Category E Submissions: Research Authorizations

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Catherine Hooper
Evaluation Oficer, Insecticides Section
Value and Sustainability Assessment Directorate

Outline

• Why do research?
• Options -- RA, RN or exemption?
• What is needed to apply for an RA or RN?
• How long does it take for an RA or RN?
• When does the RA or RN expire?
• What do I need to do after receiving my RA or RN?
• Additional assistance?

Why do research?

• Research is pivotal to development of pest control products.
• The research authorization system allows for trials to be conducted to generate new data and/or confirmation of results drawn from other studies to support the registration of a new product or use.

Options

• All research on pest control products conducted solely in a laboratory are exempt - no matter what the active ingredient is.
• Microbial Active Ingredients
  • Research authorization
  • Research notification
• Semiochemicals and Pheromone Actives
  • Research authorization
  • Exemption
• Chemical Ingredients
  • Research authorization
  • Research notification
  • Exemption

Research Notification - Microbial A.I.

1. It does not involve aerial application.
2. The micro-organism is indigenous to the area where it is intended to be used.
3. With the exception of pest control products containing Bacillus thuringiensis registered for use on agricultural crops, treated food and feed crops from research sites and meat, milk and eggs must not be sold (i.e. crop destruct)
4. The application of the pest control product is carried out:
   1. on a maximum of 10 ha of land owned or operated by the research establishment;
   2. on a maximum of 1 ha of surface area for bodies of water that are wholly contained on land owned or operated by the research establishment.

Exemption - Semiochemicals and Pheromones A.I.

• For active ingredients other than an arthropod pheromone:
  1. Unregistered active ingredient:
     • Application of the test product is carried out by the researcher alone on a maximum of 5 ha of land owned or operated by the research establishment.
  2. Registered active ingredient:
     • Application of the test product is carried out by the researcher or cooperator on a maximum of 10 ha of land owned or operated by the research establishment or cooperator.
• For active ingredients that are arthropod pheromone:
  1. The application of the product is carried out on a maximum of 100 ha of land owned or operated by the research establishment or cooperator and the maximum use rate does not exceed 375 g of active ingredient/ha/year.
  2. If used in a food or feed crop, the pheromone is contained in an affixed solid matrix dispenser or in a retrievable-sized polymeric matrix dispenser and the dispenser is not in direct contact with the crop.

Exemption - Chemical Active Ingredients

1. Unregistered active ingredient:
   • The application of the test product is carried out by the researcher alone:
     1. On a maximum of 5 ha of land owned or operated by the research establishment or
     2. On a maximum of 1 ha or 5% of the total area of the crop under research, whichever is less, for land owned or operated by a cooperator
2. Registered active ingredient:
   • The application of the test product is carried out by the researcher or cooperator on a maximum of 10 ha or 20% of the total area of the crop under research, whichever is less.
   • The land may be owned or operated by the research establishment or cooperator.

Research Notifications - Chemical Active Ingredients

1. Unregistered active ingredient:
   • The application of the test product is carried out by the researcher alone:
     1. On 5 to 50 ha of land owned or operated by the research establishment or
     2. On 1 to 5 ha of land owned or operated by a cooperator
2. Registered active ingredient:
   • The application of the test product is carried out by the researcher or cooperator on 10 to 50 ha of land owned or operated by the research establishment or cooperator.

Exceptions - Chemical Active Ingredient Only

• In addition, the following 2 criteria must also be met for research involving chemical active ingredients to qualify for a research notification or exemption:
  1. Treated crops must not be sold for human consumption or for feed for meat or dairy animals, or for chickens or other fowl that supply eggs for human consumption, unless the residues conform with the existing maximum residue limits (MRLs) as defined in Division 15 of the Food and Drugs Regulations.
  2. For registered active ingredients, there is reasonable expectation that the research will not increase occupational exposure above the level that is expected when the pest control product is used in accordance with its conditions of registration.
• May include: New formulations and new uses of a registered active ingredient with potential to increase worker exposure (e.g. a major change in use pattern or within a use pattern, significant changes in application methodology, or bystander access).

Exceptions - Chemical, Semiochemical and Pheromone A.I.

• If the research trial involving a chemical, semiochemical or pheromone does not meet all of the following criteria, then the research does not qualify for an exemption or notification:
  1. It does not involve the application of a pest control product to a body of water or where runoff water may remove residues from the research site.
  2. It does not involve the use of a antimicrobial agent.
  3. It does not involve aerial application.
  4. It does not involve the use of a pest control product in any of the following areas: greenhouses, residential areas (including lawns, gardens, parks), industrial premises and food-handling areas.
  5. It does not involve the use of a pest control product for either structural pest control or fumigation.
  6. It does not involve the use of a pest control product that contains a formulant that is on Part 1 of the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern or a contaminant that is on Part 3 of that List.

What is needed to apply?

1. Cover letter*
2. Completed Application for Research Authorization or Research Notification form*
3. Completed Control Product Specification form*
4. Electronic proposed experimental label that is specific to the research*
5. Site Information/List of cooperators*
6. Research plan should be submitted
7. Application Fees form and the $150 fee (Research Authorizations only)*
8. MSDSs
9. E-indexes are not required but are highly recommended
10. Data may also be required (Refer to Directives referred to in the References section)

How long does it take?

Research Authorization -
Registered Active Ingredient:
90 days*

Research Authorization -
Unregistered Active Ingredient:
180 days*

Research Notification:
30 days*

*Assuming the application package is not deficient!!!

When does the RA or RN expire?

• A research authorization/notification certificate expires on 31 December of the year in which it is issued unless another expiry date is specified in the certificate.
• Research authorizations/notifications are not renewable or transferable.

What do I need to do after receiving my research authorization/notification?

1. Import the product
   • PMRA's Declaration of Importer of Control Products Form
   • Canadian Border Services
   • Canadian Food Inspection Agency (Microbial A.I.s)
2. Inform and get approvals from the provincial authorities
3. Make any corrections to the experimental label
4. Inform PMRA of where the final trial locations are.
5. Post signs at trial location.
6. Ensure that the experimental label and all conditions are followed.

Additional assistance?

• PMRA Information Services
• Directives Related to Research:
  • DIR98-05: Chemical Pesticide Research Permits Guidelines
  • PRO93-05: Research Permit Guidelines for Microbial Pest Control Agents
  • PRO2002-02: Guidelines for the Research and Registration of Pest Control Products Containing Pheromones and Other Semiochemicals
• Handouts provided