Proposed Registration Decision PRD2021-05, Alcohol anhydrous, Restrain Fuel, Restrain Ethylene Generator Model B100, Restrain Ethylene Generator Model B200

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Pest Management Regulatory Agency
7 July 2021
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2021-5E-PDF (PDF version)

Summary

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 PRD2021-05, Alcohol anhydrous, Restrain Fuel, Restrain Ethylene Generator Model B100, Restrain Ethylene Generator Model B200 please contact our publications office.

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

Table of contents

Proposed registration decision for alcohol anhydrous

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 Restrain Technical, Restrain Fuel, Restrain Ethylene Generator Model B100 and Restrain Ethylene Generator Model B200, containing or using the technical grade active ingredient alcohol anhydrous, for use in outdoor air-cooled and mechanically cooled storage areas for sprout inhibition of potatoes and onions or in greenhouses for ripening acceleration of tomatoes.

Alcohol anhydrous (also known as denatured ethanol or ethyl alcohol) is currently registered as a sanitizer. It is registered for domestic use as a sanitizer for hard non-porous surfaces and fabrics.

For details, see Proposed Re-evaluation Decision PRVD2018-04, Ethyl Alcohol and Its Associated End-use Products, and Re-evaluation Decision RVD2018-25, Ethyl Alcohol and Its Associated End-use Products.
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 PRD2021-05, Alcohol anhydrous, Restrain Fuel, Restrain Ethylene Generator Model B100, Restrain Ethylene Generator Model B200 provides detailed technical information on the human health, environmental and value assessments of alcohol anhydrous and Restrain Fuel, Restrain Ethylene Generator Model B100 and Restrain Ethylene Generator Model B200.

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 acceptableFootnote 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 valueFootnote 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:

Before making a final registration decision on alcohol anhydrous, Restrain Fuel, Restrain Ethylene Generator Model B100 and Restrain Ethylene Generator Model B200, Health Canada's PMRA will consider any comments received from the public in response to this consultation documentFootnote 3. Health Canada will then publish a Registration DecisionFootnote 4 on alcohol anhydrous, Restrain Fuel, Restrain Ethylene Generator Model B100 and Restrain Ethylene Generator Model B200, 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 PRD2021-05.

What is alcohol anhydrous?

Alcohol anhydrous (called denatured ethanol on the product labels) is the active ingredient of Restrain Fuel and is converted to ethylene by the Restrain Ethylene Generators. Ethylene is a naturally occurring plant growth regulator that inhibits sprouting of potatoes and onions and accelerates ripening and colouring of tomatoes.

Health considerations

Can approved uses of alcohol anhydrous and ethylene affect human health?

Alcohol anhydrous and ethylene are unlikely to affect human health when used according to label directions.

Potential exposure to ethylene may occur when handling and applying these products. 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.

Based on registrant-supplied published scientific literature and publicly available information, the technical grade active ingredient, Restrain Technical, and the end-use product, Restrain Fuel, are considered to be of low acute oral, dermal, and inhalation toxicity, severely irritating to the eyes, minimally irritating to the skin, and are not dermal sensitizers. Published scientific literature and publicly available information also supports that ethylene, produced by the devices, Restrain Ethylene Generator Model B100 and Restrain Ethylene Generator Model B200, is considered to be of low acute inhalation toxicity.

Additional information from the published scientific literature and publicly available information was assessed for the potential of denatured alcohol and ethylene to cause short-term toxicity, developmental toxicity, genotoxicity, and various other effects. Publicly available information states that repeated ingestion of ethanol, a major component of the denatured alcohol, by pregnant mothers has been shown to adversely affect the central nervous system (CNS) of the fetus, producing a collection of effects which together constitute the fetal alcohol syndrome. These effects include mental and physical retardation, disturbances of learning, motor and language deficiencies, behavioural disorders, and small head size. Long-term repeated oral exposure to ethanol in alcoholic drinks may result in the development of progressive liver injury with fibrosis or exacerbate liver injury produced from other causes. Treatment related adverse effects in animals administered repeated high doses of ethylene gas were not observed.

The risk assessment protects against the findings noted above as well as any other potential effects by ensuring that the level of human exposure is well below the lowest dose at which these effects occur in animal studies.

Residues in water and food

Dietary risks from food and water are acceptable.

Restrain Fuel is not applied to food or feed, but the ethylene generated by either device (Restrain Ethylene Generator Model B100 or Restrain Ethylene Generator Model B200) is proposed for use on tomatoes, potatoes, and onions. It is anticipated that the amount of ethylene present as a food residue after application will not exceed the naturally occurring ethylene background concentrations currently found in the environment or produced by fruit and vegetables. In addition, when the end-use products are used as directed by the label, the likelihood of Restrain Fuel and ethylene contaminating drinking water supplies is low and therefore not a health concern. Consequently, health risks from dietary exposure 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.

Restrain Fuel as a precursor for the production of ethylene, generated from the devices, Restrain Ethylene Generator Model B100 and Restrain Ethylene Generator Model B200, is proposed for use as a plant growth regulator on stored potatoes and onions and tomato plants in greenhouses. Product labels will include measures to reduce bystander exposure such as ensuring the exclusion of any unauthorized personnel from the treated areas and limiting re-entry to the worker responsible for the operation, cleaning, and maintenance of the devices. Residential and non-occupational exposure to Restrain Fuel, the devices and generated ethylene 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 Restrain Fuel, Restrain Ethylene Generator Model B100, and Restrain Ethylene Generator Model B200

Occupational risks are acceptable when Restrain Fuel, Restrain Ethylene Generator Model B100, and Restrain Ethylene Generator Model B200 are used according to the label directions, which include protective measures.

Workers handling Restrain Fuel can come into direct contact with denatured alcohol through contact on the skin or in the eyes. To protect workers from exposure to Restrain Fuel, the labels require workers to wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes and protective eyewear during loading, application, clean-up and repair. If early entry is necessary before the levels of ethylene oxide, a principal metabolite of ethylene generated by the devices, are below the permissible level of 1 ppm (ACGIH TLV - TWA), workers will also be required to wear a respirator with a NIOSH-approved organic-vapour-removing cartridge with a prefilter approved for pesticides, or a NIOSH-approved canister approved for pesticides.

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

Environmental considerations

What happens when alcohol anhydrous, as part of Restrain Fuel used with Restrain Ethylene Generators, is introduced into the environment?

Restrain Fuel, containing 90% alcohol anhydrous (denatured ethanol) as an active ingredient, is converted to ethylene gas in situ when used with the Restrain Ethylene Generators. Ethylene is a naturally occurring plant growth regulator used to accelerate ripening of greenhouse tomatoes and reduce sprouting in stored potatoes and onions.

When ethylene gas is vented from greenhouse or storage facilities, this compound would be rapidly diluted in outdoor air to concentrations within naturally occurring levels. In addition, ethylene gas dissipates and degrades rapidly in the environment through chemical reactions in air in the presence of sun light. Due to the non-persistent nature of ethylene, it is not likely to travel long distances from where it is applied, or to accumulate in tissues of plants or animals.

Ethanol is essentially non-toxic to aquatic organisms while ethylene is slightly toxic to some aquatic species. Terrestrial plants are known to be sensitive to ethylene gas. Based on the proposed indoor use in greenhouse and storage facilities, and the fact that ethylene gas rapidly breaks down in air and does not readily enter soil or water, exposure of aquatic habitats is not expected, while exposure of terrestrial habitats would be to concentrations within naturally occurring levels.

When label directions are followed, the use of Restrain Fuel in Restrain Ethylene Generators is acceptable from an environmental perspective.

Value considerations

What is the value of Restrain Fuel, Restrain Ethylene Generator Model B100 and Restrain Ethylene Generator Model B200?

The application of Restrain Fuel to generate 10 and 15 ppm ethylene to stored potatoes and onions, respectively, delays sprouting, inhibits sprout development, improves commodity quality, and therefore increases their market value. The application of Restrain Fuel to generate 1.4 ppm ethylene accelerates the ripening process and improves the ripening uniformity of greenhouse tomatoes.

Restrain Ethylene Generator Model B200 is specifically designed for conversion of Restrain Fuel to the recommended level of ethylene gas for use in storage facilities as well as in the greenhouse. Similarly, Restrain Ethylene Generator Model B100 is specifically designed for conversion of Restrain Fuel to the recommended level of ethylene gas for use in the greenhouse. Both generators are only to be used indoors under controlled environmental conditions.

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 Restrain Technical, Restrain Fuel, Restrain Ethylene Generator Model B100 and Restrain Ethylene Generator Model B200 to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures

Human health

The signal words "DANGER – EYE IRRITANT" are required on the principal display panels of the labels for Restrain Technical and Restrain Fuel. Standard hazard and precautionary statements are also required on the technical grade active ingredient label and the end-use product label to inform workers of the eye irritation of the product.

Workers will be required to wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes and protective eyewear during loading, application, clean-up and repair. If early entry is necessary and the level of ethylene oxide is greater than 1 ppm, workers will also be required to wear 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 alcohol anhydrous, Restrain Fuel, Restrain Ethylene Generator Model B100 and Restrain Ethylene Generator Model B200, Health Canada's PMRA will consider any comments received from the public in response to PRD2021-05. Health Canada will accept written comments on PRD2021-05 up to 45 days from the date of publication of PRD2021-05. 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 alcohol anhydrous, Restrain Fuel, Restrain Ethylene Generator Model B100 and Restrain Ethylene Generator Model B200 (based on the Science Evaluation of PRD2021-05). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room.

Footnotes

Footnote 1

“Acceptable risks” as defined by subsection 2(2) of the Pest Control Products Act.

Return to footnote 1 referrer

Footnote 2

“Value” as defined by subsection 2(1) of the Pest Control Products Act: “the product’s actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product’s (a) efficacy; (b) effect on host organisms in connection with which it is intended to be used; and (c) health, safety and environmental benefits and social and economic impact.”

Return to footnote 2 referrer

Footnote 3

“Consultation statement” as required by subsection 28(2) of the Pest Control Products Act.

Return to footnote 3 referrer

Footnote 4

“Decision statement” as required by subsection 28(5) of the Pest Control Products Act.

Return to footnote 4 referrer

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