Guidelines for pre-submission consultations for fertilizer and supplement products regulated Under the Fertilizers Act and Regulations

Introduction

The Fertilizers Act is the legislative authority under which the Canadian Food Inspection Agency (CFIA) monitors and controls fertilizers and supplements sold in or imported into Canada. This legislation helps to protect consumers and the general public against potential health hazards and helps ensure safety for plants, animals and the environment. Agricultural fertilizers, specialty fertilizers, and supplements are all controlled and regulated under the Fertilizers Act and Regulations.

To obtain approval of a registerable product for sale in Canada, product proponents must make submissions to the Fertilizer Safety Section of the CFIA. For cases where proponents are unsure of how their product is classified, or of the regulatory requirements, the Fertilizer Safety Section offers services of product-specific inquiries and pre-submission consultation meetings. These activities serve as valuable communication tools, as they provide regulatory interpretation and guidance to industry prior to submission of a registration application package. To ensure that the pre-submission consultations follow a standardized process, and the information provided by both the company and the CFIA is recorded and maintained, the following meeting guidelines have been developed.

Purpose

The purpose of the pre-submission consultation is for the Fertilizer Safety Section to provide product proponents with guidance, and clarification on the regulatory requirements, current policies and standards for fertilizer and supplement products. This information can then assist product proponents in the preparation of a complete submission that adequately supports the product's safety and meets the prescribed labelling requirements. This can significantly expedite the review process. The meeting can be used to obtain guidance for products that require registration or pre-market approval, or products that are exempt from registration but are still regulated. These meetings may also provide regulatory foresight for the Fertilizer Program in terms of industry trends, and innovative products that are currently under development. In this way, the CFIA can ensure that its policies and requirements meet the needs of stakeholders, as well as identify program areas that require review, change and/or improvement.

Initiate contact with an inquiry

The Fertilizers Act and Regulations delineates and explains which products require registration, and which products do not require registration. Products that do not require registration may still be regulated under the Fertilizers Act and Regulations. Please note that the classification of products and the registration requirements are based largely on the product label, and the intended use pattern.

Product proponents, especially those who are unfamiliar with the Fertilizers Act and Regulations, or who are uncertain of the regulatory requirements specific to their product, are encouraged to start the process with the submission of an inquiry.

To determine if a product requires registration, and what the specific regulatory requirements may be, the information found in the submission checklist for a Product Specific Inquiry must be submitted to the Fertilizer Safety Section.

When this information is received by the Fertilizer Safety Section, an Inquiry file will be opened, and you will receive a response from an evaluator within 30 working days. The response provided will explain the categorization of the product under the Fertilizers Act and Regulations, as well as the requirements specific to that product type.

An inquiry may provide the answers that a proponent requires and eliminate the need for a meeting. However, if a product proponent or the Fertilizer Safety Section feels that a more detailed face-to-face consultation is warranted, a pre-consultation meeting may be requested. This is especially relevant for innovative products where the regulatory and policy requirements may be in transition or in the initial stages of development.

Procedure for requesting a meeting

A meeting request should be made by a product proponent (registrant, importer, manufacturer, Canadian representative, etc.) in writing (via e-mail or letter) at least three weeks in advance of the meeting. Please address the request to the Fertilizer Safety Section.

Having a meeting will not affect or change the service delivery standards for submission review once the application is received by the Fertilizer Safety Section.

Meeting inclusions

The meeting can include:

1. communication of general information about the Fertilizer Program and the regulatory framework;
2. clarification of requirements, policies and administrative processes within the Fertilizer Safety Section; and
3. a discussion of the data/information requirements specific to the product.

Meeting exclusions

The meeting will not include:

1. an onsite review or assessment of data, label or other information pertinent to the product;
2. a decision on the acceptability of the data or the product;
3. a discussion of confidential business information belonging to another company; or
4. information regarding pending or current enforcement action(s) and/or complaints submitted against the product proponent/company.

Roles and responsibilities

Company representative

Prior to the meeting, the product proponent is required to supply the following information to the Fertilizer Safety Section:

1. Proposed meeting agenda;
2. Draft label;
3. A complete list of ingredients;
4. The manufacturing method; and
5. The mode of action for the active ingredient (if known).

The proposed meeting agenda should indicate the length of time required for the meeting, and the specific questions or topics of discussion. This is required to aid the Fertilizer Safety Section in preparing for the meeting and compiling all relevant information/requirements for the given product type. The requested information must be submitted, at minimum, two weeks prior to the meeting to allow for sufficient review time and preparation. The product proponents are also expected to prepare for the meeting by reviewing the relevant sections of the Fertilizers Act and Regulations and applicable guidance materials (e.g. Trade Memoranda, Guide to the Canadian Federal Regulatory Requirements for Fertilizers and Supplements, etc.) available on the CFIA website.

During the meeting, product proponents are invited to present a brief overview of the product as well as record minutes of the meeting. The role of the minute recorder has been assigned to the company representative to ensure that the information they deem important and relevant is captured.

Following the meeting, product proponents are responsible for submitting the minutes to the Fertilizer Safety Section for review.

Fertilizer safety section

The Fertilizer Safety Section contact will work with the product proponent to arrange a mutually convenient time for a meeting, and coordinate the attendance of the appropriate Fertilizer Safety Section representatives. It is the responsibility of the Fertilizer Safety Section representatives to prepare for the meeting by reviewing the information submitted by the company.

During the meeting, the role of the Fertilizer Safety Section representatives is to provide guidance on the regulatory requirements as prescribed by the Fertilizers Act and Regulations and the current policies and standards. Data and/or information requirements specific to the product will also be discussed, however, product-specific guidance will be based solely on the accuracy and completeness of the information provided by the company prior to the meeting.

Following the meeting, the Fertilizer Safety Section will review and comment on the minutes recorded by the company. The final meeting minutes will be returned to the company representative within 30 days of their receipt. The following disclaimer will be added to the minutes:

Disclaimer

The above guidance provided by the Fertilizer Safety Section is based on current CFIA policy and the quality and accuracy of the information supplied by the company prior to the meeting. There may be intervening legislative, regulatory, or policy changes, or significant new information may come to the attention of the Fertilizer Safety Section, which could affect the validity of the advice provided from this consultation. It is the sole responsibility of the company to keep abreast of any policy or legislation changes that may alter or impact the guidance provided. It must be recognized that the guidance provided by the Fertilizer Safety Section is not intended to alter or qualify in any way the Agency's authority and responsibility to evaluate and decide on the acceptability of a product in accordance with the Fertilizers Act and Regulations.

The information provided by the company prior to the pre-submission consultation meeting, together with the meeting minutes, will be maintained by the Fertilizer Safety Section, and assigned a file submission control number. This number can be referenced at a later date when the application package for registration or product approval is formally submitted.

All information contained in the file and/or discussed at the pre-submission consultation meeting will be considered confidential business information. As such, access to the file will be restricted to the applicant/product proponent or person(s) that are granted signing authority by the applicant.

(For more information on signing authority please consult Trade Memorandum T-4-95: Signing Authority, Delegated Representatives and Canadian Agents).

Contact information

If you have any questions about pre-submission consultation meetings, please contact the Pre-market Application Submissions Office (Fertilizer Safety Section): cfia.paso-bpdpm.acia@inspection.gc.ca