Canada Gazette, Part I, Volume 152, Number 39: Regulations Amending the Pest Control Products Regulations (Labelling)

September 29, 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

Lack of clarity of term "bulk container"

The Standing Joint Committee for the Scrutiny of Regulations (SJCSR) has requested clarification of the meaning of "bulk container," in respect of labelling requirements set out in section 31 of the Pest Control Products Regulations (PCPR). The term "bulk container" is not defined in the PCPR nor in the Pest Control Products Act (PCPA). In seeking to respond to the SJCSR's request, Health Canada found that there was no consensus on the meaning of the term, with different interpretations across industry and between Government and industry. In addition, container labelling compliance issues were found, likely due in part to a lack of understanding of the type of containers to which the labelling requirements set out in sections 26, 28, or 31 of the PCPR applied.

Health and safety issues with bulk container labelling provisions

During Health Canada's review of the issue, the Department found that key health and safety information (such as hazard symbols, precautionary statements, and use instructions) was not required for containers labelled in accordance with section 31 requirements (bulk containers). If this information were left off the label it could result in pest control products not being handled properly, thereby increasing risks for human health and the environment.

Given the current section 31 provision, information that has not been reviewed by Health Canada could appear on a container labelled in accordance with the current section 31 provision, as that provision does not require that information printed on the label be taken from the registered product's approved label information as found in the Health Canada Register of Pest Control Products. This could also pose health and safety risks if the label text does not provide sufficient information for the product to be handled and used properly.

However, these health and safety gaps are considered to be hypothetical at this time as no examples of containers being labelled pursuant to section 31 were found.

Practicality of labelling provisions

The current labelling provisions, under the authority of section 8 of the PCPA, allow for a reduced amount of information to appear on the principal display panel of a pest control product container if the registrant (meaning a person in whose name a pest control product is registered) receives approval from Health Canada to put the full label information in a brochure or leaflet, and the leaflet or brochure meets the requirements of section 28 of the PCPR. However, section 28 provisions also require the brochure or leaflet to be attached to the container at all times. Having to attach brochures to containers at all times is not always practical, for example under the current rules,

• If a pest control product is being shipped to a grower in a 1 000 L plastic tote in the back of a pick-up truck, the brochure would have to be attached directly to the container, which could result in it either being damaged by the elements or getting blown off and lost.

In addition, the current rules pose practical problems in the case of outer containers (meaning packaging that includes a container, wrapping, covering or holder in which a pest control product is wholly or partly contained, placed or packed). At present, registrants must either put the full label on the outer container (including information not required for the safe handling of a shipping container — such as use instructions), or apply for approval to use a reduced label (under subsection 8(2) of the PCPA and section 28 of the PCPR); however, in the latter case, they would still have to attach the brochure to the outer container. Both of these options impose unnecessary costs. As a result, registrants must choose between these higher cost options or non-compliance (e.g. by putting less information on outer containers without applying for permission to do so).

Finally, transport truck tanker-trailers and railway tank cars were found not to be labelled in accordance with sections 26, 28 or 31 of the PCPR. This is likely because putting temporary pesticide labels on these containers was considered impractical (especially given that pesticides that are dangerous goods would already be labelled in accordance with the requirements of the Transportation of Dangerous Goods Act, 1992). This non-compliance has not resulted in any known health or environmental incidents, but it does create a regulatory integrity issue.

Background

Before pesticides can be used or sold in Canada, they must undergo pre-market approval, and be registered or otherwise authorized under the PCPA. In order to be registered, a product must undergo a thorough pre-market, science-based assessment by Health Canada and meet strict health and environmental standards, and it must have value. If the specified uses of a product pose risks of concern to human health or the environment, that product is not registered for use in Canada.

In addition, Health Canada conducts post-market reviews of registered pesticides to confirm their continued acceptability via periodic re-evaluations (no later than one year after 15 years have elapsed since the most recent decision, or earlier if the Minister initiates a re-evaluation under subsection 16(1) of the PCPA) and special reviews (conducted when the Minister has reasonable grounds to believe that health or environmental risks of the product are, or its value is, unacceptable). In both cases, the Minister could decide to continue the registrations as they are, modify them (e.g., by establishing measures to mitigate risks), or cancel them.

During pre- and post-market reviews, to determine whether a pesticide poses an acceptable risk (i.e., the pesticide is safe when used according to label directions) and has value, Health Canada assesses applicant/registrant- supplied data and establishes measures to mitigate risks through approved label elements, in accordance with section 26 of the PCPR, including directions for the safe handling, storage, display, distribution, disposal, and use of the pest control product. In certain instances, products can also be labelled in accordance with conditions specified by the Minister under subsection 8(2) of the PCPA and under section 28 or section 31 of the PCPR.

Section 28 of the PCPR

Under subsection 8(2) of the PCPA and section 28 of the PCPR, the Minister may allow specific, approved label information required under section 26 (e.g. directions for use) to be shown in a leaflet or brochure attached to the container, rather than have it appear on the container itself. The Minister may exercise this authority where, for example, the pest control product container is too small for all of the approved label text to appear on it (e.g. ant traps).

Section 31 of the PCPR

The bulk container labelling requirements under subsection 31(1) of the PCPR have been in place since 1972, and were created to allow pest control product containers that were not generally handled by users (such as large-volume refillable/reusable containers used to store, transport and distribute varying amounts of unpackaged products — i.e. "bulk containers") to bear a label that did not include use-related or safety information.

In 2006, it was recognized that in some cases, such "bulk containers" were being used to distribute products directly to users. The PCPR were therefore amended with subsection 31(2) to require that where pest control products are distributed in bulk containers directly to users of the products, some additional user-related safety label information be included on the labels of those bulk containers. For example, today, a common agricultural pest control product can be found in containers ranging in size from 1 L to 20 L jugs that can be carried by hand, to 1 000 L plastic totes that can be loaded by a fork lift onto the back of a pick-up truck to be transported, to 8 000 L stationary tanks that can be refilled via transport truck. All of these containers could be distributed directly to farms that use the product. However, products labelled in accordance with section 31 of the PCPR are not required to include all standard safety information or directions for use.

The SJCSR wrote to the Minister of Health, most recently in 2016, requesting clarification of the meaning of "bulk container" or suggesting that a definition be included for the purposes of section 31 of the PCPR. In response, Health Canada undertook a review of the section 31 provisions of the PCPR and the types of containers and labels that are used by the pesticide industry.

Outer containers

Outer containers are packages (including wrappings, coverings or holders) in which another packaged pest control product is contained (e.g. a cardboard box containing bottles of registered weed killer). At present, outer containers of registered pest control products must be labelled in accordance with section 26 or 28 of the PCPR; however, some may also be labelled as per section 31 of the PCPR, as some stakeholders might have interpreted an outer container to be a "bulk container" (given that the latter is not defined currently).

Objectives

The proposed amendments are intended to

• Modernize labelling requirements across a variety of different pest control product container types, including large refillable containers, railway tank cars and transport truck tanker-trailers, as well as outer containers (e.g. cardboard boxes) and single use disposable containers; and
• Address the SJCSR request that Health Canada clarify the meaning of the term "bulk container" (hence the application of the section 31 bulk container labelling provisions of the PCPR).

Description

Label information to accompany railway tank cars and transport truck tanker-trailers in transportation

Subsection 31(1) would be replaced with a provision indicating that where a pest control product is transported in a railway tank car or transport truck tanker-trailer and the tank car / trailer is the only container of the pest control product, the required information from subsections 26(1) and (2) and any conditions specified by the Minister under subsection 8(2) of the PCPA must be shown in documents that accompany the shipment while the product is being transported. This approach acknowledges the difficulty of applying a temporary label to these containers, and the fact that the containers are likely to be handled by only a small number of people (e.g. the shipping employees) who would need to know what is in the container. It also ensures that information about the product is available (i.e. in the shipping papers) in the case of an accident or spill.

Railway tank cars and transport truck tanker-trailers in storage and dispensing

Subsection 31(2) would be replaced with a provision indicating that when a railway tank car or transport truck tanker-trailer is the only container of the pest control product and the container is in storage or is being used to distribute or dispense the product from the container, then the documents referred to in subsection 31(1) must be attached to the container in a manner that makes them readily available for review by workers or persons handling the product or container, and, if applicable, within reach of the discharge control valve (i.e. for dispensing/discharging the pest control product). This is to ensure that workers have easy access to the information necessary to handle such containers safely.

Indicating label information could accompany the product (rather than be attached)

Paragraph 28(a) of the PCPR would be amended to provide the option to use either "ATTACHED" or "ACCOMPANYING" on the principal panel label statement, as applicable, depending on what the Minister approves under section 8 of the Act. The new statement could read: "READ ATTACHED BROCHURE (or LEAFLET) BEFORE USING" or "READ ACCOMPANYING BROCHURE (or LEAFLET) BEFORE USING". This change would clarify that label information contained in a leaflet/brochure does not have to be physically attached to the container. Rather, it could accompany the container, subject to approval by Health Canada. However, for Domestic Class products, Health Canada expects to continue its requirement that these leaflets/brochures be attached at all times.

Pest control product distributed to a user

Sections 28 and 31 would each have provisions added to require that when a pest control product is distributed to a user of the product, the full label information be provided to that user. The provision under section 28 would require that the approved brochure (or leaflet) be provided, and the provision under section 31 would indicate that the required section 26 information must be provided, both of which include directions for use. This provision would apply to all classes of pest control products, and would include the approved brochure or leaflet when those are not attached to the container (i.e. when they are accompanying the container). This is to ensure that the users (meaning applicators, growers, and the public) have access to the full use instructions and other information for the product required to handle and use it safely.

Outermost packages such as cartons (cardboard boxes), skids (shrink wrap), and kits (with other products)

Where a pest control product is contained in more than one package, section 26 would have a provision added to require that the outermost package of a registered pest control product that is visible under normal conditions of storage, transportation or handling bear, at a minimum, the following subset of its approved label information:

• product name / trade name;
• hazard nature and degree, including symbols, signal words, statements;
• active ingredient statements with concentration;
• PCPA registration number;
• registrant's name;
• registrant's contact address and telephone number in Canada;
• information that is relevant if any significant risk exists while the pest control product is contained in the outermost package; and
• the following statement — "For first aid instructions or the toxicological information essential for treatment, obtain and read the approved label from the registrant or phone the number indicated on this container."

In addition to this new option, registrants would continue to have the option to seek approval to have different or less information on outermost packages, under subsection 8(2) of the PCPA and section 28 of the PCPR (i.e. via an application to register or amend a registration). This new option would not apply if the outermost container were the only container of the pest control product. Furthermore, if the outermost package were transparent or otherwise allowed the label on the inner package or container to be visible, then using the default provisions would not be necessary.

Coming into force

The proposed amendments would come into force six months after the date of publication in the Canada Gazette, Part II.

"One-for-One" Rule

The "One-for-One" Rule does not apply as this regulatory proposal would not impose any administrative cost burden 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. The regulatory proposal is expected to decrease compliance costs for business.

Consultation

Stakeholder consultation

In 2016, Health Canada consulted the industry groups representing most registrants (CropLife Canada and the Canadian Consumer Specialty Products Association [CCSPA]), as well as provincial and territorial governments, to better understand the problem and to discuss potential solutions. These consultations informed Health Canada that there were differences in interpretation of what was considered to be a bulk container. For example, in the agricultural sector, some representatives indicated that containers over 23 L were generally considered to be bulk containers. Others considered any container over 200 L (e.g. a drum) to be bulk, while others did not consider 1 000 L totes to be a bulk amount due to their common use. Other comments included that although bulk containers are usually large, they should not be defined by or restricted to a size or size range, as smaller containers can also be used to distribute "bulk" (i.e. "loose" or "unpackaged") amounts of product.

On December 5, 2017, Health Canada consulted key stakeholders via a public webinar presentation to seek their input on the proposed amendments. Stakeholders had until December 15 to provide any written comments they might have. Over 25 company and association representatives participated in the webinar, including major pest control product registrants, the CCSPA, and CropLife Canada. Following the webinar, Health Canada received a written submission from each of the following: CropLife Canada, the CCSPA, Premier Tech, and Cleanfarms. The only substantive concern raised by all four respondents was with respect to providing clarification regarding the current requirement to seek approval under subsection 8(2) of the PCPA and section 28 of the PCPR to use a reduced label (with a brochure) on an outside package or container. These respondents indicated that applying for such reduced labels would be costly and time consuming.

To address these issues, the proposed regulatory amendments include a new provision allowing all registrants to use a specific set of approved label elements on outer containers, without having to apply for a label change. This proposed amendment would address the concern expressed by registrants while ensuring that the risks associated with such outer containers are still addressed. In follow-up discussions, CropLife Canada, the CCSPA and Premier Tech have all indicated that this approach would address their concerns.

Rationale

Health and safety benefits

Health and safety benefits are expected as the proposed labelling provisions would ensure that pest control products being distributed to users include the information required to handle and use the products safely (including all needed safety information and use instructions, which currently are not required for "bulk containers"). Moreover, the updated labelling provisions for outer containers would help ensure they bear the information required to handle, store and transport them safely.

Benefits to the economy, business and trade

The proposed changes would make the Canadian label requirements more similar to those of the United States. The United States Environmental Protection Agency (U.S. EPA) allows leaflets and brochures to accompany pest control product containers in certain circumstances, instead of them being attached at all times (subject to registration approval by the U.S. EPA). The proposed change for pest control products transported in railway tank cars and transport truck tanker-trailers would likewise align with requirements in the United States, requirements that are the same as those set out in the proposed amendment.

The proposal to allow label brochures to accompany pest control product containers would also have practical benefits. For example, registrants would not be required to find a way to attach such brochures to large refillable containers (e.g. 1 000 L totes) used to distribute pest control products to a grower; rather, the brochure could be transported in the cab of the truck making the delivery and provided to the user upon delivery.

The proposal to establish optional default labelling requirements for outer containers is expected to result in minor savings for registrants, who would no longer be required either to put the full label on the outer container (which might be more expensive than printing the shorter default label), or to apply (and pay an application fee) for approval under subsection 8(2) of the PCPA and section 28 of the PCPR to put certain label information in a brochure, rather than putting full label information on the outer container.

Costs

Eliminating the section 31 bulk container labelling provision could result in additional compliance costs for registrants using section 31, as they would have to re-label their products. However, Health Canada expects these costs to be minimal since an industry survey in June 2016, industry consultations in December 2017, and ad hoc site inspections by Health Canada inspectors did not reveal any instances of registrants using section 31 to label pest control product containers. It is likely that few or no pest control product containers are being labelled in accordance with section 31, which would mean that few or no such containers require their labels to be changed.

Should there be pest control products labelled in accordance with section 31, registrants would have these options to re-label their products:

• A registrant could apply for approval (under subsection 8(2) of the PCPA and section 28 of the PCPR) to put certain label information in a brochure. Such a change could be processed via a streamlined application process, requiring only the $252 fee for applications that do not require an evaluation, if the only information the registrant wished to remove from the label attached to the package were the use instructions. Typically, if the application requested approval to have less information on the container and more information than the directions for use in the brochure or leaflet, this would require the $1,156 fee for Category C applications. The costs to registrants to prepare for making such applications would be limited since such applications simply explain how the registrant wishes to reorganize existing label information. It is estimated that it would take from one hour to a maximum of one day (a one-time cost) to prepare the application. Industry stakeholders (represented by CropLife Canada members) have indicated that the average cost of producing a label brochure is $0.49.
• Alternatively, a registrant could choose to apply the full label to the pest control product, which would not require an application or associated costs.

In these two scenarios, the costs to physically print and attach the label/brochure would be carried by the registrant; however, these costs are expected to be low.

Implementation, enforcement and service standards

Health Canada would use its existing compliance promotion tools to assist registrants, manufacturers, distributors, and workplaces in these revisions to container labelling obligations under the PCPA. The proposed amendments would come into force six months after they are published in the Canada Gazette, Part II.

Contact

Jordan Hancey
Policy, Communications and Regulatory Affairs Directorate
Pest Management Regulatory Agency
Health Canada
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 paragraph 67(1)(r) ^{footnote a} of the Pest Control Products Act ^{footnote b}, proposes to make the annexed Regulations Amending the Pest Control Products Regulations (Labelling).

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, Director, 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, September 20, 2018

Jurica Čapkun
Assistant Clerk of the Privy Council

Regulations Amending the Pest Control Products Regulations (Labelling)

Amendments

1 Section 26 of the Pest Control Products Regulations ^{footnote 1} is amended by adding the following after subsection (2):

Outermost package

(3) If a pest control product is contained in more than one package, the outermost package that is visible under normal conditions of storage, transportation or handling must carry a label that shows the following information as it appears on the approved label for the product:

• (a) the information required under paragraphs (1)(a), (e), (h), (i), (k) and (l);
• (b) the information required under paragraph 2(b) that is relevant if any significant risk referred to in that paragraph exists while the pest control product is contained in the outermost package; and
• (c) the statement "For first aid instructions or the toxicological information essential for treatment, obtain and read the approved label from the registrant or phone the number indicated on this container".

Exceptions

(4) Subsection (3) does not apply if

• (a) the outermost package is transparent or otherwise allows the label that meets the requirements set out in subsection (3) to be legible; or
• (b) the information required under subsection (3) is otherwise specified in any condition under subsection 8(2) of the Act.

2 Section 28 of the Regulations is replaced by the following:

Brochures or leaflets

28 (1) 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 either the statement "READ ATTACHED BROCHURE (or LEAFLET) BEFORE USING." or the statement "READ ACCOMPANYING 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.

Exception

(2) The statement in paragraph (1)(a) does not need to appear on the container if, pursuant to subsection 31(1), a pest control product is transported in a railway tank car or a transport truck tanker-trailer and that tank car or tanker-trailer is the only container.

Provided at distribution

(3) Any brochure or leaflet referred to in subsection (1) must be provided to any user of the product at the time the product is distributed to them.

3 Section 31 of the Regulations is replaced by the following:

Product transported in a railway tank car or a transport truck tanker-trailer

31 (1) Subject to subsections (2) and (3) and to any condition specified by the Minister under subsection 8(2) of the Act relating to the label, if a pest control product is transported in a railway tank car or a transport truck tanker-trailer and that tank car or tanker-trailer is the only container, the information required under subsections 26(1) and (2) must be shown on the documents that accompany the shipment.

Storing or dispensing the product

(2) If a pest control product is stored in a railway tank car or a transport truck tanker-trailer or if the tank car or tanker-trailer is being used to dispense the product directly, then the documents required under subsection (1) must be

• (a) affixed to the tank car or tanker-trailer and readily available for review by all persons handling the product, the tank car or tanker-trailer; and
• (b) if applicable, near the control valve that is used for distributing or dispensing the product.

Providing information

(3) Subject to any condition specified by the Minister under subsection 8(2) of the Act relating to the label, if a pest control product referred to in subsection (1) is distributed directly to a user of the product, the information required under section 26 must be provided to the user at the time of distribution.

Coming into Force

4 These Regulations 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.