Proposed Registration Decision PRD2019-05, 1-Octanol and 1,4Zap

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The online consultation is now closed.

Pest Management Regulatory Agency
29 May 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-5E-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 PRD2019-05, 1-Octanol and 1,4Zap 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 1-Octanol

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 1,4Zap Technical, and 1,4Zap, containing the technical grade active ingredient 1-octanol, for post-harvest application on stored potatoes to control emerged sprouts in ventilated storage facilities only.

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 PRD2019-05, 1-Octanol and 1,4Zap provides detailed technical information on the human health, environmental and value assessments of 1‑octanaol and 1,4Zap.

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 Pest Control Products 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 1-octanol and 1,4Zap, Health Canada’s PMRA will consider any comments received from the public in response to PRD2019-05. Health Canada will then publish a Registration Decision on 1-octanol and 1,4Zap, 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 PRD2019-05.

What Is 1-Octanol?

1-octanol is a fatty alcohol compound, which, when applied to potato tubers in storage, controls sprouting, thereby improving tuber longevity and maintaining tuber quality.

Health Considerations

Can Approved Uses of 1-Octanol Affect Human Health?

1,4Zap Technical, containing 1-octanol, is unlikely to affect human health when it is used according to label directions.

Potential exposure to 1-octanol may occur through the diet 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. The health effects noted in animals occur at doses more than 100-times higher (and often much higher) than levels to which humans are normally exposed when pesticide-containing products are used according to label directions.
In laboratory animals, 1-octanol was of low acute toxicity via the oral, dermal or inhalation routes. It was moderately irritating to the eyes and skin. 1-Octanol is not considered to be a skin sensitizer.

The toxicology profile for 1,4Zap is low acute toxicity via the oral, dermal or inhalations routes, moderately irritating to the eyes and skin and not a predicted dermal sensitizer.

Information for animal toxicity tests, as well as supplemental data and published scientific literature, were assessed for the potential of 1-octanol to cause short-term toxicity, developmental effects, genotoxicity, and various other effects. Adverse effects in animals given repeated high doses resulted in effects on organs (skin, adrenal) and reduced body weights. There was no indication that the young were more sensitive than the adult animal. There was no evidence that octanol induced mutagenic or genotoxic effects. The risk assessment protects against the finding 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.

Dietary exposure to 1-octanol may occur through consumption of treated potatoes; however, given its low toxicity, volatility and natural occurrence in a variety of fruits, vegetables and meats, 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.

There are no residential uses for 1,4Zap, as the product will be applied to potatoes stored in commercial storage facilities. Therefore, risk due to residential and bystander exposure is acceptable.

Occupational Risks From Handling 1,4Zap

Occupational risks are acceptable when 1,4Zap is used according to the label directions, which include protective measures.

During loading and handling, individuals can come in direct contact with 1-octanol by skin or eye contact. For this reason, the label states that handlers and loaders must wear coveralls over long-sleeved shirt, long pants, chemical-resistant gloves, socks and chemical-resistant footwear, and protective eyewear.

Due to the closed and automated nature of the application system, no applicator exposure is expected. Occupational bystander exposure to 1-octanol is also not expected to occur due to the nature of the application. Precautionary and hygiene statements on the label are considered adequate to protect individuals from occupational exposure.

Re-entry activities that take place before the ventilation period is complete are considered to potentially represent a high exposure scenario and the primary routes of exposure would be ocular, inhalation and dermal. Precautionary statements (for example, wearing of personal protective equipment (PPE)), including restricted-entry intervals (REIs), are aimed at mitigating exposure, and are considered to adequately protect individuals from such exposure.

Exposure from postapplication activities is expected to be low, and not of concern.

Environmental Considerations

An environmental assessment was not required for the application to register the end-use product as minimal environmental exposure is expected with this use pattern. Therefore, risks to the environment are not expected.

Value Considerations

What Is the Value of 1,4Zap?

1,4Zap is used to manage sprouting in potatoes.

Sprouting of potatoes in storage occurs when dormancy is lost. It occurs earlier in varieties with relatively low dormancy and/or in unrefrigerated or partially refrigerated conditions. Sprouted potatoes are less firm, bruise more easily, are lower in quality and therefore are less marketable as table stock or less desirable for processing.

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 1,4Zap Technical and 1,4Zap to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

The signal words “WARNING – EYE and SKIN IRRITANT” are required on the principal display panels of the labels for both 1,4Zap Technical and 1,4Zap. 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 and loading 1,4Zap will be required to wear standard personal protective equipment including coveralls over long-sleeved shirt, long pants, chemical-resistant gloves, socks and chemical-resistant footwear, and protective eyewear.

A restricted-entry interval (REI) is included on the label for 1,4Zap which specifies that workers are not allowed to enter into the treated area until complete ventilation of the storage facility has occurred with aerosol particles visibly settled.

Early-entry workers entering into the treated areas during application, or prior to ventilation or settling of aerosol fog, must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, socks and chemical-resistant footwear, goggles, and a respirator with a NIOSH-approved organic vapour-removing cartridge with a prefilter approved for pesticides or a NIOSH-approved-canister approved for pesticides.

Next Steps

Before making a final registration decision on 1-octanol and 1,4Zap, Health Canada’s PMRA will consider any comments received from the public in response to PRD2019-05. Health Canada will accept written comments on PRD2019-05 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.

Other Information

When the Health Canada makes its registration decision, it will publish a Registration Decision on 1-octanol and 1,4Zap (based on the Science Evaluation of PRD2019-05). In addition, the test data referenced in PRD2019-05 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).

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