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the Canadian Environmental Protection Act, 1999
LIST OF ACRONYMS AND TERMS Canadian Environmental Protection Act, 1999 Suspected of being ‘toxic’ or capable of becoming ‘toxic’ based on criteria described in Section 64 of CEPA 1999. DSL Domestic Substances List LC50 Median Lethal Concentration EC50 Median Effective Concentration IC50 Median Inhibition Concentration ED50 Median Effective Dose ID50 Median Infective Dose LD50 Median Lethal Dose NSNR (Organisms) New Substances Notification Regulations (Organisms) The Regulations New Substances Notification Regulations (Organisms) SNAc Significant New Activity as per section 106 or 110 of the CEPA 1999 PURPOSE AND SCOPE OF DOCUMENT This document outlines the systematic steps used by the Health Canada and Environment Canada Substances Assessment Programs to conduct science-based risk assessments of micro- organisms in which the assessment is based on a determination of “toxic” as defined under section 64 of the Canadian Environmental Protection Act, 1999 (see next page). In other words, it describes a framework of the basic concepts considered when conducting this assessment based on available information on hazard and exposure for both ‘existing’ (i.e., those on the Domestic Substance List) and ‘new’ micro-organisms (i.e., those notified under the New Substances Notification Regulations (Organisms) in order to determine whether any of the conditions described in section 64 will or could be met. CEPA 1999 ‘CEPA toxic’
OVERVIEW OF THE PROPOSED APPROACH TO MICROBIAL RISK ASSESSMENT The proposed approach (illustrated in Figure 1), describes a series of steps to be followed during the risk assessment of a micro-organism. The approach is structured to ensure that micro-organisms undergo a rigorous, consistent and expeditious analysis to determine whether or not they are toxic (see “Risk Characterization”). This approach is based on the evaluation of “toxic”, as defined under section 64 of CEPA 1999, using the paradigm that risk is proportional to the product of hazard and exposure. Risk ∝ Hazard × Exposure
or 3 . Not CEPA Toxic for intended (proposed) use(s) or exposure scenario(s) but. A substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that: (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity. This risk is characterised as Low. a prioritization was performed in order to ensure that micro-organisms with the greatest potential for hazard are assessed first.In the context of the screening assessment of DSL micro-organisms. The determination of exposure sources and characterization of exposure levels are based on available information describing current known use patterns. under another significant new activity. the identification and determination of the severity of hazard are based on an exhaustive literature review and other sources such as experimental data from completed and ongoing research projects. or other potential uses. For ‘new’ micro-organisms. as required under the New Substances Notification Regulations (Organisms). Medium or High depending on the hazard severity and potential for exposure (see “Risk Characterization”). as defined under section 64 of CEPA 1999. risk assessment is based on the information provided. The outcome of the risk assessment will be used to determine whether or not the micro-organism meets the description of CEPA “toxic”. decisions from other jurisdictions. During risk assessment of DSL micro-organisms. The risk assessment will result in one of the three following conclusions: • • Not CEPA Toxic for all reasonably foreseeable use(s) or exposure scenario(s): no further action. or (c) constitute or may constitute a danger in Canada to human life or health. (b) constitute or may constitute a danger to the environment on which life depends. proposed uses. may become toxic : application of the SNAc provision may be recommended to allow for the notification and assessment of new uses/activities. This process is described in detail in the ‘Prioritization of Micro-organisms on the Domestic Substances List prior to the Screening Assessment under paragraph 74(b) of CEPA 1999’. and taking into consideration weight of evidence and scientific uncertainties (see “Considerations for Science-Based Evaluations”).
Application of SNAc provisions recommended “CEPA Toxic” for known. or intended use(s) but may be toxic for a significant new activity. Figure 1: Approach to risk assessment of micro-organisms Micro-organism Hazard Assessment Identification and characterization Exposure Assessment Sources of exposure and characterization Consider weight of evidence and address any remaining uncertainties Low Risk Medium Risk High Risk Not “CEPA Toxic” No further action Not “CEPA Toxic” for known.• CEPA Toxic: appropriate control measures or risk management actions will be recommended to the Minister in order to mitigate the risk. forseeable or intended use(s) Risk management or control measure recommended 4 .
history of the strain is also considered in the assessment. if there is insufficient information on the specific micro-organism and the choice of surrogate is supported by a sound scientific rationale. but are not limited to: information and data supplied by the notifier [in the case of new micro-organisms covered under the NSNR (Organisms)] or nominator (in the case of existing micro-organisms). all stages of the life cycle of the micro-organism and their potential effects must be considered. The hazards may be posed by the micro-organism itself. Sources of hazard information include. information on all directed or intentional changes made to the organism is assessed. No single method is sufficient for an accurate identification. Factors affecting the degree of hazard may be strain specific and therefore the assessment must address the factors known or suspected to be produced by the notified or nominated strain. adaptations. and stability of the modifications. methods used to modify the organism. the scientific literature.RISK ASSESSMENT FRAMEWORK HAZARD ASSESSMENT A hazard assessment characterizes the micro-organism and identifies the potential adverse effects on the environment and/or human health and predicts the extent and duration of these effects. mutagenesis. and any completed or ongoing research studies. Genetic Modifications: For genetically modified micro-organisms. For this reason. genetic recombination) source. Characterization of the micro-organism • Taxonomic identification: The accurate identification of a micro-organism is the key element in a microbial hazard assessment. preferably to the strain level.g. Strain history: From its original source of isolation until final product development. Strong and defensible identification. or its toxins. selection conditions and modifications to the micro-organism.. Hazard information considered in the assessment may be for the specific microorganism being assessed. as well as those known or suspected to be produced by other strains of the species (or genus). or a suitable surrogate. is important for the hazard characterization of the micro-organism. storage. The degree of hazard may also be affected by the life stage of the organism. A combination of classical and molecular methods is often necessary. This will allow a more effective distinction from related pathogenic micro-organisms. culturing conditions. as well as the life stage of the microorganism in the final product. This would include the type of genetic manipulation (e. nature and function of any inserted genetic material. • • 5 . its genetic material. This information includes any strain bank accession numbers and the history of isolation. metabolites or structural components.
g. o Natural occurrence. o Description of the life cycle of the organism. o Unusual properties of the notified or nominated strain that differ from the classical description of the species. in the absence of evidence of effects. o Mode of action in relation to known. Biological and Ecological Properties of the Organism: Information about the biology of the organism contributing to the assessment of hazard may include the following: o Physiological properties. pH. to a determination of low hazard.. Effects • Pathogenicity/Toxicity Under this heading. insertion sequences. temperature. environmental dose/concentration. habitats. integrons. including the characteristics of various different forms and mechanisms of microorganism dispersal. transposons. • • History of Safe Use: A documented history of safe use of (or prior environmental exposure to) a micro-organism over significant time periods lends confidence. growth and replication. is assessed. transduction or conjugation) and the elements involved (such as plasmids. including humans. 6 . However. route of exposure) must be fully considered to ensure that the exposure history compares to exposures likely from proposed or predicted uses.• Horizontal Gene Transfer: The assessment considers the capacity for transfer of genetic material between organisms. ecological niches. including the mechanisms of possible transfer (including transformation. including information on geographical distribution. to help determine conditions required for and conditions that limit survival. include growth parameters (e. metals and environmental factors such as sunlight and desiccation. saprophytic or pathogenic relationships) and level of natural occurrence in the environment. the ability of a micro-organism to cause lethal or sublethal adverse effects on living plants or animals. gene cassettes and genomic islands). redox potential. preferred or obligate hosts (for symbiotic. the particulars of exposure associated with a history of safe use (life stage of the micro-organism. bacteriophages. intended or predicted uses. nutritional dependence and susceptibility to antibiotics. osmotic minima. integrative conjugative elements. maxima and optima).
including: o pathogenicity and/or toxicity test on aquatic plants. vertebrates and invertebrates species o pathogenicity and/or toxicity test on terrestrial plants. structural components or metabolites).. colonization. Some toxins can be lethal to the target organisms.g. as is the presence or absence virulence factors that enable it to infect. exotoxins. Live microorganisms need not necessarily be present for a toxic effect to occur (e. vertebrates and invertebrates species 7 . Virulence refers to the degree of pathogenicity. Different species or strains of microorganism may exhibit different level of virulence. This term describes the capability of the microorganisms to escape clearance measures and to invade and persist in a viable state or multiply within or on an organism. Pathogenicity of microorganisms is generally the result of two processes that may or may not be linked: the ability to infect the host (invasion. multiply. A toxin is a substance produced by a micro-organism that may have a harmful effect on a living organism. adherence. Toxicity refers to the degree to which a substance (toxin) or an organism can cause harm to living organism as a whole. in toxin-mediated food poisoning or for toxic products of microorganisms used in industrial applications). biochemical or structural features that enable the microorganism to cause disease or harm to the host. They can have cytotoxic activity towards a narrow or wide range of cells and can induce death of specific cell types or general tissue damage. establish itself. irrespective of the presence of the living micro-organism (endotoxins. It also refers to its capacity for horizontal transmission (how readily a pathogen is passed from one individual or group to a previously uninfected individual or group). inflict injury or damage or cause disease or adverse immunological effects in a host. This ability is a property of the pathogen and the extent of damage done to the host depends on host-pathogen interactions. Ideally. Toxins are some of the major determinants of virulence.Relatedness of the microorganism to known pathogens is considered. with or without disease manifestation. Virulence factors are any genetic. in vivo test data are used to evaluate the effects of the organism. evasion of the immune system) and toxigenesis (the production of toxins that may or may not play role in the infectious process). Infectivity refers to the ability of a microorganism to cross or evade natural host barriers to infection. its tissue or its cells. Key elements relating to the assessment of pathogenicity and toxicity include the following: Pathogenicity refers to the ability of an organism to cause harm or disease to the host.
loss of habitat). host range is considered. Report EPS 1/RM/44. taking into account its environmental expression and fate. If adverse effects are reported at this dose or concentration. • Other Ecological Effects Other ecological effects are considered in the assessment of hazard such as the ability of the micro-organism to adversely alter biotic and abiotic components of the ecosystem (e.o pathogenicity and/or toxicity test in laboratory mammals. loss of biodiversity. such as median infective. March 2004). effective or lethal dose or concentration (ID50/IC50. medium or high. they are convenient for communicating the relative degree of concern associated with micro-organisms. as a surrogate for potential effects on human health For micro-organisms. especially as there is generally a paucity of quantitative data on the hazards posed by many micro-organisms.g. and ideally to identify an appropriate statistical endpoint. A review of case reports and outbreaks in the scientific literature is another key element in the assessment of pathogenicity and toxicity. in vitro pathogenicity/toxicity testing in plant. Table 1 describes considerations for each of the environment hazard severity categories used in the risk assessment of micro-organisms. proposed and predicted releases of the micro-organism. in vivo pathogenicity/toxicity testing typically starts with a single dose or concentration test at a maximum hazard (challenge) dose or concentration (Environment Canada. Report EPS 1/RM/46. as well as incidence. Determination of the appropriate model is dependent on the micro-organism itself and the effects tested. While these categories are qualitative. Environment Environmental hazard level determination considers the diversity of living organisms and habitats that could be affected by the known. 8 . morbidity and mortality and effects at the population or ecosystem level. ED50/EC50. a range of lesser challenges may be used to establish a dose-response relationship. including differential susceptibility of human populations and the range of plant or animal hosts. If in vivo tests are not possible or available. In evaluating documented effects on the environment and human health. March 2005). animal or human cell culture (primary or cell line) could be used to determine toxic and infectious properties of a micro-organism toward higher organisms. and differential susceptibility of the organisms and ecosystems likely to be exposed. Hazard Characterization Hazard severity can be characterized as low. LD50/LC50) (Environment Canada.
Low Considerations that may result in a finding of low hazard include a microorganism that: • • • • Is not known to be a non-human pathogen. serious disease). May have theoretical negative impacts for a short period but no predicted long term effect for microbial. Human Health Elements that are used in determining the hazard severity of a micro-organism towards humans include: • Virulence Infectivity Severity of effects (including toxicity) Duration Sequelae Reversibility (self-limiting or requiring treatment) Potential community burden of disease Potential for horizontal transmission • 9 . loss of habitat.g. plant and/or animal populations or ecosystems.Table 1: Considerations for hazard severity (environment) Hazard High Considerations Considerations that may result in a finding of high hazard include a microorganism that: • • • Is known as a frank pathogen. Has irreversible adverse effects (e. Has a history of safe use over several years. characterization or possible effects. Medium Considerations that may result in a finding of medium hazard include a micro-organism that: • • Is known as an opportunistic non-human pathogen or for which there is some evidence in the literature of pathogenicity/toxicity. loss of biodiversity. Has significant uncertainty in the identification.. Combinations of the factors within each generalized environmental hazard level above are possible and would affect the overall assessment. Is well characterized and identified with no adverse ecological effects known. Has some adverse but reversible or self-resolving effects.
and are limited to invasive exposure routes (i. localized and rapidly self-resolving in healthy humans. asymptomatic. morbidity. • Effects at maximum hazard/challenge dose in laboratory mammals are not lethal.Incidence and prevalence i. particularly where there is an absence of case reports in the scientific literature. intravenous. or case reports associated with predisposing factors are rare and without potential for secondary transmission and any effects are mostly mild. Table 2 defines each of the human health hazard severity categories used in the risk assessment of micro-organisms. • Low potential for horizontal transmission. Table 2: Considerations for hazard severity (human health) Hazard High Considerations Considerations that may result in a finding of high hazard include a microorganism for which: • disease in healthy humans is severe. 10 . mortality rates in the general population The circumstances in which humans have been exposed to the micro-organism or its close relatives (history of safe use. or benign •No adverse effects seen at maximum challenge dose in laboratory mammals by any route of exposure.. •Lethal or severe effects in laboratory mammals at maximum hazard/challenge dose trigger multiple-dose testing Medium Considerations that may result in a finding of medium hazard include: • Case reports of human disease in the scientific literature are limited to susceptible populations or are rare.e. • Potential for horizontal transmission/community-acquired infection. intratracheal) or are mild and rapidly self-resolving.e.. of longer duration and/or sequelae may result. Low Considerations that may result in a finding of low hazard include: • No case reports of human disease in the scientific literature. prior environmental exposure) may also be considered. • Disease in susceptible humans may be lethal. intraperitoneal.
). magnitude. Sources of Exposure Exposure to the micro-organism may be direct (e. dermal. duration. While these categories are qualitative. and estimates the likelihood. proposed or predicted uses. is categorised as low. persist. and/or extent of human and environmental exposure. • exposure to toxins. its genetic material. • routes of exposure (ingestion. etc. environmental compartments into which release is expected). Environmental release is assessed from known. • the life stage of the micro-organism at the time of exposure (vegetative cells or spores. 11 . structural components or genetic material. the potential for persistence and bio-accumulation. metabolites and structural components. nature of release (e. its toxins. disperse. quantity. emissions. deep well injection. Exposure Characterization Exposure to a micro-organism. ground application. which may be used to predict: • the ability of the micro-organism to survive. and frequency of release.EXPOSURE ASSESSMENT An exposure assessment identifies the mechanisms by which a micro-organism is introduced into a receiving environment. or wastes). animals. • for genetic material. metabolites and/or structural components. Assessment of the environmental expression and fate of the micro-organism considers the biology and life cycle of the organism. live or dead). • for toxins.g. aerial spray. the potential for dispersal of traits. duration). proliferate and become established in the environment to which it is released.. Indirect exposure assessment considers how the micro-organism is released into the environment through known. and the environmental fate of the micro-organism. metabolites.g.. inhalation. they are convenient for communicating the predicted degree of exposure. humans or ecosystems. In relation to the exposed plants. duration. toxins. proposed or predicted: • • • sites of release (including geographical location(s). medium or high. through contact with consumer or industrial products) or indirect. the following factors are considered: • magnitude of exposure (quantity. • potential for dispersal or transport to other environmental sites or compartments. frequency. considers its environmental expression and fate. metabolites and structural components.
Exposure to a toxin. In relation to exposed organisms. disperse or proliferate in the environment where released. duration and/or frequency of release is moderate. the organism is likely to survive. routes of exposure are permissive of toxic or pathogenic effects in susceptible organisms.For micro-organisms. Low Considerations that may result in a finding of low exposure include a microorganism for which: • • • • It is no longer in use. duration and frequency of release of micro-organisms that are not expected to survive. the nature of release makes it likely that susceptible living organisms or ecosystems will be exposed and/or that releases will extend beyond a region or single ecosystem. duration and/or frequency are high. but quantity. persist. 12 . exposure is generally estimated qualitatively due to capacity of micro-organisms to increase or decrease in numbers. routes of exposure are not expected to favour toxic or pathogenic effects. persist. The nature of release and/or the biology of the micro-organism are expected to contain the micro-organism such that susceptible populations or ecosystems are not exposed. Table 3: Considerations/examples for levels of exposure (environment and humans) Exposure High Considerations Considerations that may result in a finding of high exposure include a micro-organism for which: • • • • • the release quantity. It may persist in the environment. and the general paucity of models or environmental fate data for micro-organisms. The potential for dispersal/transport is limited. dispersal or transport to other environmental compartments is likely. Table 3 describes the considerations for assessing the likelihood of exposure for both environmental and human health endpoints. but in low numbers. In relation to exposed organisms. It is used in containment (no intentional release). metabolite or structural component can sometimes be estimated quantitatively using established chemical models. The nature of release is such that some susceptible living organisms may be exposed. disperse proliferate and become established in the environment. Low quantity. Medium Considerations that may result in a finding of medium exposure include a micro-organism for which: • • • • • It is released into the environment.
other considerations modifying hazard and exposure. For example. Risk is typically described as the probability of an adverse effect occurring based on hazards and a particular exposure scenario. . • there must be some likelihood that an adverse effect to human health or the environment will result from exposure to the identified hazard. and may also affect the selection of control measures and/or risk management approaches. In addition. However the specifics of the hazard assessment may modify the significance of a particular exposure scenario. an organism that is innocuous on oral ingestion or dermal contact may be pathogenic on inhalation. the outcomes of the hazard assessment and exposure assessment are combined to determine the likelihood that an exposure will or may impact on the environment and/or human health as described in section 64 of the Act. Note that hazard severity and level of exposure are defined in isolation. The following three categories are considered to estimate the risk level: 13 . The text below outlines three categories of risk. so the likelihood of aerosol formation on release or dispersal of the organism may cause the estimation of risk to change relative to the scheme outlined above. based on estimates taking into account known or proposed/foreseeable uses and/or assumptions. a ‘proportional’ relationship which is usually expressed as: Risk ∝ Hazard × Exposure As emphasized throughout this document. also play a role in estimating risk and linking it to an assessment conclusion as described in Figure 1. RISK CHARACTERIZATION For the determination of CEPA “toxic”. Estimation of Risk The assessment of the magnitude of risk is based on the assumption that the hazard will be realized due to environmental exposure. • there must (or there is likely to) be exposure to humans or the environment to that hazard. as outlined in the next section (Considerations for Science-Based Evaluations). the following must be true: • there must (or there is likely to) be a hazard related to the micro-organism to human health or the environment.Combinations of the factors within each generalized exposure level above are possible and would affect the overall exposure assessment. in order for a micro-organism to be considered CEPA “toxic”. based on the severity of the hazard and the potential for exposure as described above.
under another significant new activity.. A conclusion of CEPA-toxic would result from this determination of risk level and control measures or risk management would be recommended. a qualitative approach is used. Although laboratory testing in a suitable animal model may provide quantitative values for potential pathogens. such data are rarely available to evaluators.High risk: A determination of high risk implies that severe. growth requirements) and ecology of the microorganism being assessed and suitable surrogates. application of the SNAc provision may be recommended to allow for the assessment of new uses/activities should those new activities be proposed. Medium risk: A determination of medium risk implies that adverse effects predicted for probable exposure scenarios may be moderate and self-resolving. Weight of evidence considers several component lines of evidence to reduce overall uncertainty. considering several lines of evidence. randomized.g. risk assessments incorporate the precautionary principle and a weight of evidence approach. enduring or widespread adverse effects are probable for exposure scenarios predicted from known. Lines of evidence are weighted based on the net persuasiveness of many factors. including epidemiology and clinical case reports and information on the biology (e. statistical analysis) 14 . • Decisions from other domestic and international jurisdictions and experts • History of safe use. among other factors. Qualitative Data and Information In the absence of quantitative evidence. including: • The number of studies supporting a particular line of evidence • Study design (multivariate. The conclusion (CEPA-toxic or not) is determined based on the particulars of the case. physiology (e. including: • Literature searches for information. and SNAc provisions may or may not be applied. foreseeable or intended uses. may become CEPA-toxic. The conclusion would be not CEPA-toxic. virulence factors. Low risk: A determination of low risk implies that any adverse effects predicted for probable exposure scenarios are rare. for intended (proposed) use(s) or exposure scenario(s) but.. or mild and self-resolving. and likelihood of prior environmental exposure for relevant life stages of the micro-organism Weight of Evidence Under CEPA 1999. toxin production). In the case where the conclusion is not CEPA-toxic.g. CONSIDERATIONS FOR SCIENCE-BASED EVALUATIONS Quantitative Data Quantitative risk assessment for micro-organisms is made difficult by their ability to proliferate in the environment and their host-specificity.
In situations where sound scientific information is limited but where the impacts could potentially be important. etc. and states that "where there are threats of serious or irreversible damage. 15 . species extrapolation) • Data quality • Scope relative to the risk assessment (same or closely related strain. risk assessment reports may be reviewed by third party experts to ensure a high degree of rigor and quality in the report. lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. the approach to risk management measures is prudent. in order to protect the environment and human health.) • Effect size The Precautionary Principle The precautionary principle is one of the guiding principles set out in the preamble of the CEPA 1999. where appropriate. Scientific Uncertainties Risk estimates always contain some level of uncertainty resulting from the limited availability of scientific data. indication of whether more data would enhance the overall confidence in the assessment conclusion Assumptions used to bridge data gaps. The effect of these uncertainties on risk estimates must be thoroughly considered and documented. In addition. Professional Judgement The minister of the Environment and the Minister of Health share the ultimate authority and accountability for any decision arising from the risk assessment of micro-organisms under CEPA 1999. scientific experts may be sought out to provide advice. Professional judgement is used to make risk management decisions in the face of uncertainty or conflicting lines of evidence. and the challenge of extrapolating available data to real situations.• Number of tested hypotheses • Sample size • Validity and degree of extrapolation (spatiotemporal. climate of study area. including: • • • Identification of major data gaps and." Sound scientific information remains the cornerstone of all assessments. and the bases for those assumptions Identification of any ‘unacceptable’ uncertainties requiring application of the precautionary principle until new data become available to resolve the uncertainty Experts and Peer Reviewers If the necessary expertise cannot be found within the Government.
b. The DSL for living organisms is a compilation of all reported living organisms that were either (i) in Canadian commerce between January 1. Under paragraph 74(b) of CEPA 1999. Existing versus New Substances Existing substances are substances that are listed on the Domestic Substances List (DSL). the Archaea.asp?lang=En&n=E621534F-1 for more information). or sub-viral particle.gc.ec. 1984. but other relevant information may be 16 . polymers. any culture other than a pure culture. a ’micro-organism’ is defined in subsection 1(1) of the New Substances Notification Regulations (Organisms) as: “a microscopic organism that is: a. ‘living organisms’ refers to micro-organisms. ‘Substances’ include chemicals. other than a cell used to propagate the organism.ca/subsnouvelles-newsubs/default. 1999 (CEPA 1999) takes a proactive and preventative ‘cradle to grave’ approach to pollution prevention and protecting the environment and human health by regulating new and existing substances.asp?lang=En&n=01A1CDCF-1 for more information). The Regulations outline notification and information requirements for these (see http://www.e. As of September 2010. a cultured cell of an organism not referred to in paragraphs (a) and (b). which includes protozoa and algae. or (ii) that were added to the DSL in accordance with CEPA 1999 after assessment of the information outlined in Schedule 1 (micro-organisms) of the Regulations. classified in the Bacteria.ca/subsnouvellesnewsubs/default. there were 67 microbial strains and 1 complex microbial culture (i. the Protista. c. For new living organisms. and in the context of this document. and living organisms. and December 31. New substances are substances that are not listed on the DSL. consortium) on the DSL because they met criterion (i) or (ii) (see http://www. New microorganisms require pre-import and pre-manufacture notification under subsection 106 (1) of CEPA 1999 and are assessed under subsection 108(1) of CEPA 1999. Substances listed on the DSL do not require notification prior to manufacture or import. which is a complex unformulated natural combination of microorganisms. or d. is regarded as any culture other than a pure culture.CONTEXT The Canadian Environmental Protection Act. the Minister of the Environment and the Minister of Health are required to conduct a screening assessment of these organisms based on information gathered or generated by the Government of Canada. which includes yeasts. or the Fungi. virus-like particle.gc..” A consortium. 1986. information supporting the assessment originates with the proponent.ec. a virus. Definition of micro-organism For the purposes of CEPA 1999.
gathered for use in the assessment.ca/subsnouvelles-newsubs/default.asp?lang=En&n=22FC25C8-1).asp?lang=En&n=E621534F-1) and Guidelines for the Notification and Testing of New Substances: Organisms (http://www.gc.ec.ec.ca/subsnouvelles-newsubs/default.gc.gc. Additional background information More information about micro-organisms assessment under CEPA 1999 is found at the Living Organisms (Biotechnology) section of the New Substances website (http://www. More information about risk management of chemical substances under CEPA 1999 can be found at http://www.ca/subsnouvelles-newsubs/default. for chemical new substances.ca/aboutapropos/index-eng.chemicalsubstanceschimiques.gc. The government is bound to the assessment timelines as prescribed in the Regulations. visit http://www.ec.asp?lang=En&n=7BC7614A-1) 17 .php.
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