to G8 members could be inspected for some
illustration of the above:
Report of the Task Force for the Safety of Novel Food and Feeds [PDF
318KB] Report of the Working Group for the Harmonisation of Regulatory
Oversight in Biotechnology [PDF 210KB]
Available at http://www.oecd.org/subject/biotech/g8_docs.htm

iii. Independent research with peer reviewed publication of results
will not resolve the crisis (in opposition to RV 2.; supporting DL 1.)
Research and testing programs have accompanied the introduction of GMO
into the open environment from the beginning. Publicly funded research
has elaborated on a broad spectrum of risk assessment or risk perception
issues and much of it has been published in peer reviewed journals, or in
documents which are available to the public. Though increasing our
knowledge base to some extent, most general and also more case specific
research did make a minor contributions to improvements of risk assessment
- and so far did not suggest a significant modification of (potential)
testing regimes as used in toxicology and ecotoxicology. With respect to
an
improvement of inferences this research did much more stress the limitat
ions of ambitious objectives of prediction than to improve the respective
potential.

Also, companies have published much of their testing efforts - which did
include some scientific investigations on novel approaches - in reviewed
journals, if suitable (which might not be the case for lots of some
negative outcomes of testing for toxicity, allergenicity, or substantial
equivalence). In fact, I am not aware of any significant results of safety
testing, that are not available to the public. (By the way, the review by
regulatory authorities - together with an adherence to specified criteria
of "Good Laboratory Practice" could be regarded as reassuring as the
review process in most journals - which, however, is a matter of public
confidence).
(The situation here is totally different from conventional registration
procedures, e.g. of pesticides, where one might notice some lack of
transparency caused by declaration of confidential business information in
defence of a competing position (AA 3.). A mechanism to provide the public
with the "testing results of interest" (AA 2.) is becoming installed in
this area to some extent and might contribute to increasing public
confidence.)
Also, the amount of testing and research is unprecedented in our history
of coping with novel plant varieties or novel food such that "a level of
testing never before applied" (DL 8., RR 2.) has indeed been performed.
(With respect to balancing, the question of adaptation has to be posed:
which testing is necessary and sufficient to cope with a multitude of
future genomic modifications of different plants - and which type of
testing should be imposed onto "conventional" breeding results,
importation of "exotic" animals, plants, and seeds, etc.? (DL 7.).
Thus, the deadlock might not be ended by a consensus about needed
research, in particular, if the sides being in opposition do not share
its objectives "to restore public confidence" (RV 4.).
Research and testing generally does not seem to be well suited to
contribute to public reassurance: Its biases and limitations are
difficult to communicate, and interpretation may finally be shaped by
perceptions (see the press echoing of A. Pusztai?s experiments). Thus,
the public might not envisage any research as reasonable (RV 5.), since
it cannot obtain the "reassurance that is now clearly needed" (RV 3.,
Could we tell the public, that no testing - and no post marketing
monitoring - will indicate a level of risk, as low as the risk
originating from "mad cows", if we don't have a similarly unambiguous
correlation between risk source and disease endpoint???). Science cannot
provide a reassurance of zero risk. But, even in the case of unknown risk
scenarios and risk magnitudes, it could contribute to a fair balancing
with accepted similar risks. Insurance companies certainly will find their
solution to cope with the
particular degrees of uncertainty, and they have to do this by setting
the premium, irrespective of the amount of testing that has been
performed (RV 1.). (For the time being, it is difficult for me to imagine
the type of testing/research that would significantly reduce the premium.)

iv. Practicable alternatives to testing in response to consumer fears??
(RV 7)
Having mentioned the difficulties of interpreting testing results, I
would also question the contribution of additional and increased testing
to public confidence. The opposite might be true, sometimes. An increase
in the number of multifactorial testing regimes will not always result in
an unequivocal rejection of any health risk. Then interpretation becomes
biased by the prepossession with respect to general risk potentials and
such research might contribute to losses and would not as such be
considered as sensible PR (RV 7.). Sensible PR instead should, in my view,
very clearly state the limits of testing and science with respect to risk
prediction - and try to justify the balancing of a particular approach.
At some point in time, when protection objectives and levels of
protection (with respect to presently accepted levels of risk and
uncertainty) have been clarified within the political agenda, the case
might again be handed over to the responsibility of regulatory expertise.
Regulators should be obliged to communicate their approaches to risk
assessment, where testing will play its role, eventually more flexible
and case specific than conventionally. The communication of risk
balancing and evaluation should be open to criticism by divergent other
experts and the public, but should
not compromise regulatory responsibility. Politicians, corporate, and
opinion leaders might precede the general public in regaining some
confidence into regulatory institutions and processes installed by our
society.

A fluctuating distribution of responsibilities among politicians,
regulators, NGO?s, and the public at large does neither appear to enhance
public confidence, nor to support the achievement of objectives which
might form some consensus in our society:
to minimise the negative interference with the biosphere, to protect
diversity to strive for a sustainable development, to protect the rights
of minorities, to follow a precautionary principle, and
to adjust the investment into risk management to the best estimate of its
magnitude.

Priority setting among such objectives is a matter of the society as a
whole; but science must be involved in defining and testing endpoints
suitable as indicators of approaching or conflicting with those
objectives. Public awareness, fluctuating in response to media coverage
or signalling events produced by the perceptions of social groups active
by their particular agenda, does not seem to be suited to contribute to
approaching an objective scaling of risks. An investment of limited
resources into the handling of risks should preferably be adapted to such
scaling, in regard of economy (point 5). However, within a saturated
society the balancing among the two latter points will remain a matter of
discussion, frequently
not being solved in favour of economy or progress.

Horst Backhaus
---------------------------
Prof. Dr. Horst Backhaus
BBA - Institute PS (Plant Virology, Microbiology, Biosafety)
Messeweg 11/12
D-38104 Braunschweig
GERMANY

TEL: (49) 531 299 3806;
FAX: (49) 531 299 3013
email: h.backhaus@bba.de