1. B: Questions for discussion
Objective
1. Does the proposed LLP Policy and Implementation Framework provide sufficient
transparency and predictability on how the Government of Canada will manage occurrences of
LLP:
a. in imported grain? If not, please explain why.
b. in other imported food and feed products? If not, please explain why.
ANSWER: The proposed LLP Policy and Implementation Framework (the “LLPP Policy”) does not provide
sufficient transparency and predictability on how the Government of Canada will manage occurrences of
LLP in imported grain and the other imported food and feed products.
The reasons are set out below.
i) Not Predictable
The descriptions provided on how the Government of Canada will manage LLP occurrences are not
predictable. One reason is that, although the Policy sets out proposed threshold levels, the actual
implementation of the Policy is in no way predictable because the decision making process and the
decision makers are not clear. For example, the LLP Policy applies where Canada has recognized that
the safety assessment conducted by a foreign county is consistent with the Codex Guideline for the
Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL 45-2002)
(the “Codex Guidelines”). However it is not clear who from Health Canada and the CFIA will be tasked
with communicating with individual countries. It is not clear what the means of communication will be
and whether it will be consistently utilized with all countries. The basis upon which the assessment of
consistency will be made is not set out. All of these points indicate that the Policy is not predictable. It
is further submitted that an assessment process of a foreign country should follow the Codex Guideline
rather than just be consistent with it, otherwise the proposition that the assessment is adequate is not
made out.
In addition, with respect to “imported food and feed products” other than grain , the LLP Policy does not
provide sufficient transparency and predictability, because it relies on the Codex Guidelines and the
Codex Guideline does not even deal with food or feed products. In the first section of the Guidelines
that deals with the scope of the Guidelines, it is made clear that the focus of the Guidelines is “discrete
chemical entities such as food additives and pesticide residues, or a specific chemical or microbial
contaminant that have identifiable hazards and risks; they are not intended to apply to whole foods as
such”. Further, in the scope section of the Codex Guidelines it is stated that “this document does not
address animal feed or animals fed with the feed. ” It is difficult to have transparency and predictability

2. with respect to managing imported food and feed products when food and feed are not even addressed
in the Policy and Framework.
ii) Not transparent
The Government of Canada through its departments has jurisdiction over health, the environment and
agriculture. All three of these departments have some aspect of jurisdiction over occurrences of LLP. As
stated in Current Federal Legislative Framework for Biotechnology Products: Fact Sheet from Industry
Canada:
“In the federal government, legislative responsibility for health and environmental assessment
of biotechnology products is divided primarily among four institutions: Environment Canada,
Health Canada, the Canadian Food Inspection Agency and the Department of Fisheries and
Oceans.
The Canadian Environmental Protection Act is a key part of the framework. It ensures that new
biotechnology products are assessed for health and environmental impacts under CEPA
regulations, unless they undergo such an assessment under other legislation. …
The Food and Drugs Act provides the authority to Health Canada for the assessment and control
of the nutrition, quality and safety of food….. This authority also applies to products from
biotechnology. Under this authority, Health Canada can establish conditions for the
manufacture, sale and advertisement of food…...
The Feed Act specifies that all ingredients be evaluated prior their use in livestock feeds,
including novel feeds. The legislation applies to imported … products. The assessment of feed
focusses on toxicity to livestock, human safety in terms of the transfer of harmful residues to
human foodstuffs, ….”
Environment Canada has jurisdiction over the environment under the Canadian Environmental
Protection and Enhancement Act (“CEPA”), which is an Act respecting … protection of the environment
and human health in order to contribute to sustainable development. Health Canada has jurisdiction
over the safety of food under the Food and Drugs Act, which is an Act respecting food. The Canadian
Food Inspection Agency has jurisdiction over feed under the Feeds Act, which is an Act to control and
regulate the sale of feeds.
The possibility exists for quantities of a genetically modified crop to be imported into Canada without an
assessment of health and environmental impacts, the safety of the crop as a food or its toxicity to
livestock or the transfer of harmful residues t human foodstuffs. In other words, the quantity could be
imported without the appropriate regulatory authorities exercising any oversight or jurisdiction over it.
It is not evident how the relevant departments are fulfilling their mandates under the LLP Policy, and
thus the LLP Policy is not transparent. This is not consistent with the principles of the Federal
Accountability Act, which is to provide for “measures respecting administrative transparency, oversight
and accountability”.

3. Scope of the Policy
2. Is the scope of the proposed Policy appropriate?
No.
3. Do you support the inclusion of a common low Action Level for all crops to manage potential
trace amounts (e.g. dust) of LLP in imported grain?
No I do not support the inclusion of any low Action Level for any crops to manage potential trace
amount of LLP in imported grain. The reasons are set out below.
i). The basis for the establishment of the Action Level is set out in in the LLP Policy (6.1) that “Since the
food safety assessment that the GM crop has passed is consistent with the [Codex Guidelines], below
the Action Level, LLP is unlikely to pose a risk.”
It is submitted that this statement (that below the Action Level, LLP is unlikely to pose a risk) is not true.
Risk assessment is to take into account exposure assessment and risk characterization. Exposure
assessment is the “qualitative and/or quantitative evaluation of the likely intake of biological, chemical
and physical agents via food, as exposures from other sources if relevant”. If low level presence is
allowed into the crop strain, then it will likely be present in some quantity in the crop that is used as
food or to create food products. It will be taken up in the food.
Risk characterization is “the qualitative and/or quantitative estimation, including attendant
uncertainties, of the probability of occurrence and severity of known or potential adverse health effects
in a given population based on hazard identification, hazard characterization and exposure assessment”.
(EDES: Handbook 1.8 Food Safety Policy: Risk Profiles, Strategy and Evaluation of Political Priorities in
Animal and Public Health).
The literature points to heightened risk associated with genetically modified foods. One study from
China (cited as Zhang, et al. Exogenous plant MIR168a specifically targets mammalian LDLRAP1:
evidence of cross-kingdom regulation by microRNA. Cell Research, (20 September 2011) |
doi:10.1038/cr.2011.158) shows that food consumed by humans can actually alter gene expression in
humans. Another study , underlines this point, by showing that genetic material in soybeans that cause
the beans to be tolerant to herbicides actually transferred into human gut bacteria and continued to act
as a poison in the gut. (Netherwood et al, “Assessing the survival of transgenic plant DNA in the human
gastrointestinal tract,” Nature Biotechnology 22 (2004): 2 ) A more recent and well-known study is that
of Seralini et al, which found significant effects of GM diets on the animals tested, particularly to the
liver and kidneys. Further, the researchers concluded that the 90 day long tests are insufficient to
evaluate chronic toxicity’ and suggested that studies should be ‘improved and prolonged’. Of note is
that in groups fed GM maize, 50% of males and 70% females died prematurely, before the average life

4. expectancy, and also that the mortality rates were not dose-dependent on the concentration of
genetically modified maize in the diet.
Based on the above, it is the case that the exposure assessment and risk characterization components of
risk assessment would indicate that allowing LLP into crop strains would provide for wide exposure and
that the potential adverse health effects are quite severe. Based on the above, there is no basis for the
statement that below the Action Level, LLP is unlikely to pose a risk.
ii) The establishment of an Action Level assumes that by “dilution of quantity” any potential harm arising
from the dust will be dissipated. However the very nature of genetically modified substances is such
that they can have unintended effects on consumers. It cannot be stated that the harm is dissipated by
a dilution in quantity of exposure. The Royal Society of Canada, in response to requests from the
relevant federal regulatory authorities, stated that the “default prediction” that GM crops would include
“a range of collateral changes in expression of other genes, changes in the pattern of proteins produced
and/or changes in metabolic activities”. (“Element of Precaution: Recommendations for the Regulation
of Food Biotechnology in Canada; An Expert Panel on the Future of Food Biotechnology prepared by The
Royal Society of Canada at the Request of Health Canada , Canadian Food Inspection Agency and
Environment Canada” the Royal Society of Canada, January 2001)
iii). I do not support the establishment of a common low Action Level on the proviso that the relevant
GM crop has been approved in at least one country using the Codex Guidelines. The only way to
manage potential trace amounts of LLP is to perform a full safety assessment in Canada, not utilize a
safety assessment the basis of which is an approval in another country under the Codex Guidelines.
Some of the concerns with the 2 stage approach and a safety assessment under the Codex Guidelines
are explained below.
a) CODEX Guidelines with Action Level do not provide an effective risk-based approach to managing LLP
CODEX is based on the principle of “substantial equivalence”. The Codex Guidelines describe this as the
principle that “the safety of foods derived from new plant varieties, including recombinant-DNA plants,
is assessed relative to the conventional counterpart having a history of safe use, taking into account
both intended and unintended consequences. Rather than trying to identify every hazard associated
with a particular food, the intention is to identify new or altered hazards relative to the conventional
counterpart.” (para 4., p.1 of Guidelines). “This concept is used to identify similarities and differences
between the new food and its conventional counterpart. … [I]t focuses on assessing the safety of an
identified difference so that the safety of the new product can be considered relative to tis conventional
counterpart”.
However substantial equivalence analysis does not protect the health and safety of humans (one of the
objectives of the LLP Policy) because it does not assess or purport to assess the safety of food. The
Codex Guidelines themselves are clear in the scope section that an approach that is more focused is
required where the safety of a whole food is being considered. It states that Codex principles of
analysis “are not intended to apply to whole foods as such. Indeed, few foods have been assessed in a
scientifically in a manner that would fully characterize all risk associated with food. Further, many foods

5. contain substances that would likely be found harmful if subjected to conventional approaches to safety
testing. Thus a more focused approach is required where the safety of a whole food is being
considered”.
Further, the literature indicates that a genetically modified plant can have a different composition to its
“conventional” counterpart by virtue of the genetic modification. This means that a safety assessment
of the new plant relative to its conventional counterpart does not make sense because the two plants
could have different compositions. Examples include canola that was modified to contain Vitamin A,
which had an altered oil-fat composition; increased levels of sucrose, mannitol and glutamic acid found
in rice genetically modified to have an insecticidal characteristic; and differing proteins in the plant in
maize that had been genetically modified. (footnote 23, 25, 21 on page 35). [Zhou J, MaC, XuH, et al.
Metabolic profiling of transgenic rice with cryIAc and sck genes: an evaluation of unintended effects at
metabolic level by using GC-FID and GC-MS. J Chromatogr B Analyt Technol Biomed Life Sci. 15 Mar
2009; 877 (8-9): 725-732. [Shewmaker C, Sheehy JA, Daley M, Colburn S, KeDY. Seed specific
overexpression of phytoene synthase: Increasein carotenoids and other metabolic effects. Plant J. 1999;
20(4): 401-412X] [[Zolla L, Rinalducci S, antonioli P, Righetti PG. Proteomics as a complementary tool for
identifying unintended side effects occurring in transgenic maize seeds as a result of genetic
modifications. J proteome Res. May 2008; 7(5): 1850-18]
b). A safety assessment in a foreign country is not appropriate for or in the Canadian context
The first point here is that a foreign country has an environment different from those in Canada. A
safety assessment under the Codex Guidelines has different components to it and some of the analysis
on the components will be different because they occur in a different country. For example, the Codex
Guidelines require information on: “history of cultivation and development through breeding”; “the
history of use… on how the plant if typically cultivated, transported and stored, whether special
processing is required to make the plant safe to eat, and the plant’s normal role in the diet (e.g. which
part of the plant is used as a food source, whether its consumption is important in particular subgroups
of the population, what important macro- or micro-nutrients it contributes to the diet)”; “[t]he
potential effects of food processing, including home preparation, on foods derived from recombinant-
DNA plants should also be considered.”
That differing environments might yield different results is acknowledged in the risk assessment
literature. Thus relying on a safety assessment conducted in a different country does not provide a good
assessment of risk. This is evident from the Working Principles for Risk Analysis for Application in the
Framework of the Codex Alimentarus (the “Working Principles”) which is to guide risk analysis as set out
in the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. The Working
Principles (p.2) allow that risk assessment may take into account qualitative information. Because of the
qualitative components involved in the risk assessment steps, and the requirement for assessment
evaluation of exposures from sources other than food, it is the case that risk assessments will vary
depending on the environment in which they are conducted. Relying on a safety assessment from
another country does not take this fact into account.

6. The Working Principles also point out that risk assessment is also to “take into account relevant
production, storage and handling practices used throughout the food chain including traditional
practices, methods of analysis, sampling and inspection and the prevalence of adverse health effects”
(p.2). As mentioned, the items without question would differ in a foreign country as compared to
Canada.
It is also clear in para. 52 of the Working Principles that “[b]ecause of geographical and cultural variation
in food consumption patterns, nutritional changes to a specific food may have a greater impact in some
geographical areas or in some cultural population than in others. “ (p. 7)
An additional point is that administrators in a foreign country may be influenced by factors different
from Canadian administrators. The degree of political, monetary or industry pressures that would
influence approvals under the Codex Guidelines may vary depending on the country in which the
assessment is being conducted.
c) Reliance on a foreign safety assessment and a determination as to whether that is consistent with
Codex is neither transparent nor predictable.
In a foreign safety assessment, there is no assurance that the Canadian administrator will have access to
the data used in the safety assessment or to the analysis employed in the safety assessment.
Confidence in the system will require an ability of the Canadian administrator to review the data and
analysis made in the context of the CODEX principles to judge whether the principles were applied
appropriately and correctly. As already indicated, there are qualitative determinations and value
judgements that need to be made within the confines of the CODEX principles. For example, there may
be instances where traits exhibited result in the potential for accumulation or evidence toxicity, and in
both instances CODEX directs the authority to perform conventional approaches for assessing
accumulation or toxicity. The basis upon which such determinations were made by the foreign
administrator would not be evident on the face of the approval. Without such transparency, there is no
predictability either.
Paragraph 3.5 (p. 8) of the LLP Policy indicates that “Health Canada and the CFIA will communicate with
individual countries to assess whether their food safety assessment process is consistent with the Codex
Guideline and therefore provides confidence that the LLP of GM crops approve by the country is unlikely
to pose a risk to food or feed safety”.
It is not clear who from Health Canada and the CFIA will be tasked with communicating with individual
countries. It is not clear what the means of communication will be and whether it will be consistently
with all countries. The basis upon which the assessment of consistency will be made is not set out. All
of these points indicate that the Policy and Framework is not transparent and therefore not predictable.
It is further submitted that an assessment process of a foreign country should follow the Codex
Guideline rather than just be consistent with it, otherwise the argument that the assessment is
predictable (one of the objectives of the LLP Policy) cannot even be made.

7. 4. What would be the positive or negative impact for you, your business, or the stakeholders you
represent if an Action Level is established?
The impact for me and the rest of the general public if an Action Level is established such that LLP enters
our food and feed would be negative:
- From a health perspective, I hold the belief, which is growing in the general public and scientific
literature, that food sensitivities to items such as nuts and gluten, celiac disease, and autism, to name a
few, are the result of or have been amplified by consumption of genetically modified foods. If LLP is
allowed, I would mostly likely cease eating items made with the particular crop. If others do the same,
then consumption of some staple crops and products could decrease, which would not help participants
in the grain industry, one stakeholder the LLP Policy is trying to bolster. Further, if the belief proves
accurate, then obviously the health of Canadians would be extremely negatively affected.
5. Does an Action Level of 0.1% meet the objectives described in the proposed Policy?
An Action Level of any kind, based upon an assessment of consistency in accordance with the Codex
Guidelines, does not meet any of the objectives described in the proposed Policy.
The objectives of the LLP Policy are stated as follows:
The objectives of the Policy are to:
- minimize disruptions to trade while protecting the health and safety of humans, animals and the
environment;
- facilitate an effective and efficient risk-based approach to managing LLP; and
- provide transparency and predictability for importers and exporters.
It is submitted that the LLP Policy is not appropriate for meeting any of the objective of the Policy. In
effect, the Policy is stated to apply to imported grain, food and feed products that contain LLP where the
GM crop has been approved for use as food in at least one country, and Canada has recognized that the
safety assessment conducted by that country is consistent with the Codex Food Safety Assessment
Guidelines. It is then stated that foreign feed assessment is not required because most components of
a food safety assessment also apply to feed.
The reasons that the Action Level and associated reliance on the Codex Guidelines do not meet any of
the objective is that these principles in the LLP Policy do not protect the health and safety of humans,
animals and the environment; a safety assessment under the Codex Guidelines is not an effective or
efficient risk-based approach to managing LLP; and reliance on a foreign safety assessment and a
determination as to whether that is consistent with Codex Guidelines is neither transparent nor
predictable. These reasons are set out in greater detail below.

8. a) The health and safety of humans, animals and the environment are not protected
As discussed above in the answer to question 2, it is the case that the exposure assessment and risk
characterization components of risk assessment would indicate that allowing LLP into crop strains would
provide for wide exposure and that the potential adverse health effects are quite severe. This does not
meet the objectives of protection enumerated.
Further, the wording of the Codex Guidelines itself is clear that “this document does not address animal
feed or animals fed with the feed. This document also does not address environmental risks”. Thus the
exclusion in the LLP Policy of a foreign feed assessment on the basis of the similarity of most
components to a food assessment allows for some components of a feed assessment to not be
conducted. Allowing LLP in feed without even an assessment under the Codex Guidelines runs counter
to the stated objective of protecting the health and safety of humans, animals and the environment. It
also does not meet the state objective of providing for an effective risk-based approach to managing
LLP.
b) A safety assessment under the Codex Guidelines is not an effective or efficient risk-based approach to
managing LLP and the assumption that a safety assessment conducted in one country is appropriate for
or in the Canadian context is not supportable.
With respect to effectiveness, please see the answer to Question 3, paragraphs “CODEX Guidelines with
Action Level do not provide an effective risk-based approach to managing LLP”.
With respect to efficiency, it is submitted that it would be more efficient to just employ the safety
assessments in place now for LLP in genetically modified crops rather than undertake the analysis as to
whether the Codex Guidelines applied in another country are appropriate and consistent. This is again
clear from the Codex Guidelines themselves. The Guidelines speak to instances of accumulation of
pesticide residues or other substances relevant to human health and indicate that “[c]onventional
procedures for establishing the safety of such compounds (e.g. procedures for assessing the human
safety of chemicals) should be applied.” Section 54 of the Codex Guidelines indicates that “Some
recombinant-DNA plants may exhibit traits (e.g. herbicide tolerance) which may indirectly result in the
potential for accumulation of pesticide residue, altered metabolites of such residues, toxic metabolites,
contaminants, or other substance which may be relevant to human health. The safety assessment
should take this potential for accumulation into account. Conventional procedures for establishing the
safety of such compounds (e.g. procedures of assessing the human safety of a chemical) should be
applied.”
The Codex Guidelines also indicate that appropriate oral toxicity studies may need to be carried out
where a protein present in food is not similar to proteins that have previously been consumed safely in
food, taking into account its biological function. Potentially bioaccumulative and toxic substances in
Canada are the mandate of federal regulatory authorities in Canada, generally Environment Canada
under CEPA, and require their own assessments. Since the Codex Guidelines and safety assessment
recognize and incorporate these principles, the application of the Codex Guidelines by a foreign country
would likely point to using conventional safety assessment procedures.

9. c) Reliance on a foreign safety assessment and a determination as to whether that is consistent with
Codex Guidelines is neither transparent nor predictable.
Please see the answer to Question 3, paragraphs “Reliance on a foreign safety assessment and a
determination as to whether that is consistent with Codex is neither transparent nor predictable”.
Please also see the answer to Question 1.
6. Would an Action Level of 0.2% meet or better meet the objectives described in the
proposed Policy? Please explain your answer with examples, as appropriate.
An Action level of 0.2% would not meet or better meet the objectives. Any threshold Action Level does
not meet the objectives of the LLP Policy as argued above.
Threshold Level Questions
Crop-specific Threshold Levels will be set for individual crop types and will be higher than the Action
Level. The Threshold Levels will be set to reflect achievable levels for unintentional presence based
on best management practices for each crop type while respecting the realities of the systems in
place that support the commercial trade of agricultural commodities around the world. These
Threshold Levels will only be applicable for an individual GM crop after a Canadian LLP risk
assessment has determined that the presence of the GM crop at the proposed level is unlikely to
pose a food, feed or environmental safety risk.
7. Do you support the inclusion of a Threshold Level, where a LLP Risk Assessment has been
conducted by Canadian regulators, to manage higher trace amounts of LLP in imports?
No I do not support the inclusion of a Threshold Level even where a LLP Risk Assessment has been
conducted. As argued in the answer to question 3, the inclusion of a threshold level assumes that at a
certain quantity, the risk associated with LLP is not severe. However this assumption is not supported
on the facts. Please see the answer to question 3.
Moreover, the basis for using 0.1%, 0.2% or Threshold Levels is arbitrary.
Also, the use of a Threshold Level is regulating the quantity of the LLP. The harm that arises from the
occurrence of genetically modified foods is not a function of quantity, but a function of exposure.
8. What would be the positive or negative impacts for you, your business, or the stakeholders

10. you represent if Threshold Level(s) are established?
Please see the response to question 4.
9. Do you support having crop specific Threshold Levels, as described in the proposed Policy?
No I do not support having crop specific Threshold Levels. The reasoning is set out in the answer to
question 7.
10. Do you agree with using the biology of the crop (e.g. rate of outcrossing) and the grain
handling practices as considerations in establishing the Threshold Levels? Please explain your
answer with examples, as appropriate.
As stated above, the establishment of Threshold Levels assumes that LLP is unlikely to be harmful if the
quantities are diluted. Because this assumption is not supportable, Threshold Levels should not be
established. Accordingly there should be no considerations.
The fact that the rate of outcrossing is stated as a possible consideration is remarkable. It is implicit in
the statement that genetically modified crops will cross breed and pollinate with the conventional crops.
Any cross-breeding or pollination that occurs would likely occur in a cumulative and synergistic basis,
which leads to the conclusion that LLP cannot be managed to stay at a low level.
Some considerations that might be considered in safety assessments are: the rate of uptake of the
genetically modified crop in the environment, animals and humans; long term studies on impacts;
requirement that the data and information for the assessment be provided by objective third party
sources and not the regulated parties.
11. Please see the answer to number 10 on considerations that might be considered in safety
assessments.
12. The members of the committees should include:
- people who can address the considerations outlined in point 10 (the rate of uptake of the genetically
modified crop in the environment, animals and humans; long term studies on impacts; requirement
that the data and information for the assessment be provided by objective third party sources and not
the regulated parties);
- scientists;
- representatives with appropriate mandates from Health Canada, Environment Canada and the
Canadian Food Inspection Agency
- CBAN representatives

11. - representatives from the Institute for Responsible Technology
- representatives from any NGOs dealing with ethical issues of biotechnology
- proponents of labelling GMS
- farmers
13. I don’t believe that the importation of LLP unauthorized GM crops would have an impact on exports
from Canada. The importing countries will be unlikely to change their own laws and standards just
because Canada is doing so, especially if it is understood that the likely reason for the change in
Canadian laws is to promote Canadian exports. Further if it is assumed that the reason for the LLP Policy
is to promote Canadian exports, then the question arises: why would the time and effort of the
Canadian government go into drafting the LLP Policy when the answer to this question is not known.
14. n/a
15. Absolutely not. As discussed above, I am of the view that genetically modified foods pose a serious
risk to the health of Canadians and the Canadian environment. I also am of the view that the science
will prove this out. If my views are correct, then I would not be proud that Canada supports a policy that
harms its own people. The impacts of such a decision on the general public would be far-reaching.
Moreover, because one of the aims of the LLP Policy is clearly to promote Canadian exports, it would be
difficult to support a Canadian government that allowed for harm to come to its citizens for reasons of
trade. Especially when historical disruptions to trade have occurred by virtue of sovereign countries
applying their own laws.
The impact on my sector, the general public, would be negative and significant. Please see the answer to
question 4.
16. The additional points I would like to make are to provide an explanation to my answer of “No” for
Question 3, on whether the Scope of the LLP Policy is appropriate:
The scope of the policy is not appropriate. The question becomes “appropriate for what?” The answer,
presumably, is appropriate for meeting the objectives of the policy, appropriate in terms of the mandate
of the Government of Canada, and appropriate in law. All are addressed below.
i) Not appropriate in terms of the mandate of the Government of Canada
As described above, the mandates of Health Canada, Canadian Food Inspection Agency and the
Department of the Environment are to regulate food safety and feed and protect the environment and
human health. Each department has jurisdiction over some aspect of the LLP occurrence. These
departments do not, however, have authority in the LLP Policy even though they have jurisdiction. As
such, the scope of the proposed Policy is not appropriate. It is not wide enough to provide the
departments with the authorities to fulfill their mandates. As such, an order of mandamus in
administrative law would be applicable.

12. ii) Not appropriate because in law because the LLP Policy is breaking the law, and doing so on the basis
of conjecture/ supposition
The LLP Policy is not appropriate because the proposals are, in effect, proposals to allow genetically
modified organisms with a certain characteristic to enter Canada without a risk assessment. As such,
implementation of the LLP Policy represents a breach of current Canadian law. It is understood and
expected that the LLP and Implementation Framework would become more of a policy and actually
achieve the status of law, and that the current statutes in place would be modified to allow for
exceptions represented in the LLP Policy.
The grounds provided for breaking the law are based on assumptions about future events. They are
suppositional. See the “Background” section of the LLP Policy and the Frequently Asked Questions:
- “….it is expected that the number and variety of genetically modified (GM) products
commercialized will continue to increase” [Background (i)].
“As a result of the lack of synchronization in the approvals of new GM crops by countries and
the expected increase in the commercialization of GM crops around the world, the likelihood of
LLP entering into Canada is expected to increase”. [Background (iii)]
“The enforcement actions taken when an unauthorized GM crop is detected may disrupt trade
and increase costs to industry and to governments, on both the import and the export side.
Under the current legislation, such disruptions and costs could occur despite the fact that the
unauthorized FM crop, present at low levels, is unlikely to pose a risk to human or animal health
or the environment”. [Background (vii)]
“Currently, the potential for LLP to enter Canada through imports is low…. However the
likelihood of LP in Canadian imports is expected to increase as other countries develop more
and more GM crops intended to domestic use. …..[T]hese products could commingle with
exports destined for Canada and therefore, the likelihood of LLP to enter the country is
expected to increase in the future.” [FAQ #5]
Moreover, even if it is assumed that the suppositions will in fact prove correct, ie. that the expectation
that GM products commercialized will increase, this is no basis for changing the law if it is otherwise not
appropriate. In effect, this would be stating that because something is expected to occur, and it is
difficult to manage, that it should be allowed, which is not appropriate. If laws need to be amended so
that they are no longer being breached, and this is done on the basis of supposition or conjecture ie. no
harm has occurred, this is not appropriate.
III) The Scope is Not Appropriate Because it does not allow the Objectives of the LLP Policy to be met
Please see the explanation in the Answer to Question 5 “An Action Level of 1% and Reliance on the
Codex Guidelines does not meet the objectives of the Policy”

13. End Stuff (not part of my submission)
The second study is the reknowned study by Séralini et al (*) published in September 2012, that was
peer-reviewed. The study revealed strongly negative health effects on rats when fed genetically
modified maize over 2 years, as compared to the typical 90 day tests performed in safety assessments.
The study is summarized in “Setting the Record Straight on the Seralini GM Maize Rat Study: Why the SA
Government Must Urgently Intervene” (African Centre for Biosafety: 12 September 2012) as follows:
On the 26th of September 2012 Professor Gilles-Eric Séralini, and his research team at the University of
Caen, published the findings of a two year study in which laboratory rats were fed Monsanto’s GM
maize variety NK603. The two year study in which laboratory rats were fed Monsanto’s GM maize
variety NK603. The study built on previous work done by Professor Séralini and his team when he
reviewed 19 GM maize and soya animal feeding studies. The necessary raw data to enable such a study
was only obtained from Monsanto through legal action. This data revealed significant effects of GM
diets on the animals tested, particularly to the liver and kidneys. Further, the researchers concluded that
‘the 90 day long tests are insufficient to evaluate chronic toxicity’ and suggested that studies should be
‘improved and prolonged’.16 The rationale behind the present study was to replicate the 90 day
toxicology study over the lifetime of the animal (2 years in the case of laboratory rats), and hence gain a
better insight into any potential chronic effects of consuming NK603 and traces of the Roundup
herbicide that is used in conjunction with it.
Two hundred rats (100 male, 100 female) were divided into groups of 10. For each sex, one control
group of ten rats was given access to plain water and a standard diet from the closest isogenic non-GM
maize variety. Six groups were fed with 11, 22 and 33% GM NK603 either treated or not treated with
Roundup herbicide (to simulate the presence of Roundup residues that are found in the maize).The final
three groups were fed with the controlled diet and had access to water supplemented with0.2 ppb
Roundup (a contamination level found in some tap water samples), 0.09% Roundup (the US maximum
residue level of glyphosate in some animal feeds) and 0.5% Roundup (half of the minimal agricultural
dilution).
Summary of results:
• Control males survived an average of 624 days, control females averaged 701 days. In the control
group, 3 males (30%) and 2 females (20%) died.
• In groups fed GM maize, 50% of males and 70% females died prematurely, before the average
life expectancy. Mortality rates were not dose-dependent on the concentration of genetically

14. modified maize in the diet.
• As early as 24 months, that is to say at the end of their lives, from 50% to 80% of females fed
GMOs had developed tumours (fibroadenomas and keratoacanthomas) as against only 30% fed
the GMO-free diet.
• In females, mammary tumours (93% of tumours) and pituitary tumours developed earlier than in
the control rats.
• In males, the majority died of liver or kidney problems. “We found progressive chronic kidney
disease in greater numbers in rats fed GM corn, especially in the males,” says Dr Spiroux, coauthor
of the study.
• Males who received GM maize did not have more tumours than controls. However, the authors
state that in the three groups of males who received the transgenic maize, tumours, or kidney
and liver pathologies appeared as early as the 4th month and exploded in the 11th and 12th
months. For the control group, the tumours occurred mainly at the end of life, in the 23rd month
and 24 months.
• The authors state that the results are similar in terms of tumour incidence and mortality in
animals fed NK603 without Roundup and those fed NK603 with Roundup.
Given the heightened risk that is now known to be associated with geneticially modified foods the level
of assessment and management should be heightened. With respect to assessment, each food should
be subjected to its own assessment rather than an assessment based on substantial equivalence and the
length of the studies should be longer so that a meaningful assessment can be obtained. The problem is
that the risks associated with geneticially modified foods, and traces of them, are too high in terms of
severity to warrant anything but a full assessment. This is consistent with the precautionary principle,
which forms part of * and which is or should be applicable here by virtue of the environmental aspects
of the issue.
Risk Assessment stuff:
Risk assessment can be generally described as “characterizing the potential adverse effects to life and
health resulting from exposure to hazards over a specified time period”,
There are four steps required of risk assessment, which are set out in the Working Principles for Risk
Analysis for Application in the Framework of the Codex Alimentarus which is to guide risk analysis as set

15. out in the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. The four steps
are hazard identification, hazard characterization, exposure assessment and risk characterizations. All
but the first step have a qualitative component to them, and exposure assessment is to look at exposure
from sources other than the food as well. The Guidelines (p.2) allow that risk assessment may take into
account qualitative information. Because of the qualitative components involved in the risk assessment
steps, and the requirement for assessment evaluation of exposures from sources other than food, it is
the case that risk assessments will vary depending on the environment in which they are conducted. A
risk assessment conducted in a foreign country would in all likelihood yield different results from one
conducted in Canada because the environments are different.
The Guidelines also point out that risk assessment is also to “take into account relevant production,
storage and handling practices used throughout the food chain including traditional practices, methods
of analysis, sampling and inspection and the prevalence of adverse health effects” (p.2). The items
without question would differ in a foreign country as compared to Canada.
It is also clear in para. 52 of the Guidelines that “[b]ecause of geographical and cultural variation in food
consumption patterns, nutritional changes to a specific food may have a greater impact in some
geographical areas or in some cultural population than in others. “ (p. 7)