Health Canada formalizes approach to “treated articles” under the Pest Control Products Act

New amendments to the Pest Control Product Regulations (PCPR) were published in the Canada Gazette, Part II on December 7, 2022¹. Among other changes, these amendments codify the regulation of “treated articles” by the Pest Management Regulatory Agency (PMRA). These specific amendments will come into effect on June 7, 2023 to allow industry time to review the changes and implement product changes as necessary.

What you need to know

• Legacy PMRA approach to treated articles. To date, the PMRA’s approach to treated articles has been governed by guidance².
• New formalized approach to treated articles. Pursuant to the amendments, any non-food products that are treated with a pest control product will be subject to regulation under the PCPR as a treated article, unless exempted. Manufacturers and importers should review product lines in view of these pending changes, as treated articles extend beyond the types of products typically thought of as pest control products. Whether a product is a treated article is a fact-specific assessment, but a treated article can include, for example, any consumer product treated with an antimicrobial.
• Exempt items. Certain treated articles governed under another regulatory scheme will be exempted from the PCPR. Treated articles which are exempted include food and, when treated with an “antimicrobial preservative”, drugs, cosmetics, feeds, fertilizers, supplements and Class II-IV medical devices.
• Exemptions from registration. For treated articles that will be expressly regulated under the PCPR, manufacturers will not be required to register the article with the PMRA if (1) the pest control product applied or incorporated into the product is an antimicrobial preservative that is registered with, or otherwise authorized or recognized by, the PMRA and (2) the antimicrobial preservative is used for the purposes of protecting or preserving the article itself. However, if an unauthorized antimicrobial preservative, or other pest control product, is applied or incorporated into the product or the product is intended to “deliver” the antimicrobial treatment, the treated article itself will also need to be registered with the PMRA, unless otherwise exempted.

What products are considered treated articles?

The amendments to the PCPR require several levels of assessment to determine whether a product will be explicitly caught as a treated article.

First, consider whether there is a “pest control product” involved at any stage of manufacturing or production. If so, assess whether the product may now be captured as a treated article. Finally, assess if any exemptions and exclusions might apply. As the Pest Control Products Act (PCPA) and PCPR already include several exceptions and caveats, with new exemptions being added as part of these amendments, this analysis will be very fact specific.

What are pest control products?

Pest control products are often thought of as traditional pesticides (e.g., for farming or gardening) or insect repellents. However, the legal definition of pest control product under the PCPA is much broader and includes any products or ingredients that are used for “directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects”. While this does include products commonly understood as pesticides, it also includes other substances, such as antimicrobial agents commonly used to treat clothing, toys and furniture, among other consumer goods.

What are treated articles?

The broad scope of pest control products is important under these new amendments, as certain products treated with a pest control product may be expressly regulated as a treated article once the amendments are in force.

The amended regulations define a treated article as any non-food inanimate product or substance that:

• is treated with a pest control product during manufacturing by (a) incorporating the pest control product into the article or (b) applying the pest control product to the article and;
• has the primary purpose before the treatment was not pest control.

What are the exemptions?

Following the existing structure of the PCPR, the amendments include two levels of exemptions. Certain products that could be treated articles will be entirely exempted from the PCPA framework by section 3(1) of the PCPR, as amended. Other products will be regulated under the PCPA, but with lighter regulatory requirements.

Exemption Level No. 1

Regarding the first level of exemption, responsible parties should first consider whether an exemption applies under section 3(1) of the PCPR. This section has historically exempted certain products from the PCPA, which may otherwise have been pest control products, and will be amended to include a specific exemption for certain treated articles. Assessing whether one of these exemptions under section 3(1) applies is driven by the type of product and other regulatory regimes that apply to that class of product.

If the treated article is treated with an antimicrobial preservative, and is a drug or cosmetic regulated under the Food and Drugs Act, feed regulated under the Feeds Act, fertilizer or supplement regulated under the Fertilizers Act or Class II-IV medical device regulated under the Medical Devices Regulations, the product will be exempted from regulation under the PCPA/PCPR. Antimicrobial preservatives are chemicals incorporated into, or applied to, an article for the purpose of preserving it from deterioration or degradation by preventing the growth of micro-organisms. Notably, Class I medical devices and consumer goods, such as clothing and furniture, are not expressly exempted by the new amendments. Therefore, responsible parties would need to assess whether another existing exemption may apply to those products.

Exemption Level No. 2

If an exemption under section 3(1) does not apply, responsible parties should consider the second level of exemptions under section 4(1) of the PCPR. This section includes classes of products exempt from registration by the PMRA but still subject to other requirements under the PCPA/PCPR. Again, there are already a number of existing registration exemptions under this section, but these amendments will add new exemptions specifically directed to treated articles. Assessing whether an exemption under section 4(1) applies is driven by the type of pest control product applied to the article and the purpose of the treatment.

Notably, a treated article will not need to be registered if (1) it has only been treated with an antimicrobial preservative (and no other pest control product), (2) the sole purpose of the treatment is to preserve or protect the article and (3) the preservative used is registered or otherwise authorized or recognized by the PMRA. If those requirements are not met, the treated article itself will need to be registered with the PMRA, unless another exemption applies.

The PMRA has not yet published updated guidance on how it will interpret whether the antimicrobial treatment is intended to preserve the article itself, or alternatively whether the article acts as a delivery mechanism for the applied treatment. Under its prior policy position, the PMRA had provided the following examples:

• The purpose of applying an antimicrobial to an article of clothing to control odour was preserving or protecting the clothing. Therefore, the antimicrobial needed to be registered but the treated article of clothing did not.
• The purpose of applying a mosquito repellant to clothing was delivery of the mosquito repellant. Therefore, the mosquito repellant and the treated article required registration.