Canada Gazette, Part I, Volume 146, Number 27: Regulations Amending the Pest Control Products Regulations

July 7, 2012

Statutory authority

Pest Control Products Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issue

The central issues that the proposed amendments seek to address are that (1) existing Regulations with respect to grower importation of pest control products allow for the determination of chemical equivalence outside the “two step” approach under which the current importation program successfully operates; (2) the Regulations do not empower national grower groups to indicate which products they would nominate for equivalency determination; and (3) the existing Regulations do not recognize exclusive data protection on registrants’ products which could be considered to be a disincentive for registering new products. These proposed amendments will address recommendations from the 2006 Own Use Import Task Force.

Underpinning the current program is the requirement that candidate products being considered for import would have the support of and would be nominated for inclusion into the import program by at least four national grower organizations. Subsequent to the nomination, the Pest Management Regulatory Agency (PMRA) solicits information from Canadian registrants so that chemical equivalence between a Canadian registrant’s product and a foreign product sold by an affiliated company, can be determined (Step 1 — paper-based equivalency). If this information is not forthcoming from the registrants (e.g. not provided), a party may seek to establish chemical equivalence (Step 2) between the same Canadian registered product and any foreign product (including a product sold by a foreign company that is not affiliated with the registrant of the product sold in Canada).

Without regulatory amendments that provide grower-prioritized nominations and the two step equivalency determination approach, a party who is neither a grower nor a registrant might opt to first seek to determine equivalency via Step 2 (i.e. a determination of equivalency through laboratory analysis). This would ultimately put at risk continued support for the program as it has been functioning under policy for the last five years with participation of both Canadian growers and registrants who are integral to this process.

Included in this proposal are administrative amendments which will clarify certain provisions and correct inconsistencies between the English and French versions of the PCPR.

Objectives

The Pest Control Products Act (PCPA) and the Pest Control Product Regulations (PCPR) provide the legislative mandate to regulate pest control products in Canada. Under the PCPA, the Minister has the authority to allow the use of unregistered pest control products (i.e. a pest control product that is not registered in Canada), if the use of such products does not pose any unacceptable health or environmental risks. Using this authority, provisions in the Pest Control Products Regulations currently allow the importation of a foreign product, exempt from Canadian registration requirements, provided it is deemed to be equivalent to a Canadian registered product and has an equivalent label. These provisions have commonly been referred to as the Own-Use Import Program (OUI). The program, put in place in 1993, was intended as a price-discipline mechanism for the Canadian pesticide industry by providing Canadian users access to lower-priced foreign products.

During the first 12 years of the program, only three products were eligible for import and virtually no product crossed the border. However, between 2005 and 2007, the program was used extensively with a total of approximately 19 million litres of a generic herbicide imported and 10 291 import authorizations issued. As a result of the extensive use of the program, stakeholders raised a number of issues with the program (e.g. concerns were raised regarding the establishment of a new distribution system with no product stewardship program, as well as the methodology for determining equivalency between foreign products and those which are registered in Canada). Health Canada, with the support of stakeholders, assembled the 2006 Own Use Import Task Force (Task Force) to review the issues and identify solutions. As a result of the Task Force recommendations, a new import program was established in 2007.

The primary objectives of the proposed amendments are to ensure that Canadian agriculture producers continue to have access to an import mechanism that

• — promotes price discipline in the Canadian pesticide marketplace;
• — is aligned with other instruments also aimed at enhancing competition for this agricultural production input;
• — ensures that imported products under this program do not present unacceptable health and environmental risks; and
• — balances the interests of product registrants and growers by providing product price discipline while respecting registrants’ investments in Canadian product registration.

Description

The proposed regulatory amendments seek to ensure that the regulations with respect to the importation of pest control products are aligned with the existing importation program. Key provisions can be summarized as follows.

The role of national grower organizations

The proposed Regulations would establish the requirement that candidate products being considered for import have the support and be nominated for inclusion into the import program by at least four national grower organizations. The purpose of this requirement is to ensure that the activities of the PMRA, with respect to the import program, are in line with the national interest of Canadian growers. It is expected that the grower organizations are to represent a not-for-profit, nationally-based grower group with a direct interest in the import program; represent their respective organization’s interests and concerns while remaining flexible regarding national and regional needs; and, through their member organizations, promote and support the success of the import program for the benefit of its Canadian growers.

Before submission to the PMRA, candidate products would be screened for eligibility (i.e. formulations, active ingredient concentration) by the nominators. In addition to the criteria outlined in the Regulations, other business complexities should be taken into consideration in advance of nomination, and registrants should be consulted as much as possible to further define grower priorities.

Since 2006–2007, the following organizations have been voluntarily meeting as a group to nominate products for the import program:

• Canadian Canola Growers Association
• Canadian Federation of Agriculture
• Canadian Horticultural Council
• Grain Growers of Canada
• Pulse Canada
• Canadian Nursery Landscape Association
• Flowers Canada Growers

Equivalency determination

Health Canada’s primary mandate is the protection of Canadians’ health and environment. The Department must ensure that foreign-registered products entering Canada meet a similar level of acceptability to that of Canadian registered products.

The determination of equivalency between a Canadian product and a foreign product is an important component of the proposed amendments. Throughout the development of the pilot program, the determination of equivalency was discussed at length and the proposed amendments reflect the recommendations received through consultations with stakeholders.

The proposed Regulations also reflect the existing two-step process to obtain the data that is necessary to make a decision on equivalency. This process is as follows:

Step 1 — The foreign product being compared to the registered Canadian product must originate from a company that is affiliated with the Canadian registrant. Canadian registrants and their affiliated companies have the option of providing to the PMRA information regarding all the ingredients in the product so a comparison of the product’s components can be conducted and a decision made on whether they are materially equivalent. The information provided by registrants includes that of foreign and domestic specification forms for the technical active ingredient and the associated end-use product for review of the active ingredient concentration (i.e. a guarantee statement), level of impurities, formulants, efficacy, and health and environmental effects. In addition, electronic versions of the labels, information regarding container size, formulation type and packaging type, and the material safety data sheet of the domestic and foreign products would be included if available.

Significant improvements are realized with the registrant-provided information process including the following:

• Minor formulation changes for listed products would not necessarily render products ineligible for import;
• Registrant involvement makes determination of equivalency possible without costs borne by growers;
• The potential impact on health and the environment is minimized; and
• More products can be approved under the program in a shorter time frame.

Step 2 — If the situation where a registrant declines to provide information necessary to establish equivalency were to arise, the Step 2 equivalency determination can be initiated. The application provided in Step 1 would be returned to the applicant for a decision as to whether to continue to support the application within Step 2. It is anticipated that the grower organizations would discuss the application with the registrant and make a decision either to continue to support the application or withdraw the application. If the applicant continues to support the application then any party may seek an authorization to import a product by establishing equivalency between the Canadian registered product and any foreign product by submitting detailed laboratory analyses.

In either of the above-mentioned situations (Step 1 or Step 2), if the PMRA determines that the two products are equivalent, a certificate of equivalency is published and the PMRA begins to accept applications for import.

Third-party facilitation

The role of third-party facilitators or intermediaries has been discussed extensively with stakeholders. The original concept of the program, as described when the provisions were brought into effect in 1993, was based on the premise that individual growers would import products for their own use. The Government’s interpretation of the current regulation is that it does not preclude the use of third parties to facilitate the importation of the product. This has included the use of commercial carriers to ensure safe transport, and seeking assistance with logistical or regulatory matters related to the importation process.

The proposed amendments to the Regulations would continue to allow growers to utilize intermediaries to facilitate the certificate application process and facilitate transportation and importation of products. However, the requirement that products be imported solely for the use and financial benefit of the certificate holder (growers) remains, and proof of purchase and associated certificates for import in the growers’ name would be required for importation. Resale of imported products remains prohibited by the Pest Control Products Act.

Data compensation

As a result of stakeholder consultations, the proposed regulatory amendments include a provision that states products are not eligible for the program during the exclusive-use period established by the regulatory amendments regarding the protection of proprietary interests in pesticide data. This provision is intended to balance growers’ interest in importing pest control products and Canadian registrants’ interest in ensuring that the expense and financial risks incurred in supporting the domestic registration of products is rewarded by precluding others from relying on this data (without the registrant’s consent) for a period of at least 10 years.

Other

In addition to the main issues above, the proposed amendments will also seek to

1. Clarify certain sections to improve transparency by addressing inconsistencies between the French and English versions and other administrative changes. As these amendments are administrative in nature, they will not have any impact on stakeholders.
2. Decrease the administrative burden on growers and registrants by increasing the validity period of the equivalency certificate from one to two years and by removing requirements to provide duplicate copies of labels and forms.

Regulatory and non-regulatory options considered

Patent issues

Some stakeholders proposed including provisions regarding patents and patent protection in the Regulations. This option was rejected since patent protection is a separate and independent legal regime and neither the registration of products nor other specified actions authorized under the PCPA (such as importation of unregistered products) authorizes infringement of intellectual property rights held by registrants. Compliance with the Patent Act (and all other laws of Canada) would continue to be required. Patent issues can be discussed between grower groups and registrants prior to the nomination of products for equivalency determination. Moreover, independent of the pesticide importation program, judicial avenues exist for claims of patent infringement to be assessed.

Container disposal

National grower associations, in collaboration with CropLife Canada, have gained access to the container management program used for other registered pest control products to ensure responsible disposal of pest control product containers. In order to ensure this stewardship program continues to operate successfully, it was decided that growers must provide proof of participation in a container management program as a condition for obtaining a certificate of importation, and as a condition of authorization. Therefore, prescribing a method of proper container disposal in the proposed regulatory amendments is no longer required because this issue has already been addressed by industry in the absence of a specific regulatory provision.

Benefits and costs

The impact of the proposed regulatory amendments relative to the status quo (retaining the new import program as a policy instrument with no force in regulations) relates principally to mitigating the risk that parties may opt to seek importation outside the current process. If this risk were to materialize, it could jeopardize Canadian registrants’ support for the importation program, including their support for the products currently eligible for importation. Additionally, the proposed amendments are intended to formalize an approach to establishing equivalence that is already reflected in the existing pesticide importation program, as well as to simplify certain administrative aspects of the program. The proposal is not expected to have a significant economic impact.

Rationale

Establishing this import program in regulations would help ensure that the existing pesticide import mechanism (the result of recommendations from a task force broadly representative of stakeholder interests) endures. It mitigates risks that may, in the absence of regulatory amendments, jeopardize support for, and the continued functioning of, an importation program that offers benefits to growers, while balancing the interests of Canadian registrants.

Consultation

Stakeholder consultations have been ongoing since 2005 when issues with the previous import program were identified to the PMRA. Formal consultations, through the Task Force, occurred regularly in 2005 and 2006. These meeting were attended by representatives of many agri-food sectors, including six grower and farming groups, pesticide manufacturers and retailers, federal and provincial governments.

The PMRA was called to speak and respond to questions from the Standing Committee on Agriculture and Agri-Food to discuss and provide feedback on the import program in 2005 and 2006, the piloted program in 2007, and the implementation of the full program in 2008 and 2009.

In 2010, two regulatory intent discussions were organized by the PMRA with the objective of providing a full range of stakeholders (grower organizations, pesticide manufacturers, their representatives and retailers, companies facilitating importation and Government) with an opportunity to discuss key issues relating to the existing program and to provide input into the development of the regulatory amendments. Overall, stakeholders are supportive of the intent to formalize the existing program into regulations. The proposal aims to strike a fair balance between the interests of stakeholders in addressing the concerns expressed during the consultations (as described in the “Regulatory and non-regulatory options considered” section).

Implementation, enforcement and service standards

The proposed amendments do not alter existing compliance mechanisms under the provisions of the Pest Control Products Act and the Pest Control Products Regulations. The proposed amendments are formalizing an existing program that was introduced in 2007.

Performance measurement and evaluation

The effectiveness of this proposal would be evaluated as part of the broader pesticide regulatory program evaluation, which is done on a regular basis.

Contact

Rob Ward
Policy, Communications and Regulatory Affairs Directorate
Pest Management Regulatory Agency
Health Canada
2720 Riverside Drive
Address Locator 6607D1
Ottawa, Ontario
K1A 0K9
Telephone: 613-736-3847
Fax: 613-736-3659
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 67 of the Pest Control Products Act (see footnote a), proposes to make the annexed Regulations Amending the Pest Control Products Regulations.

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice, and be addressed to Rob Ward, Policy, Communications and Regulatory Affairs Directorate, Pest Management Regulatory Agency, Department of Health, Address Locator: 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (fax: 613-736-3659; email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca).

Ottawa, June 19, 2012

JURICA ČAPKUN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE PEST CONTROL PRODUCTS REGULATIONS

AMENDMENTS

1. (1) The definitions “own use” and “own-use import certificate” in subsection 1(1) of the Pest Control Products Regulations (see footnote 1) are repealed.

(2) The definition “equivalency certificate” in subsection 1(1) of the English version of the Regulations is repealed.

(3) The definition “research establishment” in subsection 1(1) of the Regulations is replaced by the following:

“research establishment”
« établissement de recherche »

“research establishment” means a person who is engaged in research that pertains to a pest control product.

(4) The definition “certificat d’équivalence” in subsection 1(1) of the French version of the Regulations is replaced by the following:

« certificat d’équivalence  »
“certificate of equivalency”

« certificat d’équivalence » Certificat établi aux termes du paragraphe 39(1) à l’égard d’un produit étranger.

(5) Subsection 1(1) of the Regulations is amended by adding the following in alphabetical order:

“foreign product use certificate”
« certificat d’utilisation d’un produit étranger »

“foreign product use certificate” means a certificate that is issued under subsection 41(3) with respect to an imported foreign product.

(6) Subsection 1(1) of the English version of the Regulations is amended by adding the following in alphabetical order:

“certificate of equivalency”
« certificat d’équivalence »

“certificate of equivalency” means a certificate that is issued under subsection 39(1) with respect to a foreign product.

2. Paragraphs 3(1)(d) and (e) of the French version of the Regulations are replaced by the following:

• d) le produit antiparasitaire qui est utilisé pour détruire ou rendre inactifs des virus, bactéries ou autres micro-organismes en vue du traitement, de l’atténuation ou de la prévention des maladies chez les humains ou les animaux, sauf en ce qui concerne son utilisation dans une piscine ou un spa;
• e) sauf en ce qui concerne son utilisation comme agent de conservation du bois ou de toute autre matière, comme myxobactéricide ou dans une piscine ou un spa, le produit antiparasitaire qui est utilisé à la fois :
  
  • (i) pour détruire ou rendre inactifs des virus, bactéries ou autres micro-organismes en vue du traitement, de l’atténuation ou de la prévention des maladies chez les humains ou les animaux,
  • (ii) pour réduire les populations des virus, bactéries ou autres micro-organismes qui causent soit des maladies chez les humains ou les animaux, soit des moisissures, du mildiou ou des odeurs;
    

3. (1) Paragraph 4(1)(d) of the Regulations is replaced by the following:

• (d) a pest control product that is a foreign product imported under a foreign product use certificate; or

(2) Section 4 of the Regulations is amended by adding the following after subsection (3):

No manufacture or distribution in Canada

(4) A pest control product that is exempt from registration under paragraph (1)(d) may not be manufactured or distributed in Canada.

4. (1) Subparagraph 6(1)(g)(iii) of the English version of the Regulations is replaced by the following:

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

(2) Paragraph 6(1)(i) of the French version of the Regulations is replaced by the following:

• i) les dimensions, le type et les spécifications de l’emballage dans lequel le produit antiparasitaire doit être distribué;

5. Section 7 of the Regulations is repealed.

6. (1) Paragraphs 8(f) and (g) of the Regulations are replaced by the following:

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

(2) Paragraph 8(m) of the French version of the Regulations is replaced by the following:

• m) les propriétés chimiques et physiques du produit, ou son espèce ou sa souche et ses propriétés biologiques, sa composition, ainsi que ses spécifications et procédés de fabrication, y compris les processus d’assurance de la qualité;

7. (1) The portion of subsection 9(1) of the Regulations before paragraph (a) is replaced by the following:

Additional information — affidavit and contents

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

(2) Paragraph 9(1)(a) of the English version of the Regulations is replaced by the following:

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

(3) Paragraph 9(1)(d) of the French version of the Regulations is replaced by the following:

• d) la déclaration portant que les renseignements, ainsi que toutes copies de ceux-ci, seront retournés au ministre lorsque l’objectif de la consultation aura été atteint.

(4) Subsections 9(2) and (3) of the Regulations are replaced by the following:

Copying or other use

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

Return of information

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

8. (1) The portion of subsection 17(1) of the Regulations before paragraph (a) is replaced by the following:

Additional information — affidavit and contents

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

(2) Paragraph 17(1)(a) of the English version of the Regulations is replaced by the following:

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

(3) Paragraph 17(1)(d) of the French version of the Regulations is replaced by the following:

• d) la déclaration portant que les renseignements, ainsi que toutes copies de ceux-ci, seront retournés au ministre lorsque l’objectif de la consultation aura été atteint.

(4) Subsections 17(2) and (3) of the Regulations are replaced by the following:

Copying or other use

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

Return of information

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

9. Section 20 of the English version of the Regulations is replaced by the following:

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 as a result it could 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.

10. Section 21 of the French version of the Regulations is replaced by the following:

Interdiction

21. Aucun terme affirmant ou laissant entendre que l’administration fédérale ou l’un de ses ministères ou organismes préconise, cautionne ou recommande l’utilisation d’un produit antiparasitaire ne peut paraître sur l’emballage du produit, ni dans aucune publicité sur celui-ci.

11. Subsections 22(1) and (2) of the Regulations are replaced by the following:

Official languages

22. (1) Subject to subsection (3), all information on a label must be in both English and French.

12. The marginal note to subsection 24(1) of the French version of the Regulations is replaced by “Maladies chez les humains”.

13. (1) The portion of subsection 26(1) of the Regulations before paragraph (a) is replaced by the following:

Principal display panel

26. (1) Unless otherwise specified by the Minister under subsection 8(2) of the Act, the principal display panel of a registered pest control product must show all of the following information:

(2) Subparagraph 26(1)(h)(iv) of the English version of the Regulations is replaced by the following:

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

(3) The portion of subsection 26(2) of the Regulations before paragraph (a) is replaced by the following:

Secondary display panel

(2) Unless otherwise specified by the Minister under subsection 8(2) of the Act, the secondary display panel of a registered pest control product must show all of the following information:

14. Sections 27 and 28 of the Regulations are replaced by the following:

Brochures or leaflets

28. If, under subsection 8(2) of the Act, the Minister specifies in the conditions of registration relating to the label that information required by these Regulations to be shown on the principal and secondary display panels may instead be shown in a brochure or leaflet that accompanies the pest control product, the following requirements must be met:

• (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 specified information.

15. Subsection 34(1) of the Regulations is repealed.

16. (1) The portion of section 36 of the Regulations before paragraph (a) is replaced by the following:

Declaration and contents

36. (1) A pest control product — except one that is the subject of a foreign product use certificate — may be imported into Canada only if it is accompanied by a declaration, in English or French, signed by the importer, that sets out all of the following information:

(2) Paragraph 36(1)(f) of the Regulations is amended by adding “and” at the end of subparagraph (ii), by striking out “or” at the end of subparagraph (iii) and by repealing subparagraph (iv).

(3) Section 36 of the Regulations is amended by adding the following after subsection (1):

Retention

(2) The information set out in a declaration must be kept for two years after the importation of the pest control product in respect of which the declaration was made.

17. The heading before section 37 and sections 37 to 45 of the Regulations are replaced by the following:

USE OF FOREIGN PRODUCTS

Requirements

Procedure

37. For the purpose of subsection 41(1) of the Act, the following requirements must be met before an authorization may be made with respect to the use of a foreign product:

• (a) the Minister determines under section 38 that the foreign product is equivalent to a registered pest control product;
• (b) the Minister issues a certificate of equivalency under subsection 39(1) with respect to the foreign product;
• (c) the Minister approves the foreign product use label under section 40; and
• (d) the person who wishes to use the foreign product applies to the Minister for an authorization in accordance with subsections 41(1) and (2).

Product Equivalency

Conditions

38. (1) Subject to subsection (4), the Minister may make a determination that a foreign product is equivalent to a registered pest control product if all of the following conditions are met:

• (a) a grower or group of growers requests the Minister to make the determination;
• (b) four national grower associations support the request;
• (c) the person who makes the request provides the Minister with all of the information listed in subsection (4);
• (d) the foreign product meets the requirements of subsection (2); and
• (e) the registered pest control product meets the requirements of subsection (3).

Eligibility — foreign products

(2) A foreign product must meet all of the following requirements to be considered in making a determination of equivalency:

• (a) it is not an organism;
• (b) it is not under review in the foreign country where it is registered with respect to its health and environmental risks and is available and is being sold in the foreign country;
• (c) it does not contain an active ingredient that is under special review in Canada; and
• (d) it is manufactured by a person who is related to the registrant of the registered pest control product, within the meaning of the definition “related persons” in subsection 251(2) of the Income Tax Act, whether the related person is located in or outside Canada.

Eligibility — registered pest control products

(3) A registered pest control product must meet both of the following requirements to be considered in making a determination of equivalency:

• (a) it does not have the product class designation “RESTRICTED” described in paragraph 5(c); and
• (b) none of the test data described in paragraphs 17.5(1)(a) to (c) that support its registration are subject to the exclusive use of the registrant.

Preliminary steps

(4) Before making the determination of equivalency, the Minister must first find that the foreign product and the registered pest control product are sufficiently similar so as to justify proceeding with the determination, based on the following preliminary information:

• (a) the name and registration number of the registered pest control product, the name and product identifier of the foreign product and the name of the country where the foreign product is registered;
• (b) the name of the registrant of the registered pest control product and the name of the holder of the registration of the foreign product;
• (c) the labels of both products;
• (d) the information described in subparagraphs 26(1)(h)(ii) to (iv) with respect to both products;
• (e) their type of formulation;
• (f) their type of package;
• (g) the health and environmental risks that were evaluated by the regulatory body that registered the foreign product; and
• (h) the standard of acceptability of risk that was applied by the regulatory body that registered the foreign product.

Further information

(5) If the Minister finds that the foreign product is sufficiently similar to the registered pest control product, the Minister must so inform the registrant and request that they provide the Minister with the following information, in respect of both the registered pest control product and the foreign product:

• (a) the composition of all formulations of the end-use products and of the technical grade active ingredients used in their manufacture, 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;
• (b) the name and address of the manufacturer of the active ingredient that is used to manufacture each of the products;
• (c) the name and address of the place of manufacture of the formulation of each end-use product;
• (d) the information described in subparagraphs 26(1)(h)(ii) to (iv); and
• (e) the material safety data sheets, if any.

Written consent of registrant

(6) Instead of providing the information required by subsection (5), the registrant may provide their written consent to the Minister to use or rely on any information that they had previously provided to the Minister.

Alternate information

(7) If the Minister is unable to obtain the information from the registrant under subsection (5) or the consent of the registrant under subsection (6), paragraph (2)(d) does not apply and the Minister may instead consider, on the request of any person, the following information with respect to the registered pest control product and any foreign product in making the determination:

• (a) all of the information set out in paragraphs (5)(a) to (e); or
• (b) a detailed and comprehensive analysis with an accompanying description of methodology and analytical validation that permits the determination of the acceptability of procedures, results and conclusions concerning the composition of both the foreign product and the registered pest control product, including the identity and concentration of their active ingredients and any formulants and contaminants of health and environmental concern.

Certificates of Equivalency

Issuance

39. (1) If the Minister determines that a foreign product is equivalent to a registered pest control product, the Minister must issue a certificate of equivalency and place it in the Register.

Validity

(2) A certificate of equivalency is valid until December 31 in the second year after the year in which it is issued and may be reissued with respect to the same two products in accordance with the requirements of section 38. A certificate of equivalency ceases to be valid in any of the following circumstances:

• (a) the basis on which the foreign product and the registered pest control product were determined to be equivalent no longer applies;
• (b) any of the requirements set out in subsection 38(2) or (3) are no longer met;
• (c) the registration of the registered pest control product is cancelled or expires, and the sale and use of the registered pest control product is no longer authorized under the Act; or
• (d) the foreign product is no longer registered in the country referred to in paragraph 38(2)(b).

Foreign product use label

40. (1) When the Minister issues a certificate of equivalency, she or he must also approve a foreign product use label.

Brochures or leaflets

(2) If the Minister permits the directions for use to be shown instead in a brochure or leaflet that must accompany the foreign product, the following requirements must be met:

• (a) the label 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 otherwise required to be shown on the label.

Authorizations to Use a Foreign Product

Application for authorization

41. (1) A person who wishes to use a foreign product in respect of which a certificate of equivalency is in effect must apply to the Minister for an authorization under subsection 41(1) of the Act.

Contents

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

• (a) the person’s name, address and signature;
• (b) the name of the foreign product;
• (c) the number of the applicable certificate of equivalency;
• (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 certificate

(3) If the Minister authorizes the use of the foreign product, she or he must issue a foreign product use certificate that sets out all of the following information:

• (a) the identity of the certificate holder;
• (b) the amount of the foreign product that may be imported and used under the certificate; and
• (c) the location where the foreign product is to be used by the certificate holder.

Validity

(4) A foreign product use certificate is valid for only one growing season and for only one importation. It is valid for one year after the day on which it is issued but ceases to be valid if the applicable certificate of equivalency ceases to be valid.

Not transferable

(5) A foreign product use certificate is not transferable.

Importation of foreign product

42. (1) A person may import a foreign product whose use is authorized if all of the following conditions are met:

• (a) the person holds a foreign product use certificate;
• (b) that certificate holder purchases the product directly from the foreign source without the intervention of an agent or mandatary;
• (c) in advance of the importation, the certificate holder provides the Minister with all of the following information:
  
  • (i) the date of the proposed importation,
  • (ii) the name of the person who will transport the foreign product into Canada, and
  • (iii) the name of the entry point;
• (d) immediately after the importation of the foreign product but in any case before its use, the certificate holder affixes to it a copy of the approved foreign product use label, in a way that its product identifier that relates to its registration outside Canada remains visible at all times, and ensures that a copy of any brochure or leaflet that sets out the directions for use accompanies the product; and
• (e) the quantity of the product imported does not exceed the amount set out in the foreign product use certificate.

Pooled purchases

(2) Two or more persons may together import in one shipment their authorized quantities of foreign products set out in their respective foreign product use certificates if the importation meets the conditions of subsection (1).

Transport

(3) The person who transports the foreign product into Canada must carry it to the location of use specified in the foreign product use certificate and have the following documents in their possession:

• (a) proof of purchase in respect of each quantity of foreign product in the shipment, including the name of the foreign source from whom it was purchased; and
• (b) copies of all of the relevant foreign product use certificates.

Register

Information in Register

43. The Minister must place all of the following information in the Register with respect to every request for the determination of equivalency made under section 38:

• (a) the name of the person who made the request and the date on which it was made;
• (b) the name of the registered pest control product and its registration number;
• (c) the name of the foreign product, its product identifier and the name of the country where it is registered; and
• (d) the outcome of the request, including the reasons.

Records

Requirements

44. (1) The holder of a foreign product use certificate must keep records that contain all of the following information in respect of each foreign product that they import and use:

• (a) a copy of the foreign product use certificate;
• (b) the name and quantity of the foreign product;
• (c) the method of empty container disposal;
• (d) the method of disposal of any unused foreign product;
• (e) proof of purchase of the foreign product and the name of the foreign source from which it was purchased;
• (f) the name of the person who transported the foreign product into Canada; and
• (g) the date of importation.

Retention

(2) Records in respect of a foreign product must be kept for five years after the end of the year in which the foreign product use certificate that relates to the product expires or ceases to be valid.

Production of records

(3) Records in respect of foreign products must be made available to the Minister on request.

18. Section 47 of the Regulations is replaced by the following:

Application of certain provisions to research

47. Sections 48 to 50 and 56 to 68 apply to an authorization under subsection 41(1) of the Act to use an unregistered pest control product for the purpose of research.

19. Section 48 of the French version of the Regulations is replaced by the following:

Demande d’autorisation de recherche

48. Quiconque souhaite obtenir une autorisation de recherche pour un établissement en fait la demande au ministre.

20. Subsection 50(1) of the Regulations is replaced by the following:

Authorization

50. (1) When the Minister authorizes the use of a pest control product for the purpose of research under subsection 41(1) of the Act, the Minister must consider the health and environmental risks and whether the proposed experimental label meets the requirements of section 60.

21. The portion of subparagraph 53(b)(vii) of the English version of the Regulations before clause (A) is replaced by the following:

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

22. (1) The portion of subparagraph 55(2)(b)(vii) of the English version of the Regulations before clause (A) is replaced by the following:

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

(2) Subparagraph 55(2)(c)(vi) of the English version of the Regulations is replaced by the following:

• (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 only by a researcher on a maximum of 5 ha of land owned or operated by a research establishment,

23. Paragraph 59(c) of the French version of the Regulations is replaced by the following:

• c) elles sont posées avant l’utilisation du produit et restent en place jusqu’à ce que toutes les cultures traitées destinées à la consommation humaine ou animale soient récoltées, s’il y a lieu, ou tant que dure la collecte des données;

24. Paragraph 61(b) of the Regulations is replaced by the following:

• (b) produce a copy of the experimental label to the Minister on request.

25. Section 62 of the Regulations is repealed.

26. The portion of section 63 of the Regulations before paragraph (a) is replaced by the following:

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63. A research establishment must maintain records that contain all of the following information for each research project, for five years after the end of the project:

27. Paragraph 69(b) of the French version of the Regulations is replaced by the following:

• b) si des agents microbiens sont utilisés, autres qu’un agent microbien contenant le Bacillus thuringiensis homologué pour utilisation sur les cultures, les cultures traitées destinées à la consommation humaine ou animale provenant des sites de recherche, ainsi que la viande, y compris le gras et les sous-produits de viande, le lait et les œufs susceptibles de contenir des résidus à la suite des travaux de recherche ne peuvent être vendus.

28. The portion of section 70 of the English version of the Regulations before paragraph (a) is replaced by the following:

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 may contain residues as a result of research must not be sold unless

29. Section 2 of Schedule 2 to the Regulations is replaced by the following:

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

30. The portion of item 2 of the table to section 6 of Schedule 2 to the English version of the Regulations before paragraph (a) is replaced by the following:

2. A declaration of net quantity of the pest control product in the package, expressed

COMING INTO FORCE

31. These Regulations come into force six months after the day on which they are published in the Canada Gazette, Part Ⅱ.

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