[00:00:00] Speaker 00: Case number 25-1140. [00:00:04] Speaker 00: Inray, Iowa's Church of Healing, petitioner. [00:00:07] Speaker 00: Mr. Steele, petitioner. [00:00:08] Speaker 00: Mr. Sturgill, respondent. [00:00:11] Speaker 00: All right, Mr. Steele, good morning. [00:00:13] Speaker 00: Good morning, Your Honors. [00:00:14] Speaker 00: My name is Simon Steele. [00:00:16] Speaker 00: I represent Petitioner, Iowa's Church of Healing, which I'll refer to as the church. [00:00:21] Speaker 00: I'd like to reserve two minutes for a bottle, please. [00:00:26] Speaker 00: In Roman Catholic Diocese of Brooklyn v Cuomo in 2020, it took the US Supreme Court just 16 days to grant a petition to exempt Catholic sacraments from public health laws restricting gathering sizes. [00:00:42] Speaker 00: The court treated that matter as an emergency based on the well-established principle that the loss of First Amendment freedoms, even for minimum periods of time, unquestionably constitutes irreparable injury. [00:00:57] Speaker 01: No doubt, but the use of a schedule one hallucinogen was not on the other side of the balance. [00:01:04] Speaker 00: To be sure, Your Honor. [00:01:07] Speaker 00: But just to be clear, in this case, my client has been subject to a prior restrict on its primary sacrament, completely prohibiting the sacrament for a total of 80 months. [00:01:18] Speaker 00: Now, to be clear, in our petition on pages 9 to 14, we detailed the history of that. [00:01:24] Speaker 00: We concede that some of that period of delay was due to us. [00:01:29] Speaker 00: However, more than five years of that delay has involved the application and or supplemental information [00:01:37] Speaker 00: sitting in front of the DEA and the DEA taking no apparent action on it. [00:01:43] Speaker 00: The DEA took no action on our application for the first three years. [00:01:47] Speaker 00: For the past 15 months it's taken no application until a week ago. [00:01:51] Speaker 01: Could I ask what basically you're seeking? [00:01:56] Speaker 01: At times you say [00:02:01] Speaker 01: What you primarily want is just the registration and you understand the government's concerns and you're willing to work with them on diversion controls and record keeping and all of that. [00:02:17] Speaker 01: And yet on the face of the application, you are asking for a blanket exemption from everything. [00:02:25] Speaker 00: Right, so we've attempted to follow the government's guidance, which you see in Appendix B. The guidance isn't entirely clear as to what the preferred procedure is. [00:02:37] Speaker 00: It's very clear that the DEA will decide what the procedure is. [00:02:41] Speaker 00: Our position all along has been [00:02:44] Speaker 00: However you folks want to handle this, we're prepared to fill out any forms you want. [00:02:49] Speaker 00: We're prepared to go through all the regulations. [00:02:52] Speaker 00: If you want us to, you know... [00:02:56] Speaker 00: tie the safe to the wall with brackets and so on. [00:03:01] Speaker 00: We'll do that. [00:03:02] Speaker 00: If you want us to do all the registrations, we'll do that. [00:03:08] Speaker 00: If you want to waive some of the registrations, you can do under 822D and 957. [00:03:13] Speaker 00: We'll do that. [00:03:16] Speaker 00: We're happy to do it anyway. [00:03:20] Speaker 00: We got a bit more guidance than the [00:03:22] Speaker 00: the guidance document itself, at least we thought we did, when we saw the Church of the Eagle on the Condor case, where the government entered into a detailed settlement a year and a half ago, and we immediately proactively said, [00:03:37] Speaker 00: folks. [00:03:38] Speaker 00: We understand every case is different. [00:03:39] Speaker 00: We'll understand mutatis mutandis. [00:03:41] Speaker 00: You'll want to change a few details, but we're happy to follow precisely the protocol that you did there. [00:03:48] Speaker 00: We're happy to fill out the registration forms. [00:03:51] Speaker 00: The government gave us certain forms when they did the site inspection back in July 2024. [00:03:56] Speaker 00: We filled them out immediately. [00:03:58] Speaker 00: The government has at various points said, we don't want you to do it like this. [00:04:04] Speaker 00: We want you to do it like that. [00:04:05] Speaker 00: One thing where our position has shifted, but it shifted in response to the government, is we originally said we plan to import plants from which the ayahuasca would be made. [00:04:18] Speaker 01: So the short answer is you're willing to work with them. [00:04:21] Speaker 00: absolutely has been true all along, and with the one exception of the period between 22 and 23, when we were in Comunicado for a while, we have responded essentially within a week as we did last week, and I hope you received the documents that were sent two days ago. [00:04:40] Speaker 00: We've responded immediately to all of these queries. [00:04:43] Speaker 00: And I'd also like to note that [00:04:46] Speaker 00: of the church against the IRS that at that point we were addressing the issue of is the church essentially an illegal entity that's trying to do illegal stuff? [00:05:03] Speaker 00: And we still are, but if you look at the government's correspondence in every question they've asked for the last two to three years, with long gaps in between, it's all been about [00:05:14] Speaker 00: registration details, and as you say, Judge Katz's anti-diversion details, it hasn't been about whether we essentially have a right under RUFRA to do this. [00:05:26] Speaker 00: It's been about, okay, what are the precise details that we're going to work out as to how we latch the safe to the wall and which forms we fill out. [00:05:35] Speaker 04: I expect counsel for the government might get up and say, this is a mandamus petition. [00:05:40] Speaker 04: What we did last week shows we're on it. [00:05:44] Speaker 04: There's no need for the court to intervene. [00:05:46] Speaker 04: Could you just directly address how you would answer that argument? [00:05:49] Speaker 00: Absolutely, Your Honor. [00:05:50] Speaker 00: There have been several cases in this court where this court has heard this [00:05:54] Speaker 00: that argument from various government agencies, call communications, center for biological diversity are certainly two such cases. [00:06:06] Speaker 00: What this court has typically done is sort of take what is almost like a trust but verify [00:06:12] Speaker 00: kind of approach to that. [00:06:14] Speaker 00: Okay, the government says it's on it and that's great. [00:06:18] Speaker 00: We'll retain jurisdiction. [00:06:20] Speaker 00: We'll either set a deadline or we'll require the government to report back in 30 days or so. [00:06:27] Speaker 00: And in this case in particular, again, I would stress if you look at the correspondence from last week, what were they asking for? [00:06:37] Speaker 00: They were asking for, okay, who are your suppliers? [00:06:42] Speaker 00: We told them. [00:06:43] Speaker 04: Your supplier, how much and will you bolt the fridge? [00:06:46] Speaker 04: You told us about 15 months ago to the great. [00:06:48] Speaker 00: We told them back in January 2024, we named waking herms one of the suppliers that we've listed. [00:06:53] Speaker 00: We provided all their details then. [00:06:55] Speaker 00: OK, we've got some updates now unsurprisingly after a year and a half, but it's not like we were the delay there. [00:07:03] Speaker 00: They were the delay. [00:07:04] Speaker 00: Why did it take them 15, 15 months? [00:07:07] Speaker 00: Indeed, almost two years since January 2024. [00:07:10] Speaker 00: to ask us to confirm that detail. [00:07:12] Speaker 00: That should be a one-day question. [00:07:14] Speaker 00: Why did it take them 15 months after a site inspection to say, hey, your safe looks great. [00:07:21] Speaker 00: Can you just pin it to the wall and show us how you've pinned it to the wall? [00:07:24] Speaker 00: That should be a one-day conversation. [00:07:26] Speaker 00: It took 15 months at the end of a process that's taken six and a half years. [00:07:32] Speaker 00: So we're here to, we continue to want to work with them. [00:07:37] Speaker 00: We're very hopeful that [00:07:39] Speaker 00: The correspondence last week is a positive sign, but we are here after six and a half years and countless unreasonable delays to frankly ask this court to hold their feet to the fire in terms of getting this done soon. [00:07:51] Speaker 02: Let me ask you about 822D. [00:07:56] Speaker 02: And unless I'm reading it incorrectly, it says the attorney general may by regulation waive the requirement for registration and so forth. [00:08:07] Speaker 02: Now, it doesn't say anything about guidance. [00:08:09] Speaker 02: It says by regulation. [00:08:11] Speaker 02: And if you had done what the Native Americans had done with peyote, which was by a rule, and they had sat on your petition for a rule for six years, [00:08:25] Speaker 02: You'd be in a lot better. [00:08:26] Speaker 02: position, at least in our ability to say, make a decision DEA. [00:08:35] Speaker 02: Why am I reading this wrong? [00:08:37] Speaker 02: In other words, when I read it, I thought, well, I would think you'd say this was maybe not ultra veris, but for the DEA to use the guidance procedure rather than what the statute itself requires, which is by regulation. [00:08:56] Speaker 00: Right, Your Honor, I appreciate that point. [00:08:59] Speaker 00: First of all, as a matter of practical reality, the guidance has been there since 2009. [00:09:07] Speaker 00: We followed the guidance. [00:09:09] Speaker 00: It's their guidance. [00:09:11] Speaker 00: Secondly, our application pursuant to the guidance was really, as Judge Katz has sort of indicated, an application in the alternative. [00:09:22] Speaker 00: And that's how we've persistently framed it. [00:09:25] Speaker 00: If the agency believes, and if you believe, that a waiver is a proper course, not a standard word, regulation in 822D, that would be great. [00:09:36] Speaker 00: And we understand that in practice, the agency has waived at least various aspects in cases like this. [00:09:47] Speaker 00: For example, it waived the fees that would normally be required for registrations in the Church of the Eagle on the Condo case. [00:09:54] Speaker 00: Secondly, however, in the alternative, we don't need 822D. [00:10:00] Speaker 00: We're not asking for action that is ultra-virus. [00:10:04] Speaker 00: We have 823A and B. They can register us. [00:10:09] Speaker 00: And under 958 as well, they can register us. [00:10:14] Speaker 00: They shall register us. [00:10:16] Speaker 00: That's clear duties act, if it's in the public interest or not contrary to the public interest, depending on which provision you're looking at. [00:10:22] Speaker 00: And we are asking in the alternative for registration. [00:10:25] Speaker 00: And indeed, it is registration. [00:10:27] Speaker 00: Registration is the basis on which we're proceeding per their informal guidance during this process for the past couple of years. [00:10:35] Speaker 01: Is the guidance, just following up on this distinction, is the guidance its own freestanding process for RFRA exemptions? [00:10:49] Speaker 01: Or is it an elaboration on the regulatory scheme under 21 CFR 1307? [00:10:59] Speaker 00: The guidance itself does not report to have legal effect. [00:11:05] Speaker 01: I thought it was separate, and yet we're primarily considering this case under the guidance, but your application says you're going under the reg. [00:11:17] Speaker 01: I'm not sure if anything turns on it. [00:11:19] Speaker 01: I'm just trying to figure out what scheme we're under. [00:11:23] Speaker 00: Right. [00:11:23] Speaker 00: Subject to Judge Henderson's point about the word regulation in 822D, which, as I said, I believe we can bypass by using 823 and registration, we believe the guidance is consistent. [00:11:38] Speaker 00: And so certainly the government doesn't suggest it's inconsistent. [00:11:41] Speaker 00: with both the CSA and RFRA. [00:11:45] Speaker 00: And of course, given the role of RFRA as a sort of super statute that amends other statutes, obviously the CSA has to be nudged a little bit around the corners where it's inconsistent with, where aspects of it might be inconsistent with RFRA to provide remedies that are required by RFRA. [00:12:07] Speaker 01: On your view, what's the legal source of the government's mandatory duty to act here? [00:12:15] Speaker 00: There are two independent legal sources. [00:12:20] Speaker 00: First, under the CSA, it shall register in appropriate cases based on the public interest, and RUFRA obviously informs what the public interest is. [00:12:30] Speaker 00: So that's CSA 823A, 823B. [00:12:35] Speaker 00: And we quoted the, we cited the import provision, I believe it's 958, maybe A, I'm not sure. [00:12:41] Speaker 01: I thought it was a formulation like shall register if the attorney general finds. [00:12:46] Speaker 00: public interest. [00:12:47] Speaker 00: Consistent with or not inconsistent with the public interest. [00:12:50] Speaker 00: And there's also an implementing regulation 21 CFR 1301.31 which says the administrator shall, I'm not putting an ellipsis here, determine whether the applicable standards of 823 or 958 have been met by the applicant. [00:13:08] Speaker 00: And if I may just add one thing to that, Your Honor, the government briefed national nurses on the issue of clear duty to act. [00:13:16] Speaker 00: In that case, it's distinguished by national nurses. [00:13:18] Speaker 00: This court held that the statute in that case required the government to engage in a notice and comment rulemaking process to decide whether to issue a rule. [00:13:29] Speaker 00: However, a statutorily permissible result of that was to say, okay, we've decided to issue no rule. [00:13:38] Speaker 00: Therefore, in that case, the petitioners had asked for a remedy to which they weren't entitled, which was the actual issuance of occupational safety rule. [00:13:47] Speaker 00: Here, we're not asking for a remedy to which we're not entitled. [00:13:50] Speaker 00: We're not asking this court to compel them to grant us [00:13:54] Speaker 00: an exemption slash registration. [00:13:56] Speaker 00: We're asking this court to compel them to reach a decision on that within a reasonable time. [00:14:01] Speaker 04: I thought part of your duty-to-act argument also involved RFRA, essentially that RFRA itself... Sorry, absolutely, Judge Garcia. [00:14:09] Speaker 00: I got sidetracked and was going to get to that. [00:14:11] Speaker 00: Absolutely, RFRA imposes mandatory statutory duties, CBEG, where the NICS. [00:14:18] Speaker 00: The government has described both in the 11th Circuit and in papers in this case, its guidance and its implementation of its guidance as its discharge of its statutory obligations under RFRA. [00:14:30] Speaker 04: And so I just want to make sure I understand your answers to, this goes back to Judge Katz's first questions. [00:14:36] Speaker 04: But your position is essentially, RFRA arguably imposes an affirmative duty. [00:14:41] Speaker 04: We are trying to do what DEA has asked us to do to secure an exemption. [00:14:47] Speaker 04: And so we're trying to follow the guidance. [00:14:50] Speaker 04: And you can see that the guidance process is a little bit unclear about how it connects back to the statutory authority. [00:14:57] Speaker 04: But [00:15:00] Speaker 04: You are essentially seeking, asking us to compel them to conclude this guidance process. [00:15:05] Speaker 04: Is that a fair characterization? [00:15:07] Speaker 00: Absolutely. [00:15:08] Speaker 00: And if I can just very briefly add one thing going to your point. [00:15:14] Speaker 00: But for the guidance process and the way the guidance process has been interpreted in particularly the Solquest case, we could very well be in a district court saying, hey, we have a clear right under RUFRA. [00:15:30] Speaker 00: Please apply RUFRA strict scrutiny standard and decide whether we get an exemption. [00:15:34] Speaker 00: This guidance process is a substitute that DEA created for referral suits in which we would have a clear right to obtain a decision applying the street scrutiny standard. [00:15:46] Speaker 00: And the guidance process should not take away that clear right under referral. [00:15:52] Speaker 00: Thank you. [00:15:53] Speaker 02: Okay. [00:15:53] Speaker 02: Thank you for a couple minutes and we start. [00:15:58] Speaker 02: Mr. Sturgell. [00:16:05] Speaker 03: Good morning, may I please the court, Lowell Sturgill from the Department of Justice representing the government. [00:16:10] Speaker 03: So DEA has a compelling interest in conducting a full and thorough investigation about whether an exception can be made to the controlled substance act based on RFRA or any other statute. [00:16:24] Speaker 03: And it's the Supreme Court in Ocentro said that [00:16:28] Speaker 03: ayahuasca is an extremely dangerous substance. [00:16:31] Speaker 03: So we know from the SoulQuest case that people have died in religious ceremonies using ayahuasca. [00:16:39] Speaker 03: So what we're asking again, as Judge Garcia noted, is allow the agency to continue and make a thorough investigation before it makes a ruling. [00:16:49] Speaker 01: Mr. Sturgill, how complicated can this be? [00:16:53] Speaker 01: I mean, this is maybe a month's long process. [00:16:57] Speaker 01: It's not a year's long process. [00:17:00] Speaker 03: So two answers. [00:17:00] Speaker 03: First of all, it is very complicated. [00:17:02] Speaker 03: And I think you're looking at the Sullivan agreement in churches. [00:17:06] Speaker 01: Register thousands, tens of thousands of physicians who prescribe and you have whatever rules you have about the safest in the wall or not. [00:17:18] Speaker 01: So, you know, the locks are, you know, it's a skiff or it's not, I mean, this is not, this is not breaking massive new ground to work out these details. [00:17:32] Speaker 03: So respectfully, this is very different. [00:17:34] Speaker 03: And again, that settlement agreement is key. [00:17:36] Speaker 03: First of all, ayahuasca has to import these drugs from another country. [00:17:42] Speaker 03: So that raises innumerable complications. [00:17:46] Speaker 03: Who are they importing this from? [00:17:49] Speaker 03: And we have asked them that question several times. [00:17:53] Speaker 03: We've gotten answers. [00:17:54] Speaker 03: Well, it might be this person. [00:17:56] Speaker 03: And finally, in response to the recent letter, we have [00:18:01] Speaker 03: a representation, yes, it's going to be from this person in Peru. [00:18:08] Speaker 03: OK, well, this person's in Peru. [00:18:10] Speaker 03: And DEA needs to have the opportunity to investigate this person to see what their track record is and make sure they're not just diverting it to other uses. [00:18:18] Speaker 04: The problem, from my perspective, is less about the complexity and sensitivity of the decision, which may very well be true. [00:18:24] Speaker 04: But I don't know how I can look at this record and think that anyone at DEA was doing anything about this case. [00:18:31] Speaker 04: for the past 15 months. [00:18:33] Speaker 04: There was a flurry of activity in the summer of 2024 after the site visit, and there were some follow-up questions. [00:18:41] Speaker 04: And it's been radio silence since. [00:18:44] Speaker 04: And the strong impression is that you asked a few follow-up questions, about three questions, because there was an argument next week in the DC Circuit. [00:18:54] Speaker 04: And is there anything you can say to disabuse me of that notion? [00:18:58] Speaker 03: So to unpack that, first of all, ayahuasca treats this case as if they're the only matter pending before the DEA diversion control office. [00:19:06] Speaker 03: There are numerous matters. [00:19:07] Speaker 03: And during this time period, if I could say, one of the things DEA was doing was granting [00:19:13] Speaker 03: religious exemptions for ayahuasca use by other applicants who had jumped in front of ayahuasca in line, because as you've heard this morning, ayahuasca itself took itself on offline for almost a year and a half. [00:19:27] Speaker 03: And that alone would have entitled DEA to just deny the petition. [00:19:32] Speaker 04: Is that been happening since August 2024? [00:19:34] Speaker 03: So the Church of Gaia [00:19:39] Speaker 03: application was granted in May of 2025. [00:19:41] Speaker 03: And the EGLE and Condor was in April of 2024. [00:19:45] Speaker 03: I'm told by DEA, this is not on the record. [00:19:48] Speaker 03: There was another grant to Santo Dime in December of 2024. [00:19:53] Speaker 03: So again, IOSC is not the only matter before DEA. [00:19:57] Speaker 03: And DEA has been granting other exemptions. [00:20:01] Speaker 03: So what are just, I'm sorry. [00:20:03] Speaker 04: So where is this application in the queue now? [00:20:05] Speaker 04: It's been pending for six years. [00:20:08] Speaker 03: So it's being actively looked at. [00:20:11] Speaker 03: And that is shown by this most recent letter, which was not an attempt to influence the court. [00:20:17] Speaker 03: In fact, if anything, it was issued during the lapse. [00:20:19] Speaker 03: If the EA was looking to push this process back, it would have, I would think, used the lapse as an excuse to not do anything, at least during that period. [00:20:28] Speaker 03: So again, DEA has been acting as fast as it could, consistent with other responsibilities and with the very important issues in front of it, very complex issues about how to make sure that this material is safely used and is not diverted for other uses. [00:20:48] Speaker 04: We had some questions about how this guidance process connects to the statutory authority. [00:20:54] Speaker 04: And can you just tell us what DEA's view of this is? [00:20:57] Speaker 04: And if I could try to simplify, I'm interested in when DEA grants or denies this exemption, what authority will it be acting under? [00:21:11] Speaker 03: So we'll be acting under the Controlled Substances Act, first of all, because it's only the Controlled Substances Act that gives DEA authority to begin with to regulate illegal drug, I'm sorry, not illegal, Controlled One Substances. [00:21:25] Speaker 04: Do you sort of view this as a step towards registration under 822A, a step towards exemption from registration under 822D? [00:21:35] Speaker 04: Is there any theory of how this action connects to a specific statutory provision? [00:21:40] Speaker 03: So it could be either. [00:21:42] Speaker 03: And as you've heard from the beginning, their application mentioned that they were seeking a total exemption from the CSA, but they also said they were willing to work with DEA. [00:21:53] Speaker 03: So a total exemption would be [00:21:55] Speaker 03: I think an 822D exemption, and there's a regulation 1307, which allows a religious applicant or really any applicant to seek that. [00:22:07] Speaker 04: Another way of asking this question, I guess, is you're treating this as a request for an exemption and registration under the process announced in this guidance. [00:22:18] Speaker 04: Is that just fair to say? [00:22:20] Speaker 03: So after the Supreme Court decision in Ocentro, before Ocentro, the DEA had taken the position there was no opportunity for any religious exemption to the CSA. [00:22:30] Speaker 03: It was a closed system. [00:22:31] Speaker 03: Supreme Court decides Ocentro, and then DEA says, OK, well, we'd like to give people some help in figuring out what they should do. [00:22:40] Speaker 03: So they put this guidance out, and they say, OK, well, you should submit a petition. [00:22:44] Speaker 03: And submitted to this person, and because you're seeking a religious exemption, please tell us what your religion is. [00:22:50] Speaker 03: Please demonstrate why it's sincere. [00:22:52] Speaker 03: Please explain why denying your exemption, it was a substantial burden on you free exercise the religion. [00:22:59] Speaker 03: And then be aware that as we look into this, we're going to investigate whether granting exception would be consistent with public health and safety and would allow us to prevent diversion of these materials. [00:23:11] Speaker 03: So that was, I think, good government. [00:23:13] Speaker 01: Do you need any formal regulatory [00:23:19] Speaker 01: exemption, or can we just think of this as the agency's attempt ex ante to figure out the interaction of the Controlled Substance Act with RFRA and when strict scrutiny will or will not turn off the CSA by operation of RFRA. [00:23:45] Speaker 03: I think it's the latter because RFRA, by its terms, amends all federal statutes. [00:23:52] Speaker 03: So RFRA is going to self-operational. [00:23:56] Speaker 03: So RFRA itself amends the Controlled Substances Act. [00:24:00] Speaker 01: But that doesn't mean that... I mean, if there were no regulatory exemptions built into the CSA, you would still have to do all the same things because RFRA makes you... [00:24:14] Speaker 01: or you would have to do all of the same things if you wanted to figure out when the CSA governs and when RFRA governs. [00:24:23] Speaker 03: Right. [00:24:24] Speaker 03: And again, but I think this sort of relates to the jurisdictional question. [00:24:29] Speaker 03: Even though that's true, the 11th Circuit in Solquest correctly held that the Court of Appeals has exclusive jurisdiction over these questions under Section 877 because [00:24:44] Speaker 03: The question are still arises under both statutes. [00:24:48] Speaker 01: I'm sorry. [00:24:48] Speaker 01: You're acting under both statutes. [00:24:51] Speaker 03: So they held that, but they also held that. [00:24:54] Speaker 03: Even if that weren't true, the first thing was this arises under the CSA because in apply and. [00:25:00] Speaker 03: In analyzing whether to grant this exception, DE has to apply the standards of the CSA, which includes health and safety and prevention of diversion. [00:25:10] Speaker 03: So that was the first holding. [00:25:12] Speaker 03: And the second holding was, you're right, Judge Katz, even if it could be said to arise both under the CSA and under RFRA, 877 still applies, because it doesn't require that something arise solely under the CSA. [00:25:27] Speaker 01: Back to the chronology for a minute. [00:25:31] Speaker 01: There have been a lot of extensive delays here, and some are attributable to the government and some to the church. [00:25:40] Speaker 01: So tell me if there's anything wrong with this framing, which is at the beginning of the process, there was a long, concerning three-year delay by DEA. [00:25:57] Speaker 01: Then there was a long concerning 16 month delay. [00:26:02] Speaker 01: By the church, which would have entitled you to team the application abandoned. [00:26:09] Speaker 01: So, taking all of that into account. [00:26:13] Speaker 01: 1 could reasonably just. [00:26:16] Speaker 01: restart the clock around June of 2023, when the church finally gets back to you on your initial requests. [00:26:28] Speaker 01: And if that's true, we are now, I mean, close to 30 months out from the start of the clock, and we're 16 months out from when you inspected their facilities. [00:26:42] Speaker 01: Do you quarrel with that framing? [00:26:45] Speaker 03: Maybe only with the description of the initial delay is concerning. [00:26:50] Speaker 01: Those are not small numbers. [00:26:53] Speaker 04: I understand. [00:26:54] Speaker 04: Beyond that, that's accurate. [00:26:58] Speaker 04: question about the duty to act requirement. [00:27:01] Speaker 04: And I wonder how you reconcile your position on that issue with how you describe the interaction with RFRA and the CSA, which I believe you think accurately said. [00:27:11] Speaker 04: RFRA requires DEA to [00:27:17] Speaker 04: consider circumstances in which an exemption is warranted. [00:27:22] Speaker 04: And that sounds a lot like a duty to act than the way we've talked about it in mandamus cases. [00:27:27] Speaker 04: So can you address that issue? [00:27:30] Speaker 03: Sure. [00:27:30] Speaker 03: So I think, respectfully, I believe my friend hasn't characterized exactly correctly what we said in SoulQuest. [00:27:37] Speaker 03: What we said in SoulQuest is that RFRA provides an agency authority to consider a religious exemption request. [00:27:44] Speaker 03: We didn't say that RFRA requires [00:27:47] Speaker 03: the agency to grant or even make a ruling on such a request. [00:27:51] Speaker 03: We just said it gives them authority to do so. [00:27:54] Speaker 03: I think that's consistent with the text of the statute and with the Supreme Court's decision on Little Sisters, how it is true. [00:28:00] Speaker 04: The cases where we have found no duty to act would be the equivalent of saying, RFRA says you may consider whether to not substantially burden religious exercise, but you actually don't have to reach a decision on that. [00:28:15] Speaker 03: So we relied on national nurses in that respect. [00:28:17] Speaker 03: And it's a difficult argument. [00:28:20] Speaker 03: I think national nurses says things like, well, the statute in that case didn't require the agency to act at any particular time. [00:28:30] Speaker 03: And the court said, well, that's discretion. [00:28:33] Speaker 03: And the existence of discretion argues against granting extraordinary relief. [00:28:39] Speaker 03: And it also made a point about how agencies are faced with making [00:28:45] Speaker 03: but having limited staffing and have to make decisions, prioritize matters, and that relates to this case too. [00:28:51] Speaker 03: But I understand the point. [00:28:52] Speaker 03: I think the simplest way to rule for the government in this case is just apply the track factors on whether this delay is extraordinary. [00:28:59] Speaker 03: And when you go down the factors, we've made a powerful demonstration of why you should let the process run its course. [00:29:07] Speaker 03: And the most important, again, is this is a health and safety case, which the health and safety case [00:29:12] Speaker 03: On the government side, as opposed on the other side, you decided a couple of ocean cases where the health and safety factor ran in favor of the applicant. [00:29:21] Speaker 03: Well, it's it's flipped here. [00:29:23] Speaker 03: And all is trying to do is make sure that. [00:29:27] Speaker 03: if it's able to grant this exception, it's done safely and to prevent diversion. [00:29:33] Speaker 03: And again, I think this recent letter is really instructive because it shows a lot of things. [00:29:38] Speaker 03: First of all, there are only two questions. [00:29:41] Speaker 03: So I don't have a projected date about whether this can happen. [00:29:46] Speaker 03: Things do seem to be moving in a direction where there are fewer questions. [00:29:51] Speaker 03: And so the second thing is that [00:29:55] Speaker 03: these questions that DEA asked are reasonable. [00:29:58] Speaker 03: Ayahuasca has never said that anything DEA has asked them for is unreasonable. [00:30:02] Speaker 03: And they have gotten back again on this. [00:30:04] Speaker 03: But even that, I mean, again, they've identified a new supplier. [00:30:08] Speaker 03: So DEA needs time to investigate them. [00:30:10] Speaker 03: And they've identified a new way of storing the material safely. [00:30:16] Speaker 03: And I mean, to me, I don't know whether that's good or not. [00:30:19] Speaker 03: They put it in a closet. [00:30:22] Speaker 03: glued it to the wall and maybe that's good enough. [00:30:24] Speaker 03: I don't know, but this is kind of thing I think you'd want DEA to have the time to look at. [00:30:29] Speaker 03: And final thing, if I could crack, both denied the petition for mandamus, but also retained jurisdiction. [00:30:38] Speaker 03: I think you should deny the petition and not retain jurisdiction, but- You want to fall back. [00:30:44] Speaker 03: Denying and retaining jurisdiction or holding in the case in advance would be far superior [00:30:51] Speaker 03: to issuing some kind of order, setting an arbitrary date for DA to try to finish this up. [00:30:57] Speaker 03: And yes. [00:30:58] Speaker 01: Just one last question on duty to act. [00:31:01] Speaker 01: I had thought the strongest basis for a duty to act was the APA. [00:31:06] Speaker 01: And nobody cites it. [00:31:08] Speaker 01: But it has a provision which says [00:31:14] Speaker 01: agency has to conclude a matter presented to it within a reasonable time. [00:31:18] Speaker 01: And Judge Henderson has an American Rivers opinion, which says that creates a mandatory duty to act for mandamus purposes. [00:31:27] Speaker 03: Our only response is national nurses and what it says about if there's discretion that doesn't seem to matter. [00:31:34] Speaker 03: But it's a honestly difficult subject that I'm sure you will be able to figure out. [00:31:41] Speaker 03: I'm not sure. [00:31:42] Speaker 03: Thank you. [00:31:42] Speaker 02: Thank you. [00:31:45] Speaker 02: Mr. Steele, why don't you take two minutes? [00:31:50] Speaker 00: Thank you. [00:31:51] Speaker 00: First of all, on Judy to Act two points, I absolutely agree with Judge Katz. [00:31:57] Speaker 00: You didn't cite it. [00:31:58] Speaker 00: I was addressing Judy to Act questions earlier in terms of is there a duty to take any action under this statute, which seems to me is the question raised by national nurses. [00:32:11] Speaker 00: Absolutely, courts in cases like Norton and American Rivers and so on have held that you do not need a statutory deadline to create a duty to act by a particular time because the APA, as you said, Judge Katz, is in that gap. [00:32:32] Speaker 00: Second separate question on duty to act. [00:32:35] Speaker 00: Mr. Sturgill referred to the South West case. [00:32:39] Speaker 00: Here's the quote from the 11th circuit. [00:32:41] Speaker 00: The government has the authority and indeed the duty to consider an ayahuasca church's refer rights in deciding whether to allow the church to handle ayahuasca free from DEA enforcement. [00:32:54] Speaker 00: I'm turning quickly to the timeline and the delays. [00:33:00] Speaker 00: I think Judge Kansas summarized the timeline very accurately. [00:33:05] Speaker 00: I would, however, contend that in terms of looking at who is where in the queue, it is not irrelevant [00:33:12] Speaker 00: that we filed in February 2019 a complete application. [00:33:17] Speaker 00: The government never suggested that application was incomplete or defective. [00:33:21] Speaker 00: The government's guidance doesn't say an application has to provide for site details and a site inspection immediately. [00:33:29] Speaker 00: The guidance mainly says your initial application should talk about your religion, which we amply did. [00:33:35] Speaker 00: We did that. [00:33:36] Speaker 00: The government sat on that and did nothing for three years. [00:33:39] Speaker 00: That should count in terms of where we are in the queue. [00:33:42] Speaker 00: The Church of Gaia case was decided start to finish in two and a half years. [00:33:46] Speaker 00: We're at two and a half years, as George Katz has pointed out, after what happened in 2022 to 2023, even if you know that prior three years. [00:33:56] Speaker 00: And just to say let the process play out, we've seen how the process [00:33:59] Speaker 00: plays out. [00:34:00] Speaker 00: It's taking far too long. [00:34:02] Speaker 00: And this court has on many occasions, without a hard statutory deadline, said, OK, enough is enough. [00:34:09] Speaker 00: We order you to report to us in 30 days, or we order you to make a decision within four or five months. [00:34:16] Speaker 02: Thank you.