PMRA Guidance Document, Guidance for the Pest Control Products Incident Reporting Regulations

Health Canada – Pest Management Regulatory Agency
14 April 2023

Table of contents

• Document history (revision/update)
• Disclaimer
• Introduction
• General
• Interpretation
• Classification of incidents (section 2 of the IRR)
• Prescribed information: What must be reported
• General requirements
• Reporting requirements
• Reporting time limits
• Annual summary
• Evaluation of incident reports
• Records
• Placement in the public registry
• Coming into force (section 19 of the IRR)
• Report forms
• Personal information
• Reference links for personal information
• Appendix I – Human and animal symptoms classified by severity
• Appendix II – Decision tree for the classification of incidents involving humans and animals
• Appendix III – Definitions of the animal and plant groups
• Appendix IV – Definition of terrestrial and aquatic plant symptoms
• Appendix V – Supplemental guidance related to incidents related to scientific studies
• Appendix VI – Frequently asked questions

Document history (revision/update)

Updated	Update/Rationale
April 2023	Revised to include clarifications
February 2022	Revised to include updated regulations
September 2007	Publication of original document

Disclaimer

This document does not constitute part of the Pest Control Products Act or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies.

Introduction

Pest control products (pesticides) are regulated in Canada under the federal Pest Control Products Act.

Under the Pest Control Products Act, a pesticide must be registered by the Minister of Health before it can be used in Canada. Health Canada's Pest Management Regulatory Agency (PMRA) administers the Pest Control Products Act on behalf of the Minister. A pesticide may not be registered or may not continue to be registered unless its health and environmental risks and its value have been determined to be acceptable by the Minister.

Although pesticides are tested and evaluated for safety before they are registered, some adverse effects may not become evident until the product is used under "real-life" circumstances. One of the provisions of the Pest Control Products Act (section 13) is the requirement for registrants, and applicants for the registration of a pesticide, to report incidents of adverse effects, or scientific studies indicating a potential new hazard or risk, that involve their pesticides. Requiring registrants to provide incident reports contributes to Health Canada's ongoing collection of safety information that occurs once products are registered.

Incident reports provide Health Canada with valuable information regarding potential risks to humans, animals, or the environment from the use of pesticides. If evaluation of this information identifies a safety issue, appropriate action will be taken. Such action could range from minor label changes to discontinuation of a product.

While the Pest Control Products Act provides Health Canada the authority to require mandatory reporting, the Pest Control Products Incident Reporting Regulations (IRR) specify the actual reporting requirements, including the types of information to be reported and the time frames for reporting the information. Under the IRR, registrants and applicants are required to report information concerning pesticide incidents that occur in Canada and the United States as well as new or increased effects that are identified in scientific studies.

Incidents include effects on humans, animals (including pets or wildlife) or plants (including both terrestrial and aquatic), and packaging failure that could result in human exposure or injury. An incident that results from an act or activity that would constitute an offence under the Criminal Code is not included under the IRR.

The following guidance document is intended to provide further explanation of some sections of the Regulations. It is not to be considered comprehensive. A copy of the Regulations can be obtained from the Department of Justice website.

General

The following is relevant to all IRR sections:

• An incident must be reported whether the suspected substance is the active ingredient, another component, or a derivative of the pest control product.
• The requirements prescribed in the IRR apply to registrants of pest control products and applicants for the registration of pest control products. In this guidance document, the term "registrant" will be used to indicate registrants and applicants unless otherwise noted.
• Reporting an incident under these Regulations does not exempt the responsibility of the registrant to report under other Acts or regulations.

Who is required to report incidents?

Registrants of pest control products and applicants for the registration of pest control products are required under section 13 of the Pest Control Products Act to report all prescribed information relating to pesticide incidents.

Foreign registrants

Foreign registrants must designate a representative who resides in Canada (subsection 62(2) of the Pest Control Products Act). The obligation to provide incident reports rests with the registrant; however, if the registrant chooses, they may provide incident reports through their representative instead. If the representative fails to properly carry out the registrant's obligations, any action taken by the Minister will be against the registrant, not against the representative.

Former registrants

If a registrant ceases for any reason to be the registrant of a particular pest control product, they must still provide incident reports for the period where they were responsible for the product.

Voluntary reporting

In addition to incident reports provided by registrants, Health Canada also receives reports from the general public via the Public Engagement Portal Voluntary Incident Reporting Form.

Interpretation

What is an incident (subsection 1(1) of the IRR)?

In the IRR, incident means an incident whose effects relate to the health or environmental risks or the value of a pest control product. If the substance alleged to be responsible for the incident is the end-use product, active ingredient, other component contained within the product or a derivative of the product, it is considered to be related to the health or environmental risks or the value of the pest control product. Registrants must report an incident if it meets the conditions of one or more of the categories described in section 2 of the IRR and it involved their pest control product. The incident categories are:

• effects on humans, animals, terrestrial or aquatic plants:
• packaging failure that could result in human exposure or injury;
• scientific studies that suggest an increased risk;
• identification of a new hazard, risk, or undetected component or derivative identified in a pest control product.

What is excluded under the definition of "incident"?

For the purposes of the IRR, an incident does not include one that results from:

1. an act or activity that constitutes an offence under the Criminal Code; or
2. the exposure of a targeted organism of a pest control product that is manufactured for the purpose of controlling such an organism (for example, if the label of a broad-spectrum herbicide warns that direct application will result in injury to desirable vegetation, such injury is not considered an incident).

What is an incident report (subsection 1(1) of the IRR)?

An incident report is a report that contains the information a registrant must provide regarding an adverse event associated with a pest control product. Under section 13 of the Pest Control Products Act, the Minister can direct the form and manner for reporting incidents. Consequently, registrants must use the PMRA incident reporting forms when providing an incident to Health Canada. In addition, the report must be provided electronically. Guidance on how to complete the reporting forms is provided on the Canada.ca website on the registrant portal.

Are registrants required to investigate the information that they receive (subsection 1(2) of the IRR)?

When registrants report incidents to Health Canada, they are not required to prove or substantiate the information. They are required to accurately complete the mandatory reporting forms based on the information provided to them. Relevant supplemental information such as opinion or commentary, can also be provided. While registrants may not be required to investigate the information they receive, they are obligated to provide additional information in situations where an active ingredient is implicated in multiple incident reports (see below).

What is an annual summary (section 15 of the IRR)?

An annual summary is a critical analysis of all incident data pertaining to a single active ingredient in a year. Annual summaries are required if, over the course of a calendar year, a single active ingredient is implicated in at least 10 incidents in the same organism of exposure (for example, 10 in humans or 10 in plants, but not in 5 of each) have occurred.

Classification of incidents (section 2 of the IRR)

Incident categories (paragraphs 2(a) through 2(h) of the IRR)

Registrants are required to classify incidents using the categories listed below, based on the organism and effects of the exposure to the pest control product. Health Canada then evaluates the report using the criteria outlined in the Evaluation of Incidents Reports section and in the appendices of this guidance document.

Classification categories for incidents occurring in Canada are:

1. an incident whose effect is a human death;
2. an incident that has a major effect on a human, namely, that a human had or has symptoms that indicate a condition that could be life-threatening or result in adverse reproductive or developmental effects, neurotoxicity or in chronic disability;
3. an incident that has an effect on a human other than the effects set out in paragraph (a) or (b);
4. an incident whose effect is an animal death or, if the incident occurs in the United States, a domestic animal death;
5. an incident that has an effect on an animal other than death;
6. an incident that has an effect on terrestrial or aquatic plants;
7. an incident of package failure that could result in the exposure of a human to a pest control product or in injury to a human; and
8. an incident whose effects are identified in a scientific study, namely, that the effects are observed during a human epidemiological study or a scientific investigation, whether concluded, discontinued or ongoing, and the study or investigation is sponsored by the registrant or applicant and indicates:
   1. any new health or environmental hazard associated with a pest control product,
   2. any health or environmental risk associated with a pest control product that may be greater than the risk determined at the time of registration, or
   3. the presence of a previously undetected component or derivative of a pest control product.

Classification categories for incidents occurring in the United States are:

1. an incident whose effect is a human death;
2. an incident that has a major effect on a human;
3. an incident whose effect is a domestic animal death.

Guidance for incidents affecting human health (paragraphs 2(a), (b) and (c) of the IRR)

Registrants must report any incident resulting in an adverse effect to human health. Health Canada will classify each incident using the criteria included in the appendices of this document. Registrants are required to provide a degree of severity only when the effects are severe, meaning a human incident that results in death, or that is classifiable as "major" (i.e., could be life-threatening, results in adverse reproductive or developmental effects, neurotoxicity or results in chronic disability).

Definitions of "medical treatment" and "hospitalization"

For the purpose of the IRR and to ensure clarity in reporting, "medical treatment" includes any medical intervention, whether it is medication or physical treatment, prescribed or provided by a medical professional. It can include prescription medication, over the counter medication, physiotherapy, etc. If a person visits a medical professional, such as a physician or a nurse, but does not receive any form of medical intervention, they would not be considered to have received medical treatment. Similarly, a person is considered to be hospitalized by Health Canada if they have been admitted to a hospital as an inpatient. Treatment at a hospital as an outpatient is not considered hospitalization by Health Canada.

Guidance for incidents affecting animals (paragraphs 2(d) and (e) of the IRR)

Registrants must report incidents resulting in an adverse effect to animals. For incidents occurring in Canada, any incidents that result in an adverse effect to a wild animal or any animal under the care and control of humans (domestic animal) must be reported. For incidents occurring in the United States, only incidents affecting animals under the care and control of humans must be reported. For wild animals, it may not be possible to include any details other than death; however, the reporting of as many details as possible is encouraged including, but not limited to pesticide application information, other symptoms observed, and the number of animals affected.

Death (euthanasia)

If an animal is euthanized as an outcome of the incident, the incident would not be classified as subparagraph 2(d) "animal death". Instead, its classification would be based on the severity and duration of the symptoms and requirement of medical treatment as discussed above. "Euthanized" would be indicated as the outcome on the incident report.

Guidance for incidents affecting terrestrial or aquatic plants (paragraph 2(f) of the IRR)

Registrants are required to report any incident resulting in an adverse effect to terrestrial or aquatic plants. Registrants are encouraged to report as many details as possible including, but not limited to, the area affected, the symptoms observed and temporal and spatial factors such as distance from treated areas, spray buffer zones observed, etc. Incidents relating to terrestrial or aquatic plants refer to non-target organisms only. Effects on plants that were the target of the pesticide application are not required to be reported; for example, if the label of a broad-spectrum herbicide warns that direct application will result in injury to desirable vegetation, such injury is not considered an incident.

Refer to Appendix IV for information relating to the classification of plant groups.

Guidance for incidents related to packaging failure (paragraph 2(g) of the IRR)

Registrants are required to report incidents where the packaging fails to contain the product and that failure may lead to human exposure or injury. This is limited to incidents of packaging failure that occur during the normal use and storage of the product. Examples of packaging failure that are reportable include water soluble packaging degrading before being added to the tank or a container that explodes during proper storage. Incidents of packaging failure that occur in situations outside of the normal storage and use of a product, such as a case of product falling off a truck during loading or a cracked product package resulting from a drop during normal transport or use, are not required. The latter types of reports may still be reportable under the IRR if adverse health effects were experienced by the individual as a result of product exposure (human incident) or if there were adverse environmental effects (environment incident) due to a spill.

Guidance for incidents related to scientific studies (paragraph 3(2) and Section 9 of the IRR)

Under paragraph 2(h), registrants must provide a scientific study they have sponsored if it indicates either a new health or environmental hazard, increased health or environmental risk or the presence of a component or derivative that has not been previously detected. In addition to concluded studies, this requirement also includes studies that are ongoing or discontinued before completion if they indicate an adverse effect.

For the purpose of these Regulations, "sponsored" means that the registrant contributed to the research, whether the contribution was financial or an "in kind" contribution. In some way, the registrant contributed to the research.

Prescribed information: What must be reported

What is "prescribed information" (section 3 of the IRR)?

According to section 13 of the Pest Control Products Act, registrants must report any prescribed information they receive as listed in section 3 of the Regulations. This prescribed information is also the basis of the questions on the mandatory Incident Report form. The form is dynamic and will provide prompts for the specific information required for each category and condition.

Prescribed Information

The following information that is received by a registrant or an applicant about an incident that is associated with their pest control product, or with any pest control product that has the same active ingredient, and that is required by sections 7, 8 and 16, is prescribed information for the purpose of section 13 of the Act:

1. contact information for the registrant or applicant;
2. the date on which the incident occurred;
3. the date on which the registrant or applicant received the information about the incident;
4. the city, province or state, and country where the incident occurred;
5. the identification of the pest control product;
6. information about the application of the pest control product, including the site, method and date of its application;
7. the category of the incident, determined in accordance with section 2 (of the Pest Control Products Act);
8. information about the circumstances of the exposure to the pest control product, including the site, date, route of exposure, weather conditions, duration and affected subject information, which, in the case of a human subject, is restricted to age, gender and whether the subject is pregnant;
9. information about the incident and its effects, including the symptoms, duration and outcome; and
10. scientific test information, including information about the sample, the method of analysis and the results.

Additionally, the following information about an incident that is associated with the registrant's or applicant's pest control product, or with any pest control product that has the same active ingredient, and that is required by section 9, is prescribed information for the purpose of section 13 of the Act:

1. contact information for the registrant or applicant;
2. the title and date of the study and the name of the author;
3. the identification of the pest control product;
4. the category of the incident, determined in accordance with section 2 of the Act;
5. the scientific study and the test data generated during the study; and
6. the type of scientific study, an indication of which of subparagraphs 2(f)(i) to (iii) is the reason for submission, and the information the study reveals about the incident and its effects.

Questions on the Incident Report form that are not "prescribed information"

There are two questions on the form that are not aimed at collecting prescribed information. These questions provide registrants an opportunity to include their own opinion about the incident. Registrants are not required to answer these questions, but any information provided will be posted on the electronic public registry. The questions are:

1. "In your opinion, was the product used according to the label instructions?" and
2. "Provide supplemental information here." See What is considered "supplemental information" (subsection 18(1) of the IRR)?.

What are "test data" (Paragraph 3(2)(e) of the IRR)?

In paragraph 3(2)(e) "test data generated" include methodology, results (including raw data) and any discussion/conclusions.

What is the minimum amount of information in order for an incident to be reportable?

All the information described in section 3 of the IRR or on the reporting forms, is prescribed information. However, two elements of prescribed information are required in order for an incident to be reportable to Health Canada: 1) the identification of the pest control product; and 2) information about the incident and its effects (paragraphs 3(1)(e) and (i), and 3(2)(c) and (e)). Identification of the pest control product could be the end-use product or active ingredient. Any additional prescribed information the registrant receives must also be reported.

What are registrants required to do with prescribed information they receive after an incident has been sent to Health Canada?

Any additional information the registrant receives after the incident report has been sent to Health Canada and that is considered prescribed according to section 3 of the IRR must be provided to Health Canada. The time frame for providing this information is based on the severity category of the report in the case of death or major effects, or the timelines outlined in the IRR. If the additional information results in a change in severity category, it should be provided in the time frame based on the new category. For example, if a report classified as a Canadian human major was provided to Health Canada, after which, the registrant received information that the person had died, that new information would need to be provided to Health Canada within the time limit for Canadian human death (15 days).

General requirements

What is a "related corporation" (paragraph 4(1)(b) of the IRR)?

In addition to information received by a registrant, information received by a related corporation, regardless of where the related corporation is located, must also be provided to Health Canada by the registrant within the appropriate time limit. Health Canada defines "related corporation" using the definition of "related persons" in subsection 251(2) of the Income Tax Act:251 (2) For the purpose of [the Income Tax Act], "related persons", or persons related to each other, are

1. individuals connected by blood relationship, marriage or common-law partnership or adoption;
2. a corporation and
   • a person who controls the corporation, if it is controlled by one person,
   • a person who is a member of a related group that controls the corporation, or
   • any person related to a person described in subparagraph 251(2)(b)(i) or 251(2)(b)(ii); and
3. any two corporations
   • if they are controlled by the same person or group of persons,
   • if each of the corporations is controlled by one person and the person who controls one of the corporations is related to the person who controls the other corporation,
   • if one of the corporations is controlled by one person and that person is related to any member of a related group that controls the other corporation,
   • if one of the corporations is controlled by one person and that person is related to each member of an unrelated group that controls the other corporation,
   • if any member of a related group that controls one of the corporations is related to each member of an unrelated group that controls the other corporation, or
   • if each member of an unrelated group that controls one of the corporations is related to at least one member of an unrelated group that controls the other corporation.

Language of reports (subsections 6(1) and 6(2) of the IRR)

Incident reports must be filed in English or in French. If translation of a scientific study cannot be completed within the reporting time limit, the registrant must provide a summary of the document in English or in French within the prescribed timeframe for providing the incident report. The summary should be attached to the mandatory reporting form and must not be longer than one page. The completed translated study must be provided as soon as feasible after the incident report.

Reporting requirements

General reporting requirements (sections 7, 8 and 9 of the IRR)

Registrants are required to provide a report of any prescribed information they receive. They are not to alter or omit any of the prescribed information they have received when they report the incident to Health Canada. Registrants are not required to substantiate or investigate the incident (subsection 1(2)).

Incidents that occur in the United States (section 8 of the IRR)

Registrants are required to provide reports of incidents that occurred in the United States if the pesticide alleged to be responsible is related to one of their Canadian products and the incident was human death, a major effect in a human or a domestic animal death. A product from the United States would be considered related to a Canadian product if it contained the same active ingredient. The formulation, including co-formulation with other active ingredients, use pattern or pest species do not need to be the same.

Reporting time limits

General

The time limits provided are the maximum amount of time in which a registrant must provide an incident report to Health Canada. Incident reports, particularly for the more serious effects, should be provided as soon as possible within the time limit. Incidents that occur in the United States can be provided to Health Canada according to the United States Environmental Protection Agency time limits as specified in section 6(a)(2) of the American Federal Insecticide, Fungicide, and Rodenticide Act.

15 Days (section 10 of the IRR)

If a registrant or applicant receives information about an incident listed under section 10 of the IRR, the registrant or applicant must send a report to Health Canada within 15 days. These include:

• an incident whose effect is a human death (section 2(a) of the IRR)
• an incident that has a major effect on a human (section 2(b) of the IRR)

30 Days (section 11 of the IRR)

If a registrant or applicant receives information about an incident listed under section 11 of the IRR, the registrant or applicant must send a report to Health Canada within 30 days. This includes:

• any incident whose effects are identified in a scientific study (section 2(h) of the IRR)

Exception for scientific studies (subsection 4(2) of the IRR)

If an employee or agent of a related corporation receives information, the registrant is given an additional year to report that information. For example, a study received by an employee or agent of a related corporation in May 2007 must be submitted to the PMRA by the registrant before the end of June, 2008.

90 Days (section 11.1 of the IRR)

If a registrant or applicant receives information about an incident listed under section 11.1 of the IRR, the registrant or applicant must send a report to Health Canada within 90 days. These are:

• Incidents in Canada whose effect is an animal death (section 2(d) of the IRR)

Quarterly reports: 3 months accumulation, 2 months to report (section 12 of the IRR)

All incidents listed under section 12 of the IRR that are received by the registrant are to be accumulated in a three-month period (reporting period) and sent to Health Canada before the end of the second month following the reporting period (filing date). The time frame for the reporting periods and filing dates are specified in the table below.

This includes:

• an incident that occurs in the United States and whose effect is a domestic animal death;
• an incident that has an effect on a human other than major effects or death;
• an incident that has an effect on an animal other than death;
• an incident that has an effect on terrestrial or aquatic plants; and
• an incident of package failure that could result in the exposure of a human to a pest control product or in injury to a human.

Reporting period	Filing date
January 1 to March 31	May 31
April 1 to June 30	August 31
July 1 to September 30	November 30
October 1 to December 31	February 28, or February 29 in the case of a leap year

Date to file annual summary (sections 15(3) of the IRR)

The date on which an annual summary is to be provided is by March 31 of the year that follows the year during which the registrant receives information about the incidents.

Registrants must provide their annual summaries by March 31 of the next calendar year. For example, any annual summaries for incidents that took place in the 2022 calendar year must be provided by 31 March 2023.

Annual summary

Under what conditions is an annual summary required (subsection 15(1) of the IRR)?

Registrants are required to provide an annual summary for each active ingredient for which they have received 10 or more reports of incidents that relate to the same type of organism of exposure (human, animal or one set out in paragraphs 2(f) to (h)) within that reporting period.

What should be included in the annual summary (subsection 15(2) of the IRR)?

Registrants must provide two parts for the annual summary; the number of incidents reported and their corresponding category within that reporting period, including American incidents, and a concise critical analysis of the incidents associated with their pest control products. Below is an example of a format that could be used to indicate the number of incidents reported in a given year.

Active Ingredient	Product Name	Number of Incidents per Category From January 1, 2022 to December 31, 2022
		Human			Animal		Plant	Other		Total per active
		Death	Major	Other	Death	Other	Any	Study	Pack. Failure
Active Ingredient A	Product A	3	1	-	-	-	-	-	-	-
	Product B	-	-	11	1	2	-	-	-	-
	Total	3	1	11	1	2	-	-	-	18
Active Ingredient B	Product not known	2	5	-	-	-	1	1	5	-
	Product D	1	-	-	-	-	-	-	-	-
	Product E	2	-	-	-	-	-	-	-	-
	Total	5	5	-	-	-	1	1	5	17

For the critical analysis, the registrant should provide:

1. a comparison with the number of incidents reported for that active ingredient in previous years and possible explanations for any differences observed;
2. an explanation of any new or increased risks that have been observed including possible reasons for the occurrence of the incidents and probability of re-occurrence;
3. a list of possible methods to mitigate the new or increased risks, and a discussion of the potential effectiveness and feasibility of each mitigation strategy. Include an implementation plan for the selected mitigation strategy. Examples of mitigation strategies are: adding chemical resistant gloves to the label, change in packaging, increase buffer zone, add a pre-harvest interval, etc.; and
4. a list of Health Canada incident report numbers for each incident referenced in the annual summary.

Date to file annual summary

Registrants must provide their annual summaries by March 31 of the next calendar year. For example, any annual summaries for incidents that took place in the 2022 calendar year must be provided by March 31, 2023.

Evaluation of incident reports

How does Health Canada evaluate an incident involving humans and animals?

Health Canada evaluates incident reports through an internal review. The severity of the incident (whether the effects are minor, moderate or major) is determined using the criteria listed in Appendices I, II, III, IV, V and VI.

The type of symptoms, duration of the symptoms, and any required medical treatment are considered by Health Canada in the classification of incidents. If an incident meets the criteria for more than one category, classification is based on the most severe of the categories. For example, if two of the symptoms for the incident are minor and the third symptom is major, the incident would be classified as major.

A list of symptoms categorized by severity is provided in Appendix I. This list was developed to classify the severity of incidents.

The criteria listed below are used as a guide by Health Canada to determine the severity level of a reported human or animal incident. Other factors, such as the intensity of the symptom and the presence of other symptoms will also be considered when classifying the incident. A decision tree for the criteria is provided in Appendix II.

Minor classification

Minor incident: minimally bothersome symptoms that normally resolve rapidly, such as skin rash, itching, drowsiness, headache, restlessness or diarrhea. Typically, the symptoms resolve without treatment. A human or animal incident is categorized as minor if all of the following criteria are met:

1. the symptom is categorized as minor (see Appendix I);
2. professional medical treatment was not provided; and
3. the symptom lasted for less than 1 month.

Moderate classification

Moderate incident: symptoms that are more pronounced, more prolonged or of a more systemic nature than minimally bothersome symptoms, and for which some form of treatment is usually required, although the symptoms do not indicate a life-threatening condition and the person or animal is likely to return to their pre-exposure state of health without any chronic disability. A human or animal incident is categorized as moderate if any of the following criteria are met:

1. the symptom is categorized as moderate (see Appendix I);
2. if hospitalized, stay was 72 hours or less; or
3. the symptom lasted for less than 6 months.

Major classification

Major incident: symptoms that indicate a condition that could be life-threatening or result in adverse systemic effects (for example, reproductive or developmental effects, neurotoxicity) or in chronic disability. This level of effect commonly involves hospitalization and might include the need for continued health care and limitations or modification of normal activities. The person or animal may sustain permanent functional impairment. A human or animal incident is categorized as major if any of the following criteria are met:

1. the symptom is categorized as major (see Appendix I);
2. hospitalization stay was greater than 72 hours; or
3. the symptom lasted for 6 months or more.

How are incident reports used by Health Canada?

In general, the information reported by registrants, as well as voluntary incident reports provided by stakeholders, are used to:

• provide an early alert mechanism for health and environmental risks that require investigation and possible corrective action;
• provide post-registration information for prioritizing re-evaluations;
• initiate a special review if there are reasonable grounds to believe that health or environmental risks of a registered pest control product, are unacceptable (under subsection 17(1) of Pest Control Products Act).
• help validate and, when necessary, improve the Health Canada pesticide registration process;
• identify trends, for example, types of pesticides and populations involved, and recommend further investigations and/or corrective action;
• make recommendations to improve agricultural practices (protective clothing, application practices, etc.), as well as improve practices relating to pest control products used in and around residential areas such as homes;
• develop prevention and education programs in collaboration with users and industry;
• improve the quality of product labels; and
• provide information to medical or toxicovigilance communities and the public.

How are potential health and environmental risks associated with incident reports detected and evaluated?

Health Canada uses trend analysis to identify potential health and environmental risks associated with pesticides. Analysis of incident reports considers the number of incidents reported for a pesticide, particularly in relation to the amount of pesticide sold, as well as the nature of exposures reported in incidents.

If a potential risk is identified, Health Canada evaluates the information provided in the incident reports in conjunction with other relevant information that is available in the public domain (for example, incident databases in other jurisdictions, scientific literature) or the Health Canada database (for example, toxicology or exposure data). If evaluation of this information identifies a safety issue, appropriate action is taken. Such action could range from minor label changes to discontinuation of the product. Caution is exercised in evaluating incident reports since the information accompanying them may be incomplete and unsubstantiated.

The following criteria are used to evaluate potential health or environmental risk relating to incident reports:

• the plausibility of the effect based on the properties/toxicity of the pest control product;
• repetition of the effects;
• the severity of the incident;
• relevance of the concern in relation to the registered use pattern of the product;
• whether the information has been considered in a previous Health Canada evaluation; and
• whether the information indicates that the health or environmental risks or value of the product may no longer be acceptable.

Records

What information must registrants keep for 6 years and provide to Health Canada on request (section 17 of the IRR)?

The registrant must keep a record of every incident report and any information they have that relates to or is in connection with that report for 6 years. Information that the registrant may collect and that is not included in the report but that relates to the report could include: contact information of caller, contact information of the affected subject (if not the caller), etc.

Placement in the public registry

What will be posted in the electronic public registry and when (subsections 18(1) and (2) of the IRR)?

All incident reports that relate to registered pest control products, including supplemental information received from the registrant, will be placed in the Register and, subsequently, on the electronic public registry (Canada.ca). The only information that will not be placed in the electronic public registry is personal information as defined by the Privacy Act, confidential test data, and confidential business information. All confidential test data and confidential business information should be provided in an attachment to the report, not in the body of the incident report itself. Attachments will not be posted on the electronic public registry.

To protect privacy, the data fields identifying the city and province for human incidents and the names of authors of scientific studies will not be placed on the electronic public registry. In addition, although we strongly advise registrants not to provide any unrequested personal information, in the event it should occur, it will not be posted.

The electronic public registry provides clear guidance on how to use the information provided in incident reports. It explains that incidents are only potential or suspected associations and that these allegations have not been substantiated or verified.

What are considered "reports that relate to registered pest control products"?

In addition to registrants, applicants for the registration of pest control products are also required to report incidents that relate to their products. As such, Health Canada may receive incident reports involving active ingredients that are under review at Health Canada for registration but are not yet registered. Most likely, these would be incidents that occurred if the product was registered for some time in the United States, during research, or in a scientific study. However, as stated in the Regulations, only incident reports that relate to a registered product in Canada will be posted on the electronic public registry. If the active ingredient involved in the incident is not registered in Canada, the report will not be posted. If the active ingredient is registered, the report will be posted, even if the end-use product involved in the incident is not registered.

It is the applicant's responsibility to indicate if the active ingredient is not registered in Canada, by providing the submission number of their application on the Incident Report form (Subform I: General Information, question 7a). If a submission number is not provided, Health Canada will assume the active ingredient is registered in Canada and will post the report.

What is considered "supplemental information" (subsection 18(1) of the IRR)?

Subsection 18(1) of the IRR states that Health Canada will post in the Register "supplemental information in support of the report that is volunteered by the registrant or applicant, such as any relevant opinion or commentary." Supplemental information is any information the registrant considers relevant and that explains the circumstances or interprets the significance of the incident report.

Supplemental information can be included on the incident report form where indicated. It is within this space that registrants can describe why the pesticide was or was not the likely cause of the reported incident.

Confidential test data and confidential business information

Information that is either confidential business information or confidential test data, as defined in the Pest Control Products Act, will not be placed in the electronic public registry. Confidential test data will be available to the public in reading rooms upon request in accordance with section 43 of the Pest Control Products Act whereas confidential business information will not be available to the public.

Since the incident report will be published on the public registry, confidential business information and confidential test data should be provided in an attachment to the report and not in the report itself. It is the responsibility of the registrant to identify confidential business information. Attachments will not be posted on the public registry.

Coming into force (section 19 of the IRR)

These amended Regulations come into force January 1, 2022. Incident information that is received by regulated parties before the amended Regulations come into force will continue to be subject to the categorization and reporting timelines of the previous version of the IRR. Any regulated party mid-way into their annual reporting cycle when the amendments come into force will be required to submit any incident reports that they would have submitted annually by the prescribed date of 28 February 2022; and by 31 March 2022 for annual summaries.

Report forms

What format must registrants use to provide incident reports?

Registrants must use the Incident Report form supplied by Health Canada when providing an incident report. The form is available on the Mandatory Incident Reporting web page. See the 'User Guide for Incident Report Form' for instructions on how to complete this form.

Electronic reporting

Registrants may provide incident reports to Health Canada electronically through the Electronic Pesticide Regulatory System Secure Web Portal. Health Canada will accept emailed incident reports, noting that it is not considered a secure method.

Registrants may also provide incident reports by physical mail; however, this is not preferred.

Providing reports

Reports should be provided to Health Canada by an officer or employee of the registrant who is duly authorized to do so.

For purposes of the IRR:

• "officer" means a person who serves in the registrant's or applicant's organization in an executive capacity, such as a President or Chief Executive Officer; and
• "employee" means a person, other than an "officer", who serves in the registrant's or applicant's organization.

In addition, "agent" means a person who is not an "officer" or "employee" of the registrant or applicant but is authorized by the registrant or applicant to receive information that the registrant or applicant is required to report in accordance with regulations. Agents should not be providing incident reports to Health Canada directly.

Personal information

What is personal information?

According to the Privacy Act, personal information is any recorded information that could identify an individual (for example, race, religion, age, education, social insurance number (SIN), etc.).

What personal information is prescribed?

Personal information requested on the reporting forms has been limited to city and province (for human incidents) and name of the author of a scientific study. City and province are not considered personal information on their own but, if combined with external sources such as a newspaper article, could be used to identify the individual. Other than this prescribed information, registrants are NOT to provide any other personal information on the reporting forms. This includes the name of a veterinarian or medical doctor that examined the person/animal, name of the owner of the animal, name of person affected, name of person reporting the incident, etc.

What are the statutes that cover personal information?

There are three statutes that regulate the use of personal information: Privacy Act, Personal Information Protection and Electronic Documents Act and Access to Information Act.

Reference links for personal information

• Privacy Act
• Personal Information Protection and Electronic Documents Act (PIPEDA)
• PIPEDA Regulations Specifying Publicly Available Information
• Your Privacy Responsibilities: A Guide for Businesses and Organizations

Appendix I – Human and animal symptoms classified by severity

The symptoms listed in this appendix are used by Health Canada as part of the internal classification of each incident; along with the definitions listed below, they should be referred to by registrants to determine what human incidents would be classified as human Major.

The animal symptoms listed below are primarily used for incidents relating to animals under the care and control of humans.

Definition of symptoms

Major symptoms are those of major severity that indicate a condition that could be life-threatening or result in adverse systemic effects.

Moderate symptoms are those considered to be of moderate severity that are more pronounced, more prolonged or of a more systemic nature than minimally bothersome symptoms, and for which some form of treatment is usually required. However, if any of them are life-threatening or result in chronic disability (for example, if blurred vision or blindness was chronic rather than temporary), they would be classified as major.

Minor symptoms are those considered to be of minor severity that are minimally bothersome and normally resolve rapidly; however, if any of them require medical treatment or do not resolve rapidly, they would be classified as moderate or major depending on the treatment required or duration of the condition.

Source:

1. the United States Environmental Protection Agency "Recognition and Management of Pesticide Poisonings",
2. NIOSH Characteristic Signs and Symptoms for Several Pesticide Active Ingredients and Classes of Pesticides,
3. The United States Environmental Protection Agency list of symptoms from reported 6(a)2 incidents,
4. symptoms reported to the California Environmental Protection Agency Pesticide Illness Surveillance Program between 1992 and 2004, or
5. pesticide incident data in animals collected by the American Society for the Prevention of Cruelty to Animals Animal Poison Control Center in 2004.

Appendix II – Decision tree for the classification of incidents involving humans and animals

Appendix II - Text description

The image is a flow chart showing how a registrant or applicant may classify incidents involving humans and animals. Certain types of incidents must be classified by the registrant/applicant, as described below.

Note that if there are multiple symptoms for an adverse effect, the classification of the adverse effect should be based on the most severe symptoms.

The registrant receives information from the reporter. If the adverse effect was fatal, the incident is classified as "Death". For incidents affecting wild animals, it is understood that the only observable symptom may be death.

If the most severe symptom is considered a major symptom as defined in Appendix I, a hospital stay, if required, lasted more than 72 hours, or the symptom(s) lasted for more than 6 months, the registrant or applicant is required to classify the incident as "Major" in their incident report to Health Canada.

If the most severe symptom is considered a moderate symptom as defined in Appendix I, a hospital stay, if required, lasted less than 72 hours, or the symptom(s) lasted for less than 6 months, the incident is considered "Moderate". A registrant or applicant is not required to classify this type of incident in their incident report to Health Canada.

For non-fatal effects, if the most severe symptom is considered a minor symptom as defined in Appendix I, no professional medical treatment was provided, and the symptom(s) lasted for less than 1 month, the incident is considered "Minor". A registrant or applicant is not required to classify this type of incident in their incident report to Health Canada.

Appendix III – Definitions of the animal and plant groups

This table is used by Health Canada as part of the internal evaluation of incident reports to determine the species group(s) that were potentially affected.

GroupFootnote *	Definition	Examples
Predatory bird	Carnivorous bird of the orders Falconiformes and Strigiformes which feed on meat taken by hunting.	hawks, owls
Birds that flock	A group of birds that live, travel or feed together.	geese, ducks
Songbirds	A bird belonging to the suborder Oscines of Passeriformes, in which the vocal organ is developed in such a way as to produce various sound notes.	finches, swallows
Beneficial insect	Any pest, predator or parasite which functions naturally or as part of an integrated pest management program to control another pest.	parasitic wasp, lacewing
Amphibians	A cold-blooded, smooth-skinned vertebrate of the class Amphibia, that characteristically hatches as an aquatic larva with gills. The larva then transforms into an adult having air-breathing lungs.	frogs, salamanders
Small mammals	Warm-blooded vertebrates (placentals, marsupials, or monotremes) of the class Mammalia characterized by a covering of hair on the skin and, in the female, milk-producing mammary glands for nourishing the young.	bats, mice
Large mammals	Warm-blooded vertebrates (placentals, marsupials, or monotremes) of the class Mammalia characterized by a covering of hair on the skin and, in the female, milk-producing mammary glands for nourishing the young.	fox, deer
Reptiles	Cold-blooded, usually egg-laying vertebrates of the class Reptilia, having an external covering of scales or horny plates and breathing by means of lungs.	snakes, turtles, lizard
Schooling fish	A group of fish that swim together, usually composed of the same species or sub-species.	juvenile fish, salmon during breeding season, carp, threadfin shad
Non-schooling fish	Fish that typically do not swim in large numbers.	pike, bass
Large aquatic invertebrates	An animal that has no spinal column, a non-vertebrate animal, and that lives in the water.	lobster, mussel, crayfish
Trees and shrubs	Tree - a large, perennial, woody plant. Shrub - is a horticultural rather than strictly botanical category of woody plant, distinguished from a tree by its multiple stems and lower height, usually less than 6 m tall.	apple tree, oak tree, lilac bush
Herbaceous plant	Any annual or perennial plant with a non-woody stem that dies back to the roots in the winter, and includes turf.	lupine, wildflowers, grasses, strawberries
Aquatic plants	A plant that grows partly or wholly in water whether rooted in the mud, as a lotus, or floating without anchorage, as the water hyacinth.	water lilies, bullrushes
Domestic Animals	Animals under the care and control of humans	Farm animals, pets, farmed fish
Footnote * For the purposes of this guidance document, the plant and animal groups do not include any plants or animals that were the intended target of the pesticide application. Return to footnote * referrer

Appendix IV – Definition of terrestrial and aquatic plant symptoms

PMRA reviews incidents involving terrestrial and aquatic plants to determine pesticide have impacted non-target terrestrial and aquatic plants in the environment. The following non-exhaustive list of symptoms should be reported if observed. Only Incidents referring to non-target plants are assessed. Effects on plants which were the target of the pesticide application are not required to be reported.

Terrestrial and Aquatic Plant Symptoms

• Abnormal abscission
• Abnormal flower quality or number
• Abnormal leaf discolouration
• Abnormal plant stance
• Death
• Deformities
• Visual injury (chlorosis, necrosis, leaching)
• Epinasty
• Reduced emergence
• Reduction in seed or fruit yield
• Stunted vegetative growth
• Terminal bud death
• Other

Appendix V – Supplemental guidance related to incidents related to scientific studies

PMRA interprets paragraph 2(h) of the IRR as being in effect under the following conditions:

1. A new health or environmental hazard or increased risk is relative to what had been determined at the time of registration or the last re-evaluation.
   1. Studies should be provided if toxicological effects occur:
      • at a higher incidence or frequency
      • at a lower dosage
      • after a shorter exposure period
      • after a shorter latency period
      • in a different organ or tissue of the test organism
      • in a different species, strain, sex, or generation of test organism
      • by a different route of exposure
   2. It also includes:
      • an exposure monitoring study that indicates higher levels of risk or exposure than would be expected based on previously available reports, data, or exposure estimates
      • a study indicating a previously undetected toxicological end-point such as a neurotoxic effect or positive response in genotoxicity assay
      • a study indicating the concentration of the pesticide, or any of its components or derivatives in food exceeds the maximum residue limit
   3. Environmental studies of the toxicity of a pesticide to terrestrial or aquatic wildlife or plants should be provided if, relative to all previously provided studies, they show an adverse effect under any of the following conditions:
      • At levels 50 percent or more lower than previous acute toxicity studies with similar species, including determinations of the median lethal dose (LD50), median lethal concentration (LC50), or median effective concentration (EC50).
      • At lower levels in a chronic study than previous studies with similar species.
      • In a study with a previously untested species the results indicate the chronic no observed effect level (NOEL) is 10 percent or less of the lowest LC50 or LD50 for a similar species.
      • For plants when tested at the maximum label application rate or less, if:
        1. More than 25 percent of terrestrial plants show adverse effects on plant life cycle functions and growth such as germination, emergence, plant vigour, reproduction and yields.
        2. More than 50 percent of aquatic plants show adverse effects on plant life cycle functions and growth such as germination, emergence, plant vigour, reproduction and yields.
2. Subparagraph 2(h)(iii) is not limited to detection of a new component or derivative but also includes presence of a component or derivative at a level higher than that determined at the time of registration.

Incomplete studies

Information from an incomplete study of the toxicity to any organism of a registered pesticide product or any of its ingredients, impurities, metabolites, or degradation products, which would otherwise be reportable should be submitted if the information meets any one of the following three sets of criteria:

1. Short-term studies. A study using a test regimen lasting 90 calendar days or less, and all of the following conditions are met:
   • All testing has been completed.
   • A preliminary data analysis or gross pathological analysis has been conducted.
   • Final analysis has not been completed.
   • A reasonable period for completion of the final analysis not longer than 90 calendar days following completion of testing has elapsed.
   • Comparable information concerning the results of a completed study would be reportable.
2. Long-term studies. A study using a test regimen lasting more than 90 calendar days, and all of the following conditions are met:
   • All testing has been completed.
   • A preliminary data analysis or gross pathological analysis has been conducted.
   • Final analysis has not been completed.
   • A reasonable period of completion of final analysis (no longer that 1 year following completion of testing) has elapsed.
   • Comparable information concerning the results of a completed study would be reportable.
3. Serious adverse effects. Any study in which testing or analysis of results is not yet complete but in which serious adverse effects have already been observed and may reasonably be attributed to exposure to the substances tested under the following conditions:
   • the effects observed in exposed organisms differ from effects observed in control organisms
   • the effects are atypical in view of historical experience with the organism tested, or otherwise support a reasonable inference of causation, and
   • 30 days have passed from the date the registrant first has the information.

Appendix VI – Frequently asked questions

1. Are registrants required to search for information about incidents or are they only required to report information that comes into the possession of an employee?

Registrants are not required to search for information about incidents. They are required to report information that they, including a related corporation, receive. This applies to all incident information, including scientific studies and incidents that occur in the United States.

2. Are registrants required to validate or substantiate an incident report before providing it to Health Canada?

No. Incident reports are, for the most part, only suspected associations. By providing an incident report, you are contributing to the ongoing collection of safety information that occurs once products are registered.

3. If a registrant submits an incident, will it be interpreted by Health Canada as evidence of causation?

No.

4. If one registrant owns a product that has Master Product status and a Master Copy is registered from that Master Product by a different registrant, who is responsible for reporting incidents, the Master Product registrant or the Master Copy registrant?

All registrants are required to report any information about an incident related to their product that they receive regardless of whether they are the registrant of a Master Copy or a Master Product.

5. Are incidents required to be reported if the label provided cautionary information of potential effects, such as eye irritant or effect to non-target plants?

Yes. Any incident described in section 2 of the IRR is required regardless of whether there is an existing warning on the label.

6. If a scientific study, which has already been provided to Health Canada under the IRR, is subsequently used to support an application for registration, is the study subjected to cost recovery?

Yes.

7. How will industry be able to participate in the process?

On each incident reporting form, industry can "provide any explanatory or qualifying information surrounding the incident". In addition to any further details about the incident, this section can also include additional information from the registrant as to why the pesticide was or was not the likely cause of the reported incident. All information in the incident report form, including information provided by industry, will be published on the Canada.ca website (electronic public registry).

8. Who is responsible for reporting incidents related to products used under the Own Use Import program?

Registrants, which includes registrants of end-use products and active ingredients, are required to report information about incidents that they receive and that is related to their products. Although end-use products accepted into the program are not registered in Canada, the active ingredient is and the registrant of the active ingredient is required to report information on incidents that they receive. Applicants for the registration of the active ingredient are also required to report information they receive.

9. Should incidents of major human adverse effects include debilitating chronic illnesses such as chronic fatigue syndrome, fibromyalgia and multiple chemical sensitivities?

A Major effect in a human includes any systemic effect (for example, reproductive or developmental effects, neurotoxicity) or any symptom that indicates a condition that could be life-threatening or result in chronic disability. Note that multifactorial diseases such as cancer cannot necessarily be linked to a single event.

10. Are registrants required to report target crop damage such as phytotoxicity?

No.

11. If a domestic animal experiences an incident with symptoms of paralysis and is then euthanized, what would be the severity classification?

This would be classified as major based on the symptoms. On the report form, euthanasia would be recorded as the outcome of the incident.