Health Canada – through the Pest Management Regulatory Agency (PMRA) – is supposed to approve every pesticide used in Canada before it’s sold or used in Canada. While the PMRA itself cautions against claims that the pesticides it approves are safe, proponents of pesticide use often make just this claim. Meanwhile, environmental and health groups often see the PMRA as overly tied to industry and point to the difficulties in ensuring that pesticides are safe over the long-term (especially on the basis of laboratory testing provided by experts paid for by the pesticide companies).
But the question of how pesticides are evaluated and re-evaluated is especially important right now, as the PMRA is consulting the public on how it should conduct periodic re-evaluations of pesticides. This consultation, which was originally scheduled to close at the end of January, has been extended to March 2nd. Under the Pest Control Products Act every product is supposed to be re-evaluated every 15 years – and earlier if new science comes along. So the PMRA’s new approach to re-evaluation will have an impact for some time to come.
The proposed re-evaluation process
According to the PMRA’s consultation document, the current re-evaluation of pesticides originally registered before 1995 has had some fairly major results:
As of September 2010, over 90% of the 401 active ingredients covered under the original approach have been addressed, with the vast majority of assessments resulting in changes to the conditions of use. A significant proportion of the active ingredients (over 20%) have been identified for phase-out (i.e. discontinuation) as a result of the PMRA's review or voluntarily discontinuation by their manufacturers. Very few active ingredients have been accepted for continued use without any label changes.
So pretty dramatic changes (although it’s difficult to know if they go far enough). One might have thought that this was a success story from the PMRA’s point of view. However, the Agency notes: “there have been challenges and lessons learned” and is now proposing a fairly dramatic overhaul of the re-evaluation process.
The proposed process:
introduces a scoping phase early in the re-evaluation process during which the PMRA would complete an internal file review to assess the quality of the data already available to the Agency. This file review would include identifying recent evaluations for the active ingredient and a scan for new information such as new scientific literature and incident reports.
If a previous evaluation has not considered all available data or is not up-to-date, a new or revised evaluation may be required. … On the other hand, the file review may indicate that a previous evaluation in a specific area (e.g. dietary risk assessment) is acceptable as measured against current standards. The PMRA will complete an analysis to ensure that the conditions of use assessed in the previous evaluation remain reflective of the current situation - that is, nothing has changed substantially since the previous risk assessment. If this is the case, this component of the re-evaluation may be considered complete and the previous risk assessment will stand.
Our submissions on the new process objected strongly to this internal scoping phase for a number of reasons. While we recognize the need not to unnecessarily complicate re-evaluation processes, some of our concerns include:
- Self-evaluation: PMRA scientists are reviewing work done by PMRA scientists to determine its quality. This is hardly arms-length, independent or transparent. There may be circumstances (if the requirement of a review every 15 years is realised or where a special review is required) in which PMRA scientists are involved in assessing research that they were involved in, or which their superiors were involved in.
- Adequacy of information assessment: We are not scientists, but we wonder whether the quality of data can be truly determined from a cursory review of the type contemplated. Will new information that calls into question the impacts of inactive ingredients or particular formulations be enough to result in a broader review? What about studies showing developmental, reproductive or endocrine related health problems – problems which are not generally tested for by the PMRA and which are difficult to test for in a controlled manner? On this point a British study recently demonstrated that 30 of 37 pesticides examined block male hormones – a health issue not generally evaluated by the PMRA (or the US Environmental Protection Agency).
To what extent would an information assessment examine empirical and sociological information (which the PMRA can and should be tracking) about actual instances of pesticide poisoning, contamination or environmental-impacts, patterns of pesticide use, cultural attitudes of users, levels of compliance with the labels, etc.?
- Public Consultation: The Note seems to suggest at times that the scoping decision will not be open to public consultation. While noting the legal requirement to consult the public, the Note suggests that only some “stages in the re-evaluation” will be “open to consultations” and suggests that only “the PMRA’s conclusions [related to ‘those areas of risk assessment that require an update’] … will be published for consultation…” By contrast the result of the scoping phases (an “outline [of] the anticipated focus of the re-evaluation”) is to be shared with “stakeholders” – a term which may not include the general public. This further emphasizes the self-referential nature of the scoping decision and the potential for errors and abuse.
- Failure to quantify the New Approach’s impact: Finally, given that the PMRA has almost a decade of experience with the Old Approach it would be useful to know how the outcomes of the New Approach might compare. The PMRA could, for example, complete a series of parallel re-evaluations of pesticides under both the New and Old Approaches (conducted independently) and then compare the results.
This is not to say that there were not some significant problems with the current re-evaluation process. For example, the fact that re-evaluating endosulfan took about 8 years to complete (and the pesticide’s use won’t be phased out more than almost a decade after the review began).
However, it seems to us that the PMRA’s new approach does not really address those problems and instead will be less transparent and less accountable than the old process.
By Andrew Gage, Staff Lawyer
- Blog Post: Endosulfan - a Case Study in Re-evaluation
- Publication: West Coast Environmental Law Submissions on Pesticide Re-evaluation, January 2011