World Intellectual Property Organization

Canada

Pest Control Products Regulations (SOR/2006-124)

 

 


Pest Control Products Regulations (SOR/2006-124)

Enabling Statute: Pest Control Products Act

Regulation current to February 3rd, 2011

Attention: See coming into force provision and notes, where applicable.

Pest Control Products Regulations

SOR/2006-124

Registration June 6, 2006

PEST CONTROL PRODUCTS ACT

Pest Control Products Regulations

P.C. 2006-483 June 6, 2006

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

a S.C. 2002, c. 28

PEST CONTROL PRODUCTS REGULATIONS

INTERPRETATION

Definitions

1. (1) The following definitions apply in these Regulations.

“Act”

« Loi »

“Act” means the Pest Control Products Act.

“antimicrobial agent”

« agent antimicrobien »

“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.

“approved label”

« étiquette approuvée »

“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.

“CAS registry number”

« numéro d’enregistrement CAS »

“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.

“common chemical name”

« nom chimique commun »

“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.

“conditional registration”

« homologation conditionnelle »

“conditional registration” means a registration to which section 14 applies.

“cooperator”

« collaborateur »

“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.

“device”

« dispositif »

“device” means an article, an instrument, an apparatus, a contrivance or a gadget.

“display panel”

« aire d’affichage »

“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.

“domestic animal”

« animal domestique »

“domestic animal” means an animal that is under the control of humans and dependent on them for its survival.

“equivalency certificate”

« certificat d’équivalence »

“equivalency certificate” means a certificate issued under subsection 39(5) with respect to a foreign product.

“experimental label”

« certificat d’équivalence »

“experimental label” means a label that is for use during research.

“foreign product”

« produit étranger »

“foreign product” means a pest control product that is registered in a country other than Canada.

“marketplace label”

« étiquette de marché »

“marketplace label” means a label that matches the approved label and that has added to it graphic designs or symbols that relate to the pest control product.

“metric unit”

« unité métrique »

“metric unit” means a unit of measurement set out in Schedule I to the Weights and Measures Act.

“microbial agent”

« agent microbien »

“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.

“own use”

« approvisionnement personnel »

“own use”, with respect to an imported foreign product, means that the product is imported by or on behalf of the holder of an own-use import certificate for the holder’s own use.

“own-use import certificate”

« certificat d’importation pour approvisionnement personnel »

“own-use import certificate” means a certificate issued under section 41.

“pheromone”

« phéromone »

“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.

“principal display panel”

« aire d’affichage principale »

“principal display panel” means the part of the display panel that is visible under normal conditions of display for sale.

“registration certificate”

« certificat d’homologation »

“registration certificate” means a certificate issued under section 12 that states that the pest control product named in it is registered under the Act.

“research”

« recherche »

“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.

“research authorization certificate”

« certificat d’autorisation de 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.

“researcher”

« chercheur »

“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.

“research establishment”

« établissement de recherche »

“research establishment” means an individual, a corporation or an unincorporated entity, or part of one, that is engaged in research that pertains to a pest control product.

“research notification certificate”

« certificat d’avis 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.

“research site”

« site 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.

“secondary display panel”

« aire d’affichage secondaire »

“secondary display panel” means the part of the display panel other than the principal display panel.

“seed”

« semence »

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

“semiochemical”

« écomone »

“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.

“validity period”

« période de validité »

“validity period” means the period specified under paragraph 8(1)(c) of the Act.

Definition of “common chemical name”

(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

Prescribing

2. 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; and

(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.

EXEMPTION OF CERTAIN PEST CONTROL PRODUCTS

Exemption from application of Act

3. (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;

(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 used to destroy or inactivate viruses, bacteria or other micro-organisms in order to treat, mitigate or prevent disease in humans or animals, except in respect of its use in a swimming pool or spa;

(e) except in respect of its uses as a preservative for wood or other material, as a slimicide or in a swimming pool or spa, a pest control product that is used both to

(i) destroy or inactivate viruses, bacteria or other micro-organisms in order to treat, mitigate or prevent disease in humans or animals, and

(ii) reduce the level of viruses, bacteria or other micro-organisms that cause mould, mildew or odour, or disease in humans or animals; and

(f) a pest control product, other than an organism, that is imported into Canada primarily for use by the importer in or around the home, if the quantity being imported is not more than 500 g or 500 mL and the value of the quantity imported is not more than $100.

Exemption for named uses only

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

EXEMPTION FROM REGISTRATION

Exemption — unregistered pest control products

4. (1) Subject to subsection (2), a pest control product is exempt from the application of subsection 6(1) of the Act if it is

(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 manufactured only for export from Canada and that contains an active ingredient that is registered in Canada;

(d) a pest control product that is imported under an own-use import certificate; or

(e) a pest control product that is imported for the purpose of conducting research in accordance with sections 46 to 70.

No exemption

(2) A pest control product is not exempt from the application of subsection 6(1) of the Act if it is an active ingredient that is used in a pest control product of a type described in Schedule 2.

Use in manufacture only

(3) A pest control product that is exempt from registration under paragraph (1)(a) may not be used for any purpose other than the manufacture of a registered pest control product.

PRODUCT CLASSES

Designation

5. 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.

APPLICATION FOR REGISTRATION

Contents

6. (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 the place of manufacture of the pest control product;

(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 specifications 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 there is one, the name and address of the supplier of each formulant, each formulant’s percentage of the total weight of the product, and the purpose of each formulant 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 guarantee statement described in paragraph 26(1)(h).

Electronic copy of label

(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.

Certification

(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.

When Minister requests amendment

7. If the Minister requests a registrant to amend the registration of a pest control product, the registrant must make an application to amend the registration.

Additional information required

8. 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) acceptable methods of analysis for detecting the components and measuring the specifications of the pest control product;

(g) acceptable 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.

Additional information — affidavit and contents

9. (1) When, in the context of an application for registration or to amend a registration, the Minister considers confidential information under paragraph 7(6)(b) of the Act, 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 given;

(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.

Copying or other use

(2) The applicant to whom access is given to confidential information under subsection (1) may 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.

Return of confidential information

(3) Confidential 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.

Reference in Register

10. 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.

Samples on request

11. 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.

Registration certificate

12. 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

Maximum validity period

13. Subject to subsections 14(6) and (7), the validity period with respect to a pest control product must end no later than December 31 in the fifth year after the year in which the product is registered.

CONDITIONAL REGISTRATION

Valid up to three years

14. (1) Despite section 13 and subject to subsection (2), if a notice is delivered to the registrant under section 12 of the Act when a pest control product is registered or the registration of a pest control product is amended under subsection 8(1) of the Act, the registration becomes a conditional registration and

(a) the validity period must end no later than December 31 in the third year after the year in which the product is registered or the registration is amended; and

(b) subsections 28(1) and 35(1) and paragraphs 42(2)(c) to (e) of the Act do not apply.

Further notices under section 12 of the Act

(2) When a notice is delivered to the registrant under section 12 of the Act in relation to the reinstatement of an expired conditional registration or the continuation of a conditional registration after the evaluation of data, paragraph (1)(a) applies.

Amendment

(3) Paragraphs (1)(a) and (b) apply to an amendment of a conditional registration.

Exemption

(4) Despite subsection 81(2) of the Act, paragraph 42(2)(f) of the Act applies to all registrations referred to in that subsection if a registration decision of a type described in paragraph 28(1)(a) of the Act has been made and the validity period has been fixed.

No extension

(5) Subject to subsections (6) and (7), the validity period of a conditional registration may not be extended.

Automatic extension

(6) The validity period of a conditional registration is extended for a period of two years when the registrant complies with the requirements of the notice delivered under section 12 of the Act.

Extension for consultation

(7) The Minister may extend the validity period for a period of sufficient duration to allow the Minister to carry out the consultation required by section 28 of the Act, if the application to amend or renew is made before the end of the validity period.

Expanded scope of section 14 — associated products

15. (1) Paragraphs 14(1)(a) and (b) apply to the registration of any pest control product that contains an active ingredient in respect of whose registration a notice has been delivered under section 12 of the Act.

Expanded scope of section 14 — associated active ingredients

(2) Paragraphs 14(1)(a) and (b) apply to the registration of an active ingredient that is contained only in a registered pest control product in respect of which a notice has been delivered under section 12 of the Act.

RENEWAL OF REGISTRATION

Five-year periods

16. (1) Subject to subsections (2) and (3), 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.

Renewal and delivery of new notice — conditional registrations

(2) A conditional registration may be renewed on application by the registrant to the Minister, and on the renewal a new notice is delivered to the registrant under section 12 of the Act and paragraph 14(1)(a) of these Regulations applies.

Exception

(3) Despite subsection (2), in the case of a conditional registration to which subsection 15(1) or (2) applies, no notice need be delivered.

Information required with renewal applications

(4) An application to renew the registration of a pest control product must be accompanied by all of 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 the Minister requests them, an electronic copy of the approved label and two hard copies of the marketplace label; and

(e) in the case of a registration that was issued in the circumstances described in sections 17.7 to 17.94, a valid letter of access, as defined in section 17.1.

SOR/2010-119, s. 1.

RE-EVALUATIONS AND SPECIAL REVIEWS

Additional information — affidavit and contents

17. (1) When, in the context of a re-evaluation or special review, the Minister considers confidential information under paragraph 19(1)(c) of the Act, 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 given;

(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.

Copying or other use

(2) The registrant to whom access is given to confidential information under subsection (1) may 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.

Return of confidential information

(3) Confidential 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.

PROTECTION OF TEST DATA

Interpretation

Definitions

17.1 The following definitions apply in sections 17.2 to 17.94.

“agreement”

« entente »

“agreement” means an agreement described in subsection 66(1) of the Act.

“compensable data”

« données soumises à des droits d’utilisation »

“compensable data” means test data other than the following:

(a) test data that was submitted to support the registration of a new active ingredient and the pest control products associated with that ingredient, including any test data that was part of the additional information reported under section 12 of the Act in relation to that ingredient and those products;

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

(c) test data that is generated by a scientific study that is fully funded by a government or one of its institutions.

“crop group”

« groupe de cultures »

“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.

“letter of access”

« lettre d’accès »

“letter of access” means a document that is signed by a registrant in which the registrant authorizes a named person to use or rely on identified test data.

“letter of confirmation of source”

« lettre de confirmation de source »

“letter of confirmation of source” means a document that is signed by a registrant in which the registrant confirms that they have agreed to provide an identified registered pest control product to a named person.

“minor use”

« usage limité »

“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) a federal or provincial agricultural authority supports the use; and

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

“representative crop”

« culture répresentative »

“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.

“test data”

« données d’essai »

“test data” means test data that is included in the information used by the Minister in any of the following circumstances:

(a) to support an application to register a pest control product or to amend a registration under section 7 or 12 of the Act;

(b) in response to a notice delivered to the registrant under subsection 16(3), 18(1) or 19(1) of the Act; or

(c) in support of a registration before June 28, 2006.

SOR/2010-119, s. 2.

Application

Equivalent active ingredients

17.2 Sections 17.1 and 17.3 to 17.94 apply only to applications to register a pest control product whose active ingredient has been determined by the Minister under subsection 7(2) of the Act to be equivalent to the active ingredient of a registered pest control product.

SOR/2010-119, s. 2.

Re-evaluations and special reviews

17.3 Sections 17.1, 17.2 and 17.4 to 17.94 apply, with any necessary modifications, to a registrant who wishes to use or rely on test data of another registrant for the purpose of subsection 16(5) or 18(3) of the Act.

SOR/2010-119, s. 2.

Non-application — product copies

17.4 When an applicant wishes to use or rely on test data of a registrant in order to register a pest control product that is equivalent to the registrant’s product, using a pest control product provided by that registrant, sections 17.5 to 17.94 do not apply if

(a) the registrant provides the Minister with a letter of confirmation of source; and

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

SOR/2010-119, s. 2.

Exclusive Use

Exclusive use period

17.5 (1) The registrant of a new active ingredient has the exclusive use of the following test data for 10 years after the date of registration:

(a) test data that was provided in support of the initial application to register the active ingredient;

(b) test data that was provided in support of a concurrent application to register a pest control product that contains that active ingredient; and

(c) test data that was included in any additional information that was reported to the Minister under section 12 of the Act in relation to those applications.

Exclusive use — compounds and substances

(2) The registrant of a new pest control product described in paragraph 2(b) has the exclusive use of the test data submitted in support of the initial application to register it, for 10 years after the date of registration, if the product has never been an ingredient in a registered pest control product.

Extension — minor uses

(3) The Minister must extend the exclusive use period in all of the following circumstances:

(a) the registrant

(i) includes minor uses in an application to register a pest control product referred to in paragraph (1)(b), or

(ii) on or after August 1, 2007 but in any case within seven years after the date of registration of a pest control product referred to in paragraph (1)(b), either makes an application to amend that registration to add minor uses or makes an application, that includes minor uses, to register a new pest control product that contains the same active ingredient;

(b) the registrant requests an extension of the period, within eight years after the date of registration; and

(c) the Minister determines that the proposed minor uses are minor uses, as defined in section 17.1, and approves their addition to the registration.

Calculation of extension

(4) The following rules apply when calculating an extension:

(a) the exclusive use period is extended at the rate of one year for each three minor uses that are added to the registration, to a maximum total period 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.

When minor use withdrawn or removed

(5) A one-year extension is cancelled if the registrant withdraws a minor use from their registration, or the Minister amends the registration and removes a minor use, such that the remaining number of minor uses is insufficient to support the extension.

SOR/2010-119, s. 2.

Letter of access

17.6 During the exclusive use period, an applicant may use or rely on test data of a registrant in an application to register a pest control product or amend a registration if the registrant provides the applicant with a letter of access.

SOR/2010-119, s. 2.

Agreements

Conditions — use or reliance

17.7 (1) Subject to subsection 17.94(2), an applicant may use or rely on compensable data of a registrant if they pay compensation to the registrant in accordance with an agreement for the relevant period described in subsection (2) and provide the Minister with a copy of a letter of access.

Compensable period

(2) Compensation is payable in respect of the following compensable data that is submitted to or considered by the Minister for the first time, for the following periods:

(a) in the case of test data that supports an application to register a pest control product whose active ingredient is already registered, for 12 years after the date of the application;

(b) in the case of test data that supports an application to amend a registration, for 12 years after the date of the application;

(c) in the case of test data submitted in response to a notice delivered to the registrant under subsection 16(3), 18(1) or 19(1) of the Act, for 12 years after the date on which the Minister receives the data; and

(d) subject to subsection (3), in the case of foreign test data considered by the Minister in the course of a re-evaluation or special review, for 12 years after the date on which the Minister initiates the re-evaluation or special review.

Condition — foreign test data

(3) Foreign test data is compensable only if the registrant is able to provide the Minister with the foreign test data on request.

SOR/2010-119, s. 2.

Minister to identify compensable data

17.8 (1) For the purpose of subsection 7(2) of the Act, the Minister must provide the applicant with a list of the compensable data that they may use or rely on and in respect of which they will need to enter into an agreement with the registrant.

Request to enter agreement

(2) On receipt of the list of compensable data, the applicant may send a copy of an agreement to the registrant to enter into with respect to such of that data that they wish to use or rely on, by certified or registered mail or any other method of delivery that provides proof of delivery.

SOR/2010-119, s. 2.

Negotiation and Arbitration

Agreement entered into

17.9 (1) On delivery of the proposed agreement, the applicant and the registrant must enter into the agreement and begin to negotiate the compensation payable in respect of the data that the applicant wishes to use or rely on.

Negotiation period

(2) The parties must reach a negotiated settlement with respect to the compensation payable within 120 days after delivery of the agreement.

Extension

(3) If the parties fail to reach a negotiated settlement within the 120-day period, they may continue negotiating if they both agree to do so.

SOR/2010-119, s. 2.

When no negotiated settlement — notice of arbitration

17.91 (1) If the parties fail to conclude a negotiated settlement in accordance with section 17.9, the applicant may, by notice in writing delivered to the registrant, submit the determination of the compensation payable to binding arbitration in accordance with the agreement.

Parties’ offers in writing

(2) The notice must include the last offers of the parties, if they were presented in writing at the end of the negotiation.

Method of delivery

(3) The notice must be delivered by certified or registered mail or any other method of delivery that provides proof of delivery.

Arbitral award

(4) An arbitral award must be made within 120 days after delivery of the notice, unless the parties agree to an extension.

SOR/2010-119, s. 2.

When no offer in writing

17.92 If the registrant does not put their last offer in writing at the end of the negotiation, the applicant may make the request referred to in subsection 17.93(1) without having to meet the conditions set out in section 17.93.

SOR/2010-119, s. 2.

Conditions on early registration

17.93 (1) If a negotiation ends without a negotiated settlement, the applicant may, once a notice referred to in section 17.91 has been delivered, use or rely on the compensable data and request that the Minister register their product in the absence of a letter of access, if the following conditions are met:

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

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

(c) pursuant to the escrow agreement, the applicant deposits with the third party an amount of money equal to the registrant’s last offer referred to in subsection 17.91(2); and

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

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

(ii) on receipt of a copy of the registration certificate, the third party pays the registrant an amount equal to the applicant’s last offer referred to in subsection 17.91(2),

(iii) on receipt of a copy of the negotiated settlement or arbitral award, the third party pays the registrant the amount determined in that settlement or award, less the amount paid under subparagraph (ii), and

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

Copy and proof to Minister

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

SOR/2010-119, s. 2.

Letter of access

17.94 (1) On the determination of the compensation payable, whether by negotiated settlement or arbitral award, the registrant must provide the applicant with a letter of access in accordance with the settlement or award.

Failure to provide letter of access

(2) If the registrant fails to provide the letter of access, the applicant may use or rely on the compensable data without having to comply further with the negotiated settlement or arbitral award.

SOR/2010-119, s. 2.

EMERGENCY REGISTRATION

Validity period and exemption

18. Despite section 13, if a pest control product is registered for, or the registration of a pest control product is amended to permit its use in, the emergency control of a seriously detrimental infestation,

(a) the validity period must not be longer than one year and may not be extended;

(b) subsections 28(1) and 35(1) and paragraphs 42(2)(c) to (f) of the Act do not apply; and

(c) the registration may not be renewed.

STANDARDS

Trifluralin

19. A pest control product that contains trifluralin (2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)benzenamine) as its active ingredient or that contains an active ingredient that is based on or derived from trifluralin must not contain N-nitrosodi-n-propylamine (NDPA) in excess of one part per million parts of trifluralin.

DENATURATION

When required

20. If the physical properties of a pest control product are such that its presence may not be detected when it is used and it is likely to expose a person or domestic animal to a severe health risk, the pest control product must be denatured by means of colour, odour or any other means specified as a condition of registration by the Minister under paragraph 8(1)(a) of the Act to provide a signal or warning as to its presence.

ADVERTISING

Prohibition

21. A word or an expression that states or implies that the Government of Canada or any of its departments or agencies promotes, endorses or recommends the use of a pest control product must not appear on the package of, or in any advertisement for, a pest control product.

LABELS

General

Official languages

22. (1) Subject to subsections (2) and (3), all information on a label must be in both English and French as of the earlier of

(a) the day after December 31, 2002 on which the registration of the pest control product is granted, amended or renewed, and

(b) January 1, 2008.

Exception — emergency

(2) Until January 1, 2008, if the entirety of the information on the label is not already in both English and French, the amended label, following the amendment of a registration under section 18, is exempt from the requirement of subsection (1).

Exception — products destined abroad

(3) The information on the label of a registered pest control product that is not authorized to be manufactured, imported, sold or used in Canada may be in either English or French, or in both.

Label — presentation

23. (1) All information that is required to be shown on a label must appear in a manner that is clearly legible and indelible.

Marketplace label — additional information

(2) Any graphic design or symbol that relates to the pest control product may be shown on the marketplace label if it does not detract from or obscure the required information.

Diseases of humans

24. (1) A label must not represent a pest control product as a treatment, preventive or cure for any disease, disorder or abnormal physical state listed in Schedule A to the Food and Drugs Act.

Diseases of domestic animals

(2) A label must not represent a pest control product as a treatment, preventive or cure for any disease, as defined in subsection 2(1) of the Health of Animals Act, that is required to be reported under that Act.

Display Panel

Principal and secondary display panels

25. The display panel of a registered pest control product must consist of the principal display panel and the secondary display panel.

Principal display panel

26. (1) Subject to subsection 8(2) of the Act, the principal display panel of a registered pest control product must show all of the following information:

(a) the product name of the pest control product, which may include a distinctive brand or trade-mark and the common chemical name of its active ingredient, if established;

(b) the product type of the pest control product, which must be descriptive of its purpose;

(c) the physical form of the pest control product;

(d) the product class designation of the pest control product as set out in section 5;

(e) information concerning the nature and degree of hazard inherent in the pest control product, which must identify the nature and degree of hazard by appropriate precautionary symbols and signal words selected from Schedule 3, together with a statement that indicates the nature of the primary hazard to which the symbol relates;

(f) the statement “READ THE LABEL BEFORE USING.”;

(g) if the pest control product has the product class designation “DOMESTIC”, the statement “KEEP OUT OF THE REACH OF CHILDREN.”;

(h) a guarantee statement, as follows:

(i) the word “GUARANTEE”, followed by a colon,

(ii) 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,

(iii) the concentration of the active ingredient, expressed, if the pest control product is

(A) a liquid, as a percentage by mass, or as mass per unit volume, or both, as specified by the Minister in the conditions of registration under paragraph 8(1)(a) of the Act,

(B) a dust, wettable powder or other dry formulation, as a percentage by mass, or

(C) neither a liquid nor a dry formulation, in terms specified by the Minister in the conditions of registration under paragraph 8(1)(a) of the Act, and

(iv) the viscosity, specific gravity, particle size or any other property or specification that the Minister may specify in the conditions of registration under paragraph 8(1)(a) of the Act;

(i) the registration number of the pest control product, as follows: “REGISTRATION NO. (assigned registration number) PEST CONTROL PRODUCTS ACT” or “REG. NO. (assigned registration number) P.C.P. Act”;

(j) a declaration of net quantity of the product in the package, expressed

(i) by volume, if the product is a liquid or gas or is viscous,

(ii) by mass, if the product is a solid or pressure-packed, and

(iii) in terms specified by the Minister in the conditions of registration under paragraph 8(1)(a) of the Act, in any other case;

(k) the registrant’s name; and

(l) the name, postal address and telephone number of a contact person in Canada to which public inquiries may be directed.

Secondary display panel

(2) Subject to subsection 8(2) of the Act, the secondary display panel of a registered pest control product must show all of the following information:

(a) under the heading “DIRECTIONS FOR USE”, the directions for the use of the pest control product, including application rates, timing and frequency of application, and any limitations on its use;

(b) information that identifies any significant risk associated with the handling, storage, display, distribution and disposal of the pest control product, and instructions on procedures to reduce those risks and, if specified by the Minister in the conditions of registration under paragraph 8(1)(a) of the Act, instructions on decontamination procedures and disposal of the pest control product and its empty packages;

(c) under the heading “PRECAUTIONS”, information that identifies any significant risk to health, the environment or anything in connection with which the pest control product is to be used, and instructions on procedures to reduce that risk;

(d) under the heading “PRECAUTIONS”, the following statement:

(i) if the pest control product does not have the product class designation “DOMESTIC”: “KEEP OUT OF THE REACH OF CHILDREN.”, or

(ii) if the pest control product is to be used only in the manufacture of another pest control product: “PREVENT ACCESS BY UNAUTHORIZED PERSONNEL.”;

(e) under the heading “FIRST AID”, instructions that

(i) set out the practical measures to be taken in the event of poisoning, intoxication or injury caused by the pest control product, and

(ii) include the statement “Take the container label or product name and Pest Control Product Registration Number with you when seeking medical attention.”;

(f) under the heading “TOXICOLOGICAL INFORMATION”, information that is essential to the treatment of persons who are poisoned, intoxicated or injured by the pest control product that includes all of the following:

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

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

(iii) a list of the components of the product, not including the active ingredient, that may affect the treatment; and

(g) the following notice to users: “NOTICE TO USER: This pest control product is to be used only in accordance with the directions on the label. It is an offence under the Pest Control Products Act to use this product in a way that is inconsistent with the directions on the label. The user assumes the risk to persons or property that arises from any such use of this product.”

Optional contact information — principal display panel

27. (1) The principal display panel of a registered pest control product may also show the registrant’s Internet address or the e-mail address to which public inquiries may be directed.

Optional contact information — secondary display panel

(2) The secondary display panel of a registered pest control product may also show the name and address or telephone number of persons other than the registrant, if the function of each other person with respect to the product is identified.

Brochures or leaflets

28. (1) Despite section 26, any of the information that is required to be shown on the principal and secondary display panels may, if specified by the Minister in the conditions of registration relating to the label under subsection 8(2) of the Act, be shown instead in a brochure or leaflet that accompanies the pest control product.

When subsection (1) applies

(2) If the information referred to in subsection (1) is shown elsewhere than on the display panel,

(a) the principal display panel must have prominently shown on it the statement “READ ATTACHED BROCHURE (or LEAFLET) BEFORE USING.”; and

(b) the brochure or leaflet must contain all of the information that is to be shown on the principal and secondary display panels in addition to the information described in subsection (1).

Product class designation “RESTRICTED” — notice

29. (1) If the principal display panel shows the product class designation “RESTRICTED”, the notice that is required by paragraph 26(2)(g) must appear prominently at the top of the secondary display panel, followed by the heading “RESTRICTED USES”, followed by the directions for use, the application rates, the timing and frequency of application and the limitations on the use of the pest control product to which the restriction relates. All of the foregoing must be circumscribed by a line to set the information apart from all other information that is required to be shown on the secondary display panel.

Product class designation “RESTRICTED” — brochure or leaflet

(2) Despite subsection (1), if the principal display panel shows the product class designation “RESTRICTED”, the directions for use, the application rates, the timing and frequency of application and the limitations on the use of the pest control product to which the restriction relates, together with the information required by paragraphs 26(1)(a) to (l) and (2)(a) and (c) may, if specified by the Minister in the conditions of registration relating to the label under subsection 8(2) of the Act, be shown instead in a brochure or leaflet that accompanies the pest control product.

Prescribed Devices

Requirements

30. The label for a pest control product that is a device of a type described in Schedule 1 must contain the information set out in paragraphs 26(1)(i), (k) and (l) and (2)(a) to (c).

Bulk Containers

Required information

31. (1) If a pest control product is distributed in a bulk container, the information required by paragraphs 26(1)(a) to (d) and (h) to (l) and (2)(e) and (f) must be shown

(a) on the bulk container; and

(b) on the documents that accompany the shipment.

Additional information

(2) If a pest control product is distributed in a bulk container directly to a user of the product, the information required by paragraph 26(1)(e) must also be shown in accordance with paragraphs (1)(a) and (b).

Units of Measurement

Metric units

32. (1) Quantities shown on a label must be expressed in metric units.

Decimal system

(2) The declaration of net quantity must be shown in the decimal system to three figures, except that, if the net quantity is less than 100 g, 100 mL, 100 cm3, 100 cm2 or 100 cm, it may be shown truncated to two decimal figures, and, in either case, any final zero that appears to the right of the decimal point need not be shown.

Net quantity less than one

(3) A net quantity that is less than one must be shown in the decimal system, with a zero before the decimal point, or in words.

Metric units

(4) The metric units in the declaration of net quantity must be shown

(a) in millilitres, if the net volume of the pest control product is less than 1 000 mL, except that 500 mL may be shown as 0.5 L;

(b) in litres, if the net volume is 1 000 mL or more;

(c) in grams, if the net mass is less than 1 000 g, except that 500 g may be shown as 0.5 kg; and

(d) in kilograms, if the net mass is 1 000 g or more.

Optional Canadian units of measurement

(5) In addition to being expressed in accordance with subsection (1), quantities shown on a label may also be expressed in the Canadian units of measurement set out in Schedule II to the Weights and Measures Act.

PACKAGING

Packages

33. (1) The package of a pest control product must be constructed to contain the product safely under normal conditions of storage, display and distribution.

Safe access to contents

(2) Every package must be constructed to permit

(a) the withdrawal of any or all of the contents in a manner that is safe to the user; and

(b) the closing of the package in a manner that will contain the pest control product safely under normal storage conditions.

Minimize degradation

(3) Every package must be constructed to minimize the degradation or change of its contents.

When package essential to safety

(4) If the package is essential to the safe and effective use of the pest control product, it must be constructed to meet any specifications that the Minister may specify in the conditions of registration under paragraph 8(1)(a) of the Act.

STORAGE AND DISPLAY

Conditions

34. (1) Pest control products must be stored and displayed in accordance with any conditions set out on the label.

Procedure to avoid contamination

(2) Pest control products that bear the signal word POISON superimposed on the precautionary symbol for danger set out in item 2 of Schedule 3 must not be stored or displayed with human food or animal feed, but must be stored or displayed in a separate room or be separated in such a way as to avoid any possible contamination of the food or feed.

DISTRIBUTION

Conditions on documents

35. When conditions of registration that relate to the distribution of a pest control product are specified by the Minister under paragraph 8(1)(a) of the Act, those conditions must be shown on the documents that accompany the shipment.

IMPORT

General

Declaration and contents

36. A pest control product may be imported into Canada if it is accompanied by a declaration, in English or in French, signed by the importer, that sets out all of the following information:

(a) the name and postal address of the shipper;

(b) the product name of the pest control product;

(c) the chemical, common chemical or other name of the active ingredient of the pest control product and the amount of it contained in the product;

(d) the total amount of the pest control product being imported;

(e) the name and address of the importer; and

(f) the purpose of the importation, as follows:

(i) “For Resale”, together with the registration number of the pest control product, if it is registered and is being imported for resale,

(ii) “For Manufacturing Purposes”, if the pest control product is being imported for use in the manufacture of a registered pest control product,

(iii) “For Research Purposes”, if the pest control product is being imported for research purposes, or

(iv) “For Own Use”, if the pest control product is being imported under an own-use import certificate.

Own-use Import

Specified purposes

37. For the purpose of subsection 41(1) of the Act, the use of an imported foreign product for a person’s own use and the importation of that product are specified purposes.

Conditions of import

38. A pest control product may be imported by or on behalf of a person for that person’s own use if the following conditions are met:

(a) it is a foreign product for which an equivalency certificate is in effect; and

(b) it is imported under an own-use import certificate.

Equivalence

Application

39. (1) A person or an organization may apply to the Minister to determine whether a foreign product that meets the requirements of paragraphs 43(a) to (d) is equivalent to a registered pest control product that does not have the product class designation “RESTRICTED”.

Contents

(2) The application must include information that indicates that the requirements of paragraphs 43(a) to (d) are met, a copy of the proposed own-use import label that shows the information referred to in section 40, and the following information in respect of both the foreign product and the registered pest control product:

(a) all of the following information:

(i) the composition of the product and of the active ingredient that is used to manufacture it which, in the case of the registered pest control product and its active ingredient, must be the composition specified by the Minister in the conditions of registration under paragraph 8(1)(a) of the Act,

(ii) the name, manufacturer and manufacturing process of the active ingredient that is used to manufacture each of the products, and

(iii) the guarantee statement described in paragraph 26(1)(h); or

(b) a detailed and comprehensive analysis, with an accompanying explanation of methodology that, on its own merits, permits validation of procedures, results and conclusions, to determine the composition of the foreign product and of the registered pest control product, including the identity and concentration of the active ingredient, formulants and contaminants of the two products.

Written consent equivalent

(3) Instead of providing the information required by subsection (2) with respect to the registered pest control product, the applicant may provide the written consent of the registrant of that product for the Minister to use or rely on any information that the registrant had previously provided to the Minister.

Information in Register

(4) The Minister must place all of the following information in the Register with respect to an application to determine equivalence made under subsection (1):

(a) the name of the applicant;

(b) the date of the application;

(c) the product name and registration number of the registered pest control product and the product name and product identifier of the foreign product; and

(d) the country of registration of the foreign product.

Issuance of equivalency certificate

(5) If the Minister determines that a foreign product is equivalent to a registered pest control product, the Minister must issue an equivalency certificate.

Equivalency certificate

(6) An equivalency certificate

(a) applies only to the foreign products for which the Minister has determined equivalency under subsection (5);

(b) expires on the date specified in the certificate, which must be no later than one year after it is issued;

(c) is no longer valid if the composition of either the foreign product or the registered pest control product changes; and

(d) is no longer valid if any of the circumstances described in paragraphs 43(b) to (d) occurs.

Renewal

(7) On the expiry of an equivalency certificate in accordance with paragraph (6)(b), the Minister may renew it, on application, if he or she is satisfied of both of the following:

(a) that the circumstances described in paragraphs 43(b) to (d) continue to be true; and

(b) that the composition of neither the registered pest control product nor the foreign product has changed.

Own-use import label

40. When the Minister issues an equivalency certificate, the Minister must also approve the proposed own-use import label if it shows the information that is relevant to the intended use and disposal of the foreign product in Canada that is shown on the approved label of the equivalent registered pest control product.

Authorization and Certificate

Authorization required

41. (1) A person who wishes to import for their own use and use a foreign product for which an equivalency certificate is in effect must apply to the Minister for authorization to do so.

Application and contents

(2) The application must include all of the following information:

(a) the applicant’s name, address and signature;

(b) a copy of the applicable equivalency certificate;

(c) a copy of the approved own-use import label;

(d) a description of the intended use of the foreign product, including the location where it will be used; and

(e) the quantity of the foreign product required for that intended use for one growing season.

Issuance of own-use import certificate

(3) If the proposed use meets the conditions described in section 43, the Minister must authorize the use by issuing an own-use import certificate that sets out the conditions specified under subsection 41(1) of the Act and that includes all of the following:

(a) the identity of the certificate holder;

(b) the amount of the foreign product that may be imported under the certificate; and

(c) the location where the foreign product is to be used by the certificate holder.

Own-use import certificate

(4) An own-use import certificate

(a) is valid for one growing season only;

(b) expires on the date specified in it, which must be no later than one year after it is issued; and

(c) is no longer valid if the relevant equivalency certificate is no longer valid.

Not transferable

(5) An own-use import certificate is not transferable.

No distribution

(6) The holder of an own-use import certificate may not distribute any of the foreign product that was imported under the certificate.

Disposal of unused product

42. The holder of an own-use import certificate must dispose of any unused foreign product in accordance with the disposal information set out on the approved own-use import label.

Conditions of authorization

43. The Minister must authorize a person to use an unregistered pest control product that is imported under an own-use import certificate if the product

(a) is a foreign product that is not an organism;

(b) is not under official re-evaluation or special review in the foreign country where it is registered;

(c) does not contain an active ingredient that is under re-evaluation or special review in Canada;

(d) does not contain a formulant that is on the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern and that has not been accepted for use in Canada;

(e) is the subject of a valid equivalency certificate;

(f) is intended for a use that is specified in the conditions of registration of the equivalent registered pest control product and will be imported in a quantity of not more than the amount that is required for that use for one growing season; and

(g) bears, in addition to any other label, an approved own-use import label.

No inconsistent use

44. A foreign product that is exempt from the application of subsection 6(1) of the Act under paragraph 4(1)(d) must not be used in a manner that is inconsistent with the conditions set out on the own-use import certificate.

Notice of Import

Notice

45. A person or an organization that imports a pest control product under an own-use import certificate must notify the Minister of the importation without delay in accordance with the conditions set out on the certificate.

RESEARCH

Manufacture for Research

Non-application of subsection 6(1) of the Act

46. Subsection 6(1) of the Act does not apply to the manufacture of a pest control product that is for use only in conducting research under these Regulations.

Research Authorization

Specified purpose

47. For the purpose of subsection 41(1) of the Act, research is a specified purpose.

Application

48. A person who seeks permission for a research establishment to conduct research must apply to the Minister to obtain a research authorization.

Contents

49. An application for a research authorization must include the information specified in subsections 6(1) and (3) in addition to all of the following:

(a) an electronic copy of the proposed experimental label;

(b) a copy of the research plan; and

(c) any other information described in section 8 that the Minister may require to evaluate the health and environmental risks posed by the proposed research.

Authorization

50. (1) If the Minister considers that the health and environmental risks are acceptable and that the proposed experimental label meets the requirements of section 60, the Minister must authorize the use of the pest control product to conduct the research.

Issuance of research authorization certificate

(2) When the Minister authorizes the use of a pest control product to conduct research, the Minister must issue a research authorization certificate to the research establishment that sets out the conditions specified under subsection 41(1) of the Act, including those that relate to the experimental label.

Research Notification

Exemption

51. A research establishment is exempt from the application of subsection 6(1) of the Act and section 48 if the Minister confirms under section 54 that the proposed research meets all of the criteria set out in section 53.

Notice and contents

52. A research establishment that wishes to obtain confirmation under section 54 must notify the Minister by providing the information specified in subsections 6(1) and (3) in addition to both of the following:

(a) an electronic copy of the proposed experimental label; and

(b) a copy of the research plan.

Criteria

53. The following are the criteria referred to in section 51:

(a) the research does not involve the use of a semiochemical;

(b) in the case of research that involves the use of a chemical pest control product,

(i) it does not involve the use of an antimicrobial agent,

(ii) it does not involve aerial application,

(iii) it does not involve the application of a pest control product to water or to a place where runoff water may remove residues from the research site,

(iv) it does not involve the use of a pest control product in any of the following areas:

(A) greenhouses,

(B) residential areas, including lawns, gardens and parks,

(C) industrial premises, and

(D) food-handling areas,

(v) it does not involve the use of a pest control product for either

(A) structural pest control, or

(B) fumigation,

(vi) it does not involve the use of a pest control product that contains a formulant that is on Part I of the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern or a contaminant that is on Part 3 of that List,

(vii) in the case of a pest control product that contains an unregistered active ingredient, the application of the pest control product is carried out by the researcher alone

(A) on 5 to 50 ha of land owned or operated by a research establishment, or

(B) on 1 to 5 ha of land owned or operated by a cooperator, and

(viii) in the case of a pest control product that contains a registered active ingredient,

(A) the application of the pest control product is carried out by a researcher or cooperator on 10 to 50 ha of land owned or operated by a research establishment or a cooperator, and

(B) there is a reasonable expectation that the research will not increase occupational exposure above the level that is expected when the pest control product is used in accordance with its conditions of registration; and

(c) in the case of research that involves the use of a microbial agent,

(i) it does not involve aerial application,

(ii) it does not involve the use of a pest control product that contains a formulant that is on Part 1 of the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern or a contaminant that is on Part 3 of that List,

(iii) the micro-organism is indigenous to the area where it is intended to be used, and

(iv) the application of the pest control product is carried out on a maximum of 10 ha of land owned or operated by a research establishment or, in the case of an aquatic application, on a body of water that has a maximum of 1 ha of surface area and that is wholly contained on land owned or operated by a research establishment.

Issuance of research notification certificate

54. If the Minister confirms that the proposed research meets the criteria set out in section 53 and the proposed experimental label meets the requirements of section 60, the Minister must issue a research notification certificate to the research establishment.

Exemptions and Conditions

Exemption — research solely in laboratory

55. (1) A research establishment is exempt from the application of subsection 6(1) of the Act and sections 48, 52 and 59 to 63 if the research is conducted solely in a laboratory.

Exemption and criteria — research not solely in laboratory

(2) A research establishment is exempt from the application of subsection 6(1) of the Act and sections 48 and 52 if all or part of the research is conducted outside a laboratory and meets all of the following criteria:

(a) it does not involve the use of a microbial agent;

(b) in the case of research that involves the use of a chemical pest control product,

(i) it does not involve the use of an antimicrobial agent,

(ii) it does not involve aerial application,

(iii) it does not involve the application of a pest control product to water or to a place where runoff water may remove residues from the research site,

(iv) it does not involve the use of a pest control product in any of the following areas:

(A) greenhouses,

(B) residential areas, including lawns, gardens and parks,

(C) industrial premises, and

(D) food-handling areas,

(v) it does not involve the use of a pest control product for either

(A) structural pest control, or

(B) fumigation,

(vi) it does not involve the use of a pest control product that contains a formulant that is on Part 1 of the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern or a contaminant that is on Part 3 of that List,

(vii) in the case of a pest control product that contains an unregistered active ingredient, the application of the product is carried out by the researcher alone

(A) on a maximum of 5 ha of land owned or operated by a research establishment, or

(B) in the case of land owned or operated by a cooperator, on a maximum of 1 ha or 5% of the total area of the crop under research, whichever is less, and

(viii) in the case of a pest control product that contains a registered active ingredient,

(A) the application of the product is carried out by a researcher or cooperator on a maximum of 10 ha of land owned or operated by a research establishment or a cooperator, or on a maximum of 20% of the total area of the crop under research, whichever is less, and

(B) there is a reasonable expectation that the research will not increase occupational exposure above the level that is expected when the pest control product is used in accordance with its conditions of registration; and

(c) in the case of research that involves the use of a semiochemical,

(i) it does not involve aerial application,

(ii) it does not involve the application of a pest control product to water,

(iii) it does not involve the use of a pest control product in any of the following areas:

(A) greenhouses,

(B) residential areas, including lawns, gardens and parks,

(C) industrial premises, and

(D) food-handling areas,

(iv) it does not involve the use of a pest control product for either

(A) structural pest control, or

(B) fumigation,

(v) it does not involve the use of a pest control product that contains a formulant that is on Part 1 of the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern or a contaminant that is on Part 3 of that List,

(vi) in the case of a pest control product that contains an unregistered active ingredient, other than an arthropod pheromone, the application of the product is carried out by the researcher alone on a maximum of 5 ha of land owned or operated by a research establishment,

(vii) in the case of a pest control product that contains a registered active ingredient, other than an arthropod pheromone, the application of the product is carried out by a researcher or cooperator on a maximum of 10 ha of land owned or operated by a research establishment or cooperator, and

(viii) in the case of a pest control product that contains an active ingredient that is an arthropod pheromone,

(A) the application of the product is carried out on a maximum of 100 ha of land owned or operated by a research establishment or cooperator and the maximum use rate does not exceed 375 g of active ingredient per hectare per year, and

(B) if used in a food or feed crop, the pheromone is contained in an affixed solid matrix dispenser or in a retrievable-sized polymeric matrix dispenser, and the dispenser is not in direct contact with the crop.

General Requirements for Certificates

Expiry

56. A research authorization certificate and a research notification certificate expire on December 31 of the year in which they are issued, unless another expiry date is specified in the certificate.

Not renewable

57. Neither a research authorization certificate nor a research notification certificate is renewable.

Not transferable

58. Neither a research authorization certificate nor a research notification certificate is transferable.

Signage at Research Sites

Requirements

59. Unless otherwise specified as a condition by the Minister under subsection 41(1) of the Act, a research establishment must post signs at every research site that

(a) show all of the following information:

(i) the following primary message, in both English and French:

“PEST CONTROL EXPERIMENTAL SITE / SITE D’EXPÉRIMENTATION DE LUTTE ANTIPARASITAIRE

DO NOT ENTER WITHOUT AUTHORIZATION. / ACCÈS INTERDIT SANS AUTORISATION

CONTACT (contact name) AT (phone number). / S’ADRESSER À (nom du responsable) AU (no de téléphone).”, and

(ii) the research authorization certificate number or research notification certificate number, when there is one;

(b) are visible, legible, indelible and posted at every entrance to the research site on each side of the entrance;

(c) are posted before treatment begins and remain posted until any treated food or feed crop is harvested or as long as data are being collected; and

(d) may include the name of the pest control product that is the subject of the research and the name and logo of its manufacturer, if they are printed smaller than the primary message.

Experimental Labels

Requirement

60. (1) A research establishment must ensure that every pest control product that is used in research is accompanied by an experimental label.

Contents

(2) An experimental label must

(a) show all of the information specified in section 26, except paragraphs 26(1)(d), (g), (i) and (k) and (2)(d);

(b) show

(i) the following information on the principal display panel:

(A) the statement “EXPERIMENTAL USE ONLY”,

(B) the research authorization certificate number or the research notification certificate number, when there is one, as follows:

(I) “RESEARCH AUTHORIZATION/NOTIFICATION NO. (assigned number) PEST CONTROL PRODUCTS ACT”, or

(II) “RESEARCH AUTHORIZATION/NOTIFICATION NO. (assigned number) P.C.P. ACT”,

(C) the statement “SALE PROHIBITED. NOT FOR DISTRIBUTION TO ANY PERSON OTHER THAN A RESEARCHER OR COOPERATOR.”,

(D) the statement “KEEP OUT OF THE REACH OF CHILDREN”,

(E) the manufacturer’s name and address, and

(F) when the research involves the use of a pest control product that contains a formulant that is on Part 2 of the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern, the statement “Warning: contains the allergen (name of allergen)”,

(ii) on the secondary display panel, when the research involves the use of an unregistered pest control product, in the instructions on decontamination procedures and disposal referred to in paragraph 26(2)(b), the statement “Any unused product must be returned to the manufacturer.”, and

(iii) on the secondary display panel, despite paragraph (a), the statement set out in subparagraph 26(2)(e)(ii) amended to read as follows: “Take the experimental label with you when seeking medical attention.”; and

(c) represent the intended research as described in the research plan.

Exception

(3) Despite paragraph (2)(a), when the research involves the use of a registered pest control product, the following information need not be shown on the experimental label if that label is used in conjunction with the approved label:

(a) the net quantity referred to in paragraph 26(1)(j);

(b) instructions on decontamination procedures and disposal referred to in paragraph 26(2)(b);

(c) information that identifies any significant risk to the environment, and instructions on procedures to reduce those risks, referred to in paragraph 26(2)(c); and

(d) the notice to users referred to in paragraph 26(2)(g).

Copies

61. A research establishment must

(a) supply to every researcher and cooperator involved in the research a copy of the experimental label, which must be the approved experimental label if a research authorization certificate or research notification certificate has been issued; and

(b) produce a copy of the experimental label to an inspector, on request.

No inconsistent use

62. A researcher or cooperator must not handle, store, transport, use or dispose of a pest control product in a way that is inconsistent with

(a) the research plan, if a research authorization certificate or research notification certificate has been issued; or

(b) the directions on the experimental label.

Records

Contents

63. A research establishment must keep records that contain all of the following information for each research project:

(a) the name and quantity of every pest control product used;

(b) the names of the researchers and cooperators;

(c) the locations of the research sites;

(d) a description of the application methods; and

(e) the test data generated.

Import for Research Purposes

Conditions for import

64. A research establishment may import an unregistered pest control product for the purpose of conducting research if

(a) the product is imported in accordance with section 36; and

(b) the quantity being imported is not more than that specified in a research authorization certificate or research notification certificate, or, if the quantity is not so specified, the amount that is necessary to conduct the research.

Unused Pest Control Products

Unregistered products

65. A research establishment must return to the manufacturer any unused unregistered pest control products.

Registered products

66. A research establishment must return to the manufacturer any unused registered pest control product unless it is kept by the research establishment to be used by a researcher or cooperator involved in the research in a way that is consistent with the directions on the approved label.

Distribution

Researchers and cooperators only

67. A research establishment may not distribute a pest control product that is used in the conduct of research to any person that is not a researcher or cooperator involved in the research, except in accordance with section 65 or 66.

Treated food and feed crops

68. When a research authorization certificate is issued, treated food and feed crops from research sites and meat (including meat by-products and fat), milk and eggs that may contain residues as a result of the research must not be sold unless

(a) written authorization to do so is set out on the certificate; and

(b) in the case of research that involves the use of a chemical pest control product, residues do not exceed an amount that would result in the sale of the food being prohibited under section 4 of the Food and Drugs Act.

Research — section 53 criteria

69. In the case of research that meets the criteria set out in section 53 and for which a research notification certificate is issued,

(a) in the case of research that involves the use of a chemical pest control product, treated food and feed crops from research sites and meat (including meat by-products and fat), milk and eggs that may contain residues as a result of research must not be sold unless the residues do not exceed an amount that would result in the sale of the food being prohibited under section 4 of the Food and Drugs Act; and

(b) in the case of research that involves the use of a microbial agent, other than one that contains Bacillus thuringiensis registered for use on agricultural crops, treated food and feed crops from research sites and meat (including meat by-products and fat), milk and eggs that may contain residues as a result of research must not be sold.

Research — subsection 55(2) criteria

70. In the case of research that meets the criteria set out in subsection 55(2), treated food and feed crops from research sites and meat (including meat by-products and fat), milk and eggs that contain residues as a result of research must not be sold unless

(a) in the case of research that involves the use of a chemical pest control product, residues do not exceed an amount that would result in the sale of the food being prohibited under section 4 of the Food and Drugs Act; and

(b) in the case of research that involves the use of a semiochemical, the research meets the criteria set out in subparagraph 55(2)(c)(viii).

SAMPLING

Representative samples

71. A sample of a pest control product that is taken by an inspector under paragraph 48(1)(b) of the Act must be representative of the lot from which it is taken and may consist of

(a) the entire package, in the case of a liquid packaged in containers of less than 5 L;

(b) the entire package, in the case of a dry material packaged in containers of less than 5 kg; and

(c) the entire device, in the case of a device.

DETENTION

Detention tag

72. If a pest control product is seized under subsection 52(1) of the Act, the inspector must attach a detention tag to at least one package of the pest control product in the lot that is seized.

TRANSITIONAL

Meaning of “old Regulations”

73. (1) In subsections (2) to (4), “old Regulations” means the Pest Control Products Regulations, C.R.C., c. 1253, as they read immediately before the coming into force of these Regulations.

Deemed equivalency certificates

(2) A letter of acceptance with respect to a pest control product that was issued by the Minister on the basis of a determination of equivalence under section 5 of the old Regulations within two years before the day on which these Regulations come into force is deemed to be an equivalency certificate issued under subsection 39(5) of these Regulations with an expiry date that is one year after that day.

Completed applications

(3) When information that is required under section 17 of the old Regulations was provided before the coming into force of these Regulations but a final registration decision has not been made when these Regulations come into force, the information requirement is deemed to have been imposed for the purpose of these Regulations by delivery of a notice under section 12 of the Act, and section 14 of these Regulations applies to the registration.

Incomplete applications

(4) When the holder of a temporary registration has not provided the information required under section 17 of the old Regulations before these Regulations come into force, they may make a new application for registration in accordance with the Act.

REPEAL

74. [Repeal]

COMING INTO FORCE

Coming into force

75. These Regulations come into force on June 28, 2006.

SCHEDULE 1

(Paragraph 3(1)(a) and section 30)

PRESCRIBED DEVICES

1. Garment bags, cabinets or chests that are manufactured, represented or sold as a means to protect clothing or fabrics from pests.

2. Devices that are manufactured, represented or sold as a means to attract or destroy flying insects, or to attract and destroy them.

3. Devices that are manufactured, represented or sold as a means to repel pests by causing them physical discomfort by means of sound, touch or electromagnetic radiation.

4. Devices for attachment to garden watering hoses that are manufactured, represented or sold as a means to dispense or apply a pest control product.

5. Devices that are manufactured, represented or sold as a means to provide the automatic or unattended application of a pest control product.

6. Devices that are sold for use with chemical products that contain cyanide as a means to control animal pests.

SCHEDULE 2

(Subparagraph 4(1)(b)(i) and subsection 4(2))

PEST CONTROL PRODUCTS EXEMPT FROM REGISTRATION

1. Feed for animals, if the pest control product contained in the feed is registered under the Act for the purpose of mixing with feed.

2. A fertilizer that is subject to the Fertilizers Act, if the pest control product contained in it is registered under these Regulations.

3. Seed that has been treated with a pest control product that is registered for the purpose of treating such seed, if

(a) the seed is sold and shipped in bulk and the documents that accompany the shipment include the common chemical name of the active ingredient of the pest control product used to treat the seed or, if it has no common chemical name, its chemical or other name; or

(b) in the case of seed that is packaged for distribution, the label shows the statement “This seed is treated with”, followed by the name of the pest control product, including the chemical name or common chemical name of its active ingredient, together with the appropriate precautionary symbols and signal words set out in Schedule 3 and any other applicable statements that are required by these Regulations.

4. A water conditioner that

(a) is represented to control algae and is for use in or around homes in humidifiers, aquariums, waterbeds or any appliance that has a water reservoir;

(b) contains as its only active ingredient at most 60% copper sulphate registered under the Act; and

(c) is in a package whose label shows all of the following information:

(i) on the principal display panel,

(A) the identity of the water conditioner in terms of its function referred to in paragraph (a),

(B) the information set out in items 1 to 3 of the table to section 6,

(C) in the case of a water conditioner whose concentration of copper sulphate is set out in column 1 of item 2 or 3 of the table to this section, the precautionary symbol set out in column 2 of item 7 of Schedule 3, and

(D) the appropriate signal words set out in column 2 of the table to this section, and

(ii) on the secondary display panel, the information set out in items 4 to 7 of the table to section 6.

TABLE TO SECTION 4

Column 1

Column 2

Item

Concentration of Copper Sulphate in Water Conditioner

Signal Words

1.

Less than 12%

None

2.

12% or more but less than 30%

“Caution — Poison”

3.

30% or more but not more than 60%

“Warning — Poison”

5. A device that is manufactured, represented or sold as a means to attract and destroy flying insects indoors, by means other than the use of an active ingredient that is a chemical, if

(a) the device is certified by the Canadian Standards Association as meeting the requirements of Standard CAN/CSA-C22.2 No. 189-M89, entitled High-Voltage Insect Killers, as amended from time to time; and

(b) all of the following information appears on the label of the device:

(i) the logo of the Canadian Standards Association,

(ii) the identity of the device in terms of its function,

(iii) the information set out in items 3 to 6 of the table to section 6,

(iv) the precaution statement “This device should not be installed directly on or over surfaces where food is exposed, processed or prepared.”, and

(v) the statement “To aid in the reduction of housefly population, use this device in conjunction with sanitary practices.”.

6. A device that is manufactured, represented or sold as a means to attract and destroy flying insects outdoors, by means other than the use of an active ingredient that is a chemical, if

(a) the device is certified by the Canadian Standards Association as meeting the requirements of Standard CAN/CSA-C22.2 No. 189-M89, entitled High-Voltage Insect Killers, as amended from time to time; and

(b) all of the following information appears on the label of the device:

(i) the logo of the Canadian Standards Association,

(ii) the identity of the device in terms of its function,

(iii) the information set out in items 3 to 6 of the table to this section,

(iv) the statement “For Outdoor Use Only.”, and

(v) the statement “This device does not control blackflies, mosquitoes or other biting flies.”.

TABLE TO SECTION 6

1. The following guarantee statement:

(a) the word “GUARANTEE”, followed by a colon;

(b) 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

(c) the concentration of the active ingredient, expressed, if the pest control product is

(i) a liquid, as a percentage by mass, or as mass per unit volume, or both, or

(ii) a dust, wettable powder or other dry formulation, as a percentage by mass.

2. A declaration of net quantity of the package, expressed

(a) by volume, if the pest control product is a liquid or gas or is viscous; or

(b) by mass, if the pest control product is a solid or pressure-packed.

3. The name and postal address of the distributor.

4. The directions for the use of the pest control product, including application rates, timing of application and any limitations on its use.

5. Information that identifies any risks associated with the handling, storage, display, distribution and disposal of the pest control product, and instructions on procedures to reduce those risks.

6. Information that identifies any risks to health, the environment or anything in connection with which the pest control product is to be used, and instructions on procedures to reduce those risks.

7. Instructions in first aid, under the heading “FIRST AID INSTRUCTIONS”, that set out the practical measures to be taken in the event of poisoning, intoxication or injury caused by the pest control product.

7. A swimming pool product that

(a) is represented or sold as a product whose function is to control bacteria or algae, or both;

(b) contains as its only active ingredient a registered active ingredient of the type, concentration and percentage of available chlorine set out in the table to this section; and

(c) is in a package and whose label shows all of the following information:

(i) on the principal display panel,

(A) the identity of the product in terms of its function referred to in paragraph (a),

(B) the information set out in items 1 to 3 of the table to section 6,

(C) the appropriate signal words set out in column 4 of the table to this section,

(D) in the case of an active ingredient set out in column 1 of the table to this section, the precautionary symbol set out in column 5 of item 1 or of paragraph 2(b), 3(b), 4(b), 5(b) or 6(b) of that table, as applicable, and

(E) in the case of an active ingredient set out in column 1 of any of items 2 to 6 of the table to this section, the precautionary symbol set out in column 5 of paragraph 2(a), 3(a), 4(a), 5(a) or 6(a) of that table, as applicable, and

(ii) on the secondary display panel, the information set out in items 4 to 7 of the table to section 6.

TABLE TO SECTION 7

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Active Ingredient

Concentration (%)

Available Chlorine (%)

Signal Words

Precautionary Symbol

1.

Sodium Hypochlorite

10.8

10.3

“Warning — Corrosive”

2.

Calcium Hypochlorite

65 or 70

65 or 70

(a) “Warning — Poison”

(a)

(b) “Caution — Corrosive”

(b)

3.

Lithium Hypochlorite

29

35

(a) “Warning — Poison”

(a)

(b) “Caution — Corrosive”

(b)

4.

Trichloro-s-triazinetrione

100

90

(a) “Caution — Poison”

(a)

(b) “Caution — Corrosive”

(b)

5.

Sodium Dichloro-s-triazinetrione

100

62

(a) “Caution — Poison”

(a)

(b) “Caution — Corrosive”

(b)

6.

Sodium Dichloro-s-triazinetrione dihydrate

100

56

(a) “Caution — Poison”

(a)

(b) “Caution — Corrosive”

(b)

8. A spa product that

(a) is represented or sold as a product whose function is to control bacteria or algae, or both;

(b) contains as its only active ingredient a registered active ingredient of the type, concentration and percentage of available chlorine set out in the table to this section; and

(c) is in a package and whose label shows all of the following information:

(i) on the principal display panel,

(A) the identity of the product in terms of its function referred to in paragraph (a),

(B) the information set out in items 1 to 3 of the table to section 6,

(C) the appropriate signal words set out in column 4 of the table to this section,

(D) in the case of an active ingredient set out in column 1 of any of items 1 to 3 and 5 of the table to this section, the precautionary symbol set out in column 5 of paragraph 1(b), 2(b) or 3(b) or item 5 of that table, as applicable, and

(E) in the case of an active ingredient set out in column 1 of any of items 1 to 3 of the table to this section, the precautionary symbol set out in column 5 of paragraph 1(a), 2(a) or 3(a) of that table, as applicable, and

(ii) on the secondary display panel, the information set out in items 4 to 7 of the table to section 6.

TABLE TO SECTION 8

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Active Ingredient

Concentration (%)

Available Chlorine (%)

Signal Words

Precautionary Symbol

1.

Lithium Hypochlorite

29

35

(a) “Warning — Poison”

(a)

(b) “Caution — Corrosive”

(b)

2.

Sodium Dichloro-s-triazinetrione

100

62

(a) “Caution — Poison”

(a)

(b) “Caution — Corrosive”

(b)

3.

Sodium Dichloro-s- triazinetrione dihydrate

100

56

(a) “Caution — Poison”

(a)

(b) “Caution — Corrosive”

(b)

4.

Sodium Bromide

35

N/A

None

None

5.

Potassium Monopersulfate

32

N/A

“Caution — Corrosive”

SCHEDULE 3

(Paragraph 26(1)(e), subsection 34(2) and Schedule 2)

SIGNAL WORDS AND PRECAUTIONARY SYMBOLS

Column 1

Column 2

Item

Signal Word

Precautionary Symbol

1.

Caution

2.

Danger

3.

Warning

4.

Corrosive

5.

Explosive

6.

Flammable

7.

Poison

RELATED PROVISIONS

— SOR/2010-119, s. 3:

3. (1) These Regulations apply to an application to register a pest control product or to amend a registration made on or after August 1, 2007 and before the day on which these Regulations come into force, if the applicant wishes to use or rely on compensable data of a registrant and the Minister has requested in writing that the parties negotiate the amount of compensation payable for that use or reliance.

(2) Despite subsection (1), if the Minister’s request is made more than 60 days before the coming into force of these Regulations and the applicant sends a copy of an agreement to the registrant under subsection 17.8(2) of the Pest Control Products Regulations, as enacted by section 2, the 120-day period specified in subsection 17.9(2) of those Regulations, as enacted by section 2, is reduced to 60 days from the day after the agreement is sent.

— SOR/2010-119, s. 4:

4. Despite paragraph 17.5(3)(b) of the Pest Control Products Regulations, as enacted by section 2, the Minister must extend the exclusive use period established in accordance with section 17.5 of those Regulations, as enacted by section 2, if all of the following conditions are met:

(a) there remain at least six months before the exclusive use period expires;

(b) minor uses are added to the registration on or after August 1, 2007 but before the day on which these Regulations come into force; and

(c) the registrant requests an extension of the exclusive use period within 30 days after the day on which these Regulations are published in the Canada Gazette, Part II.

Last updated: 2011-02-24

 

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