Download Approval and Regulation of New Genetically Engineered Plant

Approval and Regulation of
New Genetically Modified/Genetically Engineered
Plant Varieties in Canada
To deal with the products of genetic engineering, or genetically modified organisms (GMOs), the Canadian
government created a new term and category called novel foods or plants with novel traits which includes genetic
engineering among other technologies. The CFIA states, "This term covers products that have not been
previously available for sale in Canada, have been substantially modified, or are produced by a new process."
GMOs are considered “novel foods” and “plants with novel traits” or PNTs.
1. Before a new GMO can be grown and sold as a crop in Canada it first must be
a) approved for food safety by Health Canada, and
a) approved for feed safety and unconfined environmental release by the Canadian Food
Inspection Agency (CFIA).
2. Commercial seed varieties (whether GMO or not) must be registered.
a) For most crop kinds, the variety undergoes independent field trials to demonstrate that it meets
merit criteria. A Recommending Committee of experts on that crop reviews the results and may
recommend registration if the variety meets or exceeds the performance standard for the crop.
The CFIA then registers the variety based on this recommendation.
b) Vegetable seed and commercial corn seed do not require variety registration.
3) The federal government is planning to change the seed regulations to eliminate the field trial and
recommending committee process for soybeans and all forages.
4) Companies that sell GMOs normally patent the relevant genes, or obtain licenses to use patented genes
from the patent owner. Companies that sell new non-GMO crop varieties usually seek and obtain plant
breeders rights (PBR). Obtaining gene patents and PBRs are separate processes outside of the GMO
regulatory process, but once these rights are given they affect the dynamics of the seed system.
Canada’s Regulatory Approach
1) Reviews the product, not the process: Plants in Canada are regulated on the basis of the traits expressed
and not on the basis of the method used to introduce the traits.
2) Safety reviews are based on concepts called "familiarity" and "substantial equivalence."
· Familiarity is defined as “our knowledge of the characteristics of a plant species and experience with
the use of that species in Canada.”
·
Substantial equivalence is defined as “the equivalence of a novel trait within a particular plant
species, in terms of its specific use and safety to the environment and human health, to those in
that same species, that are in use and generally considered as safe in Canada, based on valid
scientific rationale.”
3) Testing: no long term testing or monitoring is required, and there is no independent testing; instead the
government relies on data provided by corporations.
Variety Registration Vegetable seeds used by home gardeners and market gardens are not covered by the variety registration
system.
Before 2009, all new varieties of commercial crops except for corn were registered using the Part I process
(described below). Corn has been exempt from variety registration because most growers have adopted
hybrid seed. In 2009, the variety registration system for commercial crops changed, and the three tiers (Part
I, Part II and Part III) were introduced. Crop kinds can now be moved from Part I to Part II or Part III by
amending the Seeds Act regulations. In 2009, potatoes were moved to Part III.
Part II
Part I
The new variety must undergo
two or three years of field trials,
depending on the crop kind,
conducted by an independent
third party (usually Ag Canada or a university).
Data from the field trials is submitted to the
Recommending Committee, a group of experts
on that crop. The Recommending Committee
reviews the data and evaluates the variety on
specific criteria such as agronomic performance,
disease resistance and quality. Since 2009, merit
can be determined on the basis of performance on
as little as one criterion. If the variety meets or
exceeds the performance of a reference variety, it
is considered to have merit, is eligible for
registration and the Recommending Committee
may recommend that it be registered. If the
variety is recommended, the seed developer may
submit its registration information, and the CFIA
can register the variety.
Requires field-testing and submission of data to
the Recommending Committee. There is no
merit requirement and the data may not be
published, as it is considered confidential
business information. Varieties with inferior
performance can be registered under Part II.
Safflower is the only crop kind in Part II.
Part III
There is no requirement for merit or field
testing. A seed breeder or seed breeding
company can apply to have a new variety
registered simply by submitting basic
information about the variety to the CFIA. The
CFIA has the authority to deny registration
only if it considers the new variety a threat
health or safety. Potatoes and sunflowers (nonornamental) are in Part III. The proposed
amendment to the regulation would place all
forages and soybeans into Part III as well.
Patenting Genes Canada does not permit patenting of higher
organisms; however, it does permit genes to be
patented. The 2004 Supreme Court of Canada
decision in Schmeiser v. Monsanto determined that if
a gene-patented plant occurs in a farmer’s field
without the patent-holder’s permission, regardless of
how it got there and regardless of whether the
farmer made use of the trait conferred by the gene,
the farmer is guilty of patent infringement. To
avoid legal action by patent holders, therefore,
many farmers purchase gene-patented seed, pay
royalties and agree to the company’s terms and
conditions outlined in Technology Use Agreements
or other contracts that prohibit saving seed for
planting. As a result, farmers must purchase new
seed every year.
Approval and Regulation of New GMO Plant Varieties in Canada National Farmers Union, June 2013 — www.nfu.ca Plant Breeders’ Rights The Canadian Plant Breeders’ Rights (PBR) Act conforms with
the International Union for the Protection of New Varieties of
Plants (UPOV) 1978 standard. It grants property rights to the
owners of new plant varieties, giving them18 years of exclusive
rights to collect royalties on seed when it is sold. Under UPOV
’78, a seed owner cannot hold both patent rights and plant
breeders’ rights on the same variety.
The federal government is expected to attempt to amend the PBR Act and related laws and regulations to
conform with the UPOV 1991 standard. This newer regime confers greater rights on the PBR owner for a
longer term, and makes it more expensive and difficult – in practice, impossible – for farmers to save and
replant seed. It also permits simultaneous patent and PBR rights on the same variety. UPOV ’91 allows PBR
owners to collect royalties at any point, including on the sale of the harvested crops grown from their seed
varieties. Royalty collection rights are granted for at least 20 years under UPOV ’91.
Canadian
Food Inspection Agency (CFIA)’s Role •
•
Assesses environmental impact and livestock feed safety
Responsible for Seeds Act, Plant Protection Act, Feeds Act, Fertilizers Act, Health of Animals Act and
Regulations, Food & Drugs Act and Novel Foods Regulations
safety standards through inspection and
monitoring activities and also provides consumer
information which generally supports the current
policy bias toward allowing corporations to selfregulate their operations. There seems little
recognition of the inherent conflict of interest that
is evident in allowing a self-interested corporation
to self-regulate.
The CFIA is the lead agency responsible for
regulating genetically engineered plants or "plants
with novel traits" for environmental safety under the
Seeds Act. It grants approval for field trials of GMO
crops during their development and for commercial
growing (unconfined release). The CFIA also
approves crops for use as animal feed under the
Feeds Act and Regulations. The CFIA enforces food
Health Canada’s Role • Assesses food safety for human consumption
• Responsible for Food and Drug Act and Novel Foods Regulations
Health Canada is responsible for assessing the
human health safety of genetically engineered foods
as well as the safety of veterinary drugs,
pharmaceuticals, pesticides and cosmetics.
The specific criteria for the safety assessment of such
foods are outlined in the Health Canada publication
Guidelines for the Safety Assessment of Novel Foods.
National Farmers Union, June 2013 — www.nfu.ca For Novel Foods from GMOs it examines the
following: characterization of derived line; genetic
modification considerations; history of organism;
dietary exposure; nutritional considerations;
toxicology considerations; allergenicity
considerations; and chemical considerations.
Approval and Regulation of New GMO Plant Varieties in Canada Environment Canada’s Role • Responsible for the Canadian Environmental Protection Act
Environment Canada plays a small role, and only regulates products that fall outside the responsibilities of
other departments (genetically modified animals, for example).
What are GMOs?
Genetically modified organisms contain genes altered by using molecular processes to manipulate genes and
genomes, a process called genetic engineering (GE). One of the most common GE technologies used to make
GM crops is recombinant DNA, which takes DNA from several sources, often different species, to create novel
DNA sequences with desired characteristics that do not occur naturally in the host organism. The
‘recombined DNA’ with its desired trait activated is then inserted into the host, and the genetically modified
organism is created.
The result is that completely new (exotic) genes can be created, and that new genetic material can be
transferred between entirely unrelated species. For example, genes from a soil bacterium (Bt) known to have
insecticidal properties have been put into the DNA of corn, which turns every cell in the plant into a factory
for making its own insecticide. The technology enables science to cross the species barrier - a natural barrier to
genetic exchange between unrelated species. This has never happened before – has never been done before –
and cannot be achieved through traditional plant breeding techniques, including hybridization. Essentially,
therefore, genetic engineering can introduce into food crops genes that have never before been part either of
the human diet or of the ecological system where the crop is grown.
References:
NFU Backgrounder on changes to the Variety Registration System. http://www.nfu.ca/story/government-ignores-concerns-varietyregistration-change-and-plows-ahead-anyway
Regulating Genetic Engineering... for Profit. Lucy Sharrat. Polaris Institute, 2002. http://cban.ca/content/download/173/1078/file/
Guide%20to%Regulation%20of%20GE.pdf
Guidelines for the Safety Assessment of Novel Foods. Health Canada. Accessed May 10, 2013. http://www.hc-sc.gc.ca/fn-an/
legislation/guide-ld/nfu-an/guidelines-lignesdirectices-eng.php
Frequently Asked Questions - Biotechnology and Genetically Modified Foods. Health Canada. Accessed May 10, 2013. http://www.hc-scgc.ca/fn-an/gmf-agm/fs-if/faq_1-eng.php#p2
Genetically Modified Organisms. Environment Canada. Accessed May 10, 2013. http://www.ec.gc.ca/inre-nwri/default.asp?
lang=En&xml+E8A9C49D-9F73-4EC2-90BB-F4C3FDF49A3F
Acts and Regulations under CFIA administration. http://www.inspection.gc.ca/about-the-cfia/acts-and-regulations/
eng/1299846777345/1299847442232
Acts and Regulations under Health Canada administration. http://www.hc-sc.gc.ca/ahc-asc/legislation/acts-reg-lois/acts-reg-loiseng.php
Acts and Regulations under Environment Canada administration. http://www.ec.gc.ca/default.asp?lang=En&n=48d356c1-1
Approval and Regulation of New GMO Plant Varieties in Canada National Farmers Union, June 2013 — www.nfu.ca