Canada Gazette

Notice

Vol. 140, No. 23 — November 15, 2006

Registration
SOR/2006-260 October 26, 2006

PEST CONTROL PRODUCTS ACT

Pest Control Products Incident Reporting Regulations

P.C. 2006-1136 October 26, 2006

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 Act (see footnote a), hereby makes the annexed Pest Control Products Incident Reporting Regulations.

	PEST CONTROL PRODUCTS INCIDENT REPORTING REGULATIONS
	INTERPRETATION
Definitions	1. (1) The following definitions apply in these Regulations.
"Act" « Loi »	"Act" means the Pest Control Products Act.
"domestic animal" « animal domestique »	"domestic animal" means an animal that is under the control of humans and dependent on them for its survival.
"incident" « incident »	"incident" means an incident described in section 2 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 would constitute an offence under the Criminal Code.
"incident report" « déclaration d'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.
"individual of a species at risk" « individu d'une espèce en péril »	"individual of a species at risk" means an individual of a species set out in the List of Wildlife Species at Risk in Schedule 1 to the Species at Risk Act.
Application of definition "incident report"	(2) 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.
	CLASSIFICATION OF INCIDENTS
Categories	2. Incidents are classified, according to the subject of the exposure to the pest control product and the degree of severity of their effects, into the following categories: (a) in the case of a human being, (i) an incident whose effect is a human death, (ii) an incident that has a major effect on a human, when an individual has or has had symptoms that indicate a condition that could be life-threatening or result in adverse reproductive or developmental effects or in chronic disability, (iii) an incident that has a moderate effect on a human, when an individual has or has had 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 indicated, although the symptoms do not indicate a life-threatening condition and the individual is likely to return to their pre-exposure state of health without any chronic disability, and (iv) an incident that has a minor effect on a human, when an individual has or has had minimally bothersome symptoms that normally resolve rapidly, including skin rash, itching, conjunctivitis, drowsiness, transient cough, headache, joint pain, agitation, restlessness or mild gastro-intestinal symptoms such as self-limited diarrhea, stomach cramps or nausea; (b) in the case of a domestic animal, (i) an incident whose effect is a domestic animal death, (ii) an incident that has a major effect on a domestic animal, when a domestic animal has or has had symptoms that indicate a condition that could be life-threatening or result in adverse reproductive or developmental effects or in chronic disab ility, (iii) an incident that has a moderate effect on a domestic animal, when a domestic animal has or has had 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 indicated, although the symptoms do not indicate a life-threatening condition and the animal is likely to return to its pre-exposure state of health without any chronic disability, and (iv) an incident that has a minor effect on a domestic animal, when a domestic animal has or has had minimally bothersome symptoms, such as skin, eye or respiratory irritation, that normally resolve rapidly; (c) in the case of the environment, (i) an incident that has a major effect on the environment, when (A) the number of individuals of a group or subgroup set out in column 1 or 2, respectively, of the schedule that die is at least the number set out in column 3, or (B) an individual of a species at risk has or has had at least one of the symptoms set out in column 6 of the schedule, (ii) an incident that has a moderate effect on the environment, when the number of individuals of a group or subgroup set out in column 1 or 2, respectively, of the schedule that have or have had at least one of the symptoms set out in column 6 is the number, or a number within the range, set out in column 4, and (iii) an incident that has a minor effect on the environment, when the number of individuals of a group or subgroup set out in column 1 or 2, respectively, of the schedule that have or have had at least one of the symptoms set out in column 6 is less than the number set out in column 5; (d) an incident whose effect is residues in food, when a pest control product or one of its components or derivatives is detected in food in an amount that would result in the sale of the food being prohibited under section 4 of the Food and Drugs Act; (e) an incident of packaging failure, when packaging failure is observed that could result in the exposure of humans to a pest control product or in injury to humans; and (f) an incident whose effects are identified in a scientific study, when 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.
	PRESCRIBED INFORMATION
Section 13 of the Act	3. (1) 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: (a) contact information for the registrant or applicant; (b) the date on which the incident occurred; (c) the date on which the registrant or applicant received the information about the incident; (d) the city, province or state, and country where the incident occurred; (e) the identification of the pest control product; (f) information about the application of the pest control product, including the site, method and date of its application; (g) the category of the incident, determined in accordance with section 2; (h) 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; (i) information about the incident and its effects, including the symptoms, duration and outcome; and (j) scientific test information, including information about the sample, the method of analysis and the results.
Section 13 of the Act	(2) 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: (a) contact information for the registrant or applicant; (b) references to the scientific study; (c) the identification of the pest control product; (d) the category of the incident, determined in accordance with section 2; and (e) the type of study or scientific investigation, an indication of which of subparagraphs 2(f)(i) to (iii) is the reason for submitting it, information it reveals about the incident and its effects, and the test data generated during the study or investigation.
	GENERAL REQUIREMENTS
Reports deemed received	4. (1) 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 (a) an employee or agent of the registrant or applicant; or (b) 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	(2) 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.
Transfers of registration	5. On the transfer of a registration, these Regulations continue to apply to the former registrant with respect to information about incidents and their effects that is received by them before the transfer and for five years after it.
Language of reports	6. (1) Incident reports must be filed in English or in French.
Translation delays	(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 filing the incident report, the registrant or applicant must provide the Minister with a summary of the study, in English or in French, within the prescribed time limit and request an extension of the time for filing the report.
	INCIDENT REPORTS
Incidents in Canada	7. The registrant of a pest control product or an applicant for the registration of a pest control product must file with the Minister, in accordance with the time limits specified in sections 10 to 14, a complete and accurate report of any information set out in subsection 3(1) that they receive about an incident that occurs in Canada, in accordance with the categories described in paragraphs 2(a) to (e).
Incidents in the United States	8. The registrant of a pest control product or an applicant for the registration of a pest control product must file with the Minister, in accordance with the time limits specified in sections 10 to 12, a complete and accurate report of any information set out in subsection 3(1) that they receive about an incident that occurs in the United States, if the incident fits within any of the following categories described in section 2: 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.
Scientific studies	9. The registrant of a pest control product or an applicant for the registration of a pest control product must file with the Minister, in accordance with the time limit specified in section 11, a complete and accurate report of any information set out in subsection 3(2) about an incident whose effects are identified in a scientific study.
	REPORTING TIME LIMITS
Time limit — 15 days	10. Every registrant and applicant must file an incident report within 15 days after the day on which they receive information about any incident in the following categories: (a) an incident whose effect is a human death; (b) an incident that occurs in Canada that has a major effect on a human; and (c) an incident that has a major effect on the environment.
Time limit — one month	11. (1) Every registrant and applicant must accumulate the information that they receive in a month about incidents in the following categories and file the required incident reports before the end of the next month: (a) an incident that occurs in the United States that has a major effect on a human; (b) an incident that has a moderate effect on a human; (c) an incident that occurs in Canada whose effect is a domestic animal death; (d) an incident that has a moderate effect on the environment; (e) an incident whose effect is residues in food; (f) an incident of packaging failure; and (g) an incident whose effects are identified in a scientific study.
When study already submitted	(2) For the purpose of paragraph (1)(g), in the case of a scientific study that has already been submitted to the Minister, the registrant or applicant may properly reference the study in their incident report instead of resubmitting it.
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 file the required incident reports on the date set out in column 2: (a) an incident that occurs in the United States whose effect is a domestic animal death; and (b) an incident that has a major effect on a domestic animal.
TABLE

Item	Column 1 Reporting Period	Column 2 Filing Date
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 February 29 in the case of a leap year

Filing of 12-month report	13. Subject to subsection 14(4), every registrant and applicant must accumulate the information that they receive in a 12-month period established in accordance with section 14 about incidents in the following categories and file the required incident reports in accordance with that section: (a) an incident that has a minor effect on a human; (b) an incident that has a moderate effect on a domestic animal; (c) an incident that has a minor effect on a domestic animal; and (d) an incident that has a minor effect on the environment.
Time limit — table	14. (1) Subject to subsections (2) to (4), every registrant and applicant the first letter or number of whose name is set out in column 1 of the table to this subsection must file the incident reports described in section 13 and the annual summary described in section 15 within two months after the end of the reporting period set out in column 2.
TABLE

Item	Column 1 First letter or number of registrant's or applicant's name	Column 2 Reporting period
1.	A or a number	December 1 to November 30
2.	B	January 1 to December 31
3.	C	February 1 to January 31
4.	D	March 1 to February 28, or February 29 in the case of a leap year
5.	E, F or G	April 1 to March 31
6.	H, I or J	May 1 to April 30
7.	K or L	June 1 to May 31
8.	M	July 1 to June 30
9.	N	August 1 to July 31
10.	O, P, Q or R	September 1 to August 31
11.	S	October 1 to September 30
12.	T, U, V, W, X, Y or Z	November 1 to October 31

Name change	(2) If a registrant or an applicant changes their name after having filed a first incident report described in section 13 or a first annual summary described in section 15, the time limit for filing subsequent reports and summaries under those sections remains the time first established in accordance with subsection (1).
Amalgamation	(3) If two or more registrants or applicants amalgamate after one of them has filed a first incident report described in section 13 or a first annual summary described in section 15, the time limit for the amalgamated registrant or applicant filing subsequent reports and summaries under those sections is the earliest of their time limits first established in accordance with subsection (1).
First report and summary	(4) The first incident report described in section 13 and the first annual summary described in section 15 that are filed in accordance with subsection (1) may be for a reporting period shorter than 12 months.
	ANNUAL SUMMARY
When annual summary required	15. (1) A registrant must file an annual summary with respect to an active ingredient in the following circumstances: (a) the active ingredient is a component of a pest control product that is the subject of an incident report filed by the registrant in the year; and (b) the active ingredient is implicated in at least 10 such reports in the same year.
Content	(2) The annual summary must contain the following information: (a) with respect to each incident report referred to in paragraph (1)(b), the category of incident described 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 in the year in the risk profile of any pest control product of which the active ingredient is a component.
Timing	(3) The annual summary must be filed at the same time as the incident reports required by section 13.
	DANGEROUS SITUATIONS
Health or environment	16. Every registrant must provide the Minister with all information set out in subsection 3(1) that they receive and that has not already been reported, within 24 hours after the Minister requests it for the purpose of responding to a situation that endangers human or domestic animal health or the environment.
	RECORDS
Keep and submit on request	17. Every registrant and applicant must keep a record of every completed incident report and any information they have that relates to or is in connection with that report for six years after the day on which the report is filed with 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.
	PLACEMENT IN REGISTER
Incident reports and supplemental information	18. (1) 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	(2) 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
Coming into force	19. These Regulations come into force six months after the day on which they are registered.

SCHEDULE
(Paragraph 2(c))

INCIDENT EFFECTS IN THE ENVIRONMENT

Item	Column 1 Group	Column 2 Subgroup	Column 3 Major Effect	Column 4 Moderate Effect
1.	Birds	(a) Predatory birds	(a) 3	(a) 1 or more but fewer than 3
		(b) Birds that flock, except songbirds	(b) 150	(b) 50 or more but fewer than 150
		(c) Songbirds and all other birds	(c) 30	(c) 10 or more but fewer than 30
2.	Amphibians	Adults	30	10 or more but fewer than 30
3.	Mammals	(a) Small mammals such as bats, rabbits, squirrels and mice	(a) 30	(a) 10 or more but fewer than 30
		(b) Large or solitary mammals such as foxes, deer and moose	(b) 15	(b) 5 or more but fewer than 15
4.	Reptiles		30	10 or more but fewer than 30
5.	Fish	(a) Schooling fish	(a) 1,500	(a) 500 or more but fewer than 1,500
		(b) Non-schooling fish	(b) 150	(b) 50 or more but fewer than 150
6.	Large aquatic invertebrates, such as lobsters, mussels and shrimp		600	200 or more but fewer than 600
7.	Terrestrial invertebrates	(a) Honey bees	(a) 3,000 bees from each of 5 or more colonies, or 30% of the bees in any one colony	(a) 1,000 or more but fewer than 3,000 bees from each of 5 or more colonies, or 10% or more but less than 30% of the bees in any one colony
		(b) All other non-target terrestrial invertebrates, including beneficial insects used in integrated pest management	(b) N/A	(b) N/A
8.	Trees and shrubs		N/A	25 or more non-target plants in 5 or more incidents that occur within a calendar month
9.	Herbaceous plants		N/A	25% or more of non-target plants within the targeted spray area or within 20 m of its edge in 5 or more incidents that occur within a calendar month
10.	Aquatic plants		N/A	25% or more of the non-target plants in a body of water in 5 or more incidents that occur within a calendar month

Item	Column 1 Group	Column 5 Minor Effect	Column 6 Symptoms
1.	Birds	(a) N/A	(a) Death, impairment of health, reproductive impairment or congenital anomalies
		(b) 50	(b) Death, impairment of health, reproductive impairment or congenital anomalies
		(c) 10	(c) Death, impairment of health, reproductive impairment or congenital anomalies
2.	Amphibians	10	Death, impairment of health, reproductive impairment or congenital anomalies
3.	Mammals	(a) 10	(a) Death, impairment of health, reproductive impairment or congenital anomalies
		(b) 5	(b) Death, impairment of health, reproductive impairment or congenital anomalies
4.	Reptiles	10	Death, impairment of health, reproductive impairment or congenital anomalies
5.	Fish	(a) 500	(a) Death, impairment of health, reproductive impairment or congenital anomalies
		(b) 50	(b) Death, impairment of health, reproductive impairment or congenital anomalies
6.	Large aquatic invertebrates, such as lobsters, mussels and shrimp	200	Death, impairment of health, reproductive impairment or congenital anomalies
7.	Terrestrial invertebrates	(a) 10% of the bees in any one colony	(a) Death or abnormal behavioural effects
		(b) Any number of individuals	(b) Death
8.	Trees and shrubs	Any number of non-target plants in a single incident	More than 25% of the tree or shrub exhibits abnormal abscission or abnormal leaf discolouration, or there is a reduction in seed or fruit yield
9.	Herbaceous plants	Any percentage of non-target plants in a single incident at any distance from the targeted spray area	Death; injury visible to the naked eye: chlorosis, necrosis, bleaching, vein discolouration or abnormal abscission; terminal bud death; stunted vegetative growth; reduced seed or fruit yield; reduced emergence; abnormal flower quality or number; deformities, for example, in tubers; and epinasty
10.	Aquatic plants	Any percentage of the non-target plants in a body of water in a single incident	Death, abnormal plant stance or abnormal leaf discolouration

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

Pest control products (pesticides) are regulated in Canada under the federal Pest Control Products Act (PCPA). Health Canada's Pest Management Regulatory Agency (PMRA) administers the PCPA and Pest Control Products Regulations (PCPR) on behalf of the Minister of Health. A new PCPA was brought into force with the PCPR on June 28, 2006.

Under the PCPA, pesticides must be registered by the Minister of Health before they can be used in Canada. 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. Under the PCPA (section 13), registrants, a company in whose name a pesticide is registered, and applicants for the registration of a pesticide, are now required to report prescribed information (such as incidents) about their pesticides.

The Pest Control Products Incident Reporting Regulations (IRR) will enable PMRA to monitor adverse impacts on health and the environment in a timely fashion. Incident information reported will be evaluated and, if there are reasonable grounds to believe that the risks or value of the pesticide are no longer acceptable, appropriate measures, for example a special review, will be taken. Such a review may result in amendment or cancellation of a registration.

The IRR prescribe the information received by registrants and applicants that they are required to report and the time frames within which they are to report. The IRR define "incidents" as meaning an incident whose effects relate to the health or environmental risks or the value of a pest control product and that is described in section 2 of the IRR. The IRR also include general requirements about administration, such as the transfers of registration, language of reports, and record keeping.

The IRR require registrants and applicants to accurately report, within the following specified time frames:

human death; major incidents involving humans that occur in Canada; and major incidents in the environment are to be reported within 15 days;
major incidents involving humans that occur in the United States (U.S.); moderate incidents involving humans; domestic animal death that occurs in Canada; moderate incidents in the environment; residues in food; packaging failure; and incidents whose effect are identified in scientific studies are to be reported within one month after one month of accumulation;
domestic animal death that occurs in the U.S.; and major incidents involving domestic animals are to be reported within two months after three months of accumulation;
minor incidents involving humans; moderate and minor incidents involving domestic animals; and minor incidents in the environment are to be reported within two months following a 12-month accumulation period.

Incident reports, including supplemental information volunteered by the registrant, will be placed in the Register of Pest Control Products established under subsection 42(1) of the PCPA. The public will have access to any information in the Register that is not confidential or private. In addition, if as a result of an incident report it is concluded that a pesticide poses a significant risk, the PCPA requires that information to be actively disseminated to the public.

The form and manner by which the information is to be reported by registrants or applicants will be specified in supporting guidance documentation. This documentation will provide examples of the various categories of incidents.

In addition to the mandatory reporting requirements for registrants and applicants, the medical and research community, government and non-governmental organizations and individuals will also be able to report directly to PMRA through a voluntary incident reporting system. In some cases, for example potentially major incidents in the environment such as large bird or fish kills, federal or provincial authorities may report directly to PMRA in advance of the mandatory time frames for reporting by registrants. Although the voluntary reporting process is not formalized in regulations it is currently being refined to make it more consistent with the mandatory incident reporting system.

The IRR are very similar to the proposal that was pre-published for comment in the Canada Gazette, Part I, on October 23, 2004. In response to comments received, the IRR have been modified from the proposal in order to enhance efficiency and cost-effectiveness.

Alternatives

Section 13 of the PCPA cannot operate until the information to be reported and time frames for reporting are prescribed by regulation, therefore, there is no alternative to making a regulation. The IRR was designed to be consistent with other Canadian legislation (i.e., the Food and Drug Regulations and the new Species at Risk Act) and to be harmonized with the U.S. Environmental Protection Agency's (EPA) program to the extent possible. When more cost-effective alternative mechanisms were available, certain information (e.g., residues in water, efficacy failure, pest resistance) were not made subject to mandatory reporting in the IRR. This will contribute to increasing efficiency in reporting of incidents throughout North America.

Benefits and Costs

Benefits

The Minister of Health's mandate under the PCPA is to prevent unacceptable risks to people and the environment from the use of pesticides. It is important that PMRA has access to timely post-registration information regarding incidents related to pesticides. In order to ensure that the risks of registered pesticides continue to be acceptable, PMRA must be aware of, and must evaluate, new information that could cause their registration to be amended or cancelled. The PCPA requires that a special review be initiated where there are reasonable grounds for believing that the risks or value of a product are no longer acceptable.

The information on incidents reported under the IRR will provide information that will permit the identification of trends in relation to products, uses and geography. This will help PMRA prioritize re-evaluations and feed into reviews; help identify the need for improvements to pesticide labels; and help plan prevention and education activities in collaboration with consumers, users, the medical community, industries and governments. It was also determined through a strategic environmental assessment that this regulatory initiative may result in positive environmental impacts.

Costs to industry

Based on cost statements of the U.S. program, the cost of the Canadian system was estimated to be approximately $4,900,000 CAD in the first year and $3,800,000 CAD in subsequent years. The cost estimate provided by industry in Canada in 2004 was $48 million annually.

In the U.S., a statement of the cost of the adverse effects reporting program to registrants must be prepared and approved approximately every three years. The 1997 U.S. statement estimated the costs for registrants in the first year of the program to total $15,668,232 US ($257,760 US for reporting studies, $2,778,552 US for reporting incidents, $11,439,750 US for training). The most recent statement, prepared in 2003, calculated the annual cost of the ongoing U.S. program to be $12,039,547 US ($78,650 US for reporting studies, $7,341,600 US for reporting incidents, $4,619,297 US for training) or an average of $6,414 US for each of the 1,877 U.S. registrants.

To refine the estimated cost of the Canadian system, the differences between the U.S. program and the Canadian system and the difference in the number of incident reports that would be received in Canada compared to the U.S. were considered. Differences include: the scope of reportable information, the categories of incidents in the environment, the requirement to submit an annual summary, the report forms, aggregate reporting, etc. Differences in the number of incident reports between Canada and U.S. were estimated by comparing the number of registrants and registered products. Canada has far fewer registrants and registered products. There are 715 registrants and the number of registered products is 5,403, representing 38% and 29% of the number in the U.S. respectively. The number of incidents reported in Canada is therefore expected to be correspondingly less.

Given the reduced requirements of the Canadian program, the smaller number of Canadian registrants and registered products, and the general comparability of other program aspects, the cost estimate to Canadian industry is roughly one third of the calculated cost to the U.S. industry.

Costs to Government

The ongoing costs to Government to establish and maintain a system and procedures for receiving and evaluating the information on incident reports have been estimated at $1.1 million annually. The PMRA has previously been allocated funds to address this cost.

Conclusion

The significant benefits of mandatory reporting of incidents in enhancing the Government's ability to prevent unacceptable risks to people and the environment from the use of pesticides clearly outweigh the costs to industry and Government of implementing the IRR.

Evaluation

The design and continued relevance and cost-effectiveness of the IRR will be evaluated periodically. Annual reports will be made to the Parliament as required under the PCPA.

Consultation

Extensive consultation on the subject was conducted during the passage of the PCPA and the development of the IRR. Proposed Regulations were pre-published for comment on PMRA's website on May 22, 2003, and in the Canada Gazette, Part I, on October 23, 2004. Discussions also took place at meetings of the Pest Management Advisory Council (PMAC) in 2004 and 2005. Several other meetings were held with stakeholder associations. Respondents expressed general support for the proposed Regulations. Suggestions for improvements were incorporated, where possible. The comments received, as well as changes made to the proposed Regulations, are summarized below.

Title of the Regulations

Respondents expressed concerns regarding the perception that causality is established during the reporting process, and that this is reinforced by the earlier proposed title Pest Control Products Adverse Effects Reporting Regulations. In response, the term "adverse effect" was replaced with "incident" throughout the regulations. The word incident more accurately expresses the type and nature of the required reports. The title of the regulations has been changed to IRR.

Classification and Reporting Time Lines

Respondents requested that PMRA adopt the EPA's classification for incidents to avoid confusion and inefficiency, and reduce costs and risks of obtaining incomplete data collection, especially for Canadian registrants that are also U.S. registrants. Others supported that harm to a species at risk be included in the definition of an incident in the environment.

In general, the classification in the IRR was harmonized with EPA's, with some exceptions (e.g., domestic animal death and incidents in the environment).

The categories of "domestic animal death" and "an incident that has a major effect in a domestic animal" in the IRR differ from EPA's. The reference to euthanasia in the category of "domestic animal death" was removed from the IRR because euthanasia is not an incident in itself but rather a consequence of the incident. It was felt more appropriate to classify the incident according to the symptoms presented before the euthanasia. The category of "an incident that has a major effect in a domestic animal" was revised to include reproductive and developmental effects, in order to be consistent with the category of "an incident that has a major effect in a human".

The number of categories for incidents in the environment also differ from EPA's. The IRR define three categories for incidents in the environment, i.e., major, moderate and minor; those categories replace what was proposed in the Canada Gazette, Part I, to be consistent with the human health and domestic animal reporting categories. In EPA's regulations, only two categories are used: those incidents reportable on an individual basis (major) and those reportable on an aggregate basis (minor). The retention of the three categories will allow for more refined time lines for reporting. The schedule was also revised to incorporate more details to improve the readability of the IRR by inserting columns for each category of incident in the environment. Certain triggers (the number of individuals in a group or subgroup) were also modified to be more in line with the population dynamics of certain groups (e.g., predatory birds for which it would be unusual to recover 3 or more dead birds at one time).

Respondents also requested that PMRA adopt the EPA's aggregate reporting program particularly for incidents that occur in the U.S. In the U.S., aggregate reporting is permitted for certain specified incidents. Others supported the reporting of incidents on an individual basis. In response, the requirement to report incidents individually was retained as consultations with other government officials indicated that aggregate reporting can lead to an over-summarization of the effects associated with a particular pesticide.

Respondents also requested that PMRA harmonize time lines for reporting incidents with EPA's. Others supported the shorter time lines. In general, the reporting time lines in the IRR are harmonized with EPA's, except for certain incidents. For major incidents involving humans, domestic animal death, and major incidents in the environment, the time lines are shorter in Canada to allow for faster regulatory action, should this be warranted. Additionally, the time lines for reporting human death and major incidents involving humans are consistent with the time lines for reporting serious adverse drug reactions.

Misuse and Label Notices

Respondents also requested that incidents of intentional misuse not be excluded. The suggestion was accepted since it would be difficult to differentiate between intentional and accidental misuse. The reporting form will include a question asking registrants whether they believe the product was used according to label directions.

Respondents also requested that incidents that result from use of a pesticide, for which the label provides notice of the risk, be excluded from the reporting requirements. The suggestion was not accepted. Such incidents are subject to mandatory reporting. The reports will help PMRA determine whether further action is needed to prevent incidents from occurring.

Residues in water

Respondents requested that residues in water not be reported. Others supported maintaining such a requirement. In response, the requirement to report residues in water was not included in the IRR. Most of the water monitoring data in Canada are generated by provincial and federal departments. Requests for provincial monitoring data related to drinking water and drinking water sources are done through the Water Quality Health Bureau, located in Healthy Environments and Consumer Safety, within Health Canada. Through memoranda of understanding with federal departments and the federal/provincial/territorial committee on pesticides, PMRA will receive most Canadian water monitoring data from these government sources.

Packaging Failure

Respondents requested clarification on the scope of "packaging failure". In response, the category "packaging failure" was modified to include incidents that could result in injury to humans. A detailed guidance document will provide further clarification about the kinds of incidents that must be reported.

Pest Resistance and Efficacy Failure

Respondents requested that pest resistance and efficacy failure not be reported as this would create undue burden to registrants and data management issues within PMRA. Others supported maintaining such requirements.

In response, the requirement to report pest resistance was not retained. Pest resistance may only be evident over an extended period of time and may be difficult to prove, therefore, it should be left to academic, research and extension organizations. The amount of useful information that would result from such a requirement would be limited because demonstration of resistance requires laboratory testing. In addition, occurrence of pest resistance is already monitored by well established organizations, for example, the Herbicide Resistance Action Committee (HRAC), the Canadian Weed Science Society (CWSS), the Fungicide Resistance Action Committee (FRAC), the Canadian Phytopathological Society, the Insecticide Resistance Action Committee (IRAC) and the Canadian Entomological Society. The PMRA will obtain information on pest resistance directly from researchers.

The requirement to report efficacy failure was also not retained. The PMRA will become aware of potential problems more quickly by working directly with public health officials to identify incidents of efficacy failure.

Scientific Studies

In response to comments suggesting that all scientific studies be reported, not only those indicating new or increased risks, no revisions were made as this would result in a large amount of redundant information. Only incidents whose effects are identified in scientific studies sponsored by registrants or applicants are required to be reported.

Scientific Literature

In response to comments, the requirement to report information from the referenced published scientific literature was not included since literature searches are routinely conducted by PMRA staff.

Related Corporations

Concerns were expressed about a proposed requirement for a registrant to report information received by the employees and agents of related corporations located in other countries as this would be overly burdensome. In response, the IRR specify that scientific studies are not deemed to have been received by the registrant until one year after it was received by the related corporation. This is in consideration of the time required to compile and analyse information about studies sent from a related corporation to a Canadian registrant. The registrants' headquarters, many of which are located outside Canada, would receive information about registrant or applicant sponsored studies conducted anywhere in the world and it is important that this information be reported. The requirement to report other information according to specified time lines has been retained since the information would be readily available.

Incidents that Occur Outside Canada

Respondents requested that incidents that occur outside of Canada not be included. Others supported that all incidents that occur in the U.S. be reported. In response, the requirement to report an incident whose effect is a human death, that has a major effect in a human, or whose effect is a domestic animal death occurring in the U.S., has been retained. However, the requirement to report major incidents in the environment that occur in the U.S. has not been retained. PMRA will have access to the data on environment through the U.S. Ecological Incident Information System database. This will minimize the burden on registrants.

Multiple Registrants of Same Active Ingredient

In response to comments that duplication of reporting could occur where an active ingredient has multiple registrants, no changes were made. In most cases, incidents will be product-specific and in the few other cases, PMRA will sort the information to identify duplicate reports.

Annual Summary

Respondents requested that it not be required for registrants to provide a concise critical analysis annually since it would be too costly. In response, the IRR only require an annual summary from registrants who have submitted ten or more reports involving the same active ingredient during the year. This will allow PMRA to capture the most relevant annual summaries while reducing the burden on registrants.

Record Retention

Respondents suggested that the retention period be reduced to three or five years. Others supported an indefinite retention period. In response, a period of six years has been retained to be consistent with the maximum validity period for a pesticide registration.

Coming Into Force

In response to comments, the IRR will come into force six months from the date of registration of the regulations to allow time for both industry and PMRA to prepare for implementing the new requirements.

Disclosure of Information

Concerns were expressed that disclosing unverified, unresolved incident reports may unfairly impact products and/or registrants, particularly with false reports made by individuals. It was suggested that an offence for making a false report be included. Others suggested that incidents be reported by the public directly to the PMRA, rather than through the registrant, to ensure that all information is reported accurately.

In response, information on PMRA's website will be accompanied by a statement to advise that reported incidents have not been verified and do not indicate causality. The statement will advise that the information was reported by the registrant in order to comply with the IRR and carries no legal inference that the registrant accepts causality or responsibility for the incident. Any supplemental information provided by the registrant, including their opinions, will also be posted after removing any confidential information.

An offence for an individual making a false report cannot be added because the IRR apply only to registrants and applicants and cannot be extended to apply to a third party. The EPA has advised that they have not received any reported cases or complaints from industry about false reports in the seven years that their program has been operating. Even if a false report is made, it should be noted that it is very unlikely that a regulatory decision would be made on the basis of only one report. Rather, all available information about the issue will be considered in evaluating the risks posed by the product.

The obligation to report information also arises under the IRR when the information comes into the registrant's possession. The registrant cannot legally avoid that obligation by entering into an agreement with the information provider or anyone else. Since information about incidents will be posted on the website, an individual who has reported an incident to a registrant can check the website and inform PMRA if it appears the report is missing or incorrect. In addition to reporting incidents to registrants, individuals will also be able to report directly to PMRA.

The pro-active posting of incident reports will increase transparency and is consistent with the approach taken with adverse drug reaction reports. It will reduce the need for submitting access to information requests by pro-actively providing access to information to the public and medical community. Stakeholders will be notified when the system is in place. In addition, a link to a single window for reporting has been developed for the Health Canada Web site home page http://www.hc-sc.gc.ca/ahc-asc/ media/reaction/index_e.html.

Compliance and Enforcement

The PMRA promotes, maintains and enforces compliance with the PCPA through compliance promotion programs, inspections, both monitoring and surveillance, and investigations. The programs aim to educate, facilitate and promote compliance as well as to communicate regulatory information. Monitoring inspections are designed to determine the level of compliance of users, distributors and registrants of pesticides with specific terms and conditions of registration and re-evaluation and the provisions of the PCPA and regulations.

Enforcement response actions may include education (written and oral), administrative monetary penalties or warning under the Agriculture and Agri-Food Administrative Monetary Penalties Act (AMPA) and prosecutions under the PCPA. The goal of any enforcement response is to achieve and maintain compliance. Since the majority of the regulated community will comply with the law if they understand it and have the capacity to comply, many violations are dealt with and corrected using education as a means to address non-compliance situations and behaviour.

In general, compliance with the PCPA and regulations is achieved through a network of officers and inspectors across Canada. Health Canada regional staff also have formal agreements providing a basis to collaborate with provincial pesticide regulatory officials in investigations and in the development and delivery of programs.

The PMRA will follow an established compliance policy to promote and enhance fair treatment of the regulated community. The document is available on PMRA website at http://www.pmra-arla.gc.ca.

Contact

Francine Brunet
Alternative Strategies and Regulatory Affairs Division
Pest Management Regulatory Agency
Health Canada
2720 Riverside Drive
Address Locator 6607D1
Ottawa, Ontario
K1A 0K9
Telephone: (613) 736-3678
FAX: (613) 736-3659
E-mail: pmra_regulatory_affairs-affaires_reglementaires_arla@hc-sc.gc.ca

Footnote a

S.C. 2002, c. 28

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with hypertext language (HTML). Its content is very similar except for the footnotes, the symbols and the tables.


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Updated: 2006-11-23