Pest Management Regulatory Agency registration toolkit

With described video

Transcript

Transcript

Narrator:

Text on screen says how to register pesticides with Health Canada's Pest Management Regulatory Agency PMRA.

An application to register a pest control product follows a series of steps.

Seven circles with text written in them create a big circle with arrows connecting each. The text in the various circles say, pre-submission consultation, assembling an e-file in ePRS, loading an eFile, verification and screening, science review, decision making, and registration. A spray bottle is in the centre of the big circle.

The purpose of your application determines the data and non-data elements required.

Various Health Canada forms appear on screen. Text above the forms says data and non-data elements.

Once that has been identified, you may request a pre-submission consultation to better understand the data requirements and obtain written guidance.

Three text bubbles appear and one of them has a spray bottle in it. Text on screen says pre-submission consultation and has the word free pointing to it.

Narrator:

Text on screen says, is a pre-submission consultation necessary?

A pre-submission consultation is not always required except for Joint Reviews and Microbial applications.

A computer screen scrolls through the pre-submission consultations page of the Government of Canada website.

Narrator:

Text on screen says, how should the data package be submitted to the PMRA?

Once your application package is complete, visit the PMRA website to obtain directions on how to compile the data package into "PRZ" format. Then you can submit it through the secure electronic pesticide regulatory system, by mail or email.

A computer screen scrolls through the electronic pesticide regulatory system page of the Government of Canada website. The screen transitions to a graphic of a file with PRZ written on it, along with a laptop, plant, a container with pens and pencils in it, and a USB.

The system will then set up the submission on a first come, first served basis and assign a submission number.

The file with PRZ written on it disappears into an envelope graphic as a cursor clicks it. The screen transitions into number of envelopes being placed in a row.

Narrator:

Text on screen says, is your submission package complete?

Your submission will be verified and screened to ensure the package is complete before the science review begins.

The PRZ file is going through a scanner with text over top that says verification and screening process.

The verification process ensures that all non-data elements have been provided.

A magnifying glass is being moved over the PRZ file.

During the screening process, submissions are reviewed to confirm the category of submission and ensure it meets the format, data, fee requirements and that the labels follow current guidelines and directives.

The PRZ file is on screen with a dotted line that connects to a circle. The dotted line and circle move around the file and a green checkmark appears after each text graphic comes on screen. The text says, format, data, and fee. The screen transitions to show an industrial pesticide sprayer.

You may receive clarification requests by e-mail and you will have 10 calendar days to respond.

A male character on a laptop. An email notification pops out of the laptop. The screen zooms out to reveal he is sitting on an hour glass. 10 days is written on screen.

If deficiencies or insufficient information are identified, a notice of deficiencies will be issued and you will have 45 calendar days to respond. If there is no response or an incomplete response is received, the application will be refused.

A clipboard has three green checkmarks and two red X marks. Text appears on screen that says, deficiencies and insufficient information. The screen transitions to reveal and computer screen that has a notice of deficiencies email in an inbox. A calendar appears with a date circled and 45 days written on it. The screen transitions to a file folder that has a refused stamped on it.

Narrator:

Text on screen says what happens during the science review stage?

In the science review stage, a team of scientists evaluate the health and environmental risks

A female character on screen holds a flower. The text above her head says human health risk assessment. Three bubbles appear with a nose, mouth and hand inside of them. The text beside the bubbles say inhalation, oral and dermal. The screen transitions to a farm with ducks swimming in a pond. The text says environmental risk assessment.

As well as the value of the pesticide and product chemistry to determine if they are acceptable.

A field of vegetables is shown and a pesticide is being sprayed. The weeds die while the vegetables continue growing. The text says value review. The screen splits and test tubes in a rack appear with text below it that says chemistry review.

Narrator:

Text on screen says, how should applicants respond to information requests during the science review stage?

Just like in the screening process, you will have 10 calendars days to respond to clarification requests.

Calendar on screen that has a line through some of the days of the week. A counter is increasing to 10 days on the left-hand side.

If deficiencies are identified, you will receive a Notice of Deficiencies and have 90 calendar days to fulfill the outlined requirements. It should be noted that the science review is suspended until a response received.

Bugs crawl on the screen. The screen transitions to a calendar, a female character working on a computer at a desk and a number counting up to 90 day as the calendar flips pages with lines striking through the weeks. The screen zooms into the female character and a sent email appears on her computer.

Narrator:

Text on screen says, how does PMRA reach its decisions?

Once the rigorous science-based evaluation is complete, the findings of the science review teams undergo peer review and manager approval.

A set of test tubes in a rack, a female character, field of vegetables, farm with ducks swimming in a pond are in individual circles and float around on screen.

Then, all assessment results and science team recommendations are consolidated. For new active ingredients or major new uses, these are presented to PMRA's Science Operations Committee for discussion and then to Science Management Committee for decision.

A document entitled "Science team recommendations" appears on screen. Text that says new active ingredients and major new uses of pesticides appears to the right. The screen transitions to a group of characters in a meeting with the words SOC below. Another group of characters in a meeting appear with the words SMC below.

Narrator:

Text that says, how should applicants respond to PMRA's request for comments on pesticide labels?

At the end of the review stage, the bilingual revised labels are sent to applicants by e-mail to provide an opportunity to comment and to clarify issues arising from the revisions.

A laptop, cup of coffee, cellphone, papers, pen and a pencil appear on screen. The screen zooms into the laptop screen and an email appears that says one more change. The mouse moves a skull and cross bones icon onto the bottle of pesticide that is on the laptop screen.

Narrator:

Text that says, "what does PMRA do to ensure transparency in decision making?" appears on screen.

A bilingual consultation document is published on the Health Canada website for all major decisions which outline major findings and the proposed decision.

A computer screen that has the registration decision page of the Government of Canada website. Text above it says major new uses of a pesticide and new registrations.

The public may submit comments on the consultation document to the PMRA within 45 days after its publication.

A number of hands are raised as a number counts up to 45 days after the date of publication.

All comments received from the consultation period are considered before a final decision is made. The final decisions are posted on the Health Canada website.

The hands lower and a number of text bubbles appear and connect to each other. The screen transitions to a computer that has the registration decision page of the Government of Canada website.

Narrator:

Text on screen says, "how can applicants and other stakeholders access information about registered pesticides?"

Anyone can access information about registered pesticides through the Public Registry. It is a collection of non-confidential and publicly available information for currently registered pesticides.

A female character sits on a couch in a living room with her cat beside her. A tablet appears to the right with public registry on it. The tablet flips and says pesticide product information database, regulatory and policy documents and approved bilingual labels.

Narrator:

For more information and guidance on how to register pesticides, contact the Pest Management Information Service or visit Canada.ca/pesticides

A farm landscape appears. The screen transitions to the Pest Management Information service and pesticides in Canada page of the Government of Canada website. The Health Canada logo appears with text underneath that says contact Pest Management Information Service or visit Canada.ca/pesticides.

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