Proposed Registration Decision PRD2020-07, Bacillus amyloliquefaciens strain PTA-4838 and AVEO EZ Nematicide

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Pest Management Regulatory Agency
15 June 2020
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2020-7E-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 PRD2020-07, Bacillus amyloliquefaciens strain PTA-4838 and AVEO EZ Nematicide please contact our publications office.

Should you require further information please contact the Pest Management Information Service.

Summary

Table of Contents

Proposed registration decision for Bacillus amyloliquefaciens strain PTA 4838

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 AVEO Technical Powder and AVEO EZ Nematicide, containing the technical grade active ingredient Bacillus amyloliquefaciens strain PTA-4838, as a seed treatment for early season protection against particular parasitic nematodes on corn and soybeans.

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 PRD2020-07, Bacillus amyloliquefaciens strain PTA-4838 and AVEO EZ Nematicide provides detailed technical information on the human health, environmental and value assessments of Bacillus amyloliquefaciens strain PTA-4838 and AVEO EZ Nematicide.

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:

Before making a final registration decision on Bacillus amyloliquefaciens strain PTA-4838 and AVEO EZ Nematicide, Health Canada’s PMRA will consider any comments received from the public in response to PRD2020-07. Health Canada will then publish a Registration Decision on Bacillus amyloliquefaciens strain PTA-4838 and AVEO EZ Nematicide, 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 PRD2020-07.

What is Bacillus amyloliquefaciens strain PTA-4838?

Bacillus amyloliquefaciens strain PTA-4838 is a naturally present root colonizing bacterium. It produces enzymes that may impact certain parasitic nematodes. The exact mode of action is unknown.

Health considerations

Can approved uses of Bacillus amyloliquefaciens strain PTA-4838 affect human health?

Bacillus amyloliquefaciens strain PTA-4838 is unlikely to affect your health when AVEO EZ Nematicide is used according to the label directions.

Potential exposure to Bacillus amyloliquefaciens strain PTA-4838 may occur when handling and applying AVEO EZ Nematicide. When assessing health risks, several key factors are considered:

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.

Toxicology 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 AVEO EZ Nematicide was tested on laboratory animals, there was low toxicity following oral, inhalation and dermal exposures, no dermal irritation and minimal eye irritation. Furthermore, there was no sign that the microbial pest control agent, Bacillus amyloliquefaciens strain PTA-4838, caused any disease.

Residues in water and food

Dietary risks from food and water are acceptable.

Based on the lack of dietary exposure resulting from the proposed use of AVEO EZ Nematicide, the health risks are acceptable for all segments of the population, including infants, children, adults and seniors. Even in the event of exposure, the health risk is acceptable since there were no signs that it caused any significant toxicity or disease in studies on laboratory animals.

Occupational risks from handling AVEO EZ Nematicide

Occupational risks are acceptable when AVEO EZ Nematicide is used according to label directions, which include protective measures.

Workers handling AVEO EZ Nematicide can come into direct contact with Bacillus amyloliquefaciens strain PTA-4838 on the skin, by inhalation, or in the eyes. To protect workers from exposure to AVEO EZ Nematicide, the label states that workers must wear personal protective equipment, including waterproof gloves, long-sleeved shirt, long pants, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes.

Risks in residential and other non-occupational environments

Estimated risk for non-occupational exposure is acceptable.

AVEO EZ Nematicide is proposed for use as a commercial seed treatment in commercial facilities only. Residential and non-occupational exposure to AVEO EZ Nematicide is expected to be low when label directions are observed. Consequently, the risk to residents and the general public is acceptable.

Environmental considerations

What happens when Bacillus amyloliquefaciens strain PTA-4838 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. Under adverse conditions, this microorganism produces a resilient endospore that allows it to readily survive in soils, dusts and aerosols. If protected from sunlight, endospores may survive for very long periods.

No overt adverse effects to terrestrial and aquatic arthropods, birds or fish were observed during testing. AVEO EZ Nematicide is intended for use as seed treatments on corn (all types) and soybean. The end-use product isnot intended for aquatic uses and its use as a seed treatment is not expected to significantly increase the levels of this microorganism in soil. Exposure to aquatic environments is also expected to be low and limited to leaching and run-off after the seeds are sown in fields. While published scientific literature on the environmental fate of this species suggests that strain PTA-4838 will survive in soils and sediment under various environmental conditions, the populations of Bacillus amyloliquefaciens strain PTA-4838 in soil and sediment are expected to return to naturally sustainable levels.

Based on a critical review of studies, scientific rationales and information from public sources, no significant effects to birds, wild mammals, fish, terrestrial and aquatic arthropods, and plants are expected when AVEO EZ Nematicide is applied according to directions on the label.

Value considerations

What is the value of AVEO EZ Nematicide?

AVEO EZ Nematicide, containing Bacillus amyloliquefaciens strain PTA-4838, is a corn and soybean seed treatment product used for the partial suppression of certain parasitic nematodes.

This microbial product provides an additional option for managing nematodes when used as a part of an integrated pest management strategy that includes crop rotation and the use of nematode resistant varieties, such as those with resistance to soybean cyst nematode. AVEO EZ Nematicide is compatible with certain other chemical seed treatments.

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 label of AVEO Technical Powder and AVEO EZ Nematicide to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures

Human health

All microorganisms, including Bacillus amyloliquefaciens strain PTA-4838, contain substances that are potential sensitizers and thus, sensitivity may possibly develop in individuals exposed to potentially large quantities of Bacillus amyloliquefaciens strain PTA-4838. In turn, workers handling or applying AVEO EZ Nematicide must wear waterproof gloves, a long-sleeved shirt, long pants, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes.

Environment

The end-use product label will include environmental precaution statements to reduce contamination of aquatic systems from the use of AVEO EZ Nematicide.

Next steps

Before making a final registration decision on Bacillus amyloliquefaciens strain PTA-4838 and AVEO EZ Nematicide, Health Canada’s PMRA will consider any comments received from the public in response to PRD2020-07. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2020-07. 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.

Other information

When the Health Canada makes its registration decision, it will publish a Registration Decision on Bacillus amyloliquefaciens strain PTA-4838 and AVEO EZ Nematicide (based on the Science Evaluation of this consultation document). 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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