Proposed Registration Decision PRD2022-08, cis-Jasmone and Trunemco

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Pest Management Regulatory Agency
30 June 2022
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2022-8E-PDF (PDF version)

Summary

Table of contents

• Proposed registration decision for cis-Jasmone
• What does Health Canada consider when making a registration decision?
• What is cis-Jasmone?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for cis-Jasmone

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 Jasmone Technical Concentrate and Trunemco, containing the technical grade active ingredient cis-jasmone, to be used as a seed treatment in soybean, field corn, popcorn and sweet corn.

Trunemco also contains Bacillus amyloliquefaciens strain MBI 600 (previously classified as Bacillus subtilis strain MBI 600), which is currently registered for use as a seed treatment. For details, see Proposed Registration Decision PRD2009-17, Bacillus subtilis strain MBI 600 and Integral Liquid Biological Fungicide, and Registration Decision RD2010-04, Bacillus subtilis strain MBI 600 and Integral Liquid Biological Fungicide.

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 PRD2022-08, cis-Jasmone and Trunemco provides detailed technical information on the human health, environmental and value assessments of cis-jasmone and Trunemco.

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^{Footnote 1} 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^{Footnote 2} 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 cis-jasmone and Trunemco, Health Canada’s PMRA will consider any comments received from the public in response to t PRD2022-08.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on cis-jasmone and Trunemco, 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 PRD2022-08.

What is cis-Jasmone?

cis-Jasmone is a biochemical plant nematicide product able to activate a plant’s internal defense system against nematode attacks and can prime treated seed by stimulating expression of genes resistant to nematode infection. In turn, Bacillus amyloliquefaciens may induce systemic resistance through the production of bacterial metabolites that protect plants against attacks of pathogenic microbes, viruses and nematodes. The combination of these two active ingredients supresses certain nematodes and provides a consistent yield benefit in soybean and corn.

Health considerations

Can approved uses of cis-Jasmone affect human health?

cis-Jasmone is unlikely to affect human health when it is used according to label directions.
Potential exposure to cis-jasmone may occur through the diet (food and water) or when handling the product or when handling and planting treated seeds. When assessing health risks, two key factors are considered:

• the levels where no health effects occur and
• the levels to which people may be exposed.

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 for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose where no effects are observed.

In laboratory animals, cis-jasmone was considered to be of low acute toxicity by the oral, dermal, and inhalation routes, minimally irritating to the eyes and skin, and not a dermal sensitizer.

Short-term dermal toxicity testing, prenatal developmental toxicity testing, and genotoxicity/mutagenicity testing, as well as information from published scientific literature on cis-jasmone were also assessed. Adverse effects in animals given repeated high doses of cis-jasmone resulted in skin irritation. There was no indication that the young were more sensitive than the adult animal. cis-Jasmone is not considered genotoxic or mutagenic.

In laboratory animals, the end-use product, Trunemco, was considered to be of low acute toxicity by the oral, dermal, and inhalation routes, minimally irritating to the eye and slightly irritating to the skin. Since Trunemco contains a microbial pest control agent, Bacillus amyloliquefaciens strain MBI 600, the end-use product is considered a potential sensitizer. The Trunemco label also requires a soy allergen warning statement.

Residues in water and food

Dietary risks from food and water are acceptable.

Based on the proposed use pattern as seed treatment, there is no direct application of Trunemco to the edible portions of the plants, and residues are not expected to be present on the harvested crops. In addition, the likelihood of residues of cis-jasmone in drinking water will be very low. Consequently, health risks are acceptable for all segments of the population, including infants, children, adults and seniors.

Risks in residential and other non-occupational environments

Estimated risk for residential and other non-occupational exposure is acceptable.

Trunemco will only be applied to seed in commercial seed treatment facilities, therefore, bystander exposure is not expected to occur. There are no residential uses of the product. Residential and non-occupational exposure to Trunemco is expected to be low when label directions are observed. Consequently, the risk to residents and the general public is acceptable.

Occupational risks from handling Trunemco

Occupational risks are acceptable when Trunemco is used according to the label directions, which include protective measures.

Workers handling Trunemco can come into direct contact with cis-jasmone on the skin or by inhalation during handling, loading, clean-up and repair, bagging, sewing, stacking, as well as during handling and planting of treated seeds. Minimal eye exposure is also possible.

To protect workers from exposure to Trunemco, the label requires workers to wear a long-sleeved shirt, long pants, waterproof gloves, socks and shoes and a NIOSH-approved particulate filtering facepiece respirator with any N, R or P filter during handling, loading, clean-up and repair, bagging, sewing, stacking, as well as during handling and planting of treated seeds.

Treated seed must be labelled or tagged with instructions for workers handling seed outside of the seed treatment facility.

The occupational risks are acceptable when the precautionary statements on the label are observed.

Environmental considerations

What happens when cis-jasmone is introduced into the environment?

cis-Jasmone is a natural product in plants and is ubiquitous in the environment. Jasmone Technical Concentrate, containing two isomeric forms of jasmone, cis-jasmone (93%) and trans-jasmone (6.9%), enters the environment when the end-use product Trunemco is applied as a seed treatment nematicide for soybean and corn. trans-Jasmone is a minor component of Jasmone Technical Concentrate; it is not considered in this assessment. cis-Jasmone is found as a natural element in the volatile portion of plant essential oils. Like other terpenoid compounds, cis-jasmone is expected to be rapidly broken down by microorganisms; thus, cis-jasmone is non-persistent in nature and not likely to travel long distances from where it is applied, or to accumulate in tissues of plants or animals.

When used according to label directions, cis-jasmone poses acceptable risks to terrestrial organisms, and potential exposure to aquatic systems from its use on seeds is not expected.

Value considerations

What is the value of Trunemco?

The registration of Trunemco will provide Canadian growers with a new product to manage root-knot nematode in corn, or soybean cyst nematode in soybean, which can cause serious crop and economic losses.

Trunemco is applied as a seed treatment to protect soybean and corn from root damage caused by parasitic soybean cyst nematode or root-knot nematode.

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 Jasmone Technical Concentrate and Trunemco to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures

Human health

The hazard signal words “WARNING: Contains the allergen soy” are required on the principal display panel of the label for Trunemco. Since Trunemco also contains a microbial pest control agent, which is considered to be a potential sensitizer, the hazard statement “POTENTIAL SENSITIZER” is required on the principal display panel. Standard precautionary statements are also required on the end-use product label to avoid eye and skin contact and inform of the potential for sensitization.

Workers handling, loading, and performing clean-up and repair, and during all other activities involving the handling of treated seeds will be required to wear a long-sleeved shirt, long pants, waterproof gloves, socks and shoes and a NIOSH-approved particulate filtering facepiece respirator with any N, R or P filter.

To limit worker and residential bystander exposure, Trunemco and treated seed must be handled in a way that both do not come in contact with workers or residential bystanders. Additionally, only workers wearing personal protective equipment may be in the area where treating, bagging, sewing, stacking or loading for transport is occurring.

Treated seed must be labelled or tagged with instructions for workers handling seed outside of the seed treatment facility.

Next steps

Before making a final registration decision on cis-jasmone and Trunemco, Health Canada’s PMRA will consider any comments received from the public in response to PRD2022-08. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2022-08. 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 cis-jasmone and Trunemco (based on the Science Evaluation of PRD2022-08). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA’s Reading Room. For more information, please contact the PMRA’s Pest Management Information Service.

Footnotes