T-4- 122 – Service delivery standards for fertilizer and supplement registration-related submissions under the Fertilizers Act and regulations

1. Purpose

The purpose of this document is to outline the service delivery standards for registration-related submissions for fertilizers and supplements regulated by the Canadian Food Inspection Agency (CFIA) under the Fertilizers Act and regulations. Service standards are an important management tool for measuring, assessing, communicating and improving service performance relating to registrations of fertilizer and supplement products. These timelines offer time-to-market predictability for product proponents so that they can plan their business accordingly.

2. Service standard development

The Treasury Board has outlined the principles that should be followed by federal departments and agencies when developing service delivery standards. Characteristics of a good service standard include that they are: relevant to the client, based on consultation, measurable, consistent across government, ambitious but realistic, endorsed by management, communicated, transparent and continuously updated.

The Service Delivery Standards (SDS) were developed in consultation with the stakeholder community and implemented in 2008. They were based on several assumptions:

• the average number of active files in the review queue does not significantly exceed 300 to 400 submissions
• the proportion of each file type at pre-screening level, and in the various review streams is consistent with past trends and
• approximately half the files in the first review stage also require a second and third review. The time standards presented in appendix A have not changed since their implementation in 2008

See Appendix A for tables that present service delivery standards for the CFIA's review of applications for permissions under the Fertilizers Act, and Appendix B for timelines for applicant responses to CFIA requests.

3. Overview of file review procedures and associated service standards

The file review procedures consist of a pre-screening/completeness check, followed by a maximum of 3 review cycles. The associated time standards are provided in working days and include the actual CFIA review time and the queue time, since all files are processed in the order they are received. The SDS vary by application type due to the nature and complexity of the assessment required. At the end of each review phase, the CFIA will either:

• approve the request
• deny the request, or
• request product label changes and/or additional information from the applicant

Please note that unless there are deficiencies identified in the application, the file may not require all 3 reviews. A complete submission can be approved and the product can be registered at the end of first review. Therefore, it is critically important that applicants invest the time and effort to familiarize themselves with the registration requirements before they submit an application to the CFIA.

It is mandatory that all applications be submitted through MyCFIA. MyCFIA is the electronic submission platform for applicants seeking registration under the Fertilizers Act. The My CFIA digital service delivery platform allows you to request, pay for and track the status of services online anytime, anywhere through a secure account that can be tailored to suit your business model. To apply, you must first create a My CFIA profile. Once enrolled, you will see the PASO services available. Guidance documents, videos and step-by-step walk-throughs for how to sign up for an account, manage an account and request services online can be found at: My CFIA guidance.

4. Submission types

The Service delivery standards described in this document apply to new registrations, re-registrations, "me too" registrations, major amendments and minor amendments.

4.1 New registration

Products that require registration under the Fertilizers Act must obtain it prior to importation and sale in Canada. When seeking registration for the first time, a product must apply for a new registration. To streamline the information required to support registration under the Fertilizers Act and regulations, the CFIA has implemented a tiered approach whereby the extent of the safety data requirements varies depending on the application type, nature of the product and its risk profile.

All applications for registration require the submission of core product information (safety assessment level I), some also require results of analysis (safety assessment level II) to allow for verification of consistency in production or effectiveness of treatment as well as purity of the final product with respect to contaminant levels. Products with a higher or unknown risk profile necessitate a full safety assessment (safety assessment level III), for which scientific rationales, supplemental safety data and/or additional results of analysis are required. The requisite assessment level (I, II or III) is determined based on the product ingredients (both active and inert) and their sources, potential residues, contaminants, and degradation by-products as well as the manufacturing process, use pattern and application rate and frequency. For more information on safety data requirements, please refer to the guide.

4.2 "Me-too" registration (Private Label)

"Me-too" registrations are reserved for specific cases where an applicant wishes to register a fertilizer or supplement product that is already registered under a different name and/or brand.

The "me-too" product can be marketed by a different company (not a requirement). To be considered a "me-too" registration, the changes to the product are restricted to:

• the name and/or brand
• the name and address of the registrant and/or manufacturer
• net weight or
• the colour and format of the label

The "me-too" product must have the same composition, guarantee(s), use pattern(s) and label claim(s) as the registered product and, all data required to support an application for registration under the Fertilizers Act must be submitted at time application is made – it is not acceptable to simply reference an older submission and state that all parameters remain the same.

Note: In MyCFIA, me-too applications can be identified using the "Private Label" submission type.

4.3 Re-registration

Registered products require renewal every 5 years in order to continue to be legally sold and/or imported into Canada. Applications to re-register products are reviewed to verify that products remain in compliant with the requirements of the Fertilizers Act and regulations.

Additional safety data may be required:

• if the registrant either makes changes to the constituent materials, their sources, manufacturing methods or directions for use or
• due to emerging safety risks, CFIA may request additional information/data as new scientific information or sources of concern arise

4.4 Amendments

Section 7 of the Fertilizers Regulations states that a person shall not change the label, chemical composition or ingredients of a fertilizer or supplement that is registered, if the change could reasonably be expected to affect its performance as a fertilizer or supplement, its safety or its use, unless the registration is amended accordingly (a major or minor amendment required). Changes to a product or its label that require an amendment to the registration can be made only after the CFIA has approved the request. Alternatively, these changes can be made at the time of re-registration. Changes that will not affect product identity as a fertilizer or supplement, safety or use can be made without prior approval from the CFIA and they do not require notification. Contact the CFIA if you have any questions about whether or not changes you intend to make to your product(s) trigger a requirement to submit an amendment.

Applications to amend product registrations can be made at any time, and fall into 2 broad categories:

Minor amendments are reserved for changes in:

• the name or address of the registrant or
• the product name

The minor amendment fee is applicable only when the product proponent wishes to amend a product between registration periods, minor amendments may be made at time of registration renewal with at no additional cost. The processing of a minor amendment in between registration periods does not extend the duration of the product's registration.

Major amendments are required for all changes that could reasonably be expected to affect the performance of a product as a fertilizer or supplement, its safety or use, other than what is permitted under a minor amendment (as outlined above). A safety review is usually required to approve a major amendment and, as a result, the safety review fee will typically be charged for these applications (for example if application rate is being increased, a new application scenario is introduced, or active ingredients are altered).

When a major amendment is granted, the expiry date for the product's registration is also extended (60 months from the date the amendment is approved). Major amendments made at the time of re-registration will be charged the major amendment fee rather than the renewal fee (the safety assessment fee will also typically be applied).

Note: the CFIA Fees Notice, Part 5 currently identifies some additional changes to those mentioned above that would require an amendment to the registration (for instances changes to the colour or format of the label and the declaration of net weight). In accordance with the modernized Fertilizers Regulations (November 10th, 2020), these no longer trigger the requirement to amend the registration, as they do not affect product's identity, performance as a fertilizer or supplement, its safety or its use.

4.5 Ingredient Source Change Inquiry (ISCI)

Section 7 of the Fertilizers Regulations states that a person shall not change the label, chemical composition or ingredients of a registered fertilizer or supplement if the change can reasonably be expected to affect its performance as a fertilizer or supplement, as the case may be, its safety or its use, unless the registration is amended accordingly. A proponent may wish to change the source of an ingredient in their product (not the ingredient itself), but be uncertain if that change could affect product safety. In such cases, the proponent is advised to submit an inquiry to the CFIA that details the proposed change and request guidance. These requests are processed free of charge and in accordance with a service delivery standard of 30 days. The outcome of the ISCI review may be either:

• Approval
  • Approval of the Ingredient Source Change Inquiry (ISCI) without further review will be granted if the change in the source of ingredient(s) does not pose any concerns with respect to the safety of the final fertilizer or supplement product. A note will be added to the product file indicating that the new source has been reviewed and is deemed acceptable.
• Request for major amendment
  • Changes in source of ingredients that may impact the safety or identity of the fertilizer or supplement product (for example switching from a mined source to a reclaimed one with a history of contamination) will require more detailed review by the CFIA. In these cases, the proponent will be directed to submit for an amendment prior to implementing the change in source.

5. File submission management process

The Premarket Application Submission Office (PASO) coordinates all the administrative services and activities related to pre-market assessment and product registration.

The application review process can be broken down into the following steps:

5.1 Pre-screening

The pre-screening process is divided into 2 phases:

1. The completeness check

   During this check, it is determined whether the information submitted is sufficient for an evaluator to initiate the review. The information required for a submission to be considered "complete" may be found in the applicable submission checklist.

   Submissions containing poor or incomplete information (for example only placeholder information was populated rather than addressing the specific information requirement) in mandatory fields will be identified at first review and closed at that time – the application fee will not be refunded.

2. The first response

   This step is a non-technical scan after the submission has entered the CFIA's file tracking system to ensure all mandatory information appears to have been included in the submission. This scan does not address the quality of the information submitted. Any deficiencies identified during this step will be outlined for the applicant via a first response letter (electronic notification within My CFIA, with a timeline of 30 days to respond. If applicant's response does not fully address each deficiency or is not received by the stated deadline, the application is closed, and any safety fees submitted are refunded (safety reviews do not commence until an application reaches the first review stage). If there are no outstanding information requirements, the applicant will be informed that their application has been entered into the first review queue and of the deadline (calendar date) for the CFIA's first review.

5.2 Technical review of applications for permissions

During the technical review stages, evaluators review the information in the submission against the requirements of the Fertilizers Act and regulations and associated policies. All administrative requirements are also dealt with during the review. The application review (both for label compliance and safety) is divided into 3 possible iterative reviews (not all of which are mandatory):

5.2.1 First review

Depending on the submission type and the complexity of the supporting data, the file may be required to undergo more than 1 type of assessment during the first review (label review, biological safety review, and/or toxicological safety review).

Once the first review is complete, the product may be registered under the Fertilizers Act. If the application lacks details necessary to complete a safety review, or the product label requires changes to comply with the regulations, a letter detailing deficiencies is sent to the applicant identifying any missing information or necessary label changes.

When the applicant receives a first review letter from the CFIA (through the My CFIA portal or by email/mail), the applicant must respond by the stated deadline and must adequately address each deficiency in their response. If all the requested information is received by the CFIA at or before the stated deadline, the application is moved into the next review queue and the CFIA's service delivery clock starts (CFIA time standards). If the response is incomplete or received after the deadline provided, the application will be closed (denied) and the fees are not refunded.

5.2.2 Second review

Many applications require a second review to address label changes and/or safety concerns prior to registration. Once the second review is complete, either a letter detailing remaining deficiencies is sent to the applicant or if the response to the first review letter satisfied the deficiencies identified, the product is registered under the Fertilizers Act.

Much like the first review, if all the requested information is received by the CFIA at or before the stated deadline, the application is moved into the next review queue and the CFIA's service delivery clock starts (CFIA time standards). If the response is incomplete or received after the deadline, the application will be closed (denied) and the fees are not refunded.

5.2.3 Third review

Some submissions undergo a third review if the information provided in the first or second reviews raised additional safety-related concerns or resulted in additional label changes. Once the third review is complete, if the applicant has not addressed all of the questions or deficiencies in an adequate manner, the application is closed. If the applicant has addressed the requirements identified in the second review letter, the product is registered under the Fertilizers Act.

Please note: if applicants are seeking an extension to the provided deadline for response, they must do so in writing (by email or letter submitted to PASO). Please note that requesting an extension excludes the product from service delivery standards. More details on appeals follow in section 6.

6. Appeals, complaint and redress mechanism

The CFIA aims to deal with any expression of dissatisfaction with the registration process, positively and constructively, with the objective of making further improvements to the service delivery standards. As well, product proponents wishing to appeal a specific element/requirement of a review, or the outcome of the review may appeal to the Fertilizer Safety Section through the following process.

Process for lodging an appeal or complaint:

Complaints and appeals related to the service delivery standards should be sent either by mail or email to the Pre-market Application Submissions Office (PASO).

Step 1: When the PASO receives an appeal or complaint an acknowledgment of its receipt is sent to the client and the appeal or complaint is forwarded to the National Manager of the Fertilizer Safety Section for action.

Step 2: The National Manager must thoroughly and objectively investigate the complaint. If the appeal or complaint is related to a specific file or product and can be dealt with immediately, the National Manager will assess the problem and advise the client of the outcome.

Step 3: If necessary, the Director may evaluate all of the information provided by the National Manager, and may address the client's appeal or complaint by either: further investigation, conciliation, mediation, or mitigation and must identify the actions required to rectify the problem and prevent its recurrence. Response time will vary based on complexity and seriousness of the situation. The CFIA may not be able to remedy some appeals or complaints due to the nature of the problem (for example failure to meet the requirements) and corrective action may occur over a longer term. Irrespective of the outcome, a final response must be provided to the client.

Step 4: If product proponent is still not satisfied after Steps 1, 2, and 3, they are encouraged to submit a formal complaint in writing to the Complaints and Appeals Office. Once received, the Complaints and Appeals Office will start an impartial and transparent review of the matter.

It is important to note that appealing a review letter will exclude the product file from service delivery standards.

7. Quality service improvement plan

The key objective of the CFIA's Fertilizer Program is to ensure the safety and proper labelling of all fertilizer and supplement products imported into and sold in Canada. Activities that constitute the core of the Fertilizer Program's mandate include; product assessment, submission review, overseeing the delivery of marketplace monitoring programs, policy development and periodic review of policies, procedures and forms, standard setting, systematic regulatory review and program re-design. By consulting with clients, monitoring service delivery performance, and implementing improvements to program delivery, the fertilizer safety section will be able to provide higher quality service and better enable access to market for innovative products.

The CFIA continues to closely monitor trends in application volumes and in complexity of safety reviews to allow for continuous improvements to the Service Delivery Standard model with the view to maximize efficiency and reduce time to market whenever possible.

The electronic submission platform (through the My CFIA portal) is further intended to streamline and expedite file processing while providing the applicants with convenient, fast and secure tool for applying and obtaining permissions under the Fertilizers Act.

8. Contact information

Fertilizer Safety Section
Canadian Food Inspection Agency
Phone: 1-855-212-7695

cfia.paso-bpdpm.acia@inspection.gc.ca

Appendix A: current time standards for the CFIA's review of registration related submissions

Note: performance target is 90% of all registration related submission types to be reviewed within the times shown (not all reviews may be required for a given submission). Adherence to SDS is monitored by submission type and per review stage. If a file misses a deadline at any of these review stages, it is considered to exceed the overall SDS.

Appendix B: current time standards for applicant response to CFIA requests following the review of a registration-related submission

Note: if a response to a CFIA request is not received within the relevant time period, the application will be closed.