Evaluation Report ERC2011-07, Paecilomyces fumosoroseus strain FE 9901

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Pest Management Regulatory Agency
12 October 2011
ISSN: 1911-8082 (PDF version)
Catalogue number: H113-26/2011-7E-PDF (PDF version)

Summary

Table of Contents

• Registration Decision for Paecilomyces fumosoroseus strain FE 9901
• What Does Health Canada Consider When Making a Registration Decision?
• What Is Paecilomyces fumosoroseus strain FE 9901?
• Health Considerations
• Environmental Considerations
• Value Considerations
• Measures to Minimize Risk
• What Additional Scientific Information Is Being Requested?
• Other Information

Registration Decision for Paecilomyces fumosoroseus strain FE 9901

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the  Pest Control Products Act and  Regulations, has granted conditional registration for the sale and use of NoFly Technical and NoFly WP, containing the technical grade active ingredient Paecilomyces fumosoroseus strain FE 9901, to control whiteflies in greenhouse crops.

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.

Although the risks and value have been found acceptable when all risk reduction measures are followed, the applicant must submit additional scientific information as a condition of registration.

This summary describes the key points of the evaluation, while the Science Evaluation of Evaluation Report ERC2011-07, Paecilomyces fumosoroseus strain FE 9901 provides detailed technical information on the human health, environmental and value assessments of NoFly Technical and NoFly WP.

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 (for example, those most sensitive to environmental contaminants). These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides. For more information on how the PMRA regulates pesticides, the assessment process and risk-reduction programs, please refer to the following:

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

What Is Paecilomyces fumosoroseus strain FE 9901?

Paecilomyces fumosoroseus strain FE 9901 is a fungus that can cause a fatal disease in many insects. Formulated into the end-use product NoFly WP and applied as a foliar spray, it can provide control of whiteflies, which are serious pests of a wide variety of greenhouse crops in Canada.

Health Considerations

Can Approved Uses of Paecilomyces fumosoroseus strain FE 9901 Affect Human Health?

Paecilomyces fumosoroseus strain FE 9901 is unlikely to affect your health when NoFly WP is used according to the label directions.

People could be exposed to P. fumosoroseus strain FE 9901 when handling and applying NoFly WP. When assessing health risks, several key factors are considered:

• the microorganism's biological properties (for example, production of toxic byproducts);
• 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.

Toxicological studies in laboratory animals describe potential health effects from large doses in order to identify any potential pathogenicity, infectivity and toxicity concerns. When spores of P. fumosoroseus strain FE 9901 were tested on laboratory animals, there were no signs that it caused any significant toxicity or disease. Furthermore, P. fumosoroseus strain FE 9901 does not grow at temperatures above 35°C and no adverse effects to P. fumosoroseus were reported in published scientific literature. 

Residues in Water and Food

Dietary risks from water and food are not of concern

The  Food and Drugs Act  prohibits the sale of food containing a pesticide residue that exceeds the established maximum residue limit (MRL). Pesticide MRLs are established for the Food and Drugs Act purposes through the evaluation of scientific data under the Pest Control Products Act. Each MRL value determines the maximum concentration in parts per million (ppm) of a pesticide allowed in or on certain foods. Food containing a pesticide residue that does not exceed the established MRL does not pose an unacceptable health risk.

Asthere are no direct applications to food, there is no concern for risks posed by dietary exposure of the general population, including infants and children, or animals. Consequently, the establishment of an MRL is not required for P. fumosoroseus strain FE 9901. As well, the likelihood of residues contaminating drinking water supplies is negligible to non-existent. Consequently, dietary risks are minimal to non-existent.

Occupational Risks From Handling NoFly WP

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

Growers handling NoFly WP can come into direct contact with P. fumosoroseus strain FE 9901 on the skin, in the eyes or by inhalation. For this reason, the product labels specify that growers exposed to these end-use products must wear waterproof gloves, long-sleeved shirts, a NIOSH-approved respirator (with any N-95, P-95, R-95 or HE filter for biological products), long pants and shoes plus socks. Eye goggles are not required as the eye irritation studies submitted indicated minimal eye irritation potential.

For the bystander, exposure is expected to be much less than that of handlers and mixer/loaders and is considered negligible. Therefore, health risks to bystanders are not of concern. 

Environmental Considerations

What Happens When NoFly WP Is Introduced Into the Environment?

Environmental risks are not of concern

Following application, Paecilomyces fumosoroseus strain FE 9901 is likely able to survive in the environment under favourable environmental conditions (i.e. temperature, humidity) but that over time populations of P. fumosoroseus strain FE 9901 are expected to return to natural background levels.

The effects of P. fumosoroseus strain FE 9901 on beneficial and/or environmentally-important insects were examined. Studies showed that P. fumosoroseus strain FE 9901 was toxic or infectious to some beneficial insects, however, no adverse effects to wasps were found. The end-use product label will advise users that NoFly WP may be harmful to pollinators, including bees, and to some beneficial insects, and will alert users to avoid applying NoFly WP directly to bees while they are foraging. This is a precautionary measure aimed at minimizing exposure of bees even though there are no reports indicating that P. fumosoroseus is pathogenic or toxic to bee species.

Although avian pulmonary/inhalation/injection, wild mammal, fish, aquatic insect, earthworms, microorganisms, and plant testing were not conducted, adequate information was available to determine that significant adverse effects to these non-target organisms are not expected. There are no published reports of disease associated with P. fumosoroseus strain FE 9901 in birds, wild mammals, fish, aquatic insects, earthworms, microorganisms, and plants. Also, minimal exposure to non-target organisms is anticipated from the proposed use of NoFly WP to control whiteflies in greenhouses.

Value Considerations

What Is the Value of NoFly WP?

Applied as a foliar spray, NoFly WP can provide control of whiteflies on greenhouse crops and is compatible with the use of Encarsia species as biological control agents.

The value of NoFly WP is that it provides an effective alternative for control of whiteflies in the greenhouse environment. Whiteflies are serious pests of a wide variety of greenhouse crops in Canada and certain species have been known to develop resistance to chemical insecticides. NoFly WP provides a new, non-chemical, mode of action and has been shown to be compatible with the use of Encarsia species, parasitoids that are commonly used as biological control agents for whiteflies in greenhouses. 

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 NoFly WP to address the potential risks identified in this assessment are as follows:

Key Risk-Reduction Measures

Human Health

As with all microbial pest control products, there are concerns with users developing allergic reactions through repeated high exposures to P. fumosoroseus strain FE 9901. Therefore, anyone handling NoFly WP must wear waterproof gloves, long-sleeved shirts, a NIOSH-approved respirator (with any N-95, P-95, R-95 or HE filter for biological products), long pants and shoes plus socks. Eye goggles are not required as the eye irritation studies submitted indicated minimal eye irritation potential. An additional risk reduction measure is a 4-hour restricted entry interval immediately following product application. All early-entry workers to treated sites will be required to wear personal protective equipment, including a NIOSH-approved respirator until spray mists have settled.

Environment

As a general precaution, the label prohibits the direct application of the product to aquatic habitats (such as lakes, streams and ponds). The label also directs growers to notallow effluent or run-off from greenhouses containing this product to enter lakes, streams, ponds or other waters and toavoid contaminating surface water by disposal of equipment wash waters.

The product label further advises users that NoFly WP may be harmful to pollinators (including bees) and to some beneficial insects that may be used in greenhouse integrated pest management programs. A statement will also instruct users to avoid direct applications to bees while they are foraging.

What Additional Scientific Information Is Being Requested?

Although the risks and value have been found acceptable when all risk-reduction measures are followed, the applicant must submit additional scientific information as a condition of registration. More details are presented in the Science Evaluation of Evaluation Report ERC2011-07, Paecilomyces fumosoroseus or in the section 12 Notice associated with these conditional registrations. The applicant must submit the following information within the time frames indicated.

Human Health

Confirmatory analysis data for potency and microbial contamination are required from five full-scale production lots of NoFly WP and NoFly Technical produced at the proposed site of manufacture. The data must be provided to the PMRA within three years of the original registration decision for these products.

Other Information

As these conditional registrations relate to a decision on which the public must be consulted, the PMRA will publish a consultation document when there is a proposed decision on applications to convert the conditional registrations to full registrations or on applications to renew the conditional registrations, whichever occurs first. 

The test data cited in Science Evaluation of Evaluation Report ERC2011-07, Paecilomyces fumosoroseus (i.e. the test data relevant in supporting the registration decision) will be made available for public inspection when the decision is made to convert the conditional registrations to full registrations or to renew the conditional registrations (following public consultation). If more information is required, please contact the PMRA's Pest Management Information Service.