Summary of SAC-PCP’s recommendations on the first charge question

This page describes a summary of the Committee’s recommendations on the first charge question (draft scientific eligibility criteria for the proposed Ministerial authorizations pathway) and the PMRA's response.

On this page

• Context
• Meeting summary
• Charge question
• Summary of SAC-PCP's recommendations and the PMRA's response
• More information

Context

The objectives of the SAC-PCP's inaugural meeting, which occurred virtually over Zoom on July 8, 2022, were to:

1. Familiarize the SAC-PCP members to the mandate of the SAC-PCP;
2. Provide an overview of the PMRA's mandate and processes related to regulation of pest control products in Canada;
3. Provide an orientation session on the PMRA's scientific approach to pesticides reviews; and,
4. Present the SAC-PCP members with their first official charge question relating to the draft scientific criteria for the proposed new Ministerial authorization pathway for low-risk pest control products.

Meeting summary

The meeting summary from the inaugural SAC-PCP meeting can be found here: July 8, 2022: Science Advisory Committee on Pest Control Products (SAC-PCP): Meeting summary - Canada.ca.

Charge question

Under the proposed Ministerial authorizations pathway, Health Canada proposed to broaden the Minister's powers to authorize pest control products of low or well-characterized risk:

• Low-risk pest control products are defined as those with low environmental or health risks that are already available to the public for other uses, for example, cinnamon powder or garlic juice.
• Well-characterized risk products are specifically the pool and spa products and water conditioners already authorized under the Pest Control Products Regulations (PCPR). Under the proposal, these products would move from the Pest Control Products Regulations (PCPR) to the new Ministerial authorizations pathway.

The charge question that was presented to the SAC-PCP concerned proposed eligibility criteria for low-risk pest control products only. The question was as follows:

"From a scientific point of view, are proposed eligibility criteria 1 and 2 [with respect to low-risk pest control products] sufficient to meet the goals of the authorization proposal?"

To be considered for authorization, the products must meet all of the following criteria:

1. With respect to health effects, the pest control product^{Footnote 1} or an or any of its derivatives, as the case may be, is not or does not contain a substance that:
   1. is chronically toxic under its intended use;
   2. is genotoxic, carcinogenic, neurotoxic or immunotoxic;
   3. causes reproductive or developmental effects; or
   4. bioaccumulates; and
2. With respect to environmental effects, the pest control product2 or any of its derivatives, as the case may be, is not or does not contain a substance that:
   1. is chronically toxic under its intended use;
   2. causes reproductive or developmental effects;
   3. is persistent or, if persistent, is not toxic to human health or the environment under its intended use; or
   4. bioaccumulates; and
3. The active ingredient or the product is available to the public for non-pesticidal uses.

Summary of SAC-PCP's recommendations and the PMRA's response

1. Make the intent of the proposal more transparent (providing lower commercial value products, minor use products to a market underserved by the major companies that typically produce conventional pesticides).

   PMRA's response:
   PMRA agrees that it is important to continue to be clear about the intent of the proposal. The proposed new Ministerial authorization pathway would provide a new administrative process for approving low-risk products (e.g., food-derived products, like baking soda) as pesticides, following a risk assessment and public consultation. This would facilitate access to such products by organic growers and other users; such products are rarely registered as they are often of low commercial value, since they are already on the market for non-pesticidal purposes. The authorization process would be faster and less cumbersome compared to the existing process of authorizing such products via individual regulatory amendments and would maintain desired health and environmental safety outcomes.

2. Consider revising the proposal (Part 1), from "authorizing products of low or well-characterized risk" to "low and well-characterized risk".

   PMRA's response:
   PMRA agrees that the risk of all pest-control products, including those defined as "low risk" must be well understood. However, in the context of the PMRA's legislative proposal, the meaning of "products of well characterized risk" is very specific: it refers to the pool and spa products and water conditioners that are already authorized under the Pest Control Products Regulations (PCPR). "Low-risk pest control products" are defined as those with low environmental or health risks that are already available to the public for other uses, for example, cinnamon powder or garlic juice. The question posed to the SAC-PCP pertained only to the eligibility criteria for products of low-risk. Going forward, PMRA will refer to pool and spa products and water conditioners as products "already authorized by regulation", when appropriate.

3. Add a statement on use patterns.

   PMRA's response:
   PMRA agrees that the use pattern is very important when determining if a product has acceptable risk and value and can be authorized under the Pest Control Products Act (PCPA). PMRA will include any necessary conditions on the use pattern to ensure there is reasonable certainty of no harm to human health and the environment. These conditions would be included in the proposed authorization decision for public consultation, and specified in the conditions of authorization, including the use directions for the product.

4. Make food-based products part of the definition if most products will be in this category.

   PMRA's response:
   PMRA agrees that many products in this category will be food-derived products and therefore they were listed as a major example of the types of pest control products that might be considered under the low-risk eligibility criteria. However, the proposal is broader than just food-derived products as other products such as low concentration acetic acid (vinegar) and certain other commodity chemicals might meet the eligibility criteria. As a result of the recommendation, food-derived products have been referenced in the introduction to the eligibility criteria (Item 7).

5. Clarify whether all criteria must be met for a product to be considered for authorization.

   PMRA's response:
   Yes, only products that meet all eligibility criteria would be considered for authorization following assessment to determine whether health and environmental risk and value are acceptable, subject to consultation on the proposed authorization decision.

6. Set requirements for concentration and application rates, and monitor these after authorization.

   PMRA's response:
   PMRA agrees and clarified that concentration and application rate are important when determining if a product has acceptable risk and value and can be authorized under the Pest Control Products Act (PCPA). The concentration and application rate are key parts of the scientific assessment for any product that meet the eligibility criteria. Acceptable concentrations and application rates, required to ensure the product can be used safely in terms of human health and the environment, would be included in the proposed authorization decision and specified in the conditions of authorization and the use directions for the product.

7. Revise the eligibility criteria to the following:
   1. The active ingredient or pest control product is already available to the public for non-pesticidal uses.
   2. With respect to human and environmental health effects, the pest control product or any of its derivatives is a substance or contains a substance that, under its intended pest control use;
      1. is not chronically toxic at any time during the organism's complete life cycle;
      2. is not genotoxic, carcinogenic, neurotoxic, immunotoxic, mutagenic, reprotoxic, hepatotoxic, or nephrotoxic;
      3. does not cause reproductive or developmental effects [be more inclusive here], or exhibit endocrine disrupting activity;
      4. does not bioaccumulate [add bioaccumulation factors, pKa, biotransformation half-life with Kow];
      5. is not persistent [include criteria for half-lives in various environmental media];
      6. does not cause transgenerational effects; and,
      7. does not cause unintended exposure to other crops, resulting in phytotoxicity.

• PMRA's response:
  PMRA agrees that the criteria be revised as per the SAC recommendation to capture toxicity to specific organ systems, re-order and re-number the criteria, and to incorporate the "is not or does not" language to the individual criteria. Separating criteria for health and environmental effects avoids ambiguity when determining if applicable criteria are met within each scientific review framework and in line with the Pest Control Products Act (PCPA).

  Revisions were made to the criteria to incorporate the specific human health and environmental criteria recommendations, which are broad in order to capture any effects of concern that would prevent products from being considered for authorization. For example, "chronic toxicity" encompasses histological, biochemical and other effects on all major organ systems, including the endocrine system, as well as any toxicity over the entire life cycle of an organism. In addition, evidence of certain types of genotoxic, reproductive, or developmental effects would indicate the potential for effects on future generations. Further, "environmental effects" refers to effects on any non-target species (excluding humans) that are potentially exposed when pesticides are applied, which includes both plants and animals. Criteria indicating that products would not have a harmful effect on survival or growth would include phytotoxic effects on non-target plants, which may include non-target crops. Detail has been added to criteria below.

  To be considered for authorization, the products, such as food-derived products, must meet all of the following criteria:

  1. The active ingredient or pest control product is already available to the public for non-pesticidal uses.
  2. With respect to human and environmental health effects, the pest control product or any of its derivatives is a substance or contains a substance that, under its intended pest control use:
     1. With respect to health effects:
        1. is not chronically toxic (i.e., over the life cycle of the organism), including that it is not hepatotoxic or nephrotoxic, and does not exhibit effects on the endocrine system;
        2. is not genotoxic (this includes mutagenicity), carcinogenic, neurotoxic or immunotoxic;
        3. does not cause reproductive or developmental effects including potential effects on future generations;
        4. does not bioaccumulate
     2. With respect to environmental effects (which includes non-target animals and plants):
        1. is not chronically toxic (i.e., over the life cycle of the organism), including that it does not have a harmful effect on survival or growth;
        2. does not cause reproductive or developmental effects;
        3. is not persistent or, if persistent, is not toxic to human health or the environment;
        4. does not bioaccumulate.

8. Address (and define) trophic movement in the criteria.

   PMRA's response:
   PMRA clarified that trophic movement is part of the risk assessment process. The potential for movement of an applied substance to an unintended location is considered during the environmental assessment of persistence in water, soil, sediment, and air under the regulatory framework, as long-lived substances may ultimately move within or between media. Similar requirements to those required for registration applications would be developed for the authorization scheme before any legislative amendments came into force; see paragraph 8(e) of the Pest Control Products Regulations (PCPR). The potential for bioaccumulation in environmental organisms is also characterized from the assessment of data obtained from studies conducted according to internationally accepted guidelines. The assessment of trophic movement for substances that are not expected to bioaccumulate is less straightforward, and would rely on expert judgment of available, non-standard information, such as predictive modelling, stand-alone research studies, or real-time measurement of environmental concentrations.

9. Combine the health and environmental effects criteria for a One Health approach.

   PMRA's response:
   PMRA supports a One Health approach. The framework laid out in the Pest Control Products Act (PCPA) requires PMRA to assess the human health risks and environmental risks of pesticides separately. To be registered, a product must present acceptable risk to both health and the environment. To avoid ambiguity in the determination of eligibility in the specific scientific review areas and frameworks, as well to ensure continued alignment with the requirements of the Pest Control Products Act (PCPA), the criteria for health and environmental effects will be kept separate and distinct. While the two criteria must be looked at separately, to be approved for authorization, both criteria are required to be met.

10. Address marine, freshwater and soil/terrestrial environments in the criteria.

    PMRA's response:
    PMRA agrees and clarified how all environments are considered in the existing criteria. Regarding the environmental criteria recommendations, the environmental criteria consider all environments, as per definition of environment in the PCPA, including terrestrial and aquatic (freshwater and marine). The broad definition of environment is reflected in the Framework on Risk Assessment and Risk Management, available on the PMRA's website. The definition of environment in the PCPA: environment means the components of the Earth and includes (a) air, land and water; (b) all layers of the atmosphere; (c) all organic and inorganic matter and living organisms; and (d) the interacting natural systems that include components referred to in paragraphs (a) to (c).

More information

Consistent with Government principles of openness and transparency, SAC-PCP Advisory Reports are available upon request through Pest Management Information Services. For all other inquiries, please reach out to the SAC-PCP Secretariat: pmra.sacpcp-ccspa.arla@hc-sc.gc.ca.