Vol. 148, No. 5 — February 26, 2014

Registration

SOR/2014-24 February 7, 2014

PEST CONTROL PRODUCTS ACT

Regulations Amending the Pest Control Products Regulations

P.C. 2014-106 February 6, 2014

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 67 of the Pest Control Products Act (see footnote a), makes the annexed Regulations Amending the Pest Control Products Regulations.

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use” and “own-use import certificate” in subsection 1(1) of the Pest Control Products Regulations (see footnote 1) are repealed.

(2) The definition “equivalency certificate” in subsection 1(1) of the English version of the Regulations is repealed.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

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

(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:

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

5. Section 7 of the Regulations is repealed.

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

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

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:

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

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

Copying or other use

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

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:

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

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

Copying or other use

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

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 le gouvernement du Canada 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:

(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:

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) The importer of a pest control product — except a foreign product that is the subject of a foreign product use certificate — must provide the Minister with a declaration at the time of the importation, 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 the use of a foreign product may be authorized:

Product Equivalency

Conditions

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

Eligibility — foreign products

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

Eligibility — registered pest control products

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

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:

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:

Additional information

(6) If the information provided under subsection (5) with respect to the registered pest control product or the foreign product is insufficient to enable the Minister to make the determination, the Minister may request additional relevant information from the registrant in order to make the determination.

Written consent of registrant

(7) 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.

Notice of no further action

(8) If the Minister is unable to obtain the information from the registrant under subsection (5) or the consent of the registrant under subsection (7), the Minister must notify the person who made the request that no further steps will be taken by the Minister and place a copy of that notice in the Register.

Resumption of request by any person

(9) In the circumstances described in subsection (8), paragraph (2)(d) does not apply and any person may, within two years after the notice is placed in the Register, request that the Minister make the determination of equivalency and for that purpose must provide the Minister with either

Additional information

(10) If the information provided under subsection (9) is insufficient to enable the Minister to make the determination, the Minister may request additional relevant information from the person who made the request in order to make the determination.

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:

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:

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:

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:

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:

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:

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:

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:

Retention

(2) The records 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) The records 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 de recherche en fait la demande au ministre.

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

Authorization

50. (1) Before 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:

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:

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

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

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

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:

Contents

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:

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.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Background

The Pest Control Products Act (PCPA) and the Pest Control Products 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), provided the use of such products poses no unacceptable health or environmental risks. Using this authority, provisions in the PCPR allow the importation of a foreign product, exempt from Canadian registration requirements, provided it is determined to be equivalent to a Canadian registered product and has an equivalent label. These provisions enabled the establishment in 1993 of the Own-Use Import Program (OUI), a price-discipline mechanism for the Canadian pesticide industry which provided Canadian users with access to lower-priced equivalent 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 approximately 19 million litres of a generic herbicide being imported and 10 291 import authorizations issued. As a result of the extensive use of the program, stakeholders raised a number of issues with its operation (e.g. concerns were raised about the establishment of a new distribution system which lacked product stewardship controls, as well as the methodology for determining equivalency between foreign products and registered Canadian products). 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.

Issues and objectives

The amendments implement recommendations from the 2006 Own-Use Import Task Force and address three central issues: (1) the previous Regulations on grower importation of pest control products allowed for the determination of chemical equivalence outside the “two-step” approach under which the current importation program successfully operates; (2) the Regulations did not empower national grower groups to indicate which products they would nominate for equivalency determination; and (3) the Regulations did not recognize exclusive data protection on registrants’ products, thereby discouraging the registration of new products.

Underpinning the current program is the requirement that candidate products being considered for import have the support of and be nominated for inclusion into the import program by at least four national grower organizations. Subsequent to the nomination, Health Canada’s 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).

The regulatory amendments enable grower-prioritized nominations and the two-step equivalency determination approach. The amendments will require parties to first seek equivalency via Step 1, consistent with the recommendations of the Task Force.

Also included are administrative amendments which clarify certain provisions and correct inconsistencies between the English and French versions of the Pest Control Products Regulations (PCPR).

The amendments provide Canadian agriculture producers with access to an import mechanism that

Description

The amendments align the Regulations with the existing importation program. Key provisions can be summarized as follows:

The role of national grower organizations

The Regulations establish the requirement that candidate products being considered for import have the support of, and be nominated for inclusion into the import program by, at least four national grower organizations. The purpose of this requirement is to provide Canadian growers the opportunity to provide input into the activities of the PMRA with respect to the import program, and to help ensure that they are in line with the national interest of Canadian growers. It is expected that the Canadian 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. The continued expectation is that the national grower associations will not have any ties to pesticide companies, vendors or third-party providers. As third-party providers can already assemble grower orders and provide logistics and transport, allowing third-party providers to nominate products for inclusion in the program could represent a real or perceived conflict of interest.

Under the Regulations, before submission to the PMRA, candidate products will 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 in finalizing product nominations.

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

Equivalency determination

Health Canada’s primary mandate is the protection of Canadians’ health and environment. The Department must be confident 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 amendments. Throughout the development of the pilot program, the determination of equivalency was discussed at length and the amendments reflect the recommendations received through consultations with stakeholders.

The Regulations also reflect the existing 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 that a comparison of the product’s components can be conducted and an equivalency determination can be made. 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 should be included, if available.

Significant improvements are realized with the registrantprovided information (Step 1) including the following:

Step 2 — If the Minister is unable to obtain the information necessary to establish equivalency from the registrant, the Step 2 equivalency determination can be initiated. 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), applicants have the ability to withdraw an application at any time during the equivalency determination process.

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 authorizations.

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 Regulations is that they do not preclude the use of third parties to facilitate the importation of the product. This includes the use of commercial carriers to provide safe transport, and seeking assistance with logistical or regulatory matters related to the importation process.

The amendments to the Regulations will 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 (grower) remains, and proof of purchase and associated certificates for import in the grower’s name will be required for importation. Resale of imported products remains a prohibition under the Pest Control Products Act.

Data compensation

As a result of stakeholder consultations, the regulatory amendments include a provision making products ineligible for the program during the exclusive-use period established by the data protection provisions of the PCPR. This provision is intended to balance growers’ interest in importing pest control products and Canadian registrants’ interest in offsetting some of the expenses and financial risks incurred to support domestic registrations by precluding others from relying on the data (without the registrant’s consent) for a period of at least 10 years.

Other

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

1. Make administrative corrections and address inconsistencies between the French and English versions of the Regulations. These amendments are minor in nature and 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 suggestion was not adopted 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) will 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 domestically registered pest control products. This provides a provincially approved method for the responsible disposal of imported pest control product containers. To support this stewardship program, it was decided that growers must provide proof of participation in a container management program as a condition of obtaining an importation certificate, and as a condition of authorization. Therefore, prescribing a method of proper container disposal in the regulatory amendments is not required.

“One-for-One” Rule

No new administrative burden would be imposed on the regulated community as a result of the adoption of the proposed amendments. The proposed amendments are administrative in nature and serve to incorporate the existing import policy in the Pest Control Products Regulations. Overall, a slight reduction in administrative burden would be realized by the adoption of the proposed Regulations.

Impact on pesticide registrants

There are no mandatory requirements placed on registrants under the new Regulations. The amendments recognize the voluntary submission of data during the equivalency determination step. Registrants have historically been supportive of the program.

Impact on Canadian growers

The proposed Regulations represent a slight reduction in administrative burden for participating agricultural growers. Proposed changes to the program application/import process would require growers to retain import records. However, growers would be required to submit only one form, as opposed to two. In addition, growers would no longer be required to complete import declaration forms for GROU products. The estimated reduction in administrative burden is $1,924 for the sector, i.e. $11,547 (existing program) minus $9,623 (proposed program).

The new proposed amendments would continue to support Health Canada’s primary objective to protect human health and the environment by ensuring that pesticides imported under this program are equivalent to those already registered for use in Canada.

Small business lens

The small business lens does not apply to this proposal, as there are no costs (or insignificant costs) on small business.

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 meetings were attended by many representatives of the agri-food sector, including six grower and farming groups, pesticide manufacturers and retailers, federal and provincial governments.

The PMRA was called to speak to 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 pilot 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.

The Regulations were prepublished in the Canada Gazette, Part I, on July 12, 2012, followed by a 75-day comment period. Comments were received from five respondents, representing grower and registrant organizations. Overall, stakeholders support formalizing the existing program into regulations. The comments are summarized as follows:

1. Compliance

Two comments recommended that Health Canada take enforcement measures in the event of non-compliance with the GROU Program to ensure the future success of the program and to protect regulatory integrity.

Health Canada will continue to use a risk management approach to compliance as described in the Compliance Policy (www.hc-sc.gc.ca/cps-spc/pubs/pest/pol-guide/dir2007-02/index-eng.php).

2. Container management

One comment suggested that specific provisions be added to address the issue of container management in the Regulations.

As mentioned previously, the issue of container management was addressed through the adoption of the OUI Task Force recommendations, making participation in a container disposal program mandatory. Based on these considerations, no regulatory amendments were made to address this comment. However, Health Canada will continue to require evidence of participation in a container disposal program as a condition for obtaining a foreign product use certificate.

3. Eligibility — Data requirements

Several stakeholders recommended that language be added to allow the Minister to require additional data in cases where the health and environmental risks of the foreign product remain unclear.

Health Canada is in agreement, and subsections 38(6) and 38(10) were amended to enable the Minister to request additional information, as necessary, regarding either the pest control product or the foreign product.

4. Eligibility — Formulation changes and validity period of equivalency certificates

In the Canada Gazette, Part I, publication, Health Canada proposed extending the validity period of an equivalency certificate from one to two years. A comment from industry questioned whether Health Canada would be able to track formulation changes in approved GROU products during an extended two-year validity period. Conversely, several other commenters suggested that the validity period of an equivalency certificate should be further extended to four or five years, as a means of increasing the number of products in the program.

Based on of the experience of the last six years, Health Canada does not expect that any significant formulation changes which would increase risks to human health or the environment will occur during an extended two-year validity period. Registrants may inform Health Canada of a formulation change or any other change that may affect the product’s eligibility under the GROU program at any time.

Health Canada determined the risk of further extending the validity period of an equivalency certificate to four or five years to be unacceptable due to the greater likelihood of manufacturers changing their formulations during that time frame. Health Canada will continue to explore policy options with the goal of realizing administrative efficiencies that would allow the program to be expanded within allocated resources.

Based on the considerations above, no further regulatory amendments were made to address the comments.

5. Eligibility — Foreign product availability and sale

Health Canada received comments concerning paragraph 38(2)(b), suggesting that the paragraph be reworded such that a product’s availability in the foreign country should not limit its eligibility. This would allow the product to continue in the GROU process despite possible short-term shortages in the foreign country or in regions of the foreign country.

Health Canada agreed with the suggestion and the Regulations have been amended to reflect this change.

6. Product equivalency — Eligibility of foreign products

Several comments suggested that the criteria for related companies as an eligibility requirement for the GROU program [paragraph 38(2)(d)] are too limiting and that the Regulations should be amended to allow the nomination of products in cases where ownership has changed. Additionally, there were several comments expressing concerns that registrants may attempt to circumvent the GROU eligibility criteria.

Health Canada cannot reasonably place obligations on registrants to provide equivalency information for a product which they no longer own. In response to the concerns about registrants circumventing the eligibility criteria, Health Canada has not identified any evidence of this occurring since the initiation of the GROU program.

Based on the considerations above, no regulatory changes were made to address the comments.

7. Source of technical grade active ingredient changes

No regulatory amendments were recommended; however, the issue of alternate sources of technical active ingredient was raised by industry. The registration of a new source of active ingredient can take up to 18 months to complete, whereas an approval for an alternate source related to an equivalency certificate under the GROU program may only take a few weeks.

Health Canada has in the past discussed the issue of sources of technical grade active ingredient (TGAI) in GROU products with the GROU Nomination Committee and registrants. Health Canada has consistently indicated that a GROU approval may be granted for an end-use product with an unregistered source, provided the source is acceptable based on a review of the technical grade active ingredient specifications. While industry has expressed concern with this approach, Health Canada has indicated that it is acceptable in the context of a GROU approval, which does not confer the same rights and privileges as a product registration. Further, section 41 of the PCPA allows the Minister to authorize the use of unregistered products for specified purposes. As a result, Health Canada continues to review, and potentially authorize, the use of unregistered sources of TGAI in GROU products, provided the review of the TGAI is determined to be acceptable.

8. Product nomination

One comment suggested removing the need to re-nominate a product after the two-year validity period has expired.

No regulatory amendments were made to address the comment, as re-nomination is required so that the most current grower priorities are reflected within the list of candidate products for the GROU program. Health Canada continues to work towards streamlining the re-nomination process to minimize work required by growers.

9. Nomination committee — Definition

Several comments suggested that a definition of a nomination committee be included in the Regulations and that it be clarified that the Canadian national grower associations are not-for-profit for consistency with the RIAS.

While the Regulations do not require the formation of a nomination committee per se, the requirement that candidate GROU products are supported by at least four national grower associations achieves this goal. It is expected that the national grower associations which will select the products for nomination should have no ties to any pesticide company, vendor or third-party provider that could represent a real or perceived conflict of interest.

Health Canada agrees that the national grower associations participating in the nomination process must be not-for-profit, consistent with the RIAS. The Regulations have been amended to specify this requirement in paragraph 38(1)(b).

10. OUI and the determination of chemical equivalency

Some comments supported maintaining the OUI program (Step 2) as a separate program, and conversely, one comment supported the use of the OUI as the second step of the program, as was presented in the prepublication in the Canada Gazette, Part I.

As has been stated during the consultations with stakeholders throughout the development of the program since 2006, the intent of these amendments to the PCPR is to incorporate the existing GROU program into regulations and to address the recommendations of the OUI Task Force report. It is critical there be one clear set of regulations so that all players, be they innovators, generics or producers, have clarity for the business environment in which they operate.

Without regulatory amendments that establish the two-step equivalency determination approach, a party who is neither a grower nor a registrant could opt to first seek to determine equivalency via Step 2 (i.e. a determination of equivalency through laboratory analysis). This would put at risk continued support for the program as it has been functioning under policy with participation of both Canadian growers and registrants who are integral to the process. No changes to the Regulations were made as a result of these comments.

11. Step 2 equivalency determination — Initiation

Comments recommended that the wording of subsection 38(7) reflect the intent that the Step 2 process is only initiated when the registrant actively declines or refuses to provide the information or consent through subsection (6), as described in the RIAS.

To provide an appropriate balance between the needs of growers and registrants, the process by which Step 2 is initiated will remain unchanged. In situations where registrants are unable to provide the required information, discussions between growers and registrants during the nomination and equivalency determination stages are encouraged.

12. Step 2 equivalency determination — Confirmation of support

One comment indicated that the RIAS describes a process whereby the applicant and the national grower groups must continue to support the application in order for Step 2 chemical analysis to be initiated, whereas no such provision exists in the proposed Regulations. A change to the Regulations to address this comment is unnecessary because applicants have the ability to withdraw an application at any time during the equivalency determination process.

The comment also indicated that the proposed Regulations are silent on the Minister’s course of action in the event that support for an application is withdrawn. If no withdrawal is made at the time Step 2 is triggered, Health Canada will assume that the national grower groups continue to support the application. Subsection 38(8) has been amended to indicate that Health Canada will notify applicants of the opportunity to withdraw their application prior to initiation of Step 2.

13. Step 2 equivalency determination — Chemical analysis

One comment questioned what analysis is acceptable during the Step 2 equivalency determination. No recommendations for regulatory amendments were made.

Due to the complexity of establishing equivalency through chemical analysis, it is recommended that the applicant contact Health Canada directly through the Pre-Submission consultation process (www.hc-sc.gc.ca/cps-spc/pest/registrant-titulaire/pre-consult/index-eng.php).

14. Language consistency

One comment suggested replacing the phrase “sufficiently similar” in the Regulations with the phrase “materially equivalent.”

The term “sufficiently similar” is correctly used in subsections 38(4) and 38(5) to describe the pre-screening of an application where a cursory examination of two products would justify proceeding to a determination of chemical equivalence between two products. Therefore, no amendments were made to address the comment.

Additional changes

It was recognized during the review of the Canada Gazette, Part I, comments that no time frames were established for the receipt of data packages in support of an equivalency determination. A two-year window of opportunity has been specified for an applicant to submit data after Step 2 is initiated [subsection 38(9)]. The two-year window is judged to be sufficient time for persons to generate the information needed to satisfy the requirements for an equivalency determination. If, after two years, no data has been submitted to support an equivalency determination, any future applications regarding the product would begin again at Step 1.

Rationale

The amendments will mitigate the risk of parties seeking importation outside of the current process. This is expected to maintain Canadian registrants’ support for, and participation in, the importation program. The amendments also formalize an approach to establishing equivalence that is already practised in the existing pesticide importation program, and simplify certain administrative aspects of the program.

Establishing this import program in regulations will help ensure the continuation of the existing pesticide import program, which is the result of recommendations of the OUI Task Force and broadly representative of stakeholder interests. The amendments mitigate risks that jeopardized support for, and the continued functioning of, a program which offers benefits to growers, while balancing the interests of Canadian registrants.

Implementation, enforcement and service standards

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

Contact

Robert 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