Proposal for Provisional Registrations under Fertilizers Act

As a part of program modernization and in an effort to facilitate farmer access to innovative agricultural production tools, the Fertilizer Program of the Canadian Food Inspection Agency (CFIA) has developed a policy for Provisional Registrations (PR) under the Fertilizers Act.

Proposal for Provisional Registrations under Fertilizers Act

Purpose:

The Crop Inputs Division (CID) of the Canadian Food Inspection Agency is seeking stakeholder input and perspective on the implementation and criteria for establishing Provisional Registrations (PR) under the Fertilizers Act.

Background:

It is prohibited to import or sell a fertilizer or supplement that does not conform to prescribed standards (Section 3b of the Fertilizers Act). As per requirements of the Fertilizers Regulations, fertilizer and supplements must be safe with respect to human, plant, animal health and the environment (Section 11.1); efficacious for every purpose for which the product is represented or sold (Section 11.2) and properly labelled to avoid product misrepresentation and consumer fraud (Sections 16, 17, 18 and 19).

In April 2010, the House of Commons and the Minister of Agriculture adopted the Honourable MP Bev Shipley's Motion 460, which states:

"That, in the opinion of the House, the government should ensure that production management tools available to Canadian farmers are similar to those of other national jurisdictions by considering equivalent scientific research and agricultural regulatory approval processes by Health Canada, the Pest Management Regulatory Agency, and the Canadian Food Inspection Agency".

Facilitating farmer access to innovative agricultural production tools (including fertilizers and supplements) appears in the current Government of Canada platform and remains a parliamentary priority. During various stakeholder consultations, feedback from industry has indicated that the combination of lengthy Service Delivery Standards and the time required to generate the efficacy data needed to support registration delays the introduction of innovative products into the Canadian marketplace.

The CID strives to facilitate innovation and farmer's access to new technologies while respecting the Agency's mandate to ensure that all products sold or imported into Canada are safe, accurately labelled and efficacious for their intended use. In light of the above, the CID is implementing several strategies in line with the objectives of Motion 460; one of these strategies is the introduction of Provisional Registrations (PR).

Considerations:

The Fertilizers Act and Regulations require that all regulated products be safe, efficacious for their intended purpose and clearly and accurately labelled. However, Sections 3b (Fertilizers Act) and 11.2 (Fertilizers Regulations) are not prescriptive in defining how efficacy is to be demonstrated; instead efficacy requirements are outlined in policy. As a result, if a product can be demonstrated to meet a minimum threshold for efficacy (based on scientifically sound and defensible information) it may be registered provisionally, allowing the proponent to sell the product in Canada while a full product-specific efficacy data set is being generated to meet the full registration requirements as outlined in T-4-108. In these instances, the efficacy data used to support a PR may be derived from foreign trials so long as the conditions and crop types are comparative to Canadian conditions. However, at the time of submission for a Full Registration, the provisions of Trade Memorandum T-4-108, Section 3.4 must be satisfied, with at least 50% of the data being derived from trials conducted in Canada, in the appropriate Agro-climatic region(s) for which the product is intended to be used.

Notwithstanding the efficacy considerations, the product must be deemed safe and meet all of the prescribed safety standards and requirements (in effect, the product must undergo and pass a full safety assessment before a PR is granted).

Pursuant to section 19 of the Fertilizers Regulations, a product label cannot contain any incorrect or misleading information, mark, brand or name that would tend to deceive or mislead the purchaser with respect to the composition or utility of the product. To that effect, it will be important for the label to clearly indicate the provisional nature of the registration and the extent of performance data that was used to support it. This way, the consumer who purchases the product is aware of any potential performance risks and liabilities.

Proposed Requirements:

The CID is proposing that provisional registrations be based on sufficient efficacy information (such as foreign data or limited domestic data) to provide a reasonable level of scientific certainty that the product will be efficacious when used according to label directions in Canada. However, the data required would not be of the scope needed to fulfill the requirements of a full registration (FR). Therefore, the product proponent will have the opportunity to conduct additional efficacy trials in Canada while selling the product, and would be expected to fulfill the more rigorous efficacy requirements as outlined in T-4-108 at the time of full registration (within 24 months of receiving the PR).

Please note that the only fertilizer or supplement products eligible for provisional registration are those that require efficacy data, as outlined in Appendix A of T-4-108: Efficacy data requirements for fertilizers and supplements regulated under the Fertilizers Act.

Information to be submitted for a Provisional Registration (PR) includes:

• Full safety as required for a New Registration (see Appendix A of Trade Memorandum T-4-122: Service Delivery Standards for Fertilizer and Supplement Registration-related Submissions under the Fertilizers Act and Regulations for specific safety requirements);
• Core/basic efficacy information based on some combination of domestic/foreign data (greenhouse and/or field trials), and/or scientific literature;
  • A minimum of 50% (or a minimum of 3 trials, whichever is greater) of the efficacy data required to support a full registration must be submitted for provisional registration (see Trade Memorandum T-4-108: Efficacy data requirements for fertilizers and supplements regulated under the Fertilizers Act for specific efficacy requirements); and,
  • Evidence of the mode of action for the active ingredients, if known;
• The label must be in compliance with the Fertilizers Act and Regulations, and also include the following mandatory label statement:
  • "This product was registered on [insert date] for 36 months. This is a provisional registration. The product has only been tested under limited soil and environmental conditions representative of the Canadian regions in which it is to be used. Before the registration of this product is renewed, additional field trial data will be collected to confirm the product's effectiveness under various Canadian growing conditions".
• A signed statement accepting the conditions of a PR, including:
  • the requirement for a supplemental data package submission within 24 months,
  • accepting that there are no provisions for extensions, and
  • proponents may not reapply for a PR with the same product;
• Appropriate fees
  • Registration ($350.00 + applicable HST)
  • Safety data review – if required ($500.00 + applicable HST)
  • Efficacy data review – if required ($250.00 + applicable HST)
  • The maximum fee payable for the consideration of an application = $1000.00 + applicable HST

The PR will be valid for a period of 36 months in accordance with Section 5(9) of the Fertilizers Regulations, during which time the product proponent may submit a registration package to seek a Full Registration. The remaining information to support the full registration must be submitted to the Crop Inputs Division within 24 months of the PR being granted, so that the CFIA will have a sufficient period to review the efficacy data in preparation for the receipt of an application for full registration.

Data from all efficacy trials conducted under a provisional registration must be submitted as part of a single complete package by the 24 month deadline, along with a table summarizing the results obtained. During the course of conducting field trials, circumstances may arise which negatively impact the results of a trial to such a point that the trial should be removed from consideration in the evaluation of product's efficacy. Petitions for the removal of efficacy trials must be made before data analysis is conducted. In these instances, the product proponent must submit, in writing, to the Crop Inputs Division for the removal of such a trial from consideration. The removal of a trial must be substantiated by documented evidence of the circumstances which the product proponent feels have negated the results of the trial. Petitions for removal of efficacy trials are assessed only on the merits of the evidence submitted. Examples where the exclusion of a trial may be appropriate include severe drought, hail, flood, wind lodging, killing frost, severe pest damage, or human error in the application of treatments.

The data requirements required to move from "Provisional Registration (PR)" to a "Full Registration (FR)" will be identified in Trade Memorandum T-4-108: Efficacy data requirements for fertilizers and supplements regulated under the Fertilizers Act. Generally, it will consist of filling the data gaps between the PR application and the requisite requirements for a FR. Specifically, the data to support a full registration must reflect both the geographical and duration requirements for experimental sites (i.e. location and site selection), as well as, the minimum number of trials. If the data package submitted by the 24 month deadline does not provide sufficient evidence of product efficacy to support a full registration, the registration will be cancelled and the registrant will be required to remove the product from the marketplace. A product whose provisional registration has been cancelled due to a failure to demonstrate efficacy may no longer be legally sold in the Canadian marketplace, nor will an extension be granted to collect additional trial data. Products which are granted a PR and then subsequently fail to provide sufficient efficacy data to support a full registration may NOT reapply for a PR with the same product. However, a company may re-approach the CFIA and apply for a full registration at a later date, once all the requirements can be met for the registration.

Following preliminary stakeholder consultations, implementation of PRs is anticipated to commence in the winter 2012. As this will be the first year of issuing PRs, the CFIA will be monitoring the number and quality of PR submissions and their overall impact on Service Delivery Standards for all file reviews. Based on this pilot and its evaluation, additional measures may be implemented to ensure timely review and prevent delays in product approvals.

Proposed time standard for provisional registration

While all efforts have been made to accelerate the review process, PR applications require both efficacy review and a full safety review, which precludes further reductions in the queue times assigned for CID review. The CID has proposed the following service delivery standard for provisional registrations.

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
Provisional Registration	45	15	150	30	90	15	30	375

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

For comparison, the following are the current time standards as described in T-4-122.

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.

Proposed "Tabbed Submission Format" Pilot:

The SDS timelines proposed for PR represent a significantly accelerated review process for files that will require detailed safety and efficacy review. In order to ensure that submissions received are as complete and clearly organized as possible, the CID will be piloting a new Tabbed Submission Format (TSF) as part of the process of launching PR. The TSF is intended to facilitate the accelerated review of product submissions, such as the proposed PR process. If successful, it is the intent of the CID to expand the requirement for tabbed submissions to all other product submission types.

The structured information requirements contained in the TSF proposal are provided to assist applicants in preparing complete and well organized submissions when applying for PR. Submissions prepared according to this guidance are more likely to pass the initial screening steps within the CID submission review process, and complete and well-organized submissions will contribute to the increased efficiency of the file review process. The CID is receptive to comments on the TSF proposal and will carefully consider comments from all respondents in order to ensure the process remains user-friendly while still improving submission quality and permitting increased efficiencies in the file review process.

In order to facilitate timely review, the CID will require that PR submissions adhere to the following tabbed format. Please note that all submissions require that the following information be submitted. Where proponents believe that information is already on file with the CID or not relevant to the submission, they must include a statement to that effect under the appropriate tab. It is NOT acceptable to omit a required tab. Submissions without all required tabs will be deemed incomplete and the file will be closed.

1. Administrative Forms and Fees
   1. Cover Letter explaining the intent of the submission
   2. Completed Fertilizer and Supplement Registration Application Form
   3. Designation of signing authority (T-4-95)
   4. Declaration of Canadian Agent Form
   5. Registration fee ($1000 + applicable taxes)
2. Proposed Marketplace Label
3. Manufacturing information
   1. Detailed method of manufacture
   2. Constituent materials
   3. Other qualities
4. Safety Data
   1. Rationale for product safety when used as directed (for humans, plants, animals & the environment)
   2. Quality Control / Quality Assurance procedures
   3. Results of analyses
   4. Copies of all referenced safety-related publications / documentation
5. Efficacy Data
   1. Overall product efficacy summary
   2. Research Trial Efficacy Data
   3. Public Domain Efficacy Data
   4. Copies of all referenced efficacy-related publications / documentation

For a detailed breakdown on what should be included under each tab, a separate guidance document specific to TSF requirements will be provided to industry.

In addition to the file review process, the CID provides several services, at no charge to industry, to assist in identifying the regulatory requirements for a specific product. These services help to ensure that a complete and comprehensive submission package is received. Therefore, it is strongly recommended that a product proponent seek input from the CFIA prior to submitting for a PR through:

• a product-specific inquiry; and/or
• a pre-submission consultation.