Regulatory capture is when a regulatory agency, like Health Canada, is captured by a particular group, like Syngenta, and serves the interests of that group instead of the public interest.
This is the story of how Syngenta captured the Pest Management Regulatory Agency (PMRA) of Health Canada in its assessment of the pesticide abamectin. The chapters show the actions taken by PMRA, and the Syngenta influence.
Abamectin damages the brains of the young. It is toxic to the developing young and/or the reproductive system, and suspected of damaging fertility or the unborn child. It is fatal if inhaled, and considered a highly hazardous pesticide.
PMRA intends to re-register this toxic pesticide and increase or expand the legal limits for residues allowed on many foods: including crops like tea, almonds, apples, blueberries, carrots, cherries, chives, corn, cranberries, eggplant, grapes, grapefruits, kiwi, oranges, lemons, pineapple, papaya, peaches, pear, pecans, peppers, plums, strawberries and tomatoes.
The re-registration is proposed in Proposed Re-evaluation Decision PRVD2023-01, and the increases and expansions are proposed in Proposed Maximum Residue Limits PMRL2024-13. Safe Food Matters Inc. provided comments in September, 2024, endorsed by Vigilance OGM.
In Europe, abamectin was recently restricted to use in closed greenhouses to prevent release into the environment, and even this is being challenged. In Canada and the US, there is no such restriction.
Chapter 1: Take Regulatory Actions that Serve Industry
(Syngenta says “jump”, PMRA says “how high?”)
In PMRL2024-13, PMRA says it needs to increase levels of abamectin and also expand these MRLs to all crops within a designated crop group. It says it needs to align with the “tolerances” allowed in the US so that “these food commodities may then be imported into Canada”. Syngenta requested the new MRLs.
This rationale – of needing to align with US tolerances – doesn’t hold water. History show that it was PMRA that first set the residue levels for many of these crops, not the US. In 2013, Syngenta requested that the PMRA set MRLs for most of the crop groups now covered by PMRL2024-13, because “[a]t the time, there were no US tolerances established for uses on these revised/updated crop groups/subgroups”. The PMRA obliged. (Dietary Evaluation – Integrated Assessment, PMRA 2021, p.12)
(For detail on all the foods included in crops groups, see Residue Chemistry Crop Groups).
Chapter 2: Discount Scientific Findings
(Syngenta Hides Sound Science, PMRA Discounts it)
PMRA’s assessment of the toxicity of abamectin is based on its 2016 Syngenta Evaluation Report. In this report, PMRA reviewed studies submitted by Syngenta, including two developmental neurotoxicity (DNT) studies, and also a “rationale to support a reduction in uncertainty factors”.
The DNT studies clearly showed abamectin was toxic. So much so, Syngenta withheld them from the European Food Safety Authority (EFSA). Once the EFSA saw them, it lowered the thresholds for toxicity (meaning it considered toxic effects to occur at lower levels).
PMRA did review the studies, but then discounted them – by calling the results “equivocal”. However, the results were unequivocal:
“At the mid dose, statistically significant reductions in measurements of several regions of the brain were noted in PND 12 and/or PND 63 animals [types of rats]. Consistently lower values for almost all brain region measurements were recorded for the low-dose group.”(Evaluation Report p. 3)
In science language, this means the hypothesis that abamectin caused the reduction in brain size was proven to a high degree of certainty.
The PMRA downplayed this finding by saying there were “interpretation” problems.
- It said there were “challenges in with respect to the interpretation of the .. brain data” because the pups who received high doses had died.
- For the low dose group, it said that storage conditions had an effect on the low brain and also not all brain areas were looked at, so the low dose findings ‘were of limited utility in assisting in the interpretation of potential adverse effects’, and that “in view of this, the morphometric findings noted in PND 12 and/or PND 63 animals and considered equivocal…”.
This explanation doesn’t cut it. Interpretation problems don’t detract from statistically significant findings.
Chapter 3: Ignore What Others are Doing
(PMRA Radio Silence)
When the EFSA finally saw the DNT studies, it lowered the quantities of abamectin associated with toxicity (endpoints/ points of departure) – for determinations of both the acceptable daily intake (ADI) of abamectin and the quantities that cause acute toxicity, the acute reference dose (ARfD). (See Appendix A to EFSA’s assessment).
In its assessments of abmectin, PMRA did NOT consider the DNT studies good enough to set the acute reference dose, but it did use them to set the point of departure for the ADI. PMRA did not comment on the fact that the EFSA thought the DNT studies were good enough to use to set acute toxicity, or the fact that the Europe registration has been restricted to just greenhouse uses.
In fact, it appears from the PRVD and the PMRL that the current assessment of the EFSA was not even reviewed by PMRA.
Chapter 4: Don’t Follow Your Own Policy
(Syngenta Feeds PMRA Bad Rationale)
The Evaluation Report indicates Sygenta submitted supplied PMRA with “a rationale to support a reduction in uncertainty factors”. PMRA apparently adopted this rationale completely, even though it conflicts with the Pest Control Product Act (the Act) and with its own policy Science Policy Note 2008-01: The Application of Uncertainty Factors and the Pest Control Products Act Factor.
The “Pest Control Product Factor” is to be applied when running the numbers for a risk assessment, and it requires a safety factor of 10 be applied to levels of pesticides used around infants and children, so as protect them. Section 7(b)(iii) of the Act says this factor can only be lowered on the basis of “reliable scientific data”.
Science Policy Note SPN2008-01 indicates that if studies show a “serious endpoint” this indicates a high degree of concern and:
“[i]f the level of concern is high, the 10 fold PCPA factor will be retained”.
The abamectin studies showed at least three serious endpoints: congenital malformations, pup mortality, and reduction in brain size. SPN2008-01 also indicates that if a low dose elicits a high, disproportionate response, there is a high degree of concern, because “[a] steep dose response could heighten concern since a small increment in exposure could have a significant impact”. The Syngenta Evaluation Report reported that:
“A steep dose-response was demonstrated in many of the studies”.
But PMRA did not “retain” the 10 fold PCPA factor despite the high degree of concern shown by at least 3 serious endpoints and a steep dose-response. It instead adopted a rationale that spoke to only one of the serious endpoints – the reduction in brain size of rat pups shown by the DNT studies – and concluded “there remains uncertainty with respect to sensitivity of the young’.
The rationale was that rodent infants are more sensitive than humans with respect to abamectin toxicity because of differences in expression of a protein and development of the blood-brain barrier; and it is unclear how abamectin would impact humans “during critical periods of fetal development”.
However, data to support this rationale was not discussed in the Evaluation Report, even though this is what the Act requires. Also, the entire internationally accepted scientific process for determining toxicity proceeds on the basis of animal studies, and accounts for differences between humans and animals by application of a different uncertainty factor. Conjecture and explanations on how the pesticide affects humans are not relevant to this process.
The Courts want regulatory agencies to follow their own policies. In fact, the 9th Circuit Court of Appeals in 2022 disallowed the attempted reregistration of glyphosate by the Environmental Protection Agency, on the basis of such “inconsistent reasoning”.
The rationale provided by Syngenta is scientifically and legally unacceptable. Yet PMRA adopted it.
Chapter 5: Don’t Disclose Damaging Info
(Highly Uncertain Data Doesn’t Serve Syngenta)
The new levels of residues proposed on crops in PMRL2024-13 are almost all “uncertain estimates”. This is the warning message spit out by the OECD Calculator, the tool PMRA uses to set MRLs. It is proprietary to Monsanto. Below is the output page for a subgroup of the crops, for illustration purposes. Details regarding the other uncertain estimates can be found in SFM’s comments.
PMRA did not disclose these “high uncertainty” warnings in its public facing documents. In fact, when Safe Food Matters asked for them, it was told PMRA does not keep the output pages because they are “transient” files. PMRA in the end reran the calculations for some of the crops, as set out above.
These warnings are completely relevant and should be part of the public facing documents for two reasons:
- First, because PMRA is supposed to apply a scientifically based approach in its assessment of pesticides (s. 7 of the Act) and it purports to adopt such an approach when using the OECD Calculator for setting MRLs.
- Second, PMRA cannot legally approve a registration unless it has “reasonable certainty that no harm to human health, future generations or the environment” will result from exposure to the product. This “reasonable certainty” means certainty based on science, and with uncertain MRL estimates there can be no such reasonable certainty.
Transparency and disclosure of relevant information serves the public interest because it provides “the opportunity for public participation to enhance decision-making and increase public confidence in it”. (Safe Food Matters Inc., v. AG 2022 FCA 19)
Not disclosing such information serves the interests of Syngenta.
The End of the Story
In the story of abamectin, we’ve seen evidence of capture: from PMRA working with Syngenta to set up the first MRLs, to PMRA discounting valid scientific findings of the DNT studies and ignoring their relevance in Europe, to accepting Syngenta’s spurious scientific rationale even when it conflicts with PMRA’s own policy, to not disclosing information that could damage the proposals requested by Syngenta.
In the face of clear science showing the toxicity of abamectin, particularly to the young, this story of the capture of PMRA may end with Canadians consuming a highly hazardous pesticide on many foods they eat everyday.
Let’s be clear: capture of a regulator means the capture of individuals. The only hope for a happy ending is:
– identify the people prone to capture, and
– put in place safeguards and checks to prevent capture of the regulator and its people.
