T-4-109: Requirements for rhizobial inoculants and pre-inoculated seed under the Fertilizers Act

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I Introduction

1. Purpose

This document is intended to outline the safety and labelling requirements specific to rhizobial inoculants and pre-inoculated seed under the Fertilizers Act and Regulations.

2. Regulatory Authority

The Fertilizers Act and Regulations is the federal legislation governing the sale and importation of fertilizer and supplement products in Canada. Supplements are defined as; "any substance or mixture of substances, other than a fertilizer, that is manufactured, sold or represented for use in the improvement of the physical condition of soils or to aid plant growth or crop yields". Products containing viable microorganisms (such as rhizobia), if represented for the above uses, are considered supplements and are regulated by the Canadian Food Inspection Agency (CFIA) under the Fertilizers Act. The legislative authority of the Fertilizers Act governs the sale and importation of these products (including environmental release for experimental purposes), while their manufacture, proper use and safe disposal are controlled by provincial and municipal rules and regulations.

3. Prescribed Standards

Supplements containing viable microorganisms, as prescribed by the Regulations (Section 10.2), must be applied at rates that do not interfere with the commonly used seeding rates for the given crop, and (including pre-inoculated seed) must not contain levels of microorganisms that would be generally detrimental or seriously injurious to human, animal or plant health or the environment.

II Administrative Requirements

Information required to be submitted for registration of a new supplement product can be found in the applicable submission checklist; Supplement – NR – With data or Supplement – NR – No data. To determine whether your registration submission requires a safety data package, please refer to section III below.

III Safety Requirements

Rhizobia are generally considered to be low hazard microorganisms with a well-established history of safe use. They are not known to be pathogenic to plants, animals or humans. Generally, rhizobia do not produce toxins, or by-products that are known to have negative effects on the environment or human health. Given optimum conditions for growth and survival, like most microorganisms, introduced rhizobia may establish themselves, proliferate, and persist in the environment. However, rhizobia are not known to be invasive, and do not pose a threat to biological diversity.

1. For Registration

A core safety data package (product specifications only) is required for products that contain:

  1. Rhizobia (species of the genera Rhizobium, Bradyrhizobium, Mesorhizobium and Sinorhizobium), that are substantially equivalent/representative of the rhizobia group Footnote 1; and
  2. are non-genetically modified; and
  3. are the only active microorganism in the product.

Information requirements for a core safety data package can be found under the heading "Tab 3: Product Specifications" in the Tab Submission Format guidance document.

If the required information is not available to the applicant, the manufacturer/distributor may submit it to the Fertilizer Safety Section directly. This information will be protected as confidential business information and will not be shared with the applicant without the expressed consent of the manufacturer/distributor. Any changes to the ingredients, their sources or the supplier(s) may require a major amendment to the product registration.

A full safety data package is required for products that contain:

  1. genetically-modified or deliberately modified rhizobia;
  2. other microorganism(s) in addition to rhizobia; or
  3. ingredient(s) that pose safety concerns.

Information requirements for a full safety data package can be found under the heading "Tab 5: Full Safety Data Package" in the Tab Submission Format guidance document.

Further guidance on the safety standards and type of information required in a full safety data package to support a new registration of a rhizobia product can be found in one or more of the following Trade Memoranda:

2. For Research Trials

Product proponents who wish to conduct research trials in Canada on novel supplements Footnote 2 require a Research Authorization under the Fertilizers Act and Regulations prior to import into Canada or environmental release.

All applicants wishing to conduct research trials are required to complete the Application for Research Authorization under the Fertilizers Act and Regulations (CFIA/ACIA 5475). Generally, non-genetically modified rhizobial inoculants fall into Category A of research authorizations which is a streamlined regulatory process for testing supplement products that pose negligible risk to plant, animal, human health and the environment. However, depending on the nature and properties of all ingredients in the novel supplement (as described on the application form), a Category B research authorization may be assigned to the trial, in which case a more detailed safety data package will be required to complete the safety assessment and issue a research authorization for the novel supplement.

For further guidance on the research authorization requirements, please consult Trade Memorandum, T-4-103 - Guidelines for Research Authorizations for Testing of Novel Supplements.

Note: The Fertilizer Safety Section 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.

IV Labelling Requirements

As per the Fertilizers Regulations (Section 19.(2)), labels must not have any incorrect or misleading information or mark or brand or name that would tend to deceive or mislead a purchaser with respect to the composition or utility of the product. All information on the label must be supported by the information listed in the Fertilizer or Supplement Registration Application (CFIA/ACIA 3778).

1. The Main Panel of the Product Label

The main panel of the label must display at least the product name, the product net weight and the name and address (including: the street address or Postal Office Box, City, Province/State, Postal/ZIP Code, and if manufactured outside Canada, the country) of the registrant or the manufacturer of the product; or in the case of pre-inoculated seed, the person who packaged the product.

2. Lettering, Fonts, Colouring, and Pictures

All information on the label must be printed conspicuously, legibly and indelibly. To this end, information printed on the label that is not specifically required by the Fertilizers Regulations must not emphasize or obscure any information required to be printed on the label by the Fertilizer Regulations; and the colouring of the lettering of the information required to be on the label must contrast with the background of the label. All information must all be printed in a font size that would be legible from a normal distance without the aid of magnifying devices.

3. Languages

All information on the label must be printed in either English or French, or in both English and French. Information on additional language requirements in the province of Quebec may be obtained from:

Office québécois de la langue française
Telephone: 1-888-873-6202
Facsimile: 514-873-3488
Email: info@oqlf.gouv.qc.ca

Please note that products containing prohibited material, as defined in the Health of Animals Regulations, must have certain warning statements listed on the label. These warning statements are required to be listed in both English and French, therefore the entire label must be in both English and French (Fertilizers Regulations, Sections 18.(1) (g.1) and 19.(1.2)).

4. Units of Measure

Units of measurement shown on the label shall be expressed in accordance with the International System of Units (metric) as set out in Schedule I of the Weights and Measures Act. If the manufacturer wishes to use imperial units of measure, the imperial measurement may also be present, and all conversions must be accurate.

5. Net Weight

All products must be sold by weight, and the net weight must be listed on the label. Dry formulated products must be described in grams (g), kilograms (kg) or tonnes (t). Liquid formulated products must be described in grams (g) or kilograms (kg), but the volume in millilitres (ml) or litres (L) may be included in addition to the weight.

6. Brand Name

If a brand name is listed on the application for registration, it must also appear on the product label. The brand is any distinctive mark or trade name other than a name or grade required by the Fertilizers Regulations, to distinguish a product from any other product. The brand name must not deceive or mislead the purchaser with respect to the composition or utility of the product.

7. Product Name

The product name must not deceive or mislead the purchaser with respect to the composition or intended use of the product.

8. Guaranteed Analysis

The number of viable cells of the active genus and, where known, the species, must be guaranteed as a minimum number per gram of product.

e.g. Guarantee: This inoculant contains a minimum of 200 million (or 2×108) viable cells of Rhizobium meliloti per gram

9. Registration Number

The registration number of the inoculant product must appear on the label in the following manner:

Registration Number xxxxxxxA Fertilizers Act

Where "xxxxxxxA" denotes the number provided by the CFIA, after all registration requirements have been met. The registration number consists of three elements: the year in which the registration was initially granted (first four digits), the number of registered products in that year (next 3 digits), and the suffix letter denoting the type of product (A = supplement).

10. Directions for Use

Complete directions for use require rate of application, frequency of application, time of application and dilution (if applicable). They must also include the types of crops or soils on which the product is to be used. The requirement for directions for use does not apply in all instances to pre-inoculated seed (Please see point 19 below).

11. Company Information

The name and address of the registrant or manufacturer or packager must appear on the product label. If the label states a Canadian company name and address, but is manufactured or produced and labelled in a country other than Canada, the name and address must be preceded by the words "imported by" or "imported for" unless the geographic location of the pre-packaged product is stated on the label. Where any reference is made in respect of the place of manufacture of the label or container and not the place of manufacture of the product, the reference must be accompanied by an additional statement indicating that the place of manufacture refers only to the label or container. For example: "Bags made in the U.S.A.".

12. Seller's Guarantee

A seller's guarantee states that the manufacturer is responsible for the recommended uses but not for the misuse of the product. The seller's guarantee is not required, but if present must not contain any information that would contravene the Fertilizers Act and Regulations, and any associated policies. The following is an example of a seller's guarantee: "Notice: Seller's guarantee shall be limited to the terms set out on the label and subject there to. The buyer assumes the risk to persons or property arising from the use or handling of this product and accepts the product on that condition."

13. Lot Numbers

A lot number is defined as: any combination of letters and/or numbers by which a fertilizer or supplement can be identified and traced. A lot number should be assigned to unique batches of product derived from a single production run, mining date/location, delivery date, packaging date, static pile, wind row, etc. Each lot or batch should be assigned on the belief that all product in the lot or batch is of similar chemical, biological, and physical characteristics. All supplements are required to have a lot number listed on their label. The lot number must be printed on each package of a supplement. The lot number must be legible and indelible, and should be preceded by the phrase "Lot number", "Batch number", or equivalent. The lot number is necessary to facilitate product traceability and recall if required. Please note that supplement products found to be in contravention of the Fertilizers Act and Regulations will be subject to enforcement action and that all product in Canada, with the same lot number, can be detained.

14. Websites

Many fertilizer and supplement manufacturers have developed websites for their products. If the website address is listed on the product label, all the information on the website must comply with the Fertilizers Act and Regulations and match the information listed on the product label.

15. Label Claims

The Fertilizers Act and Regulations are the authorities under which the Canadian Food Inspection Agency may pursue enforcement and compliance actions against misleading claims. Below are examples of claims that are not permitted on a product label:

  • Reference or statements suggesting that the product is completely safe and non-toxic to humans, animals or the environment (e.g. environmentally safe, safe for children and pets, ecologically friendly. Such statements could give the consumer the impression that reasonable precautions (e.g. do not consume, etc.) are unnecessary. Also, all products must be safe with respect to plant, animal, human health and the environment; such claims are not permitted as they would imply that other products may pose risks.
  • Pictures or reference to application of the product outside of the scope of the precautionary statements listed on the product label (e.g. applicator not wearing appropriate personal protective equipment, grazing of beef cattle on land where prohibited materials had been applied, etc.). Such reference could give the consumer the impression that the product can be safely used, regardless of precautionary statements.
  • Pictures or reference (e.g. brand or product name, label claim, etc.) to food crops on label when product has not been approved for use on food crops. Such reference could give the consumer the impression that the product could be safely used on food crops when the safety of the use pattern has either not been reviewed, or has been reviewed but not supported by the safety data available.
  • Reference or statements indicating that the product is pathogen free when there is potential for pathogens to survive in the product matrix. Such statements could give the consumer the impression that the specific product has been analyzed to determine any potential pathogen presence. Even with product approvals, the approvals are based upon samples of specific batches/lots, and are tested against pathogen indicators (i.e. not every batch/lot is tested pre-market, and not every potential pathogen is analyzed for).

16. Ingredients

It is not necessary for constituent materials (includes all ingredients used to formulate the product) to be included on the label. However, if desired, the list of ingredients may appear on the product label to enable consumers to make an informed decision about the product.

17. Expiry Date

Products containing viable microorganisms or other active ingredients subject to degradation or loss of viability over time must have an expiry date on their labels which indicates the date after which the product's performance can no longer be guaranteed.

18. Cautionary Statements

Depending on the composition and intended use of the product, precautionary statements deemed appropriate to protect humans, animals, plants, and the environment should be included on the label.

For example, rhizobial inoculant products that contain non-sterile peat or clay carriers may contain microorganisms which may pose potential health concerns. Therefore, for non-sterile peat based products, registrants are required to include precautionary statements protecting users from potential hazards. The Fertilizer Safety Section recommends the following precautionary statements:

"This product may contain fungi and bacteria, and may cause adverse effects to individuals who are allergic to certain microorganisms including moulds, and also to immune deficient individuals. Avoid exposure through inhalation, or to open wounds and eyes. Wear standard protective clothing and equipment during product handling and storage. Use this product in well ventilated areas."

The statements listed above are currently required for all new registrations.

Please note that the cautionary statements do not have to be used verbatim as long as the intent of the statements is adequately reflected and conveyed to the user. The precautionary statements will be reviewed on a case-by-case basis and must be approved by the Fertilizer Safety Section before the product is granted registration, re-registration and/or approval.

19. Pre-inoculated Seed

The above labelling requirements are required for seed pre-inoculated with a registered inoculant with the following exceptions:

Pre-inoculated seed is not required to include Directions for Use or a Guaranteed Analysis on the seed tag if the following statement is included:

"This product is treated with (species name or genus of the active microorganism) inoculum."

Please note that pre-inoculated seed is not required to be registered if the inoculant used to treat the seed is registered. Inoculants must be registered prior to application on seed. In addition, the inoculant registration number must also be displayed on the seed tag of pre-inoculated seed.

V Inoculant Extenders

1. Background

Legume inoculant extenders are typically applied to seed at the time of inoculation. These products usually claim to extend the on-seed survival of rhizobia past the recommended planting window. Inoculant extenders when sold alone do not fall under the purview of the Fertilizers Act. However, once the extender is applied to seed for sale, the resulting pre-inoculated seed is regulated under the Fertilizers Act and Regulations (Section 3.1(3)(d)). The inoculated seed with the extender must meet the prescribed safety and labelling requirements.

As such, requirements apply to individuals/establishments that pack the pre-inoculated seed for sale; however, manufacturers of extender products may submit the required data/information directly to the Fertilizer Safety Section to facilitate the sale of pre-inoculated seed treated with an extender in the marketplace. These requirements are not intended as an additional burden to manufacturers of co-products (inoculant + extender in same product package), as the safety of both the inoculant and extender should be assessed during the initial product registration process.

2. Administrative Requirements

The following information is required by the Fertilizer Safety Section in order to constitute a complete submission package for the review of an inoculant extender product:

  • Cover letter outlining the purpose of the submission;
  • Copy of the extender product label (this should include; rates of application, formulations of inoculant to be used with, etc.);
  • Information required to review the safety of the proposed use of the extender (please see point 3 below); and
  • Designation of Signing Authority and Incorporation Papers as per Trade Memorandum T-4-95: Signing Authority, Delegated Representatives and Canadian Agents.

3. Safety Requirements

In accordance with the Fertilizers Act and Regulations, all fertilizers and supplements must be safe and properly labelled. For inoculated seeds treated with extenders, the applicant is required to submit a scientifically-based, properly-referenced rationale that attests to the safety of the extender product (and its ingredients) to humans (workers and bystanders), terrestrial and aquatic organisms (including the target plants) and the environment when the product is used according to directions. For guidance on the type of information that is required for establishing product safety, please consult Trade Memorandum T-4-113: Guidelines to Safety Assessments of Fertilizers and Supplements and to Information to be Submitted in Demonstrating Product Safety, and its supplement, T-4-113 (Supplement 1): Data Requirements for Product Safety Evaluations: Explanatory Notes.

In addition to the scientifically-based, properly-referenced rationale, all of the following information must be submitted:

  • identification of all the ingredients in the extender, including the Chemical Abstract Service Registry Number (CAS RN) or other registry number/identifier for each ingredient;
  • identification of any potential contaminants (chemical or microbial) that may be present in the product or its ingredients;
  • the concentration of each ingredient in the final product;
  • a detailed description of the manufacturing process and blending process (if applicable) including Quality Assurance/Quality Control procedures;
  • the citation for every reference that is used to support the safety of the product (please provide copies of any cited references); and
  • Material Safety Data Sheet (MSDS) of the products or ingredients (if available).

Please note that the Fertilizer Safety Section reserves the right to request additional information to assess the safety of the product. Also note that if the extender is manufactured in Canada and includes a preservative as one of its ingredients, the preservative must be registered for such use under the Pest Control Products Act (PCPA) through the Pest Management Regulatory Agency (PMRA).

Once the safety of the product has been reviewed, the appropriate precautionary statements for the product label will be established.

VI Contact Information

If you have any questions, please contact:

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

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