Pest Control Products Regulations

Contents

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 67 of the Pest Control Products Act, hereby makes the annexed Pest Control Products Regulations.^note

Interpretation

1Definitions#

(1)The following definitions apply in these Regulations.

Act means the Pest Control Products Act. (Loi)

antimicrobial agent means a non-agricultural pest control product that is manufactured, represented, distributed or used as a means to directly or indirectly control or destroy the following on or in inanimate objects, industrial processes and systems, surfaces, water and air:

(a)micro-organisms; and

(b)organisms that are not vascular plants and that cause fouling. (agent antimicrobien)

antimicrobial preservative means a chemical substance, or a mixture of chemical substances, that is intentionally incorporated into, or applied to, an article for the purpose of preserving it from deterioration or degradation by preventing the growth of micro-organisms. (agent de conservation antimicrobien)

approved label means a label that meets the conditions of registration relating to the label as specified by the Minister and that is placed in the Register. (étiquette approuvée)

CAS registry number means the identification number that is assigned to a chemical substance by the Chemical Abstracts Service Division of the American Chemical Society. (numéro d’enregistrement CAS)

certificate of equivalency means a certificate that is issued under subsection 39(1) with respect to a foreign product. (certificat d’équivalence)

common chemical name, with respect to an active ingredient of a pest control product, means the name set out in International Standard ISO 1750:1981 (E/F), entitled Pesticides and other agrochemicals — Common names, published by the International Organization for Standardization, as amended from time to time. (nom chimique commun)

conditional registration [Repealed, SOR/2017-91, s. 1]

cooperator means an individual, a corporation or an unincorporated entity, or part of one, that agrees to use or allows the use of a pest control product for research purposes on a site owned or operated by it. (collaborateur)

device means an instrument, gadget, apparatus, appliance or other similar object. (dispositif)

display panel means the part of the label that is affixed to the container, wrapping, covering or holder in which a pest control product is wholly or partly contained, placed or packed. It does not include any brochure or leaflet that accompanies the product. (aire d’affichage)

domestic animal means an animal that is under the control of humans and dependent on them for its survival. (animal domestique)

equivalency certificate [Repealed, SOR/2014-24, s. 1]

experimental label means a label that is for use during research. (étiquette de stade expérimental)

foreign product means a pest control product that is registered in a country other than Canada. (produit étranger)

foreign product use certificate means a certificate that is issued under subsection 41(3) with respect to an imported foreign product. (certificat d’utilisation d’un produit étranger)

marketplace label means a label that matches the approved label and that has added to it any other written, printed or graphic matter that relates to the pest control product. (étiquette de marché)

metric unit means a unit of measurement set out in Schedule I to the Weights and Measures Act. (unité métrique)

microbial agent means a pest control product whose active ingredient is a micro-organism. It includes any metabolites and toxins produced by the micro-organism. (agent microbien)

own use [Repealed, SOR/2014-24, s. 1]

own-use import certificate [Repealed, SOR/2014-24, s. 1]

ozone-generating device means a device that is manufactured, represented, distributed or used to control, destroy or inactivate viruses, bacteria or other micro-organisms that are human pathogens or to reduce their population levels — other than in swimming pools, spas or wastewater or drinking-water treatment systems — by means of the generation of ozone. (dispositif générateur d’ozone)

pheromone means a semiochemical that is produced by an individual of a species and that affects the behaviour of other individuals of the same species. (phéromone)

principal display panel means the part of the display panel that is visible under normal conditions of display for sale. (aire d’affichage principale)

product certification body means a body that is accredited by the Standards Council of Canada to give third-party written assurance that a product meets the specified requirements for the product, including initial certification and maintenance of that certification. (organisme de certification de produits)

registration certificate means a certificate issued under section 12 that states that the pest control product named in it is registered under the Act. (certificat d’homologation)

research means tests that are carried out to generate test data in support of an application for registration of a pest control product or an application to amend a registration, using a pest control product that contains an unregistered active ingredient, using an unregistered pest control product that contains a registered active ingredient or using a registered pest control product in a manner or for a use that is not specified in the conditions of registration. (recherche)

research authorization certificate means a certificate issued under subsection 50(2) that states that the pest control product named in it may be used in conducting research. (certificat d’autorisation de recherche)

researcher means an individual who is employed by or who provides service to a research establishment and who is responsible for using or supervising the use of a pest control product for research purposes. (chercheur)

research establishment means a person who is engaged in research that pertains to a pest control product. (établissement de recherche)

research notification certificate means a certificate issued under section 54 that confirms that proposed research meets the criteria set out in section 53. (certificat d’avis de recherche)

research site means an area that is treated or to be treated with a pest control product for the purpose of conducting research. (site de recherche)

secondary display panel means the part of the display panel other than the principal display panel. (aire d’affichage secondaire)

seed means a generative part of a plant that is used for propagation purposes. It includes seed-like fruits, bulbs, tubers and corms but does not include whole plants or cuttings. (semence)

semiochemical means a message-bearing chemical that is produced by a plant or an animal, or a synthetic analogue of such a chemical, that evokes a behavioural response in individuals of the same or another species. (écomone)

Stockholm Convention means the Stockholm Convention on Persistent Organic Pollutants, signed at Stockholm on May 22, 2001, as amended from time to time. (Convention de Stockholm)

treated article means an inanimate product or substance, but does not include a food as defined in section 2 of the Food and Drugs Act,

(a)that, during the manufacturing process, is treated with a pest control product either by intentionally:

(i)incorporating the product into the article; or

(ii)applying it to the article, and

(b)whose primary purpose, prior to that treatment, is not, directly or indirectly, to control, destroy, attract or repel a pest or to mitigate or prevent the injurious, noxious or troublesome effects of a pest. (article traité)

treated seed means seed into which a pest control product is intentionally incorporated or to which the product is applied. (semence traitée)

ultraviolet radiation-emitting device means a device that is manufactured, represented, distributed or used to control, destroy or inactivate viruses, bacteria or other micro-organisms that are human pathogens or to reduce their population levels — other than in swimming pools, spas or wastewater or drinking-water treatment systems — by means of ultraviolet radiation. (dispositif à rayonnement ultraviolet)

validity period means the period specified under paragraph 8(1)(c) of the Act. (période de validité)

(2)For the purpose of the application of the definition common chemical name in subsection (1), the common chemical name “carboxin” is to be read as “carbathiin” wherever it appears in the Standard referred to in that definition.

Prescribed Pest Control Products

2Prescribing#

For the purpose of paragraph (c) of the definition pest control product in subsection 2(1) of the Act, the following are prescribed to be pest control products:

(a)a device that is manufactured, represented, distributed or used to directly or indirectly control, destroy, attract or repel a pest or to mitigate or prevent the injurious, noxious or troublesome effects of a pest;

(b)a compound or substance that is not an ingredient of a pest control product described in paragraph (a) of that definition but is added to or used with such a product to enhance or modify its physical or chemical characteristics or to modify an effect on host organisms in connection with which the product is intended to be used;

(c)an active ingredient that is manufactured, represented, distributed or used to directly or indirectly control, destroy, attract or repel a pest or to mitigate or prevent the injurious, noxious or troublesome effects of a pest;

(d)a treated article; and

(e)treated seed.

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Exemption of Certain Pest Control Products

3Exemption from application of Act#

(1)The following pest control products are exempt from the application of the Act:

(a)a pest control product that is a device of a type not described in Schedule 1;

(a.1)despite paragraph (a), an ultraviolet radiation-emitting device or ozone-generating device that is a device as defined in section 2 of the Food and Drugs Act and classified as a Class II, III or IV medical device under the Medical Devices Regulations;

(b)a pest control product that is subject to the Food and Drugs Act and that is used only

(i)to control arthropods on or in humans or animals, if the pest control product is to be administered directly and not by topical application, or

(ii)during the cooking or processing of food for humans to preserve the food;

(c)a pest control product that is used to control viruses, bacteria or other micro-organisms in premises in which food is manufactured, prepared or kept for sale;

(d)a pest control product that is a drug, as defined in section 2 of the Food and Drugs Act, that is used to destroy or inactivate micro-organisms, or to reduce or control their number, on a non-living and non-liquid surface, other than a pest control product that is a biocide, as defined in subsection 1(1) of the Biocides Regulations, to which the exemption in subsection 66(1) or (3) of those Regulations applies;

(e)[Repealed, SOR/2024-110, s. 85] (repealed)

(f)a pest control product — other than an organism, a device of a type described in Schedule 1 or a treated article — that is imported by a user for their personal use, that is in their possession at the time of the importation and that meets the following conditions:

(i)the total quantity of the product does not exceed 500 g or 500 mL,

(ii)by virtue of its active ingredient and concentration, the product would have the product class designation “DOMESTIC” if it were registered in Canada,

(iii)the product is registered or otherwise authorized in the country of origin as a product equivalent to a pest control product,

(iv)the product is in its original package with the original label intact,

(v)the information on the package and label is in either English or French, is clear and legible, allows for the determination of the active ingredient, concentration and quantity of the product and includes the registration or authorization number assigned by the regulatory body in the country of origin;

(g)a pest control product that is a treated article into which the only pest control product that is incorporated or to which the product is applied is an antimicrobial preservative, if

(i)the product is imported by a user for their personal use,

(ii)the product is in their possession at the time of the importation,

(iii)the product is in its original package with the original label intact, and

(iv)the information on the package and label is in English or French and is clear and legible; and

(h)a pest control product that is

(i)an antimicrobial preservative when it is used in the manufacture of a treated article that is

(A)a feed that is regulated under the Feeds Act,

(B)a fertilizer or supplement that is regulated under the Fertilizers Act,

(C)a drug or cosmetic that is regulated under the Food and Drugs Act, or

(D)a medical device that is a device as defined in section 2 of the Food and Drugs Act and classified as a Class I, II, III or IV medical device under the Medical Devices Regulations, or

(ii)a treated article that is described in any of clauses (i)(A) to (D) into which the only pest control product that is incorporated or to which the product is applied is an antimicrobial preservative.

(2)A pest control product that is exempt under paragraph (1)(c) or (d) is exempt only in respect of any use described in that paragraph.

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3.1Import solely for export#

(1)A person may import a pest control product that is intended solely for the purpose of export.

(2)A person may possess, handle, store or transport the imported pest control product for the purpose of export.

(3)Sections 3.2 to 75 do not apply to a pest control product that is imported under subsection (1) if it is subject to the Transportation of Dangerous Goods Act, 1992.

(4)Sections 4 to 75 do not apply to a pest control product that is imported under subsection (1) if it is not subject to the Transportation of Dangerous Goods Act, 1992.

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3.2Safety information#

(1)The information set out in subsection (2) and the safety information set out in subsections (3) to (8) must

(a)appear in documents that accompany the shipment of the pest control product during transport through Canada and during any short-term storage in Canada;

(b)be readily available for use in emergency response to any accidents or incidents involving that product;

(c)appear in a manner that is clearly legible and indelible;

(d)appear in either English or French; and

(e)appear in documents that accompany each load of a shipment, if the shipment is broken into loads that are sent to different destinations.

(2)The shipment of the pest control product must be accompanied by documents that contain all of the following information:

(a)the name of the product, which may include a distinctive brand or trademark;

(b)a declaration of net quantity of the product in the package;

(c)the name of the importer and the names of the exporter and owner of the product, if either is different from the importer;

(d)the name, postal address, email address and telephone number of a contact person to whom public inquiries may be directed; and

(e)the physical form of the product.

(3)The shipment of the pest control product must be accompanied by documents that contain information that identifies the nature and degree of hazard inherent in the pest control product by appropriate precautionary symbols and signal words selected from either Schedule 3 or 4. For precautionary symbols and signal words selected from Schedule 4, a hazard statement that indicates the nature of the primary hazard to which the precautionary symbol relates must also be included.

(4)The shipment of the pest control product must be accompanied by documents that contain the following information:

(a)the common chemical name of the active ingredient of the pest control product or, if it has no common chemical name, its chemical or other name; and

(b)the concentration of the active ingredient.

(5)The shipment of the pest control product must be accompanied by documents that contain the following information:

(a)instructions that set out the practical measures to be taken in the event of poisoning, intoxication or injury caused by the pest control product and that include the statement “Take the documents accompanying the shipment or the container label, if it contains the same information, or the product name with you when seeking medical attention.”; and

(b)information that is essential to the treatment of persons who are poisoned, intoxicated or injured by the pest control product, including

(i)antidotes and remedial measures or, if no specific antidote or remedial measure exists, the statement “Treat symptomatically.”,

(ii)a description of the injury or the symptoms of poisoning or intoxication, and

(iii)a list of the components of the product that may affect the treatment.

(6)The shipment of the pest control product must be accompanied by documents that contain information that identifies the appropriate measures to be taken with respect to firefighting, handling, transportation and storage of the pest control product.

(7)The shipment of the pest control product must be accompanied by documents that contain instructions on the procedure to be followed

(a)in case of accidental release;

(b)for decontamination; and

(c)for the safe disposal of the pest control product and its packages.

(8)The shipment of the pest control product must be accompanied by documents that contain information that identifies any significant risk to health and the environment, and instructions on procedures to reduce that risk.

(9)The packaging of the pest control product must be constructed

(a)to contain the product safely under normal conditions of storage and transportation; and

(b)to minimize degradation or change of its contents.

(10)The pest control product must be stored and transported in a separate compartment from any human food or animal feed or in such a way as to avoid any possible contamination of the food or feed if

(a)the product bears the signal word “POISON” superimposed on the precautionary symbol for danger set out in item 2 of Schedule 3; or

(b)the product bears the signal word DANGER and the hazard statements “Fatal if swallowed”, “Fatal in contact with skin”, “Toxic if swallowed”, “Toxic in contact with skin”, “Toxic if inhaled” or “Fatal if inhaled” set out in item 4 of Schedule 4.

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3.3Information to be provided on request#

(1)The importer, exporter or owner of the pest control product imported solely for the purpose of export must provide the following information to the Minister, in the manner requested, on request:

(a)the name of the importer and the names of the exporter and owner of the product, if either is different from the importer;

(b)notification of import of the product 30 days in advance of the expected date of import;

(c)notification of export of the product;

(d)the place of entry or port of unloading;

(e)the name of the freight forwarder, if any;

(f)the name of the shipper or carrier; and

(g)any other information required under subsections 3.2(2) to (8).

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Unregistered Pest Control Products

4Permitted activities#

(1)A person may manufacture, possess, handle, store, transport, import, distribute or use the following unregistered pest control products under the Act:

(a)an active ingredient that is used only in the manufacture of a registered pest control product that was registered on January 1, 1984, or was registered after January 1, 1984 and the application for its registration was received by the Minister on or before that date, and the active ingredient meets the relevant conditions of registration of the registered pest control product;

(b)a pest control product

(i)that is of a type described in Schedule 2 and that meets the applicable conditions set out in that Schedule, and

(ii)the active ingredient of which is registered under the Act;

(c)a pest control product that is an ultraviolet radiation-emitting device, other than an ultraviolet lamp or other component that emits ultraviolet radiation, if

(i)the device is certified by a product certification body as meeting the applicable Canadian electrical safety requirements,

(ii)the certification mark of the product certification body appears on the label of the device,

(iii)any claim of efficacy that is made in respect of the device is made only in relation to supplemental sanitization,

(iv)no express or implied claim in relation to the treatment, mitigation or prevention of disease is made in respect of the device,

(v)its ultraviolet lamp, or other component that emits ultraviolet radiation, is fully shielded or enclosed in the device, in a manner that prevents exposure to ultraviolet radiation,

(vi)the device has a mechanism that

(A)locks the device to prevent access to the ultraviolet lamp, or other component that emits ultraviolet radiation, during operation, or

(B)automatically shuts off the device if it is opened during operation,

(vii)a user of the device who follows the instructions referred to in paragraph 30.1(3)(c) for replacing the ultraviolet lamp or any other component that emits ultraviolet radiation is not exposed to the radiation,

(viii)the device does not produce or generate any other substance, including ozone or hydroxyl, that may be harmful to human health during operation, and

(ix)the device is used in commercial or industrial premises or in educational institutions, health care facilities or similar institutions or facilities and, as applicable,

(A)it does not meet the requirement set out in subparagraph (v), is contained within the ventilation system in a manner that prevents exposure to ultraviolet radiation and is installed by an electrician who is the holder of a licence issued by the applicable provincial licensing authority, or

(B)it does not meet one of the requirements set out in subparagraph (v) or (vi) and is certified by a product certification body either as being part of the Exempt group classification set out in the IEC 62471 standard developed by the International Electrotechnical Commission entitled Photobiological safety of lamps and lamp systems, as amended from time to time, or as meeting the applicable requirements of one of the standards set out in the List of Equivalent Standards for Ultraviolet Photobiological Hazard Assessment, published by the Government of Canada on its website, as amended from time to time;

(d)an ultraviolet radiation-emitting device that is an ultraviolet lamp, or other component that emits ultraviolet radiation, if the component

(i)is manufactured, represented or distributed solely for use in a device referred to in paragraph (c), and

(ii)meets the conditions set out in subparagraphs (c)(iii) and (iv);

(e)an ultraviolet radiation-emitting device that is an ultraviolet lamp, or other component that emits ultraviolet radiation, that is manufactured, represented or distributed for use as a component in a registered device, if

(i)the component is evaluated as part of an application to register, amend or renew the registration of the device, and

(ii)the label of the component contains any information specified by the Minister in the conditions of registration;

(f)a pest control product that is a treated article into which the only pest control product that is incorporated or to which it is applied is an antimicrobial preservative, if

(i)the sole purpose of the treatment is to protect or preserve the article,

(ii)the active ingredient of the preservative is registered or otherwise authorized under paragraph 21(5)(a) of the Act for incorporation into, or application to the article,

(iii)in the case where the article is treated in Canada, the preservative is registered or otherwise authorized under paragraph (b) or paragraph 21(5)(a) of the Act,

(iv)in any other case, the treatment

(A)includes the same active ingredient as that contained in a preservative registered in Canada or otherwise authorized under paragraph (b) or paragraph 21(5)(a) of the Act, and

(B)meets any conditions of registration or authorization, as the case may be, that relate to the method of application, the uses for which the preservative may be applied to or incorporated into the article and the range of application rates as specified by the Minister under the Act or as set out in Schedule 2; and

(g)a pest control product that is also a food additive set out in column 1 of the List of Permitted Preservatives, published by the Government of Canada on its website, as amended from time to time, if

(i)the product is used as an antimicrobial preservative,

(ii)the sole purpose of the treatment is to protect or preserve the article, and

(iii)the quantity of preservative protects or preserves the article, but does not exceed the quantity necessary to do so.

(2)A pest control product referred to in paragraph (1)(a) must not be used for any purpose other than the manufacture of a registered pest control product.

(3)A person may possess, handle, store, transport, import or use a foreign product that is imported under a foreign product use certificate.

(3.1)[Repealed, SOR/2022-99, s. 5] (repealed)

(4)A person may manufacture, possess, handle, store, transport, import or use a pest control product for the purpose of conducting research in accordance with sections 46 to 70.

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Unregistered Pest Control Products for Export

4.1Permitted activities — for exportation of certain products#

(1)A person may manufacture, possess, handle, store or transport — or import for use in manufacturing — the following unregistered pest control products under the Act, solely for the purpose of export:

(a)an ultraviolet radiation-emitting device;

(b)an ultraviolet lamp or other component that emits ultraviolet radiation;

(c)an ozone-generating device; and

(d)a pest control product that contains an active ingredient that is registered in Canada.

(2)Before a pest control product referred to in any of paragraphs (1)(a) to (c) is shipped, the manufacturer must prepare an export certificate, in the manner specified by the Minister, indicating that the product does not contravene any known requirements of the law of the countries to which it is shipped, consigned or about to be consigned.

(3)If the pest control product or the country of export changes, the manufacturer must prepare a new certificate.

(4)The manufacturer must keep a record of the certificate for five years after the date of the last shipment.

(5)The manufacturer must provide the certificate to the Minister on request and within the period specified.

(6)Subsections 3.2(1) to (3), and (6) to (10) apply to the pest control products referred to in paragraphs (1)(a) to (c).

(7)A pest control product referred to in paragraph (1)(d) must meet the requirements of section 3.2.

(8)Section 33 does not apply to a pest control product referred to in subsection (1).

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Product Classes

5Designation#

The following are the classes of pest control products:

(a)“DOMESTIC”, if the pest control product is to be distributed primarily to the general public for personal use in or around their homes;

(b)“COMMERCIAL”, if the pest control product is to be distributed for use in commercial activities that are specified on the label;

(c)“RESTRICTED”, if the pest control product is one for which the Minister, out of concern for its health or environmental risks, has set out additional information to be shown on the label concerning essential conditions respecting the display, distribution or limitations on use of, or qualifications of persons who may use, the product; and

(d)“MANUFACTURING”, if the pest control product is to be used only in the manufacture of a pest control product or a product regulated under the Feeds Act or the Fertilizers Act.

Methods of Electronic Delivery

5.1Electronic delivery#

(1)For the purpose of subsection 62(1) of the Act, notices or other documents required or authorized to be delivered under the Act may be delivered electronically through the website of the Government of Canada or by another means of electronic communication.

(2)A notice or other document that is delivered electronically is considered to have been delivered

(a)if it was delivered through that website, on the earlier of

(i)the date of its delivery as indicated through that website, and

(ii)the date of its delivery as indicated by a means of automatic electronic communication generated by that website; and

(b)if it was delivered using another means of electronic communication, on the date that is indicated as the day of its delivery by the other means.

(3)A deemed time of delivery of a notice or other document may be set aside on the basis of any metadata or data from any other tracking system that relates to the notice or other document.

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Application for Registration

6Contents#

(1)An application to register or amend the registration of a pest control product must include all of the following information:

(a)the applicant’s name, address and signature or, if the application is made by a representative of the applicant, both the representative’s and applicant’s name and address and the representative’s signature;

(b)the name and address of

(i)each place of manufacture of the pest control product, if it is or contains a microbial agent, and

(ii)each place of production and formulation of the pest control product, in any other case;

(c)the product name referred to in paragraph 26(1)(a);

(d)the product type referred to in paragraph 26(1)(b);

(e)the product’s physical form referred to in paragraph 26(1)(c);

(f)the registration number referred to in paragraph 26(1)(i), if there is one;

(g)in the case of

(i)a chemical pest control product that is an active ingredient, its chemical name, common chemical name and CAS registry number, its percentage of the total weight of the product in which it is contained, the name of each contaminant and other impurity that it contains, and the percentage of total weight of each contaminant and impurity,

(ii)a chemical pest control product other than an active ingredient, the chemical name, common chemical name and CAS registry number of each active ingredient in the product, each active ingredient’s percentage of the total weight of the product, and the registration number of each active ingredient or other pest control product used to manufacture the product, and

(iii)any other pest control product, any characteristics that are relevant to its health or environmental risks or value;

(h)in the case of a pest control product that contains one or more formulants, the name of each formulant, its CAS registry number if any, its percentage of the total weight of the product and its purpose in the product;

(i)the size, type and specifications of the package in which the pest control product is to be distributed; and

(j)the statement described in paragraph 26(1)(h).

(2)The applicant must include an electronic copy of the proposed label with every application to register a pest control product and with any application to amend the registration of a pest control product that would result in a change to the label.

(3)The applicant must include with every application to register or amend the registration of a pest control product a statement signed by the applicant certifying that the information in the application is accurate and complete.

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7Records#

(1)An applicant referred to in subsection 6(1) or a registrant referred to in subsection 16(1) must keep records of

(a)in the case of a pest control product other than one that is or contains a microbial agent, the address of each place of manufacture of a pest control product, other than a place of production or formulation; and

(b)in the case of a pest control product that contains one or more formulants, the name and address of the supplier of each formulant.

(2)The applicant or the registrant must keep the records for five years after, as the case may be, the date of registration, its amendment or its renewal.

(3)If the information contained in the records changes, the applicant or registrant must update it but the previous records must be kept for five years after the day on which the update occurs.

(4)On request by the Minister, an inspector or an analyst, the applicant or registrant must provide any records to the Minister, the inspector or the analyst within the period specified in the request.

7.1Stockholm Convention — evaluations not necessary#

(1)No evaluation under paragraph 7(3)(a) of the Act is necessary when

(a)the application is to register or amend the registration of a pest control product that is or contains an active ingredient that is listed as a chemical in Annex A (Elimination) or Annex B (Restriction) of the Stockholm Convention;

(b)the application pertains to a production or use of the active ingredient that is prohibited under the Convention;

(c)the amendment to the Convention that resulted in the listing has been ratified by Canada by the deposit of its instrument of ratification with the Secretary-General of the United Nations acting as the Depository of the Convention; and

(d)the proposed production or use of the active ingredient in the application:

(i)is not subject to a specific exemption, or acceptable purpose, notified by Canada under the Convention, as set out in the Register of Specific Exemptions, or a Register of Acceptable Purposes, established under that Convention, or

(ii)is not otherwise permitted under the Convention.

(2)For the purpose of subsection 8(4) of the Act, the health or environmental risks of a pest control product described in subsection (1) are not acceptable.

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8Additional information required#

In addition to the information required by section 6, the applicant must provide the Minister with any other information that the Minister may require to evaluate the health and environmental risks and the value of the pest control product, including, if relevant to the product and its conditions or proposed conditions of registration, the results of scientific investigations respecting any of the following:

(a)the efficacy of the pest control product for its intended purpose;

(b)the risks posed by the pest control product and its derivatives to humans or animals that may be exposed to it, including when it is manufactured, handled, stored, transported or distributed or during or after its use or disposal, in accordance with its conditions or proposed conditions of registration;

(c)the effect of the pest control product and its derivatives on host organisms in connection with which it is intended to be used;

(d)the effect of the pest control product and its derivatives on representative species of organisms not targeted by its intended use;

(e)the degree of persistence, retention and movement of the pest control product and its derivatives in the environment, including the degree to which the pest control product and its derivatives may leach or dislodge from things treated with the product;

(f)methods of analysis for detecting the components and measuring the characteristics of the pest control product;

(g)methods of analysis for detecting and determining the amount of the pest control product and its derivatives in human food, animal feed and the environment when the product is used in accordance with its conditions or proposed conditions of registration;

(h)appropriate methods for detoxifying or neutralizing the pest control product in water, air or soil, or on any surface;

(i)appropriate methods for disposing of the pest control product and its empty packages;

(j)the stability of the pest control product under normal conditions of storage and display;

(k)the compatibility of the pest control product with other pest control products with which it is recommended to be, or is likely to be, mixed;

(l)the effect of mixing the pest control product or using it simultaneously with other pest control products on its value and the health and environmental risks associated with its use;

(m)the chemical and physical properties, or the species or strain and biological properties, of the pest control product, its composition, and specifications and processes for its manufacture, including quality control processes;

(n)the fate of the pest control product in humans or animals exposed to it, including the identity and quantity of all the major metabolites and other derivatives that result from its use;

(o)the residues of the pest control product and its derivatives that may remain in or on human food or animal feed after its use in accordance with its conditions or proposed conditions of registration;

(p)the risks posed to humans or animals exposed to the pest control product or its derivatives through their diet or drinking water when the product is used in accordance with its conditions or proposed conditions of registration;

(q)the effect of storing and processing, including post-market processing, human food or animal feed in relation to which the pest control product was used on the dissipation or degradation of the pest control product and any of its derivatives;

(r)the proposed maximum residue limits for the pest control product and its derivatives in or on human food; and

(s)the fate of the pest control product and its derivatives in subsequent crops of human food or animal feed.

^note

9Additional information — affidavit and contents#

(1)When, in the context of an application for registration or to amend a registration, the Minister considers additional information under paragraph 7(6)(b) of the Act that is not publicly available, the applicant must be given access to that information by the Minister for the purpose of making representations under that paragraph with respect to the information, if the applicant submits to the Minister an affidavit made under oath or a statutory declaration under the Canada Evidence Act made before a commissioner for oaths or for taking affidavits that

(a)identifies the information to which access is being requested;

(b)acknowledges that the access is given only for the purpose of enabling the applicant to make representations to the Minister with respect to the information;

(c)states that the applicant will not use the information or make it available to any person for any other purpose; and

(d)states that the information and any copies of it will be returned to the Minister when the stated purpose has been achieved.

(2)The applicant to whom access to additional information is given under subsection (1) must not use the information or provide it to any person for any purpose other than to make representations under paragraph 7(6)(b) of the Act with respect to the information.

(3)Additional information to which access is given under subsection (1) and any copies of it must be returned to the Minister by the applicant immediately after they have made their representations with respect to the information.

^note

10Reference in Register#

For the purpose of subsection 42(4) of the Act, evaluation reports that are placed in the Register under paragraph 42(2)(f) of the Act must include a reference to information placed in the Register under paragraph 42(2)(e) of the Act.

11Samples on request#

On application to register or amend the registration of a pest control product, the applicant must, if requested by the Minister, provide the Minister with a sample of

(a)the pest control product;

(b)the technical grade of its active ingredient; and

(c)the laboratory standard of its active ingredient.

12Registration certificate#

When a pest control product is registered or a registration is amended under section 8 of the Act, the Minister must issue a registration certificate that bears the registration number of the pest control product and sets out any conditions of registration specified by the Minister.

Validity Period

13Maximum validity period#

The validity period of a registration of a pest control product must end no later than December 31 in the fifth year after the year in which the product is registered.^note

14 #

[Repealed, SOR/2017-91, s. 4] (repealed)

15 #

[Repealed, SOR/2017-91, s. 4] (repealed)

Renewal of Registration

16Five-year periods#

(1)The registration of a pest control product may be renewed, on application by the registrant to the Minister, for additional periods of not more than five years each.

(2)An application to renew the registration of a pest control product must be accompanied by the following:

(a)the information required by subsection 6(1);

(b)the statement required by subsection 6(3);

(c)the information required by section 8;

(d)if sections 17.05 to 17.11 apply, whichever of the following documents is applicable:

(i)a document that establishes that, as of the date the application is made, a negotiated settlement between the registrant and the data holder has been reached or an arbitral award has been made in respect of the test data and the data holder has not provided a letter of access referred to in section 17.1 to the registrant, or

(ii)a copy of the letter of access referred to in section 17.1; and

(e)if sections 17.12 to 17.17 apply, whichever of the following documents is applicable:

(i)a document that establishes that, as of the date the application is made,

(A)the registrant and data holder are negotiating the compensation payable in respect of the test data,

(B)the determination of the compensation payable in respect of the test data has been submitted to binding arbitration and an arbitral award has not been made, or

(C)a negotiated settlement between the registrant and the data holder has been reached or an arbitral award has been made in respect of the test data and the data holder has not provided a letter of access referred to in section 17.17 to the registrant, or

(ii)a copy of the letter of access referred to in section 17.17.

(2.1)In subsection (2), data holder and test data have the same meanings as in section 17.01.

(3)The registrant must, if requested by the Minister, provide the Minister with an electronic copy of the approved label and two hard copies of the marketplace label.

^note

Re-evaluations and Special Reviews

17Additional information — affidavit and contents#

(1)When, in the context of a re-evaluation or special review, the Minister considers additional information under paragraph 19(1)(c) of the Act that is not publicly available, the registrant must be given access to that information by the Minister for the purpose of making representations under that paragraph with respect to the information, if the registrant submits to the Minister an affidavit made under oath or a statutory declaration under the Canada Evidence Act made before a commissioner for oaths or for taking affidavits that

(a)identifies the information to which access is being requested;

(b)acknowledges that the access is given only for the purpose of enabling the registrant to make representations to the Minister with respect to the information;

(c)states that the registrant will not use the information or make it available to any person for any other purpose; and

(d)states that the information and any copies of it will be returned to the Minister when the stated purpose has been achieved.

(2)The registrant to whom access to additional information is given under subsection (1) must not use the information or provide it to any person for any purpose other than to make representations under paragraph 19(1)(c) of the Act with respect to the information.

(3)Additional information to which access is given under subsection (1) and any copies of it must be returned to the Minister by the registrant immediately after they have made their representations with respect to the information.

^note

Protection of Test Data

Definitions

17.01Definitions#

The following definitions apply in this section and sections 17.02 to 17.17.

agreement means an agreement referred to in subsection 66(1) of the Act. (entente)

compensable data means test data that the Minister considers for the first time in support of a registration, confirmation of the registration or amendment of the registration, but does not include

(a)test data that is referred to in the definition exclusive rights;

(b)test data that is included in a scientific study that has been published; or

(c)test data that is generated by a scientific study that is fully funded by a government or one of its institutions. (données assujetties à des droits à payer)

crop group means a group of crops in which the residues at harvest are similar, based on similarities in appearance, harvestable commodity, edible portions and growth habits. (groupe de cultures)

data holder means a registrant to whom compensation may be payable in respect of test data. (détenteur de données)

exclusive rights means the exclusive rights to use or rely on any of the following test data that the Minister considers for the first time in support of a registration:

(a)test data that the applicant provides in support of an application to register a new active ingredient;

(b)test data that the applicant provides in support of a concurrent application to register a new pest control product that contains the new active ingredient referred to in paragraph (a); or

(c)test data that the applicant provides in support of an application to register a new compound or substance referred to in paragraph 2(b), if the compound or substance has never been an ingredient in a registered pest control product. (droits exclusifs)

minor use, in respect of a pest control product, means a use the demand for which originates with a grower or a group of growers and which product is intended to be used on a particular pest in connection with a particular host organism, in all of the following circumstances:

(a)the use is for an agricultural purpose;

(b)the use is supported by a federal or provincial agricultural authority;

(c)the use is supported by crop residue data or dislodgeable foliar residue data. (usage limité)

representative crop means a crop in a crop group from which extrapolations of residue levels and maximum residue limits may be made to one or more crops in the group. (culture répresentative)

test data means test data that is provided to the Minister

(a)in support of an application to register a pest control product or to amend a registration made under section 7 of the Act, or

(b)in the context of a re-evaluation or special review, in response to a notice initiating the process under subsection 16(3) or 18(1) of the Act or a notice requiring additional information under paragraph 19(1)(a) of the Act. (données d’essai)

^note

Application

17.02Non-application — product copies#

When an applicant wishes to use or rely on the test data of a registrant in order to register a pest control product that is equivalent to the registrant’s product by using an active ingredient provided by the registrant, sections 17.03 to 17.11 do not apply if

(a)the registrant provides the Minister with a letter, signed by the registrant, that specifies the active ingredient that they agree to provide to the applicant; and

(b)the only active ingredient used in the manufacture of the applicant’s pest control product is the one provided by the registrant.

^note

Exclusive Rights

17.03Period — general#

(1)A registrant has exclusive rights for 10 years after the date of registration of the new active ingredient, of the new pest control product that contains the new active ingredient or of the new compound or substance.

(2)The Minister must extend the period of exclusive rights if all of the following conditions are met:

(a)the registrant meets one of the following requirements:

(i)they proposed a minor use in the concurrent application to register a new pest control product referred to in paragraph (b) of the definition exclusive rights in section 17.01, or

(ii)they made one of the following applications within seven years after the date of registration of the product referred to in subparagraph (i):

(A)an application to amend its registration by adding a minor use, or

(B)an application to register another new pest control product that contains the same active ingredient as the product and in respect of which a minor use is proposed;

(b)the registrant requests an extension of the period of exclusive rights, within eight years after the date of registration of the new active ingredient referred to in paragraph (a) of the definition exclusive rights in section 17.01;

(c)the Minister determines that the proposed minor use is a minor use and approves its addition to the registration of the product referred to in subparagraph (a)(i) or the other new pest control product referred to in clause (a)(ii)(B).

(3)The Minister must apply the following rules when calculating an extension:

(a)the period of exclusive rights is extended by one year for every three minor uses that are added, whether one or more at a time, to the registration for a total period of exclusive rights of 15 years; and

(b)the maximum number of minor uses in respect of a crop group is the number of representative crops in the crop group.

(4)The Minister must cancel any extension of one year if

(a)the Minister, on his or her own initiative or in response to a request from the registrant, amends the registration and removes one or more minor uses; and

(b)the remaining number of minor uses is insufficient to uphold the extension.

^note

17.04Consent#

Subject to paragraph 17.05(1)(b), during the period of exclusive rights an applicant may use or rely on a registrant’s test data in an application to register a pest control product or amend a registration if the registrant provides the applicant with written consent to use or rely on the test data.^note

Compensation Payable

Registration

17.05Conditions — use of or reliance on test data#

(1)Subject to subsection 17.1(2), an applicant who makes an application to register a pest control product or to amend a registration may, in accordance with the agreement concluded with the data holder under subsection 17.07(2), use or rely on the following test data if they pay compensation to the data holder in accordance with the negotiated settlement or arbitral award for the period provided for in subsection (2) and if the applicant provides the Minister with a copy of a letter of access:

(a)compensable data that the applicant wishes to use or rely on;

(b)test data for which the data holder has exclusive rights, if the test data is relevant to the pest control product of the data holder and the test data is relevant to an active ingredient that is not equivalent to the active ingredient contained in the applicant’s pest control product; and

(c)test data that was considered during an evaluation or review of a pest control product by a foreign regulatory authority and that the data holder has not previously provided to the Minister, if the following conditions are met:

(i)the Minister has considered for the first time the decision that results from the evaluation or review of the pest control product by the foreign regulatory authority in support of the re-evaluation or special review decision of the data holder’s pest control product,

(ii)the Minister requests that the data holder provide the Minister with the following in the form and manner directed by the Minister:

(A)documents demonstrating that the test data was provided to the foreign regulatory authority in support of the evaluation or review of the pest control product, or in response to a request from the foreign regulatory authority relating to the evaluation or review,

(B)documents demonstrating that the foreign regulatory authority considered the test data in support of its decision of the evaluation or review, and

(C)the test data, and

(iii)the data holder complies with the request.

(2)The period for which compensation is payable by the applicant to the data holder commences on one of the following days and must not exceed 12 years, except in the case of the test data referred to in paragraph (d) for which the period must not exceed the period set out in section 17.03:

(a)in the case of compensable data in support of an application to register a pest control product of the data holder, the day on which the Minister receives the application;

(b)in the case of compensable data in support of an application to amend the registration of a pest control product of the data holder, the day on which the Minister receives the application;

(c)in the case of compensable data that is considered by the Minister during a re-evaluation or special review of a pest control product of the data holder, if the test data was provided by the data holder in response to a notice initiating the process under subsection 16(3) or 18(1) of the Act or a notice requiring additional information under paragraph 19(1)(a) of the Act, the day on which the Minister receives the data;

(d)in the case of test data referred to in paragraph (1)(b), the day of registration referred to in subsection 17.03(1); or

(e)in the case of test data referred to in paragraph (1)(c), the day on which the Minister initiates the re-evaluation or special review.

^note

17.06Minister to identify test data#

For the purpose of subsection 7(2) of the Act, the Minister must provide the applicant with a list of the test data referred to in subsection 17.05(1) for which compensation may be payable by the applicant and in respect of which an agreement is required to be entered into between the applicant and each data holder whose data the applicant wishes to use or rely on.^note

17.07Proposed agreement on test data#

(1)On receipt of the list of test data, an applicant may deliver to each data holder a proposed agreement that specifies the test data that the applicant wishes to use or rely on.

(2)On receipt of the proposed agreement, the data holder must enter into the agreement with the applicant.

^note

17.08Negotiation of compensation payable and settlement#

(1)When the agreement is entered into, an applicant and a data holder must, in order to reach a settlement, begin to negotiate the compensation payable in respect of the test data that the applicant wishes to use or rely on.

(2)The applicant and the data holder must reach a negotiated settlement in respect of the compensation payable

(a)within 120 days after the day on which the data holder receives the proposed agreement; or

(b)by the end of any additional negotiation period, if the parties agree in writing to continue negotiating.

^note

17.09Arbitration#

(1)Despite subsection 17.08(2), in the absence of a negotiated settlement at the end of the negotiation and in accordance with the agreement entered into by the parties, the applicant may, by delivering to the data holder a written notice, submit the determination of the compensation payable to binding arbitration.

(2)The notice must contain the last offers of the applicant and the data holder, if they were presented in writing at the end of the negotiation.

(3)The arbitrator must make an arbitral award within 120 days after the day on which the notice is delivered, unless

(a)the parties agree to an extension before the end of that period and provide written notice to the arbitrator; or

(b)the arbitrator provides written notice of an extension to the parties before the end of that period.

^note

17.1Letter of access#

(1)When a negotiated settlement is reached or an arbitral award is made, the data holder must provide the applicant with a letter of access, signed by the data holder, confirming that the applicant may use or rely on their test data.

(2)If the data holder fails to provide the letter of access within the period specified in the negotiated settlement or arbitral award, the applicant may use or rely on the test data without having to continue to comply with the settlement or award.

^note

17.11Early registration#

(1)The applicant may, as soon as a notice referred to in subsection 17.09(1) has been delivered to the data holder, request that the Minister register their pest control product before obtaining a letter of access and may use or rely on the test data of the data holder if all of the following conditions are met:

(a)the applicant enters into an escrow agreement with a third party;

(b)the third party is entitled under the laws of a province to receive and hold an amount of money on behalf of another person;

(c)under the escrow agreement, the applicant deposits with the third party an amount of money equal to the data holder’s last offer referred to in subsection 17.09(2);

(d)the escrow agreement contains all of the following terms:

(i)the third party holds the money until it becomes payable in accordance with the escrow agreement,

(ii)on receipt of a copy of the registration certificate, the third party pays the data holder an amount of money equal to the applicant’s last offer referred to in subsection 17.09(2),

(iii)on receipt of a copy of the negotiated settlement or arbitral award, the third party pays the data holder the compensation payable as determined in the settlement or award, less the amount paid under subparagraph (ii),

(iv)the third party pays any remaining balance to the applicant.

(2)The applicant must send the Minister both a copy of the escrow agreement and proof that the applicant has deposited the money in accordance with paragraph (1)(c).

(3)If the data holder’s last offer was not made in writing at the end of the negotiation, the conditions set out in subsection (1) and subsection (2) do not apply.

^note

Re-evaluation and Special Review

17.12Conditions — use of or reliance on test data#

(1)Subject to subsection 17.17(2), in the context of a re-evaluation or special review and on receipt of a notice initiating the process under subsection 16(3) or 18(1) of the Act or a notice requiring additional information under paragraph 19(1)(a) of the Act, a registrant may, in accordance with the agreement concluded with the data holder under subsection 17.14(2), use or rely on the following test data if they pay compensation to the data holder in accordance with the negotiated settlement or arbitral award for the period set out in subsection (2):

(a)compensable data that the registrant wishes to use or rely on that is

(i)provided to the Minister, in the context of the re-evaluation or special review, by the data holder in response to a notice initiating the process under subsection 16(3) or 18(1) of the Act or to a notice requiring additional information under paragraph 19(1)(a) of the Act, and

(ii)relevant to the pest control product that is the subject of the re-evaluation or special review; and

(b)test data that the Minister considers in support of the re-evaluation or special review decision in respect of the pest control product but that was not provided in response to one of the notices referred to in paragraph (a) and that is relevant to an active ingredient that is not equivalent to the active ingredient contained in the pest control product that is the subject of the re-evaluation or special review if

(i)the test data is already compensable data, or

(ii)the data holder already has exclusive rights in respect of the test data.

(2)The period for which compensation is payable for the following test data by the registrant to the data holder commences on one of the following days and must not exceed 12 years, except in the case of the test data referred to in subparagraph (b)(ii) for which the period must not exceed the period provided for in section 17.03:

(a)in the case of compensable data provided by the data holder under paragraph (1)(a), the day on which the Minister receives the data; or

(b)in the case of test data referred to in paragraph (1)(b),

(i)if the data is already compensable data, one of the days referred to in paragraph 17.05(2)(a), (b), (c) or (e), as the case may be, or

(ii)if the data holder already has exclusive rights in respect of the data, the day of registration referred to in subsection 17.03(1).

^note

17.13Minister to identify test data#

For the purposes of subsections 16(5) and (5.1) and 18(3) and (3.1) of the Act, the Minister must make available to data holders and other registrants, on the day on which the Minister makes public the decision statement referred to in subsection 28(5) of the Act, a list of the test data referred to in subsection 17.12(1) in respect of which compensation may be payable by any of those registrants and in respect of which an agreement is required to be entered into between the registrant and each data holder whose data the registrant wishes to use or rely on.^note

17.14Proposed agreement on test data#

(1)Either the registrant or the data holder may deliver to the other party a proposed agreement that specifies the test data that the registrant wishes to use or rely on no later than 60 days after the day on which the decision statement referred to in subsection 28(5) of the Act is made public.

(2)The registrant or the data holder must, on receipt of the proposed agreement from the other party, enter into the agreement with the other party.

^note

17.15Negotiation of compensation payable and settlement#

(1)When the agreement is entered into, a registrant and a data holder must, in order to reach a settlement, begin to negotiate the compensation payable in respect of the test data that the registrant wishes to use or rely on.

(2)The registrant and the data holder must reach a negotiated settlement in respect of the compensation payable

(a)within 120 days after the day on which the decision statement referred to in subsection 28(5) of the Act is made public; or

(b)by the end of any additional negotiation period, if the parties agree in writing to continue negotiating.

^note

17.16Arbitration#

(1)Despite subsection 17.15(2), in the absence of a negotiated settlement at the end of the negotiation and in accordance with the agreement entered into by the parties, the registrant or the data holder may, by delivering to the other party a written notice, submit the determination of the compensation payable to binding arbitration.

(2)The notice must contain the last offers of the registrant and the data holder, if they were presented in writing at the end of the negotiation.

(3)The arbitrator must make an arbitral award within 120 days after the day on which the notice is delivered, unless

(a)the parties agree to an extension before the end of that period and provide written notice to the arbitrator; or

(b)the arbitrator provides written notice of an extension to the parties before the end of that period.

^note

17.17Letter of access#

(1)When a negotiated settlement is reached or an arbitral award is made, the data holder must provide the registrant with a letter of access, signed by the data holder, confirming that the registrant may use or rely on their test data.

(2)If the data holder fails to provide the letter of access within the period specified in the negotiated settlement or arbitral award, the registrant may use or rely on the test data without having to continue to comply with the settlement or award.

^note