Proposed Registration Decision PRD2019-11, Octanoic Acid, Decanoic Acid, and BioLink Herbicide EC

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Pest Management Regulatory Agency
23 September 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-11E-PDF (PDF version)

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To obtain a full copy of Proposed Registration Decision PRD2019-11, Octanoic Acid, Decanoic Acid, and BioLink Herbicide EC please contact our publications office.

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Summary

Table of Contents

Proposed Registration Decision for Octanoic Acid, Decanoic Acid, and BioLink Herbicide EC

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 BioLink FA Blend, and BioLink Herbicide EC, containing the technical grade active ingredients octanoic acid (also known as caprylic acid) and decanoic acid (also known as capric acid), for non-selective, post-emergent weed control in and around food and non-food crop areas, as well as non-agricultural and industrial sites.

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 PRD2019-11, Octanoic Acid, Decanoic Acid, and BioLink Herbicide EC provides detailed technical information on the human health, environmental and value assessments of octanoic acid, decanoic acid, and BioLink Herbicide EC.

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 octanoic acid, decanoic acid, and BioLink Herbicide EC, Health Canada’s PMRA will consider any comments received from the public in response to this PRD2019-11. Health Canada will then publish a Registration Decision on octanoic acid, decanoic acid, and BioLink Herbicide EC, 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 PRD2019-11.

What Are Octanoic Acid and Decanoic Acid?

Octanoic acid and decanoic acid are non-conventional, non-selective contact herbicides that act by disrupting cell membranes, resulting in the leakage of cell contents followed by plant tissue death.

Health Considerations

Can Approved Uses of Octanoic Acid and Decanoic Acid Affect Human Health?

Octanoic Acid and Decanoic Acid are unlikely to affect human health when it is used according to label directions.

Potential exposure to octanoic acid and decanoic acid may occur through the diet (food and water) or when handling and applying the product. When assessing health risks, two 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 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, the end-use product, BioLink Herbicide EC, was of low toxicity via the oral, dermal and inhalation routes. It was mildly irritating to the skin, moderately irritating to the eyes, and was not considered a dermal sensitizer.

Scientific rationales, as well as information from the published scientific literature, were assessed for the potential of octanoic acid and decanoic acid to cause short-term toxicity, developmental toxicity, genotoxicity, and various other effects. Octanoic acid and decanoic acid are naturally occurring fatty acids. Adverse effects in animals given repeated high doses included effects on the stomach, and reductions in body weights and food consumption. There was no indication that the young were more sensitive than the adult animal. There was no evidence that octanoic acid and decanoic acid induced mutagenic or genotoxic effects. The risk assessment protects against these findings noted above as well as any other potential effects by ensuring that the level of exposure to humans is well below the lowest dose at which these effects occurred in animal tests.

Residues in Water and Food

Dietary risks from food and water are acceptable.

Although proposed for use on field and greenhouse food crops, BioLink Herbicide EC is directed to soil. Residues of octanoic acid and decanoic acid on treated food crops are possible at the time of harvest; however, toxicity to these active ingredients is low. In addition, the likelihood of residues of octanoic acid and decanoic acid in drinking water will be 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.

BioLink Herbicide EC is proposed for use on agricultural fields and residential areas. The product label will include measures to prevent bystander exposure such as reducing spray drift and restricting access to the treated area until sprays have dried. Residential and non-occupational exposure to BioLink Herbicide EC is therefore expected to be low when label directions are observed. Consequently, the risk to residents and the general public is acceptable.

Occupational Risks From Handling BioLink Herbicide EC

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

Workers handling BioLink Herbicide EC can come into direct contact with octanoic acid and decanoic acid primarily on the skin and eyes. To protect workers from exposure to BioLink Herbicide EC, the label states that mixers, loaders, and applicators must wear chemical-resistant gloves, goggles or face shield, long-sleeved shirt, long pants, and socks and shoes. A restricted-entry interval of 24 hours is prescribed for treated agricultural sites, and re-entry is restricted until the sprays have dried for non-agricultural uses. If re-entry into treated agricultural sites is necessary during the restricted-entry interval, workers must wear chemical-resistant gloves, goggles or face shield, long-sleeved shirt, long pants, socks and shoes. If re-entry into treated non-agricultural sites is required before sprays have dried, individuals must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes.

Environmental Considerations

What Happens When Octanoic and Decanoic acids Are Introduced Into the Environment?

Octanoic acid and decanoic acid may enter the environment when BioLink Herbicide EC is used to control weeds around ornamental plants, turf, greenhouses and other food and non-food crops. Octanoic acid and decanoic acid are fatty acids that are soluble in water and can enter the atmosphere. In air, they are expected to breakdown very quickly or be removed by rain. Octanoic and decanoic acids are not expected to move through soil to groundwater. Fatty acids are a natural component in soil and water in the environment, and are broken down very quickly in soil and water by microorganisms. Build-up in the environment and long-term effects on plants and animals are not expected.

In general, fatty acids comprise a significant part of the normal daily diet of mammals, birds and terrestrial invertebrates. Octanoic and decanoic acids do not pose a risk of concern to bees, beneficial arthropods, birds and wild mammals.

Exposure to octanoic and decanoic acids can affect aquatic invertebrates, amphibians, and terrestrial plants. However, proposed application methods including spot treatment, directed or broadcast applications using shielded nozzles, and coarse spray will prevent drift to non-target organisms. Owing to the rapid dissipation in the environment, exposure to aquatic organisms from run-off is also not expected.

After a scientific review of the available information, the environmental risks associated with the proposed uses of BioLink FA Blend and its associated end-use product, BioLink Herbicide EC, have been determined to be acceptable when used according to the proposed label directions.

Value Considerations

What Is the Value of BioLink Herbicide EC?

BioLink Herbicide EC is a non-conventional herbicide that provides control of several annual and perennial broadleaf, grass and sedge weed species in and around food and non-food crop areas, as well as non-agricultural and industrial sites.

BioLink Herbicide EC is expected to be of benefit to users by providing access to another non-conventional product where the use of conventional herbicides is either not desirable or not permitted, such as in organic agriculture.

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 BioLink Herbicide EC to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

The signal words “CAUTION – SKIN IRRITANT” and “WARNING – EYE IRRITANT” are required on the principal display panels of the labels for both BioLink FA Blend and BioLink Herbicide EC. Standard hazard and precautionary statements are also required on the end-use product labels to inform workers of the irritation potential of the active ingredient to the skin and eyes. Workers handling BioLink Herbicide EC will be required to wear standard personal protective equipment including chemical-resistant gloves, goggles or face shield, long-sleeved shirt, long pants, and shoes plus socks.

A restricted-entry interval of 24 hours is required for agricultural uses of BioLink Herbicide EC. Similarly, individuals are restricted from re-entering treated non-agricultural areas until the sprays have dried. If re-entry into treated agricultural sites is required during the restricted-entry interval, workers must wear chemical-resistant gloves, goggles or face shield, long-sleeved shirt, long pants, socks and shoes. If re-entry into treated non-agricultural sites is required before the sprays have dried, individuals must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes.

Environment

Label statements to indicate the hazard to terrestrial plants and aquatic organisms are required.

Next Steps

Before making a final registration decision on octanoic acid, decanoic acid, and BioLink Herbicide EC, Health Canada’s PMRA will consider any comments received from the public in response to PRD2019-11. Health Canada will accept written comments on PRD2019-11 up to 45 days from the date of its publication.

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 octanoic acid, decanoic acid, and BioLink Herbicide EC (based on the Science Evaluation of PRD2019-11). In addition, the test data referenced in PRD2019-11 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).

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