Regulations Amending the Pest Control Products Regulations (Applications and Imports): SOR/2022-241
PEST
P.C. 2022-1217 November 17, 2022
Canada Gazette, Part II, Volume 156, Number 25

Regulations Amending the Pest Control Products Regulations (Applications and Imports): SOR/2022-241

Canada Gazette, Part II, Volume 156, Number 25

Registration
SOR/2022-241 November 17, 2022

PEST CONTROL PRODUCTS ACT

P.C. 2022-1217 November 17, 2022

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health makes the annexed Regulations Amending the Pest Control Products Regulations (Applications and Imports) under section 67footnote a of the Pest Control Products Act footnote b.

Regulations Amending the Pest Control Products Regulations (Applications and Imports)

Amendments

1 (1) The definition device in subsection 1(1) of the Pest Control Products Regulations footnote 1 is replaced by the following:

device
means an instrument, gadget, apparatus, appliance or other similar object. (dispositif)

(2) The definition seed in subsection 1(1) of the Regulations is replaced by the following:

seed
means a generative part of a plant that is used for propagation purposes. It includes seed-like fruits, bulbs, tubers and corms but does not include whole plants or cuttings. (semence)

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

antimicrobial preservative
means a chemical substance, or a mixture of chemical substances, that is intentionally incorporated into, or applied to, an article for the purpose of preserving it from deterioration or degradation by preventing the growth of micro-organisms. (agent de conservation antimicrobien)
Stockholm Convention
means the Stockholm Convention on Persistent Organic Pollutants, signed at Stockholm on May 22, 2001, as amended from time to time. (Convention de Stockholm)
treated article
means an inanimate product or substance, but does not include a food as defined in section 2 of the Food and Drugs Act,
  • (a) that, during the manufacturing process, is treated with a pest control product either by intentionally:
    • (i) incorporating the product into the article; or
    • (ii) applying it to the article, and
  • (b) whose primary purpose, prior to that treatment, is not, directly or indirectly, to control, destroy, attract or repel a pest or to mitigate or prevent the injurious, noxious or troublesome effects of a pest. (article traité)
treated seed
means seed into which a pest control product is intentionally incorporated or to which the product is applied. (semence traitée)

2 (1) Section 2 of the Regulations is amended by striking out “and” at the end of paragraph (a), by adding “and” at the end of paragraph (b) and by adding the following after paragraph (b):

  • (c) an active ingredient that is manufactured, represented, distributed or used to directly or indirectly control, destroy, attract or repel a pest or to mitigate or prevent the injurious, noxious or troublesome effects of a pest.

(2) Section 2 of these Regulations is amended by striking out “and” at the end of paragraph (b) and by adding the following after paragraph (c):

  • (d) a treated article; and
  • (e) treated seed.

3 (1) The portion of paragraph 3(1)(f) of the Regulations before subparagraph (i) is replaced by the following:

  • (f) a pest control product — other than an organism, a device of a type described in Schedule 1 or a treated article — that is imported by a user for their personal use, that is in their possession at the time of the importation and that meets the following conditions:

(2) Subsection 3(1) of the Regulations is amended by striking out “and” at the end of paragraph (e) and by adding the following after paragraph (f):

  • (g) a pest control product that is a treated article into which the only pest control product that is incorporated or to which the product is applied is an antimicrobial preservative, if
    • (i) the product is imported by a user for their personal use,
    • (ii) the product is in their possession at the time of the importation,
    • (iii) the product is in its original package with the original label intact, and
    • (iv) the information on the package and label is in English or French and is clear and legible; and
  • (h) a pest control product that is
    • (i) an antimicrobial preservative when it is used in the manufacture of a treated article that is
      • (A) a feed that is regulated under the Feeds Act,
      • (B) a fertilizer or supplement that is regulated under the Fertilizers Act,
      • (C) a drug or cosmetic that is regulated under the Food and Drugs Act, or
      • (D) a medical device that is a device as defined in section 2 of the Food and Drugs Act and classified as a Class II, III or IV medical device under the Medical Devices Regulations, or
    • (ii) a treated article that is described in any of clauses (i)(A) to (D) into which the only pest control product that is incorporated or to which the product is applied is an antimicrobial preservative.

4 Subsection 4(1) of the Regulations is amended by striking out “and” at the end of paragraph (d) and by adding the following after paragraph (e):

  • (f) a pest control product that is a treated article into which the only pest control product that is incorporated or to which it is applied is an antimicrobial preservative, if
    • (i) the sole purpose of the treatment is to protect or preserve the article,
    • (ii) the active ingredient of the preservative is registered or otherwise authorized under paragraph 21(5)(a) of the Act for incorporation into, or application to the article,
    • (iii) in the case where the article is treated in Canada, the preservative is registered or otherwise authorized under paragraph (b) or paragraph 21(5)(a) of the Act,
    • (iv) in any other case, the treatment
      • (A) includes the same active ingredient as that contained in a preservative registered in Canada or otherwise authorized under paragraph (b) or paragraph 21(5)(a) of the Act, and
      • (B) meets any conditions of registration or authorization, as the case may be, that relate to the method of application, the uses for which the preservative may be applied to or incorporated into the article and the range of application rates as specified by the Minister under the Act or as set out in Schedule 2; and
  • (g) a pest control product that is a preservative set out in column 1 of Part 2 – Class 2 Preservatives or in column 1 of Part 3 – Class 3 Preservatives of the List of Permitted Preservatives (Lists of Permitted Food Additives), published by the Government of Canada on its website, as amended from time to time, if
    • (i) the product is used as an antimicrobial preservative,
    • (ii) the sole purpose of the treatment is to protect or preserve the article, and
    • (iii) the quantity of preservative protects or preserves the article, but does not exceed the quantity necessary to do so.

5 The Regulations are amended by adding the following after section 5:

Methods of Electronic Delivery

Electronic delivery

5.1 (1) For the purpose of subsection 62(1) of the Act, notices or other documents required or authorized to be delivered under the Act may be delivered electronically through the website of the Government of Canada or by another means of electronic communication.

Deemed time of delivery

(2) A notice or other document that is delivered electronically is considered to have been delivered

  • (a) if it was delivered through that website, on the earlier of
    • (i) the date of its delivery as indicated through that website, and
    • (ii) the date of its delivery as indicated by a means of automatic electronic communication generated by that website; and
  • (b) if it was delivered using another means of electronic communication, on the date that is indicated as the day of its delivery by the other means.

Setting aside deemed time of delivery

(3) A deemed time of delivery of a notice or other document may be set aside on the basis of any metadata or data from any other tracking system that relates to the notice or other document.

6 (1) Paragraph 6(1)(b) of the Regulations is replaced by the following:

  • (b) the name and address of
    • (i) each place of manufacture of the pest control product, if it is or contains a microbial agent, and
    • (ii) each place of production and formulation of the pest control product, in any other case;

(2) Paragraph 6(1)(h) of the Regulations is replaced by the following:

  • (h) in the case of a pest control product that contains one or more formulants, the name of each formulant, its CAS registry number if any, its percentage of the total weight of the product and its purpose in the product;

7 The Regulations are amended by adding the following after section 6:

Records

7 (1) An applicant referred to in subsection 6(1) or a registrant referred to in subsection 16(1) must keep records of

  • (a) in the case of a pest control product other than one that is or contains a microbial agent, the address of each place of manufacture of a pest control product, other than a place of production or formulation; and
  • (b) in the case of a pest control product that contains one or more formulants, the name and address of the supplier of each formulant.

Retention

(2) The applicant or the registrant must keep the records for five years after, as the case may be, the date of registration, its amendment or its renewal.

Change of information

(3) If the information contained in the records changes, the applicant or registrant must update it but the previous records must be kept for five years after the day on which the update occurs.

Production of records

(4) On request by the Minister, an inspector or an analyst, the applicant or registrant must provide any records to the Minister, the inspector or the analyst within the period specified in the request.

8 The Regulations are amended by adding the following after section 7:

Stockholm Convention — evaluations not necessary

7.1 (1) No evaluation under paragraph 7(3)(a) of the Act is necessary when

  • (a) the application is to register or amend the registration of a pest control product that is or contains an active ingredient that is listed as a chemical in Annex A (Elimination) or Annex B (Restriction) of the Stockholm Convention;
  • (b) the application pertains to a production or use of the active ingredient that is prohibited under the Convention;
  • (c) the amendment to the Convention that resulted in the listing has been ratified by Canada by the deposit of its instrument of ratification with the Secretary-General of the United Nations acting as the Depository of the Convention; and
  • (d) the proposed production or use of the active ingredient in the application:
    • (i) is not subject to a specific exemption, or acceptable purpose, notified by Canada under the Convention, as set out in the Register of Specific Exemptions, or a Register of Acceptable Purposes, established under that Convention, or
    • (ii) is not otherwise permitted under the Convention.

Denial of application

(2) For the purpose of subsection 8(4) of the Act, the health or environmental risks of a pest control product described in subsection (1) are not acceptable.

9 Paragraph 18(a) of the Regulations is replaced by the following:

  • (a) the validity period must not be longer than three years and may not be extended;

10 Section 19 of the Regulations and the heading before it are repealed.

11 (1) The portion of subsection 31(2) of the French version of the Regulations before paragraph (a) is replaced by the following:

Entreposage ou déchargement du produit

(2) Les documents visés au paragraphe (1) satisfont aux conditions ci-après si le produit est stocké dans le wagon-citerne ou la remorque-citerne ou est déchargé directement à partir de l’un ou de l’autre :

(2) Paragraph 31(2)(b) of the Regulations is replaced by the following:

  • (b) if applicable, within reach of and clearly visible to the person operating the control valve that is used for dispensing the product.

12 Section 36 of the Regulations is replaced by the following:

Declaration — general

36 (1) Subject to subsection (2), the importer of a pest control product — except a pest control product described in paragraph 4(1)(f) or (g) — must provide the Minister with a declaration at the time of the importation, in English or French, signed by the importer, that sets out

  • (a) the shipper’s name and postal address, along with their email address or telephone number;
  • (b) the importer’s name and address, along with their email address or telephone number;
  • (c) the name of the pest control product, which may include a distinctive brand or trademark;
  • (d) if applicable, the number of the pest control product’s licence, certificate, permit, registration, foreign product use certificate, research authorization certificate or research notification certificate;
  • (e) the quantity of the pest control product being imported, expressed
    • (i) by volume, if the product is liquid, gaseous or viscous,
    • (ii) by mass, if the product is a solid or pressure-packed,
    • (iii) by number of units being imported, if the product is a device or a treated article, and
    • (iv) in terms specified by the Minister in the conditions of registration under paragraph 8(1)(a) of the Act, in any other case;
  • (f) if applicable, the chemical name, common chemical name or other name of each active ingredient of the pest control product, along with its quantity in the pest control product; and
  • (g) the purpose of the importation of the pest control product, expressed as follows:
    • (i) “For Distribution, Including Sale”, if the product is being imported for distribution, including sale,
    • (ii) “For Manufacturing Purposes”, if the product is being imported for use in the manufacture of a registered pest control product,
    • (iii) “For Research Purposes”, if the product is being imported for research purposes,
    • (iv) “For Grower Requested Own Use”, if the product is being imported under a foreign product use certificate issued under subsection 41(3), and
    • (v) “For (importer to specify the purpose)”, in any other case.

Declaration — treated seed

(2) The importer of treated seed must provide the Minister with a declaration at the time of the importation, in English or French, signed by the importer, that sets out

  • (a) the shipper’s name and postal address, along with their email address or telephone number;
  • (b) the importer’s name and address, along with their email address or telephone number;
  • (c) the name of the kind or species of seed;
  • (d) the country where the crop from which the seed is derived was grown;
  • (e) if applicable, the number of the treated seed’s licence, certificate, permit, registration, foreign product use certificate, research authorization certificate or research notification certificate;
  • (f) the quantity of treated seed that is being imported, expressed by mass;
  • (g) the chemical name, common chemical name or other name of each active ingredient of the pest control product that is incorporated into, or applied to, the seed, along with its quantity, expressed by mass or volume, as applicable, per 100 kg of seed;
  • (h) the name of the treated seed, including any distinctive brand or trademark; and
  • (i) the purpose of the importation of the treated seed, expressed as follows:
    • (i) “For Distribution, Including Sale”, if the seed is being imported for distribution, including sale,
    • (ii) “For Manufacturing Purposes”, if the seed is being imported for further manufacturing,
    • (iii) “For Research Purposes”, if the seed is being imported for research purposes,
    • (iv) “For Grower Requested Own Use”, if the seed is being imported under a foreign product use certificate issued under subsection 41(3), and
    • (v) “For (importer to specify the purpose)”, in any other case.

Retention

(3) The importer must keep the information set out in a declaration for two years after the day on which the importation of the pest control product in respect of which the declaration was made.

13 Section 71 of the Regulations is amended by striking out “and” at the end of paragraph (b) and by replacing paragraph (c) with the following:

  • (c) the device, in the case of a device; and
  • (d) the treated article, in the case of a treated article.

Coming into Force

14 (1) Subject to subsection (2), these Regulations come into force on the day on which they are published in the Canada Gazette, Part II.

(2) Subsections 1(1) and (3) and 2(2) and sections 3, 4, 8, 9 and 11 to 13 come into force on the 180th day after the day on which the Regulations are published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

As part of a comprehensive review of the Pest Control Products Regulations (PCPR), Health Canada has identified a number of elements of the PCPR that will benefit from modernization.

More precisely:

  • Three aspects of the application process in the PCPR impose an unnecessary regulatory and administrative burden pertaining to manufacturing site information, formulant supplier information, and the maximum validity period of emergency registrations;
  • Five technical issues, including an issue raised by the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) outside of the comprehensive review process, must be rectified; and
  • Five processes currently implemented by policy are better codified in the PCPR, to provide industry with predictability.

Background

The Minister of Health’s primary mandate under the Pest Control Products Act (the PCPA) is to prevent unacceptable risks to individuals and the environment from the use of pest control products. The PCPA requires that the Minister of Health, to meet this objective, conduct premarket assessments of pest control products to determine if the risks to human health and the environment are acceptable and the products have acceptable value. The PCPA also allows regulations to be made that authorize the import, manufacture, distribution or use of unregistered pest control products, based on specified conditions.

In January 2016, Health Canada’s Pest Management Regulatory Agency (PMRA) launched a comprehensive review of the PCPR, the first such review since the Regulations came into force in 2006. The review is aimed at modernizing the PCPR and ensuring they continue to meet program objectives (for example health and environmental protection) in an effective and efficient manner, while attempting to minimize the regulatory burden on regulated parties.

Moreover, the SJCSR has identified an issue with the wording of the PCPR with respect to container labelling.

This set of regulatory amendments consolidates 13 issues either identified through the PMRA’s comprehensive review or raised by the SJCSR, and will amend certain application and importation requirements for pest control products in Canada.

Objective

While maintaining health and environmental protection, the amendments will

  • streamline three identified aspects of the application process to reduce the regulatory and administrative burden;
  • make the five technical changes identified, including the issue raised by the SJCSR outside of the comprehensive review process; and
  • codify the five processes currently implemented by policy into the PCPR.

Description

To address the issues identified, the amendments will streamline some aspects of the PCPR.

Streamlining regulatory or administrative burden

The measures to streamline the regulatory or administrative burden are outlined below.

Streamlining requirements for certain manufacturing site information

Manufacture is defined in the PCPA as “[including] produce, formulate, package, label and prepare for distribution or use.” Furthermore, paragraph 6(1)(b) of the PCPR requires registrants and applicants to provide information on manufacturing sites for their pest control products and to provide updates about the sites should the sites change. Registrants have noted challenges with efficiently meeting these requirements in circumstances where a product is packaged or labelled at several sites. For example, if the packaging site of a product changes on a regular basis, the registrant must apply to amend the registration of their product every time. Since manufacturing site information is not always pertinent to the product’s evaluation, the constant updates may pose an unnecessary regulatory burden.

The amendments will remove the requirement for registrants and applicants to provide the names and addresses of certain places of manufacture on an application to register or amend the registration of a pest control product.

  • If the pest control product in question is or contains a microbial agent, there will be no change (because these types of products are more sensitive to the locations in which they are manufactured).
  • If the pest control product in question is not a microbial agent, registrants and applicants will still have to provide names and addresses for the places where the pest control product is produced and formulated, but are not required to provide the names and addresses for where the product is packaged and labelled.

Instead of providing this information when applying to register or amend the registration of a pest control product, registrants and applicants of pest control products that are not microbial agents will be required to keep records pertaining to all manufacturing sites not provided, meaning the names and addresses of every place that a given pest control product is (or has been) packaged, labelled, or prepared for distribution or use. These records must be kept for five years, starting from, as applicable, the date the product was registered, the date the product’s registration was renewed, or the date the site changed.

Streamlining requirements for certain formulant supplier information

The PCPA defines a formulant as “any component of a pest control product that is added intentionally to the product and that is not an active ingredient.” Examples of formulants include flavourings used in baits (such as “bacon flavouring”) and compounds that adjust the solubility of the product (such as ethanol).

Paragraph 6(1)(h) of the PCPR requires applicants and registrants to provide information on the formulants contained in their pest control products, including the name and address of the supplier of each formulant, when applying to register or amend the registration of a pest control product. Registrants have noted challenges in efficiently meeting the requirement to provide the names and addresses of the suppliers of each formulant in circumstances where the formulant supplier changes often. For example, if a product uses a commodity formulant that can be sourced from any number of suppliers, the registrant must apply to amend the registration of their product every time they use a different supplier for a production run. Since formulant supplier information is not always pertinent to the product’s evaluation, the constant updates may pose an unnecessary regulatory burden.

The amendments will remove the requirement for registrants and applicants to provide the names and addresses of formulant suppliers on an application to register or amend the registration of a pest control product.

Instead of providing this information when applying to register or amend the registration of a pest control product, registrants and applicants of pest control products will be required to keep records pertaining to the names and addresses of their formulant suppliers. These records must be kept for five years, starting from, as applicable, the date the product was registered, the date the product’s registration was renewed, or the date the supplier changed.

Permitting extended validity periods for certain emergency registrations

Section 18 of the PCPR currently allows for products to be registered, or have an existing registration amended, for “the emergency control of a seriously detrimental infestation.” In these cases, “the validity period must not be longer than one year and may not be extended,” and “the registration may not be renewed.” Provincial partners have indicated that single-year validity poses challenges in certain situations, such as those involving products intended to address issues pertaining to aquatic invasive species. Many situations can be identified at the onset as requiring multiple years to be addressed. If a situation is known to require multiple years to be addressed, an additional regulatory and administrative burden may be carried from resubmitting substantively similar information with incremental updates each year.

The amendments will allow a maximum validity for emergency registrations of up to three years, rather than up to one year.

Technical issues

The measures to address technical issues are outlined below.

Addressing an issue with the definition of “seed”

The term “seed” in the PCPR is defined as “a generative part of a plant that is used for propagation purposes. It includes true seeds, seed-like fruits, bulbs, tubers and corms but does not include whole plants or cuttings.” This definition contains a redundancy: a definition that is structured with “includes” is intended to provide clarity on what could be ambiguous in the defined term. Since “true seeds” are clearly “seeds,” an “includes” definition need not mention “true seeds.”

The amendments will remove the reference to “true seed” from the definition of “seed.”

Addressing non-formulated pest control products

The PCPA defines a “pest control product” as “a product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants…” As noted previously, a formulant is further defined in the PCPA as “any component of a pest control product that is added intentionally to the product and that is not an active ingredient.”

While the majority of pest control products regulated under the PCPA contain formulants, a small subset of these products consists only of their active ingredient, meaning no formulants have been added. While products manufactured with only active ingredients can pose health and environmental risks, are regulated under the PCPA, and are registered as pest control products, there is some ambiguity as to whether they fall under the definition of pest control product of the PCPA.

Section 2 of the PCPR will be amended to prescribe that active ingredients are pest control products that are “manufactured, represented, distributed or used to directly or indirectly control, destroy, attract or repel a pest or to mitigate or prevent the injurious, noxious or troublesome effects of a pest.” This will remove any ambiguity about whether pest control products that contain only active ingredients fit the definition of “pest control product” in the PCPA. This will codify current practice.

Codifying current practice regarding electronic document delivery

Currently, most registrants and applicants provide electronic documents (labels, statements of product specification, incident reports, etc.) to Health Canada through a secure web portal. Subsection 62(1) of the PCPA requires documents to be delivered “by any method that provides proof of delivery,” or by any method that is set out in regulation. However, sending documents electronically is not considered a method that provides proof of delivery, regardless of whether the documents are sent via the secure web portal.

The amendments will prescribe electronic document delivery as acceptable, both for communication from regulated parties to Health Canada and vice versa. The amendments will also establish provisions in the regulations that outline what date a given communication is presumed to have been sent or received, based on such identifying information as confirmation pages or associated metadata.

Repealing a duplicative provision concerning impurities

Section 19 of the PCPR establishes a limit on the permissible amount of a single impurity, N-nitrosodi-n-propylamine (NDPA), in pest control products containing the herbicidal active ingredient trifluralin. NDPA is a member of a class of chemical called nitrosamines. Nitrosamines are a by-product of the chemical synthesis of certain compounds, including pest control products, and exposure to them can result in health impacts. The PMRA already takes levels of this impurity, and other impurities of toxicological concern, into consideration when evaluating the health and environmental risk of a pest control product, meaning that the established limit in section 19 is unnecessary.

The amendments will repeal section 19 of the PCPR.

Addressing a concern of the SJCSR

Where a pest control product is stored in a railway tank car or a transport truck tanker-trailer, or one of those containers is being used to dispense the product directly, paragraph 31(2)(b) of the PCPR requires that the mandated health and safety documents be affixed “near the control valve that is being used for distributing or dispensing the product.” The SJCSR has noted that requiring something to be “near” is vague and should be expressed more clearly, for example, whether the documents must be within reach of the person operating the control valve.

Paragraph 31(2)(b) will be amended to clarify that the mandated health and safety documents must be affixed “within reach of and clearly visible to the person operating the control valve.” Health Canada interprets “clearly visible” to mean “visible and with nothing obstructing its view.”

Codifying processes in the Pest Control Products Regulations

The measures to address process clarity are outlined below.

Clarifying regulatory requirements for treated articles and establishing criteria for authorizing certain treated articles

Non-food products treated with a pest control product, to directly or indirectly control, destroy or repel a pest or for mitigating or preventing its injurious, noxious or troublesome effects, meet the definition of a pest control product and, as such, are subject to the PCPA. These products are commonly referred to as “treated articles.” Articles can be treated with pest control products such as antimicrobials (for example textiles treated with a preservative), insecticides (for example insecticide-treated clothing), and herbicides (for example herbicide-treated landscape fabric).

The PCPA does not define “treated article.” However, the terminology has been used in industry and by regulators for some time. Stakeholders had been asking for published information on the regulation of treated articles, as the PMRA had been communicating regulatory guidance on a case-by-case basis.

In 2018, the PMRA published an Information Note on treated articles to broadly communicate treated article regulatory guidance to stakeholders. The Information Note also stated that articles treated with antimicrobial preservatives were exempt from registration when certain conditions are met:

  • The antimicrobial preservative used to treat the article is registered or otherwise authorizedfootnote 2 under the PCPA;
  • The use is limited to preventing degradation or damage to the product from micro-organisms; and
  • The article is treated according to the antimicrobial preservative’s approved uses (in other words, the same use specified on the label of the registered or authorized end-use product) and within the registered or authorized range of rates.

These registration exemption conditions should be established in the PCPR rather than through the Information Note. This would provide regulatory clarity for stakeholders. Including a definition for “treated article” in the PCPR would further clarify the scope of what constitutes a treated article and modernize the regulatory framework.

The amendments will remove the word “article” from the definition of “device” and then explicitly define and prescribe a “treated article” as a pest control product. Furthermore, articles treated with antimicrobial material preservatives will be authorized under the Regulations (meaning they will not have to be registered) if they meet the following conditions:

  • The antimicrobial preservative used to treat the article is registered or otherwise authorized under either paragraph 21(5)(a) of the PCPA or paragraph 4(1)(b) of the PCPR;
  • The use is limited to preventing degradation or damage to the product from micro-organisms; and
  • The article is treated in accordance with the approved range of application rates, the approved method of application, and the approved uses of the registered or authorized antimicrobial preservative. The approved range of application rates is set out in the approved end-use product labels associated with the active ingredient. It is commonly expressed on the label as the amount of the active ingredient on or in the treated article that a consumer could be exposed to, measured in parts per million.
Codifying current practice by exempting certain antimicrobials used in products that are regulated under certain Acts

Antimicrobial preservatives are pest control products that are used to extend the durability or shelf life of an article or material, by controlling micro-organisms that may degrade or damage that item (preservation). Treating an item with an antimicrobial used for preservation is thus intended to make the item last longer, which is a desired quality for many consumers. Many items are treated with a pest control product (such as an antimicrobial used for preservation) during their manufacturing stage. In many cases, the final product is regulated under federal legislation other than the PCPA, which means that certain items containing an antimicrobial preservative are already evaluated for similar health and environmental outcomes as would be required by the PCPA. Health Canada has used enforcement discretion and not enforced the PCPA for antimicrobial preservatives when they are used to treat products that are regulated under the Feeds Act; the Fertilizers Act; or drugs, cosmetics and certain medical devices regulated under the Food and Drugs Act. These Acts have existing and established premarket and/or post-market review requirements, which include the assessment of material preservatives used in the end-use products they regulate. To require material preservatives used in these products to be reviewed and registered by the PMRA would be a duplication of efforts by the Government as well as an administrative burden to industry.

Subsection 3(1) of the PCPR will be amended to exempt antimicrobials used for preservation from the application of the PCPA, when those antimicrobials are used in treated articles regulated under the Feeds Act, the Fertilizers Act or the Food and Drugs Act. With respect to the Food and Drugs Act, this includes drugs and cosmetics, as well as devices classified as a Class II, III or IV medical device under the Medical Devices Regulations. The treated article itself will also be exempted from the application of the PCPA. This exemption will only apply to the use of those antimicrobials in or on the treated articles regulated under those Acts, and will not apply to additional uses of the antimicrobial preservative outside the scope of the Food and Drugs Act, Feeds Act or Fertilizers Act (i.e. any additional uses of the antimicrobial preservative will require registration under the PCPA). This will codify current practice.

For example, consider a hypothetical pest control product, Antimicrobial X. Antimicrobial X is used in a fertilizer. It is reviewed under the Fertilizers Act during the product assessment and does not require to also be reviewed under the PCPA when used in a fertilizer. If Antimicrobial X were also used in a can of paint, then the use in paint will be subject to the PCPA, and Antimicrobial X will require registration under the PCPA for that use. Paint is not regulated under one of the three prescribed Acts, so there is no duplication of review.

Codifying current practice by exempting certain food additives regulated under the Food and Drugs Act

Food additives are regulated in Canada under the Food and Drugs Act, with marketing authorizations made under that Act being used to exempt certain products from the prohibitions found in either the Food and Drugs Act or the Food and Drug Regulations. More than 150 pest control product formulations contain food additives as preservatives, such as rodenticides (e.g. bait) that contain calcium propionate as a mould inhibitor or insecticides (e.g. personal insect repellants) that contain benzoic acid as an oxidation inhibitor.

Health Canada’s List of Permitted Preservatives (“List 11”) is a document incorporated by reference in the Marketing Authorization for Food Additives That May Be Used as Preservatives. List 11 sets out food additives authorized to be used to control micro-organisms or oxidation in food, and their conditions of use. Part 2 and Part 3 of List 11 set out permitted food preservatives that control antibacterial or antifungal micro-organisms, respectively (meaning that they are pest control products).

Section 6.3.3 of PMRA’s formulants policy (DIR2006-02, “Formulants Policy and Implementation Guidance Document”) states that “[c]onsideration will be given to waiving the requirement for registration of preservatives that are already regulated as food additives under the Canadian Food and Drugs Act where the levels of exposure from pest control products are consistent with the levels of exposure as food additives.” While the PMRA regulates formulation preservatives, to avoid regulatory duplication, the PMRA has not regulated formulation preservatives that are on List 11, as such products have already been evaluated under the Food and Drugs Act and are approved only if the health risk is determined to be acceptable. Given that the PMRA has been consistently waiving the requirement to register these preservatives, this exemption is best placed in the Regulations and not enacted through policy.

Subsection 4(1) of the PCPR will be amended to authorize Class 2 (antibacterial) and Class 3 (antifungal) substances on List 11 (meaning they will not have to be registered). This authorization will apply when a permitted food additive is used as a preservative in a pest control product, and the additive protects or preserves the article but does not exceed the quantity necessary to do so. This will codify current practice.

Health Canada’s “A Guide for the Preparation of Submissions on Food Additives” lays out instructions on how a petitioner can make a submission to modify the Lists of Permitted Food Additives, including information requirements. Proposals to amend the Lists of Permitted Food Additives, whether initiated by the Government of Canada or at the request of a petitioner, are subject to a notification and comment period. This comment period includes both domestic consultation and a parallel World Trade Organization notification, to inform member countries of the proposal and allow for their comments as well.

Supporting Canada’s commitment to meeting its obligations in multilateral environmental agreements

Canada has ratified international agreements that have obligations to prohibit the use of certain chemicals. For example, Canada is a party to the Stockholm Convention on Persistent Organic Pollutants, and Cabinet makes individual ratification decisions on prohibiting chemicals listed under the Convention. For example, the Stockholm Convention prohibits the use of lindane, among other things. Lindane was determined likely to lead to significant adverse human health and environmental effects, in consideration of its potential for persistence, bioaccumulation, long-range environmental transport and adverse effects, such that global action was warranted. As a result, Canada ratified the prohibition of lindane on April 4, 2011.

Despite the prohibition of the use of certain chemicals imposed by the Stockholm Convention, the PMRA is required by the PCPA to evaluate applications to register products that are or contain such prohibited substances as active ingredients, and can only deny the registration based on the outcome of the evaluation (i.e. the fact the substance is included in the international agreement itself is insufficient). However, if such a product is already registered, or is registered as a result of such an application, section 27 of the PCPA allows the Governor in Council to cancel the registration of that pest control product, if necessary, to implement Canada’s international obligations. The PMRA participates in the process by which substances are ratified under the Stockholm Convention. Products being submitted for registration under the PCPA could contain active ingredients that Canada has agreed to prohibit under the Stockholm Convention. Having the PMRA evaluate such applications may pose unnecessary regulatory and administrative burden or duplication, both for the Government of Canada and for applicants submitting products for registration. While the PMRA has not received an application to assess and register a pest control product in which the active ingredient is or contains a prohibited chemical, it may be unclear to stakeholders what substances are or are not permitted to be in pest control products.

The amendments will deny an application pertaining to a product that is or contains an active ingredient that Canada has, through the ratification process, agreed to prohibit pursuant to the Stockholm Convention on Persistent Organic Pollutants.

Aligning import declaration requirements with current information-collection practices

Section 36 of the PCPR requires importers of pest control products to declare their imports, and describes the information that must be declared. This is primarily done in collaboration with the Canada Border Services Agency (CBSA), which monitors the importation of pest control products, with Health Canada being engaged for admissibility decisions as needed. The information on imports that the CBSA collects at the border is more extensive than that currently required by Health Canada, and is of value to Health Canada for regulatory oversight and policy development.

Section 36 of the PCPR also currently requires importers to declare the purpose of the importation:

  • Resale, if the product is registered and is being imported for resale;
  • Manufacturing, if the product is being imported for use in the manufacture of a registered pest control product; and
  • Research, if the pest control product is being imported for research purposes.

The PCPA contains specific prohibitions against the manufacture, possession, handling, storage, transportation, importation, distribution or use of a pest control product that is not registered or otherwise authorized under the Act or Regulations. The term “resale” does not reflect the terms used in the PCPA. The term “distribute” would be more accurate in this case, as it is defined in the PCPA as “distribute in any way, whether or not for consideration, and includes sell, offer for sale or distribution, and expose, display or advertise for sale or distribution.”

In order to better align the wording in the PCPR with the wording in the PCPA, section 36 will be amended to note the ability to declare an importation for the purpose of “distribution, including sale,” rather than for “resale.”

Section 36 of the PCPR will be amended to codify current practice, and align Health Canada’s pest control product import declaration requirements with the information already collected at the border by the CBSA. This includes removing the existing exemption from declaration requirements for importation done under a foreign product use certificate, as the CBSA collects such information regardless. In total, the following declaration requirements will be added or changed:

  • Contact information (telephone or email) for the shipper (previously, only the name and postal address were required);
  • Contact information (telephone or email) for the importer (previously, only the name and postal address were required);
  • Where any exist, the licence, certificate, permit, or other numbers (meaning the registration number, the foreign product use certificate number, research authorization certificate number or research notification certificate number);
  • Additional precision on how to declare the total amount of pest control product being imported;
  • The option of declaring an import for “grower-requested own use” when it is being imported with a foreign product use certificate; or declaring an import for any other reason not specified.

Authorized treated articles will be exempted from import declarations. For details on the change in respect of those treated articles, see the earlier heading “Clarifying current regulatory requirements for treated articles and establishing criteria for authorizing certain treated articles.”

Finally, because treated seeds have specific information requirements that do not consistently align with how the information requirements are described in subsection 36(1) of the PCPR, for greater clarity, the amendments will lay out the information requirements for treated seed in a separate subsection 36(2). The requirements will be similar to those in subsection 36(1), but will include providing the name of the kind or species of seed; the country where the crop from which the seed is derived was grown; the name and quantity of the active ingredient used to treat the seed; and the name of the treated seed, which may include a brand name or trademark.

Regulatory development

Consultation

The PMRA has conducted two regulatory pre-consultations on the items addressed by the amendments.

On November 30, 2018, the PMRA published a regulatory preconsultation discussion paper, the summary of which is available online [Regulatory Proposal PRO2018-03, Pre-Consultation – Proposed Amendments to the Pest Control Products Regulations (Product Exemptions)]. This paper proposed amendments that would address issues that included those for treated articles. The consultation period lasted 90 days.

On October 28, 2020, the PMRA sent industry stakeholders, non-governmental organizations, Indigenous organizations, and federal/provincial/territorial partners a regulatory pre-consultation discussion paper entitled Pre-Consultation – Proposed Amendments to the Pest Control Products Regulations (Applications and Imports). This paper proposed amendments for most of the remaining issues — it did not include the issue identified by the SJCSR or the minor issue with the definition of seed — and requested feedback on costing information that would inform the cost-benefit analysis. The consultation period lasted 75 days.

Pre-consultation comments on treated articles

The PMRA received 9 comments related to treated articles during the course of the first consultation, and 17 comments from 16 stakeholders during the course of the second.

Overall, stakeholders are supportive of the proposed changes, as most proposed changes are intended to address their concerns or were specifically requested by them. The CBSA, other federal departments, and provincial/territorial partners were also supportive, as the proposed amendments would minimize regulatory duplication.

Some commenters noted a desire to have a transition period between final publication and coming into force, so that their member companies could have adequate time to make any necessary changes to business practices. The PMRA will provide a transition period of 180 days before the coming into force of the Regulations, where warranted, to give industry the sufficient opportunity to familiarize themselves with the amendments and adapt business practices if required.

A commenter representing an industry organization further noted that they believed this proposal did not go far enough in its exemptions; specifically, they noted their opinion that treated articles should not be considered pest control products, and asked for additional exemptions for more classes of products, such as those regulated under the Canada Consumer Product Safety Act. No changes were made to the proposal as a result of this comment: the PMRA has maintained that treated articles are pest control products, as the articles meet the criteria to be regulated under the PCPA. They are manufactured or distributed to control or mitigate the troublesome effects of various pests on the article. The exemption criteria being proposed take into consideration whether the pesticidal component of the treated article (or chemical itself) is evaluated under other regulatory frameworks. They are designed to prevent potential regulatory gaps, such as a situation where an antimicrobial chemical would not be evaluated under any regime due to the establishment of exemption criteria in the PCPR.

Moreover, the criteria under which treated articles would not have to be registered (i.e. they would be authorized) is not codified in the current PCPR. As a result, the proposed amendment is necessary in order to properly establish those criteria. The amendments, as proposed, did not pose any additional burden over current practice.

Lastly, an industry stakeholder noted if authorized antimicrobial treated articles were to be subject to the import declaration requirements, then it would pose a considerable administrative and compliance burden on both industry and government, and it would dilute the effectiveness of notifications for pesticide products. Therefore, they recommended that import declaration requirements only apply to registered treated articles. The PMRA concurs, as this would codify current practice, and has incorporated this recommendation into the amendment.

Prepublication in the Canada Gazette, Part I

The amendments were prepublished in the Canada Gazette, Part I, on April 2, 2022, followed by a 70-day comment period. Comments were received from eight respondents during the consultation period. Comments were generally in favour of the proposed Regulations, with certain suggestions raised. Comments that were considered to have the greatest potential to affect the regulatory proposal or related policies, as well as the PMRA’s responses, are included below.

One comment noted the regulatory burden associated with fulfilling registration requirements for lower risk innovative products, such as biopesticides, and asked Health Canada to consider incentives and data waivers for low-risk products. This comment is out of scope for the current regulatory package, but is being considered in the context of future legislative and regulatory amendments.

One comment requested clarification on the compliance verification process for imported antimicrobial treated articles, including seeking confirmation that compliance would be determined by the business verifying the conditions of authorization, based on “existing definitions of the antimicrobial active within a regulatory body recognized by Health Canada.” This is accurate. All regulated parties are expected to comply with the PCPA and PCPR, including any conditions related to the use of the product, and this requirement extends to those who are importing the product. This is derived from the registered product used in the country of origin, as there is no formal recognition process.

One comment supported the clarification pertaining to non-formulated pest control products, but questioned whether the amendment would lead to confusion on the regulatory status of macro-organisms, such as nematodes or ladybugs. Organisms used for pest control are pest control products, as per the definition in the PCPA, and are regulated through an interdepartmental process involving PMRA, the Canadian Food Inspection Agency, Agriculture and Agri-Food Canada, and Natural Resources Canada. Health Canada intends, as part of future work, to further clarify how macro-organisms are regulated under the PCPA and other applicable federal legislation.

One comment asked whether registrants and applicants would be permitted to use the existing approach, and continue to submit information on all manufacturing sites. The five-year record-keeping requirement would still apply once that provision comes into force, regardless of whether the registrant or applicant chooses to submit the additional information as part of the renewal or application process. The comment then asked for confirmation of when the Agency would accept applications with the abbreviated requirements, in light of the 180-day coming into force. In order to facilitate reduced administrative burden to the extent possible, the streamlined requirements for providing manufacturing site and formulant supplier information will come into force on the date of publication, rather than 180 days following the date of publication. This will allow registrants and applicants to submit streamlined applications immediately. Moreover, technical amendments that do not require familiarization with new requirements will also come into force on the date of publication.

One comment supported the clarity provided by addressing the concern of the SJCSR, but suggested paragraph 31(2)(b) read, “if applicable, affixed within reach and clearly visible to the person operating the control valve that is used for dispensing the product.” Health Canada concurs with the recommendation to add “clearly visible” to this provision. Health Canada does not believe that “affixed” needs to be in paragraph 31(2)(b), as it is already applicable from paragraph 31(2)(a) [“affixed to the tank car or tanker-trailer and readily available for review by all persons handling the product, the tank car or the tanker-trailer”].

Two respondents further noted that the proposed regulatory text may lead to unnecessary confusion surrounding the importation of pest control products used to treat seeds, and treated seeds themselves. The name of the pest control product used to treat seeds imported into Canada may have a different commercial name in the exporting country, and that the name of the active ingredient in the pest control product is the most accurate information. To address this, the respondents recommend that import declaration requirements prescribed in the PCPR avoid the use of brand or commercial names, as commercial names often vary from country to country. Health Canada concurs with this recommendation, and has adjusted the regulatory text to require the name of the treated seed itself, rather than the name of the pest control product used to treat the seed. The name of the active ingredient used to treat the seed will continue to be required.

One respondent reiterated their serious concerns with the proposed approach to treated articles. In particular, they raised concerns about PMRA’s authority to regulate treated articles, the potential costs to stakeholders, and the insufficiency of the 180-day delay to the coming into force.

Regarding PMRA’s authority to regulate treated articles, the commenter noted that they did not believe that the PMRA had the authority to implement policy pertaining to treated articles, including the publication of the Information Note on treated articles and subsequent updates thereto. The PMRA notes, however, that the Information Note did not impose additional requirements; instead, it established the PMRA’s interpretive guidance for regulated parties. Because treated articles affect pests, they are pest control products, and therefore fall under PMRA authority. In the absence of the Information Note, the PMRA would be addressing treated articles on a case-by-case basis. As noted above, stakeholders had noted the PMRA’s lack of transparency, and requested published guidance on how treated articles were regulated. The Information Note was published to address this lack of transparency, and provided additional information on the criteria for authorized treated articles.

Regarding the potential costs to stakeholders, the commenter noted that the PMRA did not take into account costs to evaluate compliance on products being imported into Canada, including both the raw materials and finished products themselves. However, PMRA has long regulated such products, and continues to register treated articles. Because treated articles are pest control products, and thus are already subject to the PCPA, the requirements laid out in the Information Note apply irrespective of this regulatory amendment. As a result, there are no additional costs realized by the amended process, as importers and manufactures are currently expected to be abiding by the requirements of the PCPA and PCPR.

Regarding the insufficiency of the 180-day delay to the coming into force, the commenter noted that the European Union (EU) provided a 4-year transition for its regulatory amendment pertaining to treated articles, and the United States Environmental Protection Agency (U.S. EPA) provided a one-year transition for its regulatory clarifications pertaining to treated articles. As the regulatory amendment codifies current practices, and does not represent a deviation from existing regulatory authorities, the PMRA has established a 180-day delay so that regulated parties can familiarize themselves with the wording of the requirements. The 180-day delay is not intended to reflect the time required to have new active ingredients registered for use in treated articles, as the current PCPA and PCPR would require their registration irrespective of this regulatory amendment. The PMRA continues to work with regulated parties to facilitate the registration of new active ingredients, so that disruptions can be minimized.

Modern treaty obligations and Indigenous engagement and consultation

No impacts have been identified in respect of the Government’s obligations in relation to Indigenous rights protected by section 35 of the Constitution Act, 1982, or its modern treaty obligations.

Instrument choice

For each issue that will be addressed by the amendments, an analysis was performed to evaluate whether the baseline scenario (no action), a change to policy, or a regulatory amendment would be the best option. In each instance, the issue is best addressed by a regulatory amendment, as the baseline scenario would not address the issue identified and an exclusively policy-level approach would not be consistent with obligations under the PCPA and the PCPR.

Regulatory analysis

Benefits and costs

In order to analyze the benefits and costs associated with the amendments, Health Canada examined internal data, and conducted a costing survey with industry stakeholders in conjunction with the preconsultation process in October 2020.

In particular, Health Canada obtained information on the record-keeping practices of registrants and applicants, the amount of time it takes to apply to amend information about a registration’s manufacturing site or formulant supplier, the amount of time it takes to prepare and submit an application for an emergency registration, and the type of staff who perform each of those activities. Wage rates were based on data in the Statistics Canada 2018 Labour Force Survey.

The costing survey informed Health Canada’s key assumptions that were used for data analysis.

  • Most registrants and applicants already retain records pertaining to manufacturing sites and formulant suppliers. Retention periods varied, but were often 5 years, 10 years for locations in the United States, or indefinite.
  • In some cases, record keeping was performed by partners along the supply chain rather than by the registrant or applicant directly.
  • The creation of the first statement of product specification form (SPSF) takes between 3 and 4 days, with the time required to make subsequent updates about manufacturing sites and formulant suppliers varying between 15 minutes and 4 hours.
  • No changes to trends in updating frequency were anticipated if the status quo were to be maintained.
  • The creation and submission of a typical emergency registration application take between 5 and 40 hours, with the amount of time being consistent year-to-year.
  • Technical specialists or regulatory staff were the primary type of staff who performed these activities.

Overall, it is anticipated that the amendments will reduce the administrative burden on registrants and applicants, and that registrants and applicants will assume negligible compliance costs while becoming familiar with the amended Regulations. In addition, it is estimated that the costs to Government to implement the regulatory amendment will not be significant.

Reduction of regulatory and administrative burden

The following regulatory amendments are anticipated to reduce the regulatory and administrative burden on registrants and applicants.

Streamlining requirements for certain manufacturing site information

It is anticipated that the amendments will reduce the regulatory and administrative burden on regulated parties due to the reduction in time and effort required to collect, process, and complete forms, and report on changes about manufacturing sites. While the amendments will institute record-keeping requirements that currently do not exist, most registrants and applicants indicated that they already keep and retain records pertaining to manufacturing sites as a component of standard business practices.

Streamlining requirements for certain formulant supplier information

It is anticipated that the amendments will reduce the regulatory and administrative burden on regulated parties due to the reduction in time and effort required to collect, process, and complete forms, and report on changes about formulant suppliers. While the amendments will institute record-keeping requirements that currently do not exist, most registrants and applicants indicated that they already keep and retain records pertaining to formulant suppliers as a component of standard business practices.

Permitting extended validity periods for certain emergency registrations

It is anticipated that the amendments will reduce regulatory compliance costs for certain regulated parties due to the reduction in time and effort required to collect, process, and complete forms, and submit information pertaining to emergency registrations.

Amendments without incremental impact on stakeholders

The following amendments are anticipated to have no incremental impact on stakeholders.

Addressing an issue with the definition of “seed”

This is a non-substantive amendment to eliminate the redundancy in the definition of “seed.” Therefore, it is not expected to have an impact on stakeholders.

Addressing non-formulated pest control products

At this time, the PMRA regulates approximately 50 pest control products that consist of only their active ingredient (without added formulants). This amendment provides greater clarity that non-formulated products are adequately captured in the definition of “pest control product” in subsection 2(1) of the PCPA. It is anticipated that this amendment will not result in any change to current business practices and will therefore have no impact on stakeholders.

Codifying current practice regarding electronic document delivery

Currently, the majority of registrants and applicants already use the secure web portal for electronic document delivery. Others who cannot or who choose not to use the portal use either physical mail or email to deliver documents. Prescribing in the PCPR that electronic document delivery be one of the acceptable methods will not result in any change to current business practices and will therefore have no impact on stakeholders.

Repealing a duplicative provision concerning impurities

Section 19 of the PCPR establishes a limit on the permissible amount of a single impurity (N-nitrosidi-n-propylamine) in pest control products containing trifluralin. Currently, as a normal practice, this impurity is taken into consideration during the health and environmental evaluation process of the products, with or without section 19 of the PCPR. Removing this duplicative requirement will neither have an impact on stakeholders nor cause negative implications for health and environmental protection.

Addressing a concern of the SJCSR

This is considered a non-substantive amendment that will provide further clarification on how to affix the health and safety documents (from the current wording of “near the control valve that is being used for distributing or dispensing the product” to the wording of “within reach of and clearly visible to the person operating the discharge control valve”). It is expected that this amendment will not have an impact on stakeholders.

Codifying current practice by exempting certain antimicrobials used in products that are regulated under certain Acts

Currently, the PMRA does not require registration of antimicrobial preservatives for use in or on products regulated under the Feeds Act or the Fertilizers Act, or for drugs, cosmetics and certain medical devices regulated under the Food and Drugs Act. These Acts have existing premarket and/or post-market review processes in place to assess the antimicrobial preservatives used in or on the end-use products they regulate. Exempting these products from the application of the PCPA will not result in changes to current practice and is not expected to have an impact on stakeholders.

Codifying current practice regarding certain food additives regulated under the Food and Drugs Act

To date, the PMRA has not required the registration of formulation preservatives that are regulated as food additives under the Food and Drugs Act. Authorizing antibacterial (Class 2) and antifungal (Class 3) substances on List 11 would not be a change to current practice and will not have an impact on stakeholders.

Supporting Canada’s commitment to meeting its obligations in multilateral environmental agreements

To date, the PMRA has not received an application to register a pest control product where the active ingredient is or contains a chemical substance that Canada has, through the ratification process, agreed to prohibit under the Stockholm Convention on Persistent Organic Pollutants. It is expected that, with or without this change, the PMRA would not be approached with such an application. It is expected that this amendment will have no impact on stakeholders.

In the unlikely event that an application to register includes one of the active ingredients prohibited under the Stockholm Convention, this amendment will save Health Canada from expending resources to conduct an evaluation that would end up in the denial of the application. This amendment also allows for better alignment of PMRA processes prescribed by regulation with Canada’s international obligations under the Stockholm Convention for those active ingredients whose prohibition Canada has ratified.

The Government of Canada will provide guidance, if needed, to assist registrants and applicants in determining whether a given chemical may be subject to a prohibition or ban, or if a given chemical is subject to a critical use exemption under the Stockholm Convention.

Aligning import declaration requirements with current information-collection practices

Section 36 of the PCPR requires importers to declare their pest control product imports. This is primarily done in collaboration with the CBSA, which collects import declaration information at the border. The current information collected by the CBSA is more extensive than that required by the PCPR. Moreover, the CBSA requires declarations for products imported under a foreign product use certificate, even though these products are currently exempted from section 36 declaration requirements in the PCPR. This proposal would align import declaration requirements in the PCPR with the current information-collection practices of the CBSA. The proposal would also remove the declaration exemption of products under a foreign product use certificate in the PCPR.

Aligning the import declaration requirements of the PCPR with existing CBSA import declaration processes should not result in any significant change to current business practices. This amendment will therefore have negligible to no impact on stakeholders.

Amendment with possible, minor compliance costs for stakeholders

The following amendment may result in minor compliance costs to stakeholders while they familiarize themselves with the change.

Clarifying regulatory requirements for treated articles and establishing criteria for authorizing certain treated articles

Treated articles are pest control products and subject to the PCPA and the PCPR. As indicated in the Information Note on treated articles, some antimicrobial treated articles will not have to be registered (i.e. they will be authorized under the Regulations) if they meet the criteria. While the amendments will codify the existing approach, some regulated parties (e.g. importers who are bringing in products from foreign countries to Canada) might have to verify whether their products meet the conditions for authorization. It is anticipated that these businesses will have to spend an average of one hour familiarizing themselves with the authorization conditions before this proposal comes into force.

The PMRA will provide a transition period before the coming into force of the Regulations to give industry stakeholders sufficient time to familiarize themselves with the amendments and adapt business practices, if required. It is anticipated that the related compliance cost will be minimal.

Of note, treated articles that are authorized under the Regulations will not be subject to the import declaration requirements. Therefore, this will not impose an additional administrative burden on stakeholders.

Government implementation costs

It is anticipated that the Government of Canada will need to spend time and resources in modifying electronic forms (e.g. the Statement of Product Specification Form) and providing interpretive guidance (e.g. extending the validity period for emergency registration) to potential applicants. The implementation costs are not anticipated to be significant and will be absorbed by Health Canada.

Small business lens

It is anticipated that the regulatory amendment will not impose incremental administrative burden, but will result in cost savings in both reducing administrative and compliance costs to registrants and applicants. Based on research conducted by PMRA in collaboration with Statistics Canada in 2018, it is estimated that about 80% of registrants are small businesses. In addition, based on PMRA’s administrative data, it is estimated that the changes will have an impact on about 219 businesses in total. Therefore, it is reasonable to assume that the amendments will result in net reduction of administrative burden on approximately 175 small businesses. Under the existing regulations, small businesses are required to spend time and resources in processing and submitting information to PMRA on the product packaging and labelling sites and formulant suppliers, and to provide updates through submitting notifications to PMRA every time the packaging/labelling sites or formulant suppliers are changed. That research also indicates that small businesses have lower gross operating margins than larger registrants. It is expected that small registrants will improve their bottom line to a larger extent than those larger firms would see by reducing administrative burden after the amendments are implemented.

There could be some compliance costs associated with small businesses familiarizing themselves with the changes; however, these costs are expected to be negligible. It is assumed that it will take an average of one hour for a person to get familiarized with the authorization criteria for the treated articles subject to the proposal. There are no flexible compliance options that would alleviate this cost on small businesses. However, efforts will be made to ensure that all businesses are aware of the changes to the regulatory process.

One-for-one rule

The one-for-one rule applies since there is an incremental decrease in administrative burden on business, and the proposal is considered burden out under the rule. The total annualized administrative cost savings for all regulated parties are estimated to be $138,130, or approximately $609 per regulated party (based on 2012 constant dollar).

This reduction will be a result of registrants and applicants no longer having to provide and update information on manufacturing sites and formulant suppliers on a regular basis.

Key assumptions

  • Cost savings by streamlining requirements for certain manufacturing site information
  • For changes related to manufacturing site information during initial applications, it is estimated that 219 applicants will benefit from this amendment by saving an average of 2 hours about 13 times per year for one employee in the field of natural and applied sciences and related occupations. The hourly wage, including overhead, is estimated at $41.76.
  • For changes related to updating the manufacturing site information, it is estimated that 46 applicants will save about 15 minutes for 2 times per year. The staff level is the same as the case above.
  • Cost savings by streamlining requirements for certain formulant supplier information
  • It is assumed that this change will save 59 businesses 2 hours for 5 times per year for an employee with the same level as in the case above.

Regulatory cooperation and alignment

The amendments will support Canada’s commitment to meeting its obligations under the Stockholm Convention on Persistent Organic Pollutants, and reduce the potential for misalignment in the future, by making it possible to deny applications outright for products that are or contain prohibited active ingredients.

Where possible, environmental scans have been performed to explore whether the amendments will align with the approaches taken by other jurisdictions or international organizations. No impacts due to misalignments between the approach and those of other jurisdictions or international organizations have been identified or are anticipated. For example:

Streamlining requirements for certain manufacturing site information

The U.S. EPA requires every site that manufactures, formulates, packages, repackages or labels a pesticide to have a U.S. EPA establishment number. Each establishment is required to provide a yearly report of their activities and the product label will have the establishment number printed on it.

There are some 15 000 establishments worldwide. The sheer volume of establishments that are registered and tracked can pose challenges when managing specification form changes. These amendments are consistent with the U.S. approach, and will pose less administrative burden than the current U.S. system, as reporting will only be required upon request.

Streamlining requirements for certain formulant supplier information

The U.S. EPA regulates formulants (known as “inert ingredients” or “inerts” in the U.S. system) very similarly to how Canada regulates them. The registration process at the U.S. EPA requires registrants to provide information on suppliers of inert materials, similar to the current Canadian process. Certain inerts, however, are considered “commodity chemicals,” with a list of commodity chemicals being maintained on the U.S. EPA web page. Registrants do not have to provide information about suppliers of commodity chemicals; instead, they are required to keep records pertaining to the suppliers of a given commodity chemical.

The PCPR amendments to remove requirements for formulant suppliers will align with the current U.S. requirement for commodity chemicals, and will reduce administrative burden even further by removing the requirement for all formulants, not just those considered commodity chemicals.

Clarifying regulatory requirements for treated articles and establishing criteria for authorizing certain treated articles

The U.S. EPA and the European Chemicals Agency (ECHA) both regulate treated articles similar to how Canada will regulate them. The respective legal instruments used by the EPA and ECHA define antimicrobial treated articles, and exempt those articles from registration if the claims are related to the protection of the article itself, and the active ingredient used in the treatment is registered for that use.

For example, the U.S. EPA uses the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to regulate pesticides, and requires the registration of any substance intended to prevent, destroy, repel or mitigate pests. Treated articles or substances are exempted from registration if the pesticide is used to protect the article or substance itself, if the pesticide is registered for such use.

The EU uses Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products to regulate biocidal products, including treated articles. Treated articles are only exempt from registration requirements if they contain an active substance approved in the EU for that use, and the treated article does not have a primary biocidal function (i.e. the treatment protects the article).

The U.S. EPA and ECHA regulatory frameworks address both domestic and imported treated articles. These amendments are therefore consistent with the approaches taken in both the U.S. and the EU. Under Canadian law, certain pest control products can be authorized, rather than registered, under the PCPA. As such, the amendments to the PCPR include references to authorized active ingredients or products, in addition to those registered under the PCPA.

Moreover, Canada is a member of the Organisation for Economic Co-Operation and Development (OECD) Working Group on Biocides, which is a forum where member countries coordinate policies and activities on topics that could include treated articles. As a result, Canada is able to collaborate on and develop best practices.

Permitting extended validity periods for certain emergency registrations

Section 18 of FIFRA authorizes the U.S. EPA to allow emergency exemptions for unregistered uses of pesticides to address emergency conditions. Under such an exemption, the U.S. EPA allows limited use of the pesticide in defined geographic areas for a finite period of time once the U.S. EPA confirms that the situation meets the statutory definition of “emergency condition.” As a result, the U.S. EPA may exempt any federal or state agency, at their request, from any part of FIFRA when a serious pest problem jeopardizes production of agricultural goods or public health. No pesticides are currently registered for that situation. Similar to this amendment, the U.S. EPA may authorize a maximum three-year exemption. Three-year exemptions are used to control the introduction or spread of any pest that is an invasive species or not known to be widely prevalent or distributed within the United States and its territories.

Article 53 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC provides the regulatory framework for emergency registrations in the EU in situations where it “appears necessary because of a danger which cannot be contained by any other reasonable means.” Authorizations last for 120 days, but can be extended or repeated. As a result, the three-year validity that will be permitted by this amendment will surpass the 120-day maximum validity period permitted by the EU and the Council, noting that the EU regulatory framework could be extended such that it could equal that of the proposal.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for this proposal.

Implementation, compliance and enforcement, and service standards

Implementation

The regulatory amendments pertaining to the following elements will come into force on the day on which they are published in the Canada Gazette, Part II:

  • Streamlining requirements for certain manufacturing site information;
  • Streamlining requirements for certain formulant supplier information;
  • Addressing an issue with the definition of “seed”;
  • Addressing non-formulated pest control products;
  • Codifying current practice regarding electronic document delivery; and
  • Repealing a duplicative provision concerning impurities.

Otherwise, to provide registrants and applicants with time to adjust to the remaining elements, Health Canada will delay coming into force as part of the implementation. The remaining amendments will come into force six months after the day on which they are published in the Canada Gazette, Part II. The existing Information Note on treated articles and the conditions under which articles treated with antimicrobial preservatives will not have to be registered (i.e. authorized under the PCPA) will remain in effect until the amendments come into force.

These regulatory amendments may result in changes to related policies and interpretive guidance. Consistent with Health Canada’s obligations under the PCPA, consultation on those changes to policies and guidance will take place as required.

Compliance and enforcement

Health Canada encourages, promotes, maintains and enforces compliance with the PCPA through active prevention; inspections, including surveillance; and enforcement response actions. Active prevention aims to educate, facilitate and promote compliance as well as to communicate regulatory information. Inspections are designed to determine the level of compliance of users, distributors and registrants of pesticides with the general provisions of the PCPA and its regulations, as well as specific terms and conditions of registration.

Enforcement response may include warning letters; detention, seizure and forfeiture of products; compliance orders under the PCPA; and notices of violation with warning or monetary penalty under the Agriculture and Agri-Food Administrative Monetary Penalties Act.

Compliance with the PCPA and its regulations is achieved through a network of officers and inspectors across Canada. Health Canada regional offices also have formal agreements with provincial pesticide regulatory departments, providing a basis to collaborate with them in inspections and in the development and delivery of compliance activities.

Health Canada follows an established compliance and enforcement policy for pesticides to promote and enhance fair treatment of the regulated community.

Service standards

PMRA follows established service standards, or defined timelines, for evaluating new or amended registrations as outlined in PMRA Guidance Document, Management of Submissions Policy.

Contact

Please direct all questions and inquiries to

Jordan Hancey
Policy and Operations Directorate
Pest Management Regulatory Agency
Health Canada
2720 Riverside Drive
Ottawa, Ontario
K1A 0K9
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca