SAFE FOOD MATTERS, BUT NOT TO HEALTH CANADA ?

 

BUT NOT TO HEALTH CANADA ?

Safe food matters to you and me, but does it matter to Health Canada? We aren’t convinced.  Why not?  We have been in a David vs. Goliath battle with them since 2017 regarding their regulatory approach to safe food, and have two basic observations.  First, in our view, Health Canada hasn’t followed the intent or the letter of the law. Second, the conduct of the regulator has been problematic. 

This article provides detail on these two points. With respect to the first point, it explains how on our file Health Canada did not conduct a strong risk assessment, was not transparent, and delayed the file by more than a decade.

On the second point, it shows that the regulator: was not upfront about the process, did not provide relevant documents, did not provide the qualifications of reviewing scientists, and worked to counter rather than properly consider the objections that were presented.

Our Story

We are Safe Food Matters Inc., a Canadian non-profit corporation that promotes public health and the environment through education and fostering public engagement on safe food issues.  We started this battle by filing a Notice of Objection (NoO) to Health Canada when it decided in 2017 to allow glyphosate to be used in Canada until at least 2032 – – a 15 plus year renewal. 

Health Canada (HC) took 18 months to look at our objection (as well as the seven other objections that were filed), and dismissed them all in January 2019.  HC said the objections did not raise “scientifically founded doubt” about the evaluation they had conducted on the risks of glyphosate. 

We and the other groups were not told that we had to raise “scientifically founded doubt” (SF Doubt).  Still, we thought we’d raised valid concerns about the evaluation of risks, so in February 2019 we filed for judicial review in Federal Court to make the case. The judge of the Federal Court dismissed our case in January 2020, disagreeing with our arguments on the scope and content of SF Doubt.

We have now filed in Canada’s Federal Court of Appeal, on the basis that the judge erred in her interpretation of SF Doubt.  We are asking for the lower judgement to be set aside. We are asking that the Court of Appeal find that we did raise SF Doubt. If the Federal Court of Appeal agrees, we’ll ask for the establishment of an independent review panel to look at aspects of the evaluation of risks of glyphosate. Why? The establishment of such a panel is allowed if a NoO raises a SF Doubt and the advice of a panel would assist.

Friends of the Earth, Environmental Defence and David Suzuki Foundation are joining us as intervenors at the Federal Court of Appeal. Ecojustice is representing them.

Detail on the Two Reasons

We don’t think safe food matters much to Health Canada because of what we’ve seen in our own case and those of the other objectors: we don’t think HC followed the intent or letter of the law, or behaved in a manner the Canadian public and lawmakers expect.  

1. Didn’t Follow the Intent or Letter of the Law

a) The Law

Glyphosate is a pesticide. Pesticides are designed to kill (insects or weeds) and so by their very nature are dangerous. They fall under the Pest Control Products Act (the “Act”) and are regulated by the Pest Management Regulatory Agency (PMRA), a division of Health Canada. 

PMRA is supposed to make sure the risks posed by pesticides are “acceptable”, in that there is a “reasonable certainty of no harm” to human health, future generations and the environment (Act s. 2(2)).  The scheme of the Act sets out three main ways to ensure “acceptable risk”:

1. Strong scientifically based risk assessments;
2. Transparency so the public can examine the risk assessments and the science behind them;
3. Mandatory review of main pesticides every 15 years to ensure the risks are still acceptable.

b) What PMRA Did

We believe PMRA failed on all three counts in its 2017 evaluation of glyphosate. 

Not a Strong Risk Assessment.

With respect to point 1, our view is the risk assessment of glyphosate was lacking. A strong risk assessment would examine all of risks that arise from the chemical. It would be based on current, accurate scientific information and studies, and apply appropriate weighting to the information. It would use current, sound methodologies.

From our perspective, these criteria were not met.  One of our concerns was that the assessment did not examine a particular risk, the risk that arises when glyphosate is used as a “desiccant”. Desiccation is when the grower sprays glyphosate right on the crop when it’s almost ready to be harvested.  Studies show that this “pre-harvest” spraying causes glyphosate to move to and concentrate at high levels in the fruits, beans and grains of the crop we eat. PMRA did not examine this risk.

Moreover, the assessment of glyphosate in the Canadian diet was based on outdated, inaccurate data and used an older methodology.  It was based on what Americans ate in the 1990s, not on what Canadians eat in the 2010s. It didn’t account for the massive increase in consumption by Canadians of legumes (which are desiccated) in recent years. It also used an older version of the dietary risk assessment model (DEEM) than the one that was available to PMRA at the time.  (HC even admits in its own document that there are problems with its approach to dietary risk assessments).

Not Transparent.

PMRA in 2009 published the document “Getting involved in Canada’s Pesticide Regulatory Process”.  It said it wanted the process to be transparent so the public can meaningfully participate.  A public registry was supposed to provide citations to the research used in the evaluations.  The public was supposed to be able to view the confidential test data considered by PMRA in the risk assessments.  Both proved to be a dismal failure. 

First, the public registry is not transparent about the research used.  The citations listed at the end of PMRA’s preliminary risk assessment of glyphosate (called PRVD 2015-01) include unpublished research, so it cannot be seen. Further, the list includes this statement, which makes it clear that the list is incomplete:

ADDITIONAL PUBLISHED INFORMATION

Note: Only published studies that are cited in the PRVD are listed below; a full list of published information considered in the re-evaluation is available upon request.

The public was also not able to review the confidential test data during the time frame for the risk assessment process.  PMRA opened up the reading room on glyphosate only after the time for submitting a notice of objection had passed!  When some objectors pointed this out, they were allowed to submit their objections later, but this was obviously not fair.

And transparency was only available to those in or around Ottawa.  The reason is one has to actually visit  PMRA headquarters in Ottawa to view the studies.  Copies cannot be taken. An affidavit has to be signed.  PMRA states that it “is aware that this may be burdensome for some requestors and is investigating alternative approaches for the future that may allow the inspection of data through other means (for example, satellite reading rooms, secure portals, etc.)”. Too little too late.   

Not a 15 Year Review Cycle: 39 Years for the Review!

Glyphosate was registered for use in Canada in 1976. The intent of the legislative scheme (as shown in the Parliamentary debates) was that older pesticides be re-evaluated 15 years after they are registered.  Unfortunately, the Act (s. 16(2)(a)) says the re-evaluation is to be initiated every 15 years.   In the case of the very old pesticides that were registered prior to 1995 (like glyphosate), the Act required that the re-evaluation be initiated by April 1, 2005 (s. 16(2)(b)).

PMRA did not comply with the Act and initiate a re-evaluation by April 1, 2005.  The record shows an internal HC email from 2006 indicating that the re-evaluation had been started in 2006, but a follow up email stated:

“The re-evaluation of glyphosate is going to be postponed, probably for several years.  So there is a plan to revoke the announcement that it is under re-evaluation.”

It was indeed postponed until 2009, and it wasn’t until 2015 that the “proposed” re-evaluation decision was published by PMRA — a decade after April 1, 2005.  Two years later, in 2017, the final re-evaluation decision was published (RVD2017-01).

2. PMRA’s Conduct

Our second reason for believing that safe food does NOT matter to Health Canada is PMRA’s conduct throughout this objection process.  There have been problems: with the procedure not being clear;  with not providing documents; with lack of disclosure on qualifications; and with the review of the objections.     

a) Procedural Problems: Not Being Upfront.

The “transparency” goal of the Act wants the public to be involved in the  risk assessment process.  Input from the public can point out problems with the process and new information that might not have been considered.

In order to participate, the public needs to know the rules of the game. But in the glyphosate case, the PMRA did not tell the public that they had to raise a “scientifically founded doubt” about the validity of the re-evaluation.  It is not mentioned in the publications of the proposed and final re-evaluation decisions, PRVD2015-01 and RVD 2017-01.  The wording is set out in the Review Panel Regulations, but many objectors did not know about these regulations, or thought they were about something other than the required content for an objection.   

This perception was underlined by PMRA. One objector was told by PMRA’s Charles Smith (Senior Science Coordination Officer, Registration Directorate, who appeared to be point for communicating with the objectors), that:

“The Regulations deal with the enforcement of the PCP Act and not the process by which submission/applications are actually reviewed “.

PMRA finally told the objectors about the regulations on January 11, 2019 in a telephone call.  This was the date when PMRA dismissed the objections: it was 18 months after the objections were filed. Too little, too late.

b) Not Providing Documents

During the court case, we saw a reference in PMRA’s record to a draft Discussion Document authored by PMRA. The document discussed several criteria for finding this “scientifically founded doubt about the validity of the evaluations”.  The PMRA’s record was supposed to contain everything relevant, so we thought they’d just missed putting it on the record at the lower court level.  But when we asked for it to be put on the record for the appeal, they refused.  We had to go to Court to ask for it, but were not successful.

A second document we consider relevant was in a file provided to another objector pursuant to an Access to Information request.  It contained an email exchange that spoke about the wording of PMRA’s response to our objection.  It shows that the wording in the final version we received had changed.  Again, this was not provided to us.

A third document was a key study on “white beans”. This 1992 study formed the entire basis for allowing glyphosate spraying on chickpeas.  It shows that spraying on these crops has never been looked at, rather this “white bean” was used as a proxy for chickpeas.  It also shows that the reviewers had some concerns about this study. We asked for a copy of the study, and PMRA said it was coming, but never provided it —  until we went to court. It showed up in the record they provided to us.  

c) Not Providing the Qualifications of the Evaluating Scientists

On January 11, 2019 Health Canada issued a press release that stated it was rejecting all eight of the NoOs. The press release included this statement:

“To help ensure an unbiased assessment of the information, Health Canada selected a group of 20 of its own scientists who were not involved in the 2017 re-evaluation to evaluate the notices of objection.”

One of the objectors, Ms. Josette Wier, asked for the qualifications of these 20 scientists (among other things).  After many e-mail exchanges and rewordings, she made clear her request:

“My question remains regarding the qualifications required by Health Canada/PMRA for defining a “scientist”, in particular for assessing the scientific literature associated with the evaluation of glyphosate.”

The PMRA has to date not provided the qualifications required by PMRA for the scientists involved with the evaluation of glyphosate. It has said it “employs a diverse range of scientists” and referred her to the general qualification standards for the public administration.

The case law on this point states: 

The requirements and qualifications for a position are indeed determined by the government institution, and their disclosure to the public meets the objectives of federal access to information legislation, namely, to increase transparency in government, contribute to an informed public and enhance an open and democratic society. (Nault v. Canada 2011 FCA 263, [2013] 2 FCR 491)

It is also not even clear that twenty scientists were involved in the actual review of the NoOs, meaning actually working “on the file” as “evaluators”. It appears from the record that only eight people met in June 2018 on the issue of responding to the NoOs. A recent letter sent to Ms. Wier from the Information Commissioner of HC references only “eight individuals involved in the re-registration of glyphosate”.

After Ms. Wier asked questions about the scientists, internal emails from HC questioned the number twenty, stating:

“We had only one principal EAD [Environmental Assessment Directorate] evaluator on the file ……, but if the agency count is 20, were other people from EAD included? That seems like a lot of people for this file.  I was thinking perhaps names of a peer reviewer or minor contributors from EAD might have been pass on to whomever prepared the list of names. Could you please let me know who is on the list from EAD?”

The response was merely, “As for the number, yes it included peer reviewers and section heads”. Elsewhere the same person responded there were an “indeterminate” number of Health Canada employees, including senior evaluators, section heads and directors.   Peer reviewers, section heads and directors are not evaluators.

We believe disclosure of this information is integral to the risk assessment process. In Europe, there is a whole set of rules around this, including the rule that “The procedures used for the selection of experts should be transparent and applied in a consistent manner”. 

d) Dismissing Rather than Considering Whether the Objections Raised SF Doubt

In responding to the various glyphosate objections, it appears PMRA’s focus was on dismissing rather than considering whether the objections raised SF Doubt about the risk evaluations of glyphosate.  Internal meeting notes show that when looking at many of the objections the main focus was on finding the right wording to dismiss the objections (from previous responses, other chemicals, other regulatory agencies). Various tactics were used to dismiss the objections.  For example, PMRA would not respond to points raised, or mischaracterize the points so they could be dismissed.

PMRA used one tactic in particular on several occasions.  In its response to an objector, it would first say “We didn’t look at that particular issue or risk in the risk assessment”, and then move on and purport to look at the issue or risk in their response to the objector.  But the proper place for such an analysis was in the risk assessment, not these responses.  In our view, the fact that PMRA provided an analysis “after the fact” shows there was a gap in the initial evaluation.

 Three examples are set out below. 

Example 1: Glyphosate’s Impact on the Human Microbiome

One objector raised concerns about PMRA’s review of glyphosate’s impact on the human gut, or microbiome. She indicated the review was in inadequate, in that:

“There was absolutely no scientific evidence presented to indicate that independent studies have ruled out an impact on the microbiome or that such studies have even been undertaken”. 

PMRA’s response indicated that it does not require studies on the microbiome (WE DON’T ASSESS THAT RISK), even though the Act allows PMRA to ask the chemical company to provide additional data for the risk assessment, and if it does not then the Minister can remove the pesticide from the market.

PMRA then proceeded to look at the issue itself and dismiss it. It said that it looks for signs of toxicity on the gut, and to PMRA this is “considered protective of potential effects on the gastrointestinal tract”.  In our view, this is not a satisfactory response if problems can arise in the gut that may not be associated with toxicity in the gut.  

Other objectors raised the issue concerning the microbiome, and again PMRA looked at the issue itself and dismissed it.  The objectors pointed to eight animal studies in the Reading Room that showed signs of microbiome effects in animals, and indicated further study was required.  PMRA responded that there is information on the impact to the gut based on “in vitro” studies (meaning studies in in a test tube or laboratory dish), but then dismissed the issue with the statement that the evidence from “in vivo” studies (meaning studies on animals) is very limited and inconclusive. 

So even though there was evidence of a problem (evidence (in vitro), the chemical company was not asked for “in vivo” information.   

PMRA also dismissed the issue with the same type of “gut toxicity” explanation provided above.  It indicated that the doses in Canada are lower than those that cause system toxicity and so the doses “are therefore protective of potential effects of the gastrointestinal tract”.

Example 2: Glyphosate Chelates Minerals/ Metals

Objectors raised the point that glyphosate chelates (binds with) vital minerals in soil and plants, and this could lead to depletion of essential minerals and/or mobilization of some toxic metals in soil and plants, including perhaps cadmium which has been found in wheat.

PMRA responded with “PMRA does not currently assess the risk of the chelating potential of pesticides” (WE DON’T ASSESS THAT RISK).   It continued with the statement “however, the information provided in the NoO relevant to this comment was examined to determine whether it provides compelling evidence impacting the validity of the glyphosate risk assessment document”. It found that the one study provided was not compelling, then PRMA looked at the issue itself and dismissed it.  It provided its own explanation that “it is not expected that glyphosate will significantly affect the uptake of metals by plants in most situations”.

Example 3: Glyphosate’s Impact on Soil

Objectors raised the concern that the “PMRA failed to consider evidence of the effects of glyphosate on soil microbiomes”. PMRA responded with its previous statement “PMRA does not assess risks to soil microorganisms” (WE DON’T ASSESS THAT RISK).

However, PMRA then made the same statement as above, namely that it examined the information provided in the NoO to determine whether it provided “compelling evidence impacting the validity of the glyphosate risk assessment document”.  It added “Other sources of information were also consulted, for completeness”.

PMRA then took it upon itself to go on for eight paragraphs, the longest response for any of the objections, to ACTIVELY COUNTER the evidence presented in the objection. The evidence of the objectors showed adverse effects of glyphosate on individual microbial species and communities, and PMRA even agreed that glyphosate affects individual species and “could cause a shift in the assemblage of the soil microbiome”. But then PMRA pointed to other studies to suggest that some soil is not affected and that some soil activities may not be or are not affected.

When PMRA looked at the studies provided by the objectors, it did not disagree with them. It even agreed that one particular group of studies  “indicated that glyphosate caused adverse effects on mineral nutrition, microbial species/community and microbial activities in the soil of GR crop”.   To us, this appears to raise a doubt based on scientific studies that warrants further review. 

But instead PMRA countered the doubt with “a literature review of more than 8000 relevant peer-reviewed papers (Duck and Lydon, et al, 2010)” that disagreed. (Even though in its response on another objection it discredited review article information because “the review articles themselves, are not actual studies, but a summary of several individual studies”).

PMRA described this as a situation of “conflicting results”, then took it upon itself to provide an explanation for “these conflicting results on the effects of glyphosate exposure on the soil microbiome”.  The explanation resulted in PMRA dismissing the objection.

Summary of Examples.

In our view, the required scientific doubt was raised in each of these three examples by the very fact that the evaluation didn’t assess these three risks that had a scientific basis.  In our view the independent review panel should have been struck. 

Instead, the PMRA it took it upon itself to do the job of the independent panel, without having the scientific evidence that such a panel would require.  It provided explanations (“it is not expected” , “is considered protective”) without having data.  It found conflicting science, brought in studies not previously considered, and even resorted to literature reviews it elsewhere discredited. And then came to its own conclusions and dismissed the objections. 

This is not what the Act or the legislators had in mind. If it was, when could a review panel ever be struck? 

 Conclusion: Safe Food, and Other Risk Areas, Require Improvement 

Because safe food matters, we are working in the court system to get the PMRA to conduct proper risk assessments on pesticides that affect our food. 

Our hope is for improved risk assessment and objection processes that can be applied in other areas where there are risks to our health, risks to the environment, and risks to future generations.  Because we are living in a world of high risk;  now, perhaps more than ever before.

Please support us and help cover our legal costs in our David vs. Goliath battle.