IRA FLATOW: You’re listening to Science Friday. I’m Ira Flatow, and this week, a House committee held a hearing to review an Environmental Protection Agency proposal. The proposal is called Strengthening Transparency in Regulatory Science.

Researchers would be required to disclose underlying data, which could include private medical and health information for any scientific studies that the agency would use in determining environmental regulations. Scientists fear that the proposal could be used to weaken EPA regulations and discount scientific studies.

Plus, they fear the proposal could affect researchers who conduct long-term epidemiological studies. To talk about this further, let me introduce my guest. Lisa Friedman is a reporter for The New York Times climate desk. She wrote a recent article about the proposal. Thank you for joining us, Lisa.

LISA FRIEDMAN: Thanks for having me.

IRA FLATOW: Joshua Wallach is an assistant professor of epidemiology at Yale School of Public Health and a member of the Collaboration for Research Integrity and Transparency. Dr. Wallach, thank you for being with us.

JOSHUA WALLACH: Hi, Ira. Thanks for having me on the show.

IRA FLATOW: Just to try to get some reaction, we did reach out to the EPA for comment, and they provided the statement that in part says, “Science transparency does not weaken science, quite the contrary. By requiring transparency, scientists will be required to publish hypothesis and experimental data for other scientists to review and discuss, requiring the science to withstand skepticism and peer review.”

And that’s just part of a longer statement that you can read the full statement at ScienceFriday.com. Lisa, let’s talk about that. This is not a new proposal, right? This is an update to one that came out in 2018.

LISA FRIEDMAN: Right. I mean, there’s a lot to unpack there in how EPA is putting forward how it views this. But just to set the stage of what this is– this is an effort that, really, initially, took off under former administrator of the EPA, Scott Pruitt, but it has its roots in Congress.

Lamar Smith, the former Republican head of the science committee in the House, introduced legislation that would do just this. That would only allow the EPA to consider studies where the underlying data is made available publicly. It wasn’t able to pass Congress, and the EPA has since taken it up as a regulation.

It met with overwhelming opposition, about 600,000 comments heavily tilted toward deep concern from almost the entire scientific community. EPA said they were delaying the measure and it might come out again in 2020. And then we see from this leaked version that we obtained this week that EPA has been moving full steam ahead to move forward with and even expand this proposal.

IRA FLATOW: Mm-hmm. And speaking of expanding it, then what is in this new updated version? Lisa?

LISA FRIEDMAN: Oh, yeah, of course. Sorry. There’s a couple important things. But the first thing does is it says, EPA proposes broadening this provision to include all data and models rather than just restricting the coverage of the provision to dose response. And that being specific kinds of studies in which, for example, levels of toxicity are studied in humans or animals.

So they are both broadening the types of studies and dated models that would be covered by this. They are making it much more possible and likely to use this information retroactively. And by that I mean, that one could use this rule to not just allow future studies that don’t show all of the datas of models and, in some cases, confidential health information, but to no longer use studies that have been used in the past to uphold regulations when these regulations come up again.

One small example, every five years, the EPA reviews national ambient air quality standards. Those levels are based on a wealth of data that EPA has. This new version really calls into question, will the EPA be able to justify, if need be, strengthening some of the air quality standards by using, as evidence, some of these studies that have been used in the past? It seems unlikely, from this new proposal.

IRA FLATOW: Mm-hmm. Dr. Wallach, what is your feelings about this?

JOSHUA WALLACH: Yeah, this is– I was very glad to read the article in The New York Times that this was getting additional coverage. I spend my time studying open science and promoting reproducibility, and I’ve also been tracking this initiative since 2015. And it was part of a kind of strengthening of science proposal, but the concern really was about this so-called secret science that was happening at the EPA.

And I think the initiatives to ensure research as transparent is important, and I’m supportive of it. But I think responsible data sharing is necessary. And we shouldn’t judge research alone by one factor, which is whether or not the data alone is openly available. But we should make sure that we understand some of the limitations for certain studies when it comes to data sharing. In particular, when it comes to long-term studies that deal with human health.

IRA FLATOW: I know, as I mentioned before and you just talked about it, the proposal is called The Strengthening Transparency and Regulatory Science. You’re part of a group that works on transparency in scientific research. What is your take, then, on what transparency means in this proposal?

JOSHUA WALLACH: So based on my reading of this proposal and the previous ones, it is well aligned with the key definitions of “research transparency,” when it comes to open access to the information so that an external researcher or someone in the public can understand, assess, reanalyze, or replicate certain findings. And so, essentially, they’re talking about data transparency. So having, essentially, clean data available so that people can analyze it the same or different way.

So this aligns well with how I think about transparency, so making all of the information publicly available so that you can repeat the study designs, the methods. This includes the code and models, but the important thing that I think and that is such a such concern to me is that this can’t be the only factor that’s used to judge science. And there are many studies, just like the one that was mentioned the Six Cities study where we have to wonder whether or not we can actually make data openly available. And if we make data openly available for something like that, who will have access?

IRA FLATOW: Mm-hmm. Do you think that the EPA is trying to come up with a different definition of transparency? Trying to co-opt it?

JOSHUA WALLACH: No, I think that’s– the co-opting is a key concern, and also potentially using this as a method to exclude certain studies. I was listening to the hearing on Wednesday and some questions that were raised were related to well, how can we get access to the information from old studies to re-analyze and see whether or not something is true, whether or not a finding was true, and could that end up altering a regulation? How could we change a regulation?

So I do think there has been pressure with these previous proposals in 2015 and 2018 thinking about all right, if we have access to this data, what can we potentially change? So I worry that it could be used to pick and choose to choose data, and I think that’s concerning because it’s about accumulating evidence not about picking and choosing or excluding research findings.

IRA FLATOW: Lisa, there are patient protections, right? Like, HIPAA, to keep information private. Would HIPAA be able to override something like this proposal?

LISA FRIEDMAN: Well, it’s not clear. I mean, you know what EPA says in the sort of options they layout is they offer one option, for example, in which OK, let’s say we give confidential information just to researchers and not to the general public. Well, in addition to HIPAA, a lot of studies, like Harvard Six Cities have signed agreements with participants of their study that their personal information won’t be disclosed.

So it really leaves an open question– would EPA have the authority to grant the researchers the ability to view the raw data with personally identifiable information? If EPA doesn’t really have a legal ability to do, I think a lot of these questions are really still left open.

IRA FLATOW: Joshua, do you agree? Is there is there a worry that private patient data could be exposed under this kind of proposal?

JOSHUA WALLACH: Yes, I think it is a worry and it is a concern. And this is why there are so many questions and why there were 600,000 comments that were submitted when the 2018 proposal was released. A lot of concerns about there are certain studies with vulnerable populations where you have personal identifiable information– zip codes, you have birth dates, death information about timings for deaths.

And in order to reconstruct studies, some of this information would need to be available, and there are concerns about re-identification. And I’d like to note that when they claim that this isn’t the final version and it may not be the final version, but they do outline that they are considering different methods for data sharing. And I do think that some of these might be more viable.

So like, a tiered system is something that they note. And when you’re not dealing with human subjects research, I believe that there’s a clear need to make data as transparent as possible. But in order to make human subject research completely publicly available, that’s where I think there should be some additional threshold for who can access the information and who’s accessing the information for what reason.

IRA FLATOW: Yeah, Lisa, the EPA has made no secret about rolling back regulations and policies. Is this proposal just along those lines or is it anything different?

LISA FRIEDMAN: Well, look, I mean, I think there’s a couple ways to answer that. And first, I would just point out that I think part of what a lot of this comes down to, and I’d be interested in hearing Dr. Wallach’s view on this, is even a large part a matter of trust. I mean, because this administration has been so intent on rolling back regulations, in part there is a fundamental mistrust that this proposed regulation, which is, as the EPA contends, about transparency and openness and about scientific integrity, is really a straw man and a way to undo regulations.

Secondly, I’ll say, what this does is it is taking things another layer down. The EPA has rolled back dozens and dozens of environmental regulations. Measures like this go one step further. it cuts at the ability to create new regulations in the future. And not just rolling things back but curbing sort of the fundamental basis for creating regulations in the first place.

IRA FLATOW: Mm-hmm. I’m Ira Flatow. This is Science Friday from WNYC Studios. If you’re listening to us online and you’d like to tweet us or you can send us, @SciFri, S-C-I-F-R-I, a question and we’d be very happy to ask our guests.

So where does all this go from here? I mean, if this is a proposal now, is it still in flux? Is it open to new amendment? What happens to it now, Lisa?

LISA FRIEDMAN: Sure. So the next step is that the EPA– they say in 2020 maybe sooner, this rule is that the White House Office of Management and Budget right now, it’s getting White House review. The EPA contends that what is going to come out is going to look even different than what we’ve reported here. So we’ll have to wait and see just how different it is.

But EPA will formally propose a regulation. When that happens, they intend to give the public 30 days to comment– pardon me, they’re going to to formally propose that the supplements to the regulation. They’ll give the public another 30 days to comment on it, and they hope to finalize it in 2020.

This is a regulatory process, there isn’t really much of an amendment ability per se, but the agency will have to respond to the public’s comments. And it remains to be seen if that will prompt further changes or not.

IRA FLATOW: Mm-hmm. And Joshua, are you going to keep an eye out for this–

JOSHUA WALLACH: Yes.

IRA FLATOW: –proposal as it moves along?

JOSHUA WALLACH: This is something that I’ve been kind of tracking for a while and am going to continue to track. And we were one of the 600,000 comments, and a lot of the concerns that Lisa wrote about and a lot of the concerns that were voiced by other research groups and other individuals.

We voiced those same concerns. The EPA has a long and successful history of protecting the health of individuals and the environment, so we’re, of course, concerned about the manipulation of this. It’s impossible to argue with the importance of transparency, but when you’re jumping upon this movement in science, this transparency movement but potentially using it to exclude or discredit some science or to go after or to question findings, I think this is something that I’m quite concerned about and I’m continue to monitor.

IRA FLATOW: And you think other scientists will be watching it along with you?

JOSHUA WALLACH: Oh, I think that’s definitely the case considering– and thanks to reporting about this issue. I hope that scientists continue to look out for this, and they do submit comments and they do voice their concerns. And I hope that these concerns are answered in future versions of the supplement because it’s still kind of vague whether or not it’s fully prospective or retrospective, et cetera.

IRA FLATOW: Joshua Wallach, Assistant Professor of Epidemiology at Yale and Lisa Friedman, the reporter for The New York Times climate desk. Thank you both for taking time to be with us today.

JOSHUA WALLACH: Thanks for having me.

LISA FRIEDMAN: Thank you.

IRA FLATOW: You’re welcome. We’re going to take a break and we’re going to come back and talk about something you think about all the time– milking ticks, right? Some people who are milking ticks to find out all about how they behave and what’s in there. We’ll talk about it after the break. Stay with us.

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