Existing substances screening assessments: micro-organisms

Table of Contents

Background

Micro-organisms are broadly defined as bacteria, fungi, yeasts, protozoa, algae, viruses, eukaryotic cell culture, and any culture other than a pure culture.

The following are examples of products that may contain new and existing micro-organisms that may be subject to the Canadian Environmental Protection Act, 1999 (CEPA). Please note that these lists are not exhaustive.

Micro-organisms intended for use in:

Micro-organisms in products also subject to the Food and Drugs Act, including:

Screening assessments are a requirement under CEPA. Under paragraph 74(b), the Minister of the Environment and the Minister of Health are required to conduct screening assessments of the micro-organism strains on the Domestic Substances List (DSL) in order to determine whether they are “toxic” or capable of becoming “toxic” as defined under the Act.

Section 64 of the Act states that a substance 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; or
  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.

The DSL is a compilation of all reported substances (chemicals, polymers and micro-organisms) that were:

The Minister of the Environment is responsible for amendments to the DSL. The list currently contains about 23,000 chemicals, 67 microbial strains and 2 complex microbial cultures. Sixty eight micro-organisms currently on the list were nominated because of the commerce provisions described above and one complex microbial culture was added to the DSL following notification and risk assessment, in accordance with the New Substances Notifications Regulations (Organisms). A list of living organisms on the DSL can be accessed through Substances Search

Micro-organism strains currently on the DSL that have the potential to cause harm to human health or the environment must undergo a screening assessment under paragraph 74(b) of CEPA.

To establish whether micro-organisms on the DSL continue to be manufactured in or imported into Canada, a Notice with respect to animate substances (micro-organisms) on the Domestic Substances List (see page 6 in the PDF) pursuant to paragraph 71(1)(a) of CEPA was published in Part I of the Canada Gazette on October 3, 2009 for the 45 micro-organisms that were on the list in October 2009. Since then, 23 strains were added to the DSL and these were not subject to this notice.

Assessment Approach for Higher Hazard (Priority A) and Moderate Hazard (Priority B) Micro-organisms

The following diagram gives a summary of the screening assessment process.

Figure 1: Diagram (See long description below)
Long description of the diagram

Figure 1: The Screening Assessment Process

This flow chart outlines seven important steps in the screening assessment process for existing micro-organisms. The first step is Prioritization. The second step under the screening assessment process is the preparation of a joint Environment Canada and Health Canada screening assessment report. The various information sources used at this step to inform the assessment are shown as input from the left hand side of the flow chart. The sources listed are in-depth literature review, experimental data, section 71 notice, decisions from other jurisdictions and others. The third step under the screening assessment process is the internal scientific review. The fourth step is the external scientific review process. On the right hand side of the flow chart, the contribution of the Technical Expert Group to the screening assessment process is shown as inputs to steps one through four. That is the Technical Expert Group provides recommendations to the Government on prioritization, preparation of the joint draft screening assessment report, and the internal and external scientific review. The fifth step is the finalization of the draft screening assessment report. The sixth step under the screening assessment process is the publication of the draft screening assessment report in Canada Gazette Part 1 for a 60-day public comment period, along with the proposed risk management scope (as needed). The 60-day public comment period is shown as input from the right hand side of the sixth step. The seventh step is the publication of the final screening assessment report and the final risk management approach in Canada Gazette Part 1.

The micro-organism strains on the DSL will be assessed in order of priority. The criteria used to rank the priority of micro-organisms are described in the document "Prioritization of Micro-organism Strains on the Domestic Substances List prior to the Screening Assessment under paragraph 74(b) of CEPA".

The systematic steps used to conduct science-based risk assessments of micro-organisms is described in the document "Framework for Science-Based Risk Assessment of Micro-organisms" regulated under the Canadian Environmental Protection Act, 1999.

After the preparation of the draft screening assessment report, the report undergoes a scientific review by experts internal to Environment and Climate Change Canada and Health Canada followed by an external scientific review. The review process ensures that the screening assessment reports are scientifically sound, complete, and based on the most up-to-date information.

The Technical Expert Group (TEG) is a multi-stakeholder group that contributed to the implementation of the screening assessment of micro-organisms since 2007 and provides advice to the government on scientific and technical issues pertaining to the screening assessment. Members represent environment non-government organizations, health non-government organizations, other government departments, industry and academia. The TEG progress reports are available on request.

Proposed Measures

Environment and Climate Change Canada (ECCC) and Health Canada publish a summary of the screening assessment report in the Canada Gazette, Part I, along with the proposed measure. The proposed measure could take the form of one of the following recommendations:

The public is invited to comment on the proposed conclusion for a 60-day period, after which the public’s comments are reviewed and addressed.

ECCC and Health Canada then publish the final assessment conclusion and final measure in the Canada Gazette, Part I.

Even though a micro-organism strain on the DSL can be found to be “not toxic” under CEPA , a Significant New Activity (SNAc) notice can still be issued for the living organism by ECCC and Health Canada. A notice can be issued when the use of a substance or other activity will result or may result in:

SNAc notices are published when there is a suspicion that an alternative use of the living organism may result in the organism becoming toxic. The Notice communicates the criteria under which the government must be re-notified. The government assesses the new information on the substance to determine if it is toxic in relation to the SNAc.

Publication in Canada Gazette, Part I

The official Notices for Priority A and Priority B are published in the Canada Gazette, Part I to announce the Government’s proposed conclusions, followed by a 60-day public comment period. Public comments will be addressed before notice of the final conclusion is published in Canada Gazette, Part I. For more information, please visit the Government of Canada’s Chemical Substances Micro-organisms webpage.

Assessment Approach for Lower-Hazard (Priority C) Micro-Organisms on the Domestic Substances List (DSL)

Introduction

Under paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health are required to conduct screening assessments of living organisms added to Domestic Substances List (DSL) under section 105 of CEPA (List of Organisms on the Domestic Substances List) to determine whether they present or may present a risk to the environment or human health. For more details on the screening assessment process, please refer to the General Information on the Screening Assessments of Micro-organisms or to the Micro-organisms webpage.

Lower-hazard (Priority C) DSL micro-organisms were identified for expedited assessment because of a lack of evidence of pathogenicity or toxicity to species, including humans, or of adverse ecological effects. The following diagram gives a summary of the screening assessment process for lower-hazard (Priority C) micro-organisms.

 

Figure 2: Flow chart (See long description below)
Long description of the flow chart

Figure 2: This flow chart outlines six important steps in the screening assessment process for existing micro-organisms that have been deemed low concern for human health and the environment.

The first step is Prioritization.

The second step under the screening assessment process is the grouping of the Priority C micro-organisms into batches for assessment.

The third step under the screening assessment process is the preparation of the draft screening assessment report.

The various information sources used at this step to inform the assessment are shown as input from the left hand side of the flow chart. The sources listed are in-depth literature review and the section 71 notice (also referred to as the Survey).

The fourth step is the scientific peer review process.

The fifth step under the screening assessment process is the publication of the summary of the draft screening assessment report in Canada Gazette, Part 1 for a 60-day public comment period, along with the proposed conclusion. The 60-day public comment period is shown as input from the right hand side of the fifth step.

The sixth step is the publication of the summary of the final screening assessment report and the final conclusion in Canada Gazette, Part I.

Prioritization

There are 68 organisms currently on the Domestic Substances List (DSL). As described in the document "Prioritization of Micro-organisms on the DSL prior to the Screening Assessment under paragraph 74(b) of CEPA", these organisms were prioritized into three groups (Priority A, B, C) based on a review of pathogen lists and the scientific literature against the following criteria:

i. Pathogenicity or toxicity for humans
ii. Pathogenicity or toxicity to non-human species
iii. Potential for adverse ecological effects

Twenty-seven micro-organisms were considered to be of lower hazard (Priority C) because of a lack of evidence of pathogenicity or toxicity to species, including humans, or of adverse ecological effects. Therefore, these were identified for expedited assessment.

Lots

Within the lower-hazard (Priority C) group, micro-organisms were further sub-divided into ‘Lots’ for assessment according to their taxonomic classification (genus or species) and known and potential uses related to their biological properties (Table 1). All the lower-hazard (Priority C) micro-organisms that were confirmed to be in Canadian commerce by the Notice [under section 71 of Canadian Environmental Protection Act, 1999 (CEPA)] with respect to animate substances (micro-organisms) on the DSL, published in the Canada Gazette, Part I: Vol. 143, No. 40 - October 3, 2009 (see page 6 in the PDF) were grouped in Lots 1 and 2 to be assessed before those in Lots 3 and 4, which appear no longer to be in commerce (Table 1).

Table 1: Priority C Lots

Lot #1
Organism Strain/Accession Number
Nitrobacter winogradskyi ATCC 25391
Nitrobacter species 18132-6Table note[*]
Nitrobacter species 16969-4[*]
Nitrosomonas europaea ATCC 25978
Nitrosomonas species 16968-3[*]
Nitrosomonas species 18133-7[*]
Rhodopseudomonas palustris ATCC 17001
Rhodopseudomonas species 18136-1[*]
Lot #2
Organism Strain/Accession Number
Paenibacillus polymyxa ATCC 842
Paenibacillus polymyxa ATCC 55407
Paenibacillus polymyxa 13540-4[*]
Nitrococcus species 16972-7[*]
Nitrosococcus species 16971-6[*]
Alteromonas species 18116-8[*]
Lot #3
Organism Strain/Accession Number
Cellulomonas biazotea ATCC 486
Cellumonas species 18130-4[*]
Arthrobacter globiformis ATCC 8010
Alcaligenes  species 18115-7[*]
Micrococcus species 18125-8[*]
Thiobacillus species 18128-2[*]
Lot #4
Organism Strain/Accession Number
Bacillus species 1 18120-3[*]
Bacillus species 3 18119-2[*]
Bacillus species 5 18122-5[*]
Pseudomonas denitrificans ATCC 13867
Pseudomonas species 1 18117-0[*]
Pseudomonas species 3 18126-0[*]
Pseudomonas species 4 18127-1[*]

Preparation of Draft Screening Assessment Report (DSAR)

The "Framework for Science-Based Risk Assessment of Micro-Organisms Regulated under the Canadian Environmental Protection Act, 1999" outlines the elements considered in the risk assessment of micro-organisms, regardless of assigned priority. Features that are particular to the assessment of lower-hazard (Priority C) micro-organisms are described below.

Hazard Assessment

A review of the biological and ecological properties of the micro-organism is performed to confirm its low hazard potential (i.e., identification of potential virulence factors or characteristics that could permit the organism to adversely affect human health or the environment). If evidence of significant hazard is identified, the micro-organism is removed from the Lot and appropriately reprioritized for further assessment.

Exposure Assessment

The exposure assessment considers exposure from the deliberate addition of the micro-organism to consumer or commercial products or its use in industrial processes in Canada, using conservative assumptions that are protective of the environment and human health. Sources of exposure are identified from known uses, including uses identified through any section 71 Notice under Canadian Environmental Protection Act, 1999 (CEPA), and uses predicted from industry information, the scientific literature, patent searches and the biological characteristics of the micro-organism. Exposure to the environment is characterized through consideration of probable sites of release, characteristics of the receiving environments, and the ability of the micro-organisms to survive, reproduce, persist or disperse in ecological niches available there. Human exposure is characterized through consideration of routes of direct exposure through known and predicted uses and indirect exposure resulting from release of the micro-organism into the environment.

Risk Characterization

Risks are characterized as low when no adverse effects attributable to the micro-organism from known and probable exposure scenarios are likely.

Considerations

This approach is consistent with the principles of the Framework mentioned above, including the use of weight of evidence in assessing hazard and the use of conservative assumptions that are protective of the environment and human health in assessing exposure to lower-hazard (Priority C) micro-organisms. Uncertainties always exist and if new information becomes available it will be considered. Such information may be identified from a number of different sources, including:

Scientific Peer Review

The draft screening assessment reports undergo a scientific peer review. The review process ensures that the screening assessment reports are scientifically sound, complete, and based on the most up-to-date information.

Publication in Canada Gazette, Part I

An official Notice for each lower-hazard (Priority C) Lot will be published in the Canada Gazette, Part I, to announce the Government’s proposed conclusions, followed by a 60-day public comment period. Public comments will be addressed before notice of the final conclusion is published in Canada Gazette, Part I. A Draft Screening Assessment Report and Public Summary for Lot 1 were published on the Government of Canada’s Chemical Substances website.

Contact Information

If you have questions or comments, please Contact us. Indicate on the envelope or subject line "Screening Assessment of Existing Micro-organisms Inquiry".

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