Canada – Consultation Summary: Notice of Intent Enhanced Transparency of the Pesticide Regulatory Process, NOI2022-01

Mar 18, 2023 | International

Health Canada’s Pest Management Regulatory Agency

17 March 2023

Table of Contents

The consultation
Summary of comments received
Conclusion

On 4 August 2021, the Ministers of Health, Agriculture and Agri-Food and Environment and Climate Change announced that the Government of Canada would be investing $42 million in Health Canada’s Pest Management Regulatory Agency (PMRA) to further strengthen its human and environmental health and safety oversight and protection, and improve transparency of the pesticide review process. Several strategies are in process of being implemented by the PMRA to make more information available to the public and enhance transparency of the pesticide regulatory process.

The consultation
On 25 October 2022, the PMRA published a Notice of Intent and initiated a 30-day consultation on a proposal for enhanced transparency of the pesticide regulatory process (NOI2022-01). The proposal outlined PMRA’s intent to disclose the names of applicants and registrants once the review process is initiated, for those pre- and post-market reviews described in Appendix I. This would consist of the name of any person, including an individual, who is an applicant or registrant and would appear in:

The electronic public registry (via the Pesticide Product Information Database (PPID);
Consultation documents posted on the Pesticides section of the Canada.ca website (in other words, Proposed Registration Decision (PRD) and Proposed Maximum Residue Limit (PMRL)); and subsequently
Registration Decision documents.

In total, eleven responses were received. Nine responses were from industry stakeholders and two from non-governmental organizations (NGOs). Of note, comments received that went beyond what the proposal set out in the consultation document were not considered for the purpose of this proposal.

Summary of comments received

Comments from NGOs and some industry stakeholders confirmed support for PMRA’s proposal.

Overall, there is strong support for this PMRA initiative to enhance the transparency of the pesticide regulatory process that will improve confidence in the regulatory system. There is agreement that this initiative aligns with the Government of Canada’s commitment of August 2021. There is support to align with similar transparency practices implemented by other branches of Health Canada and international pesticide regulators such as the United States Environmental Protection Agency (USEPA) and the Australian Pesticides and Veterinary Medicines Authority (APVMA) for applications pending a regulatory decision. Disclosing regulatory ownership of review activities requested of the PMRA was acknowledged as key to transparency for the public.

Some industry stakeholders requested additional clarifications on who is considered to be the applicant in the context of this proposal and whether there is a distinction between applicant and registrant.

PMRA response:

The term “applicant” is not defined in the Pest Control Products Act or the Pest Control Product Regulations, whereas the term “registrant’’ is defined as “a person in whose name a pest control product is registered.” However, in the Act and Regulations, the term “applicant” is used to mean a person who makes an application:

to register or amend the registration of a pest control product under section 7 of the Pest Control Products Act,
to have an MRL specified for an unregistered active ingredient or an unregistered use under section 10 of the Pest Control Products Act, and
to renew a registered pest control product under section 16 of the Pest Control Product Regulations.

The “applicant’s name” refers to the name of the proposed or current registrant as identified in the Application Form for New or Amended Registration (form 6005), Box 3 Registrant Name (full legal name, no abbreviations). The registrant’s name is the intended or current registrant of the product, in whose name the Certificate of Registration would be issued.

The applicant’s or registrant’s name, whether the name of an individual, a company or another organization, will be made publicly available in the PPID, in Consultation Documents posted on Pesticides section of Canada.ca (in other words, PRD and PMRL, and subsequently in Registration Decision (RD) documents.

Some industry stakeholders commented that the PMRA’s proposal may impact the protection of the intellectual property of Canadian innovators and affect commercial interests, resulting in a competitive disadvantage.

PMRA response:

This proposal is consistent with the approach taken by Health Canada in respect of regulated products under the Food and Drugs Act. Since the implementation of the disclosure of applicant’s or registrant’s name for drug applications in 2015, stakeholders have not raised any concerns about a negative impact on their commercial interests. The PMRA does not expect any negative impact on commercial interests of disclosure of the names of applicants or registrants for pest control product applications. While it may be possible for the PMRA to receive an application for a new active ingredient or new innovative device for which there is a patent application pending, it is expected that this would happen on rare occasions. This type of situation could be managed on a case-by-case basis when an applicant or registrant identifies within their application cover letter that a patent application is pending, including the information required for verification. Additionally, while the PMRA proposes to disclose the applicant’s or registrant’s name, it will continue to maintain confidentiality of the product name while the application is under review, and when an application is withdrawn including instances where applications are rejected prior to making it to a full science review assessment. These considerations are expected to support the protection of intellectual property of Canadian innovators and allow the applicant to pursue its innovation efforts at a later date, as needed.

Some industry stakeholders questioned the transparency benefits and objective of disclosing the applicant’s or registrant’s name.

PMRA response:

In support of the Government of Canada’s initiatives towards Open Government as well as its commitment to enhanced transparency of the pesticide review process, additional information is being released in the PPID.  Currently the following information is released in the Public Registry for open applications for a variety of regulatory activities:

Application number and date received
Active ingredient(s)
Purpose (i.e., new, amendment, minor use)
Category of application (i.e., A, B, C, L, etc.)
Product type (i.e., insecticide, material preservative)
Marketing class (i.e., technical, commercial, domestic)

The addition of the applicant’s or registrant’s name will provide additional information about the application that has been filed to further support meaningful public participation in the regulatory process. PMRA recognizes that the transparency and openness of its work is critical in strengthening trust in the regulatory decisions. Disclosing the applicant’s or registrant’s name in the public registry is a first step in revisiting the types of information and data that we make available.

Some industry stakeholders commented that the PMRA’s proposal may lead to brand stigmatization, specifically when an applicant’s or registrant’s name is disclosed in relation to a negative outcome.

PMRA Response:

Following a review of the information and comments provided during consultation, the PMRA conducted an analysis of additional considerations. This analysis, which included the review of historical pest control product applications, confirmed that the applicant’s or registrant’s name has never been designated as confidential business information (CBI). This supports PMRA’s view that an applicant’s or registrant’s identity is unlikely to be information that meets the definition of CBI under the Pest Control Products Act, even when disclosed in association with the information that is already disclosed during the application review stage.

As described above, the PMRA will continue to maintain confidentiality of the product name, while the application is under review, and in certain instances of a negative outcome. This is expected to minimize brand stigmatization and limit prejudice in the marketplace, allowing the applicant to pursue re-application for their new or amended pest control product at a later date, as needed. It is PMRA’s position that the disclosure of the applicant’s or registrant’s name in relation to a negative outcome is not expected to lead to brand stigmatization or prejudice competitive position in the marketplace.

Conclusion
Following consideration of the comments received from stakeholders, as of 1 April 2023, the PMRA will be implementing the disclosure of the names of applicants, after administrative screening of a complete application package, once the application enters the review stream, for a variety of regulatory activities.

This information will be included in:

The Register (via the PPID) for applicable applications received on or after 1 April 2023; and
Consultation (in other words, PRD, PMRL) and Registration Decision documents posted on the Pesticides section of Canada.ca for applicable applications received on or after 1 April 2023.

Appendix I Types of regulatory activities released in the pesticide product information database
Category A – New Active Ingredients, Major New Uses, Maximum Residue Limits on unregistered active ingredients.

Category B – New or Amendments to Existing Registrations plus Emergency Registrations

Category C – Precedent Based Registrations and Amendments plus Minor Use Registrations

Category D – Importation for Manufacturing and Export Program (IMEP), User Requested Minor Use Label Expansion (URMULE), Master Copies, Private Labels, Renewals, Discontinuations

Category H – Notices of Objection and Review Panels

Category L – Data Protection Applications and Registrations

Category N and R – Re-Evaluations and Special Reviews