Document: WT/DS291/R/Add.7 WT/DS292/R/Add.7 WT/DS293/R/Add.7 Page I-1 ANNEX I COMMENTS BY THE PARTIES ON THE REPLIES BY THE SCIENTIFIC EXPERTS TO THE QUESTIONS POSED BY THE PANEL Contents Page Annex I-1 Comments by the United States on the replies by the scientific
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

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

Contents Page
Annex I-1 Comments by the United States on the replies by the scientific
experts to questions posed by the Panel (31 January 2005)
I-2
Annex I-2 Comments by Canada on the replies by the scientific experts to the
questions posed by the Panel (31 January 2005)
I-35
Annex I-3 Comments by Argentina on the replies by the scientific experts to
the questions posed by the Panel (31 January 2005)
I-80
Annex I-4 Comments by the European Communities on the replies by the
scientific experts to the questions posed by the Panel (28 January
2005)
I-197

4. And, in fact, the advice of the experts provid es compelling evidence that many of the requests
for information presented by EC regulators we re not necessary for the evaluation of the product
applications. For example, and as detailed in the body of this submission, the advice of the experts
support findings that the following types of qu estions were unnecessary for conducting a safety
assessment:
– questions related to safety effects of antibiotic resistance marker genes;
– repeated requests for additional and new types of molecular characterization;
– requests for new and different types of detection methods;
– requests for detailed information on envi ronmental effects when the application
sought approval only for import and processing, and not for planting;
– vague and open-ended requests for in formation on environmental effects;
– requests for semi-chronic toxicity studies;
– repeated requests for additional whole-food studies; and
– requests for studies on the composition of food produced from animals that consumed
biotech feed.
The fact that many of the questions posed by EC regulators were not needed for the assessment of the
biotech product applications both (i) supports a finding that the EC did not process the applications
without "undue delay," and (ii) more generally, su pports a finding that the EC did in fact adopt a
moratorium on biotech approvals.

5. With regard to the member State safeguard measures, the EC does not dispute that
Community-level scientific bodies reached positive assessments with respect to each product covered
by a safeguard, and the EC does not dispute that the same bodies considered and rejected the
rationales that the member States put forth to jus tify the measures. Moreover, the EC has not yet
explained what specific scientific information mi ght serve as a basis for adopting these measures
under the SPS Agreement, nor has the EC expl ained how or whether the Community-level
assessments were incorrect.

6. Where, as here, the defending Party has not even proffered a scientific basis for an SPS
measure, there is no need to turn to expert a dvice to reach a finding under the SPS Agreement.
Nonetheless, and as explained below, the expert r esponses further support findings that the safeguard
measures are inconsistent with the EC obligati ons under the SPS Agreement. For example, the
experts explain that, contrary to member State claims, there is no basis related to food safety for
adopting any of the member State safeguards, and that there was no environmental basis for safeguard
measures on products which received EC approval for import and processing (and not for planting).

7. In a few cases, an expert pointed to some hypot hetical risks that, at the time of the adoption of
the safeguard, the expert believed might have provided a basis for concern. But even in these cases,
the expert wrote that by this time (i.e., January 2005), the member States have had more than adequate
time to conduct a full assessment of any such risks, and that in light of available risk management

measures, total product bans were unnecessary. In short, the responses of the experts are of no
assistance to the EC in defending the member State safeguards.

II. COMMENTS ON EXPERTS' RESPONSES1
A. GENERAL QUESTIONS
Question 1: On the basis of the information be fore the Panel, is there any scientific evidence to
support the hypothesis that antibiotic resist ance marker genes (ARMG) pass from a biotech
food or feed product to bacteria or other micro-organisms present in the human or animal gut?
(a) If scientific evidence indicates that such an event could occur, what risks, if any,
would arise from that event? What is the comparative relevance or magnitude
of this risk in relation to the likelihood of such a transfer from other sources of
antibiotic resistance not involving the use of recombinant DNA technology?
(b) If such risks have been identified, what is the likelihood of adverse effects to
human or animal health, in light of the processing of raw biotech products into
human food or animal feedstuffs?
(c) Are these consequences relevant to the specific types of ARMG currently used in
the products at issue in this dispute? Please explain.
(d) If such risks have been identified, wh at risk management options are available to
mitigate those risks and what is their efficacy?
8. The expert advice offered in response to these questions confirms that member State
objections based on potential risks from antibiotic marker genes are not supported by scientific
evidence. Rather, the expert concurred with the opinions of the Scientific Committee on Plants (SCP)
that examined this issue as part of their evalua tion of the products containing such genes: that the
presence of these genes do not present a significant risk to human health. Professor Nutti explained as
follows:

"According to FAO/WHO (2000), DNA transfer from plants to microbial or mammal
cells, under normal circumstances of dietary exposure, would require all the
following events to occur:
– the relevant gene(s) would have to be released, probably as a linear fragment;
– the gene(s) would have to survive nucleases in the plant and in the
gastrointestinal tract;
– the gene(s) would have to compete for uptake with dietary DNA;

1 The US comments are organized se quentially, following the numbering of the Panel's questions. The
United States has commented on those responses of the expert s that it believes are most relevant to the issues in
this dispute. The absence of comments on a particul ar question does not indicate either agreement or
disagreement with the experts' responses to that question, and the United States may, as appropriate, provide
comments on the issues raised in such responses at later stages of this proceeding.

– the recipient bacteria or mammalian cells would have to be competent for
transformation and the gene(s) would have to survive their restriction
enzymes; and
– the gene(s) would have to be inserte d in the host DNA by rare repair or
recombinant events.
There have been numerous experiments aimed at evaluating the possibility of transfer
of plant DNA to microbes and mammalian cells. To date, there are no reports that
marker genes in plant DNA transfer to these cells
The transfer of marker genes which confer resistance to kanamycin, ampicillin and
streptomycin to bacteria in the human gut is unlikely to present a significant health
impact since bacteria resistant to these antibiotics are already spread all over or are
naturally found in the human gastrointestinal tract (Smalla et al., 1993; Calva et al.,
1996; Shaw et al., 1993; Smalla et al., 1997). Besides, kanamycin/neomycin and
streptomycin are rarely used for humans due to their collateral effects (WHO 1993)."
2
9. Taking this advice into account, as well as the information previously provided by the United
States,3 member State objections based on such concerns can at best be considered to raise merely
theoretical risks.

Question 3: On the basis of the information be fore 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 organ isms 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?
10. With respect to Bt crops, specifically Bt cotton and/or Bt maize, both experts responding to
this question provide similar assessments of the likelihood that Bt crops would be expected to
adversely affect non-target organisms. Dr. Andow states that while "there is some scientific evidence
to support the hypothesis that wide-spread cultiv ation of Bt crops adversely affects non-target
organisms ... this evidence is insu fficient to establish the hypothesis that such adverse effects are
expected to occur." 4 Similarly, Dr. Squires notes that "[t]he evidence is insufficient to confirm
whether widespread cultivation of Bt crops in Europe would affect non-target organisms."5

2 Dr. Marilia Regina Nutti's Answers to Questions to Experts.
3 See US Supplementary Rebuttal, p. 36 et. seq; See also US comments on Expert Answers to
Questions 69-77 infra.
4 Dr. David A. Andow's Answers to Questions to Experts, paras. 03.01, p. 2. See also Dr. Andow's
Answers to Questions to Experts, para. 04.06, p. 7 (" Generally speaking, of all of the potential environmental
risks of transgenic Bt crops, it can be said that resistan ce in the target pests is a real, tangible risk, while risks
associated with gene flow and risks to non-target organisms are mostly only potential risks."); para. 03.16, p. 6
("Coupled with paragraph 03.12, it is unlikely that eith er Bt crops or Bt insecticides will adversely effect
mammals through direct toxicity.")
5 Dr. Geoff R. Squire's Answers to Questions to Experts, "Responses to Questions 3 to 5."

11. While both experts acknowledge that these crops may present "possible hazards" to non-target
organisms from Bt crops, 6 both experts agree that – even assuming the crops present more than a
theoretical risk – risk management measures are avai lable to mitigate any potential risks. Dr. Squire
states that:

"[i]t [is] much more easy to confine maize within cropped fields than it is oilseed rape
or beet, for example ... [I]f 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 uncertainty is the effect of Bt maize on the soil food web ... . Effects
in the soil would be harder to monitor because it is very difficult to assess soil
biodiversity, particularly among bacteria and fungi. Nevertheless, any adverse effects
should be mitigatable through a rotation."7
12. Dr. Andow similarly confirms that there are a variety of risk management options short of a
complete ban that are available to deal with any potential adverse effects on non-target organisms:

"[r]isk management measures should be commensurate to the risk. ... Another
approach [in the alternative to a complete ban] would be to limit the area of the
transgenic crop until a reasonable assessme nt of the possible hazards and potential
risks are completed. As the information is gathered, the risk management measure
can be modified consistent with the principl e of 'modification.' For actual risks, such
as the presumed risk to monarchs, geographic restrictions in use of the Bt crop could
be considered ... Monitoring of the population at risk could be required, although this
would likely be more expensive than restricting or managing use ... 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 m itigation of risk or tolerance of risk
could also be considered."
8
13. These experts' conclusions – that there is no scientific evidence supporting any actual,
expected adverse effects on non-target organism s from Bt crops and that hypothesized potential
hazards can be feasibly mitigated through risk mana gement measures or at least monitored and risk
management measures subsequently developed – clearly do not support the EC's claim that Bt crop
applications were "duly" delayed by member Stat es' concerns about potential adverse effects on non-
target organisms. As the United States explaine d in its Supplementary Rebuttal, certain member
States simply objected to applications based on hypo thesized risks to non-target organisms, without
considering any risk management options that mi ght be available to miti gate or avoid alleged
hypothetical hazards.

14. The experts' answers highlight the EC's oblig ation under the SPS Agreement to evaluate risk
management options when consider ing applications for biotech pr oducts. Under the SPS Agreement,
an assessment must "... [e]valuat[e] the likelihood of entry, establishment or spread of a pest or

6 Dr. Andow's Answers to Questions to Experts, paras. 03.02-03.13, pps. 2-5 (Dr. Andow describes a
potential risk to C. carnea from Cry1Ab Bt maize, but opines that "the actual risk to C. carnea would not be
large." para. 03.09, p. 4); Dr. Squire's Answers to Questions to Experts, "Responses to Questions 3 to 5" ("The
weight of the evidence ... 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.")
7 Dr. Squire's Answers to Questions to Experts, "Responses to Questions 3 to 5" (emphasis added)
8 Dr. Andow's Answers to Questions to Experts, paras. 03.17, 03.19-03.20, 03.23, p. 6.

disease within the territory of an importing Memb er according to the sanitary or phytosanitary
measures which might be applied, ... ." 9 Accordingly, even allowing for such hypothetical risks, it
was incumbent upon the EC to analyze the risk mana gement options available to mitigate or avoid
entirely such effects and to make a decision on the application accordingly. As the experts' statements
confirm, such management options were available and should have been evaluated.

Question 4: On the basis of the information befo re 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 emergen ce of Bt-resistant target organisms under field
conditions? If so, what risk management options exist to mitigate any resulting risks and what
is their efficacy?
15. Both experts similarly attest to the availab ility of risk management options to minimize the
likelihood of emergence of Bt-resistant target organi sms as a result of Bt maize cultivation (as well as
other, non-biotech applications of Bt toxins) Dr. Andow notes:

"[t]here are several risk management options for Bt maize, but they are all concerned
with reducing the selective advantage of resi stant alleles in populations of the target
species. The most widely used resistance management strategy for Bt maize (and all
Bt crops) has been the high-dose/refuge strategy. This has been used by the US
Environmental Protection Agency. For Bt maize, it is generally accepted that a 20%
refuge is needed for the high-dose refuge strategy to be effective. Low-dose Bt
events will require a greater refuge. There is no scientific consensus as to how big a
refuge is needed... . Additional resist ance management strategies may become
possible to develop after resistance in the target pest is identified and characterized... .
Theory has predicted that the high-dose/re fuge strategy will be efficacious ... These
assumptions have been confirmed 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 w estern 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 attribut ed to the efficacy of the high-dose/refuge
strategy."
10
16. Dr. Squires states:

"[t]he processes involved in Bt resistance and its management are generally
appreciated by scientists, and mitigation stra tegies that have a strong scientific basis
have been considered. By the late 1990s , mathematical models of the population
dynamics of resistant and susceptible bi otypes were being used to estimate the
number of years for which the GM trait would remain effective in the face of genetic
adaptation by the pest. The point is that sound scientific knowledge has been applied
to this problem for several years... . The strategies [for mitigation] might involve
providing refuges in or near the crop wher e 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

9 WTO Agreement on the Application of Sanitary and Phytosanitary Measures ("SPS Agreement"),
Annex A, para. 4.
10 Dr. Andow's Answers to Questions to Experts, paras. 04.07-04.08, 04.09, 04.10, 04.13, pp. 7-10.

sympathetic to integrated pest management based on genetic and ecological
principles ... ."11
17. While the United States does not necessarily agre e with all of the specific details regarding
the nature of the risk management measures descr ibed above, the United States does agree with the
overall points the experts make regarding the availab ility of risk management options for dealing with
Bt resistance. The experts' testimony confirm th at resistance is not a new or unusual risk posed
uniquely by biotech Bt maize. Rather, it is a well-known potential risk posed by many non-biotech
applications of insecticides, and consequently, well-understood, efficacious mitigation strategies
predicated on "strong scientific bases" have been de veloped (often referred to as insect resistance
management (IRM) strategies)

18. Given the availability and use of such IRM pl ans, the experts' conclusions confirm that the
delay of Bt crop applications under the EC's pre-market approval system cannot be justified by
alleged concerns over the emergence of Bt-resistance where objecting member States failed to address
the validity of the IRM plans already submitted by applicants, particularly when those plans were
deemed acceptable by the relevant EC scientific committees.

Question 9: In what ways does molecular charac terization inform the risk assessment for any
particular biotech product? Can a risk assessment be carried out in the absence of a
comprehensive molecular characterization of each transformation event?
19. The United States notes that Dr. Marion Healy's answer to question 9 supports the US
position regarding the proper approach to assessing the safety of biotech products.12 Dr. Healy states

"[i]t is well accepted that assessment of ... foods from genetically modified organisms
... involves the use of the 'comparative approach', whereby GM foods are compared to
their counterpart foods produced using conve ntional techniques and which have been
safely consumed over significant periods of time. The objective of such a
comparison is to identify any differences w ith the conventionally produced food.
Any identified differences are then examined for their biological impact in terms of
health and safety ... . The comparative approach ... encompass[es] three major
elements: molecular characterisation of th e inserted gene (transgene); biochemical,
structural and functional properties of the protein product from the inserted gene; and
analysis of the composition of the food... ."13
In other words, whether a differen ce has been detected is not in itself important: what matters is
whether that difference has any impact on health and safety. Thus, when evaluating biotech
applications, it is not sufficient for the EC only to identify the existence of some difference between
the biotech product and its conventional counterpart. Rather, the pertinent issues are the the potential
significance of that difference to human and environmental health and safety.

20. Yet, the United States has provided numerous examples where member States objected to
biotech applications simply because of an identif ied difference between the biotech product and its
conventional counterpart (often times simply the ge netic modification itself), without examining the
actual "biological impact" of such difference.
14 In doing so, these member States ignored the

11 Dr. Squire's Answers to Questions to Experts, "Responses to Questions 3 to 5."
12 US Supplementary Rebuttal, paras. 128-133.
13 Dr. Marion Healy's Answers to Questions to Experts, p. 1.
14 See US Supplementary Rebuttal, Section IV.

substantial evidence that existed for each appli cation establishing the product's safety. Dr. Healy
confirms,

"[t]he totality of information available from these types of studies should be
considered in coming to a view about the safety of the food; information from each
element contributes to the assessment of safety ... . [T]he molecular characterisation
is not the only mechanism for identifying unintended effects and the information
from such studies should be considered in conjunction with the information from the
other elements of the safety assessment... . [T]he issue does arise as to how
comprehensive the molecular characterisa tion should be in order to fulfil the
requirements of an appropriate safety assessment. In large part, the answer to this
question depends on the type and quality of information available for the three
elements of the safety assessment, the information revealed from these studies and the
state of knowledge about the gene(s) to be transferred, the donor organism and the
recipient organism."
15
21. The member States ignored the "totality of information" supporting the safety of particular
biotech applications and requested additional information of questionable probative value.
16 Indeed,
as Dr. Healy has noted in her answer to question 9, all of the plants at issue in this dispute contain
relatively simple genetic modifications and have been engineered to produce one or more well-
characterized proteins, a fact which member Stat es' requests for additional information failed to
reflect.
17 Dr. Healy explains:

"It must also be acknowledged that the commercially produced GMOs generated to
date have utilised well defined crops as recipients of the genetic modification and
well defined genetic elements in the transgenes. Generally, the genetic elements have
been extensively studied at both the DNA and protein levels. Consequently there has
been a high level of confidence in the assessments carried out to date."18
22. Dr. Healy's expert opinion also provides additional support for the US contention that certain
member States' requests for multiple whole food studies in which animals are fed with the biotech
food for a period of several weeks to assess potential toxicity to humans and livestock were
unfounded.
19 According to Dr. Healy, the comparative approach

15 Dr. Healy's Answers to Questions to Experts, pp. 1-2.
16 For example, various member States reques ted, among other things: additional molecular
characterization beyond the standard molecular character ization already provided by the applicant; additional,
long-term or repeat dose (chronic) tests to prove the lack of the toxicity of the protein, despite the results of
acute toxicity tests and the homology comparisons confirming the product's safety; additional whole food
studies, despite the submitted safety results of compos itional analyses and of the initial whole food study;
additional assessments on hybrid biotech plants despite the submitted data confirming the safety of the parental
biotech lines; additional studies to confirm the safety of food derived from animals fed biotech feed, despite
compositional analyses demonstrating that the nutritiona l makeup of the feed fell within normal biological
ranges of variation established for non-engineered, commercially available feed and despite data showing that
the introduced protein was rapidly degraded or excreted, like any other dietary proteins. See US Supplementary
Rebuttal, Section IV.B
17 US Supplementary Rebuttal, paras. 134-138 (det ailing member States' demands that applicants
conduct additional, long-term or repeat dose (chronic) tests to prove the lack of the toxicity of the protein
involved in the biotech product).
18 Dr. Healy's Answers to Questions to Experts, p. 3 (emphasis added).
19 US Supplementary Rebuttal, paras. 143-144.

"is used in place of the traditional approach of assessing the safety of discrete
chemicals added to, or present in, food ... that are generally subjected to a range of
toxicological evaluations in animal studies in a dose dependent manner. (WHO,
1987) The toxicological approach is not a ppropriate for whole foods because of the
complex mixture of chemicals present in a whole food, some of which will be present
at very low levels, and the difficulty of conducting meaningful dose response studies
in animals while providing a nutritionally balanced diet."
20
23. Finally, in its Supplementary Rebuttal, the Un ited States explained that a pattern of deliberate
delaying tactics by the EU was also illustrated by other types of scientifically baseless objections or
requests for information that would have no relevance to an evaluation of the product's safety. The
United States cited as one example Italy's objec tions to the Bt corn CRY1F (1507) application
21 and
the application for Roundup Ready maize NK 603. 22 In those cases, Italy demanded, without
providing any rationale, a proteomic analysis.

24. Both experts' answers to question 9 support a finding that Italy's request was scientifically
unjustified. Dr. Andow states in response to Quest ion 9 that "[m]any other molecular methods are
under development, including proteomics and others, but these are not yet ready for use in risk
assessment now."
23 Similarly, Dr. Healy notes in response to question 9, "[s]ome of the technologies
being developed are currently not appropriate for use in safety assessments as they do not yet provide
any further assurance of safety or the results cannot be fully interpreted."24

B. ISSUE 1 (APPLICATION-SPECIFIC QUESTIONS)
Bayer oilseed rape (Falcon GS40/90), C/DE/96/05 (EC chronology 62)
Question 10: Given the information before the Pa nel, including the notification by AgrEvo
(EC-62/At.1-30) and the EC SCP's opinion (EC-62/At.74), was the information to assess the
long-term effect of the newly expressed protein on the biogeochemical cycle and the food chain
requested by the Italian CA (EC-62/At.95) necessa ry to ensure that conclusions of the safety
assessment were valid?
25. The response of the experts supports the US position that this type of general request for
additional information – particularly when submitted after a full safety evaluation by EC scientific
committees – represents a delaying tactic rather than a good faith effort to evaluate the application.
As explained in the US supplementary rebuttal, an important delaying tactic was to ask for additional
information regarding various vague, potential e nvironmental effects – such as vague requests for
information on geochemical processes.
25 In his response, Professor Andow explains why this type of
vague request is unwarranted:

"A request for additional/clearer assessment of the possible effects on the
environment would not be clear or specific enough to allow a notifier to know how to
respond, and hence although information on the environmental impacts is necessary
to ensure that conclusions of the safety assessment were valid, a general request for

20 Dr. Healy's Answers to Questions to Experts, p.1.
21 US Supplementary Rebuttal, para. 188.
22 US Supplementary Rebuttal, para. 194.
23 Dr. Andow's Answers to Questions to Experts, para. 09.03, p.19.
24 Dr. Healy's Answers to Questions to Experts, p. 3.
25 US Supplementary Rebuttal, section IV.B.7.

such an assessment would not be an appropria te way to request such information. In
a similar way the request by the Italian CA is not clear or specific enough to be
considered necessary. There are hundreds of possible processes in biogeochemical
cycles that could be investigated, and thousands of possible ways to evaluate food
chains. Unless the Italian CA can point to prior regulatory precedents where these
terms are clarified, the phrasing of the request is not scientifically justified.
Alternatively, had the Italian CA specifi ed certain biogeochemical cycles and food
chains to assess, then it would be possible both for the notifier to assess them and for
me to determine their necessity to ensure that conclusions of the safety assessment
were valid."
26
26. Similarly, the United States explained in its supplementary rebuttal that requests for
additional food toxicity tests were unwarranted wher e all of the available data indicated that the
product presented no risk to food safety.
27 In her response, Professor Nutti supports the US position
that the type of additional food safety information sought by the Italian CA was unwarranted:

"Based on the information provided by the a pplicant and the analysis carried out by
the EC Scientific Committee for Plant (SCP) and following the Codex Guidelines, my
understanding is that the request by the Italian CA (EC-62/At.95) was not necessary
to ensure that conclusions for the safety assessment of the newly expressed protein in
the food chain were valid. As pointed out by the EC SCP, the new protein has a very
low potential for being allergenic or toxic and also is degraded within the gastric
fluids. In my opinion, the conclusion of the EC SCP that the protein was safe for
consumption in the food chain is correct and was based on sound scientific evidence,
which was presented by the applicant."
28
Question 12. Given the information before the Pa nel, including the notification by AgrEvo
and the conclusions of the EC SCP, was the information regarding the molecular
characterization of this product requested by th e lead CA (EC-62/At.106) necessary to ensure
that conclusions of the safety assessment were valid?
27. This question regarding a request for additio nal molecular characterization – combined with
the experts responses to this question – illustrates one of the themes of the US supplementary rebuttal.
That is, when evaluating whether a request for information was warranted for conducting a safety
assessment (or was instead a delaying tactic) one must consider all of the information provided by the
applicant, and the importance of any additional information not for the purposes of general scientific
inquiry, but instead for the purpose of evaluating the safety of the product.

28. Professor Snape, in his response, indicates that he personally woul d have preferred more
information on molecular characterization, and indeed would even like to see types of data beyond the
additional data requested by the lead CA. Professor Snape's opinion, however, is phrased in terms of
what information he would like to see as a scientist specializing in genetic changes, and is not phrased
in terms of what actual information is required to evaluate the safety of the product.29

29. In contrast, Dr. Healy does consider the request for additional molecular characterization in
the context of the entire application, and with an eye to the ultimate goals of the EC approval process.

26 Andow Response, Question 10.
27 US Supplementary Rebuttal, section IV.B.2.
28 Nutti Response, Question 10.
29 Snape Response, Question 12.

In context, and with these goals in mind, Dr. Healy concludes that the request for additional data was
not warranted:

"Additional information of the sequences at the sites of insertion may reveal fine
structural details and identify similarities and differences with the parental line at
these sites. Such detailed structural analyses usually aim to provide an indicator of
unintended effects from the genetic modification. However, in some cases it may be
difficult to determine the biological signif icance of any sequence differences because
of a lack of knowledge about the extent of sequence variation between individual
organisms within the parental line. Furthermore, other indicators of unintended
effects, that are biologically meaningful, are obtained from other elements of the
safety assessment (eg analysis of protein, composition of food).
A comprehensive package of informati on was provided that addressed the key
elements required in a safety assessment and there was no indication of any safety
issues when all the available data was take n into account. Furthermore, the pat/PAT
gene/protein is well characterised, has been utilised successfully in a number of crops
and their resultant food products and was derived from a well described organism.
CONCLUSION: The additional molecular characterisation requested by the Lead
CA is unlikely to affect the conclusions of the safety assessment and was not
necessary to ensure that the conclusions of the safety assessment were valid. The
totality of information provided in the dossier to that point in time were adequate to
support the validity of the conclusions of the safety assessment without the need for
the additional data requested in the letter dated 2 April 2002."
30
Bayer hybrid oilseed rape (MS8/RF3), C/BE/96/01 (EC chronology 63)

Question 15: Given the information before the Pane l, including the conclusions of the EC SCP,
was the information regarding the assessment of the long-term effect of the newly expressed
protein on the biogeochemical cycle and the food chain requested by the Italian CA (EC-
63/At.87) necessary to ensure that conclusions of the safety assessment were valid?

30. This question, and the experts' responses, ar e essentially the same as for Panel's Question 10
on Exhibit 62. In particular, Professor Andow's re sponse supports the US view that vague questions
on unspecified environmental effects are unwarranted, and Professor Nutti's response supports the US
view that when all available data indicates the absence of a food safety problem, it is unnecessary to
request yet additional studies addressed to food safety.

Question 16: Given the information before the Panel, including the conclusions of the SCP, was
the information regarding molecular characterizati on of this product requested by the lead CA
(EC-63/At.107) necessary to ensure that conclusions of the safety assessment were valid?

31. Dr. Healy's response to this question once ag ain emphasizes the need to evaluate the entire
application in order to determine whether a request for additional information is necessary to evaluate
the safety of the product, or instead is a question for theoretical scientific inquiry. As in her answer to
the Exhibit 62 question on molecu lar characterization, Dr. Healy explains why no further molecular
characterization was required to evaluate the safety of the product:

30 Healy Response, Question 12.

"The additional molecular characterisation da ta sought by the lead CA in 2002 were
not required to demonstrate the safety of food products derived from MS8, RF3 or
MS8xRF3 hybrid lines. The rational[es] for this view are:
– Finely detailed molecular analysis of a defined chromosomal region in
commercially adapted plant lines such as oilseed rape is likely to reveal
minor nucleotide differences between vari ous lines that have no significance
with respect to the safety of derived food products. In the absence of an
equivalent nucleotide analysis from a number of commercial food-producing
oilseed rape lines, these data do not co ntribute substantially to the bank of
information that is necessary to adequately characterise MS8 and RF3 at the
molecular level. Moreover, it is not clear how such data should be interpreted
in an assessment of transgenic plants.
– The data provided at that point in tim e (i) allowed adequate description of the
insertion events in both transgenic lin es, (ii) was sufficiently detailed,
presented clearly and of acceptable quality , and (iii) was consistent with a
generally accepted approach to the mol ecular characterisation of transgenic
crops used for food production.
– The most significant elements of the assessment of MS8 and RF3 oilseed
rape lines more appropriately focus on the molecular characterisation of the
insertion events and the resultant novel gene products, particularly in terms of
their potential toxicity and allergenicity. The food products derived from
transgenic oilseed rape are likely to contain at most only trace amounts of
plant proteins due to processing. Comparative compositional data from the
seeds of both transgenic lines and the corresponding isogenic lines therefore
provides necessary information to determine unintended effects.
Conclusion: The totality of information provided in the dossier to that point in time
contained sufficient information to support the validity of the conclusions of the
safety assessment without the need for the additional molecular characterisation data
requested in the letter of the Biosafety Council dated 28 March 2002."
31
Question 17: Were detection meth ods commercially available in 2001 sufficient to enable the
detection of the transgenic proteins expressed by the plant line hybrid oilseed rape MS8/RF3?
Given the information before the Panel, including the SNIF (EC-63/At.109) and the updated
environmental risk assessment (EC-63/At.110-14 0), was additional information regarding a
quantitative detection method (EC-63/At.141) necessa ry to ensure that conclusions of the safety
assessment were valid?

31 Healy response, Question 16.

32. Both experts that responded to this question were of the opinion that detection methods were
available in 2001, 32 and that additional information regard ing a quantitative detection method were
not required for a safety assessment.33

Question 18: Given the information before th e Panel, including the SNIF and the updated
environmental risk assessment (referenced ab ove), was the information regarding molecular
data requested by the CA (EC-63/At.144) necessar y to ensure that conclusions of the safety
assessment were valid?

33. Dr. Healy's answer to this question exemplifies another type of problem with some EC
requests for additional data. In particular, give n the continual progress of science and technology,
finer tests are developed over time. But, if an a pplication is always required to be updated with the
results of the latest testing methodologies, no application would ever be approved. Rather, as Dr.
Healy explains, the pertinent question is whether, in the context of the overall application, the results
of a newly-developed test are actually required for a safety assessment of the product. Dr. Healy
explains this point in the context of Exhibit 63:

"Given the pace of advancing knowledge in the field of molecular biology and plant
biotechnology and the rapidly evolving tec hnical capabilities, for a foreseeable time,
there will often be a discrepancy between the scientific data submitted in a dossier for
assessment, and the information possible from the most recently developed
experimental techniques. In the specific case of the frequently updated dossier on
MS8, RF3 and hybrids, it is clear from the wording of the request to the company that
the additional information sought is for the purpose of "simply" making the file
consistent with the current Belgian guide lines on molecular data. This additional
information does not add substantially to the weight of evidence that supports the lack
of human health and safety concerns associate d with the use of the transgenic oilseed
rape.

Conclusion: The additional information s ought by the CA in the email of 14 July
2003 (EC 63-144) on molecular data was requested to update the dossier to new
guidelines and was not necessary to ensure the conclusions of the safety assessment
were valid."
34
Question 19: Given the information before the Panel, including the SNIF, the updated
environmental risk assessment and the clarific ation provided by the notifier (EC-63/At.147),
was the information regarding ecological effect s of this product on agricultural systems

32 Healy Response, Question 17 ("Conclusion: The available evidence indicates that
immunoassay-based detection methods suitable for the detection of PAT protein in MS8xRF3 hybrid transgenic
plants were commercially available as early as 2000. "); Nutti Response, Question 17 ("My conclusion is that
the method presented was technically sufficient for th e safety assessment, although it would have to be
validated.").
33 Healy Response, Question 17 ("Conclusion: Additional information regarding an event specific,
quantitative detection method requested in February 2003 is not necessary to ensure that the conclusions of the
safety assessment are valid."); Nutti Response, Qu estion 17 ("Although a quan titative method will provide
relevant information for labelling and to the consumer, it is not necessary to ensure the validity of the safety
assessment. ")
34 Healy Response, Question 18.

requested by the lead CA (EC-63/At.149) necessary to ensure that conclusions of the safety
assessment were valid?

34. This question again illustrates the problem with vague information requests addressed to
unspecified and highly speculative possible effect s on the environment. Each of the experts
responding to this questions has somewhat different views on what, if any,
specific environmental
issues might have been appropriate for further inqu iry, but all agree that an applicant cannot be
expected to respond to an entirely open-ended inquiry that does not specify the environmental concern
or the specific matter to be investigated. For example:

Professor Andow:

"As there are literally hundreds of species of non-target organisms that could be
tested, it can always be argued that more species should be evaluated. Indeed, several
important ecological functional groups were not evaluated, including parasitoids and
detritivores. Without a specific reason, it is difficult to argue that testing a parasitoid
is necessary for the risk as sessment. A case could be made that a detritivore would
have been a better choice for study than epigeal predators. However, if this was the
specific concern of the lead CA, it would have been appropriate to clarify the point.
Hence, I conclude that the request by the lead CA for more information on point 5
was not necessary to ensure that conclusions of the safety assessment were valid."35
Professor Snow:

"The vagueness of this request and the lack of related information from the notifier
make it difficult to provide a clear answer to this question from the Panel.
The lead CA asked for information about effects on "farmland diversity
(macro-fauna, weed flora and microbial soil ecosystem), food web integrity (trophic
structure), population dynamics of key species, life-cycles, etc." (EC-63/At. 149
translation). Although this request seems to ask for some unnecessary data (and the
request is quite vague), several Member St ates were concerned about the ecological
effects of more intensive herbicide use. I assume that this is the focus of concern -
that more information was requested to determine the effects of cultivating new
herbicide-tolerant crops on the weed plants that support insect and animal populations
in farmland habitats in these countries.
Realistically, this is a difficult set of ques tions to answer, regardless of whether one
uses basic theory or empirical research. As noted above, the indirect effects of
introducing herbicide-tolerant crops to countries like the UK are still being
investigated, so in this sense the request ed information could be considered as
necessary.
However, it not feasible to obtain scientific data on all of the processes
listed by the CA without extensive multi-year studies. Even the Farm Scale
Evaluations are too short and too small-scal e to answer these questions (e.g., Andow
2003, Squire et al. 2003). Adverse effects on flora and fauna are mentioned in SPS
and ISPM 11,
but it is not possible to test for all of these effects prior to deregulation.

35 Andow Response, Question 19 (emphasis added).

Instead, scientific committees typically u se their best judgement to recommend
approving or denying applications for marketing."36
Professor Squire:

"The updated environmental risk assessment is comprehensive on topics for which
data are available. The further information 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 measurements 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 effects on the ar able flora (i.e. different from those of
other oilseed rape varieties with other herb icides), 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 the argument to proffer their standard or comparator
against which the new technology should be judged."37
35. In sum, although the experts may have somewh at differing views on potential environmental
effects, all agree that it is not possible for an app licant to respond to vague requests asking for data on
every possible effect on the environment, no matte r how remote. Instead, such vague, open-ended
questions are a formula for endless delays.

Monsanto Roundup Ready oilseed rape (GT73), C/NL/98/11 (EC chronology 70)

Question 27. Given the information before the Panel, including the notification, was the
information regarding feed safety aspects of this product requested by the Netherlands
(EC-70/At.8 and 13) necessary to ensure that conclusions of the safety assessment were valid?

36. In its Supplementary Rebuttal, the United States explained that continual requests for
additional animal feeding studies were not required for safety assessment, but instead were commonly
used as a delaying tactic. 38 Professor Nutti's response to Question 27 provides yet another example
where requests for additional feeding studies were not required in order to evaluate the safety of the
product. Professor Nutti explains:

"Based on the information provided by the applicant in EC-070/At.8 and 13, and the
analysis done by the EC SCP and accordi ng to the Codex Guideline for the Conduct
of Food Safety Assessment of Foods De rived from Recombinant-DNA Plants (Page
4, paragraph 53), some foods may require additional testing; regarding animal feeding
studies, extra studies may be warranted if ch anges in the bioavailability of nutrients
are expected or if the composition is not comparable to conventional foods. Although
the product was concluded to be substan tially equivalent, the notifier carried out
animal feeding studies with rainbow trout, quail, broilers and lamb. In all these
studies, no differences were detected am ong the animals fed conventional and GM

36 Snow Response, Question 19 (emphasis added).
37 Squire Response, Question 19 (emphasis added).
38 US Supplementary Rebuttal, paras. 182-184.

oilseed rape based feeds. Therefore, it is concluded that the studies requested by the
Netherlands were not necessary to ensure the product's safety assessment."39
Monsanto Roundup Ready corn (NK603), C/ES/00/01 (EC chronology 76)

Question 37. Given the information before the Pa nel, including the notification (EC-76/At.1-2
and 27), was further information regarding mol ecular characterisation, nutritional analysis,
and environmental impact requested by the le ad CA (EC-76/At.6) necessary to ensure that
conclusions of the safety assessment were valid?

37. Experts responded to the nutritional analysis a nd environmental impact parts of this question,
and in both cases the experts believed that the further information sought by the lead CA was not
needed to assess the product.

38 With respect to nutritional analys is, Professor Nutti explains as follows:

"Based on EC-76/At.1-2 and 27, and regard ing nutritional analysis, compositional
analysis of NK603 maize grain has demons trated substantial equivalence with
traditional maize. This is supported by lack of differences show n in the results of
feeding NK603 to broiler chickens compared with birds fed with NK603 parental line
or with five commercial reference lines, as well as repeated dose feeding studies in
rats, which contribute to determine the composition and nutritional equivalence.
Whatever studies were further requested by the lead CA in EC-76/At.6, such studies
were not necessary to ensure that conclusions of the safety assessment were valid
since all the relevant information had already been provided. In EC-76/At.27, the
Spanish Biosafety Commission had already estimated that for the uses considered and
at the current scientific and technical "state of the art", there was no scientific
evidences which indicated any risk for human and animal health of NK603 maize."
40
39. With respect to environmental impact anal ysis, the experts' responses indicate that it was
unnecessary for the EC to conduct an in-depth analysis of environmental issues because the
application was for
import and processing , and not for cultivation. Although Dr. Squire writes that
some additional environmental information may r easonably have been sought, he does not support
requiring all the detailed environmental data that might be called for if the application were for
cultivation.41 Moreover, Dr. Andow explains in detail w hy the limitation of the application to import
and processing reduces the amount of data that is required to assess the environmental safety of the
product, and why the lead CA's questions were not required to assess the product:

"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.

39 Nutti Response, Question 27.
40 Nutti Response, Question 37.
41 Squire Response, Question 37.

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.
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 information is neces sary to consider how gene escape can occur
either during processing, storage or transport, but detailed information is not
necessary.
37.08. As the GM plant is not to be cultivated under the present notification,
information on herbicide application is not needed."
42
Monsanto Roundup Ready corn (GA 21), C/ES/98/01 (EC chronology 78), C/GB/97/M3/2 (EC
chronology 85)

Question 40. Given the information befo re the Panel, including the application
(EC-85/At.25-26), questions by Denmark (EC-85/At.32) and responses to these questions
(EC-85/At.41), was the additional information requested by Denmark (EC-85/At.42) necessary
to ensure that conclusions of the safety assessment were valid?

40. This application provides another example in which a CA has requested additional animal
feeding studies which are not required for a safety assessment of the product. As Professor Nutti
explains,

"Base[d] on the information provided by the applicant (EC-85/At.25-56) and
responses to the questions raised by Denmark (EC-85/At.41 and EC-85/At.32,
respectively), regarding animal feeding studies, my understanding is that the
applicant has provided sufficient relevant information. According to the Codex
Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived
from Recombinant-DNA Plants (CAC/GL 45- 2003, paragraph 53), additional animal
testing will be required if the composition is not comparable to conventional foods,
which is not the case of Monsanto's event corn GA 21."43
Monsanto/Syngenta Roundup Ready sugar beet, C/BE/99/01 (EC chronology 88)

Question 42. Given the information before the Panel, including the notification (EC-88/At.1)
and additional information provided by the notifier (EC-88/At.10-11), was the information
regarding allergenicity, molecular characterisa tion, and gene transfer in digestive tracts
requested by the lead CA (EC-88/At.12) necessary to ensure that conclusions of the safety
assessment were valid?

41. This question illustrates a case where the CA 's question may have been relevant to the
assessment of the product, but where the applicant's original notification had provided the information
sought by the CA. Professor Nutti's response care fully analyzes this question, and concludes with
respect to all three aspects (alle rgenicity, molecular characterization, and gene transfer) that the

42 Andow Response, Question 37.
43 Nutti Response, Question 40.

requested information had already been provided in the application. As a result, the lead CA's
additional request resulted in needless delay in the processing of the application.44

Monsanto MaisGard Roundup Ready (MON 810 & GA21) corn (stack), C/ES/99/02 (EC
chronology 94)

Question 44. Given the information before the Pane l, including the notification (EC-94/At.1-3),
was the information requested by the Neth erlands(EC-94/At.12) concerning molecular
characterization, DNA sequence analysis of the insert ion event, analysis of protein levels, effect
of glyphosphate treatment, composition, toxico logy and the request for a study on dairy cows
necessary to ensure that conclusions of the safety assessment were valid?

42. Professor Nutti provided a detaile d analysis of four additional types of food-safety data
requested by the Netherlands, and in each case she concluded that the information requested was not
required for a safety assessment.

43. For example, the applicant was asked to provi de a semi-chronic feeding study on mice, even
though acute exposure studies and all other available data indicated that no such additional studies
were required. Professor Nutti explains as follows:

"Based on Codex Alimentarius Guidelin es for the Conduct of Food Safety
Assessment of Foods Derived from Re combinant-DNA Plants (CAC/GL 45-2003),
paragraphs 34 to 43, Assessment of Possible T oxicity, we have at para 37 that the use
of appropriate conventional toxicology or other studies on the new substance may be
necessary, if taking into account its function and exposure, there are doubts on the
safety of the new substance. In this case the applicant has provided in the dossier
(EC-94/At.1-3), all the information usually requested for the food safety assessment,
for toxicological assessment he presented safety studies on protein digestion in
mammalian gastric and intestinal systems, acute gavage studies in mice, homology to
known toxins and allergens and expos ure to human diet. Based on Codex
Alimentarius Guidelines for the Conduct of Food Safety Assessment of Foods
Derived from Recombinant-DNA Plants (CAC/GL 45-2003), paragraphs 53, my
understanding is that additional animal feeding studies may be warranted for GM
foods if changes in the biovailability of the nutrients are expected or if the
composition of the GM food is not comparable to conventional food, that is not the
case of the new hybrid MON 810x GA21 maize. My understanding is that the
information submitted by the applicant was su fficient to ensure the validity of the
safety assessment."
45
Syngenta Bt-11 sweet corn , (EC chronology 92)

Question 46. Were detection methods commercially available in 2002 sufficient to enable the
detection of the transgenic proteins expressed by the plant line Bt11 sweet corn?

44. This question highlights an application wher e the processing was delayed by requests for the
development of a detection method, when in fact a detection method was available to EC regulators.
After a detailed analysis, Dr. Healy concludes that "that an immunoassay based detection method

44 Nutti Response, Question 42.
45 Nutti Response, Question 44.

suitable for the detection of Cry1A(b) protein in Bt-11 transgenic plants was commercially available
in 2002."46

Bayer LibertyLink soybeans, (EC chronology 93)

Question 49. Given the information before the Pa nel, including the application (EC-93/At.1-2),
was additional information regarding nutritional and biochemical characterization and toxicity
of the transgenic plant requested by the G reek and Italian authorities (EC-93/At.16-17)
necessary to ensure that conclusions of the safety assessment were valid?

45. This question provides an example where a CA delayed an application by requesting food
safety data on an herbicide, when in fact herbicide residues are regulated through a different regime.
As Professor Nutti explains,

"Questions 1 and 2 [of the Italian authority] related to the herbicide treatment in the
tests and possible residues of this treatmen t in the final product. My understanding is
that the risk assessment conducted here is related to the GMO and not to the
herbicide, so this information is not re levant for the conclusions of the safety
assessment. It is important to point out that the herbicide residue in the product has to
be within the limits established by J EFCA and the Codex Alimentarius, so the
herbicide has been assessed in a different study. Sometimes, companies that are
carrying out the safety assessment of herbicide resistant GMOs, perform field tests
with and without herbicides, but this is not the main objective of the evaluation, as we
need to compare the transgenic and non tran sgenic crops and not the utilization of the
herbicide."
47
Monsanto Roundup Ready corn (NK603), (EC chronology 96)

Question 53: Given the information before the Pa nel, including the application (EC-96/At.1-2),
was information regarding molecular characteriza tion, toxicity effects of unintended changes
and compositional data requested by Gezondheitsraad (EC-96/At.7) necessary to ensure that
conclusions of the safety assessment were valid?

46. Nk603 Roundup Ready corn is another instan ce where a CA requested additional feeding
studies, when existing studies and all other availabl e information indicated that no additional studies
were required. As Professor Nutti explained,

"Question 2 [of the Gezondheitsraad] concerning the request for a semi chronic
toxicity study in mice or rats, using maize grain or meal, in order to rule out possible
undesired effects of additional, unidentified changes. Based on the Codex
Alimentarius Guidelines for the Conduct of Food Safety Assessment of Foods
Derived from Recombinant-DNA Plants (CAC/GL 45-2003), paragraphs 34 to 43,
Assessment of Possible Toxicity, we have at para 37 that the use of appropriate
conventional toxicology or other studies on the new substance may be necessary, if
taking into account its function and exposure, there are doubts on the safety of the
new substance. In this case the applicant has provided in the dossier (EC-96/At.1-2)
all the information usually requested for the food safety assessment, for toxicological
assessment he presented safety studies on CP4EPSPS protein digestion in mammalian

46 Healy Response, Question 46.
47 Nutti Response, Question 49.

gastric and intestinal systems, acute gavage studies in mice, homology to known
toxins and allergens and exposure to human diet. It was also confirmed that the GM
maize was equivalent in composition and nutrition to the conventional counterpart.
Therefore, in my opinion, there was no n eed for requesting a semi chronic toxicity
study in mice or rats, using maize grain or meal, in order to rule out possible
undesired effects of additional, unidentified changes."
48
Pioneer LibertyLink and Bt (T25 x MON 810) corn (stack), (EC chronology 101)

Question 57: Given the information before the Pa nel, including the application (EC-101/At.1-3)
and the additional information provided by Pioneer (EC-101/At13), was additional information
molecular characterization, field trials, seconda ry plant metabolites, and toxicological tests
requested by the Netherlands (E C-101At.14) necessary to ensure that conclusions of the safety
assessment were valid?

47. This product presents yet another exampl e where the CA requested unnecessary semi-chronic
oral toxicity studies. Both Professor Nutti and Pr ofessor Andow state their view that such studies
were not required in light of the studies already provided showing the absence of toxicity.49

Monsanto/Syngenta Roundup Ready sugar beet (77), (EC chronology 102)

Question 58. Given the information before the Panel, including the application (EC-102At.1-20)
and the information provided by Monsanto/Novartis (EC-102/At.22, 26 and 27-30), was
additional information regarding food safety a ssessment of derived proteins requested by the
Netherlands (EC-102/At.32) necessary to ensure th at conclusions of the sa fety assessment were
valid? Did the food safety assessments provide d by the applicant follow the Codex Guideline
for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants.

48. Again, the only expert to examine the i ssue – Professor Nutti – states that additional food
safety data (in the form of semi-chronic toxicity studies) were not required. With respect to the
second half of the question, Professor Nutti states her view that the applicant did in fact follow the
relevant Codex guidelines:

"Based on the Codex Alimentarius Guide lines for the Conduct of Food Safety
Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL 45-2003),
paragraphs 34 to 43, Assessment of Possible T oxicity, we have at para 37 that the use
of appropriate conventional toxicology or other studies on the new substance may be
necessary if, taking into account its function and exposure, doubts about the safety of
the new substance remain. In this case, the applicant has provided in the dossier
(EC-102/At.1-20) all the information usually requested for the food safety
assessment. Also, for the toxicological assessment he presented safety studies on
protein digestion in mammalian gastric and intestinal systems, acute gavage studies in
mice, homology to known toxins and allergens, and exposure to hum-an diet.

48 Nutti Response, Question 53.
49 Nutti Response, Question 57 ("Therefore, the reque st from the Netherlands for semi-chronic oral
toxicity study on mice or rats with maize grain, were not necessary to ensure that conclusions of the safety
assessment were valid, as the data provided by the notif iers confirmed that T25 and MON 810 are substantially
equivalent to other commercial maize."); Andow Response, Question 57 (semi-chronic study "not necessary to
ensure conclusions of the safety assessment were valid.").

Based on the Codex Alimentarius Guidelines for the Conduct of Food Safety
Assessment of Foods Derived from Re combinant-DNA Plants (CAC/GL 45-2003),
paragraphs 53, my understandi ng is that additional animal feeding studies may be
warranted for GM foods if changes in the bi ovailability of the nutrients are expected
or if the composition of the GM food is not comparable to conventional food, that is
not the case of Monsanto/Syngenta Roundup Ready sugar beet ."
50
C. ISSUE 2 (MEMBER STATE SAFEGUARD MEASURES)
Oilseed Rape MS1 x RF1 (notification C/UK/94/M1/1)

French Safeguard measure (Questions 59-61)

49. The United States notes several points of interest with respect to the experts' advice on this
notification. First, the experts have confirmed that the evidence establishes th at the French safeguard
measure cannot be justified on the grounds of any pote ntial risk to human or animal health. As Dr.
Nutti has explained,

"I would like to point out that there [was] no scientific evidence regarding to food and
feed safety assessment, for animal and human consumption, on which France['s
safeguard measure] could be based."
51
50. In addition, the advice from the experts with respect to risk management indicates that the
absence of a basis for a total product ban, and that in stead risk management measures were available.
In his response to question 61, Dr. Andow concludes that

"Several other risk management options [than the French safeguard measure] could
also have been justified in November 1998 and July 2001. Risk management
strategies include risk avoidance, risk mitig ation, and risk tolerance. In 1998 and
2001 mitigation and tolerance strategies we re probably inappropriate....One risk
avoidance strategy would have been to allo w limited planting in a restricted region.
In the first year, this could have been at a scale of a large field trial, and build up from
there. This would allow determination of scale effects. Another strategy is outlined
in paragraph 3.19.
Today several alternative risk management op tions are available. In addition to risk
avoidance as in the previous paragraph, risk mitigation strategies may also be
possible to control HT volunteers and wild species. It would appear that France is
now convinced that if HT volunteers or wild species occur that they can be detected
rapidly enough and eliminated."52
51. Dr. Squire similarly concluded that "[t]he ri sk management options were and are similar to
those indicated generally for oilseed rape at Responses 6d and 101."53

50 Nutti Response, Question 58.
51 Dr. Marilia Regina Nutti's Answers to Questions to Experts, Q. 60. See also Dr. Nutti's responses to
questions 59 and 61 in which she concludes that adequate information was available to allow France to assess
the risks to human and animal health.
52 Andow Response, Question 61.
53 Dr. Squire's Answers to Questions to Experts Q. 61, p. 15.

52. As a final point, the United States notes that the EC has not even attempted to explain how
this measure falls within the parameters of Article 5.7.54

Topas 19/2 (notification C/UK/95/M5/1)

French Safeguard Measure (Questions 62-66)

53. The experts' advice provides unanimous confirmation that the scientific evidence presented by
the EC fails to demonstrate that the French safe guard measure is consistent with the relevant SPS
disciplines.

54. The experts unanimously confirmed that the findings of the UK farm scale evaluation study
were not relevant to evaluating this application for import and processing of this notification, and
therefore, provided no scientific support for a prohibition on the import and processing of these
oilseed rape seeds.55

55. The experts further confirmed that the av ailable information provides no support for the
French measure on the basis of any human or animal health risk. As Dr. Nutti explained,

"[T]he scientific evidence submitted by France does not support a temporary
prohibition on the import and processing of oilseed rape Topas 19/2."56
56. Nor did the experts believe that the availabl e information was insufficient to permit either
member State to evaluate the potential risks to hum an or animal health. Dr. Nutti explains that:
"Based on the information presented by the notifiers and by the evaluation of SCP, my understanding
is that there is NO reason to believe that the sci entific evidence available to France in November 1998
and July 2001 was NOT sufficient to permit it to undertake an appropriate assessment of potential
risks to human, plant and anim al health, and the environment from the import and processing of
oilseed rape Topas 19/2."
57

57. The experts also confirmed that the justification the member State offered to support the
temporary prohibition had no scientific support. W ith respect to the French measure, Dr. Snow
concluded that:

54 As the United States has previously stated, while the scientific experts can provide advice on specific
scientific questions, they cannot be called upon to develop their own arguments, or otherwise speculate as to
why a safeguard measure is consistent with the obligati ons under the SPS Agreement. Experts can provide a
panel with vital perspectives, information, and advice on scientific and technical issu es, but this advice cannot
substitute for the risk assessment required by Article 5.1 of the SPS Agreement. Nor is such advice sufficient to
demonstrate that a measure falls within the parameters of Article 5.7. For example, in this specific case, the EC
has not identified any available pertinent information upon which the safeguard might be based; the EC has not
explained how the information was insufficient for a risk assessment when the EC's own scientific committee
completed a risk assessment; the EC has not shown that France "sought the information necessary for a more
objective assessment of the risk," and the EC has not sh own that France reviewed its ban "within a reasonable
period of time." These same points regarding the respec tive roles of disputing Parties and scientific experts
applies equally to all of the member State safeguard measures.
55 Dr. Andow's Answers to Questions to Experts, para 62.01; Dr. Squire's Answers to Questions to
Experts; Q. 62; Dr. Allison Snow's Answers to Questions to Experts; Q. 62, p. 24.
56 Dr. Marilia Regina Nutti's Answers to Questions to Experts; Q. 65.
57 Dr. Marilia Regina Nutti's Answers to Questions to Experts; Q. 63

"I did not find any convincing arguments for why further scientific research would be
needed to investigate environmental eff ects of a product that is only intended for
import and processing and not for cultivation."58
58. Similarly, Dr. Andow concluded that "[ t]he scientific evidence and other information
submitted by France does not support the adoption of a temporary prohibition on the import and
processing of oilseed rape Topas 19/2."59 He explained as follows:

"63.03. The argument used by France that was based on spatial scale does not hold
for this case. With importation and processi ng, it is highly unlikely that large-scale
production of GMHT oilseed rape is possible. Thus, the data on small-scale dispersal
is probably sufficient to complete a risk assessment even in 1998.
63.04. Moreover, the hazard of widespread HT resistance in oilseed rape or related
wild species does not hold for this case. Th is hazard is also scale-dependent, and
with the small-scale releases and poor surv ival expected in spillage and other
accidental releases, it is not feasible that th is hazard will occur. Even if it were
possible (see paragraph 62.01), there would many, many other possible ways to
manage this risk short of a prohibition. Thus, the rationale stated by France does not
argue that a risk exists that requires management."
60
59. Although one expert attempted to suggest ra tionales on which France might have relied to
support the safeguard measure, 61 the EC did not rely on these ratio nales and the EC has not explained
them. In addition, this same expert goes on to not e that France did not seek to obtain the additional
information necessary for a more objective assessment of the risk. Dr. Andow explains:

"However, I believe that had France collected the necessary data to complete this risk
assessment promptly after implementing their temporary prohibition that they could
have had sufficient data to make a decision in 2001."62
Greek Safeguard Measure

60. The experts unanimously confirmed that the findings of the UK farm scale evaluation study
were not relevant to evaluating the application for import and processing of this notification, and
therefore, provided no scientific support for a prohibition on the import and processing of these
oilseed rape seeds.63

61. The experts further confirmed that the ava ilable information did not identify a human or
animal health risk that would support the Greek safeguard measure. Dr. Nutti explained:

58 Dr. Allison Snow's Answers to Questions to Experts; Q. 62-66, pp. 24.-
59 .Dr. Andow's Answers to Questions to Experts, paras. 63.01 p.
60 Dr. Andow's Answers to Questions to Experts, pa ras. 63.03-63.04; see al so Andow Answers to Q.
64 and 65.
61 E.g., Dr. Andow's Answers to Questions to Experts, paras 63.05 and 65.01.
62 Dr. Andow's Answers to Questions to Experts, paras 63.07.
63 Dr. Andow's Answers to Questions to Experts, para 62.01; Dr. Squire's Answers to Questions to
Experts; Q. 62; Dr. Allison Snow's Answers to Questions to Experts; Q. 62, p. 24.

"[T]he scientific evidence submitted by Greece does not support a temporary
prohibition on the import and processing of oilseed rape Topas 19/2."64
62. Nor did the experts believe that the availa ble information was insufficient for Greece to
evaluate the potential risks to human or animal health. Dr. Nutti explained:

"[A]ll the information for the safety assess ment of potential risks to human and
animal health that was submitted by the applicants and evaluated by UK and SCP was
adequate and in accordance to the C odex Guidelines (FAO/WHO Codex Principles
for the Risk Analysis of Foods Derived from Modern Biotechnology; FAO/WHO
Codex Guideline for the Conduct of Food Sa fety Assessment of Foods Derived from
Recombinant-DNA Plants; FAO/WHO Codex Annex on Possible Allergenicity
Assessment)."
65
63. The advice from the experts also confirms th at environmental concerns would not justify the
measure. Dr. Snow concluded that

"I did not find any convincing arguments for why further scientific research would be
needed to investigate environmental eff ects of a product that is only intended for
import and processing and not for cultivation. The specific arguments provided by
Greece seem flawed. I do not understand why Greece assumes that feral populations
would become established or why they would cause environmental problems. Even if
such populations become established, there is no scientific reason to expect that gene
flow could harm the genetic diversity or abundance of wild relatives of oilseed rape
in Greece."
66
64. Although one expert attempte d to suggest rationales that Greece might have cited to support
the safeguard measure, 67 the EC did not rely on these rationales nor has the EC explained them. In
any event, the same expert concl udes that the current state of scientific knowledge would not support
the Greek safeguard: " Even on these grounds, the temporary prohibition probabl y could not be
justified past 2001."68

65. In addition, the same expert also concludes that instead of a total product ban, other, less
drastic risk management measures were available to meet those concerns. In his advice, Dr. Andow
states his view that such alternatives existed in 1998, and are currently available:

"Several other risk management options [t han the temporary prohibition] could have
been justified in November 1998. Risk management strategies include risk
avoidance, risk mitigation, and risk to lerance. In 1998 mitigation and tolerance
strategies were probably inappropriate. A nother risk avoidance strategy would have
been to request additional molecular ch aracterization data and allow limited
importation with attendant monitoring so that the practical aspects of controlling
escapes from spillage could experienced.

64 Dr. Nutti's Answers to Questions to Experts; Q. 65.
65 Dr. Nutti's Answers to Questions to Experts; Q. 68
66 Dr. Allison Snow's Answers to Questions to Experts; Q. 66
67 Dr. Andow's Answers to Questions to Experts; paras 66.05 and 68.01
68 Dr. Andow's Answers to Questions to Experts; para 68.01 (emphasis added).

These options were available in 2001 and remain today. In addition risk mitigation
strategies may also be possible to control HT volunteers and wild species."69
66. Finally, Dr. Andow notes that if Greece had in fact been concerned with such environmental
issues, it had more than sufficient time to gather the necessary information to assess them, but Greece
failed to do so: "I believe that had Greece collected the necessary data to complete this risk
assessment promptly after implementing their te mporary prohibition that they could have had
sufficient data to make a decision in 2001."
70

Maize Bt-176 (notification C/F/11-03)

Austrian Safeguard measure (Questions 69-71)

67. The expert advice confirmed that Austria's reliance on potential risks to human and animal
health from the bla gene conferring ampicillin resistance as a ju stification for its safeguard measure is
not supported by the scientific evidence. As Dr. Nutti explained,

"Based on the information presented by the notifiers and by the evaluation of four
different scientific committees, my understanding is there is NO reason to believe that
the scientific evidence availabl e to Austria in February 1997 was NOT sufficient to
permit it to undertake an appropriate assessme nt of potential risks to human, plant
and animal health, and the environment from the importation and use of Maize Bt-
176.71
As far as my knowledge goes, concerning food safety and nutrition, the scientific
evidence submitted by Austria does not support a temporary prohibition on the import
and use of Maize Bt-176.
In EC-144, Austrian Contribution for the WTO-Dispute-Expert-Meeting of the
European Commission 14 January 2004 in Brussels, I found that Austria presents
also issues related to allergenicity and toxicological risk assessment, but I cannot
agree with the points raised, as they are not in accordance with the FAO/WHO Codex
Guideline for the Conduct of Food Safety Assessment of Foods Derived from
Recombinant-DNA Plants; FAO/WHO Codex Annex on Possible Allergenicity
Assessment."
72
68. Although one expert attempted to offer rationales that the EC might have raised to support the
safeguard measure, 73 the EC has not relied on these rationales nor has the EC explained them.
Further, the same expert also concludes that instead of a total product ban, other, less drastic risk
management measures were available to meet any su ch concerns. Dr. Andow makes clear that such
alternatives existed in 1999, and are currently available:

"Other risk management options could not have been justified in February 1997.
However, had Austria worked to develop its own acceptable resistance management
measures, perhaps by 1999 other risk management options would have been possible.

69 Dr. Andow's Answers to Questions to Experts; paras 68.02-68.03.
70 Dr. Andow's Answers to Questions to Experts; para 66.05.
71 Dr. Nutti's Answers to Questions to Experts; Q.69.
72 Dr. Nutti's Answers to Questions to Experts; Q. 71.
73 Dr. Andow's Answers to Questions to Experts; paras 69.16, and 71.03--71.04.

Today several alternative risk management options are available. Risk management
strategies include risk avoidance, risk m itigation, and risk tolerance. Tolerance
strategies are probably inappropriate. One a lternate risk avoidance strategy would be
to implement country-specific resistance management measures, to limit planting to a
restricted region, and to conduct intensive non-target experiments. This would allow
progressive determination of non-target effects."
74
German Safeguard measure (Questions 72-74)

69. The expert advice confirmed that Germany's reliance on potential risks to human and animal
health resulting from the presence of an antibiotic r esistance marker gene as a justification for its
safeguard measure is not supported by the scientific evidence. As Dr. Nutti stated,

"As far as my knowledge goes, regarding food safety and nutrition issues, the
scientific evidence submitted by German y does not support a temporary prohibition
on the import and use of Maize Bt-176."75
70. The expert advice also makes clear that even if some risk had been identified, measures short
of a wholesale ban existed in 2002, and are currently available. Dr. Andow explained:

"Other risk management options could 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.
Today several alternative risk manageme nt options may be available. Risk
management strategies include risk avoidance, risk mitigation, and risk tolerance.
Tolerance strategies are probably inappropriate. One alternate risk avoidance strategy
would be to implement country-specific r esistance 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."76
Luxembourg Safeguard measure (Questions 75-77)

71. The expert advice confirmed that Luxembour g's reliance on potential human health risks
resulting from the presence of an antibiotic resistance marker gene as a justification for its safeguard
measure is not supported by the scientific evidence. As Dr. Nutti stated,

"Based on the information presented by the notifiers and by the evaluation of four
different scientific committees, my understanding is there is NO reason to believe that
the scientific evidence available to Luxembourg in February 1997 was NOT
sufficient to permit it to undertake an appr opriate assessment of potential risks to
human, plant and animal health, and the e nvironment from the importation and use of
Maize Bt-176.
77

74 Dr. Andow's Answers to Questions to Experts; paras 71.03 and 71.04.
75 Dr. Nutti's Answers to Questions to Experts; Q. 74.
76 Dr. Andow's Answers to Questions to Experts; paras 74.03-74.04.
77 Dr. Nutti's Answers to Questions to Experts; Q. 75.

As far as my knowledge goes, regarding food safety and nutrition issues, the
scientific evidence submitted by Luxembourg does not support a temporary
prohibition on the import and use of Maize Bt-176."78
72. Although one expert attempted to offer rationales that the EC might have raised to support the
safeguard measure, 79 the EC did not rely on these rationales nor has the EC explained them.
Moreover, the same expert concluded that alterna tives to a total ban existed potentially as early as
1999, and are currently available. Dr. Andow explained:

"Other risk management options [than th e temporary prohibition] 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.
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 ar e known, and considerable experience has
accumulated so that several can be feasibly implemented."
80
Maize Mon 810 (notification C/F/95/12-02)

Austrian safeguard measure (Questions 78-80)

73. The expert's advice confirmed that the scientific evidence does not support the existence of
any human or animal health risk that would jus tify Austria's safeguard measure. Dr. Nutti concluded
that

"Based on the information presented by notif iers and by the scientific evaluation
undertaken by France and by SCP, my understanding is there is no reason to believe
that the scientific evidence av ailable to Austria in June 1999 was NOT sufficient to
permit it to undertake an appropriate assessme nt of potential risks to human, plant
and animal health, and the environment from the importation and use of Maize MON
810.
81
As far as my knowledge goes, the scientific evidence submitted by Austria does not
support a temporary prohibition of the import and use of Maize MON 810."
82
74. Although one expert suggested rationales that the EC might have raised to support the
safeguard measure,
83 the EC did not rely on these rationales nor has the EC explained them. In
addition, the same expert concludes that alternatives to a total product ban are likely to be available.
Dr. Andow explains:

"Other risk management options [than th e temporary prohibition] may have been
justified in June 1999. Because the full resistance management and monitoring

78 Dr. Nutti's Answers to Questions to Experts; Q. 77.
79 Dr. Andow's Answers to Questions to Experts; paras 75.09 and 75.12.
80 Dr. Andow's Answers to Questions to Experts; paras 77.02-77.04.
81 Dr. Nutti's Answers to Questions to Experts; Q. 78.
82 Dr. Nutti's Answers to Questions to Experts; Q. 80.
83 Dr. Andow's Answers to Questions to Experts; paras 78.05-78.06.

measures were not before the Panel, the sci entific basis for a concrete discussion of
this is not possible.
Today several alternative risk manageme nt options may be available. Risk
management strategies include risk avoidance, risk mitigation, and risk tolerance.
Tolerance strategies are probably inappr opriate. 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."84
Italian safeguard measure (Questions 81-83)

75. The advice from the experts confirms that the scientific evidence does not support Italy's
safeguard measure with respect to Maize MON 810.

"My opinion is that the Italian CA did not provide any scientific information that
could change the evaluations done by the sci entific committees (Food and Plant). It is
important to point out that the information submitted by the applicant, covered all the
items needed for the comparison of the GM maize and its conve ntional counterpart,
not only with data on nutrients but also with animal feeding studies. The variation in
levels of protein was in the range of natu ral variation, so the point raised by Italy
referring to protein was not correct.
I do not agree with opinion of the Italian CA regarding the ambiguity of the term
"substantial equivalence", that, this concep t could be defined differently, given the
lack of clarity in the Community legislati on. The way to proceed for the comparison
between the GM and non GM has been presented not only at the Community
legislation but also at the OECD consensus documents, FAO/WHO Expert
Consultations 1996, 200, 2001 and Codex Alimentarius Guidelines.
My understanding is there is NO reason to believe that the scientific evidence
available to Italy in August 1988 was NOT sufficient to permit it to undertake an
appropriate assessment of potential risks to human, plant and animal health, and the
environment from ... Maize MON 810."85
76. Taking this advice into account, it is clear that the scientific evidence does not support a
finding that the Italian safeguard measure is based on legitimate scientific concerns.

Maize T25 (notification C/F/95/12-07)

Austrian safeguard measure (Questions 84-86)

77. The expert advice confirms that the scientif ic evidence provided by the EC does not support
the Austrian safeguard measure. The only support for the measure is found in the statement made by
one of the experts that scientific information did exist at the time the measure was adopted that might
justify the measure.

84 Dr. Andow's Answers to Questions to Experts; paras 80.03-80.04.
85 Dr. Nutti's Answers to Questions to Experts; Q. 81.

"The adoption of a temporary prohibition was probably not justified on the basis of
the scientific evidence and other information submitted by Austria. Austria needed to
clarify the rationale and provide substa ntial scientific evidence. A temporary
prohibition probably could have been justif ied at the time because the appropriate
scientific information did exist."86
78. However – even if an SPS measure could be justified based on reasons not put forward by the
member State (nor by the EC) – other conclusions of this expert make clear that alternatives existed in
2000, and are currently available, to manage the risks that might have been of concern to Austria.

"Several other risk management options could also have been justified in April 2000.
Risk management strategies include risk 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."
Italian safeguard measure (Questions 87-89)

79. The advice from the experts confirms that the scientific evidence does not support Italy's
safeguard measure with respect to Maize T25.

"My opinion is that the Italian CA did not provide any scientific information that
could change the evaluations done by the sci entific committees (Food and Plant). It is
important to point out that the informati on submitted by the applicant covered all the
items needed for the comparison of the GM maize and its conve ntional counterpart,
not only with data on nutrient but also with animal feeding studies. The variation in
levels of protein was in the range of natu ral variation, so the point raised by Italy
referring to protein was not correct.
I do not agree with opinion of the Italian CA regarding the ambiguity of the term
'substantial equivalence', that this concept could be defined differently, given the lack
of clarity in the Community legislation. The way to proceed for the comparison
between the GM and non GM has been presented not only at the Community
legislation but also at the OECD consensus documents, FAO/WHO Expert
Consultations 1996, 200, 2001 and the Codex Alimentarius Guidelines.
My understanding is there is NO reason to believe that the scientific evidence
available to Italy in August 1988 was NOT sufficient to permit it to undertake an
appropriate assessment of potential risks to human, plant and animal health, and the
environment from GM maize T25."87
80. Taking this advice into account, it is clear that the scientific evidence does not support the
adoption of this safeguard measure.

86 Dr. Andow's Answers to Questions to Experts; paras 86.0.
87 Dr. Nutti's Answers to Questions to Experts; Q. 87.

Maize Mon 809 (notification C/F/95/12-01/B)

Italian safeguard measure (Questions 90-92)

81. The advice from the experts confirms that the scientific evidence does not support Italy's
safeguard measure with respect to Maize Mon 809.

"My opinion is that the Italian CA did not provide any scientific information that
could change the evaluations done by the sci entific committees (Food and Plant). It is
important to point out that the information submitted by the applicant, covered all the
items needed for the comparison of the GM maize and its conve ntional counterpart,
not only with data on nutrient but also with animal feeding studies. The variation in
levels of protein was in the range of natu ral variation, so the point raised by Italy
referring to protein was not correct.
I do [not] agree with the opinion of the Italian CA regarding the ambiguity of the
term 'substantial equivalence', that this concept could be defined differently, given the
lack of clarity in the Community legislati on. The way to proceed for the comparison
between the GM and non GM has been presented not only at the Community
legislation but also at the OECD consensus documents, FAO/WHO Expert
Consultations 1996, 200, 2001 and the Codex Alimentarius Guidelines.
My understanding is there is NO reason to believe that the scientific evidence
available to Italy in August 1988 was NOT sufficient to permit it to undertake an
appropriate assessment of potential risks to human, plant and animal health, and the
environment from GM maize MON 809."88
82. Taking this advice into account, it is clear that the scientific evidence does not support the
adoption of this safeguard measure.

Maize Bt-11 (reference C/GB/96/M4/1)

Italian safeguard measure (Questions 93-95)

83. The advice from the experts confirms that the scientific evidence does not support Italy's
safeguard measure with respect to Maize Bt-11.

"My opinion is that the Italian CA did not provide any scientific information that
could change the evaluations done by the sci entific committees (Food and Plant). It is
important to point out that the information submitted by the applicant, covered all the
items needed for the comparison of the GM maize and its conve ntional counterpart,
not only with data on nutrient but also with animal feeding studies. The variation in
levels of protein was in the range of natu ral variation, so the point raised by Italy
referring to protein was not correct.
I do not agree with the opinion of the Italia n CA regarding the ambiguity of the term
'substantial equivalence', that this concept could be defined differently, given the lack
of clarity in the Community legislation. The way to proceed for the comparison
between the GM and non GM has been presented not only at the Community

88 Dr. Nutti's Answers to Questions to Experts; Q. 90.

legislation but also at the OECD consensus documents, FAO/WHO Expert
Consultations 1996, 200, 2001 and the Codex Alimentarius Guidelines.
My understanding is there is NO reason to believe that the scientific evidence
available to Italy in August 1988 was NOT sufficient to permit it to undertake an
appropriate assessment of potential risks to human, plant and animal health, and the
environment from GM maize Bt-11."89
84. Taking this advice into account, it is clear that the scientific evidence does not support the
adoption of this safeguard measure.

D. ADDITIONAL QUESTIONS
General Questions

Question 110. On the basis of the information be fore the Panel, is there any scientific evidence
to support the hypothesis that animal feed made from biotechnology plants alters the
composition of the food derived from animals consuming the feed?

(a) If so, what is the likelihood that this event could lead to adverse effects on human or
animal health? (see, inter alia, exhibit US-144)

(b) What risk management options are available to mitigate any resulting risks and what is
their efficacy?

85. Dr. Nutti's response supports the US position: "I am not aware of any scientific evidence that
supports the hypothesis that animal feed made from biotechnology plants alters the composition of the
food derived from animals consuming the feed." 90 Dr. Nutti also cites several scientific papers
showing no compositional changes in food derived from animals that consumed biotech animal feeds.

Question 112. Please provide an assessment of the statements regarding chronic toxicity testing
in paragraph 43 of Canada's Third Submission and paragraphs 134-138 of the US
Supplementary Rebuttal Submission. What relevance does the foreseen end product use(s)
have in the context of the evaluation of the toxicity of that product?

86. Dr. Nutti agrees with the scientific position put forth by the United States:

"As I had pointed out in several answers, and based on the Codex Alimentarius
Guidelines for the Conduct of Food Safety Assessment of Foods Derived from
Recombinant-DNA Plants (CAC/GL 45-2003), paragraphs 34 to 43, Assessment of
Possible Toxicity, we have at paragraph 37 that the use of appropriate conventional
toxicology or other studies on the new substance may be necessary if, taking into
account its function and exposure, doubts about the safety of the new substance
remain. My understanding is that if the toxicological assessment has conducted acute
gavage studies in mice, homology to known toxins and allergens with no indication
of adverse effects, chronic toxicity tests shall not be required."
91

89 Dr. Nutti's Answers to Questions to Experts; Q. 93.
90 Nutti Response, Answer 110.
91 Nutti Response, Answer 112.

Question 113. Please provide an assessment of th e statements regarding the purpose and use of
whole food studies in paragraphs 142-144 of th e US Supplemental Rebuttal Submission. What
relevance does the foreseen end product use(s) have in the context of using whole food studies in
the evaluation of the safety of that product?

87. Dr. Nutti agrees with the scientific position expressed by the United States:

"My understanding is that if the comparison of the composition of the GM product
and its conventional counterpart has shown to be substantially equivalent, the 90-day
oral study and at least one more feeding st udy (usually 48 day broiler chicken) has
provided information on the consumption of the whole food, the request for multiple
whole food studies in different species does not have scientific support."
92
Product-Specific Questions

Monsanto Roundup Ready corn (NK603), C/ES/00/01 (EC chronology 76)

Question 39bis: Given the information before the Panel, including the notification and
additional letter from Monsanto providing additional information (previously referenced and
EC-76/At.11-12), was additional information regarding allergenicity studies and PCR tests
requested by Austria (EC-76/At.44) necessary or u seful to ensure that conclusions of the safety
assessment were valid?

88. Dr. Nutti agrees with the US view that the additional info rmation requested by Austria was
not needed for a safety assessment:

"Based on EC-76/At.11-12 and the request by the lead CA in EC-76/At.44, regarding
to allergenicity studies and PCR tests, my opinion is that such a request was not
necessary to ensure that conclusions of the safety assessment were valid."93
Monsanto Roundup Ready corn (GA 21), C/ES/98/01 (EC chronology 78), C/GB/97/M3/2 (EC
chronology 85)

Question 40bis: Given the information before the Panel, including the first whole food study
and agronomic performance tests (attached, cover letter provided in EC 78/85/At. 19), was a
second animal whole food study requested by Denmark, Austria and Italy (EC-78/85 /At. 67, 40
and 72) necessary or useful to identify potential adverse effects that had not been previously
identified?

89. Dr. Nutti, citing Codex guidelines, agrees with the United States that a request for "a second
animal whole feeding study" was not needed for a food safety assessment.94

Monsanto MaisGard Roundup Ready (MON 810 & GA21) corn (stack), C/ES/99/02 (EC
chronology 94)

Question 44bis: Given the information before the Panel, including the first whole food study
and agronomic performance tests (EC 94/At.3, pp. 40), was a second animal whole food study

92 Nutti Response, Answer 113.
93 Nutti Response, Answer 39bis.
94 Nutti Response, Answer 40bis.

(EC 94/At.12) necessary or useful to identify potential adverse effects, including those associated
with small random DNA insertions, that had not been previously identified?

90. Dr. Nutti agrees with the position expressed by th e United States, stating her "opinion is that
such a request was not necessary to ensure that conclusions of the safety assessment were valid."

Question 44ter: In the context of this corn pr oduct which was produced through conventional
breeding from biotech parents, is data regarding the safety of the biotech parent plants relevant
to the safety assessment of the hybrid plant pro ducts? Given the results of the risk assessment
studies of the biotech parents, were additional studies necessary or useful to ensure that the
conclusions of the safety assessment related to the hybrid plants were valid?

91. Dr. Nutti agrees with the position of th e United States. She explains that

"In this case I believe that given the results of the risk assessment studies of the
biotech parents, no additional studies were necessary or useful to ensure that the
conclusions of the safety assessment related to the hybrid plants were valid."
95
Monsanto Roundup Ready corn (NK603), (EC chronology 96)

Question 53bis: Given the information before the Panel, including the first whole food study
and agronomic performance tests (EC 96/At.2 , pp. 102-103), was a second animal whole food
study (EC 96/At. 7) necessary or useful to iden tify potential adverse effects, including those
associated with small random DNA insertions, that had not been previously identified ?

92. Dr. Nutti agrees with the position of the United States. Citing to Codex standards, Dr. Nutti
states that "such a request [for a second animal whole food study] was not necessary to ensure that
conclusions of the safety assessment were valid."
96

95 Nutti Response, Answer 44ter.
96 Nutti Response, Answer 53bis.

ANNEX I-2

COMMENTS BY CANADA ON THE REPLIES BY THE
SCIENTIFIC EXPERTS TO THE QUESTIONS POSED BY THE PANEL
31 JANUARY 2005

INTRODUCTION

1. Canada is pleased to have this opportunity to comment on the answers given by the experts to
the Panel's questions. The experts undoubtedly had a difficult task before them, and Canada
expresses its appreciation to them for their willingness to undertake this task, and for the laudable
effort that they have made to respond to the Panel's questions.
2. Canada's comments on the responses to the Panel's questions provided by Drs. Andow, Healy,
Nutti, Snape, Snow and Squire are submitted with a view to assisting the Panel in understanding
Canada's position on the specific matters addressed by the experts. Canada's comments do not note
each and every instance where it agrees with the experts. Rather, they seek to identify where the
experts agree, point out what Canada considers to be inconsistencies among the experts' responses and
confirm which position Canada suppor ts, elaborate on some of the r esponses that Canada believes
require clarification or amplification, and respond to assertions with which Canada disagrees.
3. Canada is also pleased to note that, overall, the answers provided by the experts are consistent
with Canada's views and positions on the scientific issues raised by the Panel's questions. The advice
provided by the experts indicates, for the most part , that little or no scientific evidence exists with
respect to risks to human, animal or plant life or heal th, or to the environment, to justify the, in many
cases inordinate, delays by the European Communities (EC) with respect to the approval of a host of
biotech product applications. Similarly, the answers of the experts reinforce the scientific validity of
Canada's position that the EC Member State prohibitions on approved biotech products of interest to
Canada have no scientific basis. They are not supported by evidence demonstrating a risk, either from
a food and feed standpoint, or in relation to th e environment, nor can they be justified on
precautionary grounds.
4. Canada also draws the Panel's attention to the f act that some of the experts occasionally stray
beyond their respective spheres of competence in responding to the Panel's questions. In addition, in
some areas, the experts express views on issues that do not fall within the scope of the Panel's
questions, either because the issues are not scientific in nature, or because the answers, while science-
oriented, go beyond the ambit of the question. Th is leads some of the experts to engage in
unwarranted speculation in a number of places. Ca nada trusts that the Panel will disregard these
aspects of the experts' replies in so far as they cannot assist the Panel in resolving the issues before it.
5. For example, some of the experts express their views on Canada's regulatory regime for
approving the environmental release of agricultural bi otech products. In this regard, Canada is bound
to note that: (1) none of the experts have provide d any indication that they are thoroughly familiar
with Canada's regulatory regime; (2) the characterization of Canada's regulatory regime by the experts
is inaccurate in important respects; and (3) Canada's regulatory regime is not in issue in this
proceeding nor is it relevant to the questions that have been asked of the experts. If the Panel believes
it to be necessary to develop a greater understanding of Canada's regulatory regime in order to make
its findings in this dispute, Cana da would be pleased to provide a dditional information in order to
enhance that understanding, and to correct the inaccuracies found in the opinions of some of the
experts.

6. Canada takes this opportunity to observe that some of the experts' answers question or
challenge the analyses and conclusions of the re levant European Communities scientific committees
directly. It is unfortunate that the members of these committees are unlikely to be present at the
hearing or to have an opportunity to respond to the experts' observations in this regard.
7. More generally, Canada is compelled to emph asize that the current proceedings depart from
previous SPS-related disputes in that the scientific opinions of the responding party are not being
challenged by the complainants; to the contrary, it is the respondent that seeks to minimize their
impact on the outcome of the proceedings. In this context, it is useful to recall that it is not the
function of either the Panel's scientific advisors or the Panel itself to conduct a de novo examination
of the scientific assessments that have been conducted by the relevant Member State Competent
Authorities, the Community scientific committees or th e European Food Safety Authority. Rather, it
is for the EC and its Member States to show that they have based their measures on scientific risk
assessments, and that if they have chosen to disregard the scientific opinions of the Community
scientific committees, they did it on the basis of other, more compelling risk assessments. The EC has
not offered any concrete evidence that this is the case.
8. In this submission, Canada comments on the experts' answers to the following questions only:
Q1-9 (General Questions); Q14-20 (oilseed rape Ms8xRf3); Q26-28 (oilseed rape GT73); Q59-68 and
Q81-95 (safeguard measures except those pertaining to maize Bt-176 and Austria's prohibition on
MON810); Q96-106 (General Questions); and Q1 10 and 112 (Additional Questions). However,
Canada reserves its right to comment on the experts' answers to any of the other questions at the
meeting with the experts. Canada also reserves its right to comment further on the experts' answers in
subsequent submissions.
9. Canada looks forward to meeting with the experts and to the opportunity to discuss the
scientific issues raised by experts' answers to the Panel's questions in more detail at that meeting.
General Questions

1. the basis of the information before the Pane l, is there any scientific evidence to support
the hypothesis that antibiotic resistance marker genes (ARMG) pass from a biotech food or feed
product to bacteria or other micro-organisms present in the human or animal gut?

(a) If scientific evidence indicates that such an event could occur, what risks, if any,
would arise from that event? What is the comparative relevance or magnitude
of this risk in relation to the likelihood of such a transfer from other sources of
antibiotic resistance not involving the use of recombinant DNA technology?
(b) If such risks have been identified, what is the likelihood of adverse effects to
human or animal health, in light of the processing of raw biotech products into
human food or animal feedstuffs?
(c) Are these consequences relevant to the specific types of ARMG currently used in
the products at issue in this dispute? Please explain.
(d) If such risks have been identified, what risk management options are available to
mitigate those risks and what is their efficacy?

10. In her reply to this question, Dr. Nutti stat es that, despite "numerous experiments aimed at
evaluating the possibility of transfer of plant DNA to microbes and mammalian cells…there are no
reports that marker genes in plant DNA transfer to these cells."1
11. Dr. Nutti also says that even if such transfers were to take place for marker genes that confer
resistance to kanamycin, ampicillin or streptomycin , they are "unlikely to present a significant health
impact since bacteria resistant to these antibiotics are already spread all over or are naturally found in
the human gastrointestinal tract." 2 Finally, and in any event, many of these antibiotics are rarely used
on humans due to their negative side effects.
12. Dr. Nutti's conclusions are amply supported by th e literature she referenc es, as well as by
other sources.3
13. Dr. Nutti's advice fully supports the argument that there is no scientific evidence that would
support a refusal to approve, or to suspend the marketing of, a GM product on the grounds that the
presence of an antibiotic resistance marker (ABRM) gene constitutes a risk to human or animal
health.
2. On the basis of the information before the Panel, is there any scientific evidence to
support the hypothesis that antibiotic resistance develops through ways other than the uptake of
food or feed by humans or animals, that is, due to the potential persistence of plant-derived
DNA in the environment during crop cultivation and harvesting, and in soil residues?

(a) If scientific evidence indicates that such an event could occur, what risks, if
any, would arise from that event? What is the comparative relevance or
magnitude of this risk in relation to the likelihood of such a transfer from other
sources of antibiotic resistance not involving the use of recombinant DNA
technology?
(b) Are these consequences relevant to the specific types of ARMG currently used
in the products at issue in this dispute?
(c) If such risks have been identified, what risk management options are available
to mitigate those risks and what is their efficacy?
14. Although Dr. Squire and Dr. Nutti indicated that they intended to answer this question, their
reports do not contain answers to it. Dr. Squire's report contains no answer at all, and Dr. Nutti
indicates that she will not answer because the question pertains to "environmental safety".
15. Nevertheless, in an effort to advance the Pa nel's understanding, Canada notes the existence of
studies pertaining to this issue. In addition to the already cited article in the Journal of Antimicrobial

1 Answers to the Panel's Questions from Dr. Marilia Regini Nutti, 6 January 2005, p. 2. [hereinafter
Nutti]
2 Ibid.
3 See, for example, Bennett, P.M., et al., "An assessment of the risks asso ciated with the use of
antibiotic resistance genes in genetically modified plants: report of the Working Party of the British Society for
Antimicrobial Chemotherapy" Journal of Antimicrobial Chemotherapy (2004) 53, 418-431. (Exhibit CDA –
172).

Chemotherapy,4 published work by Dr. Abigail Salyers 5 and Dr. K. Smalla6 indicate that this is a low
probability event and that it would pose a minimal risk even if it were to occur.
16. Dr. Salyers provides an extensive theoretical ex amination of the issue, which considers all
potential mechanisms and refutes most of them as unlikely. Dr. Smalla has conducted field studies
that demonstrate that under normal fiel d conditions this event is unlikely, and that even if it were to
occur it would be at such low frequency that it would pose minimal risk compared to natural
mechanisms (of gene transfer between soil pathogens) or any therapeutic use.
17. Canada requests that the experts provide their comments, if any, on the relevant scientific
information in these studies to the extent that it falls within their field of expertise.
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 organ isms 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?

18. Dr. Squire responds to this question by sa ying that current expe rimental evidence is
insufficient to confirm whether widespread cultivation would affect non-target organisms.
Importantly, he observes that the weight of evid ence suggests little immediate toxic effect, although
he also "admits the possibility" of chronic effect s following long-term exposur e. He concludes that
the question can only be conclusively answered fo llowing long-term studies and the development of a
comparator.7
19. Dr. Squire also points out that any damage to in-field biodiversity can be reversed by rotating
crops.8 This would suggest that, to the extent that a risk exists, it can be managed relatively easily
using proven agronomic management practices.
20. Dr. Andow focuses his comments on the studies found in Exhibits EC-149, EC-150, EC-151,
and EC 152. Dr. Andow begins his analysis by st ating that there is some evidence to support the
hypothesis that wide-spread cultivation of Bt crops adversely affects non-target organisms but this
evidence is insufficient to establish the hypothesis that such adverse effects are expected to occur.
21. Regarding Exhibit EC-149, Dr. Andow looks at the analysis of the studies reviewed in the
exhibit, and concludes that "there is a possible hazard to collembola [ Folsomia candida ]" but
concedes that he cannot conclude that there is a po tential risk. He also concludes that there is a

4 Exhibit CDA-172.
5 Salyers, Abigail, "Genetically Engineered Foods: Safety Issues Associated with Antibiotic Resistance
Genes" Alliance for the Prudent Use of Antibiotics (Exhibit CDA-173).
6 Smalla, Kornelia et al., "Monitoring the identity and survival of genetically modified or non-modified
plant growth promoting bacteria and their impact on so il microbial communities" (Paper presented to the 7th
International Symposium on the Biosafety of Genetically Modified Organisms, Beijing, China October 2002).
(Exhibit CDA-174).
7 Answers to Questions 3 to 5 from Dr. Geoff Squire, 6 January 2005, p. 3. [hereinafter Answers to
Questions 3 to 5, Squire]
8 Ibid., p. 2-3.

potential risk to C. carnea".9 However, regarding the the Collembola study, it must be said that it is,
at best, inconclusive. Dr. Andow cites no other st udies with respect to this organism that have
reproduced the results of the study reviewed in th e exhibit, and without further details about that
study, which, according to Exhibit EC-149, was not pub lished, or a copy of the study itself, Canada is
not in a position to evaluate its methodological soun dness or the validity of its conclusions. In fact,
other studies suggest that the risk of an adverse impact of Bt on Folsomia candida is negligible.
22. As for the studies relating to the putative impact of Bt on C. carnea (Lacewing), Dr. Andow
neglects to mention that the cited studies have been effectively refuted by more recent work. 10 In
fact, although it may be true, as Dr. Andow indicates, that there have been "numerous" studies –
disregarding for the moment the indeterminate nature of the word "numerous" – majority scientific
opinion is that there is no significant adverse effect , and there has been no observed effect under field
conditions.
23. Dr. Andow also notes later in his answer that any risk to Lacewing under field conditions is
unlikely to be large; according to him, any adverse effect will be subtle and difficult to detect in the
field. However, his opinion that there will be any effect at all is largely speculative, and ties into his
later statement with respect to the absence of eviden ce of adverse effects: "the US experience [i.e. no
observed adverse effects] does not imply that th ere are no adverse effects on non-target species."
11
Of course, it is also true that the US experience cannot in any way be said to represent evidence of
such adverse effects so it is not clear how Dr. Andow's statement can be of assistance to the Panel.
24. The SCP opinion on the Bt11 application for cultivation in 20 00 took into account some of
the studies reviewed in Exhibit EC-149 in its an alysis, and the Hilbeck studies in particular. 12 The
SCP evidently did not consider that these studies presented a serious impediment to its conclusion that
"there is no evidence to indicate that the placing on the market for cultivation purposes of maize line
Bt-11…is likely to cause adverse effects on human health and the environment".
13 The SCP did,
however, recommend monitoring of the fields to pr ovide reassurance that there are no effects at the
extended field scale.
25. The SCP also notes in its opinion that "laboratory feeding studies have not shown toxicity to
earthworms and at field concentrations to Collembola [ Folsomia candida]".14 Its finding with respect
to earthworms appears to contradict the Hilbeck study in Exhibit EC-150, cited by Dr. Andow.
Although Dr. Andow states that there are other studi es that support Dr. Hilbeck's conclusions with
respect to earthworms, he provides no references.

9 Answers to the Panel's Questions from Dr. David A. Andow, 6 January 2005, p. 1. [hereinafter
Andow]
10 See, for example, Romeis, Jorg, et al., " Bacillus thuringiensis toxin (Cry1Ab) has no direct effect on
larvae of the green lacewing Chrysoperla carnea (Stephens) (Neuropt era: Chrysopidae)" Journal of Insect
Physiology 50 (2004) 175-183 (Exhibit CDA-175); Dutton, Anna, et al., "Assessing the risks of insect resistant
transgenic plants on entomophagous arthropods: Bt-maize expressing Cry1Ab as a case study" BioControl 48:
611-636,2003 (Exhibit CDA-176).
11 Andow, p. 4.
12 EC, Scientific Committee on Plants, Opinion on the submission for placing on the market of
genetically modified insect resistant and Glufosinate ammonium tolerant (Bt-11) maize for cultivation. Notified
by Novartis Seeds SA Company (Notification No. C/F/96/05-10) , adopted 30 November 2000, p. 8 (Exhibit
CDA-84).
13 Ibid.
14 Ibid.

26. In any event, it is also noteworthy that an y adverse effects can, as Dr. Squire advises, 15 be
reversed fairly easily through crop rotation.
27. Dr. Andow concludes, in paragraph 3.10, "tha t possible hazards have been identified and
potential risks are evident." 16 Although the lack of evidence means that an actual non-target risk
cannot be fully characterized, he believes that if the analysis is completed, "there will be a
documented risk of some Bt maize events to monarch butterflies". 17 This latter statement is
completely speculative. The vast majority of th e scientific literature on Bt and monarch butterfly
populations states unequivocally that there is no significant adverse effect on monarch butterfly
populations under field conditions.18
28. Bt corn has been grown widely across Canada and the United States for eight years. Despite
this fact, there is still no scientific evidence of significant non-target adverse effects under field
conditions. If, as Dr. Andow states, that even af ter all this time and widespread environmental
exposure, no one has observed significant adverse non-target effects, it is quite plausible, and even
reasonable, to draw an inference that such significant effects are not occurring. While such an
inference must be considered speculative, it is no more, and probably less, speculative than the views
expressed by Dr. Andow. And to assert that no effects have been noted because nobody is looking is
incorrect. There are in fact a number of groups conducting such work, the Canadian Corn Pest
Coalition being one of them.
19
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 emergen ce of Bt-resistant target organisms under field
conditions? If so, what risk management options exist to mitigate any resulting risks and what
is their efficacy?

29. In his reply, Dr. Squire first notes that the emer gence of pest insect resistance to pesticides
varies widely from context to context, and depends on a range of factors, such as the exposure to and
strength (dosage) of the toxin, the movement of insect populations, and the genetics and mating
system of the insect.20 He observes that resistance to Bt crops (cotton) has occurred and is influenced
by the "dose" of toxin delivered to the pest and the genetic nature of the pest, among other factors. 21
However, he suggests that managing the emergence of Bt resistance under field conditions is not

15 Answers to Questions 3 to 5, Squire, p. 2.
16 Andow, p. 4.
17 Ibid.
18 See, for example, Oberhauser, Karen S. et al ., "Temporal and spatial overlap between monarch
larvae and corn pollen" PNAS, Oct 2001; 98: 11913 – 11918 (Exhibit CDA-178); Pimentel, David S. et al., "Bt
corn pollen impacts on nontarget Lepidopt era : Assessment of effects in nature" PNAS , July 2000; 97: 8198 –
8199 (Exhibit CDA-179); Sears, Mark K. et al., " Impact of Bt corn pollen on monarch butterfly populations: A
risk assessment" PNAS, Oct 2001; 98: 11937 – 11942 (Exhibit CDA-180); Stanley-Horn, Diane E. et al.,
"Assessing the impact of Cry1Ab-expressing corn pollen on monarch butterfly larvae in field studies" PNAS,
Oct 2001; 98: 11931 – 11936 (Exhibit CDA-181); Wraight, C.L. et al., "Absence of toxicity of Bacillus
thuringiensis pollen to black swallowtails under field conditions" PNAS, Jul 2000; 97: 7700-7703 (Exhibit
CDA-182); Zangerl, A.R. et al., " Effects of exposure to event 176 Bacillus thuringiensis corn pollen on
monarch and black swallowtail caterpillars under field conditions" PNAS, Oct 2001; 98: 11908 – 11912 (Exhibit
CDA-183).
19 Canadian Corn Pest Coalition "BT CORN STEWARDSHIP INFORMATION NOW AVAILABLE
ONLINE" 2003; available online http://www.cornpest.ca/lib/news.cfm?id=9 (Exhibit CDA-184).
20 Answers to Questions 3 to 5, Squire, p. 3.
21 Ibid.

problematic. According to Dr. Squire, "the processes involved in Bt resistance and its management
are generally appreciated by scientists, and mitigat ion strategies that have a strong scientific basis
have been considered. …Sound scientific knowledge h as been applied to this problem for several
years".22
30. Dr. Andow is of the view that the emergence of resistance cannot be prevented, only delayed,
and he characterizes Bt resistance in pests as an "environmental risk". The characterization of the
emergence of Bt resistant pests, however, is misleading. The emergence of resistance largely poses
an agronomic management problem for farmers in that it will discourage them from using Bt crops.
31. Dr. Snow seems to agree that the main issue in the emergence of resistance is the "loss of a
benefit" rather than the creation of a risk. 23 She summarizes the benefits of Bt crops, including
benefits to workers' health, benefits to populations of non-target and beneficial insects, low toxicity,
and agronomic benefits of Bt proteins.
32. Although Dr. Andow claims that "there is scientific consensus that resist ance to Bt maize is
inevitable", he concedes that despite eight years of widespread cultivation throughout North America,
"it has still not been detected in the field". 24 In fact, in contrast to chemical applications of Bt,
mitigation measures used for Bt crops have delaye d emergence of resistant pests far beyond that
normally seen with chemical applications. Hen ce, Dr. Andow's statement that "widespread non-
biotech applications of Bt toxins have resulted in the Bt-resistant target pests organisms under field
conditions"25 is not really relevant in this particular context.
33. It is also important to note that Dr. Andow does not provide any reference to a time horizon.
It must be taken as a given that, if enough time pa sses, virtually anything can be characterized as
inevitable. It is fair to say that very few experts expect Bt crops to remain fully resistant to target
pests indefinitely.
34. As Dr. Squire noted, resistance management measures are available to minimize the
likelihood of Bt-resistant pest insects emerging. Dr. Andow summarizes the current thinking around
the most widely used method, that is the use of refuges, and notes that there is some evidence to
support the hypothesis that the high dose/refuge strate gy has been effective in delaying the emergence
of Bt-resistant insect pests. 26 In fact, because of on-going debates about optimum refuge size, the
current refuge sizes are conservative. In other words, they are probably larger than they need to be to
be effective.
35. In summary, the key points about the possible emer gence of pest resistance to Bt crops seem
to be the following:
− in principle, it is taken as a given;
− however, time frame is variable;
− effective resistance management measures are available that can delay it;
− the science underlying these measures is fairly well understood;
− to date, no organisms that have evolved resistance to Bt maize have been found; and

22 Ibid.
23 Answers to the Panel's Questions from Dr. Allison A. Snow, 6 January 2005, p. 9. [hereinafter
Snow]
24 Andow, p. 6.
25 Ibid.
26 Ibid., p. 9.

− it does not really constitute an environmental risk; it is an agronomic management issue.

5. On the basis of the information before the Panel, is there any scientific evidence to
support the hypothesis that Bt maize varieties a re any more toxic to humans or animals than
conventional maize under field conditions? If so, what risk management options exist to
mitigate any resulting risks and what is their efficacy?

36. Dr. Squire says assessing product toxicity to ecological processes is more complicated than
assessing toxicity as a food or feedstuff. The cont ention that nothing adve rse 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. 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. Evidence, either way, of harm to animals arising from growing
Bt crops in the field in Europe is therefore inconclusive at present. Longer term studies are needed.27
37. Dr. Nutti indicates that, based on the information before the Panel, there is no evidence to
support the hypothesis that Bt maize varieties are more toxic to humans or animals (as feed) than
conventional maize under field conditions.28
38. Canada considers that there may be some confusion as to the scope of this question among the
experts. As written, the question can be unders tood as pertaining to Bt toxicity only from the
standpoint of food and feed. Conversely, it can be taken to cover Bt toxicity to animals beyond
domesticated animals. Dr. Squire appears to understand the question to be focussing on "ecological
processes", noting the added complexities when you go beyond food and feed. To the extent that the
focus is ecological rather than food and feed, Ques tion 5 seems to be at least partly repetitive of
Question 3. Hence, Dr. Squire notes in parentheses that in some respects his answer repeats his
response to the earlier question.
39. Concerning food and feed, it is noteworthy that the Scientific Committee on Food (SCF), in
its 2002 opinion on Bt-11 for food and feed, came to the conclusion that Bt11 sweet maize is as safe
for human food use as its conventional counterparts.
29 None of the experts has challenged this
conclusion.
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 persistent in the non-agricultural
environment than their conventional counterparts? If so, do herbicide tolerant crops qualify as
a potential "pest" as the term is used in Int ernational Standard for Phytosanitary Measures
(ISPM) 11?

(a) What is the potential for the establish ment and spread of herbicide tolerant
plants arising from handling, spillage during transport of the plant/plant parts,
or any other means outside of cultivation in the absence of application of the
herbicide? How is any potential fo r 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?

27 Answers to Questions 3 to 5, Squire, p. 4.
28 Nutti, p. 4.
29 EC, Scientific Committee on Food, Opinion on a request to place genetically modified sweet maize
line Bt11 on the market, expressed 17 April 2002 (Exhibit CDA-35-J).

(b) What is the potential for the establish ment and spread of herbicide tolerant
plants in the presence of herbicide app lication (in fields, urban, domestic or
other environments)? How is any potential affected by the existence of feral
related plant species; infertile wild relatives; seed survival 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 monitori ng and review principles described in
ISPM 11?
40. Drs. Snow, Squire and Andow conclude that herbicide tolerant (HT) crops have the potential
to become "pests", supporting Canada's assertion to that effect. 30 Although the crop itself is not
"injurious to plants or plant products," Annex 3 of ISPM No. 11 lists potential phytosanitary risks for
LMOs including changes in adaptive characteristics which may increase the potential for introduction
or spread including alterations in "pesticide (including herbicide) resistance."
31 Drs. Snow and Squire
conclude that in the absence of herbicide, th e HT crop should be no more persistent in the
environment than non-HT crops, a conclusion that is seemingly at odds with Dr. Andow (para. 6.02).
41. Dr. Andow's view that "GMHT oilseed rape may be more persistent … than their
conventional HT oilseed rape" appears to be based on the fact that the GMHT varieties are more
commonly used.
42. Drs. Snow and Squire conclude that the applica tion of an herbicide to an HT plant that is
resistant to that herbicide would favour that pl ant; consequently the HT plant may become more
abundant. The more extensively the herbicide is used the stronger the selection pressure favouring the
HT plants. Thus, whether or not an HT crop is considered a "pest" depends in large part on the extent
and nature of herbicide use.
43. Canada asks that Drs. Squire and Snow clarif y whether this argument would apply equally to
crops that are naturally resistant to certain herbicides ( e.g. wheat and barley are naturally resistant to
fenoxaprop-p-ethyl+safener (PUMA), trialcoxidim, dicolfop-methyl (ACCase mode of action - these
herbicides are used throughout Europe to control gras sy weeds in wheat and barley)). For those crops
that are naturally HT, would the application of the herbicide to which they are tolerant confer a
selective advantage over other plants? Thus, w ould feral populations of wheat have a selective
advantage when sprayed repeatedly with fenoxaprop-p -ethyl? Is a solution to this problem to use a
different herbicide or mix of herbicides? Is not the nature of herbicides to provide a selective
advantage to certain plants that are resistant to those herbicides?

31 ISPM N° 11: Pest risk analysis for quarantine pests, including analysis of environmental risks and
living modified organism, FAO, April 2004 , p. 36 (Exhibit EC-130).

44. Does the agronomic usage of the herbicides gl yphosate and glufosinate-ammonium differ?
While glyphosate has multiple uses (pre-seeding burn-off, post-emergence, desiccation), glufosinate-
ammonium primarily is used as a selective herb icide on tolerant crops, with some exceptions. 32 What
impact do these different uses have on the potential for glufosinate-tolerant crops to become pests?
Could the "problem" of HT volunteers be addressed by restricting the types of uses of the herbicide?
45. The experts' opinion supports Canada's asserti on that risk management measures mitigate any
"problems" associated wi th herbicide tolerance. 33 However, on p. 15, Dr. Snow states that "by the
time the spread of herbicide resistan ce is detected in free-living pest populations, it may be too late to
prevent these plants from proliferating further." She then cites a "problem" that has arisen in Canada
in relation to the widely spread transgene conferri ng tolerance to glyphosate. However, there is little
evidence in the literature of herbic ide-resistance in weeds from the use of herbicides associated with
GMHT crops. To the best of Canada's knowle dge, there are few repor ted weeds resistant to
glyphosate34 and no reported weeds resistant to glufosinate-ammonium. 35 Indeed, resistance in weed
populations to herbicides used in conjunction with non-GMHT crops developed through mutagenesis
(e.g. varieties tolerant to imidazolinone) is a far greater problem.36
46. In terms of managing this "problem", the scien tific literature suggests that multiple herbicide-
resistant oilseed rape can be c ontrolled by alternative herbicides. 37 Thus, the "problems" identified
relate solely to the loss of efficacy of one type of weed management option, namely the application of
the herbicide to which the plant is tolerant. This does not necessarily imply the weeds are harder to
control. Can the experts confirm that the sta ndard herbicide control measure for non-HT and HT
oilseed rape (both biotech and mutation induced) is the application of phenoxy herbicides?
47. Canada would be grateful if the experts could clarify to what extent these "problems" are
comparable to problems that may be encountered w ith the use of herbicides generally. Would it be
fair to conclude that one of the purposes of soun d agricultural management is to prolong the efficacy
of the herbicide in question? Is this an environmental issue or an agronomic issue?
48. Dr. Squire indicates that more serious problems relating to the persistence of biotech HT
crops will arise if labelling or marketing ‘rules' require non-biotech crops to meet high purity levels.38

32 To Canada's knowledge, glufosinate-ammonium is used for weed control in orchards, vineyards,
vegetable cultivation and as a desiccant for potatoes and oilseed rape.
34 Glyphosate mode of action is Glycine. GLYCINES (G/9) Resistant Weeds by species and country,
Weed Science.org "Glyphosate" 2003; available online
http://www.weedscience.org/summary/ChemFamilySum.asp?lstActive=162&btnSub1=Go&lstHRAC= (Exhibit
CDA-185).
35 Glufosinate-ammonium mode of action is Glutamine synthase inhibitors. There are currently no
reported cases of weed resistance to GA.
36 Imidazolinone mode of action is ALS inhibitor. ALS INHIBITORS (B/2) Resistant Weeds by
species and country, Weed Science.org "Imazamox" 2003; available online
http://www.weedscience.org/summary/ChemFamilySum.asp?lstActive=265&btnSub1=Go&lstHRAC= (Exhibit
CDA-186).
37 Beckie H, (2004), Multiple herbicide-resistant canola (Brassica napus) can be controlled by
alternative herbicides. (Exhibit CDA-127). Also see, Senior, I.J ., et al, "Herbicide sensitivity of transgenic
multiple herbicide-tolerant oilseed rape" Pest Management Science 58:405-412 (2002) Pest Management
Science 58, 405-412, Section 4 - Conclusion (Exhibit CD A-187) and Sweet, J., et al , "Botanical and rotational
implications of genetically modified herbicide tolerance in winter oilseed rape and sugar beet (BRIGHT
Project)" Home-Grown Cereals Authority (HGCA) , Project Report No. 353 (2004), Chapters 1, 2, 3, 7, and 8
(Exhibit CDA-188).
38 Answers to the Panel's Questions from Dr. Geoff Squire, 6 January 2005, p. 8. [hereinafter Squire]

In the light of the definition of "pest" in ISPM No. 11, Canada would be grateful if Dr. Squire could
clarify whether labelling or coexistence requireme nts alone can affect whether a plant could be
considered a "pest" under the ISPM No. 11. In othe r words, could the mere presence of a transgene
be considered to be "injurious to plants or plant products"? Does Dr. Squire agree or disagree with
Dr. Snow's statement that "gene flow do es not represent an environmental concern per se, unless it
results in unwanted biological consequences"?
39
49. In terms of post-market monitoring, Dr. Squire indicates that the type of monitoring would
differ depending on the purpose of the monitoring, whether for the presence or abundance of HT
crops or for the impact of HT cropping on biodiver sity and ecosystem functioning. Canada agrees
that the monitoring provisions of ISPM No. 11 are applicable to monitoring for the establishment and
spread of potential "pests" including HT plants. However, as Dr. Squire acknowledges, the impacts
on biodiversity or the ecosystem of HT cropping are not caused by the GM crop per se, but the weed
management program, including the mode of action, dosage and timing of herbicides. Could Dr.
Squire clarify why he considers the ISPM No. 11 relevant to the monitoring of impacts on
biodiversity and the ecosystem arising from the app lication of herbicides? In Canada's view, the
monitoring plans adopted in this regard should not differ from monitoring plans for assessing the
impact of changes in agronomic practices on biodiversity generally.
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)?

50. Drs. Squire and Andow respond to this question. Dr. Squire discusses the Farm Scale
Evaluation (FSE), noting that "the difference in weed management rather than the GM or
conventional crop plants per se was the effective agent." Whet her GMHT cropping resulted in a
negative or positive impact on biodiversity depe nded on the "severity of the conventional
management." Dr. Squire concludes that "in principle, there should be no difference between the
effects of GMHT cropping and non-biotech HT cropping". Canada would be grateful if Dr. Squire
could indicate whether he agrees that the conclusi ons of the BRIGHT project report, to which he
refers, are valid.
40
51. In terms of impacts on biodiversity, it is important to recognize that the very purpose of
agriculture is to reduce biodiversity in the area under cultivation in order to favour one species over
other species that compete for nutrients, moisture etc. However, biodiversity can be preserved by
adopting sound agronomic practices such as crop rotati on and leaving fields fallow. Indeed, a far
more dramatic impact on biodiversity in the UK ha s been the widespread adoption of autumn-sown
crops (such as winter oilseed rape), which reduces the amount of time a field is left fallow. The point
here is that changes in agronomic practice affect biodiversity. There is no principled reason to
subject GMHT cropping to disproportionately great er scrutiny than other agronomic practices (in
particular, non-GMHT cropping).
52. Dr. Squire also concludes that "[a]ll eviden ce 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

39 Snow, p. 5.
40 Exhibit CDA-188.

organism different from that of non-GM plants."41 In Canada's view this conclusion is consistent with
relevant scientific evidence.
53. Dr. Andow provides a somewhat more qualified response stating that "if all the factors in
paragraphs 07.09 through 07.13 ar e equivalent between the GMHT and non-GMHT crop, then there
will be no predicted differences in the risks of adverse effects from the repeated use of a GMHT or
non-GMHT crops."42
54. Nonetheless, Dr. Andow raises a number of e ither irrelevant or scientifically unsupported
propositions to suggest that GMHT crops may cause "adverse effects", without regard for potential
adverse effects caused by non-GMHT crops. First, Dr. Andow implies that a GMHT and its related
herbicide use are "so tightly correlated" that adver se effects of herbicide use should be attributed to
the GMHT crop. He fails to indicate whether th e same concern holds true for non-GMHT crops and
associated herbicides. Moreover, Dr. Andow fails to point out that there are many variables that
influence the effectiveness of an herbicide in cont rolling weeds (e.g. mode of action, dosage, timing
and frequency of application).
55. Second, Dr. Andow states that "[t]here is abundant evidence that repeated use of a given
biotech herbicide tolerant crop would likely result in the evolution of resistance in weeds to the
herbicide." As Canada has indicated under Questi on 6, there is little evidence in the literature of
herbicide-resistance in weeds from the use of herb icides associated with GMHT crops. Indeed, the
fastest growing problem for resistance in weed populati ons is for those tolerant to herbicides used in
conjunction with non-GMHT crops de veloped through mutagenesis ( e.g. varieties tolerant to
imidazolinone).
56. Third, Andow questions the conclusions of the FS E and states that "I believe that it is likely
that additional adverse effects on non-target organism may be reported in the future." 43 Dr. Andow
does not provide support for this belief nor does he evaluate whether the same proposition holds true
for non-GMHT crops.
57. Fourth, Dr. Andow asserts that "[g]ene flow from a GMHT crop to a weed relative can create
weeds that are more difficult to control" and claims that "[t]his occurred in GMHT oilseed rape in
Canada." However, he cites no evidence to support this assertion. The clai m that weeds are more
difficult to control is without foundation. 44 The standard herbicide control measure for non-HT and
HT oilseed rape (both GM and mutation induced) is the application of a phenoxy herbicide.
58. Fifth, Dr. Andow raises the issue of so-calle d "contamination" of conventional crops resulting
from gene flow from a GMHT (the "co-existence" issue). As Dr. Andow acknowledges in his
response to Question 103, whatever "economic loss" that may result is not associated with damage to
plant life or health. 45 For instance, in response to Question 103, he argues that the definition of
"adverse effects" is a relative concept and cites the example of the organic farmer who perceives
"contamination" to be an adverse effect because "it removes his or her product from the organic food
stream." However, this has nothing to do with adverse effects on the environment. Even the
European Commission has acknowledged that "co-existence" concerns the "potential economic

41 Squire, p. 10.
42 Andow, para. 7.14.
43 Andow, para. 7.03.
44 Beckie et al. Multiple herbicide-resistant canola can be controlled by alternative herbicides, Exhibit
CDA-127.
45 Andow, para. 103.03

impact of the admixture of GM and non-GM crops." 46 The economic impact of the admixture of GM
and non-GM crops is not a relevant consideration under Directive 2001/18 , as this directive is
concerned with the adverse effects on the environment. 47 Importantly, this "potential economic
impact" is a result, not of damage to plant life of health, but by the supposed inability of European
farmers to satisfy either low tolerances for adve ntitious GM presence set fo r maintaining "organic"
status or low thresholds for GM labelling requirement s. For instance, in terms of organic agriculture,
as no threshold has been set for adventitious presence of GM products, the general threshold of 0.9%
applies.48 However, organic regulations in the EC permit the use of seeds developed through
mutagenesis, while GMO seeds are seen as antithetical to the philosophy of organic agriculture.
59. In any event, Dr. Andow is not qualified to provide expert advice on the extent of "economic
loss", if any, that may be sustained by the organi c or conventional farmer arising from the admixture
of GM and non-GM products. Indeed, the EC in this proceeding, while referring to the "risk" of co-
existence, has notably failed to put forth any analys is of the extent of any potential economic harm in
this regard.
60. Sixth, although Dr. Andow acknowledges that "the re are no reports of adverse effects on soil-
micro- or macro-flora or fauna…" 49, he advises the Panel "not [to] infer that the absence of
information implies an absence of effect." Nowhere does Dr. Andow di scuss whether the same
proposition holds true for non-GMHT crops.
61. Seventh, whatever the merits of Dr. Andow's theoretical argument that hemizygous traits are
more dominant that heterozygous, Dr. Andow is simply incorrect when a sserting that "GMHT are
typically hemizygous."50 It is common knowledge among experts that crops that are not hybrid crops
(e.g. canola, cotton, soybean) are homozygous, not hemizygous. For instance, GT73 oilseed rape is
homozygous. Conversely, hybrid crops may be a combination of hemizygous and homozygous. In
Ms8/Rf3, half the plants are hemizygous and half homozygous for the HT trait. In any event, Dr.
Andow's argument appears to be so qualified as to be speculative.
62. Eighth, Dr. Andow argues in para. 7.10 that GMHT transgenes are expressing all the time,
while non-GMHT transgenes may or may not be, and therefore this may enable the herbicide to be
used for a longer period of time resulting in a gr eater degree of weed reduction. However, as Dr.
Andow points out, the weed reduction is a function of herbicide use. The simp le solution is to use
less herbicide.
63. As a general comment, nowhere does Dr. Andow refer to the fact that, in Europe at least, HT
crops developed through mutagenesis are not subject to detailed risk assessments, and so the potential
concerns about unintended effects, adverse effect s on flora and fauna and "biogeochemical cycles",
and adverse effects caused by the herbicides as sociated with these crops (imidazolinone and
sulfonylurea) go practically ignored by European regulators. Moreover, nowhere does Dr. Andow
acknowledge the environmental be nefits of glyphosate and glufosinate-ammonium over other
conventional herbicides. In Canada's view, his response to Question 9 is unbalanced and speculative.

46 Commission Recommendation of July 2003 on guidelines for the development of national strategies
and best practices to ensure the coexistence of genetically modified crops and organic farming , p. 6 (Exhibit
CDA-165). [emphasis in original]
47 Ibid, p. 7.
48 Ibid, p. 12.
49 Andow, para. 7.06.
50 Andow, para. 7.09.

8. What are the different detection methods cu rrently available for testing for the presence
of material from genetically modified plants?

(a) Have commercially available detection methods changed since the mid- 1990's?
Were methods available in the mid-90's event specific?
(b) Please outline the steps necessary to va lidate a detection method, including the
determination of what types of reference materials needed and differences in
validation steps for qualitative and quantitative detection methods.
(c) What are the differences in the intended uses of qualitative and quantitative
detection methods? What are the di fferences between event specific and non-
event specific detection methods? How does the availability of different types of
detection methods relate to risk assessment and risk management processes?
64. Only Dr. Nutti provided a response to Question 8. Dr. Nutti indicates that protein-based and
DNA-based detection methods became available in the beginning of the 1990s. Both methods can be
used in a qualitative and a quantitative fashion. Qualitative methods indicate the presence or absence
of an analytical target (analyte) while quantita tive methods measure the quantity of the analyte
present.
 51 Dr. Nutti states that protein-based methods can confirm the presence or absence of specific
proteins expressed by different transgenic events and, while not event-specific, can identify uniquely
most commercial events.
65. Dr. Nutti indicates that the type of detection method selected depends on the intended purpose
of the detection. She concludes "[d]etection methods as applied to food or feed labelling do not have
a direct role in risk assessment or risk manage ment". Protein-based detection methods may be
relevant to assess dietary intake and exposure to expressed proteins, but the "common understanding
of detection methods is that they are used to descr ibe the presence or absence of GMO grain (seed) in
the context of conventional grain (seed)."
52 Hence, DNA-based event-specific quantitative detection
is not necessary to conduct a risk assessment.
66. Dr. Healy, in answering Question 17, also c onfirms that quantitative detection "is not a
necessary component of a safety assessment" although it is an integral part of enforcement capabilities
especially for consumer labelling regulations. 53 Thus, to the extent that the approval procedures
under Directive 2001/18 and Regulation 258/97 were delayed on the basis of the need for a
quantitative event-specific detection method, these delays are not justified.
9. In what ways does molecular characteri zation inform the risk assessment for any
particular biotech product? Can a risk assessment be carried out in the absence of a
comprehensive molecular characterization of each transformation event?

67. All experts who responded agreed that mo lecular characterizati on was an important
component of the risk assessment process. All the experts, save Dr. Andow, refer to Codex
Guidelines for the Conduct of Food Safety Assessm ent in Foods Derived from Recombinant DNA
Plants. In Canada's view, Dr. Healy's response most clearly articulates the importance of molecular
characterization for a risk assessment. As Dr. Healy states:

51 Nutti, p. 9.
52 Nutti, p. 10. Also see Dr. Nutti's response to Question 17, p. 15.
53 Healy, p. 12.

The molecular characterisation is considered to be a very important part of the safety
assessment of a biotech product. It provides information about the number of copies
of the transgene(s) that have been inser ted, presence of any multiple copies at the
same or dispersed insertion site(s) and the structural organisation of the inserted
transgene(s). The molecular characterisation also includes an analysis of the stability
of the inserted DNA. Together this information provides verification that the
intended genetic modification has occurred and provides some indication as to the
likelihood of any unintended changes. However, the molecular characterisation is not
the only mechanism for identifying unintended effects and the information from such
studies should be considered in conjunc tion with the information from the other
elements of the safety assessment.
54
68. Dr. Healy also addresses the issue as to how comprehensive the molecular characterization
should be in order to fulfill the requirements of an appropriate safety assessment. In this regard, she
emphasizes that the "answer to this question depends on the type and quality of information available
for the three elements of the safety assessment, th e information revealed from these studies and the
state of the scientific knowledge about the gene(s ) to be transferred, the donor organism and the
recipient organism." 55 She also recognizes that over time, technologies to analyse the molecular
biological and biochemical characteristics of biotech products improve. However, this does not mean
that products that were approved before such tec hnologies were developed are any less safe. Canada
shares this view. The tools that will be availa ble in future for assessing molecular biological and
biochemical characteristics will likely make today's tools seem rudimentary. However, the
inevitability of future technological innovation should not paralyze decision-making today.
ISSUE 1

Questions:

Bayer hybrid oilseed rape (MS8/RF3)
C/BE/96/01 (EC chronology 63)

14. Given the information before the Panel, including the conclusions of the EC SCP
(EC-63/At.54) in relation to the potential persi stence or invasiveness of Bayer hybrid oilseed
rape (MS8/RF3), would this product qualify as a potential pest according to ISPM 11? If so, are
the proposed post-market monitoring plans consistent with the monitoring and review
principles described in ISPM 11?

69. Both Drs. Snow and Squire agree that Ms/Rf3 has the potential to be a pest on the basis that
oilseed rape generally leaves volunteer and feral descendents, which can be considered pests. 56
Similarly, both experts agree Ms8/Rf3 is no more likely to be a pest than conventional oilseed rape,
except where the herbicide glufosinate-ammonium is used. Dr. Snow concludes if glufosinate-
ammonium became widely used resulting in an in crease in herbicide-resistant volunteers and weeds,
"other methods of weed control" could be used to manage the problem.
70. Dr. Andow appears to disagree, claiming that th ere is not sufficient information before the
Panel to determine whether Ms8/Rf3 qualifies as a pest. Specifically, he states that the SCP failed to
consider whether Ms8/Rf3 had a higher release ra te or determine "wheth er contamination of

54 Healy, p. 2.
55 Healy, pp. 2-3.
56 Snow, p. 17, Squire, p. 12.

conventional varieties was an injury to plants."57 In relation to the higher release rate, it is noteworthy
that the SCP considered various factors affecting th e persistence of Ms8/Rf3 and concluded that "the
dispersal of transgenic rape seed should not be significantly different from that of the untransformed
plants" and "[m]odified rape is no more invasive than unmodified plants." 58 In relation to the issue of
"contamination of conventional varieties", it would be helpful if Dr. Andow could distinguish
between injury to plant health or life and poten tial "economic loss" resulting from the "co-existence
issue".59
71. In terms of post-marketing monitoring, Drs. Andow, Snow and Squire conclude that the
proposed monitoring plans are consistent with th e monitoring and review principles described in
ISPM No. 11. While Dr. Andow indicates that the proposed plan is "the most thorough and well-
considered of any of the monitoring plans in the ma terial before the panel", both he and Dr. Squire
suggest more information should be required. It may be useful, however, for the experts to indicate
precisely what they view the objectives of the monitoring plans to be and thus what specific additional
information is lacking. Moreover, in order to place the information requirements into context, it may
be useful to compare what they consider to be appropriate monitoring require ments in this situation
with monitoring requirements to detect the spread of resistance to herbicides more generally.
15. Given the information before the Panel, including the conclusions of the EC SCP, was
the information regarding the assessment of the long-term effect of the newly expressed protein
on the biogeochemical cycle and the food chain requested by the Italian CA (EC-63/At.87)
necessary to ensure that conclusions of the safety assessment were valid?

72. Canada agrees with Dr. Nutti's analysis that the request by the Italian authorities cited in
Question 15 was not necessary to ensure that the conclusions of the safety assessment of the newly
expressed protein in the food chain. 60 Canada also notes that Dr. Andow concludes that the request
was "not clear or specific enough to be considered necessary." 61 This underscores Canada's argument
that certain EC Member States appear to have b een stalling the approval process for biotech products
by submitting vague and unjustified requests for add itional information. Canada agrees with Dr.
Andow that requests for additional information in the context of an approval procedure should be
"clear and specific". A request for additional info rmation should be based on a rational assessment of
the information included in an application. If that information, or prevailing scientific knowledge,
does not suggest any risk, additional requests for information are not warranted.
16. Given the information before the Panel, in cluding the conclusions of the SCP, was the
information regarding molecular characterization of this product requested by the lead CA
(EC-63/At.107) necessary to ensure that conclusions of the safety assessment were valid?

73. The two experts responding to this question reach similar conclusions. Dr. Healy directly
answers the question posed by the Panel: "The add itional molecular characterization data sought by
the lead CA in 2002 were not required to demonstr ate the safety of food products derived from MS8,
RF3, or MS8xRF3 hybrids…The totality of informati on provided in the dossier to that point in time
contained sufficient information to support the validity of the conclusions of the safety assessment

57 Andow, p. 27. Also see, Andow's response to Question 13, pp. 25-26.
58 Pending notification - Bayer hybrid oilseed rape (MS8/RF3) – C/BE/96/01 p. 6 (Exhibit EC-63 –
attachment 54).
59 See Canada's comments under Question 7.
60 Nutti, p. 14.
61 Andow, p. 29

without the need for the additiona l molecular characterization data [requested by the Biosafety
Council]."62
74. Dr. Snape does not respond to the question po sed by the Panel concerning whether the
additional information requested by the lead compet ent authority was necessary to ensure the validity
of the conclusions of the safety assessment. Dr. Sn ape's review of the information examined for line
Ms8 has led him to conclude that no further info rmation is needed to approve these lines in the
European Union. However, in relation to Rf3, Dr. Snape suggests that more information on structural
analysis of progeny plants is needed to ensure that there is structural stability across generations. In
essence, he argues that the developer should have evaluated stability of integrated sequences in Rf3
using molecular analysis (genotypic data) in add ition to determining stability of inheritance using
segregation studies (phenotypic data). Canada would like to highlight that in the original submission
evaluated by regulatory authorities, the developer addressed stability of integrated sequences in Rf3
using both molecular analysis (Southern blot) and se gregation data. Moreover, in Exhibit EC-83/At.
107, the Biosafety Council indicated that "[t]he documents are well documented and the experiments
and the results are of a high standard." Unlike Dr. Healy, who considered the totality of the
information, Dr. Snape does not appear to have co nsidered that the two copies of the barstar gene
contained in Rf3 are linked nor has he given due consideration to the segregation data.
17. Were detection methods commercially a vailable in 2001 sufficient to enable the
detection of the transgenic proteins expressed by the plant line hybrid oilseed rape MS8/RF3?
Given the information before the Panel, including the SNIF (EC-63/At.109) and the updated
environmental risk assessment (EC-63/At.110-14 0), was additional information regarding a
quantitative detection method (EC-63/At.141) necessa ry to ensure that conclusions of the safety
assessment were valid?

75. Dr. Healy's conclusions support Canada's position that the delay in the processing of Ms8/Rf3
occasioned by EC requests for an "event-specific" quantitative detection method is not justified on the
basis of safety considerations. Dr. Healy concludes that quantitative immunoassay methods to detect
the PAT protein were available as early as 2000. She also clarifies that "event-specific quantitative"
detection methods are not necessary in order to determine the validity of a safety assessment, although
such methods may be required for enforcement of labelling regulations. However, as Canada
previously has argued, the wholesale suspension of an SPS procedure pending the adoption of
labelling regulations unrelated to fo od safety is not a justifiable delay.
63 Accordingly, requiring the
submission of a detection method, the sole purpose of which is to facilitate enforcement of labelling
regulations unrelated to food safety, is not a justifiable request in the context of a safety assessment.
18. Given the information before the Panel, including the SNIF and the updated
environmental risk assessment (referenced ab ove), was the information regarding molecular
data requested by the CA (EC-63/At.144) necessar y to ensure that conclusions of the safety
assessment were valid?

76. Again, Dr. Healy responds to this question in a clear and concise fashion. She concludes that
the request for additional information was "simply" to update the dossier to conform to the new
Belgian guidelines and that the additional informati on did not add substantially to the weight of
evidence that supports the conclusions concerning the safety of Ms8/Rf3. Thus, contrary to the EC's
assertion, this information was not necessary in order to conduct the risk assessment. It is noteworthy
as well that Dr. Healy found it "surprising" that this additional information was only requested in July

62 Healy, pp. 9-10.

2003, over a year after the guidelines had been adopted, despite the fact that the development of the
guidelines proceeded in parallel with the ongoing assessment of this application. This supports
Canada's argument that any resulting delay occasioned by this request should be attributed to the EC,
not the notifier.
64
19. Given the information before the Panel, including the SNIF, the updated environmental
risk assessment and the clarification provided by the notifier (EC-63/At.147), was the
information regarding ecological effects of this product on agricultural systems requested by the
lead CA (EC-63/At.149) necessary to ensure that conclusions of the safety assessment were
valid?

77. The views expressed by Drs. Snow and Squire support the conclusion that the request by the
Belgian authorities for more information about effects on "farmland diversity (macro-fauna, weed
flora and microbial soil ecosystem), food web inte grity (trophic structure), population dynamics of
key species, life-cycles etc." is not only vague, but impossible to answer without multi-year, large
scale experiments. It is reasonable to infer that given the impossibility of conducting such
experiments prior to approval of the product, the effect , if not the intent, of this request was to thwart
the application.
78. Dr. Snow suggests that the concerns giving rise to these questions are related to the use of the
associated herbicide with HT crops, i.e. that the use of glufosinate in conjunction with HT oilseed
rape may be more effective at controlling weeds, which may have a deleterious effect on fauna and
flora. Dr. Squire underscores the need for a "sta ndard or comparator." Canada agrees and submits
that the "standard or comparator" should be othe r weed management strategies, both herbicide and
non-herbicide based.
79. Dr. Snow indicates that some of the data sought by the Belgian authorities seems
"unnecessary".65 It may be helpful if she could elaborate. It also may be helpful for either expert to
identify whether similar types of information is sought in determ ining whether to approve other
herbicide-based weed management strategies generally, including the type of herbicide (e.g. modes of
action66), appropriate uses (e.g. pre-seeding burn-off 67, pre-emergent and post-emergent in-crop weed
control) and desiccation68.
80. Dr. Andow responds by indicating that some of the additional information requested by the
Belgian CA may be necessary and so me not necessary. In paragraph 19.04 of his report, Dr. Andow
states that the notifier's response is "insufficient" and therefore a request for additional information
necessary. However, point 4 refers to "direct and indirect interactions between the GMHP and target
organisms…(if applicable)." Point 4 appears to be rele vant only to those crops specifically developed
for pesticidal qualities; consequently it is inapplicable in the context of this application.

64 Canada's Third Written Submission, para. 231.
65 Snow, p. 18.
66 There are several types of modes of action for he rbicides, including amino acid synthesis inhibitiors,
growth regulators, growing point disintegrators, seedling growth inhibitors, photosynthetic inhibitors cell
membrane disruptors, and pigment inhibitors.
67 "Pre-seeding burn-off" refers to the application of herbicides to destroy established vegetation prior
to seeding.
68 "Desiccation" refers to the application of a substa nce (desiccant) to a crop to accelerate the drying of
plant tissue in order to aid in the harvest operation. De siccants are typically applie d to increase the uniformity
of the moisture content in seeds.

81. In relation to the Belgian CA's request for additional information concerning "biogeochemical
cycles", Dr. Andow appears to misstate the notifier's claim. The notifier did not claim that oilseed
rape "does not participate in any biogeochemical cy cles", but only that "oilseed rape has not been
identified as serving a key function in such cycles."69 Moreover, Dr. Andow's response appears to be
inconsistent with his earlier conclusions in para. 10.13. 70 In March 2000, the Italian CA had
requested additional information on the impact of glufosinate-tolerant oilseed rape on
"biogeochemical cycles". 71 In dismissing that request as unclear, unspecific and scientifically
unjustified, Dr. Andow concludes that:
…[t]he request by the Italian CA [for info rmation on biogeochemical cycles] is not
clear or specific enough to be considered necessary. There are hundreds of possible
processes in biogeochemical cycles that could be investigated…Unless the Italian CA
can point to prior regulatory precedents wh ere these terms are clarified, the phrasing
of the request is not scientifically justified.
82. However, when the same request for additiona l information on the possible immediate and/or
delayed effects on biogeochemical cycles was made by the Belgian CA nearly three years later in
October 2003, Dr. Andow appears to conclude that the request for additional information was
necessary. No explanation is provided for the a pparent inconsistency in Dr. Andow's views.
Moreover, while Dr. Andow concludes that 269 days seems "excessively long to complete the review
and articulate questions", he does not comment on the fact that the first request for information on
"biogeochemical cycles" was made in March 2000 by Italy, to which the notifier responded in
November 2000.
72 It should be noted that neither the Italian nor Belgian CA, or any other EC
Member State for that matter, raised concerns about the perceived inadequacy of the notifier's reply.
There is no reason why Dr. Andow's conclusion with respect to Roundup Ready fodder beet – that a
failure to follow-up on a reply indicates that the response was satisfactory73 – should not apply here.
83. Dr. Andow cites the fact that root and leaf litter participate in carbon cycles and that this
"may" have subtle effects on phosphorous cycles. However, Dr. Andow does not cite any scientific
research to support this supposition nor does he point to any information in the dossier that would
provide a compelling reason to suspect that the pre sence of the transgene would materially affect
phosphorous cycles. The notifier first addressed this issue in its response to the Italian CA's initial
request in March 200074 and then reiterated its response in its December 2002 updated Environmental
Risk Assessment, stating that "there are no reasons to expect that the newly inserted traits alter the
cycling of elements or organic nutrients…". 75 The rationale for this conclusion was in part that "the
PAT enzyme that is produced in the glufosinate-tolerant oilseed rape is highly specific for its only
known substrate, phosphinotricin" and extensive st udies on the comparison of bacterial rhizosphere
populations of transgenic and non-transgenic oilseed rape.
84. Dr. Andow's response to this question raises a general issue of the sufficiency of information
required to conduct a risk assessment. It is quite possible to continue to pose questions regarding
virtually any possible ecological interaction, leadin g to an endless series of studies, of no or limited

69 Exhibit EC-63- attachment 112, p. 40.
70 Andow, p. 29, para. 19.10.
71 The Italian CA requested this information for both oilseed rape Falcon GS40/90 and Ms8/Rf3. Dr.
Andow's response is the same for both products.
72 Exhibit EC-63 – attachment 88.
73 Andow, para. 22.05.
74 Exhibit EC-63 – attachment 88.
75 Exhibit EC-63 – attachment 112, p. 40.

value in assessing the risks of a particular product. As Dr. Snow indicates, it is not always clear how
to distinguish between what regulators "need to know" and what is "nice to know". 76 It might be
helpful if Dr. Andow could explain why of all th e "hundreds of possible processes in biogeochemical
cycles that could be investigated", 77 he singled out the impact of phosphorous cycles as justifying a
request for additional information. It might also be useful if Dr. Andow could identify criteria that in
his view would be suitable for determining when additional information was necessary to conduct a
risk assessment. Lastly, Canada would appreciate Dr. Andow's views on whether the degree of
information necessary to conduct a ri sk assessment should be consistent across comparable situations
and whether the fact that the EC does not even require a superficial environmental risk assessment for
herbicide-tolerant crops develope d through mutagenesis informs the level of information that should
be sought in assessing risk.
85. In terms of Point 9, Dr. Andow concludes that, in part, the failure by the notifier to address
changes in tillage practices justifies the request for additional information. This is a surprising remark
given that one of the benefits of herbicide-tolerant crops is that it enables farmers to adopt low-tillage
or no tillage farming practices, practices that are wide-acknowledged to be environmentally beneficial
by reducing soil erosion, moisture loss and siltation. 78 It is curious that Dr. Andow would consider
the failure to identify a widely-recognized enviro nmental benefit as justification for delaying the
processing of an application.
86. Lastly, Dr. Andow states that the notifier faile d to address whether the "associated herbicide
use would have adverse environmental effects." 79 To the contrary, the notifier indicated that
registration for the specific use of glufosinate-ammonium with the crop in question would be
addressed under the applicable legislation in accordance with EC Directive 91/414/EEC. Building on
his comments in para. 6.15, Dr. Andow appears to assume that the specific use of herbicides in
conjunction with GMHT crops should be considered under Directive 2001/18 and not under Directive
91/414/EEC, the legislation specifically established to regulate plant protection products and their
uses.
80 The impact of the use of herbicides is not relevant to a safety assessment of the crop in
question.
20. Are the conclusions and recommendations in the Report of the Group of Experts
Mandated by the Belgian Biosafety Advisory Council (EC-63/At.167 pp.20-21) regarding the
agricultural guidelines proposed by the applicant consistent with the Belgian Biosafety Advisory
Council's conclusion that the agricultural guidelines are "impracticable, hardly workable and
hard to control"?

87. Both Drs. Andow and Squire responded to this question. Unfortunately, there appears to be
some confusion as to the meaning of the Panel's qu estion and as what the Belgian Biosafety Advisory
Council was referring to when it stated that "a number of recommendations of the agricultural
guidelines are impracticable, hardly workable and hard to control in current agricultural practices." It
is clear that the Group of Experts considered the agricultural guidelines proposed by the notifier and
made recommendations to apparently strengthen the guidelines. What is not clear is what the BBAC
is referring to in reaching its conclusion. Dr. Squi re lists several issues that he considers to present
practical problems in implementing the guidelines.
81 However, these issues refer to recommendations

76 Snow, p. 6.
77 Andow, p. 23, para. 10.13.
78 Snow, p. 9.
79 Andow, para. 19.12.
80 Canada Third Written Submission, paras. 77 and 245.
81 Squire, p. 13.

made by the Group of Experts not the agricultural guidelines proposed by the notifier. Dr. Squire
does not identify specific problems with what the no tifier proposed. Dr. Andow attempts to divine
whether the Group of Experts considered the guidelines proposed by the notifier to be "impracticable,
hardly workable and difficult to control", despite the fact that they made no such finding.
88. The Panel's question appears to be whether th e conclusion of the BBAC that the agricultural
guidelines proposed by the notifier are "impracticable, hardly workable and hard to control" is
consistent with the conclusions and recommendations of the Group of Experts. Given the fact that the
Group of Experts did not express such a conclusion and in fact made recommendations to augment
the proposed agricultural guidelines, it is difficult to conclude that the BBAC based its conclusion on
the Report of the Group of Experts. To the contrary, the BBAC appears to have reached its own
conclusion without providing any analysis.
89. In any event, what appears to be lost in this discussion is an evaluation of whether any risks
associated with the cultivation of Ms8/Rf3 can be managed by the adoption of the proposed
agriculture guidelines. Drs. Snow and Squire indica te that risk management options are available to
address any issues that may arise, although they indi cate that this will depend on local conditions and
agronomic practices. 82 What is missing from the BBAC analysis is what elements of the proposed
agricultural guidelines and recommendations are "impr acticable, unworkable and difficult to control".
These elements do not relate to risk management, but to the "co-existence" issue.
Monsanto Roundup Ready oilseed rape (GT73)
C/NL/98/11 (EC chronology 70)

26. Given the information before the Panel, including the notification (EC-70/At.1-3), was
the information regarding molecular characteriza tion of this product requested by the Dutch
CA and by the UK (EC-70/At.4, 7, and 8) necessary to ensure that conclusions of the safety
assessment were valid?

90. No expert has responded to this question. In any event, Canada does not contest that these
early requests for additional information were scientifically justified and thus, pursuing this issue does
not appear necessary. 83 The more important issue is whether the objections raised by EC Member
States after the notification was circulated at the co mmunity-level were scientifically justified in the
light of the favourable advice of the Netherla nds scientific body (COGEM) in January 2001 and
Netherlands Competent Authority's favourable assessment. 84 Canada submits that these objections
were not justified, a conclusion c onsistent with the findings of th e EFSA GMO Panel that "sufficient
molecular characterization has been carried out."85

82 Snow, p. 14. Squire, p. 9.
83 Canada's Suggestions Regarding Questions to be submitted to Experts, 16 August 2004, para. 11.
Following the Netherlands' request for additional information regarding molecular characterization (attachments
4, 7 and 8), the notifier submitted supplementary molecular analysis (attachment 10).
84 Those objections and the notifier's response are summarized in Exhibit EC-70 – attachment 103,
pp. 4-5.
85 EC, EFSA, Scientific Panel on Genetically Modified Organisms, Opinion on a request from the
Commission related to the Notification (Reference C/NL/98/11) for the placing on the market of herbicide-
tolerant oilseed rape GT73, for import and processing, under Part C of Directive 2001/18/EC from Monsanto
(Question No. EFSA-Q-2003-078) , adopted 11 February 2004, online:
http://www.efsa.eu.int/science/gmo/gmo_opinions/catindex_en.html, p. 14 (Exhibit CDA-35-N).

27. Given the information before the Panel, including the notification, was the information
regarding feed safety aspects of this product requested by the Netherlands (EC-70/At.8 and 13)
necessary to ensure that conclusions of the safety assessment were valid?

91. Only Dr. Nutti responded to this question. For the sake of clarity, it may be helpful if Dr.
Nutti could specify the information provided by the applicant to which she refers, given that she
appears to have mistakenly cited exhibits that contain the request by the Netherlands – RIKILT-DLO,
(attachments 8 and 13), not the information originally provided by the notifier (attachments 1 to 3). In
addition, Canada requests that Dr. Nutti identify th e "analysis done by the EC SCP" to which she
refers. To Canada's knowledge, the SCP did not analyze this application. The only analysis
undertaken by a Community-wide scientific commit tee was by the EFSA GMO Panel in February
2004, well after the Netherlands – RIKILT-DLO's initia l request for additional information regarding
feed safety.
28. Given the information before the Panel, in cluding the notification and the SNIF (EC-
70/At.49-53), was the additional information provided in Monsanto's submission to the
Commission (EC-70/At.84-97) necessary to ensure that conclusions of the safety assessment
were valid?

92. Drs. Andow and Nutti responded to this question. The question is intended to determine
whether the information that was considered by the Netherlands Competent Authority (including the
updated notification) was sufficient to support the au thority's favourable risk assessment. Put another
way, were the objections raised by EC Member States after the favourable assessment by the
Netherlands Competent Authority unjustified. If such objections were justified, then presumably, the
information supplied by the notifier in response to those objections (Exhibit EC-70 – attachments 84-
97) was necessary to ensure that the conclusions of the safety assessment were valid.
93. Canada has no comments in relation to Dr. Nutti's evidence, which supports Canada's position
that the objections by the EC Member States were not necessary to ensure the validity of the risk
assessment.
94. Canada has the following comments on Dr. Andow's answer, which focuses only on
monitoring. By way of background, the notifier proposed a monitoring plan to identify the occurrence
of adverse effects not anticipated in the environmental risk assessment. 86 In its favourable assessment
report, the Netherlands Competent Authority stated that, since the notification for GT73 oilseed rape
only covers import and processing and does not incl ude cultivation, post-market monitoring of the
product and its effects on the environment is not an is sue. Nevertheless, given that a monitoring plan
is required under Directive 2001/18, the competent authority recommended that the company provide
data of sales on an annual basis and amounts imported at key ports for each Member State, apparently
in addition to what the notifier had already proposed. 87 EC Member States objected to the adequacy
of the monitoring plan insisting on more oner ous conditions. The notifier responded to these
objections88 and submitted an updated monitoring plan. 89 The EFSA, taking all of the information
into consideration, concluded that the proposed m onitoring plan was acceptable in the light of the
intended use of GT73.

86 Pending notification - Monsanto Roundup Ready oilseed rape (GT73) – C/NL/98/11 (Exhibit EC-70
– attachment 51).
87 Exhibit EC-70 – attachment 66.
88 Exhibit EC-70 – attachment 85, p. 22.
89 Exhibit EC-70 – attachment 92, being Appendix 9 to Monsanto's response to reactions of EC
Member States (attachment 85)

95. Question 28 does not seek to determine whethe r the monitoring plan accepted by EFSA is
adequate or meets the requirements of Directive 2001/18 . The issue is the adequacy of the initial
monitoring plan proposed by the notifier in the SN IF and whether the objections by the EC Member
States to that initial plan were justified. It is important to emphasize that the underlying issue in
respect of the monitoring plan is not whether the monitoring plan complies with Directive 2001/18 or
how to interpret the provisions of that Directive (whether something is case-specific or not), but
whether the proposed SPS measure (i.e. the monitoring plan) is "based on" the risk assessment.
96. Dr. Andow appears to assume that the adequacy of the monitoring plan is to be determined by
reference to the aims proposed by the EC Member States. Canada disagrees. The monitoring plan is
to identify the occurrence of adverse effects on human health or the environment not anticipated in the
environmental risk assessment. The conclusions of the risk assessment are not based simply on
"exposure", i.e. the likelihood of spillage, but the conseque nces for the environment in the event of
unanticipated spillage, i.e. "adverse effect" or harm. Given the conclusions of the risk assessment
summarized succinctly by the UK competent authority - "the risk assessment does not identify risks in
relation to human health or the environment from the use of GT73 oilseed rape as defined in the
notification (i.e. for import and processing)" – there is no justification for imposing a monitoring plan
to monitor so-called "contamination of other agricultural systems".
90
97. Dr. Andow appears to accept as justifiable Italy' s concern with possible effects of glyphosate
and its metabolites. 91 Dr. Andow does not elaborate on this concern, which Canada understands as a
concern that the residues of glyphosate sprayed on the oilseed rape may remain on the seeds and may
cause adverse effects to the environment should the seeds be accidentally spilled. Given that
glyphosate metabolizes rapidly in the soil and is widely used in the EC (indeed it is approved in most
EC Member States), glyphosate residue cannot be a serious concern.
98. Lastly, given that most of the processing faciliti es for oilseed rape are located in port areas,
away from areas under cultivation, the probability of th e establishment and spread of oilseed rape into
the environment is very remote.
ISSUE 2

Oilseed rape MS1 x RF1 (notification C/UK/94/M1/1)

Safeguard measure of France

59. Given the information before the Panel, in cluding the evaluations undertaken by the UK
(EC-161/At.1), the Scientific Committee on Plants in May 1998 and May 1999 (CDA-35-A and
CDA-69, respectively), and the European Commissi on in its Decision of February 1996 (CDA-
62), as well as the information submitted by Fr ance with respect to its safeguard measure (EC -
161/At. 3 to 11; CDA-68, CDA-70, CDA-71), is there an y reason to believe that the scientific
evidence available to France in November 1998 and July 2001 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 growing for seed production of oilseed rape MS1 x RF1? If so, what
scientific evidence do you believe was insufficient?

90 Commission Recommendation on Co-existence, p. 6 and 7. "It is important to make a clear
distinction between the economic aspects of co-existen ce and the environmental and health aspect dealt with
under Directive 2001/18/EC on the deliberate release of GMOs into the environment." (Exhibit EC-165).
91 Andow, para. 28.04, 28.22 and 28.26.

(a) If the evidence was not sufficient in November 1998 and/or in July 2001, was
there sufficient evidence available to France 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 growing for seed production of
oilseed rape MS1 x RF1? If not, what scientific evidence do you believe was
insufficient?
99. In his reply to this question, Dr. Squire says that France was concerned about the up-scaling
issue (the uncertainty of what might occur if GMHT crops were grown widely in the country) and that
there was in fact insufficient inform ation available at that time to be able to predict accurately, for a
country 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. 92 Dr. Squire states that even by the end of 2003 there was
uncertainty as to what the field-to-field cross-pollination might be.93
100. In her reply, Dr. Snow expresses the view that the SCP's assumption that the risk of
establishment was low is not supported by the ev idence, including evidence that became available
during 1998-2003.94 She concludes that France had valid reasons in 1998 to follow the advice of the
CGB to carry out more research. 95 According to Dr. Snow, France needed more information about
the rate at which the transgene for glufosinate tole rance would spread to volunteer plants and related
weeds. By 2003, more scientific knowledge was available but ne w information was still coming to
light about the spread and persistence of genes for herbicide tolerance.96
101. Dr. Andow takes the position that the scientific evidence in 1998 on dispersal of oilseed rape
pollen was not sufficient to complete an accurate assessment of dispersal probability, but that
"sufficient data appeared by the end of 2002".97
102. Both Dr. Squire and Dr. Andow re ference an article published in Science.98 However, there
were methodological problems with that study. Specifically, the authors did not determine
background levels of the ALS2 mutation prior to the experiment; considering the extremely low levels
obtained, what is ascribed by the authors to long distance pollen flow could just as easily be ascribed
to population background levels of the mutation.
103. Dr. Andow also speculates about the possibility th at fields of HT oilseed rape might not be
harvested, with the result that that entire crop goes to seed – asserting this may require "exceptional"
agricultural practices to control volunteers/weeds. He states that "such possibilities were not
considered by the SCP, and France may be concerned about such scenarios." 99 However, apart from
being purely speculative both as to the occurrence of the scenario a nd France's concerns, the putative
problem he describes is not a problem specific to tr ansgenic oilseed rape. In any event, control
measures would be similar as between transgenic and non-transgenic varieties, and effective
mitigation measures exist, and tillage can always be employed as a last resort.
104. Dr. Andow indicates that "in 2001 the French Biomolecular Engineering Committee (BEC)
called for additional research in this area, but by the middle of 2003, the BEC believed that it had

92 Squire, p. 15.
93 Ibid.
94 Snow, p. 19.
95 Ibid., p. 21.
96 Ibid.
97 Andow, p. 81.
98 Squire, p. 15; Andow, fn. 25.
99 Ibid.

sufficient information to complete an assessment". 100 This view seems to be borne out by the BEC's
February 2004 opinion.101
105. In contrast with Drs. Snow and Squire, and consistent with Dr. Andow's views, Canada
considers that ample scientific evidence existed by the end of 2003 for France to complete a risk
assessment. The BEC seems to share that view given the opinion that it issued in February 2004. In
short, there is ample evidence on pollen flow, volunt eer persistence and management strategies at this
time for France to have made a decision. Interna tional seed certifying bodies have devoted extensive
time and effort to examine issues of seed purity, hence proper management practices are well
described.
106. Dr. Andow also posits what France could have argued – but did no t – in 1998 in support of its
prohibition on the marketing of oilseed rape Ms1/Rf1: that there was insufficient data to identify all of
the possible environmental hazards of GMHT oilsee d rape; that the molecular characterization was
insufficient; that the risk of evolution of resistance in weeds not related to the Brassicae had been
incompletely assessed and management of these risks required additional scientific data; and that the
data on non-target effects was insufficient. 102 Given that he also notes that sufficient information was
available by October 2003 to assess these risks, even assuming that he is correct – a matter that is not
clear given the absence of any supporting references or other documentation – it is not clear what
value this information has in the context of this proceeding.
60. 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 France evaluate the relevant risks to human, plant or animal health, and the
environment from the growing of oilseed rape MS1 x RF1 for seed production?

(a) How does the scientific evidence and other documentation submitted by France
compare with the relevant internationa l guidelines for risk assessment and
analysis identified above?
107. Dr. Andow expresses the view that scientific evidence and other information submitted by
France probably did not meet requirements fo r a risk assessment as defined in the SPS Agreement or
ISPM No. 11. 103 He asserts, however, that the science, documentation and reasoning of France is
consistent with Annex III of BSP. Be that as it may, Annex III of the BSP is not an international
standard or guideline as that term is defined in the SPS Agreement.
108. Dr. Squire indicates that "it could be argued" that France's position was compatible with the
"tone" of the definition of a risk assessment in the SPS Agreement, and compatible also with ISPM
No. 11.104 Aside from the uncertain meaning of "it coul d be argued" and "tone", Dr. Squire does not
really explain in what way exactly his view is supported by the facts.
61. Does the scientific evidence and other in formation submitted by France support the
adoption of a temporary prohibition on the growing of oilseed rape MS1 x RF1 for seed

100 Ibid.
101 French Commission du génie biomoléculaire (CGB) released a scientific opinion addressing the
potential impacts on the environment arising from the cultivation of genetically modified oilseed/rape, 13
February 2004 (Exhibit CDA-169).
102 Andow, p. 81.
103 Andow, p. 82.
104 Squire, p. 15.

production? In light of any potential risks iden tified by France, what other risk management
options were available in November 1998 and/or July 2001? What other risk management
options are now available?

109. Dr. Snow considers that she does not have enough information to answer the question. 105 She
indicates that seed production on a small scale probably would not justify a temporary prohibition;
however, if the plants are grown on a fairly large scale (1000+ hectares/yr) she appears to be of the
view that a temporary prohibition was justified.
106 According to her, the basic concern is that
herbicide resistance genes would spread in conjunction with wider use of the herbicide over time and
other herbicide resistance genes might be approved in the future (e.g. glyphosate resistance) thereby
compounding the problem.
107 She does not respond to the question about the availability of risk
management options.
110. In contrast, Dr. Squire says that risk manageme nt options exist to reduce the risk of spread
and cross-pollination, but it cannot be eliminated.108
111. In his answer, Dr. Andow expresses the view th at the adoption of a temporary prohibition can
be justified on the basis of the scientific ev idence and other information submitted by France. 109
However, he seems to suggest that less restrictive risk management options were available to France
in 1998 and 2001, such as phased-in cultivation, which would have allowed for a determination of
scale effects.
110 He also appears to agree with Canada's position that the maintenance of the French
prohibition is not justified when he says that "today several alternative risk management options are
available…it would appear that France is now convinced that if HT volunteers or wild species occur
that they can be detected rapidly enough and eliminated."
111 This view also appears to be borne out
by the BEC opinion of February 2004.112
Topas 19/2 (notification C/UK/95/M5/1)

62. Given that oilseed rape Topas 19/2 was only approved for import of seeds for
processing, what is the relevance of the findings of the UK farm scale evaluation study (EC-38)
in terms of the assessment of potential risks from Topas 19/2?

112. The experts all agree that the UK farm scale evaluation study (FSE) is not relevant to
assessing the potential risks arising from the import and processing of Topas 19/2.113
113. Their conclusions strongly support the argument that there is no scientific evidence regarding
environmental risks to support either France's or Greece's prohibition on the marketing of this
product. In fact, France's own scientists agree that the environmental risks associated with importing
and processing Topas 19/2 are no different from those associated with importing and processing
conventional oilseed rape.114

105 Snow, p. 23.
106 Ibid.
107 Ibid. p. 24.
108 Squire, p. 15.
109 Andow, p. 83.
110 Ibid.
111 Ibid.
112 Exhibit CDA-169.
113 Squire, p. 15; Andow, p. 84; Snow, p. 24.
114 Exhibit CDA-169, pp. 10-11 (translation).

Safeguard measure of France

63. Given the information before the Panel, in cluding the evaluations undertaken by the UK
(EC-162/At.1 to 3), and the Scientific Commi ttee on Plants in February 1998 (CDA-63), May
1999 (CDA-65 and CDA-73), and the European Commission in its Decision of April 1998 (CDA-
61), as well as the information submitted by Fr ance with respect to its safeguard measure (EC-
162/At. 5, EC-161/At. 3 to 11, CDA-64, CDA-66, CDA-67), is there any reason to believe that the
scientific evidence available to France in November 1998 and July 2001 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 import and processing of oilseed rape Topas 19/2? If so,
what scientific evidence do you believe was insufficient?

(a) If the evidence was not sufficient in November 1998 and/or in July 2001, was
there sufficient evidence available to France 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 import and processing of oilseed
rape Topas 19/2? If not, what sci entific evidence do you believe was
insufficient?
114. The experts appear to share the view that sufficient scientific evidence was available to
France to undertake an appropriate assessment of the potential risks associated with the import and
processing of Topas 19/2, although they differ on when that evidence was available.
115. Dr. Snow indicates that she found no convincing arguments for why further scientific
research would be needed to investigate environmen tal effects of a product that is only intended for
import and processing and not for cultivation. 115 She states that "any seed spillage that might occur
when the seeds are delivered could be managed and that it is extremely unlikely that the seeds would
be cultivated inadvertently."
116
116. Dr. Andow states his view that "the rationale put forward by France does not argue that a risk
exists that requires management." 117 However, Dr. Andow goes on to list putative arguments that
France could have made. This is the same list as for Ms1/Rf1, including insufficiency in the
molecular characterization and possible contamination of conventional oilseed rape varieties. On the
basis of that list, Dr. Andow asserts that, "given the information before the Panel, France could have
argued in November 1998 that there was insufficient evidence to complete a risk assessment.
However, I believe that had France collected the necessary data to complete this risk assessment
promptly after implementing their temporary prohibiti on that they could have had sufficient data to
make a decision in 2001".118
117. Apart from the questionable assertions regarding molecular characterization and the
contamination issue, for which Dr. Andow does no t advance any evidence, and with which Canada
does not agree, Dr. Snow and Dr. Andow express views that support Canada's position that the French
prohibition on the import and processing of Topas 19/2 is not justifiable on scientific grounds.
64. 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

115 Snow, p. 25.
116 Ibid.
117 Andow, p. 84.
118 Ibid., p. 85.

submitted by France evaluate the relevant risks to human, plant or animal health, and the
environment from the import and processing of oilseed rape Topas 19/2?

(a) How does the scientific evidence and other documentation submitted by France
compare with the relevant internationa l guidelines for risk assessment and
analysis identified above?
118. Although Dr. Snow does not appear to answer th e question directly, her answer, which states
that no further scientific research was needed, 119 implies that France's scientific evidence and other
documentation was irrelevant.
119. Dr. Andow expresses the view that France scie ntific evidence and other documentation did
not meet requirements of a risk assessment as defined in the SPS Agreement or the requirements of
ISPM No.11.120 Dr.Andow does express the view that the "science, documentation and reasoning of
France are consistent with Annex III of the Cartag ena Protocol on Biosafety to the Convention on
Biological Diversity." 121 Dr. Andow refers specifically to section 8(f) of Annex III, which is
concerned with situations "where there is uncertain ty regarding the level of risk". Canada, however,
is of the view that Annex III of the Cartagena Pr otocol does not constitute an "international standard"
as that term is defined in the SPS Agreement. In any event, the scientific evidence does not disclose
that "uncertainty regarding the level of risk" existed. Hence, Section 8(f) would not be relevant in this
particular context.
65. Does the scientific evidence and other in formation submitted by France support the
adoption of a temporary prohibition on the import and processing of oilseed rape Topas 19/2?
In light of any potential risks identified by France, what other risk management options were
available in November 1998 and/or July 2001? What other risk management options are now
available?

120. The experts support the argument that there is no scientific justification for maintaining the
French ban on Topas 19/2. This contention is also supported by France's own scientists.122
121. In particular, Dr. Andow states that the scientific evidence and other information submitted by
France do not support the adoption of a temporary prohibition. 123 He also asserts that other scientific
evidence and information before the Panel could have been used to support a temporary prohibition.
However, it is unclear what other "scientific ev idence and other information" he has in mind in
making this assertion. In any event, he concedes that, even on these grounds, a prohibition would
probably not be justifiable past 2001.
122. In contrast to Dr. Andow's equivocation, Dr. Snow states clearly that she "did not find any
convincing arguments for why further scientific research would be needed to investigate
environmental effects of a product that is onl y intended for import and processing and not for
cultivation."124

119 Snow, p. 26.
120 Andow, p. 85.
121 Andow, pp. 85-86.
122 Exhibit CDA-169, pp. 10-11 (translation).
123 Andow, p. 86.
124 Snow, p. 26.

Safeguard measure of Greece

66. Given the information before the Panel, in cluding the evaluations undertaken by the UK
(EC-162/At.1 to 3), and the Scientific Commi ttee on Plants in February 1998 (CDA-63), May
1999 (CDA-65 and CDA-73), and the European Commission in its Decision of April 1998 (CDA-
61), as well as the information submitted by G reece with respect to its safeguard measure (EC-
162/At. 4, CDA-72), is there any reason to believe that the scientific evidence available to Greece
in September 1998 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 import and
processing of oilseed rape Topas 19/2? If so , what scientific evidence do you believe was
insufficient?

(a) If the evidence was not sufficient in September 1998, was there sufficient
evidence available to Greece 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 import and processing of oilseed rape Topas 19/2
(EC-162/At.6 to 13)? If not, what scientific evidence do you believe was
insufficient?
123. The experts agree that the Greek prohibition on the importation of oilseed rape Topas 19/2 is
not scientifically justified.
124. Although Dr. Andow asserts that Greece's thir d reason for banning Topas 19/2 (increased
difficulty in managing farmland because GMHT oil seed rape winters better in Greece and could
spread faster and is hard to eliminate once establis hed as a weed) has some merit as a risk, he also
notes that risk management options other than a ban are available to address this problem.125
125. Dr. Andow also suggests that there were othe r arguments that Greece could have made to
support the ban in 1998 on grounds of insufficient sci entific evidence to comple te a risk assessment.
He does not specify what the insufficiencies were, but , in any event, he concludes that, had Greece
collected the necessary data, it would have been able to make a decision by 2001 at the latest.126
126. Again, Dr. Snow is unequivocal in rejecting the idea that Greece did not have sufficient
scientific evidence available to it to complete a risk assessment. 127 Dr. Snow indicates that she does
not understand why Greece assumes feral populations would become established or why they would
become environmental problems, and that even if such populations became established there is no
scientific reason to expect that gene flow would harm the genetic diversity or abundance of wild
relatives.128
67. 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 Greece evaluate the relevant risk s to human, plant or animal health, and the
environment from the import and processing of oilseed rape Topas 19/2?

125 Andow, p. 87.
126 Ibid., pp. 87-88.
127 Snow, p. 27.
128 Ibid.

(a) How does the scientific evidence and other documentation submitted by Greece
compare with the relevant internationa l guidelines for risk assessment and
analysis identified above?
127. Dr. Andow is of the view that Greece faile d to follow the requirements of either the SPS
Agreement or ISPM No.11 but that the science, reasoning and documentation of Greece was
consistent with Annex III of the BSP.129 As was noted earlier, Canada is of the view that Annex III of
the BSP does not constitute an international standard or guideline as those terms are defined in the
SPS Agreement.
128. Dr. Snow repeats her answers to questions 63-66.130
68. Does the scientific evidence and other info rmation submitted by Greece support the
adoption of a temporary prohibition on the import and processing of oilseed rape Topas 19/2?
In light of any potential risks identified by Greece, what other risk management options were
available in September 1998? What other risk management options are now available?

129. The experts agree that the Greek import prohibition is not scientifically justified, 131 although
Dr. Andow appears to be of the view that it was scientifically justified in 1998.
130. The advice of the experts supports the argumen t that the Greek import prohibition cannot be
justified on the basis of scientific evidence.
Maize MON 810 (notification C/F/95/12-02)

Safeguard measure of Italy

78. Given the information before the Panel, in cluding the evaluations undertaken by France
(EC-159/At.1 and 2); and the Scientific Comm ittee on Plants in February 1998 (CDA-82),
September 1999 (US-55), and September 2000 (CDA- 86), and the European Commission in its
Decision of April 1998 (CDA-81), as well as the information submitted by Italy with respect to
its safeguard measure (EC-157/At. 1 and 2, CDA-78) , is there any reason to believe that the
scientific evidence available to Italy in August 1988 was NOT sufficient to permit it to undertake
an appropriate assessment of potential risks to human, plant and animal health, and the
environment from Maize MON 810? If so, what scientific evidence do you believe was
insufficient?

(a) If the evidence was not sufficient in August 1988, was there sufficient evidence
available to Italy 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 MON 810? If not, what scientific evidence do you
believe was insufficient?
131. Dr. Nutti indicates in her reply that the informa tion provided by the applicant covered all the
items needed for the comparison of the GM maize and its conventional counterpart. 132 According to

129 Andow, p. 88.
130 Snow, p. 27.
131 Andow, p. 88; Snow, p. 27.
132 Nutti, p. 58.

her, the variation in the levels of protein was in the range of natural variation so the point raised by
Italy regarding protein levels was not correct.133
132. In conclusion, Dr. Nutti states that "there is NO reason to believe that the scientific evidence
available to Italy in August [1998] was NOT suff icient to permit it to undertake an appropriate
assessment of the potential risks to human, plant and animal health…from Maize MON810". 134
133. The expert's advice is fully consistent with th e argument that the Italian ban on MON810 was
not scientifically justified.
79. 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 Italy evaluate the relevant risk s to human, plant or animal health, and the
environment from Maize MON 810?

(a) How does the scientific evidence and oth er documentation submitted by Italy
compare with the relevant internationa l guidelines for risk assessment and
analysis identified above?
134. Dr. Nutti indicates that the information for the safety assessment provided by the applicant
and evaluated by France and the SCP and SCF were adequate and in accordance with Codex
guidelines.135 In contrast, the information and arguments submitted by Italy were not.136
135. In this regard, also, the expert's advice is fully consistent with the argument that there is a
virtually complete absence of scientific justification for Italy's ban on MON810.
80. Does the scientific evidence and other in formation submitted by Italy support the
adoption of a temporary prohibition on Maiz e MON 810? In light of any potential risks
identified by Austria, what other risk management options were available in August 1988?
What other risk management options are now available?

136. Dr. Nutti concludes that the scientific ev idence submitted by Italy does not support a
temporary prohibition on Maize MON810.137
137. The expert's advice supports Canada's position.
Maize T25 (notification C/F/95/12-07)

Safeguard measure of Austria

84. Given the information before the Panel, in cluding the evaluations undertaken by France
(EC-160/At.1 and 2); the Scientific Committee on Plants in September 2000 (CDA-75) and
September 2001 (CDA-86 and CDA-77), and the European Commission in its Decision of April
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

133 Ibid.
134 Ibid.
135 Nutti, p. 58
136 Ibid.
137 Nutti, p. 59.

scientific evidence available to Austria in April 2000 was NOT sufficient to permit it to
undertake an appropriate 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?

(a) 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?
138. Dr. Nutti states that, based on the information presented by the notifier and the scientific
evaluation undertaken by France and by the SCP, th ere is no reason to believe that the scientific
evidence available to Austria in 1999 was insufficient to allow it to undertake an appropriate
assessment of potential risks to human, plant and animal health from maize T25.138
139. From the standpoint of environmental risks, according to Dr. Andow, Austria presented six
reasons for its safeguard measure:
− environmental risks had not been sufficiently evaluated under realistic conditions;
− no post-commercialization program;
− potential risk of harm from pollen transfer, though likely absent, should be monitored;
− no measures to protect ecologically sensitive areas;
− a need for "good farming practice" guidelines to minimize risk of resistance; and
− the need to assess long-term and secondary ecological effects.139

140. Dr. Andow says (1), (3), (5) and (6) present possible justification for the safeguard measure.
He then discards (6) on the grounds that assessing lo ng-term effects is impossible in pre-commercial
assessments. He discards (3) on the grounds that Austria does not specifically identify the possible
harm. He also dismisses (1) on the grounds that Au stria does not provide any scientific evidence that
such harms might exist, with the exception of resistance risk. Notably, he says that "a risk assessment
cannot be considered insufficient if all concrete possible risks are addressed".140
141. This leaves only the issue of the evolution of resistance in weeds as a secondary
environmental effect. Dr. Andow says that the amended SCP opinion (CDA-77) does not provide an
assessment of this risk even thoug h resistance risks are widely recognized and the consistent use of
glufosinate with T25 would result in such a risk. Thus, according to Andow, "there was insufficient
scientific evidence available to the SCP and Austria to assess weed resistance risk and appropriate risk
management measures."
141
142. Dr. Andow acknowledges, however, that managing resistance risk in maize should be easier
than for oilseed rape, and says that adequate information for a risk assessment would have been
available by 2003 had the parties made concerted efforts to bring it together.
142 However, it is not
clear to Canada what the environmental risk is, or why adequate information to complete a risk

138 Ibid. p. 60.
139 Andow, p. 110.
140 Ibid. pp. 111-12.
141 Ibid.
142 Ibid.

assessment would not have been available until 2003. Clearly, resistance management strategies were
well-understood and practised before 2003.
143. Dr. Andow then goes on to offer his views on shifting evidentiary standards for what
constitutes an objective environmenta l risk assessment, particularly in relation to the molecular basis
of transformation, and regarding the emergence of contamination of conventional production as
possible new grounds for the safeguard measure. He concedes that scientific evidence to support risk
management measures to address the coexistence "ris k" were available in 2003, and concludes that
Austria could also argue that T25 was "inadequately characterized".
144. In reality, Dr. Andow's focus on the possible emergence of resistant weeds as an
environmental risk – and, moreover, one that coul d not be adequately addressed until 2003 – flies in
the face of the fact that the emergence of herbicide resistance is an endemic issue wherever herbicides
are used. Furthermore, the herbicide in ques tion – glufosinate-ammonium – has proved to be
remarkably resilient when it comes to the emergence of resistance. Despite extensive use, there is no
recorded case of weeds becoming resistant to this herbicide.
145. Canada also fails to understand Dr. Andow's comment that, "in 2003, Austria could also argue
that T25 was inadequately characterized." 143 The fact that molecular characterization techniques may
have improved in the intervening years between the Community-wide approval of T25 in 1998 and
2003, to argue five years after the fact that mol ecular characterization was inadequate while relying
on technology that did not even exist at the time the product was approved is to invite the perpetual
delay of product approvals. The question has to be as ked, is there a valid scientific reason to do so in
absence of a demonstrable risk.
85. 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 Austria evaluate the relevant risks to human, plant or animal health, and the
environment from Maize T25?

(a) How does the scientific evidence a nd other documentation submitted by
Austria compare with the relevant intern ational guidelines for risk assessment
and analysis identified above?
146. Dr. Nutti is of the view that the information for the safety assessment of potential risks to
human and animal health that was submitted by applicants and evaluated by French CA met
international guidelines (Codex) wa s adequate and in accordance with the relevant international
standard.144
147. Dr. Andow expresses doubt that Austria's scientific evidence and other information meets the
requirements of the SPS Agreement or ISPM No. 11, but he is of the view that it is "probably"
consistent with the Annex III of the BSP.145
86. Does the scientific evidence and other in formation 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 option s were available in April 2000? What other risk
management options are now available?

143 Ibid.
144 Nutti, p. 60.
145 Andow, p. 112-13.

148. Dr. Nutti says that, from the perspective of food and feed safety, the Austrian prohibition on
maize T25 was not scientifically justified.146
149. Dr. Andow says that the adoption of the prohib ition was "probably" not justified on the basis
of the scientific evidence and other information provided by Austria. 147 At the same time, he claims
that "a temporary prohibition probably c ould have been justified at the time because the appropriate
scientific information did exist". 148 Dr. Andow does not specify to what "appropriate scientific
information" he is referring, nor does he indicate th e nature of the risk to which that information
would pertain. Without knowing this, Canada is not in a position to comment on Dr. Andow's
response.
150. In the following paragraph, Dr. Andow offer the opinion that "several other risk management
options could also have been justified in April 2000", focusing on the resist ance risk, and suggests a
few.149 It is not clear what distinction Dr. Andow draws between "risk mitigation" and "risk
avoidance". What is clear is that well-understood, scientifically ve rified risk management measures
did exist in 2000 to address any concerns about weed resistance that Austria might have had at that
time, including proper crop and herbicide management. In any event, the evolution of resistant weeds
is only an issue if (1) the weed is economically important, and (2) no other suitable, sustainable
control measures exist (e.g., alternative herbicide applications).
Safeguard measure of Italy

87. Given the information before the Panel, in cluding the evaluations undertaken by France
(EC-160/At.1 and 2); the Scientific Committ ee on Plants in September 2000 (CDA-75) and
September 2001 (CDA-86 and CDA-77), and the European Commission in its Decision of April
1998 (CDA-74), as well as the information submitte d by Italy with respect to its safeguard
measure (CDA-78, EC-157/At. 1 and 2), is there any reason to believe that the scientific evidence
available to Italy in August 1988 was NOT sufficien t to permit it to undertake an appropriate
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?

(a) If the evidence was not sufficient in August 1988, was there sufficient evidence
available to Italy 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? If not, wh at scientific evidence do you believe
was insufficient?
151. Dr. Nutti indicates that there is no reason to belie ve that the scientific evidence available to
Italy in August 2000 was insufficient to allow an appropriate assessment of potential risks to human,
plant and animal health from maize T25.150
152. The expert's advice supports Canada's position th at there was no scientific reason for Italy to
impose a prohibition on maize T25 for food and feed.

146 Nutti, p. 61.
147 Andow, p. 113.
148 Ibid.
149 Ibid.
150 Nutti, p. 62.

88. 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 Italy evaluate the relevant risk s to human, plant or animal health, and the
environment from Maize T25?

(a) How does the scientific evidence and oth er documentation submitted by Italy
compare with the relevant internationa l guidelines for risk assessment and
analysis identified above?
153. Dr. Nutti concludes that the scientific evid ence submitted by Italy does not meet the
requirements of the relevant international guidelines (Codex).151
89. Does the scientific evidence and other in formation submitted by Italy support the
adoption of a temporary prohibition on Maize T25? In light of any potential risks identified by
Italy, what other risk management options were available in August 1988? What other risk
management options are now available?

154. Dr. Nutti is of the view that the scientific evidence submitted by Italy does not support a
temporary prohibition on GM maize T25.152
155. The expert's advice supports Canada's position.
Maize MON 809 (notification C/F/95/12-01/B)

Safeguard measure of Italy

90. Given the information before the Panel, including the evaluations undertaken by the
Scientific Committee on Plants in May 1998 and September 2000 (CDA-85 and CDA-86), as well
as the information submitted by Italy with respect to its safeguard measure (CDA-78,
EC-157/At. 1 and 2), is there any reason to believe that the scientific evidence available to Italy
in August 1988 was NOT sufficient to permit it to undertake an appropriate assessment of
potential risks to human, plant and animal health, and the environment from Maize MON 809?
If so, what scientific evidence do you believe was insufficient?

(a) If the evidence was not sufficient in August 1988, was there sufficient evidence
available to Italy 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 MON 809? If not, what scientific evidence do you
believe was insufficient?
156. Dr. Nutti indicates that the information submitte d by the applicant covered all the items
needed for the comparison of the GM maize and its conventional counterparts, not only for with data
on nutrients, but also with animal feeding studies.
153 The variation in levels of protein was in the
range of natural variation, so Italy's point concerning protein levels was not correct. She concludes
that "there is NO reason to believe that the scientif ic evidence available to Italy in August [2000] was

151 Ibid., p. 63.
152 Ibid.
153 Nutti, p. 64.

NOT sufficient to permit it to undertake an appropria te assessment of potential risks to human, plant
and animal health".154
157. In this regard, the expert's advice supports the position of Canada that Italy was not
scientifically justified in imposing a safeguard measure on precautionary grounds.
91. 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 Italy evaluate the relevant risk s to human, plant or animal health, and the
environment from Maize MON 809?

(a) How does the scientific evidence and oth er documentation submitted by Italy
compare with the relevant internationa l guidelines for risk assessment and
analysis identified above?
158. Dr. Nutti says that the information submitted by the applicants and evaluated by the French
CA met the requirements of international guidelin es (Codex). In contrast , "the information and
arguments provided by Italy were not in accordance with those guidelines."155
92. Does the scientific evidence and other in formation submitted by Italy support the
adoption of a temporary prohibition on Maiz e MON 809? In light of any potential risks
identified by Italy, what other risk management options were available in August 1988? What
other risk management options are now available?

159. Dr. Nutti says that the scientific evidence su bmitted by Italy does not support a temporary
prohibition of GM Maize MON 809. 156 As noted earlier, Dr. Nutti's expert advice supports Canada's
position in this regard.
Maize Bt-11 (reference C/GB/96/M4/1)

Safeguard measure of Italy

93. Given the information before the Panel, in cluding the evaluations undertaken by Great
Britain (EC-163(At.1 to 3), the Scientific Comm ittee on Plants in February 1998 (CDA-83),
November 2000 (CDA-84), and April 2002 (CDA-35-J), and the European Commission in its
Decision of April 1998 (CDA-80), as well as the in formation submitted by Italy with respect to
its safeguard measure (CDA-78, EC-157/At. 1 and 2) , is there any reason to believe that the
scientific evidence available to Italy in August 1988 was NOT sufficient to permit it to undertake
an appropriate assessment of potential risks to human, plant and animal health, and the
environment from Maize Bt-11? If so, what scientific evidence do you believe was insufficient?

(a) If the evidence was not sufficient in August 1988, was there sufficient evidence
available to Italy 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 Bt-11? If not, what scientific evidence do you believe
was insufficient?

154 Ibid., pp. 64-65 (emphasis in the original).
155 Ibid., p. 65.
156 Ibid., p. 65.

160. Dr. Nutti says that that information submitted by the applicant covered all the items needed
for the comparison of the GM maize and its conven tional counterpart, not only with data on nutrients
but also with animal feeding studies. The variation in levels of protein was not statistically
significant, so Italy's point about protein levels was not correct.157
161. She concludes that there is no reason to believe that the scientific evid ence available to Italy
in August 2000 was insufficient to permit an appropriate assessment of potential risks to human, plant
and animal health from GM maize Bt11.
162. Dr. Nutti's advice supports the argument that Italy was not scientifically justified in imposing
a safeguard measure banning maize Bt11 in food and feed on precautionary grounds.
94. 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 Italy evaluate the relevant risk s to human, plant or animal health, and the
environment from Maize Bt-11?

(a) How does the scientific evidence and oth er documentation submitted by Italy
compare with the relevant internationa l guidelines for risk assessment and
analysis identified above?
163. According to Dr. Nutti, the information subm itted by the applicant met all requirements of
international guidelines (Codex). In contrast, the information and arguments of Italy did not meet
those requirements.158
95. Does the scientific evidence and other in formation submitted by Italy support the
adoption of a temporary prohibition on Maize Bt- 11? In light of any potential risks identified
by Italy, what other risk management options were available in August 1988? What other risk
management options are now available?

164. Dr. Nutti concludes that the scientific ev idence submitted by Italy does not support a
temporary prohibition on GM maize Bt11.159
165. The expert's advice supports the argument th at the Italian ban on maize Bt11 was not
scientifically justified.
ISSUE 3

Products of biotechnology approved by the European Communities prior to October 1998

96. Has there been a significant change in the understanding of physical, chemical and
biological characteristics of biotech products, gene interactions, gene expression, gene silencing,
molecular characterization, and product specific detection since 1998?

166. Canada has no comments on the responses to this question by Drs. Squire and Nutti.

157 Ibid., p. 67.
158 Nutti, p. 68.
159 Ibid.

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 safegu ard measures), are different in nature or
magnitude as compared to the scientific understandi ng 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 the combination or successive use of
biotech products.

Does the information before the Panel support th e view that the potential risks from the
products in this dispute should be assessed differently than the risks from biotech products
approved prior to 1998?
167. Canada notes that this question concerns whether or not the risks associated with biotech
products approved prior to 1998 are different in natu re or magnitude to those biotech products that
have been in the approval process since 1998 ( i.e. those products subject to the moratorium). With
some exceptions, the biotech products approved prior to the implementation of the moratorium are
either Bt crops or crops resistant to glyphosate and glufosinate-ammonium. The biotech products
subject to this dispute are substantially the same of those approved prior to 1998 – namely, Bt crops
and glyphosate and glufosinate-ammonium tolerant crops.
168. It appears that Drs. Andow, Snow and Squire did not address the issue of whether the risks
between these two categories of products are different in nature or magnitude. The experts discuss the
development of new scientific information (e.g. gene flow amongst HT crops, potential impact on
non-target organisms of Bt crops), but this new in formation applies equally to biotech crops approved
prior to 1998 and those subject to the moratorium. Similarly, Dr. Andow discusses changes in the
approaches to risk assessment and management, but while these changes may have led to refinements
in assessment and management procedures, they ha ve not revealed differences in the nature and
magnitude of risks as between the two categories of products. Risks of the development of resistance
in pests to Bt toxins or the development of resistance to herbicides apply equally to all these products.
169. Consequently, as the biotech products subject to the moratorium are substantially the same as
those approved prior to 1998, the nature and magnit ude of the risks between the two categories are no
different.
170. With respect to food and feed, Dr. Nutti concl udes that there is no new evidence that would
suggest potential risks are different in nature or magnitude as between products approved prior to
1998 and those subject to the moratorium.
171. In terms of the specific issues raised by the e xperts, Canada directs the Panel to Canada's
comments on Questions 2 through 8.
98. From a scientific perspective, is there a significant difference in risks to human, animal
or plant health or the environment arising from the use of a bacterial antibiotic resistance
marker gene, or part thereof, in any biotech product at issue in this dispute (eg, Monsanto Bt
cotton (531), Monsanto Roundup Ready cotto n (RRC1445), Amylogene starch potato)

compared to those products of biotechnology ap proved by the European Communities prior to
October 1998?

172. Dr. Nutti states that, from a food and feed perspective, based on the existing literature and
knowledge of the subject, and from a scientific pers pective, there is no ne w evidence that would
suggest that the potential risks to human, animal or plant health arising from the use of a bacterial
antibiotic resistance marker gene, or part thereof, from any biotech product at issue in this dispute are
different in nature or magnitude as compared to those products of biotechnology approved by the
European Communities prior to October 1998.160
99. For those biotech products at issue in th is dispute for which no significantly different
nature or level of risk has been identified, do es the information 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?

173. Dr. Snow asserts that "with regard to environmental effects, if this question pertains only to
products that have no identified environmental risks, then there is no scientific rationale for obligatory
monitoring." Moreover, it is not lo gical to require monitoring of ev ery transgenic crop, regardless of
its phenotypic traits. Dr. Snow concludes that "s pecific and plausible environmental harms should be
identified before allocating time and money to these efforts." Canada agrees.
174. Dr. Nutti concludes that the products at issue s hould be treated the same as biotech products
approved prior to 1998.
175. Only Dr. Andow attempts to construct an ar gument for imposing monitoring on post-1998
products and not pre-1998. First, he appears to suggest that disagreements amongst Member States
concerning risks would justify monitoring. Sec ond, Dr. Andow states that "[a]ll of these possible
sources unanticipated [sic] effects are equally likel y to occur for plant biotech products before 1998
and plant 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." 161 Dr. Andow then asserts that changes
in methods and standards for assessing the possibilities of unanticipated effects justifies monitoring.
However, by his own logic, it would appear to make as much sense, if not more, to impose monitoring
requirements on pre-1998 biotech products.
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
agricultural management practices that differ from those for products of biotechnology
approved by the European Communities prior to October 1998?

176. Dr. Squire states that while the "innate biological qualities and behaviour of a product may
not have changed", it is possible the context with in which the product operates may have. He cites
changes in the physical or agronomic environmen t, such as the proportion of autumn-sown crops, the
area covered by oilseed rape and the increase in the use of certain pesticides (glyphosate). He also
indicates that our understanding of the GM product's ro le in the ecosystem has changed. What was
not thought to be important at that time is considered important now.

160 Nutti, p. 72.
161 Andow, para. 99.04.

177. Canada submits that, while changes in contex t may require an adjustment in agricultural
management practices, there is no reason to limit any such changes to post 1998 biotech products.
For instance, if management measures for effectivel y controlling the spread of herbicide-resistance
become necessary due to changes in cont ext, these measures should be adopted for all HT plants in
cultivation.
101. Does the information before the Panel suppo rt 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 European Communities prior to
October 1998? If so, what means of risk mitigation might be envisaged?

178. Dr. Squire states that, while products may 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. The perceived need 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. The general thrust of Dr. Squire's re sponse is that mitigation measures should evolve to
meet changing circumstances and new information. Canada agrees. However, this would apply
equally to pre-1998 products.
179. Dr. Snow states that several of the products that were approved before 1998 are the same or
similar to those in this dispute. She lists several oilseed rape and maize varieties approved prior to
1998. She then postulates that the answer to the question hinges on which potential environmental
risks might require mitigation, and whether any new scientific knowledge has become available to
justify changes to any mitigation plans that were required prior to 1998. She then points to new
knowledge relating to gene flow (in the context of HT oilseed rape) and the evolution of resistance in
target pests of Bt crops. She also notes that in the case of oilseed rape approved for import and
processing only, she cannot see any new scientific reasons for different mitigation plans as between
products approved prior to 1998, and those subject to the dispute (e.g. GT73).
180. Canada notes that even if new information came to light concerning the risks associated with
Bt or HT crops, the mitigation measures to addr ess these new risks should apply equally to pre-1998
Bt and HT crops. Indeed, Directive 2001/18 specifically provides for the reconsideration of the
original consent by the EC in the event of "new or additional information made available since the
date of the consent and affecting the environmental risk assessment." 162 However, in no cases of pre-
1998 approved products, has the EC revoked, rescinded or modified, the original consent.
Comparable novel non-biotech products, (such as plant products produced by selective
breeding, cross-breeding and induced mutagenesis)

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 animal health or to the environment
as novel non-biotech products, such as plant products produced by selective breeding, cross-
breeding and induced mutagenesis? If so, for any biotech product at issue in this dispute are
there significant differences, from a scientific pe rspective, in the nature or magnitude 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;

162 Directive 2001/18, Art. 23.

• 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 the 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.

181. Drs. Nutti, Snow and Andow respond to this question. Dr. Nutti indicates that novel non-
biotech products have not been subject to any ex tensive safety assessment, and she is of the opinion
that both novel non-biotech products and biotech products should be assessed in a comprehensive,
scientific, step-by-step, case-by-case basis, so the same safety assessment principles should be applied
in all cases. She appears to share the widely he ld consensus that the technology used to develop
biotech products does not give rise to different potential risks to human and animal health.
182. On the other hand, Dr. Snow suggests th at biotech products in this dispute " could be
considered as different from non-bi otech novel products in some cases ." Dr. Snow cites as an
example glyphosate-tolerant crops. She says that glyphosate resistance has not been introduced into
crops using non-transgenic methods, so this particular trait is linked solely to novel transgenic crops.
She suggests that extensive use of glyphosate could lead to weedy Brassica rapa populations that
have acquired the trangene through gene flow to become more common in and around farmers' fields.
She speculates about this transfer of resistance could occur to many types of crops. However, she
then says "[t]hese problems are possible with all types of herbicide-tolerant crops" but "unique
features of glyphosate make it a special case". Thus, Dr. Snow appears to acknowledge that the same
types of potential risks to human, plant, animal heal th or to the environment exist for all HT crops,
regardless of the technology used. However, she di stinguishes one type of HT crop on the basis that
the herbicide to which the crop is tolerant is widely used. This may be an argument for why
glyphosate-tolerant crops require more robust mana gement procedures, but it is not an argument for
why biotech HT crops are different from non-biotech HT crops. Unfortunately, Dr. Snow does not
discuss in any detail the types of potential risks to human, plant or animal health or to the environment
from other biotech HT crops tolerant ( e.g. those tolerant to glufosinate-ammonium) or non-biotech
HT crops developed through mutagenesis (e.g. those tolerant to imidazolinone).
183. Dr. Andow acknowledges that there are no differences in the types or kinds of risks posed by
biotech crops as compared to their non-biotech counterparts: toxicity to humans and animals;
allergenicity; nutritional qualities; potential fo r producing disease; gene flow; non-target and
biodiversity risks; and resistance risks. However, he claims that within these risks, there are new
kinds of risks associated with biotech plants.
184. Dr. Andow asserts that transgenesis does not allow more precise control than selective
breeding. According to Dr. Andow, because both transgenic and conven tional varieties undergo
selective breeding, the comparison is inappropriate. However, while both undergo selective breeding,
it is for different purposes. In the former case, th e selective breeding is random, through mutagenesis,
chance mutation or the introduction of new germplasm in order to achieve a desired phenotype; in the
latter, the selective breeding involves the introduc tion of the transgene into an "elite" germplasm
background; thus the breeding is usually into well established well-adapted lines.
185. Dr. Andow claims the magnitude of the open reading frames (ORF) and insertional
mutagenesis introduced by transgenesis is higher than that for adapted materials. It may also be
higher than deliberate or spontaneous mutations in cell culture, though Dr. Andow is less certain on

this point. However, the presence of an open reading frame is not the issue; the issue is whether there
is an expressed protein. Furthermore, these typ es of effects would be eliminated by subsequent
breeding during the development of the product, and the risk of new open reading frames and
chimeric proteins is effectively addressed during the molecular characterization.
186. Unfortunately, Dr. Andow does not compare the ri sks associated with induced mutagenesis to
the risks associated with biotech products.
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 risk 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 varieties that have been developed
using induced mutagenesis?163 If so, what means of risk mitigation might be envisaged?

187. Dr. Squire does not appear to answer the sp ecific question posed, which focuses on the risks
arising from contamination rather than the risk of contamination.
188. In any event, he observes that a certain le vel of impurity seems to have been generally
accepted for many years. 164 The specific level of impurity varied from crop to crop. Impurity is
common in oilseed rape, less common in beet and ma ize. The potential for a crop variety to convey
an impurity depends on several factors, such as the proportion of seeds that enter dormancy, the
persistence of seeds in the soil, and the relative polle n strength of potential donor and recipient fields.
Dr. Squire indicates that these factors may differ between GM and non-GM varieties but should not
differ because one is GM and the other not. He concludes that there is no reason to suppose that
biotech crops confer different degrees of impurity compared with crops produced from, say, induced
mutagenesis.
165
189. Dr. Snow also appears not to give a definitive answer to the specific question asked. She
suggests that the answer depends on "what types of risks each party is trying to avoid". 166 According
to her, if standard thresholds have been established to allow for coexistence, then by definition
contamination is an issue for all biotech products. In Canada's view, the qu estion then becomes what
is the nature of the risk that would arise from that contamination.
190. Dr. Snow also notes that labelling and traceability have not been required for novel non-
biotech products such as those developed usin g mutagenesis, nor would any high-resolution
identifying markers be available for these types of crops.167
191. She says another way to answer this question is to focus on phenotypes; this is more
appropriate if the goal is to avoid direct or indir ect harm to human, plant or animal health, or the
environment.168 She points to Part I of her answers, and her answer to Question 6 "for examples of
risks that are greater in certain GM crop s as compared to their non-GM predecessors", 169 but recourse
to these passages does not appear to provide any substantially greater cl arity in terms of a response to
the specific question asked.

163 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/.
164 Squire, p. 17.
165 Ibid.
166 Snow, p. 33.
167 Ibid.
168 Ibid. P. 34.
169 Ibid.

192. Dr. Andow says it depends on the scale of release and the nature of the adverse effect. 170
Furthermore, the definition of an adverse effect entails specification of whom or what will be affected
and how is this effect considered adverse. He a dds further complexity when he notes that "there has
been little discussion and less agreement over the nature of the adverse effects of contamination", and
muses that "it is not clear to [him] that there is agreement that these kinds of perceived risks should be
considered."171
193. Dr. Andow then posits that an organic farmer might find contamination to be an adverse
effect because of the economic impact. Dr. Andow says that in this example at least, the risk
associated with biotech crops is substantially gr eater than the risk associated with conventional
varieties (based on the definition of harm). 172 However, Canada does not understand why this would
be true. Whether an organic crop is contaminat ed with a transgenic seed or a conventional non-
organic seed ought not to matter provided that the risks to human or animal health or the environment
are the same.
194. In short, none of the three experts on environmental risks appear to have a clear or
unequivocal answer to the question as posed. Of c ourse, the question does not specify what it means
when it uses the term "risk"; is it confined to ri sks of environmental harm, or harm to human or
animal plant life or health? Does it encompass what might be called pure economic loss? It may be
that the ambiguity of the question prevented the experts from expressing themselves clearly and
unequivocally.
195. In contrast, Dr. Nutti is of the firm view that crop varieties that have been developed using
induced mutagenesis can pose the same risks to human or animal health as plants produced from
Recombinant-DNA technology, and should be assessed in the same manner.173
104. From a scientific perspective, is there a sign ificant difference in risks to human, animal
or plant health or the environment arising from the use of a bacterial antibiotic resistance
marker gene, or part thereof, in any biotech product at issue in this dispute (eg, Monsanto Bt
cotton (531), Monsanto Roundup Ready cotto n (RRC1445), Amylogene starch potato)
compared to novel non-biotech products, such as comparable plant products produced by
selective breeding, cross-breeding and induced mutagenesis?

196. Dr. Nutti indicates that the use of antibiotic resistance marker genes has been recognized as a
safe tool and its employment should be evaluated on a case by case basis. The same rule should be
applied to novel non-biotech products, such as comparable plant products produced by selective
breeding, cross-breeding and induced mutagenesis.
174
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 scientific or technical rationale for
monitoring the occurrence of pote ntial adverse effects, or of unintentional effects, arising from
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 mutagenesis? If so, would
such monitoring relate to the specific genes or tr aits introduced into a biotech product, and how
would this compare with the monitoring of induced changes in novel non-biotech products?

170 Andow, p. 127.
171 Ibid.
172 Ibid.
173 Nutti, p. 75.
174 Ibid.

197. All three experts who responded to this questi on appear to agree that transgenic and non-
transgenic plants may result in unintended effects and that monitoring may be justified. Dr. Snow
concludes that both transgenic methods and other methods of crop breeding can result in unintended
effects and that there is no basis to assume that these unintended effects would be substantially greater
in transgenic plants.175 Moreover, she states that "it does not seem logical to require monitoring if no
risk has been identified."176
198. Andow also points to "unanticipated effects" and agrees that some "conventional non-
transgenic plants have risks, some of wh ich may justify monitoring (and management)." 177 Lastly,
Dr. Nutti indicates that monitoring should be used in the same manner for biotech and novel non-
biotech based on scientific parameters.
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 scientifi c or technical rationale for requiring specific
agricultural management practices that differ fr om those for novel non-biotech products, such
as plant products produced by selective breeding, cross-breeding and induced mutagenesis?

199. Dr. Squire indicates that, 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. If thresholds are imposed, for whatever reason, then there will need to be
different agricultural practices for those GM varietie s that leave volunteers or spread genes by pollen
to neighbouring sexually compatible crops. 178 According to Dr. Squire, these different practices are
well-appreciated, by which Canada takes him to mean that they are well-understood and of proven
effectiveness.
200. Dr. Squire also says that, under a system of coexistence in which a threshold (GM in non-
GM) was imposed, the agricultural practice might well ha ve to change in a crop such as oilseed rape
to ensure that threshold would be met. Importa ntly, he adds that, "given present knowledge, these
changes would be in consequence of an imposed threshold of GM in non-GM products, not of any
inherent food-risk in the GM product itself."179
201. The basic point here is that any difference required in the agronomic management to preserve
purity is a consequence of a policy decision to segregate GM crops from non-GM crops. It would not
be based on any scientific evidence demonstrating risks to human, animal or plant health or safety.
General Questions

110. On the basis of the information before the Panel, is there any scientific evidence to
support the hypothesis that animal feed made fr om biotechnology plants alters the composition
of the food derived from animals consuming the feed?

175 Snow, p. 34.
176 Ibid.
177 Andow, p. 105.10.
178 Squire, p. 17.
179 Squire, p. 18.

(a) If so, what is the likelihood that this event could lead to adverse effects on
human or animal health? (see, inter alia, exhibit US-144)
(b) What risk management options are available to mitigate any resulting risks and
what is their efficacy?
202. Dr. Nutti states in her response that she is "not aware of any scientific evidence that supports
the hypothesis that animal feed made from biotec hnology plants alters the composition of the food
derived from animals consuming the feed". 180 She then refers to several studies that suggest there is
no relationship between the use of biotech feed and the composition of food derived from animals
given such feed.181
112. Please provide an assessment of the statem ents regarding chronic toxicity testing in
paragraph 43 of Canada's Third Submission a nd paragraphs 134-138 of the US Supplementary
Rebuttal Submission. What relevance does the forese en end product use(s) have in the context
of the evaluation of the toxicity of that product?

203. Dr. Nutti states in her answer that "if the toxi cological assessment has conducted acute agave
studies in mice, homology to known toxins and al lergens with no indication of adverse effects,
chronic toxicity tests shall not be required". 182 She points to the relevant Codex Guidelines, which
indicate that such tests may be necessary only if dou bts about the safety of the new substance remain.
It should be added that such doubts must have an empirical foundation, and cannot simply arise on the
basis of speculation.

180 Nutti, p. 79.
181 Ibid., p. 80.
182 Ibid., p. 81.