Health and the Environment

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:

• Agriculture - animal feed, human food, and pest control products;
• The energy and fuel industry - bioenergy;
• Environmental management - biomining/leaching of metals and minerals,municipal and industria l waste and wastewater treatment, and of chemical contaminants in soil and water
• Pulp and paper industry - tree biotechnology, biopulping and biobleaching for paper and wood products, and reduction in forest industry waste; and
• Day-to-day consumer goods - cosmetics, pharmaceuticals, chemicals and plastics, leather goods and textiles.

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:

• Regulating new substances, including microorganisms, other living organisms, biochemicals and biopolymers. These are biotechnology substances and may be subject to risk assessments and controls under the New Substances Notification Regulations (NSNR) of CEPA 1999;
• Assessing environmental and indirect human health impacts of biotechnology substances in products governed by the Food and Drugs Act (F&DA); and
• Establishing and maintaining the Domestic Substance List (DSL), which lists living organisms and related substances that are considered to be existing in the Canadian marketplace. Assessing human health risks posed by organisms on the DSL and the risk management of the substances that are considered to be toxic under CEPA 1999.

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:

• Establishing new scientific and biotechnology expertise and tools to assess the human health and environmental impacts of biotechnology products and substances. These tools are themselves part of biotechnology and include bioinformatics and proteomics, such as immunomics (the study of immune system genetic functions and effects), pathomics (the molecular characterization of pathogens and their effects on hosts) and toxicogenomics;
• Developing protocols and tools to support decision making regarding the identification and classification of microorganisms used in bacterial-based biotechnology products assessed under CEPA 1999
• Assessing the risks of using biotechnology-based tools in standardization of test methods and data collection of chemical and biological substances covered under CEPA 1999;
• Applying toxicogenomic tools through research in the Environmental Health Science laboratories of the Safe Environments Programme to support other priorities such as Environmental Contaminants, air quality, and endocrine-disrupting substances, the Genomics Research and Development Programme, Priority Health concerns and Programs such as Product Safety, Tobacco Control and Radiation Protection;
• Building public awareness about biotechnology products and their regulation in Canada, and engaging the public in regulatory decision making.

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:

• Health Canada policies and regulations
• Current methods, tools and practices used to evaluate new environmental products made through biotechnology;
• How Health Canada monitors and tracks environmental biotechnology products;
• Examples of environmental and industrial biotechnology applications.

Policies and Regulations

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:

• Human health;
• The environment, such as fish and wildlife; and/or
• The environment upon which life depends, such as water, soil and air.

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:

• Aquaculture treatment/management
• Biofiltration
• Biological waste recovery
• Biomass conversion
• Bioremediation
• Biosensing,
• Carpet cleaning and deodorizing
• Enhanced oil recovery
• Enzyme and chemical production
• Fossil fuel desulfuration
• Fuel production
• Microbial drain cleaning and degreasing
• Mineral leaching

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.

Environmental Risk Assessment

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:

• Biologics;
• Cosmetics;
• Food additives and novel foods;
• Pharmaceuticals;
• Medical devices;
• Natural health products; and
• Veterinary drugs .

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.

Methods, Tools and Practices

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.

Research Platforms

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.

The Tools

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.

Monitoring and Tracking

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

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.

Field Work

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.

List of common applications and processes

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.

Aquaculture Treatment/Management:

Treatment(s) using microorganisms to inactivate or eliminate undesirable aquaculture byproducts, and excess nutrients

Bioaugmentation:

The addition of commercially prepared bacterial strains with specific catabolic activities to degrade wastes

Biobleaching/biopulping pulp and paper:

Enzymes derived from microorganisms to breakdown lignin and colourants which are part of wood structures of various types of trees

Biocatalysis:

Application of enzymes as catalysts for chemical synthesis

Biodetergent:

Addition of biotechnology-derived microorganisms and/or their enzymes which degrade waste and colourants, therefore acting as brightening and cleaning agents

Biofiltration:

Breakdown of volatile organic compounds and odour-causing chemicals in air by passing through media containing biodegrading microorganisms

Bioleaching:

Use of microorganisms to extract metals and minerals from ores or mine wastes

Biomass fuels:

Include forest and mill residues, agricultural crops and wastes, wood and wood wastes, animal wastes, livestock operation residues, aquatic plants, fast-growing trees and plants, and municipal and industrial wastes. Technologies break down various plant materials (for example, cellulose, lignin and xylan from crops) into residues (sugars like glucose and xylose) and convert them to fuel-grade ethanol and other fuel-like chemicals, as well as generate heat and/or electricity. Biomass is made by growing microorganisms on organic materials.

Bioremediation:

Use of certain types of plants and microbes to contain, eliminate or decrease hazardous and radioactive wastes to environmentally safe levels

Drain cleaning and degreasing:

Use of microorganisms selected for their enhanced ability to produce enzymes, such as amylase, protease, cellulase and lipase, needed to degrade the starches, proteins, cellulose and fats common to household and restaurant wastes

Municipal and industrial waste and wastewater treatment:

Use of bacterial cultures with enhanced ability to degrade specific toxic chemicals thereby reducing their effects in municipal and industrial waste treatment systems.

Textiles:

Use of enzymes in fabric desizing, polishing, denim abrasion and bleaching and bleach cleanup.