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How to request a modification to a document incorporated by reference by CFIA into the Safe Food for Canadians Regulations or the food-related provisions of the Food and Drug Regulations

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1.0 Introduction

Sections 52 to 55 of the Safe Food for Canadians Act and section 30.5 of the Food and Drugs Act (as it relates to food) provide the authority to incorporate documents by reference into the Safe Food for Canadians Regulations (SFCR) and the food-related provisions of the Food and Drug Regulations (FDR), provided certain requirements are met.

Incorporation by reference (IBR) is a drafting technique that brings the content of a document into a regulation without the need to reproduce the document's text in the regulation itself. Documents incorporated by reference by the Canadian Food Inspection Agency (CFIA) into these regulations may be created by CFIA or by an external party. External parties may include other governmental departments, agencies or organizations, for example, the Canadian General Standards Board. They may also include international or third-party organizations or associations, for example, the International Organization for Standardization. Refer to CFIA's Inventory of documents incorporated by reference for a complete list of documents that have been incorporated by reference into regulations administered by CFIA.

To date, all of the documents that have been incorporated by reference by CFIA into the SFCR and the food-related provisions of the FDR are ambulatory, which allows them to be modified by their administrators from time to time. Although modifications to ambulatory incorporated documents do not go through the Canada Gazette process, CFIA is responsible for ensuring that these documents are maintained based on the guiding principles of accessibility, transparency, consistency, reasonableness, and clarity, in accordance with the CFIA Incorporation by Reference Policy.

2.0 Purpose

This document describes the standardized process that stakeholders, such as food businesses, industry associations and other governmental departments, follow to request a modification to an ambulatory document that has been incorporated by reference by CFIA into the SFCR or the food-related provisions of the FDR.

This document also describes the standardized process that CFIA follows when modifying the IBR documents that it has created and is responsible for maintaining.

This process does not apply to documents that Health Canada has incorporated by reference into the food-related provisions of the FDR, nor to Marketing Authorizations that are administered by Health Canada. Refer to Health Canada's guide on Incorporation by Reference to obtain information on how these documents are modified.

3.0 Acronyms

CFIA
Canadian Food Inspection Agency
FDR
Food and Drug Regulations
IBR
Incorporation by reference
SFCR
Safe Food for Canadians Regulations
WTO
World Trade Organization

4.0 Definitions

Administrator means the department, agency, organization or association that created and is responsible for maintaining an IBR document.

IBR document means, for the purpose of this document, an ambulatory document that has been incorporated by reference by CFIA into the SFCR or the food-related provisions of the FDR.

Internal IBR document means, for the purpose of this document, an IBR document created and maintained by CFIA.

External IBR document means, for the purpose of this document, an IBR document created and maintained by an external party. These non-CFIA parties include other governmental departments, agencies or organizations (for example, Canadian General Standards Board) or international or third-party organizations or associations (for example, International Organization for Standardization).

Proposal means a proposed modification to an existing IBR document that is developed by the administrator of the document.

Requester means the party who proposes a modification to an existing IBR document.

5.0 Resources

6.0 Proposed modifications to incorporated documents created by CFIA

Refer to CFIA's Inventory of documents incorporated by reference to access the documents currently incorporated by reference into regulations that the CFIA administers. For the purpose of this document, internal IBR documents are presented in the inventory as those that have "CFIA" listed under the "Source" column and either "Safe Food for Canadians Regulations" or "Food and Drug Regulations" listed under the "Regulations" column.

6.1 Submission

To request a modification to an internal IBR document, stakeholders, such as food businesses, industry associations and other government departments, submit a document containing the details of the proposed modification to one of the following addresses:

  1. By mail to:

    Executive Director, Food Safety and Consumer Protection Directorate
    Canadian Food Inspection Agency
    1400 Merivale Road
    Tower 2
    Ottawa, Ontario
    K1A 0Y9

  2. By email to: tammy.switucha@canada.ca

Include the following details in the submission document (read the Privacy notice statement):

  1. Requester's name, telephone number and email address
  2. Requester's business name and position title, if applicable
  3. Requester's Safe Food for Canadians (SFC) licence number, if applicable
  4. Date of submission
  5. Title of the IBR document
  6. Section of the IBR document
  7. Proposed modification
  8. Rationale for the proposed modification
  9. Scientific evidence that supports the proposed modification, if applicable
  10. List of stakeholder groups that could be affected by the proposed modification, for example:
    • Specific industry sectors or individual businesses
    • Industry associations
    • Consumers
  11. Potential impact on consumers, trade, regulated parties and regulators, for example:
    • Health and safety impact on consumers
    • Market access impact on trade
    • Financial burden on regulated parties
    • Resource impact on regulators
  12. Evidence of industry support, if applicable, for example:
    • Letter from industry association(s) in support of the proposed modification
    • Summary of engagement that has taken place and participants

6.2 CFIA analysis of the proposed modification

CFIA takes the following steps to analyze a submission and develop a proposal:

6.2.1 Screening

CFIA screens the submission to ensure completeness, clarity and validity. CFIA may contact the requester if the submission is incomplete, unclear, or if questions arise during the screening process.

6.2.2 Classification

CFIA may classify the proposed modification into one of the following 4 categories to help determine the extent of consultation and approvals needed to amend the IBR document:

a) Technical/complex

A proposed modification that is technical/complex has an impact on stakeholders. It may effect the quality standards of a food and/or may impact industry's ability to market their commodities in Canada and internationally. It may also address a non-immediate risk to human health, such as the mitigation of a hazard that presents a potential risk.

Examples:

b) Immediate health and safety risk

A modification that addresses an immediate health and safety risk or mitigates a hazard that presents an immediate risk to human health, such as measures to enhance food safety based on new scientific evidence.

c) Minor administrative adjustments

Minor administrative adjustments are limited to those of a "house-keeping" nature that have no impact on health and safety nor on industry's ability to market their commodities in Canada and internationally. They exclude any changes to the name of an IBR document since these would trigger a regulatory change.

Examples:

d) Consequential

Consequential modifications have no known negative impact on health and safety nor on industry's ability to market commodities in Canada and internationally. For example, to reflect new or modified Government of Canada directives or decisions, such as updating a list or compendium to include products or substances approved by Health Canada.

6.2.3 Considerations and proposal development

CFIA considers the following factors when analyzing a submission and developing a proposal to modify an internal IBR document. A working group made up of various subject matter experts may be involved at this step.

  1. Consistency with CFIA's mandate and policy objectives
  2. Potential administrative and operational modifications required for regulated parties to comply with the proposed modifications
  3. Level of clarity in understanding the document's content to ensure stakeholder compliance
  4. Resources and capacity required for CFIA inspectors to perform their duties, such as potential tools and training
  5. Impact on current CFIA programs
  6. The cost-benefit analysis contained in the Regulatory Impact Analysis Statement (RIAS) that accompanied the regulatory proposal containing the IBR document
  7. International trade implications, including CODEX standards
  8. Preliminary stakeholder support

    CFIA may identify other stakeholders that were not included in the submission and may consult with them to assess their support of the proposed modification.

  9. Transition period

    CFIA may propose that a transition period be a applied in order to give regulated parties time to adjust their practices and procedures to the modified IBR document. CFIA considers factors such as the readiness of impacted stakeholders, including the time needed to adjust for compliance, and any applicable legislative, regulatory or other formal requirements (such as international arrangements). CFIA may consult with stakeholders about the application of a transition period.

  10. Other considerations

    Refer to CFIA Incorporation by Reference Policy, Annex A – Document selection considerations, for additional factors for consideration.

6.3 Approval of proposal for consultation

CFIA senior management reviews the proposal and decides whether or not it will move on to the next step in the process as well as the timelines for these next steps. CFIA contacts the requester to notify them of the decision.

a) Approved technical/complex proposals

For approved technical/complex proposals, CFIA proceeds to Section 6.4 – Consultation.

b) Approved proposals that address an immediate health and safety risk

Approved proposals that address an immediate risk to health and safety may need to be implemented quickly in order to protect the health and safety of consumers; therefore, CFIA may proceed immediately to Section 6.5 – Final document modification.

c) Approved proposals that address minor administrative adjustments

For approved proposals that address minor administrative adjustments, CFIA may proceed directly to Section 6.5 – Final document modification.

d) Approved consequential proposals

For approved consequential proposals, CFIA may proceed directly to Section 6.5 – Final document modification.

6.4 Consultation

6.4.1 Notification and collection of comments

For an approved Technical/complex proposal, CFIA conducts a public consultation to provide stakeholders the opportunity to comment on the proposed modification. CFIA posts the consultation on its Consultations and engagement page. CFIA notifies stakeholders of the consultation using various methods, such as email distribution lists and direct discussion with industry associations. Stakeholders are also informed of the duration of the comment period and how they can provide comments on the proposal. Refer to CFIA's Consultation policy and framework for more information on the principles and stages of consultation.

For proposals that may have an impact on international trade, CFIA submits a notification to the World Trade Organization (WTO) regarding the consultation, in accordance with Canada's international obligations. A 60-day notification process is typically required.

6.4.2 Analysis of comments

Following the closure of the consultation, CFIA reviews all of the comments received and updates the proposal as needed. If significant issues are raised during the comment period, CFIA may return to Section 6.2.3 – Considerations and proposal development to further analyze and potentially amend the proposal.

6.4.3 Summary of comments

CFIA develops a summary of the comments received during the consultation, which is posted on its Consultations and engagement page. CFIA notifies stakeholders when the summary document is available online, using the same email distribution lists and direct discussions with associations and organizations used in Section 6.4.1 – Notification and collection of comments. The summary of comments contains a section on CFIA's next steps, which may include:

6.5 Final document modification

6.5.1 Modification and final approval

CFIA modifies the IBR document according to the proposal and sends it to the appropriate CFIA senior manager(s) for final approval, as required. CFIA also prepares a summary of the modifications in both official languages.

6.5.2 Publication

CFIA publishes the modified IBR document on its website in both French and English, indicating any transition period. They update the CFIA Inventory of documents incorporated by reference with a link to the modified IBR document. They also update any other links to the document on the CFIA website. CFIA archives the previous version of the document, along with the summary of the modifications.

Any modification made to an IBR document takes effect on the date the modified version is provided on CFIA's website or the date indicated on the document, unless a transition period is applied.

6.5.3 Notification

CFIA uses various communication methods, for example, email distribution lists and direct discussion with industry associations, to inform stakeholders of the publication of the modified IBR document and provide them with a link to the modified document. For modifications that may have an impact on international trade, CFIA submits a notification to WTO regarding the publication of the modified document.

7.0 Proposed modifications to incorporated documents created by an external party

Proposed modifications to externally-generated documents that have been incorporated by reference by CFIA into the SFCR or the food-related provisions of the FDR are managed by the document's administrator. Where possible, CFIA works with the document's administrator to ensure that an anticipated modification does not conflict with CFIA's policy objectives or with Canada's international obligations.

Refer to CFIA's Inventory of documents incorporated by reference to access the documents currently incorporated by reference into regulations that the CFIA administers. External IBR documents are presented in the inventory as those that have a non-CFIA party listed under the "Source" column, and either "Safe Food for Canadians Regulations" or "Food and Drug Regulations" listed under the "Regulations" column.

7.1 Submission

For a proposed modification to an external IBR document that is initiated by the document's administrator, proceed to Section 7.2 – Notification.

Stakeholders, such as food businesses, industry associations and other government departments, submit a request to modify an external IBR document directly to the document's administrator.

In cases where CFIA receives a request to modify an external IBR document, CFIA contacts the requester and asks them to re-submit the request directly to the document's administrator.

7.2 Notification

Once made aware of an administrator's intent to modify an external IBR document, CFIA directs stakeholders to the proposal and any consultation held by the administrator by:

7.3 CFIA analysis of the proposal

CFIA analyzes the administrator's proposal to modify an external IBR document to ensure consistency with CFIA's policy objectives and Canada's international obligations. A working group made up of various subject matter experts may be involved at this step. CFIA may contact the document's administrator to request additional information to support the analysis, such as justification for the modification and its anticipated timeline, if required.

Refer to Section 6.2.3 – Considerations and proposal development for a list of the factors CFIA considers when analyzing the administrator's proposal, as CFIA considers the same factors when analyzing proposals to modify both internal and external IBR documents. Note that some of the factors may have been previously considered if CFIA was involved with the development of the proposal with the administrator.

7.4 Submission of comments

CFIA submits comments to the administrator, as necessary. In cases where the administrator holds a formal stakeholder consultation, CFIA submits their comments within the comment period, using the method identified in the consultation. In addition, if CFIA receives any comments from other stakeholders on the proposal, they forward them to the administrator using the method identified in the consultation.

7.5 Summary of comments

In cases where the administrator holds a formal stakeholder consultation, following the closing of the comment period, CFIA updates its Incorporation by reference page to indicate that the consultation is closed, and provides a link to any summary of comments made available by the administrator. Unless completed by the administrator, CFIA notifies stakeholders of the closing of the consultation and any summary of comments using the same email distribution lists and direct discussions with associations and organizations used in Section 7.2 - Notification.

7.6 Publication and notification of the modified document

CFIA updates its Inventory of documents incorporated by reference to include a link to the modified IBR document once it has been made publically available by the administrator. CFIA also updates any other links to the modified document on its website and, when feasible, archives the previous version of the document, along with any summary of modifications made available by the administrator.

CFIA uses various communication methods, for example, email distribution lists and direct discussion with industry associations, to inform stakeholders of the publication of the modified external IBR document. For modifications that may have an impact on international trade, CFIA submits a notification to WTO regarding the modified document, unless completed by the administrator.

Privacy notice statement applicable to a submission for a request to modify a document created by CFIA that has been incorporated by reference by CFIA into the Safe Food for Canadians Regulations or the food-related provisions of the Food and Drug Regulations

Submission of your personal information constitutes your consent to the collection, use, storage, and disclosure of your personal information by the Canadian Food Inspection Agency (CFIA).

Personal information collected by CFIA and the Government of Canada is protected from disclosure to unauthorized persons and/or agencies pursuant to the provisions of the Privacy Act. Individuals to whom the personal information pertains have the right to the protection of and access to their personal information under the Privacy Act, subject to certain exceptions and exemptions.

For inquiries concerning the treatment of personal information in the custody of CFIA, individuals may contact the CFIA's Access to Information and Privacy Office at CFIA.ATIP-AIPRP.ACIA@canada.ca (located at 1400 Merivale Road, Tower 1, Room 0-149 Ottawa, ON K1A 0Y9, Canada).

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