T-4-122 - Service Delivery Standards for Fertilizer and Supplement Registration - Related Submissions under the Fertilizers Act and Regulations

May 2013

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 for the registration of fertilizer/supplement products. Also, product proponents are able to use these time frames to plan their business accordingly.

2.0 Background

2.1 Regulation of fertilizers and supplements in Canada

Fertilizer and supplement products imported into and/or sold in Canada are regulated under the authority of the federal Fertilizers Act and Regulations administered by the CFIA. Pursuant to the Act and Regulations all products must be: safe with respect to plant, animal, human health, and the environment; efficacious for the intended purpose; and properly labelled as to avoid misrepresentation in the marketplace. Compliance with these standards is verified by the CFIA as part of an assessment and registration process, or through the administration of marketplace monitoring programs that include product inspection, sample analysis, and label verification.

Some fertilizers and supplements are subject to registration under the Fertilizers Act and Regulations, and must be registered by the CFIA before they may be sold. Others are exempt from the registration requirement but must still meet all the prescribed safety, efficacy and labelling standards once sold. For these products, companies may approach the CFIA on a voluntary basis and request an assessment to verify product compliance with the standards.

The effective operation of the Fertilizer Program, including timely introduction of new products into the marketplace and their continued compliance with the prescribed standards, is essential in supporting the innovation, growth, competitiveness and sustainability of the Canadian agricultural sector while maintaining high environmental safety and consumer protection standards.

2.2 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. Service standards must be: meaningful to individuals/companies, based on consultation, attainable and challenging, affordable, owned by managers and employees, published, used to measure performance, and periodically reviewed and updated.

The Service Delivery Standards for registration-related submissions for fertilizer and supplement products include four elements:

description of the service intended to be provided;
specific delivery targets for key aspects of the service, and expectations of registrants;
complaint and redress mechanisms that clients can use when they feel standards have not been met; and
a service quality improvement plan.

3.0 Submission Management Process

The Service Delivery Standards described in section 4 of this document apply to registration - related submissions only. This includes new registrations, re-registrations, "me too" registrations, minor amendments and major amendments. Service standards for submissions not related to product registrations are not included in this document; until such time as standards are developed for approval-related file types, the Crop Inputs Division will be processing product approvals according to the comparable registration-related file type (for example, a Label Review without data will have the same time standard as a New Registration without data). The following paragraphs describe the different file submission types and the file submission management process.

3.1 File Types

3.1.1 New registration (data)

Every product that requires registration under the Fertilizers Act must be submitted for registration to receive authorization to be sold in Canada. Under the Fertilizers Act and Regulations, registrants have to fulfill different requirements depending on the product type submitted for registration (see Appendix A for safety data requirements.

3.1.2 New registration (no data)

3.1.3 "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 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), usage pattern(s) and label claim(s) as the registered product and, if applicable, 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 and efficacy data, and meets the CFIA's current requirements, can be used for the purpose of generating a "me too" registration.

3.1.4 Re-registration (data)

Registered products have to be renewed every three years in order to continue to legally sell the product in Canada. The submission is reviewed in order to determine whether the product continues to comply with the Fertilizers Regulations. The need to demonstrate safety can arise if the registrant either brings changes to constituent materials, usage patterns, label claims or if the Agency has completed an internal policy review. In these cases, additional data/information is requested to be submitted at the time of product re-registration.

3.1.5 Re-registration (no data)

Registered products have to be renewed every three years in order to continue to legally sell the product in Canada. The submission is reviewed in order to determine whether the product continues to comply with Fertilizers Act and Regulations. If there are no changes to the product that warrant supporting data, then no data is required to be submitted with an application for re-registration.

3.1.6 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 contents (CFIA Fees Notice, "Part 5 - Fertilizer Fees"). 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.

3.1.7 Major Amendment

In the case of an application to amend a registration for something other than the minor amendments listed above, the change would be considered a Major Amendment. Major amendments may be made at the time of re-registration; however, additional fees are applicable if a full efficacy and/or safety review is required. The processing of a major amendment between registration periods will result in a new registration fee being charged and an altered expiry date for the product registration.

3.2 File submission management process

3.2.1 Pre-Screening

All submissions are screened to determine whether the required information has been submitted. The pre-screening process is divided into two phases: 1) the completeness check and 2) the first response.

3.2.2 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 on the CFIA website. Any submissions that do not pass the "completeness" check will be returned to the applicant in their entirety, with a letter outlining the deficiencies.

3.2.3 First response

The first response check is a further pre-screening step after the submission has entered the CFIA's Product Registration System (PRS). Any further outstanding information will be requested by an Evaluator to be submitted by the applicant within 30 days. If a response is not received by the stated deadline, the submission is immediately withdrawn and returned to the applicant. If the submission has no outstanding information requirements a letter will be sent indicating that the submission has been received and that there are no outstanding requirements at this time.

3.2.4 Review Streams

During the review stage, evaluators review the submission's information 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 submission, the file may be required to go through more than one type of assessment. The reviews are coordinated by the Program Design and Delivery Unit (PDDU) and files are directed to the proper stream based on the applicable requirements. Once the 1^st review is completed, deficiencies and outstanding information will be identified by an evaluator and a letter will be sent to the applicant detailing all of the outstanding issues. If a response is not received from the applicant by the stated deadline, the submission is immediately withdrawn and returned to the applicant at the applicant's expense, or disposed of through shredding of submitted materials. If the requested information is received by the CFIA at or before the stated deadline, the submission may undergo a 2^nd and/or 3^rd review in 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 issues in a sufficient manner within the three review time frames allotted, the file is closed and returned to the applicant at the applicant's expense, or disposed of through shredding of submitted materials.

4.0 Time Standards

4.1 Description of proposed Time Standards

The pre-screening and review times presented in Appendix B and Appendix C are based on several assumptions. First, an estimation of the "normal" level of active files in the queue was determined to be approximately 300 to 400 submissions. Secondly, the proportion of each file type at pre-screening level, and in the various review streams would be consistent with those found in the background level of files based on historical file proportions. Finally, based on the current regulatory framework, it is assumed that approximately half the files in the first review stage would also require a second and third review.

The total time standard itself includes the maximum allowed times for registrant responses to any deficiencies or additional information requirements. 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 the file can be shortened significantly.

There are a number of factors that can affect the CFIA's time standards in the future. For example, the introduction of an electronic submission system; the creation of example submissions along with a comprehensive registration guide book; changes to the number of products requiring registration; and modifications to submission requirements and review procedures, are strategies that if implemented, will impact the submission review times, and could significantly improve the efficiency of the system and reduce the time standards. The table presented in Appendix C illustrates the CFIA's "target" time standards for registration related submissions that may eventually be implemented as a result of the Fertilizer Modernisation Initiative and implementation of a number of improvements to the regulatory framework.

4.2 Client Responsibilities

The CFIA's clients are expected to provide timely and accurate information if they wish to receive the indicated levels of service. Clients 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 any one item contained in a review letter, the next review will begin;
address all deficiencies identified in a review letter as soon as possible, rather than waiting for the deadline to submit;
advise the Crop Inputs Division 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 Client Services Administrator (CSA) for information on the status of the submission and not individual evaluators.

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 an item in or the conclusions of a file review, or are seeking an extension to a provided deadline for response, may appeal to the Crop Inputs Division. In order to address all submission-related appeals and complaints in a timely and satisfactory manner, the CFIA has developed an appeal and complaint management system for the fertilizer and supplement registration process.

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 Client Service Administrator (CSA) of the Fertilizer Section.

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.

A CFIA fertilizer or supplement registrant may lodge a complaint when the registrant feels that he/she has received inadequate service delivery or has experienced misconduct during the submission flow process. Complaints of the service delivery nature include rudeness, delay, failure to take action, mistakes, inefficiency, or failure to reply to correspondence. Any misconduct complaints would include instances where a client feels the CFIA was unreasonable, or unjust, or if the client feels actions were based on mistakes of the law or factual inaccuracy.

5.2 Appeal and Complaint Management System

Step 1: When the CSA receives an appeal or complaint he/she sends an acknowledgment of the receipt of the appeal or complaint to the client and forwards the appeal or complaint to the National Manager of the Fertilizer Section.

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 and corrective action may occur over a longer term. Regardless, 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.

It is important to note that appealing a review letter (including a request for extension) will exclude the product file from Service Delivery Standards.

Step 4: The Director must provide information to senior management so that services can be improved upon. The Director will, on a regular basis (annual), produce a summary report of the complaints. This report will include the number of complaints by category and identify the actions taken to rectify the problem and preventive measures taken to avoid future recurrence. The report will also include a breakdown of the methods used to deal with the complaints such as conciliation, investigation, mediation, etc. Information derived from complaints can be used to increase client satisfaction and overall service. Trends in complaints should be analysed and appropriate remediation action taken. Finally, the Director will make recommendations if he/she believes there is a need to change the current system and should include a cost analysis of any system change.

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 Section and the Fertilizer Safety Office 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 and will be reviewed periodically to monitor performance. 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 and nature of complaints (complaint management system report)
total files opened and closed
total time file is active
total time a file is open
total time file is on hold

7.0 Contact

Canadian Food Inspection Agency
Plant Health and Biosecurity Directorate
Crop Inputs Division
Fertilizer Section
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Canada
Telephone: 613-773-7189
Facsimile: 613-773-7163

Appendix A: Safety data requirements for products regulated under the Fertilizers Act and Regulations

1. Types of Data

Core safety Data:

Complete list of ingredients including their sources and proportions. Please note that for some product types the source information should include:
1. country of origin;
2. method of manufacture (i.e. by-product of another process, mining of materials, etc.); and
3. name of the distributor. If the above information is not directly available to the applicant, the distributor may submit it to the CFIA directly, and it will be protected as confidential business information;
Method of manufacture;
Material Safety Data Sheet (MSDS) for ingredients and/or product (if available);
Data support taxonomic identification of any guaranteed microorganism(s)

Results of analysis including any or all of the following:

Four sets of analyses for fecal coliform and Salmonella;
Four sets of analyses for Arsenic (As), Cadmium (Cd), Cobalt (Co), Copper (Cu), Chromium (Cr), Mercury (Hg), Molybdenum (Mb), Nickel (Ni), Lead (Pb), Selenium (Se), Zinc (Zn);
One set of analysis for dioxins and furans.

Full safety data package:

Depending on the product type, guidance on the safety standards and type of information required in a full safety data package can be found in one or more of the following documents:

T-4-93 - Standards for metals in fertilizers and supplements

T-4-107 - Registration of supplements under the Fertilizers Act

T-4-112 - Information required for the assessment of by-products and other "waste" materials sold as fertilizers or supplements

T-4-113 - Guidelines to safety assessments of fertilizers and supplements and to information to be submitted in demonstrating product safety

T-4-113 (Supplement 1) - Data requirements for product safety evaluations: explanatory notes

T-4-116 - Safety data requirements for the registration of polyacrylamide, acrylamide-acrylate copolymer and polyacrylate soil supplements as active ingredients under the Fertilizers Act

T-4-118 - Guidelines to safety assessments of microorganisms in fertilizers and supplements regulated under the Fertilizers Act

Registration Guide: Micronutrient Fertilizers

2. Products/ingredients that require the submission of core safety data to support approval or registration

Fertilizers:

NPK fertilizers without micronutrients
Lesser plant nutrients: Calcium (Ca), Magnesium (Mg), and Sulphur (S)
Fertilizer-Pesticide combinations as found in the Fertilizer Pesticide Compendium
Low analysis farm fertilizers

Supplements:

Indole-3-butyric acid (IBA) at a concentration not exceeding 1% of the product
Products used to correct soil acidity or alkalinity (e.g. liming materials)
Soil amendments represented to improve the condition of the soil by increasing organic matter (OM)
VAMs (Vesicular Arbuscular Myccorhizae) provided the species is substantially equivalent/representative of VAM group
Rhizobia (species of the genera Rhizobium, Bradyrhizobium, Mesorhizobium and Sinorhizobium), provided the species is substantially equivalent/representative of the rhizobia group
Bacillus subtilis provided the strain is representative of the species and does not produce any toxins

Please note that the presence of other active or inert ingredients in the product may trigger additional safety requirements. If any of the products listed above are made from or contain waste materials, they fall under the next section.

3. Products/ingredients that require the submission of core safety data AND results of analyses to support approval or registration

Non-chelated micronutrients
Micronutrients chelated with the following chelators: ethylenediamine-tetra-acetic acid disodium salt (EDTA), diethylenetriamine penta-acetic acid (DTPA), ethylenediamine-di-o-hydroxyphenylacetic acid (EDDHA), N-(2-hydroxyethyl) ethylenediamine-N, N', and N'- tri-acetic acid trisodium salt (HEDTA)
NPK fertilizers with micronutrients
All fertilizers and supplements containing waste derived materials (e.g. composts, processed sewage, pulp and paper sludges, etc.)

4. Products/ingredients that require the submission of a full safety data package AND may require results of analysis to support approval or registration

Fertilizers:

Fertilizers containing any of the supplements listed below
Micronutrients for foliar use
Micronutrients chelated with other chelators than those indicated above
NPK fertilizers (with or without micronutrients) containing/coated with polymers
Nano-materials and Nano-encapsulated fertilizers
Digestates and other products of microbial fermentation

Supplements:

Plant growth regulators other than IBA as described above (e.g. NAA, Kinetin)
Plant signalling compounds (e.g. LCO's, Hesperetin, Naringenin)
Wetting agents and surfactants
Water holding polymers and soil flocculants/stabilizers
Inoculant extenders (products represented to improve inoculant on-seed survival)
Any product represented as a "Bio-stimulant" (e.g. vitamins, enzymes)
Inoculants containing viable microorganisms other than VAM and Rhizobia
Microbial consortia products

NOTE: All fertilizers and supplements sold and imported into Canada must be safe with respect to human, animal, plant health and the environment. The product safety assessments performed by the Fertilizer Safety Office (FSO) are conducted on case-by-case basis and the information requirements may vary depending on the ingredients in the product (both active and inert), their sources, degradation by-products, manufacturing process, use pattern and application rate. To that effect, the FSO reserves the right to require additional safety information, data, rationale or results of analysis to support the registration/approval of any product regulated under the Fertilizers Act and Regulations

Appendix B Current time standards for registration related submissions.*

Time Standards (working days)
Submission Type	Pre- Screening	Registrant Response Time	*1st Review/ Queue time	Registrant Response Time	*2nd Review/ Queue time	*Registrant Response Time	*3rd Review/ Queue Time	Total
"Me-too" New Registration	45	30	20	N/A	N/A	N/A	N/A	90
Minor Amendment	45	30	20	30	10	N/A	N/A	135
Re-registration (no-data)	45	30	120	90	60	N/A	N/A	345
New Registration (no-data)	45	30	150	90	90	30	30	465
New Registration (data)	45	30	200	90	90	30	45	530
Re-registration (data)	45	30	200	90	90	30	45	530
Major Amendment	45	30	200	90	90	30	45	530

*Target = 90% of all registration related submission types to be processed within the times shown. * If required.

Appendix C Future target time standards for registration related submissions.*

Time Standards (working days)
Submission Type	Pre- Screening	Registrant Response Time	*1st Review/ Queue time	Registrant Response Time	*2nd Review/ Queue time	*Registrant Response Time	*3rd Review/ Queue Time	Total
"Me-too" New Registration	30	15	20	N/A	N/A	N/A	N/A	65
Minor Amendment	30	15	10	30	10	N/A	N/A	95
Re-registration (no-data)	30	15	45	30	30	N/A	N/A	150
New Registration (no-data)	30	30	90	90	30	N/A	N/A	270
New Registration (data)	30	30	120	90	60	N/A	N/A	330
Re-registration (data)	30	30	120	90	60	N/A	N/A	330
Major Amendment	30	30	120	90	60	N/A	N/A	330

*Target = 90% of all registration related submission types to be processed within the times shown. * If required.