[00:00:01] Speaker 00: Case number 22-1089, Vinyl Institute Inc. [00:00:05] Speaker 00: Petitioner versus Environmental Protection Agency. [00:00:09] Speaker 00: Mr. Gunting for the petitioner, Ms. [00:00:11] Speaker 00: Brown for the respondent. [00:00:13] Speaker 02: Mr. Gunting, good morning. [00:00:14] Speaker 04: Good morning. [00:00:16] Speaker 04: I'll reserve three minutes for rebuttal. [00:00:18] Speaker 04: First, just briefly, I'll address the merits of the task order and then I'll turn to the 19B motion. [00:00:23] Speaker 04: Two issues here. [00:00:26] Speaker 04: On the merits, when Congress amended TOSCA in 2016, it gave EPA authority to issue test orders. [00:00:32] Speaker 04: EPA can do so without warning, giving the test order recipients an opportunity to submit comments beforehand. [00:00:39] Speaker 04: However, [00:00:40] Speaker 04: Congress also put in place numerous guardrails to ensure that this test order authority is not abused. [00:00:48] Speaker 04: In other words, EPA has to show more than just a data gap. [00:00:51] Speaker 04: It has to show a data need. [00:00:54] Speaker 04: So along these lines, Congress established in Section 4 a stepwise process to ensure that expensive and time-consuming advanced testing would only be required after EPA had first considered less intrusive tiered approaches to inform [00:01:10] Speaker 04: whether there was in fact a data need. [00:01:13] Speaker 04: So as part of that tiered approach, Congress placed certain obligations on EPA. [00:01:18] Speaker 04: First, EPA must consider all reasonably available information regarding hazard and exposure. [00:01:24] Speaker 03: Mr. Godding, we have a rule against reading the argument. [00:01:28] Speaker 04: I'm sorry. [00:01:29] Speaker 05: I'll help you because I have some questions. [00:01:31] Speaker 05: Yeah, go ahead. [00:01:33] Speaker 05: And I want to start with some questions that I think are pure questions of law. [00:01:39] Speaker 05: The EPA says its test order, and I'm reading from their brief 36 to 37, the EPA says their test order does not need to explain how it ruled out alternative testing methods. [00:01:53] Speaker 05: I know you disagree with that. [00:01:54] Speaker 04: What's your best reason for disagreeing? [00:01:57] Speaker 04: They have a conclusory answer and they say, we don't know of any names. [00:02:04] Speaker 04: We know under section four and under the substantial evidence standard, [00:02:08] Speaker 04: You have to do more than a conclusory statement. [00:02:11] Speaker 04: You have to explain, what did I consider? [00:02:14] Speaker 04: What did I look at? [00:02:16] Speaker 04: And what is my reasoning? [00:02:17] Speaker 04: A conclusory statement, especially where you just rule out everything, doesn't tell me, the stakeholder, and it doesn't tell this court what they did. [00:02:29] Speaker 05: Then the EPA says on page 38 of its brief, [00:02:33] Speaker 05: Its test order does not need to cite substantial evidence in the test order itself. [00:02:39] Speaker 05: I know you disagree with that as well. [00:02:41] Speaker 05: What's your reason for disagreeing with that? [00:02:43] Speaker 04: It would be the same answer. [00:02:44] Speaker 04: The statement of need, Congress set this up, the statement of need needs to describe how the information before it led to its conclusion. [00:02:53] Speaker 04: It has to explain its decision. [00:02:57] Speaker 04: And that comes from both the statement of a need, specifically, in section four. [00:03:03] Speaker 05: What's the authority that says they can't just do that during litigation? [00:03:08] Speaker 04: So this is an APA case. [00:03:11] Speaker 04: I mean, they're limited to the administrative record. [00:03:13] Speaker 04: And let's back up. [00:03:15] Speaker 05: They say it can be in the record, but it doesn't have to be in the test order. [00:03:20] Speaker 05: And I know you think that's wrong. [00:03:21] Speaker 05: Yes. [00:03:22] Speaker 05: What's your authority for thinking that's wrong? [00:03:24] Speaker 04: I think if you look at Section 4A2, that section [00:03:30] Speaker 04: anticipates a statement of need that tells us what its reason was and how it came to decide that there was a data need. [00:03:39] Speaker 04: You cannot just say, just look at the administrative record. [00:03:42] Speaker 04: There has to be some explanation. [00:03:44] Speaker 04: It says describe. [00:03:45] Speaker 04: It says explain. [00:03:47] Speaker 05: And now I'm going to go from pure law to law applied to facts. [00:03:50] Speaker 05: And by the way, I mean, of course they can't just explain post hoc and litigation. [00:03:54] Speaker 05: Right, yes. [00:03:56] Speaker 05: What is your single best example of the EPA not explaining itself well enough? [00:04:01] Speaker 04: I think there are actually two. [00:04:03] Speaker 04: Just one. [00:04:04] Speaker 04: You can say two, but. [00:04:07] Speaker 04: I'll do one because I think they have a chart on page 010 where they identify some analogs and then they identify with an X study. [00:04:20] Speaker 04: We don't know what the study is. [00:04:21] Speaker 04: It doesn't tell us what the study is. [00:04:22] Speaker 04: It just says an acute study for birds. [00:04:25] Speaker 04: So we don't know what that study is. [00:04:27] Speaker 04: And that's an important thing because acute studies can indicate low toxicity. [00:04:32] Speaker 04: They can be used to extrapolate to chronic toxicity. [00:04:35] Speaker 04: I thought that was the ELOVARA study. [00:04:37] Speaker 04: No, this is not the L of R. Sorry, it's something else. [00:04:40] Speaker 04: So the L of R study involved 112 TCE. [00:04:43] Speaker 04: That's the chemical at issue here. [00:04:46] Speaker 06: Right. [00:04:46] Speaker 06: I thought that was the acute study. [00:04:48] Speaker 04: That is an acute study. [00:04:49] Speaker 04: Okay. [00:04:50] Speaker 04: But there's an axe in that chart that indicates there's also an acute study for 111 TCE, an analog. [00:04:59] Speaker 04: We don't know what that study is. [00:05:01] Speaker 05: This is the chart that has, I think, seven studies. [00:05:05] Speaker 05: Yes. [00:05:05] Speaker 05: Seven studies. [00:05:06] Speaker 05: And did you know which studies those were? [00:05:10] Speaker 05: No. [00:05:12] Speaker 05: I know you're saying you didn't know what this one study was. [00:05:14] Speaker 05: Yes. [00:05:15] Speaker 05: You didn't know what any of those seven studies were. [00:05:17] Speaker 04: No. [00:05:17] Speaker 04: Right? [00:05:17] Speaker 04: And we still don't. [00:05:18] Speaker 04: We still have to guess. [00:05:20] Speaker 04: Now that we have our chart that they pointed to in the Ministry of Record, which was not cited, [00:05:25] Speaker 04: in the test order, we can guess it's the Dow study, but we still don't have something connecting those two. [00:05:34] Speaker 05: We're in a world where there's going to be some testing, okay? [00:05:38] Speaker 05: The chemical needs, we need to know something more about the chemical. [00:05:42] Speaker 05: Can you walk me through a chain of events where some lower level or screening tests occur and they don't lead to vertebrate testing? [00:05:54] Speaker 04: The way they set up is a stepwise process. [00:05:56] Speaker 04: Let's say you have three or four tiered things you could do. [00:06:01] Speaker 04: If those arrows are all pointing to low toxicity, or it's actually the weight of the evidence, it's not even all the arrows. [00:06:08] Speaker 04: If the weight of the evidence and those arrows are pointing towards low toxicity and low exposure frequency in the environment, [00:06:18] Speaker 04: then EPA should be asking itself, should we order this more expensive, you know, year long, multi-year long testing? [00:06:26] Speaker 04: And so that can be done through acute studies and extrapolating to chronic. [00:06:30] Speaker 04: It can be done through doing in vitro testing. [00:06:33] Speaker 04: It can be looking at analogs. [00:06:36] Speaker 04: And so when you put all that together, we're not asking for a threshold determination on unreasonable risks like you do under 4A1. [00:06:45] Speaker 04: We're saying, look, look at all of the information, where are the arrows pointing? [00:06:50] Speaker 04: And if they all kind of seem to be pointing towards low toxicity and exposure, then maybe we shouldn't be doing a year-long test at 200 grand. [00:06:57] Speaker 05: I think I understand that now. [00:06:59] Speaker 04: Has the testing started, the quail testing? [00:07:02] Speaker 04: We have. [00:07:02] Speaker 04: We're still in the preliminary. [00:07:04] Speaker 04: We haven't started feeding the quail. [00:07:06] Speaker 04: What's the risk that this is going to become moot before we decide the case? [00:07:10] Speaker 04: I don't. [00:07:10] Speaker 04: So the testing as of right now, we think will be done in late summer, early fall with the final report later than that. [00:07:19] Speaker 04: So we're going to roll for you. [00:07:20] Speaker 04: We better do it. [00:07:21] Speaker 04: Yes, so much before summer. [00:07:23] Speaker 06: Yes. [00:07:24] Speaker 06: When did the whale die? [00:07:27] Speaker 04: I've asked that question. [00:07:27] Speaker 04: It's not quite clear, but it would be at the end because you have to have them live. [00:07:31] Speaker 04: It's a chronic. [00:07:32] Speaker 04: They have to eat over time and then actually lay eggs. [00:07:35] Speaker 04: So you start poisoning them with that. [00:07:37] Speaker 04: I wouldn't put it that way, Your Honor, but yes, but not so, I mean, they have to survive. [00:07:43] Speaker 04: They have to live. [00:07:43] Speaker 04: I mean, it's a chronic study. [00:07:47] Speaker 06: So if we can go back to what you were saying about that chart, I mean, the statute says they have to identify the need for the new information, describe how information reasonably available to the administrator was used, et cetera. [00:08:04] Speaker 06: You just seem to be asking for a level of specificity [00:08:07] Speaker 06: that it's not clear to me is required by the statutory mandate. [00:08:12] Speaker 04: So if you look at the plain language, it has a lot of guardrails that I was discussing. [00:08:16] Speaker 04: And so everything has to do with best available evidence and a weight of the evidence. [00:08:21] Speaker 04: I think to address your issue, though, EPA, this is a very discreet issue. [00:08:27] Speaker 04: It's what's the impact on BERS? [00:08:29] Speaker 04: And I think EPA is certainly qualified to quickly narrow [00:08:34] Speaker 04: the NAMS, the new approach technologies and the studies that would be relevant, you know, down to two, three, four that they have to discuss. [00:08:42] Speaker 04: So we're not saying, I think, as EPA argued, you know, you have to look at this huge mass of evidence. [00:08:49] Speaker 04: It's a very discreet question. [00:08:51] Speaker 04: And again, because, you know, EPA can narrow it down pretty quickly, but then it does have to tell us [00:08:59] Speaker 04: Whether it's the NAMS, whether it's the studies, what did they think? [00:09:02] Speaker 04: What was their reasoning? [00:09:04] Speaker 04: And I'm not seeing that in the test order or even in the administrative record. [00:09:09] Speaker 06: Didn't they say a J9? [00:09:12] Speaker 06: They talk of they explain the table. [00:09:15] Speaker 06: They say as shown in the table below. [00:09:18] Speaker 06: Terrestrial environmental hazard data were identified, et cetera. [00:09:21] Speaker 06: There seems to be some discussion in addition. [00:09:25] Speaker 06: But I guess what I'm more interested in is like, what's the legal principle you're trying to apply here? [00:09:29] Speaker 06: Because like the legal mandates pretty broad and you're saying, well, it needs to be more specific. [00:09:33] Speaker 06: So how do I know what's specific enough in your view? [00:09:38] Speaker 04: I think that the test order is so conclusory if you use that as a jumping off point. [00:09:46] Speaker 04: I do think there has to be enough that we can sit down and understand. [00:09:52] Speaker 04: So for example, with an acute study, they could say in a paragraph, here are our criticisms of this study. [00:10:00] Speaker 04: This is why we're not going to listen to it. [00:10:02] Speaker 04: We're not asking for a book or anything. [00:10:03] Speaker 06: That sounds really specific. [00:10:05] Speaker 04: But I think that's what Congress said. [00:10:07] Speaker 04: If you look at the plain language of the statute, they placed some significant burdens on EPA to do this. [00:10:14] Speaker 04: And I think it's because they didn't want EPA just issuing test orders, because they also have an option to do a consent agreement. [00:10:22] Speaker 06: No, I understand that. [00:10:23] Speaker 06: I just don't quite understand the legal standard you're asking us to apply. [00:10:28] Speaker 06: I mean, it's just a substantial evidence. [00:10:29] Speaker 06: Oh, yeah, it's a substantial evidence. [00:10:34] Speaker 06: You want just much more explanation and specificity, but I don't know why I need that just to find substantial evidence. [00:10:41] Speaker 04: I mean, if you look at the few cases where this court has implemented substantial evidence standard under Tosca, this court has gone into great detail. [00:10:49] Speaker 04: looked at the administrative record, looked at the explanations that the agency gave the EPA, and then also looked at the record for contrary evidence. [00:10:59] Speaker 04: I mean, it is not arbitrary and capricious. [00:11:02] Speaker 04: And so the flip side of that coin is that the agency has to do its job. [00:11:09] Speaker 04: It has to identify on some level the facts that it considered, what its reasoning is, what judgment calls it made, [00:11:19] Speaker 04: and how it dealt with the contrary evidence. [00:11:21] Speaker 04: That is what Congress imposed on EPA. [00:11:25] Speaker 04: That is the plain language of the statute. [00:11:31] Speaker 04: So my time is up. [00:11:33] Speaker 04: Thank you. [00:11:33] Speaker 02: We'll give you a couple minutes to reply. [00:11:35] Speaker 04: Thank you. [00:11:45] Speaker 01: Good morning, may it please the court, Laura Brown on behalf of respondent EPA. [00:11:49] Speaker 01: I'd like to begin by addressing the merits of the test order and then turning to the 19B motion. [00:11:53] Speaker 01: Now, TASCQA requires, excuse me, TASCQA requires EPA to assess the hazards and the exposures of 1, 1, 2-trichloroethane to birds. [00:12:04] Speaker 01: And in the test order, EPA explained that it conducted a systematic and comprehensive search [00:12:10] Speaker 01: On the avian toxicity, chemical poses could potentially pose. [00:12:14] Speaker 01: And it identified one study, the aloe vera study. [00:12:18] Speaker 01: And that study concluded that the chemical killed and deformed chicken embryos when it was injected into their eggs. [00:12:27] Speaker 01: EPA also explained in the test order that it had identified monitoring data that showed that this chemical is in the environment. [00:12:34] Speaker 01: It's in the air, water, soil, biota, [00:12:37] Speaker 01: all of which birds are exposed. [00:12:39] Speaker 05: How much of the test order was so generic that you could copy and paste it into the other 74 chemicals that you recently ordered testing? [00:12:53] Speaker 01: The statement of need is specific to the work that was going to be done here, the work, the information that was required and the explanation of why it was required. [00:13:02] Speaker 01: procedures that are going to be acquired, the protocol is specific to these tests, but there is nothing in the statute in Congress. [00:13:09] Speaker 05: Would it be fair to say the vast majority of the statement of need could be copied and pasted into 74 other chemicals? [00:13:17] Speaker 01: I disagree. [00:13:18] Speaker 05: Tell me why. [00:13:19] Speaker 01: The statement of need has to meet certain statutory requirements. [00:13:25] Speaker 01: However, Congress did not expect or dictate that EPA create some sort of exhaustive decisional document. [00:13:35] Speaker 01: The statement of need has four requirements. [00:13:38] Speaker 01: Identify the need. [00:13:39] Speaker 01: Explain how reasonably and available information was used to inform EPA's decision to order the test. [00:13:47] Speaker 01: Explain why you're requiring vertebra testing. [00:13:49] Speaker 01: And explain why your issue can order. [00:13:51] Speaker 01: Those are unique to this circumstance. [00:13:54] Speaker 01: And those explanations do not have to be complicated in law. [00:13:58] Speaker 01: Here, EPA identified the need. [00:14:01] Speaker 01: that one test they could find on the toxicity of 112 TCA showed it was toxic. [00:14:07] Speaker 05: I'm with you on the 1979 pheasant study. [00:14:10] Speaker 05: It's good, something for you. [00:14:15] Speaker 05: Can I ask you the two questions that I asked your opposing counsel about these two quotes from your brief? [00:14:21] Speaker 05: And I'm at 36 to 37. [00:14:23] Speaker 05: The first thing you said is your test order does not need to, quote, explain how it ruled out [00:14:31] Speaker 05: alternative testing methods. [00:14:35] Speaker 05: Now you heard Vinyl's answer to that. [00:14:39] Speaker 05: What's your response? [00:14:40] Speaker 01: There's nothing in the statute that requires EPA to explain how it ruled out alternative information. [00:14:45] Speaker 05: And then you said on the next page, page 38, your test order does not need to quote cite substantial evidence in the test order itself. [00:14:53] Speaker 05: Response to that? [00:14:55] Speaker 01: EPA can rely on the record in support of the statements made in the order. [00:14:59] Speaker 01: The standard of review for a tester is substantial evidence taken in the record as a whole. [00:15:05] Speaker 01: The petitioner would like to avoid considering the statements in the record that directly support the statement that EPA made in the record. [00:15:12] Speaker 05: But you're distinguishing between the record and your explanation in the test order, right? [00:15:16] Speaker 01: Well, I believe, yes, I am. [00:15:18] Speaker 05: I am distinguishing. [00:15:19] Speaker 05: So let's say that [00:15:21] Speaker 05: You won't like this, but let's say that I disagree with you about those two pure questions of law, whether you need to explain how you ruled out alternative test methods and whether you need to cite substantial evidence to the test order itself. [00:15:33] Speaker 05: If I disagree with you there, I think I have to vote with the petitioner here. [00:15:42] Speaker 05: Would you agree with me? [00:15:45] Speaker 01: Well, I disagree with you. [00:15:47] Speaker 01: Yes, but I'm going to try to convince you to not disagree with me. [00:15:50] Speaker 01: So I would point you to Section 424J of TOSCA. [00:15:54] Speaker 01: And in that section, the statute requires that EPA list all of the studies it considered in conducting a risk evaluation and describe the results of those studies. [00:16:04] Speaker 01: That is not required in Section 4 for a test order. [00:16:08] Speaker 01: I mean, Congress, when it [00:16:10] Speaker 01: Congress, the purpose of amending TOSCA was to assist EPA to obtain the information it needs to conduct a risk evaluation for which EPA must have 20 ongoing at a time and is subject to strict statutory deadlines. [00:16:26] Speaker 01: Congress was not going to require, it was clear in the legislative history, that Congress is not [00:16:32] Speaker 01: Creating procedural and burdensome processes, time-consuming processes for EPA to get this information. [00:16:39] Speaker 01: That was an explicit, one of the explicit intents of Congress in amending TOSCA and giving EPA this authority to issue test orders. [00:16:47] Speaker 01: And so for Petitioner and Amici to assert that EPA needs to go and explain every study it identified, explain why every new approach methodology is inappropriate, as well as setting EPA up to the issues that it faced before TASC and obtaining the information it needs to quickly conduct risk evaluations as Congress has required it to do. [00:17:10] Speaker 05: I take the argument to be a little different than that. [00:17:13] Speaker 05: I think maybe if the test order had said, [00:17:16] Speaker 05: These are the 2 or 3 closest most relevant studies that are out there already. [00:17:23] Speaker 05: And here's why they're not relevant enough. [00:17:26] Speaker 05: Here's why they're not good enough. [00:17:28] Speaker 05: And I think that might have gotten you there. [00:17:32] Speaker 01: Well, I think they did. [00:17:36] Speaker 01: had some extensive search for avian toxicity patients. [00:17:39] Speaker 01: This is described in the test report. [00:17:40] Speaker 01: It explained the databases it searched. [00:17:43] Speaker 01: It said, we found one study, the aloe vera study, but it's not good enough. [00:17:47] Speaker 01: And I think petitioners would agree it's not good enough. [00:17:49] Speaker 01: And EPA explained why it's not good enough, because it is acute study. [00:17:53] Speaker 01: That means it's only the [00:17:55] Speaker 01: that birds are being subjected to a very high dosage of the chemical in their eggs. [00:18:01] Speaker 05: And the- I'm with you on the 1979 pheasant study. [00:18:04] Speaker 01: Sure, but it's the only study. [00:18:06] Speaker 01: And they discussed it. [00:18:07] Speaker 01: And they said, this is why it's not acceptable. [00:18:09] Speaker 01: And they said, we searched for other analogs. [00:18:11] Speaker 01: And they identified them in the test order. [00:18:13] Speaker 05: Analogs are similar chemicals that they could use to- I mean, this does get awfully into the weeds. [00:18:19] Speaker 05: And I think this case probably has more to do with pure questions of law. [00:18:23] Speaker 05: But we'll ask you. [00:18:25] Speaker 05: I'm at JA 41, the order is addendum E. And I think it's describing, I think this is the 1979 pheasant study. [00:18:37] Speaker 05: I think, but it is a pheasant study about 111, does that ring a bell at all? [00:18:43] Speaker 01: CA, I'm sorry, is that what you said? [00:18:46] Speaker 05: Or ATCA. [00:18:47] Speaker ?: Yes. [00:18:47] Speaker 05: So EPA probably, presumably decided that this study wasn't enough to better understand the effects of the similar chemical 112 TCA. [00:19:01] Speaker 05: Did I get it? [00:19:02] Speaker 05: You're going to tell me the reason, but why wasn't the reason in the order? [00:19:06] Speaker 01: The reason was in the order. [00:19:08] Speaker 01: EPA explicitly stated, we need chronic toxicity data. [00:19:12] Speaker 01: And this is important because I think it's somewhat lost on non-toxicologists, but chronic toxicity data, which is clearly stated, the need EPA has is for chronic toxicity data. [00:19:22] Speaker 01: If birds are exposed to this chemical in the environment at little tiny doses for their whole lifespan, is it going to have an adverse effect on their eggs, on their growth, et cetera? [00:19:33] Speaker 06: The Elevera study- Judge Walker's question was, [00:19:36] Speaker 06: Are there chronic studies for the 1-1-1? [00:19:39] Speaker 06: No, no, they're not. [00:19:41] Speaker 06: What about, what was the study X in J-A-10? [00:19:46] Speaker 01: That's the study that Judge Walker is referring to. [00:19:50] Speaker 01: It's not chronic. [00:19:51] Speaker 01: EPA explained they didn't find any chronic studies for any of the similar chemicals, and they need chronic data. [00:19:58] Speaker 05: So whether or not they need... There is a table with seven studies, and I honestly can't tell you the JA number off the top of my head. [00:20:05] Speaker 05: I think that your opposing counsel was discussing it. [00:20:08] Speaker 05: And he said he can't figure out what those seven studies even are. [00:20:14] Speaker 05: Did should he have been able to figure it out? [00:20:17] Speaker 01: Yes, I think he should have. [00:20:18] Speaker 01: I will say it's a little hard to find. [00:20:22] Speaker 01: And so one point I wanted to raise is that I do not think it's post hoc rationalization for counsel to identify in the record where support exists. [00:20:31] Speaker 01: So I am pointing you. [00:20:32] Speaker 05: You're distinguishing between the record and the test order, right? [00:20:35] Speaker 05: And the record wasn't released with the test. [00:20:37] Speaker 01: Oh, I thought you were asking about. [00:20:38] Speaker 05: Well, then I see. [00:20:41] Speaker 01: OK. [00:20:42] Speaker 05: You're right. [00:20:43] Speaker 01: I pivoted for a second there. [00:20:44] Speaker 01: Well, I will say, in the test order, you're right. [00:20:46] Speaker 01: The studies aren't identified. [00:20:47] Speaker 01: The ones that EPA found to be irrelevant were not identified. [00:20:50] Speaker 01: The one that it found to be relevant but not enough because it was an acute exposure. [00:20:55] Speaker 01: And it explained the limitations in the test order. [00:20:58] Speaker 01: It shouldn't have been a surprise to petitioners to understand why EPA couldn't rely solely on the Elevera study. [00:21:06] Speaker 05: So are you conceding that vinyl needed the administrative record in order to understand the order? [00:21:12] Speaker 01: Nope, I'm not conceding that. [00:21:15] Speaker 01: First of all. [00:21:16] Speaker 01: The Vinyl Institute had access to the analogs EPA, searched for data. [00:21:23] Speaker 01: EPA, in its test order, explained step by step how it looked for these studies. [00:21:28] Speaker 01: They could have repeated that process. [00:21:30] Speaker 05: They never named the studies. [00:21:31] Speaker 01: They did not name the studies. [00:21:32] Speaker 05: Other than the 1979. [00:21:33] Speaker 01: That's correct. [00:21:34] Speaker 01: Because they determined they were irrelevant. [00:21:37] Speaker 01: I mean, we're at this point where is EPA's heard? [00:21:42] Speaker 01: A burden to explain everything they did in a test order and the purpose of the test order is the reason Congress has given EPA this new authority is to make it simpler, the process simpler for EPA to get the information. [00:21:56] Speaker 01: I really don't think that squares with the legislative history, the actual language in the statute, describe how you used available information. [00:22:05] Speaker 01: It does not say, explain how you ruled out using existing studies and identify those studies. [00:22:12] Speaker 01: Section 24J, to some extent, does that. [00:22:15] Speaker 01: It says, EPA, when you're issuing the risk evaluation, which will ultimately potentially regulate this chemical, then EPA has more. [00:22:22] Speaker 01: It has to show more of its work. [00:22:23] Speaker 05: I think on a spectrum between that extreme, listing every book, every article you looked at, and take our word for it, other than the 1979 study, we're not going to give you any specifics, and you have to sue to find out more. [00:22:40] Speaker 05: I think that's a broad spectrum. [00:22:42] Speaker 05: And I think probably the standard is in between. [00:22:44] Speaker 01: Well, I would say, I don't think they have to sue to find out more. [00:22:46] Speaker 01: They could have requested the record from EPA. [00:22:48] Speaker 01: They also had the opportunity to submit information to EPA. [00:22:51] Speaker 01: And I know my time is up. [00:22:53] Speaker 01: And that goes to the 19D motion. [00:22:56] Speaker 01: But for these reasons, unless your counsel has further questions, the petition for review should be denied and the 19D motion should be denied. [00:23:07] Speaker 02: Mr. Godding, why don't you take two minutes? [00:23:09] Speaker 04: Thank you. [00:23:09] Speaker 04: Just a couple of points to go back to kind of the law here. [00:23:12] Speaker 04: The way Congress set this up, let me back up. [00:23:15] Speaker 04: What EPA is saying is that there is a data gap. [00:23:18] Speaker 04: There is no chronic data. [00:23:21] Speaker 04: So Congress recognized that that would happen. [00:23:24] Speaker 04: So what did it do? [00:23:25] Speaker 04: It said, you don't go straight to advanced testing. [00:23:29] Speaker 04: You can use tiered approaches, including acute studies, [00:23:34] Speaker 04: to answer to inform that that issue and again it goes back to the where the arrows pointing what is the weight of the scientific evidence using indirect methods. [00:23:44] Speaker 04: So the fact that there's no chronic testing out there on 1, 2, 1, 1, 2, TCE Congress anticipated that and said we're going to do a step wise approach here. [00:23:58] Speaker 06: But why isn't it enough for them to say, we need this type of study to understand the effects, the chronic effects on the birds, and isn't one out there, so now we need to do one? [00:24:09] Speaker 04: I think that's what I was just talking about, that there are other ways to get to that information and that answer without requiring expensive time-consuming advanced testing. [00:24:19] Speaker 04: You do it through things like acute tests, like that analog, the 111-TC, [00:24:26] Speaker 06: computer modeling or computer modeling in vitro exactly and they were supposed to but they have a data gap spreadsheet that that explains what they looked at and what's missing from that I mean it just seems like there is a lot in the record here and I'm just trying to understand like [00:24:47] Speaker 06: Why? [00:24:48] Speaker 06: What is the basis for needing so much more? [00:24:52] Speaker 04: Because I think Congress told them that they had to engage in some level of discussion to justify the need. [00:24:59] Speaker 04: And instead of us having to take their word for it, I think if you just look at the test order itself, there's a lot of conclusory sentences where we just have to say, OK, we believe you. [00:25:10] Speaker 04: And that is not what plain language of the statute asks. [00:25:13] Speaker 06: I understand you'd be saying a lot of this needs to be in the test order. [00:25:18] Speaker 06: Isn't that just very a formality? [00:25:19] Speaker 06: Like if this testing is needed and it's supported by the record, why does it have to be in the test order? [00:25:26] Speaker 04: I think because Congress used the word describe and explain. [00:25:31] Speaker 06: But you're talking about the level of detail in describing explaining. [00:25:34] Speaker 06: It's not for a higher level. [00:25:36] Speaker 06: It just seems to me, isn't that a formality? [00:25:37] Speaker 06: You want us to remand it so they can take the information that's already there and put it in a different place. [00:25:42] Speaker 04: I don't think they have the information yet. [00:25:44] Speaker 04: If you look at the administrative record, they don't explain. [00:25:48] Speaker 04: We have a chart of names, but there's no explanation why they ruled out at least there are a couple of two key ones, we think. [00:25:55] Speaker 04: If you look at that big spreadsheet of all the studies, there's no explanation. [00:26:00] Speaker 04: What about that 11TC test? [00:26:03] Speaker 04: Were there any other studies that you thought about? [00:26:06] Speaker 04: There's no explanation. [00:26:07] Speaker 04: We just have charts. [00:26:09] Speaker 04: And so under the substantial evidence standard, even in the administrative record, they still have to point this court to something where they did some analysis. [00:26:20] Speaker 04: It's kind of like they started it, but they didn't finish it. [00:26:24] Speaker 04: And I don't think this is a failure to explain case. [00:26:27] Speaker 04: It is a failure to explain case, but I also think it's a failure to show substantial evidence. [00:26:31] Speaker 04: We don't have their explanations. [00:26:36] Speaker 03: I'm interested in what you think the standard of review is for this particular legislation. [00:26:43] Speaker 03: Do you think it's changed from when CMA said this requires a searching substantial evidence, rigorous substantial evidence, almost a sui generis substantial evidence, and you haven't even discussed that. [00:27:02] Speaker 03: Do you think the standard of review has changed since CMA? [00:27:06] Speaker 04: No, I don't think there was anything in the amendments that I'm aware of that changed the substantial evidence standard. [00:27:12] Speaker 03: It's not just substantial evidence. [00:27:16] Speaker 03: It's a heightened substantial evidence. [00:27:20] Speaker 04: Yes. [00:27:22] Speaker 04: All right, I'm glad to be with me. [00:27:25] Speaker 04: And in fact, typically a substantial evidence standard under the APA is not a way to the evidence. [00:27:30] Speaker 04: Congress said this is a way to evidence analysis. [00:27:35] Speaker 04: That's the plain language. [00:27:37] Speaker 04: Thank you.