In a recently released draft risk assessment for chlorpyrifos, the EPA determined that it would exclude some highly controversial research conducted at the Columbia Center for Children’s Environmental Health (CCCEH) because the center has refused to release the underlying data.
Green groups are crying foul, saying the EPA’s decision is a “harbinger” of what will come if the agency succeeds in implementing its rule to promote transparency in science. But transparency is a basic tenant of science, and it is necessary for researchers to reproduce the result to determine if a study has any weight. Read more about that here and here.
This case is a perfect example as to why we need a federal requirement that all science underlying regulation be transparent.
Right now, the EPA’s rule to promote transparent science is under review at the Office of Information and Regulatory Affairs (OIRA), which is a division of the White House Office of Management and Budget (OMB). While we have commented that the rule could be stronger, it is a step in the right direction and hopefully the agency will eventually finalize this proposed rule. And other agencies should follow the EPA’s example.
The EPA’s decision makes sense because, without the data, it is impossible for the agency to examine its quality and attempt to reproduce the study findings. The CCCEH claims that it can’t release the science because that would violate the confidentiality of the participants, but that’s a smokescreen. There are ways to make the data anonymous, and CCCEH could release it to the agency itself or to a limited subset of researchers who could then validate it. But the center is unwilling to release it perhaps because the researchers relied on questionable data to generate their preferred result.
The study in question maintained that children whose mothers had higher exposures to the chemical—as measured in umbilical cords—were more likely to experience developmental delays or neurological problems such as autism. The researchers conducted a statistical analysis to determine if higher levels of chlorpyrifos in the umbilical cords correlated with reduced neurodevelopment among the children. They reported that the children whose mothers’ umbilical cords had the highest levels of chlorpyrifos experienced greater developmental delays.
Even without releasing the data, it’s obvious that there were serious problems with the research, as highlighted by the EPA’s Science Advisory Panel. I detailed many issues in a paper on the topic in 2017; here is an excerpt with key details:
A majority of the panel members indicated that the agency’s reliance on a single study for its risk assessment was “premature and possibly inappropriate.” In addition, panel members raised many other significant concerns about the design and implementation practices of this specific study as well. They noted that the data was not an accurate measure of exposures.
- Using blood cord data as a measurement for exposure to infants was not appropriate. The panel noted: “Because many uncertainties cannot be clarified, the majority of the Panel does not have confidence that the CCCEH cord blood data on chlorpyrifos levels can accurately be used in quantitative risk assessment to determine a Point of Departure (PoD).” In addition: “Given the ~5 day terminal half-life of chlorpyrifos, it would seem unreasonable to think that the chlorpyrifos concentration in blood at birth would directly influence the chlorpyrifos blood concentration between 1 and 2 years of age.”
- This data set was particularly weak because it involved only one-time measurements, which may not represent actual exposure during pregnancy.
- The study offered inadequate information about “exposure patterns, labor and delivery, and blood collection.”
- Much of the data was basically fabricated. Agency officials guesstimated data for a “large fraction” of samples because the chemical exposure was too low to detect in the samples. When researchers found no traces of the chemicals, they used a “default” number rather than zero, which they had to make up without any data to support it.
- The CCCEH researchers did not employ “good laboratory practices,” which are government standards designed to ensure sound scientific practices.
- CCCEH researchers failed to make key portions of their data available, which means the study lacked transparency; hence the study could not be reproduced and validated.
- Biological plausibility that the chemical could impact neurodevelopment was questionable because all the levels measured were extremely low: concentrations were all in the “low parts per trillion.”
Clearly, this study is highly problematic and should have been excluded in the first place. However, at a minimum, if the CCCEH researchers and their green activist allies want this study to play a role in the reregistration, they should willingly provide the data in some format, but they simply refuse.
The EPA notes on its website that it requested the data from Columbia University numerous times, including on December 2014 (see Appendix 6, p. 384), April 19, 2016 (denied by the center in May 2016), June 27, 2016, January 17, 2017, January 2, 2018, and January 8, 2018.
It’s worth noting that, had the greens launched a misguided crusade to ban this chemical, even the Obama EPA may have approved it. In fact, the registration process was ongoing when President Obama was in office, and the agency was moving toward approval without relying on the CCCEH study. But that changed during Obama’s last year in office as green groups lobbied hard for the EPA to change course.
You can read all about it in my paper on the topic, but here’s a quick overview. Shortly after completing its last reregistration in 2006, which found the product was safe for agricultural uses, the Natural Resources Defense Council and the Pesticide Action Network of North America petitioned the agency, asking it to ban the chemical, and they have launched lawsuit after lawsuit to pressure it to implement a ban.
During the Obama years, EPA staff were moving toward rejection of the petition, but suddenly changed course as Obama was finishing up his lame duck term. The agency proposed a ban that solely relied on the CCCEH study. That’s when the agency’s Science Advisory Panel pointed out the study’s many flaws, but the Obama EPA proposed accepting the petition to ban the product anyway during the fall of 2016, and the Trump EPA rejected that proposal in 2017.
The Trump EPA has continued to assess the chemical’s safety profile and has rightly demanded that any decision be based on solid, validated science. The CCCEH study does not come close to meeting that standard—a reasonable assumption even without seeing the data. It’s generous for EPA staff to even bother to pursue accessing the data and considering the study at all.
It’s worth noting that, despite the fact that the CCCEH is university-based, it does not focus on producing independent, objective science. This center is more akin to an activist organization than an academic one, as I detailed several years ago. It is also part of a network of groups jointly funded by the EPA and the National Institutes for Environmental Health Sciences (NIESH), which is a division of the Centers for Disease Control and Prevention (CDC) at the National Institutes of Health (NIH). As detailed on my paper on that topic, these groups by and large peddle a left-of-center, environmental activist agenda. The EPA wisely cut its half of the funding last year, but NIH continues to fund them.
Now that EPA has taken a stand for science, we can expect alarmism on this issue to heat up in the media. The have already begun to dredge up false narratives, such as asserting that the chemical causes brain damage in kids. But don’t fall for this misinformation. You can read more about those issues here, here, and here.
We must remember, farmers need access to technologies like chlorpyrifos to produce a safe and affordable food supply. Accordingly, regulations should rely on the best science to safeguard public health and safety, allowing safe use of essential agricultural tools that benefit us all by making food more accessible.
That is why the EPA’s refusal to accept this activist-produced junk science, without even being able to access the data, should be highly commended, and activist hype dismissed.