Canada Gazette, Part I, Volume 152, Number 22: Regulations Amending the Pest Control Products Regulations (Products not Intended for the Canadian Market)

June 2, 2018

Statutory authority
Pest Control Products Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

World Trade Organization Trade Facilitation Agreement

Canada's obligations related to freedom of transit under Article 11.8 of the Trade Facilitation Agreement (TFA) require that technical regulations and conformity assessment procedures not be applied to goods in transit. "Goods in transit" are goods that pass through a territory where such passage is only a portion of the complete journey beginning and ending beyond the borders of that territory. Subsection 6(1) of the Pest Control Products Act (PCPA) prohibits the transport of unregistered pest control products in Canada, which is contrary to the intent of Article 11.8 of the TFA.

Definition of marketplace label

Since the definition of "label" in the PCPA was amended as part of the statutory changes that were made to implement the TFA, the definition of "marketplace label" in the Pest Control Products Regulations (PCPR) is no longer consistent with the definition of "label" in the PCPA.

Importation for Manufacturing and Export Program

In the 1990s, Health Canada established the Importation for Manufacturing and Export Program (IMEP), which was subsequently enshrined in regulations in 2006. The program authorized the manufacture of unregistered pest control products, provided the active ingredient used to manufacture those products was registered in Canada. The manufactured product does not require registration because it is not intended to be sold or used in Canada; however, the requirement to provide basic safety information in the form of safety data sheets was established through policy when the program was initiated. Since these requirements are not prescribed in regulations, they are not enforceable and compliance action cannot be taken if necessary.

Inconsistency between the French and English versions of the PCPR

An inconsistency has been identified between the French and English versions of the PCPR respecting the labelling requirement to identify the active ingredient on a pest control product label. The requirement to identify the active ingredient in the English version is currently expressed in the singular form while it is plural in the French version.

Background

World Trade Organization Trade Facilitation Agreement

In December 2013, Canada agreed with other World Trade Organization members to adopt the TFA. The TFA was formally adopted by the World Trade Organization's General Council on November 27, 2014, enabling the domestic implementation process to begin. Canada committed to implementing the legislative changes necessary to meet its obligations under the TFA.

Amendments to the Food and Drugs Act, Hazardous Products Act, Radiation Emitting Devices Act, Pest Control Products Act, Canada Consumer Product Safety Act and consequential amendments to the Agriculture and Agri-Food Administrative Monetary Penalties Act as well as amendments to regulations made pursuant to some of the above-mentioned statutes, were identified by Health Canada as necessary to implement articles 10.8.1 (Rejected Goods) and 11.8 (Freedom of Transit) of the TFA. Amendments to these statutes were proposed in Bill C-13, which also included amendments to the Canadian Environmental Protection Act, 1999 administered by Environment and Climate Change Canada. Bill C-13 received royal assent on December 12, 2016.footnote1

With regard to pest control products, Bill C-13 expanded the authority to exempt certain products from registration under the PCPA to include pest control products imported solely for the purpose of export, also known as "pest control products in-transit." Amendments to the PCPR are necessary to establish this exemption to meet Canada's obligations under Article 11.8 of the TFA.

Objectives

The objectives of the proposed amendments are to

Description

Exemption from registration

To address the obligation under Article 11.8 of the TFA, which states that members are not to apply technical regulations to goods in transit, section 4 of the PCPR would be amended to exempt pest control products imported solely for the purpose of export (i.e. in-transit) from registration under the PCPA.

Health and safety information

The proposal would require importers to ensure that health and safety information accompany in-transit shipments of pest control products for the duration of transport through Canada or while held for shipment or short-term storage in Canada. This information is consistent with the labelling requirements for registered products in Canada and that of most industrialized countries internationally. The proposal would require that the following information accompany pest control products in transit through Canada: product name, net quantity, name of importer, exporter or owner, and contact information. It would also require the following health and safety information: hazard identification, precautionary symbols and signal words, chemical name, active ingredient concentration, first aid and firefighting measures, environmental hazards, toxicological information, risk mitigation measures related to handling, transport and disposal, decontamination procedures and emergency contact information in the event of accidents.

Acceptable means of providing this information could include the use of existing product labels, safety data sheets that are compliant with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) standard, or other documentation as long as the information is easily accessible for use by workers and in response to an emergency.

Notifications in advance of in-transit shipments

The proposed amendments would establish a process where the Minister may require any importer at any time to provide notification of in-transit shipments as well as to submit the health and safety information that is to accompany the shipment. This notification process would assist in establishing targeted enforcement programs or to address matters of historical non-compliance with the PCPA.

Definition of marketplace label

The proposal would amend the definition of "marketplace label" and subsection 23(2) to include the term "written, printed or graphic matter" to align with the new definition of "label" in the Act.

Importation for Manufacturing and Export Program

The proposal would require that unregistered pest control products manufactured in Canada solely for export be accompanied by the same health and safety information that is proposed for in-transit pest control products.

Inconsistency between the French and English versions of the PCPR

The proposal would amend subparagraph 26(1)(h)(i) and item 1(a) in the table to section 6 of Schedule 2 of the PCPR to allow the active ingredient to be expressed in singular or plural as appropriate when identifying the "active ingredient(s)" on a pest control product label.

Storage, transportation and display

The proposal for in-transit pest control products includes a requirement under subsection 3.2(10) that pest control products bearing certain precautionary symbols and signal words be separated from food or animal feed to prevent contamination with food or animal feed during storage and transport.

Subsection 34(2) currently requires that pest control products bearing the Danger Poison precautionary symbols and signal words be separated during storage and display to prevent contamination with food or animal feed. The proposal would modify subsection 34(2) to require that certain pest control products be separated during transport in addition to storage and display. This requirement would be applicable to registered products in the Canadian market.

"One-for-One" Rule

The "One-for-One" Rule does not apply as this regulatory proposal would not impose any administrative costs on businesses.

Small business lens

The small business lens does not apply to this regulatory proposal as the total expected costs to business nationwide are less than $1 million annually.

Consultation

Industry stakeholder associations were involved during the statutory amendments that occurred in 2016 and were aware of the need for regulatory amendments to fully implement the TFA. Health Canada consulted one registrant who manufactures many end-use products under IMEP in May 2017. The registrant indicated that the use of safety data sheets is standard business practice and is normally required by the regulators in the countries where they market their products.

During December 2017, Health Canada held a webinar with stakeholders outlining the proposed regulations and policies surrounding in-transit shipments of pest control products. Industry stakeholders had no objections to the proposal during the webinar or during the comment period.

During February 2018, Health Canada consulted with CropLife Canada, the Canadian Consumer Specialty Products Association, the Canadian Association of Agri-Retailers and Responsible Distribution Canada regarding the proposed amendment to subsection 34(2) to prevent contamination with food or animal feed during storage, display or transport. Industry had no objection to the proposed amendment and noted that it would be aligned with current industry best practices and some provincial requirements.

Rationale

The PCPA's prohibition against the possession, handling, storage, transportation, importation, distribution or use of unauthorized pest control products conflicts with the obligation under Article 11.8 of the TFA. Amendments to the PCPR are therefore being proposed to exempt pest control products in-transit from this prohibition. As a result, requirements relating to health and safety and to risk mitigation, which are integral to a product's registration, would no longer apply vis-à-vis pest control products in-transit. Consequently, amendments to establish health and safety oversight for unregistered pest control products transported through Canada are necessary to meet the objectives of the Minister of Health's mandate to protect human health, safety, and the environment.

Benefits

The proposed amendments would ensure an appropriate level of health, safety and environmental oversight while the goods are in Canada by ensuring that workers and first responders have the information needed to properly handle, transport or respond to incidents involving these products while in Canada.

Additional benefits related to increased health and safety oversight by the Minister will be achieved through the proposed notification process. Information would be provided to the Minister when requested and would be used for targeted enforcement programs or to address non-compliance with the in-transit provisions of the regulations.

Incorporating the existing policy requiring the provision of safety information for products manufactured under IMEP would ensure consistent health and safety information requirements for all shipments of pest control products being transported out of Canada. Additionally, by incorporating this requirement into regulation, inspectors would be able to take enforcement action to address non-compliance with this requirement.

In addition, the proposed amendments would ensure that measures to protect food and feed from contamination apply to all pest control products that are transported, stored or presented in Canada regardless of destination or registration status.

Costs

World Trade Organization Trade Facilitation Agreement

Costs to importers of pest control products in-transit

Industry Canada's re-export information was used as a surrogate to determine a baseline of Canadian trade activity for manufacturers of pesticides to estimate the impact of this proposal. Re-export products are imported into Canada for further manufacturing and are subsequently exported. Between 2011 and 2016, the total value of Canadian re-exports of all products averaged $34 billion each year. During this time, pest control product re-exports accounted for on average only 0.03% ($8.8 million of $34 billion of total Canadian re-exports) annually. On average, from 2011 to 2016, 82% of all pest control product re-exports were destined to the United States. The remaining 18% were destined to Europe and Asia. It is therefore assumed that the majority of pest control products in-transit will have a similar destination profile as re-exports with the majority destined to or from the United States as shown in Table 1.

Table 1: Top five destinations of pest control product re-exports
Country Average Over Six Years
United States $7,219,686
China $755,380
Taiwan $266,325
Germany $246,843
Norway $135,565
Israel $76,098

The requirements for pesticide labelling under Canada's Pest Control Products Act and the U.S. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) are largely harmonized (see Table 2). Also, under FIFRA, safety data sheets are considered to be part of the pesticide label and are written in a GHS-compliant format, as required by the U.S. Occupational Safety and Health Administration (OSHA). Therefore, pest control products in-transit destined to or from the United States will be compliant with the proposed amendments, and no additional administrative costs to business from this proposal are expected.

Table 2: Comparison of label requirements between section 26 of the Pest Control Products Regulations and the U.S. Code of Federal Regulations, Title 40, Part 156
Canada United States
Product name, type, form, class Product name, brand, trade name
Ingredient statement Ingredient statement
Registration number EPA registration number, EPA establishment number
Net contents Net weight contents
Registrant's name, address, inquiries Name, address or producer/registrant
Precautionary statements Precautionary statements
Storage and disposal statement Storage and disposal statement
Hazard symbols, signal words Hazard symbols, signal words
Keep out of reach of children statement Keep out of reach of children statement
First aid instructions First aid instructions
Toxicological information Toxicological information

Most European or Asian countries have implemented the GHS in full or in part. The GHS covers all hazardous chemicals and may be adopted to cover chemicals in the workplace and in the transportation industry, consumer products, pesticides, and pharmaceuticals. The target audiences for the GHS include workers, transport workers, emergency responders, and consumers. Products transiting through Canada that are destined to or from Europe or Asia will have safety information written in a GHS-compliant format and would, therefore, meet the proposed requirements in this amendment; consequently, no additional costs are expected.

Importation for Manufacturing and Export Program

In the 1990s, Canada established IMEP and, through policy, the requirement to provide basic safety information in the form of safety data sheets. Seventeen registrants have 28 active ingredients currently registered under IMEP in Canada. An estimated 37 products are currently being manufactured under this program. The proposal would incorporate this existing policy into regulations.

There are no additional costs anticipated because it is assumed that industry is already providing this information as per the existing policy. Stakeholders were consulted on this in December 2017 and there were no objections to this requirement. Informal discussions also indicated that they are already in compliance as the provision of safety information either through safety data sheets or labelling is standard practice when shipping products to foreign markets, as they must meet the legal requirements of the foreign jurisdictions.

Marketplace label

The amendments to the definition of "marketplace label" are administrative in nature and are not expected to have any impacts on stakeholders.

Inconsistency between the French and English versions of the PCPR

For greater clarity to regulated parties, both language versions of the PCPR would allow the active ingredient to be expressed in singular or plural as appropriate when identifying the "active ingredient(s)" on a pest control product label. This is a correction addressing a typographical error related to the Regulations Amending the Pest Control Products Regulations (Statement, Notice and Conditional Registration)footnote2 [SOR/2017-91] and will follow the same implementation timelines as those established in section 12 of those Regulations. There are no expected impacts on stakeholders from this typographical correction.

Storage, transportation and display

Approximately 77% of registered products that bear the Danger Poison hazard symbols and signal words already contain label statements regarding the prevention of cross-contamination with food or feed. Although this is a handling requirement and not a labelling requirement, industry is placing these statements on their labels on a voluntary basis. Stakeholders also indicated that the separation of pest control products and food and feed is also regulated by some provinces and also through industry warehousing standards for agricultural chemicals. Stakeholders have indicated that the proposal to include transport into this requirement is not expected to cause any financial or administrative impacts on Canadian business.

Implementation, enforcement and service standards

Health Canada will use its existing compliance promotion tools to assist importers and industry in meeting their obligations under the PCPA. The requirement to provide advance information prior to import of pest control products would be used for targeted compliance programs or to address historical non-compliance with the requirements for pest control products in-transit. The proposed amendments would come into force six months after they are published in the Canada Gazette, Part II.

Contact

Jordan Hancey
Health Canada
Pest Management Regulatory Agency
Policy, Communications and Regulatory Affairs Directorate
2720 Riverside Drive
Ottawa, Ontario
K1A 0K9
Email: HC.pmra.regulatory.affairs-affaires.reglementaires.arla.SC@canada.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to section 67footnotea of the Pest Control Products Actfootnoteb, proposes to make the annexed Regulations Amending the Pest Control Products Regulations (Products not Intended for the Canadian Market).

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 Jordan Hancey, Section Head, Regulatory Affairs and Applied Analysis, Policy and Regulatory Affairs Division, Policy, Communications and Regulatory Affairs Directorate, Pest Management Regulatory Agency, Department of Health, Postal Locator 6607, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (email: HC.pmra.regulatory.affairs-affaires.reglementaires.arla.SC@canada.ca).

Ottawa, May 24, 2018

Jurica Čapkun
Assistant Clerk of the Privy Council

Regulations Amending the Pest Control Products Regulations (Products not Intended for the Canadian Market)

Amendments

1 The definition marketplace label in subsection 1(1) of the Pest Control Products Regulationsfootnote3 is replaced by the following:

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

2 The Regulations are amended by adding the following after section 3:

Exemption

3.1 (1) A pest control product that is imported into Canada solely for the purpose of export and is regulated under the Transportation of Dangerous Goods Act, 1992 is exempt from the Regulations.

Exception — section 3.2

(2) A pest control product that is imported into Canada solely for the purpose of export and is not regulated under the Transportation of Dangerous Goods Act, 1992 is exempt from the Regulations except for the requirements set out in section 3.2 of these Regulations.

Safety information

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

Identification

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

Hazard identification

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

Active ingredient

(4) The shipment of the pest control product must be accompanied by a document that contains the following information:

First aid measures

(5) The shipment of the pest control product must be accompanied by a document that contains the following information:

Firefighting, handling, transport and storage

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

Accidental release, decontamination and safe disposal

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

Toxicological and ecological risk reduction

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

Packaging

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

Storage and transport

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

Information to be provided on request

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

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

(3.1) A pest control product that is exempt from registration under paragraph (1)(c) must meet the requirements of section 3.2 of these Regulations.

4 Subsection 23(2) of the Regulations is replaced by the following:

(2) Any written, printed or graphic matter on the marketplace label of the pest control product must not detract from or obscure the required information.

5 Subparagraph 26(1)(h)(i) of the Regulations is replaced by the following:

6 Subsection 34(2) of the Regulations is replaced by the following:

Storage, transportation and display

(2) A pest control product must be stored or displayed in a separate room and transported in a separate compartment from any human food or animal feed or stored, displayed or transported in such a way as to avoid any possible contamination of the food or feed if the product bears the signal word "POISON" superimposed on the precautionary symbol for danger set out in item 2 of Schedule 3.

7 Item 1(a) of the table to section 6 of Schedule 2 to the Regulations is replaced by the following:

8 The Regulations are amended by adding, after Schedule 3, the Schedule 4 set out in the schedule to these Regulations.

Coming into Force

9 (1) These Regulations, except sections 1 and 4 to 6, come into force on the day that, in the sixth month after the month in which they are published in the Canada Gazette, Part II, has the same calendar number as the day on which they are published or, if that sixth month has no day with that number, the last day of that sixth month.

(2) Sections 1 and 4 to 6 come into force on the day on which these Regulations are published in the Canada Gazette, Part II.

SCHEDULE

(Section 8)

SCHEDULE 4

(Subsection 3.2(3) and paragraph 3.2(10)(b))

Symbols, Signal Words and Hazard Statements from the Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
Item

Column 1

Precautionary Symbol

Column 2

Signal Word

Column 3

Hazard Statements (use as appropriate)

1 flammable Danger Extremely flammable gas
Extremely flammable aerosol
Extremely flammable liquid and vapour
Highly flammable liquid and vapour
Warning Flammable aerosol
Flammable liquid and vapour
2 gasunderpressure Warning Contains gas under pressure; may explode if heated
Contains refrigerated gas; may cause cryogenic burns or injury
3 skinburns Danger Causes severe skin burns and eye damage
Causes serious eye damage
Warning May be corrosive to metals
4 fataltoxic Danger Fatal if swallowed
Fatal in contact with skin
Toxic if swallowed
Toxic in contact with skin
Fatal if inhaled
Toxic if inhaled
5 harmful Warning Harmful if swallowed
Harmful in contact with skin
Harmful if inhaled
Causes skin irritation
Causes serious eye irritation
May cause an allergic skin reaction
6 toxicaquatic Warning Very toxic to aquatic life
7 None Warning Flammable gas
Combustible liquid
Causes mild skin irritation
Causes eye irritation
8 None None Toxic to aquatic life
Harmful to aquatic life