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

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Preamble

Pre-market assessment is a key component of the science-based regulation of novel foods, novel feeds, and plants with novel traits (PNTs) in Canada. The Government of Canada (GoC) strongly encourages proponents to consult regularly with the Canadian Food Inspection Agency (CFIA) and Health Canada (HC) to verify in advance that regulatory submissions for review will address all relevant assessment criteria.

Open and ongoing communication with CFIA and HC officials is always recommended, both before and after a product's regulatory submission. For example, a proponent may wish to clarify general policies, to better understand the regulatory process, or to provide updates on new products under development. The proponent may contact CFIA and HC officials at any time to have these discussions, either formally or informally. However, these discussions fall outside of the scope and intent of this document.

Purpose and Scope of this Guidance Document

The purpose of this document is to formalize the process for a specific type of consultation: the pre-submission consultation. Focus of the consultation should remain within the confines of the specific product to be submitted for pre-market assessment, especially as it relates to the contents of the submissions to be made for novel food, novel feed and environmental safety assessments. It is acknowledged that discussion within this context may involve certain aspects of policy. Other avenues exist for general policy discussions.

Description of Pre-Submission Consultations

A pre-submission consultation is a voluntary process that occurs between proponents and CFIA and HC regulatory officials to address potential questions related to the assessment criteria of a specific novel plant product before the official regulatory submission is submitted for assessment. The consultation allows proponents to seek clarification on regulatory requirements and consult on information that may or may not be included in their regulatory submissions. It is intended to provide a mechanism for CFIA and HC officials to provide the proponent with thorough and aligned guidance and to assist the proponent in providing a quality regulatory submission.

The goal of a pre-submission consultation is to improve predictability of the regulatory assessment process and the overall quality of regulatory submissions. Pre-submission consultations also allow the CFIA and HC to provide valuable guidance to proponents who have less experience with the regulatory process and submission preparation. As such, it is reasonable to expect that one or more pre-submission consultations may occur.

During the consultation, GoC officials shall provide considerations and input regarding the completeness of the proposed regulatory submission and proponents may raise any questions with respect to a specific submission before it is submitted. This process often reduces the number of additional information requests required to complete an assessment and reach a decision, thereby increasing the overall efficiency of the assessments and resulting in more timely reviews and decision-making. Please note that all regulatory submissions, whether they were subject to a pre-submission consultation or not, are reviewed in the order that they are received.

With regard to the specific product being discussed, pre-submission consultations can include:

  • providing the proponent an opportunity to present an overview of their regulatory submission, ask specific questions regarding the content of their regulatory submission and receive clarity on the data and/or information requirements specific to the individual product;
  • clarifying the regulatory requirements, policies and administrative processes when applicable;
  • clarifying expectations for data quality and fit for purpose and the use and elaboration of scientific rationale.

Pre-submission consultations will not include:

  • assessment of data, labels or other information pertinent to the product;
  • discussion on the acceptability of a product or other socio-economic or non-safety considerations;
  • general policy discussions or requirements;
  • providing information regarding pending enforcement actions and/or complaints submitted against the product proponent/company and/or actions pending through any applicable dispute resolution mechanism.

Roles and responsibilities

Proponent:

  • Make initial contact for pre-submission consultation;
  • Provide sufficient information on the product and specific questions for which answers are required from CFIA and HC officials;
  • Submit a draft agenda and work with GoC officials to finalize it in advance of the consultation; and
  • Identify previous pre-submission consultation documentation for the product in question, where applicable;
  • Review the draft consultation summary document and provide comments.

GoC officials:

  • Assign a lead GoC official who will be the proponent's government contact for the pre-submission consultation;
  • Coordinate pre-submission consultation and provide logistical information;
  • Identify and engage the appropriate CFIA and HC groups to participate in the pre-submission consultation;
  • Share, review and discuss internally the information and questions provided by the proponent with the appropriate CFIA and HC officials;
  • Provide any questions GoC officials may have upon initial review to proponent;
  • Finalize the agenda in consultation with the proponent; and
  • Draft and edit the consultation summary document internally, share it with the proponent for comment, finalize edits and share with all participants.

Procedures

1. Proponent requests a pre-submission consultation 8-12 weeks prior to the desired consultation

Proponents requesting a pre-submission consultation should contact either the Novel Food Section of HC or Animal Feed Division or Plant Biosafety Office of the CFIA (contact information listed below) 8-12 weeks ahead of the desired time frame of the proposed pre-submission consultation. This lead time will allow for sufficient time to arrange logistical details and permit effective review of information and internal GoC consultation, if required. A representative from one of the regulatory groups will ensure that the request is coordinated amongst all participating CFIA and HC officials.

Please provide a letter or email message indicating that a request for a pre-submission consultation is being made, and include the following information:

  • the contact information of the proponent lead for the proposed submission;
  • information on the nature of the product and its intended end-use;
  • suitable dates for the consultation being proposed (suggested lead time of 8-12 weeks);
  • any history of previous pre-submission consultations for the same product (e.g. date and GoC lead); and
  • the preference for a face-to-face consultation or the use of teleconference or videoconference options.

A lead GoC official will acknowledge receipt of the request within one week and will be responsible for organizing the consultation.

Contact information:

Novel Food Section:
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
E-mail address: smiu-ugdi@hc-sc.gc.ca

Animal Feed Division and Plant Biosafety Office:
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Fax: 613-228-6614 / 613-228-6140
E-mail address: presubmissionconsultations@inspection.gc.ca

2. GoC official organizes the pre-submission consultation

Within one week of receiving a request for a pre-submission consultation, the receiving office will arrange for a GoC official to act as the lead official for the consultation. The lead official will then coordinate arrangements for the consultation, chair the meeting, and prepare a final summary document following the consultation.

The lead official will organize the consultation by:

  • engaging the relevant GoC regulatory groups, and
  • providing the logistical information such as date/time/location/conference call phone number and access code to the appropriate department/agency managers/staff and proponents).

3. Proponent provides relevant information package to lead CFIA or HC official minimum of 4 weeks prior to the consultation

Proponents are to submit electronic copies of the relevant information that they wish to discuss, including any specific questions that they would like the GoC to address, in sufficient detail at least four weeks prior to the pre-submission consultation. In addition to providing enough time for logistical planning, this lead time will allow all evaluators to review the information and prepare for the consultation in order to provide meaningful advice during the pre-submission consultation. This is particularly important if the proponent is requesting answers to questions that require internal consultation between GoC officials in advance of the consultation. Provide sufficient information on the product to enable CFIA and HC officials to identify product-specific issues that may need to be addressed at the consultation and, if applicable, provide specific questions for which answers are required from CFIA and HC officials at the consultation

In the event that insufficient information is provided, or if information is not provided at least four weeks prior to the scheduled meeting, the GoC may not be able to provide valuable feedback. In this case, the lead official may postpone the consultation and will reschedule it for a later date after the complete pre-submission consultation package has been received.

The information submitted should include the following:

  • outline of 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 consultation by the proponent;
  • a proposed agenda clearly describing any product-specific questions to be raised by the proponent;
  • The proponent may choose to provide a list of the studies completed, ongoing, and planned which will be included in the final regulatory submission. These could address each component in the final regulatory submission using the following list of assessment considerations:
    • Novel trait and its mode of action
    • 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
    • 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
    • Method of detection (CFIA only)

While data are typically provided to address assessment considerations, CFIA and HC may accept other methods (e.g. bridging to other data) if adequately justified, or accept a valid scientific rationale.

As all information provided to the GoC is subject to the provisions of the Access to Information Act and the Privacy Act, it is beneficial for the proponent to clearly identify what is actually considered confidential business information in the material provided, thereby encouraging transparency of non-confidential information.

4. Distribution of consultation information and agenda development four weeks prior to the consultation

The lead GoC official will distribute the proponent's information (described above) for the pre-submission consultation to the relevant GoC officials within a week of having received it.

It is requested that the proponent begin the development of the agenda. There is no agenda template; however pre-submission consultations commonly follow this format:

  • Introductions,
  • Brief background of the novel plant product,
  • In-depth discussion of the content of the regulatory submission, as required, and
  • Addressing specific questions related to the submission by the proponent or GoC officials.

The proponent should ensure that all topics for discussion are listed on the agenda, as well as a list of specific questions to be addressed by the GoC during the consultation. The lead GoC official will contribute to the agenda as necessary, finalize it in conjunction with the proponent and distribute it to all relevant parties.

Before each consultation, the lead GoC official will confirm with CFIA and HC participants whether an internal meeting is required to discuss the submitted questions or specific issues. This will allow for a more consistent message and thorough guidance at the consultation. If questions arise from this discussion or from the review of the provided information, the lead GoC official will provide them to the proponent so that the proponent may make the appropriate preparations to address them. These questions may be added to the agenda if required.

The lead GoC official will also distribute material from any previous consultations or discussions with the proponent that are directly relevant to the current pre-submission consultation. These documents will be reviewed by the GoC officials as part of the preparatory process in order to ensure a common understanding and knowledge level on the novel plant product.

5. During the consultation:

The appropriate representatives from each regulatory office and the proponent should be in attendance (either in person, by conference call or by video conference) to achieve the maximum benefits.

The consultation will be chaired by the lead CFIA or HC official, who will ensure that:

  • the proponent understands the role of each group in attendance;
  • the submitted agenda is followed in order to ensure that all issues and questions are adequately addressed in a coherent and comprehensive manner; and
  • notes are recorded by the GoC for later development of the consultation summary document.

The proponent is invited to present a brief overview of the product and ask any questions or points of discussion originally submitted in their consultation request/agenda. The participating CFIA and HC officials will provide advice and guidance in response to the questions under discussion. The GoC officials may or may not be able to immediately address additional questions that develop from the discussion (i.e., not provided in advance with the pre-submission consultation information), however the questions will be noted and will be addressed either separately through direct communication (email or phone call) or attached as an appendix to the consultation summary document if a response is developed during the summary document's development.

Following the consultation:

  • A draft consultation summary document will be written and provided to the proponent for review as soon as possible and within one month of the consultation. The summary document will include:
    • all submitted product-specific questions and their responses, point by point;
    • specific points of discussion relating to the product's submission,
    • additional product-relevant questions that arose in the discussion and their corresponding guidance will also be included if appropriate (see above).
  • Within three weeks of receiving the draft consultation summary document, the proponent will provide comments or request further clarification; otherwise it will be deemed final.
  • The document will be finalized and distributed within three weeks following a response from the proponent and provided to all parties.

The information provided by the proponent prior to the pre-submission consultation meeting, together with the consultation summary document, will be retained and filed accordingly by the CFIA and HC. For reference, any submission related to the consultation may cite the summary so that the pre-submission information and applicable advice/conclusions are considered when the submission is received.

Any information identified as confidential business information in the proponent's file and/or discussed at the pre-submission consultation will be treated as such and in accordance with the provisions of the Access to Information Act and the Privacy Act. Access to the file will be restricted to the proponent or person(s) granted signing authority by the applicant.

Disclaimer:

The advice and/or conclusions resulting from a pre-submission consultation should be considered applicable for an indeterminate period, except in the event of any new information becoming available about the subject product, including traits and mode of action, or in the event of any legislative, regulatory, or policy changes that would affect the guidance. To account for such possibilities, the following disclaimer will be included in all consultation summary documents:

The above advice/conclusions provided by the CFIA and HC are based on current policy and the quality and accuracy of the information supplied by the proponent. There may be subsequent legislative or regulatory policy changes, or significant new information may come to the attention of the CFIA or HC, which could affect the guidance resulting from this consultation. It is the sole responsibility of the proponent/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 HC is not intended 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 Seeds Act, Feeds Act, and the Food and Drugs Act and their respective regulations.

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