T-4-122 – Service Delivery Standards for Fertilizer and Supplement Registration – Related Submissions under the Fertilizers Act and Regulations
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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
- Consistent across government
- Ambitious but realistic
- Endorsed by management
- 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 1st 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.
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.
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:
220.127.116.11 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 color 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.
18.104.22.168 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).
22.214.171.124 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:
- 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.
- 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
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.
126.96.36.199 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.
188.8.131.52 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 1st 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 1st 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 2nd and potentially a 3rd 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
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).
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.
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, 1st, 2nd and 3rd review). If a file misses a deadline at ANY of these review stages, it is considered to exceed the overall SDS.
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
Appendix A Current time standards for registration related submissions
|Submission Type||Pre-Screening||Registrant Response Time||1st Review/ Queue timeTable Note 1||Registrant Response Time||2nd Review/ Queue timeTable Note 1||Registrant Response TimeTable Note 1||3rd Review/ Queue TimeTable Note 1||Total|
|Re-registration (Level I and II)||45||30||120||90||60||N/A||N/A||345|
|New Registration (Level I and II)||45||30||150||90||90||30||30||465|
|New Registration (Level III)||45||30||200||90||90||30||45||530|
|Re-registration (Level III)||45||30||200||90||90||30||45||530|
- Table note 1
Target = 90% of all registration related submission types to be processed within the times shown. If required.
Appendix B: Information and data requirements for registration application
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.
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