Proposed Registration Decision PRD2018-05, 2,6-Diisopropylnaphthalene Aceto Amplify II

Pest Management Regulatory Agency
16 March 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-5E-PDF (PDF version)

Summary

Table of Contents

• Proposed Registration Decision for 2,6-Diisopropylnaphthalene
• What Does Health Canada Consider When Making a Registration Decision?
• What Is 2,6-DIPN?
• Health Considerations
• Environmental Considerations
• Value Considerations
• Measures to Minimize Risk
• Next Steps
• Other Information

Proposed Registration Decision for 2,6-Diisopropylnaphthalene

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing full registration for the sale and use of Amplify Technical and Aceto Amplify II, containing the technical grade active ingredient 2,6-diisopropylnaphthalene (hereinafter referred to as 2,6-DIPN), to be used as a sprout inhibitor for potatoes in storage.

An evaluation of available scientific information found that, under the approved conditions of use, the product has value and does not present an unacceptable risk to human health or the environment.

This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2018-05, 2,6-Diisopropylnaphthalene Aceto Amplify II provides detailed technical information on the human health, environmental and value assessments of Amplify Technical and Aceto Amplify II.

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:

• Protecting Your Health and the Environment
• Pesticide Registration Process
• Pesticide Risk Reduction Program

Before making a final registration decision on 2,6-DIPN, the PMRA will consider any comments received from the public in response to PRD2018-05. The PMRA will then publish a Registration Decision on 2,6-DIPN, which will include the decision, the reasons for it, a summary of comments received on the proposed final registration decision and the PMRA's response to these comments.

For more details on the information presented in this summary, please refer to the Science Evaluation of PRD2018-05.

What Is 2,6-DIPN?

2,6-DIPN is a plant growth regulator (PGR), which inhibits sprouting of potatoes in storage.

Health Considerations

Can Approved Uses of 2,6-DIPN Affect Human Health?

Aceto Amplify II, containing 2,6-DIPN, is unlikely to affect your health when used according to label directions.

Potential exposure to 2,6-DIPN may occur through the diet or when handling the product for application. 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 dose 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 exposure is well below levels that cause no effects in animal testing are considered acceptable for continued 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, 2,6-DIPN was of low acute toxicity by the oral, dermal and inhalation routes of exposure. It was minimally irritating to the eye and skin, and did not cause an allergic skin reaction. Based on these findings, hazard statements for acute toxicity are not required on the labels.

The end-use product has the same toxicity profile as 2,6-DIPN.

Registrant-supplied short-term animal toxicity test, a prenatal developmental toxicity test, genotoxicity tests, and foreign reviews were assessed for the potential of 2,6-DIPN to cause target organ systemic toxicity, developmental toxicity, genotoxic and various other effects. Currently available information from the published scientific literature was also used to characterize the toxicity. There was no indication that the young were more sensitive than the adult animal. Adverse effects in animals given repeated high doses resulted in effects on organs (adrenal, kidney and liver) and reduced body weights.

The risk assessment protects against these 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 not of concern.

Dietary exposure to 2,6-DIPN may occur through consumption of treated potatoes; however, it is anticipated that the consumption of food commodities that have been treated with 2,6-DIPN will not pose a health risk of concern to any segment of the population, including infants, children, adults and seniors.

Available toxicology data indicates that 2,6-DIPN is of low toxicity and any potential residues of 2,6-DIPN are expected to decline in potato tissue following application. As the end-use product is used indoors, no risk due to exposure from drinking water is anticipated.

Risks in Residential and Other Non-Occupational Environments

Estimated risk for residential and other non-occupational exposure is not of concern.

There are no residential uses for Aceto Amplify II, as the product will be used in commercial potato storage facilities. Therefore, risk due to residential and bystander exposure is not a concern.

Occupational Risks From Handling Aceto Amplify II

Occupational risks are not of concern when Aceto Amplify II is used according to the label directions, which includes protective measures.

During loading and handling, individuals can come in direct contact with 2,6-DIPN by skin or eye contact or breathing the dust. For this reason, the label specifies that handlers and loaders should wear protective eyewear and a dust mask.

Due to the closed and automated nature of the application system, no applicator exposure is expected. Occupational bystander exposure to 2,6-DIPN is also not expected to occur due to the nature of the application.

Exposure for re-entry activities that take place before the ventilation period is considered to potentially represent a high exposure scenario where the primary routes of exposure are inhalation and dermal. Precautionary statements (for example, wearing of personal protective equipment), 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

What Happens When 2,6-DIPN Is Introduced Into the Environment?

When Aceto Amplify II, containing 2,6-DIPN, is used according to the proposed label directions, no risks of concern to the environment are expected.

Aceto Amplify II is proposed for indoor treatment of stored potatoes. When Aceto Amplify II is used according to the proposed label directions, no direct exposure of birds, aquatic organisms, non-target plants and non-target insects to 2,6-DIPN is expected to occur. Thus, the potential for exposure is minimal and no risks of concern are expected to non-target organisms in aquatic or terrestrial ecosystems.

Value Considerations

What Is the Value of Aceto Amplify II?

Aceto Amplify II, containing 2,6-DIPN, inhibits sprouting of potatoes in storage.

The registration of Aceto Amplify II will provide Canadian potato growers and processors another non-conventional product for sprout inhibition on potatoes in storage. Furthermore, the application of Aceto Amplify II in conjunction with chlorpropham (CIPC) provides superior sprout inhibition on potatoes when compared to the application of either product alone.

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 Aceto Amplify II to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

An REI is included on the label for Aceto Amplify II which specifies that workers are not allowed to enter into the treated area until two (2) hours of mechanical ventilation (fans should circulate outside air) or four (4) hours of passive ventilation (windows, vents and doors should be opened), or until all visible aerosol has 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 and long pants, shoes plus socks, chemical-resistant gloves, protective eyewear, and a respirator with a NIOSH-approved organic vapour-removing cartridge with a pre-filter approved for pesticides or a NIOSH-approved-canister approved for pesticides.

Next Steps

Before making a final registration decision on 2,6-DIPN, the PMRA will consider any comments received from the public in response to PRD2018-05. The PMRA will accept written comments on PRD2018-05 up to 45 days from the date of publication. Please forward all comments to Publications. The PMRA will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed final decision and the Agency's response to these comments.

Other Information

When the PMRA makes its registration decision, it will publish a Registration Decision on 2,6-DIPN (based on the Science Evaluation of PRD2018-05). In addition, the test data referenced in PRD2018-05 will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).