Oceans and Human Health and Marine Biotechnology

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					Chapter 7:
Canada — Biotechnology

Federal and Provincial Governments
   Federal Government's Canadian Biotechnology Strategy (CBS), 1998 — provides
    a common vision to all of the Government’s biotechnology activities.
   Federal departments and agencies work cooperatively and strategically with
    provincial governments, academia, NGOs, and private sectors partners to
    integrate social, environmental, economic, and ethical considerations.
   See also Canadian Government Biotechnology Gateway for overview of
    biotechnology industry, federal and provincial government programs and
    strategies, and business information
    (http://strategis.ic.gc.ca/SSG/bo01376e.html).
   Provincial governments have active strategies — see for example the Biotech
    Ontario website (http://www.biotechontario.com/).

Canadian Federal Research Programs exist in the following areas.

    Agriculture
       Agriculture and Agri-Food Canada
       Agricultural Safety Net Programs
       Eastern Cereal and Oilfood Research Centre
       Investing in Life’s Basic Building Blocks
       Pacific Agri-Food Research Centre
       Potato Research Network
       Health Canada’s Food Program
       Plant Biotechnology Institute

    Environment
       Biotechnology Research Institute (BRI)
       Environment Canada’s Commercial Chemicals Web
       Eco-Technology Innovation
       Health Canada

    Aquaculture
       Aquaculture Coordination Branch
       Canadian Food Inspection Agency (CFIA), Fish, Seafood, and Production
        programs and services
       Department of Fisheries and Oceans (DFO), Bedford Institute and Maritimes
        Region
       Environment Canada (EC), National Programme of Action
       Environment Canada (EC), Shellfish H2O Quality Protection Program
       National Research Council of Canada (NRCC), Institute for Marine
        Biosciences
       Oceans Canada

IDRC, Biotechnology, and Emerging Technologies: A Basic Primer                    149
  Health
     Biotechnology Research Institute (BRI)
     Health Canada, National Health Research Programs


Literature Review

Regulation of Biotechnology in Canada
The Canadian Food Inspection Agency (CFIA) is responsible for the regulation of products
derived through biotechnology including plants, animal feeds and animal feed ingredients,
fertilizers and veterinary biologics. For genetically modified crop plants, the CFIA assesses
the potential risk of adverse environmental effects; authorizes and oversees import permits,
confined trials, unconfined release and variety registration.

Health Canada is responsible for assessing the human health safety of products derived
through biotechnology including foods, drugs, cosmetics, medical devices and pest control
products. In the case of novel foods, each safety assessment considers the process used
to develop the novel food, its characteristics compared to those of its traditional
counterpart, its nutritional quality, the potential presence of any toxicants or anti-nutrients,
and the potential allergenicity of any proteins introduced into the food.

Consumers: Environment; Food Safety; General Information; Labelling; Legislation
Regulatory Approval Process for Products of Biotechnology
Regulatory Information; Biofertilizers; Labelling; Livestock Feeds; Plants With Novel Traits;
Seed; Veterinary Biologics
Consultation: 2002; 2001; 2000; 1999; 1998

Reports:
 Action Plan of the Government of Canada in response to the Royal Society of Canada
   Expert Panel Report
 Expert Panel on the Future of Food Biotechnology (Royal Society of Canada)
 Regulatory Framework for Animals Derived from Biotechnology
 Study on Voluntary Labelling of Foods from Biotechnology
 Response to the petition filed May 9, 2000 by the Sierra Legal Defence Fund
 Response to the petition filed July 23, 2001 by Greenpeace Canada (StarLink™ Corn)
 Response to the petition filed January 18, 2002 by Greenpeace Canada (Roundup™
   Ready Soybean)
 Response to the petition filed January 18, 2002 by Greenpeace Canada (Supplemental
   Petition on StarLink™ Corn)

Building Regulatory Capacity:
 Asia Pacific Economic Co-operation (APEC)

Related Sites: (Information may not be available in both official languages)
 Canadian Biotechnology Advisory Committee
 Canada Biotechnology Strategy (CBS)
 Environment Canada - New Substances and Biotechnology Products
 Food Biotechnology Communications Network
 Health Canada - Novel Foods
 Industry Canada - Biotechnology Regulatory Assistance Virtual Office




150                       IDRC, Biotechnology, and Emerging Technologies: A Basic Primer
    USDA, Biotechnology and Scientific Services
    Regulatory Roadmap for New Substances in Canada (including products of
     biotechnology)
    World Health Organization - 20 Questions on Genetically Modified Foods

 (Source: Canadian Food Inspection Agency website: http://www.Inspection .gc.ca/english
 /sci/biotech/bioteche.shtml)


 The Council for Biotechnology Information
 communicates science-based information about the benefits and safety of agricultural and
 food biotechnology. Its members are the leading biotechnology companies and trade
 associations… Yes, there are issues to resolve with biotechnology, some of them difficult.
 The council is committed to addressing concerns by deploying the best scientific research
 and other information in credible and understandable ways. Our research tells us that the
 more people learn about biotechnology, the more they will welcome it into the
 marketplace…

 Research and development deserve and need to continue, governed by science-based,
 regulatory systems that ensure products reaching the market are safe for people, animals
 and the environment.

 (Source: Council for Biotechnology Information website:
 http://www.whybiotech.com/index. asp?id=1648)


 The Foods and Biomaterials Network
 Government of Canada will establish two New Networks of Centres of Excellence
 Ottawa, July 4, 2003 – Allan Rock, Minister of Industry and Minister responsible for the
 Networks of Centres of Excellence (NCEs), announced today that the Government of
 Canada would establish two new Networks of Centres of Excellence. The selected
 networks are ArcticNet and The Foods and Bio-Materials Network.

 (Source: Networks of Centres of Excellence website:
 http://www.nce.gc.ca/media/newsrel/ 2003/040703_e.htm)



Canadian Corporate, Academic, Research, NGO, and Other
Organizations

Information about some of Canada’s major biotechnology research organizations,
which include: Monsanto, Aventis, Gowlings, Pioneer, and VWR International. For
additional details see:

    Biotech Canada (and May 2003 Biotech Conference), website:
     http://www.biotech.ca/EN/
    Canadian Government Biotechnology Gateway for overview of
     biotechnology industry, companies, associations, and pathways, website:
     http://strategis.ic.gc.ca/SSG/bo01376e.html
    Can Biotech Directory, website
     http://www.canbiotech.com/directory_214.asp?eId=1&countryCode=CA


IDRC, Biotechnology, and Emerging Technologies: A Basic Primer                              151
  Literature Review

About BIOTECanada
BIOTECanada is the national organization dedicated to promoting a better understanding
of biotechnology and the many ways it contributes to improving the quality of life of all
Canadians. Biotechnology is broadly defined as the use of living organisms (plants,
animals and microorganisms) to develop and improve products. BIOTECanada represents
Canadian health care, agricultural, food, research and other organizations that are involved
in biotechnology. BIOTECanada also offers a range of services to its members.
Ethics: Biotechnology Industry Statement of Ethical Principles: Preamble:
BIOTECanada represents biotechnology companies, academic institutions, regional
biotechnology centers and related organizations throughout Canada. The members of
BIOTECanada apply biological knowledge and techniques to develop products and
services for use in health care, agriculture, environmental remediation and other fields. The
benefits of these products and services include saving lives threatened by disease,
protecting the blood supply from infectious agents, improving the abundance and quality of
food, and cleaning up hazardous wastes.
While biotechnology can greatly improve the quality of life, we recognize that this new
technology should be approached with an appropriate mixture of enthusiasm, sensitivity to
social issues, and acknowledgement of the potential and power of biotechnology. While
biotechnology can provide useful tools for combating disease, hunger and environmental
contamination it can also raise important ethical issues. These issues can evolve quickly
as more development and uses of biotechnology occur. While some of these principles are
codified in government statutes and regulations, this statement is intended to provide
guidance to our industry that goes beyond legal requirements. Furthermore, our industry
will monitor laws, both domestic and international, and conform promptly as they take
effect.
With these considerations in mind, we have adopted the following statement of principles.
This is a living document. Because biotechnology is changing and growing rapidly this
Statement of Principles will evolve from consensus by Canadians on ethically appropriate
uses of biotechnology. We respect the power of biotechnology and apply it for the benefit
of humankind. We will pursue applications of biotechnology that promise to save lives or
improve the quality of life. We will avoid applications of our technology that do not respect
human rights or carry risks that outweigh the potential benefits. We will assure our
industry’s activities conform to social norms. We listen carefully to those who are
concerned about the implications of biotechnology and respond to their concerns.
The resolution of bioethical issues requires broad public discourse. We acknowledge our
responsibility to consider the interest and ideas of all segments of society. We will seek
dialogue with patients, ethicists, religious leaders, health care providers, environmentalists,
consumers, legislators, and other groups who share an interest in bioethical issues. We
will help in addressing ethical dilemmas in which appropriate courses of action may not be
clear. We help educate the public about biotechnology, its benefits and implications. For
informed debate to occur, the public and our elected representatives need greater
knowledge and a better understanding about biotechnology and its applications.
BIOTECanada and its members pledge to advance public awareness and understanding.
We place our highest priority on health, safety and environmental protection in the use of
our products.
In Canada, biotech products are extensively regulated by federal agencies such as Health
Canada, the Canadian Food Inspection Agency and Environment Canada to safeguard
health, ensure safety and protect the environment. We respect the directives of ethics



152                       IDRC, Biotechnology, and Emerging Technologies: A Basic Primer
 boards We will abide by their guidance and meet or exceed national standards for ethics in
 biotechnology research. This includes humane treatment of animals used in research.
 Biotechnology based products will be developed to improve human and animal nutrition
 and health, the quality of foods, and the quantity of food. We are sensitive to and
 considerate of the ethical and social issues regarding genetic research.
 We will not, for example, treat genetic disorders by altering the genes of human sperm or
 eggs until the medical, ethical and social issues that will arise from this kind of therapy
 have been more broadly discussed and clarified. Also, we support prohibitions on
 biotechnology for any application that is contrary to human dignity including cloning of
 entire human beings, with the understanding that research should continue on the cloning
 of genes and cells to benefit humankind. We develop our agricultural products to enhance
 the world’s food supply, and to promote sustainable agriculture with attendant
 environmental benefits.
 There are significant advantages to increasing the yield of crops. Farmers must produce
 increasing amounts of food per acre to feed a growing global population. We will develop
 our products with an eye toward good stewardship of our agricultural and environmental
 resources and the sustainability of such development. With regard to the development of
 new agriculture crops, we pledge to abide by established standards of environmental
 safety at home and abroad. We develop environmental biotechnology to clean up
 hazardous waste more efficiently with less disruption to the environment and to prevent
 pollution by treating waste before it is released.
 Many environmental engineering firms, industry, and governments are using biotechnology
 to harness the power of naturally occurring organisms to degrade contaminants at
 hazardous waste sites. We will strive to optimize the cost efficiencies and environmental
 advantages associated with using biotechnology while protecting human health and the
 environmentally-safe and cost-effective means of treating hazardous waste streams in
 industrial processes. We oppose the use of biotechnology to develop weapons. We
 support Canadian government policy that clearly and unequivocally states Canada does
 not at any time intend to develop, produce, acquire, stockpile or use chemical or biological
 agents of weapons. We continue to support the conservation of biological diversity.
 The genetic variation of animals, plants and other organisms is a valuable natural
 resource. The environment is constantly changing, and without an adequate store of
 genetic diversity, organisms will not be able to adapt. Genetic diversity decreases,
 however, every time a species, breed or crop variety becomes extinct. Working with
 governments and other organizations, will help to catalog and conserve these precious
 resources.

 (Source: BIOTECanada website: www.biotech.ca/EN/ethics.html)


 The National Research Council
 is the premiere biotechnology research agency of the Canadian federal government. The
 NRC Biotechnology Program was established in 1983 under the guiding principles of the
 National Biotechnology Strategy. Five institutes deliver the NRC Biotechnology Program
 with support from IRAP and CISTI for technology transfer and knowledge dissemination.
 The Steacie Institute for Molecular Sciences (SIMS) supports the program with specific
 basic research. The Biotechnology Program is a founding member of Genome Canada
 and contributes to Canadian innovation in genomics through the NRC Genome and Health
 Initiative. Core Competencies:
 NRC Biotechnology Research Institute (Montreal)
  Health Sector;



IDRC, Biotechnology, and Emerging Technologies: A Basic Primer                           153
     Bioprocess Platform;
     Environment Sector;
     Centre of Excellence for Brownfields Rehabilitation;
     NRC's Biotechnology Research Institute, COREM, and the City of Montréal jointly
      founded the Centre of Excellence for Brownfields Rehabilitation. Its mission is to
      promote, support and implement research and development and experimental
      programs in the areas of soil decontamination and site rehabilitation.
NRC Institute for Biodiagnostics (Winnipeg, Calgary, Halifax)
 Biosystems
 Informatics
 Magnetic Resonance Technology
 Spectroscopy
 IBD Prototyping Facility
 Intraoperative Laser-Based Diagnostic
 Medical researchers at the NRC's Institute for Biodiagnostics have developed an
  innovative laser-based diagnostic technique that will enable cardiac surgeons to gauge
  the effectiveness of bypass surgery while the patient is still on the operating table. The
  specially-designed imaging device tracks the movement of the dye as it moves through
  the arteries in the heart. The response by the medical community to the intra-operative
  coronary angio-graphy has been so overwhelming that our spin-off company, Novadaq,
  will be marketing it in North America and abroad.
NRC Institute for Biological Sciences (Ottawa)
 Neurobiology
 Immunochemistry
 Effective Vaccine against
 Meningitis-C
 NRC's Dr. Harold Jennings has developed a new, highly effective vaccine (NeisVac-C)
  that protects people of all ages, including children as young as two months of age,
  against Meningitis-C (meningococcal group C).
 A recent NeisVac-C vaccination program involving 12 million people in the UK has
  reported positive results have already been reported. NeisVac-C was approved for use
  in Canada in January of 2002.
NRC Institute for Marine Biosciences (Halifax)
 Aquaculture research
 Seafood safety
 Microscopy Facility
 Certified Reference Materials Program
 Genomics and proteomics
 DNA Sequencing Facility
 Canadian Bioinformatics Resource
 DNA Sequencing Facility
 NRC's Institute for Marine Biosciences boasts Canada's largest and most advanced
  DNA sequencing facility.

Equipped with world-class sample preparation and sequencing technologies, robotics and
advanced bioinformatics tools, the facility now provides DNA sequencing for other NRC
institutes and for national and international clients. The facility greatly enhance the
Institute's research capacity and support the development of biotechnology applications
leading to improvements in human health, food crops, and the environment.




154                        IDRC, Biotechnology, and Emerging Technologies: A Basic Primer
 NRC Plant Biotechnology Institute (Saskatoon)
  Cell Technology;
  Legume Performance;
  Promoter/Gene Discovery;
  Gene Expression;
  Molecular Pathology;
  Carbohydrate Modification;
  Seed Oil Biotechnology;
  Growth Regulation;
  DNA Technology Unit;
  Spectroscopy Services;
  Transgenic Plant Centre;
  Plant Transformation System
 NRC's Plant Biotechnology Institute is working to kick-start a Canadian breeding program
 for nutraceutical plants. The research will enhance the uniformity of plants grown for their
 therapeutic attributes and will eventually lead to the production of improved lines of these
 high-value plants.

 Canadian Bioinformatic Resource (Halifax):
  Bioinformatics is fundamental to making sense of the immense data generated from
    the surge in genomics research. NRC's Canadian Bioinformatics Resource (CBR) in
    Halifax, gives lightening-fast access to sequence information. It also provides
    databases and tools for universities and research organizations across Canada.
  The resource provides two distinct services: CBR-I supplies high-speed access to
    sequence information to NRC and associate members only. CBR-II makes
    bioinformatics available to universities and research organizations across Canada.
 NRC's Genomics and Health Initiative
    Genome Science Infrastructure (DNA sequencing, bioinformatics, proteomics)
    Agriculture
    Pathogenesis
    Age-related human disease
    Health Diagnostics
 With the Genome and Health Initiative (GHI), NRC in collaboration with other federal
 agencies, industries and universities, is making key contributions to national efforts to
 exploit advances in the areas of genomics and health.
 BioMiner Software
  NRC's Institute for Information Technology and NRC's Institute for Biological Sciences
    are working in collaboration to address the need for data mining capability for genomics
    research. Funded under the NRC's Genome and Health Initiative, the project has led to
    the development of a prototype data analysis software package, called BioMiner.

 (Source: National Research Council, Canada, biotechnology website:
  http://www. nrc-cnrc.gc.ca/randd/areas/biotechnology_e.html)




IDRC, Biotechnology, and Emerging Technologies: A Basic Primer                               155
    ProMetic in life-saving alliance with Tunisia: Firm’s technology to be used in
    new plant
    October 2003—A landmark alliance to bring life-saving cancer and hepatitis drugs to
    developing countries is set to be unveiled today between a Montreal biotech company and
    the North African country of Tunisia. Under the accord, ProMetic Life Sciences Inc. will
    license its drug manufacturing and purification technology to a new company, which will
    build a $30-million plant at Sidi thabet Technocity, Tunisia…. ProMetic is offering
    technology it recently licensed from the National Research Council in Montreal that
    dramatically boosts the quantity and speed, and lowers the cost of making pharmaceutical
    proteins from yeast or mammalian cells.

    (Source:                                                           www.infomedia.gc.ca/nrc-
    cnrc/articles/unrestricted/2003/10/nrc065127541259_30.htm ).


    Institute on Governance: Biotechnology and Governance1
    New biotechnologies affect every aspect of society - from the way food is produced and
    processed, to the treatment of human illness, and the production of fuel. Modern
    biotechnology should probably be understood as a "transformative technology"
    comparable to the invention of writing, the steam engine and electricity. Transformative
    technologies pose unique governance challenges, and demand a unique way to frame
    questions and go about finding practical solutions. For these reasons, the Institute is
    pursuing a program of learning and research to unravel some of the complicated
    governance questions that are posed by these new technologies.
    In the first phase of its work, the Institute sponsored two forum sessions involving a cross-
    section of people from government, academia, and industry. The first session (January
    2001) looked at key public policy questions and at the governance challenges on the
    horizon. From there, a research agenda was planned that resulted in two exploratory
    papers: The Impact of Transformative Technologies on Governance: Some Lessons from
    History and Linking In, Linking Out, Linking Up: Exploring the Governance Challenges of
    Biotechnology. The second session (March 2002) built on the findings of these two papers.
    It assembled a diverse group of senior government officials who were asked to deliberate
    on issues such as, the stewardship/innovation divide, ethics in regulatory decision-making,
    and risk management. From this well-attended evening came the affirmation of the need to
    reproduce this kind of forum. Further sessions would enable government to continue to
    explore the critical questions that biotechnology presents in the context of public policy.
    The Biotechnology and Governance Program was launched during the summer of 2002
    and is a continuation of that dialogue and research. The objectives of the Biotechnology
    and Governance Program are:
    Educate and raise awareness of current policy issues: Promote a wider awareness and
    shared understanding of some of the most significant biotech-related policy issues that are
    currently on society's 'radar screen'.
    Explore governance implications: In light of the issues raised by biotechnology and the
    principles of 'good governance', to consider how existing processes, structures,
    conventions, or modes of decision-making and consultation may need to be adapted.
    Anticipate: Look ahead. Examine how this technology may evolve over the longer term,
    and what may be done to derive the greatest net benefit for society as the technology
    develops (within the next 5 or 10 years).



1
    IDRC provided part of the support for the second forum session, referred to in this text.


156                          IDRC, Biotechnology, and Emerging Technologies: A Basic Primer
 One part of this program, the Biotechnology Forum, delves into the interesting questions
 that society faces as a result of the rapid evolution of the bio-sciences and their
 applications. The purpose of the Forum is to widen and deepen the conversation around
 biotechnology - to include, for example, issues relating to stewardship, ethics and
 accountability - by involving representatives from all sectors of society. The Forum is a
 space where government officials, researchers, members of non-governmental
 organisations and industry groups can openly discuss some of the governance and
 strategic issues that come to bear on decision-makers. The Forum is also intended to be a
 venue where a diversity of ideas and strategies can be showcased and assessed on their
 merits.
 Another pillar of the Biotechnology and Governance Program is specific research, which is
 divided into four thematic areas: (a) How to engage senior decision-makers (for example
 Members of Parliament) in the debate over biotechnology policy; (b) how to engage the
 public in novel ways; (c) how and why to use scenario methodologies in the biotechnology
 context; and (d) specific issues with relation to biotechnology ethics and stewardship.
 The IOG also participates in biotechnology events that are outside of its regular program.
 At the request of Industry Canada, it recently delivered the presentation Why Bioproducts?
 at the 7th Meeting of the OECD Task Force on Biotechnology for Sustainable International
 Development. The Biotechnology and Governance Program is a long-term project by the
 Institute On Governance. We acknowledge the contributions of these sponsors:
 Agriculture and Agri-Food Canada                      Canadian Food Inspection Agency
 Canadian Institutes of Health Research                Canadian Museum of Nature
 Environment Canada                                    Fisheries and Oceans Canada
 Food and Consumer Product Manufacturers               Foreign Affairs and International Trade
 Health Canada                                         Industry Canada
 Justice Canada                                        Law Commission of Canada
 Natural Resources Canada                              Royal Canadian Mounted Police

 (Source: IOG website: http://www.iog.ca/knowledge_areas.asp?pageID=12)


 polica.ca: A Non Partisan Resource for the Public Analysis of Canadian Policy
 Issues

    Government of Canada, Review of federal laws, regulations + policies on genetically
     modified organisms, Government of Canada: Existing regulatory system for
     biotechnology -- aspects covering health, the environment and socio-economic issues,
     as they pertain to sustainable development in this country. Overview of regulatory
     measures, "checks and balances" and planned legislation.
    The Citizen's Guide to Biotechnology, CIELAP: This Citizen's Guide explores the
     concerns about biotechnology and is intended to be thought-provoking as well as
     providing a starting point for discussion and debate. Scientists are speeding ahead with
     biotechnology, and our governments ...
    C. L. Wraight et al., Absence of Toxicity of Bacillus Thuringiensis Pollen to Black
     Swallowtails..., Proc. Natl. Acad. Sci: Researchers found no relationship between
     mortality of Black Swallowtail butterfiles and proximity to the field or pollen deposition
     on host plants. Also, pollen from plants failed to cause mortality in the lab at the highest
     pollen dose tested.
    Biosafety Protocol Backgrounder, CIELAP
    OECD, Biotechnology and Human Health (OECD web page), OECD: Collection of
     OECD work and resources on the topic of biotechnology and human health.



IDRC, Biotechnology, and Emerging Technologies: A Basic Primer                               157
     Eric S. Grace, Biotechnology Unzipped: Promises and Realities, Joseph Henry Press:
      This introductory book explores the question of "what exactly is biotechnolgy?" and
      "how should I feel about the application of biotechnolgy?" Ultimately one's attitudes
      about biotechnolgy is rooted in his/her core beliefs about nature and human nature.
     David S. Pimentel and Peter H. Raven, Bt Corn Pollen Impacts On Nontarget
      Lepidoptera: Assessment Of Effects In Nature, Proc. Natl. Acad. Sci.: Although BT corn
      pollen has the potential of adversely affecting the population levels of butterflies, we
      consider these impacts to be minimal compared with habitat loss and the widespread
      use of pesticides throughout the ecosystem.
     Canadian Environmental Protection Act, Environment Canada: Primary federal
      legislation regarding pollution prevention and the protection of the environment and
      human health in order to contribute to sustainable development.
     Anne Mitchell, Commentary: The Biosafety Endgame comes to Montreal, CIELAP: The
      past six months have seen an explosion of interest in the arrival of genetically
      engineered organisms into Canada's food supply. The public debates about the
      introduction of genetically modified foods ...
     Council of Canadians: The Council of Canadians, an independent, non-partisan
      citizens' interest group providing a critical and progressive voice on key national issues.
      This evolving site offers a fresh perspective on the current social and economic
      debates ...

policy.ca: Director, George Hoberg, UBC Political Science and UBC Forest Resource
Management; Steering Committee, Steven Brooks (University of Windsor), George Hoberg
(UBC), Denis St-Martin (University of Montreal), John Willinsky (UBC)

(Source: policy.ca website:
 http://www.policy.ca/report.php3?issue=Environment&topic =Biotechnology)




158                         IDRC, Biotechnology, and Emerging Technologies: A Basic Primer

				
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