Research authorizations under the Fertilizers Act and regulations: Eligibility requirements

Conducting research on fertilizers

A fertilizer that is imported into or manufactured in Canada for experimental purposes must be safe (section 2.1 of the regulations). But, a fertilizer is exempt from registration and labelling requirements as long as:

• the product does not contain a supplement or a pesticide
• all treated plant material and all residual product are destroyed at the end of the trial so that they don't enter the commercial food or feed chains

Research trials conducted on fertilizers that are currently registered but for a different use pattern (for example ornamental plants vs. agricultural food crops) still require that all treated plant material be disposed of at the end of the trial to prevent their entry into the commercial food or feed chains.

Requirements for conducting research on fertilizers that contain supplements are the same as for novel supplements.

Conducting research on supplements

Researchers don't need an authorization for research trials on supplements that are either:

• exempt from registration
• already registered under the Fertilizers Act when conducted in accordance with the approved directions for use

But, researchers will need a research authorization before the trial starts if the use pattern or directions for use of the product under test don't correspond to those approved. These types of authorizations are equivalent to testing novel supplements.

Research authorizations for novel supplements

Research authorizations are designed to make sure the environmental release of the novel supplement is safe.

Definitions

Novel supplement means:

• a supplement that is not registered and not exempt from registration, or
• a supplement that is derived through biotechnology and has a novel trait

A novel trait, means a characteristic of the supplement that:

• has been intentionally selected, created or introduced into a distinct, stable population of the same species through a specific genetic change, and
• based on valid scientific rationale, is not substantially equivalent, in terms of its specific use and safety both for the environment and for human health, to any characteristic of a similar supplement that is in use as a supplement in Canada and is considered safe for use as a supplement in Canada

Research authorizations prescribe:

• confinement conditions
• protective equipment
• crop disposal methods

Importation for research purposes

The quantity of the product imported must not exceed the total amount required to conduct the testing.

In some cases, an applicant may also need an import permit from 1 or more of the following Canadian Food Inspection Agency (CFIA) offices:

• Animal Health Import/Export Office
• Plant Health Import/Export office

Refer to the CFIA's Automated Import Reference System (AIRS) to find out if any further importation requirements apply to the product.

Note: A proponent that imports fertilizers and novel supplements under the research exemption provisions can't:

• use or distribute the product(s) outside the confines of the research trial
• offer the product(s) for sale

Doing so contravenes the Fertilizers Act and regulations and the proponent may be subject to enforcement action.

Criteria for research trials

All research trials conducted on novel supplements in Canada must meet the following general criteria:

• a qualified researcher must conduct trails using scientifically valid methods
  • the researcher(s) responsible for the field trials must either have:
    • successfully completed a Bachelor's or higher degree in agriculture or a related scientific field
    • previous experience in carrying out scientifically sound research trials on agricultural products
• researchers must follow good laboratory practices (GLP) and appropriate quality control procedures
  • the company or research institute doesn't necessarily need to be GLP certified
• the research institution must ensure the safety of its employees throughout the duration of the trial
• researchers must conduct the research in areas where:
  • spread of the product being tested outside the test site isn't likely to occur (for example, via run-off, erosion, drift, leaching, etc.)
  • bystander exposure to the supplement or to treated plants or soil is limited
• unless the CFIA grants the proponent a crop destruct waiver:
  • product proponents must not sell or distribute treated plants, growing media and unused product
  • researchers must safely dispose of all supplement, fertilizer and plant material, including harvested crops, from the treated sites once testing is complete
  • applicants must propose a method of safe disposal
    • methods may vary based on the:
      • nature of the supplement (microbial versus chemical)
      • probability of its spread and establishment in the environment
      • relative risk associated with the release

Contained research exemptions and research waivers (RW)

Research trials that preclude the release of the supplement into the environment, such as testing in contained facilities (laboratories, for example), don't need a research authorization. But, these trials must have appropriate measures in place to prevent release into the environment.

Applicants wishing to get an exemption from the research authorization for contained research trials must apply for a research waiver (RW). For more information about the requirements for a RW, see contained research exemptions and research waivers (RW).