Governor in Council
c/o Canada Gazette submission page
Also, by email to: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca
To whom it may concern:
Re: Canada Gazette, Part I, Volume 158, Number 24: Regulations Amending the Pest Control Products Regulations
Thank you for the opportunity to comment on the proposed Regulations Amending the Pest Control Products Regulations. Ecojustice submits these comments on behalf of the Canadian Association of Physicians for the Environment, the David Suzuki Foundation, Environmental Defence, Friends of the Earth, the National Farmers Union, Prevent Cancer Now, Safe Food Matters, and Vigilance OGM. For further descriptions of the signatories, please refer to the appendix.
Summary
The proposed regulations will not strengthen maximum residue limits, nor will they strengthen environmental oversight of pesticides in any significant way. The regulations propose to leave the discretion to the PMRA regarding whether to request information on species at risk and cumulative environmental effects. This power already exists in the Pest Control Products Act and the regulations do not represent a “strengthening” of the environmental review powers of Health Canada. This will not increase public confidence and is entirely inadequate as an action to advance Target 7 of the Kunming-Montreal Global Biodiversity Framework. There is no change from the status quo for maximum residue limits, although the regulations do clarify submission requirements that are already in place.
The regulations propose to make the release of that confidential test data discretionary. This is unacceptable and would be ultra vires the Pest Control Products Act, which provides a right of access to any “person”. While we agree with the proposed changes (most of which are outside of this regulation) to make data, once released, more easily utilized and analyzed by researchers, the loss of the right of access would undermine these improvements.
Confidential test data
Recommendation: The provisions restricting the public right of access and attempting to re-define confidential test data should be removed from the regulation.
In May of 2000 the House of Commons Environment Committee recommended changes to the Pest Control Products Act. These included a recommendation that the new act should provide for the public disclosure of “all information provided to the pest management regulatory agency in relation to pesticides” including all information other than confidential business information, which should be subject to an overriding public interest discretion. They recommended that “confidential business information” should be defined narrowly and that the Act should require that information that should be made public including “all information concerning the objectives, methodology, results or significance of any test or experiment performed with a registered or previously registered pesticide or its separate ingredients, impurities or degradation products.”
When Bill C-53 was tabled by Minister of Health Anne McLellan in 2002, she noted that the bill established a reading room “where the public can view confidential test data, which are the results of the scientific studies on which the PMRA’s evaluations of risk and value are based;” This public right of access was encoded in section 43 of the Pest Control Products Act, which provides for a right for any “person” to view confidential test data. The Minister could only deny access if the person intends to use the test data to register a pest control product in Canada or elsewhere, or to amend a registration, or to make the test data available to others for the purpose of registering a pest control product in Canada or elsewhere, or of amending a registration. If the Minister is satisfied that the purpose of the request is not to register a pest control product there is a clear right of public access, for any other purpose.
The proposed regulations would purport to eliminate this fundamental public right of public access to any person and replace it with a discretionary access process that is only for “research purposes” and only where the PMRA wants to provide the data. Further, access would be restricted to “residents of Canada”.
It is entirely inappropriate for the PMRA to control all access to confidential test data, and purporting to allow them to do so would be ultra vires the Pest Control Products Act. The Act requires the Minister to provide access unless the Minister reasonably believes that the purpose is to use the data for registering a pest control product. The regulation-making power in section 67 of the Act does not authorize the Cabinet to remove this right of access.
The Act defines confidential test data as “test data to which access may be refused under the Access to Information Act” and the permitted refusals under the Access to Information Act do not include those set out in the proposed regulations. The Directive on Access to Information Requests in 4.1.33 also sets out the principle that there is a fundamental public right of access and that exclusion and exemptions should be read narrowly to align with the principle that information should be available to the public. Schedule C of the Directive sets out the grounds for refusing access and guidance on whether there is discretion to refuse access; none of which extend to the discretion and grounds put forward in the proposed regulations.
Health Canada administers the Food and Drugs Act. Under this Act, confidential information is construed narrowly and all information in respect of clinical trials is released inclusive of test data involving human subjects, subject to very narrow exceptions: data not relevant to the submission, and information used exclusively by the manufacturer. The rationale provided in the Consultation was: “Providing public access to clinical information will enable independent or secondary analysis of the information by researchers, which would lead to a fuller understanding of the benefits, harms and uncertainties of drugs and medical devices”. Confidential test data should likewise be construed narrowly under the Pest Control Products Act.
The proposed regulation is ultra vires in the following respects:
- It purports to restrict the right of access granted by section 43 of the Act to “any person” to only persons resident in Canada;
- It purports to allow the PMRA to police whether the access is requested for a “research purpose” which removes access to the public for transparency purposes and allows the PMRA to second guess the value or bone fides of independent scientific research;
- It purports to grant a broad and unbounded discretion for the PMRA to refuse access to the public or to researchers that is contrary to the obligation to provide access set out in the Act;
- It purports to allow the PMRA to prevent the public from utilizing confidential test data to make public comments, submit special review or re-evaluation requests or in support of notices of objection; and
- It purports to redefine confidential test data more broadly than the definition in the Act.
We fully expect that if this provision is passed, all public access and a large amount of research access to confidential test data will be removed. Making access to test data subject to the discretion of the PMRA is not “strengthening” the transparency of the pesticide approvals process; it is making it worse. That this change would even be considered, let alone included in a Canada Gazette posting is surprising. This proposed change would undermine the objective of improving transparency in the pest control products regulatory process. This change could severely compromise scientific research and contributions to pesticide safety – by making the PMRA the arbiter of what a legitimate “research purpose” is. Further, by restricting access to residents in Canada, it would prevent international comparisons of pesticide data and contributions to analyses of pesticide safety by international researchers.
By narrowly defining “research” the proposed regulation threatens to remove the public right of access currently enshrined in the Act. The regulation does not appear to permit access for the purpose stakeholder regulatory submissions from the public. The proposal would also be contrary to principles of solicitor-client privilege by requiring legal counsel for members of the public to disclose the purpose of their requests. The requirement to disclose the purpose (beyond that it is not to register a pesticide) would fundamentally undermine administrative transparency and accountability by allowing the PMRA to conceal information from the public and stakeholders who challenge the PMRA’s decisions, while the PMRA itself could wield its discretion over access, to interrogate the purpose of questions from the public in detail.
The purpose of the research and a description of how the data request is related to the research or reanalysis is not the concern of PMRA and it has no jurisdiction to ascribe to itself a gatekeeping function. There is also the problem that until the confidential test data is disclosed, the recipient cannot know how the data relates to any potentially intended research.
The regulation also proposes an additional discretion for the PMRA to refuse data, even when it is from a Canadian researcher for a research purpose. The proposed broad discretion to refuse access would allow the PMRA to pick and choose which researchers it grants access to and could result in decisions that privilege certain researchers and stakeholders over others. This reinforces the close ties of the PMRA to industry science and reaffirms its refusal to open up its processes to broad scientific and public scrutiny. The proposal to include a broad discretion to refuse access contradicts the right of access in section 43 of the Act and is unacceptable.
The regulation would also grant the PMRA a power to refuse to grant access to confidential test data before a final decision is made. This appears to be intended to prevent public comments at the consultation stage – a move that forces members of the public to make comments only after a final decision through the objection process. There is no reason provided explaining why the public should not have access to test data at any time, including when a decision is pending. The effect of this is that while the PMRA has moved to disclose more information on pending applications on the public registry, the public will still not be able to access any information about those proposals until after a decision is made and must make public comments without key information. This offends the objective of the Act of facilitating “public access to relevant information and public participation in the decision-making process”.
Further, the proposed regulation attempts to broaden the definition of “confidential test data” in the Pest Control Products Act by making it different from the range of data to which access may be refused under the Access to Information Act, even though the Act defines “confidential test data” as “test data to which access may be refused under the Access to Information Act.” In this way the proposed regulation is also ultra vires the Pest Control Products Act, which does not contain a power for the Cabinet to re-define confidential test data. The proposed “definition” of confidential test data is ultra vires as it is not consistent with the definitions in the Access to Information Act.
It is not clear why the PMRA would be granted discretion to define confidential test data more broadly than the Act nor why it needs an incredibly broad discretion to refuse to provide the access that the Pest Control Products Act provides for. There is no evidence that requests for confidential test data are frivolous or that they are not for legitimate purposes. On the contrary, confidential test data has been used to engage in the decision-making process and point out scientific issues that may have been missed by PMRA. The regulatory commentary associated with these changes fails to explain why any of these proposed restrictions on access are needed. It indicates that access would be refused if it is “unreasonable” to respond to a request, taking into account prescribed factors, all of which basically say PMRA does not want to respond to the request because it is too hard or they are being asked too often for data. The commentary on the proposed regulation does not describe a legitimate harm.
In our experience, the PMRA fails to adequately work with stakeholders to streamline requests for test data by ensuring that clear descriptions of the data the PMRA relied upon are provided in public documents. Then, the PMRA applies an overly-broad definition of confidential test data, which is essentially anything that the registrant submitted, or any document that contains any reference to something the registrant submitted – including the PMRA’s own modelling or analysis. The PMRA has repeatedly refused to use the well-established test in the Access to Information Act or to acknowledge the principles of access when determining what is confidential test data. Further, in processing requests for data the PMRA redacts things like the names of researchers, labs and sample locations, on spurious privacy grounds, causing weeks of delay. The PMRA could reduce the burden of providing data by better ensuring that the redactions are necessary under privacy legislation, which currently does not require this information to be redacted.
Instead of reconsidering its overly broad understanding of confidential test data and finding solutions to make more information available on the public registry – the PMRA blames stakeholders for its own culture of secrecy and seeks to further restrict access.
In one recent example, Ecojustice, on behalf of several stakeholders requested water monitoring data regarding a carcinogenic breakdown product of common fungicides. The PMRA’s original assessment indicated that exposure to this breakdown product was too high, but reversed this decision after being exposed to industry pressure – stating that monitoring data showed exposure was lower. We wanted to understand this reversal and requested the data. The PMRA stated that the water monitoring data was confidential test data. After it was requested, the PMRA spent weeks redacting the lab names and states where water samples were taken in data – information that is essential to understanding if the data was relevant. As it turned out, once details of the document were known, this data was completely publicly available (including names of researchers, labs and sample locations) through the US EPA. Moreover, the document stated right on the material that it was not confidential – a feature common to a large number of documents that the PMRA treats as confidential test data. As a result of these features, it could not under any interpretation of the Access to Information Act be considered confidential test data or private information and should have simply been released in full. Because the PMRA would not disclose relevant aspects of the data, it had to be obtained from the USEPA, which processed the request quickly and with no redactions. Canadians should not have to go to the United States to find information that Health Canada relied on for key decisions about the health of Canadians. This is typical of PMRA behaviour in relation to transparency.
The regulation proposes to grant the PMRA broad discretion to refuse access whenever it is not convenient for them, or not for a “research” purpose. It can be expected that the PMRA will not release data to members of the public who seek to scrutinize their decisions. This will grant industry even more privileged access than they already have and further bias the scientific process towards industry-sponsored science– since the industry alone will have access to all studies. The public right of access presents an essential counterbalance to these forces. Withdrawing that right would be incredibly irresponsible.
There is also no redress in the proposed regulations if access is refused. The PMRA does not have to even provide a reason for its refusal to provide access.
The PMRA also indicates that it will not apply the new test for confidential test data to older data, despite its clear obligations under the Pest Control Products Act and the Access to Information Act to promote access using the same test for all confidential test data. This will create a confusing and un-manageable system wherein whether something is considered confidential test data will depend on when it was submitted and not on the principles under the Access to Information Act that the definition of “confidential test data” in the Pest Control Products Act incorporates.
Recommendation regarding access to confidential test data
The proposal for the changes to the definition of and access to confidential test data in the Canada Gazette should be abandoned. Confidential test data should continue to be defined in the Access to Information Act, as required by section 2 of the Pest Control Products Act. The right of access to confidential test data in section 43 of the Pest Control Products Act should be maintained.
Implement proposed changes that would permit researchers to manipulate and analyze data.
Species at Risk and Cumulative Environmental Effects
As noted in the Regulatory Impact Analysis Statement (RIAS) published with the draft regulations, under the Pest Control Products Act, the Minister of Health already has the authority to require information to conduct environmental risk assessments, which can include information on cumulative environmental effects and information regarding species at risk. The strategic environmental assessment concludes that direct, positive effects would be limited in the near term. We disagree that these inconsequential amendments would “enhance public trust in Health Canada’s scientific review process”, as the RIAS suggests. On the contrary, pursuing a status quo approach under the title of “Strengthening the Regulation of Pest Control Products in Canada” will only enhance public cynicism and skepticism. Despite the broad authority under the Act to require information and conduct evaluations of environmental risks, the status quo approach systematically ignores cumulative effects and the particular vulnerabilities of species at risk. What’s needed is new mandatory requirements to consider information on cumulative environmental effects and species at risk.
With respect to cumulative environmental effects, a broader ecological perspective is also needed. To the extent that consideration of cumulative effects remains limited to active ingredients with a common mechanism of toxicity, amendments to the regulation should at a minimum mirror existing requirements for the consideration of cumulative effects on human health in sec. 7(2)(b)(i) and 19(2)(b)(i) of the PCPA and not be discretionary or conditional on the “availability” of applicable scientific methodologies. A better way to address sequencing concerns raised by industry stakeholders during consultations on NOI2023-01 would be to allow time for publication of methodologies (or interim methodologies) before new regulatory provisions enter into force. As we have seen with consideration of cumulative risks to human health (albeit after lengthy delays and still needing improvement), clear requirements will drive development of methodologies, while the reverse is not necessarily true.
With respect to species at risk, amendments to the regulation should include mandatory requirements for applicants/registrants to provide information on risks to species at risk and their critical habitat (i.e., indirect risks such as effects on food sources). In conducting evaluations of environmental risks, the Minister should be required to:
- Apply an ecological evidence-based approach that avoids incremental harm and multiple stressors to vulnerable species and ecosystems.
- Apply more protective risk-acceptability thresholds for species at risk, including more use of uncertainty factors.
The Kunming-Montreal Global Biodiversity Framework recognizes that urgent policy action is required to reduce and/or reverse threats to nature (including pesticides and other pollution) and allow for ecosystem recovery. Under Target 7, Canada has committed to:
Reduce pollution risks and the negative impact of pollution from all sources, by 2030, to levels that are not harmful to biodiversity and ecosystem functions and services, considering cumulative effects, including: reducing excess nutrients lost to the environment by at least half including through more efficient nutrient cycling and use; reducing the overall risk from pesticides and highly hazardous chemicals by at least half including through integrated pest management, based on science, taking into account food security and livelihoods; and also preventing, reducing, and working towards eliminating plastic pollution. (Emphasis added.)
Canada’s 2030 Nature Strategy presents amendments to the PCPR as a key strategy for advancing action on Target 7. However, as drafted, the proposed amendments to the regulations are unlikely to achieve the stated objective of strengthening environmental protection and only reinforce Canada’s existing regulatory gaps with respect to Target 7 – unless the PMRA is going to systematically update data requirements to require information on cumulative environmental effects and species at risk, and unless the PMRA is going to update its risk assessment framework to routinely and explicitly consider these effects.
Moreover, we are concerned that the proposed changes could undermine environmental risk assessment by encouraging the PMRA’s practice of treating aspects of environmental risk assessment that are clearly mandatory in the Act as discretionary.
Recommendations regarding species at risk and cumulative environmental effects
Replace proposed redundant and discretionary provisions related to information on cumulative environmental effects with mandatory requirements that, at a minimum, mirror existing requirements in sec. 7(2)(b)(i) and 19(2)(b)(i) of the PCPA and are not conditional on the availability of applicable scientific methodologies.
Replace proposed redundant and discretionary provisions related to information on species at risk with mandatory requirements for applicants/registrants to provide information on effects on species at risk and their critical habitat (i.e., indirect risks such as effects on food sources).
Require the minister to:
- Apply an ecological evidence-based approach that avoids incremental harm and multiple stressors to vulnerable species and ecosystems.
- Apply more protective risk-acceptability thresholds for species at risk, including more use of uncertainty factors.
Maximum residue limits (MRLs)
We support the addition of information requirements for MRL applications under new sections 12.2 and 12.3. We highlight that these are minor administrative changes that largely reflect existing PMRA practices.
Commodities imported into Canada may contain residues higher than the MRL that would result from approved Canadian uses. This includes situations where there are approved uses for Canadian commodities, but the use is different from that in a foreign jurisdiction, and situations where a pesticide is not approved for use in Canada at all or on the particular commodity.
We are concerned about attempts to rely on foreign or international risk assessments to set an MRL for a pesticide that has approved Canadian uses on a particular commodity. This creates a disconnect between the MRL that would result from lawful use of a pesticide in Canada and the MRL, which frustrates Canadian compliance. For example, if Canadian uses of a pesticide would result in a level of 0.1 ppm on oats when the label is complied with, and an applicant uses subsection 10(2) to apply for an MRL of 0.2 ppm based on foreign uses on oats that are higher.
Utilizing higher “international” MRLs as a matter of course under s.10(2) is creating serious obstacles to identifying Canadian label compliance – which relates to issues beyond dietary risk and includes occupational exposure and environmental risk. We reiterate our request that a domestic MRL should be set separately. Further Canada continues to use a non-health based and scientifically indefensible default GMRL of 0.1 ppm for commodities without an MRL, which discourages applications for international MRLs that are based on current science. Where the Canadian registrant, or the applicant under s.10(2) of the Act has failed to provide up to date toxicity data the MRL should be automatically revoked.
While foreign and international dietary risk assessment information may be relevant, it is still necessary to assess Canadian dietary exposure with Canadian dietary information and to utilize up-to-date toxicity information at the time the MRL is assessed. This is particularly important when the pesticide is approved for Canadian uses on the same commodity and where consumption of imported foods is high. It is not clear that the proposed amendment to the regulation will result in the Minister requiring this information and conducting this assessment. The regulation should make it clear that this information is required. It would be irresponsible to rely on assessments of dietary risk that do not reflect Canadian dietary exposure to the pesticide or which do not use Canadian dietary information. It would also be irresponsible to use out of date toxicity information and dietary assessments from other jurisdictions.
Recommendations regarding MLRs
Set a separate domestic MRL for compliance purposes and amend the regulation to include this.
Clarify that the registrant shall submit up-to-date toxicity information and that the Minister shall conduct a Canadian dietary risk assessment using Canadian exposure and dietary data.
Eliminate the GMRL.
Amend the regulation to provide that the Minister shall not approve an application under 10(2) where a Canadian registrant has failed to provide toxicity data for a Canadian registration or where up-to-date toxicity data is not provided.
Conclusion
We submit these recommendations regarding the proposed Regulations Amending the Pest Control Products Regulations. If you have any questions regarding the recommendations, please do not hesitate to contact us.
Sincerely,
Jane McArthur, Toxics Program Director, Canadian Association of Physicians for the Environment (CAPE)
Lisa Gue, National Policy Manager, David Suzuki Foundation
Laura Bowman, Staff Lawyer, Ecojustice
Cassie Barker, Toxics Senior Program Manager, Environmental Defence
Beatrice Olivastri, CEO, Friends of the Earth Canada
James Hannay, Policy Assistant, National Farmers Union
Meg Sears PhD, Chair, Prevent Cancer Now
Mary Lou McDonald, LL.B., President, SafeFoodMatters.org
Laure Mabileau, Responsable des Communications, Vigilance OGM
Appendix – descriptions of signatory organizations
The Canadian Association of Physicians for the Environment (CAPE) is a national physician-led organization working to better human health by protecting the planet. CAPE collaborates with other organizations, nationally and internationally, to work effectively and build power together. We support physicians to be advocates for healthier environments and ecosystems. We take action to enable health for all by engaging with governments, running campaigns, conducting research, and drawing media attention to key issues.
The David Suzuki Foundation is a leading Canadian environmental non-profit organization, founded in 1990, with offices in Vancouver, Toronto and Montreal. We collaborate to find solutions to create a sustainable Canada through scientific research, traditional ecological knowledge, communications and public engagement, and innovative policy and legal solutions. Our mission is to protect nature’s diversity and the well-being of all life, now and for the future.
Ecojustice uses the power of the law to defend nature, combat climate change, and fight for a healthy environment. Its strategic, public interest lawsuits and advocacy lead to precedent-setting court decisions and law and policy that deliver lasting solutions to Canada’s most urgent environmental problems. As Canada’s largest environmental law charity, Ecojustice operates offices in Vancouver, Calgary, Toronto, Ottawa, and Halifax.
Environmental Defence is a leading Canadian advocacy organization that works with government, industry and individuals to defend clean water, a safe climate and healthy communities.
Friends of the Earth Canada is the Canadian member of Friends of the Earth International, the world’s largest grassroots environmental network campaigning on today’s most urgent environmental and social issues.
The National Farmers Union is a grassroots farmer organization advocating for farm families across Canada since 1969. Members work together to achieve agricultural policies that ensure dignity and income security for farm families while protecting and enhancing rural environments for future generations.
Prevent Cancer Now is Canada’s science-based, public advocacy voice for primary cancer prevention. This involves making informed, least-toxic choices individually, and by regulators and governments, for healthy food, water and environments.
Safe Food Matters works in the regulatory and legal arenas to ensure our food is safe from harmful inputs like pesticides.
Vigilance OGM is a Quebec based non-profit organization (NPO), which forms a network bringing together groups and individuals from various backgrounds: farmers, environmentalists, consumers, citizens, everyone We are concerned about what we put on our plate every day and about the impact of the production methods of genetically modified (GM) crops – and their associated pesticides – on human and environmental health.
