The 9th Circuit Court of Appeals made a very straightforward administrative law judgement — they did not make any statement on the health or safety of glyphosate. EPA made a language mistake (inconsistent logic) in their registration decision memo, something clearance should have caught, but didn’t. And so now they get another bite at the apple to fix their mistake.
On June 17, 2022, the AP ran a story that says, “A federal appeals court on Friday rejected a Trump administration finding that the active ingredient in the weed killer Roundup does not pose a serious health risk and is “not likely” to cause cancer in humans.” That appears to say that the 9th Circuit Court of Appeals found that glyphosate is a serious health risk, and that EPA’s conclusion that glyphosate is “not likely” to cause cancer is wrong.
This is another case of a great deal of nuance being dropped in favor of simplification. When it comes to administrative law courts aren’t typically in the business of saying chemicals are safe or unsafe. Courts generally lack the expertise to make those decisions, so they vacated and remanded (that’s the fancy way of saying they took out what they felt was wrong, and they sent it back) to the Agency for further consideration. That’s what happened here.
1. What Did the 9th Circuit Court of Appeals Actually Say?
The Court’s opinion is here, and it’s rather short and easy to read.
To be clear:
The 9th circuit court of appeals did not REJECT epa’S FINDING THAT GLYPHOSATE IS SAFE
Here’s the Lyle’s Notes version:
1.1 On Cancer
The Court found that EPA violated its own Cancer Guidelines. The Court believes that EPA cannot say that the evidence for non-Hodgkin’s lymphoma is inadequte and then turnaround and say glyphosate is not likely to cause cancer.
The Court’s argument boils down to this: to say something is not likely to cause cancer you need evidence that it doesn’t cause cancer. If you lack that data then you cannot make any conclusion about whether or not it causes cancer.
Seems reasonable.
So did EPA conclude that glyphosate is “not likely to be carcinogenic to humans”? Yes, see page 10 of the Glyphosate Interim Registration Review Decision.
Did EPA also conclude that there was “insufficient evidence to conclude that glyphosate plays a role in any human diseases”? Yes, see page 10 of the Glyphosate Interim Registration Review Decision.
So what do the Cancer Guidelines say should be done? If there is “little or no pertinent information” regarding the ability of a chemical to cause cancer, or if the “negative results…are not sufficiently robust for the descriptor, “Not Likely to Be Carcinogenic to Humans” then the descriptor “Inadequate Information to Assess Carcinogenic Potential” must be used. [EPA Cancer Guidelines, page 2-57].
1.1.1 But…EPA Actually Concluded…
If you read EPA’s epidemiology review, you’ll see what EPA actually concluded regarding the epidemiology data on non-Hodgkin’s lymphoma:
We conclude that this additional information…does not impact the
US EPA, 2020 — Epidemiology Review of Zhang et al. (2019) and Leon et al. (2019)
conclusions presented in the EPA Revised Glyphosate Issue Paper which itself concludes that the strongest support based on the weight-of-evidence is for glyphosate being categorized as “not likely to be carcinogenic to humans”.
So, wait a second. EPA concludes here that there is sufficient information to state that glyphosate is “Not Likely to Be Carcinogenic To Humans”. But in their Interim Registration Review Decision they say the data is inadequate in one place, and in another they say the data is clear that glyphosate is “Not Likely to Be Carcinogenic To Humans.” What gives?!
1.1.2 EPA Forgot The Key Rule of Writing Regs…
It would appear that whoever wrote, or more likely edited and cleared, the Regulatory Decision document made a very unfortunate mistake. It appears clear, based on the evidence provided in the Epidemiology Review that EPA feels like there is sufficient evidence to conclude that glyphosate is “Not Likely to Be Carcinogenic To Humans”. Therefore, EPA never should have used the language “insufficient evidence to conclude that glyphosate plays a role in any human diseases.”
The reason is clear: EPA made “insufficient evidence” a special phrase in terms of the Cancer Guidelines. Thus, it appears that EPA is making a declarative statement using a special phrase. In common English usage what EPA wrote would not be a problem, but for, the Cancer Guidelines.
This is a clear mistake that occured at the clearance level — and should be turned into an opportunity to teach the next generation of all EPA scientists and managers the importance of “key phrases” in regulatory decisions.
1.1.3 So the Court Vacated Part of the Registration Decision
The Court vacated and remanded the part of the Interim Registration Decision regarding human health to the EPA for additional thought, based on the Court’s reasoning.
My Prediction: EPA is likely to update it’s language inconsistencies, and make very clear that there are no human health issues, cancer or otherwise, with respect to glyphosate. EPA will then draw the conclusion that glyphosate is “Not Likely to Be Carcinogenic To Humans”.
1.2 Endangered Species Act Claim
The Court concluded that EPA failed to perform its consultation requirements with the US Fish and Wildlife Service or the National Marine Fisheries Service. However, the Court did not vacate parts of the Interim Registration Decision, other than the human health part (discussed above). Instead, the Court found that the Interim Registration Decision did have some protections/mitigation to prevent ecological impacts, and they did not want to vacate those protections/mitigations else the resolution would be worse than EPA’s prescription (i.e., getting rid of ecological protections is worse than having some).
1.3 NRDC’s Ecologial Risk Assessment Challenge
The Natural Resources Defense Council (NRDC) challenged the ecological risk assessment, the cost-benefit analysis, and the mitigation requirements mentioned above. The EPA asked the Court to allow it to revisit these aspects, thus remanding (sending it back to EPA), without vacating (dropping/getting rid of) ecological risk assessment, cost-benefit analysis, and the mitigation requirements. The Court requires EPA to still meet Congress’ October 2022 deadline for the Registration Decision on Glyphosate.
