Summary of SAC-PCP's recommendations on the third science question

This page describes a summary of the Committee's recommendations on the third science question (science literature review strategy under the continuous oversight framework) and the PMRA's response.

On this page

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

Context

One of the objectives of the third SAC-PCP meeting, which occurred virtually over Zoom on December 5, 2022, was to present the Committee members with their third science question for advice relating to the proposed science literature review strategy under the proposed continuous oversight framework.

PMRA is developing a Continuous Oversight (CO) Policy to enhance PMRA's ability to protect human health and the environment against risks posed by pesticides in Canada. This proposed framework will apply across pesticide review programs, including applications for registration, re-evaluations and special reviews.

The proposed Continuous Oversight framework would be comprised of several improved processes working together to create an enhanced oversight continuum throughout a pesticide's lifecycle, which includes timely consideration of emerging scientific literature. PMRA would apply a standard approach to systematically screen the relevant published scientific literature for new findings and information related to registered or authorized pesticides in Canada that may warrant further assessment or regulatory action.

Meeting summary

The meeting summary from the third SAC-PCP meeting can be found here: Science Advisory Committee on Pest Control Products: Meeting summary December 5, 2022 - Canada.ca.

Science question

The purpose of the presentation on the science question as it relates to the proposed science literature review strategy under the continuous oversight framework was to:

• Introduce the context around PMRA's proposed science literature review strategy to enhance reviews of published scientific literature as part of a continuous oversight approach; and,
• Seek input from Members of the Committee on the proposed science literature review strategy, particularly on the following question.

The third science question was presented as follows:

"Will the proposed systematic science literature review strategy help ensure that relevant published scientific literature, which would inform current and future regulatory actions related to pesticides, will be identified and addressed in a timely manner?

What further details would the SAC-PCP recommend for inclusion in the proposed science literature review strategy?

What additional considerations are recommended by the SAC-PCP?"

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

1. Consider re-naming "continuous oversight" to, for example, "systematic oversight". Consider re-naming "touchpoints" to "review".

   PMRA's response:

   Agreed. PMRA has revised the design of the proposed continuous oversight policy to be more continuous and move away from "touchpoints".

   The Continuous Oversight policy proposes a risk-based approach where PMRA will systematically screen literature for higher priority pesticides as it is published to determine what, if any, actions are needed to protect human health and the environment. For lower priority pesticides, literature will be monitored using a risk-based approach.

2. Clarify on pg. 10 of document #1 when full reviews will occur under continuous oversight.

   PMRA's response:

   PMRA agrees. The material provided to SAC in December 2022 did not sufficiently identify when the full review of literature will be conducted.

   The proposed continuous oversight policy, planned for public consultation in Fall 2023, has been updated to provide more clarity on the process for monitoring and triaging new published literature, and the timing for when a more fulsome review will occur.

3. Consider re-naming "literature review" to, for example, "literature search for database development" or "pesticide toxicity effects database".

   PMRA's response:

   PMRA agrees. The terminology in the Continuous Oversight policy should distinguish between the process by which PMRA monitors published literature and the full scientific review. The terminology used in the Continuous Oversight policy has been revised accordingly.

   In developing its standardized methodology for searching, considering and using published literature in regulatory decisions, PMRA is proposing to align its approaches with the steps outlined in the WHO guidance on systematic literature reviews.

   The WHO guidance informs the design of continuous oversight policy and other related literature projects (see response to recommendation #5 below).

4. Increase transparency in the study selection process by posting a publicly available table indicating how many studies were excluded and why, and an evidence map (pie chart) showing how many studies were in each line of evidence, and how many studies (out of all studies, including those that were excluded) are required for decision making.

   PMRA's response:

   PMRA agrees and recognizes the importance of transparency in the study selection process.

   Enhanced transparency will be advanced by documenting:

   • the search methodology, relevance determination and triaging
   • the criteria and framework for how PMRA uses published studies in regulatory decisions
   • the results of literature study selection processes in its regulatory decisions in a table and evidence map, including reasons why certain relevant studies were not included

   PMRA intends to publicly disclose the results of literature assessment process in its regulatory decisions including the screening assessment tables and an evidence map summarizing the references considered and is currently exploring how this can be best made available publicly.

5. Post the assessment data in a publicly available table.

   PMRA's response:

   PMRA agrees that it needs to be more transparent about assessment conclusions of individual studies. As described in response to recommendation 4, PMRA is exploring options for improving transparency and access to various aspects of published literature assessments.

6. Share with the committee case studies/previous examples of successes and failures of the review process (i.e., when high quality studies were/were not found in a timely manner).

   PMRA's response:

   PMRA agrees. Case studies would help clarify how the proposed approach would improve the current process.

   Moving forward, PMRA will seek advice from the SAC to select examples.

7. Share with the committee all relevant documents that form a review and an overall summary, not only the toxicology review document (data evaluation record).

   PMRA's response:

   PMRA agrees. PMRA will explore opportunities at future SAC-PCP meetings to present additional documents to assist in better understanding the science review process.

8. Make the public aware of the (limited) number of studies available for new pesticides.

   PMRA's response:

   PMRA agrees.

   In this context, "limited" refers to the number of published studies typically available for a new pesticide.

   In response, PMRA will amend its pre-market consultation documents to inform the public of the nature and source of the studies that underpin the assessment. PMRA will also continue to explore opportunities to improve public communication strategies, particularly in relation to pesticide data requirements for new pesticide registration and post-market review processes.

9. Develop and document clear screening criteria for toxicology, effects, exposure, and epidemiologic studies so the reasons for excluding a study are clear, and scientists can better plan their studies and anticipate the studies' use or non-use by PMRA.

   PMRA's response:

   PMRA agrees. We recognize that current criteria, such as USEPA's screening criteria for human health assessment of common toxicology studies (as per Appendix C of document #2), may not be applicable to epidemiologic studies.

   PMRA will seek additional advice from the SAC on additional criteria for how published literature should be considered moving forward in its regulatory decisions.

10. Review the existing criteria to make sure government-funded studies (e.g., CIHR and other health agencies) aren't excluded because they didn't use GLP and epidemiologic studies aren't excluded because they don't conform to the existing criteria (e.g., raw data is not available).

    PMRA's response:

    PMRA agrees. We will seek additional advice from the SAC on additional criteria for how published literature is considered in its regulatory decisions. SAC will also be engaged on the process for transparently explaining how studies are considered, or not considered, in regulatory decisions.

11. Reduce the number of citations needed (from >100 to 20–30) to trigger a literature review, or define a relative increase in studies (e.g., 10-fold increase) needed to trigger a review (set the threshold based on a historical relative increase in studies that resulted in changes to decisions based on new science).

    PMRA's response:

    PMRA agrees.

    PMRA revised its continuous oversight policy to continuously review studies as they are published rather than relying on a certain number of citations or set period in time to consider new evidence. For high priority pesticides, PMRA will consider new science literature as they are published and triage them to determine if immediate regulatory action is needed. For lower priority pesticides, literature will be monitored using a risk-based approach.

    Furthermore, PMRA will develop processes to monitor for trends across relevant studies as well as for new assessment methodology, new assays or new science areas.

12. Make the source of funding apparent in reviews. How many reviews are based on industry-funded studies?

    PMRA's response:

    PMRA appreciates the recommendation and will take it into consideration as it develops its transparency approach for published literature.

13. Reconvene the committee to continue the discussion on this topic.

    PMRA's response:

    PMRA agrees with the recommendation and will continue to engage the SAC-PCP members on the screening criteria and transparency of literature reviews in 2023/24.

14. Share with the committee examples of previous re-evaluations.

    PMRA's response:

    PMRA agrees with the recommendation and commits to working collaboratively with the SAC-PCP to set priorities for the committee and develop a forward agenda.

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.