Summary: Health Canada is being forced to re–evaluate glyphosate and accept comments until June 11, 2015. It proposes to do nothing except change the labels on glyphosate products. However, the Science Evaluation relied upon lowers the legislated safety factor for children by a factor of 10 (except for one endpoint), and does not address demonstrated toxicity to mammals, bird, bees, arthropods, aquatic organism (including fish) and ground plants. It also explains away the WHO finding that the substance is “probably carcinogenic to humans”.
The Pest Control Products Act (the “Act’) requires a re–evaluation of glyphosate at this time, because it has been registered for 15 years. Glyphosate is an herbicide and the active ingredient in “Round–up” and is being applied to forests, crops, outdoor parks and domestic lawns. The feds proposed decision (“PVRD”) (full text attached) is that “products containing glyphosate do not present unacceptable risks to human health or the environment when used according to the proposed label directions”.
This is despite the finding by the World Health Organization that “the herbicide glyphosate… is probably carcinogenic to humans“ and despite the link between glyphosate and gluten intolerance and celiac disease.
Health Canada (“HC”) gets around the WHO cancer study by stating “[I]t is important to note that [the WHO’s] hazard classification is not a health risk assessment. The level of human exposure, which determines the actual risk, was not taken into account by WHO (IARC)”.
But the Science Evaluation in the PVRD, which purports to examine exposure, is problematic in on at least 3 fronts:
- 1. the PVRD skews the exposure analysis for infants and children;
- 2. it ignores exceedances of levels of concern for mammals, birds, bees and arthropods;
- 3. when there is a recognized exceedance, the solution is to change the labels on glyphosate products.
Risk Analysis Skewed for Children and Infants:
- HC removes the safety threshold for children: The Act (s. 7) requires the application of a 10–fold factor to the exposure threshold for assessing exposure of children and infants to glyphosate in food and spraying around homes and schools (unless the Minister determines a different margin would be appropriate on the basis of “reliable scientific data”).
HC’s Fix? Health Canada looked at studies on rats and rabbits, and on this basis indicated there were “no residual uncertainties” and overall did not apply the 10 fold factor for the young and infants PVRD p.17) (although it did apply a 3 fold factor for one endpoint, fetal cardiovascular malformations).
- HC changes the exposure assumption: The aggregate risk assessment looks at the combined potential risk associated with food, drinking water and various residential exposure pathways. The initial exposure assumption was 2 applications of glyphosate with a 7 day interval in between them, which was based on label directions (PVRD p.25). However it was found that with these assumptions, children younger than 2 years old were exposed at levels exceeding the targeted margins of exposure (MOE) for the “postapplication + incidental oral exposure + chronic dietary scenario”.
HC’s fix? (PVRD p. 28) Look at just 1 application, and take the average of residues over a 7 day span. The reason provided was “it is unlikely that children would be exposed to turf residues of the highest rate, at the lowest interval of application immediately after application”. But how does Health Canada know on what day’s infants play on grass in domestic and public spaces?
Risk Analysis Explains Away Levels of Concern for Mammals, Birds, Bees and Arthropods
The Science Evaluation in the PVRD sets out a “screening level” of risk assessment then a second level “refined” risk assessment (PVRD p.31). The results of the screening level risk are compared to a level of concern (LOC), and if the LOC is exceeded then a “refined” risk assessment is performed to look at “more realistic exposure scenarios”.
The LOC was exceeded in ALL instances in not only the screening level risk assessment but also the refined risk assessment for mammals, birds, bees and arthropods (including the springtail) in at least one category. In the PVRD the exceedances are simply explained away to support the conclusion that the risks are low. Typical was the explanation for mammals (PVRD p. 35): “This [refined] assessment found only very small exceedances of the LOC and concluded that the risk to mammals from acute oral and reproduction exposure to glyphosate and its formulations is expected to be low.”
The Proposed Regulatory Action is “Label Amendments”
With respect to aquatic organisms, the LOC was exceeded for most organisms at the level of both the screening level assessment and the refined risk assessments that took into account spray drift and run–off. The LOC was also exceeded at both levels for terrestrial plants (except the LOC was not exceeded for seedling emergence at the refinement level).
HCs fix? Put more information on labels. The label changes include: statements that glyphosate is toxic to aquatic organisms and ground plants; buffer zones for application; directions to not spray during periods of dead calm, or when winds are gusty; to not spray above plants to be treated; and to “apply only when the potential for drift to areas of human habitation or areas of human activity such as houses, cottages, schools and recreational areas is minimal”.
What to do?
You are likely exposed to glyphosate every day. If you don’t trust that label amendments will stop your exposure:
- provide comments to HC by June 11, 2015. Comments are to be emailed to pmra.publications@hc–sc.gc.ca HC has provided a form for comments.
- HC is required to consider the written comments (the Act, s. 28). Ensure they do.
- HC is also required by law to consult affected provincial departments before making a final decision. Contact your provincial representative to ensure accountability on the province’s comments.
Any person can request a Special Review (the Act, s. 17(4)) at any time, and the Minister shall conduct it if there are reasonable grounds to believe that the health or environmental risks are unacceptable, taking into account the precautionary principle.
Full text of PVRD: PRVD2015-01-eng (1)