WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
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  ANNEX I-3 
 
COMMENTS BY ARGENTINA ON THE REPLIES BY THE 
SCIENTIFIC EXPERTS TO THE QUESTIONS POSED BY THE PANEL 
31 JANUARY 2005 
 
 
COMMENT ON REPLIES TO QUESTIONS BY DR. ANDOW
 
 
Question 3  
 
3. On the basis of the information before the Panel, is there any scientific evidence to support 
the hypothesis that wide-spread cultivation of Bt crops such as biotech maize of the Bt variety 
adversely affects non-target organisms which may be ex posed to such crops under typical agricultural 
practice?  (See, inter alia, EC-149, EC-150, EC-151, EC-152)  If so, how does this risk compare with risks to non-target organisms arising from non-biotech applications for Bt toxins (i.e., the use of Bt 
toxin as an insecticide in conventional and organic farming)?  What risk management options are 
available to mitigate any resulting risks and what is their efficacy?  
 
Scientific evidence
 
 
03.01.  In the answer to this question, I will concentrate on Bt maize and Bt cotton.  
Yes. there is some scientific evidence to  support the hypothesis that wide-spread 
cultivation of Bt crops adversely affects non-target organisms which may be exposed 
to such crops under typical agricultural practice.  However, this evidence is 
insufficient to establish the hypothesis that su ch adverse effects are expected to occur. 
Comments by Argentina  
 
This statement starts mentioning that there is " some  (sic) scientific evidence to support the 
hypothesis"…, of non-target effects on organisms, " which may be exposed", and ends that " this 
evidence (sic) is insufficient to establish the hypothesis that such adverse are expected to occur" . It 
is clear from this wording that there is no solid evidence  to support the fact   that the organisms 
will actually be exposed  in a way which may be of concern about the safety of the Bt crops 
mentioned.  
03.02.  The review of non-target effects of Bt plants in EC-149  covered 13 laboratory 
studies evaluating potential hazard, and 14 fi eld studies aimed at evaluating potential 
risk.  Of the 13 lab studies reviewed, I conclude that five studies did not expose the test organisms properly and therefore are i rrelevant hazard evaluations (an organism 
must be exposed to evaluate hazard).  In two additional studies, four of eight test 
species were not properly exposed.  Of th e remaining, seven species were studied.
1  
Of these seven, six were on Bt maize and none were on Bt cotton.  Bt toxin had 
significant adverse effects on two of these six species, the collembolan Folsomia 
candida  (a soil organism) and the lacewing Chrysoperla carnea .  In neither case 
would adverse effects on these species been  predicted based on the known spectrum 
of toxicity of the Cry toxin.  There have been no studies to fo llow up the result with 
F. candida .  Hence, I conclude that there is a possible hazard (adverse effect) to 
collembola  from Cry1Ab Bt maize, but until this is confirmed, I ca nnot conclude that 
there is a potential risk to collembola.  There have been numerous studies that  WT/DS291/R/Add.7 
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  confirm that C. carnea  is somehow adversely affected by Cry1Ab toxin.  Hence, I 
conclude that there is a potential risk to C. carnea  from Cry1Ab Bt maize. 
 _______________ 
 
1 Folsomia candida , Coleomegilla maculata , honey bee adults, Hippodamia 
convergens  adults, 2 parasitoid species, Crysoperla carnea .   
Comments by Argentina  
 
Footnote 1 is not quoting literature, and therefore is not an argument.  
 
On the phrase: "There have been no studies to fo llow up the result with F. candida.  Hence, I 
conclude that there is a possible hazard (adverse  effect) to collembola from Cry1Ab Bt maize, 
but until this is confirmed, I cannot conclude th at there is a potential risk to collembola", we 
observe the following:  
 
1. it states "to follow up the results", but it does not quote or mention to which results is 
the Expert referring to;   2. it is not easy to understand how, if th ere have been no studies, hence, the Expert 
concludes that there is a possible hazard;  
 
3. how from the above, it can be concl uded that there is a potential risk  . 
 
03.03.  Of the 14 field studies reviewed in EC-149 , six used plot sizes larger than 
0.1 ha.  Because most of the study organisms are mobile at spatial scales much larger 
than the plot sizes used, it is necessary to have larger plot sizes and to tailor the 
sampling methods to detect possible transient differences in population sizes between treatments.  Otherwise, false negatives become problematic.  The observed lack of significant differences between Bt and non-Bt treatments in nearly all the studies with 
small plot sizes is difficult to interpret,  because the absence of an observed difference 
in these kinds of experiments is not a good indication that there were no differences.  
The only differences detected in these small plot studies were in the potato 
experiment, which will not be discussed here.  Of the remaining six, two studies had 
insufficient replication.  This low level of  replication might allow the researchers to 
detect only differences larger than an order of magnitude.  This detection threshold is 
much larger than what would be considered  an adverse effect, so it is possible that 
some adverse effects were not detected.  Th e remaining four studies had an equivalent 
of eight replications in each of two years.  No adverse effects were observed.  Unfortunately, the sampling methods were  not sufficiently tailored to detect 
differences in population size.  Taken as a whole, excepting the results on Bt potato, 
the other 13 studies would indicate that very large, order of magnitude adverse effects 
on non-target species are unlikely.  However, the data do not address the likelihood of 
other large adverse effects on non-target organisms.  Additional research would be 
needed before claims about safety can be  supported with scientific evidence.  In 
particular, the cited field studies do not enable an evaluation of the likelihood of 
risk to C. carnea . 
Comments by Argentina
 
 
The above paragraph is somewhat confusing. We observe: WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
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1. Sentence 1 states that six studies were done on plot sizes larger than 0.1 ha. Sentence 2 indicates studies should be done on much larger  than the plot sized used; it is not clear how 
much larger than 0.1 ha is needed; 
 2. Sentence 1 mentions six of 14 studies. Senten ce 6 states "the remaining six" and only the 
potato experiment is mentioned before.  
3. The number of studies-problem shows again when the Expert states : "the other 13 
studies", excluding only the potato one. It is a ssumed that the Expert is referring "as a whole" 
to the (initially) mentioned 14 studies.  Other comments: 
 
4. The Expert admits that "Taken as whole" the (other) 13 studies "would indicate that very large … adverse effects on no n-target organisms are unlikely". In the next sentence, it is 
said that "the data do not address the like lihood of …other  adverse effects on non-target 
organisms", and later on that "the cited field studies do not enable an evaluation of the likelihood of risk to C. carnea ", and that "additional research would be needed".  Not only the 
above shows some ambiguity, but also poses a quest ion which is of a genera l validity in Science: 
there would always be the need for additional studies to prove something. Scientific knowledge 
is knowledge that has been validated through ex periment, and its validity is not questioned just 
because future experiments (which there will always be) may or may not  confirm its validity. 
Moreover, the need of additional knowledge is always one of the last sentences in a scientific 
paper. 
 Recent studies, however, have revealed a higher t oxicity of Bt pollen and anthers than found in 
previous studies:  Anderson, P.L., Hellmich, R.L., Sears, M.K., Sumerford, D.V. & Lewis, L.C. (2004).  Effects of 
Cry1Ab-expressing corn anthers on monarch butterfly  larvae.  Environ. Entomol., 33, 1109-1115.  
 Dively, G.P., Rose, R., Sears, M.K., Hellmich, R.L., Stanley-Horn, D.E., Calvin, D.D., Russo, J.M. & Anderson, P.L.  (2004).  Effects on monarch  butterfly larvae (Lepidoptera: Danaidae) after 
continuous exposure to Cry1Ab-e xpressing corn during anthesis.  Environ. Entomol., 33, 1116-
1125. 
 Jesse, L.C.H. & Obrycki, J.J.  (2004).  Survi val of experimental cohorts of monarch larvae 
following exposure to transgenic Bt corn pollen and anthers.  In: The monarch butterfly. biology 
and conservation (eds. Oberhauser, K.S., Solensky, M.J. ).  Cornell University Press, Ithaca, pp. 69-
75. 
 
1. On the paper by Anderson et al, we reproduce here the abstract: (italics and underlined are ours. In capital letters, we indicated the rel evant findings which contradict the contention 
that Bt toxin is a significant risk for monarca butterfly):  
Previous studies suggest that exposure to corn, Zea mays  L., anthers expressing 
Bacillus thuringiensis  (Bt)-derived protein may have adverse effects on the 
larvae of monarch butterfly, Danaus plexippus  (L.). To examine the potential 
effects of Bt anthers on monarch butterflies, studies were designed to test toxicity in the laboratory
; examine anther distribution in space and time;  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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  compare distributions of anthers, pollen, and larval feeding; and measure effects 
of long-term exposure in the field . In the laboratory, mo narch butterfly larvae 
fed on whole corn anthers, but anther feeding was sporadic. Larvae exposed to 
0.3 ANTHER/CM2 fed and weighed less after 4 d compared with larvae exposed 
to non-Bt anthers. Adverse effects increa sed with increasing anther density. 
Monarch butterfly larvae exposed to 0.9 ANTHER/CM2 had reduced feeding, 
weight, and survival and increased develo pmental time compared with larvae 
exposed to non-Bt anthers. Later instars were more tolerant of Bt toxin. For all 
studies, laboratory testing probably magnified e ffects because larv ae were confined 
to petri dishes. Field studies showed  toxic anther densities are uncommon on 
milkweed (Asclepias) leaves in and near cornfields during anthesis. Mean anther 
densities on milkweed leaves in cornfields  during peak anthesis were between 0.06 
AND 0.1 ANTHER/CM2 ( 3–5 ANTHERS PER LEAF). When exposure to a 
density OF FIVE ANTHERS PER LEAF WAS TESTED IN FIELD-CAGE 
STUDIES, no effects on growth, development, or survival were detected. Based on 
probability of exposure to toxic de nsities, BT ANTHERS ALONE ARE NOT 
LIKELY TO POSE A SIGNIFICANT RISK TO MONARCH BUTTERFLIES IN 
IOWA.  
2. On the paper by Dively et al, we repro duce here some excerpts: (italics and underlined 
are ours. In capital letters, we indicated the rel evant findings which contradict the contention 
that Bt toxin is a significant risk for monarca butterfly): 
 
The potential non-target risks to monarch butterfly, danaus plexippus l., of 
transgenic corn transformed with a gene from the bacterium Bacillus 
thuringiensis (Bt) have been the focus of much scientific research and debate 
after a laboratory study by Losey et al. (1999) revealed toxicity to monarch 
butterfly larvae consuming Bt corn pollen deposited on milkweed plants 
(Asclepias spp.). SUBSEQUENT STUDIES INDICATED THAT THE ACUTE 
EFFECT OF BT CORN POLLEN EXPRESSING LEPIDOPTERAN-ACTIVE 
CRY PROTEIN ON MONARCH BUTTERFLY POPULATIONS WAS 
NEGLIGIBLE (SEARS ET AL.2001) . LARVAL EXPOSURE TO POLLEN ON A 
POPULATION-WIDE BASIS IS LOW, GIVEN THE PROPORTION OF 
LARVAE IN CORNFIELDS DURING POLLEN SHED, THE PROPORTION OF 
FIELDS PLANTED IN BT CORN, AND THE LEVELS OF POLLEN WITHIN 
AND AROUND CORNFIELDS THAT EXCEED THE TOXICITY THRESHOLD 
(OBERHAUSER ET AL. 2001, PLEASANTS ET AL.2001).CONSERVATIVELY, 
THE PROPORTION OF THE MONARCH BUTTERFLY POPULATION 
EXPONED TO BT CORN POLLEN WAS ESTIMATED TO BE 0.8% (SEARS ET 
AL.2001).LABORATORY BIOASSAYS A LSO SHOWED THAT ACUTE TOXIC 
AND SUBLETHAL EFFECTS OF POLLEN FROM THE MOST WIDELY 
PLANTED BT CORN HYBRIDS (EVENTS MON810 AND BT11) ARE 
UNLIKELY, EVEN AT PEAK LEVELS OF POLLEN SHED (HELLMICH ET 
AL.2001).THE ONLY TRANSGENIC CO RN POLLEN THAT CONSISTENTLY 
AFFECTED MONARCH BUTTERFLY LARVAE WAS FROM THE CRY1AB 
EVENT 176 HYBRIDS, WHICH HAVE BEEN PHASED OUT OF 
COMMERCIAL USE IN THE UNITED STATES. FURTHERMORE, FIELD 
STUDIES PERFORMED IN IOWA, MARYLAND, NEW YORK, AND ONTARIO, 
CANADA, REPORTED THAT GROWTH TO ADULTHOOD OR SURVIVAL OF 
MONARCH BUTTERFLY LARVAE WAS UNAFFECTED AFTER EXPOSURES 
FOR 4-5 D TO MILKWEED LEAVES WITH NATURAL DEPOSITS OF WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-84 
  
  CRY1AB EXPRESSING (EVENTS BT 11 AND MON810) CORN POLLEN 
(STANLEY-HORN ET AL.2001).THESE RESULTS INDICATED NEGLIGIBLE 
EFFECTS OF BT POLLEN TO MONARCH BUTTERFLY LARVAE FROM 
SHORT-DURATION EXPOSURES IN FI ELD SETTINGS. ALL SCIENTIFIC 
INFORMATION ON ACUTE TOXICITY AND EXPOSURE SUPPORTS THE 
ONCLUSION THAT BT CORN POSES A LIMITED RISK TO MONARCH 
BUTTERFLY POPULATIONS (SEARS ET AL.2001).WHAT RISK EXISTS IS 
CAUSED BY THE LIMITED EXPOSURE OF MONARCH BUTTERFLY 
POPULATIONS TO BT POLLEN IN  NATURE. NEVERTHELESS, THE 
STUDIES TO DATE EXAMINED ACUTE AND SUBLETHAL EFFECTS 
AFTER 4-5 D OF EXPOSURE OF DEVELOPING LARVAE TO BT POLLEN.IN 
CORNFIELDS, LARVAE HATCHING AT THE ONSET OF ANTHESIS MAY 
BE EXPONED TO BIOLOGICALLY ACTIVE CRY1AB PROTEIN FOR 
PERIODS OF 12 D OR MORE (RU SSELL AND HALLAUER 1980).THIS 
WORST-CASE SCENARIO COULD POTENTIALLY IMPACT THE 0.8% OF 
THE MONARCH BUTTERFLY POPULATION EXPOSED TO BT …  
Long-term exposure of monarch butterfly larvae throughout their development 
to Bt corn pollen is detrimental to only  a fraction of the breeding population 
because THE RISK OF EXPOSURE IS LOW . When this impact is considered 
over the entire range of the Corn Belt, THE ECOLOGICAL OUTCOME IS 
VERY SMALL.  Moreover, BT CORN ADOPTION IS ASSOCIATED WITH 
LOWER INSECTICIDE USE AGAINST TARGET LEPIDOPTERA (PILCHER 
ET AL.2002), AND MOST INSECTICID ES ARE ACUTELY TOXIC TO LARVAE 
OCCURRING IN CORN OR IN OTHER CROPS THAT PROVIDE HABITAT 
FOR MONARCH BUTTERFLY POPULATIONS . In field bioassays, larvae died 
within hours after feeding on milkweeds exposed to a single application of a pyrethroid insecticide (Stanley-Horn et  al.2001) … . 
… IT IS LIKELY THAT BT CORN WILL NOT AFFECT THE 
SUSTAINABILITY OF MONARCH BUTTERFLY POPULATIONS IN NORTH 
AMERICA  … . 
(Note of this reviewer) The above shows that Bt corn could be considered a 
protection to monarca butterfly, as its use would decrease the use of chemical 
insecticides, which are acutely toxic to larvae. 
3. On the paper by Jesse and Obrycki (2004) , we reproduce here some excerpts from the 
abstract:  
 
1. We present THE FIRST EVIDENCE that transgenic Bacillus thuringiensis (Bt) corn pollen naturally deposited on Asclepias syriaca; common milkweed, in a corn field causes signific ant mortality of Danaus plexippus L. 
(Lepidoptera: Danaidae) larvae. Larvae feeding for 48 h on A. syriaca plants naturally dusted with pollen from Bt corn  plants suffered significantly higher rates 
of mortality at 48 h (20±3%) compared to  larvae feeding on leaves with no pollen 
(3±3%), or feeding on leaves with non-Bt pollen (0%). Mortality at 120 h of D. plexippus larvae exposed to 135 pollen grains/cm2 of transgenic pollen for 48 h ranged from 37 to 70%. … We conclude th at the ecological effects of transgenic 
insecticidal crops NEED TO BE EVALUATED MORE FULLY before they are 
planted over extensive areas.  WT/DS291/R/Add.7 
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 Page I-85 
  
  We agree that the results shown here are the first  evidence of an effect, but they should be 
validated by further research, as the authors recognized.  
03.04.  EC-150  is a scientific paper that evaluated the effects of Bt maize litter (Bt11) 
on the earthworm Lumbricus terrestris  in laboratory and semi-field experiments.  
There were no effects on survival or grow th of immature earthworms in the semi-
field experiment.  There were no difference in adult survival or growth during the first 160 days in the laboratory experiment.  Adults were about 20% smaller with Bt 
litter than non-Bt litter at 200 days.  In to tal and compared with other published 
results, the results of this study indicate that adverse effects on L. terrestris , if they 
exist, are likely to be subtle.  In addition, they suggest that there is a possible hazard 
to earthworms  from Cry1Ab Bt maize litter, but until this is confirmed, I cannot 
conclude that there is a potential risk to earthworms.   
Comments by Argentina
 
 
Again, the statements are confusing, star ting with an "approval" sentence ("… adverse 
effects…, if they exist …") followed by a "disapproval" one ("… they suggest that there is a 
possible hazard …"). Adding to this, the statement ends with the impossibility to "… conclude 
that there is a potential risk".  One ends being not sure about the resulting opinion. 
 
03.05.  EC-151  documents a novel route of exposure of soil organisms to Cry1Ab 
toxin from Bt maize.  Cry1Ab toxin is exuded from living maize roots.  There has been some controversy as to whether the exudates are from damaged root cells or 
from a process involving living root cells, however, the evidence suggests that there 
is a process involving living root cells.  This result was not anticipated.  
Theoretically, the Cry1Ab protein was consid ered too large to be exuded from living 
plant roots.  This study does not document a possible adverse effect of Bt maize , 
however, it demonstrates that species inhab iting the maize root rhizosphere can be 
exposed to Cry toxin.  This is significa nt because these species had been considered 
not at risk previously, and opens the possib ility that unanticipated adverse effects to 
rhizoshere species might be identified. 
Comments by Argentina
 
 
From the statement "This study does not document  a possible adverse effect of Bt maize," it 
cannot be concluded (or even just "… opens the possibility that") "unanticipated adverse effects 
… might be identified".  This sequence of premises is equivalent to the following logic: "If the 
occurrence of a fact is not documented, it follows  that this fact might occur". This cannot be 
posed as an argument in the above context.   
03.06.  EC-152  demonstrates that Cry toxins persist, accumulate and remain 
insecticidal in soil by binding to humic acids in soils.  Previous work had 
demonstrated similar results in binding to clay in soils.  Moreover, the toxins 
maintain toxicity for at least 234 days (the longest time examined).  Together these studies demonstrate that Cry toxins will pers ist in soils much longer than previously 
believed, and that the mechanism of persis tence is related to adsorption to clay 
particles and humic acids in the soil.  Together with EC-151, these studies 
demonstrate that soil organisms are likely to be exposed to Cry toxin via root 
exudates and litter.  None of these studies document a possible adverse effect of Bt 
maize .  Together, however, they suggest that more species in the soil may be at risk WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-86 
  
  than previously expected.  These results  suggest that additional studies may be 
needed to evaluate these possibilities. 
Comments by Argentina
 
 
We observe in this answer the same kind of reasoning as before (see above): From "None of 
these studies document a possible adverse effect…" , it follows (suggests?) "that more species in 
the soil may be at risk…". Moreover, the adsorpti on to clay and humic acids of macromolecules 
and phosphorous compounds used as fertilize rs, is a well known phenomenon. However, 
persistence is not equivalent to availability . In the case of plasmi d DNA or phosphorous 
compounds used as fertilizers, it was demonstrat ed that laboratory trea tments are needed to 
release them from the adsorbed complexes. Of course, there are microorganisms able to 
promote this release ( Penicillium bilanyi , for example). Then, we are led through a never ending 
process in which, the last word, is always that risk can be (sic) "expected" and "that additional 
studies may be needed".  
 As an example of the consequences of extrapolat ing this reasoning, consider the anti-nutritional 
factors present in non-biotech crops. Some of th em exhibit a strong deleterious action (e.g., 
ribosome inactivating proteins, or rips, which a re present in many plants). They are present in 
crops at concentrations close to the newly expresse d proteins in biotech crops. Persistence in soil 
(by the same mechanisms as before) can be predicted in these cases, but subsequent toxic effects 
to other organisms has been found to be very spec ific in the field (e.g., as defence mechanisms), 
or in in vitro , laboratory conditions. These factors may be of much higher concern, as it should 
be admitted in the context of the answer above , and are present in non-biotech crops. If the 
same reasoning is applied, one is to expect "t hat more species in the soil may be at risk than 
previously expected", and "that additional studies may be needed" before any regular, familiar 
crop is sowed again.   
 
03.07.  During 1999, concerns were expr essed that monarch butterflies would be 
adversely affected by Bt maize pollen falling on their host plant, common milkweed.  This result was followed up with a series of studies to assess the risk to monarchs.  
The authors of these follow-up studies concluded that the risk to monarch populations 
was insignificant for Mon810 and Bt11, because only a small proportion of butterflies would be exposed to these and the toxicity of pollen was low.  The events and findings associated with these studies are su mmarized in an excellent review.  Recent 
studies, however, have revealed a higher toxicity of Bt pollen and anthers than found 
in previous studies.  Although some suggest ed that the risk to monarchs remains 
insignificant, a close reanalysis of the issues may allow other interpretations of risk to 
monarchs.   
Comments by Argentina
 
 
Same as before: it is said that "Although some suggested that the risk to monarchs remains 
insignificant (studies quoted support that), a close reanalysis  of the issues may allow  other 
interpretations of risk to monarchs".  Again, the succession of approval and disapproval sentences conducting to a need for more studies, seems to be recurr ent. Again, one is left with 
the impression that, although risks are not proven or remain insignificant, further analysis would be needed. In other words, one is caught in the logic of "if a proof exists, further analysis 
may show that the proof does not exist". We observe  that this should not be considered valid in 
the present context.   
  WT/DS291/R/Add.7 
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  03.08.  Most these same papers also addr essed the potential risk to monarchs from 
Event 176 BT maize.  Although they conclude d that there was no risk to monarchs 
from Event 176, this was based largely on the assumption that Event 176 would not 
be used very much in production.  Had Ev ent 176 gained greater market share, it 
would likely have put monarchs at risk. 
Comments by Argentina
 
 
See above. 
 
03.09.  As mentioned in paragraph 03.02, C. carnea  is under a potential risk from Bt 
maize.  Although this has not yet been studied in the field, I expect that the actual risk to C. carnea  would not be large.  In maize in temperate regions, this species feeds 
primarily on aphids, mites, thrips, and lepi dopteran eggs and larvae.  Previous studies 
have shown that the main aphid on maize does not contain any Cry toxin when 
feeding on Bt maize, and that mites contain the Cry toxin, but they do not adversely affect C. carnea .  It is not known if thrips or Le pidopteran eggs contain Cry toxin.  
Adverse effects on C. carnea  have been documented only when it feeds on diets 
containing Cry toxin or on Lepidopteran larvae that had fed on Bt maize.  Any adverse effect from Lepidopteran larvae a nd possibly thrips and eggs would be 
diluted by feeding on aphids and mites.  Consequently, I believe that any adverse 
effect on C. carnea  in the field will be subtle and difficult to detect in the field. 
Comments by Argentina
 
 
After saying that C.carnea  is at risk, it is admitted above that the adverse non-target effects in 
the field (the Expert expects that) " will not be large ".  Studies are quoted in support of that, and 
it is concluded that, if any , these effects will be subtle and difficult to detect in the field . It is hard 
to find here a conclusive statement, when pr oven evidence is towards "approval" of the biotech 
crop. Not being large, or being difficult to det ect, are expressions which seem to be addressed at 
avoiding to give a relevant answer, i.e., that not risk has been proved.  
03.10.  Relatively few non-target studies have been conducted on Bt cotton.  This 
limits discussion of potential risks.  
Comments by Argentina
 
 
Approval requirements always call for non-target effects studies. These must include foreign 
and local data.  
 
03.11.  It has been argued that the experien ce in using Bt maize and Bt cotton in the 
US provides evidence that there are no adverse effects on non-target organisms.  It is 
true that Bt maize and Bt cotton have been used widely in the US, and it is also true 
that no adverse effects to non-target speci es have been reported and confirmed.  
However, these two facts do not imply that there have been no adverse effects on 
non-target organisms, because there is vi rtually no monitoring for such adverse 
effects.  If such effects are not looked for, it is unlikely that they will be found, even 
if they exist.  It can be reliably argued  that the US experience with these crops 
suggests that there have been no immediat e catastrophic adverse effects to non-target 
species.  Such catastrophes would have beco me noticeable even if they were not 
actively looked for.  However, it is more likel y that adverse effects, if they exist, will WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-88 
  
  be more subtle, and would not be readily noticed.  Hence, the US experience does 
not imply that there are no adv erse effects on non-target species . 
Comments by Argentina
 
 
See comments below 03.02 and 03.09 and others. 
 
03.12.  In any event, Cry toxins are unlik ely to adversely affect mammals through 
direct toxicity.  They exert their toxic eff ect by binding first with specific glycolipids 
in the gut.  These protein-glycolipid complexes then bind to specific receptors 
(cadherin-like receptors) on the wall of the gut.  The entire family of the specific glycolipid and receptor molecules are ab sent from mammals, thus Cry toxins cannot 
act in their normal way in mammals.  
Comments by Argentina
 
 
A clear answer to the question is not provided above. By stating that "Cry toxins cannot act in 
their normal way  in mammals", omission is made of the fa ct that, considering the mode of action 
of Cry toxins, an adverse effect on mammals is unlikely to occur.    
03.13.  Conclusion.  Possible hazards have been identified and potential risks are evident, however, it cannot be concluded that an actual non-target risk of Bt maize or 
Bt cotton has been fully characterized.  Howe ver, it is likely that if the analysis is 
completed, that there will be a documented ri sk of some Bt maize events to monarch 
butterflies.   
Comments by Argentina
 
 
The Expert mentions that "possible hazards" h ave been identified (but not proven), and that 
"potential risks are evident ", but it cannot be concluded that they exist. Consequently, any conclusion referring to any existence of risks would be entirely speculative. Moreover, we consider that the last sentence, ending "it is likely that if the analysis is completed, there will be 
a documented risk of some Bt maize events to monarch butterflies" is an anticipated judgement, 
not a scientifically based argument. 
 Comparison with Bt insecticides
 
 
03.14.  There are significant differences in  exposure probability and exposure routes.  
Bt insecticides have low likelihood of a non- target risk because they do not persist 
very long after application.  The Cry toxi n is degraded rapidly under UV light, and 
efficacy of the insecticide is lost usually w ithin a few days.  This contrasts with Bt 
crops, which produce Cry toxin constitutivel y over the entire growing season at high 
concentrations throughout the plant tissue, and as noted above, can persist in the soil. 
Comments by Argentina  
 
Following the "likely to occur" reasoning, it s follows that Bt formulated insecticides can 
probably persist in soil by similar mechanis ms as plant-expressed Bt toxins. Also, "high 
concentrations" tends to ignore the fact that th ese concentrations are of the order of  0.001 % 
total protein, or lower. 
  WT/DS291/R/Add.7 
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 Page I-89 
  
  03.15.  It is theoretically possible that hazards will be different, but this depends on 
the protein structure of the Cry toxin in th e plant compared with the insecticide.  For 
example, Event 176 Cry1Ab is significantly smaller than Cry1Ab toxin in the 
bacterium, Bacillus thuringiensis .  The full protein in the bacterium must be 
shortened to a form that shows active toxi city.  Event 176 protein is already in an 
active form.  Thus, if the shortening pro cess affects hazards, then Event 176 protein 
may exhibit a different spectrum of hazards than the bacterium protein.  However, it 
has not been scientifically demonstrated th at this difference in structure actually 
affects hazard.  There are also differen ces between Mon810 and Bt11 Cry1Ab and the 
Cry1Ab in the bacterium.  There appear s to be little difference between Event 1507 
Cry1F and the Cry1F in the bacterium. 
Comments by Argentina
 
 
We consider that this is a speculative reasoni ng. The expert calls for theoretically possible 
hazards, involving, for example, the protoxin- toxin processing in the insects gut, and the 
different structure (produced by plant vs. bacter ium) which can affect hazard. But then, the 
Expert surprisingly omits to ment ion the only case of the latter (which will work in favour of his 
stand), that is, the modified Cry 9C protein in CBH 351 event. In this case, the different structure was an intended change, and its eff ects on mammals digest ive process was quickly 
recognized by specific and mandatory tests in the GM  crop review process. As the safety of this 
event was not being satisfactorily proven, this event was not approved or partially approved (for 
feed purposes only). This example is brought here to show the strictness of the regulatory 
systems in place in the countries which are part in this Panel. (As a further comment, this 
structure difference was anyway later proved to have no adverse effects on mammals).    
 
03.16.  Both are unlikely to adversely a ffect mammals.  The Bt insecticides have 
undergone significant number of studies on mammalian toxicity, and none have been 
found to be toxic to any of the mammals studied.  Coupled with paragraph 03.12, it is unlikely that either Bt crops or Bt insect icides will adversely effect mammals through 
direct toxicity. 
Comments by Argentina
 
 
Although this point is favourable to an approval of  the Bt events, we note that the Expert refers 
to "direct" toxicity, suggesting the possible existence of other, indirect  toxicity, which is entirely 
speculative but cast doubt in the mind of laypersons.  
 
Risk management options  
 
03.17.  Risk management measures sh ould be commensurate to the risk. 
03.18.  One risk management option is to prohibit the use of the Bt crop.  If this 
option is considered, it should be necessary to provide a worst-case risk assessment to 
provide a basis for concluding that a prohibition is commensurate to the risk.  For 
example, what would be the harms if all earthworms were 20% smaller after feeding on Bt maize litter for more than 160 days (see paragraph 03.04)? 
Comments by Argentina
 
 
See our comments under 03.04. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-90 
  
   
03.19.  Another approach would be to lim it the area of the transgenic crop until a 
reasonable assessment of the possible hazards and potential risks are completed.  As 
the information is gathered, the risk manage ment measure can be modified consistent 
with the principle of "modification." 
03.20.  For actual risks, such as the presumed risk to monarchs, geographic 
restrictions in use of the Bt crop could be considered.  Incentives to use alternatives to the Bt crop can be provided.  Disincentives for the use of the Bt crop could be 
imposed.  Monitoring of the population at risk  could be required, although this would 
likely be more expensive than restricting or managing use, and may be difficult to 
justify based on the principle of equivalence. 
Comments by Argentina
 
 
We agree on geographic restrictions when proven to be necessary. This is not the case with 
monarchs, as geographic (and other) factors are against the existence of adverse effects (as the 
Expert states in the pertinent points). Incentive s to use alternatives should always exist, for 
biotech as well for non-biotech crops, because maxi mising the benefits/risks ratio should always 
be pursued. We disagree with the concept of disi ncentives for any particular way agriculture is 
practiced, being traditional, biotech or organic; we rather promote co-existence, determined by 
overall benefits. 
 
03.21.  Efforts to improve risk assessment procedures could be viewed as a form of 
risk management.  Improved procedures w ould be more effective at identifying 
potential risk, reducing uncertainty and a llowing risk assessment to proceed more 
rapidly. 
03.22.  Another option would be to have  no risk management.  Here it seems 
necessary to have a risk assessment that concludes that there are no significant non-
target risks and that unanticipated effect s will be either absent or insignificant. 
03.23.  By no means should the Panel assume that this is an exhaustive list of possible 
management options.  These are suggestions of approaches to risk management 
emphasizing avoiding risk.  Approaches that emphasize mitigation of risk or 
tolerance of risk could also be considered. 
Question 4  
 
4. On the basis of the information before the Panel, is there any scientific evidence to support 
the hypothesis that the wide-spread cultivation of Bt  maize or other, non-biotech applications of Bt 
toxins, leads to the emergence of Bt-resistant ta rget organisms under field conditions?  If so, what 
risk management options exist to mitigate any resulting risks and what is their efficacy? 
 
Evidence for resistance  
 
04.01.  Widespread non-biotech applications of Bt toxins have resulted in the Bt-
resistant target pest organisms under field conditions.  Probably the best studied example is diamondback moth on cabbage, whic h has developed field resistance to Bt 
insecticide applications in several countries, including the US (Hawaii), Japan, Philippines and elsewhere.    WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-91 
  
  04.02.  There is strong evidence that resi stance will develop in the field to any 
insecticide applied uniformly over wide areas for a long enough period of time.  This has been a scientific c onsensus since the 1980s. 
Comments by Argentina
 
 
We agree. Moreover, any selective pressure in the fi eld will result in resistant individuals. It is 
evolution.  
04.03.  Bt-resistant target organisms have been found – pink bollworm ( Pectinophora 
gossypiella ) to Bt cotton in the field, but this has not yet led to field failures. 
04.04.  Evolutionary theory predicts that the evolution of resistance will proceed as 
directional selection, at least up to the point resistance becomes common.  This means that resistance in the field cannot be prevented, it can only be delayed. 
Comments by Argentina
 
 
We agree. From the above statement by the Ex pert, it follows that, since a fundamental 
evolutionary phenomenon is unavoidable with any selective pressure, it cannot be called to support the rejection of approval of Bt crops.  
04.05.  There is a scientific consensus that r esistance to Bt maize is inevitable, even 
though it still has not been detected in th e field.  This is based on the preceding 
empirical and theoretical evidence. 
04.06.  Generally speaking, of all of the pot ential environmental risks of transgenic Bt 
crops, it can be said that resistance in the target pests is a real, tangible risk, while 
risks associated with gene flow and risk s to non-target organisms are mostly only 
potential risks.   
Comments by Argentina
 
 
We fully agree.  
 
04.07.  There are several risk management options for Bt maize, but they are all 
concerned with reducing the selective advantag e of resistant alleles in populations of 
the target species. 
04.08.  The most widely used resistance management strategy for Bt maize (and all 
Bt crops) has been the high-dose/ refuge st rategy.  This has been used by the US 
Environmental Protection Agency (US-EPA).  For Bt maize, it is generally accepted 
that a 20% refuge is needed for the high- dose/ refuge strategy to be effective. 
04.09.  Low-dose Bt events will require a greater refuge.  There is no scientific 
consensus as to how big a refuge is needed.  One approach, used by the US-EPA is to 
require a 20% refuge during the initial pe riod of use, when market penetration 
remains low.  This may provide enough time  for the scientific evidence to accumulate 
so that an appropriate refuge size can be determined.  A different approach was used 
by Australia, where a very large refuge was required initially, which was gradually 
reduced over time to a 70% refuge. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-92 
  
  04.10.  Additional resistance management st rategies may become possible to develop 
after resistance in the target pest  is identified and characterized.   
04.11.  The efficacy of the high-dose/refuge strategy cannot be assessed empirically 
in the field.  Indeed, it would probably  be unethical to conduct such a field 
experiment because it would be necessary to have a positive control treatment where resistance was encouraged.  Resistant in sects in such a control treatment could 
escape, leading to field failures that underm ine the efficacy of the high-dose/ refuge 
strategy. 
04.12.  Some greenhouse experiments have  confirmed the efficacy of the high-
dose/refuge strategy. 
04.13.  Theory has predicted that the high- dose/ refuge strategy will be efficacious 
when resistance allele frequency <0.001,  resistance is rece ssive, and there is 
sufficient adult movement between the ref uge and Bt fields to ensure matings 
between resistant and susceptible phenotypes. 
04.13.  These assumptions have been confir med scientifically for European corn 
borer ( Ostrinia nubilalis ) in the northern US corn belt.  These assumptions are likely 
for European corn borer in the southern US  and in western Europe.  They have not 
been confirmed for southwestern corn borer ( Diatraea grandiosella ) in the southern 
US, for European corn borer in eastern Eu rope, or for Mediterranean corn borer 
(Sesamia nonagrioides ) in southern Europe.  Hence, it can be concluded that in some 
circumstances it is possible to predict that the high-dose/ refuge strategy should be 
efficacious.  It is possible that the absence of detection of field resistance to Bt maize in the US is partially attributed to the efficacy of the high-dose/ refuge strategy. 
Comments by Argentina
 
 
We agree. We observe, however, that the need of a practicable (and in fact set in place) 
management strategy to delay resistance, should  not be construed as an impediment for 
approval.  
 
Question 6  
 
6. On the basis of the information before the Panel, is there any scientific evidence to suggest 
that herbicide tolerant crops (whether biotech or developed through mutagenesis) are more persistent 
in the agricultural environment or more persisten t in the non-agricultural environment than their 
conventional counterparts?  If so, do herbicide tolera nt crops qualify as a potential "pest" as the term 
is used in the International Plant Convention' s (IPPC) International Standard for Phytosanitary 
Measures (ISPM) 11 (EC-130)?    
(a) What is the potential for the establishment and spread of herbicide tolerant plants 
arising from handling, spillage during transpor t of the plant/plant parts, or any other 
means outside of cultivation in the absence of  application of the herbicide?  How is 
any potential for establishment and spread affected by environmental conditions, the 
presences of wild or conventional relatives of the herbicide tolerant plants in an area, or other factors?  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-93 
  
  (b) What is the potential for the establishment and  spread of herbicide tolerant plants in 
the presence of herbicide application (in fields, urban, domestic or other 
environments)?  How is any potential affected  by the existence of feral related plant 
species;  infertile wild relatives;  seed su rvival in relevant pedoclimatic conditions;  
the reproduction biology of the species;  or other factors? 
(c) Is this potential different for biotech crops tolerant to two wide-spectrum herbicides?  
Please explain.  
(d) If significant risks of establishment and spread have been identified, what risk 
management options exist to mitigate any resulting risks and what is their efficacy? 
(e) What types of post-market monitoring and data collection activities could be 
envisaged on the basis of the monitoring and review principles described in ISPM 
11? 
06.01.  I will provide a theoretical res ponse to the main question and address only 
part (e) of the subparts of this question.  I will use the seven kingdom taxonomy here 
and throughout in discussing organisms. 
06.02.  Persistence of herbicide tolerant cr ops (whether biotech or developed through 
mutagenesis) will be determined by the re lative fitness of the crop with the trait and 
the degree of release of the trait.  Th e only way that a GMHT would be more 
persistent than a non-GMHT crop would be if  it had a higher relative fitness and/or it 
was released at a higher rate.  Both factors would have to be assessed on a case-
specific basis.  For GMHT maize, cotton,  soybean and beet, the question is moot 
because there are no comparably good non- GMHT varieties.  For GMHT oilseed 
rape, evidence from Canada suggests that the GMHT varieties are used more commonly than the non-GMHT varieties, thus  there is some scientific evidence to 
suggest that GMHT oilseed rape may be mo re persistent in the agricultural or non-
agricultural environment than their conventional HT oilseed rape.   
Comments by Argentina
 
 
It is not clear to us the meaning attached to  the expression "degree of release of the trait".  
 
06.03.  A similar argument holds for persiste nce of herbicide tolerant crops (whether 
biotech or developed through mutagen esis) compared to their conventional 
counterparts.  When examining release rate, however, the relevant release rate for the conventional counterpart is that of a single variety. 
06.04.  Annex 2 of ISPM 11 specifies "P hytosanitary risks from LMOs may result 
from certain traits introduced into the or ganism, such as those that increase the 
potential for establishment and spread, or from inserted gene sequences that do not 
alter the pest characteristics of the organism  by that might act independently of the 
organism or have unintended consequences. "  Thus phytosanitary effects of the 
transgene outside of the original organism of introduction are covered by ISPM 11. 
06.05.  Annex 2 elaborates on this further in the next clause, which states "In cases of 
phytosanitary risks related to gene flow, th e LMO is acting more as a potential vector 
or pathway for introduction of a genetic c onstruct of phytosanitary concern rather WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-94 
  
  than as a pest in and of itself.  Theref ore the term "pest" should be understood to 
include the potential of an LMO to act as a vector or pathway for introduction of a 
gene presenting a potential phytosanitary risk."   Phytosanitary risks associated with 
gene flow and persisten ce are covered by ISPM 11. 
06.06.  Moreover, Annex 3 "Determining the potential for a living modified organism 
to be a pest", specifies that "potential phy tosanitary risks for LM Os may include: a. 
Changes in adaptive characteristics which may increase the potential for introduction 
or spread, … b. Adverse effects of gene flow or gene transfer.  This indicates that the 
potential for introduction and spread are a part of phytosanitary risk, as well as 
adverse effects of gene flow. 
06.07.  From the perspective of gene flow  and persistence, GMHT crops may qualify 
as a potential pest according to ISPM 11, as lo ng as they can be shown to be released 
at a higher rate and/or have a selectiv e advantage compared to a conventional 
counterpart.   
06.08.  Of course it is possible for a GM HT crop to qualify as a potential pest 
according to ISPM 11 if persistence is e xpected to be the same as a conventional 
counterpart.  This would occur if it potentiall y resulted directly or indirectly in some 
adverse effect that was different from the conventional counterpart.  For example, if 
contamination of conventiona l crop germplasm (related to the "coexistence" issue) 
were considered an injury to the conventi onal plant, then there would be a reason to 
believe that all GMHT crops can be considered potential pests under ISPM 11.  All other potential pest risks would probably have to be considered on a case by case 
basis. 
Comments by Argentina
 
 
We observe the conditionals in the above paragra ph: "… if persistence is expected to be the 
same …", "… if it potentially resulted directly or indirectly in some adverse affect …", "… if 
contamination … . were considered an injury … then there would a reason to believe …", "… 
potential pests risks". The above have a speculative  nature, not leading to a clear statement. The 
whole paragraph deals with speculations. 
 
06.09.  ISPM 11 is ambiguous whether all possible effects of GMHT crops can be 
considered phytosanitary risks.  The defin ition of "pest" is given on page 6 of ISPM 
11 as "Any species, strain or biotype of plant, animal or pathogenic agent injurious to plants or plant products [FAO, 1990; revised FAO, 1995; IPPC, 1997]"  The concept 
of "injurious to plants includes environm ental risks, as indicated in supplementary 
text S1. 
06.10.  Annex 2, which covers the scope of IPPC for LMOs states "PRA may 
constitute only a portion of the overall risk analysis for import and release of a LMO.  For example, countries may require the asse ssment of risks to human or animal 
health, or to the environment, beyond that covered by the IPPC."  This is a clear 
acknowledgement that there are some environm ental risks that are not covered by the 
IPPC. 
06.11.  Annex 1 addresses the scope of the IPPC in regard to environmental risk.  
This text is reproduced here.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-95 
  
  "The full range of pests covered by the I PPC extends beyond pests directly affecting 
cultivated plants.  The coverage of the I PPC definition of plant pests includes weeds 
and other species that have indirect effects on plants, and the Convention applies to 
the protection of wild flora.  The scope of the IPPC also extends to organisms which 
are pests because they: 
– directly affect uncultivated/unmanaged plants  
Introduction of these pests may have few commercial consequences, and therefore 
they have been less likely to be evaluate d, regulated and/or placed under official 
control.  An example of this type of pest is Dutch elm disease ( Ophiostoma 
novo-ulmi ). 
– indirectly affect plants  
In addition to pests that directly affect host plants, there are those, like most 
weeds/invasive plants, which affect plants primarily by other processes such as 
competition (e.g. for cultivated plants:  Canada thistle ( Cirsium arvense ) [weed of 
agricultural crops], or for uncultivated/ unmanaged plants:  Purple loosestrife 
(Lythrum salicaria ) [competitor in natural and semi-natural habitats]). 
– indirectly affect plants through effects on other organisms  
Some pests may primarily affect other organisms, but thereby cause deleterious 
effects on plant species, or plant health in habitats or ecosystems.  Examples include 
parasites of beneficial organisms, such as biological control agents. 
To protect the environment and biological diversity without creating disguised 
barriers to trade, environmental risks and risks to biological diversity should be 
analyzed in a PRA." 
06.12.  In considering indirect effects, Annex 1 addresses "indirect effects on plants" 
and "indirect effects on plant through effects on other organisms."  Indirect effects are 
not defined, but the two examples provided are two of the five fundamental two-species interactions in ecological science, consumption (parasite-host or predator-prey or herbivore-plant), competition, mu tualism, amensalism, and commensalism.  
Thus, indirect effects occur via any combination or pathway of these to-species interactions.  This is the standard interpreta tion of the concept of indirect interactions 
which give rise to indirect effects in the field of ecology.  As the IPPC is science-
based, I assume that standard scientific usage is appropriate for interpreting key terms 
taken from science. 
06.13.  Under this interpretation (and other interpretations as well), the effects of the 
herbicides applied to the GMHT crops is not covered under Annex 1 and can not be 
considered a phytosanitary risk.  Herbicid e use cannot be considered a direct or 
indirect effect of the GMHT crop, because humans apply the herbicides.  It is inaccurate to say that this is an indirect  effect of the GMHT crop through effects on 
other organisms.  The GMHT crop does not affect humans to apply herbicides.  Causality works the other way.  Humans a ffect the distribution of the GMHT crops 
and at the same time affect herbicide use.  Thus, the effects of herbicide use on 
GMHT crops is not covered under Annex 1. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-96 
  
  06.14.  Section 2.3 of ISPM 11 cove rs "Assessment of potential economic 
consequences" and also covers environmenta l risk.  Under 2.3.1.2, indirect pest 
effects are considered.  This is a list of potential endpoints to consider given that it is 
an indirect effect.  Thus, section 2.3 does not provide an interpretation to cover the 
effects of herbicides applied to GMHT crops as a phytosanitary risk. 
06.15.  It would be disingenuous to suggest that herbicide effects should be 
considered as if they were independent of  the use of a GMHT crop.  While it may be 
true that the environmental effects of herbicides are regulated under independent 
regulatory structures, this does not change the fact that they are used part and parcel 
with GMHT crops because that is their intended use.  Thus GMHT crops almost 
always will be accompanied by the use of the specific herbicide. 
06.16.  The only ecologically consistent position would be to identify humans as the 
potential pest.  This, however, is absurd under ISPM 11. 
06.17  Thus I conclude that GMHT crops can qualify as a potential "pest" as the term 
is used in the International Plant Conve ntion's (IPPC) International Standard for 
Phytosanitary Measures (ISPM) 11 (EC-130).  However, not all of the risks associated with GMHT crops can be considered phytosanitary risks. 
Comments by Argentina
 
 
We contend that GMHT crops do not qualify as a potential "pest", as the Expert suggest by the 
use of quotation marks. Only a forced int erpretation would allow this qualification.  
 The key concept is that the LMO nature of a plan t or plant product is not inherently related to 
(and/or considered a priori to be) a pest and/or  a phytosanitary risk as such. However, IPPC 
documents (as well as their wording), regarding phy tosanitary risks can be used as a guidance 
in the elaboration of documents regarding LMO. 
 
Also note: The use of the acronym PRA implies that LMO are considered like pests, which is 
not right (with the guidance exception mentioned ab ove). LMOs are intended to be agricultural 
crops which have been reviewed for safety for flora, animal, human health and environmental 
safety by sound, scientifically based biosafety (th e term used in the above is risk) analysis. 
Although we would not correct the PRA expressions here, which should be just RA, it must be 
considered with this strong restriction.    (e) Post-market monitoring and data collection 
 
06.18.  Section 3.6.1 of ISPM 11 d escribes the monitoring and review of 
phytosanitary measures.  This  concentrates on the principle of "modification", and is 
repeated here. 
3.6.1 Monitoring and review of phytosanitary measures 
The principle of "modification" states:  "As conditions change, and as 
new facts become available, phytosanitary measures shall be 
modified promptly, either by inclusion of prohibitions, restrictions or requirements necessary for their success, or by removal of those  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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 Page I-97 
  
  found to be unnecessary" (ISPM N° 1:  Principles of plant 
quarantine as related to international trade ). 
Thus, the implementation of pa rticular phytosanitary measures 
should not be considered to be pe rmanent.  After application, the 
success of the measures in achieving their aim should be determined by monitoring during use.  This is often achieved by inspection of the 
commodity on arrival, noting any interceptions or any entries of the pest to the PRA area.  The information supporting the pest risk 
analysis should be periodically reviewed to ensure that any new 
information that becomes available does not invalidate the decision 
taken. 
06.19.  This suggests that an important part of the risk management measures applied 
to GMHT crops should include a process to review the necessity of the management 
measures.  Given that many ecological effects are scale-dependent, manifesting more 
readily at larger spatial and temporal scales, some management measures could be linked to the spatial extent of use of the GM HT crop.  If the spatial extent of use is 
not great enough, then certain manage ment measures could be considered 
unnecessary.  Alternatively, if the GMHT tra it persists in a given locality for long 
enough, additional management measures could become necessary. 
06.20.  In a similar fashion, after certa in time and area thresholds have been 
exceeded, it would be reasonable to review management measures to determine if the measures need to be dropped, retained or strengthened.  Such thresholds should be 
agreed upon in advance.   
06.21.  Finally, for precautionary management measures, there should be certain time 
and area thresholds specified which would trig ger a review to determine if sufficient 
information had accumulated to merit a reduction in the level of precaution.  Presumably the precautionary management measures would provide data from which it would be possible to assess their necessity. 
Question 7
 
 
7. On the basis of the information before the Panel, is there any scientific evidence to support 
the hypothesis that repeated use of a given biotech herbicide tolerant crop has adverse effects on flora 
and fauna, including soil micro- and macro-fauna?  If so, how does this compare with any similar risks of adverse effects from the repeated use of a non-biotech herbicide tolerant crop (i.e, one 
developed through mutagenesis)?   
07.01.  I will restrict this answer to th e following genetically modified herbicide 
tolerant (GMHT) crops:  oilseed rape, fodde r beet, cotton, maize, soybean, and sugar 
beet.  I will use the seven kingdom taxonomy in discussing organisms. 
Adverse Effects of GMHT Crops
 
 
07.02.  There is abundant evidence that repeated use of a given biotech herbicide tolerant crop would likely result in the e volution of resistance in weeds to the 
herbicide.  While it can be debated if this adverse effect results from repeated use of 
the GMHT crop or from the repeated use of the herbicide of which the GMHT crop is WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-98 
  
  tolerant, in practice the two are so tightly correlated, and the GMHT crop is expected 
to have the herbicide applied to it.  Hen ce a risk assessment should consider both as 
correlated causal factors.  In the language be fore the panel, weed resistance is a risk 
resulting from the associated cha nges in agricultural practices. 
Comments by Argentina
 
 
We agree in that distinction is not made between biotech and non-biotech HT crops, as it is 
properly pointed out that "changes in agricultural practices" are in the focus of this question. 
 
07.03.  Adverse effects on non-target flora and fauna could arise directly from 
transgene products, directly from the herbicide compounds, or indirectly through the effects of the transgenic crop or the he rbicide on the environment.  Although the 
authors of the Farm-Scale Evaluation (FSE) Trials of GMHT crops in the UK 
concluded that all adverse non-target effect s arise indirectly fro m the effects of the 
herbicide on the environment, this highly credible argument is not proved 
conclusively.  In any event, the FSE Trials demonstrate that some, but not all, GMHT 
crops can have adverse effects on non-target or ganisms.  I believe that it is likely that 
additional adverse effects on non-target organisms may be reported in the future. 
Comments by Argentina
 
 
The above challenges the FSE trials, which other Expert calls (in a confusing way, in our view) 
in support of non-target effects.  See the comments below, by J. L. London in "Biosafety trials 
darken Outlook for transgenic crops in Europe ", Nature, 425:751, 2003); some excerpts (bold 
and underlines are ours): 
 
"Britain's Farm Scale Evaluations, Pub lisher on 16 October, show that two 
genetically modified crops – spring oilseed ra pe and beet – are likely to have harmful 
impacts on farmland biodiversity. Researchers say the levels of weeds, seeds and insects in fields of transgenic crops were lower than those in plots of conventional 
varieties, and that this could have a knoc k-on effect on the birds and small animals 
that feed off these populations.  
Although the problems are caused by th e herbicide-spraying regime associated 
with the crops, rather than the crops them selves, the results are likely to make it 
politically impossible  for the British government to license transgenic crops in the 
immediate future, many observers say. … Th e trials, which took place between 2000 
and 2002 and are published as eight papers in the Philosophical Transactions of the 
Royal Society B , compared conventional and transgenic varieties across 200 plots. 
Positive results for a third crop — maize (corn) — have been called into doubt, 
as the weed-killer used on most of the conventional plants is to be phased out.  
But the other results have not been direc tly challenged by most supporters of the 
technology. The data show that the number of seeds on the ground in the plots of 
transgenic oilseed rape and beet was one -third to one-sixth lower than in the 
conventional plots.Levels of some insects and weeds were also lower. "We could see 
a long-term decline in weeds that feed bi rds," says Les Firbank, a land-use specialist 
at Lancaster University, who led the trials. Firbank and the other authors stress 
that it is the herbicide-spraying regime, not the genetic modification, that is the  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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 Page I-99 
  
  root of the problem
. Herbicide-resistant crops are engineered to resist broad-
spectrum weed-killers that remove almost all weeds from a field. (*)  
During the farm-scale evaluations, farmers sprayed the crops once or twice with a 
broad-spectrum herbicide.  This reduces the labour requi red for conventional weed 
management, which involves repeatedly applying less powerful weed-killers. But the 
more powerful herbicide used with th e transgenic crops also removes more 
weeds , as well as the seeds they produce. Repr esentatives of the agri culture industry 
point out that this leaves open the possibilit y that another herbicide-spraying regime 
might have lessened the impact on biodiversity while still reducing farmers' labour. 
…"… given the intense public opposition to transgenic agriculture, the chances of 
commercializing herbicide-resistant crops in the short term are slim (see Nature 425, 
656–657; 2003)…. No decision will be made until a panel of scientific advisers has 
considered the results for the government. But environment minister Elliot Morley 
has already said that no commercial planting will take place in 2004. In the 
meantime, work on better spraying regimes continues. " 
(End of quote) 
* Note of  this reviewer: The removal of all the weeds from a field is one 
characteristic of modern agriculture. 
 
Regarding this FSE trials, we observe the following:   1. They are qualified as "highly credible" but not conclusive.   2. Moreover, the statement:  
 
"In any event, the FSE Trials demonstrat e that some, but not all, GMHT crops 
can have adverse effects on non-target organisms.  I believe that it is likely that additional adverse effects on non-target organisms may be reported in the future",  
is an anticipated judgement reflecting the Expert  beliefs about future research, but no the basis 
for that is given.  
 3. Also, the Expert states that    
"Adverse effects on non-target flora and fauna could arise indirectly  through the 
effects of the transgenic crop or the h erbicide on the environment". Here, an 
indirect effect is mentioned. This statement contrasts with the authors of the FSE 
trials opinion, stressing "that it is the herbicide-spraying regime, not the genetic 
modification, that is the root of the problem ." 
07.04.  Gene flow from a GMHT crop to a weedy relative can create weeds that are 
more difficult to control with herbicides.  This occurred for GMHT oilseed rape in 
Canada.  GMHT maize, cotton and soybean  have not yet been grown legally in 
locations where there are weedy relatives a nd none occur in Europe, the US, Canada 
or Argentina, so this risk is not possible in these countries.  Beets have wild relatives WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-100 
  
  in Europe, and weedy beets have develope d as a consequence of gene flow in the 
past.   
07.05.  Gene flow from a GMHT crop to another crop cultivar can contaminate seed 
supplies (part of the "coexistence" issue) or reduce genetic diversity in the crop. 
Contamination is a serious concern, although it can be debated if this adverse effect is 
on the flora (the crop) or the growers of the crop.  It is clear that the harm is to the growers of the crop.  Genetic diversity of cotton, maize and soybean is not known to be great in Europe, so this is unlikely to be  a concern.  It may be possible that there 
are significant sources of genetic diversity in  oilseed rape and beets in Europe.   
Comments by Argentina
 
 
1. The same as the term "coexistence" is between quotation marks, the term 
"contamination" should be treated equally, as the proper wording is "adventitious presence". 
 
2. About genetic diversity of cotton, maize and soybean, it is stated in the above that is 
"not known to be great in Europe, so this is unlikely to be a concern". An equivalent, but subtle different way of saying the same, would be that "genetic diversity…is known not to be great in Europe, so …". In this latter way, a definite idea  is expressed, instead of an open question (… is 
not known …). 
 
07.06.  To my knowledge there are no reports  of adverse effects on soil micro- or 
macro-flora or fauna separate from those in the UK-FSE trials.  Nor are there any reports of adverse effects on soil dwelling bact eria, algae, or protozoa.  However, to 
my knowledge there have not been any studies of any of these possible effects.  The 
Panel should not infer that the absence of information implies an absence of effect. 
Comments by Argentina
 
 
We disagree with the last sentence, addressed at making the Panel to think of or to expect that, 
effects will (or may) occur. Strictly speaking, the absence of information implies that an effect, if 
any, have not been studied. Following the same line of reasoning as the suggestive way used in 
the commented response, it can be equally said that "the absence of information does not imply 
the presence of effect". To this wording, we can add that "there are no reports" of the presence 
of effects. We strongly believe that language should not be addressed at suggesting perceptions, 
but should objectively dealing with actual facts.  
07.07.  To my knowledge, all reports have not found adverse effects on flora or fauna 
from antibiotic resistance genes or gene products.  Extensive studies on nptII  did not 
find any adverse effects, and found that any undetected adverse effects would likely be several orders of magnitude sma ller than naturally occurring phenomena. 
Comments by Argentina
 
 
We agree.  Comparison with non-GM HT Crops
 
 
07.08.  There are several ways in which GMHT and non-GMHT crops may differ that 
are significant to risk to flora and fauna.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-101 
  
  07.09.  GMHT traits are typically hemizygous, which means that there is only one 
copy of the locus in the plant.  Normal plan t genes occur in two copies, that are either 
different (heterozygous) or the same (homoz ygous).  Gene flow to wild relatives or 
other crop varieties will result in hemizygous  offspring for GMHT traits, which are 
likely to exhibit dominant expression.  For non-GMHT traits, hybrid offspring are most likely to be heterozygous and may ex hibit varying degrees of dominance.  This 
means that whatever the selective advantage of  the trait in the original HT plant, it is 
likely to be similar for GMHT hybrids, but possibly less for non-GMHT hybrids.  
Because selective advantage is one of key determinants of spread of genes, this would 
suggest that GMHT traits could be more likely to spread than equivalent non-GMHT 
traits. 
Comments by Argentina
 
 
Sexual compatibility is not mentioned above. This is often (but not always) a significant barrier 
against gene flow via pollen. The last sentence above is speculative, and, to date, no scientific findings would support it.  
07.10.  The promoters on most GMHT transg enes keep the transg ene turned on and 
expressing at all times.  The non-GMHT transgenes are regulated by plant promoters, 
which may or may not keep the gene turned  on all the time.  This may enable the 
herbicide to be used for a longer period of time on the GMHT crop than the non-GMHT crop.  If so, greater degrees of weed reduction may be possible in GMHT than non-GMHT crops, which would result in greater non-target effects and higher 
selection for weed resistance in more species of weeds. 
Comments by Argentina
 
 
The constitutive nature of most promoters used in GMHT crops, allows for a reduction, rather 
than for an increase in the use of herbicides, as a whole. Also, non-target effects have not been 
proved, and selection for weed resistance would be  similar in biotech and non-biotech crops. 
"More species of weeds", in the context above, suggests that the GMHT may have acquired the 
ability to jump species barriers, which is not co nsidering the need for sexual compatibility for 
hybridization to take place.    
07.11.  Most of the GMHT crops tolerate glufosinate and glyphosate, while most of 
the non-GMHT crops tolerate imidazolinone  and sulfonylurea herbicides.  It is 
possible that there are important differences in these herbicides that result in different 
risks to flora and fauna.  I am unaware of studies that address this possibility.  In addition, the options for managing resist ant weeds are likely to differ among the 
different herbicides. 
Comments by Argentina
 
 
"Most of the GMHT crops tolerate glufosinate a nd glyphosate" is not an accurate statement. 
Instead, it should be said that most of the events in GMHT crops are addressed at expressing 
tolerance to either glufosinate or glyphosate . Although the suggested double tolerance is 
technically feasible, there are not be en developed, to our knowledge.  
 
The Panel should also take into account th e alleged unawareness of studies that address the 
possibility of the suggested (not supported) differences between GMHT and non-GMHT crops. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-102 
  
   
07.12.  Scale of use has a significant effect  on risk.  Some GMHT crops have gained 
significant spatial scales of use that dwarf those of non-GMHT crops.  For example, 
RoundUp Ready
® soybean now occupies >60 of the US soybean area (>20 million 
hectares), while no non-GMHT trait has come close.  With greater scale, small effects 
can reinforce each other and become more a pparent.  This would be especially true 
for non-target effects, such as those found in the FSE trials. 
Comments by Argentina  
 
The same "scale of use" argument can be constr ued to state the opposite, that is, that being 
gained significant spatial scales of use, effects w ere still not found. A word of caution: the effects 
of the extended use of a GMHT crop has been found to be not different to the similar extended 
use of any non-GMHT crop, under the same scale and agro-ecological conditions. However, this 
is an effect of agricultural practice and does no t depend on the GM nature of the HT crop, as 
found in the FSE trials mentioned by the Expert.    
07.13.  If contamination is an adverse effect on flora, then GMHT crops have this risk 
while non-GMHT crops do not.  This is based on the definition of harm, which is premised on distinguishing between GM and non-GM traits. 
Comments by Argentina
 
 
We find here an intentional use of the word  "contamination", which has a pejorative 
connotation and can possibly predispose laypersons  to think that GMHT crops are inevitably a 
dangerous source of hazard. Moreover,  it is hard to find a definite statement in the above. It is 
not clear to which kind of "contamination" the Exp ert is referring to, as there are, at least, the 
following possibilities: a) gene flow via pollen;   b) adventitious presence (seeds, grain). We 
believe that it is proper to use the appropriate wording as indicated as a) or b). Therefore, we 
object the wording used by the Expert.   Also, The word "If" at the start of the above  point, casts doubts about all that is said 
afterwards. We believe that this wording, in the context of the Expert's opinion above, is not to 
be considered as a scientific argument.   Finally, we note that the Expert is relaying in a definition (rather than an actual finding) in support of his statement. 
 
07.14  If all of the factors mentioned in paragraphs 07.09 through 07.13 are 
equivalent between the GMHT and non-GMHT crop, then there will be no predicted 
difference in the risks of adverse effect s from the repeated use of a GMHT or non-
GMHT crop.  
Comments by Argentina
 
 
See 07.13 on the use of "If", in this case in support of the opposite. We note here the 
contradictory statement, which is again using the conditional (if) and the final admission that there will be no predicted difference in the risks. 
  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-103 
  
  Question 9
 
 
9. In what ways does molecular characterizati on inform the risk assessment for any particular 
biotech product?  Can a risk assessment be carri ed out in the absence of a comprehensive molecular 
characterization of each transformation event? 
09.01.  A risk assessment cannot be carried  out in the absence of a comprehensive 
molecular characterization of each transformation event.  A risk assessment could not address the risks specific to the transgene of  interest without this information.  
Without the information, there would be no clear basis for knowing when all 
reasonable scientific risks have been assess ed and there would often be an uncertain 
basis for determining if a specific risk was sci entifically justifiable or unjustifiable.   
Comments by Argentina
 
 
We agree.  
 
Question 24  
 Monsanto Roundup Ready cotton (RRC1445)
 
C/ES/97/01  (EC chronology 66) 
 
24. Does the information before the Panel, including the full application (EC-66/At.3-12) and the 
EC's SCP opinion (EC-66/At.43), provide scientific s upport for the objections raised by EC member 
States (EC-66/At.57) concerning the adequacy of the monitoring plan, the antibiotic resistance marker genes, and herbicide residues?  
 (a) What criteria can be used to judge if the final monitoring plan submitted by 
Monsanto in January 2003 was complete?  
 
Scientific support for objections
 
 
24.01.  This response addresses only issues rela ted to the adequacy of the monitoring 
plan, and does not address issues related to  antibiotic resistance marker genes and 
herbicide residues. 
24.02.  The lead CA reached the followi ng conclusions (EC-66/At.05, Submission of 
lead CA to COM, 19 Nov 1997, Overall Assessment).   
2. From the risk assessment it is  concluded that there is no 
reason to suppose that the harv est and handling of RRC Line 1445 
tolerant to glyphosate herbicide, have adverse effects on the environment and human health. 
9. The dossier was considered by National Commission on 
Biosafety.  The main aspects consid ered in the risk assessment were: 
– Capacity to survive, establish and disseminate. 
– Potential for gene transfer. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-104 
  
  – Products of expression of inserted sequences. 
– Phenotypic and genetic stability. – Pathogenicity to other organisms. 
– Potential for adverse effects to humans. 
10. The National Commission on Biosafety considers that, for 
the considered uses, there is no significant difference as far as 
environmental and human health risks related to other cotton. 
16. Finally, as far as potential effects for non-target organisms is 
concerned, CP4 EPSPS protein is  broadly present in nature.  
Therefore organisms which feed with plants and microorganisms are exposed to this protein.  Studies with birds feeded with RRC line 1445 cottonseed meal have been conducted and no significative difference of this feeding was detected.  Moreover, EPSPS protein 
exist in nature and is considered non-toxic to animal species.  On the 
other hand, cotton is a unique crop that mammals and other species which consume vegetation avoid f eeding on the plant due to both 
gossypol in the plant and the morphology of the plant. 
24.03.  These excerpts show that the risk  assessment dated 19 November 1997 by the 
NCB did not consider indirect effects on no n-target organisms, long-term or spatial 
scale effects on non-target species, effects associated with changes in the cropping 
system or the evolution of resistance in weeds to glyphosate.  The NCB does consider 
whether there are any significant differences between anticipated risks from RRC 1445 compared to conventional cotton.  A lthough the NCB concludes that there are 
no significant differences (point 10), they do not provide a scientific argument that 
this conclusion extends to the potential effect s not considered in the risk assessment.  
Because the NCB considered that the risk s they assessed were inconsequential, the 
NCB did not propose any monitoring plan. 
Comments by Argentina
 
 
To "consider indirect effects on non-target organ isms, long-term or spatial scale effects on non-
target species, effects associated with chang es in the cropping system or the evolution of 
resistance in weeds to glyphosate", which the Ex pert claims, seem addressed at a justification 
for a "no decision" stand. These considerations ref er to effects that have not been found in 
previous studies, have long-term timeframes for execution of the needed research (e.g., 
"changes  in the cropping system") or  are speculative in the sense that: 
 
to any biosafety analysis, new and renewed condi tions are feasible to be imposed, in a never-
ending process.  
 By its very nature, biosafety analysis must rea ch a conclusion based on the state of (all) 
knowledge available at the time of the analysis . At any rate, new knowledge would indicate if 
the biosafety analysis should be revised. It is not the matter if the effects are "inconsequential", 
but if they are significant, or have not been taken into account because of a non exhaustive 
consideration of the available data. To suggest th at the above effects should be examined for a  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-105 
  
  decision to be reached, will only produce th e result that, once the new requested data is 
presented, new knowledge will be required, and so on.  
In fact, if a decision body will be determined to  an indefinite suspension, one strategy will be to 
delay approval. Since accumulation of new knowledge  is a constant process, when the time for a 
decision comes, new questions may arise that will require the elaboration of new data, which will in turn delay approval. The lack of data argument could so work as an indefinite 
suspension strategy. 
 
24.04.  The SCP provided the following Opinion (EC-66/At.43, 14 July 1998.  
Opinion of the Scientific Committee on Plants). 
6.3.3. Safety to non-target orga nisms:  Exposure of non-target 
species to seeds can be considered very low, due to the morphology 
of the boll.  Feeding studies with birds (seeds) and mammals (both 
proteins) indicate very low toxicity of the proteins which also occur ubiquitously in the environment in plants and microorganisms.  Field 
studies on agronomic performance showed equivalent susceptibility of line RRC 1445 and non-modified varieties to diseases and insect pests. 
6.3.4. Resistance and tolerance i ssues:  Any selective advantage of 
cotton line RRC 1445 is restricted to cases where no herbicide other 
than glyphosate is used on early stages of cotton.  Under normal application rates, the introduced gl yphosate-tolerance is effective up 
to the 4-leaf stage only.  Other herbicide, cultivation of rotational 
crops or winter conditions will kill both modified and non-modified 
plants.  Volunteers should be dealt with by standard agricultural practice except that glyphosate should not be used. 
24.05.  These excerpts show that the did not consider indirect effects on non-target 
organisms, long-term or spatial scale eff ects on non-target species, effects associated 
with changes in the cropping system or the evolution of resistance in weeds to 
glyphosate.  Because the SCP consider ed that the risks they assessed were 
inconsequential, the SCP did not propose any monitoring plan. 
Comments by Argentina
 
 
See comments under 24.03.  
 
24.06.  Sweden commented as follows (EC-66/At.57, 26 April 1999.  Consultation of 
the Committee by Written Procedure).   
Sweden has, in different EU contexts and in earlier statements, put 
forward the view that herbicide tolerant crops should not be placed on the market until the long-term eff ects of herbicide tolerant crops 
on the environment have been better analysed.  Common principles 
for evaluation and monitoring of the risks connected to the cultivation of herbicide tolerant  crops should be established. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-106 
  
  24.07.  Sweden suggests that long-term effects should be studied prior to marketing 
and that principles for monitoring risks relate d to the cultivation of herbicide tolerant 
crops should be established.  Sweden is sayin g that effects associated with changes in 
the cropping system should be considered both in the assessment and monitoring of 
risk.  The scientific literature at that time  indicated that long-term effects frequently 
elude detection when assessed on short time scales, so one of the only reasonable ways to address these kinds of effects is via monitoring.  It does not seem appropriate to require long-term experiments for risk assessment because that could delay the 
process by a decade, so monitori ng is a possible alternative. 
Comments by Argentina
 
 
It is not clear from the above if long term monito ring is suggested as an alternative of biosafety 
analysis. 
 
24.08.  The United Kingdom commented as follows (EC-66/At.57, 26 April 1999.  
Consultation of the Committee by Written Procedure).  
We would also like to draw to the attention of other Member states 
where GM cotton might be widely grown, that this cotton line may have a negative impact on biodive rsity arising from changes in the 
way the herbicide tolerant crop is managed. 
24.09.  The United Kingdom is drawing atten tion to spatial scale effects and effects 
associated with changes in the cropping syst em.  The scientific literature at that time 
indicated that large-scale effects frequent ly elude detection when assessed at smaller 
spatial scales.  One of the reasonable ways to address these kinds of effects is via 
monitoring. 
24.10.  The information in the full application (EC-66/At.3-12) and the EC's SCP 
opinion (EC-66/At.43) do not provide scien tific support for the objections raised by 
EC member States (EC-66/At.57) concerning the adequacy of the monitoring plan.  
This is because the scientific informati on in the full application and the EC-SCP 
opinion do not address the scientific basis for the objections raised by the EC member 
states concerning the adequacy of the monitoring plan. 
Comments by Argentina
 
 
See above comments under the points referring to objections raised by EC member States. 
 
24.11.  The objections of the member St ates (EC-66/At.57) concerning the adequacy 
of the monitoring plan raise new scientific  issues that were not assessed in the full 
application (EC-66/At.3-12) or the EC's SCP opinion (EC-66/At.43).  There is no monitoring plan proposed in either the fu ll application (EC-66/At.3-12) or the EC's 
SCP opinion (EC-66/At.43), so the EC member States' objections can only be interpreted that a monitoring plan may be or is necessary.    WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-107 
  
  Comments by Argentina
 
 
As stated before, monitoring is included in the safety analysis, as the nature of the GM and the 
state of knowledge at the time will lead to specifi c monitoring strategies. This is so for any new 
product or technology.   On the other hand, we would point out a lack of  consistency: had monitoring been applied to 
conventional crops under current agricultural prac tices, they would have most probably qualify 
for delayed approval, as the same kind of eff ects the Expert and the EC member States are 
raising could similarly be applied to them (e .g., consider the effects of current agricultural 
practices with conventional crops, on biodiversi ty, environmental quality derived from the use 
of agrichemicals, changes in the cropping systems, etc).  
24.12.  The objections of the member States (EC-66/At.57) concerning the 
adequacy of the monitoring plan  are scientifically justifiable .  The EC member 
States raise specific scientific issues that  can be addressed in a monitoring plan.  
However, the necessity of a monitoring plan cannot be determined from these 
objections.   
Comments by Argentina  
 
The above statement is not clear: it starts emphasi zing that the adequacy of a monitoring plan is 
justifiable, but ends that the need of a monitori ng plan cannot be derived from the objections by 
the EC member States.   
At any rate, the need for a monitoring plan and the way it is to be implemented, is strongly 
crop-dependent, a feature which has not been raised specifically be fore by the EC member 
States. As an example, the case of GM cotton wo uld be one in which monitoring in the field 
would have little sense, as there are not wild relat ives in Europe. Of course, if an approval delay 
is pursued, it can always be invoked as an excuse that the monitoring of the long term effects of 
the associated agricultural practice is needed before approval.  
 
24.13  It should also be noted that the objections of the member States (EC-66/At.57) 
concerning the adequacy of the monitoring  plan are not all clearly stated as 
monitoring issues, and the objections do not provide clear guidance to an applicant for how to fully respond.   
Comments by Argentina
 
 
See comments under the preceding point.  
 
24.14.  Excerpt from EC-66/At.64.  Letter from Spanish CA to Monsanto requesting additional information regarding the monitoring plan, 1 January 2003. 
Plan de seguimiento 
Se deberán concreter y desarrolla r aquellos aspectos susceptibles de 
ser sometidos a una vigilancia general, indicando las posibles actuaciones en cada caso. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-108 
  
  En este sentido, el Plan de seguimiento deberá contemplar, en su 
caso, el uso del herbicida Glifosato y sus potenciales efectos a largo plazo (incidencia de malas hierb as, resistencias, etc), así como 
cualquier otro efecto relacionado con cambios en las prácticas 
agrícolas convencionales. 
24.15.  I believe the Spanish CA is requ esting that the monitoring plan address 
potential effects of large spatial scale (for ex ample, weed incidence, resistance) and in 
relation to changes in agricultural practi ce.  These echo the comment of the UK (EC-
66/At.57) and some of the comment of Sweden (EC-66/At.57). 
Comments by Argentina
 
 
The comments under the preceding points are also  applicable here. Note that the monitoring 
recommendation is not clear (genera l surveillance, possible measures, any other effect) and the 
only specific mention is made on the agricultural  practices, not on the GM nature of the crop.  
 
24.16.  The UK Farm Scale Evaluations (FSE) of GMHT crops published in 2003 
indicate that one anticipated effect of GMHT crops is an alteration in weed 
populations and communities compared to conventional production.  The precise 
alteration probably depends on the herb icides used on the GMHT crop and the 
conventional crop.  Nearly all other adver se effects on non-target species would likely 
follow from these changes in weed populati ons and communities.  Changes to weed 
populations and communities have not been reported in GMHT cotton on a scale similar to the UK-FSE trials.  These stud ies follow on a concern published in 2000 
that GMHT crops could adversely affect skylarks in the UK.  Although none of these 
studies existed at the time of the decisions by the NCB or the SCP, they partially 
validate some of the hypothetical concerns expressed by the various countries, especially related to spatial and temporal scale.   
Comments by Argentina
 
 
See comments under 07.03 on the FSE trials. We also observe the conditional (unproven) 
quality of the following excerpts from the above paragraph:  
 1. "… alteration probably  depends on the herbicides used…". The authors of the work 
quoted did not have any doubt about that.   
2. "Changes in weed populations and comm unities have not been reported in GMHT 
cotton …".   3. Existing studies "… partially validate  some of the hypothetical concerns …". 
 
24.17.  Considerable theory and evidence indi cates that another anticipated effect of 
GMHT crops is the development of resistance to glyphosate in some weed 
populations.  Resistance to glyphosate in a species of morning glory, which is a weed found in GMHT cotton in southeastern US, has been recently reported.  However concerns about resistance have been wide ly recognized for some time before 1998.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-109 
  
  Comments by Argentina
 
 
As the Expert has stated before, development of resistance in a inescapable evolutionary 
phenomenon and should be expected to occur wi th any selective pressure applied in the field.  
 This will apply to any crop, biotech or non- biotech, agricultural practice and agrichemicals 
which are used.  
 
24.18.  Potential long-term effects of GMHT  cotton have not yet been identified and 
verified scientifically.   
Comments by Argentina
 
 
The argument of the "long-term effects" is recu rrent in the language of the objectors of GM 
crops. As it has been stated before, it is funda mental aim of the biosafety analysis to predict 
these effects. Had the long-term effects on the biodiversity and the environment quality derived 
from conventional modern agriculture been pr edicted, the latter would not been granted 
approval by any regulatory body. Also, we agree with what the Expert points out under 24.18.   
24.19.  The Member States submitted questions  to the notifier on 22 February 1999.  
The notifier submitted materials to the SCP on 6 July 1998.  The SCP returned an 
Opinion on 14 July 1998.  The notifier submitted additional information that was 
circulated on 20 November 1998.  After this follow 3 decisions to postpone the decision-making process.  Depending on which dates are used, the Member States used either 94 or 231 days to respond to the most recent submission by the notifier.  
The shorter time frame is reasonable, esp ecially as it spans the winter holiday season 
when most offices are closed for long peri ods of time.  The longer period of time 
seems excessive to formulate and pr ovide the responses to the notifier. 
Criteria to judge monitoring plan
 
 
24.20.  The specific purpose of monitoring should be clearly stated.   This purpose 
should be linked to the management of some  risk.  This linkage ties monitoring to 
risk management, and delimits the monito ring endpoint.  Although Annex VII.A of 
Directive 2001/18/EC provides a statement about the objective of a monitoring plan, this statement is not specific enough as the purpose of any particular monitoring plan.  The plan should be more closely linked to actual potential risks, as indicated in 
Annex VII.C.1-2 of Directive 2001/18/EC. 
24.21.  For example, there are several po ssible purposes for monitoring herbicide 
resistance in weeds, including: 
• Purpose R1.  Document/Measure the occurre nce of herbicide-resistant weeds.  
This would provide information prior to  any control failures that could be 
used to alter the use of the herbicide or herbicide-tolerant crop to delay or 
avoid higher levels of resistance in the weed.  Because this occurs before any 
control failures, it would provide time to develop a reasoned response to the threat.  This would be particularly a dvantageous to prolong the useful life of 
the herbicide in question, especially if  it had replaced herbicides that caused 
greater damage to the environment. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-110 
  
  • Purpose R2.  Document/Measure the o ccurrence of a weed problem that 
cannot be controlled by the herbicide.  This could provide information of 
localized control failures that could be u sed to alter the use of the herbicide or 
herbicide-tolerant crop to delay or avoi d higher levels of resistance in the 
weed.  Because some control failures will have occurred, it may be necessary to mobilize a rapid response to prolong the useful life of the herbicide. 
• Purpose R3.  Document/Measure the widespread occurrence of a weed 
problem that cannot be controlled by the herbicide.  This would provide information of widespread occurrence of  the risk, and would be an indication 
that the risk management practices had failed.  One crucial use of monitoring 
is to determine when a predefined point of failure is reached. 
Comments by Argentina
 
 
We agree with the above explanation by the Expert , as he gives a general view on the subject, 
not distinguishing between biotech of non-biotech crops. 
 
24.22.  Similarly there are several possibl e purposes for monitoring changes in weed 
populations and communities, including:   
• Purpose W1.  In the UK, there has been a concern that GMHT crops would 
adversely effect the skylark, a desirable species.  Skylarks feed on weed seeds, so monitoring of weed populatio ns and communities could be aimed to 
monitor the abundance of food for skylarks.  This approach could be 
extended for any other non-target species of concern. 
• Purpose W2.  There is a possibility th at "unanticipated" or "unexpected" 
adverse effects could follow from changes in weed populations and 
communities.  Monitoring these weeds w ould be a prelude to discovery of 
unanticipated or unexpected adverse effects. 
Comments by Argentina
 
 
Here we point out that work published in 2000 is  called to support a decision (actually a "non 
decision") taken well before. As stated before, safety analysis draws from knowledge existing at the time of the decision process. Otherwise, a indefinite postponement may occur.  
 
24.23.  In addition, there are several possible purposes served for monitoring for 
"unexpected" or "unanticipated" effects, including: 
• Purpose U1.  Document the geographic and temporal pattern of use of the 
GMHT crop so that there is a database available that would enable retrospective epidemiological-like investig ations should an "unanticipated" or 
"unexpected" effect be observed.   
• Purpose U2. Train personnel who norm ally visit agricultural fields and 
natural areas near agricultural fields to be aware of the possibility that 
agriculture generally and GMHT crops  specifically may have "unexpected" 
or "unanticipated" effects.  Inform these people of the occurrence of GMHT crops.  Training should include inform ation about the potential mechanisms  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-111 
  
  by which such effects could possibly ar ise.  For example, "unanticipated" 
effects of weed community shifts should receive attention.  This training will provide the many eyes needed to notice possible changes in the environment. 
• Purpose U3.  Document ch anges in agricultural prac tices associated with the 
use of GMHT crops.  There is a possibility that "unanticipated" or "unexpected" adverse effects could follow from changes in agricultural 
practices.  Monitoring these practices could be a prelude to discovery of unanticipated or unexpected adverse effects. 
Comments by Argentina
 
 
See comments under the preceding point.  
 
24.24.  Clear specification of the purpose of monitoring is probably the most critical 
step in developing a useful monitoring system. 
Comments by Argentina  
 
We agree. Most of the references to monitoring which preceded this point lack of this "clear 
specification".   
24.25.  Monitoring must have a sequel.
  The act of monitoring should not be an end 
in itself.  The information gathered duri ng the monitoring activities should be used to 
make a response.  This response should be  related to the risk, including activities 
ranging from those to better estimate the risk  to those activities to avoid, mitigate or 
tolerate the risk.  Specification of a response is probably the second most critical step in developing a useful monitoring syst em.  Although Annex VII.C.6 of Directive 
2001/18/EC states that a response should be considered, it does not require a 
response. 
Comments by Argentina
 
 
We agree with the Expert.  
 
24.26.  Action Trigger .  In addition to a sequel, a monitoring system must have a 
well-defined action trigger.  An action trigger is a criterion or set of criteria, which if 
met (or exceeded) according to the information from monitoring, would require taking the response actions.  Without a clear  action trigger, it could become quite 
difficult to determine when monitoring would precipitate a response.   
Comments by Argentina
 
 
We agree with the Expert.  
 
24.27.  Important logistical issues  include: (1) who will monitor, (2) who is 
responsible for monitoring, (3) who handles and synthesizes the monitoring 
information, (4) who verifies the quality of the monitoring, information obtained from monitoring and synthesis of this information, (5) to whom are monitoring results reported and at what frequency, (6) how will the monitoring effort be sustained, (7) 
how can monitoring be conducted in a cost-effective manner.  Most, but not all, of WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-112 
  
  these logistical issues are recognized in Annex VII.C.3 and 5 of Directive 
2001/18/EC. 
Comments by Argentina
 
 
We agree with the Expert. 
 
24.28.  Important methodological issues  include: (1) what ‘endpoint' will be 
monitored, (2) what frequency will monito ring be conducted, (3) what will be the 
spatial density (grain) of monitoring, (4 ) can monitoring be stratified by potential 
risk.  A few of these issues are rec ognized in Annex VII.C.3 of Directive 
2001/18/EC.  The endpoint of monitoring is what is actually measured and/or 
estimated by the people conducting the monito ring.  For example, for weed resistance 
it could be the frequency of resistance genes or resistant phenotypes in the weed 
population; for non-target effects, it could be total weed biomass, production of weed 
seeds that are normally consumed by skylarks, and so on.  Choice of endpoint can enable or restrict possible responses.  The frequency of monitoring will depend on several factors, including the anticipated response.  If the response involves a series 
of processes that would take several years to complete, it might be appropriate to increase monitoring frequency so that the monitoring process does not introduce 
additional delays in responding to a potential threat.  The grain of monitoring will be 
depend on several factors, including the expected grain of the effect being monitored.  For example, if regional weed  resistance is the concern, then monitoring can be done 
at a regional scale.  If weed resistance on farms is the concern, then monitoring will probably need to occur at a finer grain.  Weed community shifts might be done on 
several spatial scales.  If the adverse consequences are focused on bird species, 
regional monitoring may be sufficient.  If they are focused on less mobile species, 
then a finer grain will be necessary.  Fina lly, it will be essential that monitoring is 
stratified so that it occurs at places and times most likely related to possible risks.  
Monitoring is costly and monitoring res ources must be allocated efficiently.  For 
example, monitoring for unanticipated e ffects could be stratified according to the 
geographic distribution of the GMHT crop.  Monitoring could occur mostly or only at 
places where the GMHT crop is used consid erably, with a threshold intensity of 
usage determining the distribution of monitoring effort. 
Comments by Argentina
 
 
We agree with the Expert. 
 
24.29.  Monitoring for unanticipated or une xpected effects.  The first step in 
developing a monitoring system for these possible effects is to specify clearly what effects, if any, are anticipated  or expected.  Without this clear statement, it will not be 
possible to determine if any observed eff ect is unanticipated or unexpected.  For 
example, if no adverse effects are anticipated  or expected, then it must be granted that 
any subsequently observed effect must be considered unanticipated or unexpected.   
Comments by Argentina
 
 
We fully agree with the Expert. Most of the moni toring claims by the EC member States do not 
comply with the above recommendations by the Expert.  
  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-113 
  
  24.30.  General critique of proposed monitoring plan (EC-66/At.62).  (1) Specific 
purpose of the proposed monitoring plan is to monitor for unanticipated or 
unexpected effects.  It does not address con cerns associated with weed resistance or 
changes in weed populations and communities, as indicated by the EC officials.  The 
purpose of the monitoring for unanticipated or unexpected effects is not entirely clear.  Consequently it is difficult to know how the proposed monitoring will enable the 
identification of any unanticipated or une xpected effects. (2) The proposed response 
is to conduct a scientific evaluation of the observed potential unanticipated effect to 
confirm that it is in fact an unanticipated effect.  While it is stated that the response 
should be proportionate to the risk, it is not  clear what procedure and standard will be 
used to determine a proportionate response.  Second is unclear who is responsible for 
conducting the scientific evaluation and how to  ensure that this information will be 
collected in a timely fashion, who w ill have access to the information, who 
determines the adequacy of the design of th e evaluation and so on.  (3) The triggers 
for initiating a scientific evaluation are not clear.  It would be folly to initiate a scientific evaluation of all possible observations of possible adverse effects.  How will these be screened to trigger a scientific  evaluation?  When does the scientific 
evaluation provide sufficient evidence to tr igger remedial action?  These issues are 
not resolved in the present proposed monitori ng plan.  (4) The logistical issues are 
better specified than the other compone nts of the proposed plan.  Important 
weaknesses in the proposal include lack of specification for how the seed supply and 
distribution network will be linked to the monitoring procedures, that key external 
networks are not committed to monitoring, procedures to verify the quality of monitoring, information from monitoring and s ynthesis of this information, short time 
span and long intervals for reporting, and so on.  (5) Methodologically, the proposal 
has several important weaknesses.  No endpoi nt is specified and it is not clear how 
people who might be monitoring would recogni ze an unanticipated effect.  In this 
case these people should be informed that any adverse effect must be considered an 
unanticipated effect, and should be repor ted.  The frequency and grain of these 
observations is unclear.  There seems to be  little stratification of effort by potential 
risk.  
Comments by Argentina
 
 
We believe that the proposed monitoring plan, even in the case it deserved the critique by the 
Expert, would not be a valid reason to del ay approval (see also comments under 24.11). 
 
Monsanto Roundup Ready corn (NK603)  
C/ES/00/01  (EC chronology 76)  Question 37
 
 
Necessity to ensure validity of safety assessment  
 
37. Given the information before the Panel, incl uding the notification (EC-76/At.1-2 and 27), was 
further information regarding molecular charact erisation, nutritional analysis, and environmental 
impact requested by the lead CA (EC-76/At.6) necessa ry to ensure that conclusions of the safety 
assessment were valid?    
37.01.  I will cover the environmental impact aspects of questions 37 and 38. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-114 
  
  Environmental impact of the GMO 
Although this is not the direct purpose of this notification, the 
application covers aspects relati ng to the imminent request for 
authorization for cultivation in another Member State.  In view of this 
eventuality, the National Biosaf ety Committee raises the following 
questions: 
16. Page 14, Section 3 – Survivability:   The comments on plant 
survival are incorrect, given that crop repetition is common in many 
areas and that, in many cases, grain from fallen ears germinates to 
produce plants in the next season. 
17. Page 16, Section 7 – Potential interactions:   This point 
must be looked into as broadly and deeply as necessary.  The environmental impact of these interactions on target or non-target 
flora and fauna must be evaluated more thoroughly. 
18. Page 58, Point D.6. – Transferability of genetic material 
from the genetically modified plant to other organisms:  Although 
the application refers exclusively to authorization of the grain, detailed knowledge of the dispersal capacity of the pollen under various conditions is necessary a nd would be of relevance for 
authorization of cultivation in the State concerned by the application.  
This information could be decisive when the time comes to draw up a future monitoring plan. 
19. Page 98 – Appendices:   Doses and conditions for 
application of the herbicide (phenolog ical condition of the plant, dose 
and date). 
37.02.  The relevant questions from the lead CA are in EC-76/At.5, 15 February 2001 
and are reproduced below. 
37.03.  It is clear from the opening paragraph of these questions that the lead CA 
justifies the questions on the basis of an  imminent request for authorization for 
cultivation in another Member State.  T hus, I conclude that the lead-CA does not 
believe that the questions on environmenta l impact are necessary to ensure that 
conclusions of the safety assessment were valid. 
37.04.  I believe that none of the questions posed under environmental impact are 
necessary to ensure that conclusion s of the safety assessment were valid . 
37.05.  Given that the notification is not for cultivation, whether survival is slightly 
better in continuous maize than in rotate d maize ignores the bigger point, which is 
that maize does not survive very well.  While the CA is correct in noting the 
difference, this difference is not necessary to ensure that conclusions of the safety 
assessment were valid.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-115 
  
  Comments by Argentina
 
 Maize survival is indeed difficult without man's help, as the crop has been extensively 
bred for 
production in highly man's managed agroecosystems. It is highly unlikely that grains are to 
survive and germinate in the ground during transportation.  
37.06.  While it is true that potential inter actions need to be looked into broadly and 
deeply if the GM crop were to be cultivated, it is not true that such an investigation is 
necessary for the present notification.  It would be better to focus attention on 
detecting accidental releases and quickly eliminating them. 
Comments by Argentina
 
 We agree with the first sentence. 
 
37.07.  Although it is true that detailed information on transferability of genetic 
material from the GM crop to other organism s is needed if the GM crop were to be 
cultivated, it is not true that detailed information is needed for the present 
notification.  Some informa tion is necessary to consider how gene escape can occur 
either during processing, storage or tran sport, but detailed information is not 
necessary. 
Comments by Argentina
 
 We agree. 
 
37.08.  As the GM plant is not to be  cultivated under the present notification, 
information on herbicide application is not needed. 
Comments by Argentina
 
 We agree. 
 
37.09.  From the time that the notification was received (2 January 2001) to the time 
that the lead CA sent questions for clarification to the notifier (15 February 2001), 44 days had elapsed.  This seems to be a rapid turn around time.  
Question 38
 
 
38. Given the information before the Panel, including the notification and letter from Monsanto 
providing additional information (EC-76/At.7-9),  was additional information necessary regarding 
molecular composition and environmental impacts asso ciated with accidental germination requested 
by the lead CA (EC-76/7-9 and 10) necessary to ensure t hat conclusions of the safety assessment were 
valid?   
 
38.01.  Having received answers from the notifier (5 September 2001), the lead CA 
requested additional information.  On the issue of environmental impacts, the lead 
CA asked the following question. 
• Although cultivation of this maize is not covered by this 
application for marketing authorisation, details of the WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-116 
  
  potential environmental impact of any accidental 
dissemination or germination are needed. 
38.02.  Based on the SNIF (EC-76/At.2, 4 A ugust 2000) and the responses to the first 
set of questions from the lead CA (EC-76/At .7-8, 5 September 2001), it is clear that 
the notifier has not addressed this question.   The notifier believes, probably rightly, 
that the likelihood of accidental dissemin ation and germination (exposure to the 
environment) is small.  If this is true, the notifier is arguing that when exposure is 
small, risk is small.  Consequently, the notifier may believe that it was not necessary 
to address this question. 
Comments by Argentina
 
 Since cultivation is not contemplated, the only way an environmental impact may be possible is 
from accidental spills during transport. Therefore,  the Expert is right in considering that the 
risk is small, since germination and appearing la ter as volunteers plants is very unlikely. Indeed, 
if no cultivation is contemplated, we are dealin g here with grains, not with seeds intended to be 
planted. 
 
38.03.  In either event, the lead CA ma y reason as follows: if the hazard associated 
with a rare exposure event is large, th en the risk may be large.  Hence the question is 
necessary to ensure that conclusions of the safety assessment are valid .  However, 
it would be helpful to the notifier to specify that the lead CA is concerned about large 
potential environmental impacts.  Moreover,  it would be even more helpful to the 
notifier to suggest some possibilities.  For example, if contamin ation of conventional 
production (related to the "coexistence" issu e) is a major concern (and is considered 
an environmental impact), the notifier w ould be able to propose how the concern 
could be managed, thereby facilitating the more rapid completion of the notification 
process. 
Comments by Argentina
 
 See questions below and our comments on the use of the term "contamination", in paragraphs 
07.05, 07.13, 69.16 (commenting on point 4), and 103.03. 
 It is also very unlikely that from an accident al spillage of grains, a plant will emerge in the 
places travelled through transportation. Also, for this reason (see also the comments under 
paragraph 38.02), we do not agree with the contenti on that the risk of spillage and germination 
of isolated grains is a great hazard and therefore a great risk.  
38.04.  The time from the responses to the first set of questions from the lead CA 
(EC-76/At.7-8, 5 September 2001) to the time of the second set of questions from the lead CA (EC-76/At.10, 10 October 2001) was 35 days.  This seems to be a rapid turn 
around time.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-117 
  
  Maize Bt-176 (notification C/F/11-03)
 
 
Safeguard measure of Austria 
 
Question 69:  
 
69. Given the information before the Panel, in cluding the evaluations undertaken by France (EC-
158/at. 1 to 3);  the Scientific Committee for An imal Nutrition in December 1996 (EC-158/At. 4 and 
5);  the Scientific Committee for Food in Dece mber 1996 (US-64) and in March 1997 (US-58);  the 
Scientific Committee for Pesticides in December 1996 (EC-158/At.6) and in May 1997 (US-57);  the 
Scientific Committee for Plants (SCP) in Septemb er 2000 (US-66);  and the European Commission in 
its Decision of January 1997 (ARG-37), as  well as the information submitted by Austria  with respect 
to its safeguard measure (US-52, EC-158/At.11, 12 and 15; EC-144, EC -147), is there any reason to 
believe that the scientific evidence available to Au stria in February 1997 was NOT sufficient to permit 
it to undertake an appropriate assessment of potential  risks to human, plant and animal health, and 
the environment from the importation and use of Ma ize Bt-176?  If so, what scientific evidence do you 
believe was insufficient?    If the evidence was not sufficient in February 1997, was there sufficient evidence available to Austria 
in August 2003
 to permit it to undertake a more objecti ve assessment of potential risks to human, 
plant and animal health, and the environment fr om the importation and use of Maize Bt-176 (EC-
158/At.30 to 42)?  If not, what scientific evidence do you believe was insufficient?    
69.01.  In my response to this question, I will not address issues related to the antibiotic marker gene and will focus my remarks on environmental risks. 
69.02.  The initial assessment of Event 17 6 by France provided in EC-158/At.1-3 
(10 January 1995, 1 March 1995, 3 March 1995)  does not contain the details of the 
assessment by the French Biomolecular Engineering Committee (BEC).   
69.03.  The Opinion of the Scientific Co mmittee on Pesticides (EC-158/At.6SCI, 9 
December 1996) on Event 176 did not assess th e risk of resistance evolution in the 
target pests because it considered this ri sk to be an agricultural risk, not an 
environmental risk.  In either event, th e Committee felt that resistance management 
should be fully considered.  The Committ ee also did not assess non-target effects. 
Comments by Argentina
 
 
See our comments on non-target e ffects below, under paragraph 69.06. 
 
69.04.  The Opinion of the SCAN (EC-158/At.4, 13 December 1996) did not address any environmental risk, including environmentally mediated indirect effects on animal health.  The Opinion of the SCF (US-64, EC-158/At.5, 13 December 1996) did not address any environmental risk, in cluding environmentally mediated indirect 
effects on human health.   
69.05.  On 23 January 1997, the EC decided to allow the placing on the market of 
Event 176 (ARG-37). 
69.06.  On 13 February 1997, Austria decided to ban the commercialization of Event 
176 in Austria (US-52).  Austria gave three re asons for this action.  1. A concern that WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-118 
  
  the risks of the bla gene (ampicillin resistance) are gr eater than that assessed by the 
SCAN and the SCF (paragraph 69.04).  2. That the Cry1Ab toxin in Event 176 could have risks to non-target organisms, including those in the soil such as collembola.  3. 
There is an environmental risk that the ta rget insects will evolve resistance to the 
Cry1Ab toxin, and resistance management measures should be required (they were not required by the EC). 
Comments by Argentina
 
 
On the reason 1: By 1997 there was sufficient evidence indicating that the risks of the bla gene 
in a GM plant are nebligible (see, e.g., Schlüter, K et al, "Horizontal" Gene Transfer from a Trangenic Potato Line to a Bacterial Pathogen ( Erwinia chrysantemi ) Occurs –if at all- at an 
Extremely Low Frequency. Biotechnology , 13:1094-1098, 1995); 
 
On the reason 2: By the time of the EC deci sion, there was sufficient evidence supporting that 
there is a negligible probability fo r Bt entomotoxins to have toxi city or otherwise being harmful 
to non-target organisms; that is, the knowledge on the mode of action of the Bt entomotoxins was showing the high specificity of these toxins  for insect Orders, based in the binding to 
specific receptors in the mid-gut of the susc eptible insects; therefore, there was sufficient 
information pointing that the risks for non-targ et organisms was not a concern so the decision 
by Austria has no justification; 
 On reason 3: Development of resistance is an essent ial phenomenon in evolution, so it is to be 
expected to occur whenever a selective pressure is a pplied in the field; by the time of the EC 
decision, management of this risk was a standa rd agricultural practice in countries in which Bt 
events were commercial (the high-dose/refugia strategy). 
 All in all, we do not see reasons to contradict the decision by the EC, which we considered was 
correct.  
69.07.  In the Further Opinion of the Sc ientific Committee on Pesticides (US-58, 12 
May 1997), "The Committee concluded that  the reasons and information submitted 
by the Austrian Authorities did not add ne w relevant evidence to that already 
considered by the Committee and that none of its conclusions on the risk to the environment were affected by the Austrian arguments." 
69.08.  The reasoning in the Further Opinion of the Scientific Committee on 
Pesticides (US-58, 12 May 1997) is false a nd did not take into account the scientific 
information known at the time.  The conclusions it reached (paragraph 69.07) do not follow from the evidence available at the time.   
Comments by Argentina
 
 
This argument is discussed below, when the Expert breaks down the SCP-Austria subject. 
 
69.09.  (1) On page 2 the Committee stated  that it "recognized the complexity of 
comparing the exposure of a pest to genetically modified plants, where exposure may be prolonged and maintained, and conventionally applied p esticides, with shorter and 
repeated exposure.  The potential for development of resistance could be either 
accelerated or retarded."  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-119 
  
  On the comparison problem mentioned above, when  considering development of resistance, it 
seems that the Expert considers that continuous  exposure to a toxin at the level of 0,001 % of 
total biomass protein (order of magnitude), wh ich is produced by ubiquituous (and harmless) 
bacteria is considered a potential risk higher than  the exposure to a agrichemical proven to be 
toxic (as most chemical insecticides). Is the Expert  indicating that a hypothetical risk of the 
above kind has a higher value than a proven health and environmental risk? To date, provided Bt plants are properly used (as it should be with any agricultural input), no resistance has been detected that may be considered to be of con cern. Moreover, the Exp ert seems to ignore the 
impact to the environment of the alternatives (non-b iotech) to Bt plants. In the case of Bt maize, 
for instance, these impacts are neg ligible and have proved to be even an added benefit, since 
through an indirect effect on the insects, they prevent the crop to be infested with mycotoxin-
producing fungi.  
(a) In its 9 December 1996 Opinion, the Committee nowhere recognized the 
complexity of comparing the exposure of a p est to genetically modified plants, where 
exposure may be prolonged and maintained , and conventionally applied pesticides, 
with shorter and repeated exposure.  It  must be granted that this is a new 
consideration for the SCP that was introduced by Austria.  (b) While it is true that 
theoretically the difference in exposure coul d result in faster or slower resistance 
evolution, the SCP is not discussing a theoretical case.  There was more than 
adequate data available in 1995 from the no tifier's efficacy trials (and efficacy trials 
on Event 176 conducted by public sector sci entists) and a long history of efficacy 
trials of Bt insecticide sprays on maize to demonstrate without question that Event 176 would exert a selection pressure on corn borers many times stronger (I would 
estimate ~1000x) than a typical Bt insecticide spray.  The conclusion of the 
Committee either is not case-specific and therefore inappropriate, or it is case-specific and therefore false. 
Comments by Argentina
 
 
The rather strong sentence at the end of point (b ) above, seems to based on the estimation by the 
Expert of a ~ 1000x increase of the selection pressure (Bt plants vs. Bt sprays), but no 
appropriate reference is given, in spite of the Expert mentioning that "there was more than adequate data available in 1995 …". Key comparison  data in support of the Expert's estimate 
are not found even in the comprehensive st udy by the Expert as a co-author, ( Fitt, G.P. et al , 
Resistance Risks and Management Associated with Bt Maize in Kenya, in Hilbeck, A. and 
Andow, D.A., eds., (2004) Environmental Risk Assessment of Genetically Modified Organisms . 
Vol. 1. A Case Study of Bt Maize in Kenya. CAB International, Wallingford, UK, pp. 209-250). 
Thefore, to say that the conclusion of the Co mmittee is "… inappropriate … or … false" is 
going too far. Moreover, we can find ( Schnepf, E. et al , Bacillus thuringiensis  and Its Pesticidal 
Crystal Proteins, Microbiol. Molec. Biol. Rev., (1998) 62:775-806, see pp, 796) the statement below (obioulsly based in research existi ng before the date of publication): 
 
"If transgenic plants can express a cry gene at doses high enough to kill even 
homozygous resistant insects, that crop will become a nonhost. While such an ultra high dose migh be impractical with a sprayable product…it may be possible with toxin-engineered plants , taking into account the currently 
attainable levels of Cry expression in planta. (A reference is quoted) … For 
example, a Colorado potato beetle po pulation 100-fold resistant to a Cry3A- 
containing B. thuringiensis  spray could not survive on potato plants expressing 
the same protein (Two references are quoted)" End of quote. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-120 
  
  From the above, we can conclude that: 1) the Committee has reached and appropriate and valid 
conclusion, and 2) data presented here seem to lead  to a conclusion wich is the opposite to the 
one expressed by the Expert. 
 
69.10  (2) On page 2, the Committee stat ed "Based on available information, soil 
exposure from the GMO maize plants will be  less than the exposure resulting from a 
single conventional spray application including the run-off from the plants.  Only trace amounts of toxin can be detected in the roots of the maize and furthermore, 
normal agricultural practice would involve removal of the greater part of the plant at 
harvest.  The plant remains are often shredde d and transformed into silage for use as 
animal feed at a later stage." (a) In its 9 December 1996 Opinion, the Committee nowhere made the assessment that based on available information, soil exposure from 
the GMO maize plants will be less th an the exposure resulting from a single 
conventional spray application including th e run-off from the plants.  Nowhere did 
the Committee note that these issues were addressed satisfactorily in the dossier 
submitted by the notifier.  It must be granted that these considerations are new to the Committee and that they were  introduced by Austria. 
Comments by Argentina
 
 
From the wording of the quoted Committee stat ement, we reach the conclusion that the 
Committee did have and processed the relevant in formation on which the conclusion was based. 
This information combined toxin concentratio n data in soil and the effects of normal 
agricultural practices. Is the Expert suggesting that  the above kind of data do not satisfactorily 
address the issue? 
 
(b) The conclusion that soil exposure fro m the Event 176 maize plants will be 
less than the exposure from a single Bt spra y application was debatable even in May 
1997.  The Committee did not appear to take into account that nearly all of the Cry 
toxin applied in a Bt spray would be inactiv ated by sunlight in less than week after 
spraying. 
Comments by Argentina  
 
The Committee was not dealing with a Bt spray but with a Bt plant. Therefore, the relevant 
information was of the kind discussed above.  
The Committee did not appear to consider that most farmers incorporate maize 
residue into the soil after harvest.  This w ould incorporate several tons of biomass per 
hectare, putting Cry toxin out of the sun, where it could persist for some time.  The 
Committee seemed to believe that the mai ze residue would be ensiled.  Silage 
requires green plant material, and most s ilage maize is cut while still green, long 
before it would be harvested for grain.  T hus it is not clear that very much residue 
would be removed for silage.  Finally ri sk assessments should not rely on one study 
for key conclusions (in this case the Palm et al. study, cited as study 4 in the Opinion).  The SCP assessment should have  acknowledged that scientific information 
was scarce at that time, and it would have been better had the SCP maintained a more 
agnostic position with respect to the risk assessment.   WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-121 
  
  Comments by Argentina
 
 
On the information available at the time of the SC P assessment, see above. It  seem to be odd the 
recommendation for "a more agnostic position" for the SCP. 
 (Note of this reviewer: Agnosticism : Phylosofical doctrine that declares that every notion of the 
absolute is not accessible to the human understanding , so Science is reduced to the knowledge of 
the phenomenologic and relative). As the phenomeno logic facts were analized by the SCP, and 
Science goes well beyond the phenomenologic, we a re left with the impression that the Expert is 
suggesting that the SCP should have admitted that a definitive understanding is not accessible to us humans, and therefore decla red the impossibility to take a po sition. Also, the Expert seems 
to shift the issue towards a epistemological questio n, departing from the core, technical issue, by 
using a meta-language argument. 
 
Thus, I conclude that the Committee did not consider all available scientific evidence 
and did not appropriately weigh potentially  conflicting information when coming to 
their conclusion. 
69.11.  (3) On page 2-3, the Committee stat es "The Committee stated in its previous 
report of 9 December 1996 that resistance management strategies are needed during 
the years of use of any pesticide, Bt spra ys included.  The Committee drew attention 
once again to the need for effective resi stance management, including monitoring on 
agronomic grounds, to prolong the effectiv eness of Bt toxin both in conventional 
sprays and in genetically modified maize.  It also felt that the submission of a satisfactory monitoring and resistance management programme should be a 
requirement for the authorization to use ge netically modified maize seeds expressing 
Bt-toxin.  (a) In its 9 December 1996 Opinion, the Committee nowhere made the recommendation that the submission of a satisfactory monitoring and resistance management programme should be a requirement
 for the authorization to use 
genetically modified maize seeds expressi ng Bt-toxin.  The acknowledgement that it 
should be a requirement in this 12 May 1997 Opinion is a major change in the 
conclusions and recommendations of the Comm ittee.  It must be granted that this 
change was due to Austria's insistence that resistance management measures are 
required for commercial authorization.  (b) The Committee does not address Austria's main point on this issue, which is that resistance risk should be considered an environmental risk.  The Committee also see ms to be unaware of the position of the 
US-EPA in 1996, which was that resistance risk is an environmental risk.  This is a 
critical issue because it determined whether resistance risk could be considered under 
Directive 90/220/EEC.  Thus, the Committee did not engage on a critical reason submitted by Austria. 
Comments by Argentina
 
 
From the above wording by the Expert on the conclusions  of the SCP (the Expert quotes the SCP under 69.10 (2)), it seems quite clear that, what ever the claim made by Austria, the issue at 
focus was environmental. Toxin presence and persistence in soil, effects on agricultural 
practices, are clearly environmentally-related is sues. Which additional environmental issues 
were ignored by the SCP? 
 
69.12.  (4) It must be granted that the reasons and information submitted by the 
Austrian Authorities added new relevant evidence that the Scientific Committee on WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-122 
  
  Pesticides had not considered in their prev ious deliberation, and that that a key 
conclusion was affected by the Austrian arguments.  Moreover, the key conclusions 
by the Committee in this Opinion on non-ta rget risks are overstated and/or false. 
Comments by Argentina
 
 
On non-target effects, see comments under paragraph 69.06. 
 
69.13.  I conclude that the scientific evid ence available to Aust ria in February 1997 
was NOT sufficient to permit it to underta ke an appropriate assessment of potential 
risks to plants and the environment fro m Event 176.  The evidence on risks to non-
target organisms, including those in the so il such as collembola was insufficient.  
Austria could have mustered sufficient evidence to argue that there was an 
environmental  risk that the target insects will evol ve resistance to the Cry1Ab toxin, 
and resistance management measures should be required .  There was probably 
insufficient evidence available to determine what measures should be required.  This 
determination by Austria was in direct contra diction to the EC decision.  In this case, 
Austria probably did not then and does not now need to claim that their safeguard 
measure is a precautionary one. 
Comments by Argentina  
 
On non-target effects, see comments under paragraph 69.06. On the other hand, since the 
Expert comments on what Austria could or co uld not have done, including the last sentence 
above on the non-precautionary nature of the safeguard, we observe that it is somewhat 
contradictory. Austria's safeguard was a precautionary measure, as the Expert himself 
recognizes "… that the scientific evidence available to Austria in February 1997 was NOT 
sufficient to permit it to undertake an appropri ate assessment of potent ial risks…". The very 
essence of a precautionary measure is that comple te available knowledge is not available to take 
a decision.  On the other hand, the Expert says  that Austria do not need to claim it was a 
precautionary measure. 
 
69.14.  By 2003, the basis for risk assess ment of Bt crops had changed because 
several significant scientific points had co me to light.  (1) It became widely 
appreciated that the molecular basis of  transformation was more complex than 
originally thought, and the implications of  these findings for risk assessment were 
articulated.  Annex II of Directive 2001/18/ EC is one consequence, but additional 
regulatory changes have occurred since then.  Indeed, knowledge in molecular 
biology continues to accumulate at remarkably fast rates, and I expect that there will 
be continued change in regulation in the future.  (2) Non-target risk assessment 
shifted from assessing indicators of environmental risk to assessing actual identified potential environmental risks.  Presently th is is done on an ad hoc basis, as no 
systematic methodology has gain ed widespread acceptance. 
Comments by Argentina
 
 
This is consequence of the case-by-case nature of the risk assessment. 
 
(3) Gene flow risk assessment has shifted from being based primarily on an assessment of the probability of gene flow  to being based on an assessment of both 
the probability of gene flow and the cond itional hazard probability.  (4) Resistance  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-123 
  
  risk is considered an environmental ri sk, and science-based resistance management 
measures are required. 
Comments by Argentina
 
 
All points (1) to (4) above show that scientifi c methods and concepts improve or change with 
time, which is to be expected in every field of human activities . We observe, however: a) it is not 
reasonable to postpone indefinitely a decision  waiting for a methodological improvement or 
change, because these will always come anyway and will turn to be obsolete with time; b) it is 
not reasonable to expect that any progress will on ly result in the detection of more risks, not 
previously detected, (as the Expert seems to su ggest), rather than in a deeper knowledge and 
understanding leading to an improvement of scientific tools; it can be argued that this improvement could also confirm the safety wi th regard to decisions previously taken. 
 
Following on the above, we do not see any valid re ason to delay approval based on the Expert's 
view under this point.  On part (1), while the Expert is right, we  note that all improvements and new knowledge 
(sensitivity increase in PCR and Southern me thods, microarrays, genomics, proteomics, 
metabolomics, the latter ones still to be perfect ed)  including those on the complexity of 
transformation, have not resulted so far in th e detection of any undesirable phenomena; change 
in regulation is justified at any time that new methods are developed that will improve 
characterization (regulation is a dynamic field, the same as Science); new knowledge about transformation is welcomed, as increases our in sight on the underlying phenomena, but it was 
never found to demand the modification of any previous decision, nor drastic changes in 
characterization data requirements. 
 On part (2): Non-target risk a ssessment based on assessing indica tors of environmental risk is 
still an accepted approach; assessing actual identifi ed potential environmental risks, done on an 
ad hoc  basis, continue to lack a systematic me thodology, but newly gained knowledge will help 
to be more specific and to make results more  and more meaningful; if by "systematic 
methodology" the Expert suggests a general, trait-independent methodology, then we would 
disagree, as the very nature of the event, the crop, the trait and the environmental issued are 
very specific.  On part (3): Continued progress in gene flow phenomena is also welcomed; several instances 
have been reported in which this issue was sp ecifically dealt with, leading to new regulation 
requirements; but, again, other than improper use (geographic location, presence of wild sexually compatible plants populations) no drasti c new restrictions appear to be necessary, so 
delay on this basis would continue to be unjustified.  On part (4): Nobody would deny that resistance risk is an environmental risk, as well as a 
technology-related one; science-based resistance management measures are in the field from the 
very inception of GM crops (e.g., insects refugia); all parties recognized the fact that the lifetime 
of their products (as well as the related biological control products, like Bt sprays) are to be protected. 
 
69.15.  Thus, evidentiary standards for wh at constitutes an objective environmental 
risk assessment had changed substantially fro m 1997 to 2003.  This is particularly 
true in Europe and the United States, and particularly true for the Bt crops.   WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-124 
  
  Comments by Argentina
 
 
See comments above. 
 
69.16.  (1) Thus, in 2003, there remains some uncertainty about non-target risks of 
Event 176, but it could be argued that a risk assessment coul d be conducted using 
scientifically justified worst-case assumptions.  On the other hand, Austria could reasonably maintain that there is still insufficient information to know which non-
target species may be at risk, and therefore it is not possible to conduct an objective 
risk assessment.  The findings in 2003 by Székács and Darvas (EC-158/At.37) – that two protected butterfly species in Hungary, Inachis io  and Vanessa atalanta , might be 
exposed to Bt corn pollen and suffer higher mortality – certainly suggests that not all 
of the non-target species at risk to Event 176 have been identified in Europe.  (2) As 
in 1997, Austria could muster sufficient ev idence in 2003 to argue that there is an 
environmental risk that the target insects w ill evolve resistance to the Cry1Ab toxin in 
Event 176, and resistance management meas ures should be required.  Moreover, in 
2003, Austria should have sufficient evidence to determine what kind of resistance management measures to require.  (3) Unlik e in 1997, in 2003 Austria could argue 
that the molecular characterization of Even t 176 is insufficient to conduct a risk 
assessment.  (4) In 2004, Austria suggested th at an additional gene flow risk that 
needs assessment is contamination of conven tional production.  It is possible that the 
scientific evidence to support risk management  measures for this risk is available to 
conduct an objective risk assessment today. 
Comments by Argentina
 
 
We observe: 
 1. On point (1): As the Expert states above, "a risk assessment could be conducted using 
scientifically justified worst-case assumptions". This is not only a "could be" situation but almost the only way to conduct risk assessments, as the instrincis nature of these is to make the 
best assumption about future facts based in the relevant current data. 
 2. On point (1): Obviously, to object to a judgment made in 1998 based on new findings that came to light in 2003-2004, is equivalent to assuming that the Committee did have an anticipated knowledge (but anyway ignored) reports to be known five years later. Is the Expert 
saying that: a) the Committee did have the ab ility to predict the future?, and/or, b) the 
Committee was aware (by a unknown mechanism which was not a regular, scientific publication) of new findings but anyway decided to ignored them? If in the view of the Expert the b) possibility is the right one, he should indicate by which mechanism this knowledge was 
available ahead of time to the Committee.  
3. On point (1): The observation by the Exp ert that "two protected butterfly species in 
Hungary, … might be exposed to Bt corn pollen and suffer higher mortality (Székács and 
Darvas, EC-158/At.37)…", should not come to a surprise, as butterfly are Lepidopteran and these are susceptible to the Bt toxin expressed in  the event under consideration. Therefore, the 
"might" situation should be illustrated by adding  the necessary data that will make this "non-
target" effect not only an undesirable effect (whi ch we agree it is, if produced in the relevant 
agroecosystem) but also a real situation (the monarch case illustrates this dilemma: after 
alarming news, the real case, field situation was found very different from the laboratory  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-125 
  
  conditions the first research was done, making the latter not relevant as far as the field 
conditions).  
4. On point (2): The statement: "As in 1997 , Austria could muster sufficient evidence in 
2003 to argue that there is an environmental risk…" is unclear, simply because the 2003 evidence was not available (or ignored?) in 1997 (see 2 above). On the development of 
resistance, please see comments above, under 69.09 (b).  
5. On point (3): The same timing problem is  in "Unlike in 1997, in 2003 Austria could 
argue that the molecular characterization of  Event 176 is insufficient to conduct a risk 
assessment". It can be added that molecular charact erization is a fast-evolving scientific field, so 
that in a given point in time there always be refinements and breakthroughs that will make the 
previous information more comple te, accurate or calling for a ne w review. The experience with 
this event, which is not showing any biosafety problem in spite of its expensive use in other 
countries, may be called to suggest that new molecula r characterization data, are, in this case, of 
the "nice to know" category and no t of the "need to know" one. 
 6. On point (4): "… contamination of conventional production ...  It is possible that the scientific evidence to support risk management meas ures for this risk is available to conduct an 
objective risk assessment today". The use of the word "contamination" are lessening the 
(desirable) objective description of the Expert's vi ew, as it brings to mind a pejorative value. We 
suggest to use "adventiti ous presence" instead. 
 7. On point (4): On the part "to conduct an objective risk assessment today", shows the 
same timing problem  indicated above. 
 Question 70
  
 
70. With reference to the definition of a risk assessment in the SPS Agreement (see Background 
above), to what extent does the scientific eviden ce and other documentation submitted by Austria 
evaluate the relevant risks to human, plant or  animal health, and the environment from the 
importation and use of Maize Bt-176?  How does the scientific evidence and other documenta tion submitted by Austria compare with the 
relevant international guidelines for ri sk assessment and analysis identified above? 
 
70.01.  In my response to this question, I will not address issues related to the 
antibiotic marker gene and will focus my remarks on environmental risks. 
70.02  With reference to the SPS Agreement,  Austria has evaluated relevant risks to 
plant health.  Specifically, Austria has take n into account available scientific evidence 
(Article 5.2).   
Comments by Argentina
 
 
The Expert do not makes it cl ear whether Austria "has taken into account available scientific 
evidence" at the time the report of the Commi ttee was released. Any scientific evidence released 
after 1997-8 will have the timing problem commented under paragraph 69.16. On the other 
hand, we have pointed out that scientific evid ence was available at the time (see comments 
under paragraph 69.16).  WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-126 
  
  70.03.  It is not clear, however, that Au stria conducted the risk assessment according 
to the phytosanitary measures which might be applied.  Austria did not present their 
safeguard measure as a possible phytosanitary measure, and did not conduct the risk 
assessment according to their safeguard measure.  Thus it is not clear that Austria 
conducted the risk assessment consiste nt with Annex A, paragraph 4. 
70.04.  Austria did take into account releva nt economic factors (Article 5.3), however 
it did not explicitly compare the relative co st-effectiveness of alternative approaches 
to limiting risks. 
70.05.  The "potential pest" concept of ISPM 11 must first be considered.  This is a 
special case of the general argument in my response to question 6, and that argument 
holds for this case because Austria argues that there is a plant pest risk. 
70.06.  For those risks with in the scope of ISPM 11 the risk assessment process is 
consistent with ISPM 11.  However, the economic assessments called for in ISPM 11 
were not conducted.   
70.07.  It appears that some of the IS PM 11 guidance on risk management has not 
been followed.  However, this is not to im ply that the actions of Austria contradict 
this guidance.  My reading of the material s before the Panel is that Austria did not 
explicitly address this guidance.  Specifica lly I note Section 3.4 (principles), and 
Section 3.4.6 (on prohibition) we re not explicitly addressed.   
70.08.  In US-52, Austria made it clear that they are applying a different standard for 
acceptable risk than reflected  in the assessments of the SCAN, SCF, Scientific 
Committee on Pesticides in the EC decision (A RG-37) itself.  In so doing, Austria 
fulfilled ISPM 11, Section 3.1 (level of acceptable risk should be expressed). 
70.09.  ISPM 11, Section 3.4.6 (prohibition) states "If no satisfactory measure to 
reduce risk to an acceptable level can be f ound, the final option may be to prohibit 
importation of the relevant commodities.  Th is should be viewed as a measure of last 
resort and should be considered in light of the anticipated efficacy, especially in 
instances where the incentives for illegal impor t may be significant."  With respect to 
resistance risk, in 1997 Austria had estab lished the existence of an environmental 
risk, and required the development of measure s to manage this risk to acceptable 
levels.  As the EC was not willing to make such a requirement, Austria had no choice 
but to intervene with its own safeguard  measure.  In 1997, however, there was 
probably insufficient scientific evidence to  establish what necessary measures should 
be taken.  Scientifically credible sugges tions at that time focused on using refuges 
(maize that was not Bt maize) ranging from 10-70% of the maize grown by any 
farmer who chose to grow Bt maize.  It is unlikely that Austria could have 
implemented any of these suggestions in time for the 1997 growing season, so I conclude that Austria had fulfilled ISPM 11, Section 3.4.6, at least for the 1997 
growing season. 
Comments by Argentina
 
 
With regard to the environmental risk in volved in resistance, see above comments under 
paragraph 69.09.   WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-127 
  
  With regard to the Expert's view that ... 
 
"In 1997, however, there was probably insufficient scientific evidence to 
establish what necessary measures should be taken.  Scientifically credible 
suggestions at that time focused on usin g refuges (maize that was not Bt maize) 
ranging from 10-70% of the maize grown by any farmer who chose to grow Bt 
maize.  It is unlikely that Austria could have implemented any of these suggestions in time for the 1997 growing sea son, so I conclude that Austria had 
fulfilled ISPM 11, Section 3.4.6, at  least for the 1997 growing season" 
... we observe that Austria chose to take a pr ecautionary stand ignoring what the Expert 
qualifies as "Scientifically credible suggestions at that time". Therefore, as "it is unlikely that Austria could have implemented any of these sugg estions in time for the 1997 growing season", 
it is implied that Austria could  have implemented these suggest ions in the following seasons 
(which the Expert recognizes by saying the me asure was correct "at least for the 1997 growing 
season").  
70.09.  The science, documentation and reas oning of Austria are consistent with 
Annex III of the Cartagena Protocol on Bi osafety to the Convention on Biological 
Diversity.  Specifically, Annex III, Section 8(f) states "Where there is uncertainty 
regarding the level of risk, it may be addr essed by requesting further information on 
the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment." 
Question 71
 
 
71. Does the scientific evidence and other inform ation submitted by Austria support the adoption 
of a temporary prohibition on the importation and use of  Maize Bt-176?  In light of any potential risks 
identified by Austria, what other risk management  options were available in February 1997?  What 
other risk management options are now available? 
 
71.01.  In my response to this question, I will not address issues related to the 
antibiotic marker gene and will focus my remarks on environmental risks. 
71.02.  The adoption of a temporary prohibition can be justified on the basis of the 
scientific evidence and other information submitted by Austria.   
Comments by Argentina  
 
Based on our arguments, we state that the information available to Austria did not justify a 
temporary prohibition.  
71.03.  Other risk management options coul d not have been justified in February 
1997.  However, had Austria worked to develop its own acceptable resistance 
management measures, perhaps by 1999 ot her risk management options would have 
been possible.  
Comments by Argentina
 
 
See comments under paragraphs 69.16 and 70.02. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-128 
  
   
71.04.  Today several alternative risk ma nagement options are available.  Risk 
management strategies include risk avoidan ce, risk mitigation, and risk tolerance.  
Tolerance strategies are probably inappropriate .  One alternate risk avoidance strategy 
would be to implement country-specific re sistance management measures, to limit 
planting to a restricted region, and to conduc t intensive non-target experiments.  This 
would allow progressive determination of non-target effects.   
Comments by Argentina
 
 
See comments under paragraphs 69.16 and 70.02. 
 
Maize Bt-176 (notification C/F/11-03)  
 
Safeguard measure of Germany  Question 72
 
 72. Given the information before the Panel, in cluding the evaluations undertaken by France (EC-
158/at. 1 to 3);  the Scientific Committee for An imal Nutrition in December 1996 (EC-158/At. 4 and 
5);  the Scientific Committee for Food in Dece mber 1996 (US-64) and in March 1997 (US-58);  the 
Scientific Committee for Pesticides in December 1996 (EC-158/At.6) and in May 1997 (US-57);  the 
SCP in September 2000 (US-66);  and the Europe an Commission in its Decision of January 1997 
(ARG-37);  as well as the information submitted by Germany
 with respect to its safeguard measure 
(US-65, EC-158/At.18-29, EC-144), is there any reason to believe that the scientific evidence 
available to Germany in March 2000 was NOT suffic ient to permit it to undertake an appropriate 
assessment of potential risks to human, plant and animal health, and the environment from the 
importation and use of Maize Bt-176?  If so, what scientific evidence do you believe was insufficient?   
 If the evidence was not sufficient in March 2000, was there sufficient evidence available to Germany 
in August 2003
 to permit it to undertake a more objecti ve assessment of potential risks to human, 
plant and animal health, and the environment from the importation and use of Maize Bt-176?  If not, 
what scientific evidence do you believe was insufficient?    
72.01.  In my response to this question, I will not address issues related to the 
antibiotic marker gene and will focus my remarks on environmental risks. 
Comments by Argentina
 
 
The Expert begins by more or less repeating what he said in respect of the Austrian safeguard.  
Only in paragraph 72.11 does he begin speaking of the German safeguard. 
 
72.02.  The initial assessment of Event 17 6 by France provided in EC-158/At.1-3 
(10 January 1995, 1 March 1995, 3 March 1995)  does not contain the details of the 
assessment by the French Biomolecular Engineering Committee (BEC).   
72.03.  The Opinion of the Scientific Committee on Pesticides (EC-158/At.6_SCI, 
9 December 1996) on Event 176 did not assess the risk of resistance evolution in the target pests because it considered this ri sk to be an agricultural risk, not an 
environmental risk.  In either event, th e Committee felt that resistance management 
should be fully considered.  The Committ ee also did not assess non-target effects.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-129 
  
  Comments by Argentina
 
 
Comments under paragraphs 69.09 (b), 69. 06, 69.16, and 70.02 are pertinent here. 
 
72.04.  The Opinion of the SCAN (EC-158/At.4, 13 December 1996) did not address 
any environmental risk, including environmentally mediated indirect effects on animal health.  The Opinion of the SCF (US-64, EC-158/At.5, 13 December 1996) did not address any environmental risk, in cluding environmentally mediated indirect 
effects on human health.   
Comments by Argentina
 
 
Comments under paragraphs 69.06, 69.09(b) through 69.11, and 69.13 are pertinent here. 
 
72.05.  On 23 January 1997, the EC decided to allow the placing on the market of 
Event 176 (ARG-37). 
72.06.  Luxembourg (US-63, 7 February 1997) and Austria (US-52, 13 February 
1997) decided to ban the commercialization of Event 176 for reasons covered in questions 69 and 75.   
72.07.  The reasoning in the Further Opinion of the Scientific Committee on 
Pesticides (US-58, 12 May 1997) is false a nd did not take into account the scientific 
information known at the time.  This is fully discussed in my response to question 69, paragraphs 69.07-69.12, and will not be repeated here. 
Comments by Argentina
 
 
See comments under paragraphs 69.09 through 69.16.  
72.08.  In my response to question 69 a nd question 75, I have concluded that the 
scientific evidence available to Luxembourg and Austria in February 1997 was NOT sufficient to permit them to undertake an a ppropriate assessment of potential risks to 
plants and the environment from Event 176.   
Comments by Argentina
 
 
See comments under paragraphs 69.06, 69.09, 69.10 and 70.02, which we elaborate on the 
information available by the relevant dates above.  
72.09.  The Regulatory Committee under Directive 90/220/EC met three times to 
consider Draft Commission Decisions to require that the temporary prohibitions by Luxembourg and Austria be repealed.  The first two meetings (EC-158/At.13, 10 November 1997 and EC-158/At.16, 22 January  1998) resulted in decisions to delay 
making a decision.  The final meeting (EC-158/At/17, 29 April 1998) resulted in no decision (neither to repeal nor not to repeal). 
72.10.  On 11 November 1997, an Expert Working Group on Bt resistance 
management was launched.  However, I cannot  find any of the proceedings of this 
Working Group in the materials before the Panel. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-130 
  
  Comments by Argentina
 
 
The Expert could have used the kind of information commented under paragraph 69.09 (b) 
above.  
72.11.  On 31 March 2000 (US-65), Germany decided to prohibit the unrestricted commercial use of Event 176 in Germany.  Germany considered the scientific 
information for risk assessment to be inad equate in the following areas: effects on 
non-target organisms, development of  resistance, countermeasures against 
development of resistance, effects of Bt toxi n in the soil, horizontal or vertical gene 
transfer of antibiotic resistance gene, harm  to humans from antibiotic resistance gene. 
Comments by Argentina
 
 
On the above subjects, please see comm ents under the following paragraphs: 
  on non-target effects: paragraphs 69.06, 69.13, and 69.16 (1)  on resistance development: paragraph 69.09 (b),  on Bt toxin in soil: paragraphs 69.09 (1), 69.10, 69.11, 69.16 (overall comment)  on horizontal gene transfer: paragraph 69.16 (1) 
 
72.12.  On 9 November 2000 (US-66), the SCP provided an Opinion on the German decision.  The SCP concluded that the scie ntific information provided by the German 
Competent Authority does not alter the orig inal risk assessments on Event 176.  The 
Opinion of the SCP is one possible scientif ic opinion that can be reached from the 
information available at the time, but the SCP should have acknowledged that the 
new information also allows several other scientifically valid opinions that were not 
justifiable in 1996. 
Comments by Argentina
 
 
The first sentence above is correct. The second sent ence leads to an epistemological question: 
that any scientific opinion based in the information available at one given time T-1,  should 
acknowledge that new information gained at a later time T-2, (being T-2  > T1) will allow for other (supposedly different) scientifically valid opinio ns that were not justifiable at time T-1. Of 
course, this is absolutely true but inconsistent with the logical reasoning applied to the facts we 
are discussing here, when the irreversib ility of the time arrow is considered. 
 
See also, our comments under paragraph 69.16, numbered (2), (3) and (4) by the Expert, 
corresponding to ours numbered 4), 5) and 7), respectively.  
72.13.  On page 3-4 of this Opinion, the SCP deliberates on non-target risks, focusing 
on three organisms, green lacewing, monarch butterfly and black swallowtail.  For the 
lacewing and monarch, the SCP considered the experiments difficult to interpret and 
extrapolate to the field.  It did not interpre t the swallowtail case.  Rather than provide 
a point by point discussion of the SCP Opini on, I will list a series of valid scientific 
perspectives and interpretations on the l acewing and monarch studies that illustrate 
some of the diversity of valid scientific opinion that is not reflected in the SCP 
Opinion.  (1) According the tiered non-tar get risk assessment protocols (which are 
consistent with ISPM 11 and Annex III of th e Biosafety Protocol and widely used in 
the US and Europe), the purpose of laborat ory experiments is to expose the organisms  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-131 
  
  to concentrations higher than would be considered typical for the field.  By doing so, 
one reduces the probability of false negativ e effects.  Experimental positives then 
should undergo additional ev aluation.  (2) Both lacewings and monarchs were 
exposed to concentrations of Cry1Ab toxin that would be expected to be higher than 
typical for the field.  Swallowtails were not  exposed to high con centrations.  (3) Both 
lacewings and monarchs were adversely affected by Cry1Ab toxin in these laboratory experiments.  (4) Additional assessment
 should have been conducted on lacewings 
and monarchs to determine the relevance to th e field.  (5) Cry1Ab is supposed to be a 
toxin specific to moths and butterflies, but lacewings are not closely related to moths 
and butterflies.  Hence the toxicity spectrum of Cry1Ab toxin is broader than 
previously expected .  (6) Several years later, it h as been suggested that Event 176 
would have caused significant risk to monarchs had it become a popularly used variety. 
Comments by Argentina
 
 
The Expert announces that he is not offering a point by point discussion but "a series of valid 
scientific perspectives and interpretations on the lacewing and monarch studies…". Here, we 
offer a point by point discussion on the Ge rman position. See please, comments under 
paragraph 72.11. 
 
On the monarch example, a conclusive body of published research is currently available, which 
can not be ignored by the Expert, indicating that the toxicity is negligible under field conditions. 
 
72.13.  On page 4 of the Opinion, the SCP deliberates on resistance risk and management, considering two organisms, European corn borer and Mediterranean 
corn borer.  The SCP advised on the establishment of non-Bt refuges adjacent to modified crops but pointed out that, in view of the slow introduction into Europe, crops would be surrounded by natural refuges for some time to come.  Rather than 
provide a point by point discussion of the SCP Opinion, I will list a series of valid scientific perspectives and interpreta tions that illustrate the prevailing
 scientific 
opinion on resistance risk and management in  2000 that is not reflected in the SCP 
Opinion.  (1) The rate of market penetra tion after initial introduction of Bt maize in 
the US was the fastest of any crop variety or crop protection technology in the history of US agriculture.  Prior to introduction,  many predicted that market penetration 
would be slow.  They were wrong.  (2) Resistance evolves locally.  Thus refuges 
must be available wherever Bt-maize is locally used.  Thus, refuges need to be 
required from the beginning.  (3) Resistan ce management is the responsibility of each 
farmer who uses Bt maize.  Thus, each farmer should be required to implement 
refuges.  Thus, refuges need to be required from the beginning. 
Comments by Argentina
 
 
See our comments under paragraph 72.11 for a po int by point discussion the Expert is not 
offering.  
72.15.  On page 4 of the Opinion, the SCP deliberates on toxin release to soil on-
target risks, focusing on degradation pr ocesses.  The SCP suggests that because 
protein turnover occurs routinely in soils and degradation of Bt toxin would be 
expected to degrade at rates similar to othe r proteins or DNA in the soil, there is no 
evidience that Bt-toxins will persist in soils  and have adverse effects.  Rather than WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-132 
  
  provide a point by point discussion of the SCP Opinion, I will list a series of valid 
scientific perspectives and interpretations that  illustrate some of the diversity of valid 
scientific opinion that is not reflected in the SCP Opinion.  (1) The actual rates and 
degradation processes for large proteins in soils is poorly understood.  (2) Bt toxin 
loading in maize fields during and after harv est can be substantial.  Thus, scale effects 
are possible.  (3) Presently it is known that Bt toxin in the soil can have an adverse 
effect on earthworms.  Whether this translates into an actual risk is not yet known.   
Comments by Argentina
 
 
On points (1): Altough basically we agree with th e Expert, we disagree in that his statement 
invalidates the SCP Opinion. We can allow ou rselves to make a series of valid scientific 
"perspectives and interpretations" on the issue (as the Expert does), and say: since one of the technical problems found in the isolation of prot eins from plant tissues is the quick release of 
proteases, we can expect that protein degrad ation following plant tissue injury (as in 
agricultural practice) will result in rapid degradation of plant proteins.  On point (2): We disagree. In the same spirit  as before, we can offer our perspective and 
interpretation and say that, since Bt toxin concen tration in plant biomass is extremely low (see 
comments under paragraph 69.09 (1)), when tota l protein content in soils is considered, we 
would come to very low figures for the Bt toxin. 
 On point (3): the Expert do not advance a specific literature reference, but refers to it as "Presently it is known that …". We object that such an argument be construed to invalidate 
SCP Opinion. This observation also have the recurrent time arrow problem referred to in 
previos paragraphs 69.16 and 72.12. 
 
72.16.  A close reading (paragraphs 72.13-72.15) of the SCP Opinion (US-66, 9 
November 2000) suggests that it has not consid ered all scientific perspectives (and in 
some cases ignored prevailing scientific opinion).  Thus, the SCP Opinion does not 
invalidate the scientific opinion of Germany. 
Comments by Argentina
 
 
On the above, please see comments under paragraphs 69.06, 69.09, 69.10 and 69.13. 
 
72.17.  I conclude that the scientific evidence available to Germany in March 2000 was NOT sufficient to permit it to underta ke an appropriate assessment of potential 
risks to plants and the environment fro m Event 176.  The evidence on risks to non-
target organisms, including those in the soil could be considered insufficient.  
Germany could have mustered sufficient evidence to argue that there was an 
environmental
 risk that the target insects will evol ve resistance to the Cry1Ab toxin, 
and resistance management measures should be required .  There may have been 
sufficient evidence available to determine what measures should be required, but 
there probably was insufficient evidence to determine how to implement these 
measures effectively.  This determination by  Germany was in direct contradiction to 
the EC decision.  In this case, Germany probably does not need to claim that their 
safeguard measure is a precautionary one.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-133 
  
  Comments by Argentina
 
 
The Expert reproduces here, almost exactly, what he has said in paragraph 69.13 for Austria. 
The same comments we did there apply here. In  addition, we note again the somewhat dubious 
comments by the Expert ("could have", "may have sufficient evidence", "but there probably 
was insufficient evidence"). And, of course, th ere is also the time arrow problem commented 
before (please see paragraphs 69.16 and 72.12).  
72.18.  By 2003, the basis for risk assess ment of Bt crops had changed because 
several significant scientific points had co me to light.  (1) It became widely 
appreciated that the molecular basis of  transformation was more complex than 
originally thought, and the implications of  these findings for risk assessment were 
articulated.  Annex II of Directive 2001/18/ EC is one consequence, but additional 
regulatory changes have occurred since then.  Indeed, knowledge in molecular 
biology continues to accumulate at remarkably fast rates, and I expect that there will 
be continued change in regulation in the future.  (2) Non-target risk assessment 
shifted from assessing indicators of environmental risk to assessing actual identified potential environmental risks.  Presently th is is done on an ad hoc basis, as no 
systematic methodology has gained widespr ead acceptance.  (3) Gene flow risk 
assessment has shifted from being based primarily on an assessment of the 
probability of gene flow to being based on an assessment of both the probability of 
gene flow and the conditional hazard probability.  (4) Resistance risk is considered an 
environmental risk, and science-based resistance management measures are required. 
Comments by Argentina
 
 
In this point, the Expert copies himself (plea se see paragraph 69.14). The same comments apply 
here.  
72.19.  Thus, evidentiary standards for wh at constitutes an objective environmental 
risk assessment had changed substantially fro m 1997 to 2003.  This is particularly 
true in Europe and the United States, and particularly true for the Bt crops.   
Comments by Argentina
 
 
Same as paragraph 69.15. 
 
72.20.  (1) Thus, in 2003, there remains some uncertainty about non-target risks of 
Event 176, but it could be argued that a risk assessment coul d be conducted using 
scientifically justified worst-case assumpti ons.  On the other hand, Germany could 
reasonably maintain that there is still insufficient information to know which non-
target species may be at risk, and therefore it is not possible to conduct an objective risk assessment.  The findings in 2003 by Székács and Darvas (EC-158/At.37) – that 
two protected butterfly species in Hungary, Inachis io  and Vanessa atalanta , might be 
exposed to Bt corn pollen and suffer higher mortality – certainly suggests that not all 
of the non-target species at risk to Event 176 have been identified in Europe.  (2) As 
in 1997, Germany could muster sufficient ev idence in 2003 to argue that there is an 
environmental risk that the target insects w ill evolve resistance to the Cry1Ab toxin in 
Event 176, and resistance management meas ures should be required.  Moreover, in 
2003, Germany should have sufficient evidence to determine what kind of resistance management measures to require.  (3) Unlik e in 1997, in 2003 Germany could argue WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-134 
  
  that the molecular characterization of Even t 176 is insufficient to conduct a risk 
assessment.  (4) It is also possible for Ge rmany to suggest that an additional gene 
flow risk that needs assessment is contamin ation of conventional production.  It is 
possible that the scientific evidence to suppor t risk management measures for this risk 
is presently available. 
Comments by Argentina
 
 
In this point, the Expert copies himself almo st exactly (please see paragraph 69.16). The same 
comments apply here. 
 Question 73
 
 73. With reference to the definition of a risk assessment in the SPS Agreement (see Background 
above), to what extent does the scientific eviden ce and other documentation submitted by Germany 
evaluate the relevant risks to human, plant or  animal health, and the environment from the 
importation and use of Maize Bt-176?  How does the scientific evidence and other documen tation submitted by Germ any compare with the 
relevant international guidelines for ri sk assessment and analysis identified above? 
 
73.01.  In my response to this question, I will not address issues related to the 
antibiotic marker gene and will focus my remarks on environmental risks. 
73.02  With reference to the SPS Agreement,  Germany has evaluated relevant risks to 
plant health.  Specifically, Germany has taken into account available scientific 
evidence (Article 5.2).   
Comments by Argentina
 
 
Please see our comments to paragraph 70.02. 
 
73.03.  It is not clear, however, that Germany conducted the risk assessment according to
 the phytosanitary measures which mi ght be applied.  Germany did not 
present their safeguard measure as a possi ble phytosanitary measure, and did not 
conduct the risk assessment according to their safeguard measure.  Thus it is not clear 
that Germany conducted the risk assessment consistent with Anne x A, paragraph 4. 
73.04.  Germany did not take into account relevant economic factors (Article 5.3). 
73.05.  The "potential pest" concept of ISPM 11 must first be considered.  This is a 
special case of the general argument in my response to question 6, and that argument 
holds for this case because Germany argues that there is a plant pest risk. 
73.06.  For those risks with in the scope of ISPM 11 the risk assessment process is 
consistent with ISPM 11.  However, the economic assessments called for in ISPM 11 
were not conducted.   
73.07.  It appears that some of the IS PM 11 guidance on risk management has not 
been followed.  However, this is not to im ply that the actions of Germany contradict 
this guidance.  My reading of the material s before the Panel is that Germany did not  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-135 
  
  explicitly address this guidance.  Specifica lly I note Section 3.4 (principles), and 
Section 3.4.6 (on prohibition) we re not explicitly addressed.   
73.08.  In US-65, Germany made it clear in some points that they are applying a 
different standard for acceptable risk than  reflected in the assessments of the SCAN, 
SCF, Scientific Committee on Pesticides in the EC decision (ARG-37) itself.  In so 
doing, Germany fulfilled ISPM 11, Section 3. 1 (level of acceptable risk should be 
expressed). 
73.09.  ISPM 11, Section 3.4.6 (prohibition) states "If no satisfactory measure to 
reduce risk to an acceptable level can be f ound, the final option may be to prohibit 
importation of the relevant commodities.  Th is should be viewed as a measure of last 
resort and should be considered in light of the anticipated efficacy, especially in 
instances where the incentives for illegal impor t may be significant."  With respect to 
resistance risk, in 1997 Austria had estab lished the existence of an environmental 
risk, and required the development of measure s to manage this risk to acceptable 
levels.  Germany concurred in 2000.  As the EC was not willing to make such a 
requirement, Germany had no choice but to intervene with its own safeguard measure.  In 2000, however, there was pr obably sufficient scientific evidence to 
establish what necessary measures should be  taken.  Scientifically credible 
suggestions at that time focused on using refuges (maize that was not Bt maize) 
ranging from 20-30% of the maize grown by any farmer who chose to grow Bt maize.  
It is unlikely that Germany could have im plemented any of these suggestions in time 
for the 2000 growing season, so I concl ude that Germany had fulfilled ISPM 11, 
Section 3.4.6, at least for the 2000 growing season. 
73.09.  The science, documentation and reas oning of Germany are consistent with 
Annex III of the Cartagena Protocol on Bi osafety to the Convention on Biological 
Diversity.  Specifically, Annex III, Section 8(f) states "Where there is uncertainty 
regarding the level of risk, it may be addr essed by requesting further information on 
the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment." 
Question 74
 
 74. Does the scientific evidence and other info rmation submitted by Germany support the 
adoption of a temporary prohibition on the importati on and use of Maize Bt-176?  In light of any 
potential risks identified by Germany, what other ri sk management options were available in March 
2000?  What other risk management options are now available?  
74.01.  In my response to this question, I will not address issues related to the antibiotic marker gene and will focus my remarks on environmental risks. 
74.02.  The adoption of a temporary prohibition (with <500ha for research purposes) 
can be justified on the basis of the sci entific evidence and other information 
submitted by Germany.   WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-136 
  
  Comments by Argentina
 
 
Although different from paragraph 70.02, th e same comments apply here as under paragraph 
70.02, with the difference that here the Expert is saying that the measure adopted by Germany 
can be justified on the basis of the submitted scientific evidence and other information.  
74.03.  Other risk management options coul d not have been justified in March 2000.  
However, had Germany worked to develop its own acceptable resistance management 
measures, perhaps by 2002 other risk mana gement options would have been possible. 
Comments by Argentina
 
 
Please see our comments to paragraph 70.02. 
 
74.04.  Today several alternative risk mana gement options may be available.  Risk 
management strategies include risk avoidan ce, risk mitigation, and risk tolerance.  
Tolerance strategies are probably inappropriate .  One alternate risk avoidance strategy 
would be to implement country-specific re sistance management measures, to limit 
planting to a restricted region, and to conduc t intensive non-target experiments.  This 
would allow progressive determination of non-target effects.   
Comments by Argentina  
 
Please see our comments to paragraph 71.04. 
 Maize Bt-176 (notification C/F/11-03)
 
 
Safeguard measure of Luxembourg 
 Question 75
  
 75. Given the information before the Panel, in cluding the evaluations undertaken by France (EC-
158/at. 1 to 3);  the Scientific Committee for An imal Nutrition in December 1996 (EC-158/At.4 and 
5);  the Scientific Committee for Food in Dece mber 1996 (US-64) and in March 1997 (US-58);  the 
Scientific Committee for Pesticides in December 1996 (EC-158/At.6) and in May 1997 (US-57);  the 
SCP in September 2000 (US-66);  and the Europe an Commission in its Decision of January 1997 
(ARG-37), as well as the information submitted by Luxembourg
 with respect to its safeguard measure 
(US-63, EC-158/At.9, EC-144), is there any reason to  believe that the scientific evidence available to 
Luxembourg in February 1997 was NOT sufficient to permit it to undertake an appropriate 
assessment of potential risks to human, plant and animal health, and the environment from the 
importation and use of Maize Bt-176?  If so, what scientific evidence do you believe was insufficient?   
 If the evidence was not sufficient in February 1997, was there sufficient evidence available to 
Luxembourg in August 2003
 to permit it to undertake a more objec tive assessment of potential risks to 
human, plant and animal health, and the environment from the importation and use of Maize Bt-176?  If not, what scientific evidence do you believe was insufficient?    
75.01.  In my response to this question, I will not address issues related to the antibiotic marker gene and will focus my re marks on environmental risks, specifically 
the resistance monitoring program.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-137 
  
  75.02.  The initial assessment of Event 176 by  France provided in EC-158/At.1-3 (10 
January 1995, 1 March 1995, 3 March 1995)  does not contain the details of the 
assessment by the French Biomolecular Engineering Committee (BEC).   
75.03.  The Opinion of the Scientific Co mmittee on Pesticides (EC-158/At.6SCI, 9 
December 1996) on Event 176 did not assess th e risk of resistance evolution in the 
target pests because it considered this ri sk to be an agricultural risk, not an 
environmental risk.  In either event, th e Committee felt that resistance management 
should be fully considered.   
Comments by Argentina
 
 
Please see our comments to paragraph 69.03. 
 
75.04.  The Opinion of the SCAN (EC-158/At.4, 13 December 1996) did not address any environmental risk, including environmentally mediated indirect effects on 
animal health.  The Opinion of the SCF (US-64, EC-158/At.5, 13 December 1996) did not address any environmental risk, in cluding environmentally mediated indirect 
effects on human health.   
Comments by Argentina
 
 
Please see our comments to paragraph 72.04.  
75.05.  On 23 January 1997, the EC decided to allow the placing on the market of 
Event 176 (ARG-37). 
75.06.  On 7 February 1997, Luxembourg decided to ban the commercialization of 
Event 176 in Luxembourg (US-63).  Luxembourg gave two reasons for this action.  1. 
A concern that the risks of the bla gene (ampicillin resistance) have not been properly 
evaluated by the SCAN and the SCF (paragraph 75.04).  3. That a monitoring program must be implemented to monitor th e development of resistance in the target 
pest to Cry1Ab toxin in Event 176. 
Comments by Argentina
 
 
See pertinent parts in comments under paragraph 72.11. We note that either the reasons were 
three (one is missing in the explanation), or only two (the numbering in the explanation was wrong). 
 
75.07.  The Further Opinion of the Scie ntific Committee on Pesticides (US-58, 12 
May 1997) is a major shift in the position of the Committee on Event 176. 
Comments by Argentina
 
 
Please see our comments to paragraph 69.14. 
 
75.08.  On page 2-3 of US-58, the Committee states "The Committee stated in its 
previous report of the 9 December 1996 that resistance management strategies are needed during the years of use of any pes ticide, Bt sprays included.  The Committee 
drew attention once again to the need for effective resistance management, including WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-138 
  
  monitoring on agronomic grounds, to prolong the effectiveness of Bt toxin both in 
conventional sprays and in genetically modified maize.  It also felt that the submission of a satisfactory monitoring and resistance management programme 
should be a requirement for the authorization to use genetically modified maize seeds 
expressing Bt-toxin.  (a) In its 9 December 1996 Opinion, the Committee nowhere made the recommendation that the submission of a satisfactory monitoring and resistance management programme should be a requirement
 for the authorization to 
use genetically modified maize seeds e xpressing Bt-toxin.  The acknowledgement 
that it should be a requirement in this 12 Ma y 1997 Opinion is a major change in the 
conclusions and recommendations of the Committee.  (b) The Committee does not 
address a significant issue implicit in Luxembourg's statement, which is that resistance risk should be considered an  environmental risk.  The Committee also 
seems to be unaware of the position of the US-EPA in 1996, which is that resistance 
risk is an environmental risk.  This is a critical issue because it determined whether 
resistance risk could be considered under Directive 90/220/EEC.   
Comments by Argentina
 
 
Please see our comments to paragraphs 69.13 (point (a)), and 69.11(point (b)). 
 
75.09.  I conclude that the scientific evid ence available to Luxembourg in February 
1997 was NOT sufficient to permit it to unde rtake an appropriate assessment of 
potential risks to plants and the environment from Event 176.  Luxembourg could have mustered sufficient evidence to argue th at there was an environmental risk that 
the target insects will evolve resistance to  the Cry1Ab toxin, resistance management 
measures should be required and resistance monitoring is a critical measure
.  There 
was probably insufficient evidence availabl e to determine what kind of monitoring 
should be required.  This de termination by Luxembourg was in direct contradiction to 
the EC decision.  In this case, Luxembourg probably does not need to claim that their 
safeguard measure is a precautionary one. 
Comments by Argentina  
 
Please see our comments to paragraph 69.13. 
 
75.10.  By 2003, the basis for risk assess ment of Bt crops had changed because 
several significant scientific points had co me to light.  (1) It became widely 
appreciated that the molecular basis of  transformation was more complex than 
originally thought, and the implications of  these findings for risk assessment were 
articulated.  Annex II of Directive 2001/18/ EC is one consequence, but additional 
regulatory changes have occurred since then.  Indeed, knowledge in molecular biology continues to accumulate at remarkably fast rates, and I expect that there will 
be continued change in regulation in the future.  (2) Non-target risk assessment 
shifted from assessing indicators of environmental risk to assessing actual identified 
potential environmental risks.  Presently th is is done on an ad hoc basis, as no 
systematic methodology has gained widespr ead acceptance.  (3) Gene flow risk 
assessment has shifted from being based primarily on an assessment of the probability of gene flow to being based on an assessment of both the probability of 
gene flow and the conditional hazard probability.  (4) Resistance risk is considered an 
environmental risk, and science-based resistance management measures are required.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-139 
  
  Comments by Argentina
 
 
Please see our comments to paragraph 69.14. 
 
75.11.  Thus, evidentiary standards for wh at constitutes an objective environmental 
risk assessment had changed substantially fro m 1997 to 2003.  This is particularly 
true in Europe and the United States, and particularly true for the Bt crops.   
Comments by Argentina  
 
Please see our comments to paragraph 69.15. 
 
75.12.  (1) As in 1997, Luxembourg could muster sufficient evidence in 2003 to 
argue that there is an environmental risk th at the target insects will evolve resistance 
to the Cry1Ab toxin in Event 176, resi stance management measures should be 
required, and resistance monitoring shoul d be required.  Moreover, in 2003, 
Luxembourg probably had sufficient evidence to determine what kind of resistance management and monitoring measures to require.  (2) Unlike in 1997, in 2003 
Luxembourg could argue that the molecular characterization of Event 176 is insufficient to conduct a risk assessment.  (3) Also in 2003, Luxembourg could argue 
that an additional gene flow risk that  needs assessment is contamination of 
conventional production.  It is possible that the scientific evidence to support risk management measures for this risk were  available to conduct an objective risk 
assessment at that time. 
Comments by Argentina
 
 
Please see our comments to paragraph 69.16. 
 
Question 76  
 76. With reference to the definition of a risk assessment in the SPS Agreement (see Background 
above), to what extent does the scientific evidenc e and other documentation submitted by Luxembourg 
evaluate the relevant risks to human, plant or  animal health, and the environment from the 
importation and use of Maize Bt-176?   (a) How does the scientific evidence and ot her documentation submitted by Luxembourg 
compare with the relevant internationa l guidelines for risk assessment and analysis 
identified above? 
 
76.01.  In my response to this question, I will not address issues related to the 
antibiotic marker gene and will focus my re marks on environmental risks, specifically 
the resistance monitoring program. 
76.02.  With reference to the SPS Agreem ent, Luxembourg has evaluated relevant 
risks to plant health.  However, it is not clear that Luxembourg has taken into account 
available scientific evidence (Article 5.2).  This is not to say that Luxembourg has not 
taken into account available scientific evidence.   WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-140 
  
  Comments by Argentina
 
 
See pertinent parts of our comments under paragraph 72.11. 
 
76.03.  It is not clear that Luxembourg conducted the risk assessment according to  the 
phytosanitary measures which might be a pplied.  Luxembourg did not present their 
safeguard measure as a possible phytosanita ry measure.  Luxembourg did not conduct 
the risk assessment according to their safeguard measure.  Thus it is not clear that 
Luxembourg conducted the risk assessment cons istent with Annex A, paragraph 4. 
76.04.  It is not clear that Luxembourg t ook into account relevant economic factors 
(Article 5.3).  This is not to say that Luxembourg has not taken into account relevant 
economic factors. 
76.05.  The "potential pest" concept of ISPM 11 must first be considered.  This is a 
special case of the general argument in my response to question 6, and that argument 
holds for this case because Luxembourg argu es that there is a plant pest risk. 
76.06.  For those risks within the scope of  ISPM 11 the risk assessment process may 
be consistent with ISPM 11.  However, the economic assessments called for in ISPM 
11 were not conducted.   
76.07.  It appears that much of the IS PM 11 guidance on risk management has not 
been followed.  However, this is not to imply that the actions of Luxembourg 
contradict this guidance.  My reading of  the materials before the Panel is that 
Luxembourg did not explicitly address this gui dance.  Specifically I note Section 3, 
S1 (measures should be designed in proportion to the risk), Section 3.1 (level of 
acceptable risk should be expressed), Section 3.4 (principles), and Section 3.4.6 (on 
prohibition) were not explicitly addressed. 
76.08.  The reasoning of Luxembourg is cons istent with Annex III of the Cartagena 
Protocol on Biosafety to the Convention on Biological Diversity.  
Comments by Argentina  
 
Please see our comments to paragraphs 69.06, 69.09, 69.10, and 70.02. 
 
Question 77  
 77. Does the scientific evidence and other info rmation submitted by Luxembourg support the 
adoption of a temporary prohibition on the importati on and use of Maize Bt-176?  In light of any 
potential risks identified by Luxembourg, what other risk management options  were available in 
February 1997?  What other risk management options are now available?  
 
77.01.  In my response to this question, I will not address issues related to the antibiotic marker gene and will focus my re marks on environmental risks, specifically 
the resistance monitoring program. 
71.02.  The adoption of a temporary prohibition can be justified on the basis of the 
scientific evidence and other information av ailable to Luxembourg.  As there are no 
materials before the Panel containing sc ientific evidence submitted by Luxembourg,  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-141 
  
  it is not possible to make a determination of the justification for the temporary 
prohibition based only on submissions from Luxembourg. 
Comments by Argentina
 
 
Please see our comments to paragraphs 69.06, 69.09, 69.10 and 70.02. 
 Also, it is useful to point out that the statem ent by the Expert seems contradictory: "… can be 
justified on the basis of scientific evidence … available…" (first sentence) vs. "… it is not 
possible to make a determination of the justific ation for the temporary prohibition based only 
on submissions from Luxembourg" (second sentence). 
 
71.03.  Other risk management options probably could not have been justified in February 1997.  However, Luxembourg could have proposed its own acceptable 
resistance monitoring measures, which perhaps by 1999 would have been possible to 
implement. 
Comments by Argentina
 
 
Please see our comments to paragraph 71.03. 
 
71.04.  Today several alternative risk management options are available for 
monitoring for resistance.  Although there is  still no scientific consensus around the 
best monitoring method, the cost-efficiency  trade-offs are known, and considerable 
experience has accumulated so that several can be feasibly implemented. 
Comments by Argentina  
 
Please see our comments to paragraph 71.04. 
 
Maize MON 810 (notification C/F/95/12-02)  
 Safeguard measure of Austria 
 
Question 78
 
 78. Given the information before the Panel, in cluding the evaluations undertaken by France (EC-
159/At.1 and 2); and the Scientific Committee on Pl ants in February 1998 (CDA-82), September 1999 
(US-55), and September 2000 (CDA-86), and the Eu ropean Commission in its Decision of April 1998 
(CDA-81), as well as the information submitted by Austria
 with respect to its safeguard measure (US-
54, EC-159/At.4, EC-144, EC-147, EC-148), is there any reason to believe that the scientific evidence 
available to Austria in June 1999 was NOT suffic ient to permit it to undertake an appropriate 
assessment of potential risks to human, plant and an imal health, and the environment from Maize 
MON 810?  If so, what scientific evidence do you believe was insufficient?   
 
If the evidence was not sufficient in June 1999, wa s there sufficient evidence available to Austria in 
August 2003  to permit it to undertake a more objective asse ssment of potential risks to human, plant 
and animal health, and the environment from Maize MON 810 (EC-158/At.30-42)?  If not, what scientific evidence do you believe was insufficient?   
 WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-142 
  
  78.01.  My response to this question is the same as my response to question 72, 
except in the following way.  It is appa rent from the Commission Decision (CDA-81, 
22 April 1998) that resistance manageme nt and monitoring measures have been 
proposed by the notifier.  However, I could not find in the materials before the Panel 
a full description of these resistance management and monitoring measures.   
Comments by Argentina
 
 
In comments under paragraphs 69.06, 69.09, 69.10 and 70.02, we show that these materials were 
in the public domain before 1999.  
78.02.  The Opinion of the SCP (CDA-82, 10 February 1998) does not provide a full description of the proposed resistance management and monitoring measures. 
78.03.  Austria decided to prohibit the unregulated commercial use of Mon810 (EC-
159/At.4, 10 June 1999).  In its explanation for this action, Austria does not provide a 
full description of the proposed resistance management and monitoring measures. 
78.04.  The further Opinion of the SCP (US-55, 24 September 1999) does not provide 
a full description of the proposed resistance management and monitoring measures. 
78.05.  Rather than repeat the arguments in my response to question 72, I summarize 
as follows.  I conclude that the scientific evidence available to Austria in June 1999 
was NOT sufficient to permit it to underta ke an appropriate assessment of potential 
risks to plants and the environment fro m Event 176.  The evidence on risks to non-
target organisms, including those in the soil could be considered insufficient.  I cannot provide a scientific judgment about th e sufficiency of the scientific evidence 
on resistance management and monitoring, because a full description of these 
measures is not available in the materials before the Panel. 
Comments by Argentina
 
 
On the information available at the relevant time above see comments under paragraphs 69.06, 
69.09, 69.10, and 70.02. 
 
78.06.  (1) In 2003, there remained some  uncertainty about non-target risks of 
Mon810, but it could be argued that a risk assessment could be conducted using 
scientifically justified worst-case assumptions.  On the other hand, Austria could reasonably maintain that there is still insufficient information to know which non-
target species may be at risk, and therefore it is not possible to conduct an objective 
risk assessment.  The findings in 2003 by Székács and Darvas (EC-158/At.37) – that 
two protected butterfly species in Hungary, Inachis io  and Vanessa atalanta , might be 
exposed to Bt corn pollen and suffer higher mortality – certainly suggests that not all 
of the non-target species at risk to Mon810 have been identified in  Europe.  However, 
the toxicity of Mon810 pollen had been dete rmined not to be high, so it is also 
possible that a worst case ri sk assessment would have found insignificant risk even 
for these unknown species exposed to pollen.  (2) Unlike in 1999, in 2003 Austria 
could argue that the molecular characterization of Event 176 is insufficient to conduct a risk assessment.  (3) In 2004, Austria sugg ested that an additional gene flow risk 
that needs assessment is contamination of conve ntional production.  It is possible that 
the scientific evidence to support risk ma nagement measures is available today.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-143 
  
  Comments by Argentina
 
 
Please see our comments to paragraphs 69.14 and 69.16. 
 
Question 80  
 80. Does the scientific evidence and other inform ation submitted by Austria support the adoption 
of a temporary prohibition on Maize MON 810?  In li ght of any potential risks identified by Austria, 
what other risk management options were availabl e in June 1999?  What other risk management 
options are now available? 
 
80.01.  In my response to this question, I will not address issues related to the antibiotic marker gene and will focus my remarks on environmental risks. 
80.02.  The adoption of a temporary prohibition can be justified on the basis of the 
scientific evidence and other information submitted by Austria. 
Comments by Argentina
 
 
Please see our comments to paragraphs 69.06, 69.09, 69.10, and 70.02. 
 
80.03.  Other risk management options may have been justified in June 1999.  
Because the full resistance management and monitoring measures were not before the Panel, the scientific basis for a concrete discussion of this is not possible. 
Comments by Argentina
 
 
Please see our comments to paragraphs 69.06, 69.09, 69.10, and 70.02. 
 
80.04.  Today several alternative risk mana gement options may be available.  Risk 
management strategies include risk avoidan ce, risk mitigation, and risk tolerance.  
Tolerance strategies are probably ina ppropriate.  Because the full resistance 
management and monitoring measures were not  before the Panel, the scientific basis 
for a concrete discussion of this is not possible. 
Comments by Argentina  
 
Please see our comments to paragraphs 69.06, 69.09, 69.10, and 70.02. 
 
Maize T25 (notification C/F/95/12-07)  
 
Safeguard measure of Austria 
 Question 84
 
 
84. Given the information before the Panel, in cluding the evaluations undertaken by France (EC-
160/At.1 and 2); the SCP in September 2000 (C DA-75) and September 2001 (CDA-86 and CDA-77), 
and the European Commission in its Decision of Ap ril 1998 (CDA-74), as well as the information 
submitted by Austria  with respect to its safeguard measure (EC-160/At.3 and 5, CDA-76, EC-144, 
EC-153), is there any reason to believe that the scien tific evidence available to Austria in April 2000 
was NOT sufficient to permit it to undertake an appr opriate assessment of potential risks to human, WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-144 
  
  plant and animal health, and the environment from  Maize T25?  If so, what scientific evidence do you 
believe was insufficient?    
(f) If the evidence was not sufficient in April 2000, was there sufficient evidence 
available to Austria in August 2003
 to permit it to undertake a more objective 
assessment of potential risks to human, plant and animal health, and the environment from Maize T25 (EC-158/At.30-42)?  If not, what scientific evidence do you believe 
was insufficient?   
84.01.  The reasons for Austria's safeguard  measure are provided by Austria (CDA-
76, EC-160/At.3, 20 April 2000).  While the exact  statement (unofficial translation) is 
reproduced below, there are 6 reasons stated.  (1) The environmental risks of T25 have not been sufficiently evaluated under realistic conditions.  (2) There is no post-
commercialization monitoring program.  (3) Although harm from pollen transfer to 
conventional maize production fields is likely  absent, the potential for this risk should 
be monitored.  (4) There is no provision for the protection of ecologically sensitive regions.  (5) There is a need for regiona lly differentiated "good farming practice" 
guidelines to minimize the danger of resistan ce.  (6) There is a need to assess long-
term and secondary ecological effects. 
The maize line T25 had not been ex amined under realistic conditions 
of the use of this herbicide and of  correspondent agricultural practice.  
Neither the notification seeking approval of the placing on the market of T25 nor the decision of the European Commission are foreseeing a monitoring programme. 
Furthermore special measures monitoring the possible – mostly 
regarded as safe – spread of pollen to fields in the surroundings 
cultivated with conventional maize are missing. 
The lack of a monitoring programme regarding long-term effects of 
genetically modified plants or herbicides can be criticized especially because of the fact that the approval conditions are not foreseeing a protection of sensitive areas (Hoppi chler J., Expert Innenbefragung 
zur Bewertung und Evaluation, "GVO-freier ökologisch sensibler 
Gebiete", Study on behalf of the Austrian Federal Chancellery, Vienna, 1999). 
Furthermore regional ecological aspect s are not differentiated:  the 
use of herbicide resistant plants in areas of unavoidable applications 
of herbicides seems to be useful , if the good agricultural practice 
minimizes the danger of a resistance development. 
Under other ecological – respectively agricultural – conditions the 
use of herbicide resistant plants such as maize should only take place after further investigations of eventual long-term – also secondary – ecological effects. 
84.02.  Regarding these reasons, (1) is po ssible grounds for the safeguard measure.  
(2) is a risk management measure and must be  justified by reference to a risk.  Austria 
does not reference any particular risk, so  this cannot be grounds for the safeguard  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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 Page I-145 
  
  measure.  (3) is a possible grounds for the safeguard measure.  (4) is a risk 
management measure and must be justified by reference to a risk.  Austria does not 
reference any particular risk, so this cannot be grounds for the safeguard measure.  (5)  
Austria provides no argument that region-s pecific guidelines are necessary even when 
the risk of resistance is regionally differen tiated.  Regarding the risk of resistance, 
Austria has not differentiated between the ri sk associated with volunteers and the risk 
associated with the evolution of resistance in  weeds.  There is no scientific ground for 
resistance risk associated with maize vol unteers in Europe.  Thus the only possible 
ground for the safeguard measure is the risk  of resistance evolution in weeds.  (6) 
presents a class of risks that are possible grounds for the safeguard measure.  Thus, I will concentrate on the following four reasons – (1) The environmental risks of T25 have not been sufficiently evaluated unde r realistic conditions; (3) Although harm 
from pollen transfer to conventional maize production fields is likely absent, the 
potential for this risk should be monitored; the specified part of (5), viz., resistance 
risk in weeds, and (6) There is a need  to assess long-term and secondary ecological 
effects – as possible grounds for the safeguard measure. 
84.03.  Regarding (6), long-term effects are certainly possible, but it is difficult to 
assess long-term effects in pre-commercial risk  assessments.  In other words, risks 
that do manifest on long-term time scales are difficult to predict, and unknown long-
term effects must be managed after the fact.  Thus, the lack of long-term assessments 
of unknown effects cannot be considered a reason for the safeguard measure.  As no 
long-term effects have been identified beyond resistance risk, this part of (6) cannot be used to justify the safeguard measure.  The remaining part of (6), secondary ecological effects, is a specific case of reason (1) and will be treated together with (1). 
Comments by Argentina
 
 
We agree. In particular, the phrase: "the la ck of long-term assessments of unknown effects 
cannot be considered a reason for the safeguard meas ure" is absolutely correct. The only way of 
dealing with long-term effects is relying in the predictive nature of a risk assessment which, of 
course, must consider all the scienti fic evidence available at the time. 
 
84.04.  Regarding (3), Austria has acknowledged that the possible harm is likely 
absent, but does not specify concretely the po ssible harm.  It is obvious that Austria 
cannot be thinking about contamination of  conventional production (related to the 
"coexistence" issue) at this time.  If it had considered this, it would not acknowledge 
that the possible harm is likely absent.  As the amended SCP Opinion (CDA-77, 20 
July 2001) also does not specific a possible harm, it is difficult to see how this reason can justify the safeguard measure. 
Comments by Argentina
 
 
We agree. The Expert correctly points out the conditions which Austria did not comply with 
regard to supporting the reasons for the safeguard measure. 
 
84.05.  Regarding (1), the amended SCP Opinion (CDA-77, 20 July 2001) does not 
provide an assessment of environmental risks beyond gene flow risks.  These would include non-target and other biodiversity risks.  However, Austria does not provide 
any scientific evidence that su ch risks may exist for T25 maize.  A risk assessment WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-146 
  
  cannot be considered insufficient if all conc rete possible risks are addressed.  In this 
respect (1) cannot be used to justify the safeguard measure. 
Comments by Argentina
 
 
Same comments as under paragraph 84.04. 
 
84.06.  This leaves only resistance risk in  weeds as the only possible grounds for the 
safeguard measure.  The amended SCP Op inion (CDA-77, 20 July 2001) does not 
provide an assessment of this environmen tal risk.  Even though Austria did not 
provided any scientific evidence that this risk  exists for T25 maize, resistance risks 
are widely recognized, and the consistent use of glufosinate with T25 maize would result in a resistance risk.  Thus, there was insufficient scientific evidence available to 
the SCP and Austria to assess weed resistance risk and appropriate risk management 
measures. 
Comments by Argentina
 
 
The development or tolerance in weeds is an  inescapable phenomenon: Any selective pressure 
applied on the field will lead to the development of tolerance. It is an evol utionary principle that 
could not be ignored by Austria.  
 
84.07.  Managing resistance risk in maize should be easier than managing resistance 
risk in oilseed rape, so I would expect that  adequate information for a risk assessment 
could have been made available by 2003, had the parties made concerted efforts to 
bring it together. 
Comments by Argentina  
 
We agree. See the results of the FSE trials in the UK. 
 
84.08.  However, as I have stated repeat edly, the evidentiary standards for what 
constitutes an objective environmental ri sk assessment had cha nged substantially 
from 1997 to 2003.  While this has been particularly true for the Bt crops, there has 
also be a shift for GMHT crops.  (1) It b ecame widely appreciated that the molecular 
basis of transformation was more complex than originally thought, and the implications of these findings for risk assessment were articulated.  Annex II of Directive 2001/18/EC is one consequence, but additional regulatory changes have 
occurred since then.  Indeed, knowledge in molecular biology continues to 
accumulate at remarkably fast rates, and I expect that there will be continued change 
in regulation in the future.  (2) The UK- FSE trials have indicated that there are 
possible risks to biodiversity associated with herbicide use on GMHT crops.  
However, for GMHT maize, no adverse eff ects were found.  (3) Contamination of 
conventional production (related to the "coexis itence" issue) is a new issue that could 
be new grounds for the safeguard measure.  It  is possible, however, that the scientific 
evidence to support risk management measur es for this risk to conventional maize 
were available in 2003.  Thus, in 2003, Austria could also argue that T25 was inadequately characterized.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-147 
  
  Comments by Argentina
 
 
See comments under paragraph 69.14. 
 
Question 86  
 86. Does the scientific evidence and other inform ation submitted by Austria support the adoption 
of a temporary prohibition on Maize T25?  In light of  any potential risks identified by Austria, what 
other risk management options were available in April 2000?  What other risk management options 
are now available? 
 
86.01.  The adoption of a temporary prohibition was probably not justified on the basis of the scientific evidence and other in formation submitted by Austria.  Austria 
needed to clarify the rationale and provi de substantial scientific evidence.  A 
temporary prohibition probably could have been justified at the time because the 
appropriate scientific information did exist. 
Comments by Argentina
 
 
We agree that there was no justification for a prohibition. 
 
86.02.  Several other risk management options  could also have been justified in April 
2000.  Risk management strategies include ri sk avoidance, risk mitigation, and risk 
tolerance.  In 2000 mitigation and tolerance strategies were probably inappropriate.  
Here I consider only the resistance risk.  One risk avoidance strategy would have 
been to allow limited planting in a restricted region.  This would allow observing how 
T25 would be used and enable assessment of the selective pressure on weeds.  Another approach would have been to limit use on any particular field to once every 4-5 years.  This would reduce selection pressure for a long time, allowing alternative management measures to be developed. 
Comments by Argentina
 
 
We recall that there was no justification for such a measure. 
 
86.03.  Today the same measures are available.  
Question 97 
 
97. On the basis of the information before the Panel, is there new scientific evidence since 1998 
that would suggest that the potential risks to human, plant or animal health, or to the environment, 
from any of the specific biotech products subject to this dispute (including products subject to the 
member State safeguard measures), are different in na ture or magnitude as compared to the scientific 
understanding of the risks associated with such biot ech products prior to 1998, taking into account: 
 
• the intended use of each product (direct  human or animal consumption, further 
processing for consumption, plantin g or any other specified use); 
 
• any potential risks that may arise from th e combination or successive use of biotech 
products.  
 WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-148 
  
  Does the information before the Panel support the vi ew that the potential risks from the products in 
this dispute should be assessed differently than the risks from biotech products approved prior to 
1998? 
 
Changes since 1998
 
 
97.01.  The main changes that have occurre d since 1998 are related to risk assessment 
methodologies and the evidence needed in  a risk assessment.  There are some 
differences between the tran sgenic crops evaluated and approved before 1998 by the 
EC and those evaluated later, but these differences are not as great as the changes in risk assessment methodologies and eviden ce needed.  These changes came about 
from increased scientific knowledge about tran sgenic crops.  This has affected risk 
assessment for transgenic crops intended for planting in the environment.  Scientific 
investigation of risks of combination biotech products has lagged behind. 
97.02.  As I indicated in previous answers, the basis for risk assessment of transgenic 
crops had changed because several significant scientific points had come to light.  (1) It became widely appreciated that the molecular basis of transformation was more complex than originally thought, and the implications of these findings for risk assessment were articulated.  (2) Non-targ et risk assessment shifted from assessing 
indicators of environmental risk to assessing actual identified potential environmental 
risks.  Presently this is done on an ad hoc basis, as no systematic methodology has gained widespread acceptance.  (3) Gene flow risk assessment has shifted from being 
based primarily on an assessment of the proba bility of gene flow to being based on an 
assessment of both the probability of gene flow and the conditional hazard 
probability.  (4) Resistance risk is cons idered an environmental risk, and science-
based resistance management measures are required. 
Comments by Argentina
 
 
See comments under paragraph 69.14. 
 
97.03.  Thus, risk assessment methodologi es and evidentiary standards for what 
constitutes an objective environmental ri sk assessment had cha nged substantially 
from 1998 to 2005.  This is particularly true in Europe and the United States, and particularly true for the Bt crops.   
Comments by Argentina
 
 
See comments under paragraph 69.14. 
 
97.04.  Below, I will sketch some of the changes in non-target  risk assessment and 
resistance risk assessment and management.   
Non-target risk assessment  
 
97.05.  Through 1997, most studies on non-target and biodiversity risks of transgenic plants showed no effect of the transgenic plant (Fitt et al.  1994; Sims 1995; Dogan et 
al. 1996; Orr & Landis 1997; Pilcher et al.  1997; Yu et al.  1997; EPA 2001; 
Monsanto Company 2002a, b).  The methodological approach used in nearly all of 
the studies was an indicator species appr oach similar to the ecotoxicological  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-149 
  
  assessments of pesticides where indicator speci es are used to extrapolate to risks in 
the actual environment.  Only one laborato ry study showed a lower survival of the 
springtail Folsomia candida  (Willem)  when fed with high concentrations of Bt corn 
leaf protein (EPA 2001), but the significance of this result is not clear.  These 
indicator species are not usually closely associat ed with the transgenic plant tested or 
the area where the plants are grown.  Based  on these studies, many scientists believed 
that non-targets were not significantly at risk. 
Comments by Argentina
 
 
We note that there is only one study, whose signific ance is not clear, indicating that a particular 
non-target organism was affected by the GM plan t trait. We believe that the indicator species 
tests are an acceptable guidance, but agree on the value of commercial-scale field studies. Again, 
with the sole exception of the monarch butterf ly, which is still under debate (and seems not to 
support the hypothesis of a significant non-targ et effect; see above, comments on the monarch 
butterfly experiments made by this reviewer), no  significant full-scale non-target effects have 
been reported. While we still agree with the Expert  in that studies on non-target effects should 
continue, we do not find this to be a justification for delaying approval, neither in 1998 nor today.  
97.06.  In 1998, studies by Hilbeck et al (1998a,b) invigorated consideration of non-
target risks by reporting an unexpected adve rse effect of Bt corn on the predatory 
green lacewing Chrysoperla carnea  Stephens.  They fed C. carnea larvae with 
Cry1Ab Bt corn-fed prey or a diet containing purified Cry1Ab toxin, and found higher immature mortality compared to controls.  These results were surprising 
because the Cry1Ab toxin is believed to be Lepidopteran-specific, while C. carnea 
belongs to the Neuroptera, an order that is more closely related to the Coleoptera than 
to the mecopteroid orders including the Lepidoptera.  These results have been confirmed by additional studies (Hilbeck et al.  1999; Dutton et al.  2002; Dutton et al. 
2003), although the mechanism is still uncer tain.  These studies suggested that Cry 
toxins may be less specific than previously believed.  
Comments by Argentina
 
 
While we would expect the exact mechanism for the above findings to come to light, we note 
that the reported results have been obtained under laboratory conditions,  which in general 
were criticized by the Expert. Moreover, when the 1999 paper by theses authors is examined, we 
find (Hilbeck et al; Entom. Exper.  Appl. 1999, 91:305-316; excerpts): 
 
"… In agreement with the previous studies,  total development time of C. carnea 
was not consistently, significantly affect ed by the Bt-treatments except at the 
highest Cry1Ab toxin concentration. However, both highest mortality and delayed development of immature C. ca rnea raised on Cry1Ab toxin 100 _g g_1 
diet – fed prey may have been confounded with an increased intoxication of S. 
littoralis larvae that was observed at that concentration. At all other B. thuringiensis protein concentrations S.  littoralis was not lethally affected. 
Comparative analyisis of the results of th is study with those of the two previous 
studies revealed that in addition to prey/herbivore by B. thuringiensis 
interactions, also prey/herbivore by plant interactions exist that contribute to the 
observed toxicity of B. thuringiensis – fed S. littoralis larvae for C. carnea. These WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-150 
  
  findings demonstrate that tritrophic level studies are necessary to assess the 
long-term compatibility of insecticidal plants with important natural enemies…" 
We observe that the above findings, while very  interesting, do not qualify for a approval delay 
of Bt crops.  
97.07.  In the years following 1998, publications on non-target risks began to shift from indicator species to the actual (or tangible) potential risks on species that naturally occur in areas where transgenic pl ants are meant to be cultivated.  In early 
1999, Losey et al.  (1999) suggested that monarch larvae ( Danaus plexippus  L.) 
suffered higher mortality when feeding on their primary host plant, the common milkweed Asclepias syriaca  L., dusted with transgenic Cry1Ab Bt pollen.  This initial 
observation was later confirmed by Jesse & Obrycki (2000) and coupled with the 
realization that ~50% of the monarch breed ing habitat is located in the Corn Belt 
(Wassenaar & Hobson 1998), this triggered c oncerns that large-scale cultivation of Bt 
corn would harm the monarch population.  M onarch butterflies attract wide interest in 
the US for multiple reasons, such as thei r beauty, iconic significance to the public, 
and spectacular migration over several thousand miles.  Stimulated by these results, a group of researchers conducted a series of studies to estimate the actual risk of Bt corn to monarch butterflies (Hellmich et al. 2001; Oberhauser et al. 2001; Pleasants 
et al. 2001; Sears et al. 2001; Stanley-Horn et al. 2001; Zangerl et al. 2001).  Sears et 
al. (2001) concluded that the risk to monarch populations was insignificant, and in an 
excellent review, Oberhauser & Rivers ( 2003) summarized the events and findings 
associated with these studies.  Recent studies (Anderson et al. 2004; Jesse & Obrycki 
2004; Dively et al. 2004), however, have revealed a higher toxicity of Bt pollen and 
anthers than found in previous studies.  Although Dively et al. (2004) suggested that 
the risk to monarchs remains insignificant , a close analysis of the issues may allow 
other interpretations of risk to monarchs. 
Comments by Argentina
 
 
1. On the paper by Anderson et al, we reproduce here the abstract: (italics and underlined 
are ours. In capital letters, we indicated the relevant findings which contradict the Expert 
contention that Bt toxin is a significant risk for monarca butterfly):  
Previous studies suggest that exposure to corn, Zea mays  L., anthers expressing 
Bacillus thuringiensis  (Bt)-derived protein may have adverse effects on the 
larvae of monarch butterfly, Danaus plexippus  (L.). To examine the potential 
effects of Bt anthers on monarch butterflies, studies were designed to test toxicity in the laboratory
; examine anther distribution in space and time; 
compare distributions of anthers, pollen, and larval feeding; and measure effects 
of long-term exposure in the field . In the laboratory, mo narch butterfly larvae 
fed on whole corn anthers, but anther feeding was sporadic. Larvae exposed TO 
0.3 ANTHER/CM2 fed and weighed less after 4 d compared with larvae exposed 
to non-Bt anthers. Adverse effects increa sed with increasing anther density. 
Monarch butterfly larvae exposed to 0.9 ANTHER/CM2 had reduced feeding, 
weight, and survival and increased develo pmental time compared with larvae 
exposed to non-Bt anthers. Later instars were more tolerant of Bt toxin. For all 
studies, laboratory testing probably magnified e ffects because larv ae were confined 
to petri dishes. Field studies showed  toxic anther densities are uncommon on 
milkweed (Asclepias) leaves in and near cornfields during anthesis. Mean anther  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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 Page I-151 
  
  densities on milkweed leaves in cornfields  during peak anthesis were between 0.06 
AND 0.1 ANTHER/CM2 ( 3–5 ANTHERS PER LEAF). When exposure to a 
density OF FIVE ANTHERS PER LEAF WAS TESTED IN FIELD-CAGE 
STUDIES, no effects on growth, development, or survival were detected. Based on 
probability of exposure to toxic de nsities, BT ANTHERS ALONE ARE NOT 
LIKELY TO POSE A SIGNIFICANT RISK TO MONARCH BUTTERFLIES IN 
IOWA.  
2. On the paper by Dively et al, we repro duce here some excerpts: (italics and underlined 
are ours. In capital letters, we indicated the relevant findings which contradict the Expert 
contention that Bt toxin is a significant risk for monarca butterfly):  
"The potential non-target risks to monarch butterfly, danaus plexippus l., of 
transgenic corn transformed with a gene from the bacterium Bacillus 
thuringiensis (Bt) have been the focus of much scientifc research and debate 
after a laboratory study by Losey et al. (1999) revealed toxicity to monarch 
butterfly larvae consuming Bt corn pollen deposited on milkweed plants 
(Asclepias spp.). SUBSEQUENT STUDIES INDICATED THAT THE ACUTE 
EFFECT OF BT CORN POLLEN EXPRESSING LEPIDOPTERAN-ACTIVE 
CRY PROTEIN ON MONARCH BUTTERFLY POPULATIONS WAS 
NEGLIGIBLE (SEARS ET AL.2001). LARVAL EXPOSURE TO POLLEN ON A 
POPULATION-WIDE BASIS IS LOW, GIVEN THE PROPORTION OF 
LARVAE IN CORNFIELDS DURING POLLEN SHED, THE PROPORTION OF 
FIELDS PLANTED IN BT CORN, AND THE LEVELS OF POLLEN WITHIN 
AND AROUND CORNFIELDS THAT EXCEED THE TOXICITY THRESHOLD 
(OBERHAUSER ET AL. 2001, PLEASANTS ET AL.2001).CONSERVATIVELY, 
THE PROPORTION OF THE MONARCH BUTTERFLY POPULATION 
EXPONED TO BT CORN POLLEN WAS ESTIMATED TO BE 0.8% (SEARS ET 
AL.2001).LABORATORY BIOASSAYS A LSO SHOWED THAT ACUTE TOXIC 
AND SUBLETHAL EFFECTS OF POLLEN FROM THE MOST WIDELY 
PLANTED BT CORN HYBRIDS (EVENTS MON810 AND BT11) ARE 
UNLIKELY, EVEN AT PEAK LEVELS OF POLLEN SHED (HELLMICH ET 
AL.2001).THE ONLY TRANSGENIC CO RN POLLEN THAT CONSISTENTLY 
AFFECTED MONARCH BUTTERFLY LARVAE WAS FROM THE CRY1AB 
EVENT 176 HYBRIDS, WHICH HAVE BEEN PHASED OUT OF 
COMMERCIAL USE IN THE UNITED STATES. FURTHERMORE, FIELD 
STUDIES PERFORMED IN IOWA, MARYLAND, NEW YORK, AND ONTARIO, 
CANADA, REPORTED THAT GROWTH TO ADULTHOOD OR SURVIVAL OF 
MONARCH BUTTERFLY LARVAE WAS UNAFFECTED AFTER EXPOSURES  
FOR 4-5 D TO MILKWEED LEAVES WITH NATURAL DEPOSITS OF 
CRY1AB EXPRESSING (EVENTS BT 11 AND MON810) CORN POLLEN 
(STANLEY-HORN ET AL.2001).THESE RESULTS INDICATED NEGLIGIBLE 
EFFECTS OF BT POLLEN TO MONARCH BUTTERFLY LARVAE FROM 
SHORT-DURATION EXPOSURES IN FI ELD SETTINGS. ALL SCIENTIFIC 
INFORMATION ON ACUTE TOXICITY AND EXPOSURE SUPPORTS THE 
CONCLUSION THAT BT CORN POSES A LIMITED RISK TO MONARCH 
BUTTERFLY POPULATIONS (SEARS ET AL.2001).WHAT RISK EXISTS IS 
CAUSED BY THE LIMITED EXPOSURE OF MONARCH BUTTERFLY 
POPULATIONS TO BT POLLEN IN  NATURE .NEVERTHELESS, THE 
STUDIES TO DATE EXAMINED ACUTE AND SUBLETHAL EFFECTS 
AFTER 4-5 D OF EXPOSURE OF DEVELOPING LARVAE TO BT POLLEN.  WT/DS291/R/Add.7 
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Page I-152 
  
  IN CORNFIELDS, LARVAE HATCHING AT THE ONSET OF ANTHESIS MAY 
BE EXPONED TO BIOLOGICALLY ACTIVE CRY1AB PROTEIN FOR 
PERIODS OF 12 D OR MORE (RU SSELL AND HALLAUER 1980).THIS 
WORST-CASE SCENARIO COULD POTENTIALLY IMPACT THE 0.8% OF 
THE MONARCH BUTTERFLY POPULATION EXPOSED TO BT …  
Long-term exposure of monarch butterfly larvae throughout their development 
to Bt corn pollen is detrimental to only  a fraction of the breeding population 
because THE RISK OF EXPOSURE IS LOW . When this impact is considered 
over the entire range of the Corn Belt, THE ECOLOGICAL OUTCOME IS 
VERY SMALL.  Moreover, BT CORN ADOPTION IS ASSOCIATED WITH 
LOWER INSECTICIDE USE AGAINST TARGET LEPIDOPTERA (PILCHER 
ET AL.2002), AND MOST INSECTICID ES ARE ACUTELY TOXIC TO LARVAE 
OCCURRING IN CORN OR IN OTHER CROPS THAT PROVIDE HABITAT 
FOR MONARCH BUTTERFLY POPULATIONS . In field bioassays, larvae died 
within hours after feeding on milkweeds exposed to a single application of a pyrethroid insecticide (Stanley-Horn et  al.2001)….. 
… IT IS LIKELY THAT BT CORN WILL NOT AFFECT THE 
SUSTAINABILITY OF MONARCH BUTTERFLY POPULATIONS IN NORTH 
AMERICA…."  
(Note of this reviewer) The above shows that Bt corn could be considered a 
protection to monarca butterfly, as its use would decrease the use of chemical 
insecticides, which are acutely toxic to larvae. 
3. On the paper by Jesse and Obrycki (2004),  we reproduce here some excerpts from the 
abstract: 
 
"We present THE FIRST EVIDENCE that transgenic Bacillus thuringiensis (Bt) corn pollen naturally deposited on Asclep ias syriaca; common milkweed, in a corn 
field causes significant mortality of Da naus plexippus L. (Lepidoptera: Danaidae) 
larvae. Larvae feeding for 48 h on A. syriaca plants naturally dusted with pollen from Bt corn plants suffered significantly higher rates of mortality at 48 h (20±3%) 
compared to larvae feeding on leaves with no pollen (3±3%), or feeding on leaves 
with non-Bt pollen (0%). Mortality at 120 h of D. plexippus larvae exposed to 135 
pollen grains/cm2 of transgenic pollen for 48 h ranged from 37 to 70%. … We 
conclude that the ecological effects of transgenic insecticidal crops NEED TO BE EVALUATED MORE FULLY before they are planted over extensive areas." 
We agree that the results shown here are the first  evidence of an effect, but they should be 
validated by further research, as the authors recognized.  
97.08.  This shift to considering tangibl e risks may have helped identify potential 
adverse effects to the Federally endangered Karner blue butterfly ( Lycaeides melissa 
samuelis  Nabokov, Lepidoptera, Lyceanidae).  Instead of focusing only on 
commercial corn fields, dispersal of polle n and the production of corn in wildlife 
refuges could expose this endangered speci es to Bt pollen.  The 2000 Scientific 
Advisory Panel (SAP) of the US Environmental Protection Agency (EPA) acknowledged the possibility that this species may come in contact with Bt pollen  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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 Page I-153 
  
  (see also Andow et al. 1995), and the EPA (2001) required additional assessment of 
the risks to Karner Blue butterfly. 
Comments by Argentina
 
 
These studies were preliminary, or published la ter than 1998. Therefore, they do not qualify ad 
a justification for delaying approval.  
97.09.  During 1999, research oriented toward assessing the tangible potential risks 
associated with soils was published.  Saxena et al . (1999) found that Cry1Ab is 
released into the soil via corn root exudates,  where it can persist for at least 350 days 
(Saxena et al . 2002).  These results suggested that Bt corn could possibly affect 
rhizosphere and soil communities.  Later, Zwahlen et al . (2003a) reported that the 
Cry1Ab toxin in Bt corn litter persisted for at least 8 months. Together these studies 
showed that long-term exposure of soil orga nisms to Bt toxins was possible and that 
the risks of Bt crops on soil ecosystem functioning should be assessed.  Zwahlen et 
al. (2003b) also showed that mortality and we ight development of adult and juvenile 
earthworms, Lumbricus terrestris  L., were not significantly different when fed Bt or 
non-Bt corn residues, with the exception that after 200 days, adult Bt corn-fed 
earthworms had a significant weight loss compared to the non-Bt corn-fed ones.   
Comments by Argentina
 
 
See comments under paragraph 97.08. 
 
97.10.  Non-target risks associated with he rbicide-tolerant crops were hardly studied 
until 2000, when Watkinson et al.  (2000) suggested that these crops might adversely 
effect skylark populations in the UK.  A large-scale field evaluation of herbicide-tolerant crops in the UK was established to investigate possible actual effects on non-
target species, and results were published in 2003.  For the most part, ecological effects propagated from whatever changes in  the weed community that resulted from 
the change in herbicide use.  The non-target  effects of herbicide tolerant crops have 
not been studied intensively elsewhere.  
Comments by Argentina
 
 
See comments under paragraph 97.08. 
 
97.11.  In 2004, Andow & Hilbeck (2004) presented the outline of a new risk 
assessment model for non-target effects of transgenic crops.  Implicitly they are 
proposing to systematize the actual/ tangibl e risk assessment process that has been 
building since 1999.  An important innovation is to select locally occurring non-target 
species that are most likely to be exposed to a transgenic crop and likely to make 
significant contributions to the ecological  functioning of the local ecosystem.   
Comments by Argentina  
 
Knowledge obtained at such later dates, could not possibly justify delay for approval. 
 
97.12.  Non-target and biodiversity risk assessments of transgenic plants continue to be improved.  While indicator species continue to be used in many risk assessments, WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-154 
  
  there is a trend towards assessing actua l/ tangible risks involving species that 
naturally occur in areas where transgenic crops will be planted.  In the future it will 
continue to be important to assess not only th e effects of the transgenic plant itself but 
also the effects associated with changes in agricultura l practices.  In addition, 
although they may be difficult to develop and verify, effective methods for biodiversity assessment have not  yet been developed.   
Comments by Argentina
 
 
See comments under the paragraphs above.  Resistance risk assessment and management
 
 
97.13.  The evolution of pest resistance to  pest control measures has been known for 
nearly 100 years, but it became a significant problem after World War II, when 
modern, intensive agricultural technologies proliferated, resulting in strong uniform 
selection over large areas.  About 536 species  of arthropods, 60 genera of plant 
pathogenic fungi, and 174 weed species have  evolved resistance to pesticides (Eckert 
1988; WeedScience.org 2003; Whalon et al. 2004), and resistance to Bt toxins has 
been documented in >17 insect species (Tabashnik 1994, Huang et al. 1999).  
Interestingly, virologists remain unconvinced that resistance will evolve to transgenic 
virus resistant crops (Tepfer 2002), however, despite some disagreement (reviewed in Tabashnik 1994), entomologists and weed scientists agree that resistance evolution is a real risk for which some management is desirable (NRC 1986).   
97.14.  At the beginning of the 1990s, it ha d proven difficult to implement effective 
resistance management for most pesticides.  Indeed, there was pessimism that a high-
dose/ refuge resistance management system could ever be implemented for insecticide resistance management be cause a high dose could not be reliably 
maintained (Roush 1989; Tabashnik 1989).  W ith the advent of transgenic Bt crops, 
hopes were renewed (Gould 1994; Roush 1994), but it was not clear that a high-dose/ 
refuge strategy would delay resistance enough with a reasonably sized refuge 
(Comins 1977).   
97.15.  In a series of simple simulations based on Comins (1977) early work, Alstad 
& Andow (1995) showed that the high-dose/ re fuge strategy could delay resistance in 
European corn borer to Bt corn for more  than 30 years with a 50% non-Bt corn 
refuge.  Subsequent research suggested that  smaller refuges would also substantially 
delay resistance, proving that effective resistance management was possible 
theoretically (Gould 1998; Shelton et al. 2000). 
Comments by Argentina
 
 
In the above statement, the Expert shows that resistance management is possible. Although 
some of the above papers were published later, th is concept was already prevailing in 1998, and 
therefore could not be construed to support delay for approval. 
 
97.16.  The focus shifted to practicalities.  Could an effective resistance management 
strategy be implemented?  In the US, this question was answered through a series of decisions made by the EPA.  In early 1995, the EPA registered Bt potato, and 
although resistance risk was recognized, no r esistance management was required. By  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-155 
  
  the end of that year, EPA issued c onditional registrations and required the 
development of resistance management for all subsequent Bt crops (Matten et al. 
1996).  Conditional registrations were u sed to motivate the development and 
implementation of a scientifically justified resistance management strategy.   
Comments by Argentina
 
 
See comments under paragraph 97.15. 
 
97.17.  The key issues in 1995 were how large a refuge was needed, did the refuge 
need to be spatially structured relative to  the Bt fields, and could the refuge be 
managed to limit pest losses?  Aspects of some of these questions remain unresolved 
today.  In Australia, Bt cotton did not provide a high-dose against the key pest, cotton bollworm Helicoverpa armigera  (Hübner), and growers and researchers agreed to 
require 70% refuges to make the likelihood of resistance remote (Fitt 1997).  In the 
US, Bt cotton provided a high-dose against the key pest, cotton budworm Heliothis 
virescens  (F.), but not against another important pest, Helicoverpa zea  (Boddie), 
however, refuge requirements were set at  4% unsprayed or 20% sprayed refuge 
outside of the Bt field with minimal requireme nts of spatial structure.  In 2001, spatial 
structure requirements were added for Bt  cotton along with other modifications.  
These initial requirements and changes represent a compromise among various 
interests, although science played a significant role.   
Comments by Argentina
 
 
See comments under paragraph 97.15. 
 
97.18.  Resistance management requirements for Bt corn developed with strong scientific input.  Early in 1997, the USDA regional research committee NC-205 reviewed model results and information on the ecology of Europ ean corn borer and 
suggested to registrants and the EPA that a 20-25% refuge was needed near all Bt corn fields (Anon. 1998).  Research r esults supporting this recommendation were 
published in the ensuing years (Onstad & Gould 1998; Hunt et al. 2001; Bourguet et 
al. 2003).  One of the key results was a bioeconomic model suggesting that a 20% 
refuge would be nearly optimal for grower s who consider the trade-off between the 
immediate costs of the refuge and delayed costs of resistance failures (Hurley et al. 
2001).  Canada required a 20% refuge within  0.5 miles (~800 meters) of Bt corn in 
1998, and during 1999 a consensus was reach ed in the US and the EPA required a 
20% refuge within 0.5 miles of Bt corn for the 2000 growing season and thereafter.   
Comments by Argentina
 
 
See comments under paragraph 97.15. 
 
97.19.  Several scientific issues remain unresolved.  Understanding the mechanisms 
of resistance is necessary to tailor resistance management to the particular system, but these are just beginning to be revealed for Bt crops (Gahan et al. 2001).  The details 
of adult movement may play a key role in the evolution of resistance (Caprio 2001; Ives & Andow 2002).  Limited dispersal of adults from natal fields (Comins 1977), 
pre- versus post-mating adult movement, a nd male versus female movement (Ives & 
Andow 2002) may have significant effects on models of resistance evolution, and WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-156 
  
  estimating these movement rates in the field is challenging.  Farming practices, such 
as crop rotation (Peck & Ellner 1997), ma nagement of the refuge (Onstad et al. 2002; 
Ives & Andow 2002), and rational approaches to pest management, may affect the 
rates of resistance evolution.  Significantly, a consensus for managing low-dose 
events has yet to emerge, and scientific anal ysis of this problem is incomplete.  For 
example, Australia implemented 70% refug es for one low-dose event, while the US 
has used 20% refuges for both high- and low-dose events.   
Comments by Argentina
 
 
See comments under paragraph 97.15. 
 
97.20.  Monitoring for the occurrence and frequency of resistance and methods to improve compliance to resistance manageme nt requirements among growers are areas 
of current research.  The key monitoring problem is how to estimate resistance when 
it is rare and recessive.  One promising approach is the F
2 screen (Andow & Alstad 
1998; Andow & Ives 2002; Stodola & Andow 2004).  It is a genic screen and works by inbreeding isofemale lines so that recessive phenotypes are expressed in the F
2 
generation, when they can be screened.  If mated females are collected from natural 
populations, each carries four haplotypes (two  of her own and two of her mate's) and 
only 250 female lines need to be screened instead of 106 field-collected individuals.  
The F 2 screen has been used fo r several species (Bentur et al. 2000, Bourguet et al. 
2003; Génissel et al. 2003).  Other genetic and pheno typic methods have been used 
on some cotton pests (Gould et al. 1997; Tabashnik et al. 2000), but usually 
phenotypic screens will have lower sensitivit y and higher cost than genic screens 
(Andow & Ives 2002).  Improving compliance will require a combination of 
bioeconomic modeling, surveys of gr ower behavior and motivations, and 
development of effective educational materials. 
Comments by Argentina  
 
See comments under paragraph 97.15. 
 
97.21.  Our understanding of resistance risk  and management continues to evolve.  
Presently, none of the Bt crops now used has suffered a resistance failure despite 
widespread use.  While this may be due to good fortune, in some cases, such as Bt 
cotton in Australia, resistance management must have been crucial to avoiding 
failure, and in other cases, such as Bt cotton in Arizona, US, other factors must also 
be important (Tabashnik et al. 2003).  Interestingly, relatively little research has 
focused on weed resistance to herbicides used  with the herbicide tolerant crops.  This 
problem has been treated as a theoretical herbicide resistance problem (Gressell et al. 
1996), but with recent reports of weed resi stance (WeedScience.org 2003), this may 
change.  
Comments by Argentina  
 
See comments under paragraph 97.15. We note that the Expert states that …  "Presently, none 
of the Bt crops now used has suffered a resistance failure despite widespread use…" This 
statement proves that, although basically correct on the need to improve methodology and 
further research, the Expert grants that no sign ificant harm was done to biodiversity, by using  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-157 
  
  concepts and knowledge already existing in 1998,  and therefore no justification for delaying 
approval would have scientific grounds. 
 
Question 99 – Monitoring
 
 99. For those biotech products at issue in this dispute for which no significantly different nature 
or level of risk has been identified, does the in formation before the Panel provide a scientific or 
technical rationale for monitoring the occurrence of  potential adverse effects, or of unintentional 
effects, arising from the consumption or use of these products compared to those products of 
biotechnology approved by the European Communities prior to October 1998? 
 
99.01.  There are some biotech products at issue in this dispute for which one committee or another has determined that were no significant risks.  I have taken 
issue with some of these determinations in  my previous responses.  For all of the 
products at issue in this dispute, there are some member countries that disagree with the assessment of the relevant SCP (for example) that there are no significant 
identified risks.  This disagreement is so metimes related to different standards of 
acceptable risk being applied by the disagreeing parties. 
Comments by Argentina
 
 
The Expert has pointed out, in the relevant co mments on the Member States claims, that most 
of them were unclear and do not have had justification at the time of the suspending approvals.  
99.02.  This disagreement provides the only rationale for monitoring potential adverse 
effects.  If all parties agreed that ther e were no significant identified risks, there 
would no need to consider monitoring for potential adverse effects.   
99.03.  Unanticipated effects could arise from a transgene by any of the following 
mechanisms:  new ORFs, insertional muta genesis, post-transcriptional or post-
translational processing, other pleiotropy or epistasis, and gene-by-environment 
interaction.  New ORFs and insertional mutagenesis can be addressed through 
molecular characterization of all transgene loci.  Post-transcriptional or post-
translational processing can be addressed to the most part by molecular and biochemical analysis.  Other pleiotropy or epistasis and gene-by-environment interaction cannot be addressed without extensive planting in the field. 
Comments by Argentina
 
 
All the above requirements were addressed in 1998, according with the state of the art at that 
date.  
99.04.  All of these possible sources unanticipat ed effects are equally likely to occur 
for plant biotech products before 1998 and pl ant biotech products after 1998.  It is 
possible that more recent events (after 2001)  are less likely to have such unanticipated 
effects than those prior to 1998.  The ma in difference between them is that new 
ORFs, insertional mutagenesis and post- transcriptional and post-translational 
processing was not looked for very much before 1998, while after 2001, the methods and standards have become increasingly ta rgeted to assess these possibilities.  This 
provides a rationale for monitoring. WT/DS291/R/Add.7 
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Page I-158 
  
  Comments by Argentina
 
 
The Expert is correct, but although methodologies were improved since 1998, none of the GM 
crops revised under the more recent techniques and concepts were shown to lead to a decision 
such as the one taken in 1998. Moreover, the new methods and regulatory requirements even 
reinforced the robustness of the early decisions.  Question 100 - Agricultural management practices
 
 
100. For those biotech products at issue in this dispute for which an approval has been sought for 
environmental release (notifications submitted und er Directives 90/220 or 2001/18), and for which no 
significantly different nature or level of risk has b een identified, does the info rmation before the Panel 
provide a scientific or technical rationale for requiring specific agr icultural management practices 
that differ from those for products of biotechnology  approved by the European Communities prior to 
October 1998?   
 
100.01.  A parallel argument to my response to question 99 holds for this question. 
Comments by Argentina  
 
See our comments under question 99.  Question 101 – Mitigation
 
 
101. Does the information before the Panel support the argument that any potential risks from any 
of the biotech products at issue in this dispute should be mitigated in a manner different than the 
products of biotechnology approved by the Europe an Communities prior to October 1998?  If so, 
what means of risk mitigation might be envisaged? 
 
101.01.  None of the products approved by the EC prior to October 1998 have been mitigated in any manner by the EC because no mitigable risks have been reported and 
verified.  Should any of the biotech products cause a verifiable risk, this would be 
sufficient argument for mitigating them differently. 
Comments by Argentina
 
 
Note that the Expert is indirectly indicating that no delay would have been justified in 1998 
based in mitigable risks. 
 
101.02.  However, as indicated in my response to question 97, there are new risk 
methodologies and assessment standards being ap plied to biotech products today than 
prior to 1998.  Thus, it is possible that ri sks will be identified for new products that 
were not even considered in the older pr oducts.  Under such conditions, differences 
could be justified. 
Comments by Argentina  
 
See comments under question 97. See also, comments under paragraph 69.14. 
  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-159 
  
  Question 102
 
 
102. Does the information before the Panel support the view that the biotech products at issue in 
this dispute (including products subject to the member State safeguard measures) give rise to the 
same types of potential risks to human, plant or ani mal health or to the environment as novel non-
biotech products, such as plant products produced by selective br eeding, cross-breeding and induced 
mutagenesis?  If so, for any biotech product at i ssue in this dispute are there significant differences, 
from a scientific perspective, in the nature or m agnitude of any potential risks from these products 
compared to comparable novel non-biotech products taking into account: 
 
• the specific genetic modification introduced and the resulting product; 
 
• the intended use of each product (direct  human or animal consumption, further 
processing for consumption, planting or other use); 
 
• any potential risks that may arise from th e combination or successive use of biotech 
products or comparable no vel non-biotech products. 
 Please explain with referen ce to specific products at issue in this dispute. 
 Comparable non-biotech products from plant breeding 
 
 
102.01.  Regarding the differences between  conventional breeding and so-called 
"molecular breeding," none of the parties fully represent the comparison accurately.  Breeding involves two important process es: (1) finding and introducing usable 
genetic variation into the breeding popula tion and (2) improving and selecting desired 
varieties from the breeding population.  The methods used will depend on the crop, 
with major differences for clonal species, such as potato and banana versus sexual 
species, such as oilseed rape, maize and soybean.  Among the sexual species, there 
are major differences in breeding methods  between outcrossing species, such as 
maize and oilseed rape, and inbreedin g species, such as soybean, and wheat. 
 
102.02.  Transgenesis is a process to introduce genetic variation into the breeding 
population.  Transgenesis is not a process for finding genetic variation or for selecting and improving varieties.  Thus, there is no such thing as molecular breeding.  Transgenesis is merely a part of the breeding process. 
Comments by Argentina
 
 
Here the Expert makes several statements that merit incidental comment.  (a) "Transgenesis is a process to introduce ge netic variation into the breeding population". 
We would prefer: "Transgenesis is a process to introduce a precise genetic construct into the 
breeding population".    
 
(b) "Thus, there is no such thing as molecu lar breeding". Since the Expert points out 
repeatedly about new methodologies, he must recognize that molecular assited selection is a very useful way to use molecular biology in conventional breeding.  WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-160 
  
  102.03.  It would seem important then to  determine a comparable conventional 
counterpart to transgenesis for introducing genetic variation into the breeding population.  A comparable conventional process would be one typically used in 
breeding programs rather than one rarely used.  If possible a comparable conventional 
process would introduce genetic variation during a similar or analogous step in the breeding process.  The breeding process can eliminate considerable genetic variation, so variation introduced very early in the breeding process, will be screened and 
selected multiple times by multiple breeding pr ograms prior to use, while variation 
introduced much later in the process will receive fewer screenings and possibly no 
additional selection. 
102.04.  Several other methods exist to in troduce genetic variation into the breeding 
population.  These include wide crossing, crossing or using unadapted material, 
mutagenesis, and recombining diverse ad apted material.  Wide crossing involves 
crosses with different species.  Unadapted ma terial are plants of the same species (or 
subspecies) that have not previously been used in breeding programs.  Adapted materials are those that have already b een used to produce modern conventional 
varieties.  There is a range of "adaptedn ess" even within these materials, with some 
breeding programs relying primarily on the most recently used popular varieties and other programs reaching further back in time for older varieties as the source of 
genetic variation.   
Comments by Argentina
 
 
We would add diversity obtained through somacl onal variation, as a way to introduce genetic 
variation into the breeding population. 
 
102.05.  Crossing methods are difficult to use routinely for clonal and inbreeding species.  For example, in potato, genetic variation is conventionally introduced by 
growing plants to flowering and crossing ma terial, or via deliberate or spontaneous 
mutation during cell culture.  The crossing methods take a longer time to produce 
usable varieties.  For example some charact ers have not been incorporated in usable 
varieties despite over 30 years of work.  Cell culture is essential for producing new 
potato seed stock, so it is a routine way to introduce genetic variation and 
transgenesis introduces genetic variation in ce ll culture.  Thus for transgenic potatoes, 
the most relevant conventional comparison is deliberate or spontaneous mutation in 
cell culture. 
Comments by Argentina
 
 
We do not see the comparison the Expert is prop osing. Spontaneous mutation in cell culture is a 
"spontaneous" process, not under control by the breeder. Further selection is under the 
breeder's control. Also, we must clarify some  confusion and distinguish between the genetic 
variation introduced through genetic engineeri ng vs. the one introduced via spontaneous 
mutation and selection: in g.e. methods, the sel ection in focused at the deliberately introduced 
character, while in conventional breeding it is addressed at the desired character, already 
existing or generated through mutation. 
 
On the other hand, cell culture is not a natura l process, and spontaneous mutations are not the 
same as those induced trough mutagenesis, whic h is made by the breeder. In conventional 
breeding, further selection of the desired indivi duals, is close to be under the breeder's control.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-161 
  
   
102.06.  For inbreeding species, such as soybean and dry bean, variation can be 
introduced by hand pollinations (usually invol ving adapted material), or by using new 
collections because inbreeding lines will breed true to type.  In some cases it is 
possible to create situations where the inbreeding plant will outcross at higher rates.  In this way, it is possible to introduce va riation using crossing methods.  However, 
because the crossing methods typically are difficult, most programs do not use them very much.  All programs rely on evaluating collections (sometimes an old collection 
in a new environment) for new, usable  genetic material.  For these species, 
transgenesis is a new and powerful method fo r introducing genetic variation directly 
into the adapted modern varieties, thereb y avoiding the expense of crossing and the 
arbitrariness of collections.  Thus, it is not clear that there is a comparable conventional method.   
Comments by Argentina
 
 
See paragraph 102.5 and our comments. 
 
102.07.  For outcrossing species, such as ma ize and oilseed rape, there are many 
means to introduce genetic variation.  Fo r modern maize breeding, however, wide 
crosses and crossing with unadapted materials are not used in the vast majority of 
breeding programs in the world.  Many public sector programs devote some resources to these, but they are viewed as long term breeding efforts that may produce improved populations over decadal periods .  These improved populations may or may 
not be picked up by other breeding programs for introduction into their unimproved 
breeding populations.  By far the most common method for introducing new genetic 
variation into a maize population for breeding is recombination of adapted material.  
However, dwarfing even this method is "backcrossing," which is a method for introducing a specific genetic trait into an ad apted inbred line.  Both conventional and 
transgenic traits are introduced into adapte d inbred lines via backcrossing.  However, 
for maize, recombination of adapted ma terial is probably the most relevant 
conventional comparison to transgenesis.  
Types of risks
 
 
102.08.  As found by all scientific pane ls addressing this issue, there are no 
differences in the types or kinds of risks po sed by biotech crops compared with their 
non-biotech counterparts.  The kinds of risks include toxicity to humans and animals, 
allergenicity, nutrition, potential for produc ing disease, gene flow risks, non-target 
and biodiversity risks, and resistance risks.   
Comments by Argentina  
 
We fully agree. We would add that non-biotech cro ps have never been regulated so stringently 
as biotech crops.  
Nature or magnitude of risks
 
 
102.09.  Within these kinds of risk, there are new risks of biotech plants. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-162 
  
  102.10.  The EC is correct in pointing out that both biolistic and Agrobacterium -
mediated transformation typically results in  multiple transgene loci, typically with 
complex structure.  Unlike bacterial transf ormation, where what is intended to be 
inserted typically is inserted just as intended , this is not typical using the present plant 
transformation methods.  One of the main concerns arising from this are new open 
reading frames (ORFs).  An ORF is a DNA sequence that could theoretically produce 
a protein.  A new ORF could theoretically produce a new protein, which could cause or influence a new risk. 
Comments by Argentina
 
 
ORFs are no a concern but a regulatory issue,  i.e., an information requirement. Complete 
characterization of inserted sequences (PCR,  Southern), will allow the detection and 
characterization of restriction fragments contai ning ORF spanning into flanking plant DNA 
sequences. Bioinformatics methods are then used to  assess the potential risk of toxicity or 
allergenicity of the putative proteins resulting from the transcription and translation of these hypothetic ORFs. Northern blots will detect new transcripts. In the future, microarrays will 
provide also very accurate and comprehensi ve information. Although most of these 
improvements and concepts were not widely in pla ce by 1998, when later applied to old (as well 
as to new) GM crops, they have shown that no risks existed that may have gone undetected by 
1998. Therefore, although advanced, new methods in  this area can not be called to justify a 
suspension of approvals. Moreover, progresses in that area have confirmed the robustness of the 
approaches in place by 1998.  
102.11.  The EC and the US is correct to  identify insertional mutagenesis as another 
outcome of transgenesis that is new to br eeding, and could cause or influence a new 
risk. 
Comments by Argentina
 
 
Insertional mutagenesis (if leading to a viable indi vidual), is likely to show a phenotypic effect, 
and thereby the generated transformants will be disca rded in the selection steps. When it does 
not, then stability of the inserts (lack of mo bility phenomena), sequencing towards the plant 
genome and other techniques (e.g.,, microarrays, genomics, transcriptomics) will provide the necessary information. The alleged risks fa ll therefore within the scope of regulatory 
requirements and would not constitute real risks, as the developer has means to detect them and 
will never be submitted for approval. 
 
102.12.  Canada is incorrect to claim that  transgenesis allows more precise control 
than selective breeding.  First both tran sgenic and conventional varieties undergo 
some level of selective breeding, so the comparison is inappropriate.  More importantly, transgenesis allows control ove r the intended result (and in this sense, 
there is no dispute that transgenesis allows more precise control), but the actual result 
is often different. 
102.13.  The US, Canada and Argentina are correct to say that translocations and 
other genomic disruptions can occur in conventional breeding.  However, these genomic disruptions are normally rare in conventional breeding.  Moreover, their 
frequency of occurrence is much higher when  genetic variation is introduced using 
wide crossing than the more typically used recombination of adapted materials.    WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-163 
  
  Comments by Argentina
 
 
We can look at this question the other way. Tr anslocations and other genetic disruptions in 
conventional breeding may lead, for instance, to the movement of transcription factors or other 
DNA binding and regulatory proteins to other regio ns in the genomes. This would lead to a 
major change in phenotype. In fact, yield, a common objective in conventional breeding, has 
been shown to be a multigenic trait, involving regulation of, e.g., circadian rithm, hormone synthesis, abiotic stress resistance factors, pathogen resistance, plant architecture, flowering 
time and other relevant multigenic traits. This  would not result in increased risks (which 
anyway are not regulated) or in different, new risks, as 100 years of "modern" breeding have shown. Recent microarray experiments (to be confirmed) indicate that a larger number of genes are turned on by conventional breeding than by g.e. transformation.  
102.14.  Thus, the magnitude of ORFs and insertional mutagenesis introduced by 
transgenesis is higher than that  introduced by recombination of adapted materials.  It 
also may be higher than deliberate or s pontaneous mutation in cell culture, although 
this is less certain. 
Comments by Argentina
 
 
See comments under the previous paragraphs.  
102.15.  There is considerable research be ing conducted to understand and control the 
transgene insertion process, and it is likel y that over the next decade technical 
improvements will alter these concerns. 
102.16.  Some of the ORFs and extraneous transgene loci can be eliminated by 
independent assortment for outbreeding plants , such as maize.  This is less possible 
for inbreeding plants and clonal plants. 
102.17.  Nearly all risks associated with novel toxins (e.g., all Bt crops) introduced 
into crop plants are new risks.  While there are comparable risk assessment models 
for assessing these risks (toxins in plants), and the risks of the particular toxins may 
have been investigated outside the plant, th e fact that the plant is used as the delivery 
vector for the toxin and the precise expressi on patterns in the plant mean that new 
species are exposed in new ways.  These are new risks. 
Comments by Argentina
 
 
Again, this is a regulatory issue. For a developer to go ahead with a transformant, the equivalence between the expressed protein in the crop to the one isolated outside the plant should be inequivocally demonstrated. The me thods to prove that were well known by 1998. 
 
102.18.  Other risks of a new nature have b een identified in some of my responses to 
the other questions. 
Comments by Argentina
 
 
See above the relevant comments. 
 WT/DS291/R/Add.7 
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Page I-164 
  
  102.19.  The intended use of the product does not affect the nature of the risk, but it 
does affect the rusk quantitatively.  This is  an effect of scale.  For example, risks 
associated with releases for processing are sm aller than the same risks for the same 
product for planting and other use.  It is not clear how much smaller, but in some 
cases (biodiversity risks of GMHT crops), it could be nil for processing uses while it at the same time is was subs tantial for cultivation uses. 
Comments by Argentina
 
 
The Expert uses here a confusing wording. It is not clear the distinction between risks in 
processing vs. risks for planting. Usually, a cro p is planted for direct use or for further 
processing. Moreover, we suggest that to use th e expression "release for processing" in relation 
to biodiversity risks, may be nonsense when talk ing on the industrial setting in which the called 
"release" is made. 
 
102.20.  Risks may change quantitatively from the combination of transgenes, 
because it will not be possible to maintain seed supplies of all possible combinations of traits.  Suppose a crop, such as cotton,  was available mainly with both a GMHT 
gene and at Bt gene.  Suppose the insect p est is a sporadic one on cotton, but a major 
one on maize.  Farmers would have less incentive to use the Bt gene, but may have a 
strong desire to use the GMHT gene.  This would lead to an over use of the Bt gene 
in cotton, increasing resistance risk both in cotton and maize. 
Comments by Argentina
 
 
We disagree. Is totally speculative, close to a futu re-predicting statement, to say that the HT and 
IR traits will be always in the same variety in the future. Developers usually go the other way, 
and develop a wider array of different products to gain access to different markets or clients. 
 Question 103
 
 
103. Does the information before the Panel support the view that any of the biotech products at 
issue in this dispute poses a substantially greater ri sk as regards the direct or indirect consequences 
of unintentional "contamination" of other plant varieties than a comparable novel non-biotech products, such as one of the 2300 different crop va rieties that have been developed using induced 
mutagenesis?
1  If so, what means of risk mitigation might be envisaged? 
 
Risk and "contamination"  
 
103.01.  This will depend on the scale of rel ease and the nature of the adverse effect. 
Comments by Argentina  
 
We agree. 
 
103.01.  Risk is a combination of exposure and an adverse effect.  Exposure will be 
determined by the properties of the crop plant and the quantity of each planted (scale 
                                                      
1 FAO/IAEA (Food and Agriculture Organization of the United Nations/International Atomic Energy 
Agency). 2001. FAO/IAEA Mutant Varieties Database .  Available online at http ://www-infocris.iaea.org/MVD/.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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  of release).  There is little  evidence to suggest that ceteris parabis , gene flow will be 
greater from a transgenic variety than a conventional one.   
103.03.  The definition of an adverse effect  entails specification of who or what will 
be affected and how is this effect consider ed adverse.  Thus an organic farmer may 
find contamination adverse because it removes his or her product from the organic food stream.  This could be considered a dverse because of economic loss and lose of 
quality of life or livelihood.   
Comments by Argentina
 
 
We object "contamination". It should be "adven titious presence". On the other hand, it is for 
organic farmer to keep his product GM-free as it commands a higher price. Also, some organic 
farmers are shifting their position and start to believe that GM crops are not incompatible with 
organic farming practices and rules. 
 
103.04.  There has been little discussion a nd less agreement over the nature of the 
adverse effects of contamination.  For ex ample, there can be economic and livelihood 
harms associated with the perception of adverse effects.  It is not clear to me that there is agreement that these kinds of perceived risks should be considered. 
103.05.  For the example in paragraph 103.03, the risk associated with biotech crops 
is substantially greater than the risk associated with any of the conventionally 
produced varieties.  However, this is la rgely due to the definition of the harm. 
Comments by Argentina
 
 
See comments under paragraph 103.3. 
 
103.06.  Although there is little data to suppor t this hypothesis, I would suggest that 
the probability of cross-contamination rises slowly with spatial scale for very small 
scale production, but once it reaches a large- size threshold, the probability rises much 
faster.  In general, "contamination" will be a spread process for which there is no 
advantage of the transgene in the invaded/  contaminated habitat, but there is an 
advantage in the habitat of origin.  In th ese cases, spread scales with the length of the 
boundary between the two habitats (not th e area of either) and linearly with the 
square of time.  However, at very small spatial scales, it is likely that managers will 
be able to take greater care in limiti ng accidents, resulting in lower contamination 
rates. 
Comments by Argentina  
 
Here the Expert is talking on "gene flow", wh ich he calls "contamination". Also, we can find 
other confusing statements by the Expert.  When talking on the "spread process" his comm ents are speculative. It does not distinguish 
between "habitats" and "agroeosystems", which is  a relevant issue. The spread the Expert calls 
"contamination" will depend on several factors, which all must be present for the so called 
"spread process" (which the Expert subtly asso ciates with invasiveness)  to occur: where the 
seed or grain falls, which is trait of the GM crop, the frequency of the spillage and its quantity, the selective advantage of the hybrid, the existe nce of the relevant selection pressure in the new WT/DS291/R/Add.7 
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  habitat and finally the risk which will result fr om the above facts occurring simultaneously. 
Frequently, the answer to this kind of questions  has been answered by recognized authorities 
with the "so what?" question. We propose this kind of exercise to be made also by the Expert. 
 
Also, when considering the above risks, the Expert is actually referring to the efficiency of the 
transportation system, rather to the GM crop properti es, as the first event, that is spillage, is the 
necessary pre-requisite for the other successive phen omena to take place. In other words, we are 
talking here on "management" but not of the crop but of the transportation system.   
 
Moreover, research is in progress to introduce "g ene restriction" constructs (t-GURTs), which 
will not allow the introduced trait to introgress into the hybrid. Although unpopular in their 
variety version (v-GURTs), trait-removing GURTs show interesting possibilities to avoid gene 
flow. 
 
Question 105
 
 Rationale for monitoring
 
 105. For those biotech products at issue in this dispute for which no significantly different nature 
or level of risk has been identified, is there a sci entific or technical rationale for monitoring the 
occurrence of potential adverse effects, or of uninten tional effects, arising fr om the consumption or 
use of these products compared to  novel non-biotech products, such as  plant products produced by 
selective breeding, cross-breeding and induced mutagen esis?  If so, would such monitoring relate to 
the specific genes or traits introduced into a bi otech product, and how would this compare with the 
monitoring of induced changes in novel non-biotech products?  
 
105.01  There are some biotech products at issue in this dispute for which one 
committee or another has determined that were no significant risks.  I have taken 
issue with some of these determinations in  my previous responses.  For all of the 
products at issue in this dispute, there are some member countries that disagree with 
the assessment of the relevant SCP (for example) that there are no significant 
identified risks.  This disagreement is so metimes related to different standards of 
acceptable risk being applied by the disagreeing parties. 
Comments by Argentina
 
 
Please see our comments to paragraph 99.01. 
 
105.02.  This disagreement provides the only rationale for monitoring potential adverse effects.  If all parties agreed that there were no significant identified risks, there would no need to consider monito ring for potential adverse effects.   
105.03.  Unanticipated effects could arise from a transgene by any of the following 
mechanisms:  new ORFs, insertional muta genesis, post-transcriptional or post-
translational processing, other pleiotropy or epistasis, and gene-by-environment 
interaction.  New ORFs and insertional mutagenesis can be addressed through molecular characterization of all transgene loci.  Post-transcriptional or post-translational processing can be addressed to the most part by molecular and 
biochemical analysis.  Other pleiotropy or epistasis and gene-by-environment 
interaction cannot be addressed without extensive planting in the field.  WT/DS291/R/Add.7 
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  Comments by Argentina
 
 
Please see our comments to paragraph 99.03. 
 
105.04.  Under present technologies, tran sgenes can generate new ORFs and 
insertional mutagenesis.  Post-transcrip tional and post-translational processing may 
relate to the structure of the transgene and the nature of the gene product.  Products 
novel to the plant probably require closer assessment.  A gene product native to the 
recipient plant may be less subject to pr ocessing, except if it is expressed in new 
tissues.  Novel products probably require cl oser assessment than native products for 
other pleiotropy or epistasis and gene-by-environment interaction. 
105.05.  Monitoring can be used to look for unanticipated effects. 105.06.  A less thorough molecular and biochemical characterization of the transgene 
locus and transgene products provides increased  potential for unanticipated effects.   
105.07.  Monitoring may be partially subs titutable for molecular and biochemical 
characterization. 
105.08.  Monitoring may also substitute for identifying all possible effects, by 
covering various categories of unanticipated effects.  If a thorough molecular analysis is conducted, it would seem important to en sure that monitoring for the remaining 
unanticipated effects is not too expensive. 
Comparison with non-biotech varieties
 
 
105.09.  For monitoring related to a specific  potential adverse effect, this would have 
to relate to the specific genes/ traits in  the transgenic crop.  For monitoring for 
unanticipated effects, a more general approach is needed. 
105.10.  First, I should make clear that so me conventional non-transgenic plants have 
risks, some of which may justify monitoring (and management). 
Comments by Argentina  
 
We fully agree. This is the case in HT crops b red from spontaneous mutants with this trait. 
 
105.11.  For potential adverse effects, the re asoning I have used here implies that the 
potential adverse effect is not a potentia l adverse effect from a conventional non-
transgenic plant.  Otherwise there would be no disagreement as I have posited in 
paragraph 105.01. 
105.12.  For unanticipated effects, there is  a quantitative difference in some of the 
concerns related to the process of transg enesis (paragraph 102.13), and differences 
related to the novelty of the transgene product (paragraph 105.04).  Native biotech products may or may not be different fro m conventional breeding for unanticipated 
effects stemming from other pleiotropy or epistasis and gene-by-environment interaction. WT/DS291/R/Add.7 
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  Rationale for management
 
 106. For those biotech products at issue in this dispute for which an approval has been sought for 
environmental release (notifications submitted und er Directives 90/220 or 2001/18), and for which no 
significantly different nature or level of risk has b een identified, does the info rmation before the Panel 
provide any scientific or technical rationale for requiring specific agricultu ral management practices 
that differ from those for novel non-biotech products , such as plant products produced by selective 
breeding, cross-breeding and induced mutagenesis?  
 
106.01.  There are some biotech products at issue in this dispute for which one committee or another has determined that were no significant risks.  I have taken 
issue with some of these determinations in  my previous responses.  For all of the 
products at issue in this dispute, there are some member countries that disagree with 
the assessment of the relevant SCP (for example) that there are no significant 
identified risks.  This disagreement is so metimes related to different standards of 
acceptable risk being applied by the disagreeing parties. 
Comments by Argentina
 
 
Please see our comments to paragraph 99.01. 
 
106.02.  This disagreement provides the only rationale for risk management.  If all 
parties agreed that there were no significan t identified risks, there would no need to 
consider monitoring for potential adverse effects.  If only some of the parties recognized the risk, then some kind of conditional risk management could be 
justified.  For example, one condition for the management measures could be the 
country of use. 
COMMENTS ON REPLIES TO QUESTIONS BY DR. SQUIRE
 
 Measures affecting the approval and marketing of biotech products
 
 
Notes on ecological and environmental standards 
 
1. These notes are intended to summarise my views on some general issues 
pertaining to the questions set by the panel. The notes touch on – 
• the general weakness of current crite ria and standards, particular in 
relation to ecological  topics, by which products of the type under 
review might be judged, 
• the importance of context and scale when assessing new global 
products for specific markets, 
• some recent and current  research in geneflow and ecological 
impacts.  WT/DS291/R/Add.7 
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  Criteria and standards 
 
Information required to prove that a biotech product is safe 
 
2. No product can be assessed as being absolutely safe. There seems to be 
general agreement on that. However, th ere is no general agreement on what 
should be considered as acceptably safe. As  information is first gathered on a 
product, the likelihood that the product is safe or not may increase quite 
steeply, but gradually each further piece  of information comes to contributes 
less and less to the likelihood that th e product is safe. (The knowledge/safety 
curve assumes the form of 'dimin ishing returns'). Among the present 
arguments, however, there seems no agre ement as to when there is enough 
information to satisfy all reasonable pa rties that a product is safe. This is 
largely because there is no benchmark or set of standards by which ecological 
safety can be judged.  
Comments by Argentina
 
 There seems to be a confusion here, in the way the issue is presented. We believe it would be more understandable to talk in this particular ca se on the "likelihood of being safe (LBS) vs. 
knowledge (K)" curve. The accep table safety standard (ST) would be a line parallel to the K 
axis so a product will be considered safe if the curve surpasses that ST line going upwards (of 
course, the ST should be considerably low er than the "irreversible damage" line). Whenever 
new knowledge is introduced, the LBS curve may depart further from the ST in either direction (e.g., Bt maize has been shown to be safer th at regular maize, with regard to mycotoxin 
contamination, the LBS curve will move upwards; trans -fatty acids have shown to behave as 
saturated, and therefore have similar risks as the latter, the LBS curve will move downwards). 
 Considering the last sentences ("Among the present  arguments, ..."), and taking this argument 
to the extreme, as new knowledge is incorporated  all the time, it seems that it will never be 
enough information that will possibly set the ST line at a given value; the practical consequence 
of this situation, is that the ST line will move  either up or down and no information will satisfy 
all reasonable parties, as th e standards themselves will move . 
 
3. There is an important set of exceptions  to the 'diminishing returns' shape of a 
knowledge/safety curve. If the body of knowledge reveals a new property of 
the biotech product, or if the external 'environment' – the context – changes, 
then the knowledge/safety curve c ould well steepen again because much 
additional knowledge is then  required to ascertain that the product is safe in 
relation to the new property or context. In some instances, new properties might emerge only after a product is grown over a period of time or over a 
wide area of land.  Several of the arguments and uncertainties in the dispute 
over geneflow and contamination are of  this type: current knowledge seems 
insufficient to model and predict the extent of a potential problem. 
Comments by Argentina
 
 
In the context of the above, there seems that th e K axis no longer refers to "knowledge" (source: 
the scientific literature) but to "additional knowl edge required to ascertain safety" (source: the 
regulatory requirements); within this interpretat ion, the Expert seems to refer to "long term 
effects"; see below on that subject; we believe that this reasoning leads to a justification of the WT/DS291/R/Add.7 
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  suspension of approvals: it will never be enough knowledge to satisfy the regulatory 
requirements for information, as the release of  new information is a never ending process . 
 
International Standards and Guidelines  
 
4. The standards and guidelines referred to  in the panel's questions are (to this 
reviewer) important steps towards an agr eed set of standards. They differ in 
their stringency and required detail. Recommendations are relatively well 
defined and stringent in the WTO Sanitary and Phytosanitary Measures , in 
ISPM 11 , and in the Guideline for the Conduct of  Food Safety Assessment of 
foods derived from recombinant-DNA plants .  The latter in particular requires 
great detail in characterising and describing the genetic material, plant 
metabolites and other constituents. Ma ny of the 'requests for further 
information' by the EC or its member states are consistent with (i.e. not 
beyond) the level of detail indicated in that publication. 
Comments by Argentina
 
 We agree with the expert that the SPS Agreeme nt is an acceptable source for standards. 
 
5. Less detailed and prescriptive are the 'Proposed draft annex on the assessment 
of possible allergenicity.....'  and the Annex III of the Cartagena protocol on 
biosafety to the Convention on Biological Diversity'. Both offer less well defined guidelines, largely because th e issues (allergenicity, impact on 
ecosystems) are complex and, as indicated at paragraphs 2 and 7, there are no 
or few obvious quantitative criteria on which to base assessments. This weakness of criteria makes risk assessment very difficult in relation to these topics.  
Comments by Argentina
 
 
We agree with the expert that the other quoted documents are less detailed and prescriptive 
than the SPS Agreement.  
6. As many others have said, non-bi otech crop plants are not subjected to 
anything like the same degree of testing as biotech plants. If they had been, the 
ecological standards might now be in place.  
Comments by Argentina
 
 The fact that non-biotech crop plants have not been subjected to anything like the same degree of testing as biotech plants, as accepted by the Expert, also implies that, since the non-biotech 
have been considered safe (as far as ecological st andards), they should constitute an acceptable 
comparator to review biotech crops. Otherwise, th is reasoning leads to a dead-end situation: 1) 
non-biotech were not subjected to testing, but ge nerally recognized as having acceptable safety; 
2) if biotech can not be compared with the suitab le non-biotech crops, then…; 3) there is no way 
to test the biotech because there are no "sta ndards" (the concept of "standards" implies the 
comparison with a specified product or set of quantitative values they should comply with), 
therefore…; 4) there is no way for biotech products to be tested or reviewed. This reasoning 
contradicts the experience over the years and in ma ny countries, indicating that the tests set in 
place in these countries (as well as the regulator y requirements that go with them) were valid  WT/DS291/R/Add.7 
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  indicators of safety, as no harmful incident ha s been reported, other that those which would 
have had occurred with non-biotech crops under si milar conditions. In the context of the above, 
there seems that the K axis no longer refers to "knowledge" (source: the scientific literature) 
but to "additional knowledge required to ascertain safety" (source: the regulatory 
requirements); within this interpretation, the Ex pert seems to refer to "long term effects"; see 
below on that subject . 
 
Criteria and comparators for ecological effects  
 
Many of the arguments around the ecological benefits or harm of biotech crops are 
carried on without reference to objective criteria.  Annex III of the Cartagena 
Protocol on Biosafety to the Convention of Biological Diversity  indicates only the 
general type of information that might be  considered. Even when discussing specific 
products in relation to specific ecosystems , neither the biotech companies nor the 
responding EC bodies refer to objective criteria when stating that a product is safe or not. For instance, an assessing body might require more inform ation on long-term 
ecological safety without stating what type  of information is necessary to ascertain 
safety. 
Comments by Argentina
 
 Again appears the argument that there are no objective criteria in international reference 
documents. The example of the long-term ecologica l safety also leads to a dead-end situation as 
proposed above. How long is "long term?". Besides this, should it be understood that an 
appropriate risk analysis has no predictive value? Among other objectives, the risk analysis 
methods and criteria are not "present value" data  (i.e., decaying in val idity with time) for 
decision making. If not were for their predicting  feature, they would be worthless. However, one 
must recognize that, for the risk analysis to have this predictive value, it has to consider 
comprehensively all the variables involved as well as all the knowledge available at the time . 
 
7. The problems referred to in paragraph 7 arise because we lack a set of 
properties –physical, chemical, biological, social and economic – which define that a production system is re silient and 'healthy'. As a stop-gap, 
ecological studies have compared GM products with non-GM isogenic lines 
when making initial comparisons on a sm all scale, and then with another 
agronomic practice when making comparisons on a field scale. Even when a comparator is used (e.g. current practice), it is not yet clear that the comparator is an appropriate standard , one that will sustain crop production. 
Neither side in the argument over any product has indicated, even in general 
terms, what a suitable set of ecological standards might be. 
Comments by Argentina
 
 The expert is criticizing both sides in the argu ment, pointing the "lack of standards" issue. 
 
Scale and context in assessing bi odiversity and ecological impact 
 
8. The arguments in paragraphs 7 and 8 are complicated further because 
ecological criteria will be influenced by the context – the combination of 
weather, soil, landscape, the agronomy and economics - of which the flora and fauna are an essential part. The companies seem to have been unaware WT/DS291/R/Add.7 
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  of, or not appreciated, the context in which biodiversity exists when 
presenting many of the cases in support of their products. Biodiversity is important primarily because it keeps an ecosystem intact and functioning and 
makes it resilient to external pertur bations. The diversity-function relation - 
i.e. that diversity in microorganisms,  plants and animals is required to 
maintain essential functions such as decomposition, nutrient transformations, 
soil formation, detoxification, regulating pests, etc. - has b een largely ignored 
in arguments over the safety of biotech crops (and non-biotech crops). 
Comments by Argentina
 
 This consideration, which is essentially true, must  be applied also to agriculture as a whole as 
practiced today. Therefore it applies also to non-biotech crops. However, biodiversity 
conservation data are an essential part in the regu latory process in our country, and has been so 
to the extent that we require data in genera l and specifically, whenev er it was reasonable to 
expect impacts, e.g., phenotype-environment inte ractions, non-target effects. All approved GM 
crops must comply with these requirements . 
 
9. It is necessary therefore that the biodi versity in the cropped field is taken into 
account as much as the biodiversity of the semi-natural habitats surrounding 
agriculture. Moreover – 
• what is considered the valuable biodiversity in one part of the world 
might be very different from what is  considered valuable in another 
part, and 
• a product that is considered to have negligible impact on total 
biodiversity in one part of the world might have a large effect in 
another (and vice versa).  
There are some large differences between  Europe and North America in these 
respects. In many parts of Europe, valuable biodiversity is considered not just that of natural and semi-natural areas (mountains, extensive forests), but must include the flora and fauna within arable fields, both fo r the reasons in paragraph 9 above (i.e. the 
diversity-function relation) and because biodiversity in the form of farmland plants, 
insects and birds is perceived by people as being valuable.  
Comments by Argentina
 
 Again, the Expert emphasizes the fact th at, in his view, there are no standards. 
 
10. Emergent properties at the landscape scale . Moreover, it is scientifically 
unreasonable to assume that an effect (positive or negative), or the absence of effect, of a biotech product when measured  at the scale of the single plant or 
small field plot will be the same when measured at the scale of the field, farm or landscape. Up-scaling of biological effect to the landscape was a major 
topic of research in the 1990s and still is. Questions include - 
• Will cross-pollination frequencies at a field or feral population rise 
substantially as the proportional area of a donor type increases in the landscape?  WT/DS291/R/Add.7 
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 Page I-173 
  
  • Will volunteer and feral populations become more competitive and 
longer persisting as they evolve through selection and the incorporation of new traits? 
• To what extent will variation in local physical conditions and 
occasional human error seriously re duce the efficacy of mitigation 
protocols? 
11. One of the main difficulties in predicting the effect of any type of innovation 
is still the uncertainty over up-scaling. What will happen as more and more of the land area is affected by the innovation? Again, progress is limited by the absence of hard criteria that define res ilient or sustainable states at the scales 
in question.  
New research since 1998 on relevant ecological
 topics  
 
12. In part to address issues in paragraphs 8 to 12, a large body of research has 
been commissioned on ecological impacts and geneflow in Europe. Much of 
the previous research on GM plants in the early and mid-1990s compared 
genetic lines with and without a GM trait,  either in containment, or in small 
areas of field. However, it was increasingly accepted during the 1990s that this was insufficient to provide know ledge of the spread, persistence and 
ecological effects of biotech crops at scales of the field and landscape. An important watershed was th e symposium held in 1999 - Geneflow in 
agriculture:  relevance for transgenic crops  - which brought together 
researchers from Europe and North America to compare latest studies on geneflow and persistence of GM and non-GM crops in the environment. This 
symposium drew attention to the fact that geneflow at the landscape-scale had spatial and temporal features that were not evident at smaller scales of 
study 
Geneflow in Agriculture: relevance for transgenic crops. (1999)  Proceedings of a Symposium 
held at the University of Keele, 12-14 Ap ril 1999. Chaired by PJW Lutman. British Crop 
Protection Council, Farnham, UK. 
13. Both the EC and several EC countries have commissioned multi-partner 
studies on geneflow and GM impacts.  Results are reported for some studies; others are in progress or partly completed. They include the following projects. 
• SIGMEA - Sustainable Introduction of GM crops into European 
Agriculture (http://sigmea.dyndns.o rg/) a EC-funded project which 
began in 2004 and has the main aims of (a) collating European information on the spread, persistence and ecological effect of the main crop species under review here  and (b) developing models and 
decision support tools for the introduction of GM crops and their 
coexistence with other forms of cropping. SIGMEA has contributions 
from 45 partner organisations, a nd will be conducted over three 
years. Progress to date indicates that a very large part of the scientific knowledge on this topic is not yet in the public domain, because it is either recently completed and not published or is still in progress.   WT/DS291/R/Add.7 
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  • ECOGEN – Soil ecological and economic evaluation of genetically 
modified crops ( http://ecogen.dk
), an EC-funded project in progress, 
examining the effect of Bt maize and other biotech crops on soil 
communities and processes at field sites in Denmark and France. 
• The Farm Scale Evaluations of GMHT crops compared GMHT and 
conventional crop management on arab le plants and invertebrates at 
more than 250 sites in the UK. The first findings for spring-sown crops were published in 2003 and the  effects of winter oilseed rape on biodiversity will be in 2004. Studies on gene movement and persistence of the GMHT trait are in progress.  
The Farm Scale Evaluations of spring-sown genetically modified crops. 2003. Philosophical 
Transactions of the Royal Society, Biological Sciences, 358, Theme Issue. 
Comments by Argentina  
 
We believe these studies do not apply and quoting th em here is taking them out of context.   
Also, it seems that the quote, if carefully anal yzed, does not put a blame the GM crops, but, on 
the contrary, indicate the weakness of the arguments against them.   See the comments below, by J.L. London in "Bio safety trials darken Outlook for transgenic 
crops in Europe" (Nature, 425:751, 2003); some excerpts (bold and underlines are ours): 
 
"Britain's Farm Scale Evaluations, Pub lisher on 16 October, show that two 
genetically modified crops – spring oilseed ra pe and beet – are likely to have harmful 
impacts on farmland biodiversity. Researchers say the levels of weeds, seeds and 
insects in fields of transgenic crops were lower than those in plots of conventional 
varieties, and that this could have a knoc k-on effect on the birds and small animals 
that feed off these populations.  
Although the problems are caused by th e herbicide-spraying regime associated 
with the crops, rather than the crops them selves, the results are likely to make it 
politically impossible  for the British government to license transgenic crops in the 
immediate future, many observers say. … Th e trials, which took place between 2000 
and 2002 and are published as eight papers in the Philosophical Transactions of the 
Royal Society B , compared conventional and transgenic varieties across 200 plots. 
Positive results for a third crop — maize (corn) — have been called into doubt, 
as the weed-killer used on most of the conventional plants is to be phased out.  
But the other results have not been direc tly challenged by most supporters of the 
technology. The data show that the number of seeds on the ground in the plots of transgenic oilseed rape and beet was one -third to one-sixth lower than in the 
conventional plots. Levels of some insects and weeds were also lower. "We could see 
a long-term decline in weeds that feed bi rds," says Les Firbank, a land-use specialist 
at Lancaster University, who led the trials. Firbank and the other authors stress 
that it is the herbicide-spraying regime, not the genetic modification, that is the 
root of the problem . Herbicide-resistant crops are engineered to resist broad-
spectrum weed-killers that remove almost all weeds from a field. (*)   WT/DS291/R/Add.7 
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  During the farm-scale evaluations, farmers sprayed the crops once or twice with a 
broad-spectrum herbicide . This reduces the labour requi red for conventional weed 
management, which involves repeatedly applying less powerful weed-killers. But the 
more powerful herbicide used with th e transgenic crops also removes more 
weeds , as well as the seeds they produce. Repr esentatives of the agri culture industry 
point out that this leaves open the possibilit y that another herbicide-spraying regime 
might have lessened the impact on biodiversity while still reducing farmers' labour. …"… given the intense public opposition to transgenic agriculture, the chances of 
commercializing herbicide-resistant crops in the short term are slim (see Nature 425, 
656–657; 2003)…. No decision will be made until a panel of scientific advisers has 
considered the results for the government. But environment minister Elliot Morley 
has already said that no commercial planting will take place in 2004. In the meantime, work on better spraying regimes continues ." 
(End of quote) 
* Note of  this reviewer: The removal of all the weeds from a field is one 
characteristic of modern agriculture . 
• Botanical and rotational implications of genetically modified 
herbicide tolerance in winter oilseed rape and sugar beet (BRIGHT project). Several years of study at 5 sites in the UK comparing the 
management of various herbic ide tolerant varieties.  
Final report at 
www.hgca.com  and look under Crop research . 
• GMO Guidelines Project, under the auspices of the International 
Organisation for Biological Control (IOBC), funded by the Swiss Development Cooperation; the aim is to develop international 
biosafety testing guidelines for tr ansgenic plants, with emphasis on 
ecological communities and processes in developing countries, but in 
principle applicable to Europe.
  
Hillbeck A. and Andow DA (Eds) 2004. Environmental risk assessment of 
genetically modified organisms. Volume 1. A case study of Bt maize in 
Kenya. Eds. CAB International, Wallingf ord, UK.  Further case studies are 
in progress. 
• Additionally, there are many othe r country-specific studies, notably 
in Germany, France, Denmark and the UK that are still in progress.  
14. In summary, the understanding of environmental and ecological risk and 
benefit has lagged behind the understandi ng of most other forms of risk. 
There is no set of agreed criteria for defining 'ideal' arable ecosystems and 
this has restricted logical and rational argument on ecological impacts in most of the cases under review.  Research is  in progress in a range of European 
contexts to provide the scientific inform ation which could be used to define 
the necessary criteria. WT/DS291/R/Add.7 
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  Comments by Argentina
 
 The expert's remarks are addressed at demonstrat ing that new knowledge is just appearing now 
(or is just in progress), so one could interpret that it is advisable to suspend approvals 
indefinitely, waiting for any new data which could justify these suspensions. The question here is whether the Technica l Commission did or did not have all the available knowledge needed for 
decision making. 
 
Annex to Notes. Persistence and movement of genes among crops, weeds and wild relatives 
The summary in Table 1 is offered as bac kground to several of the panel's questions 
that refer to persistence and spread of GM  plants. Several of the crops under review 
have the potential to shed seed and leave descendents. The following definitions are 
used. Volunteer(s): plants that originate fro m seed or vegetative material shed or left 
by a crop and that inhabit fields, usually emerging as a weed within a crop. Feral: 
plants that originate from seed or vegetative material shed or left by a crop and that 
exist outside fields, in waysides and the ma rgins of agriculture. (Some authors use the 
term feral for plants descended from a crop whether they are found inside or outside fields.) The table shows that transmis sion among crops, feral/volunteer plants and 
wild relatives is highly species-specific. Persistence and spread are generally greatest 
for oilseed rape, low for beet providing th e crop is prevented from flowering, very 
low for maize except between flowering ma ize crops and negligible for cotton as 
presently grown in EC countries. 
A relevant factor in all arguments over biot ech oilseed rape is that the perception of 
oilseed rape as a weed pest in Europe h as increased as more findings from research 
became available from the mid-1990s and through the early 2000s. Notable facts include – 
• It persists over 5 to 10 years at rela tively high density in the soil (e.g. around 
100 seeds per square metre).  
• It is very widespread in the arab le seedbank, commonly among the top 10 
species within fields and occurs  frequently as a wayside plant. 
• Its re-seeds in subsequent crops of oilseed rape. 
• Pollen-transfer causing low-frequency cr oss-pollination occurs over several 
kilometres: insect vectors are important in moving pollen. 
For the sake of balance, oilseed rape should also be seen as a valuable and flexible 
'break crop' in cereal rotations; it needs lower agrochemical inputs than many other crops and  supports a high level of in-field biodiversity.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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  Table 1.  The ability of the crops to disperse genetic material through feral or 
volunteer progeny, pollen movement and out crossing to form hybrids in Europe. 
Author's summary.   
 Beet Maize Oilseed 
rape Cotton 
Feral / volunteer weeds 
 persistence in field  persistence outside field   
medium medium  
zero
1 
low  
high medium   
zero zero 
Pollen transfer   crop to crop  
low
2  
high  
high  
low 
  crop to feral /volunteer low2 zero high zero 
  crop to wild relative low2 zero low zero 
Crossing frequency (on arrival of pollen at flowering plants)     
 crop to crop  high high high low 
 crop to feral high zero1 high - 
 crop to wild relative high (local) zero low - 
 ________________ 
  1  In most of Europe; potential for some survival in the south. 
  2 Provided few or no crop plants allowed to flower. 
 
Comments by Argentina  
 
See comments on Table 1. 
 
The presence of a GM construct should not markedly affect the qualities in Table 1 
nor the status of oilseed rape and other crops as a weed. However, if the GM construct is accompanied by genes that make the plant more or less male-fertile than other sexually compatible plants, then the GM trait might be spread differentially. 
Oilseed rape can again be used as an example since it varies commonly in male 
fertility (i.e. the proportion of plants that produce pollen): in some crop varieties all 
(or nearly all) the plants are male fertile, but other varieties plants can be mixtures of 
male-fertile (20%) and male sterile (80%) individuals. Also, volunteers (including 
GM volunteers) produced from seed shed by some types of GMHT crop plant can be 
variously male fertile or male sterile. Genera lly, crops and plants that have more male 
sterility get more cross-pollination from other fi elds or plants than those that are fully 
fertile. It is important to know when asse ssing the risk of spread and persistence 
whether the variety and its offspring are fully, partly or not male fertile. 
Replies to Questions
 
 
3. Effect of Bt maize on non-target organisms   
Bt crops are grown widely in some regions of the world. They are used to target crop-
specific pests, with a consequent, intended benefit that less chemical insecticide is 
used. They have a potential disadvantage, in that they might harm other organisms in 
the ecosystem. Among these are the predators a nd parasitoids that feed on the pests,  
and organisms not normally reached by chemical insecticides. Important examples of WT/DS291/R/Add.7 
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  the latter are soil fauna that might be exposed to the toxin if it occurs in or moves out 
of roots, and detritus feeders and other decomposers that encounter the toxin in dead or dying plant matter. There are therefore arguable advantages and disadvantages in 
the use of the product. The emerging results  from North America show that pesticides 
have been reduced, but not in all inst ances – context is important. Much less 
information on non-target organisms has come from existing Bt maize-growing areas. 
Potential for ecosystem effects . Assessments of potential eco logical harm or benefit in 
areas such as Europe have so far relied la rgely on findings from research in the 
laboratory or in contained systems in whic h the Bt plant and organisms tested have 
no, or restricted, contact with the outside wo rld. Three of the exhibits referred to in 
Q.3 (EC-150, -151 and -152) are among th is body of research. The potential
 for 
ecological effects is indicated by these and other studies, and some of them have 
shown that the toxin might well affect soil organisms. Exhibit EC-149 is a review of 
laboratory and field data up to 1999, and concludes that, because of the small area 
and short duration of the experiments, only limited inferences can be made about 
large scale or long term ecological effects. Since then, there have been few field-scale 
experiments on Bt crops in Europe comparable to those in the present ECOGEN project, from which results should be available in 2005.  
Comments by Argentina
 
 
"Potential for ecological effects", "the toxin might well affect soil microorganisms", "limited 
inferences", and finally the reference to studies  from "which results should be available in 
2005", as listed, are all statements more close to  opinions than to a rep ort of scientific facts. 
What scientific facts have already established at  all, molecular, anatomical and physiological 
levels, is that Bt entomotoxins are highly sp ecific to insect Orders. Also, because of their 
mechanism of action (which starts by binding to specific receptors in susceptible insects' mid-
gut), Bt entomotoxins are very unlikely to have harmful effects on other organisms. This lack of 
harmful effects has been widely reported in availa ble scientific literature. Also, it will help to 
point out that Bt entomotoxins, as well as the ba cteria producing them, are in the fields for over 
60 years now, in the form of sprayable, not purified insecticide formulations. The bacteria 
producing the toxins, on the other hand, are present in soils all over the world. 
 
Scaling, timescales and dilution . The published studies do not demonstrate one way 
or the other what would happen if Bt maiz e were grown widely in Europe. There is 
no general consensus among scientists of what would happen when a Bt crop is 
introduced into any new region. It is argued by some that there could be a range of 
unforeseen, negative effects. 
Comments by Argentina  
 
Expressions like "do not demonstrate one way or the other", "There is no general consensus", 
"It is argued … there could be a range of unforesee n, negative effects", are opinions rather than 
information based on available hard data. 
 
In support of this view, the authors of Exhibit EC-149 write: 
Although such regulatory trials provide valu able initial toxicity information, basing 
ecological assessments solely on bi-trophic f eeding trials that provide the insecticidal 
protein in a highly processed form directly to the non-target organism is not  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
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  sufficient. Ecologically important interac tions between plants and herbivores and 
natural enemies/non-target organisms …. may be missed.  
Comments by Argentina
 
 
The above is another example of statements of th e "information is not sufficient" kind, which is 
followed by a statement on "important" data mi ssing, often expressed by this Expert. Mention 
should also be made, to be fair, on the lack of data supporting that negative effects are actually 
observed, which he is not considering, in spite of all reports available in existing literature. 
Moreover, the expression "highly processed" used when referring to the insecticidal protein, 
could be interpreted in many ways (some of them deceptive). "Highly processed" could mean: 1) different from the relevant protein as expressed in the plant; 2) produced by genetic engineered microorganisms; 3) obtained by processing the plant tissue; 4) obtained by expressing the active protein sequence; 5) obtained by converting in vitro  the pro-toxin into the 
active toxin; 6) using only the active, truncated  protein. This ambiguity is not relevant with 
regards to the statement quoted by the Expert, bu t it reveals lack of precision and descriptive 
value. 
 
The implication here is that exposure to the Bt plant over wider spatial zones, and 
season after season, might cause negative ecological effects that are not observed in 
short-term feeding trials in the laborator y or small-plot trials in the field. 
Comments by Argentina
 
 
See above. 
 
Conversely, it is argued that 'feeding' tr ials might create such artificial conditions, 
removing choice of food, etc. that they greatly overestimate effects that would occur in an ecosystem. An example of such a 'dilu tion' of effect is that of the monarch 
butterfly in North America, for which dama ging effects of Bt maize pollen, found in 
the laboratory, were subsequently shown un likely to occur in the ecosystem. There 
were several reasons for this: much of the insect's food plant occurred outside Bt 
maize fields, the seasonal timing of the in sect and the release of pollen only partly 
overlapped and the actual exposure of the insect to the toxin was lower in maize 
fields than in the laboratory. A lay article Butterflies and Bt corn: allowing science to 
guide decisions, published b y several US universities and the USDA provides a 
summary of the study; scientific papers are assembled in the journal Proc. Natl. Acad. 
Sci. USA, vol. 98, 2001. The results of many other feeding experiments would 
similarly be 'diluted' (this reviewer believ es) when examined in the context of the 
ecosystem. 
Comments by Argentina
 
 
We fully agree with the above paragraph by the Expert. 
 
The general absence of ecological standards and comparators . As discussed in the 
introductory notes, and in relation to he rbicide-tolerance (Q.6), a context and 
comparator are vital to any assessment, and as in the case of herbicide-tolerance, they 
have rarely been taken fully into acc ount when assessing Bt crops. Assessments 
purporting to show harm, for instance, should compare the effects of the Bt crop with 
an existing practice or standard, such as current pesticide management, or options WT/DS291/R/Add.7 
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Page I-180 
  
  using application of Bt preparations (for which there appears little ecological 
information). As for assessment of GMHT crops, there is no definition or set of criteria for an acceptable, resilient and sustainable ecosystem. It should be feasible for 
scientists to define such criteria, which would be generic but with location-specific 
elements. A recent case study of Bt maize in Kenya shows what can be done quickly by combining global and location-specifi c knowledge (Hilbeck A & Andow DA, eds. 
2004. Environmental risk assessment of gene tically modified organisms. Vol 1, A 
case study of Bt maize in Kenya. CABI Publishing).  
Comments by Argentina
 
 
Again, the Expert calls on the lack of both, co mparators and criteria for establishing acceptable 
ecological safety information. Again, he ignores the body of evidence and practical information 
available. Also he is suggesting that "ecosystem" is the place in which agriculture is practiced, 
rather than the more precise concept of "agro-ec osystem", that is, a highly perturbed, man-
managed ecosystem. Also, the Expert refers to the lack of "comparators", but do not mention 
"indicators", whose reliability is often a strong indication of potential for harmful effects. 
 
Mitigation . It much more easy to confine maiz e within cropped fields than it is 
oilseed rape or beet, for example, so the eco logical risks are mainly to do with the in-
field food web and with any wide ranging organisms that visit the field (i.e. there are 
no risks in much of Europe through ferals and volunteers). To plan a mitigation strategy needs understanding of the existing state of the food web.  In the UK Farm Scale Evaluations (see Notes ), which used >60 fields of GMHT, not Bt, maize, the 
maize fields supported a small set of organi sms compared to the organisms in oilseed 
rape and beet. This was so because the persistent herbicides then used on maize 
severely reduced the arable plants available for the insects to eat. 
Comments by Argentina
 
 
Clearly, as the Expert points out, the negative effect was due to the persistent herbicides used, 
reducing the arable plants for insects to eat,  and not to the biotech nature of the crop. 
 
Moreover, only a few species in the above -ground food web were found on the maize 
itself. If maize is adopted over wide areas of a country where it had not been grown, 
that itself would affect biodiversity whether or not it was Bt maize. 
Comments by Argentina  
 
We fully agree with this consideration by the Ex pert, who, in this way, is indicating that 
agricultural practices turn an "ecosystem" (b iodiversity saved) into an "agro-ecosystem" 
(biodiversity only partially con served), no matter which, biotech or non-biotech crop is adopted. 
 
Any additional effect of Bt should be seen in relation to the effect caused by the introduction of maize as a crop species. However, if Bt maize was found to harm the 
in-field biodiversity, it should be feasible to  reverse the effect by growing different 
crops in a rotation. Perhaps the main uncertain ty is the effect of Bt maize on the soil 
food web. As indicated, the ECOGEN project should inform on this. Effects in the soil would be harder to monitor because it is  very difficult to assess soil biodiversity, 
particularly among bacteria and fungi.  Ne vertheless, any adverse effects should be 
mitigatable through a rotation.   WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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 Page I-181 
  
  Comments by Argentina
 
 
On the expression "if Bt maize was found to harm the in-field biodiversity it should be feasible 
to reverse the effect by growing different crops in a rotation", we observe the following: a) is a 
conditional statement; b) whatever crop is so wed which cause adverse effects on resources 
(minerals depletion, changes in soil texture and structure, pathoge ns concentration, viability of 
weeds, among others), it is a regular agronomic  practice to rotate crops to alleviate the 
problems; i.e., it is the same for biotech or non-biotech crops. 
 
Q.3 addresses a complex topic.  the following is offered in summary.  
• The evidence is insufficient to confirm whether widespread cultivation of Bt 
crops in Europe would affect non-target organisms. 
• The weight of evidence from contained experiments and small-plot field 
experiments generally favours the view th at little immediate toxic effect of Bt 
maize on the food web will occur in the field; but the evidence admits the 
possibility of chronic effects following long-term exposure to Bt maize. 
• The question could only be answered by long-term study of the effects of Bt 
maize and a comparator on the comp lex interactions among non-target 
organisms; it would be difficult to see how that would be done without intensely monitored, field-scale experimental plantings in Europe. 
• Criteria for resilient food webs would need to be proposed and agreed as a 
standard for any new research: without such criteria, progress is impossible. 
Comments by Argentina
 
 
The comments on the topics referred to in the above summary, are addressed in each case. 
Again, the impossibility of progress comes as an argument. Extrapolated, this argument would 
make the progress of Science impossible.  
4. Emergence of Bt resistance under field conditions  
The emergence of resistance by pest insects to pesticides differs widely from context 
to context depending on factors such as the exposure to and strength of the toxin, the 
movement of insect populations from areas wher e the pesticide is not applied, and the 
genetics and mating system of the insect. Resistance to Bt crops has occurred and is 
influenced by the 'dose' of toxin delivered to the pest and the genetic nature of the 
pest, among other factors. Because of long-standing scientific interest in pest resistance generally, knowledge has been  imported from that body of work to 
construct models for the evolution and m itigation of Bt resistance. The processes 
involved in Bt resistance and its manageme nt are generally appreciated by scientists, 
and mitigation strategies that have a strong scientific basis have been considered. By 
the late 1990s, mathematical models of the population dynamics of resistant and 
susceptible biotypes were being used to estimate the number of years for which the GM trait would remain effective in the fa ce of genetic adaptation by the pest. The 
point is that sound scientific knowledge has b een applied to this problem for several 
years.  WT/DS291/R/Add.7 
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  A strategy for mitigation needs protocols for both pre-emptive management, testing 
for resistance and managing it if found. The strategies might involve providing refuges in or near the crop where resistant individuals do not have an advantage over 
resistant ones, periodically controlling the pest by other means and growing different 
'types' of Bt maize, or Bt and non-Bt maize, either together or in sequence. Mitigation will be much easier to implement where the existing ethos is sympathetic to integrated pest management based on genetic and ecological principles. A useful, recent summary of the topic, much of it in layman's terms, directed at Bt maize in 
Kenya but based on generic arguments, is given by:  
Fitt GP et al., (2004). Resistance risks and management associated 
with Bt maize in Kenya. In Hilbeck A & Andow DA, eds. 2004. Environmental risk assessment of genetically modified organisms. 
Vol 1, A case study of Bt maize in Kenya. CABI Publishing. 
5. Toxicity to animals of Bt maize compared to conventional maize  
(This response does not address the part of this question relating to humans.  Toxicity 
was considered as part of the Response to Q.3 and some of the argument here is repeated.)  Assessing a product's toxicity to ecological processes is usually more 
complicated than assessing the toxicity of, fo r example, a feedstuff for a domestic or 
farm animal. The domestic or farm animal ma y have the food under test as its sole or 
main diet in reality, whereas non-target or ganisms generally have a wider choice of 
food throughout the habitat. Also, the expression of a toxin in a plant and its effect on animals eating the plant are influenced by local growing conditions, the weather, the 
behaviour or the local animals, etc., all of which differ between sites. Therefore 
making inferences about toxicity to animals in one part of the world (e.g. a maize 
field in a European country) from information in a constrained experiment, or field 
experience in another part of the world,  should be done with great caution.  The 
contention that nothing adverse has occurred when growing Bt maize in, say, North America, should not be taken as definitive evidence by itself that nothing will occur 
in Europe, where the organisms and their interactions are different.  
Feeding experiments in which organisms are e xposed to live or dead Bt plant matter, 
and have no other choice of food, should be  viewed as providing information only on 
the possibility that the Bt plant might be toxi c to the animals in the field. Many of the 
studies in contained experimental systems are of this type. Some do and others do not 
indicate harm occurred, but none should by th emselves be taken to indicate that harm 
will necessarily occur in the field. (Several major crop species would fail toxicity 
tests of this type.) Many of the plot-scale experiments examined in EC-149 were 
criticised by the authors of that review fo r a range of reasons, but taken as a whole, 
experiments at the scale of small field plots and one season's exposure indicate no 
acute toxicity to animals other than the pest.  
Comments by Argentina  
 
It would be convenient to remember also what is  already known about the mode of action of the 
Bt entomotoxins: their require specific receptors  in the susceptible insects, and these receptors 
are not found in other animals. It would also be  useful, that the Expert quote the experiments 
"that (do) indicate harm occurred". Also, see the underlined (by this reviewer) text. 
  WT/DS291/R/Add.7 
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 Page I-183 
  
  Evidence, either way, of harm to animals of growing Bt crops in the field in Europe is 
therefore inconclusive at present. The ques tion could be approached by a range of 
experimental studies over longer periods, but the results would need to be compared 
against the effects of other crop species on the animals, and against independent 
criteria defining a normal or healthy state for the animals in question (as for Q.3). 
Comments by Argentina
 
 
The Experts calls on the "inconclusiveness" of th e evidence, pointing out the relevance of local 
studies, with which we agree with the following exception: the value of evidence in other, non 
European areas is not considered. We agree that lo cal effects could be different in some respects 
(e.g., animals choice of feed), but the entomotoxin would be the same, and therefore will provide a strong indication on toxicity to animals. Th ese data are not considered  as valuable. Also, the 
Experts calls for studies over longer periods; we al ready pointed out that risk analysis value is 
its predictive ability.  
6. Persistence of HT plants in the environment  
The background to this question is that several of the crops have become widespread 
feral plants or weeds (see Notes, Annex). O ilseed rape has been grown in Europe for 
centuries, but has become a weed in many parts of Europe following a great increase 
in its cropped area since the 1970s. It is now  a regular and persistent member of the 
arable and wayside seedbank (buried viable seeds). Oilseed rape is not considered a 
problem on waysides and is ousted by perenni al vegetation such as grass. Within 
fields, it is treated as part of the broadleaf weed flora. It also contributes to yield of the next oilseed rape crop, but has generally  not been considered a problem in this 
respect, since the quality of oil has generally  been similar in the volunteers and crop 
plants. Similarly weed beet, arising from seeding crop beet, is common in beet-growing areas and brings similar but lesser problems.  
Are HT plants a potential pest?  Oilseed rape and beet are both crops and pests, as are 
many other crop plants (pests as defined in ISPM-11, page 6). The volunteers or ferals arising from HT crops would be no greater pests than those arising from non-
HT crops, unless the specific herbicide was used to favour them as pests, or their 
presence in the field or in the yield itself had greater significance than the presence of 
non-HT. Since agriculture began, crops and weeds of the same species have existed 
side by side and exchanges genes – but this does not mean that volunteer/feral weeds are not pests.  
More serious problems to do with their pers istence as pests will arise if labelling or 
marketing 'rules' specified that a non-biot ech crop had to be of a high degree of 
purity, i.e. to contain less than, say, 0.9% of GM in the yield. 
6a. In the absence of use of the specific herbicide, HT plants would have the 
same potential as non-HT, as indicated in 6 above. Species would differ as in Table 1. Establishment and spread depends on local c onditions in ways that are not clear. For 
example, feral wayside populations of oil seed rape differ greatly in number in areas 
studied in France and the UK. Also, wild, weedy relatives differ in their presence and 
number in different parts of Europe, as do hybridisation rates between crops and 
between crops and wild relatives.  But the essential point is that - in the absence of WT/DS291/R/Add.7 
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Page I-184 
  
  the specific herbicide to which the plants are tolerant – plants having HT and non-HT 
traits should act similarly.  
6b. Suppose that HT plants were grow ing in mixed vegetation with non-HT 
plants of the same and other species, then  applying the herbicide would favour the HT 
plants, lead to greater seed set on HT plan ts and their increase in the seedbank. This 
would happen wherever the plants were gr owing and whether the HT trait was in 
volunteer/feral plants of had been transf erred to wild relatives. Whether such 
differences occurred in practice would then  depend on the how widely the specific 
herbicides were used (which itself woul d vary between countries and crops).  
6c. In the absence of the specific herb icide, the potential for establishment and 
spread should be similar for biotech plants tolerant to the wide-spectrum herbicides 
glufosinate ammonium and glyphosate. The genes conferring tolerance to either 
should not enable the plants to be better at, say, persisting in the soil. Relative 
persistence between the two GMHT types would differ if one or both of the 
herbicides was used. As indi cated, this will be highly specific to the agronomy of a 
farm or region. For instance, in the UK, gl yphosate has risen in the last few years to 
be the second (or maybe first) most widely applied herbicide in arable fields, while 
glufosinate ammonium is used little in fields or waysides. If GMHT glyphosate tolerant plants were present in fields, then  they would be advantaged at this specific 
time and area, where glufosinate ammonium tolerant plants would not.  
6d. Risk management options should be similar to those recommended for non-
biotech varieties (oilseed rape and beet), but would need to be more stringently 
applied if cropping was to ensure the proportion of GM in non-GM remained below a threshold.  Establishment can be reduced by –  
• Reducing or preventing seed loss to the soil, e.g. by harvesting oilseed rape 
before too many pods split (not always possible), uprooting flowering beet plants.  
• Not cultivating soil after harvest, leavi ng seeds to germinate on soil and then 
killing them by cultivation or herbicide spray. 
• As part of normal broadleaf weed contro l, ensure they do not flower and seed 
in later crops of other species.  
Spread can be reduced by – 
• Clearing seed from combine harvesters and other machinery between crops. 
• Transporting seed from field to market in sealed containers or vehicles. 
• Cutting or spraying roadsides that support large populations of feral oilseed 
rape, but these practices will impinge on the semi-natural flora. 
• Using a pollen barrier to reduce field-to-field geneflow (oilseed rape and 
maize), such as a strip of flowering crop 50 to 100 m wide between the donor and recipient crops and which is not harvested as part of the recipient crop.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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 Page I-185 
  
  The main difficulty in preventing establishm ent and spread is with oilseed rape, 
specifically in that it will enter the soil and become dormant even if soil is not 
cultivated after harvest, it will flower a nd seed, usually unseen, in a later crop of 
oilseed rape and it is impractical to remove all seed from farm machinery. Lesser 
problems occur with weed beet. 
6e. Post-market monitoring  
ISPM 11 does not give great detail on monitoring. The type of monitoring in this 
instance would differ depending on purpose: for example, monitoring the effect of a 
HT cropping on biodiversity or ecosystem f unctioning would require a different set of 
measurements from monitoring the presence or abundance of a HT trait. What is clear from existing data and work in progress is th at monitoring of this type is far from 
simple and needs much time and effort, especially if the aim to measure low frequencies (e.g. 1%, 0.1%) or small effects (e.g. 1.5-fold effects on populations or 
ecological processes). Recently introduced populations are highly aggregated or 
clumped and this increases the number of samples and area over which samples have to be taken. At present, there are no reliable and accepted monitoring schemes for the presence or impact of biotech-derived plants: research is in progress to develop such 
schemes (see Notes, paragraph 14 ), but it is not even certain that it would be feasible 
or practicable to monitor low frequency o ccurrences or ecological effects routinely
 in 
the field. 
Comments by Argentina  
 
Again the Expert calls attention about research in progress or just published. On this issue, see 
above. Although the data presented refers to oilseed  rape, it is often referred to as "biotech-
derived plants" in general. This generalization  does not consider the "c ase by case" criteria, 
which is at the very foundation of the risk anal ysis.  The purpose of this text seems to stress 
again that there are not enough data for decision  making. In the following paragraphs, it is 
difficult to distinguish to which specific HT crop the Expert is referring to . 
 
7. Adverse effects on flora and fauna   
The difficulties of argument in this topic revolve around what is classed as an adverse 
effect ( Notes, paragraphs 7-10 ). There are no objective criteria for what is an ideal 
state and what therefore might be judged an a dverse effect against that state. At best, 
HT cropping has been compared against an  existing cropping system. Certainly in 
Europe, the important and relevant flora and fauna should include those within the 
managed areas of fields.  
The Farm Scale Evaluations (FSE) in the UK ( Notes, paragraph 14 ) detected small, 
but important shifts caused by using GMHT rather than the conventional management, and illustrate issues of cont ext. The difference in weed management 
rather than the GM or conventional crop plants per se was the effective agent. The 
direction of effect differed depending on the severity of the conventional 
management.  In maize, where conventional manage ment uses persistent, highly toxic 
herbicides, GMHT increased the flora and fauna; in spring oilseed rape and beet, 
where current practice was less effective against arable plants, it had the opposite effect, reducing the flora and fauna. The cr ucial point about the FSE – and one that 
has been missed or misrepresented by many international commentators – is that the WT/DS291/R/Add.7 
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Page I-186 
  
  effects on the arable flora or weeds (though small by international standards) were 
important in the context
 of the UK's arable scene in the early 21st century. The flora 
and fauna of arable fields were important in the national biodiversity as perceived by 
many people; these flora and fauna had already been severely depleted by intense 
agriculture, so further depleti on was unnecessary and unacceptable.  
Comments by Argentina  
 
The underlined  (by us) phrase above speaks for itself. 
 
In principle, there should be no difference between the effects of GMHT cropping and non-biotech HT cropping, though this h as not been compared on a suitable scale. 
The BRIGHT project ( Notes, paragraph 14 ) made some comparisons of GMHT and 
non-GM HT crops.  
A general knowledge of the macro- and micr o-fauna in the soil suggests they will be 
much less sensitive to GMHT cropping than will the above-ground flora and fauna. The FSE and some other work included macr ofauna caught on the soil surface, but no 
large-scale studies of herbicide tolerance have included soil micro-and macro-fauna. 
(ECOGEN will provide information on soil communities at three field sites for Bt maize.) All evidence from small-scale work in  field plots and containers points to the 
herbicides glyphosate or glufosinate ammonium being much less directly toxic to soil 
fauna than other agrochemicals and the GMHT  plants themselves having no effect on 
soil organisms different from that of non-GM plants.  
Comments by Argentina  
 
This underlined  (by us) phrase above speaks for itself. 
 
9. Molecular characterisation  informing  risk assessment  
The Guideline for the conduct of food safe ty assessment of foods derived from 
recombinant-DNA plants  indicate full characterisation of the genetic change should 
be provided. Such information may be essential for assessing some aspects of the 
product but is not always necessary when c onsidering spread or persistence of the 
biotech product or its effect on the ecosystem.  
Spread and persistence . In many of the studies in Europe (ongoing and not yet 
published), the purposes of the study can be achieved by detection based on an outward or phenotypic trait (i.e. whether a plant dies if sprayed with a specific 
herbicide), a protein test (e.g. an antibody based test for the protein produced by the 
genes conferring tolerance to glyphosate or glufosinate ammonium) or a DNA test for 
the gene (e.g. the bar gene). None of these tests is absolutely accurate since they are 
affected by the condition of the plant tissue.  If sampling of plant material is done in 
real agricultural fields, it is impossible to  ensure the plant tissue is in the right 
condition – often it is not. Consequently, false-positives and false-negatives occur. 
Moreover, if the GM trait is thought to be at low frequency, e.g. 0.5% or lower, and 
the individuals possessing it are unevenly distributed or clumped in the field, then very large numbers of individuals have to  be sampled to estimate presence or % 
frequency with a high degree of certainty.    WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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  Ecological impact . For some aspects of compari ng GM and non-GM plants, detailed 
knowledge of the molecular construct is not necessary. For instance, if comparing the ecological effects of GMHT or Bt plants, the studies could be done equally well 
without detailed molecular knowledge of the construct. 
More information would be necessary if research was following the volunteers or 
pollen-vectored genes originating from the GM crop: at least, knowledge of the genetic factors determining the proportions of male sterility and male fertility would 
be important, but even then the detailed molecular knowledge of the construct would 
not be essential. However, if many GM vari eties had been grown in an agricultural 
area, and if it were important to ascertain the origin of an individual plant or 
population, then more detailed molecula r characterisation would be required.  
More generally it can be argued, given the sci entific and public interest in GM issues, 
that it is reasonable for an assessing body to  request full characterisation (according 
to standards in the Guideline for the conduct…)  of a GM construct (a) to enable its 
officers to confirm whether impurities existed in the original seed if they were found or suspected (e.g. the presence in the breeding line of GM traits such as antibiotic 
resistance) and (b) to trace the persistence or spread of the GM trait if this was 
necessary in later years.  
While much of the text above under Respon ses 9 is generally appreciated by workers 
in the field, many of the scientific findings pertaining to the spread and persistence of 
GM traits in Europe are not yet in the public domain ( Notes, paragraph 14). 
ISSUE 1 
 
Bayer oilseed rape Falcon (GS40/90) 
11. If long term events or emergent properties are envisaged as a result of 
introducing a GM plant and practice (and this seems to be the case for oilseed rape in 
Europe), then it is legitimate to expect a rigorous post-event monitoring protocol to 
be integral to a pre-release risk assessment. Risk management options for this GMHT product are similar to the generic ones included in Responses 6d-e . When they are 
applied, the practices appear to work in keeping weedy oilseed rape to manageable 
levels, but the general level and type of management have not prevented it from 
becoming established throughout Europe as a weed. 
13. In that oilseed rape as a volunteer or feral plant is a pest as defined in ISPM 
11, e.g. a weed competing with a crop for resources, and having other potential 
influences, the Bayer oilseed rape (Falc on GS40/90) has the potential to be a pest, 
since it would leave volunteer and feral descendents. Whether it would be more or 
less a pest than other forms of oilseed rape depends on whether it would be sprayed as a volunteer or feral with the herbicide glufosinate ammonium (see Responses 6b-
c). That would be context-specific, e.g. wh ether farmers in the region or country used 
this specific herbicide widely or repeatedly in fields. 
Bayer hybrid oilseed rape (MS8/RF3) 
14. The basic answer is similar to that given for Q.13.  A few statements need 
comment, however. The EC SCP (EC-63/At.54, section 6.3.1) gave the opinion that WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-188 
  
  "rape is a poor competitor" and "not regarded as an environmentally-hazardous 
colonising species", and while the latter is  still probably acceptable in semi-natural 
habitats, the continued widespread persiste nce of oilseed rape in and around arable 
fields, both from original seed and from re -seeding, points to its competitive ability 
being greater than "poor" but similar to many second-order weeds (i.e. weeds that are less important than the most aggressive fe w species but are still important).  The 
proposed post-marketing monitoring plans (EC-63 At.060) are generally consistent with the principles in ISPM 11, but do not give specific detail on, say, how a field is 
to be sampled to estimate % GM presen ce among volunteers with a stated degree of 
certainty (see Responses 6e and 9 ).  
19. The updated environmental risk asse ssment is comprehensive on topics for 
which data are available. The further info rmation on ecological effects requested by 
the lead CA was clearly not available, and could only be in existence if there had 
been either large scale experimental measu rements on the habitats typical of where 
the crop would be grown commercially or specially commissioned experiments on 
trial crops, as in the UK's Farm Scale Evaluations. Since cropping with this variety and its herbicide has potentially new effect s on the arable flora (i.e. different from 
those of other oilseed rape varieties with other herbicides), which may be severely depleted in any case, it is legitimate to ask what such effects might be. However, the 
general matter of the need for a comparator is relevant here ( Notes, paragraphs 7-10 ). 
Surely it is incumbent on both sides in th e argument to proffer their standard or 
comparator against which the new technology should be judged. 
20. The question is whether the words "imp racticable, hardly workable and hard 
to control" used by the Belgian Biosafet y Advisory Council are justified on the basis 
of the report by its Group of Experts. The Group of Experts does not use this wording 
as such but makes cautionary remarks that  the guidelines are not sufficient as they 
stand and should be extended and that there could be practical problems in 
successfully implementing them. Examples include –  
• "each farmer growing B. napus , B. rapa  and B. juncea , in the neighbourhood 
of the transgenic oilseed rape field is aware of the agricultural guidelines": 
this requires that non-GM farmers need  to make themselves aware of GM 
issues, and that all farmers w ill be cooperative neighbours.  
• "every operator should be informed on the appropriate management measures 
to be taken in the case of accidental s eed spillage …etc.": this in reality is 
probably unworkable, since many spillage  events will go unnoticed, and there 
are such a large number of feral populations arising from such events. 
• "seed should be swept or shovelled in to sealed containers" and "(spillage 
sites) should be recorded and monitored in subsequent years": these are likely 
to be impracticable in commercial ag ricultural areas; the measures would 
place an intolerable burden on whoever wa s considered responsible if that 
could be decided (the grower, the transported, the buyer, the roads authority?). 
Several other of the Group of Experts' recommendations are workable, but the above 
three examples would appear to justify the Belgian Safety Advisory Council's choice 
of words.   WT/DS291/R/Add.7 
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 Page I-189 
  
  Monsanto Roundup ready cotton (RRC 1445)  
24. The EC's SCP opinion is generally posit ive about the application, whereas the 
EC member states raise several objections. The issue of antibiotic resistance was 
considered in the SCP's opinion (EC-66/At.53) and found not to pose risk, but there is 
now widespread perception that antibiotic  resistance should not be introduced 
through GMHT products. 
Comments by Argentina
 
 
Horizontal gene transfer (from GM crop to ba cteria) is a very unlikely phenomenon, and this 
has been demonstrated and published in scienti fic journals. (see, e.g., Schlüter, K. et al , 
"Horizontal" Gene Transfer from a Transgenic  Potato Line to a Bacterial Pathogen ( Erwinia 
chrysanthemi) , Occurs -if at all- at Extremely Low Frequency; Biotechnology , 13: 1094-1098, 
1995 ) 
 
The basis of objection by some member states is that general effects of HT cropping on farmland habitats are uncertain, and this applies whatever the species or the land 
area it occupies. However, the context for this biotech product in cotton is very 
different from the context of those products  which are varieties of oilseed rape. 
Cotton occupies a very small area in Eur ope and does not present potential problems 
of the type associated with oilseed rape  or even maize or beet (Table 1). 
This notwithstanding, and as in other instances, unless criteria can be given, from 
both the proposer and objector as to what is a desirable or acceptable comparator, then progress with the discussion is im possible, as it became in this instance.  
Comments by Argentina
 
 
We observe the following: a) … cotton is very di fferent from … oilseed rape; b) Cotton occupies 
a very small area in Europe and, c) … does not pr esent potential problems of the type associated 
with other crops. The fact that a crop (in this case, cotton) does not present potential problems 
of the type associated with other crops, should le d to a statement on the safety of the first crop 
(whatever this statement should be in the opinion of the Expert). We do not find this, and are 
only left with the impression that cotton is differe nt, but with no reference to its safety or to how 
the relevant safety difference would justify a suspension of approval . 
 
Additionally, we want to refer to the "no accep table standards" argument, which was discussed 
above. It goes beyond, suggesting that, being this the case, progress with the discussion is 
impossible. We do not believe that the question here is an "abstract" one, and consider that 
discussion is possible and amenable to a final judgement. 
 
(a) There appeared to be no monitoring plan in the original proposal, and in the 
2003 document, the relevant section indicated that little specific monitoring was 
necessary because of the low risk. Monitoring the effects on habitat would be feasible 
but suitable criteria on which to base monitori ng have not been proposed or agreed by 
either side.  WT/DS291/R/Add.7 
WT/DS292/R/Add.7 WT/DS293/R/Add.7 
Page I-190 
  
  Monsanto Roundup Ready Corn (NK603)  
37-39. The weakness of suitable cr iteria is again at issue here ( Notes, paragraphs 2, 
7, 8). Documentation from the company is least on environmental matters, partly 
because of changed context (what might be an acceptable impact in one part of the 
world is considered unacceptable in anothe r), while the counter-arguments take no 
step towards indicating what standards mi ght be applied. On the more specific 
question of whether GMHT maize persists (acc idental germination), it is justified to 
query the original statement since emergen ce has been recorded in some southern 
European areas . 
Comments by Argentina
 
 
It is not clear whether the weakness of criteria are from the proposal or from the reviewers. The 
approval process requires environment tests in se veral different environments (worldwide and 
local), which to date have shown to render very strong data. About the p ersistence issue, we can 
say that GM crops are not different from non-GM in this respect, and therefore it should not be 
mentioned as an argument in the context of this document. 
 
41. Pioneer/Dupont High oleic soybean  
(difficulty in viewing some of the relevant files) 
Pioneer LibertyLink and Bt (T25 x MON810) corn (stack) 
57. Similar difficulties are evident in the exchanges to those in 37-39 and 
elsewhere! Even so, the requests by the Netherlands are arguably consistent with the type of information indicated in the Codex Guideline for the conduct of food safety 
assessment of foods derived from recombinant-DNA plants . 
ISSUE 2  
 
Opinion on the value of the Guidelines and Protocols in providing criteria against which to assess biotech crops was given earlier ( Notes, paragraphs 4, 5, 7 ).  It was 
suggested that the types of information and criteria given for molecular characterisation and food safety were stronger and more definite than those given for 
environmental and ecological factors. 
Safeguard measure of France: Oilseed rape MS1 x RF1. 
59. The view expressed by France was that  insufficient information was available 
to provide clear conclusions on several asp ects of cross-pollination and persistence of 
GMHT oilseed rape. The EC Scientific Comm ittee on Plants had considered that the 
risks arising from outcrossing to volunteer, fe ral and wild relatives were definite, but 
small because any progeny could be controlle d later in the rotation. France appeared 
to take a stronger line, indicating the risks were larger or more uncertain. The EC SPC and the information submitted by France therefore agreed on the nature of this 
potential problem, but differed on its importance or extent. In November 1998 and July 2001, there was knowledge about the mechanisms involved in cross-pollination 
and persistence, but one of France's main arguments was based on the up-scaling 
effect - the uncertainty of what might occur if GMHT crops were grown widely in the  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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 Page I-191 
  
  country ( Notes, paragraphs 11, 12 ). There was insufficient knowledge at that time to 
be able to predict accurately, for a countr y such as France, what the rates of spread 
and cross pollination would be (GM to non-GM) if a large part of the rapeseed areas 
were GM. 
(a) The documentation is also correct  when it tates that relevant new 
experimental information was being pl aced before the public (see example 
references below). The new informati on was providing greater knowledge of 
cross-pollination in oilseed rape, particularly over distances of several 
kilometres. This new information would not have provided qualitatively 
different knowledge (it was already k nown that oilseed rape could cross-
pollinate at distance) but would provide better quantitative estimates of the pollination frequencies and the subsequent survival of GM hybrids among volunteer populations. Even by the end of 2003, there was still uncertainty as 
to what the field-to-field cross pollination might be if GMHT crops came to 
be grown in many fields throughout a landscape in Europe. Data in Europe 
was confined to knowledge of crossing from a relatively small source (one or a few fields of donor oilseed rape) to a large potential sink (many fields on 
recipient oilseed rape). Work is still in progress, not least as one of the main aims of the SIGMEA project ( Notes, paragraph 14 ), to estimate spread and 
cross-pollination on a regional scale in Europe.   
Rieger MA, Lamond M, Preston C, Powles SB, Roush R. 2002. Pollen-
mediated movement of herbicide resistance between commercial canola fields. Science 296, 2386-2388. 
Ramsay G, Thompson CE, Squire GR. 2003. Quantifying landscape-scale 
geneflow in oilseed rape. Final report on Project RG 0216, 48 pp. Defra: 
London. 
60. As indicated earlier, the requirements in the international guidelines are quite 
stringent. It could be argued that France' s position was compatible with the tone of 
the SPS Agreement, Annex A, paragraph 4 (including economic as well as biological 
consequences) and compatible also with  ISPM-11 Annex 3 on 'Determining the 
potential for a LMO to be a pest'. 
61. The risk management options were and are similar to those indicated 
generally for oilseed rape at Responses 6d  and 101 . The risk of spread and cross-
pollination can be reduced by such  measures but not eliminated.  
62. Topas 19/2 and the Farm scale evaluations (FSE).   
The FSE compared the effects of GMHT and conventional weed management. Its 
results should have no bearing on the risk associated with the importation of seeds for processing. Even if these seeds were spilled and became part of the wayside feral 
population or volunteer population in a fiel d, they would have no effect unless the 
management of the field changed away  from current management in a way 
comparable to the differences between GMHT  and conventional cropping in the FSE.   WT/DS291/R/Add.7 
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Page I-192 
  
  ISSUE 3 
 
96. Significant change in understanding of biotech products etc. since 1998?  
From this reviewer's perspective, most of the underlying molecular and biochemical 
knowledge of the subject has not change d substantially during this period. 
Comments by Argentina
 
 
This answer contradicts some of the above mentioned by the expert. See the "long term effects" 
problem in decision making. We agree with this new view of the reviewer. 
 
There is still uncertainty over unintended side-effects occurring in biotech products, 
and the continued stability of  phenotype in biotech plants  or continued expression of 
their genes outwith the crop itself (i.e. in volunteers and feral plants).  
Comments by Argentina  
 
It can be said that in almost 10 years of pl anting GM crops around the world, no scientific 
evidence has been published in a peer-review jour nal that will provide evidence of unintended 
side-effects (*), lack of stability of phenotype or detectable expression of their sequences 
introduced through genetic engineering in other organisms outside the crop itself, in the absence 
of sexual compatibility, all these phenomena in a way different from than with the no-GM 
species.  (*) Note of this reviewer: the expression "side- effects" is reminiscent of pharmaceutical drugs. 
In the case of these, they are known and deemed  to be tolerated when the benefits outweigh 
them. Due to this connotation, the above expressi on should be replaced by "unintended effects" 
which reflects better the phenomena under analysis  and is coherent with the wording used in 
this area. We believe the language used should not be equivocal or sugg esting associations with 
matters not pertinent to the arguments . 
 
97. Is there new scientific evidence since 1998?  
The argument presented in Notes 11-12  is that knowledge of the ecological impacts of 
biotech products and their spread and con centration in the agricultural environment 
has changed, particularly in that emerge nt properties at the scales of the field and 
landscape are now much better appreciated even if they are still far from fully 
understood. Examples of where knowledge has increased substantively are –  
Comments by Argentina
 
 
Quoted Notes are not included in this document . Should they refer to the studies quoted above 
(see Nature …), please see our comments.  
• Spread and persistence of some crops plants, notably oilseed rape. 
• The important role of insects as carriers of pollen over the landscape. * 
• The importance of the weed flora to in-field biodiversity and food webs. * 
 
* Referring to the last two points: both are no  exclusively biotech-crop-dependent but more so 
from agricultural practice.  WT/DS291/R/Add.7 
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 Page I-193 
  
   
100. Are different agricultural practices need ed for pre- and post-1998 products?  
Following the points made in answer to Q.97, the innate biological qualities and 
behaviour of a product may not have changed, but it is quite possible that the context 
in which that product would operate has ch anged, in two ways. (A) The physical or 
agronomic environment is different. The agronomy of these crops changes rapidly: examples of factors that have changed mark edly in Europe in recent times are the 
proportion of autumn-sown crops, the area c overed by oilseed rape, and the type and 
effectiveness of pesticides used. An exam ple, given already, of the change in 
pesticides is the rise in use of glyphosate as an arable herbicide in some countries in 
the past few years. (B) The understanding of  the GM product's role in the ecosystem 
has changed. It was also reported previously that some major effects of intensification 
on arable ecosystems have become well estab lished scientifically only in the last few 
years. The way arable plants and their food webs are considered is now different from 
the way they were generally considered in  the early 1990s. The question is sometimes 
referenced back to before the early 1990s:  why was the large scale change to autumn-
sown cropping in some parts of Europe not  scrutinised with the same rigour as the 
potential change to GM cropping? The answer is that it was thought not to be important, while it is now known to have been very important for farmland food 
webs. 
Comments by Argentina
 
 
On the questions here we believe: (A) we agree; (B ) GM crops are approved only if their role in 
the agro-ecosystem is the same as the comp arator non-GM crop, except for the newly 
introduced characteristic. Negative unintended effect s, to the extent that they are significant for 
the farmland food webs are carefu lly assessed and, if any, not to lerated in the approval process. 
Also, when it is referred to "ecosystems" it se ems to be referring to all crops, biotech and non-
biotech. We argue that this distinction should be clearly made in the document. It is even asked why some agricultural practice in Europe ha s not been scrutinised with the same rigour 
as…GM cropping. The use of these arguments, when applied to GM crops only, seems not well based . 
 
101. Change in mitigation of potential risk.  
The answers follow from the responses a bove to questions 97 and 100. While  
products might have very similar qualities,  mitigation might differ as a result of new 
information informing risk or a new perception of the importance of a particular risk. 
Comments by Argentina
 
 
Perception of risk is not the same as real risk . Failure in recognizing this fact, will make the 
advance of Science difficult, as any new technology implies risks, and therefore the distinction is 
relevant.  
Among ecological topics, the perceived mitigation to reduce the 'severity' of a risk to biodiversity and ecosystem functioning has changed because of a greater appreciation 
that arable systems have been affected by intense agriculture. WT/DS291/R/Add.7 
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Page I-194 
  
  Comments by Argentina
 
 
The Expert refers to intense agriculture, which has been widely recognized as negative to 
biodiversity, no matter which type of crop, biot ech or non-biotech, is used. This should not 
imply that a different approach is to be considered to agriculture as a whole.  
 
Mitigation is unlikely to remain constant. For example, some current mitigation measures which leave margins round the cropped area of land are insufficient when it 
is appreciated that biodiversity in the cr opped areas is necessary to main ecological 
function there. 
That risk has not remained the same ove r time is an inevitable consequence of 
scientific information on arable systems being collected at increasingly larger scales since the mid-1990s. Early research using GM Os in small parcels of land could not 
possibly have generated the knowledge that polle n from large fields of oilseed rape is 
moved widely in the landscape. 
Comments by Argentina
 
 
As in many occasions before, the Expert refers  to oilseed rape as an example of GM crops. 
However, this crop has characteristics of its own, non biotech-dependent, and therefore we do 
not consider appropriate to refer to it when a ge neralization is made We respectfully recall that 
any generalization would oppose to the "case-by-c ase" criteria, which we believe should apply 
to these products.  
Moreover, the present guidelines about pollen barriers, e.g. a strip of flowering crop between the GM field and non-GM recipien t field, may have to change if the 
proportion of GM fields in the landscape increased to, say, 50%. 
Comments by Argentina
 
 
As with any new technology, precautions should be exercised in its use. Unintended gene flow 
via pollen, is an inescapable phenomenon if sexu ally compatible plants are at appropriate 
distances. This is also true with non-biotech crops. Consequently, biotech crops do not deserve 
such a different treatment . 
 
103. Is contamination risk greater than for non-GM varieties  
A certain level of impurity – through one cr op type growing within or giving pollen 
to another type – seems to have been generally accepted for many years. Such 
impurity varies greatly with crop type: it is common in oilseed rape, and less common 
in beet and maize, for example. Where the nature of the yield is different, e.g. for 
high erucic oilseed rape (HEAR), impur ities are kept to acceptably low values by 
using registered growers who are familiar w ith the crop and with the requirements for 
separation, and many of whom farm in a restricted part of the country. There are clear 
criteria for the acceptable presence of HEAR in non-HEAR oil. Outside specialist varieties such as HEAR, impurities have largely gone unobserved, and in many instances where non-GM oilseed rape volunteer s emerge in a non-GM oilseed rape 
crop, the percentage impurity is unknown and is ignored. The potential of a crop 
variety to convey an impurity is not the sa me for all varieties but differs depending on 
factors such as the proportion of seeds that enter dormancy, the persistence of seeds  WT/DS291/R/Add.7 
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 Page I-195 
  
  in the soil and the relative pollen 'strength' of potential donor and recipient fields (for 
example caused by different proportions of male sterile plants). These factors may or may not differ between GM and non-GM vari eties but should not differ because one 
is GM and the other not. They would diffe r in any case. Given present knowledge of 
the life cycle and reproductive behaviour of  the crops, there is no reason to suppose 
that biotech crops confer different degre es of impurity compared with crops produced 
from, say, induced mutagenesis.  
106. Rationale for different management practices  
Provided no significant level or type of risk has been detected, then no particular 
change in practice above the highest recommended existing practice to ensure a high purity, should be needed. As in Q.103, however, if thresholds are imposed for whatever reason, e.g. 0.9%, specifically fo r GM varieties in non-GM varieties, then 
there will need to be different agricultural practices for those GM varieties that leave 
volunteers or spread genes by pollen to neighbouring, sexually compatible crops. 
These practices are well appreciated – reducing volunteers to a minimum by appropriate soil cultivation after harvest,  preventing volunteers from flowering in 
subsequent crops, leaving several years befo re growing the same type of crops again 
so that volunteer seed decays by natural means, leaving a separation strip between 
crops which is not harvested and beyond wh ich geneflow is reduced to very low 
values, and not planting crops having reduced self-pollen in the vicinity.  
Under a system of coexistence in whic h a threshold (GM in non-GM) was imposed, 
the agricultural practice might well have to ch ange in a crop such as oilseed rape to 
ensure that threshold would be met.  L onger intervals than normal between oilseed 
rape crops, some regional segregation of  GM and non-GM crop types and the 
dropping of varietal associations (80% ma le sterile, 20% own pollen) from general 
use would probably be necessary. Given present knowledge, these changes would be 
in consequence of an imposed threshold of GM in non-GM product, not of any inherent food-risk in the GM product itself. 
Comments by Argentina
 
 
Again, the discussion pertains more to oilseed rape  than to GM crops as a category. It should be 
separated clearly when the arguments do refer speci fically to oilseed rape and when they do to 
all GM crops. We recall the importan ce of the "case-by-case" criteria. 
 WT/DS291/R/Add.7 
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  (Table 1, referring to point 14 – unde r the title "Criteria and standards") 
 Table 1.  The ability of the crops to disperse genetic material through feral or volunteer progeny, 
pollen movement and outcrossing to form hybrids in Europe. Author's summary.   
 
 Beet Maize Oilseed 
rape Cotton 
     
Feral / volunteer weeds 
 persistence in field  persistence outside field   
medium medium  
zero
1 
low  
high medium   
zero zero 
Pollen transfer 
  crop to crop  
low2  
high  
high  
low 
  crop to feral /volunteer low2 zero high zero 
  crop to wild relative low2 zero low zero 
Crossing frequency (on arrival of 
pollen at flowering plants)     
 crop to crop  high high high low 
 crop to feral high zero1 high - 
 crop to wild relative high (local) zero low - 
 
Comments by Argentina  
 
No footnotes are explained in the document re ceived. They only refer to maize. We observe, 
however, with regard exclusively to maize:  1. Maize persistence outside agro-ecosystem s have been proved to have very low 
frequency, as domesticated maize hardly su rvive without man's help. Domestication has 
increased advantages on food and agronomical traits (by conventional breeding) at the 
expense of independent (feral) growth.  
 2. Volunteer weeds? Is the Expert referring to  the weed characteristics of domesticated 
maize? Is the Expert indicating that weeds (volunteer?)  other than maize can grow (al 
low frequency) outside the specific agro-ecosystem dedicated to maize production? 
 
If the observation in square 2, first data ro w, we must read, among other statements, 
that ability for "volunteer weeds persistence outsid e field" is low. It is now clear to this 
reviewer if the Expert is referring to maize as  "the crop" or to weeds in maize fields.  
 
3. Pollen transfer ability from crop to crop is indeed high. However, pollen viability is very 
low and dependent from weather conditions. This will only affect the quality of the F2 progeny. This consideration also applies to crop to crop "Crossing frequency (on arrival 
of pollen at flowering plants)"