Registration Decision RD2023-01, Bacillus amyloliquefaciens strain F727 and Stargus Biofungicide
Pest Management Regulatory Agency
23 January 2023
ISSN: 1925-0940 (PDF version)
Catalogue number: H113-25/2023-1E-PDF (PDF version)
Table of contents
- Registration decision statement for Bacillus amyloliquefaciens strain F727
- Other information
- Evaluation approach
Under the authority of the Pest Control Products Act, pesticides must be assessed before they are sold or used in Canada in order to determine that they do not pose unacceptable risks to humans or the environment and have value when used according to the label instructions. The pre-market assessment considers available data and informationFootnote 1 from pesticide registrants, published scientific reports, other governments, and international regulatory agencies, as well as comments if received during public consultations. Health Canada applies internationally accepted current risk assessment methods as well as risk management approaches and policies. More details, on the legislative requirements, risk assessment and risk management approach, are provided under Evaluation Approach of this document.
Registration decision statementFootnote 2 for Bacillus amyloliquefaciens strain F727
Health Canada’s Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act, is granting registration for the sale and use of MBI-110 TGAI and Stargus Biofungicide, containing the technical grade active ingredient Bacillus amyloliquefaciens strain F727, to partially suppress grey mould on indoor-grown cannabis and to suppress or partially suppress certain economically important diseases on field-grown hemp, grape, tomato, potato, red (garden) beet, sugar beet, cabbage and Brussels sprouts.
The Proposed Registration Decision PRD2022-13, Bacillus amyloliquefaciens strain F727 and Stargus Biofungicide, containing the detailed evaluation of the information submitted in support of this registration, underwent a 45 day consultation period ending on 9 December 2022. The evaluation found that, under the approved conditions of use, the health and environmental risks and the value of the pest control products are acceptable. Health Canada received no comments on PRD2022-13 during the public consultation period conducted in accordance with section 28 of the Pest Control Products Act.
The relevant confidential test data on which the decision is based (as referenced in PRD2022-13) are available for public inspection, upon application, in the PMRA’s Reading Room. For more information, please contact the PMRA’s Pest Management Information Service.
Any person may file a notice of objectionFootnote 3 regarding this registration decision within 60 days from the date of publication of this Registration Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact the PMRA’s Pest Management Information Service.
The Minister of Health’s primary objective under the Pest Control Products Act subsection 4(1) is to prevent unacceptable risks to individuals and the environment from the use of pest control products.
As noted in the preamble of the Act, it is in the national interest that the attainment of the objectives of the federal regulatory system continue to be pursued through a scientifically-based national registration system that addresses risks to human health, the environment and value both before and after registration and applies to the regulation of pest control products throughout Canada; and that pest control products with acceptable risk and value be registered for use only if it is shown that their use would be efficacious and if conditions of registration can be established to prevent unacceptable risk impact to human health and the environment.
For the purposes of the Act, the health or environmental risks of a pest control product are acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from exposure to or use of the product, taking into account its conditions of registration as per subsection 2(2) of the Pest Control Products Act.
Risk for the human health and environment, and value are defined under the Act subsection 2(1) as follows:
- Health risk, in respect of a pest control product, means the possibility of harm to human health resulting from exposure to or use of the product, taking into account its conditions or proposed conditions of registration.
- Environmental risk, in respect of a pest control product, means the possibility of harm to the environment, including its biological diversity, resulting from exposure to or use of the product, taking into account its conditions or proposed conditions of registration.
- Value, in respect of a pest control product, means the product’s actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product’s (a) efficacy; (b) effect on host organisms in connection with which it is intended to be used; and (c) health, safety and environmental benefits and social and economic impact.
When evaluating the health and environmental risks of a pesticide and determining whether those risks are acceptable, subsection 19(2) of the Pest Control Products Act requires Health Canada to apply a scientifically-based approach. The science-based approach to assessing pesticides considers both the toxicity and the level of exposure of a pesticide in order to fully characterize risk.
Pre-market assessments are based on a required set of scientific data that must be provided by the applicants for pesticide registrations. Additional information from published scientific reports, other government departments and international regulatory agencies are also considered.Footnote 4
Risk and value assessment framework
Health Canada uses a comprehensive body of modern scientific methods and evidence to determine the nature as well as the magnitude of potential risks posed by pesticides. This approach allows for the protection of human health and the environment through the application of appropriate and effective risk management strategies, consistent with the purpose described in the preambular text set out above.
Health Canada’s approach to risk and value assessment is outlined in A Framework for Risk Assessment and Risk Management of Pest Control Products.Footnote 5 A high-level overview is provided below.
Assessing potential health risks
With respect to the evaluation and management of potential health risks, Health Canada's risk assessments follow a structured, predictable process that is consistent with international approaches and the Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks.Footnote 6
The evaluation of potential health risks begins with a consideration of the toxicological profile of a pesticide to establish reference doses at which no adverse effect is expected and against which the expected exposure is assessed. This includes, where appropriate, the use of uncertainty (protection) factors to provide additional protection that accounts for the variation in sensitivity among members of human population and the uncertainty in extrapolating animal test data to humans. Under certain conditions, the Pest Control Products Act requires the use of another factor to provide additional protection to pregnant women, infants, and children. Other uncertainty factors, such as a database deficiency factor, are considered in specific cases. More details related to the application of the uncertainty factors are provided in SPN2008-01.Footnote 7
Assessments estimate potential health risks to defined populationsFootnote 8 under specific exposure conditions. They are conducted in the context of the proposed or registered conditions of use, such as the use of a pesticide on a particular field crop using specified application rates, methods and equipment. Potential exposure scenarios consider exposures during and after application of the pesticide in occupational or residential settings, food and drinking water exposure, or exposure when interacting with treated pets. Also considered are the anticipated durations (short‑, intermediate- or long-term) and routes of exposure (oral, inhalation, or skin contact). In addition, an assessment of health risks must consider available information on aggregate exposure and cumulative effects.
Assessing risks to the environment
With respect to the evaluation of environmental risks, Health Canada's environmental risk assessments follow a structured, tiered approach to determine the likelihood that exposure to a pesticide can cause adverse effects on individual organisms, populations, or ecological systems. This involves screening assessments starting with simple methods, conservative exposure scenarios and sensitive toxicity effects metrics, then moving on, where required, to more refined assessments that can include exposure modelling, monitoring data, results from field or mesocosm studies, and probabilistic risk assessment methods.
The environmental assessment considers both the exposure (environmental fate, chemistry, and behaviour, along with the application rates and methods) and hazard (toxic effects on organisms) of a pesticide. The exposure assessment examines the movement of the pesticide in soil, water, sediments and air, as well as the potential for uptake by plants or animals and transfer through the food web. The possibility for the pesticide to move into sensitive environmental compartments such as groundwater or lakes and rivers, as well as the potential for atmospheric transport, is also examined. The hazard assessment examines effects on a large number of internationally recognized indicator species of plants and animals (terrestrial organisms include invertebrates such as bees, beneficial arthropods, and earthworms, birds, mammals, plants; aquatic organisms include invertebrates, amphibians, fish, plants and algae), and includes considering effects on biodiversity and the food chain. Acute and chronic effects endpoints are derived from laboratory and field studies that characterize the toxic response and the dose–effect relationship of the pesticide.
The characterization of environmental risk requires the integration of information on environmental exposure and effects to identify which, if any, organisms or environmental compartments may be at risk, as well as any uncertainties in characterizing the risk.
Value assessments consist of two components: an assessment of the performance of a pest control product and its benefits.
Assessing pesticide performance involves an evaluation of the pesticide’s efficacy in controlling the target pest and the potential for the pesticide to damage host crops or use sites. Where the efficacy of a pesticide is acceptable, the assessment serves to establish appropriate label claims and directions and an application rate (or rate range) that is effective without being excessive, and with no unacceptable damage to the use site or host organism/crop (and subsequent hosts or crops) under normal use conditions.
In many cases, proof of performance alone is sufficient to establish the value of the pesticide, so that an in-depth or extensive evaluation of benefits may not be required. However, a more thorough assessment of benefits may be undertaken in particular cases where performance alone does not sufficiently demonstrate value, or while developing risk management options.
The outcomes of the assessments of risks to human health and the environment, and the assessment of value, form the basis for identifying risk management strategies. These include appropriate risk mitigation measures and are a key part of decision-making on whether health and environmental risks are acceptable. The development of risk management strategies take place within the context of the pesticide’s conditions of registration. Conditions can relate to, among other things, the specific use (for example, application rates, timing and frequency of application, and method of application), personal protective equipment, pre-harvest intervals, restricted entry intervals, buffer zones, spray drift and runoff mitigation measures, handling, manufacture, storage or distribution of a pesticide. If feasible conditions of use that have acceptable risk and value cannot be identified, the pesticide use will not be eligible for registration.
The selected risk management strategy is then implemented as part of the registration decision. The pesticide registration conditions include legally-binding use directions on the label. Any use in contravention of the label or other specified conditions is illegal under the Pest Control Products Act. Implementation of post-market decisions follow the framework articulated in the Policy on Cancellations and Amendments Following Re-evaluation and Special Review.Footnote 9
Following a decision, continuous oversight activities such as post-market assessments, monitoring and surveillance, including incident reporting, all play an essential role to help ensure the continued acceptability of risks and value of registered pesticides.
- Footnote 1
Information Note – Determining Study Acceptability for use in Pesticide Risk Assessments.
- Footnote 2
“Decision statement” as required by subsection 28(5) of the Pest Control Products Act.
- Footnote 3
As per subsection 35(1) of the Pest Control Products Act.
- Footnote 4
Information Note – Determining Study Acceptability for use in Pesticide Risk Assessments.
- Footnote 5
PMRA Guidance Document, A Framework for Risk Assessment and Risk Management of Pest Control Products
- Footnote 6
Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks - August 1, 2000
- Footnote 7
Science Policy Note: The Application of Uncertainty Factors and the Pest Control Products Act Factor in the Human Health Risk Assessment of Pesticides
- Footnote 8
Consideration of Sex and Gender in Pesticide Risk Assessment
- Footnote 9
PMRA Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review.
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