Deep Dive Episode 132 – A Conversation with EPA Administrator Andrew Wheeler: New Rule on Guidance Procedures and More

A Regulatory Transparency Project Webinar

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In May, the Environmental Protection Agency announced a new proposed rule to “establish the procedures and requirements for how the U.S. Environmental Protection Agency (EPA) will manage the issuance of guidance documents subject to the requirements of the Executive order entitled ‘Promoting the Rule of Law Through Improved Agency Guidance Documents.’” The EPA indicated that they “intended to increase the transparency of EPA’s guidance practices and improve the process used to manage EPA guidance documents.”

The comment period for the proposed rule closed in late June. Join us for an update and an informative conversation with Administrator Wheeler and Jeffrey Holmstead.


  • Andrew Wheeler, Administrator, Environmental Protection Agency
  • Moderator: Jeffrey Holmstead, Partner, Bracewell LLP
  • Introduction: Nathan Kaczmarek, Vice President & Director, Regulatory Transparency Project and Article I Initiative, The Federalist Society

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Event Transcript

Nate Kaczmarek:  Good morning. Welcome to the Regulatory Transparency Project’s webinar conversation with EPA Administrator Andrew Wheeler. My name is Nate Kaczmarek. I’m Vice President and Director of the Regulatory Transparency Project for The Federalist Society. As always, please note that all expressions of opinion are those of our guests on today’s program. 

The Regulatory Transparency Project, or RTP, promotes a national conversation about innovation, opportunity, and regulatory policy. And today we are thrilled to bring you a great conversation about the EPA’s new rule on guidance procedures and I’m sure much more. We’re fortunate to have Jeff Holmstead guide this morning’s conversation. 

Jeff is a partner at Bracewell LLP. He’s a former assistant administrator of the EPA’s Office of Air and Radiation. He previously served on the White House staff as associate counsel to former president George H. W. Bush, and he was a law clerk to Judge Douglas Ginsburg on the U.S. Court of Appeals for the District of Columbia. He received his B.A. from Brigham Young University and his JD from Yale Law School. Jeff is also the chairman of RTP’s Energy and Environment working group, and we are so grateful for his continued leadership there.

If you’d like to learn more about both of our guests today, you can visit our website—that’s—where we have our guests complete bios. In a second, I’ll turn it over to Jeff who will introduce the Administrator and guide this conversation. After their discussion, we’ll go to audience Q&A, so please think of the questions you’d like to ask the Administrator. Questions can be submitted -- for those of you who have joined us via Zoom, to ask a question you simply need to send it through the chat function. And that will go directly to Jeff. With that, Jeff and Administrator Wheeler, thank you very much for joining us today.

Jeffrey Holmstead:  Well, thank you, Nate, for that very kind introduction. I hope some of my clients are on the phone. It’s really a pleasure for me to introduce the head of EPA, the EPA Administrator Andrew Wheeler. I think most of you are familiar with some of his history, so I’m not going to go over it in detail. 

But let me just remind folks that he has been at EPA since April of 2018 when he was confirmed by the Senate to be the EPA Deputy Administrator. But then he was named as the acting EPA Administrator in July of that year and was then confirmed by the Senate as the head of EPA in February of 2019. I’m happy to be able to say that I’ve known Andrew for a long time, long before he was the head of EPA, going back to his days as a staffer in the Senate. 

Altogether, I think he served a bit more than 12 years as a member of the staff of the Senate Committee on Environment and Public Works, both as chief counsel to the Subcommittee on the Clean Air Act and Climate Change and then ultimately as the Republican Staff Director and as the most senior staff member of that committee for more than six years. Andrew also, actually, I think began his career, at least his professional career, during the administration of George H. W. Bush when he was a special assistant to an EPA Assistant Administrator. And he has also spent some time in private practice as the team leader of the energy and environmental practice group at FaegreBD Consulting where he was a principle. 

And he knows firsthand how regulations can affect the private sector. I also wanted to mention just a few things you might not have found on his official website. Those of you who know him well know that he loves Coca-Cola products. He loves The Lord of the Rings, both the books and the movies. I can say that, like me, he is a proud Eagle Scout, and probably most importantly he is a proud Ohioan who has his own secret recipe for Cincinnati-style chili, which he serves to his friends on important occasions and is insistent that they give it a try, even if they don’t think they like Cincinnati-style chili. 

Maybe most importantly I think what I would like to say is Andrew is the first Administrator in EPA history who came to the Agency with an enormous amount of knowledge and understanding about EPA’s regulatory programs and who also came with a commitment to both protecting the environments and making sure that regulation was sensible and reasonable. I will say as a former EPA appointee that, even in Republican administrations, administrators typically come and are only concerned about leaving some sort of an environmental legacy. 

And Andrew is equally concerned about that and also in proving the institution of EPA and adopting regulatory reforms that will be enormously important, I think, not only during this administration but for many years to come. So with that, I would like to turn the time over to our guest, the EPA Administrator Andrew Wheeler. 

Andrew Wheeler:  Thank you, Jeff. And I think maybe we should just end the call right now because I don’t think I can top what you’ve just said. Thank you very much for that introduction. I really do appreciate that. Thank you, Jeff. I want to thank Nate and The Federalist Society for hosting this today. But I suppose since we do have some people that have called in expecting me to talk I probably should go ahead with my remarks, even though I think there’s nothing I can say that will top what you just said. Thank you. 

So today I am very pleased to announce the final step in President Trump’s bold Executive Order to shed light on the federal regulatory guidance process. Last October, the President signed Executive Order 13891, which directed federal agencies to finalize regulations that “set forth processes and procedures for issuing guidance documents.” Guidance documents were being used by Executive Branch agencies to adopt what amounted to be regulations that imposed legally binding requirements on the public. 

This historic Executive Order is trying to change that and provide a transparent public process in which these documents are developed. President Trump directed the entire federal government to tackle two very important things that had never been done before: the first, create an online portal where these guidance documents would be posted for the public to see; the second, to develop a rule to codify a process for the development of guidance documents that includes public participation. When it comes to guidance documents, many have pointed to EPA as the poster child for reform. For years, the Agency was criticized for not making guidance documents, which are nearly the force of law, available for public review. 

Until directed by President Trump through his Executive Order, thousands of active guidance documents were not easily accessible to the public. Someone would have to go to a physical reading room, often in Washington, D.C., and go through file cabinets searching for documents that applied to them or applied to facilities in their neighborhoods. I remember when I was in private practice and I came in with my client to talk to -- I don’t want to identify the program office because they were very helpful -- but to talk to them about not even a regulation but whether or not the EPA had ever made any public comments or guidance regarding a part of a law. 

And we met with the attorneys who had worked on it for over 15 years. And they told us that they weren’t familiar with anything that the Agency had ever said on this subject matter, but they recommended that we hire somebody to go through the file cabinets because it’s very possible that something could have been said 30 or 40 years ago on the topic, which is not acceptable. It’s not acceptable for any federal agency to do that and to not make this information available to the public. 

The easiest way would have been to hire a law firm in D.C. to do the research. These lawyers would have binders of printed guidance documents to sift through. It was a very inefficient and expensive way to determine if guidance documents applied to you and, quite frankly, no way to run a federal agency or federal government. 

The cost of these guidance expeditions became a major barrier to anyone wanting to improve their communities, facilities, or companies. This was also a potential barrier to compliance for regulated entities. If you didn’t know the guidance document existed, how could you comply with it? 

Last year, EPA went through all of our guidance documents from the Agency’s beginnings 50 years ago. We asked ourselves whether the documents should be retained or rescinded. In February, we met the EO deadline by launching the first ever online portal of active guidance documents. We brought these guidance documents out of darkness by publishing them online, making our entire set of active guidance documents available to the public for the first time. 

It was a major undertaking by the staff here. I want to particularly commend Brittany Bolen and her staff in the Office of Policy for all the hard work. But it took work across all of our program offices, staff across the board, to shift through all the guidance documents. Ultimately, on the portal we have approximately 10,000 guidance documents, so people had to identify all of them, look at them to determine whether or not we needed to keep them, retain them, and then put them on the portal. 

During that process, we rescinded 1,000 guidance documents -- 1,000. So almost 10 percent of the guidance documents that the Agency had we rescinded earlier this year. Some of this was just plain housekeeping, and the guidance was no longer applicable. Some of the guidance that we rescinded was in draft form for over two years. 

If a document lingers in draft form for years on end, how can the regulated community be expected to follow it? This uncertainty put the regulated community in a bind. Do they poke the proverbial bear and ask when a guidance document will be finalized or wait for an enforcement action? Regulatory certainty is crucial for industry and the public. 

Let me be clear. Guidance documents can be important tools that provide certainty and clarity to the public and regulated community. Well-designed guidance documents serve many important functions in regulatory programs. EPA provides guidance to interpret existing law, clarifies the Agency’s view on the legal requirement, and helps clarify existing obligations for the public. 

But the reality is that guidance documents have been abused in the past to impose obligations on the public without any public notice and comment requirements. We recognize that the Agency has used guidance to regulate the public without notice or transparency. So this May, we proposed a rule to ensure guidance documents are subject to a formal development process, used appropriately to serve the public, and developed with transparency and notice to the public. 

We received dozens of public comments providing helpful feedback that we considered and crafted into a final rule. Today, just five minutes before joining this call, I signed the final guidance rule for the EPA. This is the first time our Agency has codified consistent requirements and procedures for guidance document development. 

This rule sheds light on guidance document development and provides for public participation in the process for the first time ever. Transparency is the cornerstone of good governments. The government always benefits from public input and participation, and it is crucial the government serves the people. 

This new rule, which I signed today, one, increases the transparency of our practices around guidance. It ensures guidance is subject to a formal development process. It is making the development of guidance accessible by establishing a public participation process. It creates specific procedures for the public to petition for withdrawal or modification of existing guidance documents. 

It improves the Agency’s process to manage guidance documents. It establishes minimum information requirements for petitions and requires that EPA respond to petitions within 90 days. It establishes minimum requirements for significant guidance documents, such as a 30-day comment period and disclaimer language stating that it does not bind the public. It also requires approval by the EPA Administrator or an assistant Administrator and interagency review under Executive Order 12866. And it requires guidance documents issued by EPA regional offices also be approved by the headquarters assistant administrator responsible for administrating the particular program. 

This is a huge change in administrative procedures at EPA, probably the biggest change in at least a generation. The American people deserve to know what their government is doing. The American public has a right to this information. They have a right to a seat at the table, and they have a right to understand what the government is doing, why they’re doing it, how it will affect them. And they have a duty to speak up and have their voices heard. 

This administration is prioritizing good government practices and transparency. Our guidance reforms are just one of the five pillars of reforms that we have put in place over the last three and a half years or finalizing before the end of this year. The other four pillars include reforms on our benefit-cost analysis, science transparency, regional realignment, and lien management. 

The cost-benefit rules will, for the first time, define how the Agency calculates the cost and benefits of proposed rules because the American public deserves to know the basis of our regulations. We’re also creating a science transparency rule -- umbrella rule for the entire Agency before the end of this year. And then we will start on individual science transparency rules on a statute by statute basis. People deserve to know what the science is the Agency is relying upon in order to justify our regulations. I really do believe that the more transparent we are on science and the more transparent we are on cost-benefit will make our rules more acceptable to the public and to the regulated industries. 

As Jeff mentioned, I started my career in the early ‘90s here at EPA. I worked on the Community Right to Know Act, and I fundamentally believe that all communities in the country have a right to know about the justifications for all of our regulations. I believe the science transparency regulation in particular has been attacked by a number of different groups and organizations. But I really do believe that those attacking the science transparency rule would rather have our decisions made in smoke-filled backrooms instead of transparent to the entire public. 

Our fourth pillar is our regional realignment that makes it much easier for community members to interact with the Agency. In the past, for example, we didn’t have a Clean Air Division in all of our regions. You could go to a region website and have to struggle to figure out which division in each region you needed to talk to. Today, all of our regions mirror the same organizational structure as our headquarters. 

And finally, we’ve implemented a lien management system throughout the Agency to improve the way that we operate. We must hold ourselves accountable to a common set of standards. When President Trump entered office, he called for all permits to be decided within two years, not approved, but decided. My predecessor, Administrator Pruitt, set a goal of six months for the EPA to make decisions on permits. 

What we quickly discovered, however, was that the Agency was not tracking how long it took to issue a permit. You cannot improve a process unless you know how long the process takes. So for the first time in our 50-year history, we now track how long each permit takes, and we are hitting our six-month goal on the majority of cases. 

In the last few years, thanks to the leadership of President Trump, the EPA has course corrected, and we are building a better Agency with a better version of government for the 21st century. A government of the people, by the people, and for the people requires transparency and public participation. And that is what we are doing here today.

EPA’s work affects the lives and welfare of all Americans, and the public needs to know what actions we are taking that may impact their lives. I am proud to affirm that we have made tremendous progress over the last few years and that America’s environment today is cleaner than it’s ever been in our lifetimes. I believe today’s action will help to ensure that this and future administrations will do the people’s work with people’s knowledge and consent in a transparent manner. I’m happy to take your questions. Thank you.

Jeffrey Holmstead:  Thank you very much, Administrator. As the moderator, I’ve been given the opportunity to just ask you a few things before we turn it over to everyone else who’s on the call. And I guess a question that a lot of us have -- and this goes certainly to this guidance but also to the upcoming rules on cost-benefit analysis and science transparency. Will there be any kind of enforcement mechanism to make sure that private parties that may be adversely affected by an EPA decision that doesn’t follow these procedures -- will that be a basis on which to challenge an EPA action, that the agency didn’t follow its own procedures?

Andrew Wheeler:  Yes, absolutely, which is why we’re doing this by regulation. Courts generally review an agency’s compliance with its own regulations, so we believe that all these actions will be reviewable in the courts. And this is going to help enforce the transparency for the next 50 years of EPA’s existence. 

Jeffrey Holmstead:  Okay. I think that’s great to hear. One of the concerns that I know a number of companies have had is that often it’s useful to be able to get EPA, I guess, informal guidance. It’s astonishing. As detailed as EPA’s regulations are, I’m amazed at how many new issues arise that EPA may not have thought about but that has to do with how regulations may apply in a particular circumstance. Will this new process make it more difficult for EPA to provide that kind of clarification on certain questions?

Andrew Wheeler:  No, I don’t believe it will. This rule does not affect our ability to continue to issue nonbinding direction. Rather, this will provide additional transparency regarding new guidance. So if we’re giving direction to a particular facility or company, that would not be impeded at all. 

Jeffrey Holmstead:  Okay. Okay. I obviously haven’t read the final rule yet, but I did go back through the proposal over the weekend and noticed that, not surprisingly, more procedural requirements and, in particular, an opportunity for comment only applied to significant regulation -- I’m sorry, significant guidance as opposed to all guidance. And there’s a definition of what a significant guidance document is. And like the Executive Order, it refers to guidance documents that could have a predicted impact of $100 million or more to the economy. 

In the proposal, EPA points out that it historically has not issued that kind of guidance. And in my memory, I can’t think of -- well, maybe I can think of one guidance document that might exceed 100 million, but in general, that hasn’t been EPA’s practice. But I notice that the definition of “significant guidance document” also talks about -- and I have in front of me here. So significant guidance means guidance that may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. But then it also says, “or adversely affect in a material way a sector of the economy.” 

There are certainly a number of rules -- I’m sorry, a number of guidance documents that may be important to an individual sector but don’t rise to the level of having $100 million a year impact on the economy. Is there a way for a sector, a trade association, a group of companies to ask the EPA to treat guidance as significant, even though it doesn’t clearly cause $100 million of impact on the economy?

Andrew Wheeler:  Yes, there is a way, and they can, in fact, petition EPA. But significant guidance also includes the ones that have novel legal or policy implications. So it’s not just the $100 million threshold. And one of the changes -- you mentioned you haven’t had an opportunity to read the final rule yet. One of the changes that we added from the proposal to the final is we put in a process to allow the public to petition to reinstate rescinded guidance documents. So if we do rescind a guidance document, especially the 1,000 that we rescinded, we now have a process in place for the public to petition us to reconsider those rescinded guidance documents. 

Jeffrey Holmstead:  To your five pillars on regulatory reform and transparency, I would add a sixth that is near and dear to my heart having to do with the Environmental Appeals Board. And I guess this is more of a comment than a question. But for many years, the Environmental Appeals Board, which was solely a creature of convenience for the administrator that said, you know, “I don’t want to deal with all these issues here. Here’s this board.” 

And over time, that board actually came to rule on some important legal questions and, in a couple of cases, even disagreeing with something that the Administrator had said. Can you just comment a little bit more on how that rule fits into your overall efforts to reform the Agency and how it works?

Andrew Wheeler:  Sure. You may be right. Maybe we should consider it as a sixth pillar. I’ve kind of looked at the Environmental Appeals Board reform that we did this year as sort of more of an outward facing process on dealing with the permits. But you’re right. It does change how the Appeals Board and it probably should be a sixth pillar. I’m looking at my staff now to tell them to please add it into my future speeches as the sixth pillar.

And you’re right. The Appeals Board is not supposed to issue a ruling counter to what an administrator has said because the Appeals Board is an extension of the administrator, and it was created by Secretary Reilly, I believe -- Bill Reilly. And he was very interested in the reforms that we did. And he wanted to make sure that we kept the Appeals Board.

But it’s important to remember when he created the Environmental Appeals Board that we were responsible for almost all the permits issued in the country. And today, I believe it’s around 96 to 97 percent of all water permits are issued by the states. And on the air side, all the air permits have been delegated to all but two states. So the workload for the Appeals Board has decreased over time, but the amount of time that they were taking on individual permits was considerable. And we wanted to make sure that permitees had the opportunity to go ahead and go to court much faster than what they were able to do if their permit was stuck in the Environmental Appeals Board.

So we did institute some reforms on the Appeals Board this year. And I know you weighed in on that at one point, and I appreciate your advice there. And it is very important. It is very important reforms that we’ve done. And there’s probably a lot of other reforms that I’m missing. 

When I started with the Agency, I vowed to make sure that the Agency would be in better shape when I leave than when I found it, not that it was in necessarily bad shape. But you did point out in your introduction that most administrators focus on one or two big policy initiatives, and they haven’t really focused on the day to day operations of the Agency. I came to the Agency as the Deputy Administrator, and I planned to focus on the operations of the Agency. And I guess I haven’t really given up that portfolio since I became the Administrator.

But I do believe that there are a lot of changes that we’ve made. In addition to these six pillars that we’ve talked about today -- a lot of them through the lien management process where we have improved the amount of time it takes to review state implementation plans, to move communities from nonattainment to attainment. I was very distressed to learn when I got to the Agency -- and I guess I should have known this before -- but there are a lot of communities that hadn’t -- that qualified for attainment status under the NAAQS but didn’t bother to apply for it because the process is so technical and takes so long that they just kept their status as nonattainment. 

And we have worked, and we’re continuing to work, to speed up that process so that if a community -- if a city has attained the NAAQS standards they should be able to move from nonattainment to attainment in a much easier fashion. So there’s a lot of reforms that we’ve done across the board that I haven’t really gotten into today that are very important for the way the Agency operates. 

Jeffrey Wheeler:  Well, thank you. Let me ask you about one other thing that I know you’ve talked about as one of the key priorities when you came to EPA, and that was the effort to rebalance the relationship between EPA and the states. As you well know, under all of the environmental statutes -- and the one, of course, that I know the most about is the Clean Air Act -- but there’s a significant amount of discretion that is ultimately given to states as long as they meet sort of minimum requirements. But over time, EPA essentially displaced states in a number of areas where, sure, the state was technically granting the permit, but they knew that if they didn’t do it the way EPA wanted that there was going to be problems. 

Do you feel like you’ve been successful in making the kind of institutional reforms that will ensure that that balance considers to be appropriate, that EPA is responsible for the things that, by statute, it is responsible for, but that states are given the kind of discretion and authority that they were intended to have originally?

Andrew Wheeler:  I believe so. I believe we’re moving in that direction. A perfect example is the pervious administration issued ten times the number of federal implementation plans as the four previous administrations combined, which is just a horrible situation. Instead of working with the states on the state’s submitting state implementation plans that could be approved, the Obama/Biden administration just issued FIPs, Federal Implementation Plans, ten times as many as the previous four administrations.

So we have reversed that trend. And since March of 2017, on average we have turned one existing FIP into a SIP each month. So we definitely want to work with the states more. We want to work with the states more on permitting. One thing we are going to do -- and it’s kind of a double-edged sword. We want to provide more resources for the states—and this is a second term goal for us—on helping them review the permits since the majority of permits are done by the states.

But at the same time, as we have improved the amount of time it takes for us to review permits, we want to make sure that the states are making improvements there as well. When we delegate programs to the states, the only real metric that we look at when we review that state program is the enforcement metrics. Starting next year, we’re going to be reviewing the permitting metrics as well, and I think that’s going to be a very important development. And I think it’s something where, as we do that, it will help us, and it will help the states. 

One other area that we’re looking at for the second term—and I announced this in my speech at the Nixon Center two weeks ago—is more of a focus on communities and on community-based environmentalism. And one aspect that we are looking at doing is combining a number of our smaller grant programs into one grant package for local communities, for cities to apply for. So instead of having to apply for separate grants for environmental justice, for children’s health programs and the water program or the Clean Air program, we want to combine those into one master grant application for the states. 

And what I’ve told the staff, however, is, if we take ten grant applications and each one is ten pages long, we can’t give the city 100-page grant application. So we have to streamline what we ask for in the grant applications. And I think this is going to help, one, communities think holistically on all their environmental issues and problems at the same time. But it’s also going to help the EPA think holistically and help tear down some of the silos that we have. 

The Agency is very siloed, as you know. We have our air program. We have our water program. We have our chemicals program, and we have our lands and hazardous waste program. And the Agency has not done a great job historically of working on cross-media issues across all of the programs. And I think our administration has had two big successes there. The first is our lead strategy, and the second is our PFAS strategy that we announced a little over a year and a half ago. 

And the PFAS strategy was the first time -- and I know that there are people out there that think we’re not moving fast enough -- but that was the first time we looked at all of our statutory authorities for an emerging chemical of concern, including our enforcement authorities all at the same time. And we’ve been implementing that strategy document over the last year and a half. We’ve made tremendous progress across the board. 

And that’s the first time the Agency in its 50-year history has really done that for a chemical of concern like the PFAS family of chemicals. And I think that’s a great pilot or poster child for what the Agency should do in the future. We shouldn’t have to create a special committee, which we did, of both senior and political staff across the Agency to produce that document. 

It was mostly written by the career staff, and I’m still applauding them. They got it done very quickly. But we shouldn’t have to do that. That shouldn’t have to be pulled together on an ad hoc basis. We should be able to look at things more holistically. And I think by trying to structure, starting with some of our grant programs into one holistic environmental grant for cities will help the Agency look more holistically at environmental cross media issues. 

Jeffrey Holmstead:  There’s a number of questions, and I’m going to get to them. But I want to ask one other question before I look through the list of questions you have from participants. 

Andrew Wheeler:  Sure. 

Jeffrey Holmstead:  So there’s, I think, a lot of folks who were listening who appreciate the good work you’ve been doing at EPA. And so my question is -- and I didn’t give your staff a heads up I was going to ask this question. But assuming there is a second term, how long can we expect you to remain the EPA Administrator? Another four years? 

Andrew Wheeler:  I serve at the will of the President. 

Jeffrey Holmstead:  That’s a very good answer. 

Andrew Wheeler:  He did call me this past spring and told me to start working on my plans and the agenda for the second term, which we’ve been doing and I laid out at the Nixon speech. And I certainly intend to remain here. I’m personally committed to remain at least another two years because there’s a number of things I want to see to completion. We should have finished all of our cost-benefit regulations by the end of 2022, and we should be well on our way of completing all of our individual statute regulations for the science transparency. There’s a number of things that I’m working on that’s going to take some more time, and I want to be here to see those to completion. 

Jeffrey Holmstead:  Okay. Great. Well, let me now turn to the questions that have been submitted by email or I guess on the chat feature. There are a couple that point out that there are some helpful documents, whether you call them frequently asked questions or pre-enforcement rulings, that people have relied upon, which they believe are helpful. Is there a mechanism by which -- and what they pointed out is those aren’t on the list of guidance documents that is currently in the portal. In the final rule, is there a way to seek clarification about the status of those documents that people believe are helpful and that they’ve relied upon in the past?

Andrew Wheeler:  I think there is. And while this covers all guidance documents, the Executive Order on the definition to exclude certain types of documents that we issue, such as guidance pertaining to internal operations directed to EPA employees are not considered guidance documents for the purposes of this, nor are guidance to grantees, guidance provided to specific facilities, not intended to have general applicability, and legal opinions or court filings. So as far as Q&A, if it’s written in the manner that it would be a guidance document, then that would have to be considered a guidance document. But I would imagine that most Q&A would not be considered guidance documents for the purposes of the EO. 

Jeffrey Holmstead:  Well, let’s say that it is a historic memorandum that folks have relied upon that does not appear on the list of documents. Isn’t there a mechanism for people to request that it be included? 

Andrew Wheeler:  Absolutely, yes. So the public can always reach out for clarification on a specific document. And as I said, they can petition to have a rescinded document reinstated. Or they can also petition to have an existing guidance document rescinded. And if there’s something that the Agency has put out that the people in the public believe should be considered a guidance document, they can also request that we consider that as well. So yes, the public has the opportunity in all three situations to ask for something to be considered a guidance document. 

Jeffrey Holmstead:  And then does the rule require EPA to actually respond to those petitions? As you know, people can submit petitions to EPA that often linger for years and years. 

Andrew Wheeler:  Yes, and that was -- and I have to admit that that was the subject of much internal debate on how to address that. And we ended up having a 90-day period where we have to respond to a petition. So we would have to respond to any petitions we receive within 90 days. 

Jeffrey Holmstead:  And again, so if EPA does not respond within 90 -- and again, maybe it’s because I’m a lawyer. I think of bringing lawsuits. But I assume that, if EPA doesn’t follow that regulation, then someone could attempt to bring a lawsuit -- a deadline suit. In my experience, EPA tends to settle those very quickly. If it’s a clear deadline, they say, “Okay. We haven’t met the deadline, but we’ll agree to do it by a date certain.” 

Andrew Wheeler:  Yes. By putting in the 90-day deadline and the fact that this would be -- that people could challenge any of our decisions in court under this regulation, you’re right. If we failed to meet the 90-day deadline, then that would be cause of action to go to court and enforce us to meet the deadline. Which is why, as you can imagine, there was considerable discussion between myself and the assistant administrator before we decided on the 90-day deadline. 

Jeffrey Holmstead:  I just wanted to follow up on that. It seems to me that, if you were inundated with petitions, it would be very difficult to give the kind of responses that EPA normally gives. So for example, under the Clean Air Act, as you may be aware, there’s this petition process where if someone challenges a permit term, they have a right to petition the EPA administrator. And it often takes months or even years for EPA to respond to those, just in part because they give such a fulsome, extended, well-reasoned response. 

Is the intention that EPA will have an easier way where you can simply say in response to a certain petition “This petition doesn’t meet our definition of guidance,” or “This petition --” I’m just anticipating a workload issue that, if EPA does the kind of responses that are done in response to Title V petitions, it just doesn’t seem like it could possibly be done within 90 days. 

Andrew Wheeler:  Yes, and that was part of our discussion. And you’re right. There certainly would be instances where the decision could be fairly quick, where we notify the person that we don’t consider it to be a guidance. We have minimum criteria for petitioners that they have to -- on the petition where they submit to us. And quite frankly, we may have a large number immediately of people petitioning us, but I’m guessing the number of petitions we receive will be a manageable number. 

It’s not really a petition to change a sentence or two in the guidance document. It’s whether or not the guidance document should be rescinded or whether or not something should be put out as a guidance or maybe put out as a regulation. But it’s not an opportunity to nitpick on individual lines of a guidance document. So it’s the overall guidance document that people would have to petition. So I believe after maybe an initial flurry of petitions that we will end up with a manageable workload over time. 

Jeffrey Holmstead:  Okay. Let me just read a couple of questions. Here’s one that I hope is easy for you, but I didn’t know the answer. It simply says, “Where on the EPA website may I find the list of 10,000 or so guidance documents” -- oh, I’m sorry. “Where can I find the list of the 1,000 or so guidance documents that EPA decided to remove?” So is there a list somewhere of those that were rejected as guidance documents?

Andrew Wheeler:  I don’t believe that that is publicly available at this point, no. The 10,000 guidance documents that are available are on the website. The public can -- well, if they are aware of a specific rescinded guidance document, they can certainly petition us. But we’ve not made the 1,000 necessarily public. Perhaps that’s something that we should do. 

Jeffrey Holmstead:  Okay. I’m just asking the question. I’m not -- you know --

Andrew Wheeler:  Sure. I’m just trying to answer. 

Jeffrey Holmstead:  So this is an interesting one, and it strikes me as one that probably comes from someone who either worked at EPA or OIRA. It says, “If the definition of ‘significant’ tracks as Executive Order 12866, it is binding in fact. If it meets the definition of a significant guidance document under this rule, it would --” I’m sorry. Let me get to the bottom-line question. 

Basically, the question here is how can a guidance document be expected to have $100 million in impact if it’s nonbinding? And my understanding is, as part of the rule, they’re supposed to state that the guidance documents are not legally binding. So is there a tension there? 

Andrew Wheeler:  I think there’s always an inherent tension with guidance documents to begin with. Guidance documents are typically, as you know -- and you were responsible for some of the 10,000 guidance documents that we have on the portal today. There is, of course, an inherent tension between a guidance document and a regulation. And that’s -- this does not necessarily solve that problem. 

What this does is try to provide more transparency in what the Agency considers guidance documents. We also discussed internally whether or not the requirement of allowing the petition and going out for notice and comment for major guidance documents -- why not just do a regulation instead because you have to go through the OIRA process? And I think you’ll see over time my prediction is that we will probably end up issuing more regulations and fewer guidance documents as a result of this. 

So we’re going to have to see how all this plays out in time. This is a huge change in the way this Agency operates. We put out probably more guidance documents than almost any other regulatory agency. And again, I want to applaud the staff. We were the first major agency to comply with posting the guidance documents on the portal. Most other departments and agencies had to request extensions for the Executive Order.

And we have really put a lot of time and resources and energy in not only the portal, going through the 11,000-plus guidance documents, but also this regulation. But as any new program, any new regulatory program, there’s going to be some growing pains. And we’re going to have to figure out how all this is going to operate. But my commitment is to have transparency in all of this.

Jeffrey Holmstead:  So just out of curiosity, are you aware of any other agency that surpassed the number of guidance documents that EPA identified on its website? 

Andrew Wheeler:  Not offhand. There may be, but if there are, they’re probably still working on it because I’m not sure that all the agencies have actually fulfilled the first part of the Executive Order. 

Jeffrey Holmstead:  Here’s, I think, an important question. This questioner pointed out that NATA, the National Air Toxics Assessment, has created confusion and, in this person’s view, unwarranted fear regarding certain chemicals. So NATA, as you know, is not, I guess, official. But some of the values that are used in NATA create real issues regarding particular chemical compounds that many people believe are unwarranted. Is there part of this process that can be used essentially to ask EPA whether to consider certain parts of NATA as guidance documents that should be, perhaps, even revoked or modified? 

Andrew Wheeler:  Perhaps. But for the most part, we decided that statements on -- for example, under the IRIS program, those aren’t guidance documents. If we’re putting out scientific documents or scientific information, it’s not necessarily a guidance document. It may be a guidance document may be when one of our program offices uses the information in those assessments or decisions for a guidance or a regulation. 

So we decide that the scientific documents like that were not necessarily be considered a guidance document. I could see where if one of them ends up providing actual guidance to the regulated community or to any regulated parties that that might be considered a guidance document. But for standard questions of science, that’s not considered a guidance document. 

Jeffrey Holmstead:  Okay. Are there any upcoming significant guidance documents that people should be keeping their eye out for? There certainly have been some court decisions recently that have created, I think, some uncertainty, especially under the Clean Water Act. Are you able to tell us that maybe there may be important guidance forthcoming on some of those issues?

Andrew Wheeler:  There may be. I’m supposed to be briefed soon on our response to the Maui decision, for example. And I know we’re looking internally at whether or not we can respond appropriately via guidance or if it’s going to require a regulation. And I’m not sure where the team has -- I’m not sure what their recommendations are. They haven’t made their recommendations to me yet. 

And then, for example, under the Navigable Waters Protection Act, which replaced WOTUS, we are working on a number of guidance documents that will be going out the first -- and I believe those are already out to the Army Corps inspectors. But we’re going to be making guidance documents to go out to help people understand probably on an industry by industry basis what the requirements are under basically the new WOTUS rule.

So we are working on a number of guidances that I’m personally aware of. We’re also turning some of our guidance documents into regulations. For example, on NSR, I’m not announcing anything this week, but I might be next week.

Jeffrey Holmstead:  I will look forward to that with great anticipation. When you look at the process that this regulation requires for significant guidance documents -- and I think you acknowledge this. It looks a lot like a notice-and-comment rulemaking. Is the expectation that in those cases a final guidance document would be a final Agency action that would be subject to judicial review? 

Andrew Wheeler:  I think certainly in some instances guidance documents have been interpreted by the courts as final agency actions. And I agree that it appears as though we’re setting up the same type of notice-and-comment process that we have for rules. Which is why I think ultimately I think you’ll see the Agency going and -- I’m not talking about the next six months but maybe over the next few years we’ll probably turn more of these potential guidance documents into actual regulations. 

And if you have to go through the notice and comment for a guidance document, why not go ahead and put it out as a regulation? So I think you will see maybe newer -- additional number of regulations and maybe fewer guidance documents. But I think that’s fine. Again, the important thing is that all this be made public and transparent. 

Jeffrey Holmstead:  And I’m sorry if it looks like I’m looking away from you. I’m reading the other questions just to make sure that I’ve covered them all. And I think I have, but there is a question here asking whether the final rule prohibits EPA from issuing guidance documents that have legally binding effect on private parties. Does the -- will EPA always use notice-and-comment rulemaking if it intends to impose requirements on private parties? Or does this allow the Agency to issue guidance documents that are legally binding? 

Andrew Wheeler:  No, I don’t believe so. I believe if it imposes obligations on private parties we would have to go through the normal rulemaking process. This does not change that. By shedding -- and again, by shedding light on what the Agency has put out in guidance in the past, I think there’s going to be a lot of scrutiny by -- probably a lot of scrutiny by NGOs on some of the guidance documents that they not have been aware of but also scrutiny from people in the industry when they look at some of the guidance documents that maybe they weren’t aware of either that their competitors were. 

So I think this is going to level the playing field on anyone who has to comply with our regulations. And I think this will provide more transparency and information to concerned citizens, concerned community groups and some of the national NGOs. 

Jeffrey Holmstead:  Have there been any lawsuits yet challenging documents that were put on the portal? 

Andrew Wheeler:  Not that I’m aware of. No. 

Jeffrey Holmstead:  Okay. I think that I’ve managed to cover -- I will tell you there’s several questions about this -- some concern that there are helpful documents that people have considered guidance that are not on the portal yet. But it sounds like the final rule gives people a process that would allow them to ask EPA to add documents to the portal. So I will note that that is a concern that several people have raised. 

But other than that, I see our time is up. I think I’ve covered all the questions that have been asked, and I thank you for your time and for the effort that you’ve put into reforming a number of parts of EPA’s process, including this rule, which I think will be very helpful. 

Andrew Wheeler:  Well, Jeff, I really appreciate your time today in moderating this and, again, the introduction. But I also appreciate the advice you’ve given me since I was first nominated to be the Deputy Administrator. You and I have had several conversations, and I appreciate your advice and your guidance -- and that’s guidance with a small ‘g’ -- that you’ve given me over the years on this topic and on several others, including the appeals court. Thank you. 

And Nate, again, I want to thank you and The Federalist Society. This is a very important announcement that I don’t believe has really gotten any press. But I think it’s very important to the legal community. It is again a generational change in the administrative procedures of the way the Agency operates. And I really do appreciate you allowing me to highlight this for everyone out there because I think this is something that everyone should be aware of. Thank you, Nate. Thank you, Jeff. 

Nate Kaczmarek:  Thank you. Certainly our pleasure. I think it was a momentous and informative discussion. We’re very grateful to Jeff Holmstead and, of course, Administrator Wheeler for your time and excellent conversation today. 

I’ll just note that RTP -- our next webinar is set for this Thursday at 7:00 p.m. The program is entitled “The Future of our Health,” and features a great panel, including former FDA Chief Counsel Dan Troy and former FDA Principle Deputy Commissioner Dr. Josh Sharfstein. So we hope you can join us this Thursday night for that event. As always, to our audience we welcome your feedback on today’s program by email at [email protected]. Thank you all for joining us. Have a great day.