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202-350 rue Sparks Street, Ottawa, Ontario K1R 7S8 613.230.9881 Representing Canada’s plant science industry | Représentant de l’industrie de la phytologie du Canada Re-Evaluation Concerns White Paper

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Page 1: Re-Evaluation Concerns White Paper - CropLife Canada...re-evaluation; however, this number is expected to increase significantly over the next 10 years as many of the older active

202-350 rue Sparks Street, Ottawa, Ontario K1R 7S8 613.230.9881

Representing Canada’s plant science industry | Représentant de l’industrie de la phytologie du Canada

Re-Evaluation Concerns White Paper

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Executive Summary There has been a great deal of discussion in recent months among CropLife Canada member companies and grower groups regarding the recent direction of the PMRA on re-evaluations (and, to a certain extent, other post-registration assessments).

Many of the apparent changes in the PMRA’s re-evaluation process appear to coincide with the publication of the Commissioner of the Environment and Sustainable Development (CESD) report on pesticide safety in 2015, which criticized the Agency for not making sufficient progress on the re-evaluations of older chemistries. While we understand the need to complete these re-evaluations in a timely fashion, we firmly believe that the approach the PMRA has taken to remedy this is needlessly divorced from the broader Government of Canada objective to innovate our way to $75 Billion in agri-food exports.

Based on consultations with stakeholders from across Canadian agriculture, we have identified two primary goals in seeking a resolution to the issues experienced with the re-evaluation process:

• For PMRA to revisit its re-evaluation process to seek early input from the most affected stakeholders when issues arise to ensure the proposed decision is based on the most up-to-date and accurate data.

• For the Minister of Health, and senior Health Canada officials, to acknowledge the role that the PMRA plays in facilitating, or inhibiting, access to innovative technologies and, by extension, the role it plays in realizing the vision articulated by the federal government’s Advisory Council on Economic Growth.

To support these goals, a White Paper has been drafted to provide an overview of the issues and describe potential solutions to address these in a scientifically robust and transparent fashion that also fulfils the Government of Canada’s broad policy goals of regulatory harmonization and reduced administrative burden on business without compromising human health or environmental safety. In summary the proposed solutions are as follows:

• Make improvements to the scoping period that precedes the initiation of a re-evaluation to ensure that information needs are identified in advance and registrants have sufficient time to initiate required studies before the re-evaluation commences.

• Increase the number of opportunities for stakeholders to provide input during the re-evaluation process by publishing a draft risk assessment for public consultation before publishing the proposed risk mitigation plan and re-evaluation decision.

• Actively pursue opportunities to collaborate with other regulatory agencies, including the US EPA, to share the workload of post-market regulatory reviews.

• Explore the use of emerging tools and technologies that could help streamline the re-evaluation process using cutting-edge scientific information.

• Commission a third-party review of the current PMRA re-evaluation process to identify additional opportunities for streamlining.

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202-350 rue Sparks Street, Ottawa, Ontario K1R 7S8 613.230.9881

Representing Canada’s plant science industry | Représentant de l’industrie de la phytologie du Canada

Introduction Pesticides in Canada are regulated by the Pest Management Regulatory Agency (PMRA) of Health Canada under the authority of the Pest Control Products Act (PCPA) [1]. This Act ensures the safety of all pest control products that are registered for sale and use in Canada.

The PMRA has had a process in place to review registered pest control products at least every 15 years since the late 1990s [2].1 The purpose of this re-evaluation process is to ensure that registered pest control products continue to meet current regulatory standards.

CropLife Canada is strongly supportive of the cyclical pesticide re-evaluation program, which ensures that pesticides in Canada are regulated on the basis of the best available science; however, the PMRA has published a number of proposed re-evaluation decisions in the past two years that have caused considerable concern for our members and other affected stakeholders (a summary of some of the more high-profile active ingredients that have been affected by these decisions is included in Appendix A).

Many of these decisions appear to coincide with the publication of the Commissioner of the Environment and Sustainable Development (CESD) report on pesticide safety [3] in 2015, which criticized the Agency for not making sufficient progress on the re-evaluations of older chemistries. While we understand the need to complete these re-evaluations in a timely fashion, we firmly believe that the approach the PMRA has taken to remedy this is divorced from the broader Government of Canada objective to innovate our way to $75 Billion in agri-food exports.

A subset of decisions that exemplify our concerns have been summarized in Appendix B as examples of when the current process did not allow the Agency to:

• ascertain the availability of existing data that should have been incorporated into the risk assessment;

• adequately consult stakeholders to understand the current product use pattern; and • inform stakeholders of additional information needs or potential changes to toxicological

classifications that needed to be addressed in order to refine the risk assessment and toxicological endpoints.

The purpose of this document is to provide background on the re-evaluation issues and outline potential solutions in order to inform a broader industry-wide response.

1 The program was initiated under Section 16 of the old Pest Control Products Act and formally announced in the consultation document PRO99-01: A new approach to re-evaluation. PRO99-01 was subsequently replaced by DIR2001-03.

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Background on Re-Evaluation Process There are three primary work streams within the PMRA’s re-evaluation program in Canada:

• Re-evaluations of older pesticides (typically referred to as the “original 401”) • Cyclical re-evaluations • Special reviews

Original 401 Before the new Act came in to force in 2006, the PMRA committed to reviewing the continued acceptability of the 401 registered active ingredients, and their associated end-use products, that were registered in Canada before 1995 [4].2 These 401 active ingredients, and their associated end-use products, formed the basis for the PMRA’s initial re-evaluation activities.

To streamline the re-evaluation of these 401 active ingredients, the PMRA established four sub-programs within the re-evaluation program [4]. These sub-programs were as follows:

• Program 1: Active ingredients (and associated end-use products) for which a Risk Assessment Document or Reregistration Eligibility Decision (RED) document has been published by the EPA.

• Program 2: Active ingredients (and associated end-use products) that require a full assessment by the PMRA in order to reach a re-evaluation decision.

• Program 3: Active ingredients (and associated end-use products) that are scheduled for re-evaluation under the United States Food Quality Protection Act (FQPA).

• Program 4: Special reviews.

Programs 1 and 3 draw on the existence of US re-evaluation reports while Program 2 is based solely on in-house Canadian reviews. As a result, the re-evaluation of active ingredients in Program 2 was expected to take much longer since the assessment could require the submission of new data from registrants and would necessitate detailed in-house reviews.

It’s worth noting that DIR2001-03 explicitly acknowledges that “the sheer volume of data to be reviewed could not be done in a timely or cost effective manner without reliance on existing acceptable reviews“. It goes on to state: “The priorities and the timely progress of the U.S. pesticide reregistration program will continue to exert a strong influence on the Canadian re-evaluation program. This is in part due to the strong reliance of Canadian re-evaluations on U.S. reviews and policies, but also because of the need to harmonize, as far as possible, the regulatory status and availability of pesticides.”

2 This number was originally calculated to be 405 active ingredients but was reduced to 401 because 4 disinfectant products were determined to no be longer subject to the PCPA.

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Despite this explicit acknowledgement, with the exception of Program 1 re-evaluations, we have seen little in the way of harmonized post-registration regulatory activities between the US EPA and the Canadian PMRA.

Cyclical Re-Evaluations Under the current PCPA, re-evaluations are initiated for all registered pesticides when 15 years has passed since the last major regulatory decision to determine whether they continue to meet current regulatory standards. The re-evaluation process considers all registered uses of the active ingredient and evaluates all aspects of the registration including human health, environmental risk, and value. As part of this process, Health Canada reviews all available information on the product — including, for example, epidemiology studies, toxicology data, and foreign reviews — before making a proposed decision.

Although the current PCPA came in to force in 2006, the cyclical re-evaluation process applies to all active ingredients, and associated end-use products, registered since 1995. According to the most recent update from the PMRA, there are currently 74 active ingredients under cyclical re-evaluation; however, this number is expected to increase significantly over the next 10 years as many of the older active ingredients (i.e., those registered before 1995) that were re-evaluated as part of the original 401 are scheduled to enter cyclical re-evaluation.

Special Reviews Under the PCPA, special reviews of pesticide active ingredients are triggered when there are reasonable grounds to believe that the health or environmental risks of a product are unacceptable or when an Organisation for Economic Co-operation and Development (OECD) member country prohibits the use of a product for health or environmental reasons [5].

According to the most recent PMRA update, there are currently 23 active ingredients subject to a special review. Special reviews typically take 2-4 years to complete; however, the PMRA has indicated that they expect almost half (43%) of the current special reviews to exceed 4 years.

Codifying the PMRA Re-Evaluation Process In 2010, the Agency published an update to their re-evaluation program proposing a new approach to the cyclical re-evaluation program (i.e., the 15-year program) and describing lessons learned from the “First Round” of re-evaluation (i.e., from the original 401) [6].

In spring 2016, the PMRA published a proposal to further revise the re-evaluation process to increase opportunities for engagement of stakeholders and improve the transparency and predictability of the program [7]. While industry remains strongly supportive of re-evaluations, we identified and articulated several elements of the proposed approach that were contrary to the stated goals of the Program during the consultation process. Unfortunately these concerns were not addressed in the final directive, DIR2016-04, published a few months later in the fall of 2016 [8].

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Furthermore, although the proposed process was intended to apply primarily to cyclical re-evaluations, we understand that elements of it may be adopted by the Agency as it works to complete the re-evaluations on the 35 remaining chemistries from the original 401.3 Registrants have, however, observed that the application of elements of DIR2016-04 to the remaining evaluations of the original 401 appears to be inconsistently and selectively applied depending on the active ingredient in question.

Summary of Concerns with PMRA Management of Re-Evaluation Policy A number of areas of concern were identified and highlighted in the industry’s response to PRO2016-02. These are summarized below and illustrated with real-world examples in Appendices A and B.

Inadequate engagement of stakeholders at the start of re-evaluation Engagement of stakeholders ahead of the initiation of a re-evaluation is of paramount importance to ensure that the PMRA has accurate information on use patterns, application methods, and available data.

We recommend that the PMRA commence the initiation and scoping phases of a re-evaluation 2-3 years ahead of the anticipated start date to identify potential areas of concern and ensure that the appropriate information needs are identified sufficiently in advance. This practice is consistent with the US EPA approach, under which a preliminary risk assessment is conducted to identify areas of concern and determine data needs accordingly, creating a more efficient and targeted process. The PMRA instead conducts a broad scoping exercise that is challenging and not productive and results in ineffective and inadequate stakeholder engagement.

Under DIR2016-04, registrants are typically given 90 days to provide requested data to the PMRA. This timeline can be challenging to meet for data that companies already have and is impossible to meet if data need to be generated through the initiation of new studies. It’s also a stark contrast to the US EPA approach where, after a data call-in, registrants have a substantial amount of time (determined by the type of study but often ranging from 12 months for short-term studies up to 48 months for longer-term environmental fate studies) to generate and submit the data. A similar amount of time is needed in Canada, especially if longer term studies are needed.

Limited consultation opportunities after initiation The new policy does not provide appropriate opportunities to engage registrants (or other impacted stakeholders) after the initial information gathering step. This is a critical omission since registrants, and other key stakeholders, are not given the opportunity to clarify the scientific assumptions made and/or ascertain whether additional data could help the PMRA refine the risk assessment.

3 As per the PMRA stakeholder update on November 1, 2017

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Registrants often conduct ongoing studies of their products for a multitude of reasons. Given the length of the re-evaluation review process (350-650 days as per DIR2016-04 but, in reality, considerably longer in many registrants’ experiences), new studies are often initiated after the information gathering step has been completed. We believe that these data should be permitted for consideration to ensure that the final assessment and outcomes are as scientific and robust as possible. At present, DIR2016-04 only provides registrants with the opportunity to submit new information if it demonstrates an increase in hazard, which biases the process towards increased conservatism.

In a number of recent, high-profile examples, the PMRA has published proposed decisions that include major changes in registered use patterns (including complete cancellation of all uses of critically important pest control products) following a period of many years of limited or no communications from the Agency (see examples in Appendices A and B). In many of these cases, had the Agency reached out to the registrant to make them aware of potential concerns as they arose during the science assessment, the registrant could have either submitted existing data or initiated studies to generate data to further refine the risk assessment.

We believe that this could be done in a transparent manner without negatively impacting the overall re-evaluation timeline as exemplified by the US EPA process described below.

The US EPA Process As mentioned earlier in this document, the PMRA has repeatedly stated that it will look for opportunities to leverage work completed in the US and/or seek to harmonize where possible; however, the approach that they have adopted to manage re-evaluations is notably different to that of the US EPA.

While we acknowledge that the US EPA re-evaluation process is not perfect, it does address a number of the concerns raised with the PMRA’s process. The US EPA pesticide re-evaluation process is described in detail on their website and codified in the Electronic Code of Federal Regulations (e-CFR) [9].4

The US EPA scoping period begins 2-3 years before the re-evaluation is initiated. In this time, the EPA completes a preliminary risk assessment to identify areas of concern; identify data needs; and initiate a dialogue with the registrant.

4 An overview of the U.S. EPA pesticide re-evaluation process is available on their website here: https://www.epa.gov/pesticide-reevaluation

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The US EPA process is initiated by opening of a public docket that contains a preliminary work plan that summarizes existing information about the pesticide (including current use information); anticipated risk assessment and data needs; and an estimated timeline for review. This preliminary work plan is open for public comment for a 60-day period, during which time all stakeholders can provide comments and submit data for consideration. The US EPA may also hold focus meetings with key stakeholder groups in order to address areas of uncertainty early in the review process. Details about these meetings are posted to the public docket to ensure transparency.

Based on the outcome of their preliminary risk assessment (conducted during the scoping phase, as described above), the US EPA also issues a data call-in for studies required to complete the risk assessment along with an expected timeframe for receipt of those data. The timeline for each study to be submitted is determined based on the complexity of the required study. For example, they may require a registrant to submit several studies in 12 months, 24 months and 48 months. The shorter timelines are typically associated with acute studies and the longer timelines are typically reserved for sub-chronic/chronic toxicology or ecotoxicology studies or longer-term environmental fate studies.

Perhaps the most critical difference between the US EPA and PMRA processes occurs once the Agencies have completed their draft risk assessments. In Canada, the PMRA publishes a proposed re-evaluation decision that includes both the draft risk assessment and mitigation measures for consultation. The US EPA, in contrast, publishes only the draft risk assessment for consultation. This distinction is crucial since it provides stakeholders in the US with an opportunity to address risks of concern (e.g., by proposing potential risk mitigation strategies, submitting additional data, or identifying errors in calculations) before a final draft decision is published for consultation.

To summarize, the US process includes consultation on the initial work plan, the draft risk assessment, and the final proposed decision.5 In contrast, the Canadian process only allows for consultation at the very end once a proposed decision has been published. As a result, opportunities to address information needs or clarify assumptions are missed in Canada, resulting in proposed decisions that do not reflect the true human health or environmental risk profile of the active ingredient and often run counter to those of other major regulatory bodies, including the US EPA. This is a missed opportunity for regulatory alignment, a broadly stated policy goal of the Government of Canada.

5 A brief summary of opportunities for engagement in the U.S. EPA pesticide re-evaluation process is available on the US EPA website here: https://www.epa.gov/pesticide-reevaluation/opportunities-participate-pesticide-reevaluation

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Additional Post-Market Concerns The current published PMRA re-evaluation work plan for 2017-2022 only covers those active ingredients that are already in the re-evaluation process [10]. It does not include the approximately 370 products that are scheduled to enter the 15-year cyclical re-evaluation process between 2018 and 2028 nor can it account for less predictable aspects of the re-evaluation program such as special reviews.

The latter item (i.e., special reviews) is becoming increasingly more prescient as we have seen an increase in the use of the special review provisions of the PCPA by certain stakeholders, seemingly in an attempt to bog down the federal regulatory process. For example, in recent years the PMRA has been forced to initiate special reviews of any active ingredient banned in an OECD member country even if that product is already under review, or has recently been reviewed, in Canada [11].6 This situation is unlikely to improve as the European Union continues to move towards a hazard-based approach to the regulation of plant protection products under Regulation (EC) No. 1107/2009 [12].

In order to meet their statutory obligations to conduct both cyclical re-evaluations and special reviews, the PMRA must look for efficiencies throughout the post-market registration review processes that can be implemented in a transparent and predictable fashion without impacting the scientific rigour of Canada’s risk-based regulatory system.

Potential Path Forward Collaboration with other regulatory agencies The PMRA has a long, and successful, history of conducting joint reviews with the US EPA for pre-market pesticide regulatory assessments. This partnership should serve as an excellent starting point to explore similar work sharing opportunities for re-evaluations. It would also be consistent with previous iterations of the PMRA’s re-evaluation process that explicitly stated the Agency would seek work-sharing opportunities where possible, for example: “Where appropriate, the PMRA will participate in joint reviews or work-sharing of documents and information relating to the review of a pesticide with other countries such as partners in the North American Free Trade Agreement (NAFTA) and OECD. In order to maximize efficiency, the PMRA will align Health Canada’s re-evaluation schedule with that of the United States Environmental Protection Agency (USEPA), wherever appropriate” [6].

6 A current list of OECD member countries may be found on their website here: http://www.oecd.org/about/membersandpartners/#d.en.194378

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Improve the project scoping phase of the re-evaluation The PMRA should include a longer and more robust scoping period before commencing a re-evaluation to ensure that information needs are identified sufficiently in advance. By completing a preliminary risk assessment before initiating the formal re-evaluation, the PMRA would be able to focus their evaluation on the areas of greatest concern. It would also provide registrants, and other stakeholders, with sufficient time to plan and conduct any required studies ahead of time without negatively impacting re-evaluation timelines.

Increase the number of opportunities for stakeholders to provide input into a re-evaluation The PMRA should also review the US EPA approach to re-evaluation and integrate additional opportunities for stakeholder engagement throughout the process. Recognizing the information requested by PMRA during the “Information Gathering” stage of the risk assessment occurs too early in the re-evaluation process (i.e., prior to completion of risk assessments, without visibility of re-evaluation focus areas), currently the only meaningful opportunity that stakeholders have to provide additional information to refine the risk assessment comes after the PMRA has published a proposed decision. The PMRA is a globally renowned and respected regulatory body. Once a proposed re-evaluation decision has been published, any subsequent refinements are viewed with skepticism by those groups predisposed to question the integrity of the federal regulatory system. Providing additional opportunities for stakeholder consultation throughout the re-evaluation process will help reduce the need to make significant changes to a proposed decision following the public consultation period. Indeed, decoupling the risk assessment and the risk management steps by holding a public consultation on the draft risk assessment (as is standard practice in the US) would provide all stakeholders with a meaningful opportunity to contribute information to refine the risk assessment before a proposed decision is published. [13]

Explore mechanisms to improve the public submission process The PMRA consultation process has, in recent years, become the target for a number of click-and-submit campaigns. Although the submissions that are made through these campaigns are not generally substantive in nature, the PMRA is obligated to respond to them, which takes resources away from where they are needed and significantly impacts the Agency’s ability to meet timelines.

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We encourage the PMRA to explore mechanisms to improve the scientific consultation process to ensure it is meaningful. Public consultations should include appropriate explanatory material that clarify essential information including relevant dates, next steps, and explicit information on the nature of the relevant information being sought. They should also explain that only submissions related to the contents of the document will be considered. This could be accomplished by explicitly limiting the scope of public comments to the contents of the document and using an online template to collect such feedback. This would be consistent with the process used by, for example, the European Food Safety Authority (EFSA), who clearly state that comments will not be considered if they are not related to the contents of the document; contain complaints against institutions, personal accusations, irrelevant or offensive statements or material; or are related to policy or risk management aspects, which is out of the scope of EFSA's activity [13].

Review the existing re-evaluation process to identify improvements The PMRA should commission a review of its re-evaluation program to identify possible areas for innovation and streamlining of the process. This should include identifying, for example, existing bottlenecks; areas of unnecessary duplication of efforts; potential efficiencies by work sharing; and opportunities to integrate emerging scientific and risk assessment methodologies into the re-evaluation process.

Explore the use of emerging tools and approaches While obtaining all available data on a compound before making a safety decision is conceptually appealing, in practice it wastes precious resources and can delay the risk assessment process. In order to meet their re-evaluation timelines and complete the assessment of more than 370 active ingredients over the next decade, the PMRA will need to consider alternative approaches to re-evaluation.

The science of regulatory toxicology and risk assessment is rapidly evolving [reviewed in 14] and the PMRA should explore opportunities to integrate these advances into the re-evaluation process where appropriate. For example, the Health and Environmental Sciences Institute (HESI)-coordinated Risk Assessment in the 21st Century (RISK21) project was initiated to specifically develop a scientifically robust, transparent, and efficient approach to human health risk assessment for decision making [15].

The Risk21 approach uses existing toxicity and exposure data to identify only those data that are needed to make a decision; as such, information needs for compounds in re-evaluation would only be identified if the existing information is not sufficiently “precise” to establish a margin of exposure that provides reasonable certainty of no harm [15]. Since Risk21 is an iterative process, it can also be used to compare different risk mitigation options in a transparent and scientifically robust fashion.

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Explore opportunities for regulatory efficiencies In general, we are supportive of the special review provisions found in Section 17 of the PCPA. Special reviews provide a mechanism for a targeted review of a registered active ingredient if, following registration, additional data are generated that could alter the human health or environmental risk profile of the substance. Unfortunately, however, these provisions have become a target for certain stakeholders who have used the special review mechanism to, for all intents and purposes, overwhelm the resources at the PMRA by requesting special reviews of substances that have either recently completed full re-evaluation or are currently in the re-evaluation process. Small changes to Section 17 of the PCPA would make it harder to use special reviews as a means of slowing down the regulatory system without losing this valuable mechanism for targeted evaluations.

Conclusion The PMRA is currently viewed as a global leader in the risk-based regulation of crop protection chemicals. In this White Paper, we have outlined a number of potential solutions to align the PMRA’s re-evaluation process with the broader Government of Canada trade objectives in a scientifically robust fashion that will ensure protection of human health and the environment. We strongly encourage the PMRA to revisit its re-evaluation process and incorporate these changes.

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Appendix A: Summary of Key Affected Active Ingredients This table summarizes a small number of the active ingredients that have been affected by proposed PMRA re-evaluation decisions in recent months. In most cases, these proposed decisions were unanticipated and significantly different to those of other major regulatory bodies, including the US EPA. These proposed decisions, if finalized, will have a significant negative impact on Canadian growers.

Active ingredient PRVD Expected Date of RD

Class Major registered use pattern Comments

Captan PRVD2016-13 March 2018 Fungicide

Greenhouse food and non-food crops; outdoor ornamentals; fruit trees; Hort; seed treatments.

Proposed cancellation of large number of uses. Some retained.

Chlorothalonil PRVD2011-14

REV2016-06

March 2018 Fungicide

Greenhouse; field crops; ornamentals; and paints.

PRVD2011-04 proposed continued registration. No final re-eval decision was published. REV2016-06 proposed cancellation of significant number of agricultural uses and use in paint.

Cyfluthrin PRVD2016-17 March 2019 Insecticide Broad

Continued registration with some additional risk mitigation measures.

Imidacloprid PRVD2016-20 December 2018

Insecticide Broad. Large number of agricultural crops, trees and turf, flea and tick.

Proposed phase-out of all agricultural and outdoor uses due to risks to aquatic invertebrates.

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Iprodione PRVD2016-09 March 2018

Fungicide

Wide variety of greenhouse, orchard and field crops, ornamentals and turf.

Proposed cancellation of all uses based on human health risks.

Lambda-cyhalothrin

PRVD2017-03

March 2019 Insecticide

Greenhouse food crops, terrestrial food and feed crops, shelterbelts, turf, livestock, structural sites and ornamentals

Proposed cancellation of all food and feed uses and some residential uses based on dietary and residential exposure risks.

Linuron PRVD2012-02 December 2019

Herbicide

Terrestrial food crops, terrestrial feed crops, industrial oil seed crops and fibre crops, forests and woodlots, and industrial and domestic vegetation control for non-food sites

Proposed phase-out of all uses. Dietary risks of concern from food and water. Occupational risks of concern.

Mancozeb PRVD2013-01

March 2018 Fungicide Vegetable, fruit, ornamental, and field crops.

Proposed cancellation of commercial (slurry and dry application) and on-farm (dry application) seed treatment for barley, corn, flax, oat and wheat and potato seed treatment; orchard crops including apples, pear and grapes; and greenhouse tomato.

Methomyl PRVD2016-02

December 2017

Insecticide Forest and woodlots; greenhouse food crops; terrestrial food crops; and structural.

Cancellation of food and feed uses, including tobacco, based on human health risk assessment. Continued registration of non-food uses.

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Metiram PRVD2014-03 March 2018 Fungicide

Broad range of terrestrial food crops.

Phase-out of all registered uses due to risks from dietary exposure.

Phosmet PRVD2017-07 December 2018

Insecticide Field crops and ornamentals

Proposed phase-out of all products based on risks to workers during application and post-application activities.

Thiram PRVD2016-07

June 2018 Fungicide

Seed treatment (cereal, oilseed, pulse, vegetable, fruit and feed crops), foliar spray application on tree fruits (apple, peach and plum), strawberry and celery (plant beds), root dip of sweet potato, and as an animal repellent to protect dormant outdoor ornamentals and young fruit trees.

Proposed cancellation of all uses

Ziram PRVD2016-06

June 2018 Fungicide

Apple, peach, apricot, tomato, and cucurbit vegetables as a foliar application; and as a material preservative to prevent bacterial degradation of dry starch and synthetic latex adhesive formulations

Proposed cancellation of all uses

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Appendix B This section summarizes three recent decisions that exemplify the concerns we have raised regarding the current re-evaluation process.

Imidacloprid The 15-year cyclical re-evaluation of imidacloprid was initiated in 2009 and, according to the registrant, a data call-in was issued in November 2010 covering several areas including chemistry, toxicology, occupational exposure, food residue, environmental fate, and environmental toxicology. The registrant made numerous submissions to the PMRA from 2011-2016; however, the PMRA did not raise any concerns about potential risks prior to publication of the proposed decision.

The PMRA published, for public consultation, its re-evaluation decision in November 2016 proposing a 3-5 year phase out of all agricultural uses due to concerns over potential risks to aquatic invertebrates [16]. These concerns were driven, in large part, by water monitoring data from two watersheds in eastern Canada that the PMRA acknowledged were commonly associated with greenhouse uses in Ontario; vegetable uses in Ontario; and potato and mixed vegetable/potato uses in Quebec [16]. Nonetheless, and citing a lack of robust water monitoring data from the rest of Canada (except SK), the PMRA proposed cancellation of all agricultural uses: “Robust Canadian freshwater monitoring data were available for areas of Ontario, Quebec and Saskatchewan. Monitoring data were typically scarce or not robust for other areas of Canada. However, in areas where imidacloprid is used but monitoring data are lacking, there is no reason to believe that detection patterns would differ compared to those observed in areas where monitoring data are available.”

Imidacloprid is a critical tool in the toolbox of Canadian growers in almost all sectors of agriculture; therefore the impact of this proposed decision on Canadian agriculture would be significant. In response to the publication of PRVD2016-20, Agriculture and Agri-Food Canada (AAFC) took the unprecedented step of convening a multi-stakeholder forum (MSF) of stakeholders from across the agricultural community to respond to the PMRA’s draft risk assessment for imidacloprid.

This forum identified water monitoring data from across the country (including BC, AB, SK, MB, ON, QC, PE, NB, and NS) generated by federal and provincial governments and academic researchers. These data were collected and submitted to the PMRA for their review. In addition, the MSF coordinated a targeted nation-wide series of water monitoring studies during the 2017 growing season in order to generate data to further refine the PMRA’s risk assessment. All of these data were submitted to the PMRA ahead of the Agency’s October 31, 2017 deadline so that they could meet their internal timelines.

While it is too early to pre-empt the outcome of the PMRA’s final review, the data generated in 2017 supported the hypothesis that certain greenhouse uses were the primary use of concern and suggesting that many other registered use patterns (e.g., orchards, vegetables, field crops, and potatoes) do not pose an unacceptable risk. Furthermore, follow-up work using the data generated in 2017 identified the sources of the exceedances as unintended effluent due to faulty recirculation systems in a handful of greenhouse operations and not as a result of normal use.

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Of note, the US EPA published a draft risk assessment for imidacloprid in January 2017 [17] identifying similar concerns regarding potential risks to aquatic invertebrates. However, since the US EPA re-evaluation process decouples risk assessment from the final re-evaluation decision, the EPA will complete the public consultation on the draft risk assessment and solicit input on potential risk management options before proposing a final decision.

The key points to note in the example of imidacloprid are as follows:

• After publication of the proposed decision, several provincial governments and other stakeholders came forward with water monitoring data that PMRA had been unaware of during the re-evaluation. Had PMRA engaged with stakeholders earlier during the process, these data could have been shared and included as part of the risk assessment.

• This active ingredient has a very large number of registered uses and is a key pest management tool for many commodity groups in Canada. Had the PMRA engaged the registrant and stakeholders earlier and made them aware of potential concerns, additional data to refine the risk assessment could have been generated before the PRVD was published.

• The thresholds of concern for aquatic invertebrates that were used by the PMRA are, themselves, the subject of scientific debate. Some scientists have expressed concern that the thresholds are excessively conservative since the Agency decided not to integrate higher-tier real-world data into their analyses.

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Chlorothalonil The PMRA published their proposed re-evaluation decision for Chlorothalonil in 2011, proposing continued registration and concluding that products containing Chlorothalonil did not pose an unacceptable risk to human health or the environment [18]. No final decision was ever posted following conclusion of the public consultation period and no communications were made between PMRA and the registrant from 2011 to 2016. Five years later, in 2016, the PMRA published an amended decision for consultation proposing the cancellation of many uses and significantly curtailing many others [19]. One of the primary drivers for this revised decision was an updated residential and occupational risk assessment that made several overly conservative assumptions around Canadian agronomic and production practices.

Following the publication of this revised decision, the PMRA engaged growers and other stakeholders to identify data that could help refine the risk assessment. They collected data on use patterns (including typical application rates and numbers of applications); crop-specific post-application activities (including timing relative to application); chlorothalonil-specific dislodgable foliar residue data; re-entry worker exposure data; and additional toxicity data.

According to a 2017 stakeholder update, the PMRA used these data to refine the risk assessment. Although a final decision will not be posted until 2018, the Agency indicated that they will make significant changes to their assessment by reinstating a number of the uses that had been affected in the 2016 proposal.

The PMRA did not reach out to stakeholders during the five-year period between the publication of PRVD2011-14 and PRVD2016-06 and, as a result, they published a proposed decision that was based on incomplete information. It is encouraging that the Agency has indicated their intent to revise the risk assessment based on the information provided by stakeholders; however, we believe that it is better for all stakeholders, including the PMRA, that a proposed re-evaluation decision be based on the most complete data set available. The public consultation on a proposed re-evaluation decision is not a substitute for targeted stakeholder communication and outreach during the re-evaluation process.

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References 1. Government of Canada, Pest Control Products Act, in S.C. 2002, C. 28. 2006: Canada. 2. PMRA, Regulatory Directive: Pest Management Regulatory Agency Re-evaluation Program,

Pest Management Regulatory Agency of Health Canada, Editor. 2001. 3. Commisioner of the Environment and Sustainable Development, Report 1: Pesticide

Safety, Office of the Auditor General of Canada, Editor. 2016, Office of the Auditor General of Canada: Ottawa, ON.

4. PMRA, DIR2001-03: PMRA Re-evaluation Program, Pest Management Regulatory Agency of Health Canada, Editor. 2001: Ottawa, ON.

5. PMRA, Regulatory Directive DIR2014-01, Approach to Special Reviews, Pest Management Regulatory Agency of Health Canada, Editor. 2014: Ottawa, ON.

6. PMRA, REV2010-18: Re-Evaluation Program, Pest Management Regulatory Agency of Health Canada, Editor. 2010: Ottawa, ON.

7. PMRA, PRO2016-02: Management of the Pesticide Re-Evaluation Process, Pest Management Regulatory Agency of Health Canada, Editor. 2016, Government of Canada: Ottawa, ON.

8. PMRA, Regulatory Directive DIR2016-04, Management of Pesticides Re-evaluation Policy, Pest Management Regulatory Agency of Health Canada, Editor. 2016, Government of Canada: Ottawa, ON.

9. U.S. Government, Electronic Code of Federal Regulations: Title 40, Chapter I, Subchapter E, Part 155 - Registration Standards and Registraton Review, United States Environmental Protection Agency, Editor. 1985, U.S. Government Publishing Office: Washington DC, USA.

10. PMRA, Re-evaluation Note REV2017-18, Pest Management Regulatory Agency Re-evaluation and Special Review Work Plan 2017-2022, Pest Management Regulatory Agency of Health Canada, Editor. 2017, Government of Canada: Ottawa, ON.

11. Federal Court of Canada, Federal Court Decisions: Équiterre v. Canada (Health), in Docket: T-1422-13; Citation: 2016 FC 554, Federal Court of Canada, Editor. 2016, Federal Court of Canada: Ottawa, ON.

12. European Union, 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, European Parliament and of the Council of 21 October 2009, Editor. 2009: Brussels, Belgium.

13. European Food Safety Authority, EFSA’s approach on Public Consultations on scientific outputs, European Food Safety Authority, Editor. 2015.

14. National Academies of Sciences, Engineering, Medicine, Using 21st Century Science to Improve Risk-Related Evaluations. 2017, Washington, DC: The National Academies Press.

15. Pastoor, T.P., et al., A 21st century roadmap for human health risk assessment. Crit Rev Toxicol, 2014. 44 Suppl 3(S3): p. 1-5.

16. PMRA, PRVD2016-20: Proposed Re-Evaluation Decision - Imidacloprid, Pest Management Regulatory Agency of Health Canada, Editor. 2016, Health Canada: Ottawa, ON.

17. US EPA, Preliminary Aquatic Risk Assessment to Support the Registration Review of Imidacloprid, United States Environmental Protection Agency, Editor. 2017: Washington DC, USA.

18. PMRA, PRVD2011-14: Proposed re-evaluation decision chlorothalonil, Pest Management Regulatory Agency of Health Canada, Editor. 2011: Ottawa, ON.

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19. PMRA, REV2016-06: Chlorothalonil. Amendment to the Proposed Re-evaluation Decision, Pest Management Regulatory Agency of Health Canada, Editor. 2016: Ottawa, ON.