Health Canada is under pressure from Agriculture Canada and the standing committee on agriculture and the standing committee on finance to change how the Pest Management Regulatory Agency (PMRA) operates.
Farm groups have lobbied the government for the PMRA to take their needs into consideration because the agency’s activity has significant bearing on the agriculture sector.
Agriculture Canada documents obtained by The Western Producer through an Access To Information and Privacy request (ATIP) reveal the agency approached Health Canada over the PMRA’s pesticide review process and level of international engagement.
On July 5, 2018, Agriculture Canada’s deputy minister Chris Forbes met with Simon Kennedy, deputy minister of Health Canada, to discuss the PMRA, which falls under the authority of Health Canada.
Forbes was given a briefing note to prepare for the meeting that said agriculture stakeholders feel the PMRA’s current process does not allow for sufficient information gathering and sufficient consultation with user groups prior to a proposed re-evaluation decision on a pesticide.
In the responsive section of the briefing note that is meant to outline Forbes’ queries with Health Canada, it states “it is important that PMRA regulate in a way that is open and transparent to both the public and industry stakeholders. How can AAFC (Agriculture Canada) and PMRA best collaborate when it comes to providing data and sharing information related to re-evaluations, without extending PMRA’s timelines?” the note said.
The note also questions why Agriculture Canada has not been brought into the loop with a new PMRA initiative, called the Agriculture Outreach Unit, that was touted as a way to increase engagement with agriculture stakeholders.
“To date, AAFC officials have received no additional information on this unit,” the note said.
Agriculture Canada informally approached PMRA about a process similar to the Multi-Stakeholder Forum to maintain engagement between industry and PMRA on high-priority pesticide re-evaluations, according to the briefing note.
“Does PMRA see this (Multi-Stakeholder Forum) as a possible solution?” the note said in the response section.
“If so, AAFC would require more collaboration at the working level to develop this process.”
Beyond wanting the PMRA to change its pesticide re-evaluation process, Agriculture Canada also wants the PMRA to step up its international work on pesticide maximum residue limits (MRL).
However, overburdened by a mound of pesticide re-evaluations, the PMRA might have to take a step back from international work with MRL, according to the briefing note for the July 5 meeting.
“PMRA indicated it will direct resources towards supporting its primary mandate of domestic human health and environmental protection, and away from international engagement,” the note said.
The workload at PMRA has increased, in part due to a 2015 Commissioner of the Environment and Sustainable Development audit that emphasized the need for increased pesticide re-evaluations, the note said.
Brian Innes, vice-president of Public Affairs at the Canola Council of Canada, said his organization works with other industry groups at the Canada Grains Council, which recently developed a consensus paper that calls for the PMRA to increase international involvement to support trade.
“Things need to change at the PMRA, there is insufficient international engagement, and through the re-evaluation processes there is insufficient engagement with stakeholders, insufficient resources, and insufficient data to ensure the best decisions possible on pesticide registrations,” Innes said.
An Agriculture Canada briefing note prepared for Forbes for an April 30 meeting with CropLife Canada said the PMRA has been an essential partner in reducing MRL trade risks.
The briefing notes for the April 30 meeting said industry stakeholders have indicated there are a number of pesticide MRL issues that could have implications for Canadian agricultural goods exporters. Some of the issues identified are the pace and process of standards development at Codex (the international standards-setting agency), a lack of resources for Codex scientific bodies, an increasing backlog of requests for evaluations, and foreign regulatory policies departing from science and evidence-based decision making.
“Most of the international activities in which PMRA participates require technical and scientific expertise, and/or provide opportunities to build working relationships between PMRA and foreign regulators. PMRA has been instrumental in advancing trade and market access issues related to MRLs,” the April 30 briefing note stated.
Innes said the PMRA’s role in regulatory work internationally is fundamental to the canola industry success in international markets.
“The PMRA is the expert on pesticide regulation and when we want to achieve results with international regulators we need our own regulator to talk to them. In essence, to make progress we need our scientists to talk to their scientists,” Innes said
The current memorandum of understanding (MOU) between Agriculture Canada and the PMRA was established in 2014 — it established how the departments are to collaborate for the promotion of Canada’s interest in international standard-setting for pesticide MRLs, and to address barriers to trade stemming from differing and missing MRLs internationally.
However, the briefing note for the July 5 meeting suggests the government is under pressure to re-evaluate the relationship between Agriculture Canada and the PMRA.
“Some industry stakeholders have raised the option of integrating PMRA’s international activities under AAFC’s International Affairs Branch (IAB). The type of work that PMRA does internationally would not be easy to incorporate into the operations of IAB,” the note said.
The note goes on to say Agriculture Canada is open to discussing how it can support PMRA in its effort to seek additional resources.
“The Economic Strategy Table, and its recommendation to provide additional support to international standard setting bodies, may provide an opportunity for PMRA, Health Canada, and AAFC to work together on a Budget 2019 proposal,” the briefing notes said in the responsive section.
Innes said the important point is not whether the PMRA is being entirely in one department or another, but of resources at the PMRA’s disposal.
“Agriculture Canada leads the resolution of market access issues, but they do so by bringing together a team of the right people from across government,” Innes said.
“We cannot resolve trade issues related to pesticides without the PMRA.”
PMRA’s primary mandate is to prevent unacceptable risks to Canadians and the environment from the use of the products it regulates, but because the agriculture sector depends so heavily on the PMRA, there are calls to update the mandate to reflect this relationship.
The House of Commons finance committee’s December 2018 report recommends the government “review the legislation under which the PMRA operates to include consideration of the impacts of PMRA on the competitiveness of Canadian firms and provide additional resources for pesticide re-evaluations,” the report said.
The standing committee on agriculture and agri-food’s January 2019 report calls for increased resources for the PMRA, but also a mandate change.
Under a recommendation titled Acceptance of Products by Export Markets, the January report states “the Committee recommends that the Government of Canada resolve irritants and issues that limit innovation and competitiveness in export markets to have them accept domestically approved products or technological processes.”
In the witness section of the report that substantiates this recommendation, it states “the Pest Management Regulatory Agency need to have both the mandate and the resources to promote science-based trade internationally.”
A further recommendation in the standing committee on agriculture and agri-Food’s January report calls for the PMRA to “undertake a review of its regulatory processes with the aim of evaluating how its procedures may inhibit technological advancement and innovation.”
Last summer, CropLife provided Agriculture Canada a document titled Re-Evaluation Concerns White Paper, which The Western Producer received through an ATIP request.
The purpose of the white paper is to have the PMRA change its re-evaluation process to improve stakeholder engagement, and to have Health Canada acknowledge its role in facilitating access to innovative technologies and its role in the agriculture sector’s competitiveness.
The paper explains how the PMRA re-evaluation process did not properly involve agriculture stakeholders and did not consider the effects its decisions have on the agriculture industry.
The PMRA re-evaluation process “did not ascertain the availability of existing data that should have been incorporated into the risk assessment; did not adequately consult stakeholders to properly understand the product use pattern; and did not inform stakeholders of data gaps or potential changes to toxicological classifications that needed to be filled in order to refine the risk assessment and toxicological endpoints,” the document said.
“The PMRA’s re-evaluation practices are eroding the public’s trust in Canada’s federal regulatory system and potentially creating unnecessary trade concerns.”
Pierre Petelle, chief executive officer of CropLife Canada, said the current re-evaluation process erodes public trust because once PMRA publishes a proposed re-evaluation decision, and then changes the decision after it learns about how the product is used or gets updated information, the public can be suspicious why the change was made.
“Have that dialogue with the data owner and potentially with the grower community to get a better sense of how the product is actually used, whether there is additional scientific information that may alleviate some of their concerns on the risk side. And have that done through the process, rather than in such a public way,” Petelle said.
“I’m not saying take away any transparency, being very transparent about that exchange of information, but not have expectations being one thing and then the final outcome being very different.”
He said CropLife is not suggesting the importance of human health or the environment be lessened in the review process, but the process should also include how decisions will affect the agricultural sector.
“The consideration of other factors, economic factors, what growers would use in the alternative, what the impacts might be to using alternative products, those are broader discussions that should at least be part of the consideration,” Petelle said.
The white paper also suggests the current PMRA re-evaluation processes “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,” the paper said.
Special review provisions in the current re-evaluation process say every time an Organization for Economic Co-operation and Development country bans an active ingredient, Canada’s health minister must initiate a special review, even if a review of the product had just been completed.
“There is no leeway or independence by the minister to put common sense into the decision the way it’s currently worded. And so many of the activists know this,” Petelle said.
He said activists recently took the PMRA to court to force a special review on glyphosate, even though it had just gone through a re-evaluation and there was little new data to consider.
“The activists took them to court and they won. The PMRA was forced to initiate 23 special reviews of compounds, most of which had just gone through a very recent re-evaluation. And these things take time,” Petelle said.
Health Canada was unable to respond by press time March 4, but the message from the executive director on PMRA’s 2017-2018 annual report said, “PMRA’s re-evaluation of older pesticides continues to be a significant and increasing workload pressure. PMRA updated the re-evaluation workplan for 2018-23, and the need for a new approach to this key activity is clear.”
The message said the agency has established a team to develop a more sustainable re-evaluation program, including examining international approaches, having broad stakeholder consultation, and looking to recommendations in the anticipated 2020 statutory review of the Pest Control Products Act