加拿大发布苏云金芽孢杆菌ATCC评估结果

Publication of final decision after screening assessment of a living organism �� Bacillus thuringiensis (B. thuringiensis) strain ATCC 13367 �� specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas Bacillus thuringiensis strain ATCC 13367 is a living organism on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the screening assessment conducted on this living organism, pursuant to paragraph 74(b) of the Act, is annexed hereby;

And whereas it is concluded that this living organism does not meet any of the criteria set out in section 64 of the Act;

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action on this living organism at this time under section 77 of the Act.

Catherine McKenna
Minister of the Environment

Ginette Petitpas Taylor
Minister of Health

ANNEX

Summary of the screening assessment of Bacillus thuringiensis strain ATCC 13367

Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of Bacillus thuringiensis strain ATCC 13367 (B. thuringiensis strain ATCC 13367).

B. thuringiensis strain ATCC 13367 is a facultative anaerobic Gram-positive bacterium. As a species, B. thuringiensis is generally considered ubiquitous and is commonly found in terrestrial and aquatic habitats. B. thuringiensis is able to form spores that can withstand harsh environmental conditions and survive under conditions of nutrient depletion. Various characteristics of B. thuringiensis make it suitable for use as an active ingredient in commercial and consumer products, including degreasers, detergents, and additives in bioremediation and biodegradation, and in various industrial processes.

B. thuringiensis is known particularly for the production of crystal proteins (Cry toxins), which are toxic to various orders of insects (mainly lepidopterans, dipterans and coleopterans). In particular, B. thuringiensis strain ATCC 13367 is known to produce a Cry 1B (Cry1Ba) toxin, which is known to be selectively toxic to insect species of the Order Lepidoptera and to a few species of the orders Diptera and Coleoptera. Despite the ubiquity and abundant use of various B. thuringiensis subspecies, there are no known adverse population-level effects on target species in the ecosystems where it is used, and no adverse effects on non-target terrestrial or aquatic plants, vertebrates or invertebrates.

B. thuringiensis is not considered a human pathogen; to date, no mammalian pathogenicity and toxicity study has demonstrated that commercial spore preparations of any B. thuringiensis subspecies cause adverse effects by any route of exposure. B. thuringiensis has been isolated from a few gastrointestinal, ocular and wound infections. Some B. thuringiensis strains, including ATCC 13367, have been reported to produce enterotoxins and membrane-damaging toxins. These toxins are known as important factors for pathogenicity of a close relative, Bacillus cereus, in humans. However, the significance of the presence of these virulence factors in B. thuringiensis in relation to human infections is not clear. The scientific literature reports very few cases of infection linked to B. thuringiensis. B. thuringiensis is resistant to several clinical antibiotics, but effective treatments against infection are available.

This assessment considers the aforementioned characteristics of B. thuringiensis strain ATCC 13367 with respect to environmental and human health effects associated with consumer and commercial product use and industrial processes subject to CEPA, including releases to the environment through waste streams and incidental human exposure through environmental media. To update information about current uses, the Government launched a mandatory information-gathering survey under section 71 of CEPA, as published in the Canada Gazette, Part I, on October 3, 2009 (section 71 notice).

Based on the information available, it is concluded that B. thuringiensis strain ATCC 13367 does not meet the criteria under paragraph 64(a) or (b) of CEPA as it is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. It is also concluded that B. thuringiensis strain ATCC 13367 does not meet the criteria under paragraph 64(c) of CEPA as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Conclusion

It is concluded that Bacillus thuringiensis strain ATCC 13367 does not meet any of the criteria set out under section 64 of CEPA.

The screening assessment for this living organism is available on theCanada.ca (Chemical Substances) website.