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ARCHIVED - Proposed Registration Decision PRD2011-18, Pseudomonas fluorescens Strain A506

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Notice to the reader: The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.

Pest Management Regulatory Agency
23 September 2011
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2011-18E-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 PRD2011-18, Pseudomonas fluorescens Strain A506 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 Pseudomonas fluorescens Strain A506

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Next link will take you to another Web site Pest Control Products Act and Next link will take you to another Web site Regulations, is proposing full registration for the sale and use of Pseudomonas fluorescens strain A506 and Blightban A506, containing the technical grade active ingredient Pseudomonas fluorescens strain A506, to control fire blight on apples and pears.

Pseudomonas fluorescens Strain A506 (Registration Number 29284) and Blightban A506 (Registration Number 29285) are conditionally registered in Canada. The detailed review for Pseudomonas fluorescens strain A506 and Blightban A506 can be found in Evaluation Report ERC2010-07, Pseudomonas fluorescens StrainA506. Subsequent to the original applications, an application to register Pseudomonas fluorescens strain A506 (Registration Number 29284) was reviewed and conditionally approved. The current applications were submitted to convert Pseudomonas fluorescens strain A506, and Blightban A506 from conditional registration to full registration.

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 PRD2011-18, Pseudomonas fluorescens Strain A506 provides detailed technical information on the human health, environmental and value assessments of Pseudomonas fluorescens strain A506 and Blightban A506.

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, please refer to the following:

Before making a final registration decision on Pseudomonas fluorescens strain A506, the PMRA will consider all comments received from the public in response to Proposed Registration Decision PRD2011-18, Pseudomonas fluorescens Strain A506. The PMRA will then publish a Registration Decision on Pseudomonas fluorescens strain A506, 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 Proposed Registration Decision PRD2011-18, Pseudomonas fluorescens Strain A506.

What is Pseudomonas fluorescens strain A506?

Pseudomonas fluorescens strain A506 is a naturally occurring strain of bacterium that is used as a microbial pest control agent (MPCA) for the suppression of Erwinia amylovora, the pathogen that causes fireblight on apple and pear trees. Blightban A506 is a commercial end-use product containing Pseudomonas fluorescens strain A506 as the active ingredient. Pseudomonas fluorescens strain A506 works by competitively excluding the pathogen for space and nutrients on branches and leaves and on blossoms.

Health Considerations

Can Approved Uses of Pseudomonas fluorescens strain A506 Affect Human Health?

Pseudomonas fluorescens strain A506 is unlikely to affect your health when Blightban A506 is used according to the label directions.

People could be exposed to Pseudomonas fluorescens strain A506 when handling and applying Blightban A506. The PMRA considers several key factors when assessing health risks: the microorganism=s biological properties (for example, production of toxic by-products), reports of any adverse incidents, its potential for pathogenicity, infectivity and toxicity as determined in toxicological studies as well as the likely levels to which people may be exposed to this strain relative to exposures already encountered in nature to other strains of this microorganism.

Pseudomonas fluorescens strain AGS 3001.2, a strain similar to Pseudomonas fluorescens strain A506, was found to be mildly irritating to the skin; therefore the precautionary words "CAUTION: Skin irritant" are required on the technical and end-use product labels.

No other significant toxicity or signs of disease were observed in the toxicity studies submitted to support Pseudomonas fluorescens strain A506.

Residues in Water and Food

Dietary risks from food and water are not of concern.

As part of the assessment process prior to the registration of a pesticide, Health Canada must determine whether the consumption of the maximum amount of residues, that are expected to remain on food products when a pesticide is used according to label directions, will not be a concern to human health. This maximum amount of residues expected is then legally established as a maximum residue limit (MRL) under the Pest Control Products Act for the purposes of the adulteration provision of the Next link will take you to another Web site Food and Drugs Act. Health Canada sets science-based MRLs to ensure the food Canadians eat is safe.

Strains of Pseudomonas fluorescens are common in nature. While the use of Blightban A506 in orchards will lead to transient increases in populations, over the long-term, it is not expected to significantly increase natural environmental background levels of this microorganism. Furthermore, no significant adverse effects were reported when a mixture containing Pseudomonas fluorescens strain A506 and other Pseudomonas strains, or when Pseudomonas fluorescens strain AGS 3001.2, a strain similar to Pseudomonas fluorescens strain A506, was administered orally to rats.

Also, given that Blightban A506 is applied to pome fruit trees at the flowering stage, Pseudomonas fluorescens strain A506 is not expected to come into direct contact with fruit, and consequently, the proposed food use pattern is unlikely to result in significant residues on fruit at the time of harvest. Consequently, dietary exposure is minimal to non-existent, and the establishment of an MRL is not therefore required for Pseudomonas fluorescens strain A506. 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 Blightban A506

Occupational risks are not of concern when Blightban A506 is used according to label directions, which include protective measures.

Workers using Blightban A506 can come into direct contact with Pseudomonas fluorescens strain A506 on the skin, in the eyes, or by inhalation. For this reason, the label will specify that users exposed to Blightban A506 must wear waterproof gloves, long-sleeved shirts, long pants, a NIOSH approved respirator (with any N-95, R-95, P-95 or HE filter), and shoes plus socks. Early-entry workers will also be restricted from entering areas where Blightban A506 has been applied for a period of 4 hours unless wearing the indicated personal protective equipment.

For bystanders, exposure is expected to be much less than that of workers involved in loading and application activities and is considered negligible. Therefore, health risks to bystanders are not of concern.

Environmental Considerations

What Happens When Blightban A506 Is Introduced Into the Environment?

Environmental risks are not of concern.

Based on the limited use pattern of Blightban A506 in apple and pear orchards, natural populations of Pseudomonas fluorescens strain A506 are not expected to considerably increase in the terrestrial environment, and indirect exposure to aquatic environments is expected to be minimal. Cases of infection or disease in animals associated with other strains of Pseuodomonas fluorescens are few, and none involved strain A506. Also, Pseudomonas fluorescens strain A506 is not expected to be pathogenic to plants.

Value Considerations

What Is the Value of Blightban A506?

Blightban A506 is a new biological pesticide that may be used with Streptomycin 17, a bactericide currently registered for fire blight control which has important resistance management issues. Blightban A506 is compatible with streptomycin and should be used in an integrated fire blight suppression program. Suppression of the fire blight pathogen, Erwinia amylovora, with Blightban A506 will help reduce grower reliance on streptomycin.

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.

Key risk-reduction measures previously recommended by the PMRA for the label of Blightban A506 are listed in Evaluation Report ERC2010-07, Pseudomonas fluorescens Strain A506.

Key Risk-Reduction Measures

Human Health

Because of concerns with users developing allergic reactions through repeated high exposures to Pseudomonas fluorescens strain A506, anyone handling, mixing/loading, or involved in clean-up/repair activities of Blightban A506 must wear waterproof gloves, a long-sleeved shirt, long pants and a dust/mist filtering respirator/mask (MSH/NIOSH approval number prefix TC-21C) or a NIOSH-approved respirator with any N-95, R-95, P-95 or HE filter.

Environment

Environmental risk mitigation measure can be found under Evaluation Report ERC2010-07 Pseudomonas fluorescens strainA506.

Next Steps

Before making a final registration decision on Pseudomonas fluorescens strain A506, the PMRA will consider all comments received from the public in response Proposed Registration Decision PRD2011-18, Pseudomonas fluorescens Strain A506. The PMRA will accept written comments on this proposal up to 45 days from the date of publication of this document. 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 Pseudomonas fluorescens Strain A506 (based on the Science Evaluation of Proposed Registration Decision PRD2011-18, Pseudomonas fluorescens Strain A506). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).