Environmental and industrial biotechnology uses the chemistry of living organisms through molecular biology and cell manipulation to develop new or alternative methods to find cleaner and more effective ways of producing traditional products.
Many industrial sectors use bio-based processes to make and improve their products. Some notable industrial sectors and areas of application include:
Environmental and industrial biotechnology are also used to find new ways to reduce economic and environmental impacts from the overuse of natural resources. Some common processes and applications are listed below.
To improve and protect the health and safety of Canadians and their environment, Health Canada works with Environment Canada through the Canadian Environmental Protection Act, 1999 (CEPA 1999) to regulate new biotechnology-derived products and to manage substances that pose a risk to human health or the environment. Joint responsibilities include:
Health Canada also regulates and conducts research on biotechnology-derived pest control products to protect human health and the environment.
In addition, Health Canada conducts biotechnology-related, environmental health research which is designed to improve the regulatory system by:
Health Canada also works with other federal departments, agencies and international organizations to develop science-based tools and policies to regulate biotechnology.
In this section, you will also find information on:
To meet its mandate of protecting the health and safety of Canadians and our environment, Health Canada has in place a rigorous system to regulate and assess products of biotechnology.
Health Canada and Environment Canada have shared responsibility for the risk assessment of new animate products of biotechnology. The principal regulatory authority is CEPA 1999.
Evaluators in the Biotechnology Section of the New Substances Assessment and Control Bureau assess the information submitted by notifiers as prescribed by the NSNR to determine whether a substance is toxic or capable of becoming toxic as defined in CEPA 1999.
A substance is considered toxic if it enters or may enter the environment in amounts that pose a risk to:
If Health Canada believes that a new substance that is a product of biotechnology may pose a health risk, it takes preventive action to manage the risk by imposing controls on the manufacture, import, use, release and/or disposal of the product.
Some examples of substances in biotechnology products regulated by the NSNR include those used in:
For more information on the notification and assessment of biotechnology products under CEPA 1999, please consult the New Substances Program jointly administered by Health Canada and Environment Canada.
Health Canada is developing the Environmental Assessment Regulations (EAR) to ensure that new substances, including those that are biotechnology-derived, in products regulated under the F&DA meet the requirements of CEPA 1999. These products include:
Until the regulations are in place, Health Canada will conduct the environmental and indirect human he alth risk assessment of these new substances in F&DA products under the NSNR of CEPA 1999. For more information on the Environmental Assessment Project, please refer to the Environmental Impact Initiative.
The Safe Environments Programme (SEP) of Health Canada's Healthy Environments and Consumer Safety (HECS) Branch develops, evaluates and validates new biotechnology and bionanotechnology tools used in the regulatory assessments of risks from products of biotechnology and potentially nanotechnology and their by-products. SEP also provides technical support and advice on the risk assessment of the biotechnology and nanotechnology products and chemicals themselves, as well as methods of assessing risk. These functions contribute to Health Canada's Stewardship role in Canada's product innovation and development.
Health Canada has developed and possesses considerable capacity and expertise in biotechnology, genomics and proteomics. Laboratory platforms have been assembled for the manufacture and high throughput analysis of DNA microarrays and proteomics such as immuno-based arrays. Health Canada scientists and support staff collaborate with other national and international bodies to improve research and development of innovative biotechnology and nano-based tools and assays. This leads to better regulatory assessment of human risks from exposure to chemicals, tobacco, living organisms, and bio- and nano-based materials.
Some of the tools Health Canada uses include special biohazard containment units and facilities with semi-robotic equipment to produce assay probes (DNA- and protein-based microarrays) to analyze toxicologic and immunologic effects. Other tools, such as DNA sequencing, are used to determine genetic information, including characterization of proteins and their functions. Computer-assisted imaging, such as confocal and fluorescence microscopy and scanning electron microscopy, are used to identify microorganisms and changing functions of animal cells when they interact with microorganisms and also toxins.
The use of DNA microarray technology in toxicology (toxicogenomics) is particularly innovative, and requires critical evaluation and validation against predicted phenotypic changes. To this end, a new DNA microarray for toxicology (ToxArray) has been developed by HECS SEP to facilitate a cost-effective, generic approach to using toxicogenomics for environmental health research.
To reduce animal use in toxicology, Health Canada is developing assays using cell and transgenic technology to establish more comprehensive approaches for assessing gene mutations, tumor promotion and immunotoxic impacts. In vitro and in vivo genomics-proteomics methodologies are being used to assess methods for pathogenicity (the ability to produce pathologic changes or disease), immune system responses and environmental health impacts from microbial biotechnology products as well as various chemicals released into the environment. This research includes genomics/proteomics-based genotyping in the characterization of pathogenic and toxic effects in human/rodent cell models. Related research involves molecular monitoring of pest control microorganisms in Canadian ecosystems for their genetic elements, their ability to inhibit the growth of or kill other microorganisms and their interactions with other pathogens.
To protect the health and safety of Canadians, Health Canada has the capacity to monitor and track specific environmental biotechnology products and byproducts (both pre- and post-market) by collecting, integrating, analyzing and interpreting data and disseminating the information to those who need to know. Monitoring and tracking of environmental health impacts is done to maintain and improve understanding of health and safety issues, standards and security, and to use the information for research and advise others in policy and regulatory domains.
Health Canada systematically conducts monitoring as a countermeasure and foresight activity in accordance with the North Atlantic Treaty Organization (NATO) principles of intelligence gathering through surveillance and active field work.
Surveillance is the routine and systematic scanning and recording of data emissions by electronic and manual methods. Scanning is done by searching for relevant information from bioinformatic databases, publication libraries, non-conventional journals and trade magazines, conferences and reports, and speciality networks within the federal government, academia and industry. Surveillance involves recording the national and global production of biotechnology research and development activities in various sub-sectors, such as health, environment and agriculture, and from technology platforms, such as genomics, proteomics, and bio/nanotechnology.
Environmental Health Science within SEP conducts field work in cooperation with other agencies and institutions within and outside Canada. Field work involves detecting the presence of products from environmental biotechnology applications (e.g., specific types of bioremediation and biopesticides), and measuring their persistence and fate. This is done by collecting exposure data often with biotech-based probes and specialized instruments such as quantitative bioassays.
Bio-based processes are used in new products and services in nearly all sectors of the economy. The following list shows some of the more common applications and how they are used.