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Case number 24-1382, Alaska Community Action on Toxics et al.

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Petitioners versus United States Food and Drug Administration, Ed Martin McCary in his official capacity as commissioner of the United States Food and Drug Administration.

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Ms.

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O'Brien for the petitioners, Ms.

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Neumeister for the respondents.

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Good morning, counsel.

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Ms.

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O'Brien, please proceed when you're ready.

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Good morning.

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May it please the court, Catherine O'Brien for the petitioners,

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I'd like to reserve three minutes of my time for rebuttal, please.

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This court should hold unlawful and vacate FDA's order maintaining approval for the use of five toxic phthalate chemicals as food additives.

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As FDA explained in the proceedings below, the Food Drug and Cosmetic Act makes clear that food additives must be shown to be safe.

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And FDA acknowledges that under this standard, it must revoke approval for food additives

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if the evidence before the agency does not provide reasonable certainty that the additives use will cause no harm to human health.

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But here, FDA arbitrarily rejected decades worth of evidence showing that the phthalate additives do not meet the safety standard.

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First- Let me ask you, Mrs. O'Brien, as I see the issues in this case, the first question is standing.

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Do you want to address that?

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Certainly, Your Honor.

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The petitioners have standing because it is undisputed that FDA's authorizations for the use of the phthalate additives cause petitioners, members, and their children to be exposed to these toxic chemicals in their food.

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And this places them at substantial risk of serious health harm.

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So I, too, have standing?

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Your Honor, it would depend on the foods that you eat and whether you're talking about

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foods like chicken.

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We are.

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So we're not talking about exotic dishes.

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That's correct.

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Unfortunately, the phthalate additives.

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Oh, I'm sorry.

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What case you think is strongest in support of your claim of standing?

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Well, to address your specific question, Your Honor, about the widespread nature of the harm, I would rely on this court's decision in Public Citizen versus National Highway Traffic Safety Administration at 489 F-3 1279, where the court held that the fact that many people face a risk of bodily harm does not undermine standing, because the risk of bodily injury is sufficiently particularized, even if it's widely shared.

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And do you agree that the two-pronged test in public citizen has been set aside, at least in part, by the Supreme Court in the Susan B. Anthony case?

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The formulation is different, Your Honor.

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And I think the formulation is different even in this court's cases, not all of the cases that deal with

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a risk of future injury, utilize the two part standard.

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that's articulated in Public Citizen or in the Food and Water Watch case.

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But I think fundamentally they're getting at the same question.

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And they're consistent in holding that petitioners have standing where they show that their members are exposed to a toxic chemical because of the challenge agency action.

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And they have realistic health concerns because of that exposure, as the court stated in the Clean Wisconsin case that's discussed in our briefing.

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And so the clearest statement of that is in, what, the Aikens case?

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A-T-T-I-N-S by this court.

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I'm sorry, Your Honor, the Attias versus Caracuz case?

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Excuse me, I'm sorry.

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Would you mind repeating the case name, Your Honor?

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A-T-T-I-N-S, DC Circuit, opinion written by Judge Griffith.

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Thank you.

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So that's cited in the briefs.

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But in any event, it seems to me the formulation that you've just described is what we said in Akins, that it's enough to look at what the harm is and whether the cause is the agency action that you're challenging.

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That's correct.

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In the adious versus care first case that's discussed in the briefing, the court affirmed that it's frequently upheld claims of standing based on a substantial risk of future injury and it

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how that the court considers whether the petitioner's members face a substantial risk of injury as a result of the challenge action.

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And here we know that is the case because FDA acknowledges that its authorization for the use of the phthalate additives contaminates food.

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The petitioner's members attest that they regularly eat and their children regularly eat foods in which the phthalate additives are found.

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They have specific concerns about health effects from that exposure

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including cancer, endocrine effects, and reproductive harm.

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Where does EPA acknowledge the foods your clients eat are contaminated?

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Well, FDA acknowledges that the approved uses of the phthalate additives contaminate food.

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If that were not the case, these chemicals would not require approval as food additives.

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They are regulated.

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Council, just so you're clear, I took your word contaminated to mean a danger to health.

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And EPA has authorized these additives in food.

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And so you're trying to show

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that it ought to re-examine its position.

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In other words, I didn't see that the FDA was giving away the case because it has a different view than you do of what the statute requires in the way of what I think you would agree is at least your burden of persuasion.

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That's correct, Your Honor, and I apologize if my use of the word contaminated was not precise.

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FDA does not acknowledge that the presence of the phthalate additives in food presents health concerns, but they do acknowledge that their authorizations are responsible for the presence of the chemicals in the food.

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And FDA also does not dispute that it has not considered and has not assessed the safety of these chemicals for roughly half a century.

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And in the intervening decades, substantial scientific evidence has been developed that is fundamentally- I don't think that's disputed by FDA.

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What FDA says, as I understand it, it says that it had to decide if the petition showed enough

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for the agency to conclude or find that these additives are no longer safe.

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In other words, to distinguish the status quo, which says they are safe.

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And so its response to your petition, and I acknowledge one of the problems you faced, was that you started this case with 28 additives.

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And as the case proceeded,

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It was down to five because the manufacturers stopped producing 20 other drugs.

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So didn't EPA, sorry, didn't FDA explain why your three-pronged approach in your petition was not persuasive?

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The agency did explain its view of why the three-step argument in the original petition the agency did not find persuasive.

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But that does not relieve the agency of an obligation to rationally consider and determine whether there remains a reasonable certainty of no harm from the use of the five additives that remain approved.

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The agency responds by saying, one, we're denying your petition, but

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the drugs of which you're concerned, the additives, I'll call them, are on our list to examine them.

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And furthermore, we have issued a request for information to get updated data on all of these studies regarding these additives.

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But it didn't accept your three-pronged approach.

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And don't you have a burden of persuasion at least?

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And EPA, sorry, I keep saying EPAs.

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My mistake.

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FDA explained why it found your approach unpersuasive.

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It critiqued your theory of how the drugs function.

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It critiqued your theory about a single standard.

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And to the extent you were faced with this change

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circumstances, it said it was too late to change your theory now.

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And in the objections, Your Honor, the petitioners addressed FDA's rationale in the underlying petition denial and explained why it did not provide a reasoned basis for the FDA's decision.

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And there are essentially three components to that critique, the arguments that were advanced in the objections.

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Number one, as the petitioners explained, and they bolstered the record on this at the objection stage, the FDA did not consider when it approved these additives that they cause serious health harms to people that are now well documented in the scientific literature.

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So just to provide one... It's not denying that.

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All I'm trying to understand is you came to the agency with a three-pronged petition.

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And the agency responded saying, one, you got the mechanics of the drugs wrong.

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Two, we couldn't bunch them all together and just have a single safe level.

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And you wanted to change your theory in the middle of the case.

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Normally, that's the kind of thing under an APA review we would defer to.

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Now, even under Loper-Brite, there is still under Skidmore a level of deference to agency expertise.

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And the agency argues here, the mechanics of these drugs and how they function, et cetera, is very much a matter of its expertise, not for judges.

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And this court has previously taken that position.

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So how do you respond to all that?

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Your honor, I would begin by characterizing the petition differently.

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What the petition asked was for FDA to revoke approval for 28 phthalate additives that were approved.

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at the time of the original petition a decade ago.

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Included in that group of 28, of course, were the five that we're still arguing about today.

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As to those five, the petitioners argued that none of the five meets the safety standard any longer.

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And they provided new toxicity evidence that is specific to each and every one of the five phthalate additives that are still approved.

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So the petition is breaking.

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Are you denying that your petition asked that

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all these drugs be treated alike?

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That secondly, based on that, you came up with a level showing what would be safe or unsafe consumption.

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That was your theory, wasn't it?

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That was the theory.

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That was the argument supporting the request for agency action, which was the revocation of each of the authorizations.

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And at the time, what I'm trying to focus on is I didn't think there was any dispute about what your original theory was.

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I thought the problem was the ground shifted under you and the agency took the position of that.

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It was.

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not the stage at which you could change your theory when you're dealing with objections, that you had to file a new complaint.

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That's sort of docket control and interpretation of its regulations.

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But that interpretation is not supported by the regulations or by the Food Act.

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The Food Act is clear that at the objection stage, and this is somewhat unusual for

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petition proceedings before agencies, but it's what the statute provides.

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The statute provides that petitioners can introduce new evidence at the objection stage and they can make new arguments at the objection stage.

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The key is whether the objections are within the scope of the original petition and whether the objections identify errors

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in the order rejecting the original petition and the petitioners remained within that allowable sphere here and we know that because as I said we requested revocation for the approval of these five additives in the original petition

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We presented new toxicity evidence specific to each and every one of them.

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So we were not relying on the cumulative effects argument to show that for these five chemicals specifically, there is new information that undermines the safety finding.

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We also provided in the 2016 petition exposure data specific to three of the five phthalate additives that are still approved.

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Those were the only ones that had exposure data available.

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And that data showed that exposure to those chemicals exceeds safe levels.

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The theory that was addressed in the initial decision, which is that at the time all 28 are in the case and then all 28 are treated by your petition.

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By your argument supporting your petition as uniform in that they all ought to be.

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Seen as an alignment.

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So there's 28 that are alignment and then there's an ADI acceptable daily intake.

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I think that applies to one of them and it ought to be applied to all 28.

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And then there's a spread between what's actually in took and taken and the acceptable one and that ought to be applied across the board too.

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So it was kind of an across the board argument was what was presented.

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That's correct.

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And that was necessary when we were dealing with the class of 28 because we didn't have specific toxicity and exposure information for all 28.

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And so the most persuasive case when there were 28 on the table was to make that class analysis argument.

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And that was consistent with the decision that FDA had just issued concerning

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PFAS chemicals that had been used as additives.

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And that's why the petitioners took that approach.

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But then FDA took an independent action, as Judge Rogers alluded to, to revoke approval for 23 of the 28.

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At that point, any arguments about whether those 23 were safe had become moot and it would have made no sense

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for the petitioners to continue pressing their arguments about those 23.

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Fortunately for the petitioners, their arguments about the remaining five were not dependent upon that broader cumulative effects argument for the group of 28.

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And so the petitioners went forward by simply narrowing

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the scope of the administrative relief and the scope of the arguments to focus on the five.

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And at the injection stage.

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Even if the case gets narrowed from 28 to five because of the abandonment, then it could be that the theory stays the same, which is that there used to be an alignment as to all 28.

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If there's alignment as to all 28, of course there's alignment as to the subset of the 28, because if all of them are related in the same way, then so is the subset.

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And then if that's the way that the case proceeds, then there's nothing that changes.

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It's just that you're addressing the same theory.

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It's just on a narrower set of phthalates.

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And it follows like the night follows the day, because if you were right as the petitioners were right as to the original 28, then they would necessarily be right as to a subset too.

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And the case goes forward on that understanding.

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And then what you're indicating is that, no, that's actually not what happened or the right way to look at it.

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At the objection stage,

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The theory just changes.

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The theory is no longer that what's left is in alignment in the same way that the 28 were in alignment.

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There's new evidence that comes into play and all that can be considered with respect to those phthalates that are still left on the table.

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That's correct.

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And the other thing I think that's important to understand is that the narrower arguments with respect to cumulative effects that the petitioners presented in their objections were responsive to what FDA had said when it denied the underlying petition.

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And in our view, this is exactly how the objections process is supposed to work.

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So when FDA denied the original petition in 2022, it said essentially, we don't buy this broad argument that all 28 are sufficiently related to be treated as a class.

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What we think would be more supported would be to focus only on a subset of the ballots that have been shown to have so-called anti androgenic effects, which means that they interfere with the production of testosterone during fetal development.

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In the objections, the petitioners narrowed the cumulative effects argument to do precisely what FDA had indicated would be proper and said to FDA, we seem to be in agreement that there's a group of phthalates that are still approved, that you acknowledge are established antiandrogens, and at a minimum, those have to be considered as a class.

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And in addition,

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All of the five have new toxicity evidence that establishes and exposure data that establish that there is no longer reasonable certainty of no harm.

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So while it may be the case that the regulatory landscape has changed and the

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The strongest arguments we had for the group of 28 are no longer germane.

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There is still evidence that is irreconcilable with the statutory standard, a reasonable certainty of no harm.

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And FDA was obligated to consider that rationally.

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In this regard, I think it's helpful to think about a hypothetical.

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Let's say that FDA had granted our petition based on all 28, and all 28 were still approved.

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And it accepted that broad class-based argument, the three premises that Judge Rogers described.

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And then you had a manufacturer who filed objections.

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They only manufacturer one ballot.

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Let's say it's DINP.

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I don't think FDA would argue that that manufacturer would be limited to responding to the three premises that supported our petition.

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They would be free to make out the case that DINP is safe.

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And the statute and the regulations are clear.

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that they could introduce whatever new evidence they wanted to at the objection stage, and they might be entitled to an evidentiary hearing.

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And FDA would have an obligation to consider that evidence fully.

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So the theory- Well, I understand, to the extent you're making that argument, that there is a way to read what FDA did as endorsing that.

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But FDA also critiqued the type of studies

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on which you were relying, the type of data those studies used.

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So even if your theory is the same, as you say, and you had this data as to the five on toxicity, there is this problem that FDA saw as to the nature of the studies.

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What's your response there?

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Our response is that FDA only critiqued a subset of the evidence, and the reasons that it gave for rejecting that evidence are contrary to the evidence that is actually in the record.

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And this court, while giving appropriate deference to agencies, repeatedly has held that the agency must provide a reasoned basis consistent with the evidence before it for rejecting the evidence.

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So as I understood the FDA's position, and maybe I misunderstood it,

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On your overall approach with the 28, they explained why they didn't or were not persuaded by your theory that all of these should be treated the same.

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It also said that, that aside, there's a problem with the nature of the studies on which you're relying.

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And it explained why.

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So moving to the objection stage, I understand your point about you just continued and you had new toxicity evidence.

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But what about the concern that FDA had with the nature of the studies?

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FDA identified two purported defects with the toxicological evidence specifically.

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But neither of those is consistent with the evidence before the agency.

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And under this court's precedent, for example, the LA County versus Shalala case, that is not a reasoned basis for denying the objection.

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So first, FDA.

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I understand the point about if it's not supported by the evidence in the record.

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But that was not the nature of your objection.

[00:23:05] Speaker 06:
The first objection, Your Honor, argued that FDA did not appropriately address the new toxicity studies, the new toxicity studies that established numerous health effects that FDA did not consider when it judged the chemicals safe.

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You're more familiar with the record than I am.

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But I thought an FDA can explain when it has a chance to argue that the defects it found in the studies

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that supported the 28 in the original petition remained even as to the five.

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So FDA did have a couple of particular critiques, and I would like to explain why they are not rational.

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They criticized the toxicity evidence and also the exposure evidence.

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They said two things were wrong with the toxicity evidence, neither of which is rational.

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Number one, they said that it was not appropriate for the petitioners to rely on epidemiological studies, which are studies that document adverse health effects in human populations associated with exposure to a toxic chemical.

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FDA says in this proceeding that epidemiological studies generally are not useful for risk assessment.

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That's at JA9.

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But as we explained, that attitude towards epidemiological studies is contradicted by FDA's own approach when it looked at the evidence concerning the most widely used phthalate additive, DEHP, in 2012.

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In 2012, FDA conducted an assessment of the toxicity evidence on DEHP, relying heavily on epidemiological studies and concluded that, but neither did the petitioners here, Your Honor.

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So that was the concern about the epidemiological studies, but there was a second concern.

[00:25:03] Speaker 06:
The second concern, which I imagine you're alluding to, Your Honor, was that the petitioners supposedly didn't provide dose response studies.

[00:25:11] Speaker 06:
These are the animal studies that are used to establish the level of exposure to the chemical that's associated with the toxic effect.

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But FDA's statement is simply incorrect.

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As the petitioners pointed out in our opening brief, we provided numerous dose response studies, which are cited at page 38 of our brief.

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And after we pointed this out, FDA sort of pivoted and said, OK, it's not that there were no dose response studies, but supposedly the dose response studies are deficient.

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But again, the reasons that FDA asserted for this supposed deficiency are flatly contradicted by the record.

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So first, FDA said that the dose response studies were not appropriate because they supposedly only addressed

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mixtures of chemicals, wh

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caused the toxic effect observed.

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But that is simply not correct.

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As we explained at page 20 of our reply brief, if you look at just the abstracts of those studies, they made clear that they did assess mixtures, and they also assessed and provided dose response data for individual phthalate additives.

[00:26:26] Speaker 00:
So this is not- Yeah, here's what's troubling me.

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There's a dispute here.

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as to whether or not the petitioners submitted enough for FDA to conclude that it should vacate the rule.

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Your position is the statute only requires you to raise serious questions, that you don't have a burden to

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prove that the additives are unsafe, that that's FDA's burden.

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But from the court's perspective, are you asking us to review these studies and

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basically find that there was clear error by the agency when it evaluated the animal studies and the human studies.

[00:27:44] Speaker 00:
That's what I'm trying to understand in this analysis.

[00:27:48] Speaker 00:
I don't see this as a case where, you know, did the man fall on the sidewalk and break his leg, but rather there is some expertise involved.

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EPA doesn't, I have an EPA on the mind because there was an EPA case, but the FDA does not view the types of studies for these five drugs enough for it to conclude that the petition has shown enough that it should vacate the rule.

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and disrupt what it describes as the status quo.

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That it views you as having a heavier burden than simply raising questions.

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And it makes an argument based on the statute, purpose, the structure, history, EPA's interpretation, and it distinguishes

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the EPA case, the other drug, which was an initial authorization case where the FDA actually set some conditions.

[00:29:16] Speaker 00:
So I'm just wondering, what is the court's role here under an APA?

[00:29:22] Speaker 00:
I mean, if it's an error of law, that's one thing.

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But now we're talking about judgments about technical studies.

[00:29:30] Speaker 00:
And your argument, as I understood it, is it's just flat clear that any reasonable person would understand that you raised enough of an issue that FDA ought to go so far as to vacate its current rule.

[00:29:50] Speaker 06:
So if I may judge Rogers, I think there are three important points to respond to your questions.

[00:29:55] Speaker 06:
So first, there is an error of law here.

[00:29:57] Speaker 06:
As your honor referenced, the FDA applied a legally erroneous burden of proof to the petition.

[00:30:07] Speaker 06:
requiring the petitioners to provide essentially quantitative proof that dietary exposure to the additives exceeds an established safe level and there is no basis in the Food Act or FDA's regulation for applying that burden.

[00:30:22] Speaker 06:
It talks about full studies though.

[00:30:25] Speaker 06:
And full studies were provided, hundreds of them, Your Honor.

[00:30:29] Speaker 06:
In addition, we provided authoritative assessments from FDA's peer regulators, including the Consumer Product Safety Commission, which concluded that ballots that are still approved by FDA do not meet a reasonable certainty of no harm standard and banned them from children's products despite finding that the main source of exposure to children is from food.

[00:30:54] Speaker 06:
We also provided two declarations from leading experts in the health effects of phthalates and exposure to phthalates who synthesized the evidence and concluded unequivocally that the ongoing use of these chemicals in food is presenting severe health risks to children and other members of the population.

[00:31:14] Speaker 06:
So there is a legal error with respect to the burden.

[00:31:17] Speaker 00:
In addition, this court says I started out there by asking, I assumed, but maybe I was wrong that you do not agree that you have the burden of persuasion.

[00:31:32] Speaker 00:
And the question is the burden of persuasion of what?

[00:31:37] Speaker 06:
Yes, we agree with FDA's statements in the record and in its brief that revocation petitions have to establish safety questions that are significant enough to support a finding that there is no longer a reasonable certainty of no harm.

[00:31:53] Speaker 06:
So it's not any question.

[00:31:54] Speaker 06:
It's not any one study, as FDA used as a hypothetical in its brief.

[00:32:01] Speaker 06:
The questions have to be significant enough to make it untenable to have a certainty of no harm.

[00:32:09] Speaker 06:
But that still is different from proving quantitatively, as FDA demanded here,

[00:32:15] Speaker 06:
that exposure in food is exceeding a safe level.

[00:32:20] Speaker 06:
That's where we part ways with FDA.

[00:32:22] Speaker 06:
But even assuming that FDA is correct about the burden, it did not make a reasoned decision based on the evidence in the record.

[00:32:32] Speaker 06:
And I think it is helpful.

[00:32:34] Speaker 03:
Can I just ask you just quickly on the burden?

[00:32:36] Speaker 03:
Sure.

[00:32:36] Speaker 03:
So you're agreeing that you have a burden.

[00:32:41] Speaker 03:
Yes.

[00:32:42] Speaker 03:
You have a burden to

[00:32:45] Speaker 03:
raise significant questions, you've raised questions that are significant enough to support a finding that there's no longer reasonable certainty of no harm.

[00:32:52] Speaker 03:
That's the burden that exists and that's a burden of, that's not just a burden of production.

[00:32:56] Speaker 03:
That's, you have to have, you have to introduce materials that substantively get you past the threshold.

[00:33:04] Speaker 03:
There could be some disagreement about what the threshold is, but I actually don't think there is.

[00:33:08] Speaker 03:
I think everybody agrees what the threshold is, which is that

[00:33:10] Speaker 03:
The questions have to be significant enough to support a finding that there's no longer a reasonable certainty of no harm.

[00:33:16] Speaker 03:
So with the decisions, as I read the decisions, both the first one and the second one in response to the objections, they did incant the right standard.

[00:33:27] Speaker 03:
They did.

[00:33:27] Speaker 03:
They incanted it several times.

[00:33:28] Speaker 03:
And then they incanted it in their conclusions, too.

[00:33:32] Speaker 03:
And the conclusion would be, therefore, there's not significant enough evidence

[00:33:37] Speaker 03:
that there's no longer a reasonable certainty of no harm.

[00:33:45] Speaker 03:
Lots of negatives and lots of qualifiers that I think that's roughly right.

[00:33:48] Speaker 03:
So it's not that the standard was articulated incorrectly or was not articulated correctly in its conclusion, then where's the legal error?

[00:34:01] Speaker 06:
The legal error is in the application of the standard.

[00:34:04] Speaker 06:
They did not, in fact, apply that sufficiently significant question standard.

[00:34:09] Speaker 06:
And I think there's two ways that we see this.

[00:34:12] Speaker 06:
Number one, there are statements in the record that are inconsistent with the articulation of the standard that Your Honor just offered.

[00:34:19] Speaker 06:
And we have cited them in our brief, including in the order at JA6.

[00:34:26] Speaker 06:
FDA stated

[00:34:27] Speaker 06:
that petitioners had to prove that, quote, dietary exposure levels from the approved uses exceed a safe level.

[00:34:35] Speaker 06:
So that I submit is an example of them articulating a standard that's inconsistent with what they recited elsewhere.

[00:34:42] Speaker 06:
But I think it's actually most concrete if we contrast FDA's decision here with its decision revoking approval for what we refer to as the PFAS additives.

[00:34:52] Speaker 06:
So in that decision in 2016, FDA revoked approval for existing additives because the petitioners provided new studies that were not even specific to the chemicals at issue, but new studies on related chemicals showing that there was evidence of reproductive and developmental harm.

[00:35:11] Speaker 06:
And FDA acknowledged those studies and said they had a lack of data that was specific to the additives at issue that could resolve the safety questions presented by the new studies and a lack of data to quantify exposure.

[00:35:27] Speaker 06:
And because they had new evidence of toxic effects from related chemicals that they thought was relevant and they didn't have either more specific toxicity evidence

[00:35:37] Speaker 06:
or exposure evidence to resolve those concerns and conclude that the ongoing use was safe, they revoked approval.

[00:35:46] Speaker 06:
Now, FDA's order said that the reason for the different outcomes is because there supposedly was not comparable evidence here.

[00:35:53] Speaker 06:
And I would agree.

[00:35:54] Speaker 06:
The evidence here was orders of magnitude stronger.

[00:35:58] Speaker 06:
So in the PFAS decision, as I mentioned, FDA had no toxicity studies specific to the three chemicals

[00:36:04] Speaker 06:
that the petitioners were asking to revoke.

[00:36:07] Speaker 06:
But here we have studies for each of the five phthalate additives that documents that those specific chemicals cause adverse health effects.

[00:36:16] Speaker 06:
In addition, FDA, as I noted with the PFAS additive said, we don't have data to estimate dietary exposure.

[00:36:24] Speaker 06:
We don't know how much of these chemicals people are really eating.

[00:36:27] Speaker 06:
But here, in contrast, the petitioners presented multiple lines of evidence indicating that real world dietary exposure does exceed safe levels.

[00:36:37] Speaker 06:
So the evidence here is substantially stronger, the record much more extensive, and the reason that we have a different result is arbitrary decision making.

[00:36:50] Speaker 03:
Let me make sure my colleagues don't have additional questions at this time, and we will give you some time for rebuttal.

[00:36:55] Speaker 03:
Thank you.

[00:36:57] Speaker 02:
Just one or two from me.

[00:36:59] Speaker 02:
This is Judge Katz, just orally.

[00:37:05] Speaker 02:
You do not.

[00:37:06] Speaker 02:
I'm taking you back to standing.

[00:37:10] Speaker 02:
The risk of harm must be substantial in an absolute sense.

[00:37:18] Speaker 02:
It's not enough if exposure increases a cancer risk from one in a trillion to two in a trillion on the theory that that's 100% increase, correct?

[00:37:33] Speaker 06:
I think that's correct, Your Honor.

[00:37:35] Speaker 06:
We agree that the increase in risk has to be substantial.

[00:37:38] Speaker 06:
And here, we know that the increase.

[00:37:42] Speaker 02:
But the absolute risk has to be substantial is what I'm more interested in.

[00:37:50] Speaker 06:
As opposed to the increased risk?

[00:37:52] Speaker 06:
Yes, Your Honor.

[00:37:53] Speaker 02:
That's correct.

[00:37:56] Speaker 02:
So that's a very open-ended standard.

[00:38:00] Speaker 02:
What help can you give us

[00:38:04] Speaker 02:
in thinking about this question of substantial risk where we're talking about long-term exposure to something that might in the distant future present a substantial health risk.

[00:38:28] Speaker 02:
Your best case is

[00:38:30] Speaker 02:
on standing on this point, I think your best case on standing on this point involves ozone, which is very different.

[00:38:37] Speaker 02:
You breathe ozone and your lungs get irritated and that's an Article III injury.

[00:38:42] Speaker 02:
That's easy.

[00:38:44] Speaker 02:
This seems more akin to public citizen in the sense that the causal chain is very long and hard to assess.

[00:38:57] Speaker 02:
So how do we think about substantial risk?

[00:39:00] Speaker 02:
a case like this.

[00:39:04] Speaker 06:
Your Honor, I would submit that this case is on all fours with the many cases I was discussing earlier in which the court has held that exposure to a toxic chemical attributable to the agency action can support standing.

[00:39:18] Speaker 06:
And so, for example, in the California Communities Against Toxics case that we discuss in our briefing, that case was about an exclusion from RCRA regulation for certain hazardous waste facilities.

[00:39:31] Speaker 06:
And the petitioners' members lived nearby.

[00:39:34] Speaker 06:
and they asserted that they had concerns about health consequences from looser regulation of those hazardous materials.

[00:39:43] Speaker 06:
Not necessarily that there was going to be an immediate health effect like lung irritation, but rather that they would be exposed to greater levels of toxic substances, which also would be associated with diseases that might have a long latency period.

[00:40:00] Speaker 06:
This is frequently the case in

[00:40:03] Speaker 06:
excuse me, in cases that this court adjudicates after finding standing that involve exposure to toxic chemicals.

[00:40:11] Speaker 06:
Moreover, it is the case here that the phthalate additives can pose acute health risks.

[00:40:17] Speaker 06:
So it's not necessarily the case.

[00:40:19] Speaker 06:
that the time period between exposure and effect is long.

[00:40:24] Speaker 06:
But even if it is long, this court has frequently found standing in such cases.

[00:40:29] Speaker 06:
For example, any case involving exposure to a carcinogen.

[00:40:33] Speaker 06:
the exposure is going to be remote in time from the effect.

[00:40:38] Speaker 06:
But where the petitioners establish, based on their declarations and evidence in the record, that the exposure gives rise to realistic health concerns, the court has recognized that that is an Article 3 injury.

[00:40:52] Speaker 06:
And I think it's helpful to contrast the cases that FDA relied on.

[00:40:56] Speaker 06:
The problem in the cases that FDA relied on, such as the food and water watch case, was that the court found that the petitioners were speculating about whether the action they were challenging was really going to increase their members' exposure

[00:41:12] Speaker 06:
to the substance or the activity that they alleged was causing them harm.

[00:41:16] Speaker 06:
But here, there's no need for that speculation because we know that FDA's authorizations are causing the phthalate additives to be present in food that petitioners' members eat right now.

[00:41:28] Speaker 06:
So they're experiencing exposure that's current and ongoing.

[00:41:36] Speaker 02:
So showing of exposure plus

[00:41:39] Speaker 02:
concern of harm, re reasonable fear of harm, a substantial risk, your honor.

[00:41:48] Speaker 06:
And I would assert that in this, I'm sorry.

[00:41:51] Speaker 02:
No, okay.

[00:41:54] Speaker 02:
That's, that's helpful.

[00:41:55] Speaker 02:
Thank you.

[00:41:57] Speaker 06:
And I think what's key in this case, Judge Katz, is that we're not relying on the subjective concerns of the petitioners' declarants, but rather the expert declarations in the record and the other evidence that establishes that exposure at realistic levels from the foods petitioners' members and their children are eating does pose risks of serious health harm.

[00:42:23] Speaker 03:
Can I ask you all to follow up on that?

[00:42:27] Speaker 03:
But Judge Katz, if you were going to follow up, go ahead.

[00:42:30] Speaker 02:
I'm all set.

[00:42:33] Speaker 02:
Thank you.

[00:42:35] Speaker 03:
I have one follow up on standing, which is that there's a general principle in standing law that we assume the merits in favor of the person who's seeking relief.

[00:42:47] Speaker 03:
And so in this case,

[00:42:49] Speaker 03:
I'm not completely clear in my mind on how all that works out because at some high level, your merits theory is, look, there's these additives that are unsafe, or at least there's no reasonable certainty that they're safe.

[00:43:05] Speaker 03:
And so you need to do something about it.

[00:43:08] Speaker 03:
You, the agency, need to do something about it.

[00:43:11] Speaker 03:
And for standing purposes, do we take that underlying merits theory

[00:43:19] Speaker 03:
As a given that you're right about that, and then we measure standing, assuming that baseline or do we not take that as a given because in some ways asking you to show that there's a substantial risk of harm.

[00:43:37] Speaker 03:
is similar to the ultimate merits, which is your theory is you should shift things in that you should no longer leave these authorizations in effect and you should repeal them because there is a substantial risk of hope.

[00:43:54] Speaker 06:
Yes, I think that's absolutely correct, Your Honor.

[00:43:57] Speaker 06:
And I think as the court has held routinely, the court does assume that the petitioners are right on the merits to assess standing.

[00:44:06] Speaker 06:
And here, that would require the court to assume that it was arbitrary for FDA to conclude that there are not health risks associated with the ongoing use of the phthalate additives under these authorizations.

[00:44:18] Speaker 06:
So that for purposes of standing, the court does have to assume that there are

[00:44:23] Speaker 06:
health risks, significant health risks arising from the ongoing use.

[00:44:28] Speaker 06:
Here, to be candid, we don't feel we need to really lean into that assumption because the evidence in the record is very strong from independent experts that the risk of harm is substantial.

[00:44:43] Speaker 06:
But you are absolutely correct that the presumption does apply, that we're correct on the merits.

[00:44:47] Speaker 03:
Because some of our decisions and some of the decisions in the area do

[00:44:53] Speaker 03:
articulate the requisite showing on the part of the party seeking relief as a burden to show harm, or at least a risk of harm.

[00:45:04] Speaker 03:
And in cases in which the merits inquiry is about the risk of harm too, it's just not entirely obvious how those interrelate if there's an independent Article III obligation to show a risk of harm.

[00:45:18] Speaker 03:
But if the merits then is also bound up in the risk of harm, then

[00:45:24] Speaker 03:
It's not entirely clear to me how all that washes out.

[00:45:26] Speaker 03:
But the way you're looking at it is to say you assume the correctness of our theory on the merits, which is that these phthalates need to be regulated in a way they haven't been so far precisely because of the risk of harm that they pose.

[00:45:41] Speaker 06:
That's correct.

[00:45:42] Speaker 06:
But I think even if the court determined it has an independent obligation to establish without that assumption that there's a substantial risk of harm, the record and the declarations amply support that.

[00:45:56] Speaker 03:
Make sure there's no further questions at this time.

[00:45:58] Speaker 03:
Not for me.

[00:46:02] Speaker 03:
Okay.

[00:46:02] Speaker 03:
Thank you.

[00:46:03] Speaker 03:
We'll give you a little time for a bottle.

[00:46:15] Speaker 03:
Mr. Meister.

[00:46:17] Speaker 05:
Thank you, your honor.

[00:46:18] Speaker 05:
And may it please the court McKay new Meister on behalf of the government.

[00:46:21] Speaker 05:
In authorizing the use of phthalates as food contact substances, FDA determined that there was a reasonable certainty that such use would not be harmful.

[00:46:30] Speaker 05:
Petitioners have not carried their burden of disturbing that determination or of demonstrating Article III standing to pursue this petition for review.

[00:46:37] Speaker 05:
And their submissions are inadequate on both standing and the merits because they haven't made an adequate showing regarding a lack of safety and because they're operating at a high level of generality that doesn't satisfy the robust showings applicable in these circumstances.

[00:46:51] Speaker 05:
To disturb the status quo and require FDA to repeal existing authorizations, it was not enough for petitioners to submit some new studies that raised questions about safety in the abstract.

[00:47:03] Speaker 05:
Rather, they had to submit sufficient data to establish a finding that there's no longer a reasonable certainty of no harm.

[00:47:11] Speaker 05:
The sufficient safety questions that they have to establish are sufficient because they demonstrate that there's no longer that reasonable certainty.

[00:47:20] Speaker 05:
And they have not adequately supported that finding here.

[00:47:23] Speaker 00:
Now, I'd like to start with that standard quite extreme, though.

[00:47:29] Speaker 00:
Substantial showing, I mean, there are those double knots, but I mean, that there is no longer any harm.

[00:47:43] Speaker 00:
I mean, that's what they say all their studies showed.

[00:47:47] Speaker 00:
And FDA just chose to reject that showing and decided to go its own way through the request for information.

[00:48:02] Speaker 00:
Whereas the petitioners are saying, we've met our burden of persuasion under this standard.

[00:48:14] Speaker 00:
to raise substantial questions with this double knot requirement.

[00:48:23] Speaker 00:
And my question in this case would be, what more could anyone show to meet the standard as FDA has suggested it is here?

[00:48:37] Speaker 00:
Because if the petitions are right about your own rules allowing

[00:48:43] Speaker 00:
petitioner essentially to start all over again at the objection stage, then a lot of these procedural points and docket control and deference to the agency disappear.

[00:48:59] Speaker 05:
So in order to satisfy their burden, the evidence that they're putting into the record and relying on has to be enough that would justify a finding that there's no longer a reasonable certainty.

[00:49:11] Speaker 05:
And when you're asking that question, you have to

[00:49:15] Speaker 05:
work within how FDA analyzes safety and does its risk assessment.

[00:49:21] Speaker 05:
And that's what they did in their petition in the first instance.

[00:49:24] Speaker 05:
Their food additive petition acknowledged the burden and attempted to show that there were these sufficient questions undermining the reasonable certainty by comparing the acceptable daily intake

[00:49:37] Speaker 05:
to the the estimated exposure and that's one of the ways that FDA in general looks at this safety and risk assessment by comparing those two values.

[00:49:48] Speaker 05:
The petition tried to do that and if they had succeeded then there would have been a reasonable question if they had shown that based on this new evidence that was adequate and scientifically supported that there is a reason to believe that

[00:50:02] Speaker 05:
The actual daily exposure to these substances exceeds a level that is safe based on scientifically supported evidence usable evidence based on these internationally recognized guidelines that FDA applies if they had done that.

[00:50:17] Speaker 05:
then there would be these reasonable questions.

[00:50:19] Speaker 05:
But the agency explained for three reasons why they failed to meet the burden that they had set out to meet in their petition.

[00:50:26] Speaker 05:
The first was because they were pursuing solely a class-based analysis where they were looking at- No, I understand that.

[00:50:33] Speaker 00:
My question is based on the assumption, and you can tell me that assumption is wrong, that at the objection stage, you can start all over again.

[00:50:47] Speaker 00:
So at that point, they were only dealing with five drugs.

[00:50:52] Speaker 00:
They looked at five drugs, five additives, and they introduced exposure data, and they introduced expert evidence, and they introduced studies.

[00:51:04] Speaker 00:
So my question is, if that is procedurally correct, which I did not understand your brief to accept,

[00:51:15] Speaker 00:
And that's why I said, assume that is correct, then why haven't they met their burden of persuasion along the lines that the chief judge was discussing?

[00:51:28] Speaker 05:
So it is not procedurally correct that they can do that, Your Honor.

[00:51:31] Speaker 05:
And I'd love to address the many reasons why.

[00:51:33] Speaker 05:
But assuming that they could reframe their petition this way at the objection stage,

[00:51:41] Speaker 05:
It's hard to even accept that premise because the analysis would have been very different.

[00:51:46] Speaker 05:
But even if they could, they have not shown by acceptable evidence that meets these international guidelines for what is adequate science that FDA applies in assessing these studies.

[00:52:02] Speaker 05:
They have not shown that there is this no longer reasonable certainty.

[00:52:07] Speaker 05:
But just stepping back.

[00:52:10] Speaker 05:
in their petition, they sought a class-based analysis and they specifically.

[00:52:14] Speaker 03:
Are you going to proceed really why they shouldn't, why it's not permissible to do this?

[00:52:19] Speaker 05:
Yes.

[00:52:20] Speaker 03:
Before you do that, I definitely want to hear that, but before you do that.

[00:52:25] Speaker 03:
does the agency decision in response to the objections do the even if analysis, which is that even if procedurally it's okay to proceed in this fashion, the evidentiary stuff that was introduced at this stage still wouldn't be sufficient.

[00:52:42] Speaker 05:
So it does address the new studies that they put into the record and explained why those are not sufficient.

[00:52:48] Speaker 05:
I also just want to note

[00:52:51] Speaker 05:
For the first time before this court, I'm hearing that they now want FDA to do an individual analysis of each of these five chemicals separately.

[00:52:58] Speaker 05:
That is not something that FDA understood them to be asking for in their objections, and it's not something that we understood them to be asking for in their brief.

[00:53:07] Speaker 05:
We don't read their brief to say that FDA's action was arbitrary and capricious because it didn't separately assess

[00:53:12] Speaker 05:
in each one separately and look at the reasonable certainty with each one separately.

[00:53:20] Speaker 03:
They've always been been pursuing a grouping analysis and relying on cumulative risk that are different from the original 28 at the objection stage at least still a grouping but not not individuals is the point you're making.

[00:53:32] Speaker 05:
Yes, and they proposed a completely new grouping that is outside the scope of the original 28 validates in their petition.

[00:53:39] Speaker 05:
And that's not just a difference in evidence in the record.

[00:53:42] Speaker 05:
That's a different action that they're asking for that requires a different kind of scientific analysis.

[00:53:47] Speaker 05:
And you can't short circuit the process by proposing that at the objection stage so that the agency can't seek public comment on that new analysis and can't perform the relevant science and give them an opportunity to object to it.

[00:53:59] Speaker 05:
It's very complex scientific assessments that go into this process, which is why if you're going to propose something that is outside the scope of the initial petition and outside the scope of the denial order, it has to come in a new petition.

[00:54:13] Speaker 05:
I also just want to highlight in their original food additive petition,

[00:54:17] Speaker 05:
And this is at JA 966 to 67.

[00:54:21] Speaker 05:
They specifically explain that they are asking the agency to repeal the authorizations for all of these phthalates as a group.

[00:54:30] Speaker 05:
And they are specifically saying that they are not asking the agency to go on a one-by-one basis.

[00:54:36] Speaker 05:
They say, quote, removing the approval for one orthothalate may result in its replacement with another one that is less studied and that may pose similar or greater risk.

[00:54:45] Speaker 05:
They were specifically

[00:54:46] Speaker 05:
waiving any argument that they wanted the agency to proceed on an individualized basis and so FDA has never tried to engage in that analysis here and if it did so it would look very different than the scientific analysis that it has put into this proceeding.

[00:55:03] Speaker 05:
Let's see.

[00:55:04] Speaker 05:
So fundamentally, that's why there is this issue with the sort of new proposed action and new grouping coming at this late stage of the proceeding.

[00:55:13] Speaker 05:
But that's just one reason why FDA ultimately rejected their petition and overruled their objections.

[00:55:20] Speaker 05:
So there was the grouping issue with the 28 phthalates that we explained scientifically.

[00:55:24] Speaker 05:
That kind of grouping was not supported.

[00:55:26] Speaker 05:
Their objections don't take any issue with the explanation as to the 28 phthalates.

[00:55:31] Speaker 05:
The state of play is different now, but the agency also looked at the remaining five phthalates that were within the scope of their original petition and explained why that grouping analysis also wouldn't work.

[00:55:41] Speaker 05:
And so the kind of class based analysis that they have been seeking throughout is not the kind of thing that the agency can do.

[00:55:47] Speaker 05:
in this case.

[00:55:48] Speaker 05:
The agency also looked at the two kinds of specific evidence, the toxicological data with respect to acceptable daily intake and the exposure data and explained why on both of those basis the original petition was scientifically deficient.

[00:56:02] Speaker 05:
With respect to the acceptable dose intake, one very clean way to understand why what they were trying to propose was not adequate is that the agency identified that there are studies of

[00:56:14] Speaker 05:
the phthalate at issue, DEHP, conducted in non-human primates, which are a better proxy for the kind of risk that you would expect to see in humans, that those non-human primate studies would have supported a much higher ADI level than the one that they were proposing in the petition.

[00:56:31] Speaker 05:
But petitioners simply did not account for that at all.

[00:56:34] Speaker 05:
And when you do not have a full set of reports on safety in a petition, that can unfairly bias the outcome in favor of a particular result.

[00:56:43] Speaker 05:
And that's the kind of thing that FDA can't permit in this process.

[00:56:49] Speaker 05:
And I think stepping back, it's helpful to just think about the fact that FDA is doing these analyses using a particular kind of approach to this evidence, using these internationally accepted guidelines, and asking these questions a specific way that ensures that the science is good and will support these safety determinations.

[00:57:08] Speaker 05:
It couldn't make that determination with respect to the ADI and their petition.

[00:57:12] Speaker 05:
With respect to the exposure analysis, there were similar issues.

[00:57:15] Speaker 05:
The petition essentially picked exposure numbers from a couple different studies and used the ones that were greater than the ADI without actually explaining why those underlying studies were a representative sample of the American diet and were the kind of studies that could be used to conduct this analysis

[00:57:36] Speaker 05:
One of the studies was from the UK and was outdated.

[00:57:39] Speaker 05:
The agency explained that.

[00:57:41] Speaker 05:
That kind of study might involve different supply chains.

[00:57:44] Speaker 05:
There might be different exposure levels.

[00:57:46] Speaker 05:
And it's not to say that that study can't be used, but they didn't do the work to explain why it was in fact appropriate to use here.

[00:57:53] Speaker 03:
You've seen in the briefing and then you heard this morning also the notion that the way the agency went about its analysis can't be reconciled with the way it went about the analysis in the prior proceeding involving, I guess it's called PFAS.

[00:58:08] Speaker 03:
the way we pronounce.

[00:58:12] Speaker 05:
Each of these proceedings is going to depend a lot on the kind of substances at issue and the studies that are available and the kind of inferences and qualitative assessments that can be drawn in a particular

[00:58:24] Speaker 05:
The PFAS proceeding involved only three chemicals.

[00:58:28] Speaker 05:
We were dealing with a lot more chemicals in this case.

[00:58:31] Speaker 05:
And in the PFAS proceeding, there wasn't quantitative data available as to exposure and the migration of these chemicals, but the agency determined

[00:58:40] Speaker 05:
that it was able to make a qualitative assessment based on bio persistence.

[00:58:44] Speaker 05:
And it was very specific to the record in that case, determined what evidence would actually be required to undermine a reasonable certainty and what evidence they didn't need because they could reach that same conclusion on another basis.

[00:58:57] Speaker 05:
That's not something that the agency can do here.

[00:58:59] Speaker 05:
In the FAP, petitioners specifically try to do the normal general analysis that FDA uses in these circumstances, which is comparing an ADI to an EDI.

[00:59:11] Speaker 05:
And FDA reasonably explained why their comparison simply didn't work.

[00:59:16] Speaker 05:
The values they were proposing didn't hold together, were not adequately scientifically supported.

[00:59:21] Speaker 05:
Now, in their objections, petitioners

[00:59:25] Speaker 05:
and essentially instead of trying to support the values they had previously proposed or explain why they thought the agency's analysis of those values was wrong, they just abandoned them entirely.

[00:59:36] Speaker 05:
They didn't address the non-human primate studies that FDA flagged as a problem with their ADI.

[00:59:43] Speaker 05:
They didn't address

[00:59:45] Speaker 05:
the UK diet study, they didn't address an Australian and Canadian study that FDA had flagged as potentially more valuable to them and potentially could produce exposure values that they could rely on.

[00:59:57] Speaker 05:
They didn't do that at all.

[00:59:58] Speaker 05:
Instead, they just tried to flood the zone with a bunch of new studies and pointing out various things that they see the agency didn't adequately consider.

[01:00:06] Speaker 05:
But they didn't rebut the specific areas that the agency originally identified.

[01:00:10] Speaker 05:
And by switching tack and sort of approaching it at this higher level of generality, it just underscores that their understanding of their burden in this case is not the way that it has been understood and applied by the agency.

[01:00:23] Speaker 05:
It's not enough to have

[01:00:25] Speaker 05:
a bunch of safety studies that could raise questions about that might be relevant to safety.

[01:00:30] Speaker 05:
The evidence you put in has to itself justify the finding that there's no reasonable certainty of safety.

[01:00:37] Speaker 05:
And FDA explained why they hadn't done that and that there were numerous issues.

[01:00:42] Speaker 03:
completely quibble, but I'm going to for a second.

[01:00:44] Speaker 03:
So you use the formulation justify a finding and you use that a couple of times, which I totally understand that's what the standard says is articulated to support a finding.

[01:00:53] Speaker 03:
Then one can imagine that there's an inquiry under which, and as I understand, I don't think anybody disagrees on this.

[01:00:57] Speaker 03:
It's not that the statute or the regulations actually set out what the standard is supposed to be.

[01:01:01] Speaker 03:
It's just in the decisions.

[01:01:03] Speaker 03:
So it's just the agency could shift it over time.

[01:01:06] Speaker 03:
They could

[01:01:08] Speaker 03:
treat the words as meaning one end of the spectrum of what that word could bear, or they could treat it as coming down on the other end of the spectrum of what that word could bear.

[01:01:15] Speaker 03:
But the word that's used is support.

[01:01:17] Speaker 03:
And so one possible conception of support is it's kind of like, you know, you just have to introduce admissible evidence that raises some question.

[01:01:27] Speaker 03:
And the way you're talking about it is support as in

[01:01:30] Speaker 03:
would not quite compel, but would justify.

[01:01:35] Speaker 03:
And I'm just wondering, it seems to me that that's different from just could conceivably support in one set of scenario by some individual.

[01:01:44] Speaker 05:
Yes, Your Honor.

[01:01:44] Speaker 05:
So I want to take the text on its face, but I also want to have an opportunity to speak to why the agency's understanding makes sense given the overall statute in the process here.

[01:01:53] Speaker 05:
The text of the standard is not just support a finding.

[01:01:57] Speaker 05:
It's significant enough to support a finding, which indicates that it's not enough that it tends to support or is consistent with the conclusion, that it is significant enough that it can support that finding, which in this circumstance means justify the finding, that the finding can be made on the basis of this evidence.

[01:02:16] Speaker 05:
And that understanding of the standard is consistent with how the overall statute and this process works.

[01:02:22] Speaker 05:
So food additives are deemed unsafe.

[01:02:27] Speaker 05:
before they're authorized.

[01:02:28] Speaker 05:
And that's 348A.

[01:02:29] Speaker 05:
They're deemed to be unsafe unless the agency then issues a regulation authorizing safe use.

[01:02:38] Speaker 05:
So at that point in time, the status quo has flipped.

[01:02:42] Speaker 05:
They go from being deemed unsafe to having a safety determination after a proponent meets the heavy burden of demonstrating that it will be safe, that there's no reasonable certainty of harm.

[01:02:53] Speaker 05:
of no harm.

[01:02:55] Speaker 05:
And so after that happens, the status quo shifts.

[01:02:58] Speaker 05:
The default presumption is not that these are unsafe anymore.

[01:03:02] Speaker 05:
They are authorized.

[01:03:03] Speaker 05:
And in order to disturb that status quo, petitioners have the burden of any petitioner walking into an agency and demanding agency action.

[01:03:14] Speaker 05:
The burden of persuasion is on them to require the agency to repeal what it has already authorized.

[01:03:21] Speaker 05:
And so consistent with that general allocation of burdens and the fact that the statute says they're unsafe until the agency acts, the burden is on them to put enough evidence in the record that the agency can then conclude on the basis of that evidence, there's no longer a reasonable certainty.

[01:03:39] Speaker 05:
They have not done that so in this case.

[01:03:42] Speaker 02:
Are you invoking our AUER deference on reading of that regulation?

[01:03:50] Speaker 05:
I'm not, Your Honor.

[01:03:51] Speaker 05:
Just to be clear, the language that we're discussing doesn't even come from a regulation.

[01:03:55] Speaker 05:
It comes from the agency's decisions.

[01:03:57] Speaker 05:
And no one disagrees with the wording of the standard.

[01:04:03] Speaker 02:
The word support?

[01:04:08] Speaker 05:
Yes.

[01:04:08] Speaker 05:
That doesn't come from a regulation.

[01:04:10] Speaker 05:
That just comes from the agency's decisions.

[01:04:11] Speaker 05:
If you look at JA 1676, it has the standard on that page of the record.

[01:04:16] Speaker 02:
I would think if you're

[01:04:19] Speaker 02:
If you're just framing a legal question about what it means to support a finding, to me that sounds more like there is legally sufficient evidence such that if the agency ruled in favor of your opponents, we would not set aside that determination as unsupported by substantial evidence.

[01:04:49] Speaker 02:
rather than support in the sense of meets a burden of persuasion or compels a finding the other way.

[01:05:01] Speaker 05:
Yes, I'm not, I don't know that I, I don't necessarily disagree with your honor.

[01:05:06] Speaker 02:
I'm not sure that I've quite thought this question through, but I think that the way that the ages- Maybe it doesn't matter if it's just words and phrases from your decisions, but-

[01:05:18] Speaker 05:
It is.

[01:05:19] Speaker 05:
But the way that the agency has understood that is consistent with the way that the statutory process works and normal burdens in these proceedings.

[01:05:26] Speaker 05:
And it also helps to think practically what it would mean if the burden were not that way, if it were not required that you actually have to have enough evidence that would justify this finding of no reasonable harm.

[01:05:41] Speaker 05:
And it would essentially

[01:05:43] Speaker 05:
required the agency to continually redo its safety assessments any time someone came and put into the record new studies about the safety of an established substance.

[01:05:55] Speaker 05:
And that would be an immense amount of work for the agency.

[01:05:58] Speaker 05:
And it would remove the stability of these authorizations that Congress intended them to have.

[01:06:03] Speaker 05:
Congress recognized that there are competing interests in this space.

[01:06:07] Speaker 05:
It's important to make sure that these

[01:06:09] Speaker 05:
substances are are authorized and that the agency conclude that they will be safe.

[01:06:15] Speaker 05:
But it needs to be able to do that and have some stability for those determinations because they're necessary for manufacturers and producers of food to be able to rely on those to help increase the shelf life of food and the robustness of the food supply in general.

[01:06:30] Speaker 00:
And so.

[01:06:31] Speaker 00:
Kitcheners come back and say Congress intended FDA to protect the public.

[01:06:38] Speaker 00:
from contaminated food and drugs, et cetera.

[01:06:42] Speaker 00:
So another way to look at this statute is it's sort of like a summary judgment notion that a petitioner has to come in and raise substantial questions.

[01:06:59] Speaker 00:
And then the agency has to hold a hearing and call in everybody who's relevant, the manufacturer, et cetera,

[01:07:08] Speaker 00:
and decide what to do.

[01:07:11] Speaker 00:
So what I hear partly from petitioners is the statutory language isn't that clear.

[01:07:25] Speaker 00:
It's not quite the same as the statute that was before the Ninth Circuit in the EPA case.

[01:07:35] Speaker 00:
The Alestra proceeding

[01:07:38] Speaker 00:
was different because it was an additional proceeding.

[01:07:42] Speaker 00:
But if I am a petitioner coming to FDA, I need to know what the rules are.

[01:07:51] Speaker 00:
And basically what I heard in the colloquy with Judge Katzis, although he raised an hour question and you're not raising that or relying on that, but it sort of take your chances because

[01:08:07] Speaker 00:
In 2016, the agency was more aggressive on enforcement.

[01:08:16] Speaker 00:
Now, in this case, it's not.

[01:08:22] Speaker 00:
And given the serious stakes that are involved, I mean, here, in this case, the amazing thing to me is the petition comes in on 28 additives, and the manufacturer basically

[01:08:37] Speaker 00:
stops doing 23.

[01:08:39] Speaker 00:
All right?

[01:08:41] Speaker 00:
So then you've got these five.

[01:08:44] Speaker 00:
And I think FDA agrees that the petitioners presented a lot of evidence, but it didn't stack up to the standard that FDA required, namely that FDA didn't have to do any more work

[01:09:07] Speaker 00:
It could just accept what the petitioners had presented and say, we repeal the rule.

[01:09:18] Speaker 00:
And you make a lot of arguments about statutory construction, et cetera, industry reliance, floodgates, lack of budget for EPA to start all over again.

[01:09:34] Speaker 00:
And I don't take those lightly.

[01:09:37] Speaker 00:
But it does present a difficult situation for a petitioner who, having been clear as to precisely what the agency wanted, might have been able to come up with it.

[01:09:56] Speaker 00:
And at least took some guidance from earlier decisions by FDA

[01:10:04] Speaker 00:
where some of the language is not as precise as maybe would help your argument more.

[01:10:13] Speaker 00:
So I don't see any case that has adopted this interpretation so far.

[01:10:25] Speaker 00:
And at best, we've been dealing with cases either with different statutes, different factual or procedural postures.

[01:10:35] Speaker 00:
And so to some extent, this is a question of first impression.

[01:10:44] Speaker 05:
So the report hasn't specifically addressed it, Your Honor, but there's a wealth of sources from the statute down to agency practice.

[01:10:55] Speaker 05:
And the way that board members normally work in these proceedings that demonstrates that what the agency is requiring is consistent with all those sources.

[01:11:03] Speaker 05:
So just to step back for a second, food additive petitions, like the one that was filed here, have only two outcomes.

[01:11:11] Speaker 05:
Either the petition is denied.

[01:11:13] Speaker 05:
or the petition is granted.

[01:11:14] Speaker 05:
And when you're dealing with a repeal petition, that means the agency can either say, we are compelled to repeal this authorization based on your petition, or you have not met your burden of demonstrating that repeal is required.

[01:11:30] Speaker 00:
And based on the- Because I understood it.

[01:11:32] Speaker 00:
It didn't bar the agency, and maybe I misunderstood, that the agency can deny, but

[01:11:41] Speaker 00:
before making that decision, it can hold a hearing to get more evidence, to clarify the evidence it has.

[01:11:49] Speaker 00:
It doesn't have to deal only with what the petitioner has submitted, or am I wrong?

[01:11:57] Speaker 00:
In other words, you either submit the 10 documents that the FDA says are required,

[01:12:04] Speaker 00:
or we don't move.

[01:12:06] Speaker 05:
So you're correct that hearings are permissible, Judge Rogers, but they do not serve the purpose that Your Honor is identifying.

[01:12:14] Speaker 05:
A hearing is not about additional fact finding to hear from new people and invite new evidence that's not already in the record.

[01:12:21] Speaker 00:
A hearing is to clarify what is in the record.

[01:12:26] Speaker 00:
I mean, today we're hearing that FDA said there were no animal studies.

[01:12:32] Speaker 00:
They say there are animal studies.

[01:12:34] Speaker 00:
that there were no relevant toxicity studies.

[01:12:38] Speaker 00:
They say there were toxicity studies.

[01:12:42] Speaker 00:
And I was trying to focus on this case.

[01:12:44] Speaker 00:
Well, there's a lot of expertise involved here.

[01:12:47] Speaker 00:
But that's not really the argument that's being made.

[01:12:50] Speaker 05:
So based on the agency's scientific judgment and expertise applied consistent with internationally recognized guidelines, the agency determined that based on all the evidence submitted in the record collectively and looking at evidence individually, that the science did not support that that evidence then ultimately shows no reasonable certainty of no harm.

[01:13:12] Speaker 05:
And the way that the agency uses hearings is if there is a specific

[01:13:17] Speaker 05:
It's like summary judgment, a specific genuine dispute of material fact where the agency assesses something one way and they come in with an expert and they say, actually, you're doing the science wrong.

[01:13:30] Speaker 05:
Here's how this should be done.

[01:13:32] Speaker 05:
And if there is in fact that genuine dispute by what the agency is saying being directly rebutted,

[01:13:38] Speaker 05:
then a hearing might be appropriate to resolve that very specific dispute.

[01:13:42] Speaker 05:
That's not what we have here.

[01:13:43] Speaker 05:
If you look at the basis for rejecting the food additive petition, the non-human primate studies, the concerns with the UK diet study, those are very specific objections that were not directly rebutted by any kind of expert submissions in conjunction with the objections here.

[01:14:02] Speaker 05:
And I do just want to step back and recognize that this is just one

[01:14:08] Speaker 05:
step in the process of FDA's actions in this space.

[01:14:12] Speaker 05:
It authorizes substances.

[01:14:14] Speaker 05:
Their repeal can be petitioned for.

[01:14:17] Speaker 05:
The agency can reject that petition on the basis of not satisfying its burden.

[01:14:21] Speaker 05:
But that doesn't mean that the agency just sits back and does nothing.

[01:14:24] Speaker 05:
there's a post-market review process going on right now where the agency is looking at the data that it received in response to its request for information in 2022 and it's conducting a risk and safety assessment that will incorporate that data as relevant and ultimately issue an assessment which is part of the process in determining whether the agency is going to revisit the underlying safety determinations.

[01:14:49] Speaker 03:
The agency pointed that out I think in its decision and you pointed it out in your

[01:14:52] Speaker 03:
briefing.

[01:14:53] Speaker 03:
And if I can ask a question about that related to standing for a second.

[01:14:58] Speaker 03:
So in a context in which the agency itself is saying that there's some stuff here that we need to look at.

[01:15:06] Speaker 03:
And we're doing that.

[01:15:07] Speaker 03:
Trust us, we're looking at it.

[01:15:09] Speaker 03:
It just seems to me that the necessary backdrop is, hey, there might be some problems here.

[01:15:15] Speaker 03:
We're not saying that there definitely is.

[01:15:18] Speaker 03:
We're not saying that we definitely need to change the way we're looking at things.

[01:15:20] Speaker 03:
But

[01:15:22] Speaker 03:
Trust us, we're looking at this because we understand that there may be some problems here and it's something that we need to look at seriously.

[01:15:29] Speaker 03:
If that's the case, then when a party comes in and says, the thing that you said that you're going to look at seriously because there's enough of a concern about it that you're going to look at seriously, I've got some real concerns that I've got double the exposure to it that I otherwise would.

[01:15:44] Speaker 03:
Say triple the exposure to it that I otherwise would.

[01:15:47] Speaker 03:
And then against that backdrop,

[01:15:50] Speaker 03:
to for a court to come in and say, which I think is the upshot of your standing argument that look, yes, we're looking at this.

[01:15:59] Speaker 03:
It's serious enough for us to look at.

[01:16:01] Speaker 03:
But as an absolute matter, the risk that you're talking about isn't serious enough for you to get into court.

[01:16:07] Speaker 03:
It's just not.

[01:16:08] Speaker 03:
It just strikes me that there's something a little bit.

[01:16:11] Speaker 03:
unbalanced about that.

[01:16:13] Speaker 03:
And I'm not talking about the increase because I think the increase here just seems to me to be pretty self-evident because the increase part of it, their petition says,

[01:16:23] Speaker 03:
what we want you to do is just flatly just repeal the authorization.

[01:16:29] Speaker 03:
So the inquiry seems to me it's just a difference between whether it's going to be authorized at all or whether it's just not going to be authorized.

[01:16:35] Speaker 03:
So there's a pretty significant difference between those.

[01:16:38] Speaker 03:
But on the baseline level of risk that you start with, whether that level of harm is significant enough and imminent enough as an initial matter, it just strikes me that there's something a little bit

[01:16:52] Speaker 03:
off about saying on one hand, that just isn't enough because it's out there ways.

[01:16:57] Speaker 03:
We don't, you haven't shown that it's quantifiably significant enough.

[01:17:01] Speaker 03:
And then on the other hand saying, yeah, we get it.

[01:17:04] Speaker 03:
We're looking into this because there's some real concerns here.

[01:17:07] Speaker 03:
I'm not sure what, what more we should require, especially when you fold in.

[01:17:12] Speaker 03:
And I'm sorry to go on and on, but especially when you fold in also that we're supposed to assume the merits in favor of the petition.

[01:17:17] Speaker 05:
Yes, and I think you're right to note that there does seem to be substantial overlap here between the merits because we are focused on the safety showing versus standing.

[01:17:29] Speaker 05:
And so I think for the reasons that we would say that they have not satisfied their burden on the merits, they also underscore why they haven't demonstrated standing here.

[01:17:38] Speaker 05:
But I think looking at their overall burden in the standing context and the specific background facts of what's going on with these phthalates,

[01:17:46] Speaker 05:
It just demonstrates that under this court's precedence for an increased risk of harm theory, they haven't shown enough.

[01:17:51] Speaker 05:
And I just want to quickly clarify, Your Honor was talking about increased exposure and how revoking authorizations will decrease exposure.

[01:17:58] Speaker 05:
We don't necessarily dispute that.

[01:18:02] Speaker 05:
But when you're looking at increased risk of harm standing, the concrete injury is not the exposure.

[01:18:07] Speaker 05:
It's the health harms.

[01:18:08] Speaker 05:
And so it's not enough to say their exposure goes down.

[01:18:11] Speaker 05:
They have to actually show that they're

[01:18:12] Speaker 05:
substantial risk of health harms goes down, and that if the agency revokes these authorizations, they will no longer have a substantial probability of suffering those health harms.

[01:18:22] Speaker 05:
And it's just too difficult to do that in this context, because we're talking about only five phthalates.

[01:18:29] Speaker 05:
It's not all the phthalates that are authorized.

[01:18:31] Speaker 03:
But I mean, if there's risk of harm to begin with, then there's definitely less risk of harm under their solution than yours.

[01:18:39] Speaker 03:
That's just a mathematical identity.

[01:18:43] Speaker 05:
Yes, Your Honor, but they still have to show, and looking at their brief and hearing their presentation, I actually haven't heard them to discuss at all that they have to have a substantial probability of harm.

[01:18:54] Speaker 03:
Right, so that's the baseline.

[01:18:56] Speaker 03:
That's the question, not the delta, but it's the baseline that there's got to be some baseline risk of harm.

[01:19:01] Speaker 03:
And I guess my question about that is, it just seems, it just, there's something that doesn't quite work about saying the agency thinks that there may be enough harm here that we need to look at this seriously.

[01:19:12] Speaker 03:
But what you're showing is just not enough harm.

[01:19:16] Speaker 03:
It doesn't matter.

[01:19:18] Speaker 03:
We don't have enough concrete stuff to say you've got enough harm.

[01:19:21] Speaker 03:
You've shown enough risk of a harm in the record to allow you to go forward.

[01:19:25] Speaker 05:
Well, I think it's in the context of what their petition doesn't ultimately show with respect to harm on the merits.

[01:19:31] Speaker 05:
And we're not saying that they have to prove harm.

[01:19:33] Speaker 05:
They have to prove no reasonable certainty of no harm.

[01:19:35] Speaker 05:
And because they haven't done that, it underscores the biggest disinheritance.

[01:19:38] Speaker 03:
But don't we have to assume on the merits that they would do that for standing purposes?

[01:19:41] Speaker 05:
You have to assume that they'll prevail.

[01:19:43] Speaker 05:
But as we understand their theory, it's that they don't that submitting some studies raising safety questions is enough.

[01:19:50] Speaker 05:
We understand their burden of what that actually has to show to be different than they do.

[01:19:55] Speaker 05:
But I just want to underscore also, Your Honor, that in this context, it's very different than, say, exposure to one source of hazardous waste.

[01:20:04] Speaker 05:
where there's one source of harm, understandable health effects, and you're not getting exposed to that through other means.

[01:20:11] Speaker 05:
Here we have phthalates, which they're just talking about the dietary exposure to five phthalates.

[01:20:16] Speaker 05:
Even if FDA revoked this, there are still four prior sanctioned phthalates that are authorized for food contact use.

[01:20:24] Speaker 05:
So this isn't removing exposure to all phthalates.

[01:20:27] Speaker 05:
It also doesn't do anything about their non dietary exposure to phthalates, which comes from the environment and from many other sources as the various items in the record here discuss.

[01:20:38] Speaker 05:
And also their declarations explain that they're not just worried about phthalates, they're worried about various similar chemicals that also have

[01:20:46] Speaker 05:
the same alleged effects.

[01:20:48] Speaker 05:
And so against that backdrop of this isn't removing their exposure to these phthalates.

[01:20:53] Speaker 05:
It's not addressing their exposure to other phthalates through food.

[01:20:56] Speaker 05:
It's not addressing their exposure to other chemicals.

[01:20:58] Speaker 05:
They can't show that it's these specific authorizations that are what's doing the work with respect to their health harms and that

[01:21:05] Speaker 05:
there is a substantial probability because these specific five are only authorized in food.

[01:21:10] Speaker 05:
There will no longer be that probability if these five are revoked.

[01:21:14] Speaker 05:
It's a very difficult showing just because of the context that they have here.

[01:21:18] Speaker 05:
But regardless, the reasons that we think that their standing arguments are particularly weak are also the reasons that they have not succeeded in meeting their burden on the merits with respect to a showing of

[01:21:30] Speaker 05:
no reasonable certainty of no harm.

[01:21:32] Speaker 05:
And also that they're operating at this level of generality with putting things in the record and trying to point out individual issues with addressing specific studies that sort of ignores the overall context of the agency's safety determination.

[01:21:47] Speaker 05:
It's about comparing

[01:21:49] Speaker 05:
acceptable intake to exposure.

[01:21:51] Speaker 05:
It's about actually putting that toxicological data in the context of exposure.

[01:21:58] Speaker 05:
Any substance is potentially toxic at high enough levels.

[01:22:02] Speaker 05:
If you drink enough water, you could die.

[01:22:05] Speaker 05:
That's not enough to show that something is harmful.

[01:22:08] Speaker 05:
You actually have to do that work of showing that the exposure is what's going to make it potentially harmful.

[01:22:14] Speaker 05:
And they have not done that in their petition and their objections

[01:22:18] Speaker 05:
don't remedy the errors that the agency identified.

[01:22:23] Speaker 02:
Could I follow up just on standing?

[01:22:28] Speaker 02:
Maybe these questions are driven by similar concern as the chiefs.

[01:22:35] Speaker 02:
So our cases do seem to say that the absolute level of risk has to be substantial.

[01:22:46] Speaker 02:
How do we

[01:22:47] Speaker 02:
Think about that or quantify that in the context of these latent exposure cases.

[01:22:58] Speaker 02:
I mean, right, if I think that I have a one in a hundred percent chance of getting some sort of fatal disease from some particular exposure,

[01:23:14] Speaker 02:
I'd probably think of that as substantial, even though in most legal contexts, like 1% is not going to be substantial.

[01:23:28] Speaker 02:
Is that how we should think of extantiality under public citizen?

[01:23:37] Speaker 05:
I'm not sure that I can speak to a specific levels like that, Your Honor.

[01:23:45] Speaker 05:
I think it is the kind of thing that does depend on context.

[01:23:49] Speaker 05:
And we just fall back on the fact that in the specific context here and the confounding variables and the

[01:23:56] Speaker 05:
deficiencies in their merits presentation.

[01:24:00] Speaker 05:
That's the basis that we would say that there's no standing here.

[01:24:03] Speaker 05:
If there was a slam dunk petition that did all of the work and demonstrated that there is no reasonable certainty of harm, then our standing arguments would either be non-existent or would look very different.

[01:24:16] Speaker 05:
But here, we just don't have the basis to conclude that they've shown enough.

[01:24:21] Speaker 05:
under what this court has described as the very strict showings of substantiality for this kind of increase of harm case?

[01:24:29] Speaker 00:
Well, in our NRDC decision authored by Judge Randolph, we answered that question.

[01:24:40] Speaker 00:
So there may be ways to distinguish that case.

[01:24:46] Speaker 00:
I don't know.

[01:24:47] Speaker 00:
But I mean, we did answer it.

[01:24:49] Speaker 00:
where there was a very low probability, but that was enough.

[01:24:56] Speaker 00:
And what I'm concerned about in your arguments now about standing is, and I don't think FDA did this here, but FDA can't move a petition by taking the action that the petitioner has requested.

[01:25:19] Speaker 00:
All right?

[01:25:21] Speaker 00:
So I didn't understand FDA to be taking that position.

[01:25:25] Speaker 00:
It acknowledges that if there were studies that it found adequate to show that these five drugs, substantial probability that they are no longer safe, et cetera.

[01:25:47] Speaker 00:
And it addressed the merits.

[01:25:49] Speaker 00:
of the argument.

[01:25:52] Speaker 00:
Its position was not that, well, it has these additives on the list and it's going to issue a notice of request, moves out the case.

[01:26:07] Speaker 00:
FDA could have done this at any point.

[01:26:09] Speaker 00:
That's not how it treated it.

[01:26:12] Speaker 00:
And I'm concerned that if this court were to say,

[01:26:18] Speaker 00:
that this case is moved because the agency has issued a notice or a request for information.

[01:26:30] Speaker 00:
There's no case or controversy before us.

[01:26:35] Speaker 00:
Petitioners' position, as I understand it, is they've met their burden of persuasion under the statutory language and EPA

[01:26:48] Speaker 00:
they say has violated the APA, both as a matter of law and because it's been arbitrary and capricious in terms of how it addressed other cases.

[01:27:00] Speaker 00:
And the agency responded to those arguments.

[01:27:04] Speaker 00:
So if we want to cut this off at the beginning by saying there is no standing, it seems to me we have to massage, that's a gentle word, some of our precedents

[01:27:18] Speaker 00:
about what is sufficient to show standing in these increased risk cases.

[01:27:25] Speaker 00:
And maybe the court is going to step back.

[01:27:28] Speaker 00:
But I didn't understand that to be the argument that was presented to us here.

[01:27:36] Speaker 05:
Yeah, so just to clarify, Your Honor, we're not trying to argue mootness at all based on the agency's other actions.

[01:27:44] Speaker 05:
What the agency is engaging in this post market review, which is going to produce a risk and safety assessment, unclear what could ultimately come of that with respect to whether the agency undertakes future regulatory action.

[01:28:00] Speaker 05:
That's sort of a separate question.

[01:28:01] Speaker 05:
It doesn't mean that that's not the basis for saying there's no jurisdiction here.

[01:28:05] Speaker 05:
That's just the basis for underscoring that.

[01:28:08] Speaker 05:
Overall, the way that this process is supposed to work is that the agency puts these authorizations into place and does not get rid of them unless the evidence supports that decision and the agency is doing the work to assess whether there's new evidence that was not in the record with respect to this petition that would require it to revisit its safety determination.

[01:28:31] Speaker 05:
With respect to standing, we think that

[01:28:33] Speaker 05:
our standing arguments here fall squarely within how the court explains standing in the public citizen cases and in the food and water watch case.

[01:28:42] Speaker 05:
Specifically, your honor, if the court looks at the second public citizen case where the court assessed the declarations that were put into the record in attempt to meet their burden with respect to increased risk standing, it shows the kind of heightened showing that's necessary that is not met here.

[01:29:01] Speaker 05:
I believe it was.

[01:29:02] Speaker 00:
Did it overrule the NRDC case?

[01:29:07] Speaker 05:
No, but it drew its standard specifically said that it was drawing its standard and how it applied it from both NRDC and mountain states.

[01:29:15] Speaker 05:
And so it was based on past precedent of this court was trying to synthesize what it meant to satisfy an increased risk of harm standing analysis.

[01:29:24] Speaker 00:
But remember, public citizen set up a two pronged

[01:29:31] Speaker 00:
requirement.

[01:29:33] Speaker 00:
And Susan B. Anthony, by the Supreme Court, said you didn't have to show both.

[01:29:40] Speaker 00:
All right?

[01:29:40] Speaker 00:
So that's where we are now.

[01:29:42] Speaker 05:
So the Susan B. Anthony case was about pre-enforcement standing.

[01:29:46] Speaker 05:
And the Food and Water Watch case, which post-dated Susan B. Anthony and cited Susan B. Anthony, continued to reiterate the standard that we're discussing here.

[01:29:54] Speaker 05:
And so I think this court.

[01:29:55] Speaker 00:
I agree.

[01:29:55] Speaker 00:
But it's not the two-pronged standard

[01:29:58] Speaker 00:
of public citizen.

[01:30:00] Speaker 00:
That's all I'm getting at.

[01:30:01] Speaker 00:
Public citizen said you had to do one and you had to do two and then send it back to get some more information.

[01:30:07] Speaker 00:
And then the second case came.

[01:30:09] Speaker 05:
I disagree, Your Honor.

[01:30:11] Speaker 05:
I think Food and Water Watch actually does just recite the exact same standard from public citizen having the two prongs.

[01:30:16] Speaker 05:
It didn't need to address both of them because it determined that there wasn't a sufficiently substantial increase risk.

[01:30:22] Speaker 05:
but it did recite the exact same standard as well.

[01:30:25] Speaker 00:
What did they do about Susan B. Anthony?

[01:30:28] Speaker 05:
I believe that case is really focused on pre-enforcement standing and not about an increased risk of harm of something happening.

[01:30:36] Speaker 05:
It was about whether potential future enforcement could be determined to be imminent in concrete injury for the purposes of suing in advance of something being applied.

[01:30:46] Speaker 00:
So let me be clear what your response to

[01:30:50] Speaker 00:
My colleague's question about standing was, what is your position?

[01:30:54] Speaker 00:
What is FDA's position on whether the petitioners have Article 3 standing?

[01:31:02] Speaker 05:
So in this case, we think that based on how hard it is to show increased risk of harm standing in the context of under-regulation of a third party under this court's precedence, that they simply, based on the weaknesses and the substance of their petition, they simply haven't done enough to do that here.

[01:31:20] Speaker 05:
But as Judge Srivastava noted earlier, there does seem to be a lot of substantial overlap in these questions with the merits.

[01:31:26] Speaker 05:
And so if the court disagrees or thinks those are entirely intertwined, it can simply just proceed to the merits in this case.

[01:31:32] Speaker 00:
No, I don't think that's correct after steel company.

[01:31:36] Speaker 00:
I mean, often the court has to look to the merits to determine whether or not there is Article III standing and does.

[01:31:46] Speaker 00:
All right.

[01:31:48] Speaker 00:
But that doesn't mean we can just say, well, you know, you lose on the merits.

[01:31:55] Speaker 00:
So we don't have to do anything.

[01:31:57] Speaker 00:
So I'm concerned about this issue.

[01:32:00] Speaker 00:
Because I think this increased harm area is a very difficult area in terms of what does a petitioner have to show.

[01:32:10] Speaker 00:
And I understand FDA's argument about how it interprets the statute and why.

[01:32:20] Speaker 00:
But ultimately, after Loper, right, that's a decision for us.

[01:32:24] Speaker 00:
But in any event, I guess, so your point is,

[01:32:30] Speaker 00:
that because petitioners showing, factual showing, in support of its merits argument, seeking repeal was so weak.

[01:32:49] Speaker 00:
Therefore, it doesn't have Article III standing because it can't meet these

[01:32:58] Speaker 00:
significant showing of substantial likelihood, et cetera.

[01:33:01] Speaker 05:
In the context of this case, we do think that there is those issues substantially overlap, Your Honor.

[01:33:08] Speaker 00:
And so if the court doesn't have to assume... We've seen a number of cases in the commercial area where a factory doesn't have to close, a factory doesn't have to go bankrupt, but it can still have standing to come in and challenge an agency regulation that it says

[01:33:28] Speaker 00:
is harming it.

[01:33:30] Speaker 00:
And it may be wrong.

[01:33:32] Speaker 00:
But that's a merits issue.

[01:33:36] Speaker 00:
And we haven't treated those as an Article III threshold issue.

[01:33:44] Speaker 00:
And that's what I'm trying to understand here.

[01:33:47] Speaker 00:
I mean, all these people say they eat chicken.

[01:33:50] Speaker 00:
They're very concerned about this.

[01:33:52] Speaker 00:
They joined organizations or they put up a lot of money for these organizations to pursue

[01:33:58] Speaker 00:
their interests, and they want FDA to do its job as they conceive it.

[01:34:05] Speaker 00:
And FDA isn't saying it's not going to do its job.

[01:34:09] Speaker 00:
It's just saying what you have presented to us is not enough under the statutory standard.

[01:34:18] Speaker 05:
We think that it underscores why they lack standing, but it also, because it is so in line with the merits in this case, it just demonstrates that they had this burden.

[01:34:29] Speaker 05:
The agency determined in the basis of its expert scientific judgment that they had not put in the kind of evidence that would have satisfied their burden in this case.

[01:34:40] Speaker 05:
And so the correct result is to deny the petition on that basis, and then the agency will proceed with its post-market review that it's already conducting in this space to look at new evidence and determine whether the safety determination ultimately has to be revisited.

[01:34:55] Speaker 03:
Let me make sure my colleagues don't have any additional questions at this point.

[01:35:01] Speaker 03:
If there are no further ones, we'll hear from Petitioner's Council.

[01:35:05] Speaker 05:
Thank you, Your Honor.

[01:35:06] Speaker 03:
Thank you, Ms.

[01:35:07] Speaker 03:
Newmaster.

[01:35:10] Speaker 03:
Miss O'Brien will give you the three minutes you asked for.

[01:35:12] Speaker 06:
Thank you, Your Honor.

[01:35:13] Speaker 06:
I'll endeavor to make three points quickly.

[01:35:16] Speaker 06:
With respect to standing in response to Judge Katz's question, the court affirmed in Food and Water Watch that this court does not require a quantitative analysis demonstrating a specific probability of future health harm to establish standing.

[01:35:31] Speaker 06:
Furthermore, in the Mountain States Legal Foundation case discussed in our brief, the court affirms that relatively modest increments in risk are sufficient to support these types of standing theories where the risk of injury is serious.

[01:35:45] Speaker 06:
Here we are talking about permanent harm to children's brain development, the inability to have children and other severe health risks for which a modest incremental risk is sufficient to support standing.

[01:35:59] Speaker 06:
The court also held that the existence of other factors contributing to the risk does not defeat standing.

[01:36:06] Speaker 06:
So government counsel's argument about the unfortunate presence of other chemicals that also contribute to these health risks does not undermine standing.

[01:36:16] Speaker 06:
Second, I want to note that the government is grasping for support for what are really ad hoc criteria that it applied to the petition in this case.

[01:36:26] Speaker 06:
that do not have any foundation in the statute or the regulations.

[01:36:31] Speaker 06:
The discussion about having to compare an ADI to an EDI or comply with international standards, those are not in any statutory provision, regulatory provision, or even a guidance document that the government can point to.

[01:36:44] Speaker 06:
The government does not even require those specific demonstrations for approval.

[01:36:49] Speaker 06:
petitions for food additives and we know from the record here that the agency itself had nothing like the evidence it's demanding from petitioners to support its own safety findings for these chemicals and it is fundamentally arbitrary for the agency to say we haven't done enough

[01:37:08] Speaker 06:
to disturb safety findings that are based on radically outdated toxicity evidence and no exposure evidence.

[01:37:17] Speaker 06:
That is arbitrary.

[01:37:19] Speaker 06:
Finally, the promise of a future safety review on FDA's chosen timetable is

[01:37:25] Speaker 06:
inconsistent with the scheme that Congress established here, which permits petitioners to trigger a requirement for FDA to update its assessments through the petition process.

[01:37:37] Speaker 06:
And it's also cold comfort given that FDA has been promising the public, Congress, and now this court for 18 years that it will update the safety reviews for these chemicals while we all continue to consume them in our food.

[01:37:53] Speaker 06:
FDA is now seeking this court's blessing to just keep kicking that can down the road for as long as the agency sees fit.

[01:38:01] Speaker 06:
And we respectfully urge the court not to give the agency that cover and instead to revoke, excuse me, to vacate the unlawful order that's before the court here.

[01:38:11] Speaker 06:
Thank you.

[01:38:12] Speaker 03:
Thank you, counsel.

[01:38:12] Speaker 03:
Thank you to both counsel.

[01:38:14] Speaker 03:
We'll take this case under submission.