Risk assessment of living organisms subject to the Canadian Environmental Protection Act, 1999 and the New Substances Notification Regulations (Organisms)

Fact sheet series: Topics in risk assessment of substances under the Canadian Environmental Protection Act, 1999 (CEPA)

Introduction

In Canada, the manufacture and import of living organisms is regulated under Part 6 of the Canadian Environmental Protection Act, 1999 (CEPA) and the New Substances Notification Regulations (Organisms) [NSNR (Organisms)]. The New Substances program (NS program) is managed jointly by Environment and Climate Change Canada and Health Canada. The NS program is responsible for assessing and managing risks that living organisms may pose to human health or to the environment. CEPA and NSNR (Organisms) requirements apply to all living organisms not on the Domestic Substances List (DSL), unless they are imported or manufactured for a use regulated under one of the federal acts listed in Schedule 4 of CEPA. These acts are considered equivalent to CEPA Part 6 and include the Pest Control Products Act, the Seeds Act, the Fertilizers Act, the Feeds Act, and the Health of Animals Act. 

In Part 6 of CEPA, living organisms are defined as substances that are animate products of biotechnology. These include both micro-organisms (that is, microscopic organisms such as bacteria, fungi, viruses, and algae) and higher organisms (such as fish, insects and livestock animals), whether genetically modified or unmodified. This part of CEPA requires manufacturers and importers of living organisms considered "new" to Canada to submit information to the NS program prior to their manufacture in or import into Canada. A living organism is considered new to Canada if it is not on the DSL. The NS program then conducts an assessment of potential risks to human health and the environment, including risks to biological diversity. For the purposes of Part 6 of CEPA, the NSNR (Organisms) outline information requirements to be submitted by notifiers for the assessment of new living organisms prior to manufacture or import in Canada.

Assessing risks to the environment includes looking at potential impacts on ecosystems, the plants and animals that inhabit them and their biodiversity, considering the air, water and soil upon which all life depends. The assessment of risks to human health includes both the general population of Canada and subpopulations who may be more susceptible (likely to suffer from these risks) or highly exposed to substances. These subpopulations can include people whose immune systems are compromised, elderly people, children, infants, and pregnant people, as examples. For more information, visit the fact sheet on consideration of vulnerable populations in risk assessment.

More information on these topics can be found in the Fact sheet: New Substances Notification Regulations (Organisms), which provides examples of new living organisms and sectors or products that use living organisms, as well as the type of activities that are subject to the NSNR (Organisms).

How risks from living organisms are assessed under the Canadian Environmental Protection Act, 1999 and the New Substances Notification Regulations (Organisms)

According to section 64 of CEPA, a substance, including a living organism, is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that:

1. have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
2. constitute or may constitute a danger to the environment on which life depends; or
3. constitute or may constitute a danger in Canada to human life or health.

Risk assessments generally rely on many kinds of information such as test data and other information from the notifier, as well as publicly available information such as scientific articles and public databases. When applicable, the program may also consult with other Government of Canada departments and with other regulators, including provincial, territorial and international partners.

Risk assessments of living organisms generally involve a life-cycle approach, considering each stage of the organism’s product life cycle from its manufacture or import to its use and disposal. The approach allows for the development of risk management measures to mitigate any risks identified during the risk assessment prior to manufacture or import. This process may involve estimating the amount of the living organism released into the environment based on known, intended, or potential uses and takes into account whether the organism is already present in the environment.

Assessing the risk that a living organism poses involves using expert judgement to weigh all available scientific evidence (known as the weight of evidence approach) and making conservative assumptions to protect the environment and human health (known as precaution). In addition, the precautionary principle is applied, meaning that where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental impacts. Included in the assessment of the risk posed by the living organism is a description of any uncertainties in the assessment, including how these uncertainties may impact the assessment’s conclusions.

These assessments allow the Government of Canada to determine whether some measure(s) is needed to manage the risk that the living organism poses. If such a measure is needed, the risk assessment also helps to identify the kind of measure that is best suited to reducing or preventing the potential harm.

How risk is determined

Risk assessments typically involve assessing a living organism’s hazard, that is, its potential to cause harmful effects on people or the environment based on its inherent properties. The assessments also evaluate the potential exposure of people or the environment to a living organism based on its proposed uses and potential releases into the environment.

The accurate identification and taxonomic classification of a living organism is important to better understand its characteristics and properties, and by extension the risks it may pose. A taxonomic classification is the hierarchical system used to categorize organisms to the species or even the strain level. This type of classification can also distinguish one organism from closely related ones.

The hazard of a living organism is also assessed based on its biological and ecological characteristics and whether it has a history of safe use. Some biological and ecological characteristics of the organism considered in this hazard assessment include:

• its life cycle;
• its form, size, shape and other characteristics that change as it grows;
• its genetic material and any genetic modifications made to the organism;
• environmental conditions that help or hinder its growth and survival, such as temperature, pH and other nutrient requirements;
• whether the organism is susceptible or tolerant to antibiotics and other antimicrobials;
• what type of substances or metabolites it produces;
• its ability to transfer genes and pass on harmful traits such as invasiveness or pathogenicity (causing disease);
• whether it is capable of producing toxins;
• how severe its potential impacts are on threatened and endangered species or on unique and protected ecosystems, and the extent to which the impacts are reversible;
• its interactions with other organisms in the environment and its ability to act as a carrier for parasites, pathogens, other organisms, or substances associated with negative effects on human health or the environment;
• whether it sheds, disperses, survives, reproduces or replicates (produces an exact copy of itself) in the environment; and
• how it reproduces, including what species it can interbreed with in Canada and whether it can breed with species that are not closely related.

In the case of a genetically modified organism, evaluators look at how the modification has been made, its purpose or function, and any harmful effects the modification might have on human health and the environment, including biodiversity, in particular on naturally occurring counterparts or other organisms in the environment.

Exposure to a living organism is the concentration or amount of a living organism that reaches people or the environment following its manufacture, import, or use in Canada. In some cases, exposure assessment involves predicting the concentration or amount of living organism that will reach people or the environment under different scenarios. These estimations include reasonable worst-case scenarios, such as accidental releases, and most probable scenarios that reflect actual concentrations or amounts for notified and potential uses. These exposure scenarios consider how the living organism is released into the environment through known, proposed, or potential uses by collecting and using information on the type of release (such as in liquid or solid waste or during product use), the size of the release, how long it lasts, and where and how often a release is likely to happen.

Another important consideration for these scenarios is what happens to the living organism once it is in the environment. This involves investigating whether the organism can survive, reproduce, persist, or disperse in different environments. Other factors considered include how the organism may be diluted or retained in water, soil, water treatment plants, or other media, and the characteristics of the environments that the organism may enter. The exposure assessment also considers what species the organism can reach if it enters the environment as well as the ways that people can be exposed to it (notably by ingesting it, inhaling it, or absorbing it through the skin).

In addition, the assessment of exposure considers the procedures in place that might reduce the organism’s release into the environment, such as containment or confinement to a certain area. This aspect of assessment also examines contingency plans for managing accidental releases, recommended procedures for discontinuing the introduction of an organism, specific storage conditions, and other measures for minimizing exposure to a living organism.

Once completed, the hazard and exposure assessments are combined to identify and characterize any potential risks from the manufacture, import or use of the living organism. The risk assessment concludes by recommending measures to mitigate any potential risks identified.

CEPA allows notifiers to request waivers for any of the NSNR (Organisms) information requirements with a sound science-based rationale. These waiver requests are evaluated on a case-by-case basis and may be granted if any one of the following criteria are met: a) the information is not needed to determine whether the living organism is toxic or capable of becoming toxic; b) the living organism is to be used for a prescribed purpose or manufactured at a location where the living organism can be contained in ways that protect the environment and human health; or c) it is not practicable or feasible to obtain the test data necessary to generate the information.   

Duration of the risk assessment process

Risk assessments conducted under CEPA and the NSNR (Organisms) for a living organism take between 30 and 120 calendar days depending on the intended use and the notification schedule under which it was notified. The notifier cannot manufacture or import the organism before the assessment period has expired.

All living organism notifications are eligible to have their assessment periods extended when additional time is required to complete an assessment. The Minister of the Environment may extend the assessment period for a length of time not exceeding the time prescribed for the initial assessment period. The notifier will be issued a notice of extension of assessment period at or before the end of the initial assessment period, advising them that the assessment period has been extended.

Possible outcomes

1. If the organism is not determined to be toxic under CEPA, then the notifier can manufacture the living organism in or import it into Canada.
2. If the organism is not determined to be toxic under CEPA for the notified activities, but it is suspected that new or different activities involving the organism may result in toxicity, then additional information associated with these activities may be required for assessment prior to engaging in these activities.
3. If the organism is suspected of being toxic or capable of becoming toxic, the program may request additional information from the notifier or impose measures to manage any potential risks to the environment or human health in Canada.

Where to find more information

Guidance on the information required for a New Substances Notification can be found in the Guidelines for the Notification and Testing of New Substances: Organisms. The document Supplementary Guidance Document for the Notification and Testing of New Substances: Organisms Used in Cell and Gene Therapy under Schedule 1 of the New Substances Notification Regulations (Organisms) provides information specific to notifications about living organisms used for these purposes.

Summaries of risk assessment decisions by the program are also available.

For additional information, please contact the Substances Management Information Line.