Pre-submission consultation procedures for novel foods and feeds derived from plants with novel traits

Pre-market safety assessment is a key component of the science-based regulation of novel foods, novel feeds, and plants with novel traits (PNTs) in Canada. Biotechnology regulators within the Government of Canada strongly encourage proponents to consult with regulators to verify information is complete and accurate before it is submitted for assessment. This process will help make the overall safety assessment and regulatory process more efficient.

This document outlines a process for consultations between proponents and regulators before proponents submit their official regulatory package for novel foods, novel feeds and plants with novel traits (PNTs). While pre-submission consultations are an optional step, it aims to reduce the time it takes to review a submission and minimize the number of omissions or inadequacies in the submission.

For products that are novel foods, novel feeds and PNTs, pre-submission consultations are typically held jointly between the proponent and the respective regulatory groups. This is done both for the convenience of the proponent and for the Government of Canada to provide the proponent with complete and aligned guidance.

A pre-submission consultation allows proponents to seek clarification on regulatory requirements and on specific information that should be included in their data package. Regulators will also be able to identify any specific concerns that proponents may wish to address before submitting a final package. This practice often reduces the number of requests and amount of additional information required to complete a safety assessment and reach a decision.

Whether or not a formal pre-submission consultation is held, proponents are still welcome to contact Canadian Food Inspection Agency (CFIA) and Health Canada (HC) regulators.

Pre-submission Consultations can include:

• communicating general information about the regulator’s sections/programs/bureaus and the regulatory framework concerning novel products
• clarifying the regulatory requirements, policies and administrative processes
• discussing data/information requirements specific to individual products

Pre-submission Consultations will not include:

• a review or assessment of data, label or other information pertinent to the product
• a decision on the acceptability of the data or the product
• information regarding pending enforcement actions and/or complaints submitted against the product proponent/company.

Pre-submission consultations do not affect or change the service delivery standards for submission review once the CFIA or Health Canada receives the application.

Procedures

1. Proponent determines if a pre-submission consultation is appropriate

Proponents are encouraged to use pre-submission consultations as an opportunity to discuss product-specific issues and appropriate information requirements. Such consultations can aid in the submission of a more complete safety assessment data package and a more expedient product review by reducing requests by regulators for clarification and additional information.

Proponents requesting a joint pre-submission consultation should contact each of the relevant groups, listed below, to arrange for a pre-submission consultation meeting.

Novel Food:
Submission Management and Information Unit
Food Directorate, Health Products and Food Branch,
Health Canada
251, Sir Frederick Banting Driveway
Postal Locator: 2202E
Ottawa, Ontario K1A 0K9
Phone: (613) 960-0552
Fax: (613) 946-4590
Email address: smiu-ugdi@hc-sc.gc.ca

Novel Feed /Plants with Novel Traits:
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Fax: 613-228-6614 /613-228-6140
Email address: presubmissionconsultations@inspection.gc.ca

2. Proponent provides relevant information package to regulator

Proponents should submit electronic copies of the following documents or information to each of the above contacts, preferably 3-4 weeks prior to the pre-submission to allow for sufficient time for the appropriate regulatory staff to review the information and make meeting arrangements.

The information package should include the following information:

• A cover letter or email message indicating a request for a joint pre-submission consultation that includes the lead company contact person. The proponent can also propose suitable dates for the meeting and should indicate if they would prefer a face to face meeting or use teleconference or videoconference options.
• An information package of no more than 50 pages, outlining the product description, i.e. name of product (plant line/event), new trait(s), mechanism(s) of new trait(s) introduction, proposed uses, etc., and any supporting information that is considered relevant. This package can include slides or presentation material that may be used at the meeting by the proponent.
• The proponent may choose to provide a list of the studies completed, ongoing, and being planned for inclusion to address each component in the final safety assessment submission package using the following table:
  
  

Food & Feed Assessment Considerations	Information OR type of data planned or collected to address each consideration
History of use of the trait in question
History of use of host and donor organism(s)
Dietary exposure
Describe/characterize the derived modified line
Genetic modification considerations
Nutritional considerations
Toxicology considerations
Allergenicity considerations
Chemical Considerations
Environmental Assessment Considerations
Core characterization data
Potential for weediness and invasiveness
Potential for gene-flow to wild relatives
Altered plant pest potential
Potential impact on non-target species, including humans
Potential impact on biodiversity.
Additional Information-CFIA Only
Method of detection

Proponents should clearly mark any information considered to be confidential business information, so that it can be easily identified and treated in accordance with the provisions of the Access to Information Act and other relevant law.

3. Regulators set up a consultation meeting

Upon receiving a request for a pre-submission consultation, the regulatory department/agency will:

• notify the proponent via e-mail that his/her request for a joint HC-CFIA pre-submission consultation meeting has been received.
• organize the meeting (e.g. provide the date/time/location/conference call phone number and access code to the appropriate department/agency managers/staff and proponents; prepare meeting agenda, etc.).

During the meeting:

• The appropriate representatives from each regulatory office and company should be in attendance (either in person, by conference call or by video conference) to achieve the maximum benefits.
• Any previous unilateral meetings (i.e. product pipeline updates) with the proponent prior to the request should be discussed to verify all participating regulators have the same knowledge and background on the novel product.
• The proponent is invited to present a brief overview of the product.
• Each regulatory department/agency should provide guidance for food, feed, and environmental safety criteria.

Following the meeting:

• Draft minutes will be provided to the proponent for review within two weeks of the meeting.

Meeting Records:
Between the meeting and the submission of a complete package there can be changes in the information that will be submitted, the context or the content of the submission, as well as the regulatory environment. Therefore, the minutes of a pre-submission consultation are not considered binding on either party. To highlight this fact, the following disclaimer will be included in all drafted meeting minutes:

Disclaimer
The above guidance provided by the CFIA and Health Canada is based on current policy and the quality and accuracy of the information supplied by the proponent prior to the meeting. There may be intervening legislative or regulatory policy changes, or significant new information may come to the attention of the CFIA or Health Canada, which could, in future, affect the guidance resulting from this consultation. It is the sole responsibility of the company to maintain current knowledge of any policy or legislation changes that may alter or impact this guidance. It must be recognized that the guidance provided by the CFIA and Health Canada is not intended to be advice upon which the proponent may rely or to alter or qualify in any way the Agency’s/ Department’s authority and responsibility to evaluate and decide on the acceptability of a product in accordance with the Seed Act, Feeds Act, and the Food and Drugs Act and their respective Regulations.

The information provided by the proponent prior to the pre-submission consultation meeting, together with the meeting minutes, will be retained and filed accordingly by the CFIA and Health Canada. This information can be referenced at a later date when the complete submission package is formally submitted.

Any information identified as confidential business information in the proponent’s file and/or discussed at the pre-submission consultation meeting will be treated to the same standard as confidential business information included in a submission and in accordance with the provisions of the Access to Information Act and other relevant law. As such, access to the file will be restricted to the proponent or person(s) granted signing authority by the applicant.