[00:00:00] Speaker 04: Stand please. [00:00:09] Speaker 02: This article court is again in session. [00:00:11] Speaker 02: Be seated please. [00:00:15] Speaker 01: Mr. Stockman. [00:00:20] Speaker 01: May it please the court. [00:00:21] Speaker 01: My name is Robert Stockman here on behalf of the Environmental Defense Fund. [00:00:25] Speaker 01: I would like to reserve four minutes for rebuttal. [00:00:27] Speaker 01: We respectfully ask that this Court grant the petition for review. [00:00:31] Speaker 01: At issue here is the public's right to know the specific identity of chemicals being manufactured and processed in the United States and use that information to study the health and environmental effects of these chemicals. [00:00:43] Speaker 01: We recognize that Congress allowed confidentiality claims for certain information that would otherwise be available through the inventory. [00:00:49] Speaker 01: But Congress put a number of strict limitations and requirements on those claims. [00:00:53] Speaker 01: And at every turn, EPA has disregarded the plain text of the statute in favor of greater concealment. [00:00:59] Speaker 01: We ask this Court to enforce the statute as written and to limit confidentiality claims to those permitted under the law. [00:01:06] Speaker 01: First, Section 8B4B, which governs the inventory, provided that any manufacturer or processor may seek to maintain an existing claim for confidentiality pursuant to Section 14. [00:01:18] Speaker 01: Under the plain language, a person does not maintain an existing claim if they've never made that claim before. [00:01:23] Speaker 01: This is particularly so with confidentiality claims pursuant to Section 14, which are defined in both their procedure and substance to be person-specific. [00:01:33] Speaker 01: Therefore, they are not logically interchangeable or transferable. [00:01:37] Speaker 01: Section 8B4B clearly does not permit new claims through this process, and yet EPA adopted an interpretation and an approach that effectively allows such new claims. [00:01:47] Speaker 01: Indeed, in its brief, EPA asserts that whether or not such a claim is viewed as new is a semantic matter with no legal significance. [00:01:54] Speaker 01: But the limitation of this process to existing claims gives it legal significance. [00:01:59] Speaker 01: Congress did not intend to allow new claims. [00:02:02] Speaker 01: Neither the EPA nor the interveners have identified any way that their interpretation of the statute gives meaning to the word existing claim. [00:02:09] Speaker 01: And despite working on this case for a year, I've not figured out what they think existing means. [00:02:13] Speaker 05: Well, I thought they meant a claim made by someone else. [00:02:17] Speaker 05: How hard is that? [00:02:18] Speaker 05: That's what they mean. [00:02:18] Speaker 05: You may disagree with it, but that is what they mean, isn't it? [00:02:21] Speaker 01: Well, so I suppose that must be what they mean, though they didn't actually expressly say that in the rulemaking at JA 130. [00:02:28] Speaker 01: They didn't say the claims were transferable. [00:02:31] Speaker 05: It's not that the claim is transferable, it's that some other entity has made the claim, it's on the list, and they want to continue that claim of confidentiality. [00:02:42] Speaker 05: It's not that they want to continue their claim, it's that they want to continue [00:02:47] Speaker 01: A claim that's already been made. [00:02:50] Speaker 01: I think the problem with that is that the claims are all, if you turn to the substance of what the claims are, they all turn out to be person-specific. [00:02:57] Speaker 01: So for example, under Section 14, when you assert a claim, you have to assert that disclosure of this information would cause substantial harm to your competitive position. [00:03:07] Speaker 01: So it doesn't make sense for Company A, who when they asserted a claim to say, disclosure of this information would cause substantial competitive harm to my Company A's position, [00:03:17] Speaker 01: It's simply not the same claim for company B to come in and say, well, actually, it causes substantial competitive harm to my company B's position. [00:03:25] Speaker 01: They're different. [00:03:25] Speaker 01: And that's not the only way in which section 14 makes them different. [00:03:28] Speaker 05: They are going to have to substantiate the claim somehow, right? [00:03:31] Speaker 01: They will ultimately have to substantiate the claim. [00:03:33] Speaker 05: This is just a holding pattern until that occurs. [00:03:36] Speaker 01: Yes, but it's an important holding pattern. [00:03:38] Speaker 01: I'm not saying it's not important. [00:03:39] Speaker 01: Yes. [00:03:40] Speaker 01: But it is true that they plan to, under the review plan, require substantiation of the claims, though one of our other claims goes to why their substantiation will be inadequate under the statute as written. [00:03:53] Speaker 01: Before getting to that, though, I would like to stand and maintain a claim for just a moment. [00:03:58] Speaker 01: One other problem here is even if the statute were amenable to different interpretations, the actual rationale they gave in the rule is false. [00:04:06] Speaker 01: What they said in the rulemaking is that only the original claimant would be in a position to support a claim, which seems to suggest that in their view that when later people came in they didn't have to make any confidentiality claim and that in fact you could say have company B come in, say this isn't confidential and EPA would continue to conceal it. [00:04:27] Speaker 01: That's not what the regulation said. [00:04:30] Speaker 01: The regulation said that a person may assert a claim for confidentiality for any information they submit under this part, and the claim must be submitted with a company the information when it's submitted. [00:04:40] Speaker 01: So under the rules, company B or company C or company D should have been asserting a confidentiality claim. [00:04:46] Speaker 01: And this gets to something very important to us, which is that when the second current person comes in and says this is or doesn't submit a confidentiality claim, [00:04:54] Speaker 01: Our view is that means EPA should be sharing that information with the public. [00:04:58] Speaker 01: It's not confidential. [00:04:59] Speaker 01: At a minimum, that means they should step back and say, is this really secret? [00:05:03] Speaker 01: Company B doesn't even consider it confidential. [00:05:06] Speaker 01: What EPA seems to be saying is that it can get a submission from Company B, Company C, Company D, none of which assert confidentiality, and they'll maintain the confidentiality even though it's no longer really a secret. [00:05:18] Speaker 01: So part of our problem is with their rationale, which we don't think is supported by the rule, regulations that were in place at the time, or with their public statements. [00:05:28] Speaker 01: They have, in fact, in the past said that when one submitter reveals the chemical identity, then it's generally no longer secret, and so therefore it's no longer eligible for confidentiality. [00:05:39] Speaker 01: They said that in the Federal Register notice that we signed in our brief, 83 Fed regs 5623, and also in the submission we submitted through 28J. [00:05:48] Speaker 01: So the thing that I think gets at this is their rationale was fundamentally wrong. [00:05:53] Speaker 01: It's fundamentally contrary to their regulations, and it represents an approach to confidentiality that results in greater concealment from the public than the public has the right to know. [00:06:02] Speaker 01: So for that reason alone, the fact that their rationale was arbitrary and capricious would be a reason to reverse. [00:06:08] Speaker 01: Second, I'd like to turn to the substantiation issue, which is that when Congress enacted Section 14C1B, which requires a statement accompanying the confidentiality claims, Congress clearly intended that the confidentiality claim should have to meet the requirements of that statement. [00:06:24] Speaker 01: Specifically, Congress intended that EPA should be considering whether the information is readily discoverable through reverse engineering. [00:06:33] Speaker 01: And they should deny claims when it is readily discoverable through reverse engineering. [00:06:37] Speaker 01: But they adopted a regulation that doesn't require them to consider that, and in fact doesn't authorize them to deny a confidentiality claim on that basis. [00:06:46] Speaker 01: The adoption of 2208 just straight up is a significant problem. [00:06:52] Speaker 05: Do you understand the government's position to be that if it is easily reversible, it's still confidential? [00:07:04] Speaker 05: Or do you understand the government's position to be they're just not asking another version of the same question included in the certificate? [00:07:11] Speaker 01: I understand them to, in the brief, have taken the position that they don't have to consider this factor. [00:07:16] Speaker 01: So they can decide whether or not to substantiate the claim without separately considering whether or not it meets this particular factor. [00:07:26] Speaker 01: And at a minimum, that's also what the regulations effectively do, because by cutting every single question that gets at this factor, they'll have no information to go on when assessing this particular factor. [00:07:37] Speaker 05: So I take their position. [00:07:38] Speaker 05: I'll leave aside the information question. [00:07:40] Speaker 05: I guess I was reading pages 39. [00:07:44] Speaker 05: And 40 of the brief is saying that they're still going to follow these statutory requirements, that these are the substantive requirements for the confidentiality claim. [00:07:54] Speaker 05: I guess we'll find out, but your reading is that they're going to ignore reversibility now. [00:08:01] Speaker 01: My reading is that they'll ignore it, or at a minimum, they have not committed to reviewing it. [00:08:09] Speaker 05: There was only one question about reversibility that was dropped, right? [00:08:14] Speaker 05: What was that question? [00:08:15] Speaker 01: Actually, there were at least two questions. [00:08:16] Speaker 01: Only one that really directly related to reversibility. [00:08:20] Speaker 01: Classic question is whether the product leaves, whether the chemical leaves the facility in a product that's available to the public and whether then people should be able to discover it through reverse engineering. [00:08:33] Speaker 05: A second question that gets at... Is that last part? [00:08:35] Speaker 05: Part of the question? [00:08:36] Speaker 05: I don't remember that last part. [00:08:37] Speaker 01: I guess that part, technically they didn't... Not technically, the words, the words. [00:08:42] Speaker 05: Why don't you just read those last two questions? [00:08:47] Speaker 05: which if I could have found them in my pile, I would have read myself. [00:08:59] Speaker 01: Okay, so here is one of the questions. [00:09:01] Speaker 01: Does this particular chemical substance leave the site of manufacture in any form, for example, as product, effluent emission? [00:09:07] Speaker 01: If so, what measures have been taken to guard against the discovery of its identity? [00:09:12] Speaker 01: And then another is, if the chemical substance leaves the site in a product that is available to the public or your competitors, can the chemical substance be identified by analysis of the product? [00:09:22] Speaker 01: So both of those, neither of them uses the phrase reverse engineering, but both of them clearly would at least get at that information and force someone to actually provide an account for why or why not. [00:09:32] Speaker 01: their product can be discovered through reverse engineering. [00:09:37] Speaker 05: I note this is something we're particularly concerned about because... Can I just ask, did they, so looking at the form that they had before, didn't look like there was much to be answered other than yes or no. [00:09:48] Speaker 05: Was there a serious amount of additional supporting data, even under the original notice that was supposed to be provided? [00:09:56] Speaker 01: So the original notice looked sort of messy, like I wasn't sure whether that was really what it would look like in the end. [00:10:03] Speaker 01: It didn't provide the boxes for information to be provided, but to be brutally honest, my assumption was that when they actually created the final form, they would provide boxes for people to fill out and provide that information. [00:10:18] Speaker 01: I mean, the other thing is that I think a yes or a no is not a very good substantiation. [00:10:24] Speaker 01: I mean, if someone's answer to that question is no and they provide no information about what that means, I would submit that EPA should deny the claim. [00:10:34] Speaker 05: Is your understanding that they don't do any independent review of their own after getting the answers to these questions or ask for any more substantiation? [00:10:44] Speaker 01: So this is a historically interesting question. [00:10:48] Speaker 01: Historically, they did not review. [00:10:49] Speaker 01: I only want it to be interesting for this morning. [00:10:53] Speaker 01: They did not review the substantiation questions. [00:10:57] Speaker 01: Historically, they did not review many of the claims. [00:11:00] Speaker 01: What they are supposed to do now is they are supposed to review these substantiation claims, and I think theoretically they should do follow-up where appropriate. [00:11:10] Speaker 01: This sort of gets us to one of our other problems, which is that they're not publishing any of their determinations on these claims. [00:11:17] Speaker 01: So it's actually sort of impossible for us to know whether or not they're reviewing the substantiations. [00:11:24] Speaker 01: how in-depth they're going, whether or not, I mean, this program operates like a black box. [00:11:30] Speaker 01: So we don't know whether they're actually reviewing the substantiation questions or how much information they consider to be necessary to meet these requirements. [00:11:39] Speaker 01: That's one of the things that our third claim gets at. [00:11:42] Speaker 03: Let me go back on the reverse engineering. [00:11:44] Speaker 03: The 2613C3 says that they will [00:11:50] Speaker 03: So our view is that it needs to be informed by the prior version of the statute. [00:12:06] Speaker 01: or the prior provision. [00:12:08] Speaker 01: What they're substantiating is the assertions made in the statement set forth in 14C1B. [00:12:16] Speaker 01: So our view is that here EPA needs to at least consider the need to substantiate that. [00:12:21] Speaker 01: And that's our main objection here, is they didn't even give an analysis of why they're not [00:12:26] Speaker 01: how they're going to figure out reverse engineering. [00:12:29] Speaker 01: They just literally said, we wanted to be more succinct, so we cut everything. [00:12:33] Speaker 01: So even if they have some discretion in shaping those regulations, which they do, our view is that it's an abusive discretion or it's arbitrary and capricious to completely fail to consider a relevant aspect of the problem. [00:12:45] Speaker 01: which was the reverse engineering prong. [00:12:48] Speaker 01: So our view is that they could come up with lots of different types of substantiation questions, but they at least have to consider what they're trying to substantiate. [00:12:57] Speaker 01: And our view is that it's pretty clear that Congress didn't write 14C1B to be a mere procedural formality where people make this assertion and then that all disappears. [00:13:07] Speaker 03: Congress... Is this right for a court's consideration at this point, given the way the statute is structured? [00:13:12] Speaker 03: The agency can adopt rules as it sees fit. [00:13:15] Speaker 03: In a particular case, pursuant to those substantiation rules, they don't consider reverse engineering canopy challenge? [00:13:26] Speaker 01: So the thing is, in our view, this is the rulemaking where they adopted how they're going to approach substantiation for the information that's submitted under this rule. [00:13:35] Speaker 01: So this is the set of regulations where we'll get an opportunity to challenge it. [00:13:39] Speaker 01: We won't get a later opportunity to challenge how they're doing substantiation. [00:13:44] Speaker 01: So this is the one opportunity to get at how they're doing substantiation for information submitted under the inventory rule, which includes the information that was submitted as part of the inventory, but also all the perspective moving from inactive to active notifications. [00:14:03] Speaker 01: So we're not going to get a better opportunity to get at this. [00:14:05] Speaker 01: I suppose we could bring an as applied challenge to specific determinations. [00:14:10] Speaker 01: But I think that I think that the thing is then they'll say we're in compliance with our regulation. [00:14:15] Speaker 01: And so it's too late. [00:14:17] Speaker 01: You needed to challenge our regulation. [00:14:19] Speaker 01: And they did set forth how they would do substantiation in this regulation. [00:14:23] Speaker 01: They did specifically choose to address it in this rulemaking. [00:14:27] Speaker 01: So in our view, it is right for challenge now. [00:14:29] Speaker 01: And on rightness, I would note that Congress provided a very specific 60-day statutory deadline for us to sue, which sort of counsels in favor of finding that we can sue early. [00:14:40] Speaker 01: There's an intention of Congress that rules get immediate and early review. [00:14:44] Speaker 01: And we won't get a chance to challenge this rule at some later date as a result of that 60-day deadline. [00:14:49] Speaker 03: No, is your argument that the rule that they adopted forecloses the possibility of a considering reverse engineering, reasonable basis to believe the information is not readily discoverable? [00:15:03] Speaker 01: I think the rule they adopted makes it hard to, I think it is hard to know [00:15:11] Speaker 01: that answer, but they said that things would be treated as confidential if they meet the requirements of 2208, and 2208 does not require consideration of confidential reverse engineering. [00:15:22] Speaker 01: So our concern is that later, even if they say, oh, this is discoverable through reverse engineering, someone could legitimately say, well, you said that it's confidential if it meets 2208, and that doesn't specifically require reverse engineering be considered. [00:15:37] Speaker 01: They've created a problem that needs to be addressed at this stage in the process. [00:15:43] Speaker 01: So I think we can't postpone review to a later date. [00:15:48] Speaker 02: Well, I'm just trying to figure out how realistic this is as a problem at this early stage as a facial matter. [00:15:56] Speaker 02: They do still have to show that they have taken measures to maintain confidentiality. [00:16:00] Speaker 02: And the third question is they think your business has disclosed the information to others. [00:16:04] Speaker 02: What precautions has your business taken? [00:16:07] Speaker 02: Now, if putting the thing out on the market would allow somebody to sort of [00:16:13] Speaker 02: analyze and reverse engineer the content, would that not be, is your position that wouldn't be part of what that third question? [00:16:20] Speaker 01: I think a person could easily answer that question and just decline to mention all of that. [00:16:27] Speaker 02: Don't these businesses have a lot of interest in making sure their stuff isn't reverse engineered? [00:16:31] Speaker 01: Well, I think that a lot of people will have an interest in providing EPA with less information when the information is unfavorable to them. [00:16:41] Speaker 02: So if they don't, you know, if you can read a question to say... It seems like reverse engineering, the ability to be reverse engineered is just the flip side of whether it's confidential. [00:16:50] Speaker 02: Because if you've got something out there and people can just dissect it, then you're not even going to be able to establish up front that it's confidential, right? [00:16:58] Speaker 02: Because it's out there and everybody's been able to figure out what it is. [00:17:02] Speaker 01: So I would like to think that we're true. [00:17:04] Speaker 01: What is often, I think, the case is that it's known within industry what these chemicals are. [00:17:11] Speaker 01: Many of these are known within industry because they have the resources to go about reverse engineering. [00:17:16] Speaker 01: The problem is the public doesn't have the resources to reverse engineer each chemical that comes out. [00:17:21] Speaker 01: So I mean, in an ideal world, we would do all that reverse engineering ourselves, but we don't have the resources in the laboratories to do it. [00:17:30] Speaker 01: So I think that [00:17:32] Speaker 01: I think that requiring that they inquire into this particular facet is important because they could just say, oh, well, you say it's a secret, that's good enough for me, and not inquire into this unless they're forced to do so. [00:17:47] Speaker 01: I mean, there's no evidence that they historically have inquired into this factor. [00:17:50] Speaker 02: And the statute says readily discoverable through reverse engineering. [00:17:54] Speaker 02: Is it talking about? [00:17:57] Speaker 02: discoverable by companies with the best technology and scientists, or is readily discoverable through reverse engineering suggest? [00:18:07] Speaker 01: My submission would be that it's under readily discoverable by reverse engineering was meant to get at the companies that would be engaged in reverse engineering. [00:18:18] Speaker 01: So the sort of people who have the resources to do it. [00:18:21] Speaker 01: The question isn't whether just any random person could reverse engineering. [00:18:25] Speaker 01: but whether the average competitor would be able to sit down and reverse engineer it, because that's what Congress was interested in and what Congress was interested in getting at. [00:18:33] Speaker 01: So I think that's what that standard should be trying to get at. [00:18:36] Speaker 02: Right. [00:18:36] Speaker 02: I guess it would be hard to say something. [00:18:38] Speaker 02: I'm just trying to figure out if by not having a specific question directed at that in terms of reverse engineering, we can tell from the face of this challenge of this regulation that they are ignoring [00:18:52] Speaker 02: the statutory requirement to protect against reverse engineering as opposed to the built into the very nature of demonstrating confidentiality upfront, because you just can't be confidential if other people can figure out what it is. [00:19:05] Speaker 02: And so that it is, as Judge Edwards was suggesting, more of a ripeness problem here to figure out what they meant by these questions. [00:19:12] Speaker 01: So I think that part of the problem here is they didn't address this in the rulemaking at all. [00:19:16] Speaker 01: I mean, it would be one thing if in the rulemaking they had sat down and said, [00:19:21] Speaker 01: We're incorporating all of that into our confidentiality determination. [00:19:25] Speaker 01: We have this plan to get it reverse engineering through X, Y, and Z. And that's why you have nothing to be concerned about. [00:19:30] Speaker 01: But the court can't just [00:19:32] Speaker 01: I mean, that's not what they did. [00:19:34] Speaker 01: They just chose to ignore it, which in my view is arbitrary and capricious. [00:19:39] Speaker 01: So the problem is that they didn't address this issue in the rulemaking. [00:19:44] Speaker 01: There may be more than one way to skin this particular cat, but they have to actually do it. [00:19:49] Speaker 01: I'd also note that this is a program that has had a long history of over too many confidentiality claims. [00:19:57] Speaker 01: We cited in our brief numerous GAO reports about how this program [00:20:01] Speaker 01: fails to hold confidentiality claimants to the requirements they're supposed to meet. [00:20:06] Speaker 01: So I think, and Congress very specifically revamped this whole program with the goal of getting more scrutiny on these confidentiality claims. [00:20:14] Speaker 01: So I think that it is in a situation where it makes sense to say, trust them, they'll just get to it, because historically they have not [00:20:22] Speaker 01: gotten to it. [00:20:23] Speaker 01: They have not been doing this scrutiny. [00:20:25] Speaker 01: And so it simply doesn't make sense to say, well, we can just assume that they will scrutinize these claims for this factor. [00:20:32] Speaker 02: And then for purposes of whether an as applied challenge could be brought later, put aside the procedural requirements and timing issues that you've raised. [00:20:42] Speaker 02: I'm just asking the nature, would you or people in the public have any ability to know [00:20:49] Speaker 02: whether something could be, is actually seeing that later. [00:20:52] Speaker 01: This is one of our biggest problems, is we don't know, we don't have the information and that problem hits at multiple points. [00:21:00] Speaker 01: One, when they don't make the determinations public, we don't know that there even is information that's been submitted. [00:21:06] Speaker 01: We don't know what the reasoning was behind why it's being held confidential. [00:21:13] Speaker 01: And then even if we could break that all down, we don't have the expertise that EPA has to scrutinize whether something is reverse-engineerable. [00:21:21] Speaker 01: This is something that their scientists would actually be quite good at doing if they put their scientists on the job of doing it. [00:21:27] Speaker 01: So, it's particularly important that they do it and create these robust records when they're reviewing confidentiality claims. [00:21:36] Speaker 01: It's not something that the outside community can do, and I don't think it's something Congress thought we should have to do to be able to get access to this information. [00:22:02] Speaker 00: May I please the court? [00:22:03] Speaker 00: Philip Dupre with the Department of Justice on behalf of the EPA. [00:22:07] Speaker 00: With me at council table is Elizabeth Thaler from the EPA's Office of General Counsel. [00:22:12] Speaker 05: Can we start by talking about this reverse engineering question? [00:22:16] Speaker 05: So I marked in your brief about eight places where you say that the four certified questions are the [00:22:26] Speaker 05: substantive requirements of the statute for confidentiality. [00:22:32] Speaker 05: The four-part statement generally reflects the substantive requirements for protection from disclosure, etc. [00:22:39] Speaker 05: In dropping the question, the substantiation questions about reverse engineering, [00:22:48] Speaker 05: Was that to indicate that the agency doesn't believe that that is a substantive factor that has to be satisfied for confidentiality? [00:22:58] Speaker 00: The short answer is no. [00:23:01] Speaker 00: The long answer is that the inclusion of the assertions that need to be made on a confidentiality application that are listed in 2613C1B that include a reasonable basis to believe that the information is not readily discoverable through reverse engineering [00:23:27] Speaker 00: Those statements are not, in and of themselves, the substantive requirements for confidentiality claims. [00:23:35] Speaker 05: So what does this mean? [00:23:37] Speaker 05: I'm just quoting you from page 10 of your brief. [00:23:39] Speaker 05: The four-part statement generally reflects the substantive requirements for protection from disclosure that are codified elsewhere under TSEA, as well as in existing regulations. [00:23:50] Speaker 05: Correct. [00:23:51] Speaker 05: And I thought you just told me that they don't represent substantive requirements. [00:23:54] Speaker 00: I guess what I would say is these are claims, excuse me, these are statements that go to the criteria for confidentiality that basically says FOIA Exemption 4 that says there can be substantial competitive harm if information is disclosed. [00:24:18] Speaker 00: And so, for instance, under EPA's FOIA regulations under 40 CFR 2.208C, which is cross-referenced in section 14 of TASCA, it imposes a requirement that the information is not and has not been reasonably obtainable without the business's consent by other persons by use of legitimate means. [00:24:42] Speaker 00: And so, for example, reverse engineering would fall into that category. [00:24:47] Speaker 05: Let me say again my question. [00:24:48] Speaker 05: Does the EPA agree that if something is readily, reversibly engineered, that it doesn't qualify for confidential treatment? [00:24:59] Speaker 00: Yes. [00:24:59] Speaker 05: Yes. [00:25:00] Speaker 05: And so the only question here is whether you had to ask a couple more questions about that, not about whether the deletion of the last two questions or maybe the last one question was a substantive change in the agency's understanding of its responsibilities. [00:25:18] Speaker 05: Is that right? [00:25:19] Speaker 00: Well, I think it is, there definitely is not any substantive change on the agency's part in terms of what is required for a chemical identity to be deemed confidential. [00:25:32] Speaker 00: Really, in putting together this rule, EPA was tasked with including substantiation questions. [00:25:41] Speaker 00: And those questions could go towards substantiating the claim. [00:25:46] Speaker 00: And I think what's important is to differentiate between essentially substantiating questions and the procedural requirements that Congress included that go to the assertion of a claim. [00:25:59] Speaker 00: So for instance, while Congress required under Tosca Section 14C1B that anyone who asserts a confidentiality claim includes a statement that says, [00:26:13] Speaker 00: all of what's required, including that they have a reasonable basis to believe that the information is not readily discoverable through reverse engineering, that is included in this rule. [00:26:21] Speaker 00: And everyone who submits a confidentiality claim under this rule has to include that statement. [00:26:26] Speaker 00: What I think petitioners get wrong is that there is no requirement that EPA requires substantiation for all of those statements made in support of their confidentiality claim. [00:26:39] Speaker 02: How could someone substantiate confidentiality without showing that it can't be readily reverse engineered? [00:26:48] Speaker 02: Can you be confidential if your product, your chemical can readily be reverse engineered? [00:26:55] Speaker 00: I think it would be very difficult to be. [00:26:57] Speaker 02: How is it possible? [00:26:59] Speaker 02: If it's readily reverse engineered or subject to reverse engineering, how can it still be confidential? [00:27:05] Speaker 00: It would likely not meet the confidentiality requirements. [00:27:09] Speaker 02: I'm trying to understand conceivably how the two are not mutually exclusive. [00:27:14] Speaker 00: I think they very well may be mutually exclusive, but I think the context of... How could it possibly be legitimate to leave that out? [00:27:24] Speaker 02: and put aside the assertion versus substantiation if it is essential to establishing, to substantiating confidentiality as a statute requires. [00:27:36] Speaker 02: This is an essential component of confidentiality that that not be something you ask about at the substantiation stage. [00:27:44] Speaker 00: We would disagree with that characterization of it's an essential component of confidentiality. [00:27:51] Speaker 00: Again, what [00:27:53] Speaker 00: The substantive, if we go to 2613A, which references the substantive requirements for confidentiality, except as provided in this section, the administrator shall not disclose information that is exempt from disclosure pursuant to subsection A of section 552 of Title V by reason of, and that is a reference to FOIA, okay? [00:28:19] Speaker 02: It may be broader. [00:28:20] Speaker 02: But I don't understand how, I guess I'm still getting, you couldn't conceive, as I took your answer, of how something could be confidential as that term is used in this statute and yet readily subject to reverse engineering. [00:28:35] Speaker 02: And so how can you say that's not part of what they have to do to substantiate a confidentiality claim? [00:28:42] Speaker 02: There may be other things going on. [00:28:47] Speaker 02: I just don't understand how anything could be. [00:28:49] Speaker 00: Well, I think what is problematic is the petitioner's reading is essentially saying that any scenario in which would essentially defeat a confidentiality claim has to be substantiated, and that's not at all provided for. [00:29:04] Speaker 00: I know. [00:29:04] Speaker 02: Their argument is that there's a reason. [00:29:07] Speaker 02: reverse engineering shows up in the assertions because that's critical to establishing confidentiality. [00:29:13] Speaker 02: It always has been. [00:29:14] Speaker 02: And then you come along with your new regulation and you say, don't bother about, effectively, don't bother making that reverse engineering showing. [00:29:24] Speaker 00: I would disagree with the characterization that we said, don't bother. [00:29:28] Speaker 00: Well, you took them out. [00:29:29] Speaker 00: You took the questions out. [00:29:31] Speaker 00: Of the proposed rules. [00:29:33] Speaker 00: So to be clear, it's not as if that these were longstanding questions. [00:29:37] Speaker 00: These were EPA made a proposal, and I think it's important to reference back the [00:29:43] Speaker 00: Substantiation Requirements Section. [00:29:45] Speaker 00: And here it says, a person asserting, this is 2613C3, says, except as provided in paragraph two, a person asserting a claim to protect information from disclosure under this section shall substantiate the claim in accordance with such rules as the administrator has promulgated or may promulgate pursuant to this section. [00:30:07] Speaker 00: So as an initial matter, the administrator had no obligation to promulgate any substantiation questions at all. [00:30:14] Speaker 00: But EPA did promulgate substantiation questions, and I believe there were seven or so in the proposed rule. [00:30:22] Speaker 00: The comments received by EPA said, we think these are too many questions. [00:30:29] Speaker 00: Can they be streamlined? [00:30:30] Speaker 00: EPA streamlined the questions in a manner that they saw best to [00:30:36] Speaker 00: meet the substantive benefits of substantiation questions will not be overly lengthy. [00:30:41] Speaker 02: So you're the attorney advising a company making one of these substantiation showings. [00:30:47] Speaker 02: Are you going to say that you need to show that it's not susceptible to reverse engineering, readily susceptible? [00:30:55] Speaker 00: What I would tell them is that they need to meet the substantive confidentiality requirements that include a showing that the information is not reasonably obtainable without the business's consent by other persons by use of legitimate means. [00:31:12] Speaker 02: Is it your position that encompasses this reverse engineering showing? [00:31:16] Speaker 00: I think definitely if reverse engineering would be one of the legitimate means by which it could be. [00:31:24] Speaker 02: So it's not that you... Well, I guess it's not... Their position seems to be that you just dropped that statutory requirement. [00:31:29] Speaker 02: I'm just trying to clarify your position. [00:31:31] Speaker 02: Our position... They read the dropping of those two questions as you're just not enforcing that requirement at all. [00:31:38] Speaker 02: And now what I'm hearing from you, which may be a reasonable interpretation of the regulation, is that no, [00:31:42] Speaker 02: It's already covered by this other provision. [00:31:45] Speaker 00: I'm trying to figure out if this is accurate. [00:31:51] Speaker 00: I don't think there's an obligation for an applicant to basically run through every single legitimate means by which information could be gathered and address them on a confidentiality application. [00:32:05] Speaker 00: But I want to turn real quickly to the standing argument. [00:32:10] Speaker 02: Wait, no, no. [00:32:10] Speaker 02: Before you turn, I get why you want to do that. [00:32:12] Speaker 02: But to go back. [00:32:14] Speaker 05: It's always a bad sign when you want to retreat like that. [00:32:17] Speaker 02: You just said the rules said they have to show that there's no legitimate means of acquiring this information. [00:32:23] Speaker 02: And now you're saying, I thought you just said, and tell me if I misheard. [00:32:27] Speaker 02: Well, they don't have to show that every legitimate means is far closed. [00:32:31] Speaker 00: I guess my point, Your Honor, is that what [00:32:35] Speaker 00: What the agency did here is it uses discretion in putting together substantiation questions. [00:32:45] Speaker 00: And one of the questions that they proposed that they did not end up including was a question that essentially restated what was in, what was a required statement in the assertion of claims. [00:32:59] Speaker 00: And in the assertion of claim, someone is required to certify under penalty of perjury that they have a reasonable basis to believe that the information is not readily discoverable through reverse engineering. [00:33:10] Speaker 00: The agency proposed a similar question in its substantiation questions that it declined to include in its final rule. [00:33:21] Speaker 00: And I think... Because? [00:33:26] Speaker 02: well because they wanted to streamline streamlining gets back my question streamlining is not trying to be right streamlining means that's what one does when one consolidates [00:33:37] Speaker 02: eliminates redundancies. [00:33:39] Speaker 02: And so is the agency position that reverse engineering is already covered by the question that's still required, the demonstration still has to be made about no legitimate means. [00:33:52] Speaker 02: If that's your position, that's one answer. [00:33:54] Speaker 02: And if your position is no, they wouldn't actually have to do that, which is what you, they don't have to do everything, sounded like to me. [00:34:01] Speaker 02: I'm trying to figure out, it either covers it, it's either meant to cover it or it's not. [00:34:07] Speaker 02: I'm very confused by the position. [00:34:09] Speaker 00: The substantiation questions are to the extent, there's no obligation by any applicant to submit additional information apart from the substantiation questions. [00:34:23] Speaker 00: So to that extent, [00:34:26] Speaker 02: Yes, I'm asking you what your, your substantiation question, I'm sorry, what page is it on? [00:34:31] Speaker 02: I'm trying to get it here. [00:34:32] Speaker 00: Well, the record on Federal Register 82 FR 37544. [00:34:43] Speaker 02: 14 or 13? [00:34:46] Speaker 00: I think I got a different one. [00:34:48] Speaker 00: And I guess I would say if you look at- How did you streamline? [00:34:51] Speaker 00: How did you streamline? [00:34:51] Speaker 00: Well, I think part of what's important to note is if you look at question two, will disclosure of the information likely result in substantial harm to your business's competitive position? [00:35:03] Speaker 00: If you answered yes, described with specificity the substantial harmful effects, that would likely result to your competitive position. [00:35:12] Speaker 00: It also asks about information that the business has, efforts it has taken to maintain confidentiality. [00:35:24] Speaker 00: It looks at whether or not this information is in public [00:35:28] Speaker 00: Documents, all of these questions go to whether or not the applicant meets the substantive standard for... Do they encompass reverse engineering or not? [00:35:42] Speaker 00: These questions do not specifically encompass reverse engineering. [00:35:45] Speaker 00: But again, I think reverse engineering needs to be seen as, in a sense, a sub-component of the broader substantive criteria for a confidentiality claim, which is whether or not... Sub-component, which one? [00:36:01] Speaker 02: Just so we're on the same page. [00:36:04] Speaker 00: I'm sorry, could you repeat the question? [00:36:06] Speaker 02: Which one of these would encompass [00:36:08] Speaker 02: A showing of no reverse engineering. [00:36:10] Speaker 00: I think none of these specifically encompasses reverse engineering. [00:36:16] Speaker 00: And I think the AMC was entitled to do that because reverse engineering is not itself a substantive requirement of the confidentiality provision. [00:36:29] Speaker 05: You're really confusing me. [00:36:31] Speaker 05: So Congress statute requires a certification of only four things. [00:36:38] Speaker 05: Yes. [00:36:39] Speaker 05: suggesting that all those four things are important to the Congress. [00:36:43] Speaker 05: Correct. [00:36:43] Speaker 05: And the fourth one says a reasonable basis to believe that the information is not readily discoverable through reverse engineering, correct? [00:36:51] Speaker 05: Correct. [00:36:52] Speaker 05: That's what you have to certify, right? [00:36:54] Speaker 05: Correct. [00:36:54] Speaker 05: And then your brief says the four-part statement generally reflects the substantive requirements for protection from disclosure. [00:37:05] Speaker 05: That's at your red brief page 10. [00:37:08] Speaker 05: Yes. [00:37:08] Speaker 05: And your your your brief at page 36 explains that this would provide no more information than that already. [00:37:18] Speaker 05: That is, your new questions would just provide no more information than the statement already would. [00:37:26] Speaker 00: Correct. [00:37:26] Speaker 05: Then on page 39, you say, [00:37:29] Speaker 05: Indeed, EPA must and fully intends to follow all the statutory requirements regarding confidentiality claims. [00:37:36] Speaker 05: So the way that I had read your brief, and perhaps now it was too generously, is that you were saying that these are the four substantive requirements that we, when we review these claims, we will look at these four things [00:37:54] Speaker 05: that the only reason we didn't ask for this last question about reverse engineering is we didn't think it added anything to the others, but we will still require that it not be readily discovered through reverse engineering. [00:38:10] Speaker 05: Now is that summary of your position incorrect in any respect? [00:38:16] Speaker 00: I think it is incorrect in that the [00:38:22] Speaker 00: the statements that need to be certified under section 14 that include the reverse engineering statements. [00:38:31] Speaker 00: Our view of those is that those are statements that go to whether or not the substantive requirements of the confidentiality provisions are met, but are not necessarily independent substantive requirements of the confidentiality provisions themselves. [00:38:52] Speaker 00: So, for instance, to the extent that someone certifies that a specific chemical identity is not subject to reverse engineering, that goes to show that they would be subject to substantial competitive harm if this information was publicly disclosed. [00:39:13] Speaker 00: So to that extent— Maybe not. [00:39:15] Speaker 02: I don't know why competitive harm would have to happen. [00:39:17] Speaker 02: Maybe they just don't have many competitors on this. [00:39:21] Speaker 02: they'd like to keep it confidential for whatever reasons. [00:39:25] Speaker 02: It doesn't mean, I don't know why you would think a showing of competitor harm would show that it can't be reverse engineered. [00:39:33] Speaker 02: I mean, unless you're assuming, as I had started this conversation, that it's the very essence of what it means to be confidential, that it can't be readily determined what that information is, at which point, [00:39:48] Speaker 02: We'll be back to saying these other questions capture that inquiry. [00:39:53] Speaker 00: Well, I think if Obviously [00:39:58] Speaker 00: The EPA was tasked with, or given the opportunity, if it chose to take advantage of it, to ask substantiation questions. [00:40:07] Speaker 00: And they did ask substantiation questions that went to the substantive confidentiality requirements under the stat sheets. [00:40:15] Speaker 00: And one question was originally geared towards reverse engineering. [00:40:20] Speaker 00: They dropped that question after receiving comments. [00:40:22] Speaker 05: Did they ever receive, they received a comment that said that particular [00:40:27] Speaker 05: Question was just not succinct. [00:40:29] Speaker 05: You only give any explanation for why this was done. [00:40:34] Speaker 05: It says they're trying to be more succinct. [00:40:36] Speaker 05: Correct. [00:40:37] Speaker 05: Did any comment or say drop? [00:40:39] Speaker 05: Question five or six, whichever one it is. [00:40:44] Speaker 05: Not to my knowledge, your honor. [00:40:47] Speaker 05: Not. [00:40:47] Speaker 05: Not to your knowledge. [00:40:48] Speaker 05: Not to my knowledge. [00:40:50] Speaker 05: So maybe the answer here is really to go back to the logical outgrowth claim. [00:40:58] Speaker 05: Some number of questions. [00:41:06] Speaker 05: All the way through K, A through K. You dropped only really the ones about reverse engineering. [00:41:12] Speaker 05: Those are ones that are specifically mentioned in the statute. [00:41:17] Speaker 05: How could [00:41:18] Speaker 05: Commenters have known that you were planning to actually delete those questions. [00:41:25] Speaker 05: It's one thing to say a logical outgrowth has to do with things like succinctness, but this is not just succinctness. [00:41:34] Speaker 05: This is a dropping of one of the questions that Congress itself listed. [00:41:39] Speaker 05: And how are they supposed to know to object to the dropping of one of the four questions that Congress insisted on? [00:41:49] Speaker 00: Well, in several respects, and most importantly, several commenters, and we cited to them in the brief, did ask that the questions be shortened or streamlined. [00:42:00] Speaker 05: Did anybody say that the claim you're now making, which is that reverse engineering is included somehow in something else? [00:42:15] Speaker 00: Your Honor, it's important to recognize it's not that someone told the agency, we don't think you need to include a reverse engineering question because reverse engineering is not itself a substantive criteria, but just, in a sense, a question or a lens through which to look at whether or not information should be kept confidential. [00:42:38] Speaker 05: You know, that view was always the agency's position, and so in looking to streamline... You don't think it's a substantive criteria, notwithstanding what you said in the brief. [00:42:49] Speaker 05: You don't think it's a substantive criteria. [00:42:51] Speaker 00: I think it's a... And Your Honor, I realize this may be a very... [00:42:55] Speaker 00: thin distinction, but I think we would agree that reverse engineering, if a chemical is subject to reverse engineering, it would likely not meet the substantive criteria for confidentiality, but simply because that does not necessarily make reverse engineering itself [00:43:16] Speaker 00: into the substantive criteria. [00:43:18] Speaker 05: That is a little nuance. [00:43:22] Speaker 03: Let me ask you, I'm not sure how you can fail to incorporate the mandate [00:43:32] Speaker 03: for a system of unique identifiers, at least with respect to new confidentiality claims approved after the Lautenberg Act. [00:43:41] Speaker 03: I just don't get it. [00:43:43] Speaker 03: I'm sorry, could you repeat that question, Your Honor? [00:43:45] Speaker 03: You don't have a requirement for unique identifiers, right? [00:43:50] Speaker 03: I don't know how you didn't incorporate that mandate, that you establish a system of unique identifiers for confidential chemical identities. [00:44:02] Speaker 03: I don't know how you can have that system, at least with respect to confidentiality claims, approved after the Lattenberg Act. [00:44:11] Speaker 00: Well, I think it's important to... So the Lattenberg Act had many requirements, and EPA has undergone lots of different rulemakings. [00:44:20] Speaker 00: And here, again, EPA has not approved any confidentiality claims, and in fact, [00:44:28] Speaker 00: those approvals or disapprovals of confidentiality claims will be done subject to a separate rule that is about to be proposed. [00:44:36] Speaker 00: But there's no system for unique identifiers, right? [00:44:41] Speaker 00: Well, I will say, EPA has proposed a rule that addresses unique identifiers for new confidentiality claims that came about [00:44:52] Speaker 00: essentially after this inventory rule, after the 2016 sort of cutoff date. [00:44:59] Speaker 00: So for instance, this rule just addresses updating the Tosca inventory for both active and inactive substances and then providing a mechanism by which processors or manufacturers can ask that a chemical substance maintain on the confidential portion of the inventory. [00:45:19] Speaker 00: The unique identifier rule essentially comes into place upon the approval or disapproval of [00:45:26] Speaker 00: a confidentiality claim. [00:45:28] Speaker 00: None of these confidentiality claims is going to be reviewed until a separate review rule is put in place. [00:45:36] Speaker 00: And my counsel here just noticed that I could tell you 83 FR 30168 is EPA's proposed rule for unique identifier assignment for new confidentiality claims after the Tosca inventory. [00:45:56] Speaker 03: So you say it's being done? [00:45:58] Speaker 00: Correct. [00:46:00] Speaker 02: And just real quick, I know my... So what's the time frame expected for that role? [00:46:08] Speaker 00: I would have to... [00:46:13] Speaker 02: Never mind him. [00:46:15] Speaker 00: I apologize, Your Honor. [00:46:17] Speaker 00: It should be listed in the proposed rule. [00:46:19] Speaker 00: But again, that goes to confidentiality claims that are asserted outside of the process at issue in this rule. [00:46:26] Speaker 00: And lastly, I would say, if the court does find EPA's explanation for why it cut the reverse engineering question from its proposed list of questions in the rule, [00:46:38] Speaker 00: that the proper outcome, in our view, would be remand without vacatur for a better explanation as to why that question need not have been included. [00:46:50] Speaker 05: Does the other side disagree about that? [00:46:52] Speaker 05: They don't want vacatur either, do they? [00:46:55] Speaker 00: You know, I'd have to double check their briefs, but I believe they would not want vacatur. [00:47:03] Speaker 00: Well, actually, I apologize for interrupting. [00:47:07] Speaker 00: I'll ask you. [00:47:08] Speaker 05: I didn't understand that they want vacatur of that role. [00:47:10] Speaker 01: We wanted partial vacatur. [00:47:13] Speaker 01: On other things, though, we did ask for a make-it-or of the confidentiality provision with the hopes that they would rewrite it to include substantiation questions. [00:47:22] Speaker 05: Well, you'll have a chance to come back up in a minute. [00:47:24] Speaker 05: It seems like a risky position for you, but okay. [00:47:27] Speaker 05: But any more from you? [00:47:30] Speaker 00: You know, the – no, Your Honor. [00:47:32] Speaker 00: Okay. [00:47:32] Speaker 00: Thank you. [00:47:32] Speaker 05: Thank you. [00:47:36] Speaker 05: I'm not sure if I understand what you're saying. [00:47:38] Speaker 05: You would rather have no confidentiality rule at all. [00:47:43] Speaker 05: rather than one that's not quite as good as you want while they work on adding something. [00:47:48] Speaker 01: So our main goal is a remand with a direction to promulgate a new rule governing confidentiality within, we asked for six months, but a year would also be reasonable. [00:47:58] Speaker 05: So you're not asking to vacate the whole confidentiality. [00:48:02] Speaker 05: We did originally ask for that. [00:48:03] Speaker 05: You have a chance to think about that again now. [00:48:06] Speaker 05: You really think they're gonna come, if you vacate the rule and there are no confidentiality requirements, that's better for you? [00:48:13] Speaker 01: I mean, one thing that does concern us is that they'll process a bunch of confidentiality claims in this window under the old illegitimate rule and then get to the new rulemaking and say, oh, we're all done. [00:48:26] Speaker 01: We don't have to look at them again. [00:48:27] Speaker 05: But if you vacate the rule, what would they do? [00:48:30] Speaker 01: I mean, I guess our position would be they should sit on the confidentiality claims until such time as they create a confidentiality review process that actually will scrutinize these claims for these criteria. [00:48:43] Speaker 01: But we would be very happy with the remand that directed them to promulgate a new rule that would address the flaws in their confidentiality provision. [00:48:52] Speaker 03: What's your claim with respect to the unique identifiers? [00:48:54] Speaker 01: Our claim is that it is part of the inventory rulemaking because TASCA Section 8B7 states that... Do you agree that they're adopting? [00:49:05] Speaker 01: We are happy that they are finally adopting a unique identifier program, but they have not yet done so. [00:49:11] Speaker 01: And we have deep concerns that it may not happen. [00:49:15] Speaker 01: I mean, they made a lot of progress once we brought this issue up in this lawsuit. [00:49:19] Speaker 01: So one thing that would disconcert us is if this suddenly just dropped by the wayside. [00:49:28] Speaker 01: But our goal is to get a unique identifier system. [00:49:30] Speaker 01: So if they adopt one that actually applies unique identifiers to the inventory, we would be very pleased with that outcome. [00:49:37] Speaker 01: Our concern is that they may not do so. [00:49:40] Speaker 01: And in our view, it's required by 8B7 that they apply unique identifiers to the new chemicals that are coming onto the inventory. [00:49:50] Speaker 05: Okay, any questions? [00:49:52] Speaker 05: Other questions from the bench? [00:49:54] Speaker 05: Thank you very much. [00:49:55] Speaker 05: I'll take the matter under submission. [00:49:56] Speaker 05: Thank you. [00:49:58] Speaker 04: Stand please.