Pest Control Products Incident Reporting Regulations

Pest Control Products Incident Reporting Regulations Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 67(1) of the Pest Control Products Acta, hereby makes the annexed Pest Control Products Incident Reporting Regulations. S.C. 2002, c. 28 Definitions The following definitions apply in these Regulations. Act means the Pest Control Products Act. (Loi) animal means an invertebrate or a vertebrate, other than a human. (animal) domestic animal means an animal that is under the control of humans and dependent on them for its survival. (animal domestique) 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 an act or activity that constitutes an offence under the Criminal Code; or the exposure of a targeted subject of a pest control product that is manufactured for the purpose of controlling such a subject. (incident) incident report means a report that contains the information described in section 3 and that is received by the Minister from a registrant or an applicant. (rapport d’incident) individual of a species at risk[Repealed, SOR/2019-173, s. 2] Application of definition incident report For the purpose of applying the definition incident report in subsection (1), the information need not be proved or substantiated by the registrant or applicant in order to be included in the report. Incident categories Incidents are classified, according to the subject and effects of the exposure to the pest control product, into the following categories: an incident whose effect is a human death; 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; an incident that has an effect on a human other than the effects set out in paragraph (a) or (b); an incident whose effect is an animal death or, if the incident occurs in the United States, a domestic animal death; an incident that has an effect on an animal other than death; an incident that has an effect on terrestrial or aquatic plants; 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 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 any new health or environmental hazard associated with a pest control product, 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 the presence of a previously undetected component or derivative of a pest control product. Section 13 of the Act 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: contact information for the registrant or applicant; the date on which the incident occurred; the date on which the registrant or applicant received the information about the incident; the city, province or state, and country where the incident occurred; the identification of the pest control product; information about the application of the pest control product, including the site, method and date of its application; the category of the incident, determined in accordance with section 2; information about the circumstances of the exposure to the pest control product, including the site, date, route of exposure, weather conditions, duration and subject information, which, in the case of a human subject, is restricted to age, gender and whether the subject is pregnant; information about the incident and its effects, including the symptoms, duration and outcome; and scientific test information, including information about the sample, the method of analysis and the results. 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: the title and date of the study and the name of the author; the scientific study and the test data generated during the study; and the type of scientific study, an indication of which of subparagraphs 2(f)(i) to (iii) is the reason for submitting it, and the information the study reveals about the incident and its effects. Reports deemed received Subject to subsection (2), all information about incidents and their effects that is required by these Regulations is deemed to have been received by the registrant or applicant on a certain date if it is received on that date by an employee or agent of the registrant or applicant; or an employee or agent of a related corporation, within the meaning of the definition related persons in subsection 251(2) of the Income Tax Act, whether the related corporation is located in or outside Canada. Exception In the case of an incident whose effects are identified in a scientific study, if the information is received by a person described in paragraph (1)(b), the information is deemed to have been received by the registrant or applicant one year after its receipt by that person. [Repealed, SOR/2009-94, s. 3] Language of reports Incident reports must be provided in English or French. Summary while awaiting translation 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 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. Incidents in Canada 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 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: an incident that has a major effect on a human; an incident whose effect is a domestic animal death. Scientific studies 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 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: an incident that has a major effect on a human. Time limit — 30 days 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 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 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: 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 the effects set out in paragraph 2(a) or (b); 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. [Repealed, SOR/2019-173, s. 7] Transitional period — shortened reporting period 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 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: before the day on which they cease to be the registrant; or on or before the day that is 15 days after that day. Shorter reporting period 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. Provision of annual summary A registrant must provide the Minister with an annual summary in respect of an active ingredient if 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 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 For the purposes of this section, the term year means a calendar year. Content The annual summary must contain the following information: in respect of each incident referred to in paragraph (1)(b), the category of incident set out in section 2; and 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. Timing 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 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. 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. The annual summary must be provided to the Minister by March 31, 2022. Minister’s request 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. Keep and submit at Minister’s request 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. Incident reports and supplemental information Subject to subsection (2), the Minister must place all incident reports that relate to registered pest control products in the Register, including any supplemental information in support of the reports that is volunteered by the registrant or applicant, such as any relevant opinion or commentary. Exclusion The Minister must remove from the incident reports, and from any supplemental information provided in connection with them, all personal information as defined in section 3 of the Privacy Act. Coming into force These Regulations come into force six months after the day on which they are registered. Definition of former Regulations 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 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. Subsection 14(3.1) 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.