Screening Assessment of Trichoderma Reesei Strain ATCC 74252

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Screening Assessment of Trichoderma Reesei Strain ATCC 74252 Screening assessment of trichoderma reesei strain ATCC 74252 Environment and Climate change Canada Health Canada February 2018 Cat. No.: En14-318/2018E-PDF ISBN 978-0-660-25249-0 Information contained in this publication or product may be reproduced, in part or in whole, and by any means, for personal or public non-commercial purposes, without charge or further permission, unless otherwise specified. You are asked to: • Exercise due diligence in ensuring the accuracy of the materials reproduced; • Indicate both the complete title of the materials reproduced, as well as the author organization; and • Indicate that the reproduction is a copy of an official work that is published by the Government of Canada and that the reproduction has not been produced in affiliation with or with the endorsement of the Government of Canada. Commercial reproduction and distribution is prohibited except with written permission from the author. For more information, please contact Environment and Climate Change Canada’s Inquiry Centre at 1-800-668-6767 (in Canada only) or 819-997-2800 or email to [email protected]. © Her Majesty the Queen in Right of Canada, represented by the Minister of the Environment and Climate Change, 2018. Aussi disponible en français ii Synopsis 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 Trichoderma reesei ATCC1 74252. Trichoderma reesei (T. reesei) strain ATCC 74252 is a fungus that has characteristics in common with other species of the genus Trichoderma and other strains of the same species. T. reesei, a spore forming fungus, is able to thrive in soil and on decaying plant matter as a major decomposer of plants, and is thus capable of degrading a variety of plant-based substrates. These properties allow for potential uses of T. reesei in fermentation of plant-based feedstocks, and in production of enzymes and biochemicals used in food, animal feed and in health products. T. reesei is widely considered to be a safe production organism due to its long history of safe use for the production of carbohydrase enzymes such as cellulase. Trichoderma species including T. reesei are capable of producing metabolites called peptaibols. Some T. reesei strains can produce the peptaibol paracelsin as well as other peptaibols. Paracelsin is reported to be harmful to aquatic invertebrates, to mammalian cells, and to mice in experimental conditions where natural barriers were bypassed. Paracelsin has also been reported to have antibiotic and antifungal activity. Paracelsin and other peptaibols production is not thought to occur under the conditions of industry-standard submerged fermentation in which T. reesei strain ATCC 74252 is currently used, but could occur under other growth conditions. T. reesei as a species is not naturally occurring in Canada. Despite its widespread presence in tropical soils, there are no reports of the species causing adverse effects in aquatic or terrestrial plants or animals in the tropics. In addition, Trichoderma species including T. reesei inhibit various plant pathogens. There is no evidence in the scientific literature indicating that T. reesei is a human pathogen. T. reesei strain ATCC 74252 is unlikely to cause infection in healthy or debilitated humans and is susceptible to major clinical antifungal drugs that could be used for treatment in the unlikely event of infection. Repeated exposure to commercial enzyme preparations produced by T. reesei and other Trichoderma species infrequently causes allergic reactions in humans. This assessment considers the aforementioned characteristics of T. reesei strain ATCC 74252 with respect to environmental and human health effects associated 1 American Type Culture Collection iii with consumer and commercial product use and in 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 of this microorganism, 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). Information submitted in response to the Notice indicates that 10 000 – 100 000 kg of T. reesei strain ATCC 74252 dry cell mass was manufactured in Canada in 2008 for industrial uses. Based on the information available, it is concluded that T. reesei strain ATCC 74252 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 T. reesei strain ATCC 74252 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. It is concluded that T. reesei strain ATCC 74252 does not meet any of the criteria set out under section 64 of CEPA. iv Table of contents SYNOPSIS .............................................................................................................................................................. II TABLE OF CONTENTS ............................................................................................................................................... V LIST OF TABLES ...................................................................................................................................................... VI 1. INTRODUCTION ............................................................................................................................................. 1 2. DECISIONS FROM DOMESTIC AND INTERNATIONAL JURISDICTIONS .......................................................................... 2 2.1 Domestic ................................................................................................................................................. 2 2.2 International ........................................................................................................................................... 2 3. HAZARD ASSESSMENT .......................................................................................................................................... 3 3.1 Characterization of Trichoderma reesei ................................................................................................. 3 3.1.1 Taxonomic identification and strain history ..................................................................................................... 3 3.1.1.1 Phenotypic and molecular characteristics ............................................................................................... 4 3.1.2 Biological and ecological properties ................................................................................................................. 7 3.1.2.1 Life cycle................................................................................................................................................... 7 3.1.2.2 Natural occurrence .................................................................................................................................. 7 3.1.2.3 Growth parameters.................................................................................................................................. 8 3.1.2.4 Survival, persistence and dispersal in the environment .......................................................................... 9 3.1.2.5 Resistance to antifungal agents ............................................................................................................... 9 3.1.2.6 Pathogenic and toxigenic characteristics ............................................................................................... 10 3.1.2.7 Enzymes produced ................................................................................................................................. 10 3.1.2.8 Secondary metabolites and mycotoxins: ............................................................................................... 11 3.1.3 Effects ............................................................................................................................................................. 13 3.1.3.1 Environment .......................................................................................................................................... 13 3.1.3.2 Human health ........................................................................................................................................ 15 3.2 Hazard severity ..................................................................................................................................... 18 v 3.2.1 Environment ................................................................................................................................................... 18 3.2.2 Human health ................................................................................................................................................. 19 4. EXPOSURE ASSESSMENT ....................................................................................................................................
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