Document: WT/DS291/R/Add.7 WT/DS292/R/Add.7 WT/DS293/R/Add.7 Page I-80 ANNEX I-3 COMMENTS BY ARGENTINA ON THE REPLIES BY THE SCIENTIFIC EXPERTS TO THE QUESTIONS POSED BY THE PANEL
Date: 31 January 2005
Document codes: WT/DS291/R/Add.7; WT/DS292/R/Add.7; WT/DS293/R/Add.7
Complainant: Argentina
Respondent: EU
Third parties: Australia, Brazil, Canada, Chile, China, Taiwan, Colombia, El Salvador, Honduras, Mexico, New Zealand, Norway, Paraguay, Peru, Thailand, Uruguay, U.S.
Dispute stage: Mutually Agreed Solution
Agreements cited: Art. 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7, 8, 10.1, Annex B, Annex C  Sanitary and Phytosanitary Measures (SPS)Art. III:4, X:1, X:3(a), XI:1  GATT 1994Art. 2.1, 2.2, 2.8, 2.9, 2.11, 5.1, 5.2, 5.6, 5.8, 12  Technical Barriers to Trade (TBT)Art. 4.2  AgricultureArt. I:1  GATT 1994

ANNEX I-3

COMMENTS BY ARGENTINA ON THE REPLIES BY THE
SCIENTIFIC EXPERTS TO THE QUESTIONS POSED BY THE PANEL

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 exposed 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 such 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 cannot conclude that
there is a potential risk to collembola. There have been numerous studies that

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.
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. The 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:

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;

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/CM 2 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 larvae 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/CM 2 ( 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

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 INSECTICIDES 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.

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

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 expressed 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.

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

be more subtle, and would not be readily noticed. Hence, the US experience does
not imply that there are no adverse 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 fact 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.

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 differences 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 mention 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 should 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.

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 effects 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, which has developed field resistance to Bt
insecticide applications in several countries, including the US (Hawaii), Japan,
Philippines and elsewhere.

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 consensus 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 potential 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.

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?

(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

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 persistence 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.

"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.

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 interpretation 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

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

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 changes 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

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

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 smaller 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.

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 been 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.

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.

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 scientifically 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 considered in the risk assessment were:
– Capacity to survive, establish and disseminate.
– Potential for gene transfer.

– 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

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.

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 monitoring 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.

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 practices, 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 emphasizing that the adequacy of a monitoring plan is
justifiable, but ends that the need of a monitoring 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
actuaciones en cada caso.

En este sentido, el Plan de seguimiento deberá contemplar, en su
plazo (incidencia de malas hierb as, resistencias, etc), así como
agrícolas convencionales.
24.15. I believe the Spanish CA is requ esting that the monitoring plan address
potential effects of large spatial scale (for example, 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 adverse 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 widely recognized for some time before 1998.

Comments by Argentina

As the Expert has stated before, development of resistance in a inescapable evolutionary
phenomenon and should be expected to occur with 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 provide 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 occurrence 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.

• 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 used 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 populations 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 investigations 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

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

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 monitoring. 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.

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 synthesis 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 delay 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.

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 (phenological 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 conclusions 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.

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 that 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

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 later 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 contamination 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.

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 Austria 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 Committee also did not assess non-target effects.
Comments by Argentina

See our comments on non-target effects 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

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 pesticides, with shorter and
repeated exposure. The potential for development of resistance could be either
accelerated or retarded."

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 existing 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.

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.

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 declared the impossibility to take a position. Also, the Expert seems
to shift the issue towards a epistemological question, 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

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-target 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 gained 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

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 with 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.

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 will 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

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 characterization 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 molecular characterization data, are, in this case, of
the "nice to know" category and not 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 view, as it brings to mind a pejorative value. We
suggest to use "adventitious 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 risk 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 taken 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).

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 consistent 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) were 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.

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.

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 Committee also did not assess non-target effects.

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.

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 comments 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 irreversibility 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 laboratory experiments is to expose the organisms

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

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 harvest 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.

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 will 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

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 support 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 risk 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 Annex 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

explicitly address this guidance. Specifica lly I note Section 3.4 (principles), and
Section 3.4.6 (on prohibition) were 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.

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 management 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 objective 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 remarks on environmental risks, specifically
the resistance monitoring program.

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

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 determination 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.

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 evidence 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 remarks 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.

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 phytosanitary measure. Luxembourg did not conduct
the risk assessment according to their safeguard measure. Thus it is not clear that
Luxembourg conducted the risk assessment consistent 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 argues 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 remarks 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,

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 Plants 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?

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 management measures is available today.

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,

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

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-specific 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 measure" 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 scientific 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

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 evolutionary 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.

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 biotech products prior to 1998, taking into account:

• the intended use of each product (direct human or animal consumption, further
processing for consumption, planting or any other specified use);

• any potential risks that may arise from th e combination or successive use of biotech
products.

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 occurred 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 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 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

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

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 concerns that large-scale cultivation of Bt
corn would harm the monarch population. Monarch 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/CM 2 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 larvae 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/CM 2 ( 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.

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 INSECTICIDES 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

(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,

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 the 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

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 requirements 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

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 management 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 10 6 field-collected individuals.
The F2 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

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.

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 under Directives 90/220 or 2001/18), and for which no
significantly different nature or level of risk has been identified, does the information 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 applied 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.

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 novel non-biotech products.

Please explain with reference 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 population 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 inbreeding 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.

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 cell 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 individuals, is close to be under the breeder's control.

102.06. For inbreeding species, such as soybean and dry bean, variation can be
introduced by hand pollinations (usually involving 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 adapted 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.

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.

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 being 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 methods 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.

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 substantial 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 future-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 release 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/.

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 largely 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

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 properties, as the first event, that is spillage, is the
necessary pre-requisite for the other successive phenomena 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 monitoring 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.

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 bred 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.

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 under Directives 90/220 or 2001/18), and for which no
significantly different nature or level of risk has been identified, does the information before the Panel
provide any scientific or technical rationale for requiring specific agricultural 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.

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 the 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 the 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

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 Agreement 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 suitable 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

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 argument, pointing the "lack of standards" issue.

Scale and context in assessing biodiversity 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

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 been 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 regulatory 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 for 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 that, 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?

• 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.

• 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 them 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. (*)

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 herbicide 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.

Comments by Argentina

The expert's remarks are addressed at demonstrating 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 Technical 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 margins 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.

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 low 2 zero high zero
 crop to wild relative low 2 zero low zero
Crossing frequency (on arrival
of pollen at flowering plants)

 crop to crop high high high low
 crop to feral high zero 1 high -
 crop to wild relative high (local) zero low -

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. Generally, 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

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 ecological 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

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 laboratory 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

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-specific 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 conserved), 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.

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 that 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 where 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.

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.

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 local 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

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 would 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.

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 functioning 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

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 21 st 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 depletion 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 macrofauna 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.

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 molecular 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

"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 will 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.

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 impossible, 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 different, 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 monitoring have not been proposed or agreed by
either side.

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 persistence 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

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.

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 changed 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.

100. Are different agricultural practices needed 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.

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 with 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 same for all varieties but differs depending on
factors such as the proportion of seeds that enter dormancy, the persistence of seeds

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 degrees 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 importance of the "case-by-case" criteria.

(Table 1, referring to point 14 – under 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 low 2 zero high zero
 crop to wild relative low 2 zero low zero
Crossing frequency (on arrival of
pollen at flowering plants)

 crop to crop high high high low
 crop to feral high zero 1 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)"