July 17, 2013
RE: Notice of Submission for Approval of Novel Food and Livestock Feed Use and Unconfined Environmental Release in Canada of a Plant Genetically Modified for Reduced Lignin from Monsanto Canada Inc. and Forage Genetics International LLC
The National Farmers Union would like to comment on the material submitted by Monsanto and Forage Genetics International to the Canadian Food Inspection Agency (CFIA) and Health Canada in reference to their application for approval of genetically engineered reduced lignin alfalfa. However, the information has not been made available to the public. Correspondence with the CFIA has revealed that there is no requirement for public disclosure of documentation related to approval of genetically modified plant varieties, and information is made available at the discretion of the proponent.
The CFIA directed us to contact Monsanto for any information about reduced lignin alfalfa, the product that the CFIA is considering for release into the Canadian agricultural environment and food supply. Monsanto in turn provided a link to its Petition to the United States Department of Agriculture (see page 6 below). That documentation was created to meet American regulatory requirements. Canada is a separate jurisdiction, and has separate regulatory requirements. Unless the CFIA has ceded control over regulation of Plants with Novel Traits to the USDA, it should not be acceptable for Monsanto to simply copy its US application and provide it to the CFIA.
As it stands, we have no way of knowing what information the company actually submitted to the Canadian regulatory authority. Our government agency is asking that we trust Monsanto. Since there is no evidence that the CFIA is doing any independent investigation, it may well be that we are asked to trust the USDA as well.
Clearly, this process lacks accountability and transparency. The CFIA’s approval process is a “black box”. Nevertheless, we have chosen to submit public comment to put our concerns into the public record.
What is Low Lignin Alfalfa?
Monsanto claims the benefit of this genetic modification is that:
“Alfalfa KK179 has reduced levels of guaiacyl lignin (G), a major subunit component of total lignin, compared to conventional alfalfa at the same stage of growth. This reduction in G lignin leads to reduced accumulation of total lignin in alfalfa forage. Forage quality is compromised by the presence of lignin which is sensitive to timing of harvest. KK179 is designed to provide alfalfa growers with greater flexibility in harvest timing in orderto better manage forage quality and improve the ability to meet or exceed intended quality standards for alfalfa forage production. (page 4)”[emphasis added]
In plain language, Low Lignin Alfalfa (LLA) produces less of one type of lignin, a substance that makes plant cell walls stiff. This means that mature plants would be less “stalky” so alfalfa hay could be harvested at a later stage when it is older and larger, or be cut at the recommended mid bud to early flower stage, resulting in hay with the characteristics of less fibrous and more nutritious younger alfalfa. Delayed harvest would not only increase yield, but also increase the number of flowering days before the hay is harvested. With more flowers, there would be more GE pollen, which would make cross-pollination and contamination issues more severe.
The coexistence plans proposed to manage Roundup Ready alfalfa (RRA) and reduce the likelihood of genetic contamination of non-GM alfalfa in Canada aim to ensure all RRA is cut by the time it reaches the 10% bloom stage. The selling feature of LLA, however, is that it can be left to a much later stage of bloom before cutting. Monsanto now seeks to market a trait that extends the cutting period into the 20% to 50% bloom stage without loss of palatability or nutrition, contradicting its earlier commitment, claiming this will not significantly increase gene flow (p. 204). Yet, within 2 years of deregulation, USDA research has documented adventitious presence of the RRA trait of up to 2% in US conventional alfalfa seed as well as in feral alfalfa populations in states where RRA was grown between 2005 and 2007.
Review of USDA information reveals the following:
Monsanto plans to cross-breed LLA with RRA and sell it as a stacked trait. There is no mention of this intention on the CFIA’s notice page. It appears that Monsanto expects to proceed without submitting this novel plant to any regulatory authority (in the USA or Canada) to evaluate the health and environmental effects of the combined traits. The regulatory bodies have not indicated that they will consider any synergy in the effects of Low-Lignin – Roundup Ready crosses, despite a growing body of research that shows a strong association between glyphosate application and increased fungal disease pressure in subsequent crops. The lack of CFIA examination raises the question as to whether LLA-RRA crosses will be at higher risk for disease susceptibility when sprayed with glyphosate as planned. Moreover, a CFIA examination should also consider the effect of an increased risk of disease from LLA-RRA on nearby non-GM alfalfa.
LLA uses a new technology – RNA interference (RNAi) – which is is very likely to produce unexpected consequences. RNAi technology is complex, changing RNA (messenger molecules produced within cells that are responsible for protein synthesis) to silence specific genes so that less — or none — of the protein specified by that gene is produced. RNAi interferes with gene expression. In the case of LLA, RNAi suppresses CCOMT, a key enzyme in the lignin biosynthetic pathway.
This CCOMT construct may also silence other genes, causing “off-target effects” that cannot be predicted, but which may only be discovered later. Evidence is increasing that genes and traits do not have a one-to-one correspondence (that is, one gene may be responsible for several traits and several genes may be involved in the expression of a given trait), and gene sequences may be called into action or remain latent as a result of external, non-genetic factors such as environmental stress. The loss of lignin resulting from the successful performance of the RNAi could increase stress on the plant, leading to unexpected responses as latent DNA is activated.
Proposed changes to Canada’s variety registration system – moving all forages into Part III of Schedule III of the Seed Variety Regulations — would, if passed, mean that this product could be registered as a commercial variety and be permitted into the market with no independent performance assessment. Farmers who subsequently purchased and planted the LLA seed would be left to discover and bear the costs of any unexpected results of the RNAi insertion.
Monsanto is not revealing the results of its root nodulation experiment. Root nodulation results from a symbiotic relationship between a legume and nitrogen-fixing bacteria. In the USDA Petition, Monsanto briefly describes its investigation into differences in root nodulation between LLA and conventional alfalfa, but stops short of providing the results. It says “No statistical comparisons were made between KK179 and the conventional commercial reference varieties.” (p. 405). This omission is a red flag, suggesting that LLA has poor root nodulation. Poor root nodulation means that the alfalfa would have lower protein levels and would add less nitrogen than conventional alfalfa typically contributes to the soil. The CFIA should require that Monsanto submit the original data from the root nodulation experiments and should also conduct its own unbiased investigation. Furthermore, there is evidence that glyphosate compromises rhizobia which would hinder the performance of the LLA-RRA cross. Thus, the CFIA should also require Monsanto to submit original data from experiments on the effect of glyphosate on root nodulation of LLA-RRA varieties.
Performance of LLA
Nutritional issues. Monsanto claims thatLLA would allow farmers to harvest later without losing quality, or alternatively, to harvest at the regular time and gain increased quality. On the surface, this may seem advantageous. Cattle, however, have evolved on a high fibre, grass-based diet. By adding alfalfa to grass farmers are able to increase the protein content of hay. If pure alfalfa is fed to cattle, it has to be introduced slowly and carefully in order to avoid bloat, which is often fatal. LLA would increase the risk of bloat if harvested at the 10% bloom stage. If harvested at a later stage, the hay quality would in fact be reduced because despite the reduced lignin characteristic, alfalfa would still drop its lower leaves.
Lodging. Lignin provides structural strength to plants. It is a polymer – complex carbon molecule units (monomers) bound together tightly to form fibres. Guaiacyl lignin (G lignin) and Syringyl lignin (S lignin) are the predominant monomers that form lignin polymers. With less total lignin, the plant would have weaker stems. In years with excellent growing conditions the plant would be less able to stand up under its own weight and thus, more prone to lodging, making it difficult to harvest. Hay that cannot be harvested would constitute yet another loss borne by the farmer.
Diseases and Pests. Introduction of LLA is likely to lead to more disease and pest problems. Lignin is a key part of a plants’ defence system. Besides providing structure, lignins form in response to injury or disease to protect the plant. Reducing lignin makes plants more digestible for cows, but also for other organisms that would feed on them. Less lignin means the plant is more vulnerable to disease and pests. A change in the proportion between G and S lignins in alfalfa would likely cause an evolutionary pressure that would lead to a shift in the kinds of specialized microbes, including disease-causing microbes, that would be able to attack the plant. A change in the ecology of pathogenic fungi could be harmful not only to LLA but to non-GM alfalfa and other plants. If glyphosate is sprayed on a plant weakened because of reduced lignin, disease problems will be exacerbated. LLA hay would also be more susceptible to mould, increasing the risk of mycotoxins in the feed becoming harmful to livestock.
Reduced Drought and Moisture Tolerance. Lignin constitutes an essential part of the plant xylem, which moves water from the roots to leaves. Reduced lignin would make LLA more susceptible to drought and excess moisture conditions. Changing the ratio of G to S lignin may have unanticipated effects on the ability of xylem cells to conduct water. Reduced water transport capacity in LLA may in turn contribute to poor winter survival, a problem associated with reduced lignin in perennials. If these phenotypic traits are spread to cultivated and feral non GM alfalfa as a result of gene flow, yields would be compromised, increasing losses to farmers growing conventional and organic alfalfa.
Reduced Carbon Sequestration. Lignin contains a high proportion of carbon, is very slow to decompose, and thus makes up much of the carbon sequestered in soils, as well as in humus. In soil, humus interacts with water such that it mitigates both drought and flood conditions. In the face of climate change, this capacity is essential and should be encouraged, however, LLA would diminish both the carbon sequestered and humus formed when LLA stands are terminated. In short, by removing 20% of the lignin from alfalfa, LLA will be less valuable as a soil-building crop.
Lower lignin would mean less undigestible fibre in feed, which would mean that manure would contain less organic matter, fibre, and carbon , thus affecting soil quality on land where manure is spread.
The CFIA and Health Canada should deny the application by Monsanto Canada Inc. and Forage Genetics International LLC for approval of alfalfa genetically modified for reduced lignin because:
- the Canadian regulatory process lacks transparency and denies citizens access to the information required for meaningful participation;
- reduced lignin alfalfa has not been properly assessed by independent experts;
- there are many unknown potential issues with RNAi process;
- approval would lead to increased contamination of non-GMO alfalfa due to longer pre-cutting blooms ;
- the combined effects of the RRA and LLA trait have not been assessed;
- reduced lignin has implications for disease and insect pest pressures;
- reduced lignin has implications for lodging, drought tolerance and excess moisture tolerance;
- reduced lignin has implications for feed quality, with increase risk of bloat and mycotoxins; and
- reduced lignin has implications for soil fertility due to the combined effects of genetic modification and glyphosate use on nodulation and less carbon sequestration/humus formation.
Email from CFIA:
Thank you for your inquiry regarding the recently posted notice of submission for a reduced lignin plant.
As part of its effort to provide transparency to the novel products being assessed by the Canadian Food Inspection Agency (CFIA) and Health Canada, the CFIA negotiated a voluntary Notice of Submission project with Croplife Canada. This process provides a forum for the public to provide input on matters relevant to the safety assessment of the specific product.It is important to note that in Canada there is no legal requirement for developers to participate in the Notice of Submission process nor any ability for the CFIA to require developers to participate.
The materials provided in the Notice of Submission are published at the sole discretion of the developersand provide a description of the submission. The Notice of Submission project was not designed to provide a mandatory public consultation process for individual novel product submissions. All comments received in response to the Notice of Submission are reviewed by the Government of Canada (GoC) although only those comments providing science‑based evidence are considered by the GoC as part of the assessment of the novel product. Where the author of the comments consents, comments are forwarded to the product developer.
It is important to note that the submission for authorization of novel plant products received by the regulators must contain all the required data to address the regulatory requirements before a decision regarding authorization can be made. For further details regarding the Notice of Submission project are available on the CFIA website at: http://www.inspection.gc.ca/plants/plants-with-novel-traits/notices-of-submission/eng/1300143491851/1300143550790.
Email from Monsanto:
Thank you for your recent letter directed to our Ottawa regulatory office with respect to the Notice of Submission for the Approval of Novel Food and Livestock Feed use and Unconfined Environmental Release in Canada of a Plant Genetically-modified for Reduced Lignin.
The detail you are seeking is already publicly available through the USDA petition processfor reduced lignin alfalfa. I would direct you to the following link where you will be able to access everything you are looking for:
Thank you for your interest in reduced lignin alfalfa.
Public and Industry Affairs Director
Monsanto Canada Inc.
900-One Research Rd.
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