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 using the format outlined in the "Guide to submitting applications for registration under the Fertilizers Act" (the guide). The guide is specifically designed to assist prospective registrants in preparing complete and well organized submissions in order to facilitate the file review process and ultimately expedite time to market.

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

"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.

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 (October 26^th, 2020), these no longer trigger the requirement to amend the registration for products that comply with the new regulations, 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. Applicants are strongly encouraged to use the electronic submission platform (My CFIA). While email or mail applications will still be accepted, they are slower to process and are therefore not the CFIA's preferred format/route from a file processing perspective.

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.

Whether applications are electronic or paper-based, the information required to be submitted in support of an application is the same. For guidance on the application submission process, please see the Guide to Submitting Applications for Registration under the Fertilizers Act. Each application received is processed according to the steps detailed in this section.

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.

   Any hard-copy submissions that do not pass the "completeness" check are returned to the applicant (on request) or disposed of through shredding, and a letter outlining the deficiencies is sent to the applicant – no fee is collected at this point. It is not possible to submit an incomplete submissions using the My CFIA electronic submissions platform, as all mandatory fields must be populated before an applicant can chose to submit. Incomplete applications will remain open in the My CFIA platform until all mandatory fields are populated. 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, e-mail or letter if the submission was submitted outside of 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.

Following implementation of the amended regulations (October 26^th, 2020), the CFIA will closely monitor trends in application volumes and complexity during the transition period (3 years) and beyond. This will 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. Digitization of services offered by the CFIA to regulated parties is considered a high priority for the Agency and as such businesses are strongly encouraged to transition to the new system as quickly as possible and practical.

8. Contact information

Fertilizer Safety Section
c/o Pre-market Application Submissions Office (PASO)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, ON K1A 0Y9
Canada
Phone: 1-855-212-7695
Fax: 613-773-7115

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.

1.0 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 represent an important management tool for measuring, assessing, communicating and improving service performance relating to registrations of fertilizer and supplement products. These timelines further offer product proponents time-to-market predictability so they can plan their business accordingly.

2.0 Principles for developing service standards

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 are:

• Relevant to the client
• Based on consultation
• Measurable
• Consistent across government
• Ambitious but realistic
• Endorsed by management
• Communicated
• Transparent
• Continuously updated

3.0 Time Standards

3.1 Description of the Time Standards

The Service Delivery Standards (SDS) used by the Fertilizer Safety Section allow for a maximum of three review cycles and consist of queue time (the time the file waits in a queue before the review is initiated), the CFIA review time and industry response (in cases where deficiencies and/or data gaps are identified). The SDS were developed in consultation with the stakeholder community and implemented in 2008. They were based on several assumptions: 1) the average number of active files in the review queue does not significantly exceed 300 to 400 submissions; 2) the proportion of each file type at pre-screening level, and in the various review streams is consistent with past trends and 3) 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.

It should be noted that if a submission has no deficiencies and is complete, or if the response time is kept to a minimum, the total time required to complete a file can be shortened significantly. Incomplete submissions and persistent deficiencies in the data/information submitted to the CFIA protract the registration process and delay review of applications behind them in the queue. Even though, the file review process allows for up to three reviews, using all three reviews is not mandatory and is discouraged. A complete submission can be closed and the product can be registered at the end of 1^st review if no deficiencies are identified. Therefore we strongly recommend that product proponents familiarize themselves with regulatory requirements prior to submitting an application. Companies lacking the requisite in-house expertise to generate appropriate data and/or safety rationales in support of product registration are encouraged to seek external advice and assistance.

To assist applicants with preparing complete submissions, and improve the submission review process, it is mandatory that all applications be submitted using the format outlined in the "Guide to submitting applications for registration under the Fertilizers Act" (the Guide). The Guide is specifically designed to assist prospective registrants in preparing complete and well organized submissions in order to facilitate the file review process and ultimately expedite time to market. The guide is accompanied by a PowerPoint presentation that "walks" applicants through the file review process, to offer further guidance to prospective registrants.

3.2 Client Responsibilities

The applicants are expected to provide timely and accurate information if they wish to receive the indicated levels of service. Applicants are expected to:

• Except in the case of a "me too" registration, not reference other submissions/data, but rather submit the information directly;
• Submit all requisite information, and not just minimal information for the purpose of "getting through" the completeness stage and entering the "queue";
• Address all deficiencies identified in a review letter in a single, complete package. As soon as information is received addressing all items contained in a review letter, the next review period will begin;
• Address all deficiencies identified in a review letter as soon as possible, rather than waiting for the deadline to submit;
• Advise the Fertilizer Safety Section in a timely manner of any changes in addresses, signing authority, manufacturing sites, etc.;
• Review all necessary reference material available online before contacting an evaluator;
• Contact the Pre-market Application Submissions Office (PASO) for information on the status of the submission and not individual evaluators.

4.0 Submission Management Process

The Service Delivery Standards described in this document apply to registration – related submissions only. This includes new registrations, re-registrations, "me too" registrations, minor amendments and major amendments.

The following paragraphs describe the different file submission types and the file submission management process.

4.1 File Types

4.1.1 New registration

Products that require registration under the Fertilizers Act must obtain it prior to importation and sale in Canada. Certain products require a comprehensive safety data package while others don't. The extent of the data required to support product registration depends on the risk profile of the product and its ingredients. There are three levels of safety assessments. Level I is reserved for products with well-established history of safe use and a negligible risk profile and require the submission of core information only (Appendix B). Level II is intended for products that may be contaminated with chemical or biological agents hence require core information and results of analysis and Level III assessments are conducted on products with unknown or higher risk profile and require submission of core information, results of analysis and a safety rationale and potentially supplemental data.

For more information on safety data requirements, please refer to the Guide to submitting applications for registration under the Fertilizers Act.

4.1.2 "Me-too" registration

"Me-too" registrations are reserved for fertilizer and supplement products that are already registered under a different name and/or brand. The "me-too" product may or may not be marketed by a different company. To be considered a "me-too" registration, the changes to the product are restricted to i) the name and/or brand; ii) the name and address of the registrant and/or manufacturer; iii) net weight; or iv) 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, the data used to support the original product registration must be made available to the CFIA (or referenced in the submission). A "me too" registration cannot be used to generate another "me too" registration. Only an original product registration that contains the applicable safety data, and meets the CFIA's current requirements, can be used for the purpose of generating a "me too" registration.

4.1.3 Re-registration

Registered products have to be re-registered every three years in order to continue to be legally sold and/or imported into Canada. The re-registration submissions are reviewed in order to determine whether the product continues to comply with the Fertilizers Regulations. A need to provide additional safety data can arise if the registrant either makes changes to the constituent materials, their sources, use pattern, label claims or due to policy and program redesign changes. In these cases, additional data/information is requested the time of product re-registration. If there are no changes to the product that warrant supporting data, then no safety data is required (except results of analysis) with an application for re-registration.

For more information on safety data requirements, please refer to the Guide to submitting applications for registration under the Fertilizers Act.

4.1.5 Amendments

Section 7 of the Fertilizers Regulations states that "No change in the label, chemical composition or ingredients of a fertilizer or supplement that is registered shall be made unless the registration is changed accordingly". The definitions of the different types of amendments are outlined in the CFIA Fees Notice, Part 5 – Fertilizer Fees and are described below:

4.1.5.1 Minor Amendment

A Minor Amendment is defined as an application to amend a registration outside of the re-registration process with respect to one or more of the following: (i) the name or address of the registrant and/or manufacturer; (ii) the colour or format of the label; (iii) the product name and/or brand; (iv) the declaration of net weight. Any other changes to a product registration are considered a Major Amendment.

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

4.1.5.2 Major Amendment

In the cases when an applicant/registrant wishes to make changes to the product that lie outside the scope of a minor amendment as defined above the application is considered a Major Amendment. Major amendments may be made at the time of re-registration; however, additional fees are applicable if a safety review is required. The processing of a major amendment in between registration periods will result in a new registration fee being charged and an altered expiry date (36 months from the date the amendment is approved).

4.1.5.3 Notification of source change

In order to promote industry compliance with the Fertilizers Act and Regulations and encourage notification of any changes in source of ingredients, the Fertilizer Safety Section has instituted a submission category for Notification of Source Change (NSC). These applications are processed free of charge and in accordance with a service delivery standard of 30 days. The outcome of the NSC review may be either Approval or Request for Major Amendment:

1. Approval. Approvals of the NSC 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 or identity 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.
2. Request for Major Amendment. Changes in source of ingredients that may impact the safety or identity of the fertilizer or supplement product will require more detailed review by the CFIA and, potentially, submission of supporting data. In these cases, NSC will not be approved and proponents will be directed to submit for an AM prior to implementing the change in source.

For more information please refer to T-4-125 – Notification of Source Change – process and timelines.

4.2 File submission management process

4.2.1 Pre-Screening

All submissions are to be sent to the Premarket Application Submission Office (PASO). PASO coordinates all the administrative services and activities related to pre-market assessment and product registration. PASO is also the first point of contact for questions regarding the status of a previously submitted application, or guidance on how to complete a new application package. The pre-screening process of a submission is divided into two phases: 1) the completeness check and 2) the first response.

4.2.1.1 Completeness check

During the completeness check the submission is reviewed to determine if a minimum amount of information has been submitted in order 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. Any submissions that do not pass the "completeness" check are returned to the applicant (on request) or disposed of through shredding and a letter outlining the deficiencies is sent to the applicant but the payment is not processed.

4.2.1.2 First response

The first response check is a further pre-screening step after the submission has entered the CFIA's file tracking system. This review does not address the quality or completeness of the information submitted. Detailed safety or label reviews do not commence until a file reaches the first review stage. Any outstanding information identified during first response will be requested from the applicant via a first response letter, with a timeline of 30 days to fulfill the request. If applicant's response does not fully address each deficiency or is not received by the stated deadline, the submission is withdrawn from the review queue (closed), returned to the applicant (on request) or disposed of through shredding but the fees are processed and not refunded (except the safety fee). If there are no outstanding information requirements a letter will be sent indicating that the submission has been received and has been entered into the 1^st review queue.

4.2.4 Review Streams

During the review stage, 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. Depending on the submission type and the complexity of the supporting data, the file may be required to undergo more than one type of assessment (label review, biological safety review, and/or toxicological safety review). The reviews are coordinated by the Program Design and Oversight Unit of FSS and the files are directed to the proper stream based on the applicable requirements.

Once the 1^st review is completed, the product is either registered under the Act, or deficiencies and outstanding requirements are compiled into a single response letter and sent to the applicant. If a response is not received from the applicant by the stated deadline, or if the response does not fully or adequately address each deficiency, the submission is withdrawn from the review queue (closed) and the fees are not refunded.

If all the requested information is received by the CFIA at or before the stated deadline, the submission will undergo a 2^nd and potentially a 3^rd review during which the information is screened and assessed. If the information provided is deemed complete, and meets all the CFIA's requirements, the product is registered. If the applicant has not addressed all of the questions or deficiencies in an adequate manner within the three review time frames allotted, the file is closed. Furthermore, a file is closed if during the file review process, the applicant discloses new or additional information that warrants an additional review or triggers additional requirements.

5.0 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 that wish to appeal a specific element/requirement in the review, or its conclusion may appeal to the Fertilizer Safety Section. Additionally, if applicants are seeking an extension to the provided deadline for response must do so in writing. In order to address all submission-related appeals and complaints in a timely and satisfactory manner, the Fertilizer Safety Section has developed an appeal and complaint management system for the fertilizer and supplement registrations.

5.1 Process for lodging an appeal or complaint

5.1.1 How

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).

5.1.2 When

A CFIA fertilizer or supplement registrant may request an appeal when the registrant feels that an item addressed in a review letter is unwarranted, or the conclusions of a review are in dispute. As well, an appeal may be made where the registrant cannot meet a timeframe for response and wishes to request an extension.

Furthermore, a fertilizer or supplement registrant/applicant may lodge a complaint if he/she feels that the service provided by the CFIA has been inadequate or he/she has experienced misconduct during the submission processing. Complaints with respect to the quality of service may include but are not limited to: rudeness, delay, failure to take action, mistakes, inefficiency, or failure to reply to correspondence. Misconduct complaints could include instances where a client feels the CFIA was unreasonable, or unjust, or if the client feels actions were based on mistakes or factual inaccuracy.

5.2 Appeal and Complaint Management System

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 appeal or complaint must be assessed to determine clearly the nature of the appeal or 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 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 (e.g. 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. All clients will be dealt with in a comprehensive and fair manner within the appeal and complaint process.

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 (including a request for extension) will exclude the product file from Service Delivery Standards.

6.0 Quality Service Improvement Plan

6.1 Program Objectives

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, standard setting, systematic regulatory review, and program re-design.

Some of the key activities of the Fertilizer Safety Section include the periodic review of policies, procedures and forms to ensure "client friendliness" and to find new ways for improving services through initiatives such as:

• using new technology (if cost-effective);
• using plain language;
• re-examining and redesigning or streamlining work flow (re-engineering); and
• simplifying or removing unnecessary requirements and forms.

Continuous improvement of the system will allow us to improve our service standards and maximize client satisfaction. By consulting with clients, monitoring service delivery performance, and implementing improvements to the registration process, the Fertilizer Program will be able to provide better quality service, encourage innovation, and allow access to high quality products.

6.2 Consultation

Consultation is critical to service standard development in order for government and stakeholders to gain an understanding of their respective needs and challenges. The proposed service standards have been developed in consultation with multiple stakeholders, specifically the Canadian Fertilizer Products Forum (CFPF). Setting client-driven standards and measuring the performance of the organization is a continuous process. Through this process, problems with service delivery can be identified quickly and remedial measures can be implemented in a timely manner.

6.3 Performance Indicators

A key component of a quality service culture is client satisfaction measurement. Measuring client satisfaction on an ongoing basis enables organizations to keep up to date with environmental changes and to assess the impact of resulting improvements to the system. Gaps that may exist between performance, and client needs and expectations can be identified by improving the quality and effectiveness of government services, determining service relevance and importance, and setting service standards.

The following are performance indicators that will be measured and assessed, to ensure that the CFIA can continuously improve the level of service delivered to its clients:

• Number of active files
• Number of files that met the published service delivery standards
• Percent of files processed within SDS

Note: The adherence to SDS is monitored by submission type (new registration, re-registrations and amendments) and per review stage (pre-screening/first response, 1^st, 2^nd and 3^rd review). If a file misses a deadline at ANY of these review stages, it is considered to exceed the overall SDS.

7.0 Contact

If you have any questions, please contact:

Fertilizer Safety Section
c/o Pre-market Application Submissions Office (PASO)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, ON K1A 0Y9
Canada
Phone: 1-855-212-7695
Fax: 613-773-7115
Email: cfia.paso-bpdpm.acia@inspection.gc.ca

Appendix A Current time standards for registration related submissions

Appendix B: Information and data requirements for registration application

Core Information

Tab 1: Administrative Forms and Fees (Required for Safety Assessment Levels I, II, and III)

• Cover letter
• Completed and signed Fertilizer or Supplement Registration Application (CFIA/ACIA 3778)
• Designation of Signing Authority
• Designation of Delegated Representatives (optional)
• Declaration of Resident Canadian Agent (required if the applicant/registrant does not reside in Canada)
• Registration Fee

Tab 2: Marketplace Label (Required for Safety Assessment Levels I, II, and III)

• Proposed Market Place Label

Tab 3: Product Specification (Required for Safety Assessment Levels I, II, and III)

• List of Ingredients
• Method of Manufacture
• Quality Assurance and Quality Control Procedures
• Physical Characteristics

Results of analysis

Tab 4: Results of Analysis (Required for Safety Assessment Levels II and III)

• Sets of Metal Analyses as required
• One (1) set of Dioxins and Furans (if applicable)
• Four (4) sets of Indicator Organisms (if applicable)

Safety Rationale and Supplemental Data

Tab 5: Safety Rationale and Supplemental Data (Required for Safety Assessment Level III)

• Toxicological Risk Profile (Hazard, Exposure, Risk Assessment)
• Microbial Risk Profile (Hazard, Exposure, Risk Assessment)
• References and Supplemental Documentation

For more information, please refer to the Guide to submitting applications for registration under the Fertilizers Act.