PMRA Finalizes New Labels for the Use of Fumigants April 2016

PMRA finalizes new labels for the use of fumigants that contain aluminum phosphide, magnesiusm phosphide or phosphine gas

 

On April 8, 2016, Health Canada’s Pest Management Regulatory Agency (PMRA) informed the Canadian Pest Management Association (CPMA) that they have completed review of new labels for the use of fumigants containing aluminum phosphide, magnesium phosphide or phosphine gas.  The new labels highlight additional safety and risk mitigation measures proposed in PMRA’s Re-evaluation Decision, Aluminum /Magnesium Phosphide and Phosphine Gas (RVD2015-3), published August 27, 2015 (and since revised).

The new labels include revised use restrictions and new buffer zones.  The minimum buffer zones have been reduced from the August 27^th proposed 50 metres to 30 metres on the final new labels.  As previously reported the mitigation measures also include:

• To protect workers and bystanders, a minimum buffer zone of 30 metres must be established for fumigated sites.
• A minimum buffer zone of 200 metres must be established for difficult-to-evacuate sites. These sites include schools, daycare centres, nursing homes, assisted living facilities, hospitals, in-patient clinics, and prisons.
• With respect to rodent burrow treatment on farms, this means 30 metres from buildings that are or may be occupied by humans, and/or domestic animals, and that are under the control of the owner/operator of the application site; otherwise a 500 metre restriction is applicable.
• This minimum buffer zone of 30 metres is not required for ships and railcars that are in motion (in other words, moving in transit).  However, this minimum buffer zone must be established for stationary ships in Canadian waters, ports and harbours, as well as for fumigated railcars while located at rail terminals and for any prolonged stops en route. New label mitigation measures are required specifying that railway vehicles containing treated commodities must be placed as far as possible from occupied train compartments, in order to minimize exposure to crew during in-transit fumigations.
• Once a buffer zone has been established, applicators must continually monitor hydrogen phosphide (phosphine) gas levels at several locations along the buffer zone perimeter. If hydrogen phosphide gas concentrations approach the limit restriction of 0.1 ppm, the applicator must take appropriate action such as extending the size of the buffer zone.

 

New labels will soon be available for all fumigants containing aluminum phosphide, magnesium phosphide or phosphine gas through PMRA’s Pesticide Label Search Engine. On April 14th, PMRA provided CPMA with the new label for Degesh Phostoxin Pellets available here.  Registrants are required to include the new enhanced risk mitigation labels with the sale of all new products by July 1, 2016.  Applicators are required to begin adhering to the new enhanced risk mitigation immediately, CPMA recommends checking with your distributor concerning the new labels and also monitoring the PMRA Pesticide Label Search Engine.

 

Below is a copy of a direct communication between CPMA and PMRA concerning this issue. 

CPMA is currently compiling a second round of questions to submit to PMRA to request further clarification.  If you have suggested questions or additional concerns please contact CPMA.  

 

CPMA Question: Has PMRA reviewed and accepted amended labels from the metal phosphide and phosphine registrants, containing the new buffer zone requirements?   If no, when do you anticipate that will happen?

 

CPMA Question: Is data being developed that could result in amendments to the amended language?  If so, when do you expect to receive the data and when do you expect to make a decision?

 

PMRA Response

Submissions to amend product labels as required in the re-evaluation decision (RVD2015-03) have been received from the registrants.  The PMRA review of these labels has been completed and new labels will be available after April 8, 2016 via the online Pesticide Label Search engine on the Health Canada website: http://www.hc-sc.gc.ca/cps-spc/pest/registrant-titulaire/tools-outils/label-etiq-eng.php.  Pesticide labels are also accessible through the new Health Canada Pesticide Labels mobile app available for download via the Apple App Store, Google Play or Amazon.

 

Registrants submitted air monitoring information as part of a new submission to amend the required buffer zone of 50 metres.  The review of this submission has been completed and has resulted in a revision of the buffer zone from 50 metres to 30 metres.  The new labels mentioned above will reflect the buffer zone of 30 metres.

 

CPMA Question: What is the deadline for registrants to include label language from the August 2015 directive on their labels?

 

PMRA Response

As mentioned in RVD2015-03, to comply with the re-evaluation decision, new and revised risk mitigation measures should be implemented as soon as possible, but no later than 30 June 2016. Starting 1 July 2016, all products sold by registrants and distributors/retailers must bear a new label which includes the new mitigation measures.

 

CPMA Question: Are the registrants required to resticker old-labeled product?  What about end-users?

 

PMRA Response

During the transition period where old and new labels may exist at the same time (e.g. April to June) registrants may:

1. relabel all products sold either by the registrant or sold by distributors/retailers to users as soon as the new labels have been approved by PMRA, OR
2. they are required to ensure that products with existing old labels (sold either by the registrant or sold by distributors/retailers to users) must bear a sticker referring users to consult the new label information and Applicator’s Manual.  Please note that the sale of any product with an old label (with sticker) during the transition period must also be accompanied by copies of the new label and Applicator’s Manual.
3. With respect to users’ obligations, please see the response to the question below.

 

CPMA Question: Are PMPs in possession of old-label product allowed to use those products in accordance with the use directions on the old label?

 

PMRA Response

According to subsection 6(5) of the PCPA, it is an offence to use a product in a way that is inconsistent with the directions on the label recorded in the PMRA Register (i.e. the currently registered label available through the online or mobile Pesticide Label Search – see above link).  However, if a person uses a product according to its label and believes that the directions on that label are the same as those on the label recorded in the PMRA Register, then, that person is not considered to have contravened the PCPA (subsection 6(6)).  Note that if the person using the product has been made aware of the changes to the label and they are not using the product according to the currently registered label, then, they are in contravention of the PCPA.

 

The PMRA recommends that CPMA inform their members that phosphine labels now include all new risk mitigation measures resulting from the re-evaluation decision.