Question Period Note: GLYPHOSATE

• Glyphosate is the most widely used pesticide globally. Health Canada’s Pest Management Regulatory Agency (PMRA) published its final re-evaluation decision document for pesticides containing glyphosate, on April 28, 2017, allowing its continued use in Canada (marketed under brand names such as Roundup and Vision). Several Notices of Objection (NoOs) were filed at the time, and following a review of stakeholders’ concerns, the Department confirmed that issues raised in these NoOs were not scientifically supported.
• The decision not to strike a review panel was appealed to the Federal Court of Appeal (FCA) by some of the stakeholders that filed one of the original NoOs. On February 2, 2022, the FCA ruled that Health Canada’s PMRA must now reconsider striking a review panel. Health Canada is currently reconsidering the information provided in the NoOs.
• Concurrently, PMRA is also advancing on its Transformation Agenda that will strengthen its oversight and its protection of human health and the environment. The transformation process will ensure the pesticide review process meets the expectations of Canadians in the areas of transparency and sustainability.

• Our Government takes pesticide safety very seriously, and believes strongly in making evidence-based scientific decisions. Health Canada scientists regularly re-evaluate pesticides approved in Canada to ensure they can be used safely, and that human health and the environment are protected.
• Health Canada scientists have conducted an extensive review of this chemical and have concluded that glyphosate can be used safely when label directions are followed.
• As part of its Transformation Agenda, Health Canada is strengthening its oversight of pesticides and the protection of human health and the environment. This includes increased stakeholder collaboration to generate independent data and enhanced transparency of decision-making.
• We will continue to monitor the situation for new information, and will not hesitate to take action if needed.

IF PRESSED ON HEALTH CANADA’S AWARENESS AND USE OF THE “MONSANTO PAPERS” IN THE REVIEW OF GLYPHOSATE
• Health Canada scientists are aware of concerns raised in the media around the independence of some scientific reviews of glyphosate.
• Health Canada scientists had access to all relevant data and information from the federal and provincial governments, international regulatory agencies, published independent scientific reports and pesticide manufacturers. A total of 1368 peer-reviewed scientific papers were considered in the review.

IF PRESSED ON THE INTERNATIONAL AGENCY FOR RESEARCH ON CANCER (IARC)
• Health Canada took the International Agency for Research on Cancer findings into consideration, but found that the level of exposure of Canadians to glyphosate does not cause any harmful effects, including cancer.
• Health Canada’s finding is consistent with the European Food Safety Authority, the European Chemicals Agency, the Australian Pesticides and Veterinary Medicines Authority, and the United States Environmental Protection Agency. None of these pesticide regulatory authorities considers glyphosate to be a cancer risk to humans when used according to the label.

IF PRESSED ON GLYPHOSATE FOUND IN FOOD
• Recent testing by the Canadian Food Inspection Agency shows levels found are not a cause for health concern for Canadians.

IF PRESSED ON GLYPHOSATE IN DRINKING WATER
• Health Canada has assessed potential human health risk of glyphosate from drinking water. Dietary (food and drinking water) exposure associated with use of glyphosate was found not to be of concern.
• Monitoring data from both surface and ground water sources were considered in this risk assessment.

IF PRESSED ON WHY HEALTH CANADA PAUSED DECISIONS ON INCREASES TO MAXIMUM RESIDUE LIMITS UNTIL 2022, AND THE ESTABLISHMENT OF A SCIENCE ADVISORY COMMITTEE
• The Government of Canada has paused all proposed increases to Maximum Residue Limits (MRLs), including those for glyphosate. MRL proposals will be published after Health Canada has completed reviewing the extensive comments received during MRL consultations in 2021.
• PMRA may seek advice from the Scientific Advisory Committee on proposed increases to glyphosate MRLs; however, not all MRL decisions will go to the Committee for specific scientific advice.
• Health Canada remains committed to timely, evidence-based decisions on pesticides. Health Canada will make every effort to integrate scientific advice from the Committee without affecting existing timelines to reach regulatory decisions.

• Health Canada published its Re-evaluation Decision document for glyphosate on April 28, 2017. The evaluation determined that glyphosate is unlikely to be genotoxic or carcinogenic. Health Canada considered the findings of the International Agency for Research on Cancer (IARC) that glyphosate is “probably carcinogenic to humans”, but did not alter the decision. It is important to note that the IARC classification is a hazard classification and not a health risk assessment. This means that the level of human exposure, which determines the actual risk, was not taken into account by IARC. Health Canada’s finding is consistent with the European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA), the Australian Pesticides and Veterinary Medicines Authority (APVMA), and the United States Environmental Protection Agency (USEPA).

• In May 2017, eight Notices of Objection (NoOs) to the glyphosate decision were filed with Health Canada. On January 11, 2019, Health Canada scientists concluded that the concerns raised by the objectors could not be scientifically supported when considering the entire body of relevant data. Therefore, the final re-evaluation decision for glyphosate did not change. Health Canada published its response to each notice of objection in the Public Registry.

• Following Health Canada’s decision regarding the NoOs in January 2019, an application for judicial review challenging PMRA's decision not to establish a review panel in respect of part of the glyphosate re-evaluation was filed on February 11, 2019 by two of the objectors. On February 13, 2020, the Federal Court dismissed the application for judicial review. One of the objectors appealed the decision to the Federal Court of Appeal (FCA) on March 13, 2020. On August 14, 2020, three NGOs sought leave to intervene jointly in the appeal and the Court granted leave to intervene on October 7, 2020. In December 2020, a fourth NGO filed a motion with the Court seeking leave to intervene in the appeal, which the Court denied on February 5, 2021. This NGO applied for leave to appeal the FCA’s decision to the Supreme Court of Canada (SCC) on April 7, 2021. On March 24, 2022, the SCC dismissed the NGO’s application for leave to appeal to the SCC.

• A hearing on the merits of the appeal was held December 9, 2021, before the FCA. The FCA allowed the appeal and set aside the decision of the lower Court. Health Canada is currently working on integrating the FCA’s guidance to inform future decisions in respect of NoOs. PMRA will then reconsider the NoOs as required by the FCA.

• Public interest in the safety of glyphosate used in agriculture, forestry, and by homeowners remains high. Media interest stems from the hazard classification of glyphosate as a probable carcinogen by the IARC and coverage of class action lawsuits in both Canada and the United States that have yet to be resolved. A number of Canadian municipalities are examining the issue of glyphosate use. The City of Laval, QC banned the use of glyphosate earlier in 2021.

• As part of targeted reviews of the Pest Control Products Act announced on August 4, 2021, Health Canada is pausing decisions on increases to MRLs, including glyphosate, until after completing review of extensive comments received during MRL consultations in 2021, and the consultation period on the targeted review of the PCPA, which has been extended to June 30, 2022. The announcement of August 4, 2021, also included funding that will allow the creation of a new expert panel process to provide advice, as appropriate, prior to certain evidence-based decisions on pesticides, including on MRLs.

• On January 27, 2022, Health Canada officially launched a call for nominations to create a new Science Advisory Committee on Pest Control Products in Canada. Nominations closed March 11, 2022 and the committee membership will be announced once the assessment process is complete. The role of the Science Advisory Committee on Pest Control Products is to provide scientific advice in response to targeted questions from the PMRA related to specific technical aspects of assessments or scientific reviews. PMRA may ask the Committee to provide scientific advice on certain assumptions or scientific data underpinning a particular MRL assessment; however, not all PMRA decisions will go to the Committee for specific scientific advice. PMRA will begin identifying specific scientific questions that would benefit from the independent advice of the Committee.

• The European Commission renewed the authorization of glyphosate for five years starting in December 2017, until December 15, 2022. The renewal process is currently underway. France, Hungary, the Netherlands and Sweden are acting jointly as rapporteurs. On June 15, 2021, a draft renewal assessment report and a proposal for harmonised classification and labelling was submitted to EFSA and ECHA. The draft assessment report is consistent with Health Canada’s re-evaluation decision published in 2017. A parallel public consultation by both EFSA and ECHA was recently completed in November, 2021. The rapporteurs are currently evaluating comments received. EFSA is looking to finalize their peer review by July 2023. Luxembourg became the first EU country to completely ban products containing glyphosate, effective December 31, 2020. France and Germany have announced their intention to ban or severely restrict the use of glyphosate in the next few years. These plans are contingent on alternatives to the uses of glyphosate being developed. Austria has notified the Commission of its intention to ban glyphosate.

• The USEPA published an interim registration review decision in January 2020. The EPA uses interim decisions to finalize enforceable mitigation measures. The EPA has concluded that there are no risks of concern to human health when glyphosate is used according to the label and that it is not a carcinogen. The EPA released a final biological evaluation (endangered species assessment) for glyphosate, in November of 2021. The US National Marine Fisheries Service and the Fish and Wildlife Service will now consider the report for impacts on species or habitats.

• Mexico has announced that they will gradually reduce the use of glyphosate, towards a total ban in 2024.

KEY FACTS
• Following Health Canada’s decision regarding the NoOs in January 2019, an application for judicial review challenging PMRA's decision not to establish a review panel was filed. On February 13, 2020, the Federal Court dismissed the application for judicial review. This decision was subsequently appealed. A hearing on the merits of the appeal was held December 9, 2021, and the Federal Court of Appeal set aside the decision of the Federal Court. Health Canada will reconsider the NoOs as required by the Federal Court of Appeal, taking into account the guidance provided by the Court in its reasons.
• Media and stakeholder interest in glyphosate remains high. It is the subject of class-action lawsuits in both Canada and the United States that have yet to be resolved. Much of the interest stems from the hazard classification of glyphosate as a probable carcinogen by the International Agency for Research on Cancer (IARC). This concern was addressed by Health Canada in its final decision based on an extensive risk assessment, which aligns with major pesticide regulatory bodies around the world.
• Public debate regarding the safety of glyphosate continues. There are also a number of Canadian municipalities that have banned or examining their use locally,
• In spring 2021, proposed changes to Maximum Residue Limits (MRLs) for glyphosate generated thousands of comments from concerned stakeholders. Increases to MRLs are currently paused until after completing review of extensive comments received.
• The Government of Canada has paused all proposed increases to Maximum Residue Limits (MRLs), including those for glyphosate. MRL proposals will be published after Health Canada has completed reviewing the extensive comments received during MRL consultations in 2021.