Topics raised during the question and answer session

The presentations are currently available in both official languages on the Fertilizer Canada website

In addition, a link to the recordings of the presentation on regulatory changes is also available on the Fertilizer Canada website.

Please contact the Pre-Application Submission Office (PASO) and be sure to include the word fertilizer in the subject line: cfia.paso-bpdpm.acia@inspection.gc.ca

The registered products list is updated on a bi-weekly basis. As a result, there may be a delay of up to 2 weeks between registration and inclusion in the posted registered products list.

The trade memorandum that covers metals standards is: T-4-93 – Safety standards for fertilizers and supplements

GHS, or Globally Harmonized System of Classification and Labelling of Chemical, defines and classifies the hazards of chemical products and communicates health and safety information. In Canada, GHS was enacted under the Hazardous Products Act and regulations and is referred to as WHMIS2015. WHMIS2015 replaces WHMIS1988.

Fertilizers and supplements are not excluded from the Hazardous Products Act and must comply with WHMIS1988/WHMIS2015.

An announcement will not be made by the CFIA as the Hazardous Products Act and regulations are administered by Health Canada.

This presentation was on service delivery standards for the 2019/20 fiscal year. We report each year on the fiscal year preceding the meeting. The CFIA, like you, is working hard to carry on regular business to the extent possible during the COVID pandemic, which includes processing files for fertilizer and supplement registrations, re-registrations and research authorizations. We are working with constraints and with reduced workforce so impacts on turnaround times and service standards are likely to occur. We are dedicated to keeping businesses functioning as normally as possible and will keep you updated.

We appreciate the concerns. We continue to monitor submissions received by the Pre-Application Submission Office (PASO). The standard response time is 5 working days. However, paper-based applications are prone to potential errors (timely document receipt, logging in the database and physical transfers of locations etc.) due to remote work environments. As we move towards digitization and e-submissions, these logistical challenges should be alleviated.

Non-compliance issues can arise for many reasons including registration status (products that require registration but are not registered), labelling infractions, contamination with pathogens, trace metals, dioxins and furans, and pesticide residues. The main non-compliance point is around registration where someone is selling a product that has not been registered with the CFIA. In all cases, non-compliance is very product specific.

Exceedances of nutrient tolerances would be associated with fertilizer products – not supplements.

PAH analyses are requested on a case-specific basis. Similar to any other type of contaminant analyses, they depend on the risk profile of the product, its ingredients, sources, manufacturing method as well as potential degradation products. Due to the inherent variability of analyses required to complete a safety assessment, the CFIA does not maintain a static list of PAHs to be tested. Applicants are encouraged to discuss the requirements with the evaluator assigned to the file. There are some additional resources that might be useful, such as EPA SW-846 (see https://www.epa.gov/hw-sw846/sw-846-test-method-8100-polynuclear-aromatic-hydrocarbons and https://www.epa.gov/sites/production/files/2015-12/documents/8310.pdf).

Method 8310 is based on high-performance liquid chromatography (HPLC) and lists 16 specific PAHs as falling within its scope. Method 8100 is based on gas chromatography (GC) and its scope is broader.

Where the product is or includes a polymer that is acting as a supplement, the polymer content needs to be guaranteed as a minimum percentage of the final product formulation by weight. It will appear on the Fertilizer and Supplement Registration Application (FSRA) form and also on the guaranteed analysis section of the product label.

Polymer registration under the Fertilizers Act is a direct result of the revised policy interpretation of the definition of a supplement. This, in turn, was undertaken as part of the discussions regarding nitrification and urease inhibitors, where the industry requested that they be regulated under the Fertilizers Act as supplements as opposed to the Pest Control Products Act. Consequently, the interpretation of the definition was expanded to cover materials (fertilizer additives) that both directly and indirectly affect plant growth, crop yield or impact the physical condition of the soil. Therefore polymers that fall under the purview of the Fertilizers Act are themselves considered supplements. This policy interpretation is also consistent with the intent of the amended regulations.

Considering the level of stakeholder interest in this topic, the CFIA will be holding a separate webinar devoted to polymer registrations. This is in addition to ongoing discussions with Fertilizer Canada, the Fertilizer and Supplements Advisory Committee, bilateral meetings with individual companies and participation in the industry-led working group. We hope that these multilevel engagement venues will provide the needed clarification of the regulatory requirements and allow for the development of a phase-in implementation timeline that is feasible for industry to adopt with relatively minimal disruption to their business operation.

All active ingredients are required to appear in the guaranteed analysis. Where the product includes a polymer (supplement), the polymer content needs to appear in the guaranteed analysis as a minimum percentage of the final product formulation by weight. The naming convention for the guaranteed analysis of the polymer should be in agreement with the naming that appears in the Chemical Abstracts Service (CAS) listing for that polymer.

Under the new regulations, a registered polymer can be included in multiple product formulations without triggering the registration requirement, as long as the polymer is registered for that purpose (for example, material being treated, rate of application, use pattern - food vs. non-food, etc.). So when the polymer itself is submitted for registration, the directions for use should cover all anticipated end uses. If a new end use needs to be added in the future, the responsible party can submit an amendment to the registration.

The ongoing discussions with stakeholders are designed to develop a phase-in implementation timeline for products already in commerce in Canada. New products coming to market are required to be registered prior to importation and sale.

The intent is to register the end product formula. However, under the new regulations, a registered polymer can be used in a number of products without triggering the registration requirement for the mixture, as long as the polymer is registered for that purpose (for example, material being treated, rate of application, use pattern- food vs. non-food, etc.). So when the polymer itself is submitted for registration, the directions for use should cover all anticipated end uses. If a new end use needs to be added in the future, the responsible party can amend the registration accordingly.

The directions for use on the registered polymer need to be specific enough that we can conduct a safety assessment. Therefore, the materials intended to be coated must be identified specifically.

There are ongoing discussions. The phase-in implementation timeline is only applicable to those products that are already in the market (having undergone safety assessment alone, without registration). New polymer supplements are required to be registered; new fertilizers or supplements that contain polymers may be exempt if the polymer itself is already registered for that use.

Considering the level of stakeholder interest in this topic, the CFIA will be holding a separate webinar devoted to polymer registrations. This is in addition to ongoing discussions with Fertilizer Canada, bilateral meetings with individual companies and participation in the industry-led working group. We hope that this multilevel engagement will provide the needed clarification on the regulatory requirements and allow for the development of a phase-in implementation timeline that is feasible for industry to adopt with relatively minimal disruption to their business operation.

In order for a polymer to be regulated under the Fertilizers Act, it has to either directly or indirectly impact the physical condition of the soil or aid plant growth and crop yield - other polymer uses are not regulated by the CFIA. In addition, polymer ingredients or monomers can be sold for manufacturing purposes requiring further treatment or processing (excluding mixing or blending) in which case they would be exempt from all provisions of the Fertilizers Act and regulations. Mixtures of polymers with fertilizers or supplements may be exempt from registration as long as the polymer itself is registered for that use. No other exemptions apply to polymers.

All new products are being routed to the new registration stream due to the fact that a polymer coating fits the definition of a supplement. The registration requirement for products that are or contain polymers is a direct result of the change in the interpretation of a supplement that took place (on request from industry) in the context of nitrification and urease inhibitors which are another class of additives that previously did not fit the definition under the old interpretation. There are no new safety requirements in addition to those that were in place before. The timelines between a Data with Safety (DS) assessment and a full registration are comparable especially since DS files are processed outside of the registration queue which means they are not given priority. The ongoing discussions/consultations with industry are specific to products already in the marketplace that have undergone a safety assessment but are not registered.

If the polymer has already been reviewed by the CFIA (safety) it will still require registration by the end of the implementation phase-in but the coated product does not need to be registered. If the polymer has not been reviewed then the coated product must be registered.

When consultation on the implementation timeline concludes for polymers that are currently in commerce, those products will also need to follow the implementation process.

Yes. All active ingredients are required to appear in the guaranteed analysis and when they have supplemental activity, polymers are also required to appear in the guaranteed analysis.

MRLs would be established by the Pest Management Regulatory Agency (PMRA). They have not issued any maximum residue limit with respect to cannabis for now. Once they do, it would be listed in the MRL database as any other MRLs. The PMRA sets MRLs under section 9 and 10 of the Pest Control Product Act; that is when a pesticide is registered and as necessary, or when requested, typically for imported commodities. As for residue methods, there is a list of 96 pesticides that harvested cannabis must be tested for. When residues are found, we work with the cultivators to identify the source and determine compliance. More information can be found in this document.

We certainly encourage proponents to adopt the new regulations as soon as possible. If the product meets a term listed in the List of primary fertilizer and supplement materials, and you wish to import/sell the exempt material under the new regulations, please send an email to PASO indicating your wish to close the submission due to being exempt under the new regulations. Please ensure your label is compliant with the new regulations (there are some changes to labelling requirements). Once your product meets the requirements of the new regulations you can import/sell your exempt product legally in Canada without registration.

Biochar is listed on the new List of primary fertilizer and supplement materials and is exempt from registration.

Rhizobium and Mycorrhizae require registration and are considered safety level I microorganisms. This has not changed under the new regulations.

Yes, that is correct. Results of analysis are required for the 11 priority metals in addition to each micronutrient guaranteed. Fertilizers represented to contain micronutrients are subject to upper tolerances for micronutrient content. Please refer to T-4-93 – Safety standards for fertilizers and supplements for more information.

A proponent could simply re-label the "me-too" product and add "consists of registration number" while maintaining all directions for use, etc. from the parent registration. That makes them an exempt product that only contains a registered ingredient.

Under the old regulations, any change to the product (composition, label etc.) needed an amendment.

The definitions or descriptions of amendments are found in the CFIA Fees Notice and fall into 2 broad categories:

Minor amendments include changes to:

1. name or address of the registrant
2. the colour or format of the label
3. the product name, and
4. the declaration of net contents

Any other changes triggered the major amendment category.

Under the new regulations, you can change certain aspects of the product label without notifying the CFIA altogether. More specifically, the modernized regulations require that only changes that affect the product's identity as a fertilizer or supplement, safety or its use require an amendment to the registration; other changes can be made without notifying the Agency.

The CFIA is in the process of revising these definitions to align with the intent of the amended Fertilizers Regulations. Once this process is complete detailed guidance on what changes fall under which category will be provided to stakeholders. In the meantime, contact the CFIA if you have questions about whether or not changes you intend to make to your product(s) trigger a requirement to submit an amendment.

The new registration requirements and associated exemptions were significantly streamlined in order to align regulatory oversight with the risk profile of the product. The overall premise of the regulations is exactly that - all products require registration unless they are specifically exempt in the Fertilizers Regulations.

As the topic of exemptions was identified as one of interest to the stakeholders at the November 17th virtual Canadian Fertilizer Products Forum workshop, the CFIA will be holding an additional webinar on the subject to further clarify the requirements and answer any questions. In addition, we also hope that the detailed guidance materials currently available on the CFIA Fertilizer website will contribute to compliance promotion.

Phosphite is not a source of plant-available phosphorus and can cause P-starvation response in plants when applied under P-limiting conditions. Phosphites are regulated as pest control products under the Pest Control Products Act (PCPA) in Canada. The CFIA and the PMRA will continue to enforce their respective mandates in the Canadian marketplace, which includes taking enforcement action when non-compliant products are found. This includes taking enforcement action against phosphite products that are represented as fertilizers.

The T-memo T-4-121 provides clarification regarding the regulation of phosphite/phosphorus acid materials represented for use as fertilizers.

The name and address of the manufacturer or registrant must appear on the label.

The CFIA does not monitor, record or publish the number of products sold in Canada that are exempt from registration. However, the list of exempt materials (List of Primary Fertilizer or Supplement Material) is available on the CFIA website.

Yes. The general exemption from all the provision of the Fertilizers Act and regulations for manufacturing purposes (excluding mixing and blending) is applicable to both liquid and dry fertilizers. Similarly, the exemption from registration for mixtures applies irrespective of the physical state of the product (liquid vs. dry). It is important to note that the intended use of the mixture must be consistent with the intended uses identified on the approved label of any registered product included in the mixture (in order to qualify for the exemption).

If one material is exempt and the other is neither exempt nor registered (and should be registered), then the final product requires registration. If one material is exempt and the other material is registered and the intended use pattern of the mixture is consistent with the registered label then the mixture is exempt.

Yes, a material requires registration if it does not specifically meet the exemption criteria including the compositional standards prescribed in the List of Primary Fertilizer or Supplement Materials.

First, if the aquatic plant extract is imported or manufactured in Canada and used for manufacturing purposes only (requiring further treatment, other than mixing, blending, repackaging or application to seeds), the aquatic plant extract is exempt from all provisions of the Fertilizers Act and regulations.

If the product is represented as a supplement and is sold to a company who repackages, mixes, blends or applies it to seeds without further processing, then the aquatic plant extract does not meet the exemption and requires registration prior to sale to other companies.

The company making the final product must register the final product, unless the exemption for mixtures applies.

All active ingredients are required to be listed in the guaranteed analysis. Ascorbic acid has been demonstrated to have a positive effect on plant growth and therefore is considered an active ingredient and must be guaranteed. If you have a specific situation where you do not believe that an ingredient should be considered an active ingredient, as it does not contribute to the fertilizer or supplemental qualities of the product, please feel free to contact PASO at cfia.paso-bpdpm.acia@inspection.gc.ca. with the question and associated rationale.

For a "me-too" product registered under the old regulations, a major amendment would need to be sought under the new regulations. This would allow the name change and bring the product under the new regulations (5 year registration).

The reason why the record keeping option is not available for seeds and growing media is that these products alone (namely not containing fertilizers or supplements) are not regulated under the Fertilizers Act. This is unchanged from the labelling requirements under the former regulations.

Yes, so long as all of the ingredients that require registration are themselves registered for the purpose of the mixture (and the directions for use are consistent with the approved/registered product).

In addition, appropriate records must be maintained by the regulated party. As detailed in T-4-131, the responsible party must inform the Agency of the place where the record is located. To fulfill this requirement, the following information must be sent to CFIA by emailing cfia.paso-bpdpm.acia@inspection.gc.ca:

• Product name
• Responsible party
• Complete address where the record is kept

As part of the regulatory development process, the CFIA has conducted international scans to compare approaches used by other jurisdictions around the world as well as domestic programs that govern other commodities – the 5 year interval is aligned with international approaches. The increase to a 60-month registration period significantly reduces the cost and administrative burden associated with registration and aligns the fertilizer registration period with that provided for under the Pest Control Products Act.

Actual guarantee for micronutrients should be based on lab analysis results. To be able to meet micronutrient upper tolerances, your results of analysis must be in agreement with your guaranteed analysis. Please note that the tolerances vary depending on the guaranteed amount, being more permissive as the levels of micronutrients decrease to account for the analytical variation.

Correct. Record-keeping is an option for mixtures of registered and/or exempt materials or both. Please remember that to meet the exemption, the intended use of the mixture must be consistent with the intended use of the registered product. Record-keeping requirements are as follows:

1. The mixture must be labelled with a statement indicating that the fertilizers or supplement in the mixture are registered or exempt from registration
2. The responsible party (see section 4 in T-memo below) maintains records (see section 6 in T-memo below for details on what is required in a record)
3. The responsible party informs the CFIA of the place where the record is located

Note: the record keeping option in lieu of mandatory labelling is not applicable to seed or growing media treated with registered or exempt fertilizers or supplements. Please refer to T-4-131 for record-keeping requirements.

Actual does mean the true nutrient content. However, the tolerances vary depending on the range of the micronutrient guaranteed – the tolerance is greater in the low-range guarantee and smaller if the concentration in the product is higher. For example, a 0.24% Cu guarantee has a permissible exceedance of 0.077, for a maximum acceptable Cu content of 0.317%. In your example, a 5% guarantee has an upper tolerance of 1%, for a total allowable product content of 6% of that specific micronutrient. Batch-specific labels are not required. Please refer to the following notice to industry for tolerances to micronutrient fertilizers which describes this further and Trade Memorandum T-4-93.

Correct. You may submit a major amendment to make the change from old to new regulations, and you can continue to sell your product while your amendment is under review with the CFIA. Please be aware that there are differences in labelling requirements between the old and new regulations so please plan for the label changes accordingly.

You will need to apply for a major amendment to change from old to new regulations. You may continue to sell the product under the old regulations (with your old label) while your application for a major amendment is under review with the CFIA.

Please note that there are differences in labelling requirements between the old and new regulations so please plan for those label changes accordingly. Once the registration number (under the new regulations) is issued, the new label is required to appear on the product (the old label is no longer valid for legal sale in Canada).

The fact that we approve marketplace labels (whereas PMRA approves and posts text labels only) means that it's difficult to meet requirements for posting.

Yes. You understood correctly. As long as each of the ingredients is registered for the proposed use of the mixture (or is exempt from registration), the mixture is exempt from registration.

The actives may be registered by any company.

The guaranteed analysis is compliant with micronutrient tolerances as long as the results of analysis fall under the max allowable content. Tolerances vary depending on the range of the micronutrient guaranteed – the tolerance is greater in the low-range guarantee and smaller if the concentration in the product is higher. For example, a 0.24% copper (Cu) guarantee has a permissible exceedance of 0.077, for a maximum acceptable Cu content of 0.317%. Any results within 0.24-0.317% are considered compliant. However, if after registration is issued (at which point tolerances are checked), a product with 5% guarantee of a micronutrient consistently shows over 6% nutrient content (1% allowance on a 5% guarantee for a max content of 6%) then the guarantee should be amended at the next re-registration or as a major amendment.

Yes. My CFIA dashboard is where you can submit service requests, then log in to view and monitor the status of your service requests. You will receive email notifications whenever there is a change in status of your service request, or if the reviewers require more information.

You will also be able to find your issued permission or registration on your My CFIA dashboard.

It depends what information you would like the different types of users to see, and who is ultimately legally responsible for the service requests (the issued fertilizer registrations).

It may be helpful to consider:

• What level of access to Profile information or application information would the client company like to give to the Independent Consultant?
• What level of authority would the client company like to confer to the Independent Consultant to act on their behalf in the My CFIA system?

If the fertilizer client of the Independent Consultant will be the legal entity holding the fertilizer or supplement registration, then the main client should set up a My CFIA Party Profile. This is because the permissions/authorizations are issued to the validated Legal Name in the account.

The client can then add the Independent Consultant as a Contact to their Party Profile, to perform complete and submit service requests in the system on their behalf. They would be able to see all the information about the application, but would not be able to access other service requests.

Alternatively, the client company could give greater authority to the Independent Consultant, if they were comfortable doing so, and make them the Profile Manager of the My CFIA account.

A Profile Manager is authorized by the profile authority to create and manage the profile, which could include confidential business information. They can also invite other users, and to conduct business online with the CFIA on behalf of the business.

It is the responsibility of business owners to decide what will work best for their particular business model.

You can create as many draft applications as needed if you'd like to try out the system. Just remember to either Save and Quit before submitting it, or Cancel to erase it completely. You will be able to see these service requests in Draft in your My CFIA dashboard.

In addition, the fertilizer and supplement registration service request has links to web guidance on each page of the application to assist users.

The agent's personal details will be entered into My CFIA.

You can use the same GCKey credential, with the same username and password to access all available online services, with the exception of the Canada Revenue Agency (CRA) services. (CRA's login services requires a Sign-In Partners or specific CRA User ID and password.)

This is a good point and was considered in testing phases of the system. The uploads are separated into individual requirements to prevent the limit in MB from being problematic for submissions.

Foreign clients may create a My CFIA account and include the international address of their office contact information.

Acceptable options for a Proof of Business for a foreign client might include a copy of the letters patent or certificate of incorporation, along with a list of the current directors. Documents issued by a foreign authority (federal or provincial/state) clearly showing the full legal name of the company could also be accepted.

Alternatively, a company representative who is legally responsible for the Canadian branch of a multinational organization would be acceptable. The name of the Canadian company representative acting as the signing authority must appear on a valid proof of business document associated to that Canadian branch of the business.

Once a Party Profile for a business has been successfully created in My CFIA, the user is invited to:

• add Establishments and
• add Party Contacts. However, these 2 additions are optional

Establishment information is not required for a fertilizer or supplement registration service request.

If you are stuck on the "Add Establishment" page, select "Back" to a previous screen, and then select "Save and Quit". This should return you to your Party dashboard.

The Proof of Authority Form (5805) can be signed by a current owner, partner, director, or company officer of the business.

Yes, a company representative who is legally responsible for the Canadian branch of a multinational organization would be acceptable. The name of the Canadian company representative acting as the signing authority must appear on a valid proof of business document associated to that business.