Proposed Registration Decision PRD2018-08, Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 and Helicovex

This consultation is now closed.

Pest Management Regulatory Agency
11 May 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-8E-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 PRD2018-08, Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 and Helicovex 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 Helicoverpa armigera Nucleopolyhedrovirus isolate BV-0003

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 HearNPV Technical and Helicovex, containing the technical grade active ingredient Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003, as an insecticide to provide suppression of corn earworm in sweet corn.

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 PRD2018-08, Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 and Helicovex provides detailed technical information on the human health, environmental and value assessments of HearNPV Technical and Helicovex.

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 Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 and Helicovex, the PMRA will consider any comments received from the public in response to PRD2018-08. The PMRA will then publish a Registration Decision on Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 and Helicovex, which will include the decision, the reasons for it, a summary of comments received on the proposed 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 PRD2018-08.

What Is Helicoverpa armigera Nucleopolyhedrovirus Isolate BV-0003?

Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 is an insect virus that can act as an insecticide. Originally isolated from the cotton bollworm (Helicoverpa armigera), this baculovirus is known to infect only closely related insect species. It must be ingested to cause infection, which is lethal to susceptible insects. It is the active ingredient in the commercial class end-use product Helicovex, which provides suppression of corn earworm (Helicoverpa zea) in sweet corn.

Health Considerations

Can Approved Uses of Helicoverpa armigera Nucleopolyhedrovirus Isolate BV-0003 Affect Human Health?

Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 is unlikely to affect your health when Helicovex is used according to the label directions.

Potential exposure to Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 may occur when handling and applying Helicovex and from potential residues in water and food. When assessing health risks, several key factors are considered:

  • the microorganism’s biological properties (for example, infection cycle);
  • reports of any adverse incidents;
  • its potential to cause disease or toxicity as determined in toxicological studies; and
  • the level to which people may be exposed relative to exposures already encountered in nature to other isolates of this microorganism.

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 that are determined as having no health risks of concern are considered acceptable for registration.

Studies in laboratory animals describe potential health effects from large doses of exposure to a microorganism and identify any pathogenicity, infectivity and toxicity concerns. When other baculoviruses were tested on laboratory animals and in tissue cultures, there were no signs of significant toxicity or disease. Furthermore, there have been no reported adverse effects despite the natural occurrence and prevalence of baculoviruses in the environment and the limited host range associated with baculoviruses has been well documented.

Residues in Water and Food

Dietary risks from food and water are not of concern.

Residues of Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 on the treated crops, at the time of harvest, are possible following foliar applications to agricultural crops. Although baculoviruses, including Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003, are abundant in nature, no adverse effects from dietary exposure have been attributed to natural populations of Helicoverpa armigera nucleopolyhedrovirus. Moreover, no adverse effects have been reported in acute oral toxicity and tissue culture studies with other baculoviruses. In addition, the likelihood of residues contaminating drinking water supplies is considered to be low. Consequently, dietary risks are considered to be low and not of concern.

Risks in Residential and Other Non-Occupational Environments

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

Helicovex is proposed for use on agricultural field crops, i.e., sweet corn. There are no residential uses and the label has necessary measures to prevent bystander exposure, such as to prevent spray drift from applications and restricting access to the area by unprotected persons during application. Even in the event of exposure, risk to the general population is not a concern since there were no signs of disease or toxicity noted in toxicological studies with baculoviruses.

Occupational Risks From Handling Helicovex

Occupational risks are not of concern when Helicovex is used according to label directions, which include protective measures.

Workers handling Helicovex can come into direct contact with Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 on the skin, in the eyes, or by inhalation. For this reason, the product label will specify that workers must wear waterproof gloves, long-sleeved shirts, long pants, a mist filtering mask or respirator, eye goggles and socks with shoes. In addition, to minimize postapplication exposure, workers are restricted from entering areas treated with Helicovex for 4 hours following application or until sprays have dried.

Environmental Considerations

What Happens When Helicoverpa armigera Nucleopolyhedrovirus Isolate BV-0003 Is Introduced Into The Environment?

Environmental risks are not of concern.

Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 is a naturally occurring baculovirus that specifically infects lepidopteran insects. Baculoviruses are common and persistent in aquatic and terrestrial ecosystems.

Helicovex is a new end-use product that is proposed for use as an insecticide to suppress corn earworm in sweet corn and is not intended for aquatic applications. The field use of Helicovex is not expected to result in sustained increases of Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 in terrestrial and aquatic environments beyond natural background levels.

Based on animal studies and scientific rationales, no significant effects to birds, wild mammals, fish, terrestrial and aquatic non-target arthropods, and plants are expected when Helicovex is applied according to directions on the label.

Value Considerations

What Is the Value of Helicovex?

Helicovex will provide a new mode of action to suppress corn earworm larvae and the damage they cause to sweet corn, and may be suitable for use in organic production.

Applied as foliar spray to sweet corn, Helicovex provides suppression of corn earworm larvae and the damage they cause. It contains a new active ingredient with a new mode of action for this use, and may be applied in rotation with registered alternatives to aid in resistance management. In addition, it may be suitable for use against corn earworm in organic production of sweet corn, for which there are no alternatives currently registered.

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 HearNPV Technical and Helicovex to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

HearNPV Technical and Helicovex are considered eye irritants. In addition, all microorganisms, including Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003, contain substances that are potential sensitizers and thus, respiratory and dermal sensitivity may possibly develop in individuals exposed to potentially large quantities of Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003. Therefore, workers handling or applying Helicovex must wear appropriate waterproof gloves, long-sleeved shirts, long pants, eye goggles, a mist filtering mask or respirator, and socks with shoes. In addition, to minimize postapplication exposure, all workers are restricted from entering treated areas during application and for 4 hours following application or until sprays have dried.

A standard drift statement is also required on the Helicovex label to minimize the potential for drift to areas of human habitation or areas of human activity such as houses, cottages, schools and recreational areas.

Environment

The end-use product label will include environmental precaution statements that prevent the runoff and contamination of aquatic systems from the use of Helicovex.

Next Steps

Before making a final registration decision on Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 and Helicovex, the PMRA will consider any comments received from the public in response to PRD2018-08. The PMRA will accept written comments on PRD2018-08 up to 45 days from the date of publication of PRD2018-08. 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 Helicoverpa armigera nucleopolyhedrovirus isolate BV-0003 and Helicovex (based on the Science Evaluation of PRD2018-08). In addition, the test data referenced in PRD2018-08 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: