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Inspection of Confidential Test Data: Guidance Document

Health Canada – Pest Management Regulatory Agency
12 August 2025

The purpose of this document is to provide the public with a description of the policy and procedure for inspecting confidential test data. The document explains what information can be inspected and when it is available. It also provides guidance on how to submit an application and a description of what to expect during the inspection process.

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1.0 Background

Canada's Pest Control Products Act (PCPA) provides the public with the opportunity to inspect the confidential test data (i.e., test data to which access may be refused under the Access to Information Act) supporting pest control product (also called "pesticides") registration decisions or proposed and final decisions in the case of post-market reviews (i.e., re-evaluations and special reviews).

Companies who want to register a pesticide in Canada must provide test data (i.e., scientific or technical information respecting the health or environmental risks or the value of a pest control product) to Health Canada's Pest Management Regulatory Agency (PMRA) for the evaluation of potential risks to human health and the environment as well as to demonstrate the product's value. The data are evaluated by PMRA scientists, who conduct risk and value assessments leading to decisions on whether the pesticide can be used in Canada and under what conditions. Data requirements cover several areas, such as: toxicology related to human health, bystander and occupational exposure, food residue trials, environmental toxicology and fate, as well as information supporting the efficacy, crop tolerance and benefits of the pesticide.

Members of the public may inspect confidential test data either in-person in the Reading Room, located at the PMRA's National Head Office in Ottawa, Ontario, or remotely (see Section 5 "Inspecting Confidential Test Data", below, for more information regarding these options).

Confidential test data are available for inspection:

Anyone wishing to inspect confidential test data must submit an application form to identify the confidential test data they wish to inspect as well as an affidavit or statutory declaration stating the purpose of the inspection and attesting that the confidential test data will not be used or made available to others to register or amend a product registration. The PMRA does not charge a fee to inspect confidential test data.

Providing the public with the opportunity to inspect confidential test data is intended to facilitate transparency and public participation in the regulatory decision-making process. This is particularly important for anyone who is considering filing an objection to a major registration decision (i.e., a registration decision, a special review decision or a re-evaluation decision), because they must identify the scientific basis on which the objection rests.

Anyone may submit a Notice of Objection within 60 days of the publication of a major registration decision. The objection must be related to the science evaluations that led to the decision concerning the health risk, environmental risk, or value of the pest control product and it must be supported by scientific information. If scientifically founded doubt is established as a result of the objection, PMRA may establish an external Review Panel to determine whether PMRA's decision should be maintained, reversed or varied.

For more information on how to submit a Notice of Objection, consult the Public Engagement Portal.

2.0 Availability of pesticide information

2.1 Description of available information

The inspection of confidential test data is only applicable to confidential test data in the Register at the time of the inspection request.

When a pesticide is registered, the public is encouraged to review the published evaluation reports, such as decision documents, made available on the PMRA website. These documents explain the risk and value assessments supporting a registration, a re-evaluation, or a special review decision, along with a summary of the information considered. Evaluation reports provide references to all the data considered in the evaluation, including the confidential test data submitted by pesticide registrants and any other information considered in the evaluation.

When evaluating a pesticide, throughout a registration application, a re-evaluation, or a special review, the PMRA considers information other than confidential test data provided by the registrant. While some of the information is already in the public domain (e.g., scientific publications), some of it is provided to the PMRA in confidence (e.g., unpublished research). In the latter case, if the information provided is confidential test data, it can be inspected via the Reading Room process. An appropriate reference for any information relied on during an evaluation is provided in the evaluation report.

If a person wishes to inspect the confidential test data relevant to a particular decision, they can apply (electronically) to do so. Inspections can be done in person or remotely.

In addition to domestic legal obligations, Canada has obligations under international law to protect confidential test data from disclosure and unfair commercial use. Consequently, the inspection process includes rigorous controls to fulfil these obligations and to prevent the confidential test data from being copied or distributed by the person inspecting it.

Under Section 43 in the PCPA:

The public may inspect the confidential test data supporting a pest control product when a decision is made under the PCPA to register a product, amend a registration, or when the registration is continued following a re-evaluation or special review. The confidential test data supporting a proposed post-market decision can also be inspected at the proposed decision stage for re-evaluations and special reviews published as of January 1, 2022.

2.2 What Is not available for inspection

a) Ineligible Information

Any personal information or confidential business information (CBI) is removed from confidential test data before being made available for inspection.

With respect to the former, all disclosure of personal information by federal institutions is subject to the provisions of the Privacy Act. Examples of personal information that is redacted include: signatures, initials, dates of birth, contact information, maps, educational backgrounds and resumes, job titles, GPS coordinates, and any information the PMRA reasonably believes could be used to re-identify any personal information.

The PCPA narrowly defines CBI as information provided to Health Canada under the PCPA:

Note: Information on the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern can be found in Science Policy Note SPN2020-01, Policy on the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern under paragraph 43(5)(b) of the Pest Control Products Act.

Confidential test data are not available for inspection when an application is denied, rejected or withdrawn, or if a registration is cancelled following a re-evaluation or special review (see exception in 2.2 b)). Inspection of confidential test data is only applicable for products registered in Canada.

b) Reading room requests related to cancelled pest control product registrations

A pest control product that had its registration cancelled following a post-market review may be subject to a phase-out period pursuant to subsection 21(5)(a) of the PCPA. Confidential test data relevant to a cancelled pest control product registration following a final post-market review decision (i.e., re-evaluation or special review) will not be available for inspection once the Notice of Objection period has closed (i.e., 60 days from the date of the published decision), or where applicable, after the phase-out period has ended.

2.3 Timing of confidential test data availability

The PCPA, which came into force on June 28, 2006, requires that confidential test data, with respect to registered pest control products that is in the Register, be made available for inspection, but only after a decision (or proposed decision in the case of re-evaluations or post-market reviews published as of January 1, 2022) is made under the 2006 Act. A description of when confidential test data are available for inspection is provided below:

a) Products registered before June 28, 2006

The confidential test data supporting pesticides registered before June 28, 2006, are not available for inspection until a major regulatory decision (major new use, re-evaluation or special review) requiring public consultation is made under the PCPA. Only confidential test data relevant to the decision are made available at that time.

b) Products registered or that have their registrations amended on or after June 28, 2006

The confidential test data are available for inspection after a final decision is made under the PCPA.

In the case of applications to register a new active ingredient, a major new use for a registered active ingredient or to amend a registered product, the supporting confidential test data are available after the certificate of registration is issued.

For re-evaluations or special reviews where the decision is to continue the registration, the supporting confidential test data are available for inspection after the publication of the proposed decision (for post-market reviews published as of January 1, 2022) or the final decision on the PMRA website. Following a post-market review decision where the final decision is the cancellation of a pest control product registration, the confidential test data will be available for inspection during the Notice of Objection period, and, where applicable, until the end of the phase-out period. 

c) Proposed or final decisions for post-market reviews

The confidential test data supporting a post-market review can also be inspected at the proposed decision stage for re-evaluations and special reviews published as of January 1, 2022 (or at the final decision stage, as noted in b), above).

3.0 Submitting an application to inspect confidential test data

Those wishing to inspect confidential test data must submit a completed Application to Inspect Confidential Data form (form 7000), along with a signed affidavit or statutory declaration.

3.1 Application form

The Application for the Inspection of Confidential Test Data form, or form 7000, is available upon request with the Pest Management Information Service.

3.2 Affidavit / statutory declaration

a) Requirements

In order to inspect confidential test data, the applicant must submit an affidavit made under oath, or a statutory declaration under the Canada Evidence Act.

The applicant should contact a commissioner for the taking of oaths or declarations, a notary public or someone legally authorized to administer an oath. A template of the affidavit and statutory declaration is available upon request with the Pest Management Information Service. The affidavit or statutory declaration must state:

If the affidavit or statutory declaration is completed outside Canada, it must be sworn or affirmed before a designated official of Canadian embassies, consulates, high commissions or trade commissions or before judicial officials in the foreign country who are authorized to administer, take or receive affidavits or solemn affirmations. A complete list of designated officials is listed in Section 52 of the Canada Evidence Act.

b) False statements in affidavits or statutory declarations

The making of a false statement in the affidavit or statutory declaration is an offence under subsection 43(9) of the PCPA. If found guilty of an offence, a person is liable:

Making a false statement in an affidavit or statutory declaration is also an offence under the Criminal Code of Canada.

c) Group/joint notice of objection submission

If there is a request related to a Notice of Objection where multiple members of the public intend to submit a joint objection, a complete Reading Room application (a form 7000, affidavit or statutory declaration and data inspection acknowledgement form) from each individual member who wishes to have access to the confidential test data will be required.

4.0 Processing the application

4.1 Review of application and affidavit / statutory declaration

Health Canada notifies the applicant when the application has been received and the processing has begun.

The application form is reviewed to ensure that all the required information has been provided, and that the requested confidential test data are available for inspection according to the criteria outlined in Section 2.0. If the data being requested do not meet the criteria, the applicant is informed that their application was not accepted and is provided with any applicable options for accessing or reviewing the requested data (i.e., outside the Reading Room process).

Health Canada also verifies that the contents of the affidavit or statutory declaration meet the requirements of the PCPA. An application may be denied for the following reasons:

  1. the Minister is satisfied that the person intends to use the confidential test data or make it available to others, in order to register a pesticide in Canada or elsewhere, or to amend a registration; or
  2. the Minister is satisfied that the person has used confidential test data obtained from a prior inspection for purposes described in 1.

4.2 Notice to pesticide registrant

After an application to inspect the confidential test data has been approved, Health Canada notifies the registrant who provided the data that someone has been given permission to inspect their confidential test data. The identity of the individual given permission to inspect the confidential test data is not disclosed; however, the registrant is notified of the individual's affiliation - as stated on the application form. This notification is not intended to delay the inspection or put the registrant in a position to consent or object.

4.3 Timelines

Health Canada places a higher priority on applications to inspect confidential test data associated with a recent major regulatory decision for which the 60-day reconsideration period is still open, as well as with proposed post-market decisions for which the consultation period is still open. Because the timeframe to submit a Notice of Objection is established by the PCPA and will not be extended, applicants who may wish to file such a notice should submit their application to inspect confidential test data well in advance of the close of the 60-day period. For more information on how to submit a Notice of Objection, consult the Public Engagement Portal.

All other applications for the inspection of confidential test data are processed on a first come, first served basis. To help ensure equal access and participation, Health Canada may limit the duration of the inspection or, in the case of in-person inspection, reschedule a visit if necessary.

For remote inspection (via secure USB keys), a 90-day timeframe applies for the inspection of confidential test data. Please note that extensions to the inspection duration may be considered on a case-by-case basis.

4.3.1 Requests relating to open consultations and reconsideration periods

a) Reading room requests related to open consultation periods

When a Reading Room request is made during an open consultation period, the requester must indicate if their intention to inspect the confidential test data is related to submitting comments pertaining to the proposed regulatory decision. An extension to the deadline to provide comments on the proposed decision may be granted to the requester, based on the length of time it takes the PMRA to provide the confidential test data to them. It is calculated from the date a complete Reading Room request has been received (complete Form 7000 and affidavit) to the date the confidential test data are provided to the requester.

b) Notice of Objection (NoO) 60-day reconsideration of decision period - granting supplementary time to submit supporting documentation

A Notice of Objection application must be filed before the end of the 60-day Reconsideration of Decision period. However, should the objector require additional time to inspect confidential test data through a Reading Room request to support their objection, they can request an extension to submit supporting scientific evidence or documentation. The extension period is based on the length of time it takes the PMRA to provide the confidential test data to the requester. It is calculated from the date a complete Reading Room request has been received (complete Form 7000 and affidavit) to the date the confidential test data are provided to the requester.

Where the Notice of Objection is filed jointly by several individuals, any supplemental review time will be based on the time it takes for the first requester to receive the requested confidential test data.

5.0 Inspecting confidential test data

5.1 Scheduling the inspection

Applications for the Reading Room process can be submitted by email to the PMRA's Pest Management Information Service. A complete application consists of an Application Form 7000 and a signed Affidavit or statutory declaration.

  1. If the applicant is unable to identify the documents they wish to inspect by title or number, they may request further assistance by sending an email to the PMRA's Pest Management Information Service.
  2. Documents must undergo a redaction process to remove CBI and personal information before they may be disclosed. Please be advised, this may create a delay in receiving the requested information. However, extensions may be granted, when appropriate (see Section 4.3).
  3. Once an application has been processed, Health Canada contacts the applicant by phone or email to schedule an inspection. The two options for inspecting the confidential test data are 1) an in-person inspection at the PMRA's National Head Office in Ottawa, Ontario, or 2) a remote and secure inspection of the confidential test data via encrypted USB keys.

5.2 In-person inspection

a) Requirements for building entry

A valid Canadian government-issued photo identification (e.g., driver's license) is required to enter into the building. The applicant's identity is confirmed against the previously submitted affidavit or statutory declaration.

b) Protection of data security and copy prevention

Health Canada must ensure that security concerns are considered and appropriate precautions are taken to prevent the misuse of confidential test data. To prevent copying of confidential test data, electronic devices such as cell phones, laptops and digital cameras are not permitted in the Reading Room. These items must be left with a Health Canada official for the duration of the visit. Be aware that visits are monitored.

c) Data format

The confidential test data are available in electronic format on a computer with disabled ports, in order to prevent the attachment of external copying devices. There is no access to the Internet or internal networks.

d) Note-taking

The right to inspect the confidential test data under section 43 of the PCPA does not include the right to make or obtain a copy of it. While photocopying of the confidential test data is not permitted, note-taking is allowed if the applicant provides consent on the application form to having the notes photocopied. At the end of the visit, the notes are photocopied by Health Canada and retained on file for compliance and administrative purposes.

5.3 Remote inspection

Confidential test data are saved and encrypted on a USB key and shared with the requester for inspection on their Windows System computer. The software encryption prevents copying, sharing, and printing features. Additional digital rights management measures include watermarking, document expiry, environmental controls, verification of document access, and password protection.

Following the steps outlined in section 5.1, the key steps for the virtual inspection process are:

  1. Once the inspection request has been processed and validated, the PMRA establishes a delivery date with the requester for the encrypted USB key, which is sent by courier.
  2. The requester then advises the PMRA of the encrypted USB key receipt and provides a signed Data Inspection Acknowledgement form to the PMRA. Once this form is received, the PMRA Reading Room administrator activates the encrypted USB key remotely for the requester, who can then start their inspection of the confidential test data.
  3. Upon completion of the data inspection, the requester must return the encrypted USB key to the PMRA, as agreed in the Data Inspection Acknowledgement form. On the expiry date (i.e., after 90 days), the encrypted USB key is deactivated and the documents will no longer be accessible.

6.0 Access to Information Act

The PCPA does not replace but complements the rights of Canadians to submit requests for information under the Access to Information Act (ATIA). Applicants may seek access under either or both legislation, each offering their own unique procedures, benefits and limitations.

Accessing information through the PCPA may enable applicants access to information that would not otherwise be available or disclosed through the ATIA. The ATIA requires that certain types of confidential commercial information be protected from disclosure when requested under this Act, subject to some exceptions. As a result, requests under the ATIA could result in disclosure of the same or less information than would be accessible through the PCPA, depending on the specific information and circumstances.

Obtaining access under section 43 of the PCPA does not create a right to make or obtain a copy of the confidential test data under the ATIA.

For more information

Please contact the PMRA's Pest Management Information Service.

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