Proposed Registration Decision PRD2020-04, Bacillus amyloliquefaciens strain FZB42 and AmyProtec 42
Pest Management Regulatory Agency
4 June 2020
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2020-4E-PDF (PDF version)
This page is a summary of the consultation document. If you would like to comment, please request the full consultation document.
To obtain a full copy of Proposed Registration Decision PRD2020-04, Bacillus amyloliquefaciens strain FZB42 and AmyProtec 42 please contact our publications office.
Should you require further information please contact the Pest Management Information Service.
Table of Contents
- Proposed registration decision for Bacillus amyloliquefaciens strain FZB42
- What does Health Canada consider when making a registration decision?
- What is Bacillus amyloliquefaciens strain FZB42?
- Health considerations
- Environmental considerations
- Value considerations
- Measures to minimize risk
- Next steps
- Other information
Proposed registration decision for Bacillus amyloliquefaciens strain FZB42
Health Canada’s Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act, is proposing registration for the sale and use of Bacillus amyloliquefaciens strain FZB42 Technical and AmyProtec 42, containing the technical grade active ingredient Bacillus amyloliquefaciens strain FZB42. AmyProtec 42 is proposed for partial suppression of common scab (Streptomyces scabies) on potato and basal bulb rot (Fusarium oxysporum) on garlic.
An evaluation of available scientific information found that, under the approved conditions of use, the health and environmental risks and the value of the pest control products are acceptable.
This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2020-04, Bacillus amyloliquefaciens strain FZB42 and AmyProtec 42 provides detailed technical information on the human health, environmental and value assessments of Bacillus amyloliquefaciens strain FZB42 and AmyProtec 42.
What does Health Canada consider when making a registration decision?
The key objective of the Pest Control Products Act is to prevent unacceptable risks to people and the environment from the use of pest control products. Health or environmental risk is considered acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from use or exposure to the product under its proposed conditions of registration. The Act also requires that products have value when used according to the label directions. Conditions of registration may include special precautionary measures on the product label to further reduce risk.
To reach its decisions, the PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (for example, children) as well as organisms in the environment. These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides.
For more information please refer to the following:
- Protecting Your Health and the Environment
- Pesticide Registration Process
- Pesticide Risk Reduction Program.
Before making a final registration decision on Bacillus amyloliquefaciens strain FZB42 and AmyProtec 42, Health Canada’s PMRA will consider any comments received from the public in response to PRD2020-04. Health Canada will then publish a Registration Decision on Bacillus amyloliquefaciens strain FZB42 and AmyProtec 42, which will include the decision, the reasons for it, a summary of comments received on the proposed registration decision and Health Canada’s response to these comments.
For more details on the information presented in this summary, please refer to the Science Evaluation of PRD2020-04.
What is Bacillus amyloliquefaciens strain FZB42?
Bacillus amyloliquefaciens strain FZB42 is the active ingredient in the product AmyProtec 42 Microbial Fungicide, a product for seed treatment or in-furrow spray to partially suppress common scab on potato, and for soil drench application to partially suppress basal bulb rot on garlic. It is a Gram-positive bacterium that may break up the pathogen cell membranes. Moreover, its bacterial metabolites may trigger induced systemic resistance (ISR) in the treated crops, which protect crops against certain diseases.
Can approved uses of Bacillus amyloliquefaciens strain FZB42 affect human health?
Bacillus amyloliquefaciens strain FZB42 is unlikely to affect your health when AmyProtec 42 is used according to the label directions.
Potential exposure to Bacillus amyloliquefaciens strain FZB42 may occur when handling and applying AmyProtec 42 and when ingesting treated produce. When assessing health risks, several key factors are considered:
- the microorganism’s biological properties (for example, infection cycle);
- reports of any adverse incidents;
- its potential to cause disease or toxicity as determined in toxicological studies; and
- the level to which people may be exposed relative to exposures already encountered in nature to other isolates of this microorganism.
The levels used to assess risks are established to protect the most sensitive human population (for example children and nursing mothers). As such, sex and gender are taken into account in the risk assessment. Only uses that are determined as having no health risks of concern are considered acceptable for registration.
Studies in laboratory animals describe potential health effects from large doses of exposure to a microorganism and identify any pathogenicity, infectivity and toxicity concerns. When a formulation that is toxicologically equivalent to AmyProtec 42 was tested on laboratory animals, there was low toxicity following oral, pulmonary and dermal exposures and no dermal irritation. Furthermore, there was no sign that the microbial pest control agent, B. amyloliquefaciens strain FZB42 caused any disease.
Residues in water and food
Dietary risks from food and water are acceptable
Residues of Bacillus amyloliquefaciens strain FZB42 on treated crops are possible at the time of harvest. While B. amyloliquefaciens and its close relatives, B. subtilis and B. licheniformis, are abundant in nature, only a few cases involving foodborne illness in people have been reported and only with isolates that are able to produce a toxin which is not known to be produced by B. amyloliquefaciens strain FZB42. Agricultural practices of washing these crops following harvest are expected to reduce the potential for dietary exposure to residues of B. amyloliquefaciens strain FZB42. Furthermore, no signs of infectivity or toxicity were observed when B. amyloliquefaciens strain FZB42 was tested on laboratory animals. In addition, the likelihood of residues of B. amyloliquefaciens strain FZB42 contaminating drinking water supplies from the proposed media drench, in-furrow and seed treatment applications of AmyProtec 42 on food crops is low. Consequently, dietary risks are acceptable.
Risks in residential and other non-occupational environments
Estimated risk for non-occupational exposure is acceptable.
AmyProtec 42 is proposed for use on agricultural field crops. The product label includes measures to prevent bystander exposure such as reducing spray drift and restricting access to the treated area for 4 hours or until sprays have settled. Residential and non-occupational exposure to AmyProtec 42 is therefore expected to be low when the label directions are observed. Consequently, the risk to residents and the general public is acceptable.
Occupational risks from handling AmyProtec 42
Occupational risks are acceptable when AmyProtec 42 is used according to label directions, which include protective measures.
Workers handling AmyProtec 42 can come into direct contact with Bacillus amyloliquefaciens strain FZB42 on the skin, in the eyes or by inhalation. To protect workers from exposure to AmyProtec 42, the label will specify that mixers, loaders and applicators must wear waterproof gloves, a long-sleeved shirt, long pants, goggles, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes. A restricted-entry interval of 4 hours or until sprays are settled is required, and if re-entry into treated areas is necessary during this restricted-entry interval, workers must wear the above personal protective equipment.
What happens when Bacillus amyloliquefaciens strain FZB42 is introduced into the environment?
Environmental risks are acceptable.
Bacillus amyloliquefaciens is a common microorganism that is widely distributed in the natural environment. Its habitat is predominantly soil, including soils in water columns and bottom deposits in aquatic environments. Information on the environmental fate of B. amyloliquefaciens strain FZB42 suggests that, as a soil microorganism, it is likely to readily survive after applications of AmyProtec 42 to agricultural field crops, but that over time its population should return to naturally sustainable levels.
The proposed uses of AmyProtec 42 are not expected to result in sustained increases of Bacillus amyloliquefaciens strain FZB42 in terrestrial and aquatic environments beyond natural background levels.
There are no published reports of disease associated with natural populations of Bacillus amyloliquefaciens in birds, wild mammals, fish, terrestrial and aquatic arthropods, terrestrial and aquatic non-arthropod invertebrates, or terrestrial and aquatic plants. Also, the applicant submitted studies designed to examine the effects of B. amyloliquefaciens strain FZB42 to birds, bees, terrestrial arthropods, earthworms, soil microorganisms, horticultural crops, fish, aquatic arthropods, and aquatic plants. No adverse effects were observed in birds, earthworms, soil microorganisms, horticultural crops, fish, aquatic arthropods, or aquatic plants. There were toxic and sublethal effects noted in bees and one other species of terrestrial arthropod; however, these effects occurred at levels that exceed estimated exposure levels when AmyProtec 42 is used according to the label.
Based on a critical review of applicant-submitted data and information from public sources, no significant effects to birds, bees, arthropods, wild mammals, soil microorganisms, fish, or plants are expected when AmyProtec 42 is applied according to directions on the label.
What is the value of AmyProtec 42 microbial fungicide?
Bacillus amyloliquefaciens strain FZB42, the active ingredient in AmyProtec 42 Microbial Fungicide, partially suppresses common scab on potato and basal bulb rot on garlic.
AmyProtec 42 Microbial Fungicide, applied as a seed treatment or in-furrow spray, is effective for the partial suppression of common scab on potato. It also partially suppresses basal bulb rot on garlic when applied as a soil drench application. AmyProtec 42 provides Canadian users with a product to manage these important diseases on potato and garlic.
Measures to minimize risk
Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human and environmental health. These directions must be followed by law.
The key risk-reduction measures being proposed on the labels of the technical grade active ingredient, Bacillus amyloliquefaciens strain FZB42 Technical and the end-use product, AmyProtec 42, to address the potential risks identified in this assessment are as follows.
Key risk-reduction measures
All microorganisms, including Bacillus amyloliquefaciens strain FZB42, contain substances that are potential sensitizers and thus, sensitivity may possibly develop in individuals exposed to potentially large quantities of B. amyloliquefaciens strain FZB42. In turn, workers handling or applying AmyProtec 42 must wear waterproof gloves, a long-sleeved shirt, long pants, goggles, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes. Furthermore, all unprotected workers are restricted from entering treated areas during application and for 4 hours following application or until sprays have settled.
The end-use product label will include environmental precaution statements to prohibit aerial application, limit drift, and reduce contamination of aquatic systems from the use of AmyProtec 42.
Before making a final registration decision on Bacillus amyloliquefaciens strain FZB42 and AmyProtec 42, Health Canada’s PMRA will consider any comments received from the public in response to PRD2020-04. Health Canada will accept written comments on PRD2020-04 up to 45 days from the date of publication of this document.
Please forward all comments to Publications. Health Canada will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed decision and Health Canada’s response to these comments.
When the Health Canada makes its registration decision, it will publish a Registration Decision on Bacillus amyloliquefaciens strain FZB42 and AmyProtec 42 (based on the Science Evaluation of PRD2020-04). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).
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