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Since its inception, biotechnology has been involved with food and medicine and it has experienced focused governmental inspection and keen public scrutiny. This has meant, unlike many other industries, aspects of its production and use have been regulated by the federal government from the very beginning.
Today, industrial biotechnology mainly uses microorganisms - usually yeasts, bacteria or fungi - to produce industrial enzymes or as part of whole-cell production systems. In many cases, these microorganisms are genetically engineered or enhanced to carry out the specialized tasks required in manufacturing. Because these microorganisms are used in contained, closed-loop fermentation systems under well controlled conditions in industrial facilities, there are minimal chances for unintentional release of live genetically enhanced microorganisms (GEMs) into the environment. It is important to note that the vast majority of this work is being done by enzymes. Industrial biotech researchers and companies have a very good record of safety and stewardship in this regard over the past 35 years.
The OECD correctly notes that the microorganisms used for industrial bioprocessing or for production of industrial enzymes are carefully selected to avoid the use of pathogenic microorganisms. Industrial biotechnology production facilities are also subject to environmental regulations such as the New Substances Notification Regulations of Environment Canada, the Toxic Substance Control Act (TOSCA) in the United States and similar regulations in other countries. Occupational health regulations also impose rules on their handling in the workplace, and in most cases, after they have performed their assigned production tasks, they are inactivated by sterilization. The resulting material is usually heat-treated or dried, and then composted. These practices vary by country and regulation but every effort is made to insure safe and proper handling. This two-step process (sterilization and composting) breaks down the DNA and protein components. The resulting material has high organic value; for instance, in Denmark the composted biomass is sought after by local farmers who apply it as a top grade fertilizer. /1
BIO's statement of ethical principles states that "we will strive to optimize the cost efficiencies and environmental advantages associated with using biotechnology while protecting human health and the environment." In addition, members of the BIO Industrial and Environmental Section (IES) believe in and practice proper stewardship during production and handling of these microorganisms for industrial use. The BIO IES specifically states in its bylaws that the activities of the section shall include efforts:
- to promote safe experimental and industrial practices within the biotechnology industry that protect and serve public interests, and maintain the integrity of the environment and other living organisms; and
- to gather and promote the exchange of information on industrial and environmental biotechnology and the responsible growth of the industry; and
- to encourage environmental stewardship through the promotion of industrial sustainability.
Footnote
1/ Novoymes, "Using surplus materials as fertilizer," (Nov 2000) available at http://www.novozymes.com/ (last visited Mar 16, 2004).
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