Regulations Amending the Pest Control Products Incident Reporting Regulations: SOR/2019-173
Canada Gazette, Part II, Volume 153, Number 12
SOR/2019-173 June 3, 2019
PEST CONTROL PRODUCTS ACT
P.C. 2019-608 May 31, 2019
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 67(1) footnote a of the Pest Control Products Act footnote b, makes the annexed Regulations Amending the Pest Control Products Incident Reporting Regulations.
Regulations Amending the Pest Control Products Incident Reporting Regulations
1 The title of the French version of the Pest Control Products Incident Reporting Regulations footnote 1 is replaced by the following:
Règlement sur les rapports d’incident relatif aux produits antiparasitaires
2 (1) The definition individual of a species at risk in subsection 1(1) of the Regulations is repealed.
(2) The definition déclaration d’incident in subsection 1(1) of the French version of the Regulations is repealed.
(3) The definition incident in subsection 1(1) of the Regulations is replaced by the following:
incident means an incident whose effects relate to the health or environmental risks or the value of a pest control product. It does not include an incident that results from
- (a) an act or activity that constitutes an offence under the Criminal Code; or
- (b) the exposure of a targeted subject of a pest control product that is manufactured for the purpose of controlling such a subject. (incident)
(4) Subsection 1(1) of the Regulations is amended by adding the following in alphabetical order:
animal means an invertebrate or a vertebrate, other than a human. (animal)
(5) Subsection 1(1) of the French version of the Regulations is amended by adding the following in alphabetical order:
rapport d’incident Rapport qui comporte les renseignements visés à l’article 3 et que le ministre reçoit d’un titulaire ou d’un demandeur d’homologation. (incident report)
(6) Subsection 1(2) of the French version of the Regulations is replaced by the following:
Application de la définition de rapport d’incident
(2) Pour l’application de la définition de rapport d’incident au paragraphe (1), il n’est pas nécessaire que les renseignements soient justifiés ou corroborés par le titulaire ou le demandeur d’homologation pour figurer dans un rapport.
3 Section 2 of the Regulations is replaced by the following:
2 Incidents are classified, according to the subject and effects of the exposure to the pest control product, into the following categories:
- (a) an incident whose effect is a human death;
- (b) an incident that has a major effect on a human, namely, that human had or has symptoms that indicate a condition that could be life-threatening or result in adverse reproductive or developmental effects or in chronic disability;
- (c) an incident that has an effect on a human other than the effects set out in paragraph (a) or (b);
- (d) an incident whose effect is an animal death or, if the incident occurs in the United States, a domestic animal death;
- (e) an incident that has an effect on an animal other than death;
- (f) an incident that has an effect on terrestrial or aquatic plants;
- (g) 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
- (h) 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
- (i) any new health or environmental hazard associated with a pest control product,
- (ii) 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
- (iii) the presence of a previously undetected component or derivative of a pest control product.
4 Section 6 of the Regulations is replaced by the following:
Language of reports
6 (1) Incident reports must be provided in English or French.
Summary while awaiting translation
(2) In the case of a scientific study published in a language other than English or French, if the translation of the study cannot be completed within the prescribed time for providing the incident report, the registrant or applicant must provide the Minister with a summary of the study, in English or French, when the incident report is provided.
Provision of translated study
(3) In the case referred to in subsection (2), the registrant or applicant must provide the completed translated study as soon as feasible after the incident report is provided.
5 The heading before section 7 of the French version of the Regulations is replaced by the following:
6 Sections 7 to 12 of the Regulations are replaced by the following:
Incidents in Canada
7 Every registrant and applicant must provide the Minister, in accordance with the time limits specified in sections 10, 11.1 and 12, with any information referred to in subsection 3(1) that they receive about any incident that occurs in Canada and that corresponds to any of the categories set out in paragraphs 2(a) to (g).
Incidents in the United States
8 Every registrant and applicant must provide the Minister, in accordance with the time limits specified in sections 10 and 12, with any information referred to in subsection 3(1) that they receive about any incident that occurs in the United States and that corresponds to any of the following categories set out in section 2:
- (a) an incident whose effect is a human death;
- (b) an incident that has a major effect on a human;
- (c) an incident whose effect is a domestic animal death.
9 Every registrant and applicant must provide the Minister, in accordance with the time limit specified in section 11, with any information referred to in subsection 3(2) about an incident whose effects are identified in a scientific study.
Time limit — 15 days
10 Every registrant and applicant must provide an incident report within 15 days after the day on which they receive information about any incident that corresponds to either of the following categories set out in section 2:
- (a) an incident whose effect is a human death;
- (b) an incident that has a major effect on a human.
Time limit — 30 days
11 Every registrant and applicant must provide an incident report within 30 days after the day on which they receive information about any incident whose effects are identified in a scientific study.
Time limit — 90 days
11.1 Every registrant and applicant must provide an incident report within 90 days after the day on which they receive information about any incident that occurs in Canada and whose effect is an animal death.
Time limit — table
12 Every registrant and applicant must accumulate the information that they receive in a reporting period set out in column 1 of the table to this section about incidents in the following categories and provide the required incident reports by the time limit set out in column 2:
- (a) an incident that occurs in the United States and whose effect is a domestic animal death;
- (b) an incident that has an effect on a human other than the effects set out in paragraph 2(a) or (b);
- (c) an incident that has an effect on an animal other than death;
- (d) an incident that has an effect on terrestrial or aquatic plants; and
- (e) 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.
|Item|| Column 1
| Column 2
Time Limit for Providing Report
|1||January 1 to March 31||May 31|
|2||April 1 to June 30||August 31|
|3||July 1 to September 30||November 30|
|4||October 1 to December 31||February 28 or, in the case of a leap year, February 29|
7 Section 13 of the Regulations is repealed.
8 Section 14 of the Regulations is replaced by the following:
Transitional period — shortened reporting period
13.1 A registrant or applicant who, during the year preceding the day on which this section comes into force, accumulates information in accordance with section 13 of these Regulations as they read immediately before that day must provide the incident reports referred to in that section for the portion of the applicable reporting period immediately preceding that day and must do so by February 28, 2022.
No longer a registrant
14 (1) If a registrant ceases for any reason to be the registrant of a particular pest control product, they must provide the incident reports referred to in sections 10 to 12 and the annual summary referred to in section 15, in respect of any information that they receive about that product before the day on which they cease to be the registrant, either:
- (a) before the day on which they cease to be the registrant; or
- (b) on or before the day that is 15 days after that day.
Shorter reporting period
(2) If a registrant ceases to be the registrant of a particular pest control product before the end of the reporting period applicable to the information that will be the subject of the incident reports referred to in section 12 or the annual summary referred to in section 15, that reporting period is deemed to end on the day that the registrant ceases to be the registrant.
9 Section 15 of the Regulations is replaced by the following:
Provision of annual summary
15 (1) A registrant must provide the Minister with an annual summary in respect of an active ingredient if
- (a) the active ingredient is a component of a pest control product that is the subject of an incident about which the registrant received information during the year; and
- (b) the active ingredient is implicated in at least 10 incidents of the type set out in paragraph (a), each of which relates to the same type of subject of exposure referred to in section 2, namely, a human, an animal or one set out in paragraphs 2(f) to (h).
Definition of year
(1.1) For the purposes of this section, the term year means a calendar year.
(2) The annual summary must contain the following information:
- (a) in respect of each incident referred to in paragraph (1)(b), the category of incident set out in section 2; and
- (b) a concise critical analysis of all the data relating to the active ingredient, including a comparison with analyses of past years and commentary on any changes that arose during the year in the risk profile of any pest control product of which the active ingredient is a component.
(3) The annual summary must be provided by March 31 of the year that follows the year during which the registrant receives information about the incidents specified in subsection (1).
Transitional period – annual summary
15.1 (1) A registrant who, during the year preceding the day on which this section comes into force, receives information about any incident that is associated with one of its pest control products must also, by the date set out in subsection (3), provide an annual summary in respect of any active ingredient that is a component of one of its pest control products and that is implicated in at least 10 incidents about which it has received information in that calendar year.
(2) The annual summary must contain the information referred to in subsection 15(2) as it read immediately before the day on which this section comes into force.
(3) The annual summary must be provided to the Minister by March 31, 2022.
10 Section 16 of the Regulations is replaced by the following:
16 Every registrant must provide the Minister with the information referred to in subsection 3(1) that they have received but have not already provided, within 24 hours after the Minister requests it for the purpose of responding to a situation that endangers human health, animal health or terrestrial or aquatic plants.
11 Section 17 of the Regulations is replaced by the following:
Keep and submit at Minister’s request
17 Every registrant and applicant must keep a record of every incident report and any information they have that relates to that report for six years after the day on which the report is provided to the Minister. The record must be provided to the Minister, on request, for the purpose of making comparisons or a historical analysis of the incidents or to permit the Minister to exercise powers under the Act.
12 Section 18 of the French version of the Regulations is replaced by the following:
Rapports d’incident et renseignements additionnels
18 (1) Sous réserve du paragraphe (2), le ministre verse au Registre les rapports d’incident portant sur tout incident dont l’effet est associé à un produit antiparasitaire homologué, y compris tout renseignement additionnel — notamment des avis ou des observations utiles — fourni volontairement par le titulaire ou le demandeur d’homologation à l’appui des rapports.
(2) Le ministre retire des rapports d’incident et des renseignements additionnels tout renseignement personnel au sens de l’article 3 de la Loi sur la protection des renseignements personnels.
13 The schedule to the Regulations is repealed.
Definition of former Regulations
14 For the purposes of sections 15 and 16 of these Regulations, former Regulations means the Pest Control Products Incident Reporting Regulations as they read immediately before the day on which these Regulations come into force.
Sections 10 to 12
15 Sections 10 to 12 of the former Regulations continue to apply in respect of any information a registrant or applicant receives before the day on which these Regulations come into force about any incident corresponding to the categories set out in those sections.
16 Subsection 14(3.1) of the former Regulations continues to apply in respect of a registrant that ceases for any reason to be the registrant of a particular pest control product before the day on which these Regulations come into force.
Coming into Force
17 These Regulations come into force on January 1, 2022.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Health Canada’s Pest Management Regulatory Agency (PMRA) internal program evaluation and interaction with industry stakeholders have identified areas for improvement in the Pest Control Products Incident Reporting Regulations (IRR).
Complex and ambiguous requirements
The IRR schedule that describes the severity classification for environmental incidents is complex, difficult for some registrants to follow, and not of value for identifying the actual implications of incidents. These classifications were based on the criteria established by the United States Environmental Protection Agency (EPA) and the EPA has noted the same issues.
Health Canada scientists validate all incident reports to verify that incidents are assigned the proper degree of severity. It is currently estimated that 5% of reports received are not properly classified.
Furthermore, incidents involving certain animals, such as honeybees or fish, may be classified as either domestic animal incidents or environmental incidents, since some species of animals can be both domesticated and “wild” in the environment. This leads to confusion on the part of regulated parties, and the ambiguity can result in additional administrative burden for Health Canada during the identification of trends in the data.
Time limits to report incidents are too long in some cases, and too short in others
Currently, all incidents that are classified as having a minor effect on a human, as well as all incidents that are classified as having moderate or minor effects on a domestic animal, and minor effects on the environment, must be accumulated by registrants for a 12-month period and submitted within the prescribed time frames to Health Canada. footnote 2 The 12-month period is staggered, based on the first letter or number of the registrant’s name, meaning that the period can span different calendar years.
With respect to data analysis, the staggered 12-month reporting time limit has resulted in difficulty in consistently identifying trends in pest control products that have multiple registrants, thus making it difficult to monitor compliance, analyze data and plan outreach activities. As well, the staggered 12-month reporting time limit makes it challenging to accurately report data in the Incident Reporting Program’s annual reports, which reflect information received in a calendar year.
This staggered 12-month reporting time limit has also resulted in technical issues, such as slow processing times and forms being rejected when registrants submit a large number of incidents at once, due to the file size submitted via electronic reporting.
Currently, incidents of packaging failure are required to be reported on a monthly basis. Packaging failure incident reports received by Health Canada to date have not indicated that the level of risk identified in these reports warrants the short reporting time limit of one month. Registrants and applicants have, as a result, requested that the time limit for these incidents be changed to quarterly, rather than monthly.
Food residue incident reports do not serve their intended purpose of improving health and environmental protection
Currently, incidents must be reported where the effect is a pesticide residue in food, detected in an amount that would result in the food being prohibited for sale under the Food and Drugs Act. In the five incidents reported to date since the inception of the Incident Reporting Program in 2007, no information has been received in the incidents that would require a risk of excessive residues in food for sale in Canada to be addressed. Therefore, this requirement has not met its intended purpose as laid out in the IRR.
Reporting requirements when registrations are transferred or cancelled are not comprehensive
If a registrant ceases for any reason to be the registrant of a particular pest control product or transfers the registration to another registrant, then, within 15 days of them ceasing to be a registrant, the current IRR requires them to submit any outstanding annually accumulated incident reports, as well as annual summaries. This limitation to only receiving annually accumulated incident reports, rather than any incident reports (such as reports required to be provided within a shorter time period), may impede Health Canada’s ability to receive crucial incident reports that identify more severe incidents. For example, certain incidents that involve the death of an animal in the environment are classified as “moderate” under the current system, and the incidents could potentially go unreported upon transfer.
Trigger for providing an annual summary
A registrant must file an annual summary with respect to an active ingredient if it has been implicated in at least 10 incident reports in the same year. Annual summaries that pertain to multiple incident categories (e.g. humans, domestic animals, or the environment) are not useful for identifying trends. A trend is specific to the category of incident. For example, the risk of an animal in the wild eating rodenticides is very different from the risk of a human developing a skin rash, which is different from the risk of grass wilting where a rodenticide has been placed. The content of an annual summary is far more challenging to prepare if regulated parties must perform a critical analysis of why incidents occurred in domestic animals, humans, and the environment, when each of these incidents occurred only a limited number of times.
Inconsistency of terms used between the Pest Control Products Incident Reporting Regulations and the Pest Control Products Act
The IRR currently uses “file,” “filing,” and its related verb forms when describing the submission of an incident report. This is inconsistent with the Pest Control Products Act, which states that “a registrant shall report any prescribed information.”
The Minister of Health’s primary mandate under the Pest Control Products Act (PCPA) is to prevent unacceptable risks to human health and the environment from the use of pest control products (pesticides). Under the PCPA, pesticides must be registered or otherwise authorized by the Minister of Health before they can be used in Canada. While 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.
The PCPA requires registrants, and applicants for the registration of a pesticide, to report incidents involving their pesticide. The reporting process is set out in the IRR. Registrants and applicants are required by the IRR to submit reports on incidents that
- have effects on humans, domestic animals, or the environment;
- involve packaging failure that could result in human exposure or injury;
- involve excessive residues in food; or
- indicate an increased risk or new hazard in a scientific study sponsored by the registrant or applicant.
Incidents include those that occur in either Canada or the United States (U.S.). The reporting of incidents that occur in the U.S. is only mandatory if the incident falls within any of the following categories described in section 2 of the current IRR:
- an incident whose effect is a human death;
- an incident that has a major effect on a human; or
- an incident whose effect is a domestic animal death.
If 10 or more incidents involving a given active ingredient occur in a single year, registrants and applicants must submit an annual summary that describes the incidents that occurred and analyzes the changes in the risk profile of the active ingredient from year to year.
Health Canada evaluates all reported incidents to identify unacceptable risks to health or the environment, and incorporates the findings into its pesticide regulatory decisions. Since the Incident Reporting Program’s establishment, Health Canada has investigated a number of reported pest control product incidents. Some investigations have resulted in regulatory actions, such as amending the use instructions or requiring changes to the packaging.
Health Canada maintains information online regarding the Incident Reporting Program.
Without negatively affecting the long-term outcome of improving health and environmental protection, the amendments will
- clarify incident reporting requirements;
- reduce regulatory and administrative burden;
- facilitate Health Canada’s ability to identify trends and analyze incident data; and
- address stakeholders’ concerns.
In order to meet the objectives of this proposal, the amendments will do the following:
Clarify the definition of “incident”
The amendments will exclude effects from being considered an incident if they are observed on the intended target of the pest control product.
Remove ambiguity in animal and environmental reporting
The amendments will change the classification of incidents from those affecting “domestic animals” and those affecting “the environment” to those affecting “animals” and those affecting “terrestrial or aquatic plants.” This will remove the ambiguity previously identified, without affecting the total number of incident reports that would be submitted. For example, any incident that under the previous system would have been classified as affecting an animal in the environment, such as non-target wildlife, will now be reported as an incident affecting an animal.
The term “domestic animal” will be maintained, but only so that incidents involving domestic animal death occurring in the U.S. will continue to be reported.
Remove requirements for registrants and applicants to classify incidents by their degree of severity, except for the most serious cases
The amendments will require registrants and applicants 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. is life-threatening, results in adverse reproductive or developmental effects, or results in chronic disability), or an animal incident that results in death. Every other incident will no longer require a degree of severity to be assigned by the registrant or applicant, resulting in reduced administrative burden on regulated parties. Since Health Canada scientists validate the degree of severity for all incident reports, the amendments will not affect the level of scientific rigour applied to the analysis, thus allowing Health Canada to continue to meet its long-term outcomes of improving health and environmental protection.
Harmonize reporting timelines for all incidents except for the most serious cases
The amendments will eliminate the 12-month and one-month time limits for most reports, and instead require that incidents be accumulated over a 3-month period (i.e. quarterly), and then reported within 2 months from the end of that quarter. This change will more closely align the reporting process for registrants who are required to report incidents in both Canada and the U.S. It also addresses the technical and analytical issues that arise from the staggered 12-month reporting period.
Certain types of incidents are sufficiently serious that incident reports should be submitted faster than the possible maximum of five months:
- Incidents that result in a human death, are life-threatening to humans, result in adverse reproductive or developmental effects in humans, or result in chronic disability in humans will continue to be reported within 15 days.
- Incidents that indicate an increased risk or new hazard in a scientific study sponsored by the registrant or applicant will be reported within 30 days, to align the reporting requirements with those of the United States. This is a change from the current IRR, which require incident reports regarding scientific studies to be submitted within one month of the month in which the study was identified.
- Incidents that involve the death of an animal in Canada will be reported within 90 days. This represents a change for the reporting limits in the current IRR. Some reporting time limits, such as the current 30-day requirement for domestic animals, will be longer; others, such as the current annual accumulation of minor environmental incidents that involve the death of animals, will be shorter.
Remove the requirement to report incidents involving excessive residues in food
The amendments will remove reporting requirements for residues in food, reducing burden on regulated parties without compromising Health Canada’s long-term outcomes of improving health and environmental protection.
Expand reporting requirements when registrations are transferred or cancelled
The amendments will require registrants to provide all incident reports, not just those for minor incidents, that a registrant receives if they cease to be a registrant for any reason, including the transfer or cancellation of a product’s registration. It is necessary for Health Canada to receive all relevant incident reports, not just reports for minor incidents, when a registrant ceases to be a registrant. This will improve Health Canada’s ability to monitor and respond to potential issues and ensure that incidents continue to be reported for the period during which a registrant was responsible for their product.
Revise the trigger for providing an annual summary
The amendments will require regulated parties to provide an annual summary when the active ingredient is implicated in at least 10 incidents involving the same subject, such as 10 incidents involving animals or 10 incidents involving humans, rather than in at least 10 incidents across all subjects. This will reduce the number of summaries reported, reducing administrative burden on registrants, while still allowing the capture of the most pertinent annual summaries. Streamlining the focus of the annual summary will also help to improve the ability to identify trends, since more information relating to similar incidents will be available to analyze.
Align the wording of the Pest Control Products Incident Reporting Regulations with the Pest Control Products Act and make other miscellaneous changes
The amendments will align the terms used in the IRR more consistently with what is in the PCPA. For example, using “provide” (“fournir” in French) instead of “file” (“déclarer” in French); and “rapport” (instead of “déclaration”) in French. Similarly, the use of the phrase “complete and accurate,” in the context of incident reports that regulated parties must provide, is unnecessary, since it is necessary that any information provided in an incident report must be done completely and accurately to fulfil the regulatory requirement. As a result, the phrase “complete and accurate” will be removed.
The regulatory amendments are expected to decrease administrative costs for registrants. Therefore, the “One-for-One” Rule applies and the proposal is considered an “OUT” under the Rule. The total annualized administrative cost savings for all regulated parties are estimated to be $21,797, or $31 per regulated party.
This reduction will be largely due to
- the removal of requirements for registrants and applicants to calculate the degree of severity for most incident reports, which in turn makes it possible to submit incident reports in less time and with less effort; and
- the changes to the trigger for submitting an annual summary, which in turn will reduce the number of summaries that registrants and applicants are required to write.
These results are based on the following assumptions:
- Of the near 700 registrants and applicants, incident reports collected since the start of the Incident Reporting Program indicate that approximately 100 regulated parties are expected to be required to report an incident within any given year.
- The average wage rate for a natural and applied science employee, who completes the incident reports, is estimated to be $33.27/hour.
- The average degree of severity is estimated to take approximately 30 minutes to calculate for each incident report involving the environment, and approximately 15 minutes to calculate for each other incident report.
- The changes to remove the degree of severity calculations from most incident reports would result in approximately 2 600 incidents per year no longer requiring a severity classification, or a total of 640 hours’ worth of time savings for all regulated parties per year. This number does not include any incidents that occur in the U.S. that are reportable in Canada.
- The average incident report involving a human, a domestic animal, or the environment currently takes one hour to complete, regardless of the complexity.
- The removal of the requirement to report incidents involving excessive food residues would result in regulated parties having to provide fewer incident reports. However, these incidents are quite rare, currently occurring less than once a year for all regulated parties. As a result, the savings are negligible.
- The average annual summary report is estimated to take 6 hours to complete.
- The changes to the trigger for reporting an annual summary would reduce the total number of annual summaries that all regulated parties provide by more than half, from an annual average of 70 to 33 reports, which will result in approximately 200 hours’ savings for all regulated parties.
Health Canada obtained information regarding the number, type, and submission frequency of incident reports from its internal databases.
Health Canada estimated the amount of time to complete an incident report, the amount of time to calculate the degree of severity, and the amount of time to complete an annual summary report, based on consultation with industry stakeholders from CropLife Canada and the Canadian Consumer Specialty Products Association (CCSPA). Wage rates were based on data in the Statistics Canada 2010–2011 Labour Force Survey.
Small business lens
The small business lens does not apply to these amendments, as there are insignificant changes to costs for small business.
The need to amend the IRR has been discussed with industry stakeholders over several years.
The initial proposal was discussed with industry stakeholders, including CropLife Canada and the CCSPA, starting in 2014. On May 22, 2015, a pre-consultation document that outlined the proposed amendments was published online for a 30-day public comment period.
Industry associations were generally supportive of the proposed amendments, as they would simplify the reporting process and decrease administrative burden. Some concerns had been raised by individual industry members that the reduction in time limits for some incidents from annual to quarterly reporting is not preferred.
While many suggestions were taken into consideration during the development of the proposed amendments, Health Canada notes that the shift to quarterly reporting is generally aligned with the requirements for reporting incidents in the United States, and that, while this may require some incident reports to be submitted sooner than before, the number of incident reports that will be submitted will not increase, and other types of reports will be submitted later than before. Moreover, requiring that certain reports be provided quarterly assists Health Canada in identifying risks that need to be managed and meeting its health and environmental objectives under the PCPA.
The amendments to the IRR were prepublished in the Canada Gazette, Part I, on December 22, 2018, for a 45-day consultation period. During this consultation period, Health Canada received four comments from stakeholders.
One commenter asked about the existing and future enforcement options for reporting incidents involving excessive residues in food, and how this would assist Health Canada in meeting its mandate of health and environmental protection. Through this regulatory amendment, registrants and applicants are no longer required to report these incidents to Health Canada; however, any food that has pesticide residues that exceed the maximum residue limit would remain non-compliant with the Food and Drugs Act. As a result, the existing inspection and enforcement system for food remains in place for addressing potential non-compliance issues, which in turn supports Health Canada’s long-term outcomes of improving health and environmental protection. The Canadian Food Inspection Agency is responsible for food inspection activities.
Another commenter expressed general support for the proposal, but noted that both non-target wildlife and target animals should be included in incident reporting. Health Canada will continue requiring the reporting of incidents involving non-target wildlife. The amendments will instead classify all animals into one reporting scheme, be they, for example, non-target wildlife, pets, or host animals treated with a pesticide to control a pest. The effects of a pest control product on the target animal, or pest, are not reportable under the IRR; rather, they are anticipated based on the value information provided by registrants at the time of registration. A pesticide incident is any unintended effect on human health, animal health or the environment resulting from exposure to a pesticide. The change to the definition of an incident will clarify that the actual target pest (including those that are mammals, such as gophers) is not reportable, for the above reasons.
A third commenter expressed general support for the proposal, but noted that the increase of reporting frequency from annually to quarterly for a subset of incidents will be onerous for registrants, especially when products are “in season,” and suggested semi-annual reporting as a compromise. Health Canada recognizes that registrants might be required to submit reports when products are “in season”; however, some registrants already submit incident reports throughout the year, rather than annually. As well, there will be no change in the total number of incident reports submitted per year, since forms must be completed for each incident report regardless of the reporting frequency. Also, as noted above, this aligns more closely with the U.S. regulatory requirements, meaning that those registrants that operate in both countries are aware that it is feasible. A few regulatory changes have also been made to reduce administrative burden for the registrants overall, including removing some of the severity classification requirements. Accordingly, Health Canada does not believe that the increase of reporting frequency from annually to quarterly would represent undue administrative burden on registrants.
Furthermore, the commenter questioned whether more closely aligning reporting timelines with the U.S. would actually reduce administrative burden for registrants, given that certain aspects of the Canada and U.S. regulatory requirements differ. While it may simplify procedures for those registrants reporting to both countries, Canada–U.S. alignment is not expected to yield any significant benefits since the costs to comply with U.S. regulatory requirements are out of the scope of the cost-benefit analysis. As a result, Health Canada did not monetize those benefits.
A fourth commenter expressed general support for the proposal and provided additional feedback. The commenter questioned the need to report incidents involving packaging failure, since they are not required under the U.S. regulations and may be captured under other categories. Packaging failure is intended to be separate from other four categories because it captures incidents that could potentially have adverse effects resulting from the failure, whereas an incident that is reported under any of the other categories has a direct and reported negative consequence. As a result, incidents involving packaging failure provide important information that could identify human, animal and/or environmental risks. Furthermore, the commenter noted that the 15-day time limit to report when registrations are transferred or cancelled may lead to issues when the products are still in the marketplace. Health Canada notes that this is an existing requirement, and only the scope of incidents to be reported is increasing.
Health Canada notes that the coming-into-force date of the amendments has been changed to January 1, 2022, to ensure that there is consistent reporting by regulated parties during the year preceding that in which the new requirements come into effect, and that the necessary changes can be made to reporting forms and internal databases.
Health Canada has engaged with its regulatory counterparts in the EPA since before the inception of the Incident Reporting Program in 2007. In fact, the EPA’s incident reporting program was used as the model for the Canadian program, and the IRR were drafted with the U.S. program in mind. Since 2007, Health Canada and the EPA have met annually and discussed their respective programs, as well as anticipated regulatory changes.
In spring 2018, Health Canada consulted with its regulatory counterparts at the EPA regarding the proposed amendments to incident reporting. EPA officials were overall supportive of the proposed amendments at the time, and did not indicate that the areas of misalignment between Canadian and American requirements posed a risk to trade.
For the majority of incidents, the timelines for a regulated party to submit an incident report will be identical, resulting in alignment between the two jurisdictions.
Certain areas of the regulatory amendments remain out of alignment with the U.S. regulations. However, for these few unaligned areas, Health Canada has determined that the proposed time limits for submitting incident reports, and the detail required to be provided in the reports, are necessary to effectively monitor and assess pesticide-related incidents. In some cases, such as the elimination of the requirement for registrants and applicants to provide degrees of severity for environmental incidents, the U.S. has indicated that they would like to align their regulations with the Canadian amendments.
Moreover, the incident reports that are received and reviewed by the Incident Reporting Program are intended to inform decision making, and are not directly related to the trade of goods. As a result, there are no direct implications to Canada–U.S. trade as a result of differences in incident reporting, and it is not anticipated that there will be any impacts on Canada–U.S. trade as a result of the few remaining differences between Canadian and American incident reporting requirements.
The amendments will provide the potential for health and safety benefits, as well as environmental benefits, by improving the ability for Health Canada to analyze trends in incident reports that are submitted. By improving the ability to analyze trends, Health Canada will be better able to identify unacceptable risks to health or the environment more quickly, and incorporate those findings into pesticide regulatory decisions in a more responsive manner.
The amendments will also simplify the process for regulated parties to prepare and submit incident reports, resulting from the removal of the degree of severity classification requirements, the removal of the requirement to submit incidents pertaining to excessive food residues, and changes to reporting requirements to align more closely with those of the United States. This, in turn, will reduce the amount of time that it takes to fulfill regulatory requirements and therefore reduce administrative burden.
Finally, the amendments are expected to more than halve the number of annual summaries that would need to be submitted by regulated parties per year without compromising health and safety, or the environment, which in turn would decrease the burden on regulated parties associated with preparing and submitting the summaries. As a result of the expected reduction in the number of summaries to be processed, the Government of Canada would also realize efficiencies.
The amendments, through the syntax and grammar changes, will improve consistency and readability between the IRR and the PCPA, which in turn will remove ambiguity and therefore improve the quality of reports submitted.
The amendments are expected to impose a small, one-time, upfront compliance cost on regulated parties of $35,210 for all registrants, or approximately $50 per registrant, to familiarize themselves with the new obligations.
The amendments will also impose a one-time upfront cost on the Government of Canada, to modify the electronic forms and software infrastructure that are used to submit, process and review incidents.
Taken on the whole, the expected benefits that will be realized by the amendments far outweigh the one-time costs that will be borne by regulated parties and the Government of Canada.
Implementation, enforcement and service standards
The amendments will come into force January 1, 2022, to ensure that there is consistent reporting by regulated parties during the year preceding that in which the new requirements come into effect, and that the necessary changes can be made to reporting forms and internal databases. All incidents about which regulated parties received information before the amended Regulations come into force will continue to be subject to the categorization and reporting timelines in the current IRR. Any regulated party in the middle of their annual reporting cycle when the amendments come into force will be required to submit any incident reports that have not yet been submitted by a prescribed date. Health Canada will provide information and a revised Guidance Document for the Pest Control Products Incident Reporting Regulations to those involved in submitting incident reports. The revised documents will be available on the canada.ca website.
Health Canada encourages, promotes, maintains and enforces compliance with the PCPA through active prevention; inspections, including surveillance; and enforcement response actions. Active prevention aims to educate, facilitate and promote compliance as well as to communicate regulatory information. Inspections are designed to determine the level of compliance of users, distributors and registrants of pesticides with the general provisions of the PCPA and its regulations, as well as specific terms and conditions of registration.
Enforcement response may include
- education (written and oral);
- detention, seizure and forfeiture of products;
- compliance orders under the PCPA;
- administrative monetary penalties or warnings under the Agriculture and Agri-Food Administrative Monetary Penalties Act and the Agriculture and Agri-Food Administrative Monetary Penalties Regulations Respecting the Pest Control Products Act and Regulations; and
- prosecutions under the PCPA.
Compliance with the PCPA and its regulations is achieved through a network of officers and inspectors across Canada. Health Canada regional offices also have formal agreements with provincial pesticide regulatory departments, providing a basis to collaborate with them in inspections and in the development and delivery of compliance activities.
Non-compliance with most provisions of the amended IRR will continue to be subject to the administrative monetary penalty regime, namely Part 4 of Schedule 1 to the Agriculture and Agri-Food Administrative Monetary Penalties Regulations Respecting the Pest Control Products Act and Regulations. As a result, should administrative monetary penalties be used as a component of the enforcement response, violations of these IRR provisions may result in a warning or a penalty. The maximum penalty for a violation is set out in the Agriculture and Agri-Food Administrative Monetary Penalties Act. Amendments to Part 4 of Schedule 1 of the Agriculture and Agri-Food Administrative Monetary Penalties Regulations Respecting the Pest Control Products Act and Regulations are required to align the violations with the amended IRR. These amendments will be published, and come into force, at the same time as the amendments to the IRR come into force (i.e. they will come into force January 1, 2022).
Health Canada follows an established compliance policy to promote and enhance fair treatment of the regulated community.
Please direct all questions and inquiries to
Policy, Communications and Regulatory Affairs Directorate
Pest Management Regulatory Agency
2720 Riverside Drive